cyrilzakka/clinical-trials huggingface dataset:
'HI-4-TU' Study: Health Improvement for Teen Ugandans Study

This randomized clinical trial is an adolescent focused implementation science study directed at improved social support and prevention of both HIV/STI's and subsequent unplanned pregnancies. The study population is pregnant adolescents who are attending antenatal care in Kampala, Uganda The acceptability and effectiveness of two enhanced peer lead, reproductive health promotion interventions compared to routine health care will be studied. The study participants will be individually randomized to one of three arms.

The overall goal of this research to test the acceptability and effectiveness of two enhanced adolescent friendly reproductive health prevention interventions versus current routine care. In each intervention group, 152 adolescent mothers will be randomized to either the enhanced group peer support education and counseling intervention or to the enhanced one-to-one (individual) peer support education and counseling group with a young, model, peer educator trained to deliver Reproductive Health Education and counseling messages, beginning during pregnancy (≥ 28 weeks) and followed up to 9 months postpartum or study end at or after 6 months (whichever comes first). The control group will consist of 215 adolescent mothers randomized to routine care as provided at Mulago hospital (or the designated health facility) where midwives deliver group sessions during antenatal and postpartum care visits as well as standard PMTCT services including routine opt-out HIV C\&T and availability of partner C\&T. Syphilis testing should also be routinely provided and treatment provided for infected pregnant mothers and their partners as per local standard of care.

The 3 groups will be enrolled with study visits at 3, 6 and 9 months post partum however the intervention groups (Arms 2 and 3) will have additional visits at 36 weeks Antepartum, delivery, 6 and 10 weeks postpartum, Quantitative baseline data will be collected on routine demographic characteristics, reproductive history, pregnancy intentions and sexual risk/perceptions and HIV/Sexually Transmitted Infection status.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant at ≥28 weeks of gestation
* Agreeing to provide written informed consent to be screened for and take part in the study
* Agreeing to provide adequate locator information with residence within 30 km
* Agreeing to a home visit
* Agreeing to come for follow up visits and to receive study follow up phone calls

Exclusion Criteria:

* Serious illness or social conditions that would prevent adherence to study requirements
* High risk pregnancy or fetal death in utero (with the exception of risk defined only by maternal age)
Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine

Prospective within-subject study of dexmedetomidine sedation paired with CLAS conditions in repeated blocks. Intervention will consist of CLAS in-phase with EEG slow waves. Anti-phase stimulation will serve as an active control while sham stimulation will serve as a passive control.

Both nonpharmacologic and pharmacologic interventions augment expression of EEG slow waves that mimic those of natural sleep. Closed loop auditory stimulation (CLAS) is a noninvasive inexpensive approach to augment the spectral power and duration of these slow waves. Whether in-phase CLAS may address this need is unknown, since acoustic potentiation of pharmacologically-induced slow waves has not been investigated. This prospective within-subject study of dexmedetomidine sedation paired with CLAS will assess the feasibility of augmenting EEG slow waves during sedation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years
* Healthy volunteers (American Society of Anesthesiologists Physical Status 1-2).

Exclusion Criteria:

* Diagnosed sleep disorders
* Habitually short sleepers
* Diagnosed psychiatric disorders
* Use of psychoactive medication (e.g., antidepressants, mood stabilizers or antipsychotics), diagnosed hearing disorder
* Neck circumference \> 40 cm
* Body Mass Index \> 30
* Acknowledged recreational drug or nicotine use
* Resting heart rate during slow wave sleep \< 40 beats per minute
* Pregnancy or nursing
* Persistently inconsistent or elevated QST heat pain tolerance thresholds (\>50 ºC).
PRC-4016 (Icosabutate) Phase I Drug-drug Interaction Study

The aim of the study is to evaluate the effect of PRC-4016 at steady state on the pharmacokinetics (PK) of cytochrome P450 (CYP) 3A substrates (midazolam, simvastatin), a CYP2C9 substrate (omeprazole) and a CYP2C19 substrate (flurbiprofen) in healthy male/female subjects.

Day 1: Subject will receive single oral doses of 2.5 mg midazolam, 20 mg omeprazole and 50 mg flurbiprofen morning Day 2: Subject will receive a single oral dose of 40 mg simvastatin on the morning of Day 2. Day 4: Subjects will commence the multiple-dose regimen for PRC-4016 (600 mg once daily) for 11 days. Day 12: Subjects will be given single oral doses of 2.5 mg midazolam, 20 mg omeprazole and 50 mg flurbiprofen co-administered with 600 mg PRC-4016.

Day 13, subjects will be given a single oral dose of 40 mg simvastatin co-administered with 600 mg PRC-4016.

All subjects will return for a post-study visit 7 to 10 days after their final dose.

Eligibility Criteria:
Inclusion Criteria:

* males or females
* any ethnic origin
* age 18-60 years
* BMI 8.0 - 35.0 kg/m2
* generally good health
* signed informed consent

Exclusion Criteria:

* males or females not willing to use appropriate contraception
* recent blood donation
* recent blood received
* high consumption of alcohol
* high consumption og tobacco
* subjects who have engaged in heavy exercise last two weeks
* prescribed systemic or topical medication taken recently, or supplements/remedies interfering with study procedures or safety
* other medication known to alter drug absorption or elimination
* abnormal hearth rate or blood pressure
* significant history of drug allergy or hypersensitivity to treatment ingredients
* other significant medical history or physical findings
* pregnant or lactating
* Poor metabolizers for CYP2C9 or CYP2C19
* subjects previously taken part in or withdrawn from study or subjects that according to investigator should not participate
SeaCare's Care Coordination for Diabetes Management in a Primary Care Office

The purpose of this study is to determine whether it is possible to improve health outcomes for patients with Type II diabetes, a community-based health care agency will offer care coordination to half of a study group in a family practice office. The intervention will include assessing patients' status using two instruments:

a depression screen (the PHQ9) and a motivation to change scale (the Patient Activation Measure, PAM). A masters-level social worker will counsel patients in the intervention group. Changes in patients' health status, PHQ9 scores and PAM scores over one year will be measured. Outcomes will be compared between the study group and the group without intervention.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes type II

Exclusion Criteria:

* Non-English speaking
Early Post-Marketing Study of ELIQUIS (Apixaban) in Mexico

The primary objective of the study is to report adverse events of on-treatment AEs by the treating physicians during a specified 24-month study period in patients with venous thromboembolism at the sentinel site(s) for the National Center of Pharmacovigilance (CNFV) in Mexico.


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

Inclusion Criteria:

* Patients 18 years old with DVT and PE at the sentinel site who received at least 1 dose of apixaban for the treatment and/or prevention of recurrence of DVT and PE during the specified 24-month study period

Exclusion Criteria:

* Subjects who received apixaban as part of a clinical trial
* Subjects who received apixaban for any indication other than local approved
* Contraindications included in the approved Mexican prescribing information
Study of the Effectiveness and Safety of SugarDown vs. Placebo in Type 2 Diabetic Subjects Treated With Metformin

To assess the safety and effectiveness of two doses of SugarDown in two different doses vs. placebo on serum glucose levels after meals in subjects with Type 2 Diabetes treated with metformin alone. There will be five visits, a screening visit, baseline visit, and 3 treatment visits. The study duration will be five weeks. Subjects will all receive placebo tablets at the baseline visit, eat a standard rice meal, and then serum glucose levels will be measured in frequent intervals over four hours immediately following the meal. Subjects will be randomized to one of the six treatment sequences. Patients will take in an unknown order one week of placebo, one week of 4 g dose and one week of 8 g dose of SugarDown immediately before breakfast, lunch and dinner meals. Patients will continue their usual metformin regimen during the trial period.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to any trial-related activity
* Male or female, between 25-75 years of age
* A diagnosis of Type 2 Diabetes for at least one year prior to screening visit
* Stable daily dose of metformin (up to 1.7 g daily) for at least 3 months prior to screening visit
* Body Mass Index (BMI) between 25 and 35
* HbA1c between 6.5% and 9.0%
* Fasting blood glucose \< 180 mg/dL

