cyrilzakka/clinical-trials huggingface dataset:
Testosterone for Fatigue in Men With MS

Fatigue is a major symptom in people with multiple sclerosis (MS), for which treatments are limited. Several studies have shown that a large proportion of men with MS have low testosterone levels. We propose a two-site clinical trial using topical testosterone gel as a treatment for MS-related fatigue in men with progressive MS who have low or low-normal testosterone levels.


Eligibility Criteria:
Inclusion Criteria:

1) Men with SPMS or PPMS, 2)18-60 years old, 3) EDSS of 1.0- 6.5, 4) Low or low-normal T \< 499ng/dL and 5) FSS scores of \>3.6.

Exclusion Criteria:

1) Prostate specific antigen \> 2.5 (\<49yr of age) or \>3.5 (age \>50yr of age), 2) baseline hematocrit greater than the upper limit of normal for the laboratory used, 3) EKG with ischemic changes, 4) history of myocardial infarction, unstable angina, stroke, transient ischemic attack, or deep vein thrombosis, 5) history of prostate or breast cancer, 6) screening T level \>500ng/dL, 7) diabetes requiring treatment, 8) current drug/alcohol abuse, 9) disease other than MS causing fatigue, such as obstructive sleep apnea or other sleep disorder, or untreated thyroid dysfunction, 10) RRMS, 11) Beck Depression Inventory-II (BDI) score over 20, 12) cognitive dysfunction such that subject cannot perform study tests, 13) inability to undergo MRI, 14) current or expected use of amphetamines, or 15) anticipated changes in medical treatments that might affect fatigue scores (e.g., expected changes in spasticity, sleep, or depression medications).
Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis

To compare the safety/tolerability and efficacy of a 14-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 14-day course of amoxicillin-clavulanate tablets (875/125 mg BID) for the treatment of ambulatory subjects with Acute Bacterial Sinusitis (ABS).


Eligibility Criteria:
Inclusion Criteria:

* The female must be non-lactating and at no risk for pregnancy.
* Subject must have a diagnosis of ABS. The diagnosis must be based on the following:

  * A sinus radiograph (Water's view) or CT scan with evidence of maxillary opacification or
  * Air/fluid levels purulent discharge from the nose
  * At least two of the following additional signs and symptoms lasting longer than seven days prior to and no longer than 28 days before Evaluation 1.
  * A pre-treatment sample from a sinus puncture or
  * Middle meatus endoscopy must be obtained for bacterial aerobic culture
  * Susceptibility testing (applicable only for selected investigative sites).
* Subject must be a suitable candidate for oral antibiotic therapy and able to swallow tablets intact.

Exclusion Criteria:

* A medical history of hypersensitivity or allergic reactions to clarithromycin, erythromycin, amoxicillin/clavulanate, any penicillin or any of the macrolide antibiotics.
* History of amoxicillin-clavulanate associated cholestatic jaundicehepatic dysfunction.
* Females who are pregnant or lactating.
* Subject has either of the following:

  * Chronic sinusitis (signs and symptoms lasting longer than 28 days immediately prior to Evaluation 1)
  * Significant anatomical abnormalities of the sinuses any other infection or
  * Condition which necessitates use of a concomitant systemic antibiotic.
* Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, psychiatric or endocrine disease, malignancy, or other abnormality (other than the disease being studied).
* Any underlying condition/disease, that would be likely to interfere with the completion of the course of study drug therapy or follow-up.
* Known significant renal or hepatic impairment (or disease).
* Subject who has taken: a systemic antibiotic within 2 weeks before study drug administration or a long-acting injectable antibiotic (e.g., penicillin G benzathine) within 4 weeks before study drug administration.
* Immunocompromised subjects (e.g., neutropenic subjects).
* Subjects with known HIV infection.
* Treatment with any other investigational drug within 4 weeks prior to study drug administration.
The 'Hidden' Biological Impact of Vitamin D Deficiency: a Biomarker Study; Part 2

The investigators major aims are to: determine the vitamin D status of a group of young, apparently healthy adults in Hong Kong; examine inter-relationships between vitamin D status and biomarkers of DNA damage and repair, oxidative stress, inflammation and endothelial health; and, in part 2 of the study, investigate effects of improvement in vitamin D status on these biomarkers and other measures of well-being in those young adults shown to be deficient in vitamin D.

