cyrilzakka/clinical-trials huggingface dataset:
Sport and Self Esteem in Patients Living With HIV

Adapted athletic activity has shown benefits in patients with certain chronic diseases, including improving fatigue and pain in patients with cancer, and improving the symptoms of severe depression.

Among Patients Living with Human Immunodeficiency Virus (PLHIV), sport appears to be less common than for people who do not live with HIV. In fact, 44% of PLHIV in a Swiss cohort (10,500 patients) were inactive in 2014, whereas this percentage was 26% in the general population in Switzerland. We did not find any French data on the prevalence of sports activity among PLHIV.

The benefits of sport in PLHIV are numerous: meta-analyzes on interventional studies of aerobic and resistance exercises show a significant improvement in maximum oxygen consumption, muscle strength, percentage of body fat, quality of life and symptoms of depression. An improvement in cognitive function was noted in a randomized study. An Iranian randomized study of 2017 showed an improvement in the CD4 count, after 8 weeks of resistive exercise, but two meta-analyzes of 2016 and 2017 did not find a significant change in CD4 or viral load with physical exercise.

On the other hand, several studies have shown that sports practice improves self-esteem. In addition, an Australian randomized study in 2006 showed an improvement in self-efficacy in PLHIVs after a six-month exercise (aerobic and resistance) program. Furthermore, self-esteem (defined as positive self-esteem) is a factor facilitating adherence to antiretroviral therapy.

The objective of this descriptive study is to evaluate the prevalence of sports activity in a French adult population infected with HIV and to seek an association with self-esteem. In addition, the investigators will look for an association between sport and fatigue, pain, sleep, lymphocyte T CD4 cell levels, viral load.


Eligibility Criteria:
Inclusion Criteria:

* patient with HIV
* aged over 18
* Patient followed by a physician in one of the participating centers of the Regional coordination of the fight against HIV infection (COREVIH) Pays de la Loire

Exclusion Criteria:

* Refusal or unability to answer the self-questionnaire.
* Patient Under guardianship
A Classroom-based Intervention to Promote Physical Literacy in Children: ALPHYL Study Protocol

The goal of this study, named the Active Learning for PHYsical Literacy (ALPHYL) study, was to describe a multicomponent class-based physically-active learning randomized control trial (RCT) in primary school children. The main purpose was to promote children's physical literacy, academic achievement and cognitive function. The ALPHYL study is mainly based on physical literacy, active school models and Supportive, Active, Autonomous, Fair and Enjoyable principles.

The ALPHYL is an 8-10-week RCT that will be conducted in six primary schools (12 classes) in Valencia and its metropolitan area. Schools will be randomly assigned to the intervention or a waiting-list control group. After a 30 h in-person training course for teachers and weekly meetings in the three months of resource preparation, the ALPHYL intervention will be conducted in physical education (PE) and non-PE lessons by teachers. The intervention consists of at least three physically active learning sessions per day plus model-based PE classes. Its feasibility will be evaluated weekly according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. To assess its effectiveness, a pre-test, post-test and retention (8-10 weeks after the intervention) with primary outcomes (i.e. physical activity level, motor competence, perceived motor competence and physical literacy, motivation, perceived social support, academic achievement and cognitive function), secondary outcomes and covariates will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Participants enrolled in 5th grade (i.e., 10-11 years old).
* Schools must have at least two groups of primary school 5th grade and the teachers involved in both agree to participate.
* Each class group includes at least 75% of the participants.
* Children must not have taken part in other physical activity promotion interventions in the two previous years.

Exclusion Criteria:

• None.
Non-invasive Hemoglobin Monitoring in Outpatient Total Joint Arthroplasty

This research is being done to better understand the accuracy of noninvasive hemoglobin tests on patients that recently underwent total joint arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients age ≥ 18.
* Undergoing either primary total knee or total hip arthroplasty for a primary underlying diagnosis of osteoarthritis.

Exclusion Criteria:

- Individuals \< 18 years of age.
Laparoscopic Versus Vaginal Approach Closure Complications

Hysterectomy is considered as a common operation in Gynecology. Hysterectomy could be made by vaginally, laparoscopically or abdominally. The American Congress of Obstetricians and Gynecologist advises the use of a minimally invasive technique for the sake of women and to decrease hospital stay and costs.

Laparoscopic hysterectomy (LH) is a minimally invasive operation that could be made when vaginal hysterectomy is not accessible due to anatomical problems.

Vaginal cuff dehiscence (VCD) is a severe adverse event and occurs more frequently after total laparoscopic hysterectomy (TLH) compared with abdominal and vaginal hysterectomy.

