cyrilzakka/clinical-trials huggingface dataset:
StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns

Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the patient's own body (donor site) to the burned part. Autografting is the usual treatment for full-thickness (FT) burns.

It works to close the wound, but can cause other problems:

* Donor sites are painful, can become infected or scarred, or can even become FT wounds themselves
* Treatment problems can require more grafting
* Additional surgery increases risk of medical problems caused by the treatment

Stratatech is trying to find a safe and effective treatment option for severe burns that uses less donor skin.

All participants in this study will receive meshed autograft on one part of their burn (AG Tx). They will receive more widely meshed than AG Tx site autograft with a StrataGraft covering (SOMA Tx) on a different part of their burn.

Each participant will be involved in the study up to about 14 months.


Eligibility Criteria:
Inclusion Criteria:

* Has 2% to 49% (inclusive) total body surface area (TBSA) thermal burn area, including areas of FT injury clinically indicated for surgical excision and autografting, appropriate for protocol-defined treatment areas
* Meets protocol-specified criteria for qualification and contraception
* Is willing and able to comply with all study procedures and requirements
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* Is a prisoner, pregnant, or had previous autografting to treatment sites
* Is expected to survive less than 3 months
* Is participating in another interventional trial, or did within 30 days before enrollment
* Has anticipated treatment sites that are outside protocol-specified parameters
* Has concurrent clinically significant inhalation injury, inadequate fluid resuscitation, or burns of chemical or electrical (non-thermal) etiology
* Has other signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant
  2. the study objectives
Link Between the Sensitivity of Kisspeptin Signalling and Pubertal Onset in Boys.

The specific objective of this study was to investigate the sensitivity of Kisspeptin receptor 1 (KISS1R) by determining the responsiveness of GnRH neuron to kisspeptin administration across the pubertal stages and adult group through measuring plasma LH (luteinizing hormone) and testosterone concentrations.

No studies in humans are available regarding KISS1R signalling that, whether expression of the KISS1 or KISS1R sensitivity increases during the pubertal transition in boys. Kisspeptin regulates HPG (hypothalamic pituitary gonadal) axis by secreting GnRH that acts on the pituitary gonadotrophs to secrete LH and FSH. But in contrast to pubertal period, juvenile period kisspeptin pulsatility is reduced, that leads to low GnRH pulsatility and low level of plasma LH, FSH and testosterone. The objective of this study was to determine the response of exogenous kisspeptin in various juvenile stages up to puberty and also in the adults by measuring the level of plasma LH and testosterone. This study would help us to determine that whether there is any link between the increased sensitivity of kisspeptin signalling and puberty onset?, Or at what Tanner stage pre pubertal boys enter into puberty.

Eligibility Criteria:
Inclusion Criteria:

* Boys were classified into 5 different Tanner stages (I-V) according to the criteria of Feingold D. In Atlas of physical diagnosis. Pediatric endocrinology. 2nd ed. Philadelphia. WB Saunders; 1992, pp. 16-19. For comparison, adult men were also recruited.

Exclusion Criteria:

* Individuals with chronic illness or disorder, i.e. hepatic and renal complications, epilepsy, pneumonia, asthma, orchitis, hernia, cryptorchidism, mental retardation, etc. were excluded from this study
Evaluation of Reporting of Immune Checkpoint Inhibitor Associated Cardio-vascular Adverse Reactions

Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) on the cardio-vascular system. This study investigates reports of cardio-vascular toxicity with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the World Health Organization (WHO) database VigiBase.

ICIs have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and used in combination. However, irAEs can occur. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify cases of cardiovascular adverse drug reaction following treatment with ICIs.

Eligibility Criteria:
Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2017
* Adverse event reported were including the MedDRA terms: Cardiac and vascular investigations (excl enzyme tests) (HLGT), Vascular disorders (SOC), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT), Sudden cardiac death (PT), Cardiac disorders (SOC), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Congenital cardiac disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT)
* Patients treated with ICIs included in the ATC: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity
Ionized Magnesium Balance During Hemodialysis Session

Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the balance of total and ionized magnesium according to different types of dialysate used in clinical practice (acetate + Mg 0.50 or 0.75 mM vs citrate + Mg 0.50 ou 0.75 mM)


Eligibility Criteria:
Inclusion criteria:

* Chronic Kidney Disease patient on dialysis (stage 5D) for more than 1 month
* Anuric patient

Exclusion criteria:

* Patient protected by law
* Patient under guardianship ou curatorship
* Patient deprived of liberty
SPY003-207 in Health Volunteers

This is a Phase 1, randomized, double-blind, placebo-controlled, single dose, first in human safety, tolerability, and pharmacokinetic study of SPY003-207 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Willing and able to attend the necessary visits to the CRU, comply with all testing requirements, remain at the study site unit for the duration of the confinement period and return for the outpatient visits

Exclusion Criteria:

* Participation in more than one cohort
* Evidence of clinically significant abnormality or disease
* Known history of illicit drug use or drug abuse, harmful alcohol use or alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study drug
* History of severe allergic reactions or hypersensitivity
* Donation or loss of \>1 unit of whole blood within 1 month prior to dosing
Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis

The primary objective of the study was to compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) response criteria (ASAS 20%) at week 12.


Eligibility Criteria:
Main inclusion criteria

* Diagnosis of AS (defined by Modified New York Criteria for Ankylosing Spondylitis).
* Active AS (defined by the average of scores on the visual analog scale \[VAS\] of ≥ 30 for duration and intensity of morning stiffness and by 2 of the following: VAS for patient global assessment ≥ 30; average of VAS for nocturnal and total pain ≥ 30; BASFI ≥ 30 (all scores on a scale of 0 to 100).
* 18 to 70 years of age.

Main exclusion criteria

* Complete ankylosis (fusion) of spine.
* Previous receipt of etanercept, antibody to tumour necrosis factor alpha (TNFα), or other TNFα inhibitors.
* Use of disease-modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, or methotrexate within 4 weeks of baseline.
Chidamide in Combination With Vincristine Metronomic Chemotherapy for Advanced Triple-negative Breast Cancer

The mechanism of action of cidabenamide and the advantages of vincristine metronomic chemotherapy make it possible to combine the two drugs. Therefore, it is necessary to conduct a prospective study to investigate the value of chidamide in combination with vincristine metronomic treatment for triple-negative breast cancer.

The mechanism of action of cidabenamide and the advantages of vincristine metronomic chemotherapy make it possible to combine the two drugs. Therefore, it is necessary to conduct a prospective study to investigate the value of chidamide in combination with vincristine metronomic treatment for triple-negative breast cancer.The current study was designed to explore the efficacy of oral two-metronomic agents (chidamide in combination with vincristine) in advanced triple-negative patient in China.

Eligibility Criteria:
Inclusion Criteria:

* female;
* aged ≥ 18 years and ≤75 years;
* histologically proved metastatic triple-negative breast cancer;
* at least one measurable or evaluable lesion based on RECIST 1.1 criteria;
* estimated life expectancy ≥ 3 months; (6) normal heart, liver, and kidney function;
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; -
* informed consent signed by the participants.

Exclusion Criteria:

* received neoadjuvant or adjuvant therapy containing vinorelbine or capecitabine within one year prior to treatment initiation;
* participated in other new drug clinical trials within 4 weeks before enrollment;
* inflammatory breast cancer;
* symptomatic visceral disease;
* second primary malignancy;
* mental disorder.
Non Invasive IDentification of Gliomas With IDH1 Mutation

The recurrent mutation IDH1Arg132His leads to the cellular accumulation of D-2-hydroxyglutarate (2-HG), thus representing a diagnostic marker (this change is almost specific for gliomas) and prognostic (mutated gliomas have longer survival) of interest.

The main objective is to identify the patients with IDH1 mutated glioma by three complementary approaches -genetic (identification of IDH1 mutation in plasmatic DNA), biochemical (2-HG dosage in the urine of patients) and radiological (2-HG

Our preliminary results indicate an extremely high amount of D-2HG in gliomas and CSF of the patients, and therefore the possibility to detect its presence by spectro-MRI, and to establish a non-invasive diagnosis of glioma with IDH1 mutation. Our goal is to identify and quantify by high-field MRI spectroscopy the presence of D-2HG to identify gliomas with IDH1 mutation. In parallel, we developed a technique for selective amplification of the mutated form of IDH1 (COLD PCR): by combining this technique with digital PCR, we already are able to detect IDH1 mutation from free plasma DNA with a sensitivity of 58% and a specificity of 100%. At the same time we have shown that D-2HG levels in urine of patients correlate with the status of the tumor IDH1.

The main objective is to identify using this triple approach (detection of the mutation on plasma DNA detection, detection of urinary D-2HG, detection of tumor D-2HG by spectro-MRI) patients with IDH1arg132His mutation, the secondary objective is to evaluate the value of these markers for patients follow-up and for differentiating recurrence from treatment induced damage. 40 patients with grade II and grade III gliomas (20 mutated, 20 non mutated) will be included and followed up for one year (five measurements are planned).

