cyrilzakka/clinical-trials huggingface dataset:
SF-QUALIVEEN Turkish Validity and Reliability Study

Urological dysfunction is common in patients with Multiple Sclerosis (MS) and its prevalence has been reported at a high rate of 32-97%. Bladder dysfunction is associated with a significant deterioration in the quality of life of people with MS. In chronic diseases such as MS, patients experiences need to be measured directly in order to have information about patients perceptions about the effect of the disease on quality of life. However, there are a small number of valid and reliable Turkish scales on this subject.SF-Qualiveen is a validated scale for patients with MS who assess the urinary-specific quality of life by examining the impact of a wide range of bladder problems.The aim of our study is to make the Turkish cultural adaptation, validity and reliability of the SF-Qualiveen scale.

The aim of this study is to reveal the Turkish cultural adaptation, validity and reliability of the SF-Qualiveen scale. In our study, Sf-Qualiveen and Urogenital Distress Inventory (UDI-6) scales will be used. Pre-testing will be done in 10 patients with multiple sclerosis.Then, the validity and reliability of the scale will be performed in 80 patients with multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

1. age 18-65;
2. definitive diagnosis of MS according to McDonald criteria;
3. ability to read and write in Turkish.

Exclusion Criteria:

1. acute attacks of MS (within 3 months);
2. cognitive impairment (Mini Mental test result 24 points and below);
3. any chronic disease other than MS;
4. active malignant tumors;
5. symptomatic urinary tract infections;
6. patients who changed treatment within the test-retest period.
Computer Assisted Implant Surgery and Immediate Loading

Purpose: The aim of this study was to analyze the clinical and radiographic outcomes of 23 edentulous jaws treated with 3D software planning, guided surgery, immediate loading and restored with Cad-Cam Zirconia and titanium full arch frameworks.

Material \& methods: This study was designed as a prospective clinical trial. Twenty patients have been consecutively rehabilitated with an immediately loaded implant supported fixed full prosthesis. A total of 120 fixtures supporting 23 bridges (8 mandible, 15 maxilla) were placed , 22 of which in fresh post extraction sockets. All the implants were inserted with an insertion torque of 35/45 Ncm. 117 out of 120 implants were immediately loaded the other 3 were delayed loaded.

Outcome measures were implants survival, radiographic marginal bone-levels and bone remodeling, soft tissue parameters and complications.


Eligibility Criteria:
Inclusion criteria were:

-edentulous patients or patients with hopeless teeth in need to be restored with full arches prosthesis

Exclusion criteria were:

* presence of systemic diseases (i.e. haematologic disease, uncontrolled diabetes, serious coagulopathies and diseases of the immune system)
* irradiation to the head or neck region within 12 months before surgery
* presence severe bruxism or clenching habits
* pregnancy
* poor oral hygiene
* poor motivation to return for scheduled follow-up visit
The Predictive and Diagnostic Value of Cystatin C and High Sensitive Troponin

Our study is planning to evaluate patients with chronic kidney disease who come to the emergency department with chest pain. Estimated GFR (cisGFR) with cystatin and estimated GFR (creaGFR) with creatinine will be calculated. Symptoms, ECG and troponin values of patients will be evaluated for diagnosis of acute coronary syndrome

Our study is planning to evaluate patients with chronic kidney disease who come to the emergency department with chest pain. Estimated GFR (cisGFR) with cystatin and estimated GFR (creaGFR) with creatinine will be calculated. Symptoms, ECG and troponin values of patients will be evaluated for diagnosis of acute coronary syndrome and the final diagnosis of AMI will be adjudicated by 2 independent cardiologists.Serial troponin measurements and eGFR values will be proportioned. These values the will be evaluated and compared for patients with acute coronary syndrome(culprit lesion on conventional coronary angiography) and non-ACS ones . With these data we aim to facilitate the diagnosis of acute coronary syndrome,increase the specificity and sensitivity of cardiac troponins for the diagnosis of acute coronary syndrome of patients with chronic kidney disease, increase the utility of high sensitive troponins for patients with chronic kidney disease. Again, with these data, it is aimed to reduce the number of false negative and false positive diagnosis of acute coronary syndrome .

Eligibility Criteria:
Inclusion Criteria:

1. Age over 18,
2. chronic kidney diease having chest pain or equivalent of chest pain (dyspnea, diaphoresis, syncope, nausea, vomiting) -

Exclusion Criteria:

1. STEMI,
2. age less than 18,
3. missing data,
4. patients referred to or accepted from another medical facility
The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC110114 Tablets in HCV-infected Subjects

A Phase Ib/IIa, Single Center, Randomized, open, Sofosbuvir-controlled, Multiple Ascending Dose Study to Access the Tolerability，Pharmacokinetics and Pharmacodynamics of HEC110114 Tablets in HCV-infected Subjects

A total of 24 evaluable patients will be enrolled in this study. The study randomly divided into three dose groups and HEC110114 tablets planned dose levels are 600, 800, and 1200 mg, sofosbuvir tablets planned dose levels are 400 mg .

Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions;
* Be able to complete the study according to the trail protocol;
* Subjects (including partners) have no pregnancy plan within six months after the last dose of study drug and voluntarily take effective contraceptive measures;
* Male subjects and must be 18 to 65 years of age inclusive;
* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive, and a body weight ≥50 kg for males and ≥45 kg for females;
* No previous treatment with any direct-acting antiviral (DAA) drugs for HCV, such as Simeprevir, Sofosbuvir, Daclatasvir etc;
* HCV RNA ≥10\*5 IU/mL at screening (Roche COBAS Taqman);
* Chronic genotype 1-6 HCV Infection, multiple genotypes, subtype unidentifiable or others ;
* Serum ALT ≤5 times ULN.

Exclusion Criteria:

* Allergies constitution ( multiple drug and food allergies);
* History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine);
* Donation or loss of blood over 450 mL within 3 months prior to screening;
* History of any non-HCV liver diseases, including but not limited to hemochromatosis, primary biliary cirrhosis, Wilson's disease, autoimmune hepatitis, drug or alcoholic hepatitis, non-alcoholic steatohepatitis, etc;
* 12-lead ECG with clinically significant;
* Pregnant or lactating women;
* Creatinine clearance \< 60 mL/min;
* Subjects deemed unsuitable by the investigator for any other reason.
Effects of Home-based Exercise in Parkinson's Disease

Home-based exercise program focusing on axial rigidity could be used as an adjunct rehabilitation program to improve rotational movement, gait and functional movement associated with axial rigidity in individuals with PD.

Typically, individuals with PD revert to more primitive movement patterns, which lack many of the automatic postural adjustments and axial movements that accompany simple activities, such as supine to standing, getting up from sitting or turning over in bed. The present study is designed to allow patients and their relatives to perform exercises by themselves conveniently at home. The results were considered a vital component of a complex intervention and were played an integral part in the implementation process of exercises in functional performance. Furthermore, this study will prove sufficient high-quality evidence to investigate whether improvements in function due to exercise-based rehabilitation are associated with reducing axial rigidity in individuals with PD.

Currently, there is a lack of evidence for the effectiveness of home-based exercise programs in PD patients in Thailand. For the present study, we devised a home-based 10-week exercise program focusing on segmental rotation and task-specific movements for turning practice to determine effects on axial mobility and turning. The aimed of this study to examine the effects of a 10-week task specific home-based exercise program on turning kinematics, gait and stepping characteristics, the Functional Reach test (FRT), the Unified Parkinson's Disease Rating Scale (UPDRS), the Freezing of Gait questionnaire (FOG) and the Fall Efficacy Scale International (FES-I) in individuals with PD.

Eligibility Criteria:
1. Inclusion Criteria;

   * Clinically diagnosed with PD stages 1.5 to 3 as assessed by the modified Hoehn and Yahr scale
   * The age groups between 50 and 75 years
   * Taking PD medication regularly for at least a month
   * No signs of wearing-off phenomenon
   * Able to walk independently without any assistive device and 6) able to follow commands and instructions
2. Exclusion Criteria;

   * Clinically diagnosed with dementia or other neurological or cardiopulmonary diseases
   * Musculoskeletal problems that could influence the test performance such as arthritis or severe leg pain
   * High blood pressure (more than 140/90 mmHg)
   * Haemodialysis
   * Visual problems that could not be adjusted with lenses or glasses
   * Taking medicine which affected to functional movement.
Efficacy and Safety of Dianicline Treatment as an Aid to Smoking Cessation in Cigarette Smokers (AMERIDIAN)

The primary study objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are to assess the: craving for cigarettes, nicotine withdrawal symptoms, and safety of dianicline.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients, over legal age, smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit.

Exclusion Criteria:

* Patients who have taken an investigational drug within the past six months prior to the screening visit.
* Patients who had a previous quit attempt (= or \>1 day with the aid of pharmacological adjunct) in the previous three months (before screening).
* Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco product (other than cigarettes such as cigars, pipes, smokeless tobacco, etc) more than 3 times within the 3 months preceding the screening visit.
* Patients who currently present with (based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition \[DSM-IV\]):

  * Psychotic disorder
  * Major depressive episode
* Pregnant or breast-feeding women.
* Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy. Medically acceptable methods of birth control for this study include approved hormonal contraceptive medications or devices, approved intra-uterine contraceptive devices, use of two combined barrier methods.
* Patients who have suffered from a myocardial infarction, unstable angina or other major cardiovascular event within the past week prior to screening.
* Patients who have a history of multiple allergic reactions to medications in two drug classes.
* Patients who have QTcF \> 500 ms on the electrocardiogram (ECG).
* Patients with mild, moderate or severe renal impairment.
* Patients who have an abnormal laboratory test of potential clinical significance at screening.
Exercise and Genes in Obese (EGO)

Regular exercise has several positive health effects including increased physical fitness and muscle mass. It is well known that increased muscle mass is associated with increased resting energy expenditure which may facilitate weight loss and maintenance. Previous studies have, however, failed to show any consistent association between the intensity of physical exercise and energy expenditure, or relate the variance in these adaptations to genetic variability. Whether high-intensity exercise (HIE) is associated with improved health related quality of life in severely obese patients remains unknown.

This PhD-project is based on a planned randomised controlled study including 50 or more treatment seeking morbidly obese patients who will be randomised to either a 24 week moderate-intensity exercise (MIE) programme or a 24 week high-intensity exercise (HIE) programme. The investigators main hypothesis is that patients randomised to the HIE-program will achieve higher energy expenditure during rest and physical activity after treatment than those allocated to the MIE-programme. In addition, the investigators hypothesise that the HIE-group will achieve a better health related quality of life than the MIE-group after treatment. The investigators also hypothesize that inter-individual variability in adaptation to the two training regimens may be due to genetic factors. If the investigators hypotheses are confirmed, this project might have beneficial clinical implications for future obesity treatment strategies.


Eligibility Criteria:
Inclusion Criteria:

* Treatment seeking weight stable morbidly obese patients (BMI ≥ 40 kg/m2 or BMI 35 to 39.9 kg/m2 with ≥ 1 co morbidity) attending the outpatient Obesity Center, Vestfold Hospital Trust, will be informed about this RCT .

Exclusion Criteria:

* Uncompensated heart failure
* Recent myocardial infarction or stroke (\<½ years)
* Severe arrhythmia or heart failure
* Unstable angina pectoris
* Renal failure
* Pregnancy
* Severe eating disorders
* Active substance abuse
* Being on a diet
* Taking medication known to affect appetite or metabolism (including thyroxin).
A Study of KL130008 in Adults With Severe Alopecia Areata

The purpose of this study is to assess KL130008 is safe and effective in adults with severe alopecia areata

This is a multi-center Phase 2 study to evaluate the safety and effectiveness of an investigational drug in adults (≥18 years and ≤65 years) who have 50% or greater scalp hair loss, including alopecia totalis (AT) and alopecia universalis (AU).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects with the age of ≥18 and ≤ 65 years old at the time of informed consent.
2. Able to understand the procedures and methods of this study, and will to provide a signed and dated informed consent form.
3. Diagnosed alopecia areata(AA) without other reasons caused alopecia.
4. Have severe AA, as determined by all of the following:Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, including alopecia totalis (AT) and alopecia universalis (AU);No spontaneous improvement over the past 6 months;Current episode of severe AA of less than 8 years.
5. All women of childbearing potential and all men must be willing to use at least one highly effective method of contraception from the signing of informed consent, throughout the duration of the study, and for 3 months after the last dose of investigational drugs.

Exclusion Criteria:

1. Known history of anaphylaxis to any of the ingredients and/or other similar products.
2. Participated in a clinical trial of any drug or medical device and has used an investigational product (including placebo and control group) or treatment within 1 month or 5 half-lives before randomization.
3. Previously treated with JAK inhibitors.
4. Corticosteroids, finasteride, minoxidil,topical immunotherapy treated within 8 weeks before randomization.
5. Diphenylcyclopropenone (DPCP), HMGCoA reductase inhibitor, Chinese herbal medicine treated within 4 weeks before randomization.
6. With other diseases: acute "diffuse" type of AA, lymphoproliferative disease, tumor, severe chronic gastrointestinal disease, thyroid disorders, serious cardiovascular disease.
7. Subjects with evidence of clinical laboratory abnormalities at screening that, in the opinion of the investigator, may affect the safety of subjects or the interpretation of study results: Hemoglobin level \< 10.0 g/dL. Absolute white blood cell (WBC) count /absolute neutrophil count (NEUT)/absolute lymphocyte count(LYMPH)\<LLN. Aspartate aminotransferase (AST), or alanine aminotransferase (ALT) \> 2 × ULN, total bilirubin(TBIL)\>1.5 × ULN. QTcF\> 450ms. Subjects with eGFR ≤ 60 mL/min based on Cockcroft-Gault calculation.
8. The subject had or currently has a severe infection, and had a severe infection judged by the investigator within 1 month before randomization: HBV, TP-Ab, HIV, HCV, TB positive.
9. Subjects who are unsuitable to the trial, as identified by the investigator.
Chronic Thromboembolic Disease Registry

The goal of this patient registry is to learn about the natural history in patients with chronic thromboembolic disease (CTD) and/or chronic thromboembolic pulmonary hypertension (CTEPH). The main question\[s\] it aims to answer are:

* Long-term outcome after various types of treatment, including medication, balloon pulmonary angioplasty, and pulmonary endarterectomy
* Effect of treatment on patient's quality of life and exercise tolerance Participants will be followed longitudinally to assess their health outcomes and quality of life via chart review and health quality surveys.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred with CTED and/or CTEPH defined as:

  1. Mean pulmonary arterial pressure (mPAP) \> 20 mmHg at rest with pulmonary vascular resistance (PVR) \> 2 Wood units (WU); or if mPAP ≤ 20 mmHg or PVR ≤ 2 WU at rest, have exercise limitations from chronic thromboembolic pulmonary disease (CTEPD) without pulmonary hypertension (PH)
  2. Radiologic finding of chronic thromboembolic disease, including abnormal ventilation perfusion scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram
  3. Post-embolic exercise intolerance and evidence of chronic thromboembolic disease in the absence of resting pulmonary hypertension
* Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH or CTEPD without PH
* Age ≥ 18 years

Exclusion Criteria:

* Main cause of PH other than World Health Organization (WHO) group 4 (CTEPH)
* Patient's refusal to participate in clinical research and/or receive intervention
Promoting Organ Donor Registration in Family Physician Offices

This study evaluates the effects of using reception staff to prompt patients by providing a pamphlet and an opportunity to register in the waiting room via a mobile tablet on deceased organ donor registration rates.

Background: There is a worldwide shortage of organs available for transplant, leading to preventable morbidity and mortality. While the majority of the general public in many countries support organ donation, actual donor registration rates are substantially out of step with these views. For instance, in Canada most Canadians support organ donation but less than 25% in most provinces have registered. The family physician office is a promising yet underused setting in which to address known barriers and facilitators to registration for deceased organ and tissue donation and to provide an immediate opportunity to register while in the waiting room for those wanting to do so.

Methods/Design: The investigators aim to evaluate the effects of having reception staff in family physician offices to prompt patients upon check-in with an educational pamphlet using a cluster, stepped-wedge randomized design. A mobile tablet will also be added to the waiting area to provide patients with the immediate opportunity to register. Family physicians are also provided with an educational booklet and encouraged to discuss organ donation with their patients. The investigators will use behaviour change techniques designed to address previously anticipated barriers and enablers to organ and tissue donation registration. The investigators will evaluate the effectiveness of the intervention conducted in six family physician offices in Ontario, Canada. Following a two-week baseline control period, offices will cross sequentially into the intervention arm in a random sequence at two-week intervals until all offices deliver the intervention (baseline + two weeks for each of six offices). The primary outcome will be the proportion of patients that have registered for deceased organ donation following in the 7 days following their office visit, using routinely collected registry data (i.e. administrative databases). The investigators will also conduct a qualitative post-trial process evaluation will assess reception staff and family physicians experiences with the intervention.

Discussion: Promoting organ and donor registration remains an important strategy for organ procurement organizations and patients worldwide. The results of this trial will inform a provincial roll-out strategy to promote organ donation in family physician offices.

Eligibility Criteria:
Inclusion/Exclusion Criteria for Patients

Inclusion Criteria:

* Patients that visited a family physician
* Patients that are at least 16 years of age with a valid health card (eligibility criteria to register for organ donation in Ontario)

Inclusion/Exclusion Criteria for Family Physicians (Cluster level)

Inclusion Criteria:

- Working at a site that sees at least 100 patients per week

Exclusion Criteria:

- Working at multiple sites that cannot be separated in analyses
Digital VS. Conventional Ear Impression

What is known:

Ear impressions are made in conventional manner by impression materials which may affect the accuracy of the obtained data and consume time and effort .

What this study adds:

Predesigned ear markers facilitate ear scanning using an intraoral scanner that decreases the probability of in-accuracies using the conventional manner with less time and effort

Prosthodontic maxillofacial rehabilitation of acquired or congenital ear defects is considered a challenging procedure. This clinical trial introduces a novel approach for digital scanning of the unaffected contralateral ear using an intraoral scanner in comparison to the conventional impression techniques. CAD/CAM is a very promising design and fabrication of an auricular prosthesis for patients with unilateral ear defects.

Purpose: This study aims to compare digital impression technique using an intra-oral digital scanner IOSfor the unaffected ear with markers /without markers versus traditional techniques with hydro colloidal impression materials.

Eligibility Criteria:
Inclusion Criteria:

* any normal patient

Exclusion criteria:

* no exclusion criteria