cyrilzakka/clinical-trials huggingface dataset:
Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds

A prospective randomized controlled study to determine the safety and feasibility of using processed amniotic fluid (pAF) to expedite healing in chronic wounds.

The goal of our study is to assess, in an outpatient setting, the safety and the time to wound closure in chronic wounds treated with processed amniotic fluid (pAF). We will include patients with lower extremity full thickness wounds that are greater than 3 months old and less than 12 months old. The wound size must be greater than 5cm2 and less than 75 cm2. We will exclude anyone that requires skin grafting, or wounds with sinus tracts. Our primary objective is to determine the safety and feasibility of using pAF to treat patients with chronic wounds. The secondary objective is to determine the efficacy of pAF compared to standard of care in reducing wound area.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18-85 years old.
2. Patients with chronic lower extremity wounds (including thermal) that are greater than 3 months, but less than 12 months old.
3. Patients with full thickness wounds.
4. Patients with at least one wound that is ≥5 cm2 and\<75 cm2 in size.
5. Patient who is able to complete required site study visits and procedures in good faith

Exclusion Criteria:

1. Patients admitted to the hospital at the time of enrollment.
2. Patients who are pregnant, nursing or plan to become pregnant while participating in the study. If of child-bearing potential, unwillingness to use effective birth control while participating in the study.
3. Suspicion of or diagnosis of osteomyelitis underlying the wound.
4. Patients who have received an investigational agent or intervention within the prior 30 days or plan to use within the study period.
5. Patient with sinus tracts, enterocutaneous fistulas or other epithelialized tracts.
6. Patients who require skin grafting.
7. Patients diagnosed with a highly disruptive, non-controlled mental health disorder (e.g.., bipolar, or schizophrenia.
8. Patients with a history of prior drug abuse.
Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients (RECOVER-19)

Following the acute phase of COVID, some patients may have sequelae, such as breathing difficulties or malnutrition. We hypothesize that a functional and respiratory rehabilitation program associated with personalized nutritional care will improve quality of life, physical performance and respiratory capacities and will decrease the prevalence of malnutrition among those patients.

In France, more than 150 000 patients have been infected by the SARS-CoV-2 virus and COVID has been responsible for more than 100 000 hospitalizations. Following the acute phase of this disease, some patients may have sequelae, such as breathing difficulties or malnutrition. However, the prevalence and intensity of those sequelae still remain unknown. Thus, a functional and respiratory rehabilitation program associated with personalized nutritional care may be necessary to improve those patients' prognosis.

This study aims to evaluate the effectiveness of a 4-week rehabilitation program following the acute phase of COVID. This program includes regular physical activity supervised by a physical acticity educator, a systematic malnutrition screening and a nutritional follow-up performed by a dietitian. Patients will be randomized in two groups: rehabilitation program (intervention group) or usual care (control group). Quality of life, physical performance, respiratory capacities and nutritional status will be assessed in both groups at inclusion and one month later (corresponding to the end of the rehabilitation program for the intervention group).

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Laboratory (RT-PCR and/or serology) confirmed infection with SARS-CoV-2
* Date of first symptoms of SARS-CoV-2 infection \> 4 weeks and \< 4 months
* Persisting functional and/or respiratory deficit and/or asthenia and/or malnutrition beyond the first 4 weeks after COVID, defined as :
* Increase of mMRC (Modified Medical Research Council) score ≥ 1 between the month before COVID and beyond the first 4 weeks after COVID and/or
* Asthenia score (Pichot asthenia scale) \> 22 beyond the first 4 weeks after COVID, if patient had no asthenia before COVID (asthenia score \<8) and/or
* Weight loss \> 5% within 6 months, comparing minimum weight between the month before COVID and beyond the first 4 weeks after COVID and/or
* BMI (Body Mass Index) \< 20 (if age \< 70 years) or \< 22 (if age ≥ 70 years) if BMI (Body Mass Index) ≥ 20 (if age \< 70 years) or ≥ 22 (if age ≥ 70 years) the month before COVID
* Patient affiliated to social security system
* Patient gave written informed consent

