cyrilzakka/clinical-trials huggingface dataset:
Health Game Intervention to Promote the Physical Activity of Early Adolescents

The study evaluates the effectiveness of the game-intervention in promotion of physical activity self-efficacy and physical activity behavior among early adolescents (10-13 year olds). Half of the study participants will receive the game-intervention and half of the study participants will receive a commercially available sport and fitness application for running, cycling and every-day training.

The study evaluates the effectiveness of the game-intervention in promotion of physical activity self-efficacy and physical activity behavior among early 10 to 13 years old adolescents. Participants allocated to the Health game intervention group will use a game called Movenator, during a four week intervention and participants allocated to the Sport and fitness-intervention group will use a commercially available Sport and fitness application for running, cycling and every-day training, during a four week intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Goes to school at 4th, 5th or 6th grade
* Understands and can communicate either in Finnish
* Has daily access to a smart phone (Android) during free time

Exclusion Criteria:

* Physical activity impairments
Anesthesia for Catheter Aortic Valve ImplantATIOn Registry

In modern cardiac surgery and cardiology Transcatheter Aortic Valve Implantation (TAVI) is an emerging procedure for high-risk patients that are assumed to be otherwise inoperable. The investigators want to evaluate the specific intraoperative anesthesiologic characteristics cardiac anesthesiologists have to face during these procedures.


Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing transcatheter aortic valve implantation (TAVI)

Exclusion Criteria:

- Refusal by patient
Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer

The purpose of this study is to learn about possible changes in brain anatomy and function, and in thinking abilities, such as memory skills, in patients with ovarian cancer who receive treatment with chemotherapy. Cancer patients treated with chemotherapy may experience changes in thinking abilities, and these may interfere with quality of life. Most of the research to date has involved patients with breast cancer, and there are no studies in women with ovarian cancer looking at at treatment-related changes in brain anatomy and function.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with stage I-IV ovarian, peritoneal or fallopian tube cancer
* completed first-line taxane and platinum-based chemotherapy 1-4 months prior to being enrolled in the study (can be on bevacizumab maintenance)
* in remission of their disease at the time of enrollment between 21 and 70 years of age
* fluent in English
* in the judgment of the consenting professional, have capacity to give consent

Healthy Control Inclusion Criteria:

* no diagnosis of cancer except basal cell carcinoma
* between 21 and 70 years of age
* fluent in English
* has a mini-mental state exam (MMSE) score of 26 or higher
* in the judgment of the consenting professional, have capacity to give consent

Exclusion Criteria:

* active or recurrent disease, or diagnosis of another cancer (except basal cell carcinoma) as per medical records at the time of enrollment
* exposure to chemotherapy or radiation therapy for any medical condition unrelated to ovarian cancer
* on hormonal therapy at the time of enrollment
* neurological disorder or moderate to severe head trauma (loss of consciousness \> 60 min)
* neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc.
* self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia
* unable to complete cognitive tests
* with standard contraindications to MRI examinations

Healthy Control Exclusion Criteria:

* exposure to chemotherapy or radiation therapy for any medical condition
* on hormone replacement therapy at the time of enrollment
* neurological disorder or moderate to severe head trauma (loss of consciousness \> 60 min)
* neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc.
Assessing the Use of MY-RIDE, a Just-in-time Adaptive Intervention, to Improve HIV Prevention and Substance Use in Youth Experiencing Homelessness

The purpose of this study is to determine whether Motivating Youth to Reduce Infections, Disconnections, and Emotion dysregulation (MY-RIDE) decreases substance use , to determine whether MY-RIDE increases human immunodeficiency virus (HIV) prevention strategies and to evaluate MY-RIDE effects on willingness to take Pre-Exposure Prophylaxis (PrEP), stress, substance use urge, and use of mental health and substance use services when compared to attention control youth


Eligibility Criteria:
Inclusion Criteria:

* have engaged in substance use (alcohol or illicit drugs)
* speak English
* are experiencing homelessness
* engaged in sexual activity in the last 6 months or plan to in the next month
* are not planning to move out of the metro area during the 12-month study period.

Exclusion Criteria:

* Youth Experiencing Homelessness (YEH) who have low literacy based on the Rapid Estimate of Adult Literacy in Medicine-Short Form (scores \< 4)
Vitamin B12 for Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease the entrapment of nerve to restore blood supply. In addition, the Vitamin B12 was considered to be beneficial for peripheral neuropathy and pain relief. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided hydrodissection with Vitamin B12 in patients with CTS.

