cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Safety and Efficacy Study of RGN-137 Topical Gel for Junctional and Dystrophic Epidermolysis Bullosa

The objective of this study is to compare the efficacy and safety of RGN-137 topical gel with that of placebo gel for treatment of junctional epidermolysis bullosa (JEB) or dystrophic epidermolysis bullosa (DEB).

RGN-137 will be evaluated for efficacy and safety compared to a Placebo. A matched-pair design will be used to evaluate RGN-137 treatment versus placebo for treatment of 15 subjects with JEB or DEB. Eligible subject must have 1 set of matched-pair wound. The investigator will assign pair of index wounds, each wound with an area between 5cm2 and 50cm2, inclusive, for the eligible subject on Day 1, and for each pair, one wound will be randomized to receive RGN-137 gel and the other to receive Placebo gel. Subjects and independent evaluator will be blinded to the treatment assignments for each wound.

Eligibility Criteria:
Inclusion Criteria:

* Male or female and at least 4 years old with a diagnosis of DEB or JEB
* Patients and their parents or guardians must be willing and able to provide written informed consent/assent
* Presence of 1 pair of stable index wounds within the specified size range at study

  1. Index wounds must have a surface area between 5 cm2 and 50 cm2, inclusive at the screening visit
  2. The index wounds selected as pairing must be relatively matched in terms of size and location
* Women of childbearing potential must have a negative pregnancy test prior to randomization
* Sexually active subjects must agree to use medically accepted methods of contraception during the study

Exclusion Criteria:

* Have any clinical evidence of local infection of the index lesion
* Use of prior or concomitant medication (Any investigational drug within 30 days, Immunotherapy or cytotoxic chemotherapy within 60 days, Systemic steroidal therapy within 30 days, and topical steroidal therapy within 14 days)
* History of sensitivity to any component of the treatment
* Neurological, cardiovascular, respiratory, hepatic, renal, or metabolic disease likely to interfere with the subject's participation in or completion of the study (At the discretion of investigator, participants with cardiomyopathy can participate)
* Current or former malignancy, including a history of squamous cell carcinomas
* Arterial or venous disorder resulting in ulcerated wounds
* Uncontrolled diabetes mellitus
* Pregnancy or breastfeeding during the study
* Girls or women who have had menarche but have not completed menopause
* Any condition or situation likely to cause the subject to be unable or unwilling to participate in the study procedures
Prospective Monitoring of Children Born in Haute Vienne From Uterine Life to Adulthood

The purpose of this survey is to collect data from intrauterine life until the age of 18 of children born in Haute Vienne.

The interest to realize such survey is to find correlations and interactions that may exist between the events that occurred during intrauterine life and those that will occur after the birth of the child. The investigators will examine every aspect of these children's lives from the perspectives of health, social sciences and environmental health

These are medical events (occurrence of disease, medication), but also socio-cultural for this child (living environment, exposure to possible contaminants, events in family history).

This cohort aims to include 3000 children a year (whose parents consented to their inclusion), all born at Haute-Vienne.


Eligibility Criteria:
Inclusion Criteria:

* Any child born in one of the three maternity hospitals in the Haute-Vienne (CHU Limoges, Clinique des Emailleurs, Hospital Saint-Junien).
* Any child who's parents consented to their inclusion.

Exclusion Criteria:

* Children born at home.
* Children abandoned at birth.
Efficacy of Internet and Smartphone Application-delivered Tinnitus Retraining Therapy

The purpose of this study is to prove the efficacy of the internet and smartphone application-delivered tinnitus retraining therapy (TRT).

to investigate the effect of TRT with minimized counseling

Eligibility Criteria:
Inclusion Criteria:

* chronic subjective tinnitus

Exclusion Criteria:

* THI \< 18
Exoskeleton and Spinal Cord Injury

The purpose of the current study is to investigate the effects of powered exoskeleton (EKSO) on cardiovascular performance as measured by resting blood pressure and heart rate, peak oxygen consumption during walking, energy expenditure, whole and regional body composition assessments. The effects of exoskeleton training on walking kinematics including stand-up time, walking time, distance covered and speed of walking will also be evaluated.

