cyrilzakka/clinical-trials huggingface dataset:
Buprenorphine Versus Methadone Maintenance in Hepatitis C Patients Receiving Peg-Intron and Rebetol (Study P04279)(TERMINATED)

This randomized, single-center, controlled study is designed to evaluate the safety, tolerability, and efficacy of treatment with Peg-Intron with Rebetol in methadone or buprenorphine maintenance patients with hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with a history of intravenous drug abuse, who are willing to undergo methadone or buprenorphine substitution.
* Patients with newly diagnosed chronic hepatitis C.
* Age 18-65.
* Hepatitis C virus (HCV)-ribonucleic acid (RNA) positive in serum as measured by polymerase chain reaction (PCR) within the last 4 weeks.
* Genotype 2 or 3.
* Elevated alanine aminotransferase (ALT) levels.
* In women of child-bearing age, pregnancy must be excluded prior to entry into the study, and the use of a safe contraceptive device (intrauterine device, oral contraceptive, diaphragm + spermicide, condom + spermicide, tubal ligation) must be documented.
* Lab parameters:

  * Hemoglobin: \>=12 g/dL (women) or \>=13 g/dL (men)
  * Leukocytes \>=3,000/µL
  * Thrombocytes \>=100,000/µL
  * Prothrombin time (PT)/partial thromboplastin time (PTT)/coagulation within the normal range
  * Albumin: not more than 10% deviation from lower normal value
  * Thyroid-stimulating hormone (TSH) normal
  * Creatinine normal
  * Uric acid normal
  * Antinuclear antibodies \<=1:160
* Signed informed consent.

Exclusion Criteria:

* Refusal by women of child-bearing age or by sexually active patients to use a safe contraceptive.
* Breast-feeding women.
* Cirrhosis stage B and C according to Child-Pugh.
* Signs of decompensated liver disease (ascites, bleeding varices and spontaneous encephalopathy).
* Confirmed co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV).
* Existing psychiatric comorbidity.
* Alcohol abuse.
* Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma).
* Existing psoriasis or other dermatological disorder (relative exclusion criterion: due to great differences with regard to the severity of the disorder and the individual therapy compatibility, the therapy decision is at the discretion of the physician).
* Treatment with a study drug within the last 30 days.
* Any uncontrolled underlying medical conditions (e.g. diabetes).
* Clinically significant electrocardiogram (ECG) abnormalities and / or significant cardiovascular dysfunction within the last 6 months (angina, heart failure, recent myocardial infarction, severe hypertension or significant arrhythmia) is an exclusion criterion. In case of other suspected heart disease, a cardiologic examination is required prior to inclusion of the patient.
* Any liver disorder of other genesis than the study indication (with regard to elevated iron levels, only patients with manifest hemochromatosis are excluded).
* Autoimmune disorder (except LKM-positive patients: these patients may be included in the study).
* Misuse of buprenorphine or methadone.
Can Cervical Stiffness Predict Successful Vaginal Delivery After Induction of Labour?

The purpose of this study is to determine if a new antenatal test of cervical stiffness can be used to predict which patients will have a successful vaginal delivery following an induction of labour.

A licensed, CE-marked, vacuum-aspiration device called the Pregnolia system has been developed to give quantitative cervical stiffness index score during pregnancy. The CASPAR study will compare cervical stiffness scores to bishop's scores prior to induction of labour and correlate the results to the outcome of delivery.

CASPAR is a single site prospective, exploratory, cohort study of 100 women with singleton pregnancy undergoing induction of labour at the Liverpool Women's Hospital (LWH).

All eligible participants giving written informed consent will be asked to undergo a sterile speculum examination for cervical stiffness assessment, prior to routine vaginal digital examination for Bishop's score assessment. Participants will then proceed with their induction of labour as per the unit policy.