Exclusion Criteria:

* Patient unable to undergo a rehabilitation program due to comorbidities, such as major cardio-vascular disease or severe dementia
* Patient currently benefiting from physiotherapy sessions, in particular motor and / or respiratory therapy and / or an exercise re-training and / or respiratory rehabilitation program
* Patient living in a residential facility for dependent elderly people
* Patient not speaking french
* Pregnant women
Supervised Nurse Assisted Preoperative Assessment (SNAP)

Compare the experience of patients receiving an "optimized" preoperative anesthesia consultation (PAC) performed by a Nurse Anesthetist (supervised by an anesthetist) to those receiving a "standard" CSA ( CSA by an anesthetist alone).

Preoperative anesthesia consultations (PACs) are a key moment in the perioperative care journey. During the PAC, the doctor assesses the patient's state of health (allowing an assessment of the perioperative risk), establishes the anesthesia protocol and writes the preoperative prescriptions. PAC also helps inform and educate patients to reduce their anxiety.

Indeed, if the perioperative care pathway and the risks associated with anesthesia are poorly understood, there is an increased risk of preoperative anxiety, poor compliance with preoperative prescriptions, and therefore potential cancellation of the surgical intervention.

In many countries, preoperative PACs are performed by nurses trained and supervised by anesthetists. These PACs take longer than a consultation carried out by a doctor alone, but would on the one hand have a positive effect on patient education and, on the other hand, ultimately reduce the time and costs associated with the PAC . On the other hand, the impact of PACs performed by nurses supervised by physicians on the perioperative experience of patients and on the rate of cancellations of scheduled interventions has not yet been demonstrated.

Since 2013, so-called "optimized" consultations (PAC carried out by a state-certified nurse - IDE - supervised by an anesthesiologist) have been carried out at the Adolphe de Rothschild Foundation (Paris), for patients having a scheduled surgery intervention. cataract under locoregional or general anesthesia. First, the IDE collects the patient's history and treatments and informs him of the perioperative care pathway. In a second step, the doctor performs the pre-anesthetic medical examination, completes the medical examination and writes the appropriate pre and postoperative prescriptions. This method of consultation made it possible to optimize medical time while providing complete, even better, information to the patient.

That is why optimized PACs may improve the patient's perioperative experience and reduce preoperative cancellations regardless of the type of surgery. programmed.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Must benefit from an anesthesia consultation for general or regional anesthesia for scheduled surgery, whatever it is.
* Express consent to participate in the study
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman
* Patient unable to understand and read French, as well as to complete a self-administered questionnaire
* Patient with mental retardation with impaired judgment
Examination of Trends in Colorectal Cancer Patients' Clinical Study Experiences

Clinical study participation percentages haven't always been fully representative of a given demographic.

Participation in this observational clinical research is extremely valuable since it allows people with colorectal cancer to contribute their own experiences and unique viewpoints.

These vital contributions have the potential to affect the development of novel therapies and support services dramatically.

Trial's findings will be critical in furthering the understanding of colorectal cancer, ultimately leading to better patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Participant has a diagnosis of colorectal cancer
* Patient has self-identified as planning to enroll in a clinical trial for colorectal cancer
* Patient is at least 18 years of age

Exclusion Criteria:

* Inability to perform regular electronic reporting
* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
* Pregnant or lactating woman
Efficacy and Safety of Mycograb as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS

This is a multicenter, randomized, efficacy and safety trial to evaluate Mycograb®. Subjects will be randomized to one of the 3 arms: 1/ Amphotericin B (0.7 mg/kg/d) plus 5-flucytosine (100 mg /kg/d); 2/ Amphotericin B plus Mycograb® (dosed 1 mg/kg via a central line or peripheral venous line twice daily for 7 consecutive days); 3/ Amphotericin B plus 5-flucytosine plus Mycograb® (dosed 1 mg/kg via a central line or peripheral venous line twice daily for 7 consecutive days). After 2 weeks, all patients will be switched to fluconazole at 400 mg/d for 8 weeks and 200 mg/d thereafter. The total duration of the study will be approximately 24 months


Eligibility Criteria:
Inclusion criteria:

* Male or non-pregnant female who is \> 18 years old.
* HIV-positive or unknown, with acute, either first or recurrent episode of cryptococcal meningitis.
* Currently on no treatment, or receiving treatment (\< 3 days) with either amphotericin B plus 5-flucytosine, or amphotericin B alone.
* Positive CSF culture for Cryptococcus neoforman.
* Physical signs and symptoms of meningitis, evidenced by one or more of the following: fever, headache, meningeal signs and neurologic findings.

Exclusion criteria:

* Excluded for coma, or significant other medical conditions.
* Subject has other opportunistic fungal infections that requires other systemic antifungal therapies.

Other protocol-defined inclusion/exclusion criteria may apply
Metabolic Capacity of Israeli Populations

The ability to metabolize drugs varies greatly among individuals. Major fraction of this variability lies in genetic polymorphisms of genes encoding for enzymes responsible for both phase I and phase II reactions.

The purpose of this study ws to evaluate the phenotypic activity and the frequency of genetic polymorphisms in different phase II and phase I enzymes among various populations residing in Israel.


Eligibility Criteria:
Inclusion Criteria:

* Age range 20-50
* Absence of significant disease state

Exclusion Criteria:

* The presence of significant disease states
* The regular use of drugs (including birth control pills)
Spinal Cord Stimulation (SCS) Therapy Study

The purpose of this study is to evaluate the effect of different spinal cord stimulation settings in the treatment of leg pain. Subjects will receive a randomized order of four different programmed stimulation settings for 3 weeks each followed by a fifth and final setting.


Eligibility Criteria:
Inclusion Criteria:

* At least 22 years of age or older at the time of informed consent
* Implanted with a Medtronic RestoreSensor or RestoreUltra SCS system for an on-label indication at least 6 months for the treatment of chronic leg pain, with or without back pain
* Implanted with one or more Medtronic leads located in the epidural space within the thoracic area
* Receiving some level of pain relief with current SCS therapy
* On a stable dose (no new, discontinued or changes in) of all prescription pain medications and willing to maintain or only decrease the dose of all prescribed pain medications
* Read and understand English without assistance
* Willing and able to comply with all study procedures, study visits, and be available for the duration of the study

Exclusion Criteria:

* Diagnosed with complex regional pain syndrome (CRPS), peripheral causalgia, or reflex sympathetic dystrophy (RSD), or causalgia
* Has leg, knee, or foot pain unrelated to on-label indication for SCS therapy (for eg, arthritis, knee surgery, etc.)
* Implanted with both a surgical and percutaneous lead
* Implanted with a peripheral lead for subcutaneous or peripheral nerve stimulation
* Has had any of the following procedures:

  * Neuroablative procedure within six months
  * Neurolytic block within two months
  * Injection therapy for pain within four weeks
  * Sympathetic block within two weeks
* Has an active implanted device (besides RestoreUltra or RestoreSensor neurostimulator), whether turned ON or OFF
* Pregnant or lactating, inadequate birth control, or at risk of pregnancy during this study
* Has an untreated psychiatric comorbidity
* Has serious drug-related behavioral issues
* Has active malignancy or has been diagnosed with cancer and has not been in remission for at least one year
* Has secondary gains which, in the opinion of the investigator, are likely to interfere with the study
* Participating or planning to participate in another clinical trial while enrolled in this study
Effects of PNF Patterns Training on Trunk Balance, and Gait in Chronic Stroke Patients

To determine the effects of PNF patterns Training on trunk balance and gait in chronic stroke patients.