The study shows effects of the laparoscopic approach versus the vaginal route for the management of vaginal cuff closure during total laparoscopic hysterectomy on female sexual function.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who undergo laparoscopic hysterectomy
2. Age ranged from 40 to 80 years.
3. Patients suffering from chronic pelvic inflammatory disease (PID)
4. Dysfunctional uterine bleeding
5. Adenomyosis
6. Endometriosis
7. Fibroid
8. Endometrial hyperplasia
9. Benign ovarian cyst

Exclusion Criteria:

* Patients with known malignancy
Accurate Controlled Dental Sedation

The aim of this study is to evaluate benefits of the method of dental sedation using Target controlled infusion (TCI) combined with Bispectral index (BIS) monitoring in patients with Mental Retardation and challenging behavior.

The intravenous sedation of using of propofol is very effective for dental patients with Mental Retardation and challenging behavior. However, it is very difficult to titrate the dose of propofol for maintaining the adequate sedative depth because of the difficulty of verbal communication with them. Therefore, the infusion of excessive propofol dose elicits the complications and delay of recovery.

Eligibility Criteria:
Inclusion Criteria:

1. Participants aged 16 or over,
2. American Society of Anesthesiologists (ASA) physical status 1 or 2
3. The treatments of dental caries, endodontics, periodontics and prosthesis were planed
4. Participants had moderate or severe Mental Retardation, and were not completely cooperated with dental treatment

Exclusion Criteria:

1. Patients could communicate and cooperate with dental treatment, but used dental sedation for decrease of the anxiety and the fear about dental treatment or another reasons,
2. Patients needed premedication
3. Patients had uncontrolled or sever medical condition
Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease

This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.


Eligibility Criteria:
Key Inclusion Criteria:

* Documented clinical diagnosis of idiopathic PD
* Modified HY stage \< 5
* Able to administer study drug or have a caregiver throughout the duration of the study to help administer drug
* Willing to continue diet, exercise and medications reported at baseline consistently throughout participation in the trial. Essential changes are permitted
* If taking PD medications or any nutraceuticals, must be on a stable dose for at least 30 days prior to Screening Visit. Essential changes will be permitted.
* If subject is taking chronic antidepressant or an anxiolytic, must be on a stable dose for at least 90 days prior to Screening. Essential changes will be permitted.

Key Exclusion Criteria:

* Clinical diagnosis of Type 1 or Type 2 Diabetes Mellitus
* Glycated hemoglobin (HbA1c) level ≥ 6.5%
* History of hypoglycemia and/or documented plasma glucose levels of ≤ 50 mg/dL with or without symptoms of hypoglycemia
* Mini-Mental State Exam (MMSE) score of ≤ 24 at Screening
* Positive COVID-19 test at Screening and/or within 30 days of Screening
* Change in or escalation of dose of a chronic therapeutic agent that has the potential to impair cognitive functioning
* Chronic inflammation of nasal cavity that may prevent absorption of study treatments
* Insufficiently controlled respiratory disease (i.e., asthma, COPD).
* History of any significant neurologic or psychiatric disease other than PD
* Current diagnosis of epilepsy and had a history of seizures as an adult within 1 year of Screening, or unexplained recent loss of consciousness, or history of significant head trauma with loss of consciousness
* History of non-lacunar ischemic and/or hemorrhagic stroke
* Unstable or uncontrolled cardiac disease that could expose the subject to additional safety risks
* Use of the following medications: Insulin or any other anti-hyperglycemic agent(s) except if used during isolated gestational diabetes, Supplementation with GSH or any medication shown to increase glutathione, and Beta Blockers
A RCT of Telephone-supported ACT in MS

This study will investigate the feasibility of running a randomised controlled trial (RCT) of a psychotherapy called "Acceptance and Commitment Therapy (ACT)", delivered in a self-help format with additional telephone support from a therapist, for people with Multiple Sclerosis (MS) and low mood.

A large proportion of people with Multiple Sclerosis (MS) suffer from emotional problems, therefore a large percentage of people with MS would be eligible to take part in a study offering a psychotherapeutic component to address these issues.

Acceptance and Commitment Therapy (ACT) has been found to be effective for mood problems, and been successfully used in self-help format, but no study has thus-far examined potential for use as an effective intervention in this (MS) population.

People will MS and low mood will be recruited from a neurology outpatient clinic. They will be randomized to either receive treatment as usual, or an ACT self-help book with 8 supportive telephone calls from a trainee clinical psychologist. Measures of anxiety, depression, quality of life and physical health will be administered at baseline, post-intervention and six month follow up. A sub sample of 10 participants will be interviewed to find out their view on taking part in the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS. Over 7 on the Hospital Anxiety and Depression Scale

Exclusion Criteria:

* Already receiving psychotherapy
Real-life Dual-Task Training

Older adults have difficulty optimizing two tasks at once and typically experience greater interference than younger adults when dual-tasking, meaningful that there is greater decline in performance of at least one task when comparing single and dual-tasking. Difficulty dual-tasking may actually predict falls in community-dwelling older adults. Dual-task training has been shown to improve cognitive outcomes (attention, memory), motor outcomes (balance, gait), and dual-task performance in older adults; however, most dual-task training involves simulated tasks that do not reflect functional dual tasks in the real world. Greater dual-task improvements could be seen when training functionally specific tasks. One way to increase task specificity is to offer real-life, contextually-relevant, dual-task training embedded in instrumental activities of daily living (IADLs). Limited evidence exists for dual-task training interventions for older adults with T2DM; however there is early evidence of improvements in cognitive and motor effects with simulated dual-task training, which could translate to improved dual-task performance, reduced impact on everyday life, and reduced fall risk. Therefore, the purpose of this study is to assess feasibility, acceptability, and preliminary efficacy of a real-life dual-task training program for older adults at risk to fall.


Eligibility Criteria:
Inclusion Criteria:

* at least 65 years old
* ambulatory around the home with or without an assistive device
* answered yes to at least one of the fall risk questions with their therapist
* scheduled to receive occupational therapy services with instrumental activity of daily living goals through Covell Care.

Exclusion Criteria:

* Not fluent in English
* Self-reported diagnosis of dementia
Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures

Clavicle (collar bone) fractures account for about 33% of all fractures around the shoulder. Some surgeons suggest that surgical treatment is the best option, while others suggest that nonoperative care is the best treatment. There is no evidence to date that either option in superior. For this reason, we propose to conduct a prospective, randomized clinical trial of surgical versus non-surgical treatment of displaced high-energy clavicle fractures. This study will use both objective clinical and patient-based outcome measures. The purpose of this study is to see if there is a difference between clinical outcomes (healing rate, time to healing, time to return to work, Constant Score, complications), functional outcomes (DASH Score), and health related quality of life (SF-36) in nonoperative care and two types of surgical care for displaced fractures of the clavicular shaft in adults.

Included patients will be randomized into one of three groups: nonoperative care (Group N); surgical care using plates and screws (Group P); and surgical care using intramedullary pin put inside of the clavicle to stabilize it (Group I).


Eligibility Criteria:
Inclusion Criteria:

* ages of 18 and 85
* a midshaft clavicle fracture
* fracture displaced the width of the clavicle or shortened at least 1.5 cm
* less than 21 days since the injury

Exclusion Criteria:

* injury involving the lateral ligaments
* fracture involve the sternoclavicular joint
* Pathologic Fracture
* Open Fracture
* Fracture with neurovascular compromise
* Displaced fracture with impending skin compromise
* Medical comorbidities that preclude surgery
* Associated injuries to ipsilateral shoulder girdle
* severe cognitive disability or injury that may inhibit study form completion
Preconception Nutrition Education Intervention for Prospective Brides

This research focuses on the importance of preconception health care. In this research, an intervention was carried out providing health education regarding preconception nutritional preparation. Research methods used is a Quasi Experiment with the Non Equivalent Control Group method. Example used in this research were 100 prospective brides and grooms in Indonesia. The intervention group will be provided with education through a preconception nutrition education module and the brides health card, and the control group was given education using the brides health leaflet.


Eligibility Criteria:
Inclusion Criteria :

* Women aged 20 to 35 years old
* Have no history of disease that weakens anemia and nutritional intake
* Examination maximum 3 months before the wedding
* Prospective bridal couples do not delay the pregnancy program

Exclusion Criteria :

* Not complete premarital reproductive health examination
Peroneal and Achilles Tendon Repair Indications With CLARIX® CORD 1K

Peroneal and Achilles tendon tears are common diseases that present challenges to surgeons due to tendon adhesion complications. Functional recovery is compromised by limiting post-operative range of motion, mobility, and can lead to considerable amount of post-operative pain for the patient.

Amniotic membrane tissue has demonstrated clinical success as an anti-inflammatory and anti-scarring agent and promoting wound healing towards regeneration.

Cryopreserved human amniotic membrane and umbilical cord (AM/UC) tissue in the form of CLARIX® CORD 1K has been used to treat over 5000 orthopedic patients. The investigators hypothesize that its use in peroneal and Achilles tendon surgical repair will enhance the overall functional recovery of the patient.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients 18 years to 80 years of age
2. Confirmed tendon pathology via MRI, if clinically necessary, with planned surgical repair that have failed conservative management (PT) for a minimum of 2 months for chronic and partial thickness tears; acute full thickness tears or tendon rupture immediately eligible.
3. Willing to follow the instructions and complete the visits required.

