cyrilzakka/clinical-trials huggingface dataset:
Phase 1 Study of MPC-6827 and Carboplatin in Recurrent/Relapsed Glioblastoma Multiforme

This is an open-label, dose finding, multiple-dose study in subjects with recurring/relapsing glioblastoma multiforme. Three dose levels of MPC-6827 will be administered with carboplatin to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with carboplatin.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven WHO Grade IV glioblastoma multiforme at time of diagnosis or relapse
* Prior treatment with radiotherapy and temozolomide
* Evidence of measurable recurrent or residual primary tumor by contrast-enhanced MRI
* Be a minimum of 4 weeks since prior surgical resection, major surgical procedure, radiation therapy or cytotoxic chemotherapy (6 weeks since prior BCNU or CCNU)
* Have a Performance Scale of Karnofsky \> 60%, ECOG \< 2 or WHO \< 2
* If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week

Exclusion Criteria:

* Hypersensitivity to Cremophor EL
* Have evidence of current/active intratumor hemorrhage by MRI
* Have greater than second relapse
* Have had prior treatment with platinum-based chemotherapy
* Have cardiovascular disease
* Have cerebrovascular disease
* Have uncontrolled hypertension
* Have a cardiac ejection fraction \< 50%
* Have Troponin-I elevated above the normal range
Study on the Tailored Intervention Strategy of Childhood Obesity Based on Monitoring Physical Activities and Dietary Behaviors

The project aims at developing the tailored intervention strategy of childhood obesity based on monitoring physical activities with accelerometer and dietary behaviors using diary. It probably raise the passion of obese children to control weight, form healthy life style, be effective in sustaining weight loss and early prevent adulthood diseases.

The overweight and obese primary school students from 1-5 grades will be recruited according to "Body Mass Index Reference for Screening Overweight and Obesity in Chinese School-age Children". The participants with will be allocated with schools as the unit to four groups: tailored intervention based on monitoring physical activity and dietary behaviors, exercise intervention group based on the Happy 10 program, nutrition education intervention group. The three intervention groups received the designed interventions for the duration of 1 year. Before and after the intervention, we will carry out a questionnaire survey, a physical measurement, a fitness test, and a metabolic markers detection

Eligibility Criteria:
Inclusion Criteria:

* Overweight and obese children from grade 1-5 primary schools

Exclusion Criteria:

* Students with any contraindication or physical diseases (heart, Lung, liver, kidney, other vital organs, endocrine diseases and drug side effects et al.) and psychological illnesses that may prevent them from participating in physical activity and eating a normal diet were excluded
RYGB AL 150cm BPL 100cm vs RYGB AL 100cc BPL 150cm

A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized according the limb lengths:

* Group 1: Alimentary limb (AL) 150cm and biliopancreatic limb (BPL) 100cm
* Group 2: AL 100cm and BPL 150cm

Weight loss will be evaluated 1 year after surgery

A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized according the limb lengths:

* Group 1: Alimentary limb 150cm and biliopancreatic limb 100cm
* Group 2: Alimentary limb 100cm and biliopancreatic limb 150cm

Weight loss will be evaluated 1 year after surgery

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 40 Kg/m2
* BMI \> 35 Kg/m2, associated with obesity-related comorbidities
* Patients undergoing Roux-en-Y gastric bypass as bariatric procedure

Exclusion Criteria:

* Patients undergoing Roux-en-Y gastric bypass as revisional procedure
* Patients lost to follow-up
Development and Test of a Headset for BCI Until Obtaining an Efficient and Comfortable System That Can be Used in Daily Practice by ALS People

"Brain-computer interfaces (BCIs) are computer-based systems that acquire brain signals, analyze them, and translate them into commands that are relayed to an output device to carry out a desired action. BCIs represent a very active and promising field of research among devices for people with severe motor disabilities. As the currently available systems correspond to research prototypes, they are not adapted to daily live situations. On the other hand, some systems have recently been commercialized, principally for video games but they are not satisfactory for use as a substitute technology in disability.

A BCI's prototype for alternative communication using a virtual keyboard, the P300 Speller, has been developed by the National Institute for Research in Digital Science and Technology (Athena team - Nice University). This prototype includes an EEG-cap with gel based active electrodes. A recent study conducted on 20 patients with ALS (University Hospital, Nice) demonstrated the usability of the system and the patient satisfaction concerning the ease of use and utility. To achieve a system that can be used in daily live in severely disabled patients, technical developments are necessary.

The investigators have conceptualized and developed an ergonomic, comfortable, headset, including dry electrodes to allow a prolonged use of the system.

The purpose of the study conducted all along the development of the headset is to improve the developed system until a successful system is achieved. This study is a monocentric usability study conducted on ALS people.


Eligibility Criteria:
Inclusion criteria

1. Age ≥ 18 years old
2. For women of childbearing potential, use of contraception for the duration of the study
3. Diagnosis of suspected ALS, possible, probable with ENMG, probable, defined according to the criteria of the World Federation of Neurology (revised El Escorial criteria, Airlie House Conference 1998)
4. Understanding of the objective of the study after describing the principle of the P300 Speller and the course of the study
5. Ability to follow the study procedure and to comply with the schedule of visits when entering the study
6. Expression of a P300 wave under the conditions of the study

Exclusion criteria

1. Psychiatric illness or dementia that may interfere with the patient's ability to follow study procedures
2. History of photosensitive epilepsy
3. Patient subject to protective measures
4. Non-correctable visual disturbances
5. Limited ability to concentrate.
6. Women who are pregnant or breastfeeding or who have planned a pregnancy during the course of the study.
7. Persons deprived of their liberty by a judicial or administrative decision
Facing Eating Disorder Fears for Anorexia Nervosa

FED-F is a modular treatment that enhances exposure therapy with psychoeducation and cognitive skills teaching how to face fears of (a) food, (b) weight gain, (c) interoception/body, and (d) social situations. The study goals are to (1) refine and test the acceptability and feasibility of FED-F treatment (Phase I), (2) test if this treatment outperforms treatment as usual (TAU) delivered post-acute treatment as adjunctive to stepdown specialty care (Phase II), and (3) to examine if treatment targets the hypothesized mechanism of action: approach behaviors (Phase II). These goals will lead to a highly deployable and accessible virtual treatment targeted at core AN mechanisms that predict relapse. Specific aims are to (1) refine FED-F into a fully virtual format with input from patients and stakeholders and collect preliminary data (N=10) on its feasibility and acceptability (Phase I), (2) conduct a small pilot RCT (randomized controlled trial) of FED-F (n=30) as compared to TAU (n=30; Phase II), and (3) examine if FED-F targets approach/avoidance behaviors and test if this mechanism is associated with clinical outcomes (Phase II).


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Meets criteria for DSM-5 defined AN, AN partial remission, or AN full remission, Atypical Anorexia Nervosa (AAN), AAN partial remission, or AAN full remission
* Has been discharged from intensive (i.e., inpatient, residential, or partial hospital program) in the past 6 months

Exclusion Criteria:

* Under 18
* Over 65
* Does not meet criteria for DSM-5 defined AN, AN partial-remission, or AN full-remission
* High and active Suicidality
* Active Mania
* Active psychosis
* Medically Compromised Status including extremely low weight (less than or equal to 75% median BMI for age, sex, and height)
* Does not meet criteria for DSM-5 defined AN, AN partial remission, or AN full remission, AAN, AAN partial remission, or AAN full remission
* Has not been discharged from intensive (i.e., inpatient, residential, or partial hospital program) in the past 6 months
Thermic Effect of Three Different Meals in Healthy Women

This study will investigate the acute effect of three isocaloric meals varying in level of food processing, including a whole foods, gluten-free, and highly processed meal on energy metabolism and blood glucose in 8-12 young adult, normal weight females. A secondary aim of this proposed study is to compare palatability, satiety, and perceived energy ratings among highly processed, unrefined, and gluten-free unrefined isocaloric meals.