In this part 2 of the study the investigators will investigate the effect of vitamin D supplementation on biomarkers of these 'hidden' changes in apparently healthy young adults. The investigators will also explore the effect of improvement in vitamin D status in young apparently healthy adults in regard to muscular strength and response time, glucose control, a hormone that is linked to vitamin D (parathyroid hormone (PTH) ) and mood.

Eligibility Criteria:
Inclusion Criteria:

* apparently healthy, non-smokers
* non-obese
* found (in part1) to have low vitamin D status

Exclusion Criteria:

* chronic illness
* serious illness requiring medical treatment in previous 6 months
* pregnancy
* on regular medication or taking supplements on a regular basis
Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma

The purpose of this study is to evaluate a method of sampling interstitial fluid from subcutaneous sewn wicks.

Fluid loss from circulating plasma volume is one of the contributors of oedema formation. Measurement of colloid osmotic pressure (COP) both in plasma and in interstitial fluid can be utilised in planing of fluid therapy in patients with oedema. Different methods of sampling interstitial fluid are well validated in animal models, but not in human. Sampling of interstitial fluid by subcutaneous sewn wicks is a well-known method and can be painful. Local anaesthetics can reduce pain. By comparing interstitial fluid taken from areas with or without application of local anaesthetics, a possible influence in COP values can be detected.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years

Exclusion Criteria:

* Ongoing illness
* Medication
Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal

The purpose of this study is to evaluate and document appropriate clinical safety and performance of the Remon CHF Implantable Pressure Sensor including the corresponding delivery system, the Remon CHF Home Unit, the Remon CHF Clinic System devices and associated application software. It is a small clinical trial to determine the feasibility of the device. The primary outcome measure relates to feasibility and not to health outcomes.

This study was a prospective feasibility, non-randomised, singlearm, multi-centre, interventional clinical investigation performed at 4 international sites. Patients were implanted with the Remon CHF Implantable Pressure Sensor utilizing the corresponding delivering system. Measurements were taken with the Remon CHF Home Unit and the Remon CHF Clinic System. Follow-up visits took place at one, three and six months after implant.

Per protocol, a minimum of 30 patients was required to demonstrate safety of the device.

The study was conducted in accordance with ISO 14155:2003 (parts I and II), the Declaration of Helsinki and all applicable local and national regulations in the countries of submission.

Eligibility Criteria:
Inclusion Criteria:

* Patients who exhibit signs and symptoms of NYHA Class III or IV heart failure.
* Patients who are able to visit the clinic frequently during the 6 months following implantation.
* Patients who are willing and able to perform all follow-up procedures.

Exclusion Criteria:

1. Patients under the age of 18
2. Pregnant women or women that plan to get pregnant during the study.
3. Patients with, tricuspid or pulmonic stenosis, pulmonary stents, right sided mechanical heart valves
4. Contraindication to antiplatelet therapy (aspirin and clopidogrel)
5. Patients suffering from active infection (on antibiotic therapy)
6. Known intracardiac mass (right atrial or right ventricular)
7. Patients who have been implanted with a VAD
8. Patients who are candidates for listing for heart transplantation if it is deemed that they have a possibility of receiving a heart within the next 6 months
9. Patients that have lead implanted at the heart right side of the heart within the last 6 months
10. Patients with any terminal illness, or with a life expectancy of less than 6 months
11. Patients that are unable to lie flat for the duration of the procedure
12. Patients that are unable to operate the home unit (due to physical or mental constrain)
13. Patients after pneumonectomy
14. Patients treated with oral anticoagulants INR \> 1.5 prior to catheterization
15. Patients with severe chronic renal failure (creatinine \> 2.5 mg/dl)
16. Patients suffered from acute myocardial infarction within the three months prior the study
17. Patients that underwent open heart surgery within 4 weeks prior the study.
Granulocyte Colony Stimulating Factor (G-CSF) in Acute Liver Failure and Alcoholic Hepatitis

Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis

In this study 4 groups have been taken. Two groups of cases including Alcoholic patients and acute liver failure which are given G-CSF therapy and two groups of controls given standard therapy. Primary end point is to see the mobilization of CD-34 hematopoietic cells and survival. Secondary end point is to see the clinical and biochemical improvement in liver functions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Acute Liver failure as defined by AASLD.65
* Patients with Alcoholic hepatitis defined as follows: decades of heavy alcohol use (mean intake, approximately 100 g per day).The combination of an aspartate aminotransferase level that is elevated (but \<300 IU per milliliter) and a ratio of the aspartate aminotransferase level to the alanine aminotransferase level that is more than 2, a total serum bilirubin level of more than 5 mg per deciliter (86 μmol per liter), an elevated INR, and neutrophilia.