Once recruited the participants will remain in the study until after delivery and discharge from hospital for the mother and baby, or 1 month after delivery, whichever comes first. Outcomes will be collected from electronic records.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Being induced
* Singleton pregnancy
* Primiparous
* ≥37+0 weeks gestation
* Intact membranes
* Able to provide informed consent

Exclusion criteria:

* Previous cervical surgery
* Any cervical pathology at 12 o'clock position on cervix
* Vaginal bleeding evident on examination
* Visible, symptomatic cervical or vaginal infections
* Known congenital uterine anomalies
* Known or suspected structural/chromosomal fetal abnormality
* Known HIV
* Cervical carcinoma
Study to Evaluate the Efficacy, Safety, and Tolerability of PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED)

This is a Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing Motor Complications of Levodopa Therapy


Eligibility Criteria:
Inclusion Criteria:

* Between 35 and 85 years of age, inclusive, at the time of signing informed consent
* Diagnosed after the age of 30 years with idiopathic PD
* A documented medical history of idiopathic PD for at least 3 years
* Disease severity of 2 to 4 on the modified Hoehn and Yahr scale when in the OFF state
* Been treated with a stable regimen of levodopa-containing therapy
* Subjects must be receiving at least 3 doses per day of levodopa-containing therapy, and must be on a stable dose for at least 2 weeks for immediate-release levodopa or at least 6 weeks for prolonged-release levodopa preparations prior to the first screening visit
* Experienced LID over a period of at least 3 months prior to randomization
* If needed, in the opinion of the investigator, subjects must have a caregiver
* Female subjects will be women of non-childbearing potential

Exclusion Criteria:

* Patient is currently participating in or has participated in another study in the last 3 months
* Subjects with atypical, secondary, or drug-induced Parkinsonism
* Subjects with a history of dyskinesia that was exclusively diphasic, OFF state, myoclonic, dystonic, or akathetic without peak-dose dyskinesia
* Subjects with a MoCA score of \<25
* Subjects who have, or who had a history of, any clinically significant hepatic or gallbladder disorder, as determined by the investigator
* Subjects who have dementia, currently active psychosis, or hallucinations.
* Suicide attempt within 1 year prior to the first screening visit, or severe suicidal ideation within 6 months prior to the first screening visit
* Subject has a current diagnosis of epilepsy,
* Any known contraindication to the use of levodopa, including a history of malignant melanoma or a history of narrow-angle glaucoma
* Carcinoma or successfully treated squamous cell carcinoma of the skin and no sing of disease recurrence for at least 5 years
* Subjects who have had a clinically significant illness within 4 weeks before the first dose, as determined by the investigator
* Subjects with scheduled surgeries/hospitalizations during the study period
* Any advanced, severe, or unstable disease (other than PD) that may interfere with the primary and secondary study outcome evaluations
* Subjects who have undergone prior neurosurgical operation for PD,
* Subjects currently taking (or expected to be administered during the course of the study) any of the prohibited medications (amantadine, safinamide, dopamine-antagonists).
The Effects of Red Spinach Extract on Physical Performance Following Chronic Resistance Training in Trained Males

Red Spinach is a natural food which is a rich source of nitrates, which are beneficial in hemodynamics, cardiovascular function, and have natural hypotensive and antianginal effects . In recent research, Red spinach extract has been shown to be beneficial in acute exercise performance. However, currently it is unclear how these acute increases in performance may translate to long term training adaptations.

This research study is designed to measure the effects of red spinach extract (RSE) on markers of physical performance, body composition, and health following chronic resistance training and anaerobic exercise.

The investigators aim to measure muscle strength, athletic performance, body composition, and muscle size in two groups of adults before and after 11 weeks of intervention in a randomized, double blinded study. One group (n=15 ) will receive an intervention of resistance exercise and a Red Spinach Extract supplement, and the other group (n=15) will receive resistance exercise and a placebo (maltodextrin).

Eligibility Criteria:
Inclusion Criteria:

* 18-35 years old
* At least 1 year of resistance training experience
* Are free of musculoskeletal injuries
* Are not taking medications that may interfere with study measurements

Exclusion Criteria:

* Participant that cannot take either the RSE or placebo supplement will be excluded, as this will be a double-blind study.
* Furthermore, participants that cannot participate in pre- and post-research testing, and/or those that cannot commit to regular training sessions will be excluded.
* Inability to perform physical exercise (determined by health and activity questionnaire)
* Taking any other nutritional supplement or performance enhancing drug.
* Any chronic illness that causes continuous medical care.
Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension

The purpose of this study is to determine if there is greater blood pressure reduction using ramipril or hydrochlorothiazide alone or ramipril and hydrochlorothiazide together.


Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed, or newly diagnosed essential hypertension. Blood pressure must be within a minimum and maximum range prior to drug treatment.

Exclusion Criteria:

* Inability to discontinue all prior antihypertensive medications
* Heart failure
* History of stroke, myocardial infarction, or chest pain within 3 years, or an abnormal heart rhythm
* Liver or kidney disease
* Certain drugs used to treat other conditions like an enlarged prostate gland, or arthritis
* Allergy or reactions to certain medications used to treat high blood pressure

Other protocol-defined inclusion and exclusion criteria apply.
Spanish Atrial Fibrillation And Resynchronization Study

The aim of the present study is to compare the response to cardiac resynchronization therapy (CRT) in patients with chronic advanced heart failure and permanent atrial fibrillation (AF) depending on atrio ventricular junction (AVJ) is ablated or not.

Cardiac resynchronization therapy (CRT) improves the functional capacity and the quality of life and reduces the mortality of patients with dilated cardiomyopathy, low ejection fraction and wide QRS.

Only 2% of patients included in CRT randomized trials were in AF.

To obtain a good response to CRT, percentage \>90% of ventricular pacing must be obtained.

Based on observational studies, current guidelines of CRT recommend the atrio ventricular junction (AVJ) ablation in those patients with permanent atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

* Dilated cardiomyopathy (LVEDD \>56 mm)
* wide QRS (\> 120 msec)
* NYHA III-IV
* EF\<35%
* Permanent AF
Anesthetic and Perioperative Risk Assessment Before Programmed Surgery: Anesthetic Teleconsultation Versus Face-to-face Anesthesia Consultation.

The anesthesia safety decree made it compulsory in 1994 to carry out a pre-anesthesia consultation before any operative or interventional act. With the inclusion of telemedicine in the Public Health Code then the publication of Addendum 6 in 2018 and finally the derogatory decree in March 2020, it is possible to perform and bill for pre-anesthesia consultation via telemedicine.

The consultation is always followed by a pre-anesthetic visit upon admission of the patient the day before or the day of the operation to verify the information recorded during the consultation and the patient's state of health. This identifies elements omitted during the pre-anesthesia consultation (face-to-face or remotely) and reduces the risks of potential postponement.

The study investigators hypothesize that there would be no difference in the quality of the information given, the collection of medical, paramedical and medication elements and the evaluation of the operative risk in anesthesia consultation via teleconsultation versus face-to-face. The critical points are the medication reconciliation of the patient's treatments, the overall assessment of the operative risk and anticipated difficulty of access to the airways (mouth opening: ≥ or \<35 mmm).


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Patient with scheduled surgical intervention (outpatient or hospitalization) at the Nîmes University Hospital requiring a preoperative anesthesia consultation.
* Patient with computer equipment at home allowing the use of the Téléo software (computer equipment with web cam, audio and microphone or smartphone).

Exclusion Criteria:

* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient who has already had an anesthesia consultation for surgery within the previous 6 months.
* Emergency or radiology and / or interventional surgery (eg. gastroscopy, biopsy under scanner, etc.).
Football 4 Health in Middle-aged to Older Adults

Ageing in humans is accompanied by a progressive decline in lower-limb muscle power production. In addition to a decline in musculoskeletal fitness, ageing is associated with a reduction in cardiovascular and metabolic fitness. Therefore, if exercise interventions aim for a high impact on the overall health status of middle-aged and older adults, they should combine endurance, high-intensity interval training and muscular strengthening activities. Recreational football training combines all these training components, which implies that it could constitute an adequate training modality for participants of all ages. What remains to be investigated in more detail, is whether recreational football training can improve muscle power production in middle-aged to older adults and whether this potential improvement is present across the full force-velocity (F-V) profile. Next to a detailed analysis of the leg-extensor F-V profile as primary outcome, simultaneous effects on functional capacity, body composition and endurance exercise capacity were investigated. In addition, feasibility and the physical demands (internal and external load indicators) of the training program were tracked throughout the intervention period.


Eligibility Criteria:
Exclusion Criteria:

* Unstable cardiovascular disease
* Neurological disorders
* Cognitive malfunctioning
* Acute infections or fever
* Severe musculoskeletal problems
* Systematic engagement in (resistance) exercise in the 12 months prior to participation
Ambulatory vs Office BP Management Usual Care for Diagnosing and Managing Hypertension: A Pilot Study

The purpose of this study is to compare the effectiveness of ambulatory blood pressure monitoring to usual care (blood pressure measurement in the office) in diagnosing and managing hypertension.

The usual strategy for detecting hypertension-repeated office blood pressure (BP) measurements-is inefficient and inaccurate. When paired with ambulatory BP monitoring (ABPM), which takes a multitude of measurements over 24 hours, it is clear that office BP measurements may convey a falsely positive diagnosis known as white-coat hypertension. What is less well-known is that office BP measurements may also convey a falsely negative diagnosis termed masked hypertension (MH). That is, office BP may measure as normal, yet 24-hour ambulatory measurements show elevated BP. People with MH have cardiovascular risk that is similar to that of people with diagnosed hypertension, yet MH goes unrecognized, and therefore, untreated. Ultimately, identifying the best strategy for accurately detecting hypertension is vital to improving overall BP control and reducing cardiovascular events. Without a feasible ABPM strategy, MH will continue to go unrecognized and untreated.

Participants enrolled in the study will be randomized to either the usual care group or the ABPM-guided group. All participants will have a baseline ABPM. ABPM will be used to make a diagnosis and determine anti-hypertensive treatment in the ABPM-guided group only. Participants in the ABPM-guided group will have a follow-up ABPM in 2 months. All participants will have a final ABPM 4 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 30 years and ≤ 65 years
* Most recent (within 14 days) clinic systolic BP 126-150 mm Hg
* Able/willing to wear a BP monitor for 24 hours on multiple occasions
* Able/willing to take daily anti-hypertensive medication if indicated
* Able to read and speak English

Exclusion Criteria:

* Pregnant or trying to become pregnant
* Known heart disease
* History of persistent atrial fibrillation
* Currently taking antihypertensive medication
* Currently taking Simvastatin \> 20mg daily
* Clinician recommends against participation
Intensive Self-care on Glycemic Control in Outpatients With Type 2 Diabetes Mellitus: The Diabetes Care (D-CARE) Study

Type 2 diabetes mellitus (T2DM) leads to a high burden of morbidity and mortality, usually attributable to cardiovascular (CVD) causes. A major concern about the disease is that the success of the treatment is highly dependent on self-management, which very often incurs the necessity of behavior change. However, modifying such behaviors, usually linked to daily-life activities, is challenging. Then, the investigators aimed to test the optimal self-management that could be achieved in a reasonable manner carried forward through the Prochaska and DiClemente behavior-changing strategy in a follow-up of 18 months, compared to usual care. Our primary outcome is the between-group difference in HbA1c (%) levels.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients diagnosed with type 2 diabetes mellitus - T2DM (HbA1c % - ≥ 6.5%, or taking at least one oral hypoglycaemic agent, or medical diagnosis);
* To be regularly assisted by the Sistema Único de Saúde and to have been saw at least one year before randomization;
* Readiness for behavior-changing within the pre-action stages: pre-contemplation, contemplation and preparation;
* T2DM patient of challenging handling (e.g., frequent hypoglycaemic seizures, cardiovascular disease (CVD), etc.);

Exclusion Criteria:

* Pregnant women;
* People living with HIV/AIDS;
* T2DM patients taking erythropoietin, recent blood loss, recent blood transfusion and severe anaemia;
* T2DM patients with CVD under non-optimized treatment; or those that made any CVD procedure; or CVD event (e.g., myocardial infarction) within three months before randomization;
* T2DM patients with severe eye and retine disease;
* Patients participating in another study simultaneously;
* Patients living with others in the same place.
Cognitive and Aerobic Resilience for the Brain

This is a randomized controlled trial (RCT) of the effectiveness of cognitive and exercise training versus control condition on cognitive function in older adults with mild cognitive impairment (MCI).

Exercise and cognitive training hold promise for delaying progression of MCI. Exercise improves cognitive ability, brain function, and brain structure in older adults. Cognitive training has been shown to durably improve mental abilities and functional status in older adults. In addition, persons with MCI respond to some forms of cognitive training just as robustly as healthy older adults.

This pilot study is a 4 group design with a home-based multi-modal physical exercise intervention, cognitive training, combined cognitive and physical training, and a social contact control enrolling older adults with MCI.

This pilot study is designed to be consistent with current recommended approaches to establishing trial feasibility. If the aims are achieved, it will provide a conceptual and practical rationale to support a large, multi-site, randomized clinical trial to test the efficacy of combined physical and cognitive training in delaying time to a clinical diagnosis of dementia.

Eligibility Criteria:
Inclusion Criteria:

* subjective memory complaint
* minimal impairment in daily function per Functional Activity Questionnaire (FAQ)
* sedentary
* English speaking
* access to telephone

Exclusion Criteria:

* dementia or Alzheimer disease
* stroke, past 12 months
* myocardial infarction, past 12 months
* angina
* Parkinson disease
* multiple sclerosis
* epilepsy
* AIDS
* brain tumor, infection, or surgery
* brain injury with \> 30 minute LOC
* schizophrenia
* bipolar disorder
* cancer with short life expectancy
* current chemotherapy or radiation therapy
* depression
* alcohol consumption ≥ 8 drinks per week for women, or ≥15 drinks per week for men
* prescription of Aricept or Namenda, past or present
* self-reported difficulty reading a newspaper (low visual acuity)
* low hearing or communicative ability (examiner-rated) that would interfere with interventions and outcome assessments
* prior involvement in similar cognitive training studies, programs, or online training
* prior use of online brain training or brain fitness programs
* unable to pass the Exercise Assessment and Screening for You (EASY)
* living in nursing home
* scheduling conflicts with intervention schedule
* unwilling to use a computer or be on video conferencing
* Baseline blood pressure of Systolic \> 180
* Baseline blood pressure of Diastolic \> 100
* Baseline pulse of \< 40 or \> 100
* unable to provide informed consent
Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus

Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.

1. Subjects completing Day 169 (24 weeks) on study medication may be eligible to enter an optional LTE period
2. The LTE period will remain blinded but will no longer have a placebo arm:

   * Subjects will remain on their originally assigned treatment arm unless they were on placebo
   * Subjects initially randomized to placebo arm will be automatically re-randomized into one of the existing active arms at Day 169 (24 weeks)

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Male or female aged between 18 to 70 (included)
* Diagnosed with active systemic lupus erythematosus by a doctor
* Disease must be in patient's joints or on the skin at a minimum
* Taking other medications is allowed but some are excluded

Exclusion Criteria:

* Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis
* Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus