cyrilzakka/clinical-trials huggingface dataset:
Study on the Effectiveness of Journaling As an Add-on to Cognitive Behavioral Therapy

The aim of the present study is to examine the effects of keeping a therapy journal (journaling) on the effectiveness of cognitive behavioral therapy (CBT). Homework assignments are a fundamental component of behavioral therapies. In line with the learning theory foundation of behavioral therapies, various types of homework are used to facilitate learning processes between therapy sessions and to enable patients to make progress. One way to enhance individual goal setting and reflection in patients is through the use of "therapy journals."

The goal of the planned project is to evaluate the effectiveness of goal-oriented journal writing as an additional element in cognitive behavioral therapy (CBT). To do this, N = 80 psychotherapy patients will be randomly assigned to two treatment groups: CBT vs. CBT + Journaling.

As part of this study, the investigators are examining the effectiveness of certain therapeutic techniques that could improve the effectiveness of psychotherapy. A total of 80 patients will be studied, and they will be assigned to one of two treatment groups: one group will receive standard treatment, while the second group will receive additional tasks/techniques. The study will span a period of 24 sessions (short-term psychotherapy KZT1\&2), during which the severity of their symptoms will be assessed at the beginning of each session (duration approx. 2 minutes). Additionally, participants will be asked to answer some questions about basic documentation (diagnoses, symptoms) at the beginning and end of the study (duration approx. 20 minutes).

The investigators assure that the personal data they collect will be protected in accordance with the European Data Protection Regulation. Collected data will only be analyzed in anonymized form, meaning without mentioning any names, and may be published in scientific journals. All data will be stored in encrypted form using personal codes. All data will be digitally archived for a period of 10 years on a well-secured drive at the University Hospital Tübingen; only the study leaders (Dr. Rosenbaum and Dr. Ehlis) are authorized to re-identify the data. The investigators would like to inform that the collected data will not be used for diagnostic purposes regarding possible pathological changes. There are no health risks associated with this study, and while it is unlikely to benefit personally from it, the participation will contribute to scientific knowledge.

Eligibility Criteria:
Inclusion Criteria:

* patients in ambulant cognitive behavioral therapy

Exclusion Criteria:

* none
Randomized Trial of Depression Follow-up Care by Email

The primary objective of this study is to test in a randomized effectiveness trial if e-mail delivered cognitive behavioural treatment is an effective follow-up care approach in the treatment of depression under clinically representative conditions.

Depression belongs to the most prevalent mental disorders and often goes along with a high burden of disease. Although the efficacy and the effectiveness of psychological treatments for depressive disorders have been demonstrated, there remains the problem of maintaining the benefits achieved during the initial treatment phase. Therefore options of follow-up care have to be considered. Since access to psychotherapeutic treatments is limited and costly, internet-based interventions can offer a feasible opportunity for follow-up care in order to enhance the long-term effectiveness of psychotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Depressive disorder: F32.0-F32.2; F33.0-F33.2; F34.1 according to ICD-10
* Precursory CBT
* Internet access

Exclusion Criteria:

* No knowledge of the German language
* Risk of suicide
* Acute psychosis or psychotic symptoms
* Established concurrent in vivo CBT after discharge from inpatient CBT
HR-lowering Efficacy and Respiratory Safety of Ivabradine in Patients With Obstructive Airway Disease

The purpose of this study is to investigate heart rate lowering efficacy and respiratory safety of ivabradine in patients with asthma and COPD.

In this double blind, placebo-controlled, crossover study, 20 asthmatics and 20 COPD patients received ivabradine 7,5 mg b.i.d. and placebo for 5 days in crossover manner. HR in ECG holter monitoring, peak expiratory flow rate (PEFR), symptoms, rescue medication consumption and AEs were evaluated in both periods of treatment.

Eligibility Criteria:
Inclusion Criteria:

* documented diagnosis of asthma or COPD in accordance with guidelines
* stable condition, defined as a disease without exacerbation for at least 1 month prior to study enrolment
* mean HR in holter ECG recording of ≥ 60 bpm

Exclusion Criteria:

* disease exacerbation in previous month
* inability to understand instructions on study procedures
The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness

Fluid therapy is an essential component of the management of patients with acute circulatory failure. Nevertheless, unnecessary administration of fluids in non-responders is harmful. Thus, the concept of fluid responsiveness has been suggested to guide fluid administration in critically ill patients to avoid either over or under-transfusion. The aim of this work is to investigate the ability of peripheral perfusion index to predict the hemodynamic response to mini-fluid challenge in patients with septic shock .

The concept of fluid responsiveness has been suggested to guide fluid administration in critically ill patients to avoid either over or under-transfusion.

Several methods have been suggested to detect fluid responsiveness. Mini fluid challenge with concomitant monitoring of stroke volume is one of the most robust methods for pre-load challenge.

The main foreshortening of mini fluid challenge method is the need for a real-time cardiac output monitor, to track the instantaneous change of stroke vole with changing body position. Finding a surrogate to cardiac output to trace the effect of mini fluid challenge would make the test more applicable without the need for advanced hemodynamic monitors.

There is a growing interest in the use of perfusion indices in assessment of fluid responsiveness. Perfusion indices are measures for adequacy of oxygen delivery in peripheral tissues; thus, they were hypothesized to be possible surrogates of cardiac output. Peripheral perfusion index represents "the ratio between the pulsatile and non-pulsatile component of the light reaching the pulse oximeter" . Peripheral perfusion index has been considered as a numerical non-invasive measure for peripheral perfusion. PPI has the advantage over other perfusion indices that it a non-invasive, user-friendly monitor.

The aim of this work is to investigate the ability of peripheral perfusion index to predict the hemodynamic response to mini-fluid challenge in patients with septic shock.

Mini-fluid challenge test will be performed by infusion of 200 mL Lactated Ringer's solution over 1 minute. Velocity time integral will be monitored using Transthoracic echocardiography at the left ventricular outflow tract at the apical five-chamber view. Cardiac output will be calculated, and the patient will be considered fluid-responder if cardiac output increased by 10% after fluid challenge.

Eligibility Criteria:
Inclusion Criteria:

* Septic shock patients

Exclusion Criteria:

* Evident blood loss
* Peripheral vascular disorders
* Upper limb injury or burns
High-Dose Rosuvastatin Preloading for Enhanced Outcomes in STEMI Patients Undergoing Primary PCI

To compare the efficacy of high dose rosuvastatin preloading vs placebo before primary PCI in terms of MACE at 30 days


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years Patients undergoing primary angiography

Exclusion Criteria:

* Hemodynamically unstable patients. History or clinical evidence of any co-morbidities. Taking any medications regularly even statins.
Effects of Maternal Depressive Symptomatology on Pregnancy Outcomes and Newborn Development --- How is Paternal Psychopathology Involved?

This study aims at investigating the effects of maternal depressive symptomatology on pregnancy outcomes and newborn development. How paternal psychopathology is involved in the association will also be explored.

This is a three-year prospective cohort study. Three versions of questionnaires (the mother, the father, and the infant) will be developed first. For parents, data on self-reported symptomatology such as depression, anxiety, and stress will be collected, while for infants, maternal report on newborn development will be measured. Then, two medical centers and two regional hospitals will be selected. All pregnant women who undergo a first-trimester prenatal visit, who plan to carry the baby till term, and whose spouse is also willing to participate will be invited to join the study. The investigators expect to recruit a total of 194 pairs of depressive mothers and her spouses and 278 pairs of non-depressive mothers and her spouses in the study.

After the informed consent is obtained, one baseline assessment (i.e., the first trimester) and four follow-up assessments (i.e., the second trimester, the third trimester, one month postnatal and six months postnatal) will be implemented. Basically, prenatal investigation (for both mothers and fathers) will be carried out at the outpatient prenatal visit. Postnatal investigation (for the mothers, fathers and infants) will be processed at the pediatric outpatient visit when the infants are schedule for an immunization injection. After data are collected, descriptive, analytic and longitudinal data analyses will be performed to investigate the association between parental psychopathology and pregnancy outcomes and newborn development.

This study will explore the effects of the developmental trajectories of parental psychopathology on newborn growth during the critical stage of pregnancy. It is hoped that evidence based data could be obtained, examined, and applied in future prevention-intervention program to promote parental and newborn health, both physically and psychologically.


Eligibility Criteria:
Inclusion Criteria:

* Women who are pregnant within the gestational week of 14 (the first trimester) and have a prenatal visit at the selected hospitals.
* Women who expect to carry the baby to term.
* Women who are willing to provide information on their spouse or partner. And their spouse or partner also expresses the willingness to participate.

Exclusion Criteria:

* Pregnant women who are unable to provide information on their spouse or partner.
* Pregnant women's spouse or partner is unable to participate in this study.
* Pregnant women or their spouse or partner have difficulties in appropriately reading and completing a Chinese version questionnaire (e.g., illiteracy, not familiar with Chinese (e.g., foreign spouse), have major psychiatric illness, etc.)
* Women who are not appropriate to participate based upon doctoral or professional evaluation.
Your Voice; Impact of Duchenne Muscular Dystrophy (DMD) on the Lives of Families

The purpose of this study is to improve the understanding of the treatment goals that a person with Duchenne Muscular Dystrophy (DMD) or the caregiver may be most interested in, based on the severity of the person's disease. Data will be collected by online survey when the participant accepts the study invitation ("RSVP questionnaire") and telephone interview on the functional burden and self-identified treatment goals from the perspective of people with DMD and their caregivers. Interviews will be analyzed to help identify things important to Duchenne families to measure in clinical trials and to inform the selection of key concepts of interest and development of future clinical outcome measures, including observer reported outcomes/patient reported outcomes. The study will be conducted in the United States and will enroll between 45 and 120 participants 11 years or older living with DMD as well as their caregivers. The time commitment for the online survey and the telephone interview is about one hour. It is anticipated that the entire study will be completed within one year.


Eligibility Criteria:
Inclusion Criteria:

1. Participant must be a person with DMD who is 11 years or older or The parent/legal guardian of a person with DMD who is under the age of 18 years.
2. Confirmed diagnosis of DMD with written proof of disease provided
3. Resident of the U.S.
4. Able to read, write and communicate in English
5. Able to grant informed consent
6. Willing to participate in a 45 minute telephone interview
7. Ability to view or receive a document from the interviewer before or during the interview (web browser, ability to receive a text, fax or document by mail)

Exclusion Criteria:

1. Inability to meet any of the inclusion criteria
A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)

This is a two part study.

The purpose of Part A is to determine if BMS-986020 is effective in treatment of diffuse cutaneous systemic sclerosis using one dose of BMS-986020.

The purpose of Part B is to determine if BMS-986020 is effective in treatment of diffuse cutaneous systemic sclerosis using two different doses of BMS-986020.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Diagnosis of diffuse cutaneous systemic sclerosis for 60 months or less
* Men and women ≥ 18 years of age
* Ability to comply with birth control requirements
* Certain immunosuppressive agents are permitted

Exclusion Criteria:

* Limited cutaneous systemic sclerosis or sine scleroderma
* Active ulcers on fingers
* Pulmonary arterial hypertension
* Any gastrointestinal surgery that may impact absorption of study drug
Effects Of Faradic Current Versus Ankle-Foot Orthosis In Patients With Foot Drop

This research aims to compare changes in gait quality and function between faradic current \& Ankle foot orthosis with stroke related foot drop

Randomized control trial study will be carried out at different health care units when synopsis will be approved. Enrollment of patients will be done by using purposive sampling technique. The selection of the patients will be done on the basis of exclusion criteria and inclusion criteria. The patients enrolled will be divided into 2 groups. Group A patients will be given faradic current on the other hand group B patients will be provided with ankle foot orthosis. The assessment of the patient will be done after 6 months and the outcome tools used will be 10-meter walk test, stroke impact scale, 6-meter walk test, Berg balance scale, Time up and go test. The data of the patient will be noted before giving treatment and after treatment and will be compared after 6 months. Consent will be taken from each patient. Statistical Package of Social Sciences Version 20 will be used for the entry and analysis of data

Eligibility Criteria:
Inclusion Criteria:

* Patients who had been affected by stroke
* Good communication skills so the patient can follow the instructions
* Patients of both genders with any age group

Exclusion Criteria:

* Impairment in lower limb other that foot drop
* Patient suffering with any cardiovascular disease
Prospective Becker-Heart-Study

The purpose of this study is to determine whether electrocardiogram, echocardiography, cardiac MRI, sera biomarkers can improve early detection of myocardial involvement and clinical outcome.

A cohort of 100 patients with mutations in the dystrophin gene associated with Becker muscular dystrophy and/or dilated cardiomyopathy will be included (patients with Duchenne muscular dystrophy are excluded).

Patients with undergo at baseline the following workups: electrocardiogram, echocardiography, cardiac MRI, sera biomarkers measurement.

At 3 years and 5 years, patients will be investigated according to the same protocol and occurrence of cardiac adverse events in the meanwhile will be recorded.

Statistical analysis will assess correlations between cardiac phenotype and DMD mutations and prognostic value of cardiac investigations.

