cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection

The purpose of this study is to evaluate the safety and efficacy of co-administration of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adults with chronic hepatitis C virus infection.

This was a Phase 2, randomized, open-label, combination treatment study of the 2-DAA regimen (ABT-450 150 mg QD + ritonavir 100 mg QD + ABT-267 25 mg QD) in adult HCV GT1b-infected treatment-naïve and Pegylated-interferon/ribavirin (pegIFN/RBV) treatment-experienced participants without cirrhosis and with compensated cirrhosis, and in adult GT4-infected treatment-naïve and pegIFN/RBV treatment-experienced participants without cirrhosis. Treatment Group 5 was not open to enrollment, based on a protocol-specified interim review of results from the treatment-naïve GT4 Groups 1 and 4 that indicated higher sustained virologic response (SVR) rates among participants receiving the 2-DAA regimen with RBV. All other groups completed the study.

Eligibility Criteria:
Inclusion Criteria:

* Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile
* Subjects must meet one of the following:

  * Treatment-naive: Subject has never received antiviral treatment for hepatitis C infection OR
  * Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegIFN/RBV);
* Body mass index (BMI) is ≥ 18 to \< 38 kg/m\^2.
* Chronic HCV genotype 1b infection/with or without cirrhosis or HCV genotype 4 infection/without cirrhosis for at least 6 months prior to study screening.
* Subject has plasma HCV RNA level \> 10,000 IU/mL at Screening

Exclusion Criteria:

* History of severe, life-threatening or other significant sensitivity to any drug.
* Females who were pregnant or planned to become pregnant, or breastfeeding, or GT4-infected males whose partners were pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug/RBV.
* Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
* Positive test result for hepatitis B surface antigen or anti-Human Immunodeficiency Virus (HIV) antibodies.
Overnight Weight Loss and Sleep Structure

The objectives of the present study are:

1. to evaluate if overnight weight loss is dependent on sleep structure assessed by polysomnography;
2. to compare weight loss rate during sleep and awake rest;
3. to compare night weight loss profile of normal and obese volunteers.

Weight loss can be caused by loss of body mass due to metabolism and by water loss as insensible water loss, sweating, or excretion in feces and urine. Eighty-three percent of the total weight loss is due to insensible water loss from airways and skin. Water loss rate varies according to changes in activity and ambient temperature and humidity. Although weight loss during sleep is a well-known phenomenon, there are no studies relating it to sleep structure or any other functions during the distinct sleep stages, particularly SWS and REM sleep. There is evidence suggesting a homeostatic mechanism for weight control in animal models and humans. This mechanism is thought to be dependent on energy intake, energy expenditure, and environmental conditions. The literature suggests that sleep is important for weight homeostasis on a long term since sleep shortage is associated with overweight status, but overnight weight variation had not yet been studied. Considering these facts, we hypothesized that the overnight weight loss rate is not uniform throughout the sleep period. We also intend to compare weight loss rate during sleep and awake rest.

Intervention: Normal and obese volunteers will undergo whole night polysomnography with continuous body weight and temperature register after an adaptation night. After that, volunteers will remain awake resting in bed during the following day for continuous weight and temperature register.

Eligibility Criteria:
Inclusion Criteria:

* normal and obese volunteers

Exclusion Criteria:

* serious medical or neurological condition
Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty

The purpose of this post-market research study is to gather clinical and radiographic (X-ray) information about total knee replacement surgeries completed with the VELYS Robotic-Assisted Solution and with standard manual instrumentation. The VELYS Robotic-Assisted Solution helps the surgeon to plan bone cuts and then accurately achieve the planned cuts during the total knee replacement surgery. The study aims to compare how well the VELYS Robotic-Assisted system enables the surgeon to position the implants exactly as planned compared to manual instrumentation.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is male or female and between the ages of 22 and 85 years at the time of consent, inclusive.
2. Subject has a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis or rheumatoid arthritis and in the opinion of the Investigator, is a suitable candidate for primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
3. Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor
4. Subject is currently not permanently bedridden, as determined by the Investigator
5. Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.
6. Subject is able to read and comprehend the Informed Consent Document as well as complete the required PROs in English.
7. Subject's pre-operative alignment is such that (in the opinion of the Investigator) it is appropriate for it to be adjusted to mechanical long leg alignment during surgery.

