cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Remote Ischemic Conditioning in Patients with Chronic Internal Carotid Artery Occlusion Receiving Hybird Surgery: a Pilot, Randomized Controlled Trial

The purpose of this study is to explore the safety and efficacy of remote ischemic conditioning in patients with internal carotid artery occlusion receiving hybird surgery.

In this study, 60 patients with internal carotid artery occlusion receiving hybird surgery are included in our center in China. The experimental group will receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 6 consecutive days. The control group will receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 6 consecutive days. Two groups will be followed up for 90 days to evaluate the safety and efficacy of remote ischemic conditioning in patients with internal carotid artery occlusion receiving hybird surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years, regardless of sex
* Patients with chronic carotid artery occlusion who are going to undergo hybird surgery
* Can cooperate with and complete brain magnetic resonance imaging (MRI) examination
* Signed and dated informed consent is obtained

Exclusion Criteria:

* Hemorrhagic stroke
* Severe cardiac dysfunction or arrhythmia
* Uncontrolled hypertension (defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg, despite medication taken at enrollment)
* Severe hepatic and renal dysfunction (defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times higher than the upper limit of the normal range, creatinine \>265umol/l (3mg/dl))
* The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
* Pregnant or lactating women
* He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission
* Other conditions that the researchers think are not suitable for the group
A Trial Comparing Two Breast Pumps in Mothers Expressing Milk for Their Preterm Infants

This is a randomised controlled trial investigating the performance of two, 'state of the art' electric breast pumps in mothers who have delivered preterm infants. The main data collection period will be up to day 10 post delivery data. Data collected will include a record of the weight of milk produced during the first 10 days and a short questionnaire to find the mothers' opinions of the pumps used. On Day 5 a timed and weighed expression of 15 minutes will be carried out. After the first 10 days, mothers will be asked to collect brief information on their continuing use of their pumps and subsequent duration of breast and bottle feeding, mothers will be contacted at 3 and 6 months post-term


Eligibility Criteria:
Inclusion Criteria:

* Mothers who have delivered, preterm (before 34 weeks) infants who plan to express breast milk for their infant(s). Their infants will need to be less than 72 hours old prior to enrolment and likely to remain in NICUs for at least 10 days.

Exclusion Criteria:

* Other mothers not fitting inclusion criteria.
The Effect of Beetroot Juice on Plasma Trimethylamine N-oxide Concentration

The primary aim of the current study is to determine the effect of beetroot juice consumption on plasma trimethylamine N-oxide concentration.

A secondary aims: exploring the effect of circulating trimethylamine N-oxide modification on plasma total antioxidant status, and measurement of changes in the skin nicotinamide-adenine dinucleotide reduced form (NADH) content during transient ischemia and reperfusion.

In a random order subjects will consume beetroot juice (140ml), or equimolar nitrates (NaNO3). Antecubital vein blood samples will be taken at the beginning, and every hour for 4 hours following consumption.

Plasma trimethylamine N-oxide, total antioxidant status, and nitrite/nitrate concentrations will be determined.

Using Flow Mediated Skin Fluorescence skin NADH content determined during controlled ischemia triggered by total occlusion of the brachial artery by the brachial blood pressure cuff and during reperfusion after deflation of the blood pressure cuff 2 and 4 hours following consumption.

Eligibility Criteria:
Inclusion Criteria:

healthy volunteers

Exclusion Criteria:
Vulvar Contact Dermatitis Resulting From Urine Incontinence

Vulvar contact dermatitis (VCD) is a common problem presenting as vulvar pruritus, burning or irritation. Its estimated prevalence is 20-30% in vulvar clinics, but the prevalence in the general population is unknown.

Contact dermatitis is an inflammation of the skin resulting from an external agent that acts as an irritant or as an allergen. The skin reaction may be acute, subacute or chronic, resulting from prolonged exposure to weak irritating substances.

The most common form of VCD is irritant contact dermatitis, and it usually presents as vulvar itch. The causes that contribute to VCD are increased sensitivity of the vulvar skin to irritants compared to other body parts, decrease in the skin barrier function due to exposure to sweat, urine and vaginal discharge and constant friction of the vulvar area. In menopausal women, lack of estrogen contributes to tissue atrophy and thinning, and may increase the effect of irritants on the vulvar skin.

One of the most common irritating substances that cause VCD is urine. The phenomenon of urine-induced VCD is known as" diaper rash" in babies, and it was also described in bedridden patients using diapers constantly. Women with urine incontinence (UI), a problem that its prevalence in women increases with aging, may use constantly panty liners or pads to prevent urine leakage. The urine is being absorbed in the pad, and the vulvar skin is continually exposed to urine. This can cause VCD, similar to diaper rash. The prevalence of this phenomenon in the general population is unknown.

The patients complain of itch, burning or irritation of the vulvar skin, and on exam erythema, edema and irritated skin are found. As most patients do not connect between UI to their vulvar disorder, and as most care-givers do not ask routinely about UI, the vulvar symptoms are mistakenly attributed to yeast infection or other factors. As the cause to the vulvar complaints is not recognized, patients do not receive proper treatment that requires primary management of UI.

The aim of the study is to evaluate the prevalence of VCD in women with UI and to recognize risk factors for UI induced VCD.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of vulvar contact dermatitis, with or without urinary incontinence; OR
* Patients with a diagnosis of urinary incontinence, with or without VCD; OR
* Patients without either UI or VCD, age-matched

Exclusion Criteria:

* Diagnosis of other dermatoses
Collecting and Storing Samples of Blood From Patients With Pancreatic Cancer and Healthy Participants

RATIONALE: Collecting and storing samples of blood from patients with cancer and healthy participants to test in the laboratory may help the study of cancer in the future.

PURPOSE: This study is collecting and storing samples of blood from patients with pancreatic cancer and healthy participants.

OBJECTIVES:

* Establish a central pancreatic cancer specimen (including serum and peripheral blood lymphocytes) repository to serve as a resource for current or future scientific studies.
* Utilize the clinical database to perform clinicopathologic correlation with the results of those studies.
* Test new hypotheses as they emerge.

OUTLINE: This is a prospective study.

Blood is collected from patients with pancreatic cancer at baseline and then every 3-6 months for up to 2 years. All other participants have blood collected at baseline and complete questionnaires at baseline and then every 3-6 months for up to 2 years. Serum and peripheral blood lymphocytes obtained from the blood samples are frozen and stored.

PROJECTED ACCRUAL: A total of 200 patients and 200 other participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Histologically confirmed pancreatic malignant neoplasm
  * Serologically or image-confirmed diagnosis of pancreatitis or nonmalignant pancreatic disease
  * Healthy, at-risk participant meeting the following criteria:

    * Smoker, diabetic, and/or has a family history of pancreatic cancer
  * Healthy participant (no history of cancer)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
68Ga-PSMA PET in the Prostate Cancer

Efficacy of 68Ga PSMA PET / CT in the diagnosis of lymph node metastasis in patients with prostate cancer: a single center prospective randomized controlled trial.

To identify and compare the diagnostic efficacy of 68Ga-PSMA PET/CT and mpMRI for lymph nodes in patients with newly diagnosed prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND
* ISUP Gleason grade group ≥ 4

Exclusion Criteria:

* Prior history of any other cancer in the last 5 years excluding basal cell carcinoma Proven metastases in bones or other distant metastases
* General contra-indications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia)
* Serious concomitant systemic disorders that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives
* Metal implants in the pelvic region which will deteriorate PET/MR/CT image quality.
A 14 Weeks Longitudinal Study to Investigate the Effect of Leukocyte- Platelet Rich Fibrin Plug on the Quality of the Newly Formed Bone in Ridge Preservation Procedure Following a Tooth Extraction. It is a Clinical, Radiographic and Histomorphometric Study.

This 14 weeks longitudinal study will be conducted from March 2018 to June 2020, with a 40 participants. No subjects has received placebo medication at any point in the research procedures.

Null hypothesis: The use of L-PRF plug, in combination with non-resorbable, open barrier membrane technique to fill the extraction sockets will have no effect on the quality of the newly formed bone nor on the dimensional changes of the ridge, compared to non-resorbable, open barrier membrane technique with natural blood clot.

This 14 weeks longitudinal study was conducted from March 2018 to June 2020, with a 27 participants. No subjects has received placebo medication at any point in the research procedures.

The proposed sample population has been recruited from the patient population of the University of Kentucky College of Dentistry clinics and the patient must have had an unsalvageable tooth that was planned for extraction and delayed implant placement and was assigned into a control group and a test group by chance. Fifteen extraction socket sites of the test group were filled with autogenous L-PRF Plug (Intralock) and d-PTFE membrane (Cytoplast) was laid on the top to seal the extraction socket. In the control group, d-PTFE membrane (Cytoplast) was laid on the top of twelve extraction sockets to allow natural blood clot formation in the extraction socket.

The primary aim is to assess the quality of the newly formed bone at 14 weeks the time of implant placement by comparing the percentage of new vital bone in the histomorphometric analysis. The second aim was to assess the horizontal and vertical changes of the residual bony ridge using Cone Bean Computerized Tomography (CBCT) analysis at baseline immediately after tooth extraction at 12 weeks of healing.

Null hypothesis: The use of L-PRF plug, in combination with non-resorbable, open barrier membrane technique to fill the extraction sockets will have no effect on the quality of the newly formed bone nor on the dimensional changes of the ridge, compared to non-resorbable, open barrier membrane technique with natural blood clot.

Eligibility Criteria:
Inclusion Criteria:

* The subject must have an unsalvageable tooth that is planned for extraction and delayed implant placement.
* The tooth should be free of acute odontogenic infections.
* Extraction sockets with minimal to moderate bony defect.

Exclusion Criteria:

* Any patient who is planned for full mouth extraction.
* Heavy smoker (more than 10 cigarettes a day).
* History of malignancy, chemotherapy, radiation therapy.
* Immunosuppressive disease.
* Uncontrolled systemic disease.
* Any contraindications to surgical procedures.
* Females who are pregnant or breastfeeding.
* For multi-rooted teeth, if the most coronal part of the interradicular septum is less than 5 mm below the crest of the bone.
Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails: A Multi-center Prospective Study of Functional Outcome

Determine whether patients exhibit early functional improvement after minimally-invasive placement of Illuminoss photodynamic nails for peri-acetabular pelvic metastasis at 3 months following procedure

Primary Objectives

1. Evaluate whether patients exhibit early functional improvement after minimally-invasive placement of Illuminoss photodynamic nails for peri-acetabular pelvic metastasis at 3 months following procedure

Secondary Objectives

1. Evaluate whether the procedure relieves pain
2. Evaluate radiographic stability of the implant
3. Evaluate functional outcome at earlier time points (2 weeks or 6 weeks) and at 6 months and possibly later time points
4. Evaluate reoperation rate and complications

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a histologically confirmed malignancy from prior biopsy of the primary tumor or a metastatic site. Patients with carcinoma, myeloma, and lymphoma may be included in the study. Patients should have metastatic involvement of the periacetabular region that is visible radiographically. Biopsy of acetabular disease is not required for this study.
* Age ≥18 years (Illuminoss is approved only for skeletally mature patients)
* Suitable candidate for general anesthesia
* Ability to understand and the willingness to sign a written informed consent document.
* Able and willing to fill out pre-operative and post-operative functional outcome surveys
* Absolute neutrophil count ≥ 1,500/mcL
* Platelets ≥ 50,000/mcL

Exclusion Criteria:

* Patients with uncontrolled intercurrent illness (e.g., recent pneumonia or myocardial infarction that would significantly increase risk of general anesthesia)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* Patients with psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study because of the risk of general anesthesia and radiation exposure (fluoroscopy) to the fetus
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to dental resins or PET.
Short Term Warfarin Therapy for Radiofrequency Catheter Ablation of Atrial Fibrillation

We hypothesized that in patients with low CHADS-VASc score (2 or \< 2), there is no difference in thromboembolic or bleeding events between patients with short term warfarin therapy (2 weeks after catheter ablation) and conventional therapy (3 weeks before and 8 weeks after procedure).


Eligibility Criteria:
Inclusion Criteria:

* Patients with paroxysmal atrial fibrillation who underwent radiofrequency catheter ablation
* Patients with CHADS-VASc score 2 or less than 2

Exclusion Criteria:

* Patients who do not consent to the study
* Permanent or persistent atrial fibrillation
* Patients who have underwent prior catheter ablation for atrial fibrillation
* CHADS-VASc score more than 2
* History of stroke
* LVEF \<40%
* Significant liver or kidney dysfunction
* History of major bleeding during warfarin therapy
Psychology of Minimally Invasive Surgical Scars

The purpose of this study is to examine the psychological and psychosocial impact of surgical scars after minimally invasive surgery (MIS). 100 adult patients who are about to undergo bariatric procedures through the Duke Metabolic \& Weight Loss Surgery program will be enrolled in this study. 50 patients will be randomly assigned to standard laparoscopic surgery and 50 will be assigned to the percutaneous group. All patients will complete pre-operative psychometric testing to establish a baseline body-image score as well as a patient's initial subjective perceptions around surgery and surgical scars. Follow-up visits will be done at standard of care timepoints - 3 weeks, 3 and 6 months, and 1 year after surgery. Subjects will complete the same psychometric measures to identify differences in psychological and psychosocial responses to standard laparoscopic and percutaneous scars. Patients will also complete a measure on scar satisfaction. The investigators hope to identify any differences between standard laparoscopic versus percutaneous approaches.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index 35 to 45
* Undergoing Bariatric Surgery

Exclusion Criteria:

* Body Mass Index \<35 or \>45
* Previous Bariatric Surgery
Onset of Effect of Mometasone Nasal Spray in Induced Allergic Rhinitis (Study P03431)

This was a single-dose study to determine the time it takes for mometasone furoate nasal spray to go in effect, after a single dose of 2 sprays per nostril. Patients who are eligible were exposed to ragweed pollen for 3 hours on one or two occasions. Patients who experienced adequate symptoms during the pollen exposure phase came back for a Treatment Phase visit. During the Treatment Phase visit, patients were exposed to ragweed pollen for 2 hours and then received either mometasone or placebo nasal spray. Symptom evaluations began on the patients every hour for the next 11 hours.


Eligibility Criteria:
Inclusion Criteria:

* at least 12 years old,
* had a history of SAR to ragweed pollen for at least one year
* had a positive skin test (prick) to short ragweed allergen.
* if female, had a negative urine pregnancy test (HCG) at the Screening Visit, and prior to treatment on the Treatment Visit
* were non pregnant women of childbearing potential and used a medically acceptable, adequate form of birth control.

Exclusion Criteria:

* developed signs or symptoms of bronchospasm, i.e., wheezing, dyspnea, and/or cough, during the priming sessions;
* had any significant medical condition which, in the judgment of the investigator, might interfere with the study or require treatment;
* had an upper respiratory or sinus infection within two weeks prior to treatment;
* had received escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy for treatment of rhinitis;
* were female subjects who were pregnant, breast feeding, or premenarchal;
* could not adhere to concomitant medication prohibitions;
* had a known potential for hypersensitivity, allergy, or idiosyncratic reaction to mometasone furoate nasal spray;
* had asthma that requires systemic or inhaled corticosteroid treatment;
* had large nasal polyps, marked septum deviations, or any other nasal structural abnormality that significantly interferes with nasal airflow;
* had rhinitis medicamentosa;
* had any relevant abnormal vital sign due to an unknown underlying disease and considered by the investigator and Sponsor Monitor to contraindicate study participation.
Comparative Effects of Conscious Abdominal Contraction and Closed Kinetic Chain Exercises

Subacromial pain syndrome is a general term used to describe pain which originates from the shoulder and can spread towards the neck or down the arm. It's the most common reason for shoulder pain. The aim of study was to compare the effects of conscious abdominal contraction and closed kinetic chain exercises on the activation of peri-scapular muscles in badminton players with sub-acromial pain syndrome.

A Randomized Clinical Trial was conducted at Sir Syed Sports Complex Sargodha, through convenience sampling technique on 52 patients which was allocated using random sampling through computerized generated number into Group A and Group B. Group A was treated with closed kinetic chain exercises. Group B was treated with abdominal contraction exercises for periscapular activation. These exercises were done in 3 sets with 10 repetitions. There was 3 sessions per week. Baseline measurement was taken on 1st day of evaluation and post treatment will be taken on 4th week. Data was analyzed during SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it was decided either parametric or non-parametric test was used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Male Badminton players
* Age 20 to 40 years
* Unilateral shoulder pain
* Pain with overhead activities
* Positive Hawkins Kennedy test
* Positive painful arc(60-120 degrees)
* Positive Neer impingement test
* Positive external rotation test
* Numeric pain Rating Scale NPRS value(3-7)

Exclusion Criteria:

* Adhesive capsulitis
* Know shoulder instability
* Neck pain
* Radiating pain from shoulder to hand
* Receiving any intervention for shoulder injury.
* Previous history of 6 month shoulder trauma.
* Previous history of shoulder surgery.
* Taking any critical care medicine
Post-Thoracotomy Closure Study

Post-thoracotomy Pain Syndrome (PTPS) is defined as "pain that recurs or persists along a thoracotomy scar at least 2 months following surgery." PTPS presents a frustrating challenge to patients and healthcare providers alike. PTPS can affect up to 80% of patients undergoing thoracotomies, and results in significant impairment. A proposed mechanism for PTPS is the compression of the intercostal nerves during routine closure. Closure of thoracotomies using intracostal sutures is a novel technique where sutures are passed through holes drilled into the rib; thus, avoiding compression of the nerves. We propose a double-blind, randomized control study involving 90 patients undergoing elective posterolateral thoracotomies. Participants will be randomly assigned to undergo thoracotomy closure with pericostal sutures or intracostal sutures. Our primary outcome will assess the incidence and severity of PTPS at 3, 6, and 12 months after surgery between groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18-88 years age
* Patients undergoing surgery with an open thoracotomy incision

Exclusion Criteria:

* Patient refusal
* Inability to give informed consent
* Concurrent drug addiction or methadone use
* Present chronic pain syndrome
* Significant psychiatric illness excluding depression
* Cannot understand English, read or write in English independently
Protocols of IVF/ICSI in Poor Responders

Comparing two ovarian induction protocols in poor responders in IVF/ICSI cycles

The two groups of poor responders are randomized into either; a minimal dose stimulation protocol involving letrozole, recombinant FSH and GnRH antagonist versus a microflare conventional protocol with OCP, GnRH agonist and high dose recombinant FSH, in their IVF/ICSI cycles, primary outcome will be the number of oocytes retrieved.

Eligibility Criteria:
Inclusion Criteria:

1- More than 1 year of infertility 2 - Poor ovarian responder according to the Bologna criteria:

1. Advanced maternal age
2. Previous poor ovarian response
3. Abnormal tests of ovarian reserve (AFC \< 5-7, AMH \<0.5-1.1 ng/ml)

Exclusion Criteria:

1. Age \> 43 years
2. baseline FSH \>15 mIU/ml
3. Previous ovarian surgery
4. Ovarian endometrioma
5. Uterine anomaly or myoma
6. Any medical disorder
7. Any hormonal disorder eg. hyperprolactinemia
8. BMI \> 30 kg/m2
9. Severe male factor