cyrilzakka/clinical-trials huggingface dataset:
Effects of Moderate Consumption of Lean Fish on Weight Loss

the aim of present study is to compare the specific effects moderate consumption of lean fish on weight loss of healthy obese and overweight female adults, while participants follow energy-restricted diets also to investigate the effects of this intervention on carbohydrate and lipid profiles, as cardiometabolic risk factors.


Eligibility Criteria:
Inclusion Criteria:

* female
* 18-45 years of age.
* Body mass index (BMI) between 27.5-35 kg/m²
* Must be able to have moderate exercise.
* Must be interested to lose weight

Exclusion Criteria:

* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
* Taking medications that could affect metabolism or change body weight.
* Report heart problems, chest pain, and cancer within the last five years.
* Use of supplements containing n-3 fatty acids, calcium or vitamin-D during the last 3 months.
* Consumption of fish and sea foods regularly
* Smoking
* Menopause
* Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.
Prediction of the Response to a Course of Transcranial Magnetic Stimulation (rTMS) Based on Heart Rate Variability

Changes in heart rate variability following a single session of rTMS will be tested as a predictor of response to a course of 30 rTMS sessions in patients with major depressive disorder (MDD).

The objective of this study is to investigate whether acute changes in heart rate variability following a single session of repetitive transcranial magnetic stimulation (rTMS) can predict the response to a 30-session course of rTMS in patients with major depressive disorder (MDD) with good sensitivity and specificity. Patients who are prescribed rTMS to treat an episode of MDD at one of the nine participating centres will be invited to participate in the study. The protocol includes one inclusion visit and seven evaluation visits before, during, and after the course of rTMS. The rTMS course will last for six weeks, comprising of 30 sessions with five sessions per week. Prior to the start of the rTMS course, the patient will have to fill in a number of questionnaires. Before the first session, heart rate variability will be assessed by recording the RR interval at rest using a heart rate belt on the armchair stimulation. A second RR interval recording will be taken immediately after the first rTMS session. Patients will answer questionnaires weekly and after the final rTMS session to track the progression of depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Having a prescription for a course of rTMS to treat an episod of MDD
* Unipolar MDD confirmed according to DSM-5 criteria
* Moderate to severe MDD (MADRS score \> 19)
* No use of psychotropic medication or use stabilised (no change in dose \< 4 weeks before study entry)
* Able to understand, speak, read and write French
* Express informed consent, after a period of reflection
* Affiliated with a French social security scheme or beneficiary of such a scheme

Exclusion criteria:

* History of epilepsy or convulsive seizures
* Previous brain surgery
* History of recent cranial trauma (\< 6 months)
* Presence of severe suicidal ideation
* Psychotic disorders
* Metal objects in the head, eyes or brain
* Implanted ferromagnetic equipment (pace maker, cochlear implant, etc.)
* Clinical evidence of serious or uncontrolled alcohol or substance use disorders in the three months prior to the study
* Active withdrawal from alcohol or other substances
* One or more recent rTMS sessions (\< 4 weeks)
* Other non-drug therapy recently initiated (\< 4 weeks) to treat MDD (psychotherapy, phototherapy, vagus nerve stimulation, etc.)
* Prescription of cardiotropic drugs belonging to the following classes: predominantly cardiac calcium channel blockers, Vaughan Williams class I anti-arrhythmics and beta-blockers.
* Subjects in a period of relative exclusion from another protocol
* Adults protected by law or patients under guardianship or curatorship
* Subjects deprived of their liberty by judicial or administrative decision
* Pregnant or breast-feeding women
Short-Term Effectiveness of Ultrasound-Guided Corticosteroid Hydrodissection

Aim: Steroid injections are remarkably effective as a treatment for carpal tunnel syndrome (CTS) in the short term. The aim of this study was to determine whether hydrodissection would provide an additional clinical effect when used along with a corticosteroid in the short term.

