cyrilzakka/clinical-trials huggingface dataset:
Video-Based Gaming Therapy in Pes Planus Rehabilitation

Purpose: It is aimed to evaluate the effect of structured exercise, wii-based exergame and wii-based serious game exercise protocols on functional parameters in individuals with pes planus. Method: 69 individuals with Pes Planus between the ages of 18-25 who met the inclusion criteria will be included in the study. Pedobarographic analysis, navicular drop test, flexibility, balance, femoral anteversion and lower extremity muscle strength measurements will be performed on the participants before and after the treatment. In addition, demographic information of individuals will be recorded through a survey. After the initial evaluation, participants will be randomly assigned to one of three groups. All subjects participating in the study will be treated under the supervision of a specialist physiotherapist for a total of 18 sessions, 3 days a week for 6 weeks, 40 minutes each session. Structured exercise group; short foot exercise, towel curl exercise, toe walking, heel walking, tandem walking, eccentric gastrosoleus stretching at the edge of the stairs, collecting objects from the ground with the toes, balance exercises on one foot will be performed. Penguin Slide, Tightrople Tension, Tilt Table, Soccer Heading and Balance Bubble games, which are balance games of the Nintendo wii game console, will be played for the Wii-based exergame group for 8 minutes each and a total of 40 minutes per session. For Wii-based serious game group, 3 games, Balance Surf, Balance Adventure and Balance Maze, which are among the balance games included in the Becure Balance System that works integrated with the Wii Balance Board, will be played for 40 minutes each session under the supervision of an expert physiotherapist. After the treatment, all measurements will be repeated, the difference between before and after treatment and the superiority of different treatment protocols will be tried to be determined.


Eligibility Criteria:
Inclusion Criteria:

* Those between the ages of 18-25
* Diagnosed with pes planus by pedobarographic evaluation
* Those with flexible pes planus
* Have more than 10 mm navicular drop
* Those who have not received insoles or exercise therapy before
* Volunteers will be included in the study.

Exclusion Criteria:

* Having another soft tissue or bone problem affecting the foot and lower extremity
* Having any orthopedic and neurological problems affecting balance
* History of surgery or trauma in the last 6 months
* Cardiopulmonary, visual or auditory problems
* Diabetic and pregnant individuals will be excluded from the study.
Obstacles and Facilitators to the Treatment of Police Officers With Mental Health Disorders

Police officers are subject to various professional risk factors that can contribute to the occurrence of mental health difficulties such as depression, anxiety, and post-traumatic stress disorder. In previous work, low use of specialized care structures was noted. Added to this is the carrying of a weapon which represents an element facilitating the passage to self-aggressive action.

The objective of the study is to identify and describe the barriers and facilitators to the treatment of police officers facing mental health difficulties.


Eligibility Criteria:
Inclusion Criteria:

* Be an active, administrative police officer, or scientific and technical police officer of the national police in France for more than a year,
* Or work for the Ministry of the Interior as support staff, or medical staff,
* Agree to participate in the study,
* Agree to talk about the problem without managerial or union preconceptions.

Exclusion Criteria:

* Be in post for the Ministry of the Interior for less than a year.
* Be stationed in the Bas Rhin department (France), where the principal investigator works.
Study of Sensory Deficits in the Upper Limb After Stroke

The overall aim of the project is to gain insight in sensory deficits and recovery patterns in the upper limb post stroke and its association with brain lesion localisation. Furthermore, the investigators will identify associations of deficits in sensory modalities with upper limb impairments, activities and participation at different time points after stroke. Identification of the sensory deficits, along with further insights in their relation with objective neurophysiological and neuroanatomical measures will contribute to the amelioration of goal-setting for the rehabilitation of upper extremity function after stroke. These functions are indispensable during several daily activities as well in different sports and leisure activities. This project is an important step towards a better delineating of treatment interventions for the upper limb and to a better guiding of individual needs for post-stroke treatment in the future.


