cyrilzakka/clinical-trials huggingface dataset:
The Effects of Strawberries on Blood Cholesterol.

In this study, we propose to investigate the effects of dietary achievable doses of strawberries on serum LDL-cholesterol (LDL-C) and related lipid profiles, measures of glycemia and insulin resistance, and biomarkers of inflammation in a 14 week controlled crossover study.

The screen visit will involve an 8 hour fasting state and the following procedures:

* Completing screening questionnaire
* Measuring height, weight, blood pressure, and waist size
* Drawing about 30mL blood for blood glucose and lipids and comprehensive metabolic panel All subjects will be asked to follow usual diet and lifestyle, and refrain from other sources of berries and related products while on the study. Subjects will also maintain 3-day food records at screen, 4, 9, and 14 weeks of the study. Height, weight, blood pressure and waist circumference will be measured by trained personnel at MPE 326 (KNS facility for clinical research). Blood draws will be performed by trained phlebotomists (to be hired) at MPE 326, and all procedures will be performed by trained research personnel \[PI \&Co-PI: Basu, Izuora and graduate student\]. In case of blood pressure, an average of at least three readings, 10 min apart, will be measured at each visit for each participant. Blood glucose (fasting and postprandial at two hours) will be determined at each time point. The oral glucose tolerance tests will be conducted at MPE 326 and blood samples will be sent to Quest Diagnostics, Las Vegas. Insulin resistance will be calculated using the homoeostatic model assessment (HOMA-IR). The HOMA-IR is a standard and widely used formula in calculating insulin resistance based on fasting glucose values. Screening and follow-up tests will include clinical laboratory tests for blood glucose, lipids, NMR profiles, C-reactive protein and metabolic panel to determine effects of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* elevated total and LDL cholesterol (\>116 mg/dL)
* body mass index (\> or = 30 kg/m2)
* features of the metabolic syndrome

Exclusion Criteria:

* taking glucose and lipid lowering medications (e.g. statins, metformin)
* history of chronic conditions (diabetes, CHD, anemia, renal diseases)
* allergic to strawberries
* pregnant and/or lactating
* smoking
* vegetarian or consuming special diet
A Open-label Food Effect Study With SEN0014196 in Subjects With Huntington Disease

The primary purpose of this study is to assess the effect of food upon the pharmacokinetics (PK) of SEN0014196 in subjects with Huntington disease (HD).

In addition to the pharmacokinetic endpoints, the study will assess the safety and tolerability of 100 mg once daily (qd) doses of SEN0014196 over 14 days in subjects with HD and explore potential biomarkers for use in subsequent Phase 2/3 studies.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with early to mid HD, i.e., genetically confirmed HD (cytosine, adenine, guanine \[CAG\] codon repeat length ≥ 36), motor signs of HD, and a Total Functional Capacity Subscale Score (TFC) ≥ 7
* Body mass index between 18 and 31 kg/m2 inclusive
* All subjects must have a body weight greater than 50 kg
* Female subjects must be surgically sterile, postmenopausal, or willing to practice a highly effective method of contraception. All female participants must be nonlactating and nonpregnant. Male subjects must agree to use a reliable method of birth control during the study and for 3 months after the last dose of study drug.
* Capable of providing informed consent
* MMSE ≥24
* Subjects must have a live-in competent observer

Exclusion Criteria:

