cyrilzakka/clinical-trials huggingface dataset:
Message-Based Psychotherapy and Digital Treatment Sequences for Depression

This partnership between Talkspace and the UW ALACRITY Center will determine how effective unlimited text-based psychotherapy for depression is when compared to once-a-week psychotherapy. This study will also determine what the best treatment options are for people who are not responding well to either unlimited texting or weekly psychotherapy. The results of this study will be a new product version of message-based care that can tailor psychotherapy intensity based on the needs of future consumers with depression.

This is a fast track SBIR proposal that will (1) test the effectiveness of daily, message-based psychotherapy (MBP) for depression, compared to traditionally delivered, video-chat psychotherapy (VCP) and (2) develop an evidence-based treatment sequence for those who do not respond to either daily MBP or VCP.

Phase 1 consists of a pilot study to determine the best incentive model to retain a sample of people 18 years old and older with depression into a SMART trial. Information from this pilot will inform the retention strategy for Phase 2.

Phase 2 is a 12-week, randomized clinical trial using a SMART design to test the following aims: 1. Determine the relative effectiveness of daily MBP compared to weekly VCP in treating symptoms of depression and improving social functioning; 2. For those who fail to respond to 6 weeks of weekly VCP only, determine whether the addition of daily messaging, or a switch to monthly video-chat plus daily messaging improves depression and functional outcomes; and 3. For those who fail to respond to 6 weeks of daily MBP, whether the addition of monthly video-chat or weekly video-chat improves outcomes. Participants will provide data on mood, activity, and functioning, and we will collect data on use of treatment (texts and sessions), and working alliance.

Eligibility Criteria:
Inclusion and exclusion criteria are the same for Phase 1 and Phase 2.

Inclusion Criteria:

* 18 years old or older
* English or Spanish speaking
* Live in the United States
* Score of 10 or greater on the PHQ-9 screening
* Receive a diagnosis of depression from a Talkspace intake clinician

Exclusion Criteria:

* Under the age of 18
* Non-English or Spanish speaking
* Do not meet criteria for a depressive disorder
* Participants with active suicidal ideation or with a primary diagnosis of psychosis will also be excluded and referred to intensive care.
Hypnotherapy in Patients With Chest Pain & Unobstructed Coronaries

This study will investigate whether clinical hypnotherapy can effectively treat chest pain symptoms, improve emotional wellbeing and quality of life in postmenopausal women with chest pain and coronary arteries without any narrowings. The diagnosis of chest pain with 'normal' coronary arteries is found in 25% of patients undergoing investigation of chest pain using coronary angiography (when dye is injected into the coronary arteries whilst xray pictures are taken), and the majority of these patients are postmenopausal women. Often there is no obvious physical cause. Despite symptoms being treated using conventional drugs, and life expectancy is not affected, many patients continue to suffer from debilitating chest pain symptoms, frequently resulting in visits to hospital, increased psychological illness and poor quality of life. The investigators are interested in finding ways of improving not only chest pain symptoms but also psychological wellbeing and quality of life in these patients. Previous studies of ours have found improvement in these patients after taking part in a support group, and using a relaxation technique called Autogenic training. Recently the investigators conducted a pilot study which showed a favourable effect of hypnotherapy on physical ability, well-being and quality of life. The investigators would now like to extend this study, performing a larger randomised, controlled trial. The investigators hypothesise that hypnotherapy will beneficially affect symptoms and quality of life in patients with cardiac Syndrome X.


Eligibility Criteria:
Inclusion Criteria:

* history of chest pain for ≥ 2 years
* ≥ 2 episodes chest pain per week
* angiographically smooth epicardial coronary arteries
* Willing to give written informed consent

Exclusion Criteria:

* Any epicardial coronary atheroma on angiography of the coronary arteries
* left ventricular hypertrophy or dysfunction (clinical/ECG/echo/CXR)
* previous hypnotherapy for chest pain symptoms
* participation in research project within previous 60 days
* unwilling to give written informed consent
Fostering Sustainability Through Diabetes Self-Management Support

To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.

To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.

Eligibility Criteria:
Inclusion Criteria:

* Have Type 2 diabetes for at least 6 months
* Be Black/African American
* Be a resident of metro-Detroit, Toledo, or Flint
* Be at least 21 years old
* Be under the care of a physician for diabetes
* Have transportation to attend the program

Exclusion Criteria:

* Have Type 2 diabetes for less than 6 months
* Under 21 years of age
* Not under care of physician
* Lack of transportation to attend the program
Effects of Group-based and Individual Pelvic Floor Muscle Training on Elderly Individuals With Urinary Incontinence

The purpose of this study is to asses the effects of 12-week group-based and individually planned pelvic floor muscle training on individuals aged 65 and over with urinary incontinence.

The research was conducted on participants over the age of 65 with urinary incontinence living in a nursing home. After these participants were informed about the content of the study, a signed informed consent form will be obtained. This study is an assessor-blinded, randomized controlled trial. Participants with incontinence aged 65 and over living in a nursig home were randomly assigned to intervention (IG) and control group (CG). The intervention group attended an exercise program that individualized pelvic floor muscle with Emg biofeedback training (individualized-PFMT). The control group was included in the group-based PFMT program. Duration of exercise for both groups was 45-60 minutes per session three times a week for 12 weeks. Incontinence symptoms and severity (Pelvic Floor Distress Inventory-20, bladder diary), PFM and abdominal muscle function (superficial electromyography), balance (Berg Balance Scale), functional status (Senior Fitness Test), hand grip strength, knee extansor, ankle dorsi-plantar flexion muscle srength, sleep quality and fear of falling (Falls Efficacy Scale) was measured at baseline and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Having signed the informed volunteer consent form
* Being 65 years or older
* Having urinary incontinence
* Ability to walk unaided and not use any walking aids

Exclusion Criteria:

* Having severe walking and balance problems
* Severe cognitive impairment (Mini mental state assessment test score below
* Having a serious neurological problem
* Having serious heart diseases
* Having a genito-urinary infection
* Having pelvic organ prolapse
* Six months ago he received medication for incontinence
* Having had incontinence and abdominal surgery
* Having metastatic cancer
* Having any vision problems
Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population

The purpose of this study is to in a proactive manner collect high quality data from a pediatric patients who have undergone a bone anchored hearing solution, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of using the system.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have decided to undergo a Bone Anchored Hearing Surgery
* Diagnosed with atresia
* Signed informed consent
* Patients between 2,5 - 18 years of age
* Patients eligible for one stage surgery

Exclusion Criteria:

* Not fluent in Swedish or English; subject and/or legal guardian
* Unwillingness to participate in follow up visits
Medical Yoga for Patients With Stress-related Symptoms

The purpose of this study is to compare the effect of Medical Yoga as a group treatment, to conventional treatment provided by a physical therapist, for people with perceived stress-related symptoms.

Forty people are to be randomized to either:

1. Intervention Group - Medical Yoga, group treatment for eight weeks, 60 minutes per week, with the guidance of a physical therapist.

   or
2. Control - treatment as usual (TAU) in physical therapy.


Eligibility Criteria:
Inclusion Criteria:

* Perceived stress and anxiety, which could be expressed as for example as tension in the neck and shoulders, insomnia, anxiety and headaches.

Exclusion Criteria:

* Do not understand Swedish (as group instructions need to be understood),
* Pregnancy,
* Psychotic symptoms,
* Ongoing or physical therapy treatment the last three months,
* Previously participated in Medical Yoga group.
Phase 3/Safety & Efficacy of Esomeprazole in Infants

The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.


Eligibility Criteria:
Inclusion Criteria:

* patients' parents must sign the informed consent prior to the beginning of any study-related procedures (according to local regulations)
* patients must have symptoms at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or GERD proven by a test called an endoscopy, a test using a long tube inserted in the body for diagnostic exams

Exclusion Criteria:

* patients who have used a PPI (proton pump inhibitors; used to reduce the amount of acid in the stomach) within 7 days before enrollment in the open label treatment phase (Day 0)
* patients with a history of acute life-threatening event
Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF

Prevention trial of nosocomial infections in neutropenic prematures with G-CSF


Eligibility Criteria:
Inclusion Criteria:

\< 33 weeks GA neutropenic during at least 24 hours in the first 3 weeks of life and not infected at time of inclusion \< 35 if birth weight \< 1500 g
Acute Myocarditis Registry with Prognostic, Histologic, Immunologic, Biological, Imaging and Clinical Assessment

The AMPHIBIA study is an observational ambispective and prospective cohort that aim to describe the histologic, immunologic, biological, imaging, genetic and clinical characteristics of the patients hospitalized for an acute myocarditis and to evaluate their association with prognosis.