Exclusion Criteria:

1. The Subject is a woman who is pregnant or lactating.
2. Contralateral knee has already been enrolled in this study.
3. Subject had a contralateral amputation.
4. Previous partial knee replacement (unicompartmental, bicompartamental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
5. Subject has an active local or systemic infection
6. Subject has loss of bone or musculature, osteoporosis, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to render the procedure unjustifiable in the opinion of the Investigator (e.g. absence of musculo-ligamentous supporting structures, joint neuropathy)
7. Subject has severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity.
8. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
9. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
A Static Passive Stretching on Glenohumeral Rotation Range of Movement in Elite Swimmers

Shoulder injury is a common problem of overhead athletes, as swimmers. It's reported a reduction of side-to-side glenohumeral rotation from 11 to 18 degrees can increase 1.9 points the injury risk, because an alteration in biomechanics can turn lead to clinical findings of impingement and labral pathology. Posterior deltoid is a main muscle for propulsion in swimming stroke. To our knowledge, it isn't known how a posterior deltoid static passive stretch could reduce glenohumeral rotation restriction after swimming competition.


Eligibility Criteria:
Inclusion Criteria:

* elite swimmers

Exclusion Criteria:

* shoulder surgery
* dislocation
Diffusion Weighted Imaging as a Biomarker for Detection of Chemotherapy Induced Cardiotoxicity

The goal of this study is to see if a special type of heart scan called a diffusion weighted magnetic resonance imaging (DW-MRI) that uses extra measurements, can be used to find early signs of heart damage from chemotherapy.

This prospective single institutional pilot study will enroll breast cancer patients who develop cardiotoxicity while on anthracycline and anti-HER2 therapy . The control group will be composed of patients on similar anthracycline therapy and dose but without a decline in LVEF on Cardiac MRI (CMR). Clinic visits with monitoring for cardiotoxicity occur as part of standard of care after therapy initiation. The study and control group will be composed of 15 patients each. At the discretion of the treating physician, patients will be recruited from the Breast Medical Oncology Service.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age on the day of signing the informed consent.
* Diagnosis of HER2+ breast cancer

  * History of anthracycline therapy and antiHER2 treatment
* For subjects with decrease in LVEF: Recent (within 12 weeks) drop in LVEF ≥10% on echocardiogram from baseline and confirmed by cardiac MRI for the study population. If the drop in EF is not confirmed on MRI, the subject will be removed and placed into the control group.

For control group: Less than a 10% change in EF from baseline for the control population confirmed on echocardiogram and cardiac MRI. If no change in EF is not confirmed on MRI, the subject will be removed and placed into the study group if the change in EF is equal to or greater than 10%. Note: Male breast cancer patients are uncommon and are not expected to be included in this study, however if they meet the above criteria, they will not be excluded.

Exclusion Criteria:

* Prior myocardial infarction
* Prior surgical or percutaneous coronary revascularization
* Pregnant or lactating patients
* Patients who because of general medical or psychiatric condition, or physiologic status unrelated to the presence of breast cancer cannot give valid informed consent
* Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc. MRI eligibility will be determined on the day of consent with the MRI questionnaire.
* Patients with metallic implants or device in the chest that might distort local magnetic field and compromise quality of MRI
The Effect of Sujok Therapy on Urinary Incontinence and Quality of Life in Postmenopausal Women

This study aims to investigate the effect of Su Jok therapy, a complementary medicine practice, on urinary incontinence and quality of life among postmenopausal women. A total of 120 participants will be included in the study, with 60 in the intervention group and 60 in the control group. Participants in the intervention group will receive Su Jok seed therapy applied to the hand reflex points corresponding to the bladder. The therapy will be administered by the researcher and then taught to the participants, who will continue the application for 15 days. Assessments will be conducted at baseline, day 15, and day 30 using validated questionnaires.


Eligibility Criteria:
Inclusion Criteria:

Women under 65 years of age in the postmenopausal period, Literate, No speech or communication impairment

Exclusion Criteria:

Use of diuretics

Presence of nephrotic syndrome

Diagnosis of diabetes or hypertension

Symptoms of urinary tract infection

Diagnosis of psychiatric illness

History of urinary tract surgery

Diagnosed urinary prolapse

Failure to complete the intervention
Gait Pattern and Experienced Global Change After Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus

Part 1 Patients with idiopathic Normal Pressure Hydrocephalus (iNPH) have variable disabilities regarding gait, balance, cognition and continence. Analysis of the gait pattern in iNPH has an important part in clinical diagnosing and evaluation of outcome after shunt surgery. The gait pattern is only partly explained and more detailed information about gait in iNPH is needed in relation with ordinary clinical measurements.

Part 2 Approximately 70 % of patients with iNPH improve after shunt surgery. Commonly different grading scales and measurements regarding functions are used in the evaluation. To some extent, patients improve in Quality of life after surgery (QoL). In this study, the patient´s own grading of improvements in relation with QoL, sense of coherence (SOC) and symptoms of depression and anxiety are analyzed.

Consecutive patients with iNPH, which are planed for shunt surgery at the neurological and neurosurgical departments of University Hospital of Linköping, are included. Before operation and 3 months postoperatively, the patient´s gait pattern are analyzed with RehaGait analysis system. The patients also fill in a questionnaire about SOC, QoL and symptoms of depression and anxiety at these assessment sessions. Additionally at the follow up, the patients are grading their overall experienced change and specified changes in gait, balance, continence and neuropsychology with the global Rating of Change Scale (GRC-scale). At baseline and at follow up, the patients also perform the ordinary clinical assessments with measurements covering the domains gait, balance, continence and neuropsychology in the iNPH-scale. A convenience sample of Healthy individuals aged \> 60 years, conduct the same questionnaires: SOC, QoL and symptoms of depression and anxiety and perform the RehaGait analysis system once.

Eligibility Criteria:
Inclusion criteria for patients:

* iNPH-diagnosis according to the international guidelines (2005)
* Planed for shunt surgery

Exclusion criteria for patients:

* Cognitive impairment that makes it impossible to participate
* Not able to walk 20 meters without walking aids (part 1)

Inclusion criteria for healthy individuals:

* \> 60 years of age
* Subjectively healthy without any serious disease

Exclusion criteria healthy individuals:

* Visible gait- or balance disturbance
* Dementia diagnosis
First Line Ovarian Cancer Treatment - Cohort Study

The French cooperative group GINECO proposes to implement an observational study to describe a real situation, in daily practice tolerance and methods of administration of bevacizumab (Avastin ®)

Population: Patients aged 18 years and older with an epithelial ovarian cancer, fallopian tube or primary peritoneal or witch it was decided to initiate a process comprising of Bevacizumab (Avastin ®) in first-line therapy

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and over,
* Patients with an epithelial ovarian cancer, fallopian tube or peritoneal who will receive bevacizumab (Avastin ®) in first-line therapy
* Patients should be informed of the study orally and should not have any objection their data to be processed.

Exclusion Criteria:

* Patient participation in a clinical trial
* Patient non-affiliated to a social security scheme.
Radiotherapy Vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma

Testicular tumors account for 1% of all cancers in males and germ cell tumors comprise 95% of all testicular cancers. Seminomas consist of around 50% of cases. However,adequate information is not there as 60- 80% residual disease is seen even after with the standard management of chemotherapy.

With the advent of functional imaging there was hope that it could aid in more accurately targeting these tumors to systematically evaluate the role of PET-CT imaging in identifying patients diagnosed with stage IIB-IIIC seminomatous germ cell tumor, with residual visible tumor post chemotherapy who would benefit with loco regional radiotherapy.

The therapeutic research in Seminomashas been relatively slow and such structured studies can allow analysis of large number of patients to report on acute and late effect of treatment outcomes using CTCAE and QOL (EORTC QLQ C-30) in these cancers. We hope that we will get help in identifying thrust areas for future research through this study.


Eligibility Criteria:
Inclusion Criteria:

1. Histological diagnosis of classical seminoma
2. Primary site - testis, mediastinum or retroperitoneum
3. Stage IIB-IIIC (AJCC 8th edition)
4. Age\>18 years
5. Karnofsky Performance Status at least 70
6. A response assessment FDG PETCT scan done at least twelve weeks after the first line chemotherapy, showing a persistent measurable residual mass
7. Patient willing and reliable for follow up and QOL.

Exclusion Criteria:

1. Histology other than classical seminoma
2. Non completion of planned first-line chemotherapy
3. Prior history of radiotherapy to the involved region
4. Inability to deliver adequate radiotherapy dose safely based on assessment by radiation oncologist
Cardiorespiratory Performance in Diabetic Elderly

OBJECTIVE: To analyze the influence of lipid control during a cardiorespiratory exercise test in two subgroups. DESIGN: Parallel trial study. PARTICIPANTS: The sample consisted of 40 elderly people, male and female, divided into two groups: 20 hypertensive (G1; 68.50 ±5.85 years) and 20 diabetic-hypertensive (G2; 68.95 ±6.79 years). MEASUREMENTS: Nutritional status; glucose and lipid controls - postprandial glucose (PPG), triglycerides (TG), total cholesterol (TC), low density lipoprotein (LDL-C), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C); blood pressure, and cardiorespiratory performance. The significance level was set at p\<0.05.


Eligibility Criteria:
Inclusion Criteria:

* 60-years-old or above
* diagnosis of hypertension and/or T2DM for at least 2 years
* member active of the hypertension and diabetes mellitus program
* be on optimized drug therapy for more than 3 months
* BMI above 22 kg/m²;
* no heart disease
* non-insulin-dependent,
* sedentary according to the International Physical Activity Questionnaire (IPAQ) and
* functionally independent.

Exclusion Criteria:

* ergospirometry interrupted by adaptive,
* hemodynamic, and electrocardiographic complications;
* respiratory exchange ratio (R) lower than 1.0 at the end of exertion,
* VE/VCO2 value higher than 34 in the first anaerobic threshold;
* chronic atrial fibrillation;
* neuromuscular,
* orthopedic,
* peripheral vascular,
* pulmonary diseases;
* myocardial infarction within 6 months;
* orthopedic limitation or musculoskeletal pain.
Treatment Outcome in CBT for Cocaine Use

Cognitive-behavioral treatments for cocaine abuse could be improved by an increased understanding of factors that predict treatment outcomes. The objective of this protocol is to conduct a study examining the impact of client characteristics on the effects of cognitive-behavioral therapy for cocaine abuse.

Study investigators will recruit treatment-seeking cocaine users (n = 100) from a separate protocol (#6912) who will receive a standard 12-week course of cognitive behavioral therapy for relapse prevention. Using a variety of self-report questionnaires and computer-based tasks, three major domains will be assessed and evaluated as predictors of treatment outcome: (1) impulsivity, (2) motivation to change, and (3) learning style. Measures of these factors will have been obtained in the #6912 protocol. A better understanding of the impact of impulsivity, motivation to change, and learning style on treatment outcome will provide critical information to guide the refinement of CBT for cocaine abuse. For example, the results of this study may help guide the development and introduction of more targeted cognitive remedial strategies or behavioral training components into the framework of evidenced-based practices. These additions may help ameliorate the deleterious effects of specific participant characteristics on the acquisition and implementation of coping skills, which can further improve the efficacy of CBT.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals age 18-60.
2. Currently report using cocaine via the intranasal or smoked route.
3. Be able to give informed consent and comply with study procedures.

Exclusion Criteria:

1. Individuals who meet current (i.e., within the past year) DSM-5 severe Substance Use Disorder (SUD) criteria (defined as the presence of 6 or more symptoms) for drugs other than cocaine, nicotine and caffeine.
2. Individuals who meet current (i.e., within the past year) DSM-5 moderate to severe Major Depressive Disorder criteria (defined as a score of 17 or higher on the Hamilton Depression Rating Scale).
3. Individuals who meet current DSM-5 criteria for any bipolar or psychotic disorder (other than transient psychosis due to drug use), or for all other psychiatric disorders not addressed by other exclusion criteria (e.g., anxiety disorders other than specific phobias, eating disorders, or ADHD) that require medical and/or psychological intervention.
4. Individuals with a neurodevelopmental disorder (e.g., Intellectual Development Disorder, Autism Spectrum Disorder) except ADHD.
5. Individuals with uncorrected visual or auditory deficits, or who cannot adequately read or understand the self-report assessment forms, or are so severely disabled they cannot comply with the requirements of the study.
6. Individuals with current suicidal risk.
7. Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program.
8. Individuals who are currently receiving any professional treatment (e.g., therapy, medication) for substance abuse problems outside of the current research protocol.