Eligibility Criteria:
Inclusion Criteria:

* mutation in the DMD gene
* Becker muscular dystrophy and/or dilated cardiomyopathy
* age\>18 years
* affiliation to the French medical insurance

Exclusion Criteria:

* Duchenne muscular dystrophy
* Any other chronic disease that may be associated with heart disease
A Multiple Ascending Dose Study of ETC-1002 in Subjects With Mild Dyslipidemia

This Phase 1, double-blind (sponsor open) study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 given to subjects with mild dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects of non-child bearing potential as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements
* Fasting low density lipoprotein-cholesterol (LDL-C) of 100-160 mg/dL
* Fasting triglycerides (TG) of 100-350 mg/dL (Cohort 5 only)
* Body Mass Index (BMI) of 18-32 kg/m2 (Cohort 1 to 4 only) or 18-36 (Cohort 5 only) and body weight \>50 kg

Exclusion Criteria:

* Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
* Alanine aminotransferase (ALT) or aspartate amino transferase (AST) \>1.2 x ULN; serum creatinine \>ULN; hemoglobin \<12.0 g/dL; other clinical lab tests (with the exception of ALT, AST, serum creatinine and hemoglobin) outside normal or protocol specified limits that are determined by the Investigator to be clinically significant
* Use of tobacco or tobacco products
* Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to randomization with the exception of lipid regulating drugs or supplements containing niacin \>500 mg/day or fish oil which will not have been used for 3 months prior to randomization
* Other exclusion criteria apply
Healthy Lifestyles for People With Intellectual Disabilities

Relatively few health promotion and disease prevention programs have included or targeted people with disabilities, and even fewer have focused on individuals with intellectual disabilities.

The long-term objectives of the Healthy Lifestyles for People with Intellectual Disabilities Study (HLID) are to increase the health of persons with intellectual disabilities by establishing the efficacy of a health promotion program and promoting its adoption. The HLID Study is based in the Center on Community Accessibility (CCA) at Oregon Health \& Science University. The mission of CCA is to increase the health and health-related quality of life of persons with disabilities.

A pilot study conducted by CCA has established the effectiveness of the Healthy Lifestyles (HL) intervention among a cross-disability population in increasing health behavior adoption. The specific aim of the HLID Study is to test the efficacy of the HL program specifically with adults with intellectual disabilities.

The HLID Study uses a randomized control study design. The HL intervention will be administered to 75 adults and will compare results to those of an additional 75 adults who receive no intervention. Measurement will include anthropometric assessments to measure impacts on overweight and obesity, as well as self-report measures of healthy behaviors, health status, health care utilization, and secondary conditions. Results will be shared with research participants, presented through professional conferences and newsletters, and published in peer-reviewed journals with the assistance of community partners.


Eligibility Criteria:
Inclusion Criteria:

* Living in Oregon or Southwest Washington
* Ages 18-65 years
* Have mild or moderate mental retardation/developmental disability/intellectual disability as defined by Oregon or Washington state (depending on place of residence) developmental disability service delivery system
* Eligible in Oregon or Washington (depending on place of residence) to receive services for people with mental retardation/developmental/intellectual disability
* Living in the community (i.e., group home, with family/friends, on own with or without support)
* Participant defined health status of excellent, good, or fair
* Participant expressed interest in participation in study
* Participant expressed willingness to be assigned to either Workshop or Control study group
Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%

The purpose of this study was to evaluate the efficacy and safety of a fixed combination of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components in patients with open-angle glaucoma and/or ocular hypertension.

This study consisted of 6 visits conducted during 2 sequential phases: the Screening/Eligibility phase, which included a screening visit and 2 eligibility visits, and the Treatment phase, which included 3 on-therapy visits conducted at Week 2, Week 6, and Month 3. A washout period based on previous ocular medication preceded Eligibility Visit 1. Patients who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1:1) to receive treatment with 1 of 3 study drugs for 3 months. Study drug instillation began the morning after the second eligibility visit.

Eligibility Criteria:
Inclusion Criteria:

* Sign Informed Consent document.
* Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
* Any form of glaucoma other than open-angle glaucoma.
* Severe central vision loss in either eye.
* Chronic, recurrent, or severe inflammatory eye disease.
* Ocular trauma within the preceding 6 months.
* Ocular infection or ocular inflammation within the preceding 3 months.
* Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
* Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
* Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
* Ocular surgery within the preceding 6 months.
* Ocular laser surgery within the preceding 3 months.
* Any abnormality preventing reliable applanation tonometry.
* Any other conditions, including severe illness, which could make the patient, in the opinion of the Investigator, unsuitable for the study.
* Other protocol-specified exclusion criteria may apply.