Methods: A prospective cohort of patients with CTS were retrospectively evaluated. 28 patients were selected randomly who received ultrasound (US)-guided triamcinolone hydrodissection (3 mL) as intervention group and received US-guided triamcinolone injection (1 mL) as control group, from the data (case-control ratio 1:1). Outcome measures were the Boston Carpal Tunnel Questionnaire (BCTQ), hand grip strength (HGS), fhe cross-sectional area (CSA) of the median nerve and Short Form 12 (SF-12). Assessments were recorded at baseline, 1 and 4 weeks after injection.

Background: Steroid injections are remarkably effective as a treatment for carpal tunnel syndrome (CTS) in the short term.

Aim: To determine whether hydrodissection would provide an additional clinical effect when used along with a corticosteroid in the short term.

Methods: A prospective cohort of patients with CTS were retrospectively evaluated. 28 patients were selected randomly who received ultrasound (US)-guided triamcinolone hydrodissection (3 mL) as intervention group and received US-guided triamcinolone injection (1 mL) as control group, from the data (case-control ratio 1:1). Outcome measures were the Boston Carpal Tunnel Questionnaire (BCTQ), hand grip strength (HGS), fhe cross-sectional area (CSA) of the median nerve and Short Form 12 (SF-12). Assessments were recorded at baseline, 1 and 4 weeks after injection.

Eligibility Criteria:
Inclusion Criteria:

1. aged between 18-65
2. clinically diagnosed with CTS
3. electrophysiologically confirmed mild-to-moderate CTS
4. having typical CTS symptoms for at least 3 months
5. not benefiting from splinting and resting.

Exclusion Criteria:

1. electrophysiologically diagnosed with severe CTS
2. surgery history for CTS
3. presence of metabolic, endocrine and neoplastic disorders
4. presence of other neurological disorders (such as plexopathy, cervical radiculopathy, proximal median or ulnar neuropathy, polyneuropathy and mononeuritis multiplex)
Cyproheptadine in Severe COVID-19 : A Unblinded Randomized Trial

This randomized controled open label clinical trial is to evaluate the effect of Cyproheptadine on the clinical course of patients presenting a severe SARS-COV 2 pneumonia.

Observational and biochemical studies have identified an interesting pathway in the pathophysiology of certain clinical-biological characteristics of COVID-19, linked to an excess of serotonin. We hypothesize that the antagonism of the action of serotonin could improve the clinical course of patients most severely affected by COVID-19.

One such antagonist of serotonin with a long track record of safety and tolerability is cyproheptadine. Cyproheptadine acts as an antagonist of 5-hydroxytryptamine (5HT=serotonin) receptor subtype 2 as well as histamine-1 receptor. Many of the potent effects of serotonin on lung vascular tone, respiratory rate, and systemic vascular beds are mediated by 5-HT receptor subtype 2.

Investigators will randomize approximately 200 participants, aged 18 and older, who have tested positive for COVID-19 and who will be hospitalized at Santa Cabrini Hospital in Montreal, Quebec, Canada, presenting a severe form of covid-pneumonia-19 requiring supplemental oxygen.

Study eligibility of all participants will be assessed first. Once a participant is confirmed eligible and consented, they will participate in the study.

Participants will be randomly assigned (1: 1) to either take cyproheptadine 8 mg by mouth three times a day for 5 days and receive standard care or receive standard care alone.

The dose will be adjusted according to the glomerular filtration rate.

On D1, D3, D5, D7 and D10 since randomization, participant's vital signs (including SpO2, respiratory rate, FiO2 or oxygen flow, heart rate, blood pressure and temperature), blood creatinine, bilirubin, CRP, LDH, Dimers and platelets the count will be evaluated. Any adverse event will be assessed daily and documented.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18 or older
* Hospitalized and requiring medical care for COVID-19
* Presenting respiratory failure cause by COVID 19 requiring oxygen and/or mechanical ventilation support
* With radiographic evidence of pulmonary infiltrate
* Able to give informed consent or, if unable to do so regarding the medical condition, having relatives able of consenting for the patient

