cyrilzakka/clinical-trials huggingface dataset:
Biobank Cardiac Surgery

Treatment strategies for cardiac surgery patients have been evolving significantly for the last decade. While clinical outcomes have been improving, there are still significant areas unexplored in these patients. Cardiac surgery, or cardiovascular surgery, is surgery on the heart or great vessels performed by cardiac surgeons. It is often used to treat complications of ischemic heart disease (for example, with coronary artery bypass grafting); to correct congenital heart disease; or to treat valvular heart disease from various causes, including endocarditis, rheumatic heart disease, and atherosclerosis.

Biobanking is a fundamental process required in the better understanding of human diseases together with their underlying mechanisms. Biobanking refers to the process by which samples of bodily fluid or tissue are collected for research use to improve the understanding of health and disease. For this study, the investigator's objective is to acquire elucidation in disease etiology, translation, and advancing public health by evaluating blood and tissue results of those with cardiac disease undergoing cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* All patients who undergo cardiac surgery at Advocate Children's Hospital (ACH)\& University of Chicago Medical Center (UCMC) by the ACH \& UC Cardiothoracic Surgery Research team who are pediatric neonates and up.
* Patients will only be English speaking.

Exclusion Criteria:

* Vulnerable Subjects/Subject Capacity to provide consent
Biologics for Stricturing Crohn's Diseases

Recent researches have reported that biologics might be also effective for stricturing CD. However, the data were largely retrospective. Prospective studied are needed for evaluate the efficacy of biologics for stricturing Crohn's diseases.


Eligibility Criteria:
Inclusion Criteria:

* patients with stricturing Crohn's diseases
* no surgical indication
* patients with asymptomatic penetrating diseases
* written consent acquired

Exclusion Criteria:

* patients with surgical indication
* patients with symptomatic penetrating diseases
* contraindication of biologics
* anticipating other trial
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine 2830930A Administered in Toddlers

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the GSK Biologicals' pneumococcal vaccine 2830930A in toddlers aged 12 to 23 months at study entry.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol.
* A male or female between, and including 12 to 23 months of age at the time of vaccination.
* Written informed consent obtained from the parents/LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after a gestation period of at least 36 weeks.
* Previously completed three-dose vaccination course with Synflorix.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/administration of a vaccine containing diphtheria- or tetanus- toxoid or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before the vaccine dose and ending 30 days after, with the exception of licensed influenza vaccines.

  * The licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines but should be documented in the "Concomitant vaccination" of the electronic Case Report Form.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness, including Kawasaki's syndrome.
* History of any neurological disorders or seizures, including conditions such as hypotensive-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and febrile).
* Acute disease and/or fever at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during study period.
* Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.
* Previous receipt of a booster dose (fourth dose) of Synflorix.
* Anaphylaxis following previous administration of vaccines.
Mirtazapine in Alzheimer-associated Weight Loss

Weight loss is a frequent problem associated with Alzheimers disease (AD). Mirtazapine has weight loss as a frequent side effect.

The aim of this retrospective study is to check whether mirtazapine 30 mg (once daily) can counteract weight loss in patients with AD or mixed dementia (AD + vascular).


Eligibility Criteria:
Inclusion Criteria:

* AD or mixed dementia
* documented weight loss
* mirtazapine 30 mg explicitly prescribed against weight loss

Exclusion Criteria:

* no treatment compliance
* other causes of weight loss
* other interventions against weight loss
Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for cancer of the bile duct, gallbladder, or pancreas.

PURPOSE: Phase II trial to determine the effectiveness of photodynamic therapy in treating patients who have cancer of the bile duct, gallbladder, or pancreas.

OBJECTIVES: I. Determine the safety and efficacy of photodynamic therapy using porfimer sodium in patients with unresectable malignant bile duct obstruction.

