cyrilzakka/clinical-trials huggingface dataset:
Characterization of Pulmonary Microbiome in Cystic Fibrosis Patients

The composition and role of the pulmonary microbiota is not yet well described in cystic fibrosis patients.

The objective of our longitudinal follow-up of primary colonised patients is to show the presence of a link between the composition of the microbiota and the effectiveness of antibiotic therapy.

All patients followed at the Montpellier CF center will be asked to participate in this cohort. All patients have a regular follow-up every 1 to 6 months and will be asked at each visit to keep their sputum sample in excess of the analyses requested for their follow-up

The composition and role of the pulmonary microbiota is not yet well described in cystic fibrosis patients.

According to our hypothesis, the lung microbiota shapes the lung environment of cystic fibrosis patients and modifies the effectiveness of antibiotic treatments and the course of the disease. The objective of our longitudinal follow-up of primary colonised patients is to show the presence of a link between the composition of the microbiota and the effectiveness of antibiotic therapy. Finally, the management of first colonisations could justify the characterisation of the microbiota in order to develop innovative diagnostic tests for the follow-up of patients suffering from cystic fibrosis and possibly the identification of new therapeutic agents based on the microbiota.

All patients followed at the Montpellier CF centre will be asked to participate in this cohort. All patients have a regular follow-up every 1 to 6 months and will be asked at each visit to keep their sputum sample in excess of the analyses requested for their follow-up.

Eligibility Criteria:
Inclusion criteria:

- Cystic fibrosis patient

Exclusion criteria

- Refusal to participate in this research
Effects of Warm up in Athletes With Previous Hamstring Injury

The objectives of this study is to determine the immediate and 10 minutes follow-up effects of a warm-up based on a continous run on a treadmill or the application of a hot-pack in athletes with previous hamstring injury. The investigators have as an hypothesis that the subjects, after one of this interventions show statistically significant improvements in the measurements of pain, flexibility, proprioception and postural control


Eligibility Criteria:
Inclusion Criteria:

* To be 18-27 years old
* To do sports as a minimum of 5 hours per week.
* To have done sport in the last 2 years
* Have a hamstring flexibility of ≤80º on Kendall test
* Diagnosed hamstring injury the last year

Exclusion Criteria:

* To take drugs that alter the motor o postural control
* To do a program of stretching of the hamstring
* To have lumbar pain
* Recent abdominal or spinal surgery intervention
Evaluation of Vitamin D Status in Children With Acute Burns

To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children.

The purpose of this study is to follow up our descriptive observations with a prospective randomized double blinded study to verify our clinical perception that hypovitaminosis D is prevalent postburn and to evaluate whether therapeutic supplementation will enhance specific primary outcome measures during burn convalescence.

Eligibility Criteria:
Inclusion Criteria:

* Child is \> 6 months of age but \< 19 years old
* Burn injury \> 30% total body surface area
* Admitted to SHC within 4 days of injury
* Attending physician decision that patient is likely to survive
* Parents or legal guardian give informed consent along with assent of the child as applicable

Exclusion Criteria:

* Attending physician decision that patient is not likely to survive
* Prior history of anticonvulsant or glucocorticoid use, gastric/bowel resection, parathyroid disease, liver disease, chronic renal failure or prior pharmacologic vitamin D use (\>1000 IU/D)
Antineoplaston Therapy in Treating Patients With Stage IV Pancreatic Cancer

Current therapies for Stage IV Pancreatic Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV Pancreatic Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV Pancreatic Cancer.

Stage IV Pancreatic Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with Stage IV Pancreatic Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV Pancreatic Cancer.
* To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed stage IV adenocarcinoma of the pancreas that is unlikely to respond to existing therapy
* Measurable disease by MRI or CT scan
* Tumor must be at least 2 cm

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 2 months

Hematopoietic:

* WBC at least 2,000/mm\^3
* Platelet count at least 50,000/mm\^3

Hepatic:

* No hepatic insufficiency
* Bilirubin no greater than 2.5 mg/dL
* SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

* No renal insufficiency
* Creatinine no greater than 2.5 mg/dL
* No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

* No uncontrolled hypertension
* No history of congestive heart failure
* No history of other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

* No serious lung disease, such as chronic obstructive pulmonary disease

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* No active infection
* No nonmalignant systemic disease
* Not a high medical or psychiatric risk

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunotherapy
* No concurrent immunomodulating agents

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy:

* Concurrent corticosteroids allowed

Radiotherapy:

* At least 8 weeks since prior radiotherapy

Surgery:

* Recovered from prior surgery

Other:

* Prior cytodifferentiating agents allowed
* No prior antineoplastons
* No other concurrent antineoplastic agents
Effects of Electroacupuncture on Cognitive Symptoms in Major Depressive Disorder

The goal of this pilot Study and Randomized Controlled Trial is to investigate the impact of electroacupuncture on cognitive function, quality of life (QoL), and depression severity in patients with major depressive disorder (MDD).