Exclusion Criteria:

* Pregnancy
* Patients with pre-existing terminal condition with life expectancy \< 6 months
* Patients with pre-existing severe lung disease requiring home O2
* History of seizure disorder
* History of adverse reaction to antihistamines or to Cyproheptadine
Mental Health Outcome After Surgery for Obstructed Defecation Syndrome (ODS)

Background: Obstructed Defecation Synsdrome (ODS) causes people to strain and sometimes need help to go to the toilet. They think about going to the toilet a lot, which makes their lives worse. People with Obstructed Defecation Synsdrome (ODS) are more likely to be anxious and depressed than people with other illnesses.

Aim of the study: This study looked at how mental health affects Obstructed Defecation Synsdrome (ODS) patients before and after surgery.

Aim, design, and setting of the study:

This study measures the mental burden of Obstructed Defecation Synsdrome (ODS) in patients scheduled for surgery for Obstructed Defecation Synsdrome (ODS) before and 6 months after surgery. The results are linked to how well the bowel works. All scores are checked before surgery and at 6 months after.

What do the investigators do to find this out ? The investigators look at patients' age, sex, body mass index (BMI), and other health problems. Defecation symptoms are measured using a validated questionnaire, the Altomare score, which has a maximum of 30 points. The rectal toxicity score reflects abdominal and bowel discomfort, which is determined by questions related to bowel dysfunction symptoms, such as diarrhea, meteorism, bleeding, and abdominal pain during bowel movement and defecation, and has a maximum of 32 points. The Wexner score is a 20-point questionnaire for fecal incontinence symptoms. Higher scores indicate greater severity of symptoms. Mental disorders are evaluated using the Personal Health Questionnaire 9 (PHQ-9) and General Anxiety Disorder 7 (GAD-7). Higher scores mean more severe symptoms.

Surgical procedure: For laparoscopic surgery under general anaesthesia, the patient is kept in a dorsal lithotomy position with their head down. The procedure opens the rectum, removes a part of the bowel and then rebuilds bowel continuity.

The investigators collect data on how long the operation took, how long the patient stays in hospital, and how many people have complications after the operation.

The scores will be reassessed at 6 months after surgery. For the clinical outcome, an improvement will be assumed at a reduction of 3 points and a strong improvement at a reduction of 6 points. Similarly, deterioration and major deterioration will be assumed at an increase of 3 points and 6 points. The results will be analyzed statistically.

Eligibility Criteria:
Inclusion Criteria:

* Obstructed Defecation Syndrome (ODS) scheduled for Surgery
* Conservative treatment failure
* Laparoscopic access possible

Exclusion Criteria:

• Pregnancy
Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques

Background: Circumcision is the most commonly performed surgical procedure done among the pediatric age group worldwide and is considered to be one of the oldest operations done. Circumcision should be performed properly with safe surgical techniques, with the least possibility of complications.

Objective: To compare bipolar electrosurgery versus thermocautery in the circumcision of infants under combined general and local anesthesia.

Patients and Methods: This prospective randomized comparative study was carried out on 110 infants who were candidates for elective circumcision under combined general and local anesthesia. Infants were randomly allocated into two equal groups (55 infants each); in group A, circumcised by bone-cutting forceps with cutting foreskin using a scalpel and achievement of hemostasis using bipolar electrosurgery, and in group B, circumcised by bone-cutting forceps with cutting foreskin and achievement of hemostasis using thermocautery.