Exclusion Criteria:

• Known hypersensitivity to filgrastim

* creatinine \> 150 µmol/L
* infection or hemorrhage within the last 10 days
* documented hepatocellular carcinoma
* hepatitis B,C or human immunodeficiency virus seropositivity and pregnancy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult Subjects

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of ID110521156 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged 19 to 50 years at the time of Screening.
* Body mass index (BMI) within ≥27 kg/m2; and a total body weight ≥ 50 kg
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
* For female subjects, not pregnant or lactation women, or naturally menopausal (spontaneous amenorrhea for at least 12 months) or surgically infertility (bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy etc).

Exclusion Criteria:

* Evidence or history of clinically significant hepatic, renal, neurological, immunological, pulmonary, gastrointestinal (including pancreatitis), endocrine, hematological, cardiovascular, urinary, psychiatric disease, sexual dysfunction or drug allergies.
* Treatment with an investigational drug (including a bioequivalence study) within 180 days prior to the scheduled date of first administration of the investigational product.
* Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 90 days after the last dose.
Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders

The study objective is to explore the safety and tolerability of STX209 in subjects with Autism Spectrum Disorders and to obtain preliminary data on several measures of efficacy in treating irritability. We hypothesize that STX209 will be safe and well-tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 6 to 17 years of age, inclusive.
* Diagnosis of Autistic spectrum disorders
* Clinical Global Impression - Severity (CGI-S) rating for aberrant behavior of moderate or higher at screening and at Visit 1 (Day 1).
* An Aberrant Behavior Checklist (ABC-C) Irritability Subscale score ≥16 at screening and at Visit 1 (Day 1).
* If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 3 months prior to Screening (Visit 1) and subjects and their parent/caregiver/legally authorized representative (LAR) will not electively initiate new or modify ongoing interventions for the duration of the study.
* Exclusion Criteria:
* Subjects with known genetic disorders associated with PDD such as fragile X syndrome.
* Subjects with a history of a seizure disorder who are not currently receiving treatment with antiepileptic medication.
* Subjects with any medical condition, including alcohol and drug abuse that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
* Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
* Subjects currently treated or have been treated in the last 2 weeks with any psychotropic medication except anti-epileptics or who have been treated with fluoxetine in the last 4 weeks.
* Subjects currently treated with vigabatrin or tiagabine.
* Subjects taking another investigational drug currently or within the last 30 days.
* Subjects who have a history of hypersensitivity to racemic baclofen.
A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes

This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes meeting all of the following:
* Minimum 6 month history of diabetes prior to screening visit;
* Fasting C-peptide ≥ 0.8 ng/mL at screening visit;
* HbA1C at screening visit 7-10%;
* Fasting glucose from 140-270 mg/dL on Day -7 following washout of all glucose regulating drugs and supplements.
* BMI at screening visit from 25-35 kg/m2;
* LDL-C at screening ≥ 100 mg/dL
Accuracy of the NICCI™ Monitor in Children and Adolescents

This is a prospective study that will compare the blood pressure readings from an arterial cannula with those obtained non-invasively by the NICCI device. The study will enroll 50 patients into each of three weight ranges: 10-20 kg, 20-40 kg, and 40-80 kg.

The NICCI, Pulsion/GETINGE uses novel technology to provide a continuous estimation of BP displayed as a waveform similar to that seen with an invasive arterial cannula, but is totally non-invasive by using the fingers. The patient rests their hand on the device, which is about the size of a computer mouse, and then a blood pressure cuff goes around their upper arm.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring anesthetic care and in whom an indwelling arterial cannula will be placed for the surgical procedure.

Exclusion Criteria:

* Patients with history of a peripheral neurologic or neuropathic disorder
* Patients in whom the upper extremity cannot be used for blood pressure monitoring
* Patients in whom an invasive arterial cannula cannot be placed
* Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm of the examined arm)
* Edematous patients
Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)

Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.


Eligibility Criteria:
Inclusion Criteria:

* Completion of lead-in study
* Adequate therapeutic benefit in the lead-in study to justify continuation of treatment with rapastinel in the judgement of the investigator

Exclusion Criteria:

* Suicide risk, as determined by meeting any of the following criteria:

  1. A suicide attempt within the past year
  2. Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the Columbia- Suicide Severity Rating Scale (C-SSRS) at any visit in the lead-in study
  3. Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit during participation in the lead-in study where MADRS was conducted.
* At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator
* Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during participation
* Females of childbearing potential and male partners of females of childbearing potential, not using a reliable means of contraception
The Link Between "Time In Range" Versus HbA1c and the Presence of Chronic COmplications in Type 1 Diabetes: a Longitudinal Study

HbA1c is currently the only metric of glucose control showing an association with chronic complications of type 1 diabetes mellitus (T1D). Time in range (TIR, 70-180 mg/dL) measured by real-time continuous glucose monitoring (CGM) might be a better marker. In this study, the investigators studied the clinical significance of a 10% increase of TIR over two years.

Adult subjects (age ≥ 18 years) with T1D were consecutively recruited in three multicenter studies (RESCUE, FUTURE, ALERTT1 studies) organized between September 2014 and 19 November 2021. For the TIRCO study, only the data from patients recruited at the University Hospital of Antwerp were analyzed. Initially, the data from 498 patients were collected. Pregnant patients and patients with beta-cell transplantation were excluded from the study, resulting in the inclusion of 479 patients. Consecutive patients starting CGM were proposed to participate and were included into the study after signing informed consent.

The study population consisted of 445 patients who used Freestyle libre, 21 patients who used CGM in hybrid closed loop and 13 patients who used Dexcom G4 and G6, resulting in a total of 479 patients.

In this project, the investigators looked into the link between TIR versus HbA1c and the presence of chronic complications in adults with T1D.

The primary endpoint was to evaluate the link between TIR and the presence of chronic microvascular complications as formulated by the following research question: "What is the clinical significance of a 10% increase of TIR over two years?"

The secondary endpoint was to assess the link between TIR and independent risk factors for micro- and macrovascular complications such as sex, age, BMI, lipids, blood pressure, HbA1c, time in range, mean glucose, diabetes duration, method of insulin administration (MDI or CSII), type of sensor and sensor compliance.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus
* Using Real-Time Continuous Glucose Monitoring (rtCGM), Intermittently Scanned CGM (isCGM) or (Hybrid) Closed Loop (HCL) as diabetes treatment
* Willing to sign informed consent

Exclusion Criteria:

* Pregnancy
* Patients that had beta-cell transplantation
Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis

The goal of this clinical trial is to compare a step-down strategy of spacing dupilumab injections with a standard maintenance treatment in adolescents and adults with controlled Atopic dermatitis (AD) for at least six months. The impact of dosage reduction strategies will be assessed with an innovative primary endpoint: the area under the curve of the weekly ADCT assessment.

For both groups:

At inclusion visit :

* Patient information and signature of consent form
* Randomisation
* Previous medical history
* Clinical exam
* Recording ADCT, EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L

Weekly during 12 months (by patients on https://hestia.chu-nantes.fr) :

* Self-assessment of ADCT
* Date of dupilumab injections
* Batch number of dupilumab
* Amount of topical corticosteroids

Visits at M4, M8 and M12 will be performed for :

* Clinical exam
* Recording secondary end points (EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L) and adverse events
* Collect out-of-pocket expenses (M4 and M12).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 12 years
* Moderate to severe AD treated with dupilumab every 2 weeks
* Written informed consent (patient and/or person who has parental authority)
* Dupilumab treatment for at least one year
* Controlled AD (ADCT\<7 and IGA ≤ 2) and assessed as controlled by the investigator since at least 6 months without tapering dosage of dupilumab
* Amount of topical treatment (TCS or calcineurin inhibitor) stable for 6 months and less than 60 g/month

Exclusion Criteria:

* Patients with Side effects of dupilumab
* Non controlled AD: ADCT ≥ 7 or IGA ≥ 3
* Female patient must not be pregnant\*, breastfeeding or considering becoming pregnant
* Patient under judicial protection
* Adults under guardianship or trusteeship