OUTLINE: Patients are stratified according to tumor location (proximal vs distal). Patients receive porfimer sodium IV over 3-5 minutes on day 1, followed by percutaneous or endoscopic laser light treatment on day 3. Patients achieving partial response or complete response accompanied by an increase in total bilirubin or cholangitis may repeat treatment for a maximum of 3 courses. Patients are followed weekly for 1 month, and then monthly for 1 year.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven malignant bile duct obstruction with obstructive jaundice Primary carcinoma of bile duct, gallbladder, or pancreas OR Metastatic bile duct disease Successful insertion of a percutaneous drain or endoscopic stent Unresectable disease OR Resectable disease but refusal of surgery Prior biliary plastic or metallic stent allowed, if requiring stent replacement due to recurrent jaundice or routine plastic stent change No erosion of biliary tumors into major blood vessels No evidence of bile duct perforation

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin at least 2 mg/dL Renal: Not specified Other: No history of allergies or hypersensitivity to porphyrins No porphyria No cholangitis or pancreatitis

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy or brachytherapy to the abdomen Surgery: See Disease Characteristics Other: No other prior or concurrent experimental or investigational drugs
Nebulized Dexmedetomidine Versus Oral Sumatriptan in Treatment of Post Dural Puncture Headache in Cesarean Section

comparison between oral sumatriptan and Nebulized Dexmedetomidine in Post Dural Puncture Headache in Cesarean Section

A total of 48 patients will be randomly chosen to receive either inhaled dexmedetomidine (Group D, n= 24) or oral sumatriptan (Group S, n= 24) by a random sequence number generated by the computer kept in sealed envelopes. Those envelopes will be opened once the patient is recruited and participants will receive either inhaled dexmedetomidine or oral sumatriptan as per the envelope. Data collectors will be blinded to the type of used medication (Dexmedetomidine or Sumatriptan).

Eligibility Criteria:
Inclusion criteria:

1. Pregnant female aged between 18 and 40 years old.
2. ASA II and III undergoing elective caesarean section.
3. Diagnosed with Postdural puncture headache with visual analogue score (VAS) ≥ 4 and Lybecker classification score ≥ 2.

Exclusion criteria:

1. Patient refusal.
2. History of primary headaches such as migraine, cluster and tension headaches.
3. Hypersensitivity of dexmedetomidine or sumatriptan.
4. Hypertensive disorders of the pregnancy.
5. Contraindication to spinal anesthesia as coagulopathy or infection at site of injection.
6. Symptoms of ischemic heart disease (IHD) e.g. angina.
7. Cerebrovascular disease e.g. stroke or transient ischemic attacks (TIAs).
8. Using of Monoamine oxidase inhibitors (MAOIs) in the last 24h.
SAfety and EFficacy of Bridging Antithrombotic Therapy During Elective Non-cardiac Surgery

Patients with coronary artery disease, especially after PCI, require long-term oral antiplatelet therapy. However, this patient population may inevitably require non-cardiac surgery for a variety of conditions. In order to avoid the occurrence of bleeding events, oral antiplatelet agents are usually discontinued before non-cardiac surgery in patients with coronary artery disease, which may increase the incidence of ischemic events. Therefore, it is important to provide patients with the optimal perioperative antithrombotic treatment to balance the risk of bleeding and ischemia.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or over
2. Established coronary artery disease being treated with oral antiplatelet therapy
3. Non-cardiac surgery is planned and bridging antithrombotic therapy is considered necessary
4. Agree to participate in the study and provide written informed consent

Exclusion Criteria:

1. According to the consensus of Chinese experts on antiplatelet therapy in 2013, the surgical bleeding risk is low or extremely low
2. Requiring emergency non-cardiac surgery within 24 hours after admission
3. Currently being bleeding
4. Moderate or severe ischemic stroke or spontaneous intracranial hemorrhage in the past 6 months or traumatic intracranial hemorrhage in the past 1 year
5. Intracranial diseases or hemorrhagic diathesis
6. Contraindications for LMWH or GP IIb/IIIa receptor antagonists
Preoperative Carbohydrate Loading in Elective Surgery

Postoperative infectious morbidity remain the most frequent, threatening and costly event after major surgery. Maintenance of postoperative euglycemia might be a key factor to prevent such complications and given the preliminary data on the positive effect of carbohydrate load on glucose metabolism it might also be valuable in improving outcome. If this treatment will be proved effective on relevant outcome measure such as rate of infections, it might be used routinely and extensively because preoperative carbohydrates administration is cheap, simple and applicable by everyone in any surgical ward.