Acute myocarditis is an inflammatory disease of the heart muscle. Its clinical presentation and its etiologies are multiple and make it a complex disease to treat. Its course also varies, ranging from complete clinical recovery to recurrence of ventricular arrhythmia or progression to chronic dilated heart disease, while being difficult to predict. The long-term prognosis is poorly understood.

Consecutive patients hospitalized in a tertiary university referral center cohort from 2006 to 2041 for an acute myocarditis will be ambispectively or prospectively analyzed. This project will establish a registry including up to 400 patients in the ambispective analysis cohort from 2006 to 2021 and 1000 patients in the prospective analysis cohort during a 20 years inclusion period.

The aim of the study is to describe the characteristics of patients hospitalized for an acute myocarditis and to evaluate their association wih the long term (until 20 years) prognosis.

Features of interest will include :

* Clinical
* Biological
* Etiological
* Echocardiographic
* Cardiac magnetic resonance imaging
* Genetics (for the prospective cohort)
* Anatomopathological

The collection of clinical, biological and radiological data will represent an unique source allowing research teams in the coming years to access the data necessary to answer various specific questions (pathophysiological, diagnostic, prognostic) relevant to the state of knowledge on this pathology.

Eligibility Criteria:
Inclusion Criteria:

* Acute myocarditis confirmed by cardiac magnetic resonance according to Lake Louise modified criteria or by endomyocardial biopsy according to histologic, immunologic and immunohistochemic criteria.
* affiliation to the French Health Care System "Sécurité sociale"

Exclusion Criteria:

* Severe valvulopathy
* Complex congenital cardiopathy
* Previous heart transplant
* Known significative coronary disease
Occupational Therapy Home Programs in Children With Down Syndrome

Children with Down Syndrome frequently encounter difficulties with sensory functions and feeding, such as oral sensory processing issues and developmental disorders. The aim of this study was to examine the effects of an Occupational Therapy Home Program on the sensory functions and feeding issues of children with Down Syndrome.

Although there are studies that investigate nutritional issues in children with Down syndrome, no well-structured, high-evidence, and individual-centered studies have been found. The literature assumes a relationship between the sensory functions and nutritional status of children with Down syndrome. Therefore, further studies are needed to develop intervention programs to prevent sensory processing and nutritional problems.

This study aims to evaluate the effectiveness of occupational therapy home programs in improving sensory functions and feeding problems in children with Down syndrome. The study focuses on evidence-based practices to assess the impact of these programs compared to not providing them.

The study will be conducted with children diagnosed with Down Syndrome who have applied to the Pediatrics Unit of the Department of Occupational Therapy at Hacettepe University Faculty of Health Sciences.

The study comprises pre-evaluation, final evaluation, and intervention stages. Following the initial evaluation, an occupational therapy home intervention program will be implemented for the children before and after each meal, seven days a week, for eight weeks. Evaluations will be repeated after the eight-week period.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 3-10
* Having Down Syndrome
* Families agree to participate in the study

Exclusion Criteria:

* Having previously received sensory integration and/or occupational therapy treatment
* Having a secondary diagnosis other than Down Syndrome (Mental Retardation, etc.)
Study of Music Therapy in Pain Rehabilitation Programs

The purpose of this study is to measure changes in mood, symptom burden, pain level, and stress scores in patients before and after a 20-minute music therapy intervention.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Patients that are enrolled in the Pain Rehabilitation Center, Mayo Florida

Exclusion Criteria:

- ≤ 18 years of age.
Efficacy of Short-term Immunosuppressive Therapy and Anti-allergenic Therapy in Severe Acute Exacerbation of Chronic Hepatitis B

The investigators will investigate the clinicopathological features of chronic hepatitis B patients with severe exacerbation selected by uniform criteria, and treated with early introduction or reintroduction of corticosteroids and anti-allergenic therapy, in order to clarify the benefits and limitations of the effects of corticosteroids and anti-allergenic therapy for amelioration of clinically severe exacerbation of chronic hepatitis B. The investigators also observe the immune index in the change before and after the treatment, in order to searching for some prognostic index.


Eligibility Criteria:
Inclusion Criteria:

* serum hepatitis B surface antigen(HBsAg) positive for at least 6 months;
* All patients had a poor general condition, manifested as general malaise, fatigue, jaundice and so on;
* serum T-Bil of 85.5 mmol/L or more; or serum T-Bil rises 17.1 mmol/L or more per day; or PTA of less than 60%;
* serum ALT of 20 times or more the ULN.

Exclusion Criteria:

* superinfection or co-infection with hepatitis A, C, D, E, cytomegalovirus and HIV, or Epstein-Barr virus;
* other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis;
* ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination;
* decompensated liver cirrhosis;
* severe bacterial or fungal infections;
* a history of diabetes or cardiac disease or hypertension or nephrosis.
A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems

A post market study evaluating the safety of the Prodigy MRI and Proclaim Elite MR conditional Spinal Cord Stimulator (SCS) systems.

The study will be performed as an international, multicenter, prospective and single-arm design. The study will be conducted as a Post Market Clinical Follow Up (PMCF) study and the results will be submitted to the Notified Body: BSI Group (BSI).

Eligibility Criteria:
Inclusion Criteria:

* Patient has been implanted with a Prodigy MRI or Proclaim Elite MR conditional SCS system
* Patient will receive an MRI scan in compliance with the Instructions For Use (IFU) for the implanted MR conditional SCS system
* Patient is ≥ 18 years of age
* Patient must be willing and able to comply with study requirements
* Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form

Exclusion Criteria:

* Patient has another implanted device (active or passive) that prohibits safe scanning
* Patient has previously experienced an MRI scan-related adverse event
* Patient is currently enrolled in another Abbott study that collects MRI safety data
* Patient is incapacitated, is unable to read or write, or is pregnant or breastfeeding
Indirect Resin Composite Inlays Cemented With a Self-adhesive, Self-etch or a Conventional Resin Cement

The present study was designed to provide further evidence in this particular research prospective, and this study hence aimed to clinically evaluate the 5-years adhesion durability of indirect resin composite inlays luted with three different resin cement strategies in MOD Class II restorations. The formulated null hypothesis was that there is no significant difference in the clinical performances of the three different resin cement strategies for luting indirect resin composite inlays in MOD Class II restorations for 5-years.

The research question was as follows: Do self-adhesive resin cements in class II restorations present better clinical performances than conventional etch-and-rinse and self-etch resin cements according to the USPHS criteria?

Objective: To clinically evaluate the 5 years adhesion durability of indirect resin composite inlays luted with three different resin cement strategies in MOD Class II restorations.

Materials and Methods: A randomized clinical trial was conducted following the protocol, 40 patients with three large cavities for each one that indicated for indirect MOD Class II restorations were enrolled in the current study. Then, 120 indirect resin composite inlay restorations (SR Nexco) were placed and luted with three different resin cement strategies; an etch-and-rinse (Variolink N), self-etch (Panavia F2.0) and self-adhesive (RelyX Unicem). Each resin cement was used for luting 20 inlay restorations. A single operator placed all restorations according to the manufacturer's instructions. Immediatelly after placement, the restorations were finished and polished. Clinical evaluation was performed at baseline and at 1, 3 and 5 years intervals after placement by two independent examiners using modified USPHS criteria. The changes in the USPHS parameters during the 5 years period were analyzed with Fredman test. The baseline scores were compared with those at the recall visits using Wilcoxon signed rank test, where the level of significance was set at p˂0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary caries involving occlusal surface only with ICDAS 2 and 3.
* Patients with cavities no more than one-third of the intercuspal distance.
* Patients must have a good oral hygiene.
* Patients with tooth gives positive response to testing with an electric pulp tester.
* Patients with normal and full occlusion.
* Patients with opposing teeth should be natural with no restorations.

Exclusion Criteria:

* High caries risk patients with extremely poor oral hygiene.
* Patients involved in orthodontic treatment or periodontal surgery.
* Patients with periodontally involved teeth (chronic periodontitis).
* Patients with abutments should be excluded.
* Patients with heavy bruxism habits and clenching.
Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008.

This is a Phase 2, single-center, open-label study evaluating a single dose of CA-008 4.2 mg administered with different standard-of-care anesthetic regimens during an elective unilateral transpositional first metatarsal osteotomy for the correction of hallux valgus deformity (bunionectomy).

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult aged 18 - 65 years old
2. American Society of Anesthesiology (ASA) physical Class 1, 2 or 3
3. Planning elective Bunionectomy repair
4. For both males and females: using an acceptable method of birth control
5. If a female: not pregnant or breastfeeding
6. Have a body mass index ≤ 36 kg/m2

Exclusion Criteria:

1. Have another painful condition, other than bunion-related pain, that may require pain treatment during the study period
2. Have active skin disease or another abnormality at the anticipated site of surgery that could interfere with the planned surgery.
3. Have a known allergy to study medications.
4. Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
5. Have positive results on the alcohol test (breath or saliva) or urine drug screen.