A shift towards a diet containing large quantities of highly processed foods is believed to be a major contributor to the trends in obesity. The degree of processing of foods often affects the nutritional content of the constituents. A reduction in macromolecular complexity allows for an increased rate of digestion, meaning that the body does not have to work as hard to metabolize high processed food products. Thus, the purpose of this study is to investigate the effect on energy metabolism and blood glucose after the consumption of an unrefined, whole foods meal versus two highly processed food meals, including a common Western style meal and gluten-free meal in 8-12 young adult, normal weight females. A secondary aim of this proposed study is to compare palatability, satiety, and perceived energy ratings among highly processed, unrefined, and gluten-free unrefined isocaloric meals. It is hypothesized that an unrefined meal will induce a greater postprandial thermogenic response and a smaller blood glucose response than a highly processed or gluten-free meal. Additionally, it is hypothesized that a highly processed foods meal will be considered more palatable than an unrefined or gluten-free meal.

Eligibility Criteria:
Inclusion Criteria:

* Healthy females between the ages of 18 and 24 years that have BMIs that fall in the range of 18.5 kg/m2 to 28 kg/m2.

Exclusion Criteria:

* Those with a history of celiac disease or other food allergies, metabolic disease or heart disease.
A Study to Compare Mycophenolate Mofetil and Tacrolimus in the Treatment of Membranous Lupus Nephritis

This is a prospective randomized open-label pilot study to compare mycophenolate mofetil in combination with corticosteroid treatment and tacrolimus in combination with corticosteroid treatment in membranous lupus nephritis. The change in urine protein excretion will be the primary outcome studied. The study duration will be 24 months for each patient.


Eligibility Criteria:
Inclusion Criteria:

* abnormal urine protein excretion and biopsy-proven membranous lupus nephritis
Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance:

This study assess the relationship between lower limb spasticity and trunk movements during static and dynamic balance in post-stroke patients who also underwent conventional physical therapy, visual feedback balance training and radial extracorporeal shock wave therapy intervention.

The stabilometric assessment through Prokin system complemented the clinical evaluation and provided a more objective, global insight into the combined therapeutic effect.

The stabilometric computerized system is both an assessment tool and a training system for static, dynamic balance and trunk. To date, it was used in various clinical trials as a training tool for promoting stance and balance improvement in several neurorehabilitation programs.

Additional outcomes focused on the effectiveness on pain intensity, clonus, passive range of motion, lower limb sensorimotor function, and functionality. The adverse events were also attentively monitored during the trial.

Eligibility Criteria:
Inclusion Criteria:

* a hemorrhagic or ischemic stroke in acute, subacute or chronic phase;
* no history of previous stroke;
* lower limb post-stroke spasticity and spasticity grade ≥1 on the Modified Ashworth Scale (MAS);
* pain intensity measured on Visual Analogue Scale (VAS) ≥1;
* ability to stand unassisted in upright position for 30 seconds;
* no change in anti-spastic drug dose or treatment and no changes in analgesic medication, as it could affect the results on the Modified Ashworth Scale and the Visual Analogue Scale
* adult patients (\>18 years old)

Exclusion Criteria:

* other neurological and orthopaedic disorders or lower limb deformities that could in-terfere with motor performance and balance;
* myopathies;
* severe cognitive impairment, severe aphasia or inability to understand instructions;
* severe spasticity;
* visual field conditions or hemineglect;
* patients unable to undergo follow-up evaluation and excluded from the final analysis;
* anticoagulant medication or any contraindication to receive radial extracorporeal shockwave therapy (rESWT), or any contraindication to physical therapy.
Evaluation of Gut Microbiome in Patients With Prostate Cancer

The research will focus on the possible connection between prostate cancer, and various species of bacteria in the large intestine. In consecutive patients, referred to prostate biopsies, rectal swabs will be taken before the biopsies and before antibiotic treatment. The gut flora will be examined and characterized by a microbiome analysis tool. Negative patients will serve as internal control. The investigators will look for association between prostate cancer of various grades and the presence of specific enteropathogens in the rectal flora of the participants.

Prostate cancer is the no. 1 cancer among men. Risk factors include Afro-American origin, prostate cancer in a first degree relatives and the presence of BRCA2 genetic mutations. No specific association has been described yet between prostate cancer and specific gut bacteria.

The GI tract is the home of billions of bacteria. The microbiome functions as a separate organ and contains 10 times the amount of genes compared to the human genome. The microbiome has crucial impact on the human metabolism, inflammatory processes and filtration of GI content. All of these effects may contribute to the exposure of the human body to various carcinogens and inflammatory factors, leading eventually to the development of cancer in remote organs.

The purpose of this research is to try and identify specific species that might be related to the development of prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* male gender
* age above 45
* referred for prostate biopsy

Exclusion Criteria:

* age below 45
* antimicrobial therapy in the 7 days prior to biopsy
* previous prostate or pelvic irradiation
* patients who suffer from inflammatory bowel disease
* systemic chemotherapy for any reason in the 3 months prior to the biopsy.
To Evaluate the Clinical Study of CUD005 Injection in Patients With Cirrhosis

The study is a single-center, single-arm, open-label, dose-escalation clinical study, to evaluate the tolerability, safety and preliminary efficacy of CUD005 injection in patients with cirrhosis

The study was designed according to the 3+3 principle, with a total of 3 dose levels and dose escalation.

Low-dose group: 5.0×107 cells/time; Medium-dose group: 1.5×108 cells/time; High-dose group: 5.0×108 cells/time. Subjects were sequentially placed in 3 different dose groups administered as a single peripheral intravenous dose.

According to the enrollment restriction design, a total of a minimum of 9 subjects are expected to be enrolled, and the final sample size depends on the number of DLT, the number of dose groups ascended before DLT is observed, and the MTD is determined.

Eligibility Criteria:
Inclusion Criteria:

1. BMI≤30 kg/m2
2. The results of liver histopathological examination were consistent with the Ishak stage of liver fibrosis ≥3 points；
3. Consent to liver histopathological examination before and after cell therapy (The subject is exempted from liver histopathological examination during the screening period, if he has been performed liver histopathological examination within 2 months before signing the informed consent)；
4. Subjects were able to communicate well with the investigator, cooperate with follow-up work, and understand and comply with the requirements of the study.

Exclusion Criteria:

1. Subjects who were Allergic to cell therapy, steroids, and related drugs used in the study；
2. Have malignant tumors, history of organ transplantation or tissue regeneration therapy, active, known or suspected autoimmune diseases, idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, active pneumonia, heart disease that is not well controlled, hypertension, etc;
3. Subjects with stage III or IV hepatic encephalopathy within 3 months before apheresis or currently diagnosed；
4. Virology shows anti-HCV antibodies, HIV-positive, or syphilis antibodies during the screening period；
5. Subjects were HBV surface antigen positive and HBV-DNA titer was ≥ 20 IU/mL during the screening period；
6. Subjects with clinically symptomatic ascites or pleural effusions requiring puncture drainage. Or who had received thoracic and ascites drainage within 2 weeks prior to treatment, had may only show a small amount of ascites or pleural effusions on imaging, except in those without clinical symptoms；
7. According to the judgment of the investigator, the subjects had other factors that may cause the study to be terminated halfway, such as other serious concomitant diseases (such as severe diabetes, mental illness, drug use, etc.), serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples.
Evaluation of Topical Mitomycin C as Adjuvant Drug to Esophageal Dilation in Children

This study aims to evaluate mitomycin C as an adjunct to endoscopic treatment of esophageal strictures.

This is a crossover, controlled, clinical trial in which children with esophageal stricture will be randomized in two groups to receive either topical mitomycin or no additional treatment during standard esophageal dilation session.

Topical mitomycin C has been used as an adjunct drug to endoscopic treatment of aero-digestive strictures. There has been some case reports and case series of this application in esophageal strictures in children, with good results. Nevertheless, it lacks a controlled clinical trial to access the efficacy of the mitomycin C in this context.