After obtaining written informed consent, patients with mild to moderate CTS will been randomized into intervention and control group. Participants in intervention group received one-dose ultrasound-guided hydrodissection with 3cc Vitamin B12 and control side received one-dose ultrasound-guided injection 3cc normal saline. No additional treatment after injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 2nd, 3rd and 6th month after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-80 year-old.
* Diagnosis was confirmed using an electrophysiological study

Exclusion Criteria:

* Cancer
* Coagulopathy
* Pregnancy
* Inflammation status
* Cervical radiculopathy
* Polyneuropathy, brachial plexopathy
* Thoracic outlet syndrome
* Previously undergone wrist surgery or steroid injection for CTS
A Randomized Controlled Trial on Malaria Primaquine Treatment in Timika, Indonesia (TRIPI)

Plasmodium vivax can form dormant liver stages that reactivate weeks or months following an acute infection. Recurrent infections can be associated with a febrile illness, a cumulative risk of severe anaemia, and even mortality. In co-endemic areas the risk of recurrence after both P. vivax and P. falciparum infections can be over 50% within 3 months. The only drug we have to kill P. vivax hypnozoites is primaquine which is currently given as a 14 day regimen. In Papua a retrospective study found very low effectiveness for unsupervised treatment. If true this has profound effects on treatment policy, suggesting that greater efforts are needed to encourage adherence to treatment.

We propose a cluster randomized, controlled, open label trial to assess the effectiveness of unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria. Since the risk of recurrent P. vivax is high in patients with either P. vivax or P. falciparum, both infections will be included in the study. The study will be conducted in Mimika, in the southern part of Papua Province, Indonesia. Participants will be enrolled at village health posts and provided with schizontocidal treatment plus primaquine radical cure which will be either supervised or unsupervised depending on which cluster the clinic is in. Participants will be followed up for 6 months and assessed in regular intervals for the presence of patent and sub-patent malaria. The outcome of the study will contribute to an improved treatment scheme for uncomplicated malaria in this area.


Eligibility Criteria:
Inclusion Criteria:

* Infection with Plasmodium falciparum or P. vivax either alone or mixed
* Age \>12 months
* Weight \>5kg
* Living in the study clusters

Exclusion Criteria:

* General danger signs or symptoms of severe malaria
* Anaemia, defined as Hb \<9g/dl
* G6PD deficiency (as determined by FST)
* Pregnant women as determined by Urine β-HCG pregnancy test
* Known hypersensitivity to any of the drugs given
MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma

The purpose of this study is to confirm the safety and tolerability of elranatamab (PF-06863135) in Japanese participants with relapsed or refractory MM.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple myeloma (IMWG criteria)
* Measurable disease, as defined by at least 1 of the following

  1. Serum myeloma (M) protein ≥0.5 g/dL (5 g/L)
  2. Urine M protein ≥200 mg/24 h
  3. Serum free light chain (FLC) \>100 mg/L (10 mg/dL) with abnormal kappa:lambda ratio
* Participants must have progressed on or been intolerant of at least 3 prior therapies including proteasome inhibitor, IMID drug and anti-CD38 antibody, either in combination or as a single agent
* ECOG PS 0, 1 or 2. PS 3 is permitted if PS is due solely to bone pain
* Adequate bone marrow, hematological, kidney and liver function
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1
* Not pregnant and willing to use contraception

Exclusion Criteria:

* POEMS syndrome
* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
* History of active autoimmune disorders
* Any form of primary immunodeficiency
* History of severe immune-mediated adverse event with prior immunomodulatory treatment
* Stem cell transplant within 12 weeks prior to enrollment
* Active graft versus host disease other than Grade 1 skin involvement, or that requiring immunosuppressive treatment
* Requirement for systemic immune suppressive medication
* Active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, known HIV or AIDS related illness and SARS-CoV2
* Previous administration with an investigational drug within 4 weeks or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
* Known or suspected hypersensitivity to component of elranatamab (PF-06863135), murine and bovine products
* Live attenuated vaccine within 4 weeks
SIA - Internet-administered CBT for Adolescents With Low Self-esteem

The study will investigate a novel CBT based treatment approach for low self-esteem among adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Low self-esteem, as indicated by rating of \< 20 the Rosenberg Self-Esteem Scale.
* Age between 15 and 19 years old.
* Access to a computer, smartphone, or tablet with internet access.
* Write and speak Swedish.
* In case of use of psychotropical medication, a stable dose for the past three months prior to registration and no planned changes during the treatment.

