cyrilzakka/clinical-trials huggingface dataset:
The Effect of Training Given to Patients With COPD in Line With Pender's Health Promotion Model

This study was conducted as a randomized controlled experimental study. The study was conducted with patients hospitalized in the chest diseases intensive care unit of a state hospital. The study was terminated with the participation of 140 patients, 70 in each group. Data were collected with Descriptive Information Form and COPD Self-Efficacy Scale.

This study was conducted as a randomized controlled experimental study. The study was conducted with patients hospitalized in the chest diseases intensive care unit of a state hospital. The study was terminated with the participation of 140 patients, 70 in each group. Data were collected with the Descriptive Information Form and COPD Self-Efficacy Scale. Self-efficacy of all patients was assessed at the beginning of the study. Patients in the intervention group were given training prepared in line with the health promotion model. The control group received standard practices of the clinic. After three months, patients' self-efficacy was re-evaluated.

Eligibility Criteria:
Inclusion Criteria:

* being 18 years of age or older,
* having been diagnosed with COPD at least 6 months ago,
* volunteering to participate in the study,
* being able to speak and understand Turkish and communicate effectively,
* not having a mental or physical disability that would prevent answering the questions.

Exclusion Criteria:

* having a psychiatric illness,
* having vision and hearing problems,
* having cognitive dysfunction,
* not volunteering to participate in the study.
Diagnostic Study of ACL Rupture With Anterior Drawer Test at 90° of Hip Flexion

For patients with anterior cruciate ligament rupture, the existing physical examinations have certain limitations. The researchers improved the traditional anterior drawer test in clinical work, maintained the flexion of the knee and flexion of the hip, and observed the displacement of the tibia. Good diagnostic effect, but no research statistics. The purpose of this study is to explore the effectiveness of the 90° of hip flextion anterior drawer test in the diagnosis of anterior cruciate ligament rupture.

A total of 300 hospitalized patients who were diagnosed with anterior cruciate ligament rupture by MR and prepared for anterior cruciate ligament reconstruction were included, of which 150 cases were injured in the acute phase (within 2 months after the injury) and the chronic phase (more than 2 months after the injury). After the patient was admitted to the hospital, the patients were sequentially subjected to the 90° anterior drawer test, Lachman test, pivot-shift test, and anterior drawer test. The examination results were recorded. Compare the effectiveness of different physical examinations in diagnosing the anterior cruciate ligament. The patient's age, gender, injury time, BMI, the type of ACL rupture in the surgical records, and whether meniscus or cartilage damage were combined were counted. Regression analysis was used to evaluate the influencing factors of the modified anterior drawer test to correctly diagnose the rupture of the ACL.

Eligibility Criteria:
Inclusion Criteria:

* （1）ages between 18 and 60 years old. (2) Inpatients diagnosed with unique anterior cruciate ligament rupture and ready for anterior cruciate ligament reconstruction. (3) no combined injuries.

Exclusion Criteria:

* (1) The patient is younger than 18 years old or older than 60 years old, (2) multiple ligament injuries of the knee joint are suspected, and (3) combined fractures are suspected.
Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling

The investigators propose to study the efficacy of micro-needling via the SOL Nova Device in generating hair growth in patients with Alopecia Areta (AA) who are either non-responsive or only partially responsive to combination oral JAK inhibitor plus oral minoxidil therapy.

This will be a trial evaluating the efficacy of micro-needling via tattoo device in stimulating scalp hair growth in patients with AA refractory to combination JAK inhibitor and oral minoxidil treatment. Ten healthy subjects who are at least eighteen years of age who have experienced no or partial scalp hair regrowth after ≥three months of JAK inhibitor plus oral minoxidil treatment will be enrolled. Subjects will undergo a treatment session once every thirty days for a total of six sessions over six months and will complete a total of eight visits over eight months. Procedures and visits are not standard of care but conducted for research. Each visit will last about an hour. Approximately 30 minutes will be spent on consenting and time for patient to ask questions during the first visit. The remaining 30 minutes will be allotted for the investigator to determine if the patient meets criteria for trial enrollment. During the remaining visits, 20 minutes will be allotted for photography, 15-20 minutes for the procedure and 10-15 minutes for post-procedure patient assessment. Remaining 10 minutes on visits 2 and 8 will be used for biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AA
* SALT score ≥90%
* No or minimal scalp hair regrowth after ≥three months of oral JAK inhibitor plus oral minoxidil treatment

Exclusion Criteria:

* Known concomitant androgenetic or other form of alopecia (in addition to AA)
* Patients with the following who would make poor candidates for microneedling such as skin conditions, diabetes, or history of keloid formation
* Anything additional existing comorbidities that in the opinion of the investigator may cause unnecessary risk for the patient to participate
Collabri Flex - Effect of Collaborative Care for People with Depression in General Practice

The aim of the study Collabri Flex is to:

* Develop a Danish model for collaborative care for patients with depression in general practice, based on past experience gained in the Collabri Project.
* Examine the impact of this model compared with liaison-consultation for people with depression in a randomized controlled design from selected endpoints.

The Collabri Flex model for Collaborative Care takes point of departure in the earlier study Collabri. It is changed according to gathered information under the first study of the Collabri model in order to achieve a Danish Collaborative Care model easier to implement.

The aims of Project Collabri Flex are to:

* Develop a flexible model for collaborative care (the Collabri Flex model) for patients with depression.
* Study the effects of this Collabri Flex model against consultation liaison in a randomized design on selected outcomes.

In Collabri the treatment is in line with a set of general treatment principles relevant for collaborative care interventions. The patients in the intervention group are offered cognitive behavioral therapy (CBT), psychoeducation and medication according to a stepped care model by a care manager refering to the general practitioner.

The Collabri Flex study is set up as a researcher-blinded individually randomized controlled trial with participation of an intervention group (treatment according to the Collabri Flex model) and a consultation liaison group.

This study will contribute with new knowledge on collaborative care interventions in a Scandinavian context.

Eligibility Criteria:
Inclusion Criteria:

* Danish speaking
* Diagnosis of current depression based on the Mini International Neuropsychiatric Interview (MINI) by care managers that have been trained in using MINI in close collaboration with the psychiatrist/psychologist.
* The patient has given her/his written informed consent to participate in the trial at the described terms

Exclusion Criteria:

* High risk of suicide assessed in the Mini International Neuropsychiatric Interview (MINI) and/or by the GP
* Psychotic condition detected in the MINI and/or by the GP
* Patients with a diagnosis of dementia
* Alcohol or substance misuse that hinders the person participating in Collabri treat-ment as assessed by the practitioner or care manager at inclusion interview
* If the patient has been referred or is recommended referral to secondary care treatment (mental health center) or psychiatrist in private practice
* Patients who are assessed by the GP as medically unstable making it impossible for the patient to adhere to treatment
* Bipolar affective disorder as assessed in the MINI and/or by the GP
* Pregnancy

For patients in the Collabri Flex group:

* Patients with depression who wants treatment cf. the psychologist scheme (Psykologordningen) or similar treatment and do not want the refferal to the psychologist preceded by other treatment, cf. the Collabri Flex model assessed by the GP
* Patients that wish to continue current psychological or psychiatric treatment due to anxiety or depression
Effect of Information on Service Delivery in Rural India

A lack of public awareness about entitled health and social services may contribute to poor delivery of services in developing countries. We sought to determine the impact of educating villagers about entitled services.

105 gram panchayats (village clusters) were randomized to receive information about their guaranteed health, education, and village governance rights. We then selected households within each treatment and control village to assess whether the information had made an impact.

Eligibility Criteria:
Inclusion Criteria:

* Gram panchayats in Uttar Pradesh
The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research

Transition is the planned movement of teens with chronic conditions from child-centered to adult-oriented healthcare. National bodies have published detailed guidelines about the importance of helping teens move to adult healthcare. However, there is no research regarding how to best organize and deliver Congenital Heart Disease (CHD) transition programs. Data is urgently needed. Therefore, the aim of this program is to develop research evidence that will better prepare health care providers to improve how they can help adolescents with transition.

This project will determine whether a nurse-led transition intervention program is better at preparing teens with CHD to independently manage their medical care, compared to the care that is currently provided. The most important finding of this study will be whether or not these teens subsequently attend the adult cardiology clinic that specializes in CHD problems, and the timing of when they attend.

Hypothesis: A transition intervention in combination with usual care, improved time to first Adult Congenital Heart Disease (ACHD) clinic attendance compared to usual care alone.


Eligibility Criteria:
Inclusion Criteria:

* 16 and 17 year olds with moderate or complex CHD

Exclusion Criteria:

* Significant developmental delay
* Previous heart transplantation
MAGNOLIA: Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301

This study is a non-interventional, observational extension of the Parent study, CLS1001-301 (NCT02595398). The purpose of this study is to characterize the continued clinical benefit(s) regarding safety and efficacy of suprachoroidally administered CLS-TA, triamcinolone acetonide injectable suspension, for the treatment of macular edema associated with non-infectious uveitis.

This is a non-interventional, observation extension study of up to 6 months for subjects completing the Parent study, CLS1001-301 (NCT02595398). The Parent study is a Phase 3, multicenter study to assess the safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham procedure in the treatment of subjects with macular edema associated with non-infectious uveitis.

The design of the Extension study includes 4 clinic visits over a maximum of 24 weeks. Subject eligibility will be established at Visit 1 during the crossover day from the Parent study to the extension study (Day 0). Follow-up visits will be conducted every 6 weeks up to 24 weeks (Visit 4). At Visit 4, subjects will have a final evaluation conducted 24 weeks following study entry (48 weeks from Parent study randomization).

This study was initiated prior to the completion of the parent study, therefore treatment assignment was masked prior to study entry.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the Parent study, CLS1001-301, through Visit 8/Month 6
* Willing and able to provide written informed consent prior to any study procedures; willing to comply with the instructions and attend all scheduled study visits

Exclusion Criteria:

* Received additional therapy for the treatment of uveitis or prohibited medication
* Require additional therapy for the treatment of uveitis or prohibited medication at the time of the Crossover visit
Changes in Food Reinforcement During Obesity Treatment

The reinforcing value of food, or how much a person "wants" a food, is an important determinant of food intake. Thus far, food reinforcement has only been studied in laboratory settings, and no studies have examined whether the reinforcing value of food is altered when dietary changes are made. The chronic deprivation that occurs when a low-calorie, low-fat diet is implemented for weight loss may increase the reinforcing value of all foods, but particularly for restricted high-fat foods. Greater increases in the reinforcing value of high-fat foods relative to low-fat foods may be detrimental for sustaining newly adopted eating behaviors that produce weight loss, whereas greater increases in the reinforcing value of low-fat foods relative to high-fat foods may aid in maintaining healthy eating behaviors. The aim of this application is to measure food reinforcement in a clinical setting to determine if food reinforcement changes when a traditional weight loss diet is prescribed. For this ancillary study, 147 volunteers will be recruited from the 165 overweight and obese women participating in the Program to Reduce Incontinence by Diet and Exercise (PRIDE) at The Miriam Hospital. As part of PRIDE, these participants will be randomized in a 2-to-1 ratio to either a 6-month weight loss intervention or usual care. Assessments of food reinforcement, dietary intake, and weight will occur at 0 and 6 months. Given that the intervention group changes their diet relative to the usual care group, it is hypothesized: 1) the intervention group will have greater increases in the reinforcing value of both high- and low-fat foods than the usual care group from 0 to 6 months; and 2) within the intervention group, decreases in frequency of consumption of high-fat foods will be related to increases in the reinforcing value of high-fat foods from 0 to 6 months. These results will lead to a novel line of research, examining the relationship between food reinforcement and weight loss maintenance, so that diets can be designed to promote changes in food reinforcement that aid in sustaining dietary changes and weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Participants from main parent study - PRIDE

Exclusion Criteria:

* Allergic to foods in investigation
Effectiveness of Finger and Forehead Plethysmographic Variability Index Monitoring in Pediatric Patients

In pediatric surgical patients, the sensitivity of forehead and finger PVI monitoring was similar for the prediction of fluid responsiveness, whereas the specificity of forehead monitoring was higher. The use of forehead PVI probes in the fluid management of these patients seemed to be appropriate because cephalic region was not affected by low perfusion states.

he Plethysmographic Variability Index (PVI) can be measured with both finger and forehead probes. Vasoconstriction may reduce the reliability of PVI measurements in pediatric surgical patients prone to hypothermia. The vascular structure of the forehead area is resistant to changes in vasomotor tonus. The aim of our study is to compare the efficacy of PVI values measured at the finger and forehead areas to predict fluid responsiveness in these patients.

Fifty pediatric patients with obtained parental consent and ethics committee approval underwent elective minor surgery were included into the study. Basic monitoring, finger and forehead perfusion index (PI) and PVI monitoring were applied. Hemodynamic parameters, PI, PVI, cardiac output (CO) values were recorded. The 15% increase in CO with passive leg raise (PLR) maneuver was estimated as fluid responsiveness. Two groups were created: Group R (fluid responsive); Group NR (fluid nonresponsive). Mann-Whitney U, t, chi-square and ROC tests were used in statistical evaluation.

Eligibility Criteria:
Inclusion Criteria:

written consent from their parents patients undergoing elective minor surgery with bleeding less than 500ml Children between the ages of 5-12.

Exclusion Criteria:

those who stay in the specified age range those with cardiopulmonary disease spontaneous breathing positive allen test peripheral circulatory failure vasopressor therapy anemia hypothermic
Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms

This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe and evaluate long term therapy with PTNS on overactive bladder symptoms. Subjects must have completed the 12 weekly treatments of the original protocol, the 13 week follow up assessment, be randomized to the PTNS arm, and be considered a positive responder with moderate or marked improvement in the SUmiT Trial to be enrolled in this study. All consenting responders will continue with active PTNS therapy at an initially prescribed protocol for approximately 3 months followed by individualized symptom-based frequency of visits as determined by the subject along with their treating clinician, for up to a total of 33 months post initial 12-week therapy for a total of 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who signed the informed consent and were eligible to participate in the original SUmiT Trial
* Subjects who were randomized and treated with the active PTNS therapy during their participation in the original SUmiT Trial
* Subject must be a positive responder from initial 12 weekly treatments as prescribed in original SUmiT Trial - 13 week GRA questionnaire must indicate "moderately" or "markedly improved" on question #1 of GRA
* Subjects must not have started any antimuscarinics treatment since completion of original SUmiT Trial
* Subjects must not have started any urologic Botox treatment since completion of original SUmiT Trial
* Subjects must remain off all antimuscarinics throughout participation in trial
* Subjects must initiate PTNS maintenance therapy within 2 weeks of their last PTNS treatment as part of SUmiT protocol UPC082008
* Capable of giving informed consent
* Capable and willing to follow all study-related procedures for up to 33 months for a total participation of 3 years

Exclusion Criteria:

* Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
* Subjects who were not able or willing to follow original SUmiT Trial study schedule
Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After PCI

To determine the safety and efficacy of Ticagrelor versus Clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents.

This is a multi-center, randomized, single-blind, investigator-initiated study with a parallel design. Patients with coronary artery disease undergoing percutaneous coronary intervention and presenting high platelet reactivity on clopidogrel as assessed with the PL-11 analyzer (platelet maximum aggregation ratio \[MAR%\] ≥ 55 %) at 2 hours post-clopidogrel 300mg LD (Day 0), will be randomized after informed consent, in a 1:1 ratio to the following treatment groups:

Group Α: Ticagrelor 180 mg immediate loading (on Day 0) followed by 180mg/day starting from Day 1 until Day 365 (12 months after randomization).

Group Β: Clopidogrel 150mg per day, starting from Day 1 until Day 365 (12 months after randomization).

Platelet reactivity assessment will be performed before randomization (Day 0), and 3-day after randomization (Day 3). Documentation of major adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other adverse events) will be performed until 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients who agreed to the experimental plan which was permitted by IRB;
* Patients planned to take dual antiplatelet therapy for 12 months.

Exclusion Criteria:

* Severe hepatic dysfunction defined as serum transaminase \> 3 times normal limit;
* Renal dysfunction defined as eGFR \< 30ml/min/1.73m\^2;
* Co-morbidity with an estimated life expectancy of \< 50 % at 12 months;
* Scheduled surgery in the next 12 months, which resulted protocol changes;
* Known allergy against study drug or device;
* Use of glycoprotein IIb/IIIa inhibitor during the perioperative period;
* Anticoagulation treatment including warfarin.
Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis

The purpose of this study is to determine whether tamsulosin and tolterodine are effective in the treatment of men with lower urinary tract symptoms and chronic prostatitis/chronic pelvic pain syndrome.

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder in urological clinics. Most of the clinically CP/CPPS are to some extent associated with storage (irritative) symptoms, such as increased frequency, urgency, and nocturia, namely many patients with CP/CPPS have overactive bladder symptoms. Alpha-blocker therapy has been advocated as a treatment modality for CP/CPPS. Some trials showed a statistically and likely clinically significant treatment effect, while other trials showed no benefit. Therefore, tamsulosin combination with tolterodine treatment for CP/CPPS may be more effective than tamsulosin single.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of CP/CPPS based on the classification of US National Institutes of Health, aged 18-45 years
2. total score of at least 12 on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)
3. urinary score of at least 4 on the CPSI
4. subjects who anticipate improving symptoms

Exclusion Criteria:

1. previous treatment with any other alpha-adrenergic receptor blocker and antimuscarinic agents for symptoms of CP/CPPS or for any other reason
2. those who had had previous urinary tract infection with the last year
3. those who had been treat or were taking medication that could affect lower urinary tract function
4. those who met the criteria for chronic bacterial prostatitis after lower urinary tract localization studies
5. those who had other significant medical problems