cyrilzakka/clinical-trials huggingface dataset:
SexHealth Mobile: Integrating a Mobile Clinic and a Point-of-care Contraception Counseling and Access

Pilot study aims to evaluate the effectiveness of "SexHealth Mobile" and improve access to highly effective contraception among women with substance use disorder (SUD) with "SexHealth Mobile" intervention. This intervention will consist of two existing services that will help reach women with or recovering from SUD and provide access to contraception, as well as counseling.

Pilot study aims to evaluate the effectiveness of "SexHealth Mobile" and improve access to highly effective contraception among women with substance use disorder (SUD) with "SexHealth Mobile." Our study will follow a quasi-experimental design that uses an interrupted time series (i.e., usual care \[control\] then intervention care) to compare the uptake of contraception before and after implementing the "SexHealth Mobile" intervention.

"SexHealth Mobile" integrates two existing services in our community: a mobile medical unit (MMU) operated by Swope Health Services and "SexHealth" a point-of-care contraception counseling service that our research team developed for Children's Mercy Hospital's emergency department (ED) for adolescents. Using a menu of adaptive services, "SexHealth Mobile" will bring contraceptive care to women with SUD (including the subset with opioid use disorder \[OUD\]) at recovery centers in the Kansas City community.

Our primary hypothesis is that the current use of highly effective contraception will be greater at 1-month post-enrollment among women recruited during the intervention period (i.e., "SexHealth Mobile") compared to those recruited during the usual care period. The current use and discontinuation of contraception will also be compared at 2-weeks and 3-months.

Our approach consists of enrolling (n=170) eligible women are accessing health, recovery, or community services at a site we identified in our formative research work. We will aim to recruit up to 85 women during the usual care period and 85 during the intervention period. We will follow-up with participants at 2-weeks, 1-month, and 3-months after the enrollment date.

Eligibility Criteria:
Inclusion Criteria:

Participants will be eligible if they:

* are between the ages of 18-40 years
* are biological females
* have an unmet need for contraception (sexually active, able to become pregnant, not consistently/currently using these contraception methods \[sterilization, subdermal implant, intrauterine device, injectable, pill, patch, or ring\]
* have current or recent (within the past year) problematic patterns of substance use (according to the CAGE-AID self-assessment

Exclusion Criteria:

Participants will be ineligible if they:

* have previously enrolled in the study
* are unable to provide informed consent
* are pregnant at index (recruitment) visit
Healthy Opportunities for Physical Activity and Nutrition (HOP'N) After-School Project

This study presents evaluates the effectiveness of the Healthy Opportunities for Physical Activity(HOP'N) After-School Program on preventing obesity in children. The investigators hypothesized that normal and overweight/obese children attending after-school sites randomized to the control condition will increase in weight status to a greater extent compared to children at sites randomized to receive the HOP'N program. The investigators also hypothesized that after-school intervention HOP'N sites will increase in physical activity and healthful eating opportunities compared to control sites.

The dramatic increase in the prevalence of overweight among children and adolescents has led to obesity prevention becoming a major national health priority. Although schools offer a logical choice for a setting to reach a great number of youth, these disappointing findings may be due in part to the difficulties of implementing interventions in school settings where competing demands for time have made it difficult to add anything other than academics to the school day. After-school programs may provide promise for preventing child obesity because there are fewer bureaucratic obstacles and curricular inflexibilities. A three-year group-randomized controlled trial will be conducted with random assignment at the school level . The study will use a nested cross section design with a baseline year, and two subsequent intervention years.

Eligibility Criteria:
Inclusion Criteria:

* after-school program participant in fourth grade group
* informed parental consent
* assent to participate in Body Mass Index assessment

Exclusion Criteria:

* third or fourth grade student
* participant in study in previous year
The Influence of Cholecystectomy on Secretion of Incretin Hormones

The effect of cholecystectomy on postprandial plasma GLP-1 responses (primary endpoint) and glucose metabolism will be evaluated in 30 patients planned to undergo elective laparoscopic cholecystectomy.

This is an observational, parallel-group study in 30 patients with gallstone disease and 10 healthy control subjects. In patients undergoing cholecystectomy a 4h-meal test (liquid mixed meal) will be conducted at baseline (1-2 weeks before surgery) and again within 4 weeks after the cholecystectomy. Healthy subjects will be submitted to a single 4h-meal test.

Secondary endpoints include changes in plasma glucose, insulin, glucagon, GIP, PYY, gastrin, CCK, fibroblast growth factor 19 (FGF-19) and bile acids. Furthermore, secondary endpoints include changes in gastric emptying (evaluated by the paracetamol method).

