cyrilzakka/clinical-trials huggingface dataset:
Pain Control After Cardiac Surgery Using Intravenous Acetaminophen

Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* - Males or females 18 years of age or older.
* Non-emergency cardiac surgery via a midline sternotomy at Cleveland Clinic Main Campus.

Exclusion Criteria:

1. Redo cardiac surgery.
2. Combined CABG (Coronary Artery Bypass Graft)\& valve replacement, multiple valve replacements, Ascending aortic or aortic arch surgery.
3. Weight \< 50 Kg or Body mass index \> 38 kg/m2.
4. Left ventricle EF ¡Ü 35% ,Right ventricular moderate or severe dysfunction.
5. Severe (3-4 +) Tricuspid Regurgitation.
6. Recent stroke (within 6 months).
7. Severe lung disease requiring home O2 therapy.
8. Preoperative renal insufficiency (Creatinine \> 2.0) or on dialysis.
9. History of liver cirrhosis or active liver disease.
10. Chronic pain conditions controlled by preoperative opioid administration.
11. Known allergy to acetaminophen or fentanyl.
Transcranial Direct Current Stimulation (tDCS) as a Treatment for Cognitive Deficits in Schizophrenic

This trial attempts to evaluate the effects of intensive transcranial direct-current stimulation (tDCS) on improving cognition in schizophrenia patients and changes in resting state brain network connectivity, especially increasing connectivity in the tasks related network, and increasing activation the DLPFC in a working memory task. Half of the participants will be randomized to tDCS group, while the other half will be randomized to receive sham tDCS.

Schizophrenia patients (SZ) show profound and persistent cognitive deficits in attention, executive processing, and verbal and visuospatial memory, which persist even after psychotic symptoms are ameliorated. Cognitive deficits may be more important in preventing functional, occupational, and social recovery in SZ than other symptom domains and are not effectively treated by current pharmacological approaches. Transcranial direct-current stimulation (tDCS) is less expensive than other modalities (e.g. repetitive transcranial magnetic stimulation; rTMS), easily available, and has a good safety profile in healthy controls (HC) and SZ. However, these prior studies did not make use of a validated measure such as the MATRICS consensus battery (MCCB), which is now established as the standard for assessing cognitive improvement in SZ. Despite these promising preliminary results, this effect of tDCS in SZ needs to be confirmed and the underlying biological mechanism elucidated. Therefore, the investigators employed MCCB to evaluate the effects on improving cognition and functional MRI to explore the underlying mechanism.

Half of the participants will be randomized to tDCS group, while the other half will be randomized to receive sham tDCS. Active vs. sham treatment will be randomly using computer generated lists. Subjects and researcher-administrators of tDCS and testers or evaluators will be blind to treatment.The main cognitive outcome measure, the MCCB, will be administered at baseline and 1 day after the last tDCS session.Participants will be scanned once prior to tDCS sessions, and within one day after the 10th tDCS sessions using our Siemens 3T Verio MRI scanner.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have cognitive deficits as indicated by a score of \< 85 on RBANS, and meet criteria for DSM-5 diagnosis of chronic SZ, schizoaffective disorder (SA), or schizophreniform disorder (SZF), and who are stably treated with antipsychotic medications and are not in acute exacerbation of illness symptoms.

Exclusion Criteria:

* Patients with risk factors for an MRI scan, seizure disorder, and for women of childbearing age who are pregnant or regularly engaging in sexual activity and not regularly using an acceptable birth control method (systemic or double-barrier).
Integrated Diabetes Management Protocol Using Smartphone

The investigators aim to assess whether using integrated diabetes management protocol using smartphone would increase glucose control among diabetes patients.

Smartphones and digital healthcare is expected to provide better diabetes care. The investigators aim to assess whether using integrated diabetes management protocol using smartphone would increase glucose control among diabetes patients.

Smartphone apps for food diary, activity monitor, blood glucose will be used for three months.

Blood glucose control and patient satisfaction will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes, type 1 diabetes, gestational diabetes

Exclusion Criteria:

* Medications which interfere glucose control
* Cancer
* Chronic kidney injury
Effect of Metabolic Syndrome on Complex Decongestive Physiotherapy Outcomes in Lymphedema Patients

As a result of our research, investigators could not find any study investigating the effectiveness of complex decongestive physiotherapy (KBF) in lymphedema patients with metabolic syndrome. Therefore, our aim is to compare the effectiveness of KBF in patients with and without metabolic syndrome.

This study was planned to investigate the effects of metabolic syndrome seen in patients with lymphedema on the results of complex decongestive physiotherapy. Lymphedema is a chronic disease characterized by the accumulation of protein-rich fluid in the interstitial space. Among all the treatment approaches known in the field, Complex Decongestive Physiotherapy (CDT) is accepted as the gold standard in the treatment of lymphedema. CDT is a treatment approach consisting of manual lymph drainage, skin care, compression bandage and exercises. In clinical studies conducted to date, the effectiveness of CDFT in the treatment of lower and upper extremity lymphedema has been clearly demonstrated.