Eligibility Criteria:
Inclusion Criteria:

* Infants of families who applied for circumcision
* Age from 1 to 12 months, of the male sex
* Infants should have normal preoperative laboratory investigations

Exclusion Criteria:

* Infants with congenital malformations especially hypospadias and epispadias, congenital inguinal hernia, and undescended testis
* Infants with acute penile infection, or excess suprapubic fat
* Infants with cardiovascular, neurological, respiratory, liver, renal, endocrine, blood, or immune diseases
* Allergy to any drug will be used in this study
Intralipid Therapy for Women 35-40 Years With Positive Natural Killer Cells Undergoing Intracytoplasmic Sperm Injection (ICSI)

Intralipid can suppress natural killer cells that are known to be involve in repeated implantation failure and recurrent miscarriages.Intralipid is made of purified soybean oil, egg phospholipids, glycerol and water. It provides essential fatty acids, linoleic acid, omega- 3 and 6 fatty acids and alpha-linolenic acid. The effects of Intralipid in suppressing natural killer cell activity (NKa) were found to be comparable to intravenous immunoglobulin (IVIG) by laboratory experiments.We will study the effect of intralipid infusion on the pregnancy outcome of women aged 35-40 years with history of repeated implantation failure of miscarriage and who have positive peripheral blood natural killer cells


Eligibility Criteria:
Inclusion Criteria:

Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing Intracytoplasmic sperm injection (ICSI ) cycle.

Exclusion Criteria:

* women above 40years or less than 35 years
* Disturbances of normal fat metabolism such as pathologic hyperlipidemia,Lipoid nephrosis or acute pancreatitis with hyperlipidemia.
* Allergic to eggs, soybean oil, or safflower oil.
* Severe liver disease, kidney disease, lung disease, anemia, blood coagulation disorder.
* Uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx.
* Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies (Immunoglobulin G or M)\[IgG or IgM\]); other recognised thrombophilic conditions (testing according to usual clinic practice).
* Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
* Fibroids distorting uterine cavity.
* Abnormal parental karyotype.
Vitamin E and Male Infertility

The goal of this study is to determine whether there is a correlation between the levels of Vitamin E in sperm and sperm DNA fragmentation.

Previous research has shown that damage to the DNA in sperm may cause infertility or increase the chances of miscarriage, if the damage is extensive (eg. present in the overwhelming majority of sperm). Some studies suggest that DNA damage can be caused by oxidative stress. Antioxidants, such as Vitamin E, which are present in some foods, can prevent damage to cells from "free radicals", which are naturally present by-products of metabolism. We ask whether there is a correlation between sperm DNA damage and Vitamin E

Sperm DNA damage is an emerging cause of male infertility that is likely to be more common among men with increased reactive oxygen species in the ejaculate. Vitamin E can protect the sperm membrane from oxidative damage and increased levels are associated with low levels of reactive oxygen species. This is a study of Vitamin E levels in the spermatozoa and sera of 48 infertile men, and 20 fertile men as a control group, to look for correlations between sperm vitamin E levels and the degree of sperm DNA fragmentation. Dietary intake of antioxidants will also be included.

Eligibility Criteria:
Inclusion Criteria:

* infertile men with previously abnormal semen analyses.
* Control group: fertile adult males

Exclusion Criteria:

* Proxceed use within 3 months of the start of study.
* Vitamin E supplements with \> 45 IU daily
Impact of Three Continuing Education Meetings for Community Pharmacists on Weight Management

This study is a three-arm randomized controlled trial to evaluate the effects of 1-day continuing educational meetings for community pharmacists with three distinct educational methods: 1) Didactic lecture 2) Didactic lecture plus case discussion in a large group 3) Didactic lecture plus small group education with simulated patient

Knowledge and attitude of the participants would be measured as the study outcome in three periods: pre-education, post-education and 1 month after the meetings.

The study is designed as an Instructor blinded-Randomized Controlled Trial.

An educational need assessment is undergone prior to educational content preparation by interviewing 5 community pharmacists. After educational content preparation by instructors, the outcome assessment tool (knowledge, attitude questionnaire) would be designed by a distinct investigator. Closed and Open-ended questions are included to investigate different levels of Bloom's taxonomy.

The questionnaire would be validated by specialists other than the instructors and it will piloted to investigate the reliability( Cronbach's Alfa \> 0.7).