This study will be conducted to investigate the effects of PNF patterns training on the trunk control, balance, and gait ability of chronic stroke patients. Data will be collected from stroke patients from Government Mian Munshi hospital (DHQ) and Riphah Rehabilitation center. A consecutive sampling technique will be use which is based on 6 months' time period. TIS (Trunk Impairment Scale), BBS (Berg Balance Scale), 10 MWT (Meter Walk Test) will be used as a tool to collect the data. SPSS 21 version will be used for data entry and analysis.

This study will provide the effects of PNF patterns training on the trunk control, balance, and gait ability in chronic stroke patients. All possible patients will be taken using random sampling. Single plane training and diagonal pattern training will use. The subjects will randomly assign to the experiment group (diagonal pattern training) and the control group (single plane training). Diagonal pattern training will modified with proprioceptive neuromuscular facilitation technique's chopping and lifting pattern to create 10 movements.

Informed consent will be taken from all patients.

Eligibility Criteria:
Inclusion Criteria:

* Chronic stroke patients whose onset of stroke was at least 6 months to two years
* Ability to maintain an independent standing posture for 30s, ability to walk 30m alone indoor.
* Patient with the ability to communicate enough and to understand oral instructions given by the therapist.
* Patients who were not using assistive devices
* Patients receiving drug therapy of internal medicine for the alleviation of spasticity.

Exclusion Criteria:

* Unconscious patients.
* Patients undergone Spine surgery.
* Patients with Hemi neglect.
* Sensory ataxia or cerebellar ataxia.
* Coronary heart disease (CHD) or peripheral arterial disease (PAD).
* Cardio respiratory problems.
Comparing Multicomponent and Aerobic Training: Impact on Fitness, Psychological and Quality of Life Parameters in Cancer Survivors Patients

The goal of this clinical trial is to evaluate if a multicomponent training program (MCT), including aerobic and resistance exercises, or an aerobic training program (AT) can improve physiological, physical fitness, mental well-being, and quality of life in cancer survivors currently stabilized. The main questions it aims to answer are:

Does MCT or AT improve physiological parameters, physical fitness, mental well-being, and overall quality of life compared to a waitlist control group (WLCG)? Does MCT provide superior physiological an psychological improvements compared to AT?

Researchers will compare:

MCT (a combination of aerobic, mobility, and resistance training exercises) AT (an aerobic-solo training) to see if these interventions improve fitness, health, psychological and quality of life outcomes compared to WLCG (participants not engaging in structured physical activity during the study), and if there will be significant differences between MCT and AT .

Participants will:

Complete assessments of anthropometric, physical fitness, and psychological parameters at baseline (T0) and after 24 weeks (T1).

Be randomly assigned to one of three groups (MCT, AT, or WLCG).

Engage in a 24-week structured training program (MCT or IMCT) supervised by exercise professionals, including:

Warm-up sessions (10 minutes, low-intensity walking). Main sessions (40 minutes): aerobic, mobility, resistance (MCT), only-aerobic (AT) exercises.

Cool-down sessions (10 minutes): breathing and stretching exercises.

This study will provide insights into the efficacy of tailored physical activity interventions for stabilized Cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Women/Men;
* Age between 18 and 80 years at the time of initial treatment;
* Subjects in remission for at least 3 months;
* No diagnosis of secondary cancer at baseline;
* No physical impediment to physical activity (Eastern Cooperative Oncology Groups (ECOG) performance status 0-1);
* Signature of a written informed consent form (or their legally recognized representatives must sign) indicating that the patient understood the purpose and procedures required for the study and is willing to participate in the study;
* Sedentary lifestyle (subjects who have not followed WHO guidelines for aerobic and resistance exercise in the past 3 months).
* Currently in treatment, as long as not hospitalized, in stabilized chronic condition,
* Positive medical specialist assessment of noncompetitive physical activity practice.