Metabolic syndrome is a medical term that describes the combination of various cardiovascular risk factors such as insulin resistance, impaired glucose tolerance or diabetes mellitus, obesity, abdominal fat accumulation, dyslipidemia, hypertension, and coronary artery disease. Obesity, the cardinal component of the metabolic syndrome, is a well-known risk factor for lymphedema, and increased body mass index (BMI) is associated with the frequency and severity of lymphedema. Obesity often accompanies lymphedema due to the effect of lymphedema and the characteristics of patients with lymphedema.

Our aim in this study, which was planned in the light of these data, is to examine whether the presence of metabolic syndrome in patients with lymphedema changes the effectiveness of CDT.

Eligibility Criteria:
Inclusion Criteria:

* Those between the ages of 18-65,
* To be diagnosed with lymphedema in the lower or upper extremities
* Volunteering to participate in the study
* Getting \>24 points from the Standardized Mini mental test

Exclusion Criteria:

* Having a score of \<24 on the Standardized Mini Mental Test
* Finding any problem preventing communication
ASTHMAXcel Emergency Department Study

This protocol focuses on Phase 1 of a planned two-phase research project. Phase 1 aims to test and adapt a prototype ASTHMAXcelED application for the ED. Phase 2 will be an RCT to test the efficacy of a refined ASTHMAXcelED app after being modified based on the results of Phase 1.

The original ASTHMAxcel app was developed by Dr. Jariwala, which delivers asthma education and promotes patients' adherence to the national asthma guidelines. The app was developed in accordance with Montefiore Medical Center's regulatory/compliance (determined by the Montefiore Legal department and Einstein-Montefiore Office of Biotechnology) and security (determined by Montefiore IT) policies. Over the last several years the app has been iteratively improved based on patient feedback and has been shown to improve asthma knowledge, asthma control, and asthma-related quality of life among asthma clinic patients. This version of the app has been tailored to the ED, requiring less physician directed education and focusing on common triggers and symptom management. Research associates will ask each patient to download the ASTHMAXcelED app and RA's instruct them on use of the application. RA's will also show every patient a video using the ASTHMAXcelED mobile application in which the investigators demonstrate correct use of an inhaler and discuss asthma triggers.

Eligibility Criteria:
Inclusion Criteria:

* English speakers
* at least 18+ years old with
* physician-diagnosed asthma.

Exclusion Criteria:

* severe cognitive or psychiatric conditions precluding capacity to provide informed consent,
* inability to speak English,
* lacking the technology to access the app.
Tolerability of SLIT With LAIS® 2-Tree Allergoid Tablets

To expand knowledge on the application and tolerability of immunotherapy with LAIS® 2-tree allergoid tablets as well as knowledge on the alleviation of symptoms during sublingual therapy in special consideration of the chosen titration schedule in everyday practice.

Until now, results from controlled studies with their specific requirements (patient selection, defined inclusion and exclusion criteria, close patient management and monitoring, randomisation) are available for LAIS® 2-tree allergoid tablets only for a small patient population. In addition, an open-label, controlled study and an observational study have been carried out investigating the clinical efficacy and tolerability of the preparation. Owing to the differences in the study designs, the allergen dose administered and the frequency with which the preparation was applied varied among the individual studies, making it necessary to gather further data on the safety and tolerability of the preparation in a larger patient population.

The observation schedule of this NIS (NIS in accordance with Article 67 Paragraph 6 of the German Medicinal Products Act (AMG)), which takes into account the recommendations made by the German Federal Institute for Drugs and Medical Devices (BfArM) and by the Paul Ehrlich Institute for planning, implementing and evaluating an NIS, is geared to the routine procedure carried out for patients with allergies to tree pollen.

The aim of this observational study is to observe and document the tolerability and improvement of symptoms after treatment with LAIS® 2-tree allergoid tablets under normal application conditions and in consideration of the chosen titration schedule in therapeutic practice - in accordance with the patient information leaflet - in a large patient population:

* Retrospective survey of rhinitis/rhinoconjunctivitis symptoms induced by tree pollen
* Overall symptomatology
* Documentation of restrictions caused by allergy/asthma
* Tolerability of the treatment by means of AE documentation
* Patient compliance

Additional requirements extending beyond the specifications listed in the patient information leaflet on product use, patient groups, dosage, contraindications, etc., will not be made.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 5 years or older having allergies within the scope of specifications stated in the patient information leaflet

Exclusion Criteria:

* Contraindications according to the patient information leaflet
Optimization of the Core Number and Location for Targeted Prostate Biopsy

This study aims to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy.

This is a single-center prospective study. The investigators perform MRI/US image fusion targeted saturation biopsy on prostate lesions with PI-RADS score 4, to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy.

Eligibility Criteria:
Inclusion Criteria:

1. Men more than 18 years old with clinical suspicion of prostate cancer;
2. Serum PSA ≤ 20 ng/ml within the previous 3 months;
3. No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
4. mpMRI PI-RADS V2.1 score ≥4, diameter of ≤2.5 cm；
5. Able to provide written informed consent.

Exclusion Criteria:

1. Prior prostate biopsy or prostate surgery;
2. Prior treatment for prostate cancer;
3. Contraindication to MRI (e.g. claustrophobia, pacemaker);
4. Contraindication to prostate biopsy;
5. Men in whom artifact would reduce the quality of the MRI.
A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer

This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in participants with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Participants will receive 15 milligrams/kilogram (mg/kg) Avastin intravenously (IV) on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (area under the plasma concentration-time curve \[AUC\] 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitaxel 175 milligram per square meter (mg/m\^2) on Day 1 every 3 weeks or 80 mg/m\^2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma or clear cell carcinoma or carcinosarcoma. Participants with recurrent ovarian cancer who have been previously treated with surgery alone for their early stage disease are eligible.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2
* Life expectancy greater than or equal to (\>=3) months

Exclusion Criteria:

* Participants with non-epithelial ovarian cancer, ovarian tumors with low malignant potential (i.e., borderline tumors), or synchronous primary endometrial carcinoma
* Previous systemic therapy for ovarian cancer. Prior neo-adjuvant chemotherapy is allowed
* Planned intraperitoneal cytotoxic chemotherapy
* Radiotherapy within 28 days of Day 1, Cycle 1
* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first dose of Avastin
* History or evidence of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade \>=1 arterial thromboembolic event or Grade \>=3 venous thromboembolic event within 6 months prior to enrollment
A Therapeutic Exploratory Clinical Study of DA-8010 in Patients With Overactive Bladder

A Therapeutic Exploratory Clinical Study to evaluate the efficacy and safety of DA-8010 in Patients with Overactive Bladder and to determine the optimal dose of DA-8010


Eligibility Criteria:
Inclusion Criteria:

Main Inclusion at Screening (Visit 1):

* Men and women 19 years or older with OAB symptoms for ≥ 3 months.
* Subject who is willing and able to complete the micturition diary correctly.
* Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study

Exclusion Criteria:

* Clinically significant Stress urinary incontinence or Mixed urinary incontinence where stress is the predominant factor
* Diagnosed with interstitial cystitis or bladder pain syndrome
* Clinically significant pelvic organ prolapse
* Subject who has neurologic status which is able to effect vesical function, such as multiple sclerosis, Spinal Injury or Parkinson's disease
* Medical history of malignant tumor in urinary system or pelvic organs
* Clinically significant bladder outlet obstruction or more than 200mL of post-void residual volume
Cardiovascular Risk Factors After Renal Transplantation in Children and Adults

Renal transplantation of children started in Norway in 1970.Since the beginning, \>80% of renal transplants are provided from Living Donors(mainly parents), short pre-transplant dialysis time( median 4 months) and 50% of transplantations are performed before dialysis is needed.This gives good premises for graft survival and avoidance of detrimental effects of dialysis. However, renal transplanted children are subjected to an increased cardiovascular morbidity and mortality in adulthood due to consequences of chronic renal failure and immunosuppressive treatment.Cardiovascular death comprises 30-40% of death causes. In this cross-sectional study we evaluate cardiovascular risk factors in childhood- and also in young adults renal transplanted in childhood.

Focus is cardiorespiratory fitness using treadmill testing,24h BP measurements, anthropometrics including waist circumference,echocardiography,intima media thickness of carotids, glucose intolerance test.Participants are also requested to fill out physical activity recalls and Quality of life questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Transplanted after 1983, functioning graft

Exclusion Criteria:

* Patients in dialysis
* In part of the study concerning treadmill testing: Age\<8 years, orthopedic limitations
Evaluation of the Effect of Sevoflurane and Propofol Hypotensive Anesthesia on Blood Antioxidant Levels and HIF 1 Levels

The aim of this study to evaluate the patients who underwent controlled hypotensive anesthesia under standardized depth of anesthesia with total intravenous anesthesia or inhalation anesthesia; preoperative and 30. ,60. ,120. second of intraoperative period blood HIF 1a, TAS, TOS measurement and to investigate tissue hypoxia secondary to hypotensive anesthesia and the changes of the mediators at the tissue level and which hypotensive anesthesia technique is related.