Exclusion Criteria:

* Clinically significant cardiovascular, peripheral vascular, cerebrovascular or renal disease
* Any clinical condition apart from diabetes Type 2 that affects glycemic control, examples include diabetes Type 1, liver disease, chronic pancreatitis, endocrine disease (e.g. pituitary, thyroid, adrenal gland disease), small or large intestine motility or absorptive disease, active infection, advanced malignant tumor or bariatric surgery
* Any concomitant anti-diabetic medication other than metformin, including, but not limited to, the following classes of medication: insulin, sulfonylureas, glinides, glitazones, alpha-glucosidase inhibitors, amylin agonists, DPP-4 inhibitors, and GLP-1 agonists
* Any concomitant steroid, hormonal, anorexic or other medications that could significantly interfere with glycemic control in subjects
* Lactating or pregnant women, or women of child-bearing potential unable to use adequate birth control.
* History or patient reported illicit drug abuse or alcoholism
* Participation in another clinical study one month preceding recruitment
* Any of the following laboratory abnormalities: AST or ALT \> 1.5 times upper limit normal on liver function test, glomerular filtration rate \< 60 (mL/min/1.73 m2) on chemistry panel measured by MDRD criteria, and hemoglobin \< 10 g/dL on complete blood count
Effect of Treatment With EGb 761(r) on Blood Markers of Inflammation and Oxidative Stress in Patients With MCI

Mild Cognitive Impairment (MCI) is the moderate impairment of a mental abilities to perform intellectual activities eg memory, calculation, communication... MCI is a disorder that can occur earlier than dementia such as Alzheimer's disease. It is believed that there are several factors involved such as inflammation and oxidative stress which is the production of reactive oxygen species that damage cells.

This clinical study tries to evaluate that a treatment already approved by the AEMPS, EGb 761® (Tebofortan), could reduce the levels of markers of inflammation and oxidation in the blood.

This treatment is based on a plant called Gingko Biloba. In the study, half of the participants would be administered EGb 761® during 24 months and the other half would not receive this treatment during 12 months and will received EGb 761® for the next 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Criteria for Mild Cognitive Impairment according to Petersen.
* Global score Deterioration Scale (GDS)=3 and Clinical Dementia Rating (CDR)=0.5.
* Subject's ability to comply with study requirements in the opinion of the investigator.
* Informed consent signed

Exclusion Criteria:

* Dementia (GDS=4-7) Severe auditory or visual abnormalities that could affect performance on neuropsychological tests.
* Severe psychiatric pathology.
* Hemorrhagic diathesis or anticoagulant treatment.
* Active treatment with anticholinesterase drugs or memantine. History of epilepsy or alcoholism.
* Galactose intolerance, malabsorption of glucose or galactose.
* Previous treatment with EGb 761®.
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fed Conditions

To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg ER tablets under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Safety and Effectiveness of CATHTONG™ II PICC

This clinical trial is a prospective, multi-centre, open, parallel and comparative non-inferior trial design.

Four clinical trial institutions that meet the national qualification are selected as clinical research centers. After informed consent of the subjects and meeting the selection criteria, the subjects will be included in this clinical study. After the follow-up, all the data were sorted out and analyzed. Finally, the data of the two groups were compared to prove whether the high-pressure-resistant peripherally inserted central venous catheter developed by L\&Z US, Inc. was not inferior to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Subjects volunteered to participate in the trial and signed the informed consent.
* Age 18 years old, 80 years old; gender is not limited;
* Suitable for patients who need central venous catheterization via peripheral venipuncture (life expectancy is more than 6 months): need medium-term and long-term infusion or intravenous drug therapy; need multi-chamber infusion of multiple drugs at the same time; need infusion of irritating, corrosive or hyperosmotic drugs; hyperbaric angiography or central venous pressure monitoring function;
* Patients who need to be maintained in the investigator's hospital after PICC catheterization;
* Ability to communicate well with researchers and comply with test requirements.