Eligibility Criteria:
Inclusion Criteria:

* first-ever stroke as defined by WHO
* ≤ 5 days post stroke
* motor impairment and/or a sensory impairment
* ≥ 18 years old
* sufficient cooperation to execute evaluations

Exclusion Criteria:

* other neurological impairments such as previous stroke, head injury or multiple sclerosis (these might affect sensory ability independently of the stroke)
* stroke-like symptoms caused by subdural hematoma, tumour, encephalitis or trauma
* no informed consent
* pre-stroke Barthel Index \< 95 out of 100 points (to be able to distinguish between pre-existing disabilities and disabilities resulting from the stroke)
SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly

Sarcopenia is associated with lower prognosis in solid tumors, but this has not been studied in bladder carcinoma requiring cystectomy.

According to EWGSOP recommendations, the diagnosis of sarcopenia is based on walking speed, grip strength and muscle mass. These three elements can easily be measured (specially muscle mass measurement by bioimpedencemetry or tomodensitometry).

This cohort study will collect clinical complementary elements to better understand the associated factors present with sarcopenia, in order to prepare an interventional preoperative physical reconditioning study.

The mobility measurement will be carried out by the QAPPA questionnaire (validated in French in the elderly) and the quantitative measurement of activity and rest hours during a week by a wrist actimeter.

Standardized geriatric data will also be collected: ADL, IADL for autonomy, MMSE for cognitive status, nutritional status (% weight loss, BMI), pain, GDS15 for depression screening, updated Charlson Comorbidity Index to identify polypathology and The STOPP tool for potentially inappropriate medication.

Post-operative morbidity mortality at 30 days will be evaluated according to Clavien-Dindo classification. Investigators will also evaluate 6 months geriatric complications : falls, loss of autonomy and decreased mobility and physical activity, cognitive degradation, undernutrition, institutionalization


Eligibility Criteria:
Inclusion Criteria:

* confirmed urothelial bladder carcinoma ( RTUV)

  * indication of radical cystectomy
  * Able, informed and with informed consent for the study
  * affiliated to the social security system
  * talking French

Exclusion Criteria:

* Life expectancy \<6 months

  * other active malignant tumors or other severe concomitant chronic pathologies affecting the general condition of the patient and / or likely to limit compliance with the requirements of the study.
  * treatments incompatible with the study: previous corticosteroid treatment prolonged for more than one month (induces iatrogenic sarcopenia).
AI Mobile App vs Self Exercises in Workers With Neck Pain

This study aims to compare the impact of two different methods to administer self-exercises in administrative workers with neck pain: an Artificial Intelligence embedded mobile application and written sheet.


Eligibility Criteria:
Inclusion Criteria:

* The presence of a chronic NP lasting for more than three months, and a pain level at baseline assessment ≥ 30 (VAS)

Exclusion Criteria:

* Acute neck pain, neck pain from specific causes (eg; Chronic inflammatory diseases), spine trauma or surgery, cervical radiculopathy or myelopathy, and physical therapy treatments in the last six months before baseline assessment.
Intensive Therapies to Improve Manipulation in Young Children With Hemiparesis

mCIMT and BIT are therapies applied in children with hemiplegia which have a great evidence, but not in a early age. This research has the objective to know the effects of this therapies in infants diagnosed of infantile hemiplegia from 9 to 18 months applying 50 hours of dose for both interventions during 10 weeks, executing them at home by families.


Eligibility Criteria:
Inclusion Criteria:

* Infantile hemiplegia
* Age from 9 months to 18 months.
* No use of the affected upper limb

Exclusion Criteria:

* Associated pathologies
* Epilepsy no controlled with drugs
* No collaborated families
Palliative Care in Improving Quality of Life in Patients With High Risk Primary or Recurrent Gynecologic Malignancies

This randomized clinical trial studies a palliative care program in improving the quality of life of patients with high-risk gynecologic malignancies that is original or first tumor in the body (primary) or has come back (recurrent). Palliative care is care given to patients and their families facing the problems associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual. Studying a palliative care program may help doctors learn more about patients quality of life, use of healthcare services, and the relief of pain.

PRIMARY OBJECTIVES:

I. Validate a model of proactive palliative medicine referral. II. Quantify the impact of palliative care aggressive care at the end-of-life (PCARE) versus PCARE + idiographic assessment on quality of care and patient satisfaction.

III. Utilizing CMO data Investigators will create a cost model for patients randomized to PCARE versus patients refusing randomization.

IV. Determine the impact of a proactive model of palliative care consultation at the time of diagnosis on family/caregivers.

OUTLINE: Patients are randomized 1 of 2 arms.

GROUP I (usual PCARE): Patients complete European Organization for Research and Treatment of Cancer quality of life-30 (EORTCQLQ-30) and Family Satisfaction with Advanced Cancer Care (FAMCARE) questionnaire every 6 weeks for 3 visits.

GROUP II: (usual PCARE + idiographic assessment): Patients complete EORTC QLQ-30, and FAMCARE questionnaire as in Group I and undergo idiographic assessment. Beginning within 4 weeks of their visit with the gynecologic oncologist, patients are referred to outpatient palliative medicine consultation.

After completion of study, patients are followed up periodically .

Eligibility Criteria:
Inclusion Criteria:

* Women with of primary or recurrent diagnosis of ovarian, uterine, peritoneal, cervical or vulvar cancer with any of the following:

  * \< 30 % projected 5 year survival based on histopathological stage
  * Non-pelvic recurrent malignancy
  * Persistent or progressive disease despite primary treatment with surgery, chemotherapy or
  * Palliative performance scale \< 60
* Enrollment within 6 weeks of tumor board review
Sofosbuvir/Simeprevir Plus a Flat Dose of Ribavirin in Genotype 1 Elderly HCV Cirrhotic Patients

The proportion of HCV infected patients over age 65 years in Western countries is increasing. This growth and the advent of new antiviral therapy bring into the question the real world efficacy and safety of the combination of Sofosbuvir and Simeprevir (SOF/SMV) plus a flat dose of ribavirin (RBV) in elderly patients compared to younger patients.

The proportion of HCV infected patients over age 65 years in Western countries is increasing. This growth and the advent of new antiviral therapy bring into the question the real world efficacy and safety of the combination of Sofosbuvir and Simeprevir (SOF/SMV) plus a flat dose of ribavirin (RBV) in elderly patients (Group II) compared to younger patients (Group I) Multicenter, real world investigation study of once daily treatment with SOF 400 mg + SMV 150 mg with a flat dose of RBV 800 mg/day for a duration of 12 weeks in treatment naïve or experienced HCV genotype 1-infected patients with compensated cirrhosis.To evaluate efficacy, tollerability and safety of SOF/SMV/RBV in two different Group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Naive or experienced patients with genotype 1 compensated cirrhosis

Exclusion Criteria:

* HIV and hepatitis B infection, active hepatocellular carcinoma (HCC), decompensated cirrhosis, history of organ transplant, severe psychiatric disorders or treatment with drugs that showed an interaction with antiviral treatment.
Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following Bunionectomy

The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections for treating post-operative pain following bunionectomy.


Eligibility Criteria:
Inclusion Criteria:

* Men and women must be between the ages of 18 to 70 years, inclusive. Female subjects must meet additional criteria in relation to childbearing potential.
* Subjects must be undergoing a planned bunionectomy without collateral procedures.
* Subjects must have the ability to provide written informed consent.
* Subjects must have the ability to understand study procedures and communicate clearly with the Investigator and staff.
* Subjects must be classified as American Society of Anesthesiologists risk class I to II.

Exclusion Criteria:

* Subjects undergoing emergency or unplanned surgery.
* Subjects undergoing a repeat operation.
* Subjects with pre-existing conditions (other than bunion) causing preoperative pain at the site of surgery.
* Female subjects who are pregnant or breastfeeding.
* Diagnosis of chronic pain and ongoing or frequent use of pain medications.
Determination of CRIM Status and Longitudinal Follow-up of Individuals With Pompe Disease

This is a longitudinal natural history study of Infantile Pompe disease. The investigators will regularly collect and review medical information regarding the diagnosis of Pompe disease, response to enzyme replacement (ERT) using alglucosidase alfa (Lumizyme/Myozyme) and response to immunosuppressive therapy in cases at risk for developing or those who have developed high and sustained antibodies to ERT. To follow the long-term outcomes, we will collect medical records including but not limited to the diagnosis, clinical parameters, assessments for clinical monitoring, and laboratory values including antibody testing results.

