cyrilzakka/clinical-trials huggingface dataset:
Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days' Gestation in Kazakhstan

The study will be conducted in 4 sites and will examine how a simplified outpatient medical abortion procedure using mifepristone and misoprostol, with the option to take mifepristone at a place of woman's choosing, works in Kazakhstan. The investigators intend to demonstrate the efficacy of oral administration of 200 mg mifepristone and sublingual administration of 600 µg misoprostol with gestations through 70 days, as well as the acceptability of this method. Research questions include:

1. What is the efficacy of regimen of 200 mg mifepristone, followed 24 to 48 hours later by 600 µg sublingual misoprostol and used in gestations of up to 70 days?
2. Is medical abortion procedure consisting of two visits acceptable to women in Kazakhstan?
3. Are the side effects associated with sublingual use of misoprostol acceptable to women?
4. When given a choice, do women prefer to take mifepristone in the clinic or at a place of their choosing?


Eligibility Criteria:
Inclusion Criteria:

* Have an intrauterine pregnancy consistent with gestational age less than 71 days;
* Be able to understand and willing to sign a consent form;
* Be eligible for medical abortion according to the clinician's assessment;
* Be able to return to the clinic and able to contact study staff or emergency medical services, if needed;
* Be willing to provide an address and/or telephone number for purposes of follow-up;
* Agree to comply with the study procedures and visit schedule.

Exclusion Criteria:

* Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
* Chronic renal failure;
* Concurrent long-term corticosteroid therapy;
* History of allergy to mifepristone, or misoprostol or another prostaglandin;
* History of hemorrhagic disorders or concurrent anticoagulant therapy;
* History of inherited porphyrias;
* Intrauterine device in place (must be removed before mifepristone is administered).
Capsaicin for Post-stroke Dysphagia

Randomised, double blind, Phase 2 Trial to evaluate the efficacy of oral Capsaicin in patients with post-stroke dysphagia in the (sub-)acute setting.

After inclusion and the assessment of the swallowing function (PRESS, PAS, FOIS, FEES) patients will be randomised 1:1 to receive 1mcg Capsaicin or Placebo. Oral treatment will be applied 3 times daily either during meals or during regular swallowing tests/trainings accompanied by a Speech Language Pathologist. After re-assessment of the dysphagia after 7 days, patients with persistent dysphagia and applicable for further treatment will be treated for another 23 days with a final clinical swallowing evaluation after a total of 30 days. A Patient Medication Diary will used during the Duration of the Trial to capture compliance.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic Stroke
* Impairment of oral intake with FOIS ≤ 4
* Magnetic Resonance Imaging of the brain or CT scan with the finding of a subacute ischemic stroke
* Informed Consent within 48 hours after admission, following initial swallowing assessment

Exclusion Criteria:

* Diagnosis other than ischemic stroke
* Late patient admission \>48 hours after stroke onset
* Impairment of functional oral intake scale ≥ 5
* FEES \>72h after admission
* PAS \<2
* Pre-existing dysphagia
* Dysphagia due to other cause
* No evidence of stroke on imaging
* Recurrent stroke = at least one stroke in the course of the study apart from the index stroke
* Age \<18 years
* Current drug abuse
* Amphetamine or amphetamine-like Medication
* Regular oral treatment with chilli pepper extract
* Allergies or known adverse reactions to the consumption of chilli pepper or capsaicin
* Personality disorder
* Severe dementia or delirium
* Other reasons according to physician/investigator because of which the patient cannot participate in the study (not suitable for treatment or examinations)
* withdrawal of consent by participant at any time of the study
Treatment of Suicidal Ideation With Intravenous Ketamine Infusion

This study is dedicated to achieving better treatments for suicidal thoughts. Specifically, the investigators are studying the effect of a medication called ketamine to quickly treat suicidal thoughts and depression.

This study is dedicated to achieving better treatments for suicidal thoughts. Specifically, we are studying the effect of a medication called ketamine to quickly treat suicidal thoughts and depression. Patients will be asked to participate in a research study to study how the use of a medication, ketamine, decreases your suicidal thoughts and improves their symptoms of depression. Ketamine is approved by FDA for use at higher doses in anesthesia, and recent clinical research suggests that it might benefit patients with major depressive disorder and suicidal thoughts. During clinical trials with over 10,000 patients, ketamine was proved to be safe as an anesthetic and studies with hundreds of patients with depression have demonstrated safety and lack of lasting side effects. This is a pilot study to test a new use of ketamine: treatment of suicidal thoughts. The study medication will be given in addition to usual psychiatric care.