Exclusion Criteria:

* Metastasis;
* Uncontrolled hypertension or untreated heart disease;
* Severe musculoskeletal or joint disorders with severe mobility limitations;
* Psychiatric disorders;
* Taking psychotropic drugs;
* Inability to engage in physical activity;
* Lack of fitness to practice sports.
* Expected absence of more than two weeks during the intervention period.
Intra-peritoneal Environmental Changes Following Surgery

The investigators hypothesize that the presence of tumor cells and tumor markers in peritoneal cavity are indicative for peritoneal spread during surgery, and may serve as early markers for systemic and/or intra-peritoneal recurrence of the disease and ultimately improve our understanding of tumor spread and disease recurrence.


Eligibility Criteria:
Inclusion Criteria:

* colon and rectal cancer

Exclusion Criteria:

* none
Short Term Outcomes of Robotic-assisted Intersphincteric Resection for Low Rectal Cancer

This study compared robot-assisted total mesorectal excision to treat very low rectal cancer within 2 cm from the dentate line to avoid permanent colostomy. improves the quality of life with better defecation function, urinary function and sexual function.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years \< age \< 80 years
2. Matching the diagnostic criteria;
3. tumor located 3 cm from anal verge
4. Clinically diagnosed cT1-3N0-2 M0 lesions
5. Tumor size of 4 cm or less
6. ASA 1-3 scores;
7. ECOG score is 0-1;
8. Adequate preoperative sphincter function

Exclusion Criteria:

1. Requiring a Mile's procedure
2. Fecal incontinence;
3. Previous abdominal surgery
4. Severe mental disease.
5. Intolerance of surgery for severe comorbidities
6. Emergency operation due to complication
7. Pregnant woman or lactating woman
Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols

Giving infiltration analgesia around the neck of the womb (= paracervical block, PCB) is frequently experienced as a painful procedure by women undergoing follicle aspiration. Two sedation protocols, where in the one protocol a low dose of alfentanil hydrochloride is already administered before the PCB, will be compared with each other and pain relief measured using the 'Visual Analogue Scale' and the 'Short-Form McGill Questionnaire'


Eligibility Criteria:
Inclusion Criteria:

* Healthy women and female infertility patients
* Between 18 and 43 years of age

Exclusion Criteria:

* Patients with a known allergy to alfentanil hydrochloride or comparable drugs (morphine, cocaine)
PAC-IC-SAOS Obstructive Sleep Apnea Syndrome and Ventricular Function

The aim of this clinical trial is to evaluate the effect of obstructive sleep apnea syndrome (OSAS) treatment in heart failure patients following coronary artery bypass graft (CABG) surgery or other coronary reperfusion.

This clinical trial is a double-blind, randomized, placebo-controlled study.

The first objective is to evaluate the influence of continuous positive airway pressure (CPAP) treatment for OSAS on the ventricular function improvement in heart failure patients, in comparison with OSA patients treated with sham CPAP. This treatment will be instaurated just after the coronary reperfusion surgery

Secondary objectives :

* Evaluation of the effect of CPAP treatment on the endothelial function
* Evaluation of the effect of CPAP treatment on systemic inflammation
* Evaluation of the effect of CPAP treatment on oxidative stress,
* Evaluation of the effect of CPAP treatment on insulin resistance,

after the coronary reperfusion surgery, in comparison with OSA patients treated with sham CPAP and non apneic control patients, with heart failure.

* Assessment of the impact of nocturnal desaturation level on the vascular reactivity and atherosclerosis of mammary vessels collected during surgery.
* Assessment of the impact of nocturnal desaturation level on the oxidative stress, inflammation and insulin sensitivity on abdominal and epicardiac adipose tissue collected during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Coronary Artery Bypass Surgery or other coronary reperfusion
* Heart failure patient: with altered left ventricular ejection fraction by ultrasonography (≤ 50% in 2D) or in 3D

Exclusion Criteria:

* Aortic or mitral valvular replacement
* Aortic surgery
* Triple stimulator implanted less than 6 months ago
* Patient already treated for a SAOS syndrome
* Patient with a central sleep apnea syndrome
* Patient with malignant evolutive pathology
* Pregnant or lactating women