cyrilzakka/clinical-trials huggingface dataset:
A Study on the Interaction Between Danoprevir/Ritonavir and Methadone

This multicenter, open-label study will assess the effect of multiple doses of danoprevir/ritonavir on steady-state pharmacokinetics of methadone. Subjects on stable methadone maintenance therapy (20 - 120 mg daily as single oral morning dose) will receive danoprevir 100 mg orally twice daily and ritonavir 100 mg orally twice daily for 10 days.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults, 18 - 65 years of age, inclusive
* Subjects must be on a stable methadone maintenance regimen (20 to 120 mg/day) for the treatment of opiate addiction for at least 30 days prior to screening and should be on a stable dose for at least 14 days prior to Day -1
* Body weight \>/= 50 kg
* Body mass index (BMI) 18.0 - 32.0 kg/m2
* Females of childbearing potential and males with female partners of childbearing potential must agree to use 2 forms of non-hormonal contraception during the study and for 90 days after the last study drug administration

Exclusion Criteria:

* Pregnant or lactating women and male partners of women who are pregnant or lactating
* Symptoms of methadone withdrawal at screening, on Day -2 or Day -1
* Inadequate venous access
* History or evidence of any clinically significant disease or disorder, except for drug abuse or dependence
* Positive test for alcohol or drugs of abuse at screening and up to Day -2 (with the exception of methadone)
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol); alcohol consumption will be prohibited during study confinement and for at least 48 hours before screening, dosing and each scheduled visit
* Positive for hepatitis B, hepatitis C or HIV infection
Desmopressin Acetate 0.2 mg Tablets, Fasting

The objective of this study was to compare the single-dose relative bioavailability of TEVA and Aventis Pharmaceuticals (DDAVP®) 0.2 mg desmopressin acetate tablets following a 0.8 mg dose under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult non-smoker (for at least 3 months) or light smoking (less than 10 cigarettes per day for at least 3 months) male or female subjects, 18-55 years of age;
* Weighing at least 60 kg for males and 52 kg for females;
* Subjects who had a body mass index (BMI) less than 30;
* Medically healthy subjects with clinically normal laboratory profiles and ECGs;

Females of childbearing potential should have either been sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or have been using one of the following acceptable birth control methods:

* surgically sterile (tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum. Proof was required for the hysterectomy and oophorectomy;
* IUD in place for at least 3 months;
* barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study;
* surgical sterilization of the partner (vasectomy for 6 months minimum);
* hormonal contraceptives for at least 3 months prior to the first dose of the study.

Other birth control methods were deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years were eligible.

* Voluntarily consent to participate in the study.

Exclusion Criteria:

* Female subjects who were pregnant or lactating.
* Subjects who had been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
* Any clinically significant illness within 4 weeks prior to dosing.
* Subjects with any medical condition requiring regular treatment with prescription drugs.
* The use of any pharmacological agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose.
* Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood and/or plasma in 14 days; 1500 mL of blood and/or plasma in 180 days; 2500 mL of blood and/or plasma in 1 year.
* Subjects who had donated plasma within 30 days prior to the first dose.
* Subjects who ahd participated in another clinical trial within 30 days prior to the first dose.
* Subjects who did not tolerate venipuncture.
* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.

In addition, the history or presence of:

* hypersensitivity or idiosyncratic reaction to desmopressin or any other synthetic anti-diuretic hormones;
* type IIB von Willebrand's disease;
* personal or family bleeding disorder;
* alcoholism or drug abuse within the past year.
Electroacupuncture for Chronic Neck Pain

Objective: The primary objective of this study is to evaluate the long-term efficacy of electroacupuncture for chronic neck pain. The secondary objective is to document any possible side effects of acupuncture.

Design and Subjects: Prospective, randomised controlled trial comparing the outcomes of treatment and placebo interventions. Subjects are 200 adult patients with chronic mechanical neck pain.