Powered exoskeletons using robotic suits have recently been introduced for the rehabilitation of persons with spinal cord injury (SCI). Exoskeletons offer a unique opportunity for persons with SCI to experience standing and walking at a low metabolic cost. Evidence suggested that exoskeleton assisted walking can decrease spasticity and improve bowel movement. Training may also improve the level of physical activity as well as psychological parameters that are likely to interfere with rehabilitation outcomes. Previous studies reported that a frequency of 2-3 times per week or more for 1-2 hours may be beneficial in the rehabilitation of persons with SCI. Using exoskeletal-assisted walking to improve the level of physical activity may be appealing to persons with SCI.

Exoskeleton training for 12 weeks may enhance energy expenditure, parameters of physical activity and result only on modest effects on both cardiovascular and body composition parameters. In other words, persons with tetraplegia may have greater cardiovascular and body composition adaptations compared to persons with paraplegia. Twenty subjects will participate in a powered exoskeleton (EKSO) for one or twice a week for 12 weeks. The program will involve walking with the robotic suits for 1 hour for persons with complete (n=10) and persons with incomplete (n=10) SCI.

Eligibility Criteria:
Inclusion Criteria:

1. A written clearance by the medical doctor .
2. Participants will have to be 1 year post-injury with any level of injury.
3. All participants will be between 18-70 years old, men/women,

Exclusion Criteria:

1. Participants with body weight greater than 220 lbs
2. Whole body T-scores less than -2.5 standard deviation will result in elimination from the program.
3. Hip width, upper leg length and lower leg length that do not fit in the robotic suit.
4. Previous unhealed fracture in both lower or upper extremities
5. Leg length discrepancy that is unlikely to be managed by having shoe inserts
6. High resting blood pressure greater than 130/80 mmHg
7. Sudden drop in blood pressure by 20 mmHg especially in persons with tetraplegia.
8. Medical conditions prior enrollment similar to cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin, pressures sores stage 2 or greater, or urinary tract infection or symptoms.
9. Pregnancy
A Real-world Study Evaluating the Usage of Camrelizumab in Chinese Patients With Advanced Esophageal Cancer

The trial is a multi-center, open, observational registration study, which aims to evaluate the safety and efficacy of Camrelizumab (anti-PD-1 antibody) in the treatment of Chinese patients with advanced esophageal cancer in the real world.


Eligibility Criteria:
Inclusion Criteria:

1. Sign informed consent and voluntarily participate in this study.
2. Unresectable locally advanced/recurring or distant metastatic esophageal cancer patients confirmed by histology or cytology (AJCC 8th edition);

   * Unresectable locally advanced patients who are unable or unable to receive radical treatment (including radical radio chemotherapy or radical radiotherapy, etc.) may be considered for inclusion;
   * Patients who progress or relapse after neoadjuvant or adjuvant therapy may also be considered for inclusion;
3. Age ≥ 18 years old;
4. The investigator determines that the patient can receive Camrelizumab as a single agent or combination therapy.

Exclusion Criteria:

1. Evidence suggests that the patient is pregnant or breastfeeding;
2. Other drug blinded clinical trials are currently underway;
3. Other situations that are not suitable for inclusion in this study.
Added Value of Local Clonidine for Spine Postoperative Pain Control, in Addition to Bupivacaine

The objective of this prospective randomized double-blind study is to evaluate the added analgesic value of clonidine to the conventional local bupivacaine wound infiltration in posterior spine surgery.

Patients candidates to posterior spine surgery (Micro-discectomy, Lumbar laminectomy with or without fusion, cervical laminectomy) are asked to participate to this prospective study. After verification of inclusion and exclusion criteria, patients consenting to enter the study are randomly assigned to one of the following subgroups: 1-Pre-incisional wound infiltration with 20 mL of bupivacaine 0.25%. 2- Pre-incisional wound infiltration with 150 μg of clonidine with 20 mL of bupivacaine 0.25%. Demographic parameters, co-morbidities and other pre and per operative medical data are noted. In the post-operative period, patients received a standardized post-operative analgesic protocol (NSAI and paracetamol). Patients are asked to fill their pain diary using Visual Analog Scale (VAS) from day 0 till day 8 after surgery. Morphine rescue consumption is noted. Finally, the percentage of global subjective patient satisfaction regarding the post-operative wound pain is noted from 0 to 100.

Eligibility Criteria:
Inclusion Criteria:

* First (not recurrent) posterior spinal surgery at the operated site
* American Society of Anesthesiologists class I or II (operative risk)

Exclusion Criteria:

* Allergy to local anesthetics or to clonidine
* Pregnancy
* Raynaud's syndrome
* Thromboangiitis obliterans
* History of substance abuse
* Current treatment with corticosteroids
Aspirin, Heparin and Miscarriage

Efficacy of low dose aspirin (LDA) versus LDA plus low-molecular-weight-heparin (LMWH) in patients with a history of recurrent miscarriages.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* History of 2 or more of miscarriage

Exclusion Criteria:

* Twins
A Non-Interventional Study to Evaluate Time to Event and Healthcare Resource Utilisation for Prostate Cancer Participants Throughout the Disease Trajectories Until Progression or Death

Primary objective of this study is to describe the time in each prostate cancer stage from non-metastatic Hormone Sensitive Prostate Cancer (m0HSPC), metastatic Hormone Sensitive Prostate Cancer (m1HSPC), non-metastatic Castrate-Resistant Prostate Cancer (m0CRPC), metastatic Castrate-Resistant Prostate Cancer (m1CRPC) to progression or death.

The secondary objectives of this study are to describe co-medication at each disease stage, to describe co-morbidities at each disease stage and to describe the healthcare resource use and costs associated to each disease stage.

This study has been opened and amended (amendment 2; also known as 9785-MA-3631 study) to describe the time in each prostate cancer state from m1HSPC to progression or death. The secondary objective for amendment 2 is to describe co-medication at each disease state, describe co-morbidities at each disease state, and describe PCa treatments in the m1HSPC state. The aim of the second amendment is to provide up to date real world data on the change of the treatment landscape in the m1HSPC population from 1 January 2021 to 30 June 2024.

This is a retrospective analysis of Prostate Cancer patients from m0HSPC, m1HSPC, m0CRPC, m1CRPC followed in the Prostate Cancer Database Sweden (PCBaSe) database. The patient population consists of men recorded in Patient-overview Prostate Cancer (PPC) between 1 January 2014 until death or 31 December 2016. Patient history to 2006 was collected by retrospective charted review.

Data will be extracted from PPC for the different Prostate Cancer (PCa) disease stages, from m0HSPC, m1HSPC, m0CRPC, m1CRPC until progression or death. The prostate cancer disease progression from m0HSPC, m1HSPC, m0CRPC, m1CRPC until progression or death has not been recorded in a systematic way. Given the complexity of this disease, the aim of this study is to have a comprehensive understanding about the disease progression in prostate cancer, from m0HSPC, m1HSPC, m0CRPC, m1CRPC until progression or death.

In addition, the following will be collected: co-morbidities, co-medication, health care resource utilization and costs, as well as other health economic variables such as sick leave and early retirement at the different disease stages.

Eligibility Criteria:
Inclusion Criteria:

* All patients registered in PPC.

Exclusion Criteria:

* None.
Mirror Therapy in Complex Regional Pain Syndrome Type I

The aim is to evaluate the efficacy of Mirror Therapy on pain reduction and hand function in subjects with unilateral upper extremity Complex Regional Pain Syndrome Type I.

Subjects were randomly divided into two groups. Group A carried out a ten-minute Mirror Therapy exercise daily, for a total duration of six weeks. Group B acted as a control group for six weeks followed by six weeks of Mirror Therapy with the same characteristics as Group A. Upper extremity active range of motion, strength, dexterity, limb volume, right-left temperature difference, and health-related quality of life were evaluated before and after each period. Daily records on the visual analogue scale were used for pain evaluation. Effectiveness was calculated using mixed-effects modelling for between-group comparisons and within-group variability and identifying significant predictors.

Eligibility Criteria:
Inclusion Criteria:

- diagnosis of CRPS I based on the Budapest criteria

Exclusion Criteria:

* failure to meet the diagnostic Budapest clinical criteria for CRPS I
* previous use of Mirror Therapy prior to the commencement of this study
* substantial difficulties in cooperation
* a significant change to the subjects' treatment regimen, outside of the study design
Effect of TENS for Pain and Function After Total Knee Replacement

Our primary hypothesis is that TENS decreases pain with movement by reducing hyperalgesia. Minimizing the severe pain experienced during required activities in the immediate postoperative period will promote functional recovery and prevent the development of new chronic pain syndromes.


Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of the knee
* Speak English
* Unilateral total knee replacement

Exclusion Criteria:

* No ambulation, assisted or otherwise
* Use of TENS by subject in past 5 yrs
* Current use of TENS by someone else in subject's household
* Stroke or other condition which seriously impairs sensation in legs or ability to follow directions.
* Condition that precludes use of TENS (pacemaker, allergy to nickel, etc.)
* Chronic pain (other than in surgical knee) that is currently being treated or is severe. (Do not exclude for fibromyalgia).
Anatomical Variations of Femoral Nerve Location in Relation to Femoral Artery

The goal of this observational study is to learn about the relative position of femoral nerve in relation to the femoral artery in patients scheduled for femoral fractures using ultrasound scanning.

The classical description of femoral nerve is that it lies immediately near to artery, but it is not always true. The nerve lies at a varying distance from the artery.

The main question it aims to answer are:

• Is the age sex and Body Mass Index affect the relationship between femoral artery and nerve?

The femoral nerve block is ideal for surgeries of the femur, knee, or anterior thigh and is often combined with a sciatic nerve block for near complete lower extremity analgesia. The classic teaching is that the femoral nerve lies lateral to femoral artery sandwiched between the fascia iliaca and iliopsoas muscle1.

Aim:

The objective of the study is to find out the anatomical variation in the site of the femoral nerve in relation to the femoral artery, with respect to the age, sex, weight and ethnicity of the patient.

Eligibility Criteria:
Inclusion Criteria:

* above the age of 18 coming for fixation of femoral fracture

Exclusion Criteria:

* below the age of 18
* patient not willing to participate
* patients with neurological illness that hinders from giving a valid consent
* patients with local pathology at inguinal region
Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression

Bipolar disorder is a leading cause of disability worldwide. A high proportion of patients with bipolar disorder experience persistent depressive symptoms that do not respond to standard drug treatments. Recent evidence has suggested that anti-inflammatory treatment may reduce depressive symptoms. Minocycline is a tetracycline antibiotic with good central nervous system (CNS) penetration that has been suggested to be effective as an adjunct drug in improving depressive symptoms. Celecoxib, a selective cyclooxygenase 2 (COX-2) inhibitor, has also shown promising results in the treatment of depressive symptoms. In this factorial design, double blind, randomised controlled trial the investigators will determine the efficacy of minocycline and/or celecoxib as an adjunct to treatment as usual (TAU) in patients experiencing a depressive phase of bipolar I or II disorder. The investigators hypothesise that augmentation with minocycline and/or celecoxib will lead to an improvement in depressive symptoms in participants in comparison with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years;
* Diagnostic and Statistical Manual-5 (DSM 5) diagnosis of bipolar I or II disorder and current major depressive disorder;
* Experiencing current depressive symptoms for at least 4 weeks (HAMD-17 score ≥18);
* Competent and willing to give informed consent;
* Taking the current medication for a minimum of 4 week prior to baseline;
* Able to take oral medication;
* If female, willing to use adequate contraceptive precautions and to have monthly pregnancy tests.

Exclusion Criteria:

* Relevant medical illness (HIV, renal, hepatic, cardiac, serious dermatological disorders such as exfoliative dermatitis, systemic lupus erythematosis);
* Prior history of intolerance to any of the tetracyclines or NSAIDs;
* Concomitant penicillin therapy;
* Concomitant anticoagulant therapy;
* Presence of a seizure disorder;
* Currently taking other antibiotics, other NSAIDs, acetazolamide, or methotrexate;
* Any change of psychotropic medications within the previous 4 weeks;
* Diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last 3 months according to DSM-5 criteria;
* Pregnant or breast-feeding;
* Presence of primary psychotic disorder;
* Serious risk of suicide;
* Current three or more manic/hypomanic symptoms.
Preterm Premature Rupture of Fetal Membranes: Cervical Ultrasound and Biological Markers to Diagnose Prematurity (RECHOBIOL)

Our main hypothesis is to consider that the detection of biomarkers on admission combined with the length of the cervix would improve the prediction of the latency period in case of preterm premature rupture of membranes (pPROM). The primary purpose of the protocol is to assess the performance of these tests to predict a latency period \<48 hours in case of pPROM.

Preterm premature rupture of membranes (pPROM) is defined as a spontaneous rupture before the start of labor ("premature" rupture) and before 37 weeks of gestation ("preterm"). pPROM concern 2-3% of pregnancies. It is the main cause of prematurity since it is responsible for 24 to 42% of preterm deliveries. The time between PROM and childbirth is named the latency period. Its total duration can vary from a few hours to several weeks. Childbirth occurs within 48 hours of rupture for 18 to 93% of cases, within 7 days for 56 to 96% and within 28 days for 78 to 100%. The earlier PROM occurs during pregnancy, the longer the latency period is. The factors associated with a shorter latency period are: cervical changes during admission for pPROM, a shortened cervix on ultrasound or a threat of premature delivery prior to PROM, the existence of uterine contractions, oligoamnios, and the occurrence of a materno-fetal complication of pPROM.

In a pPROM situation, a prolonged latency period improves the neonatal prognosis by increasing the gestational age of birth, gives the possibility of administering the corticosteroid treatment of fetal pulmonary maturation and also allows an in utero transfer in an adapted maternity.

Several studies have shown a correlation between the length of the cervix during rupture and the latency period in the context of pPROM.

To date, there are no effective biomarkers used in current practice to predict this latency period.

We want to assess the diagnostic performance of different vaginal (PIBF / PP14 / IGFBP1 native and total) and serum (PIBF / MIF) markers as well as the ultrasound length of the cervix to predict the duration of this latency period in order to better anticipate the risk of prematurity.

Eligibility Criteria:
Inclusion Criteria:

* Parturient admitted to the Clermont-Ferrand Hospital maternity for preterm premature rupture of membranes between 24+0 and 36+4 gestation week.
* Capacity to give informed consent.
* Coverage by a French social security scheme.

Exclusion Criteria:

* Refusal to participate
* pPROM formally occurred more than 24 hours ago (free flow or positive breakage test)
* Cervical dilatation ≥ 4 cm
* Multiple Pregnancy
* Known uterine malformation
* Fetal Malformation
* Placenta previa
* Abundant metrorrhagia
* Patient under guardianship or curatorship
Tolerability and Safety Study of Recombinant Human Acid Sphingomyelinase in Acid Sphingomyelinase Deficiency Patients

To evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profile of rhASM in adult patients with Acid Sphingomyelinase Deficiency (ASMD) following repeated-dose administration.


Eligibility Criteria:
Inclusion Criteria:

* Patients with documented non-neuronopathic acid sphingomyelinase deficiency
* The patient has a diffusing capacity of carbon monoxide (DLco) \>20% and ≤80% of the predicted normal value.
* The patient has a spleen volume ≥6 multiples of normal(MN). A partial splenectomy will be permitted if performed ≥1 year prior to Screening/Baseline and residual spleen volume is ≥6 MN.
* The patient who is receiving lipid lowering therapy should be on a stable dose and regimen of lipid-lowering therapy(ies) for at least 12 weeks prior to Screening/Baseline, with the patient expected to remain on the same dose and regimen throughout the 26-week treatment period.
* The patient who is female and of childbearing potential must have a negative serum pregnancy test for β-HCG.

Exclusion Criteria:

* The patient is female and pregnant or lactating.
* The patient has a Body Mass Index(BMI)\>30.
* The patient has received an investigational drug within 30 days prior to study enrollment
* The patient has a medical condition or any extenuating circumstance that may significantly interfere with study compliance, including all prescribed evaluations and follow-up activities.
* The patient has had a major organ transplant
* ALT or AST \>250 IU/L or total bilirubin \>1.5 mg/dL.
* The patient is unwilling or unable to abstain from the use of alcohol for 1 day prior to and 3 days after each rhASM infusion for the duration of the study.
* The patient requires medications that may decrease rhASM
* The patient is unwilling or unable to avoid the use of medications or herbal supplements that may cause or prolong bleeding, or have potential hepatotoxicity within 10 days prior to and 3 days after liver biopsy