Eligibility Criteria:
Inclusion Criteria:

* caucasians above 18 years of age, having an elective cholecystectomy performed because of gallstone disease.
* normal fasting plasma glucose and HbA1c
* normal hgb
* Normal gallbladder ejection fraction

Exclusion Criteria:

* liver disease
* kidney disease
* diabetes
* ongoing infection
* abdominal pain not related to gall stones
* BMI \<18,5 kg/m2 eller BMI \>30 kg/m2
* prior abdominal surgery
mHealth Intervention to Prevent Postpartum Smoking Relapse

This project aims to develop an adapted and enhanced mHealth couple intervention to prevent post-partum smoking relapse.

The main goal of this project is to develop, implement, and disseminate effective and sustainable interventions to prevent and reduce smoking in families over their reproductive life span. So, the purpose of this project is to adapt, enhance, and test the implementation feasibility and efficacy of an evidence-based pregnancy and postnatal smoking relapse pilot mHealth intervention. The scientific relevance of this research project is given by: 1) testing a cultural-adapted version of the iCoach mobile application for the prevention of smoking uptake after birth. 2) The cultural adaptation will be obtained based on the existing literature regarding the adaptation of preventive interventions for substance use. 3) The iCoach app intervention is enhanced with SMS-delivered content addressing the dyadic efficacy for smoking cessation aiming to improve both partners' skills to work together as a team to prevent smoking uptake after birth.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* gave up smoking 6 months before or during pregnancy
* owns a smartphone
* has a stable partner/husband
* offers the partner's contact data
* signs the informed consent
* CO level (ppm) below 4

Exclusion Criteria:

* younger than 18 years
* smoker
* does not own a smartphone
* does not have a stable partner/husband
* refuses to offer the partner's contact data
* refuses to sign the informed consent
* refuses the CO level measurement or the CO level (ppm) is above 4
Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery

The purpose of this study is to determine whether intravenous lidocaine increase the tolerability of early oral feeding after laparoscopic colorectal surgery in patients with colorectal cancer.

* Degree of nausea/vomiting.
* Degree of postoperative pain and opioids requirement.
* Time to first flatus, time to first stool, time to tolerance of regular diet, rate of postoperative complications and duration of postoperative hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* Elective laparoscopic colorectal surgery for colorectal cancer.
* Age \> 18 years.
* Informed consent.

Exclusion Criteria:

* Allergy to local anesthetics.
* Severe cardiovascular, hepatic, or renal diseases.
* Pregnant or lactating patients.
* Emergency surgery.
* American Society of Anesthesiologists (ASA) class IV
Cardiac Magnetic Resonance in Acute Myocarditis

Cardiac magnetic resonance (MR) is an established noninvasive diagnostic tool for detection of acute myocarditis. Diagnosis of myocarditis at 1.5T is currently made with the help of the Lake Louise Criteria (two of three criteria have to be positive in order to establish the diagnosis). Although these criteria are accepted and widely used in clinical routine, several disadvantages exist. Newer parameters like myocardial T1 and T2 mapping, extracellular volume fraction (ECV) and myocardial strain analysis have the potential to complement or even replace some of the Lake Louise Criteria and further enhance the diagnostic performance of cardiac MR in patients suspected of having acute myocarditis. The aim of our study is to evaluate the diagnostic performance of a comprehensive cardiac MR protocol in patients with acute myocarditis.


Eligibility Criteria:
Inclusion Criteria:

* No past medical history of cardiac disease.
* No cardiovascular risk factors (e.g. diabetes or hypertension)

Exclusion Criteria:

* Contraindications for cardiac MR
Melatonin Study Between Diminished and Normal Responder in IVF

Poor sleep quality may lead to increase in oxidative stress and free radicals which in turn may decrease the reproductive function. Many researchers have already proven improvement on reproductive function after antioxidant (melatonin) administration. The investigators wish to study the relationship between unexplained, young poor ovarian responder and oxidative stress.

Poor sleep quality may lead to increase in oxidative stress and free radicals which in turn may decrease the reproductive function. Many researchers have already proven improvement on reproductive function after antioxidant (melatonin) administration. The investigators wish to study the relationship between unexplained, young poor ovarian responder and oxidative stress.

This is an randomized controlled trial to evaluate the effect of melatonin to improve the quality of sleep and reduce the oxidative stress. 100 patients will be randomized in to two groups, the one with melatonin administration for 2 weeks and the other with placebo administration. Each group will be composed of 2 sub groups, poor responders and normal responders.

Then the serum and the follicular fluid will be collected at the time of oocyte retrieval and melatonin concentration oxidative stress marker will be measured.

Eligibility Criteria:
Inclusion Criteria:

1. Infertility patients visiting Bundang CHA hospital between the age of 20 to 40.
2. Currently, not being treated for any gynecological or medical diseases.

Exclusion Criteria:

1. Current untreated pelvic pathology (moderate-to-severe endometriosis, submucosal uterine fibroids/polyps assessed by the treating specialist to affect fertility, pelvic inflammatory disease,uterine malformations, and hydrosalpinx.)
2. Currently enrolled in another interventional clinical trial.
3. Concurrent use of other adjuvant therapies (e.g.Chinese herbs, acupuncture).
4. Autoimmune disorders.
5. Undergoing preimplantation genetic diagnosis.
6. Concurrent use of any of the following medications (Fluvoxamine,Cimetidine, Quinolones, Carbamazepine, rifampicin,Zolpidem, zopiclone, and other non-benzodiazepine hypnotic, other CYP1A2 inducers.
7. Genetic disorders regarding galactose intolerance, lactase deficiency, glucose-galactose malabsorption
8. Inability to comply with trial protocol.
Oral Polypodium Leucotomos for Melasma

Primary Objective: To determine whether there is improvement in the melasma of participants taking oral Polypodium Leucotomos Secondary Objective: To determine whether oral Polypodium Leucotomos is well tolerated in study subjects with melasma.

To determine whether treatment with Polypodium Leucotomos improves the health-related quality of life.

Polypodium Leucotomos is a fern, also known as Calaguala used by the natives of northern Honduras as a treatment against malignant tumors Used in Spain and Central America for the treatment of psoriasis, atopic dermatitis and repigmentation of vitiligo.

Oral Polypodium Leucotomos is safe and effective in patients with melasma.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects 18-50 years of age.
* Female subjects with epidermal melasma.
* Female subjects of child-bearing potential must have been willing to use an acceptable form of birth control for the duration of the study.
* Subjects with Fitzpatrick skin types II, III, \& IV
* Subjects enrolled in this trial had a 2 week washout period if on prior treatment for melasma.

Exclusion Criteria:

* Pregnant or lactating
* Dermal Melasma
* Hormonal therapies less than or equal too 4 weeks prior to study
* Use of photosensitizing medications
* Simultaneous use of any form of treatment for melasma
* Subjects who were concurrently receiving light therapies
* Subjects who were unwilling to limit the amount of sun exposure
* Simultaneous ( or past 30 day) participation in a clinical research study.
Understanding Patient Experience and Preferences for the QT Scanner Compared to Mammography

This study aims to characterize patient experience, satisfaction and preference for use of the QT Scanner in comparison to mammography by directly engaging women who have experience with both technologies.

The objectives will be addressed by first conducting structured one-on-one interviews with about 20 women (Qualitative Phase), and then administering a web-based patient survey with quantitative measurements in about 200 women (Quantitative Phase). The current Protocol registration pertains to the first, qualitative phase of the study.

Eligibility Criteria:
Inclusion Criteria:

* Have used the QT Scanner
* Have used mammography
* Speak English
* Willing to provide consent and participate in the survey

Exclusion Criteria:

• Excluded if all Inclusion Criteria are not met
An Observational Study of Epilepsy: Biology and Outcomes Using Real-world Data

The goal of this observational study is to learn more about phenotypic, genetic, biochemical, neurophysiological and radiological patterns in epilepsy.

Participants will be asked to consent to use of clinical and paraclinical data (obtained during standard care) for research, and will be asked to donate blood samples at their routine clinic visits.

This is an observational study of people with epilepsy seen in South Wales, which will employ quantitative methods of analysis to meet the study aims. The study will build upon data already collected during routine clinical appointments from people with epilepsy who have come into contact with the National Health Service (NHS) epilepsy service at Cardiff \& Vale University Health Board. The epilepsy service has clinical data on over 5000 people with epilepsy, and biological samples on approximately 400 people through the Welsh Neuroscience Research Tissue Bank.

The investigators propose to approach individuals being seen in the epilepsy clinics to gain consent for access to their routinely collected clinical and paraclinical data, and prospective donation of biological samples (predominantly blood samples, though consent will be sought for surplus brain tissue and cerebrospinal fluid (CSF) if brain surgery or lumbar puncture are being performed as part of clinical care, as well as hair, nail, and urine in some circumstances). This will enable a comprehensive disease register of a population-based sample of people with epilepsy to be established.

Interrogating the clinical and paraclinical data will allow investigation into clinical phenotypes, short- and long-term outcomes in epilepsy, and the relationship of clinical, demographic and biological variables. Biological samples will allow biochemical and genetic analysis of potential markers of disease, clinical phenotype, and prediction of outcomes including treatment responses, and allow contribution to the Epi25 international collaborative (http://epi-25.org/).

Inclusion in the study will involve no change to the normal clinical care or treatment of participants (except where participants choose to provide biological samples), and additional clinic visits will not be required outside of standard NHS care.

Eligibility Criteria:
Inclusion Criteria:

* Individual is being investigated for epilepsy and under the clinical care of the epilepsy unit at Cardiff \& Vale University Health Board or regional clinics in Cwm Taf.
* Individual is at least 16 years old.
* Informed consent sought and given by individual.

Exclusion Criteria:

* None
Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy

The study includes Caucasian patients with diagnosis of normal tension glaucoma and age- and sex-matched healthy individuals. Measurements of optic nerve head blood flow will be performed with laser speckle flowgraphy (LSFG). Also, the intraocular pressure (IOP), systolic and diastolic blood pressure, heart rate (HR), mean arterial pressure (MAP) as well as ocular perfusion pressure (OPP) will be evaluated. After baseline measurements individuals will be asked to ingest 800 ml of water in less than five minutes. Measurements will be repeated after 15, 30 and 45 minutes.


Eligibility Criteria:
Inclusion Criteria:

* presence of glaucomatous optic disc changes in biomicroscopy and visual field defects or abnormal circumpapillary retinal nerve fibre layer (RNFL) thinning (evaluated by OCT as defined by the on-board software)
* IOP ≤ 21mmHg without therapy
* normal open angle in a gonioscopic examination
* age \> 40 years

Exclusion Criteria:

* IOP \> 21 mmHg in patients' history
* ametropia \> 6 diopters
* cataract with severity greater than grade 2 of the lens opacities classification system (LOCS) classification
* presence of corneal opacities
* uncontrolled hypertension with systolic blood pressure (SBP) \> 165mmHg and/or diastolic blood pressure (DBP) \> 100mmHg
CBCT for Parents of Children With Autism

The purpose of this study is to determine if caregivers of children with a developmental delay experience a decrease in stress by participating in a meditation/cognitive training protocol.

A pilot-test, eight week, Cognitive Based Compassion Training (CBCT) program for caregivers of children with developmental delays that is comprised of eight two-hour weekly long sessions with a certified instructor followed by a twenty minute long meditation session. Sessions will focus on developing attention and stability of mind through focused attention training; cultivating insight into the nature of mental experience; cultivating self-compassion; developing equanimity; developing appreciation and gratitude; developing affection and empathy; realizing aspirational compassion; and realizing active compassion.

Eligibility Criteria:
Inclusion Criteria:

* Caregiver of child(ren) with developmental delay (including parents, grandparents, other extended family, family friends, and providers)
* Spend significant amount of time (more than 10 hours/week) with children with special needs.

Exclusion Criteria:

* Started to use any psychotropic medication within one year.
* Had any changes in any psychotropic medication doses taken within one year.
High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps

From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed.

From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed. Patients with a history of trauma or concurrent peripheral breaks were excluded. The anatomical and function outcomes, including the status of the macular hole and retina were assessed.The study was approved by the ethnic committee and research board.

Eligibility Criteria:
Inclusion Criteria:

* Macular hole with retinal detachment in high myopia

Exclusion Criteria:

* History of trauma, peripheral retinal breaks
The Utility of Performing Brain CT Scan in Non Trauma Patients at the Pediatric Emergency Unit

Pediatric patients are admitted to the emergency room for diverse causes, beside trauma, patients can present with convulsions, suspicion of brain tumor or increased intracranial pressure. In most of the cases a brain CT is performed even before physical examination by a skilled neurologist. The amount of radiation that the children are exposed is equivalent to 100 plain chest X rays. The purpose of this tudy is to examinate in a retrospective study what were the indications for CT study and what was the incidence of relevant abnormal findings that required emergency intervention or referral.


Eligibility Criteria:
Inclusion Criteria:

* All patients in the pediatric age that underwent brain CT scan in the pediatric emergency room

Exclusion Criteria:

* Patients with recent history of trauma
Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs

The purpose of this study was to investigate a possible response to nalbuphine (Nubian) and morphine with traditional Chinese herbs in healthy volunteers.

This study is a single center and open-label design to investigate the pharmacokinetic properties of Nubian, Nubian traditional Chinese herb combination dosage after single oral with oral administration, or morphine, morphine traditional Chinese herb combination dosage after single oral administration in healthy volunteers under fasting conditions.

Eligibility Criteria:
Inclusion Criteria:

* Normal healthy adult subjects between 20-40 years of age
* Body weight within 80-120% of ideal body weight
* Acceptable medical history, physical examination and clinical laboratory determinations

Exclusion Criteria:

* Recent history of drug or alcohol addiction or abuse
* Donating greater than 150 ml of blood within two months prior to Period I
* Taking any prescription medication or any nonprescription medication within 14 days prior to Period I doing
* Receiving any investigational drug within 30 days prior to Period I dosing
* Taking any drug known to induce or inhibit hepatic drug metabolism within 30 days prior to the beginning of the study
* Any clinically significant diseases
* History of allergic response to nalbuphine or related drugs and traditional Chinese herbs