Setting: Outpatient clinics.

Interventions: Patients will be randomly allocated to one of the two groups receiving either: electroacupuncture (real treatment) or placebo (sham laser acupuncture). Each treatment will last for 45 minutes. Each patient will receive a total of nine treatments (three times per week for three weeks).

Main outcome measures:

Primary outcome measures: Neck pain disability index (Northwick Park Neck Pain Questionnaire).

Secondary outcome measures: Maximum pain related to motion on visual analogue scale. Quality of life (SF-36). Use of medication. Sick leave because of neck pain. Treatment-related adverse effects, such as pain, skin irritation, bleeding and dizziness, will also be assessed.

Assessments will be made before treatment, one month, three months and six months after the treatment course. The credibility of placebo treatment will also be assessed.

Expected results: We expect that patients in the treatment group will have significant improvements on primary and secondary outcome measures, when compared with patients in the inert placebo group.

Conclusion: This study will provide credible evidence regarding whether electroacupuncture is effective in reducing chronic neck pain. Patients, healthcare professionals, and government policy makers can make use of this information to improve clinical outcomes and reduce costs


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female subjects age above 18 with mechanical neck pain for over three months.

Exclusion Criteria:

* Patients who have received acupuncture treatment for any purpose in the last 6 months.
* Patients who will be unlikely to attend all treatment sessions.
* Patients with systemic diseases, such as diabetes or cardiovascular disorder.
* Patients with a history of traumatic injury of the neck or upper back from T1-T6, precious fracture or surgery to the neck, neurological deficits (e.g., muscle weakness or changes in spinal reflex jerks), a history of malignancy, congenital abnormality of the spine, or systemic bone and joint disorders (e.g., RA).
* Patients who are seeking compensation for neck-related condition.
* Patients who have needle phobia.
* Pregnant and breast feeding women.
Preeclampsia Associated Vascular Aging

To evaluate cardiovascular health, especially endothelial health, of women after pre-eclampsia compared to women without pre-eclampsia, and to compare women who had taken PETN during pregnancy with women who had not attempted treatment

The clinical observation that women with pre-eclampsia have a high risk of early onset cardiovascular disease with increased disease-associated mortality has led to the hypothesis that the endothelial status of these women is characterized by early onset of aging. We want to investigate the relationship between endothelial aging and pregnancy disorders such as pre-eclampsia, which are dominated by endothelial dysfunction. Do endothelial changes precede pregnancy and cause pre-eclampsia and later accelerated cardiovascular aging, or does pre-eclampsia trigger premature endothelial aging in affected individuals for the first time? The aim of this study is to investigate the cardiovascular health of women 10 to 20 years after pre-eclampsia and to compare it with that of women with uneventful pregnancies. In addition, the potential long-term endothelial protective effect of the NO-donor pentaerithrityltetranitrate (PETN) is investigated.

This in vivo study will be extended in vitro by the analysis of senescence induction in endothelial cells after pre-eclampsia associated stress. Additionally, the potential protective effect of PETN on stress-induced senescence will be evaluated.

The ultimate goal is to establish a prospective long-term study on the effect of PETN on vascular health in women with pre-eclampsia to assess whether treatment of endothelial dysfunction during pregnancy could reduce endothelial aging and thus premature cardiovascular morbidity and mortality in millions of women.

Eligibility Criteria:
Inclusion Criteria:

* Participants of the PETN pilot study from 2002-2008
* controls: uneventful pregnancies from 2002-2008
* Patients with pre-eclampsia with PETN treatment 10-20 years ago
* Controls: patients with pre-eclampsia without PETN treatment 10-20 years ago
* Written Informed Consent
* Singleton pregnancy

Exclusion criteria:

* Patients who refuse to participate in the study
* Impossibility of the outpatient presentation
Comparison of Different Types of Prosthetic Foott

The main purpose of this study is to determine the experiences of patients with different types of prostetic feet (carbon, hydraulic or microprocessor controlled).

One of the main goals in the rehabilitation of amputees is to provide optimal and natural ambulation. For this purpose, suitable socket-suspension type, appropriate knee joint and foot should be prescribed. In the selection of feet, the age, occupation, characteristics of the geographical region, mental status and activity level should be considered. In addition, the previous prosthesis experience of the people should definitely be taken into account during prosthesis prescribing.The main purpose of this study is to determine the experiences of patients with different types of prostetic feet (carbon, hydraulic or microprocessor controlled).

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-65 years
* Lower limb amputation
* Having used at least 2 different foot types (carbon, hydrolic, microprocessor-controlled)

Exclusion Criteria:

* Having used the single type of foot until now
* Presence of neurological, cardiovascular, and pulmonary disease that may affect walking performance
Effects of Soluble Phosphate in Humans

The study was conducted to investigate the effect of soluble phosphate in combination with different calcium doses on calcium and phosphorus metabolism and further physiological parameters in healthy subjects. The main aim of the study is to investigate the influence of a soluble phosphate supplementation on the fasting blood phosphate concentration and the dependency of an additional calcium intake.


Eligibility Criteria:
Inclusion Criteria:

* age between 18-60 years
* physical health

Exclusion Criteria:

* postmenopausal women
* kidney diseases
* diabetes mellitus
* metabolic diseases
* osteoporosis
* intake of dietary supplements
* pregnancy and lactation
Budesonide / Formoterol in Treatment of Exacerbations of COPD

The purpose of this study is to determine whether the budesonide+formoterol combination is effective in the treatment of exacerbations of COPD with a main emphasis on investigating the effects on inflammation and a secondary emphasis on clinical efficacy


Eligibility Criteria:
Inclusion Criteria:

* smoking-induced COPD according to ATS criteria
* FEV1 \<85% of predicted at enrolment and \<70% of predicted but \> 0.7 Liter at Exacerbation
* FEV1/IVC ratio \<88% of predicted for men and \<89% for women

Exclusion Criteria:

* history of asthma
* known hypersensitivity to the study drugs
* serious concomitant diseases
* pregnancy or lactating
* abnormal Chest X-ray or blood gasses
Evaluation of Horizontal Bone Gain in the Lower Posterior Partially Edentulous Patient Comparing the Stabilization of Membranes With and Without Tacs

To address the gap of knowledge in comparing between the bone augmentation outcomes with or without tacks for membrane stabilization


Eligibility Criteria:
Inclusion Criteria:

* Patients with at least 1 missing tooth in the posterior mandibular area Patients with an age above 18 years Systemically healthy patients

Healed alveolar ridge for implant placement with:

* Deficient buccolingual dimension ( ≤5mm)
* Sufficient vertical height (≥ 10 mm)
* Sufficient mesio-distal width (≥ 6.5 mm) Inter-arch space ≥ 7 mm to allow space for implant-supported crown Presence of neighboring and opposing dentition Soft tissue phenotype with keratinized tissue width (KTW) (≥2 mm) and gingival thickness (≥2 mm) Good oral hygiene Cooperative patients who accepted the trial follow up period and sign the informed consen

Exclusion Criteria:

* Systemic diseases or medications that might affect bone metabolism, increase surgical risk or complicate post-operative healing Untreated periodontal diseases History of radiation therapy to the head and neck Heavy smokers (≥ 10 cigarettes per day) Pregnant or lactating females Alcoholism or drug abuse Psychiatric problems Patients with signs of acute infection related to the area of interest
Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis

A multicenter, prospective, non-randomized, single-arm observational study evaluating the Providence nighttime bracing system in patients diagnosed with adolescence idiopathic scoliosis.

This study is designed as a multicenter, prospective, non-randomized, single arm observational study. A temperature probe and data logger will be attached to the Providence brace to monitor patient compliance wear time. Subjects will be blinded to temperature sensor readings to maximize objectivity of brace wear.

Eligibility Criteria:
Inclusion Criteria:

* Subject/guardian is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form;
* Clinical/radiographic diagnosis of adolescence idiopathic scoliosis;
* Male/female;
* Skeletally immature (Risser grade 0, 1, or 2);
* Cobb angle between 25-40 degrees;
* Pre-menarchal or post-menarchal by no more than 1 year at the time of diagnosis;
* Curve apex caudal to T6 vertebrae;
* Physical and mental ability to adhere to bracing protocol;
* Have agreed to refuse participation in another clinical trial for the duration of the study.

Exclusion Criteria:

* History of previous surgical intervention or other invasive treatment for AIS;
* History of orthotic treatment or other brace wear for the treatment of AIS;
* Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature;
* Tumor or malignant tumor in the spine;
* Inability to communicate clearly in the English language;
* Subjects with a Risser score ≥ 3;
* Plans to relocate within the next 2 years;
* Any subject the Principle Investigator deems as an unfit candidate.
Problematic Use and Addiction in Primary Care

The morbi-mortality and social cost of addictive disorders led the French authorities to set up a government plan in 2018 to combat drugs and addictive behavior (Interministerial mission to combat drugs and addictive behaviour - (MILDECA)). In particular, it encourages early detection, which is the first stage in a validated global approach to the management of addictive disorders. Improving early identification of addictive disorders in primary care would reduce morbidity and mortality and improve quality of life for patients with addictive disorders. The identification of use disorders should be systematic in primary care and was the subject of a recommendation in 2015. Numerous tests are cited in these recommendations, but few have actually been validated in primary care, and none has been shown to be feasible. For example, only 23% of GPs claim to systematically identify alcohol consumption.

Other primary care professionals (physiotherapists, nurses, midwives, dentists, pharmacists) also have a role to play in identifying addictive disorders. The evolution of their respective professions (delegation of tasks, creation of the profession of advanced practice nurse, medical assistants) and the recent reorganization of the practice framework, both in terms of practice structures and professional community organizations, involve them in a global multidisciplinary collaboration on patient care, particularly in the early identification of addictive disorders.

The hypothesis is that the difficulties in implementing tests to identify addictive disorders in primary care are linked to the lack of specific consideration of the needs of primary care patients and caregivers.

The overall aim of the study is to improve the early detection of addictive disorders through brief training for primary care healthcare professionals.

The project comprises three successive stages:

1. Design a training program with content tailored to primary care professionals;
2. Evaluate the feasibility and acceptability of the training;
3. Evaluate the implementation of this training program by comparing the incidence of addiction disorder detection by primary care professionals between a trained and an untrained group.

Eligibility Criteria:
Inclusion Criteria:

* be a primary care professional (physiotherapists, nurses, midwives, dentists, pharmacists, General practitioner)
* in ambulatory practice. Recruitment will be carried out with the help of territorial professional health communities, to include practitioners practicing in conditions representative of the diversity of primary care practice.

GPs agreeing to take part will be divided into a control group and an intervention group, by drawing lots.

Exclusion Criteria:

* Refusal to participate.
* The same participant may not be included in more than one stage.
Machine Learning Ventilator Decision System VS. Standard Controlled Ventilation

Ventilator-induced lung injury is associated with increased morbidity and mortality. Despite intense efforts in basic and clinical research, an individualized ventilation strategy for critically ill patients remains a major challenge. However, an individualized mechanical ventilation approach remains a challenging task: A multitude of factors, e.g., lab values, vitals, comorbidities, disease progression, and other clinical data must be taken into consideration when choosing a patient's specific optimal ventilation regime. The aim of this work was to evaluate the machine learning ventilator decision system, which is able to suggest a dynamically optimized mechanical ventilation regime for critically-ill patients. Compare with standard controlled ventilation, to test whether the clinical application of the machine learning ventilator decision system reduces mechanical ventilation time and mortality.


Eligibility Criteria:
Inclusion Criteria:

1. only the first ICU stay was eligible;
2. adults ≥ 18 years of age on ICU admission;
3. estimate mechanical ventilation time ≥24 hours;
Appalachian Partnership to Reduce Disparities (Aim 2)

By combining two strategies (i.e., peer navigation and mHealth) into a complete, culturally compatible, bilingual intervention to increase the use of needed HIV, STI, and HCV prevention and care services among racially/ethnically diverse GBMSM and transgender women in rural Appalachia.

Study Investigators anticipate that participants in the intervention group, relative to counterparts in the delayed-intervention group, will demonstrate increased HIV, STI, and HCV testing.

This CBPR study will advance prevention science and practice through testing an innovative intervention to promote and support the use of needed HIV, STI, and HCV prevention and care services among GBMSM and transgender women; and developing priorities and recommendations to improve their health that will be disseminated to inform public health practice, research, and policy. By integrating peer navigation and mHealth strategies, the proposed study provides a unique opportunity to improve health among vulnerable, hidden, and neglected populations living in rural Appalachia. Findings from this research may inform strategies and approaches to address other health disparities in other rural populations.

Eligibility Criteria:
Inclusion Criteria:

* reside in one of the rural Appalachian catchment countiesreside in one of the rural Appalachian catchment counties
* be ≥18 years of age
* report being assigned male sex at birth and having had sex with at least 1 man in past 12 months
* provide informed consent
Efficacy of Black Seed Oil in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to determine the effect of black seed oil on markers of endothelial dysfunction in patients with type 2 diabetes mellitus .Also, to investigate its effect on glycemic control ,lipid profile and quality of life of those patients .


Eligibility Criteria:
Inclusion Criteria:

1. Age: adult patients with more than or equal 18 years old.
2. Previous diagnosis of Diabetes mellitus type 2 according to American Diabetes Association Criteria (ADA).
3. Approval to participate and give informed consent.

Exclusion Criteria:

1. Unstable coronary artery disease, cardiac arrhythmia or congestive heart failure.
2. Uncontrolled hypertension or recent stroke.
3. Chronic kidney disease or chronic liver disease.
4. Intake of black seed oil during the previous two months or any other antioxidant.
PRP Injections for Genitourinary Syndrome of Menopause

Platelet-rich plasma (PRP) is autologous blood which has been centrifuged to separate the supernatant resulting in a solution with high concentration of platelets. Injection of PRP stimulates cell growth and can has been proven safe and effective for uses in orthopedics, dermatology, and gynecology. Despite the relative paucity of data, the use of PRP as a therapy for sexual dysfunction and genitourinary symptoms in the setting of menopause has been patented as the O-Shot and V-Shot. This is a single-blinded randomized control trial to determine if PRP injections into the anterior vaginal wall improve sexual functioning in women diagnosed with the genitourinary syndrome of menopause (GSM) characterized by vaginal dryness/irritation.


Eligibility Criteria:
Inclusion Criteria:

* Women (assigned female at birth) at least 18 years old with a clinical diagnosis of GSM
* Sexually active with at least one episode of sexual activity per week in the preceding 4 weeks defined as follows: Partnered or solo penetrative or non-penetrative stimulation of the clitoris or vagina
* English-speaking
* Willingness and able to comply with the study requirements

Exclusion Criteria:

* Symptomatic pelvic organ prolapse protruding beyond the hymen)
* History of prior vaginal mesh or midurethral mesh sling surgery
* History of pelvic radiation or genital tract malignancy
* Current symptomatic pelvic organ prolapse (stage II or greater)
* Active vulvar dermatoses or genitourinary infection
* Unable to hold anticoagulation
* Hormonal replacement therapy (systemic, local, or vaginal) within 3 months of participation
* Pregnancy or pre-menopausal status