Exclusion Criteria:

* Other ongoing psychological treatment that affects the treatment received in the study.
* No comorbid severe depressive symptoms and no suicidal plans.
* Ongoing alcohol use disorder, as indicated by Alcohol Use Disorders Identification Test (AUDIT).
* Severe psychiatric comorbidities (e.g. psychosis, anorexia nervosa) that requires specialist care within the regular psychiatric care.
Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients

This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase


Eligibility Criteria:
Inclusion Criteria:

-Patients with chronic myeloid leukemia in the chronic phase diagnosed within 6 months of study entry

Exclusion Criteria:

* Treatment with tyrosine kinase inhibitor or other antileukemic agents or treatments (including HSCT) for longer than 2 weeks, with exception of hydroxyurea and/or anagrelide
* Uncontrolled congestive heart failure or hypertension
* Myocardial infarction or unstable angina pectoris within past 12 months
* Known T315I mutations
* QTcF \>450 msec
* Significant arrhythmias

Other protocol-defined inclusion/exclusion criteria may apply
PREconception Folic Acid Clinical Efficacy (PREFACE) Trial

A study to help understand what forms of folic acid are most effective to increase folate status during pregnancy for the best protection against neural tube defects

A multisite randomized controlled trial to determine whether supplementation with (6S)-5-methyltetrahydrofolic acid (5-MTHF) is at least as effective as synthetic folic acid in increasing maternal folate status for protection against neural tube defects (NTDs).

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant females who are:
* Currently trying to become pregnant;
* Aged 19-42 years;
* Low risk for an NTD-affected pregnancy

Exclusion Criteria:

* Trying to conceive for ≥6 months (as \~90% of pregnancies occur after 6 months of trying);
* Diagnosed ovulatory disorders (polycystic ovary syndrome, endometriosis, or menstrual irregularity);
* More than 2 miscarriages in the past year;
* Undergoing fertility assistance (including current IVF or intrauterine insemination);
* Pre-existing medical condition known to impact maternal folate status (malabsorptive and inflammatory bowel diseases, active celiac disease, gastric bypass surgery, type 1 or 2 diabetes mellitus);
* Lifestyle factors known to impact maternal folate status (current smoking, \>6 alcoholic drinks per week, recreational drug use);
* On the female or male side of those trying to conceive: personal NTD history, previous NTD-affected pregnancy, or personal or family history of other folate sensitive congenital anomalies;
* Use of folate-inhibiting medications (Chloramphenicol, Methotrexate, Metformin, Sulfasalazine, Phenobarbital, Phenytoin, Primidone, Triamterene, Barbiturates).
Investigation of the Effects of Different Exercise Approaches on Clinical Parameters in Chronic Obstructive Pulmonary Disease Patients

The beneficial effects of exercise training in individuals with chronic obstructive pulmonary disease (COPD) are well known. Standard exercise training includes structured aerobic exercise training and resistance exercise training programs applied to upper and lower extremity muscle groups. No study has been found in the literature that includes a trunk stabilization training program that includes muscles that provide whole body stabilization in COPD patients.

The investigators aimed to determine the effects of an aerobic exercise training program, resistance exercise training, and an additional trunk stabilization training program in individuals with COPD.

Individuals diagnosed with COPD between the ages of 40-80 who applied to Ankara Etlik City Hospital Chest Diseases Polyclinic will be included in the study. Data collection tools and exercise training programs will be made by the same researchers. A total of 44 COPD patients, 22 in each group, will be included in the study.

COPD individuals who agree to participate in the study will be randomised electronically using a randomisation program and participants will be divided into two groups.

Group 1: Aerobic exercise training and resistance exercise training and trunk stabilisation strength training Group 2: Aerobic exercise training, resistance exercise training and respiratory exercise training

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of COPD
* Being between the ages of 40-80
* Being clinically stable (not having had an exacerbation in the last month)
* Being able to cooperate with the tests
* Not participating in any exercise training studies
* Being willing to participate in the study

Exclusion Criteria:

* Having other lung or lung involvement diseases other than COPD
* Having uncontrolled hypertension, arrhythmia and a history of myocardial infarction in the last month, unstable angina, advanced heart failure and other cardiac instability conditions
* Being hemodynamically unstable
* Being on noninvasive mechanical ventilation (NIMV) and long-term oxygen therapy (LTOT)
* Having a history of neuromuscular disease, scoliosis, chest wall surgery
* Being pregnant and having a malignancy
* Having an orthopedic or surgical problem that would prevent participation in tests and exercise training
* Not being willing to participate in the study
Validation of Bladder Health Instrument for Evaluation in Women

