cyrilzakka/clinical-trials huggingface dataset:
Mobile Mental Health Stigma Reduction Intervention Among Black Adults

Major depressive and anxiety disorders are highly prevalent in the general population and are a leading cause of disability. Black adults have a high burden of depression and anxiety. This study aims to assess a self- administered video-based intervention to reduce mental illness stigma and medical mistrust among Black adults with moderate to severe depression or anxiety.

Major depressive and anxiety disorders affect 57.3 million adults in the U.S. These disorders are also highly stigmatized. Stigma refers to negative attitudes or beliefs about mental illness, or negative behaviors directed toward persons with mental illness (PWMI) is a leading and fundamental cause of health inequities.

The efficacy and precision of anti- stigma interventions to improve mental health outcomes among underserved Black adults are grossly limited and represent a critical public health gap. Studies show stigma compounds disabilities related to the primary symptoms of mental illness and increases morbidity and premature mortality related to mental illness. Compared with white adults, Black adults with mental illness have more chronic disease, and more severe illness at presentation. Meta-analyses have consistently shown that both face-to-face and video-based contact with individuals with mental illness can reduce stigma. Recent studies that distinguished contact delivery showed effect size for video-based contact to be comparable to face-to-face contact. Contact interventions, which are premised on the idea that positive and voluntary contact with PWMI can effectively reduce mental illness stigma, are aimed at reducing stigma and improving health outcomes.

The primary objective of this study is to evaluate the efficacy of a self-administered, video-based mobile app intervention aimed at reducing mental illness stigma among Black adults. Black adults with moderate to severe depression or anxiety will be recruited to participate in the Randomized Controlled Trial (RCT). Participants will be randomly assigned to one of three arms: two video-based intervention arms and one waitlist control arm. The video-based intervention will include first-hand lived experience stories of mental health and one's recovery journey.

Eligibility Criteria:
Inclusion Criteria:

1. If you identify as Black American or Black immigrant
2. Experience or been diagnosed with depression and/or anxiety
3. Age 18-45 years
4. Own a smartphone with internet access
5. Have not seen a psychiatrist or therapist in the last 12 months or have not been in routine healthcare
6. English speaking

Exclusion Criteria:

1. Visual, hearing, voice, or motor impairments that would prevent engagement in study procedures,
2. Diagnosis of psychotic disorder or severe suicidality for which participation would be inappropriate.
Treatment of Patients With Longstanding Unexplained Health Complaints

The purpose of this study is to determine the effect of specialized treatment (including cognitive therapy, social counselling and a recommendation letter to the patients' primary care physician) on the functional level, emotional problems, and use of health care in patients with chronic medically unexplained symptoms.

Medically unexplained or functional somatic symptoms are complaints, which are not attributable to any verifiable, conventionally defined disease, or which cannot adequately be supported by clinical or para-clinical findings.

Functional somatic symptoms are common in the population and in all clinical settings, both in primary and secondary care. The disorders range from mild, transitory cases, which are difficult to delimit in relation to normality, to severe chronic cases with multiple symptoms from different organ systems.

Chronic multiple functional somatic symptoms often cause frustration for both GPs and patients due to lack of availability of specialized treatment offers. Patients may have a high use of health care, and their social and functional level is low. In Denmark, patients with chronic multiple functional somatic symptoms account for at least 10% of the early retirement pensions each year.

Diverse interventions have been effective in the management and treatment of patients with functional disorders. Care recommendation letters for the GPs have both helped reduce the patients' use of health care and improved their level of physical functioning. Randomized controlled trials (RCT) have shown that cognitive behavioral treatment (CBT) has effect on specific patient groups with functional disorders. Through a combination of cognitive behavioral therapy, social counselling and recommendation letters, it is possible to offer patients with chronic functional somatic symptoms a presumably effective and cost-effective treatment.

Eligibility Criteria:
Inclusion Criteria:

* Multiple somatic symptoms from several organ systems, without adequate medical explanation.
* Moderate to severe influence on daily life.
* The disorder's functional component can easily be separated from a possible well-defined chronic somatic illness.
* No lifetime-diagnosis of psychoses, bipolar affective disorder or depression with psychotic symptoms (International Classification of Diseases \[ICD-10\]: F20-29, F30-31, F32.3, F33.3)
* The condition must have been present for at least 2 years.
* Patients of Scandinavian origin who understand, read, write and speak Danish.

Exclusion Criteria:

* No informed consent.
* An acute psychiatric disorder that demands other treatment, or if the patient is suicidal.
* Abuse of narcotics or alcohol and (non-prescribed) medicine.
* Pregnancy.
* Current industrial injury case or other action for damages.
WB-DWI for Early Prediction of Therapy Response in Patients With Advanced Metastatic GIST Treated With Regorafenib

The purpose of this study is to evaluate WB DWI as early predictor of response to treatment with regorafenib or placebo in patients with advanced metastatic GIST.

Aim of the study

- To assess whole body diffusion-weighted magnetic resonance imaging (WB-DWI) for the assessment and early prediction of response of treatment with regorafenib or placebo in patients with advanced, metastatic gastro-intestinal stromal tumors (GIST)

1. Evaluation of pretreatment apparent diffusion coefficient (ADC) and b1000 signal intensity (SI) of GIST visualized on the WB-DWI as predictor of time to progression, determined by progression-free survival (PFS)
2. Evaluation of WB-DWI using changes of high b-value SI and ADC early during treatment (2weeks after start of therapy; allowed optimal window 10-14 days) as early predictor of time to progression or patient benefit according to RECIST (stable disease + partial response + complete response)
3. Evaluation of WB-DWI for treatment follow-up 3 months after initiation of treatment. Confirmation of prior published pilot study (Dunet V et al, J Nucl Med 2010)
4. Comparison of WB-DWI with conventional CT imaging for response assessment

Eligibility Criteria:
Inclusion Criteria:

* patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo

Exclusion Criteria:

* in case of a known contraindication for MRI (eg. pacemaker), the patient will not be admitted to the study
The Instant Effect of Kinesiology Taping in Patients With Knee OA

The aim of this study is to determine instant effect of kinesiology taping applied to the rectus femoris on muscle activation, physical performance and proprioception in patients with knee osteoarthritis.

40 patients with knee OA will be included in the study. Intervention group and placebo group will be formed. Facilitation taping will be applied on the rectus femoris of the patients in the taping group. The patients in the placebo group will be placed tape on the rectus femoris without any tension. Muscle activation, physical performance and proprioception will be evaluated before taping and 30 minutes after taping.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 45-65 years,
* Patients with independent ambulation,
* Patients with Grade II-III knee osteoarthritis according to the Kellgren and Lawrence Classification,
* Patients not using NSAIDs during the study,
* Patients who volunteered to participate in the study

Exclusion Criteria:

* Patients with previous surgery on the lower extremities
* Patients with neuromuscular disease
* Patients with vestibular pathology
* Patients with diseases of the cardiopulmonary system,
* Patients with communication difficulties,
* Patients who have received physiotherapy or intra-articular injections in the last 6 months or who exercise
A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 18 to 49 Years of Age.

The objective of this study is to evaluate the safety and immunogenicity of different vaccines of hemagglutinin formulations of trivalent influenza vaccine or of a combined respiratory syncytial virus / human metapneumovirus / parainfluenza virus type 3 vaccine in healthy participants 18 to 49 years of age. A lipid nanoparticle will be used in this study.

Overall, the study is designed to:

* Assess the safety profile of the candidate formulations
* Describe the immunogenicity profile of the candidate formulations
* Eligible participants will be randomized to receive a single intramuscular injection of either one of the vaccine formulations.

Participants will be provided with a diary to solicit reporting of injection site reactions and systemic reactions, unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest AESIs).

Participants will also be required to record their daily temperature on the diary.

The duration of study participation will be approximately 6 months for each participant.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 49 years on the day of inclusion
* A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:

  * Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile OR
  * Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration.

Exclusion Criteria:

- Any medical condition or circumstance which, in the opinion of the investigator, might interfere with the evaluation of the study objectives

Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Internet Tools and Emergency Attendance

Over the years, there has been an increase in the flow of emergency rooms, which is gradually leading to an overcrowding of emergency unit. This overcrowding is multifactorial with, for example, a decrease in the outpatient care in family medicine and specialized medicine, emergency services unsuitable at the level of premises ... In parallel, investigator note in recent years facilitated access to internet and especially to GAFA which is the acronym for Google, Amazon, Facebook, Apple. As a result, patients have 24-hour access to medical information via websites, blogs and social networks. This information of, often, unreliable medical information can lead to ambiguity among patients about the need for urgent or delayed intervention in the management of their symptoms. In fact, "everything becomes urgent". To date, in France, no study has evaluated the impact and prevalence of consulting a website for medical purposes before consulting an emergency service. The objective of this research will be to assess, in patients presenting in an emergency department, the prior consultation of medical information on a website, the impact on the emergency consultation decision and the relevance of this consultation.

It is an observational study, monocentric, prospective. This study consists in collecting data from an anonymized questioner given to patients presenting themselves at the emergency department of Clermont-Ferrand University Hospital. Answers to the questions will not change the patient's management. The questioner, containing 17 questions, requires answering "yes" or "no" by ticking boxes, or even specify when it is stipulated. This questionnaire will be given to the patient after his registration, and filled by the latter in the waiting room, pending medical care. Answering the questionnaire will take between 5 to 10 minutes. The data is anonymous.

The patient arrives at the emergency department and registers at the entrance desks where a paper and computer file is created. Then, the Reception and Orientation Nurse takes care of the patient by welcoming him in the reception box, she realizes the taking of the hemodynamics constants, the collection of the reason of consultation with the grievances of the patient. During this phase, patient will be inform of the completion of this study and asked to participate in this study. If the patient agrees to participate, an anonymized questioner will be provided and explained by one of the investigating physicians or associated partners.

Eligibility Criteria:
Inclusion Criteria:

* Any major patient presenting to the emergency department by their personal way.

Exclusion Criteria:

* Suspicion of acute alcoholism
* dementia
* guardianship / trusteeship
* language barrier, non-communicating patient
* patient refusing to participate in the study
* patient with confusion
* patient with Glasgow scale less than 15
* patient not affiliated with social security
* patient not knowing how to read or write.
A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response

This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.


Eligibility Criteria:
Inclusion Criteria:

* Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
* Male and female subjects, 18 to 70 years of age, inclusive
* Genotype 1, chronic hepatitis C with detectable HCV RNA.
* Screening laboratory values, tests, and physical exam within acceptable ranges
* Able and willing to follow contraception requirements
* Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions.

Exclusion Criteria:

* Subject has any contraindications to Pegasys® or Copegus® therapy
* Evidence of hepatic decompensation in cirrhotic subjects
* History of organ transplant
* History of, or any current medical condition which could impact the safety of the subject in participation in the study
Progressive Muscle Relaxation Exercise on Intensive Care Nurses

Nurses who intensive care unit will be entered. Participants will be randomized to one of two study arms:

Arm 1: Progressive muscle relaxation; Arm 2: control. Hypothesis: Progressive muscle relaxation will decrease occupational stress, headache and improve well-being.

Previous reports have revealed that non-pharmacological approaches such as aromatherapy, massage, meditation, music therapy, breathing exercises, yoga and progressive muscle relaxation exercises (PGE) have been used to reduce stress and fatigue of individuals and improve their well-being.

However, there have been limited studies that directly focus on supporting intensive care nurses who face serious problems with intense work tempo, experience excessive stress, headache, tension, fatigue, are open to psychosocial problems such as anxiety, depression and burnout.

Besides, till date, no study has been conducted to determine the effects of progressive relaxation exercise on occupational stress, headache and well-being for intensive care nurses.

The present study investigates the effects of progressive muscle relaxation in a single-site, 2-arm, assessor-blinded randomized, controlled study of 100 intensive care nurses.

Arm 1: relaxation; Arm 2: Attention matched control. The investigators hypothesize that progressive muscle relaxation will decrease the severity of occupational stress and headache and improve well-being.

Eligibility Criteria:
Inclusion Criteria:

* Working in cardiovascular intensive care for at least 6 months
* Having a headache at least once a week
* No physical disability
* Those who do not have a neurological diagnosis (having cerebrovascular disease, multiple sclerosis, etc.)
* No psychiatric diagnosis
* Not applying any complementary methods at the time the research was conducted.
* Nurses who volunteered to participate in the study

Exclusion Criteria:

* Nurses followed up with the diagnosis of end-stage renal disease, Chronic Obstructive Pulmonary Disease, advanced heart failure, chronic liver disease, musculoskeletal problem, hypothyroidism and depression
* Having physical and mental health problems that prevent communication
* Nurses who practiced any complementary method (relaxation exercise, yoga, etc.) during the study.
Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease

This study evaluates the performance of the CorPath 200 System to deliver guide wires and balloons to blockages in the arteries of the leg.

