cyrilzakka/clinical-trials huggingface dataset:
Using 360° Videos in the Treatment of Anxiety Disorders

This study aims to test the feasibility and efficacy of an individualized exposure intervention using 360-degree videos for social anxiety and agoraphobia. A multiple single case design is followed with a pre-post-follow up assessment and multiple baselines. In addition, an experience sampling method is used to explore the role of dysfunctional beliefs and self-efficacy in the efficacy intervention.

There is growing evidence that supports the use of Virtual Reality (VR) to address anxiety disorders such as social anxiety and agoraphobia. The main advantage of VR is to expose participants to their fears in a controlled and safe environment. However, the access to VR remains costly for health professionals who need to pay licenses for the use of a limited number of environments. Therefore, these standardized environments only address the symptoms of standard anxious patients. As a way to provide an accessible tool that can be tailored according to patients' specific difficulties, the proposed approach builds on 360-degree videos as an alternative to VR.

The aim of the present study is to test the feasibility and efficacy of an individualized expo-sure intervention using 360-degree videos. In addition, the role of cognitive processes (i.e., dysfunctional beliefs and self-efficacy) in the exposure efficacy is examined. The intervention includes eleven sessions including five sessions of exposure in 360-degree videos de-signed especially for each patient difficulties.

A multiple single-case design (n=5) is adopted with three types of evaluations: (1) traditional assessment scale of primary/secondary outcomes and aspects related to the therapy, (2) daily ambulatory assessment with a multiple baseline design, (3) experience sampling of cognitive processes about feared situations.

Each video will also be assessed by the participants after exposure sessions.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnostic (DSM 5) of social anxiety or agoraphobia
* High level of avoidance
* French-speaking
* Having a mobile phone which met VR reading criteria

Exclusion Criteria:

* Having a history of psychotic or bipolar disorder
* Having a history of severe brain trauma or epilepsy
* Having a history of respiratory disturbances
* With a concurrent additional psychotherapy
* With acute suicidal ideation
* With a primary diagnosis of depression
* With a non stabilized medication
* Auto medication with alcohol or other substances
* Having migraine or motion sickness
Evaluation of an Integrated Care Project

The purpose of the study is to investigate the effectiveness and cost-effectiveness of the integrated care program of a statutory health insurance offering additional homeopathic treatment to their members

The German statutory health insurance 'Techniker Krankenkasse' offers an integrated additional homeopathic treatment. To date, this offer has not been evaluated. Therefore we aim to investigate the effectiveness as well as the cost-effectiveness of this program in adolescents (12-17 years) and adults with various chronic diseases.

In an observational study we plan to compare patients participating in the integrated care project with matched insured persons from the Techniker Krankenkasse that do not participate in this program.

Matching will be based on gender, age and diagnosis. Regarding the diagnosis, we plan to include adolescents with: asthma, allergic rhinitis and atopic eczema; and adults with asthma, allergic rhinitis and atopic migraine, headache and depression.

To measure effectiveness, patients have to complete diagnosis-specific questionnaires at baseline and 3, 6 and 12 months. The primary outcome for each diagnosis is measured with diagnosis-specific questionnaire at 6 months. Secondary outcomes include quality of life (SF-12) at 3, 6 and 12 months as well as the diagnosis-specific questionnaires at 3 and 12 months.

Eligibility Criteria:
Inclusion criteria:

* Newly registered for the integrated care program
* Insured for at least 1 year at the Techniker Krankenkasse
* Having access to the internet and e-mails at least once a week
* Adults with any of the following diagnoses: asthma, allergic rhinitis, atopic eczema, migraine, tension headache, depression
* Adolescents with any of the following diagnoses: asthma, allergic rhinitis, atopic eczema
* informed written consent

Exclusion criteria:

* Participation in a disease-management program
* Participation in an intervention study
* Cancer diagnosis
* current usage of a complementary therapy (control group only)
Evaluation of Anti-inflammatories in the Reduction of Bite Reactions

The purpose of this study is to evaluate two separate antiinflammatory products for the relief of symptoms through suppression of the immunological and inflammatory response following a mosquito bite. The investigators have selected ibuprofen gel as a NSAI formulation and 0.05% Clobetasone butyrate as a steroid cream with their appropriate physical matched placebo products.


Eligibility Criteria:
Inclusion Criteria:

18 to 65 years of age (inclusive). Caucasian (white or pale skin) Good health as determined by medical history and physical examination Females of child bearing potential must confirm they are not pregnant at the study start and agree not to become pregnant throughout the duration of the study.