The Prevention of Lower Urinary Symptoms (PLUS) Research Consortium is working to optimize prevention of lower urinary tract symptoms (LUTS) in women and adolescent females across their life spans. The ability to measure bladder health and key risk and protective factors is crucial to the PLUS mission. To describe and measure the spectrum of bladder health in diverse populations, researchers need a valid and reliable instrument. To date, the Consortium's work on design of a bladder health instrument has been a culmination of expert opinion, information from focus groups, and incorporation of previously validated items and language where appropriate, along with cognitive interviews of participants from the general public. The next step in the consortium's work is to prospectively collect data to test and validate bladder health instrument (BHI) items for inclusion in a final bladder health scale (BHS) that can assess the full range of bladder health of women. This will be through a combination of general population recruitment for completing mailed surveys, clinical population recruitment for completing surveys and an in-person evaluation, and postpartum women.


Eligibility Criteria:
Inclusion Criteria:

* Community dwelling
* Age ≥18 years old
* Female sex assigned at birth
* Fluent in written and spoken English
* Able to read and provide informed consent

Exclusion Criteria:

* Institutional living arrangement, e.g., skilled nursing, long term care or rehabilitation center
* Physical or mental condition that would prohibit self-administration of questionnaire either electronically or using paper and pencil (e.g., dementia/cognitive impairment/blindness/severe arthritis).
fMRI Study of Grasping in Autistic Patients

The aim of the study is to localise brain regions involved in objects recognition, in planification and adjustment of grasping, in prehension with and without eye control. The study is conducted in normal and autistic adults. We hypothesize different activations in these two populations.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of autistic disorder, right-handed, DQ\>50

Exclusion Criteria:

* epilepsia, psychotropic drugs
Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation

The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female between the ages of 18 and 80 years.
* Have been diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.
* Be an appropriate candidate for an SCS trial and the surgical procedures required in this study based on the clinical judgment of the Investigator.
* Be willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.

Exclusion Criteria:

* Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator.
* Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.
* Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).
* Have prior experience with SCS.
* Have an active systemic infection or local infection in the area of the surgical site.
* Be pregnant or nursing (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal).
* Be concomitantly participating in another clinical study.
A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults

The purpose is to study efficacy of Lactofiltrum in adult patients with atopic dermatitis. Lactofiltrum consists of 85% of hidrolytic lignin and 15% of lactulose and acts as an enterosorbent, which enables to enhance metabolism and elimination of endotoxins and to normalize metabolic and immune processes. Additionally, lactulose stimulates Bifidobacterium flora and in aggregate it could improve skin condition afflicted by atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-60 y.o. diagnosed with atopic dermatitis according to the UK refinement of the Hanifin-Rajka diagnostic criteria;
* SCORAD Index more than 25.

Exclusion Criteria:

* pregnancy and breast-feeding;
* severe diseases;
* concomitant infection diseases (including parasitic ones);
* diffusive connective-tissue (autoimmune) diseases;
* renal and hepatic failure;
* systemic or topical treatment with antibiotics, steroids, immunosuppressive, cytostatic or antimetabolite agents by the time of inclusion into the study;
* concomitant skin diseases: skin lymphoma, scab, lichen ruber planus, psoriasis;
* professional activity involving skin injury, exposure to cold, insolation, ultraviolet radiation;
* psychoses;
* application of pre-, probiotics, antibiotics, neuroleptics or tranquilizers 2 weeks before inclusion or during participation in the study;
* participation in other clinical study 1 month before inclusion or during participation in the proposed study.
Evaluation of the Sensitivity of Merz Lips Fullness Assessment Scale Following Etermis 4® Treatment for Lips Volume Augmentation

Primary objective:

- To evaluate the sensitivity of the Merz Lip Fullness Assessment Scale (MLFAS).

Secondary objectives:

* To evaluate the clinical aesthetic improvement outcome in lips appearance four weeks after Etermis 4® injection.
* To evaluate safety/tolerability of Etermis 4® treatment in lips.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female study subjects with thin to medium lips volume (grade 1 to 2 on MLFAS), seeking for hyaluronic acid (HA) for lips volume augmentation in ≥1-point improvement on the MLFAS on both the upper and lower lips and fulfilling the criteria listed in the Instruction for Use (IFU) of the Study Medical Device to be injected.

Exclusion Criteria:

* Subjects with a medical condition and/or medication according to current IFU which is contra indicated for HA filler treatment, or prior facial surgeries or surgical permanent implants, lips augmentation treatment or other aesthetic procedure in the face that could interfere with performance assessment.