Infantile-onset Pompe disease is an inherited disorder caused by lack of or defect in the enzyme acid alpha-glucosidase (GAA). GAA enzyme deficiency causes glycogen to build up and damage cells throughout the body, especially in the heart and muscles, which is normally diagnosed within the first months of life. Current treatment for Pompe disease involves enzyme replacement therapy (ERT) using the drug alglucosidase alfa (Lumizyme/Myozyme), which provides a form of the GAA enzyme to replace the enzyme that is missing or not working properly in the patient's blood.

In this study, the investigators will learn about the patient's ability to tolerate ERT. Cross-Reactive Immunological Material (CRIM) is a measurement of natural GAA production and an important factor that affects how patients respond to ERT. Children who produce some natural GAA are classified as CRIM-positive, while children who do not produce any natural GAA are classified as CRIM-negative. Children who are CRIM-positive generally tolerate ERT well. But, children who are CRIM-negative, and some children classified as CRIM-positive, have a poor response to ERT due to complications from an immune response against the drug. Treatments are currently being developed to stop this immune response and prevent complications from ERT.

This is a longitudinal natural history study of Infantile Pompe disease. The investigators will regularly collect and review medical information regarding the diagnosis of Pompe disease, response to enzyme replacement (ERT) using alglucosidase alfa (Lumizyme/Myozyme) and response to immunosuppressive therapy in cases at risk for developing or those who have developed high and sustained antibodies to ERT.

The specific aims of this study are:

1. To correlate CRIM status determined in a blood sample or cultured skin fibroblasts with GAA gene variants that are causing your child's Pompe disease.
2. To explore the clinical treatment response and natural history of CRIM-positive and CRIM-negative Pompe disease patients with and without immune modulation.
3. To investigate the role of immune response to treatment (IgG and IgE) including immune phenotyping.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of infantile, atypical or juvenile onset Pompe disease
* Must provide a written informed consent
Time-Dependent Mobilization of Circulating Progenitor Cells During Strenuous Exercise in Healthy Individuals

Only few data are available on the influence of strenuous exercise on the content of circulating progenitor cells and especially the timeframe of their release. The aim of the present study was to investigate the potential influence of 4 hours of cycling on the time-dependent release of progenitor cells.

1. What is the response of hematopoietic and endothelial progenitor cells after a standardized prolonged endurance exercise?
2. What is the kinetic of cell mobilization during this standardized exercise?

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* cardiovascular disease
Evaluation of Continuous Non Invasive Blood Pressure With Adult Volunteers

A study to collect data recorded by devices for cNIBP evaluation purposes.

The study is going to be conducted to collect data from the devices used in the study for future AMS engineering purposes as deemed appropriate by the Sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female, aged 18 years or older (≥18 years);
* Willing and able to give informed consent for participation in the study;
* Able and willing to comply with all the study requirements.

Exclusion Criteria:

* Who is pregnant or lactating;
* Who is a smoker;
* Who has consumed alcohol in the last 24 hours;
* Who has been previously diagnosed with Ataxia or balance disorder;
* Who has been previously diagnosed with Raynaud's disease/ syndrome/ phenomenon;
* Who has been previously a diagnosed cardiovascular condition requiring medication or has an internal pacemaker;
* Who has an injury, deformity, A-V fistula, or other characteristic limiting the placing of cuffs on arms/fingers;
Controlling Faecal Incontinence With a Novel Anal Device: a Cost-effectiveness Trial

The purpose of this study is to assess the cost-effectiveness and improvement in quality of life of using a novel anal insert (navina)

After being informed about the study including the potential pros and cons, patients will be given a minimum of 7 days to think about whether they would like to participate in the study. If they would like to participate, and informed consent form will need to be signed, after which the patients will undergo a screening to ensure they meet the inclusion criteria. A 2 week run-in period will take place to let patients get used to filling in an electronic daily diary. Prior to this period, patients will be asked to fill out several questionnaires. After this period, randomisation into either (1) the anal insert group or (2) the care as usual group. Group 1 will then have an 'accommodation' week in which they can try out two different sizes of the anal insert to see which size they would prefer for the treatment period. The treatment period will consist of 8 weeks In which the (1) anal insert group is expected to use the anal inserts and the (2) care as usual group is asked to continue with their treatment as usual. During the treatment period, patients will fill out an electronic daily diary as well as weekly questionnaires.At the end of the 8 week treatment period, patients will fill out additional questionnaires. The follow-up consists of 4 weeks, after which patients will be asked again to fill out several questionnaires.

Eligibility Criteria:
Inclusion Criteria:

For run in period

* Patients with FI according to Rome IV criteria (i.e. recurrent uncontrolled passage of faecal matter for at least 3 months)
* Aged between 16-85 years

For randomisation and treatment period

* Patients with FI according to Rome IV criteria (i.e. recurrent uncontrolled passage of faecal matter for at least 3 months)
* Aged between 16-85 years
* patients who experience at least 1 episode of accidental bowel leakage during the 2 week run-in period will be eligible for randomisation.

Exclusion Criteria:

* Insufficient cognitive skills to fill in patient-reported questionnaires, inability to present to hospital for screening visit and inclusion, neurological/psychiatric or physical inability to comply with the study protocol (including diary assessments) at the investigator's discretion, or insufficient command of the Dutch language.
* Anatomic abnormalities: known communication between the anal and vaginal tracts, prior diagnosis of congenital anorectal malformations, previous rectal surgery, radiotherapy to a pelvic organ (uterus, prostate, rectum).
* Prior diagnosis of inflammatory bowel disease.
* Pregnancy or intention to become pregnant during the study period.
Prevalence of Pregnancy in Polycystic Ovary Syndrome

Polycystic ovary syndrome is the most common endocrine disorder in women of reproductive age, with a prevalence of approximately 5-10%. Polycystic ovary syndrome is diagnosed according to Rotterdam criteria by at least two of the following three key features: oligomenorrhea or amenorrhea; clinical and/or biochemical signs of hyperandrogenism; the presence of polycystic ovaries on ultrasound and exclusion of other endocrine disorders including hyperprolactinemia, thyroid dysfunction and congenital adrenal hyperplasia. Polycystic ovary syndrome is also associated with insulin resistance, obesity and disorders of lipid metabolism, as well as infertility, although these findings have not been addressed in the Rotterdam criteria. Polycystic ovary syndrome is the major cause of anovulatory infertility. The recent studies suggest that anovulation resulting from ovarian follicle abnormalities in Polycystic ovary syndrome patients are 2-fold of normal ovaries. Firstly, early follicular growth is excessive, thus women with Polycystic ovary syndrome are characterized by an excessive number of small antral follicles (2- to 3-fold of normal ovaries). Secondly, the selection of one follicle from the increased pool of selectable follicles and its further maturation to a dominant follicle does not occur. This second abnormality in the folliculogenesis can cause menstrual dysfunction presented as oligomenorrhea or amenorrhea. Historically, Polycystic ovary syndrome treatment has not been curative in nature, instead treatments focus on resolution of clinical manifestations of the disease.


Eligibility Criteria:
Inclusion Criteria:

* infertile women
* age from 18 to 40 years
* poly-cystic ovary syndrome
* Body mass index 18.5-35 kg/m2

Exclusion Criteria:

1. Endocrine disorders (cushing syndrome-congenital adrenal hyperplasia)
2. Systemic disease
3. Use of oral contraceptive,glucocorticoid and antiandrogen
4. Use of ovulation induction or dopaminergic agents
5. Use of antidiabetes, anti obesity drugs
6. history of tubal or ovarian surgery