History of the following triad of symptoms following a previous mosquito bite: weal, flare, and pruritus as immediate reaction to mosquito bites at least once in the past (= mosquito bite sensitive stages III or IV).

Willingness to attend for all study procedures at designated intervals. Willingness to provide full consent to the study

Exclusion Criteria:

Abnormalities of the skin on the forearms (including sunburn) that might interfere with the study results, as determined by the investigator/clinician during physical inspection.

History of clinically significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, or other disease deemed clinically significant by investigator / clinician Use of prohibited therapies (including cosmetics on either forearm) as specified in Section 6.3.3 of the Clinical Trial Protocol (use of systemic or local antihistamines, steroids, or NSAIDs during or within 2 weeks prior to planned date of first study procedure); use of any medication considered to have an influence on the outcome of the study.

Any acute illness within the 7 days prior to planned date of first study procedure which might interfere with the study results (as determined by the investigator/clinician from medical history).

History of malignancy within 5 years of the planned date of the first study procedure Neurological or psychiatric disease, or drug or alcohol abuse which would interfere with the subject's completion of the protocol assignments.

Participated in research involving an investigational drug within 3 months of the planned date of first study procedure.

History of known anaphylactic hypersensitivity to mosquitoes bites, bee or wasp stings.

History of allergic reaction to any of the topical agents used in the study or any of their components.

History of allergy to latex or other rubber material Women who are pregnant or breastfeeding
Effects of Interrupting Sedentary Time on Glycemic Control in Older Overweight and Obese Adults

Increasing physical activity in older adults has important implications for treating obesity related metabolic conditions, however the interaction of aging- and obesity-related declines in physical function may make adding structured exercise particularly challenging for this group. Given these challenges, an alternative prescription to traditional structured exercise, may be short bouts of intermittent walking scattered throughout the day - this may be an effective strategy to increase physical activity, reduce sedentary behavior, and improve glycemic control in overweight/obese older adults. The purpose of this project is to determine how interrupting sedentary time with short bouts of moderate intensity walking affects important metabolic outcomes in older, overweight adults. It would also be of interest to compare the effects of short, frequent interruptions in sedentary behavior to a traditional exercise prescription (continuous 30 min walking bout) on metabolic outcomes (e.g., glycemic control, insulin sensitivity, and 24 h fat oxidation). Thus, the overall aims of the proposed research are to 1) Determine the effect of performing short bouts of moderate-intensity intermittent walking (IW) on glucose and insulin metabolism compared to uninterrupted sitting (US) in older overweight and obese adults. 2) To compare the effects of interrupting sedentary time (IW) vs. a traditional exercise prescription (continuous 30 m walk (CW)) on metabolism.

The investigators hypothesize that interrupting sedentary time with intermittent walking will improve glucose and insulin metabolism compared to uninterrupted sitting and it will be as effective at improving metabolism as a single continuous 30 min walk.


Eligibility Criteria:
Inclusion Criteria:

* Aged 60-85 yr • BMI 25-35 kg.m-2
* Non-exercisers (\<150 m/wk of moderate intensity exercise)
* Sedentary (\>60% of waking day sedentary)
* Able to walk on a treadmill for 36 continuous minutes at a pace of at least 2.0 mph

Exclusion Criteria:

* Self-reported acute or chronic disease (e.g. diabetes, heart disease, thyroid disease)
* Fasting plasma glucose ≥ 126 mg/dl - participants will not be excluded if they an abnormal post prandial glucose levels (e.g. glucose ≥ 200 mg/dl) following the MTT's.
* Tobacco use (cigarettes, cigars, or chewing tobacco) within the past 6 months
* Females who previously used (\> 6 months) or are currently using any formulation of estrogen-based hormone therapy (e.g., oral Premarin, transdermal 17-estradiol, selective estrogen receptor modulators).
* Resting diastolic blood pressure \> 100 mm mercury or resting systolic blood pressure \> 160 mm mercury
* Contra-indications to exercise (e.g. orthopedic limitations)
* Unable to walk on a treadmill for 36 continuous minutes at a pace of at least 2.0 mph
Functional Connectivity After Anterior Cruciate Ligament Reconstruction

Background:

Despite surgical reconstruction and rehabilitation, individuals after a primary anterior cruciate ligament injury have a significantly increased risk of relapse. The mechanisms for this increased risk may go beyond mere physiological and biomechanical changes of the reconstructed anterior cruciate ligament. The loss of ligamentous mechanoreceptors can affect sensory feedback and consequently result in a disrupted afferent input to the central nervous system. However, research on the neuroplasticity of the central nervous system after anterior cruciate ligament injury and more specifically on the cooperation between different brain areas (=functional connectivity) in motor execution and performance is limited.

Research purpose:

To investigate the changes in terms of functional connectivity in the brain after sustaining an anterior cruciate ligament injury and associated reconstruction?

Population:

* Patients after anterior cruciate ligament reconstruction
* Healthy controls

Protocol:

First, all participants are required to complete several questionnaires regarding the level of anxiety and the functioning of the knee in daily activities and sports. In addition, during the baseline testing, participants will be required to perform an experiment while electrical brain activity is recorded by means of an electroencephalography (EEG) measurement. During this experiment, the participants will have to successively perform the following exercises: 10x knee extension from sitting (left and right), 10x bipodal squat from standing, 5x 30 seconds unipodal standing (left and right).

The above protocol will be administered to the patient group for the first time 8 weeks after the anterior cruciate ligament reconstruction. When the patients do not need further rehabilitation, they will be invited a second time to execute the same protocol again. The control group will only have to carry out the above protocol once.

Finally, for one year after the last test, the patient group will be contacted monthly to monitor return to sport and the occurrence of injuries.


Eligibility Criteria:
PATIENT GROUP

Inclusion Criteria:

* Older than 18 years of age.
* Primary anterior cruciate ligament rupture and reconstruction

Exclusion Criteria:

* Major knee surgery in the past.
* Diagnosed with any knee pathology at this moment.
* Have any muscle or nerve related conditions that affect the functioning of the lower limbs.

CONTROL GROUP

Inclusion Criteria:

- Older than 18 years of age.

Exclusion Criteria:

* Major knee surgery in the past.
* Diagnosed with any knee pathology at this moment.
* Have any muscle or nerve related conditions that affect the functioning of the lower limbs.
Regional Central Database Recording of Chronic Myeloid Leukemia

It will be a centralized database , multicentre (6 centers) , regional, chronic myelogenous leukemia cases of registration (CML) prospectively and retrospectively.

Given the complexity and evolution of recommendations and to harmonize these, it appears necessary to establish a central database for recording , monitoring patients with CML supported by the participating centers the region and evaluation of care practices in use .

Indeed , the main purpose of this database is to provide diagnostic and therapeutic management of reported cases of chronic myeloid leukemia and to study the prognostic factors . The main objective is to improve significantly the percentage of patients treated adequately load in the region, in the initial stages of the disease and during its evolution.

Eligibility Criteria:
Inclusion Criteria:

* chronic myeloid leukemia Diagnosis (CML) in chronic phase , accelerated or blast
* male or female patient aged 18 years or more
* Cases transmitted by referring hematologist , one of the 6 participating centers after patient's oral information
* Clinical record presented Concertation Meeting LMC Multidisciplinary coordinated by the Institute Bergonié

Exclusion Criteria:

* none
Comparison of Bowel Cleansing Methods for Colonoscopy in Hospitalized Patients

The purpose of this study is to compare two regimens of polyethylene glycol(PEG) plus bisacodyl versus PEG alone for bowel preparation in hospitalized patients.

Inadequate bowel preparation may lead to a longer colonoscopy, and to an inability to identify lesions. PEG can provide a rapid orthograde peroral approach to colonic lavage without producing significant fluid or electrolyte changes. Thus PEG is now commonly used for bowel preparation. However, large amounts and unsatisfactory taste of PEG solution are generally poorly tolerated, especially in hospitalized patients who had comorbidity and restricted ambulation. Recently, a new PEG-based bowel cleansing agents became available. It combines PEG with a high dose of ascorbic acid or bisacodyl. Although many studies reported the efficacy of these combined solution for colonoscopy, but efficacy in hospitalized patients was under-recognized.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients for colonoscopy

Exclusion Criteria:

* age under 20 years or over 80 years
* major psychiatric illness
* known allergy to PEG
* serious condition- severe cardiac, renal, or metabolic diseases
* partial colon resection
* current acute exacerbation of chronic inflammatory bowel disease
* functional constipation defined by Rome III diagnostic criteria
Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
* Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria:

* Overactive Bladder caused by neurological condition
* Patient has predominance of stress incontinence
* History or evidence of pelvic or urological abnormality
Keep It Up! 2.0: A Comparison of Two Online HIV Intervention Programs for Young Men Who Have Sex With Men

Young men who have sex with men (YMSM) account for almost 70% of HIV diagnoses among all young people in the U.S. and are alone in facing an increasing rate of infections. Because YMSM are less likely to receive relevant sexual health education in traditional settings (e.g. schools, community), the Internet is a unique route of reaching and helping YMSM.

The purpose of this study is to compare two different versions of an online HIV prevention program for YMSM. The study is being conducted by researchers at Northwestern University in Chicago, Hunter College in New York City, and Emory University in Atlanta. A total of 900 YMSM will be enrolled into this study from the clinics of community partners in Chicago, New York, and Atlanta.

Participants will be randomly assigned to one of two versions of the program. Some topics in the program include HIV facts and myths, sexually transmitted infections (STIs), and condom use. All participants, regardless of the program version they receive, will also take at-home urine and rectal tests for the STIs chlamydia and gonorrhea. After completing the program, participants will be contacted three more times over the course of a year for follow-up sessions and surveys.

The research team hypothesizes that the YMSM-specific prevention program will lead to a significant reduction in the frequency of unprotected anal sex acts and new STI infections compared to the HIV knowledge program that is for a general audience. The YMSM-specific program will also lead to improvements in secondary knowledge, motivation, and skills outcomes.

In order for the research team to measure the effectiveness of the YMSM-specific prevention program and determine if the study hypothesis is correct, participants will be asked questions about themselves, including questions about their sexual orientation, sexual experiences, health practices, including drug use, health knowledge, and questions about their feelings and emotions. Based on this information, the research team hopes to later change, improve, or expand the program to better address the needs of YMSM.


Eligibility Criteria:
Inclusion Criteria:

* Birth male who identifies as male and reports sexual contact with another male
* Received an HIV negative test result from a participating clinic/recruitment site
* Unprotected anal sex with another male in the last 6 months
* Ability to read English at 8th grade level

Exclusion Criteria:

* HIV positive
* Female or Transgender
* No email address for contact
* Currently in a monogamous relationship lasting longer than 6 months
* Participated in previous versions of KIU!
Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment.

A single armed multicenter study enrolling 20 patients using autologous bone marrow aspirate concentrate (which is done under local or general anesthesia to aspirate around 1-2 cc/kg body weight then concentration which is done by using centrifugation and special disposable kit) local injection of 4 cc per joint under ultrasonic guidance ,completely sterile field with local anesthesia.

The anterior cruciate ligament (ACL) is key to the functional stability of the knee joint and is highly susceptible to injury, especially in athletes engaged in high-impact sports. Conventional treatment for partial tears may involve conservative management; however, complete tears often necessitate surgical reconstruction. In seeking alternative treatments, this study investigates the potential of bone marrow aspirate concentrate BMAC-a regenerative medicine approach-to promote healing and restore functionality to completely torn ACLs. The regenerative properties of BMAC, attributed to the presence of stem cells and growth factors, may facilitate ligament repair and regeneration. the team aim treating 1st and 2nd degree anterior cruciate ligament tear without retraction.

Eligibility Criteria:
Inclusion Criteria:

1- Confirmed diagnosis of complete or partial ACL tear via clinical examination and imaging studies.

2. Aged between 20 and 55 years, to encompass the typical age range of patients with sports-related ACL injuries.

Exclusion Criteria:

1- Patients with a history of bleeding disorders, as this could complicate the aspiration and injection procedures.

2. Individuals with a history of malignancy, due to the potential risks associated with growth factors present in BMAC.

3. Critically ill patients or those with comorbidities
Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.


Eligibility Criteria:
Inclusion Criteria:

* Have Type 2 Diabetes (T2D)
* Have HbA1c ≥7.0% (53 millimoles per mole (mmol/mol)) to ≤10.5% (91 mmol/mol)
* Have moderate or severe renal impairment
* Have been on the following stable diabetes treatment during 90 days prior to screening

  * basal insulin (≥20 International Units (IU)/day) with or without
  * metformin and/or SGLT2 inhibitor
* Are of stable weight for at least 90 days prior to screening
* Have a Body Mass Index (BMI) ≥23.0 kilograms per meter squared (kg/m2)

Exclusion Criteria:

* Have Type 1 Diabetes (T1D)
* Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening
* Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
* Have a history of unstable or rapidly progressing renal disease
* Have a prior or planned surgical treatment for obesity
* Have New York Heart Association Functional Classification III or IV congestive heart failure
* Have had acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening
* Have a known clinically significant gastric emptying abnormality
* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2.
* Have any lifetime history of a suicide attempt
* Had chronic or acute pancreatitis
* Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening