cyrilzakka/clinical-trials huggingface dataset:
The Effect of Motivational Interview on Hemodialysis Patients

This research consists of two stages: the first stage aims to evaluate the validity and reliability of the Hemodialysis Resilience Scale, which was developed to evaluate the resilience of patients receiving hemodialysis treatment, in Turkish society, and the second stage aims to determine the effect of motivational interviewing method on patients' psychological resilience and compliance with hemodialysis treatment in individuals undergoing hemodialysis. The main question it aims to answer is:

Does motivational interviewing has an effect on psychological resilience and treatment compliance of hemodialysis patients?

The aims of this study are to evaluate the validity and reliability of the Hemodialysis Resilience Scale, which was developed to evaluate the resilience of patients receiving hemodialysis treatment, in Turkish society, and to determine the effect of motivational interviewing method on patients' psychological resilience and compliance with hemodialysis treatment in individuals undergoing hemodialysis.

This research consists of two stages: the first stage is a methodological study for scale adaptation, and second stage is randomized, controlled, and single blinded study for determining the effect of motivational interviewing.

The first stage is carried out in patients undergoing hemodialysis in two different hospitals. The second stage of the study consists of a randomized, controlled, and single-blinded experimental study to determine the effect of motivational interviewing on individuals undergoing hemodialysis treatment, in terms of psychological resilience and compliance with treatment.

The "simple randomization method" was chosenfor allocation in order to provide an equal number of samples in the two groups. In order to reduce the selection bias in determining intervention and control groups, a list was created by a third party (dialysis center nurse) who did not have a direct role in the study, and assignments were performed using the random numbers table. The intervention and control group patients were scheduled to have hemodialysis sessions on different days. In the study, blinding was applied only to the patient groups because the groups were known by the researchers and nurses.

Eligibility Criteria:
Inclusion Criteria:

* Receiving hemodialysis treatment for at least 3 months
* 18 years old and over
* Oriantated
* literate
* Having no barrier to written or verbal communication
* Agreed to participate in the research

Exclusion Criteria:

* diagnosed with psychiatric illness
* diagnosed with dementia and Alzheimer's
A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.

The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older, female, any race
* Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
* High grade (or grade 3) serous histology or known to have gBRCAmut
* Has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 month period between penultimate platinum regimen and progression of disease)
* Has responded to last the platinum regimen, remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen
* ECOG 0-1
* Adequate bone marrow, kidney and liver function

Exclusion Criteria:

* Known hypersensitivity to the components of niraparib
* Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
* Symptomatic uncontrolled brain metastasis
* Is pregnant or breast feeding
* Immunocompromised patients
* Known active hepatic disease
* Prior treatment with a known PARP inhibitor
HoloSIM: Mixed Reality Medical Student Training in Complex Crisis Scenarios

In this study, Investigators will test a mixed reality software platform to improve and help for teaching and assessment of anesthesia crisis management among medical students.


Eligibility Criteria:
Inclusion Criteria:

* University of Toronto Medical student volunteers

Exclusion Criteria:

* Unwilling to enter the study
* Deficit of vision or hearing incompatible with Microsoft Hololens 2 use
The Effect of Branched-chain Amino Acid on the Improvement of Serum Albumin Level in Cirrhotic Patients With Ascites

To compare the efficacy of branched-chain amino acid in serum albumin level in cirrhotic patients with ascites.

Branched-chain amino acid (BCAA) is known to reduce the relapse rate of liver cancer as it is associated with insulin resistance and has been reported to improve the progression of liver fibrosis when used in combination with an angiotensin-converting enzyme. With regard to the effect of liver function improvement, in a research conducted in South Korea, approximately 41.2% of the patients showed recovery of the normal albumin level when BCAA was administered to them for about 10 weeks during radiation therapy for liver cancer. Additionally, in other overseas researches, the changes in the values of total protein and albumin were significantly smaller in the patients who underwent transarterial chemoembolization (TACE) to whom BCAA was administered than in those to whom BCAA was not administered.

The hypothesis of this study is that the serum albumin value will be increased significantly in the cirrhotic patients with ascites to whom BCAA is administered than the patients to whom placebo is administered.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 19 and ≤ 70 years;
* Presence of liver cirrhosis
* Serum albumin level ≤ 3.5g/dl, ultrasound or CT scan confirmed ascites (≥Grade 1)
* No administration of diuretics and BCAA within the past 1 week
* Voluntary consent to take part in this trial

Exclusion Criteria:

* Child-Pugh score \> 12
* Having been diagnosed as HCC within the past 5 years
* Serum creatinine \> 1.5mg/dl
* Serum bilirubin \> 5.0mg/dl
* Presence of such complications as SBP, or hepatic encephalopathy(West Haven grade ≥ 3)
* Patients who experienced organ failure by acute exacerbation of liver cirrhosis within the past 1 month
* Presence of serious cardiac or respiratory disease
* Contraindicated to either diuretics or BCAA
* Having commenced anti-viral treatment against hepatitis C, B within the past 1 month
* Pregnant or lactating women
* Chronic alcohol taker
* Woman patients who do not agree to the contraception from baseline to 12 month
* Unsuitable patients judged by investigator
* Patients participating in another clinical trial within 1 month
Exoskeleton Variability Optimization

The investigators will evaluate a potentially faster and more clinically feasible method to optimize exoskeletons in pilot tests in healthy in preparation for patients with peripheral artery disease.

This study will test different methods for optimizing exoskeletons. It will consist of an habituation session to the hip exoskeleton, an optimization session to find the optimal actuation settings using an algorithm that converges toward the optimum based on real-time measurements (human-inthe-loop algorithm) and a post-test at the end of optimization session to compare different conditions. The outcomes will be evaluated by surface electromyography (Delsys), exoskeleton sensors (Futek), ground reaction force (Bertec treadmill), walking speed (Bertec treadmill), indirect calorimetry (Cosmed), and motion capture (Vicon).

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written consent
* Chronic claudication history
* Ankle-brachial index \< 0.90 at rest
* Stable blood pressure, lipides, and diabetes for \> 6 weeks
* Ability to walk on a treadmill for multiple five-minute spans.
* Ability to fit in exoskeleton: waist circumference 78 to 92 centimeters, thigh circumference 48 to 60 centimeters, minimal thigh length 28 centimeters.

Exclusion Criteria:

* Rest pain or tissue loss due to peripheral artery disease (Fontaine stage III and IV).
* Foot ulceration.
* Acute lower extremity event secondary to thromboembolic disease or acute trauma
* Walking capacity limited by diseases which are unrelated to peripheral artery disease such as:

Neurological disorders, musculoskeletal disorders (arthritis, scoliosis, stroke, spinal injury, etc.), a history of ankle instability, knee injury, diagnosed joint laxity, lower limb injury, surgery within the past 12 months, joint replacement, pulmonary disease or breathing disorders, cardiovascular disease, or vestibular disorder. This will be determined by verbal questioning from research personnel by verbally asking about conditions limiting their walking, whether subjects are taking medications for those conditions, and physicians' recommendations about limiting activity.

* Acute injury or pain in their lower extremity or current illness.
* Inability to follow visual cues due to blindness.
* Inability to follow auditory cues due to deafness.
* Women who are currently pregnant are excluded for safety reasons.
Comparative Study Between Safety and Effectiveness of High Versus Low Power HOLEP

Holmium laser enucleation (HOLEP) has became a standard of treatment of large prostates that indicates surgery. HOLEP is widely used nowadays. Many settings are used but no optimal setting was world wide adopted. The aim of this trial is to assess the Low-power Holmium laser enucleation of the prostate (LP-HoLEP)and compare to high-power (HP-HoLEP) for enucleation efficiency pertaining to the advantages of lower cost and minimal postoperative dysuria, storage symptoms, and negative sexual impact.


Eligibility Criteria:
Inclusion Criteria:

* large prostate indicated for surgical intervention.

Exclusion Criteria:

* prostate cancer
* recurrent adenomas
* associated neurologic factors that may affect outcomes (e.g., neurogenic bladder)
Quality of Life After Rectal Cancer Surgery

Following colorectal surgery, many patients face a combination of physical and emotional problems for a long period of time. Symptoms such as pain, fatigue, and disturbed bowel and sexual function, as well as problems in social and role functioning, inevitably affect the patients' well-being. Therefore, evaluation of the self-reported quality of life (QoL) is becoming increasingly important in clinical trials. The investigators aimed to compare long term health related life quality (HRQoL) results of laparoscopic approach with open approach in patients with sphincter preserving resections for rectal cancer at a single-center.

This study is planned prospectively. All patients scheduled for operation due to rectal cancer in our clinic between January 2017 and December 2018 will be evaluated for suitability for the study. During the preoperative examination, patients will be informed about the study and their written consent will be obtained. Patients will be randomized between open and laparoscopic groups in the ratio 2:1, depending on the type of surgery. Clinical data of patients will be analyzed from the hospital database programme.

The EORTC QLQ-C30 and QLQ-CR29 questionnaires prepared by The European Organization for Research and Treatment of Cancer (EORTC) will be used to evaluate the quality of life after the operation. The EORTC QLQ-C30 questionnaire will be completed by examining the patients' daily observation notes. EORTC QLQ-CR29 will be completed with face to face interviews in the first year after surgery.

In this way, it will be aimed to compare the early and long-term quality of life (HRQoL) results of open and laparoscopic approach in patients undergoing surgery for rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent surgery (laparoscopic or open) for rectal cancer in our department.

Exclusion Criteria:

* The patients whose all oncological treatments had not been completed at least 6 months ago
* The patients with ASA IV score
* The patients with previous abdominal surgery
* The patients who had developed major surgical complications (such as anastomosis leakage, requiring re-laparotomy, evisceration)
* The patients who underwent a new abdominal surgery except for stoma closure
* The patients with local recurrence or distant metastases
* The patients who still had a stoma
* The patients who did not want to take part in the study
* The patients who missed in the follow-up period
Intervention for Veterans With Depression, Substance Disorder, and Trauma

This study will compare two different types of psychotherapy for Veterans with depression, addiction, and a past traumatic experience. Everyone in the study will receive 12 weeks of group cognitive behavioral therapy focused on depression and addiction, followed by 12 weeks of individual psychotherapy sessions. For the second 12 weeks, half of the people will receive a review of the initial therapy, and half will receive a cognitive behavioral therapy focused on trauma. Everyone will complete research interviews every 3 months for a total of 18 months.

The goal of this study is to evaluate whether a second disorder-specific intervention improves longer term (up to 18 months) treatment outcomes for male and female Veterans with co-occurring depression and alcohol/substance disorders and trauma history (with or without PTSD diagnosis). This 4 years randomized two-group design uses repeated assessments at baseline and every 3 months for a total of 12 months. The investigators are providing their recently developed integrated intervention for comorbid depression and substance disorders for the initial 12 weeks in group format (Integrated Cognitive Behavioral Therapy; Phase I). After the 12 week group intervention, participants will be randomized to receive either a review of the initial intervention in individual sessions, or a trauma-specific intervention, Cognitive Processing Therapy, with integrated addiction treatment components. Length, duration, and setting of both interventions will be the same, and all participants will meet with the program psychiatrist for medication appointments. No medications are under study and no placebo is used; medications will be prescribed using standard VA protocol. Research assessments will document diagnosis, recent substance use, depression and PTSD symptoms, medication adherence, and life stress.

Eligibility Criteria:
Inclusion Criteria:

* Veterans 18 years of age and older living in the San Diego, California area
* Who are able to attend in-person therapy sessions
* Have depression, alcohol or substance addiction, and a past traumatic experience

Exclusion Criteria:

* Non-veterans
* Individuals with schizophrenia or severe memory impairment
Observational,Prospective Study to Develop and Validate a Prognostic Tool to Optimize Therapy in Patients With HCV G1/4

Primary objective:

• Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to allow optimize treatment.

This Tool:

1. Predicting the overall impact of prognostic factors (including the new factor of genetic polymorphism of the IL28B) on Sustained Viral Response (SVR).
2. Identify those patients most likely to respond.
3. Therapy and therefore optimize resources

The validation tool will check into clinical practice its predictive power (it will consider its ability to calibrate and discriminate) and make correct inferences and interpretations of the scores obtained when applying.

Eligibility Criteria:
Inclusion Criteria:

* Patients with \> 18 years old.
* Patients diagnosed with chronic hepatitis C in the presence of HCV RNA in plasma that meet criteria for initiating antiviral therapy in routine clinical practice conditions.
* Patients Genotype 1 and 4.
* Patients with the results of all the factors evaluable at the time of inclusion.
* Patients who have accepted their participation in the study through informed consent.

Exclusion Criteria:

* Patients previously treated with interferon (IFN) and ribavirin (RBV).
* Patients with genotype 2, 3, 5 and 6.
* Patients with co-infection with hepatitis B.
* Patients with other liver diseases.
* Patients with any contraindications to the drugs used in the treatment of hepatitis C.
Adult Providing Access to the Visual Environment (PAVE) - Glaucoma Pilot

We wish to evaluate a potential training program for patients with glaucoma, to become more efficient users of prescribed low vision devices for distance and near vision tasks. We hypothesize that the devices will improve efficiency. Prescribed devices will include a stand magnifier, a handheld magnifier, spectacle magnifiers for near vision, and a handheld monocular (telescope) and a bioptic telescope (spectacle-mounted telescope) for distance vision. The success of being able to use optical devices is dependent upon training. Optical devices are currently accepted and used for patients with visual conditions that decrease their central vision. The bioptic telescope is a pair of glasses with a small telescope mounted within the carrier lens. The glasses look and feel like a normal pair of glasses, but have a black device (telescope) protruding from the top of one lens for better identifying distance objects. The spectacle magnifier is mounted in a pair of glasses also for near vision

You will be asked a series of oral questions regarding your health status and vision level of functioning (Expectations of Visual Functioning Form, NEI-VFQ, Linear Rating Scale, and Geriatric Depression Scale) in the Vanderbilt Eye Clinic. You will undergo a mobility pre-test to assess your ability to find objects in the distance as well as read . You will undergo a low vision examination in the eye clinic. You will receive the optical devices and then receive brief instructions on the use of the devices . You will then undergo a pre-training evaluation. You will receive approximately 6 training sessions with your prescribed devices for up to 1 hour each time. You will return to the Vanderbilt Eye Clinic for the post-training distance and near vision assessments with the devices . You will be asked the series of oral questions again regarding your health status and vision level of functioning .

Eligibility Criteria:
Inclusion Criteria:

* Glaucoma patients with vision less than 20/40

Exclusion criteria:

- Subjects must not have any significant physical mobility limitations and be willing to participate in the testing and training sessions.
Longitudinal Study of Quality of Life and Activity in Systemic Lupus Erythematosus

Systemic lupus erythematosus is a complex disease whose evaluation in everyday practice and in clinical research requires several aspects to be taken into account, in particular the impact of disease activity on quality of life. To date, the effect of systemic lupus on quality of life has only been described using generic questionnaires. Among the specific questionnaires for systemic lupus, the LupusQol, which has been validated in French, shows interesting psychometric properties. The determinants of quality of life specifically related to the disease are still unknown and could be studied using a longitudinal cohort thanks to the French version of the LupusQol.


Eligibility Criteria:
Inclusion Criteria:

* - Patients meeting ACR 1997 classification criteria for systemic lupus erythematosus.
* Patients able to understand written and spoken French.
* Patients aged from 18 to 75 years
* Patients who have received written and oral information about the research.

Exclusion Criteria:

* - Patients aged less than 18 years
* Patients aged more than 75 years
* Severe mental retardation Any impairment of abilities to understand that make self-evaluation impossible
A Trial to Evaluate the Effect of the Proton Pump Inhibitor Esomeprazole on the Single-dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants

The purpose of this study is to evaluate the effect of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of orally administered TAK-906.

The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy participants to evaluate the effect of a PPI esomeprazole on the PK of TAK-906.

The study will enroll approximately 12 participants. Participants will be assigned to the following treatment sequence:

• TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg

All participants will be given an oral dose of TAK-906 and Esomeprazole.

This single center trial will be conducted in the United States. The overall duration to participate in this study is 52 days. Participants will make visit to the clinic during Period 1 and Period 2 in addition to approximately 10 to 14 days after receiving their last dose of TAK-906 for a follow up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Continuous non-smoker who has not used nicotine containing products for at least 3 months prior to the first dosing and throughout the study, based on screening urine cotinine test.
2. Has a body mass index (BMI) greater than or equal to (\>=) 18 and less than or equal to (\<=) 30 kilogram per square meter (kg/m\^2) at Screening.

Exclusion Criteria:

1. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
2. QT interval corrected using Fridericia's formula (QTcF) interval is greater than (\>) 450 millisecond (msec) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening.
3. Donation of blood or significant blood loss (example, approximately 500 milliliter \[mL\]) within 56 days prior to the first dosing.
4. Plasma donation within 7 days prior to the first dosing.
5. Participation in another clinical study within 30 days or 5 half-lives prior to the first dosing. The 30 day window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Study Period 1 of the current study.
An Observational Study to Explore Clinical Characteristics of the Patients With T1 Non-small Cell Lung Cancer

The real-world observational study was designed to explore the odd factors of lymph metastases in the patients with T1 non-small cell lung cancer, the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups.

The trial is a multi-centre, real-world non-interventional observational study. In the study, the patients with T1 non-small cell lung cancer enrolled in clinics from 2015 to 2017 were included via a retrospectively review method and the study data on patient demographic/tumor biological characteristics, and clinical treatments were collected to explore the clinical odd factors of lymph metastases, evaluate the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received surgeries from 2015 to 2017;
* Pathologically diagnosed patients with T1 non-small cell lung cancer;

Exclusion Criteria:

- Patients with tumor treatments (including chemotherapies, radiotherapies, biological therapies, intervention therapies)