The main question\[s\] it aims to answer are:

* Primary : electroacupuncture has the potential to treat subjective cognitive complaints and cognitive impairment in MDD outpatients
* Secondary : electroacupuncture has the potential to treat depressive in MDD outpatients The 60 participants will randomly be assigned to either the treatment group or the control group in a 1:1 ratio. The treatment group will undergo electroacupuncture (EA), while the control group will receive sham acupuncture within 10 weeks period.

Both groups will receive antidepressants with adjunctive medication (i.e., benzodiazepines, tricyclics, or antipsychotics) as the standard treatment. All participants will be assessed for executive functions and memory using specific cognitive tests, including the Trail Making Test B (TMT-B), Stroop Color and Word Test (SCWT), category delayed recall in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), and subjective reports of concern regarding concentration, memory, problem-solving, learning, communication, and quality of life (QoL) concerns using the WHO Disability Assessment Schedule (WHODAS 2.0; sections D1.1-1.6 and H1-3), and depressive symptoms were assessed using the Thai-PHQ-9.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 55 years
* MDD diagnosed according to the DSM-5 or DSM-IV-TR criteria,
* low suicidal risk
* receiving treatment with antidepressants for at least 3 months from psychiatrists and psychiatric residents.
* Subjective cognitive symptoms from the screening using the Thai version of the Patient Health Questionnaire (Thai-PHQ-9).

Exclusion Criteria:

* severe cognitive deficits from traumatic brain injury, delirium, neurodevelopmental disorders, or intellectual disability;
* neurological disorders such as stroke, Parkinson's disease, epilepsy, or other brain lesions;
* severe medical conditions preventing lying down for 20 minutes;
* recent electroconvulsive therapy (ECT) within the last 6 months;
* Individuals with a pacemaker;
* visual or hearing impairment that could not be corrected with eyeglasses or hearing aids;
* severe MDD or scoring 20 points or more on the Thai-PHQ-9.
Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN®

The primary objective is to evaluate the Intraocular pressure reducing effect of Xalatan over 3 months. The secondary objective is to study the other efficacy parameters during treatment for 3 months


Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral open angle glaucoma or ocular hypertension (IOP (Intraocular Pressure) ≥ 21 mmHg at diagnosis).
* Naive patients (no prior anti-glaucoma pharmacological or surgical treatment) and patients with beta-blockers therapy failure
* Visual acuity (best corrected) equal to or better than 6/6

Exclusion Criteria:

* closed/barely open anterior chamber angle or history of acute angle closure glaucoma.
* history of any antiglaucoma surgical treatment (Argon Laser Trabeculoplasty and/or any ocular filtering surgical intervention).
* ocular surgery (on the globe of the eye only), or inflammation/infection within 3 months prior to baseline visit. (Applies to both fellow and study eyes.)
* other abnormal ocular conditions or symptoms preventing the patient from entering the study, in the investigator's clinical judgement.
Medical Follow-up of Medical Secretaries of General Practitioners

General practitioners are very often confronted with requests for care from their relatives (family, friends, etc.). In the United States, the recommendations advise general practitioners against taking care of their loved ones on several grounds: lack of professional objectivity, lack of information due to modesty, risk of loss of patient autonomy. Some countries even prohibit general practitioners from prescribing to a loved one except in an emergency.

In France, there is no current recommendation on the care of relatives. Half of French general practitioners have a physical secretary and are therefore potentially confronted with requests for care from their medical secretary.

The aim of the study is to describe the medical follow-up of medical secretaries of general practitioners

Eligibility Criteria:
Inclusion Criteria:

* medical secretaries of general practitioners
* work in face-to-face in the medical practice
* agreed to participate in the study

Exclusion Criteria:

* none
Do Young Triathletes Have a Greater Predisposition to Suffer Running Injuries

In running 70% of the lower limb, injuries are produced in the running segment. The vast majority of sports-related musculoskeletal injuries in young athletes are caused by overuse. Previous research has shown a clear association between running-related injuries and kinematic patterns, showing the existence of a causal relationship between biomechanical alterations and injures.

According to the evidence, that real-time visual and auditory feedback based on gait retraining should be considered to treat injured runners or prevent injuries. However, no previous studies have been carried out on whether gait retraining decreases running-related injuries incidence in young triathletes.

The investigators propose a study to determine the effect of gait retraining on the decrease in the number of running-related injuries and improve the running efficiency in young triathletes.


Eligibility Criteria:
Inclusion Criteria:

* Triathletes included in the Triathlon Plan in High Performance of the Valencian Community in Spain.
* Reported running a minimum of 2 days per week for the last 3 months with no reported injury.
* Worst pain rated a minimum of 3 out 10 on a numerical rating scale (NRS) for pain (0=no pain, 10=worst possible pain)

Exclusion Criteria:

* Previous musculoskeletal surgery.
* Neurological impairment
* Structural deformity in the knee.
* Pain suffered by trauma or sports activity, having stopped running or receiving additional treatment outside the study.
Evaluating Safety and Efficacy of Autologous Gene-edited Muscle Stem Cells (GenPHSats-bASKet)

This study is an investigator initiated first-in-human interventional open label phase 1/2a clinical trial investigating an ATMP in the orphan disease LGMD to evaluate safety and efficacy.

This trial is directed towards a first-in-human application of GenPHSats; gene edited primary human satellite cell derived muscle stem cells as a new Advanced Therapy Medicinal Product (ATMP) in a phase 1/2a clinical trial with Gene edited PHSats (GenPHSats) initiating healthy muscle development in patients with LGDM. The trial is set up to verify if GenPHSats can provide an therapy option for LGDM patients as there is currently no therapy available. The GenPHSats are an autologous product comprised of primary human satellite cell derived muscle stem cells obtained from the patient's own muscle tissue and gene edited in vitro prior to transplantation.

Eligibility Criteria:
Inclusion Criteria:

* LGDM diagnosed,
* Identified gene defect location and gene editing proved feasible,
* Age ≥14 years,
* Patient in treatment in the department at Charité, Universitätsmedizin Berlin, Muscle Research Unit and Outpatient Clinic for Muscle Disorders,
* Signed informed consent

Exclusion Criteria:

* Acute or chronic inflammatory local or systemic disease
* Coagulation disorder
* Known complications due to local anesthesia,
* Congenital heart defect, cardiac arrhythmia,
* Pathology of the airways such as micrognathia
* Pierre Robin Sequence
* Central hypoventilation syndrome/Ondine syndrome
* Significant other medical or psychiatric illness
* Positive serology for HIV and/or hepatitis A, B, C
* Pregnant or lactating women
* Known allergic reaction to constituents of the cryopreservation medium
Is Laparoscopic Excision for Peritoneal Endometriosis Helpful or Harmful?

The trial seeks to test effect of laparoscopic excision of peritoneal endometriosis on pelvic pain. Data will also be gathered on quality of life and neuropathic pain. Patients will be randomized to one of three groups: 1) laparoscopy with excision of endometrial tissue, 2) laparoscopy without excision of endometrial tissue and 3) waiting list control.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years) with suspected peritoneal endometriosis undergoing elective surgery for pain relief
* Pain intensity ≥ 5 on Numeric Rating Scale (NRS) in the four weeks prior to giving consent

Exclusion Criteria:

* Other known conditions/diseases that may cause pelvic pain
* Diagnosed personality disorder, schizophrenia or treatment with anti-psychotics
* Planned pregnancy during study period
* Women who cannot read or speak Danish
Motivational Enhancement to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse - 1

The purpose of this study is to evaluate the therapeutic usefulness of incorporating Motivational Enhancement Treatment into the standard drug abuse treatment entry process of Community Treatment Programs on improving treatment engagement, retention, and outcome.

Participants seeking treatment at the participating CTPs will be randomly assigned to either "standard" or "MET/MI" treatment, with a 1- and 3-month follow-up. Primary outcome measures will include (1) treatment retention (e.g., number of sessions/weeks completed, the rate of patients completing 3 or more subsequent sessions, and (2) substance use (e.g., urinalyses, days of opioid, cocaine, marijuana, alcohol use, rates of abstinence). Secondary outcomes will include motivation, psychosocial functioning, HIV risk behaviors, treatment utilization, and patient satisfaction. Process assessments will include measures of the working alliance as well as therapist adherence/competence ratings which will evaluate how effectively MET/MI was implemented. Participating CTPs will implement one of two independent protocols, depending on which is the best suited or feasible for the intake procedures at their clinic. Thus, following an invitation to participate, explanation of the study, and provision of informed consent, patients would complete a brief assessment battery followed by either: 1) Random assignment to 3 individual sessions of standard treatment (treatment as usual) at the program versus 3 individual sessions of MET. or 2) Random assignment to 1 individual standard assessment/evaluation session.

Eligibility Criteria:
Inclusion Criteria:

Individuals will be eligible for the protocol who:

* Are seeking outpatient treatment for any substance use disorder
* Are willing to participate in the protocol (e.g., to be randomized to treatment, be contacted for follow-up assessment, to have their sessions audiotaped)
* Are able to understand and provide written informed consent

Exclusion Criteria:

Individuals will be excluded who:

* Are not sufficiently medically or psychiatrically stable to participate in outpatient treatment
* Are seeking detoxification only, methadone maintenance treatment or residential inpatient treatment
Bioequivalence Study of BAY77-1931 Granule

The study is conducted as a randomized, non-blinded, 2-way crossover study. Target population is 60 Japanese healthy male adult subjects selected by screening examination which will be conducted within 4 weeks before the first drug administration of period 1 (before the hospitalization of period 1). Subjects will admit in the clinical institute on Day -3 and be discharged on Day 6 in each period. During hospitalization, standardized phosphate diet from Day -2 to Day 4 will start approximately 20 minutes before dosing. Subject will take about 1300 mg of phosphate evenly at breakfast lunch and dinner for each day. Subject should consume at least 95% of a meal. Distilled water not to include phosphate will be used for drinking water and meal. Subjects are to drink at least 1 L of distilled water every day in clinic to make sure enough urine volume. The 24 hours urine collection will be conducted between Day -2 and Day 4 to investigate the urinary phosphate excretion.BAY77-1931 granule 500 mg or Fosrenol chewable tablet 500 mg will be administered three times daily after each meal from Day 1 to Day 4. On day 4 single dose after breakfast will be administered. Study drugs will be administered immediately after each meal, that is within 20 minutes after start of each meal with 240 mL of distilled water. A Fosrenol chewable tablet 500 mg will be taken after chewing completely.


Eligibility Criteria:
Inclusion Criteria:

* Japanese male volunteers who must have given their written informed consent to participate in the study
* Age is between 20 and 45 years
* Body Mass Index (BMI) is between 17.6 and 26.4 kg/m2.
* Volunteers who are judged by the investigators to be suitable for enrollment in this clinical trial based upon the data from a screening test.

Exclusion Criteria:

* A history of relevant diseases of internal organs (diseases that may significantly jeopardize body systems, such as severe liver or renal dysfunction, active peptic ulcer, ulcerative colitis, Crohn's disease, narrowing of colon lumen) or, of the central nervous system (e.g., epilepsy), or other organs which are likely to show inappropriateness for participation in this study
* Conditions of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator (mental diseases that are thought to be ineligible for the communal life in the study participation, unable to consent to the participation, disables)
* Known drug hypersensitivity or idiosyncrasy
Capsule Endoscopic Miss Rates Determined by Back-to-Back Capsule Endoscopy

The purpose of this study is to determine the missing rate of capsule endoscopy using back-to-back capsule endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with obscure gastrointestinal bleeding

Exclusion Criteria:

* Intestinal stenosis or obstruction
* Swallowing difficulty
* History of abdominal surgery
* History of radiation therapy for abdominal or pelvic lesion
* Age \< 15 years
* Pregnancy
* Unstable vital sign or massive hematochezia
* Bleeding lesion, mass \> 2 cm, or intestinal stenosis found by CT angiography
Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences

The purpose of this study was to assess the effectiveness of a moderated physical exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order to control excessive maternal weight gain and its consequences. Additionally, other objectives of the study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy outcomes and on the perception of the pregnant's health

BACKROUND: Pregnancy and delivery can condition significantly women's health. In particular, an excessive gain of weight during pregnancy constitutes a risk factor which may lead to (i) different alterations during pregnancy such as gestational diabetes or hypertension, (ii) foetus health problems (macrosomia), (iii) delivery complications (dystocia, prolonged labour and increased number of caesareans) and (iv) future health disorders for the woman (overweight, obesity and cardiovascular alterations). Furthermore, during pregnancy pelvic floor health problems, such as urinary incontinence (IU) may arise or worsen.

OBJECTIVES: The main aim of this study was to assess the effectiveness of a moderate physical exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order to control excessive maternal weight gain and its consequences. Additionally, other objectives of the study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy outcomes (maternal and foetal) and on the perception of the pregnant's health.

DESIGN: A randomized, controlled trial called has been conducted. 300 healthy pregnant women were recruited and divided into an intervention group (IG, n=100) and a control group (CG, n=200). The IG participated in BEP as from week 10-12 of gestation (at least 56 sessions through 22 weeks. 3 sessions per week). The CG did not participate in any supervised program addressed to pregnant women but received regular health care. Pregnancy outcomes regarding the mother and the new born, urinary incontinence and women's habits data were obtained and registered through initial interviews, medical records and two specific questionnaires on health and urinary incontinency (ICIQ-SF and King's).

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women
* Delivering in "Hospital Universitario de Fuenlabrada"
* At week 10-14 of gestation
* Able to attend 3 sessions per week until the end of the pregnancy

Exclusion Criteria:

* Contraindications appointed by ACOG
* Less than 56 sessions