Exclusion Criteria:

1. Psychologically unstable
2. Acute infections that, in the opinion of the investigator, may complicate healing
3. Currently receiving chemotherapy
4. Systemic inflammatory arthritis or Rheumatoid arthritis
5. Uncontrolled diabetes as measured by A1C\>12
6. Bleeding disorders
7. Unable to provide informed consent
8. Has received oral or parenteral corticosteroids or cytotoxic agents for seven consecutive days in the period of 30 days before surgery OR has received a local steroid injection within 7 days of surgery
9. Immunocompromised patients
10. Active malignancy other than non-melanoma skin cancer
11. Untreated alcohol or substance abuse issues at the time of screening
12. Pregnant women at the time of randomization
13. Currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening
14. Allergy to amphotericin-B or Dulbecco's Modified Eagle Medium (DMEM).
15. Will undergo significant concurrent procedures with the tendon procedures on the affected foot that, in the opinion of the Investigator, may complicate healing or alter the post-operative visit schedule
A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled BIIB080 Co-administered With BIIB080 in Healthy Adults

In this study, researchers will learn more about a study drug called BIIB080. BIIB080 is currently a drug under investigation for treatment of Alzheimer's disease. The main question researchers are trying to answer in this study is how radiolabeled BIIB080 distributes in the brain and spinal cord. To help answer this question, researchers will use positron emission tomography (PET) scanner that can detect radiolabeled BIIB080 after a single injection of a small dose of radiolabeled BIIB080 (\[89Zr\]Zr-DFO-BIIB080) and a dose of BIIB080 together via an intrathecal (IT) injection in healthy volunteers. Researchers will also learn about the safety of injecting radiolabeled BIIB080 and BIIB080 together.


Eligibility Criteria:
Key Inclusion Criteria:

* Must be healthy adult and have a body mass index (BMI) 18 through 30 kilograms per square meter (kg/m\^2).
* Males must practice highly effective contraception and females must be of no childbearing potential.

Key Exclusion Criteria:

* Conditions that influence cerebrospinal fluid (CSF) kinetics e.g., significant scoliosis or a physical disability that limits mobility.
* Contraindication to:
* Magnetic resonance imaging (MRI) scan: e.g., indwelling ferrous metal, implanted medical devices, or claustrophobia.
* Radiation/PET scan: e.g., inability to lie flat or still for the duration of the scan) or intolerance to previous nuclear medicine scans.
* Lumbar Puncture (LP, spinal tap): e.g., current use of a medication that prolongs coagulation times, including aspirin, known disorders of the coagulation cascade, platelet function, or platelet count, low white blood cell counts, chronic low back pain; prior lumbar spine surgery, anatomical factors at or near the spinal tap site, clinical signs of raised intracranial pressure (e.g., headache, or focal neurologic signs).
* Findings from the screening MRI that may interfere with participant safety or the scientific integrity of the study e.g., Chiari malformation, high grade spinal stenosis, hydrocephalus, or neural tube defect.
* Abnormal Laboratory Values e.g., liver functions, anemia, abnormal blood coagulation profile.
* Cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or malignant disease.
* Severe allergic or anaphylactic reactions/ systemic hypersensitivity to BIIB080 or any component of the study treatment.
* Alcohol or substance abuse.
* Plans to undergo elective procedures or surgeries during the study.
* Enrollment in any other drug, biologic, device, or clinical study within 30 days or 5 half-lives, whichever is longer, prior to Check-in.
* Use of any prescription medication (except hormone therapy), over-the-counter medication (excluding acetaminophen), or dietary and herbal supplements (e.g., St. John's wort) within 28 days of the of dosing and during the study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Dermal and Subcutaneous Augmentation and Skin Assessment After Fat-, Stem Cell and Scaffold Injections

Investigate the effect of dermal/subcutaneous injection of ASC enriched fat transplant in a protective natural scaffold, designed to sustain the ASC viability after dermal/subcutaneous injection.

The study investigates the effect of different concentrations of autologous ex-vivo expanded adipose-derived stromal cells (ASCs), fat and a natural scaffold for skin rejuvenation and augmentation. The aim is to better the volume of fat grafts for cosmetic and reconstructive purposes. Fat is a near ideal filler, as it is biocompatible. However the retention rate of fat grafts often result in poor outcomes and it is unpredictable. The investigators have set up an experimental study in which participants with excess abdominal skin is recruited. They will have injections with 11 different solutions of fat, ACSs, scaffold and dermal CO2 laser in the abdominal skin. After 3 months biopsies will be taken and after 6 months all of the treated area will be removed by an cosmetic abdominoplasty.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18-30 kg/m2
* 400 mL of fat (lipoaspirate) available for liposuction in the thighs or back
* Desire for abdominoplasty
* Speaks and reads Danish
* Signed informed consent

Exclusion Criteria:

* Smoking
* Previous major abdominal surgery
* Previous cancer or predisposition to cancer
* Pregnancy or planned pregnancy
* Known chronic disease associated with metabolic malfunction or poor healing
* Pacemaker
* Allergy to necessary anaesthesia
* Intention of significant weight loss or weight gain within the trial period