Community pharmacists of Tehran,Capital city of Iran, would be invited to participate in the study. The participants would be randomly assigned to 3 groups by random number table. Each group receives the same education content with a different method:

1. Didactic lecture
2. Didactic lecture plus case discussion in a large group
3. Didactic lecture plus small group education with simulated patient(SP). Interviewing with SP is conducted by small group facilitators with Brain Storming Technic.

Each participant receives a compact disk which includes the educational material and he/she would be able to contact the instructors by phone or e-mail during the follow-up period. (Reinforcement Phase)

Eligibility Criteria:
Inclusion Criteria:

* Community Pharmacist

Exclusion Criteria:

* Less than four hours of daily work in community pharmacy
A Study of E7050 Administered Orally to Patients With Advanced Solid Tumors

The purpose of this study is to determine the maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally twice daily to patients with advanced solid tumors.

Phase I, open-label, dose-escalation study to determine the maximum tolerated dose (MTD) of E7050 given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.

Eligibility Criteria:
Inclusion criteria:

1. Subjects with a histological or cytological diagnosis of solid tumors or gastric cancer.
2. Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available.
3. Subjects with adequate organ function.
4. Patients who have no carryover of effect from prior therapy or no adverse drug reactions (excluding alopecia) that may affect the safety evaluation of the investigational drug.
5. Subjects with Performance Status (PS) 0-1 established by Eastern Cooperative Oncology Group (ECOG).

Exclusion criteria:

1. Subjects who have brain metastases with clinical symptoms or which requires treatment.
2. Subjects with the serious complications or disease history.
3. Subjects who cannot take oral medication.
4. Subjects who need continuous use of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period.
5. Female subjects who are pregnant or breast-feeding.
COVID-19 3rd Dose Vaccine in Transplant Patients

The purpose of this study is to investigate the efficient vaccine type as a booster dose for Coronavirus Disease of 2019 (COVID-19) in solid organ transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age and older
* Patients who had received a solid organ (kidney, liver, lung, heart, and pancreas) transplant patient from living or deceased donors.
* Patients with active graft with at least one immunosuppressive medication
* Completed two doses of BNT162b2 vaccination at least 28 days ago

Exclusion Criteria:

* Patient with non-active graft
* Any significant side effect with previous COVID-19 vaccination
* Within 28 days of BNT162b2 vaccine completion
* Already received more than and equal to three doses of COVID-19 vaccination
* Previously received COVID-19 vaccine other than BNT162b2 vaccine
* Previously received monoclonal Antibody treatment that are specifically directed against the spike protein for Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (CoV)-2 such as Mab, Bamlanivimab, etesevimab, Casirivimab, imdevimab, Sotrovimab and/or any combination.
* Thrombocytopenia (if less than 50,000 per microliter 30 days prior vaccination)
* History of Capillary Leak Syndrome
* Adults unable to consent
* Individuals who are not yet adults (younger than 18 year old)
* Vulnerable patients (prisoners)
* Pregnant women
Dacron vs Dardik for Fem-Pop Bypass

Clinical trial for the comparison of long-term patency of heparin-bonded Dacron and human umbilical vein vascular prostheses in above-knee femoro-popliteal bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

* age 31 to 89
* intermittent claudication
* ABI below 0.8

Exclusion Criteria:

* non elective surgery
* life expectancy below 2 yrs
* contraindication for anticoagulant therapy
Ph1 Lobeline Interaction Study - 1

The purpose of this study is to determine if there are significant cardiovascular or other interactions between sublingual lobeline and intravenous methamphetamine.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18 and 45 years of age
* Be in general good health with a history of methamphetamine (MA) abuse (but not dependence)
* If female and of child bearing potential, agrees to use birth control
* Be able to understand and provide written informed consent
* Have a body mass index between 18 and 30
* Have reported use of (MA) during the past three months without experiencing adverse consequence plus a life time MA or amphetamine use history of at least four occasions of use
* Have a negative drug test (barbiturates, benzodiazepines, amphetamines, opiates, cocaine, cannabinoids, ethanol) at screening and at the time of admission

Exclusion Criteria:

* Please contact site for details