cyrilzakka/clinical-trials huggingface dataset:
The STIC Norway RCT Study: Using Feedback in Psychotherapy.

Feedback in psychotherapy involves clients monitoring therapy process and progress, and on a frequent basis clients register these data into online questionnaires. These data are then fed back to the therapist, hence informing about the process and progress in therapy. This information can be shared with the client, something that may enhance the client involvement in evaluating and planning of the therapy. The same data can be used for research purpose. This randomized controlled multicenter study within Norwegian couple and family contexts will explore the effects of feedback in natural settings, and it collaborates closely with a similar American study in Chicago/Evanston, Ill.

The improvement rate in psychotherapy is generally regarded as 50%, while 10% of clients deteriorate after therapy. This indicates a potential for improvement. Research shows that in therapies with the lack of progress, the clients rarely express dissatisfaction about progress to their therapists, and parallel, these therapists consider the therapies to proceed in the right direction. There is therefore a need for more knowledge about (a) how to obtain reliable information about the therapy progress and process monitored frequently during the course of therapy, and (b) that this information is fed back to the therapist and the client so that they (c) jointly can evaluate and adjust the aims and means for improving the therapy, something that may (d) enable them to test more appropriate approaches. This clinical practice should also enhance the client collaboration and empowerment in therapy, hopefully leading to higher recovery rate, shorter treatments, and reduced drop-out. To date, there is limited research on whether and how the use of feedback can contribute to improved outcomes. Such research is especially lacking in couple and family therapy. In a 3-year Norwegian pilot project at the Center for Family and relationships, Modum Bad, Department of Child and Adolescent Mental Health, Sørlandet Sykehus, and at Ålesund family counseling office, the online-based feedback system STIC (Systemic Therapy Inventory of Change) has been implemented and tested. The clinical experience is positive, and the system is considered suitable. This project has evolved parallel to a similar project at the Family Institute at Northwestern University, Evanston, Ill., supervised by the founder of the STIC system, professor William M. Pinsof. The project now enters a new phase by conducting a randomized, controlled trial (RCT) at three Norwegian couple- and family therapy sites in collaboration with five American psychotherapy sites to investigate whether the use of ongoing feedback is associated to more effective therapy compared with therapy without use of feedback.

Eligibility Criteria:
Inclusion Criteria:

* individuals,
* couples,
* families in Norwegian couple- and family therapy contexts

Exclusion Criteria:

* psychosis,
* current drug and alcohol abuse,
* violent and threatening behavior,
* not enable to understand Norwegian or English language.
Delta qSOFA for Risk Stratification in Emergency Infected Patients

The study will investigate the prognostic value of qSOFA (quick Sequential Organ Failure Assessment) kinetics between H0 and H1, and between H0 and H3 in patients with suspicion of Sepsis, i.e. an initial qSOFA of at least of 2.

qSOFA has been reported as a good tool for risk stratification in the ED for patients with infection.

However, it is not clear whether qSOFA remains stable during the ED stay, nor whether its kinetics can have prognostic added value.

Patients with a qSOFA of at least 2 in the ED, and suspicion of infection will be included.

After treatment is initiated and fluids challenge performed, we will collect qSOFA value at 1 hour and 3 hours.

Our hypothesis is that a decrease in qSOFA between H0 and H3 is associated with better outcome. We assume that 50% of patients will have a deltaqSOFA \>0, with an overall mortality of 23% (according to previous cohort). Under the hypothesis of difference of at least 15% in mortality between the two groups (DeltaqSOFA \> 0 and Delta qSOFA\<=0), with a power of 90% and an alpha of 0.05, we need to recruit 322 patients.

Eligibility Criteria:
Inclusion Criteria:

* suspicion of infection by the emergency physicians
* at least two of the following criteria : respiratory rate \<= 22, systolic blood pressure \<= 100 mmHg and altered mental status

Exclusion Criteria:

* Infection ruled out by the expert after chart review
* patient who refuse to participate
A Study to Evaluate the Efficacy and Safety of DA-5204

This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of DA-5204 and to demonstrate the non-inferiority of DA-5204 compared with Stillen® tab. in patients with acute or chronic gastritis.


Eligibility Criteria:
Inclusion Criteria:

* Age is over 20 years old, under 75 years old, men or women
* Patients diagnosed with acute or chronic gastritis by gastroscopy
* Patients with one or more erosions found by gastroscopy
* Signed the informed consent forms

Exclusion Criteria:

* Patients who is impossible to receive gastroscopy
* Patients with peptic ulcer and gastroesophageal reflux disease
* Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 2 weeks
* Patients with surgery related to gastroesophageal
* Patients with Zollinger-Ellison syndrome
* Patients with any kind of malignant tumor
* Patients administered with anti-thrombotic drugs
* Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease
* Patients with neuropsychiatric disorder, alcoholism, or drug abuse
* Patients taking other investigational drugs or participating in other clinical studies in 4 weeks.
* Women either pregnant or breast feeding
Impact Evaluation of Large-Scale Sanitation and Hygiene Interventions

This study consists of an impact evaluation (IE) of the Scaling up Handwashing with Soap (HWWS) and Total Sanitation and Sanitation Marketing (TSSM) projects of the Water and Sanitation Program (WSP) of the World Bank. The objective of this study is to estimate the causal impact of the HWWS and TSSM interventions on the health and welfare of the rural poor in six developing countries: Peru, Tanzania, Senegal, Vietnam, Indonesia, and India. The IE will assess the impact of exposure to the HWWS and TSSM promotion on individual-level hygiene and sanitation practices, and on the health and welfare of children 0-5 years old. By introducing exogenous variation in handwashing and sanitation practices (through exposure to the HWWS and TSSM promotion), the IE will also answer a number of important questions related to the effect of the intended behavioral change (handwashing and improved sanitation) on health and welfare, thus providing information on the extent to which these behaviors alter intended development outcomes. This study uses a cluster-randomized experimental design, whereby the geographic units called clusters (e.g. village, commune, ward, depending on administrative structure of country) are randomly assigned to receive certain components of the Handwashing and Sanitation interventions in the case of treatment arms, and no Handwashing or Sanitation intervention in the case of control arms. . The final sample for the evaluation will consist of approximately 14,000 households, randomly selected, with at least one child between 0 and 24 months of age at baseline. Data will be collected from these 14,000 households (approximately 54,781 subjects) through household surveys, anthropometric measurements, blood and stool samples, direct observations of behaviors, and community surveys. The data collected will be analyzed using a differences in differences approach, where possible, and the results will be disseminated to country officials and others stakeholders.


Eligibility Criteria:
Inclusion Criteria:

* at least one child 0-24 months (at baseline) lives in the household
* adult family member (mother of primary caregiver of the selected children for the study) consents to participate in the study and provides consent for the child's participation

Exclusion Criteria:

* none
The Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus

This study aims to examine the effects of a lifestyle intervention based on a health belief model (HBM) supported by mobile health (mHealth) and the impact of continuous glucose monitoring (CGM) on maternal glycemic parameters, cardiometabolic risk, health behavior and infant's outcomes among women diagnosed with gestational diabetes mellitus (GDM).

Background: Women with gestational diabetes mellitus (GDM) are more likely to develop cardiometabolic risk (CMR). CMR refers to the risk factors that promote the chance of developing type 2 diabetes mellitus or cardiovascular events. However, using a family-centered approach, the effectiveness of continuous administration of both mobile health management and theoretical based lifestyle intervention from pregnancy to postpartum in preventing women at high risk of GDM from developing CMR has rarely been studied.

Methods: This randomized controlled trial will recruit 120 GDM pregnant women in northern Taiwan. The participants will be randomly assigned to the control group (blood glucose meters (BGM); n=40 people), intervention group 1 (continuous glucose monitoring (CGM); n=40 people), intervention group 2 (HBM-based lifestyle and mHealth intervention + CGM; n=40 people).The comparison group will receive the routine care and finger-prick test for blood glucose monitoring (BGM) during pregnancy.The intervention group 1 will receive CGM during pregnancy. The intervention group 2 will receive a HBM-based lifestyle and mHealth management program on 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum, including CGM during pregnancy.We intend to compare outcome variables among three groups. The outcomes variables will be assessed at baseline (24-32 weeks of pregnancy), 33 weeks of pregnancy to before delivery, 4 to 12 weeks after delivery. The primary outcomes were maternal glycemic parameters, cardiometabolic risk factors, and maternal health behavior. Outcomes will be assessed at baseline (24-32 weeks of pregnancy), 33 weeks of pregnancy to before delivery, 4 to 12 weeks after delivery. Generalized estimating equation (GEE) will be used to examine the trajectories and the effectiveness of the project for managing cardiometabolic risk on cardiometabolic risk and health behavior.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or above
2. Pregnant women diagnosed with gestational diabetes mellitus
3. Willing to participate in the study

Exclusion Criteria:

1. Diagnosed with diabetes mellitus before pregnancy
2. Allergic to materials such as tapes (e.g., redness, swelling, itching, pain, blisters, or rashes caused by breathable tapes or patches)
3. Abnormal coagulation function
Effect of Gait Training With Auditory Stimuli on Balance, Gait & Funtional Independence in Stroke

To determine the effect of gait training with auditory stimuli on dynamic balance, gait and functional independence on chronic stroke.

The purpose of this study is to find the effect of gait training with auditory stimuli using a smart phone metronome application on dynamic balance, gait and functional abilities of chronic stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* both gender
* Age between 30-70
* More than 6 months after the stroke
* Able to walk more than 10 meters independently
* MMSE score of 24

Exclusion Criteria:

* Dependent gait
* Aphasia
* Any hearing or visual defects
* Moderate to severe cognitive disorder
* People not willing to participtae
Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain

This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.


Eligibility Criteria:
Inclusion Criteria:

* Normal, healthy males and females 16 to 40 years of age
* Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale-Pain Severity Rating \[VAS-PSR\] score of at least 50 mm on a 100 mm VAS PSR) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
* Use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide

Exclusion Criteria:

* Pregnancy or breast-feeding
* Alcohol or substance abuse
* Any serious medical or psychiatric disorder
* History of stomach ulcers, stomach bleed, or other bleeding disorders
* Use of a prescription or over-the-counter (OTC) drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug (NSAID); acetaminophen (APAP); or codeine or any other opioid is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants \[including alcohol\])
Trial for the Diagnosis of Sarcoidosis

This randomized study investigates two different diagnostic strategies for patients with suspected pulmonary sarcoidosis stage I/II.

The objective is to assess the role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB).

Also the researchers investigate the additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis.

Thirdly the researchers aim to assess the rate of complications in both the endosonography and conventional bronchoscopic workup.

Sarcoidosis is the most prevalent interstitial lung disease in Western-Europe and the US. The disease is most prevalent in young adults. To set the final diagnosis of sarcoidosis, the following parameters need to be present:

1. A clinical and radiological suspicion of sarcoidosis stage I/II.
2. A tissue diagnosis of disease-specific non-caseating granulomas.
3. Exclusion of possible alternative diagnoses as lung cancer or tuberculosis.

Nowadays, a bronchoscopy with lung biopsies is advised to set a tissue diagnosis of sarcoidosis. However, these biopsies are only diagnostic in 70% of the procedures and they are associated with a 3% risk of coughing up blood and a 4% risk of a lung collapse.

Since recently, a new diagnostic procedure has come available. This procedure, endo-sonography, makes it possible to biopsy lymph nodes in the chest under direct visualization and has a diagnostic accuracy of 85%. The associated risk of complications appears to be small (\<1%)

We consider the current standard for the diagnostics of sarcoidosis to be outdated, considering the clinical availability of endo-sonography. We expect that endo-sonography is more frequent diagnostic for a tissue diagnosis of sarcoidosis.

Also we hypothesize that this technique is safer and more preferred by patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected pulmonary sarcoidosis stage I/ II
* Age \> 18 years
* Both males and females
* Written informed consent is obtained.

Exclusion Criteria:

* Patients with obvious other organ involvement of sarcoidosis where a simple diagnostic biopsy to assess granulomas can be performed.
* Löfgren's syndrome
* Inability to undergo fiberbronchoscopy, EBUS or EUS (e.g. respiratory insufficiency, esophageal stenosis
* Contraindications for a lung or nodal biopsy (e.g. coagulopathy, thrombocytopenia)
* Pregnancy
* Inability to obtain informed consent
Study of Multiple Doses of Danicopan in Healthy Participants

This was a multiple ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (75 milligrams \[mg\], 200 mg, 500 mg, 800 mg) and dose-matched placebo were administered under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical exam, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
* Body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.

Exclusion Criteria:

* History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* Any condition possibly affecting drug absorption (including gastrectomy and cholecystectomy).
* Body temperature greater than or equal to 38°Celcius on Day -1 or Day 1, Hour 0; history of febrile illness or other evidence of infection within 14 days prior to first study drug administration.
* Current tobacco/nicotine user; consumption of any alcohol within 72 hours before first study drug administration or have a history of regular alcohol consumption exceeding 21 drinks/week within 6 months of screening; positive urine drug screen at screening or Day -1.
* Clinically significant laboratory abnormalities at either Screening or Day -1.
MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)

This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not achieved specified low-density lipoprotein cholesterol (LDL-C) levels. The primary hypothesis is that the co-administration of ezetimibe 10 mg and atorvastatin 10 mg will be superior to both atorvastatin 20 mg and rosuvastatin 10 mg with respect to the percentage reduction in low-density lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.

This is a 18 week randomized, double-blind, active-controlled, multicenter study composed of a 6 week screening/run-in and 12 week double-blind treatment period (composed of 2 phases; each 6 weeks in duration). Only those participants who do not meet low density lipoprotein-cholesterol (LDL-C) goals at the end of Phase I (Week 6), were eligible to continue into Phase II (Week 12).

Eligibility Criteria:
Inclusion Criteria:

* Patient is at high cardiovascular risk and meets one of the following conditions: has never taken lipid-lowering therapy or has been off such therapy for at least 6 weeks; or, is currently taking a stable dose of certain lipid-lowering agents
* Patient is willing to maintain a cholesterol lowering diet during the study
* Female patients receiving non-cyclical hormone therapy have maintained a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen during the study

Exclusion Criteria:

* Patient is Asian
* Patient routinely has more than 2 alcoholic drinks per day
* Female patient is pregnant or breastfeeding
* Patient has congestive heart failure
* Patient has had a myocardial infarction, coronary bypass surgery, angioplasty, or acute coronary syndrome within 3 months of screening
* Patient has uncontrolled cardiac arrhythmias
* Patient has had a partial ileal or gastric bypass or other significant intestinal malabsorption
* Patient has uncontrolled high blood pressure
* Patient has kidney disease
* Patient has any disease known to influence blood lipid levels
* Patient has any disorders of the blood, digestive system, or nervous system including stroke and degenerative disease that would limit study participation
* Patient has poorly controlled or newly diagnosed diabetes
* Patient is known to be HIV positive
* Patient has a history of cancer in the last 5 years, except certain skin and cervical cancers
Kinesio Taping and Calf Muscle Fatigue

Muscle fatigue results in decreased ability in muscles to generate force. Kinesio Tape may reverse the adverse effects of fatigue. Thus this study will examine the acute effects of Kinesio tape on muscle fatigue.

The participants will be divided into three groups; 1. Experimental group: Kinesio tape with 50% tension will be applied; 2. Sham group: Kinesio tape without any tension will be applied; 3. Placebo group: Rigid tape without any tension will be applied.

Eligibility Criteria:
Inclusion Criteria:

* Healthy cooperative individuals.
* Female athletes who were engaged in training at least 3 times a week.
* The subject should perform a minimum of 23 hell raises.

Exclusion Criteria:

* Musculoskeletal injuries, cardio-pulmonary vestibular and neurological complication and systemic disorder.
* Consumption of any pre-workout supplement in the last 6 months.
* Involvement in any other training program.
The Effect Of Progressive Relaxation Exercises On The Care Satisfaction

The increase in the elderly population, insufficiencies in chronic diseases cause an increase in the number of dependent and dependent elderly. This situation negatively affects caregivers with elderly individuals. nonpharmacological interventions are commonly used to reduce the negative emotions of caregivers due to care. One of these applications is progressive relaxation exercises. This study was planned in a randomized controlled experimental study design to investigate the effect of progressive muscle relaxation exercise. on care satisfaction, care burden and depression level of caregivers who care for bed dependent elderly individuals. The study will consist of 10 interventions, 10 control groups, and 20 caregivers.

Today, changes and developments in technology and lifestyles have lengthened average life span and increased the elderly population. The physical and cognitive changes, health problems, new roles such as being retired or widowed and economic losses come one after another for the elderly, and this turns the old age into a period full of difficul ties. Due to these changes in individuals with aging, older individuals make dependent and dependent on care. Caregivers experience care burdens, emotional stress, depression and anxiety during the care process. There are various non-pharmacological applications in the literature aimed at reducing the level of depression and care burden of caregivers. The non-pharmacological methods used in this study for older people's included progressive muscle relaxation exercise.

Objective: In this study, it is aimed to determine the effect of progressive muscle relaxation exercise. on care satisfaction, care burden and depression level of caregivers of bedridden elderly individuals.

Methodology: This is randomized clinical test. The study will consist of 10 interventions, 10 control groups, and 20 caregivers. The progressive muscle relaxation technique combined with music was employed. In order to collect the data, we adopted the interview with form filling technique, using the introductory information form, The Carer's Assessment Of Satısfactıon Index (Cası-TR), the Zarit Caregiver Burden Scale (ZCBS); and the Beck Depression Scale (BDS).

Eligibility Criteria:
Inclusion Criteria:

* The age of the caregiver is 18 years old.
* Giving care to the elderly patient who is dependent on the bed for at least 3 months and above,
* No psychiatric disease diagnosed,
* No vision, speech or hearing problems that would prevent the information given from being understood and the implementation of PMR exercise,
* Individuals providing voluntary care will be included in participating in the research.

Exclusion Criteria:

* The age of the caregiver under 18
* Giving care to an elderly person dependent on bed for less than 3 months
* With a diagnosis of psychiatric illness
* Has a vision, speech or hearing problem that will prevent the information given from being understood and the implementation of the PMR exercise,
* Caregivers who do not agree to participate in the research will not be included in the research.