Controlled hypotension is the voluntary reversible reduction of arterial blood pressure. Hypotensive anesthesia is a method of anesthesia in which blood pressure is reduced in a controlled manner, especially in certain surgeries. İt reduces intraoperative bleeding and need for blood transfusion and provides a clean surgical vision in narrow-field surgeries or with high bleeding potential. Hypotensive anesthesia can be performed according to mean blood pressure (MBP) or systolic blood pressure (SBP).

A non-invasive cerebral oximeter is used to see the changes in the brain due to high oxygen-dependent metabolism during induction and maintenance of anesthesia.

Hypoxia inducible factor (HIF) is a transcription factor involved in cell adaptation mechanism activated in response to hypoxia.

The biological activity of HIF 1 is determined by the expression and activity of the HIF 1a subunit.

Total antioxidant status (TAS) shows the total effect of all antioxidants in the human body and total oxidant status (TOS) shows the total effect of oxidants.

Near Infrared Spectroscopy (NIRS) allows continuous and non-invasive monitoring of cerebral oxygenation. HIF 1a, TAS and TOS are laboratory markers that predict tissue oxygenation and perfusion.

Hypotensive anesthesia can be performed according to both MBP and SBP. However, in our study that follow-up MBP is more advantageous/protective, although it is not supported by very strong data. The investigators recommend hypotensive anesthesia compared to MBP; but further studies are needed

Eligibility Criteria:
Inclusion Criteria:

* 18-55 years old
* ASA Physical Status Classification System 1
* Undergoing to Elective rhinoplasty

Exclusion Criteria:

* Patients have any autoimmune disease
* Smoking of patients
* Development of any allergic reaction during the procedure
* Failure to collect blood to be examined at the appropriate time
* Body mass index is less than 19 or greater than 30

Termination criteria

* Development of severe hypotension and bradycardia during measurements
* Development of severe drug allergy during follow-up
* In the event of any complications related to the surgical procedure
The Effects of Discontinuation of Vitamin K Antagonists on the Rate of Elastin Degradation

Background: Elastin is a unique protein providing elasticity, resilience and deformability to dynamic tissues, such as lungs and vasculature. Elastin fibers are characterized by their high affinity for calcium. However, calcified elastin is more prone to the degrading effects of proteases and, in turn, partially degraded elastin has an even higher affinity for calcium. A disturbed balance between proteases and anti-proteases is a major underlying mechanism in the development of chronic obstructive pulmonary disease (COPD). Virtually the only protein that can protect elastin from calcification is matrix Gla-protein (MGP), which needs vitamin K for its activation. In COPD patients, a lower vitamin K status is found when compared to control subjects and an inverse association exists between vitamin K status and elastin degradation. In addition, vitamin K status is lower and elastin degradation is accelerated in Vitamin K antagonist (VKA) users.

VKAs are widely used. Nowadays, an increasing number of patients uses direct oral anticoagulants (DOACs), which do not influence vitamin K status. The hypothesis of this study is that discontinuation of VKAs results in an improved vitamin K status and deceleration of elastin degradation. In order to test this hypothesis, an observational pilot study will be conducted in which the change in elastin degradation- quantified by plasma desmosine concentrations - in patients who discontinue use of VKAs will be used as primary endpoint.

Study design: Observational study. Study population: A total of 30 VKA users who will discontinue the use of VKAs. Elastin degradation rate (quantified by plasma desmosine levels) and vitamin K status (quantified by measuring plasma levels of dephosphorylated uncarboxylated (dp-uc)MGP) will be measured during the use of VKAs and approximately 6 months after discontinuation of VKAs. Furthermore, the VKORC1 polymorphisms will be determined.

Main study parameters: The primary endpoint is the change in the rate of elastin degradation quantified by the plasma desmosine assay. Secondary endpoints are the change in vitamin K status quantified by measuring plasma levels of dp-ucMGP, the relation between desmosine and dp-ucMGP and differences of desmosine and dp-ucMGP levels among subjects with different polymorphisms of the vitamin K 2,3-epoxide reductase complex 1 (VKORC1) gene.


Eligibility Criteria:
Inclusion Criteria:

* Use of VKAs for at least 3 months
* Stop VKAs at short time
* Written informed consent
* Age ≥18 years
* Ability to comply with all study requirements

Exclusion Criteria:

* Active malignancy or cured malignancy \<12 months prior to enrollment
* Use of maintenance dose oral corticosteroids
* Serious mental impairment
* Life expectation of less than 6 months on the basis of concurrent disease
A Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia

This study will evaluate the tolerability, and effect on quality of life, in patients receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with chronic renal anemia. The anticipated time on study treatment is 10 months, and the target sample size is 60 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18-65 years of age
* Chronic renal failure (Stages I-III)
* No previous epoetin therapy

Exclusion Criteria:

* Poorly controlled hypertension
* History or evidence of malignancy
* Relevant acute or chronic bleeding (requiring therapy) within 3 months before study drug
* Women who are pregnant or breastfeeding