cyrilzakka/clinical-trials huggingface dataset:
Evaluating What's My Method? in Barbados

The purpose of this study is to measure the impact of the What's My Method game on participants' sense of agency, education, and empowerment around contraceptive decision-making. Patients receiving standard of care contraceptive counseling will be compared to those who play the game in addition to counseling.

Contraceptive self-care has been identified by the WHO as critical to achieving milestones for female empowerment and well-being. This focus reflects a shift in global public health attitudes regarding contraceptive provision from a top-down approach, where childbearing persons receive directives from medical providers, towards an approach that encourages self-determination and individual agency. Implementing contraceptive counseling and education through the lens of reproductive empowerment requires that the focus of the intervention be on the childbearing persons and their needs. There is a clear need for improvement in contraceptive counseling in Barbados. As per the United Nations dashboard, the modern contraceptive prevalence rate is 49% and providers report that abortion is often used as birth control.

Digital health interventions have been validated as successful high-impact practices to support healthy reproductive behaviors. These interventions include SMS campaigns , artificial intelligence-based chatbots, and interactive websites which provide information and offer tools to help choose appropriate methods. These studies demonstrate that digital media are an effective way to reach the target audience and communicate information about reproductive health. Barbadian clinics have not yet integrated digital technology to support CC; they rely on pamphlets and posters for information dissemination.

This study seeks assess the impact of supplementing SOC counseling with a digital game that provides detailed information about family planning methods, their benefits and side effects. The information is communicated through using animations and images and reinforced through experimentation and context.

Eligibility Criteria:
Inclusion Criteria:

* - English-speaking
* Capable of using a tablet
* Childbearing individuals
* Individuals/Couples seeking family planning counseling (one response collected per couple)

Exclusion Criteria:

* Unable to provide informed consent due to intellectual or physical impairment - Under the age of 18 unless accompanied by a parent
Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon

The aim of the study is to investigate the efficacy and safety of EGb 761® in patients with the primary Raynaud phenomenon, with regards to the frequency, duration and severity of vasospastic attacks.

Despite more than 150 years of research into the pathophysiology of Raynaud´s phenomenon it is still not understood sufficiently. Three mean mechanisms responsible for Raynaud´s phenomenon are discussed and fall into the following three categories:

* neurological malfunction
* pathological blood vessel wall and blood cell interactions
* inflammatory and immunological responses Based on these concepts different classes of drugs have been tested. Although some therapies have shown effects, prolongation of the therapy is often difficult due to side-effects.

Considering a prevalence of 5-10% in the general population, there is still a place and probably a need for the development of new treatment concepts. Ginkgo biloba has shown to have anti-oxidative and anti-platelet activities. In a small placebo controlled trial in patients with the Raynaud´s phenomenon promising results for the Ginkgo biloba extract were shown. EGb 761® is known to be safe and well tolerated. Based on the above considerations, EGb 761® may be an effective treatment for Raynaud´s phenomenon.

Aim: To determine the efficacy and safety of EGb 761® in patients with Raynaud´s phenomenon on the frequency, duration, and severity of vasospastic attacks compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Primary Raynaud´s phenomenon
* History of episodic digital or toe pallor
* Duration of Raynaud´s phenomenon at least 2 years
* Suffering form regular occuring attacks prior to enrolment

Exclusion Criteria:

* Secondary Raynaud´s phenomenon
* Connective tissue disease
* Large vessel disease
* Cryoglobulinemia, cold agglutinins disease, thrombocytosis
* Concomitant pharmacological treatment with effects on the vasculature
* Pregnancy or lactation
* Severe internal or systemic disease
Managing Challenging Behaviors-ADHD

The purpose of this study is to test whether short, time-limited parent education programs designed to help children diagnosed with ADHD and disruptive behaviors can be helpful to families that may not be able to participate in "traditional" forms of mental health care. In short, the researchers want to know if a new program is acceptable and helpful for parents or caregivers looking for ways to help their child with problem behaviors related to ADHD. The researchers hope to enroll 60 families in the study. Half will be randomly assigned to participate in a 7-session therapy program and the other half will be asked to wait 24 weeks before being offered the treatment. Parents in the study will fill out questionnaires at week 1, week 14, and week 24.

The researchers' goal is to answer 2 specific questions. 1) Is this protocol acceptable to families and do they choose to participate and 2) Are the researchers able to accurately measure our outcomes of interest, specifically, changes in children's behavior problems, changes in parenting practices, and parents' perceptions of mental health care.

This study is focused on whether the intervention and study methods are acceptable. The researchers will compare the two groups to see if there are differences, but it would require a larger group of children and parents before the researchers can determine whether these differences are meaningful .


Eligibility Criteria:
Inclusion Criteria:

1. Children between ages 3-8 receiving services at the developmental pediatrics clinic at DH Lebanon referred by their physician for help with disruptive behaviors.
2. A diagnosis ADHD, ODD, Adjustment Disorder with Conduct, or Disruptive Behavior Disorder documented in the chart.
3. Family participating is capable of receiving in-person or telehealth care and treatment materials in English

Exclusion Criteria:

1. Primary concern that would indicate that behavioral parent training would not be the treatment of choice at the time of referral, including Autism Spectrum Disorder, previously untreated Post Traumatic Stress Disorder, OCD, or Reactive Attachment Disorder. The study clinician may also use clinical judgment that the intervention is inappropriate for a particular child's needs at any point during intervention.
2. Currently receiving outpatient therapy at the time of referral. The study will not exclude children on psychotropic medications, but will document medication status and changes to medication throughout treatment.
3. Severe history of physical or mental impairment (e.g., intellectual disability, global developmental delay). Child must be capable of verbal communication with a parent.
4. Children who are in foster care or are currently wards of the state.
5. Primary caregivers under 18 years of age.
The Site of Puncture in Prelocation Technique of the Internal Jugular Venous Catheterization

Two approaches such as ultrasound (US)-guided and prelocation techniques are possible when the internal jugular vein cannulation is attempted with US. This study is a clinical trial that compares the success rates of both techniques and shows the non-inferiority of the prelocation technique. However, during prelocation technique, rotated screen of the US is used instead of original screen. The angle of rotation is determined by the degree of rotation of US probe where an accelerometer is attached.

The investigator's own developed screen-rotating program is used. An accelerometer is attached on the front surface of the ultrasound (US) probe. The angle of rotation of the probe is delivered to the laptop and becomes the information to adjust the rotating angle of screen. Immediately after induction of general anesthesia, the patient's head is turned slightly, and the table is tilted at 10 degrees. In the US group, the investigators obtain a sonographic view and try a cannulation of the internal jugular vein (IJV). In the prelocation group, a skin marker is made on the anticipated skin puncture site where a perpendicular line that passes over the center of the IJV meets the skin on the rotated US screen. It is recorded "success" when the internal jugular vein is successfully punctured without complications. It is recorded "failure" if the internal jugular vein is not punctured during repeated needle passes. The number of tries and tile to success are recorded. The success and complication rates between two groups are compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for general anesthesia

Exclusion Criteria:

* Refusal of consent
* Patients with cervical spine injuries
* Patients with atlanto-axial instability
* Patients at risk of increased intracranial pressure
Treatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells

Treatment of age-related macular degeneration using retinal stem and progenitor cells

The aim of the project is to develop a biomedical cell product based on retinal pigment epithelium cells for highly effective treatment age-related macular degeneration; to conduct the clinical trials of the biomedical cell product in the treatment of age-related macular degeneration.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of age-related macular degeneration
* The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
* Written informed consent

Exclusion Criteria:

* The presence of any malignant tumor within the last 5 years
* Acute or chronic diseases in the stage of decompensation
* Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
* Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
* Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
* Patients are unable or unwilling to give written informed consent and / or follow research procedures
* Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study
Ergonomic Benefits from Robotically Assisted Laparoscopy for Hysterectomies and Other Indications

This is a prospective, single-center, observational clinical trial at the Department of Women's Health of the University Hospital Tübingen.

Monocentric trial to evaluate differences in musculoskeletal and cognitive demands of robot-assisted laparoscopic surgery (RALS) vs. conventional laparoscopic surgery (CLS). Demographic and personal data are collected and pseudonymized. During surgery surface electromyography (EMG), electrocardiography (ECG), motion tracking data are collected and the surgery is documented by photos (1 photo/per second). Additionally, perceived physical discomfort (frequency and intensity) and mental load will be assessed within certain time intervals and at the very end of the surgery. The surgeon will not be disturbed in his actions and movement by the measurement equipment or applied procedures. Previous studies with similar designs can be seen as references in this context (549/2012BO1, 409/2013BO1, 262/2018BO1). After completing the surgery, the surgeon will rate difficulty of the surgery, work precision, eye strain and ergonomics during the surgery. Routine interventions like hysterectomies and other selected indications will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 68 years
* surgeons that are able to work in full shift
* trained surgeons in RALS and CLS
* written informed consent

Exclusion Criteria:

* persons influenced by analgesics or muscle relaxants
* persons not able to perform their common work for any reason
* persons with acute diseases
* muscle injury
A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.

Sedation is often needed for young children undergoing minor procedures in the emergency department (ED). Oral midazolam is one of the most commonly used regimens for children undergoing laceration repair but its sedative efficacy was shown to be suboptimal. In only one randomized controlled study oral ketamine has been used successfully for procedural sedation for laceration repair. A recent study showed that the combination of oral midazolam and oral ketamine provided deeper sedation compared with oral midazolam alone. However children treated wuth the combination of midazolam and ketamine required longer recovery

Hypothesis:

Oral ketamine can provide superior sedation to oral midazolam in children requiring sedation for laceration repair.


Eligibility Criteria:
Inclusion Criteria:

• Any child with laceration requiring sedation

Exclusion Criteria:

* Major trauma
* Closed head injury associated with loss of consciousness
* Abnormal neurologic examination in a previously normal child
* Significant developmental delay or baseline neurological deficit
* A patient with seizures
* Elevated intra-cranial pressure
* Hypersensitivity to midazolam or ketamine
* Hypertension
* Hyperthyroidism or a patient receiving thyroid replacement
* alcohol intoxication or a history of alcohol abuse
* Acute or chronic respiratory, cardiac, renal or hepatic abnormalities
* Glaucoma
* Known psychiatric disease
* American Society of Anesthesiologists (ASA) score of more than 2
* Informed consent cannot be obtained from legal guardian
Measurement of Bite Force in Humans

This protocol is for a clinical trial to evaluate the reliability of the bite fork as a diagnostic instrument in subjects with pulpal necrosis and apical periodontitis.

This clinical trial consists of two parts. We will first use the bite fork in normal volunteers to evaluate its test-retest and inter-rater reliability. We will then use the bite fork in subjects with differing endodontic diagnoses and compare these results with the standard clinical diagnostic test (percussion).

Eligibility Criteria:
Inclusion Criteria:

1. Patient must be at least 16 years of age.
2. Clinical indication for non-surgical root canal therapy (NSRCT).
3. 1st or 2nd maxillary or mandibular molar or premolar
4. Diagnosis must be chronic apical periodontitis (CAP) with or without symptoms.
5. Intact, mature apices.
6. American Society of Anesthesiologists (ASA) I or II.

Exclusion Criteria:

1. Failure to meet any of the above
2. Previous NSRCT
3. Previous pulpotomy or pulpectomy
4. Suppurative apical periodontitis
5. Patients taking medications which can affect their pain rating or medications which affect their immune system (such as glucocorticoids)
Clamping vs. Free Drainage Before the Removal of Short-term Indwelling Urethral Catheters in Internal Medicine Patients.

The study will be conducted at University Hospital Alcorcón Foundation, belonging to the public network of hospitals of Madrid Health Service.

The aim of this study is to evaluate the effects of clamping the urethral catheter prior to removal and determine which of the two options (clamping or free drainage) is the most recommended for removal of bladder catheterization in adults.

The interest of this study is given by the importance of proper handling of catheterization in the health of patients admitted to a hospital and are subjected to this technique. Increase its interest the need for implementation of evidence-based care, and limited scientific literature on the subject.

The study population will be patients undergoing short-term urethral catheterization at the Internal Medicine Service in the University Hospital Alcorcón Foundation.

The methodology of the study is experimental, randomized clinical trial without drug type. Interventions (prior clamped and free drainage) will be assigned in a randomized manner.

Interventions and data collection of patients who met the inclusion criteria to join the study will be conducted during 2016 and the first quarter of 2017. It is planned to present results at the end of 2017.

Keywords: BLADDER TRAINING, INDWELLING CATHETER, URINARY CATHETER, URETHRAL CATHETER, CLAMPING, REMOVAL, ACUTE URINARY RETENTION.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both sexes, aged between 18 and 85 years who require IUC 18 short-term (1 to 14 days) in the units of internal medicine at University Hospital Alcorcón Foundation.

Patients who express a desire to participate in the study by signing the informed consent.

Exclusion Criteria:

* Patients with permanent long-term (15 days or more) urinary catheter. Patients with recurrent episodes of UTI, which has submitted episodes of urinary retention in the last month, or who have urologic pathology.

Patients with cognitive impairments that hinder communication with the medical staff.

Disoriented patients in person, time and place. Anatomical and physiological genito-urinary system Alterations Patients taking a drug that affects the bladder and kidney function the week prior to catheterization.

Pregnant patients. Patients with a known history of benign prostatic hyperplasia.
Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin

The investigators examine the influence of esomeprazole versus famotidine on antiplatelet action of clopidogrel associated with aspirin. At least 100 consecutive patients suffering from acute coronary syndrome or undergoing coronary artery stent implantation , who received aspirin (80 - 160 mg/day) and clopidogrel (300 mg loading dose, followed by 75 mg/day or 75mg/day for at least 7 consecutive days), are randomised to receive either esomeprazole 20 mg daily vs famotidine 40 mg daily in a double blinded manner. Clopidogrel effect was tested by measuring residual platelet reactivity (RPR) to ADP by VerifyNow P2Y12 assay (Accumetrics Inc, San Diego, Calif). At baseline, whole blood will be obtained for RPR at least 12 h after clopidogrel loading dose or at least 7 days of maintaince dose. Immediately obtaining the baseline blood, patients will be randomized to receive either esomeprazole (20 mg/day) or famotidine 40 mg/day for 28 days. Double blinding will be performed by encapsulation of study drugs. RPR will be measured again at the 28th day.

The investigators will compare the % inhibition and the P2Y12 reaction Units (PRU) at the 28-day treatment period in the 2 groups.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from acute coronary syndrome or undergoing coronary artery stent implantation (PCI) , who received aspirin (80 - 160 mg/day) and clopidogrel (300 mg loading dose, followed by 75 mg/day), are recruited.

Exclusion Criteria:

* known active peptic ulcer disease or gastrointestinal within 8 wk
* known iron deficiency anemia with Hb \< 10 gm/dl
* mechanical ventilation
* active cancer, liver cirrhosis, end-stage renal failure
* life expectancy \< 1 yr
* known allergic to aspirin, clopidogrel, famotidine or esomeprazole
* pregnancy, lactation, child-bearing potential in the absence of contraception,
* co-prescription of NSAID, corticosteroid, or warfarin
* non-oral feeding or impaired GI absorption e.g. vomiting
* patient on proton pump inhibitor within 4 weeks
A Survey Study to See if Patients Diagnosed With Parkinson's Disease Have Higher Incidence of Melanoma

Patients with Parkinson's disease will be seen by a dermatologist who will biopsy any suspicious skin lesions.


Eligibility Criteria:
Inclusion Criteria:

Confirmed diagnosis Parkinson's disease Patient able and willing to give informed consent Patient must not be taking any investigational drug at the time of enrollment

Exclusion Criteria:

unconfirmed, undocumented Parkinson's disease unable to give consent taking any investigational product
Stabilizing Behavioral Rhythms to Improve Mental Health

In order to assess the efficacy of the Rhythm Stabilization component of HealthRhythms' product, investigators will recruit 128 outpatients between the ages of 18 and 65, presenting to the University of Utah Department of Psychiatry outpatient clinics with a current mood and/or anxiety disorder. Sixty-four of these individuals will be randomly allocated to receive the full HealthRhythms package (Rhythm Sensing, Rhythm Trending, and Rhythm Stabilization) on their smartphones, while 64 will be asked to consent to Rhythm Sensing only. Participants in both arms will receive treatment as usual (TAU) for their mood and/or anxiety disorders, as typically provided at the University of Utah clinics. The duration of the study will be 16 weeks.

The primary outcome measures of the RCT will be the PROMIS Depression, the PROMIS Anxiety and the PROMIS Sleep Disturbance computerized adaptive testing (CAT) measures. The investigators hypothesize that those receiving the full package will demonstrate lower levels of depression, anxiety and sleep disturbance. In addition, investigators will explore the relationship between sensed rhythm stability and scores on patient-reported outcome measures of mood, anxiety and sleep disturbance (PROMIS). The investigators hypothesize that positive changes in the PROMIS measures will be mediated by positive changes in rhythm stability.

The primary outcome analyses will be based on random regression models, while the mediation analyses will follow the approach described by Helena Kraemer and colleagues.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Is currently in treatment for a mood and/or anxiety disorder, as defined by the DSM-5 (American Psychiatric Association, 2013).
* Patient participants need to be on a stable medication, however changes in dosage will be allowed during the course of this study
* Ability and willingness to give informed, written consent

Exclusion Criteria:

* Severe or poorly controlled concurrent medical disorders that may cause confounding depressive symptoms (e.g., untreated hypothyroidism or lupus) or require medication(s) that could cause depressive symptoms (e.g., high doses of beta blockers or alpha interferon)
* Meets criteria for one of the following concurrent DSM-5 psychiatric disorders: any organic or psychotic mental disorder other than bipolar disorder, current alcohol or drug dependence, primary obsessive compulsive disorder, primary eating disorder, or antisocial personality disorder
* Acute suicidal or homicidal ideation or requiring psychiatric hospitalization. Those who require inpatient treatment will be excluded (or discontinued) from the study and referred to for inpatient treatment.
* Cognitive deficits precluding use of a smartphone app and/or completion of patient-reported outcomes used at the University of Utah
* Insufficient fluency in English, provide clear verbal feedback about problems with the app, complete the study assessments, or make use of a smartphone app that involves very minimal instructions written in English.