The aim of the trial is to evaluate if the normalization of blood glucose by means of preoperative oral administration of maltodextrine, in patients candidate to elective major surgery, may be effective in improve surgical morbidity.


Eligibility Criteria:
Inclusion Criteria:

* patients candidate for elective major (expected duration \> 2 hrs) abdominal, urologic, and gynecologic surgery

Exclusion Criteria:

* diagnosis of diabetes mellitus,
* baseline plasma glucose level \> 125 mg/dl,
* pancreatic resection,
* ASA score \> 3,
* malnutrition (loss of weight greater than 10%),
* emergency surgery,
* documented gastro-esophageal reflux,
* corticosteroid therapy,
* ongoing infection,
* pregnancy,
* age \< 18 years,
* denied written informed consent
Thera-band Resisted Treadmill Training for Chronic Stroke Patients

The purpose of this study is to determine if treadmill training combined with thera-band resistance to body support and forward propulsion would be more effective than treadmill training alone in improving over-ground walking ability and reducing energy cost in chronic stroke patients. This study will also characterize the neuromuscular and kinematic strategies to adapt to resisted treadmill walking in non-impaired adults and stroke patients.

This study includes chronic stroke patients who will be randomly assigned to treadmill training combined with thera-band or treadmill training alone group to receive 30 min per session, 2 sessions per week for 8 weeks walking training . Functional balance (Berg Balance Scale), gait characteristics during preferred and maximal speed level walking, and oxygen uptake during 5-minute bouts of treadmill walking will be assessed before and after training and at 2-month follow-up. Clinical sensorimotor function assessment, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale will also be conducted for subject characterization.

Eligibility Criteria:
Inclusion Criteria:

1. the diagnosis of first time unilateral stroke more than 6 months before
2. the ability to walk for at least 15 m without person assistance
3. apparent gait deficits upon visual inspection by a trained physical therapist or inability in community ambulation, i.e. walking speed \< 0.8 m/s
4. resting blood pressure lower than 150/90 mmHg.

Exclusion Criteria:

1. older than 75 years
2. inability to follow the experimental instructions or procedures
3. any pain, inflammation, or other conditions that could affect walking
4. medically unstable.
TWO DİFFERENT ELECTROSURGERY DEVICES AS MONOPOLAR HOOC AND PLASMAKINETIC BIPOLAR SPATULA EFFECTIVENESS DURING COLPOTOMY

WE DECIDED TO COMPARE TWO DIFFERENT ELECTROSURGERY DEVİCES TO PROVIDE COLPOTOMY. ONE OF THEM İS MONOPOLAR HOOC, THE OTHER DEVİCE İS PLASMAKİNETİC BİPOLAR SPATULA. WE WİLL RANDOMİSE PATİENTS FİRSTLY THEN COMPARE THE RESULTS SUCH, VAGİNAL DEHİSSENS, COLPOTOMY DURATİON, AMOUNT OF MIST DURING COLPOTOMY, AMOUNT OF BLEEDİNG.

COLPOTOMY IS A PROCESS DURING TOTAL LAPAROSCOPIC HYSTERECTOMY. WE CAN USE EİTHER ELECTROSURGERY INSTRUMENTS TO PROVIDE COLPOTOMY. IN OUR TRIAL WE WİLL RANDOMİSE PATİENTS FİRSTLY THEN COMPARE THE RESULTS SUCH, VAGİNAL DEHİSSENS, COLPOTOMY DURATİON, AMOUNT OF MIST DURING COLPOTOMY, AMOUNT OF BLEEDİNG.

Eligibility Criteria:
Inclusion Criteria:

* APPROPIATE FOR TOTAL LAPAROSCOPIC HYSTERECTOMY

Exclusion Criteria:

* MALIGNANCY
A Long-term Study for the Treatment of Painful Diabetic Neuropathy

The purpose of the study is to investigate safety and efficacy of duloxetine for patients with painful diabetic neuropathy at long-term use.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients who have completed the 13-week treatment in the preceding study (Protocol No. 0715N0831: NCT00552175).
* Patients who desire to receive continued treatment with LY248686 from the preceding study.
* Patients with latest glycosylated hemoglobin (HbA1c) ≤9.0% before Visit 7.
* Patients who can provide written consent in person.

Exclusion Criteria:

* Patients who concurrently have serious cardiovascular, hepatic, renal, respiratory, or blood disease, or symptomatic peripheral vascular disease, and thus are considered inappropriate to be included in the study.
* Pregnant patients or women who desire to become pregnant during the study period, and breast feeding patients.
* Other patients judged by the investigator/subinvestigator to be inappropriate as a subject in this study.
Non-Responsive Diabetic Macular Edema and Spironolactone

Diabetic patients with macular edema and choroidal hyperpermeability (as manifested as a thick choroid on OCT (optical coherence tomography) and ICG hyperfluorescence on ICG) unresponsive to anti-VEGF (vascular endothelial growth factor) and steroid injections will be treated with spironolactone in addition to the continued treatment of anti-VEGF injections, specifically aflibercept (Eylea).

This is a non-randomized, prospective study of 10 patients referred during the years 2018 to 2020 with the diagnosis of Diabetic Macular Edema. Each patient was noted to have pachychoroid, choroidal hyperpermeability, and most important resistant to multiple anti-VEGF and steroid intravitreal injections, and have moderate vision loss. In addition, despite the fact that we use anti-VEGF medications, we do not know the levels of VEGF in the eye, nor do we have an explanation for the inability to respond to these drugs. This study will determine the degree of VEGF concentrations, response to anti-VEGF treatments, and determine biomarkers of inflammation as a means for explaining the cause of treatment resistance. Subsequently, another pathological process will be treated with spironolactone to see if the degree of contribution of choroidal hyperpermeability to the exudative process.

Eligibility Criteria:
Inclusion:

1. Presence of persistent Diabetic cystoid macular edema despite course of anti-VEGF injections and intraocular steroids. At the time of study baseline, the patients must be on q4 week intravitreal anti-VEGF medications and have failed (poor response - less than 50% decrease in macular central subfield thickness (CST) and volume) with intravitreal steroids (triamcinolone acetonide or dexamethasone implant).
2. Evidence of pachychoroid (choroid greater than 300 microns on OCT - EDI) with pachyvessels on OCT or OCTA. In addition, ICG (Indocyanine Green Angiogram) must show evidence of hyperfluorescence.
3. Visual Acuity of 20/25 to 20/400 at screening and baseline visits using an autorefractor or Early Treatment Diabetic Retinopathy Study (ETDRS).
4. IOP ≤ 25 mmHg - Patients that screen fail due to elevated IOP ˃25 mmHg may rescreen once IOP is treated and within normal limits (≤25 mmHg).

Exclusion:

1. Exudative maculopathies due to myopic choroidal degeneration, histoplasmosis, trauma, and specifically, the presence of angioid streaks.
2. Myocardial infarction or cerebrovascular accident within the last 6 weeks
3. Previous vitrectomy
4. Hypokalemia
5. Optic neuropathy
6. Traction maculopathies
7. Allergies to fluorescein and indocyanine, dilating agents, spironolactone, triamcinolone or anti-VEGF medications

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The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS)

There is currently no effective treatment in ALS. Oxidative stress, probably interacting with other neurodegenerative processes, is hypothesized to play a leading role in pathogenesis. These include mechanisms that promote glutamate excitotoxicity, mitochondrial dysfunction and axonal dysfunction.

In a transgenic mouse model of fALS that develops a disease with a clinical phenotype similar to ALS, dietary vitamin E supplementation delayed disease onset and slowed progression, although it did not prolong survival. When used as an experimental therapy in human trials, vitamin E did not affect survival significantly, but possibly slowed ALS progression. Two large, prospective epidemiologic studies suggest that longterm use of vitamin E supplements could be inversely associated with risk of ALS or ALS death. In another study, higher baseline serum α-tocopherol was associated with lower subsequent risk of ALS. A modest, non-significant protective effect from supplementation was seen in subjects with baseline serum α-tocopherol levels below median levels. In the current study, we aim to investigate the effects of tocotrienols in patients with ALS, particularly in delaying disease progression as well as assessing its safety profile in this group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have a decrease of 1 to 4 points on the ALSFRS-R score during the 12-weeks observation period prior to screening and enrollment
* Patients of less than 2 years after the diagnosis of ALS.
* Patients without respiratory symptoms (orthopnea, dyspnea)
* Capable of giving signed informed consent

Exclusion Criteria:

* Patients who have developed respiratory failure necessitating ventilation
* Patients who have developed unsafe swallowing necessitating enteral feeding tube insertion
* Patients with other neurodegenerative disease such as Parkinson's disease and significant mental health illness
* Patients with certain concomitant diseases which may affect the assessment of safety/efficacy i.e. malignancy within the last 5 years, congestive heart disease, liver disease, kidney failure, bleeding disorders and other autoimmune diseases etc.
* Pregnant, lactating, and probably pregnant patients.
* Patients taking vitamin E tocopherol or tocotrienols supplements within 1 month from screening and randomisation.
* Patients who have participated in other trials within 12 weeks before consent, or who are participating in other clinical trials at present.
* Women of child bearing potential or nursing mother, unless they are willing to practice effective contraceptive measures.
Effects of Pentoxifylline and Vitamin E on Pregnancy Rate in Infertile Women Treated by ICSI:

Our findings will provide preliminary clinical evidence to suggest the new experimental treatment approaches, toward female factor infertility treatment with pentoxyfylline.

This randomized clinical trial will be conducted on 140 infertile patients. The study is approved by the Ethical Committee of Benha obstetrics and Gynecology Department and will be initiated after achieving written consents of the participants. The study will include infertile patients under 39 years of age without a previous history of ICSI cycle. Exclusion criteria will be hypothalamic amenorrhea, drug reactions or complications, endometriosis and fibroids. Patients will be randomly divided into two equal groups. Computer generated random number table will be used for randomization. Group assignments will be placed in sealed opaque sequentially numbered envelopes. For each participant a questionnaire will be filled by the researchers. The questionnaire contained questions about age, duration of infertility, the type and cause of infertility. Data will be collected from questionnaires, clinical, laboratory notes and ultrasound reports. Endometrial thickness will be measured on the day of the HCG prescription in both groups by one of the two attending physicians. Chemical pregnancy will be detected by serum beta-hCG analysis 14 days after embryo transfer and transvaginal ultrasound scan will be scheduled 2 weeks later to confirm the diagnosis of clinical pregnancy. The intervention group will receive pentoxifylline (Trental S.R.) 400 mg/BD plus vit E (PHARCO) 400 mg/BD 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled. The comparison group will not receive the above drugs. The main outcome measure will be clinical pregnancy rate.

Sample size calculation Sample size was calculated using PASS® version 11 program, setting the type-1 error (α) at 0.05 and the power (1-β) at 0.8. Results from a previous study (Ashraf alesyan, 2009) showed that the incidence of pregnancy rate among ttt group was 57.1% while for control group it was 39.2%, with an effect size of 12%. Calculation according to these values produced a minimal sample size of 131 cases in each group.

Results

Results will be statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* infertile female patients under 39 years

Exclusion Criteria:

* hypothalamic amenorrhea
* drug reactions or complications
* endometrioses
* fibroids