cyrilzakka/clinical-trials huggingface dataset:
A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction

This clinical trial will explore the efficacy and safety of GCSF-mobilized autologous CD34+ cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single administration of CLBS16 or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Men or women age ≥18
* History of and currently experiencing angina at least 3 times per week
* Prior diagnosis of CMD based on coronary flow reserve (CFR) ≤ 2.5 or other measures
* Canadian Cardiovascular Society (CCS) class II, III or IV chronic refractory angina
* No obstructive coronary artery disease
* On stable medical therapy for at least 30 days prior to enrollment
* Must agree to use a reliable and acceptable method of contraception for the duration of participation
* Written informed consent

Exclusion Criteria:

* Myocardial infarction within 90 days
* Prior evidence of obstructive heart disease including PCI or CABG (or planned PCI or CABG)
* Diagnosis of other specific cardiac disease
* Must meet LVEF and GFR requirements
* Current use of coumadin or DOACs
* Hypersensitivity to GCSF, apheresis or study product components
* Positive for HIV, hepatitis B or hepatitis C
* Active inflammatory or autoimmune disease, or chronic immunosuppressive state
* Drug abuse
* Pregnant or lactating
* Malignant neoplasm within 5 years
* History of Sickle Cell Disease
* Participation in another clinical study within 90 days prior to informed consent or concurrently with this study
* Previous treatment with a CD34+ cell based therapy
MindOb: A 12-month Computerized Mindfulness-based Intervention for Obese Individuals

The purpose of this study is to evaluate the efficacy of a daily 12-month computerized mindfulness-based intervention in obese patients diagnosed with Binge Eating Disorder (BED) on: impulsive eating, motivation toward exercise, and weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Adult aged between 18 and 65 years
* Obese (BMI \>= 30)
* Recruited from the nutrition pole of Ambroise Paré Hospital
* Diagnosed with Binge-Eating Disorder (BED) according to DSM5 criteria
* Informed consent provided during inclusion interview

Exclusion Criteria:

* Already participating in a clinical trial
* Bariatric surgery patients (except for gastric band removed at least 3 years before)
* Planned bariatric surgery
* Central obese (genetic)
* Pregnant women
* No internet access at home
* Difficulties to understand French language
* Patients under social protection
* Cognitive dysfunctions in understanding simple guidelines provided by the paramedical staff (e.g., diet or exercise guidelines)
* Auditory disorders not allowing to hear audio files
* Blurred vision not allowing to use Internet
Prevalence av BPPV Among Elderly in Primary Care

This study aims to investigate whether positional tests should be routinely performed on all elderly patients (65 years and older) presenting to primary care with symptoms of acute, episodic, or chronic dizziness or vertigo, unsteadiness, imbalance, and/or an increased tendency to fall in the past 12 months. Study aims to investigate whether diagnostic maneuvers should be performed regardless of the presence of conventional positional vertigo presentation associated with classical cases of benign paroxysmal positional vertigo (BPPV). Specifically, the study aims to identify "hidden" cases of BPPV and assess the potential benefits of clinical screening and initial treatment of BPPV in primary care setting thus improving the BPPV-related quality of life and reducing the risk of falls in the elderly population.


Eligibility Criteria:
Inclusion Criteria:

Patients aged 65 years or older and present to the primary care clinic with one or several of the following:

1. Acute, episodic, or chronic sensation of dizziness/vertigo.
2. Subjective or objective imbalance during stance or movements.
3. Presented with increased tendency of falls by exhibiting unintentional loss of balance resulting in a fall one or more times in the past 12 months.

Exclusion Criteria:

1. Patients not meeting the above epidemiological and medical criteria described under "Inclusion Criteria".
2. Patients presenting with pathologies in which head and neck movements/manipulations are contraindicated, including (but not limited to): cervical instability, acute head and neck trauma, known cervical disk prolapse, Arnold-Chiari malformation, vascular pathologies such as carotid sinus syncope, vascular dissection and vertebrobasilarinsufficiency, including patients with paralysis as well as those with reduced mobility, in whom diagnostic maneuvers cannot be correctly performed.
Multi-family Therapy and School Refusal: an Exploratory Study with Adolescents and Their Families

The purpose of this study is to determine whether multi-family therapy is effective in the treatment of school refusal with anxiety in adolescence.

Anxious school refusal in adolescence is a major public health problem. The involvement of families is essential and multi-family therapy has shown its effectiveness for many mental disorders. This study aims to explore the benefit of multi-family therapy in the care of anxious school refusal in adolescence.

The method will be qualitative with phenomenological analysis of semi-structured interviews with adolescents and their parents and quantitative with a SCED design to assess the evolution of the level of anxiety of adolescents and parents, as well as personalized objectives.

The objective is therefore to improve the care of adolescents with anxious school refusal.

Eligibility Criteria:
Inclusion Criteria:

* Families with an adolescent
* Aged 12 to 18
* Totally out of school for more than 2 consecutive weeks and less than 18 months
* Follow-up at the Maison de Solenn-Maison des Adolescents (Cochin Hospital AP-HP) for a school refusal
* Having agreed to participate in a multi-family therapy
* Domiciliation in Ile de France
* Agreement of the parents and the adolescent to participate in the study: Collection of the non-opposition of non-emancipated minors and their legal representatives

Exclusion Criteria:

* any family situation that makes it impossible to bring parents and children together in family therapy
* patient under curatorship or tutorship
* patient with AME (french State Medical Aid)
Acceptability and Tolerance Study of a High Energy Tube Feed with Food Derived Ingredients

Enterally fed adults and children who are assessed by the dietitian as requiring an adult high-energy, fibre-containing enteral formula will be recruited. Data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.

To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a high energy, adult enteral formula with food-derived ingredients.This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 14-day period with the new tube feed.

Participants or their caregivers will be provided with 14-day supply of the new tube feed and will be asked to complete a daily diary and short questionnaire to record information allowing assessment of the following:

* Gastrointestinal tolerance
* Compliance with prescribed feed volume

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring an enteral tube feed (taking \> 60% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition

  * Children 15 years and over
  * Adults and children requiring an adult high-energy and fibre-containing formula, as assessed by the dietitian.
  * Patients well-established and stable on enteral feeding.
  * Willingly given, written, informed consent from patient or consultee
  * Willingly given, written assent (if appropriate).

Exclusion Criteria:

* Inability to comply with the study protocol, in the opinion of the investigator

  * Children under 15 years of age
  * Patients receiving mechanical ventilation, sedation or inotropic support
  * Patients on total parenteral nutrition
  * Known food allergies to any ingredients (see ingredients list) or galactosaemia
  * Patients with significant renal or hepatic impairment
  * Patients with planned changes to medication or treatments during the study period which may alter gastrointestinal function (e.g. chemotherapy). Changes in medications or nutritional products during the study intervention must be documented.
  * Participation in another interventional study within 2 weeks of this study.
  * Patients with a clinical indication for a low fibre or fibre free diet as advised by the healthcare team.
  * Patients with known or suspected ileus or mechanical bowel obstruction
EFFECT OF USING SAME DERMATOME LİNE FOR ALL PORT SİTES IN LAPAROSCOPIC APPENDECTOMY IN ACUTE APANDICITIS

Acute apandicitis is the one of most common cause of abdominal pain.Most of center still use open appendectomy(OA) technic for acute apandisitis.But Semm was defined Laparoskopic appendectomy(LA) with 3 ports in 1983.Today surgeons skill and experience ara increasing about LA day by day. Because of advantages of LA , this technical tend to be gold standart in acute apandisitis. In LA , all of centers use same technic as 3 ports for the surgery. Port sites located 1 infraumbilical , 1 right lower quadrant and 1 left lower quadrent in this surgery. But 3 dermatome lines have been effected in this style of location .This 3 points causes more pain postoperatively.In our study we will define the port locations into the same dermatome line (T10) . Purpose of this research is incerasing the postoperative pain score ,decreasing postoperative need of analgesia and develop the patient satisfy.

Most of surgeon use 3 port sites for the Laparoscopic appendectomy in acute apandisitis. One of them places to infraumbilical region.,The other ports place to 1 right lower quadrant and 1 left lower quadrent routinly. In this study we will define T10 dermatome lregion in 40 patients who are planing to Laparoscopic appendectomy because of acute apandisitis older than 18 years old , before the surgery . All of LA port sites will put in this region .One of the port will put in infraumbilical site and the other ones will put 10 cm right and left side from infraumbilical port. In control group classic LA port sites will be used in the surgery for 40 patients.These two groups will compare after the surgery by Visual Analog Scala (VAS) Postoperative pain quantity will save by using VAS. Measurements will save in 1 hour,2 hour , 6 hour ,12 hour and 24 hour. All patients will take the same pain relief medication peroperatively and postoperatively. If the pain score would be more than 3 in VAS , all patient will take additional analgesic doses.Patients and VAS researcher will not know the patients group .Study will do as double blind.

Eligibility Criteria:
Inclusion Criteria:

* The patients who will undergo to Laparoscopic Appendectomy for Acute Apandisitis older than 18 years old.

Exclusion Criteria:

* Perforated apandisitis
* Plastrone apndisitis
Immune Response After Stem Cell Transplant in HIV-Positive Patients With Hematologic Cancer

This phase II trial studies the immune response after stem cell transplant in human immunodeficiency virus (HIV)-positive patients with hematologic cancer (blood cancer). Studying samples of blood from HIV-positive patients with cancer in the laboratory may help doctors learn more about changes that occur in the immune system after stem cell transplant.

PRIMARY OBJECTIVES:

I. Examine the development of donor-derived HIV-1-specific immune response following hematopoietic cell transplant (HCT) for treatment of hematologic malignancy in HIV+ patients.

II. Examine the affect of HCT on the pool of latently infected cluster of differentiation (CD)4+ T cells in HIV+ patients given HCT for treatment of hematologic malignancy.

OUTLINE:

Patients undergo leukapheresis for analysis of HIV-1 latent reservoir at baseline and at days +90, +180, +365, and +730, and then annually thereafter as feasible.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* Treatment with highly active antiretroviral therapy (HAART) for at least 1 month
* Viral load has decreased by \>= 1.5 logs or viral load \< 5000 copies/ml plasma on HAART therapy
* Hematologic malignancy associated with a poor prognosis or other diagnosis for which hematopoietic cell therapy (allogeneic or autologous, including gene therapy) is indicated
* Approval for allogenic regimen given at Patient Care Conference
* DONOR: Autologous or allogeneic gene modified cells allowed

Exclusion Criteria:

* A medical history of noncompliance with HAART or medical therapy
* Inability to provide informed consent
* DONOR: Allogeneic donors must not have HIV infection
Prevention of the Age-Related Cognitive Impairment by Exercise and Mental Activity - Berlin Bleibt Fit

The trial will evaluate the effects of frequent exercise and increased mental activity on the age-related impairment of cognitive function in elderly women. Furthermore, we will assess the effects of exercise and mental activity on the mood, physical performance and mental status of participants. We will also search for genetic factors which may be responsible of the observed outcomes.

Two-hundred and fifty-two women older than 70 years will be randomize to one of three groups. The first (exercise) will participate at an exercise program three times weekly for 90 minutes. The training will consist of an endurance and resistance training and will be carried out in a group. Participants in the second group (mental training) will take computer lessons, three times weekly for 90 minutes. Both interventions will be carried out for 26 weeks. Participants in the third group (control) will not participate at an structured intervention.

Eligibility Criteria:
Inclusion Criteria:

* All healthy women older than 70 years with sufficient knowledge of German can participate.

Exclusion Criteria:

* Chronic mental disorders
* Chronic neurological, cardiological, pulmonary or renal diseases.
* Severe osteoarthritis
* Disorders which can be aggravated by exercise (arterial hypertension, coronary heart disease, COLD).
* Cancer in current therapy
* Treatment with glucocorticoids or cytostatic drugs.
* Patients who received an organ transplantation
* Exercise-induced osteoarticular pain
Validation of the ADAMO Watch for the Early Detection of Fall Events in Older Patients

"La Casa nel Parco" (CANP) Project is a multidisciplinary project funded by the European Union and Regione Piemonte aimed to explore innovative technology application in the care of older subjects. In this context, ADAMO is a single arm open label trial evaluating the capability of a wearable watch device to correctly detect fall events in community-dwelling older subjects aged 75 years and older, at high risk of falls. Secondary objectives of the study are to identify specific patterns on telemetric measures and health status variations able to predict future fall events, and to evaluate the tolerability and the influence on patient's quality of life of this wearable device.

The main objectives of the study are to evaluate the impact of the intervention on 1) medication adherence after discharge 2) medication appropriateness.


Eligibility Criteria:
Inclusion Criteria:

* Aged 75 years and older
* At least 2 fall events during the 12 months previous to enrollment
* Signed written informed consent

Exclusion Criteria:

* Severe cognitive impairment
* Bedridden condition
* Patients unable to walk autonomously (walking aids allowed)
The Application of Lens Dysfunction Index (DLI) in the Timing of Age-related Cataract Surgery

Before cataract surgery, subjects in the observation group used iTrace ocular aberration analyzer（itracey Technologies）and IOL-Master 700 biometer to measure the preoperative DLI(Dysfunctional lens index) and SS-OCT image of the lens, and The researchers used the anterior segment slit lamp to take photos of the anterior segment of the subject's lens in a state of dilated pupils .and self-scoring of the preoperative visual quality assessment scale. Healthy subjects in the control group also need to complete the above inspections. After that, three experienced cataract specialist surgeons combined the preoperative optometry data of each subject, the photos of the LOCS III anterior segment and the Catquest-9SF questionnaire score to determine whether each subjects should undergo cataract surgery. The subjects were divided into cataract surgery group and non-surgical group. Finally, statistically study the correlation between the DLI index and the degree of lens opacity that has been collected, and use the ROC curve to calculate the DLI as the best cut-off point of DLI to distinguish whether to perform cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Over 40 years old
* Healthy volunteers with no history of systemic or ocular diseases
* patients with simple age-related cataracts without other ocular diseases
* those who can communicate with the tester at a normal level
* those who can express their own ideas independently

Exclusion Criteria:

* irregular corneal astigmatism
* corneal opacity
* corneal scars
* corneal dystrophy
* shallow of anterior chamber
* retinal abnormalities
* history of eye surgery or laser treatment
* pupil diameter less than 4.00mm in a dark environment
* subjects who did not cooperate well during the examination
Multi Parametric Test Predicting the Risk of Colorectal Neoplasia Recurrence

This project is dedicated to identify the patients with possible higher risk of adenoma recurrence who should have follow-up colonoscopy in yearly interval. As a result, it can lead to optimizing the of follow-up colonoscopies intervals in real-world practice.

In this project, 200 individuals (aged 18 - 75 years) with removed colorectal polyps larger than 10 mm during colonoscopy performed based on all indication (including symptoms and screening procedures) will be included. All procedures will be done with high quality endoscopes (high definition, HD).

In all polyps, the advanced imaging techniques (such as chromoendoscopy and NBI) will be used to determine parts of the polyp suspicious from high-grade dysplasia or cancer. The therapeutic method will be decided by the size and macroscopic appearance of the polyp. In case of flat, sessile polyps and LST lesions (laterally spreading tumors) EMR or ESD will be performed. Pedunculated polyp will be removed by EPE. The goal is to achieve the en-bloc resection. Pathologists (with presence of the endoscopist) will do the first step of histopathology evaluation (cutting the polyp tissue). The aim is to perform the first cut in the most advanced part of the polyp and high density cutting in this area. Standard histopathology evaluation will proceed and will be followed by initial basic molecular testing.

Subsequently, all patients will be observed by colonoscopy in one-year intervals with focus on polyp recurrence. The group of high-risk patients will be selected with at least one of these criteria: 1/ high grade dysplasia adenoma at index colonoscopy; 2/ high score of polyp heterogenity at index colonoscopy; 3/ polyps recurrence at follow-up colonoscopy.

In a high-risk patients group the extensive somatic mutations profiling will be carried out according to multitarget sequencing by NGS technologies (next generation sequencing). Same testing will be done in randomly selected patients not included in the high-risk group, which will be used as a control group for statistical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal polyp larger than 10mm removed by colonoscopy therapeutic method (EPE, EMR, ESD)
* Signed informed consent with the study and with colonoscopy

Exclusion Criteria:

* FAP, HNPCC and other hereditary CRC syndromes probands
* Recent diagnostic, follow-up or preventive colonoscopy (FOBT-positive colonoscopy, screening colonoscopy) in ≤ 3 years
* Colonoscopy contraindication
* Severe acute inflammatory bowel disease
* Severe comorbidities; likely non-compliance of the patient
The Effect of Kinesio® Tex Application on Pain, Functionality, Sleep Quality and Work Performance in Drivers

This study was planned to examine the effect of Kinesio® Tex application on pain, functionality, sleep quality and work performance in drivers experiencing neck-back pain.

50 active drivers will be included in the study. The drivers included in the study will be randomly divided into two groups as exercise group and taping group. The home exercise program will be visually explained to both groups and the exercises will be sent to the participants as video. Kinesio® Tex will also be applied to the banding group. Evaluations will be made before treatment and after 6 weeks of treatment. Within the scope of the evaluation, demographic information of the patients, work experience, daily working time, dominant hand, education information (university / high school), type of vehicle used, habit of leaning elbow on the left window, diseases and drugs used, smoking and alcohol use, given after mutual interview will be obtained by recording the answers. Joint range of motion, manual muscle test, pain severity of the individuals participating in the study with the Visual Analog Scale, neck functionality assessment with the Neck Disability Indicator, back functionality assessment with the Quebec Back-Low Back Pain Disability Scale, sleep quality assessment with the Pittsburgh Sleep Quality Index, work performance assessment To be assessed by the Work Role Functioning Questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study Having signed the voluntary consent form.
* Being between the ages of 18-65
* Working in home health services for at least 2 years
* Reporting symptoms of localized pain and discomfort in the neck-back region lasting at least 1 week in the last 12 months

Exclusion Criteria:

* The participant's wish to terminate the study
* Receiving physical therapy for neck-back pain in the last 3 months
* Findings such as pins and needles, numbness and tingling in the upper extremity
* Having an allergy to taping
* Presence of a known specific disease that may cause chronic neck-back pain (nerve root compression, postoperative condition in the neck and shoulder regions, peripheral entrapment neuropathy, cervical spine anomaly, severe neck trauma such as whiplash, malignancy, migraine).
* Alcohol and drug addiction
* Psychological conditions that may cause physical burden and recent major operations
* Presence of a skin disease that will affect the neck and back area