Eligibility Criteria:
Inclusion Criteria:

1. Age : 19-64
2. Significant suicidality score on the Columbia Suicide Severity Rating Scale (C-SSRS)
3. Willing and able to provide informed consent.
4. Individuals with current substance abuse are allowed

Exclusion Criteria:

1. Pregnant or lactating; women of reproductive potential must have a negative urine pregnancy test (urine dipstick method)
2. Post-Partum state : defined as being within 2 months of delivery or miscarriage
3. Homicide risk as determined by clinical interview
4. Treatment with any medication known to specifically target the glutamate-NMDA receptor system (ie lamotrigine, acamprosate, memantine, riluzole or lithium)
5. Any known hypersensitivity or serious adverse effect associated with ketamine treatment.
6. Any clinically significant medical condition or therapy that would preclude treatment with ketamine, to include recent myocardial infarction or unstable angina
7. Medically unstable, including acute withdrawal from alcohol or benzodiazepines requiring the use of benzodiazepine treatment.
8. Any of the following DSM-IV diagnoses or categories:

   * Any current psychosis or history of a non-mood psychotic disorder (e.g., schizophrenia)
   * Currently in a manic or mixed episode
   * Current use (defined by urine dipstick test) or abuse of hallucinogenic drugs (except marijuana) such as phencyclidine
   * Any dissociative disorder
   * Any pervasive developmental disorder (e.g., autism)
   * A cognitive disorder (e.g., Alzheimer's Disease)
   * Cluster A personality disorder (e.g., schizoid or schizotypal); note that cluster B and C personality disorders may be included
   * Any eating disorder
Hypertonic Saline for MAC

The MAC-HS study is a testing whether hypertonic saline helps improve symptoms and clearance of mycobacteria in patients with M. avium complex lung infections.

The MAC-HS study is an open label, randomized control trial of hypertonic saline in pulmonary M. avium complex patients. Eligible patients who consent to participate will be randomized 1:1 to hypertonic saline or standard of care for 12 weeks. All patients in the treatment group will take inhaled hypertonic saline twice daily for 12 weeks. Patients may continue with other airway clearance methods (i.e. flutter, acapella valve, aerobika, postural drainage, huff cough, percussion). Patients may also be treated with antibiotics targeted at other pathogens if an exacerbation occurs. Patients may also be actively treated with inhaled corticosteroid at the time of enrollment, with dosing adjustments during the trial discouraged. Patients with disease progression at any time can be discontinued from the study treatment and treated according to ATS/IDSA guidelines at the discretion of the primary investigator. However, such patients will still complete the 12 week final visit, sputum collection and AE assessment.

Eligibility Criteria:
Inclusion Criteria:

* At least 2 positive MAC sputum cultures in the last 12 months with at least one AFB positive sputum obtained within 12 weeks prior to randomization
* Meet American Thoracic Society (ATS)/ Infectious Disease Society of America (IDSA) 2007 pulmonary clinical disease criteria\[1\]
* Age 18 and older
* Diagnosis of Bronchiectasis and/or bronchiectatic findings evident on chest CT report
* Ability to provide informed consent

Exclusion Criteria:

* Any patient who is unwilling or unable to provide consent or to comply with this protocol
* Cavitary NTM disease
* Patients who are currently taking or within the prior 6 months received any of the following: bedaquiline, or any component of ATS/IDSA multi-drug recommended therapy (macrolide, ethambutol, rifampin) for MAC treatment
* Diagnosis of HIV
* Diagnosis of Cystic fibrosis
* Active pulmonary tuberculosis, fungal, or nocardial disease requiring treatment at screening
* Current use of chronic systemic corticosteroids at doses of 15 mg/day for more than 3 months
* Prior lung or other solid organ transplant
Inflammatory Markers in Saliva of Patients With Burning Mouth Syndrome

Burning Mouth Syndrome (BMS) is a chronic pain disorder that presents with inflammation and burning sensation in the oral cavity without visible lesions. Multiple therapies have been investigated without conclusive results.Objective: To analyse the efficacy of treatment with Clonazepam (Rivotril) and Low Power Diode Laser Therapy in patients with Burning Mouth Syndrome and to study the markers of inflammation present in the patients' saliva.

Methods: Randomised, single-blind clinical trial with 89 patients divided into Group 1 Laser + Rivotril (n=20), Group 2 Laser Sham placebo (n=19), Group 3 Laser (n=21) and Group 4 Rivotril (n=18). The intensity of symptomatology was rated by Visual Analogue Scale (VAS). Sialometry was performed before and after treatment and questionnaires such as the Xerostomia Inventory, the Oral Health Impact Profile-14 (OHIP14) and the Mini-Nutritional Assessment (MNA) were completed. Saliva samples were analysed by measuring markers related to inflammatory processes; Interleukins (IL2, IL4, IL 5, IL6, IL 7, IL 8, IL1β, IL 10, IL12, IL13, IL17, IL21, IL23), proteins (MIP-3α, MIP-1α, MIP-1β), Cytokine GM-CSF, Interferon gamma (IFNγ), Interferon Inducible Tα-Cell Chemoattractant (ITAC), Fractalkine and Tumour Necrosis Factor α(TNFα).

Methods: Randomised, single-blind clinical trial with 89 patients divided into Group 1 Laser + Rivotril (n=20), Group 2 Laser Sham placebo (n=19), Group 3 Laser (n=21) and Group 4 Rivotril (n=18). The intensity of symptomatology was rated by Visual Analogue Scale (VAS). Sialometry was performed before and after treatment and questionnaires such as the Xerostomia Inventory, the Oral Health Impact Profile-14 (OHIP14) and the Mini-Nutritional Assessment (MNA) were completed. Saliva samples were analysed by measuring markers related to inflammatory processes; Interleukins (IL2, IL4, IL 5, IL6, IL 7, IL 8, IL1β, IL 10, IL12, IL13, IL17, IL21, IL23), proteins (MIP-3α, MIP-1α, MIP-1β), Cytokine GM-CSF, Interferon gamma (IFNγ), Interferon Inducible Tα-Cell Chemoattractant (ITAC), Fractalkine and Tumour Necrosis Factor α(TNFα).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis Burning Mouth Syndrome (BMS) burning sensation in the oral mucosa or recurrent dysesthetics daily for more than 2 hours a day for more than 3 months, without clinically evident causal lesions

Exclusion Criteria:

* Pregnant or lactating patients
* Oncology patients
* Sjögren's syndrome
Specialized Substance Abuse Supervision (SSAS) Versus Non-SSAS Recidivism Rates Among Nebraska Felony Drug Offenders

This social science study hypothesizes that convicted felony drug offenders in Nebraska who participated in Specialized Substance Abuse Supervision (SSAS) as part of their probation or parole showed significantly better outcomes (specifically, less recidivism) at six months post-entrance to SSAS compared to those who did not participate in SSAS.

Since March 2006, Specialized Substance Abuse Supervision (SSAS) has been available at five sites in Nebraska as an enhancement of probation and parole for felony drug offenders whose scores on initial screening instruments warrant such placement. SSAS enhancements to traditional probation and parole include cognitive behavioral therapy (CBT) in groups; use of incentives; positive reinforcement; and motivational interviewing.

Records of probationers and parolees who participated in SSAS starting anytime between March 1, 2006 and February 28, 2007 were studied to assess recidivism rates. Recidivism for this study is defined as "an arrest and conviction on a new charge while on probation or parole."

The records of a matched control group of non-SSAS probationers and parolees who entered probation or parole during the same time period with similar drug felony offenses and similar screening scores were also studied. Control group was also matched, as much as possible, with similar age group, demographic data, rural/urban residence, and level of felony offense.

Investigators performed a statistical analysis to determine recidivism rates at six months post-entrance to SSAS (and for the control group, at six months post-entrance to probation or parole).

Eligibility Criteria:
Inclusion Criteria:

* convicted felony drug offender
* sentenced in Nebraska
* probationer or parolee
* entered probation or parole or SSAS between March 1, 2006 and February 28, 2007

Exclusion Criteria:

* convicted felony drug offender sentenced in Nebraska starting probation or parole between March 1, 2006 and February 28, 2007 who does not match SSAS probationers/parolees in terms of age, demographics, urban v. rural residence, and/or class of felony drug offense.
Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients

This study was designed to establish the clinical evidence for effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of subacute stroke patients.

* Purpose : to elucidate the effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of stroke patients compared to conventional occupational therapy
* Subjects : total 99 patients with stroke whose upper limb functions are impaired
* Intervention : 4 weeks of therapy (5 days per week)
* Studies : upper limb functional assessment (FMA, MFT, WMFT), computerized motion analysis
* Evaluation plan : 1) pre-intervention, 2) post-2 weeks of intervention, 3) post-4 weeks of intervention, 4) 4 weeks after end of intervention


Eligibility Criteria:
Inclusion Criteria:

* Upper FMA 7-38
* Hemiplegic patients within 6months after stroke onset
* male or female, 20 years older

Exclusion Criteria:

* Patients with cognitive impairment who are unable to comply with protocol-required procedure
* Quadriplegic or double hemiplegic patients
* Patients with musculoskeletal disease, peripheral nerve disease in upper extremity
* Patients with lower motor neuron disease
* Patients who cannot perform rTMS
* Pregnant woman
Microcurrent for Healing Autogenous Skin Donor Sites

This single-center, prospective, randomized, and controlled study evaluated the efficacy of silver-coated dressing with active microcurrent in comparison to silver-coated dressing with sham microcurrent on wound-closure time for autogenous skin donor sites.

The specific aims of the study are to evaluate the impact of active versus sham direct microcurrent application to silver nylon dressings in the treatment of donor sites for partial thickness thermal injuries. The primary endpoint is wound-closure time (re-epithelialization of 90% or more of wound surface). A secondary endpoint was infection. Exploratory assessments of clinical outcomes, including inflammation, and pain medication (type, dosage, route, timing) will also be conducted.

Eligibility Criteria:
Inclusion Criteria:

* between 18-65 years of age
* burn less than 30% total body surface area
* burns not involving donor site area
* you need skin grafting to cover burns
* agree not to use other electronic devices that generate current during your study participation
* agree to come back for follow up visits at least every other day after discharge from hospital until donor site is healed

Exclusion Criteria:

* you have an illness that may affect how your wound heals such as diabetes, blood clotting disorder, cirrhosis, liver failure, peripheral vascular disease
* you are taking medications that could affect how your wound heals such as steroids, Plavix, Coumadin
* you have an infection of the skin or your bloodstream
* you are pregnant or nursing
* you are sensitive or allergic to silver or nylon
* your burn wounds are more than 30% of your total body surface area
* your site was previously harvested for grafting
* you have an implantable pacemaker device
Clinical Characteristics, Anti-hyperglycaemic Treatment Pattern and Target Attainment of Type 2 Diabetes Mellitus Patients in Older Population With or Without Albuminuria in China

This is a multi-centre, cross-sectional, non-interventional study assessing blood glucose target attainment, anti-hyperglycaemic treatment pattern and the clinical characteristics in older outpatients with Type 2 Diabetes Mellitus (T2DM) in hospitals of China. This study is designed to collect information of older T2DM patients in a real life setting


Eligibility Criteria:
Inclusion criteria

* Patient should fully know and understand the content of consent form, and the patient is willing and able to sign an informed consent form
* Outpatient with confirmed T2DM (According to the American Diabetes Association criteria 2015 \[R16-1532\])
* Age≥60 years

Exclusion criteria

* Patients with type 1 diabetes mellitus or secondary DM
* Patients who are participating in any other clinical study, including any questionnaire-based study, any interventional study (including diet/counselling based intervention), or any clinical study in which any medications (including Chinese herbal medications) are administered
Immediate Loading of Implants in Totally Edentate Upper and Lower Jaw. Trial to Evaluate Survival of the Implants and Bridges, Quality of Prosthetic Work and Patient Satisfaction

This study is an evaluation of the survival of the implants and bridges, quality of prosthetic work and patient satisfaction after immediate loading of the implants in a totally edentate upper and lower jaw.

This study is an evaluation of the survival of the implants and bridges, quality of prosthetic work and patient satisfaction after immediate loading of the implants in a totally edentate upper and lower jaw.

Eligibility Criteria:
Inclusion Criteria:

* 18-90 years old

Exclusion Criteria:

* Medical risk patients
Turkish Translation of The Emphasis-10 Questionnaire

Pulmonary Hypertension (PH) is a hemodynamic and physiopathological condition that is defined as an increase in mean pulmonary artery pressure ≥25 mmHg when measured at rest. PH often progresses to heart failure and premature deaths. PH is a progressive disease that has many causes, which can affect people of all ages, is characterized by shortness of breath, reduced exercise tolerance, psychological distress and tiredness and reduced quality of life. Surveys of SF-36, 'Nottingham Health Profiles' and 'Minnesota Life with Heart Failure' surveys are routinely performed in PH clinically. However, none of the questionnaires are specific to pulmonary hypertension, so they are incomplete in determining the condition of the disease and the patients. There is no Turkish questionnaire for patients with pulmonary hypertension and other surveys used are inadequate in determining the condition of the patient and the patient since they are not specific to the disease. The aim is to provide a Turkish questionnaire that is specific to pulmonary hypertension in the literature.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with Pulmonary Hypertension
* Following at least 6 months of Pulmonary Hypertension policlinic
* Native Turkish
* People age 18 years or older

Exclusion Criteria:

* Those with cognitive impairment
* Those who have difficulty understanding or speaking Turkish
Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo

There is an unsatisfied medical need for a first-line treatment of localized uncomplicated proliferating Infantile Hemangioma with a good benefit/risk profile.

Pierre Fabre Dermatologie has developed a new formulation of propranolol (V0400 GL 01A) which is a topical gel adapted to paediatric use.

The objective of this study is to evaluate topical propranolol efficacy and safety in the management of localized hemangioma.


Eligibility Criteria:
Main Inclusion Criteria:

* only one proliferating Infantile Hemangioma present anywhere on the body except on the head, the neck, the hands and on the diaper area, with largest diameter diameter ≥ 1cm and ≤ 5 cm.

Main Exclusion Criteria:

* more than one Infantile Hemangioma with largest diameter ≥ 1cm
* medically unstable health status that may interfere with his/her ability to complete the study
* Infantile Hemangioma requires, according to Investigator's judgment, a systemic treatment
* the patient has previously been administered treatment for IH or surgical and/or medical procedures (e.g. laser therapy) have been performed to treat the IH
A First-in-Human, Double Blind, Single Dose Study in Healthy Subjects and Subjects With Mild Atopic Asthma.

The purpose of this study is to determine if a single dose of AMG 282 is safe in healthy subjects and subjects with mild atopic asthma.

A single SC or IV dose administration of AMG 282 to healthy subjects and subjects with mild atopic asthma will exhibit an acceptable safety and tolerability profile within the dose ranges studied.

Eligibility Criteria:
Inclusion Criteria (All subjects)

* Is a current non-smoker, has not used any nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) within the last 6 months, and cumulative smoking history is ≤10 pack years.
* Females must be of documented non-reproductive potential (ie, postmenopausal \[see definition below\]; OR history of hysterectomy; OR history of bilateral salpingectomy; OR history of bilateral oophorectomy).
* Body mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 at screening. (Subjects with mild atopic asthma only)
* Documented history of mild, stable atopic asthma within 2 years of screening.
* Has used only inhaled short-acting β2-agonists (less than twice weekly) to treat asthma.
* Pre-bronchodilator forced expiratory volume in 1 second (FEV1) \> 70% predicted at screening.

Exclusion Criteria

(All subjects)

* History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the Principal Investigator or Amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
* Subject has a history of residential exposure to tuberculosis without a documented history of prophylactic treatment of tuberculosis or subject has a positive purified protein derivative (PPD) or QuantiFERON test at screening. Subjects with a documented negative PPD or QuantiFERON test within 4 weeks prior to screening who have no known tuberculosis exposure and have not traveled to an area with tuberculosis do not need to have a test performed at screening.
* Has donated or lost ≥ 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP.

Other criteria may apply.