The CorPath 200 System is currently marketed for remotely delivering guide wires, balloons and stents to blockages in the coronary arteries. This study will evaluate the feasibility of CorPath 200 System to deliver guide wires and balloons to blockages in non-coronary arteries.

Guide wires and balloons are delivered to blockages in the lower limbs manually by doctors.If this study shows that guide wires and balloons can be safely delivered to blockages in the lower limbs, then it will be an alternative for physicians.

Eligibility Criteria:
Inclusion Criteria:

* General Inclusion

  1. At least 18 years of age;
  2. Symptomatic disease: presence of critical limb ischemia (including tissue loss or rest pain), or lifestyle-limiting claudication requiring intervention in iliac and/or superficial femoral arteries;
  3. The subject or the legally authorized representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.
* Angiographic Inclusion

Presence of superficial femoral artery and/or iliac stenosis (\>50%) or occlusion of up to 50 mm in length as determined by angiogram prior to index interventional procedure.

Exclusion Criteria:

* General Exclusion

  1. Failure/inability/unwillingness to provide informed consent;
  2. Target vessel has been previously treated with bypass;
  3. Has an abdominal aortic aneurysm contiguous with the iliac artery target lesion;
  4. Has contraindication to anticoagulation;
  5. Has bleeding or a hypercoagulability disorder;
  6. Thrombocytopenia;
  7. Elevated international normalized ratio (\>1.5);
  8. Elevated serum creatinine (≥2.5 mg/dL);
  9. Active infection;
  10. Contraindication to contrast; or
  11. Enrolled in concurrent clinical study.
* Angiographic Exclusion

  1. Target vessel:

     1. shows evidence of previous dissection or perforation, or
     2. has adjacent acute thrombus;
  2. Lesion is highly calcified;
  3. Lesion requires use of any atherectomy device during the procedure;
  4. Has a pre-existing target artery aneurysm or perforation or dissection of the target artery prior to initiation of the interventional procedure.
Evaluation of a Project to Distribute Water Filters and Cook Stoves in Western Rwanda--Phase 1B

DelAgua Health and Development, Manna Energy and the Rwanda Ministry of Health are collaborating on a project financed by carbon credits that will distribute household-based water filters and high-efficiency cook stoves to approximately 600,000 households in Rwanda. Prior to the full roll out of the campaign, the implementers are conducting research in connection with a distribution among 2000 households in western Rwanda. The objective of this matched cohort study (Phase 1B)are to investigate whether the filters and stoves delivered in October 2012 are still performing and in use, to determine whether they are associated with reductions in exposure to pathogens from drinking water and stoves, and to assembly information on health and other conditions necessary for the design of a large scale health impact evaluation.


Eligibility Criteria:
Households will be eligible to participate in the study if they reside in selected villages and are willing to participate after receiving complete details regarding the study. Intervention households must have a functioning stove and water filter in order to participate, though they do not need to be in regular use. We will enroll all households with a child under 5 years of age if they are in Ubudehe groups 1 or 2.
Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia

The purpose of this study is to analyze the effects of a intervention on a specific health prevention/intervention program aimed at caregivers of mild and moderate patients post stroke with upper limb apraxia in comparison to a control group with a no specific formation in that kind of patients.

Patients with Upper limb apraxia after stroke have severe problems to adapt their daily life.

The upper limb apraxia syndrome affects the performance of skilled movements carried out by the upper limbs and provoke that many patients´activities have to be made by their main caregiver or carers.

Caregivers usually have to occupy much time and efforts for caring their familiar or client, and it can result in a overload in different areas of the caregiver health.

Few data are available on the effectiveness of interventions in caregivers that informally works with that kind of patients.

The specific prevention health program is based on improving the awareness of the assistance that the caregivers provide, and knowing the process of the information that carer has to give to the patient while the patients have their activities made.

Eligibility Criteria:
Inclusion Criteria:

* Having an habitual role of carer (informal or formal).
* Being caring a mild-moderate poststroke patient with upper limb apraxia.
* Subjective manifestations of overload in the role as carer.
* More than two month as carer.

Exclusion Criteria:

* Uncooperativeness
* Being formed in the care of that kind of patients