The first interest is diagnostic: the presence of the IDH1Arg132His mutation allows the diagnosis of glioma. This information is particularly valuable in patients not amenable to biopsy, because of the location of the tumor considered at risk, the general condition of the patient or the co-morbidities and medications. We hope also with these parameters to better monitor patient's follow-up, and to have a new method to differentiate tumor recurrence and radionecrosis or post-radiation leukoencephalopathy.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria

* Affiliated to Health Insurance regimen (sécurité sociale)
* Patient of 18 years or more
* written informed consent
* Glioma grade II or III histologically proven
* Frozen samples available
* Known status IDH1/IDH2
* Presence of a measurable residual tumor (\> 2 cm in diameter FLAIR)
* Karnofsky Performance Status (KPS)\> 60

Exclusion Criteria:

* Contraindication to MRI \*
* The rare patients with IDH2 mutation or with non Arg132His IDH1 mutation will be excluded
* Inability to provide informed consent
* Patient under guardianship or deprived of liberty by court
A Study of SHR-1701 Plus Bevacizumab and Chemotherapy in Non-Small-Cell-Lung-Cancer

Evaluate efficacy and safety of SHR-1701 in combination with bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small-cell lung cancer with EGFR mutation after failure of TKIs


Eligibility Criteria:
Inclusion Criteria:

-

A subject must satisfy all of the following criteria to be considered for inclusion in the study:

1. Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer.
2. Failed with prior EGFR-TKIs treatments.
3. Measurable disease, as defined by RECIST v1.1
4. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1
5. Life expectancy ≥ 3 months
6. Adequate hematologic and end-organ function as defined in the protocol

Exclusion Criteria:

-

A subject who meets any of the following criteria will be excluded from study entry:

1. Histologically or cytologically confirmed mixed SCLC and NSCLC.
2. Symptomatic, untreated or active central nervous system metastases.
3. Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment
4. With any active autoimmune disease or history of autoimmune disease.
5. Inadequately controlled hypertension.
6. Tumour infiltration into the great vessels on imaging.
7. History of haemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment.
8. Uncontrolled tumour-related pain.
9. Patients with active hepatitis B or hepatitis C
10. Severe infections within 4 weeks prior to initiation of study treatment. Active tuberculosis within one year prior to initiation of study treatment.
Cardiovascular Variability and Heart Rate Response Associated With Obstructive Sleep Apnea

Obstructive sleep apnea is often associated with microarousals and a stimulation of the sympathetic nervous system. The knowledge of this autonomic activation may help understanding the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the relationship between obstructive sleep apnea severity, age, gender and heart rate response associated with obstructive sleep apnea. Drug-free patients diagnosed with obstructive sleep apneas were included. Clinical data and 24-h polysomnography recordings were analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Restless legs syndrome patients
* Hospital routine for sleep disorders breathing diagnosis
* Apnea index \> 0

Exclusion Criteria:

* Narcolepsy-cataplexy
* Sleep irregularities and sleep deprivation symptoms
* Lack of neurological or psychiatric diseases
* Periodic leg movements
* Central sleep apnea, treatment
* Cerebral lesion
* Medical illness
* Medication or drinks affecting sleep and wake state.
Effect of Dry Needling on Myofascial Trigger Point

Myofascial trigger point is one of the most common causes of musculoskeletal disorders. Myofascial trigger point in upper trapezius has been reported as a symptom in patients with neck and upper thoracic pain. The purpose of this study was to investigate the prolonged effect of dry needling on myofascial trigger point in upper trapezius muscle.

Pain intensity and Disability of arm, hand and shoulder (DASH) were collected at base line and at the end of treatment sessions, two weeks and three months follow up in both groups.

Eligibility Criteria:
Inclusion Criteria:

* 1. Presence of a palpable taut band in muscle.
* 2. Presence of a hypersensitive tender spot in the taut band.
* 3. Reproduction of the typical referred pain pattern of the MTP in response to compression. To detect active TrPs, TrP pressure tolerance was assessed using a mechanical pressure algometer. The investigator applied continuous pressure with the algometer with an approximate pressure of 2.5 kg/cm2.
* 4. Spontaneous presence of the typical referred pain pattern and/or patient recognition of the referred pain as familiar.
* 5- Pain of at least 30 mm on a visual analogue scale (VAS). The selected MTP of the UT muscle was located in the middle of the more nearly horizontal fibers of the UT 40.

Exclusion Criteria:

* had a history of fibromyalgia syndrome, whiplash injury, cervical spine surgery and fracture, cervical radiculopathy, having therapy within the past month before the study
* any systematic disease such as rheumatism and tuberculosis or cervical myelopathy, multiple sclerosis
* local infection,
* pregnancy
* taking anticoagulants (e.g. warfarin)
* long-term steroid using
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer

The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine and oxaliplatin) treatment failure in patients with metastatic colorectal cancer.

Phase II portion is an open-label, single arm study. Based on the results of the Phase I portion, weekly KRN330 (0.5 mg/kg) and biweekly irinotecan (180 mg/m2) will be used in the Phase II portion. To be eligible for the Phase II portion, a patient will have recurred or progressed within 6 months of the last cycle of FOLFOX/CapOx +/- bevacizumab (first-line or adjuvant regimen for metastatic colorectal cancer). Patients will continue the treatment until disease progression.

Per protocol, the decision was made to terminate the study based on interim analysis results. The Response Rate in Phase II did not meet the protocol-specified RR of 15% when 0.5 mg/kg KRN330 was administered weekly in combination with irinotecan(180 mg/m2)biweekly.

Eligibility Criteria:
Inclusion Criteria:

* Have histologically confirmed colorectal cancer that is metastatic with measurable disease.
* For the Phase II portion: Have recurred or progressed within 6 months of the last cycle of FOLFOX +/- bevacizumab first-line or adjuvant regimen for metastatic colorectal cancer. Note: Those who had initiated FOLFOX/CapOx but stopped oxaliplatin because of intolerable toxicity are also eligible.
* At least 4 weeks have elapsed since the last chemotherapy, radiotherapy, immunotherapy, or biologic therapy prior to enrollment (except at least 6 weeks in the case of nitrosourea and mitomycin).
* Have not received any other investigational agents within 4 weeks of study entry and have fully recovered from any adverse event due to prior therapy.
* At least 4 weeks have elapsed since any major surgery.
* Have ECOG performance status of 0, 1, or 2.
* Have adequate bone marrow and organ function

Exclusion Criteria:

* Have an active, uncontrolled infection.
* Have known HIV positive status.
* Have known or suspected cerebral metastasis.
* Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 6 months; or meet the criteria for AHA class III or IV congestive heart failure (CHF).
* Have a medical condition requiring chronic use of high-dose corticosteroids or other chronic immunosuppressive therapy (e.g. methotrexate, azathioprine).
* Have a history of greater than or equal to Grade 2 allergic reaction or hypersensitivity following exposure to humanized or human monoclonal antibodies (but not chimeric antibodies).
* Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.
A Phase 1 Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200

This is a Phase 1, open-label non-randomized, single dose study in healthy male subjects.

This is a Phase 1, open-label nonrandomized, single dose study in healthy male subjects to determine the absorption, metabolism, and excretion (AME) of \[14C\]-PBI-200

Eligibility Criteria:
Key Inclusion Criteria:

* Males, of any race, 18 to 65 years of age as of the dosing day.
* Body mass index between 18.0 and 32.0 kg/m2, inclusive.
* Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness.

Key Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
Evaluate Aerobic Exercise on Myocardial Fibrosis and Intestinal Flora in Dilated Cardiomyopathy Diagnosed First Time.

To invegstive the Changes of Intestinal Flora and the improvements of Cardiac Fibrosis in Patients With Dilated Cardiomyopathy Diagnosed for the First Time by heart Rehabilitation

Previous studies have confirmed that Aerobic exercise rehabilitation can reduce the rate of readmission of patients with heart failure and improve their cardiopulmonary endurance and exercise ability. However, whether aerobic exercise rehabilitation can inhibit myocardial fibrosis or delay the progress of fibrosis in patients with heart failure has not been reported. At the same time, some studies have shown that the change of intestinal microbial flora may promote the progress of heart failure, and regular aerobic exercise will also lead to the change of intestinal microbial flora, but whether aerobic exercise rehabilitation can improve intestinal microbial flora in patients with dilated cardiomyopathy has not been reported. In our study, patients who were hospitalized for heart failure for the first time and were finally diagnosed with dilated cardiomyopathy were recruited. Recruited patients will enter the routine cardiac rehabilitation process and make an individualized aerobic exercise plan according to the cardiopulmonary exercise test. Cardiac MRI and intestinal microflora changes will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 1、Patients hospitalized for the first time because of heart failure 2、The patient who was definitely diagnosed as dilated cardiomyopathy for the first time

Exclusion Criteria:

* 1、Other types of cardiomyopathy 2、Has been diagnosed as dilated cardiomyopathy. 3、malignant tumor 4、acute infection 5、Cannot perform cardiopulmonary exercise test.