* Participation in a study or received an investigational drug within 30 days of the Baseline Visit
* Any prior or concomitant use of compounds suspected of interfering with protein acetylation
* Any concomitant use of medications that are known inhibitors of CYP450 enzymes or substrates of CYP1A2 at the time of enrollment
* Suicide risk, as determined by meeting either of the following criteria: a) a suicide attempt within the past year or suicidal ideation within 60 days of the Screening Visit; b) Significant risk of suicide, as judged by the Investigator
* Subjects with MMSE \< 24
* Subjects with presence of clinically significant psychosis and/or confusional states, in the opinion of the Investigator
* Subjects with clinically significant laboratory or ECG abnormalities at Screening or Baseline
* Subjects with clinically relevant hematologic, hepatic, cardiac, or renal disease
* Subjects with a current or past (within the last 12 months) history of epilepsy or seizures
* A medical history of infection with human immunodeficiency virus, hepatitis C, and/or hepatitis B
* Subjects with a history of substance abuse within the past 12 months
* Female subjects who are pregnant or breastfeeding
* Known allergy to any ingredient in the study drug
* A history of malignancy of any type within 2 years prior to Screening. A history of surgically-excised nonmelanoma skin cancers is permitted.
* Any relevant condition, behavior, laboratory value, or concomitant medication which, in the opinion of the Investigator, makes the subject unsuitable for entry into the study
Evaluation of Nerve Conduction Study

the investigators study different modality to obtain nerve evoked reponses. They use different parameters of acquisition and stimulation and they compare amplitude and latency of nerve conduction response


Eligibility Criteria:
Inclusion Criteria:

* absence of previous nervous pathologies

Exclusion Criteria:

* nerve disease
* diabetes
* polyneuropathy
A Study in Patients With Fabry Disease Who Are on Chronic Hemodialysis Therapy for Treatment of End-stage Renal Insufficiency.

People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme. Fabrazyme is a drug that helps to breakdown and remove certain types of fatty substances called "glycolipids." These glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not present, or is present in small quantities. The build up of glycolipid (globotriaosylceramide or GL-3) levels in these tissues in particular is thought to cause the clinical symptoms that are common to Fabry disease. This study is designed to verify that no loss of Fabrazyme occurs during simultaneous Fabrazyme infusion and hemodialysis in patients currently receiving Fabrazyme at a dose of 1.0 mg/kg every 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patient must provide signed, written informed consent prior to any study-related procedures being performed.
* Patient is between 18 and 65 years of age, inclusive.
* Patient has documented Fabry disease.
* Patient has received bi-weekly 1 mg/kg infusions of Fabrazyme for at least 6 months prior to enrollment into the study.
* Patient has not experienced moderate or severe infusion-associated reactions (IARs) from Fabrazyme infusions, which were also associated with a rate reduction, within 3 months prior to enrollment into the study.
* Patient has been receiving chronic hemodialysis for treatment of end-stage renal insufficiency for at least 3 months prior to enrollment into the study.
* Patient has good vascular access for hemodialysis.
* Patient has not and will not have any other (investigational) drug(s) infused during their hemodialysis, and is expected to have a stable concomitant medication regimen at all PK assessments.

Exclusion Criteria:

* Patient's hemoglobin is \< 9 g/100 mL at Screening/Baseline.
* Patient has a clinically significant organic disease or an unstable condition that, in the opinion of the Investigator, would preclude participation in the study.
* Patient has a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance.
* Patient has participated in a study employing an investigational drug within 30 days prior to the start of their participation in this study.
* Patient is unwilling to comply with the requirements of the protocol.
The Effect of Combined PRP and ESWT for Carpal Tunnel Syndrome

The platelet rich plasma (PRP) and extracorporeal shock wave therapy (ESWT) are new and potential treatment for patients with kinds of musculoskeletal disorders. Although few clinical studies have showed beneficial effect of PRP and ESWT for regeneration of peripheral neuropathy, the effect of combined PRP and ESWT is absent so far.

We perform a prospective randomized, double-blinded study to investigate the combined effect of PRP and ESWT in patients with carpal tunnel syndrome.

Patients were randomized into intervention and control group. Participants in intervention group received sono-guided injection with 3cc PRP and one-session active ESWT and control group received sono-guided injection with 3cc PRP and one-session sham ESWT. The evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week after the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 20-80 year-old.
2. Typical symptoms and signs of CTS, such as positive Tinel's sign or Phalen's test, numbness/tingling in at least two of the first, second, or third digits, and in whom the diagnosis was confirmed using an electrophysiological study.

Exclusion Criteria:

1. Cancer
2. Coagulopathy
3. Pregnancy
4. Inflammation status
5. Patients who had conditions mimicking CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for CTS.
Association Between Uric Acid and Acute Coronary Syndrome

The aim of the study is to acess the association between admission serum uric acid level and in_hospital outcomes in patients with acute coronary syndromes

Prospective study

1. To acess patients with acute coronary syndrome including one of (typical Chest pain _ECGchanges _elevated cardic enzyme)
2. the complication occur in patients with hyperurecemia and those with normal uric acid

Eligibility Criteria:
Inclusion Criteria:

all patients with acute coronary syndrome with one of the Following

* Typical Chest pain
* ECG changes
* Elevated cardiac enzyme

Exclusion Criteria:

* patients aged less than 18 years
* patients with gout
* patients with treated with diuretics
* Patient with CKD
* Patient with chronic haemolytic anemia
COVID-19 Prevalence in HIV-infected Patients

North-east area of France was hit in February 2020 by the new coronavirus disease, more severely than other French regions. Factors affecting the evolution of the disease and its severity have been quickly identified, among them figuring different kinds of immune deficiency. Even if nowadays HIV infection is usually well controlled by ARV drugs, those patients with uncontrolled viral load and/or low CD4 cell counts, remain at higher risk of severe COVID infection. In this context, the primary objective of our study is aimed at evaluating the prevalence of SARS-CoV-2 antibodies in a cohort of HIV-infected patients followed-up in an HIV-infection care center. Secondary objectives are: evaluating whether the antibodies are protective or not, the kinetic of these antibodies, and HIV associated factors with the presence of antibodies.


Eligibility Criteria:
Inclusion Criteria:

* adults (\> 18 years)
* HIV-infected patients
* subjects with social insurance
* subjects able to understand study purposes, and to give a written and informed consent

Exclusion Criteria :

* subjects unable to understand informations on the study, and to provide informed consent
* subjects under guardianship or curatorship
* subjects under judicial protection
Radiofrequency Ablation for the Treatment of Large Symptomatic Heterotopic Gastric Mucosa

The heterotopic gastric mucosa found in the cervical esophagus was first described in 1805 and affects 10-15% of individuals undergoing esophagogastroduodenoscopy. It leads to laryngopharyngeal reflux (LPR), which causes symptoms like globus sensation, hoarseness and chronic cough. The Reflux Symptom Index (RSI) that ranges from 0-45 measures LPR. Scores greater than 13 are considered to be pathologic. Currently, patients that suffer from symptoms of LPR and present with a heterotopic gastric mucosa are routinely offered radiofrequency ablation (RFA) as curative treatment. Up to now, around 40 patients were already treated at the department of Surgery with 90% histologic eradication rates after 2 treatment sessions and no reported serious adverse event. Nevertheless, the placebo effect could also be responsible for perception of improving symptoms. Therefore, this prospective sham-controlled trial was designed to exclude the placebo effect. As the device is already approved and routinely used for focal ablation safety data are already available. Up to now, there were no major adverse events, whereas only 10% of patients describe a sensation of irritated throat that dissolves within the first three days after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histological proven presence of heterotopic gastric mucosa,
* pathologic Reflux Symptom Index (\>25)
* age: 18-70
* presence of symptoms \> 6 months,
* no effect on the Reflux Symptom Index to 12 weeks of standard dose proton pump inhibitor treatment
* negative symptom correlation for symptoms with reflux events in ambulatory pH monitoring

Exclusion Criteria:

* Not willing to participate in this study
* pregnancy
* lactation period
Bicarbonate Epidural Injection in Emergency Caesarian

During labor, pain is systematic. In France, epidural analgesia is the gold standard to fight pain.

Sometimes, emergency situations involve the maternal or fetal prognosis and require an emergency fetal extraction by caesarean. When an effective epidural analgesia is in place, an injection of adrenaline lidocaine converts this epidural analgesia into an epidural anesthesia allowing a surgical procedure. Sometimes, the time required to set up the anesthesia cannot be expected and a general anesthesia is performed.

Local anesthetics used during epidural analgesia have Pka between 7.8 and 8.1. In solution, local anesthetics exist in two forms: an un-ionized form and an ionized form. The non-ionized form is liposoluble and crosses the lipid membranes to reach the site of intracellular action. The non-ionized form conditions the time taken to install anesthesia.

When the pH of the solution is equal to Pka, un-ionized and ionized form are present in equal quantity. Commercial local anesthetic solutions have acidic pH and so contained a majority of ionized form. Alkalinization of local anesthetics solution should bring the pH closer to pKa and therefore to favor a greater proportion of non-ionized form.

The aim of this study is to evaluate impact of an alkalinization of adrenaline lidocaine solution for conversion of epidural analgesia into epidural anesthesia during an emergency caesarean.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women followed up in the Reims University Hospital
* women whose birth is expected by vaginal delivery in the Reims University Hospital
* women wishing to benefit from epidural analgesia
* women agreeing to participate in the research and having signed informed consent
* women aged 18 years old and more
* women affiliated to a social security system

Exclusion Criteria:

* women who don't benefit from emergency caesarian (vaginal delivery or scheduled caesarian)
* women for whom epidural analgesia cannot be used
* women for whom epidural analgesia is not effective
Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

We intend, with this study, to prove that blocking the molecular mechanisms whose blockade prevents VIDD in animals, will indeed prevent the development of VIDD in humans as well. We believe that this evidence will serve as the required basis for proceeding with large, ICU-based clinical trial(s) of a drug to prevent VIDD.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing esophagectomy

Exclusion Criteria:

* Patients with more than mild pulmonary dysfunction
* Patients with any neuromuscular disease that might compromise diaphragm function
* Patients with abnormal liver or kidney function
* Patients taking any immunosuppressant medication (including prednisone) or antifungal medications
* History of tuberculosis
* Weight loss of \>5% of body weight over previous 6 months
* Pregnancy
The Effect of Laryngeal Manual Therapy as a Management of Globus

The purpose of this study is to assess the effect of laryngeal manual therapies in the treatment of globus (sensation of a lump in the throat).

This is a prospective study that include patients who met the inclusion criteria.

Data collection includes patients age,gender,clinical manifistations,laboratory parameters and treatment.

An endoscopic examination will be done by an expert Otolaryngologist. for each patients we will perform one session of laryngeal manual massage therapy by an expert in the field .

Eligibility Criteria:
Inclusion Criteria:

* patients more than 18 years old
* male and females
* patients complaning from Globus without an organic cause
* patients who underwent throat endoscopy and was normal.
* Patients who received conventional drug therapy without benefit.
* Globus complaints more than two months .

Exclusion Criteria:

* below 18
* Patients diagnosed with reflux(as a cause to globus)
* Patients who considered at high risk of reflux according to REFLUX SYMPTOM INDEX (RSI) more than 13
* patients who diagnosed with reflux and improved after anti-reflux manegment .
* patients with laryngeal disease/finding that can explain the globus.
* patients with organic cause that can explain the globus .
Comparative Bioequivalence Study in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions

To characterize pharmacokinetic profile of test product compared to that of the corresponding reference product in adult patients, who are diagnosed to have Chronic Myeloid Leukemia \& Gastrointestinal Stromal Tumor under Fed Conditions.

To characterize pharmacokinetic profile of Imatinib Mesylate tablets EQ 400 mg base of Amneal Pharmaceuticals LLC, compared to that of the reference product - GLEEVEC® (imatinib mesylate) tablets 400 mg in adult patients, who are diagnosed to have CML or GIST and are presently receiving stable dose of imatinib mesylate tablets 400 mg, and assess their bioequivalence.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 55 years (both inclusive) and either sex
* Diagnosed case of Philadelphia chromosome positive (Ph+) CML patients in chronic phase or GIST and presently being treated with imatinib 400 mg tablets.
* Willing to give written informed consent for participation in the study as well as willing and able to comply with study visit schedule and other protocol requirements.
* Female patients of child bearing potential (except for those who have completed one year since menopause or have gone through hysterectomy or bilateral tubal ligation) must have negative serum pregnancy test at the screening, negative urine pregnancy test on check in to housing, must be non-lactating at screening and must agree to use effective contraception (barrier or hormonal) for the study period.

Exclusion Criteria:

* History of hypersensitivity to imatinib mesylate or to any of the excipients as judged by investigator.
* Patient of CML receiving treatment in Myeloid Blast Crisis or Accelerated Phase
* Abnormal laboratory results as below:
* History of a heart failure, renal insufficiency, hypereosinophilic syndrome (HES), myelodysplastic syndrome (MDS)/ myeloproliferative disease (MPD) or acute systemic mastocytosis (ASM).
* History of therapy with any of the following as per timelines before randomization: inducers of CYP3A4 activity and inhibitors of CYP3A4 activity, within 14 days, investigational product/device within last one month
* Alcohol or any drug dependence within past one year.
* Blood donation/loss exceeding 200 ml within last 60 days.
A Study to Evaluate the Safety and Effectiveness of a New Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), (+)-Calanolide A, in HIV-Positive Patients Who Have Never Received Anti-HIV Treatment

The purpose of this study is to test the safety and effectiveness of a new non-nucleoside reverse transcriptase inhibitor (NNRTI), (+)-calanolide A, in HIV-positive patients who have never received anti-HIV treatment.

Patients are randomized into 2 cohorts, with Cohort 2 receiving a higher dosage than Cohort 1. Patients in each cohort receive either (+)-calanolide A or a placebo for 14 days, followed by a 14-day follow-up period. Following study treatment, patients may elect to receive an open-label, 6-month course of anti-HIV drugs to be selected by and administered under the care of the patient's physician.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Have a CD4 count of at least 250 cells/mm3.
* Have an HIV count (viral load) of at least 5,000 copies/ml.
* Are at least 18 years old.

Exclusion Criteria

You will not be eligible for this study if you:

* Have received prescription or nonprescription medications within 14 days of study entry, or if you will need to take any of these medications during the study.
* Have ever received anti-HIV medications.
* Test positive for hepatitis B.
* Have received a blood (or red blood cell) transfusion within 3 months prior to study entry.
* Have severe diarrhea.
* Have severe heart, liver, kidney, or neurological (brain and spinal cord) disease.
* Have hemophilia or another blood disorder.
* Have received certain medications or vaccines within 30 days prior to study entry.
* Have received chemotherapy or radiation within 16 days prior to study entry, or if you will need either of these during the study.
Open Trial of a Behavioral Activation Telepsychology Intervention for People Who Inject Drugs

The study has two aims: 1) To examine the feasibility and acceptability of administering a telepsychology Behavioral Activation (BA) treatment for substance use among non-treatment-seeking people who inject drugs (PWID); 2) To test the initial efficacy of the treatment from pretreatment to a 1-month follow-up on substance-related problems, readiness to change drug use, and BA. The intervention is hypothesized to be feasible and well-accepted, and within-subject analyses are hypothesized to demonstrate decreases in substance-related problems and increases in readiness to change drug use and BA from pretreatment to a 1-month follow-up.

The study aims to recruit N=25 non-treatment-seeking PWID from a syringe exchange program (estimated treated sample n=15). Participants will receive 8 sessions of BA over 4 weeks, and assessment of study outcome measures will occur at pretreatment, post-treatment, and a one-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Reports regular recent injection drug use (defined as injecting drugs on at least one day in the last week and injecting drugs for at least two months)
* Can identify at least one goal or area of change to address during treatment
* Has regular (at least twice weekly) access to an electronic device that can make phone or video calls and has access to the internet to complete online questionnaires

Exclusion Criteria:

* Attending or on a wait list to receive psychosocial substance use treatment
* \<5th grade reading level
* Impairment due to active psychosis
* Unable to give informed, voluntary, written consent to participate.