This study aims to evaluate mitomycin C as an adjunct to endoscopic treatment of esophageal strictures.

This is a crossover placebo-controlled single-blind clinical trial.

Patients: Subjects up to 18 year-old, with esophageal stricture requiring endoscopic dilation, either due to dysphagia or by stricture preventing passage of the endoscope.

Inclusion criteria:

* peptic esophageal stricture
* post-surgical esophageal stricture
* caustic esophageal stricture

The patient will be randomized by one treatment group, either A or B.

* A. during the first endoscopic procedure it will be applied of topical mitomycin C over the esophageal mucosa after dilation, then the second procedure (in two weeks) will be performed as a standard dilation, without mitomycin C.
* B. the first procedure will be performed in a standard way, and after two weeks, in the second procedure mytomicin-C will be spread over the esophageal mucosa.

The allocation will not be informed to the patient. At the end of the study protocol, the patients will be clinically evaluated and the dilation program will continue on discretion of the assistant doctor. The target esophageal bore is 11 mm (or 12.8 mm if age above 5 yrs).

Mitomycin C will be applied over the esophageal mucosa in the site of stricture after dilation with a cotton pledget soaked in solution (0.4mg/ml) by three minutes. The pledget will he held over the mucosa with a biopsy forceps.

Clinical evaluation. Dysphagia will be evaluated by a structured questionnaire, using a Likert scale. The patient will answer the questionnaire daily.

Main outcome measure: Number of days with improved symptom (dysphagia) after a session.

Eligibility Criteria:
Inclusion Criteria:

* children with esophageal strictures
* and dysphagia
* or stricture preventing endoscope to pass over it.

Exclusion Criteria:

* congenital esophageal stricture
* stricture associated to eosinophilic esophagitis
Pain After Cesarean Sectio.

To study the strength of postoperative pain 0-24 hrs after elective cesarean sectio in spinal anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

* cesearean sectio

Exclusion Criteria:

* none
A Phase 2 Study of PH-10 for the Treatment of Atopic Dermatitis

PH-10 is a formulation of rose bengal disodium (RB) for topical administration to the skin. PH-10 is capable of undergoing photochemical reactions when activated by ambient light. This phase 2 study will assess whether topical PH-10 applied once daily to mild, moderate or severe areas of atopic dermatitis (including atopic eczema) may ameliorate inflammation of the skin when activated by ambient light.


Eligibility Criteria:
Inclusion Criteria:

* Men or women, age 18 or older.
* Mild, moderate or severe atopic dermatitis.
* Presence of atopic dermatitis areas outside the head and face with a baseline Investigator Global Assessment (IGA) of 2 (mild disease), 3 (moderate) or 4 (severe disease) at screening.
* Written informed consent by the subject or legal guardian.

Exclusion Criteria:

* Women who are pregnant, attempting to conceive, or nursing an infant.
* Subjects who have received phototherapy (UVB, PUVA) or systemic therapy (immunosuppressants, cytostatics, corticosteroids) within 4 weeks.
* Subjects who have received systemic antibiotics within 2 weeks.
* Subjects who have received topical therapy (tar, corticosteroids) within 7 days.
* Subjects who have received investigational drugs in a clinical research study within 4 weeks.
* Subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of initiation of study treatment.
* Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
* Subjects with clinical conditions that may pose a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
Impact of the Systematic Use of the Criteria STOPP/START in Short Stay Geriatric.

Assess the impact of the systematic use of STOPP/START tool during medication conciliation on the evolution of hospitalised elderly people's quality of life at 2 months.


Eligibility Criteria:
Inclusion Criteria:

* Patient with more than 75 years old
* Hospitalized in geriatrics short-stay
* Patient with a written informed consent
* Patient with a social security scheme

Exclusion Criteria:

* Severe dementia
* Not able to respond to SF-12
* Disease at final stage
* Patient under legal protection (maintenance of justice, tutelage, legal guardianship)