Exclusion Criteria:

* Local infection of puncture vein or occlusion or serious lesion of blood vessel at puncture place;
* Patients with known or suspected allergies to polyurethane;
* Pre-intubation site includes trauma history, vascular surgery history, thrombosis history, radiotherapy history, bilateral breast cancer surgery affected upper limbs, superior vena cava compression syndrome, etc.
* The prothrombin time was 6 seconds longer than the normal value and the activated partial thromboplastin time was 2.5 times longer than the normal value.
* Pregnancy and lactation women;
* The subjects had a history of difficulty in catheterization.
* Patients with pacemaker implantation in vivo;
* Researchers do not consider it appropriate to participate in this clinical trial.
Double Trigger in Patients With Low Number of Oocytes Retrieved Per Number of Preovulatory Follicles

The aim of this randomized controlled trial is to determine whether co-administration of GnRH agonist and hCG for final oocyte maturation ( 40 and 34 h prior to oocyte retrieval , respectively) can increase the oocytes yield in patients with history of poor oocytes yield, despite normal response to COH, due to low (\<50%) number of oocytes retrieved per number of follicles \> 14 mm in diameter on day of hCG administration


Eligibility Criteria:
Inclusion Criteria:

* Patients with history of poor oocytes yield in previous IVF attempt, despite normal response to COH, due to low (\<50%) number of oocytes retrieved per number of follicles \> 14 mm in diameter on day of hCG administration
* Patients with 6 to 15 mature follicles on the day oocyte trigger in the current IVF-ET attempt

Exclusion Criteria:

* Endometriosis
* PCOS
Validity and Reliability of the Turkish Version of Atrial Fibrillation Impact Questionnaire (AFImpact)

Validity and reliability of the Turkish version of 'Atrial Fibrillation Impact Questionnaire (AFImpact)' will be evaluated in the study.

Atrial fibrillation (AF) is the most common sustained arrhythmia with a reported incidence of 2.1% in Turkish population aged 60 and above. Although a minority of patients have minimal or no symptoms, palpitations, dyspnea and fatigue are frequently reported by AF patients. It is well documented that AF patients, including those with no symptoms, have poorer quality of life (QoL) compared to healthy population. Worrying about their condition, side effects of treatments and worsening health are the other factors that have an impact on QoL, beside symptoms. Management of QoL is a key therapeutic goal in AF treatment and guidelines recommend that QoL in these patients should be measured regularly. There is a concern in the literature that generic QoL measures may not be sufficiently sensitive or specific to measure AF related QoL, thus using disease specific QoL measures are recommended for AF patients. An AF-specific quality of life measure is lacking in Turkish language, thus our aim in this study is to validate the Turkish version of 'Atrial Fibrillation Impact Questionnaire (AFImpact)' in Turkish AF patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of paroxysmal, persistant or permanent atrial fibrillation
* To be able to read and understand Turkish

Exclusion Criteria:

* Diagnosis of heart failure or any chronic lung diseases
* Recent coronary bypass surgery
* Previous heart valve surgery
* Rheumatic valvular heart disease
* Recent acute myocardial infarction
* Having a pacemaker
DMSO-PDT of BCC - A 6 Year Follow up

The purpose of this study is to registrate long time clinical and histological treatment response of basal cell carcinoma (BCC) lesions treated with one or two procedures of dimethylsulfoxide supported 5-aminolaevulinic acid photodynamic therapy (DMSO-PDT).


Eligibility Criteria:
Inclusion Criteria:

* histological verified bcc.
* one or two PDT treatments with treatment interval no longer than two weeks.
* lesion complete response three months after therapy.

Exclusion Criteria:

* pregnant.
* Gorlin's syndrome.
* morpheaform or pigmented bcc.
* histology older than one year.
* tumour infiltration more than four mm.
* previous PDT treated lesions.
A Study of Ziprasidone for the Treatment of Psychosis in Patients Who Had Already Had Benefits From Ziprasidone Treatment in a Previous Study

The purpose of this study is to evaluate the efficacy and tolerability of ziprasidone in patients who successfully completed a study of ziprasidone treatment of psychosis (Protocol A1281074).


Eligibility Criteria:
Inclusion Criteria:

* Psychotic disorder
* Completion of previous study of intramuscular ziprasidone
* Ability to continue with oral ziprasidone

Exclusion Criteria:

* Concomitant treatment with other anti-psychotic agents within 12 hours prior to the enrollment; for depot agents, a period of two weeks or a cycle, whichever is longer, should occur between the last administration and the patient's enrollment.
* Treatment with antidepressants or mood stabilizers within seven days prior to the enrollment; for MAOIs (monoamine oxidase inhibitors) and moclobemide, this period should be of two weeks; for fluoxetine, five weeks.
* Resistance to conventional psychotic agents. (Resistance is defined as a failure to present a therapeutic response during the acute exacerbation after proper attempts of treatment with marketed antipsychotic agents in two or more occasions during the two years prior to the enrollment in the study.)
A Novel Method of Non-Invasive Brain Stimulation (kTMP) to Enhance Motor Function in Chronic Stroke Patients

Stroke is a leading cause of disability with many patients suffering chronic motor function impairments that affect their day-to-day activities. The goal of this proposal is to provide a first assessment of the efficacy of an innovative non-invasive brain stimulation system, kTMP, in the treatment of motor impairment following stroke.

The goal of this clinical trial is to test and validate a novel first-in-class non-invasive approach to enhance motor function in chronic stroke patients. The kilohertz Transcranial Magnetic Perturbation (kTMP) device allows the investigators to target frequency-specific neural activity non-invasively - with no patient discomfort - at and beyond stimulation intensities associated with enhanced recovery from stroke (up to 8 V/m), something that is not possible to achieve with existing NIBS methods.

The trial aims to evaluate the preliminary efficacy of kTMP in improving upper limb motor performance in patients suffering from chronic stroke. This clinical trial aims to target the perilesional motor cortex to assess both immediate and long-term improvement of motor performance, and corresponding physiological changes induced by kTMP stimulation.

Eligibility Criteria:
Inclusion criteria:

1. Age 18 or older with stable upper limb motor dysfunction caused by a single ischemic and/or hemorrhagic stroke greater than 6 months prior to recruitment
2. Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 28-60
3. Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP+), a proxy of residual corticospinal function.

Exclusion criteria:

1. Participants with cognitive impairment (MoCA \< 20), language impairment that interferes with their ability to adhere to the protocol or to provide informed consent.
2. Individuals who are pregnant, have uncontrolled medical problems including but not limited to severe cardiovascular and cardiopulmonary disease, severe alcohol or drug abuse within the past year, or major depression.
3. Contraindications related to non-invasive brain stimulation
How Well do the Current Cesarean Deliveries Adhere to the Published ERAS Guidelines?

Local guidelines for the postoperative care of women who have undergone cesarean delivery at the HUS/Women's hospital are based recommendations by the ERAS society. This study will take a prospective sample of 500 parturients who have gone through a cesarean delivery and their care will be verified against the local check-list for cesarean delivery.

The study will produce a snapshot of the current state of treatment in the third largest delivery hospital in Europe. The study will include cesarean deliveries in all urgency categories.

The data will be collected prospectively by enrolling parturients in consecutive order from the study start date. The data will be collected in the form of a paper check list that is to be filled up by the nursing staff and doctors who are taking care of the parturient through her stay at the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for ERAS protocol cesarean delivery
* Cesarean delivery for any indication
* Any anesthesia method
* Any urgency category

Exclusion Criteria:

* Age under 18 years