cyrilzakka/clinical-trials huggingface dataset:
Patch Test Skin Irritation/Sensitization of Cetaphil Daily Advance Ultra Hydration Lotion

Determine if Cetaphil Daily Advance Ultra Hydrating Lotion proves to be a contact sensitizer or irritant in certain individuals.


Eligibility Criteria:
Inclusion Criteria:

* Not currently under a doctor's care
* Free of dermatological or systemic disorder which would interfere with the results
* Free of any acute or chronic disease
* Will complete a preliminary medical history form and are in general good health
* Can read, understand, and sign informed consent

Exclusion Criteria:

* Under 18 years old
* Currently under doctor's care
* currently taking any medication
* History of acute or chronic disease
* Diagnosed with chronic skin allergies
* Pregnant or lactating
Quality of the Cardio-pulmonary Resuscitation

Patients having sudden cardiac arrest have very poor prognosis. It is devastating for patient and family. But also very expensive for nations economics when working-age people die or disable due to cardiac arrest. Recent studies have shown that high quality of cardiopulmonary resuscitation (CPR) and minimized delays increases the survival after cardiac arrest. In this objective prospective study we will use Zoll´s X Series defibrillator on every emergency medicine systems (EMS´s) unit in Pirkanmaa area, Finland, to collect information on CPR quality. Real CPR Help® will collect the information on depth, frequency and pauses during CPR. We will make an Utstein analysis on OHCA during one year period and compare the results on Utstein analysis made in the same area on 2013-2014. We will analyse the quality of CPR and compare it to the outcome from OHCA and neurological outcome 3 months after resuscitation. In addition we will analyse the CPR related injuries and compare these to the compression depth and number of persons performing CPR.

In one part of the study we will evaluate the incidence of OHCA in different risk areas of Pirkanmaa and analyse the influence of time delay and location to the outcome out of hospital and neurological outcome 3 months after resuscitation. We will also analyse if the time of post-resuscitation care before getting to the hospital or stenosis in carotid artery affects the outcome from OHCA and neurological outcome 3 months after resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* cardiac arrest
* \> 18 years of age

Exclusion Criteria:

* \< 18 years of age
* prisoners
Feasibility Study: Histological Characterization After Treatment With the Ulthera® System

Up to 6 subjects will be enrolled. Subjects who have already chosen to have a surgical facelift procedure will be enrolled. Subjects will receive selective Ulthera® ultrasound exposures in the pre-auricular regions. Subject will return for a follow-up visit up to 48 hours post-treatment, on the day of their rhytidectomy. Study images will be obtained pretreatment, immediately post-treatment, and at the follow-up visit.

This study is a prospective, single-center clinical trial. Subjects will be enrolled at the investigator's discretion if they meet inclusion/ exclusion criteria and provide written informed consent. Enrolled subjects will be treated with an assigned transducer based on their order of enrollment. At the study follow-up visit, subjects will undergo resection of the treated tissue for histological analysis prior to their planned rhytidectomy procedure.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 30 to 65 years scheduled for rhytidectomy.
* Subject in good health.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
* Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history: a) Postmenopausal for at least 12 months prior to study; b) Without a uterus and/or both ovaries; or c) A bilateral tubal ligation at least six months prior to study enrollment.

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Significant scarring in areas to be treated.
* Open wounds or lesions in the area to be treated.
* Severe or cystic acne on the area to be treated.
* Presence of a metal stent or implant in the facial area to be treated.
* Inability to understand the protocol or to give informed consent.
OPTIMIZING ROUTINE DELIVERY OF ESSENTIAL CHILD HEALTH AND NUTRITION PACKAGE THROUGH PRIMARY HEALTH CARE CONTACTS

The primary objective of the study is to assess whether optimization of an essential package of health and nutrition services for children under five years of age using vitamin A supplementation touch points (i.e., the implementation model) in selected areas in Kenya and Senegal will increase the coverage of vitamin A supplementation and the coverage of other child health and nutrition services. In addition, the study will also assess the feasibility of the implementation model and the drivers of coverage outcomes.

Background: Countries have made significant progress over the last 20 years in improving child survival with under five mortality rates. Despite this progress, many countries still experience inequalities in the coverage of several essential child health and nutrition services, including vitamin A supplementation (VAS), growth monitoring and promotion (GMP), immunization, and regular nutrition screening for early detection of malnutrition. Optimizing the delivery of an Essential Child Health and Nutrition Package ("essential package") may address this issue.

Objective: The primary objective of the study is to assess the effect of optimizing the health system for the delivery of the essential package (the "implementation model"), on the coverage of VAS and on the coverage of immunization (as measured by vaccination for measles). In addition, the study will also assess the feasibility of the implementation model and the drivers of coverage outcomes.

Methods: Target population will be children 12-59 months of age and their caregivers in Kisii County in Kenya and Fatick Region in Senegal. The study will use an effectiveness-research implementation hybrid design with two arms: 1) health system will be optimized to deliver VAS to all children 12-59 months of age using all the routine primary health care (PHC) contact points plus current standard of care (Intervention) and 2) current standard of care (Control). The study will be conducted for a period of 18 months. The optimization model will be implemented for 12 months. Baseline and endline surveys that will collect quantitative and qualitative data will be conducted to assess the coverage of essential child health and nutrition services in both arms from study participants per arm in both baseline and endline surveys and to assess implementation feasibility. Implementation fidelity will be assessed through monthly visits by the research team to health facilities.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers of children 12-59 months of age
* Health service providers

Exclusion Criteria:

- None
Classification and Prediction of Difficult Awake Tracheal Intubation With Flexible Bronchoscopes

Airway management problems are key drivers for anesthesia-related adverse events. Awake tracheal intubation using flexible bronchoscopes with preserved spontaneous breathing (ATI:FB) is a recommended technique to manage difficult tracheal intubation in anesthesia, intensive care and emergency medicine. However, a prospective developed classification for this type of airway management is lacking. Due to the absence of a specifically tailored, validated classification for awake intubation with flexible bronchoscopes, many airway operators and institutions use classification tools that were originally developed for direct laryngoscopy, such as the percentage of glottic opening (POGO) score or Cormack-Lehane classification, although their diagnostic performance for the classification of ATI:FB is unknown. This prospective model development and validation study aims to develop two multivariable prediction models: a diagnostic prediction model to classify difficult ATI:FB after ATI:FB has been performed and a second prognostic prediction model to predict the risk for difficult ATI:FB before ATI:FB is performed. An additional aim is to develop a machine learning algorithm to evaluate ATI:FB.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an anticipated difficult airways scheduled for ATI:FB
* Consent by the patient
* Minimum 18 years of age

Exclusion Criteria:

* Patients not scheduled for ATI:FB
* Pregnant or breastfeeding patients
* Consent not given by the patient
A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)

The purpose of this study is to determine the pharmacokinetics of laropiprant following administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of MK-0524A in adolescents with heterozygous familial hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Post-pubescent adolescent age 10 to 16 with heterozygous familial hypercholesterolemia
* Agree to use (and/or have their partner use) acceptable methods of birth control beginning at the prestudy visit until at least 2 weeks after dosing of study drug
* Height and weight fall between the 10th and 95th percentile for age with a minimum body weight of 23 kg
* Receiving appropriate medical care for hypercholesterolemia, such as a statin or other lipid-modifying therapy.

Exclusion Criteria:

* History of psychiatric or personality disorders that may affect the patient's ability to participate
* History of stroke, chronic seizures, or major neurological disorder
* History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases (excluding lipid abnormalities)
* Poorly controlled or recently diagnosed Type 1 or Type 2 diabetes mellitus
* History of neoplastic disease within previous 5 years
* Consumes alcohol or excessive amounts of products that contain caffeine (e.g. cola)
* Has had major surgery, donated and/or received blood within previous 8 weeks
* Participated in another investigational study within previous 4 weeks
* History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
* Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
* Cannot swallow large tablets
* Pregnant or breastfeeding
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Azerbaijan.

The goal of this study is to pilot and evaluate a telemedicine medical abortion service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers.

The goal of this study is to pilot and evaluate a telemedicine medical abortion (TMA) service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers. Providers will provide counseling by phone or video about pregnancy options and give detailed information about the medical abortion process, expected side effects, and where to seek additional care. The provider will then evaluate the woman's eligibility for TMA service by following the no-test protocol and discuss at-home follow-up using a symptom checklist and a high-sensitivity urine pregnancy test. If pre-treatment tests are needed, women will be referred to a nearby diagnostic center and test results will be forwarded to the study provider. Participants will receive medications by mail or courier service or pick them up at the pharmacy or study clinics, take medications as instructed, and complete at-home follow-ups as discussed with the provider.

Eligibility Criteria:
Inclusion Criteria:

* Is pregnant as determined by a pregnancy test or ultrasound (if obtained prior to contacting the study site)
* Has no contraindications to medical abortion
* Has access to a phone
* Is able to take mifepristone on or before 63 days of gestation

Exclusion Criteria:

* Medically ineligible for medical abortion
* Gestational age above 63 days based on LMP
Outcomes of Sleeve Gastrectomy in Obese Patients, Retrospective Study.

This study will be a retrospective study in which we will review patients who underwent laparoscopic sleeve gastrectomy at Sohag University Hospital in the period from january 2017 to May 2018.Assessment of outcomes as Effects on weight, Effects on co-morbidities and Post operative complications.


Eligibility Criteria:
Inclusion Criteria:

* age from 18 to 65 years old
* body mass index ≥ 35 kg/m2 with comorbidities disease or body mass index ≥ 40 kg/m2, with failure of non operative attempts to lose weight
* a minimum 2-year follow-up at our outpatient clinic.

Exclusion Criteria:

* secondary causes of obesity (e.g. endocrine diseases)
* patients unable to participate in medical follow-up;
* associated comorbidities or diseases impacting on weight loss.
Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS

This study is designed to primarily evaluate the impact of Gilenya (Fingolimod) on the autonomic nervous system in patients being treated for the first time with Gilenya (Fingolimod). Effects on the cardiovascular system will be studied as well. The study is conducted to answer the question, if, and if yes, what impact the treatment with Gilenya (Fingolimod) has on the autonomic nervous system. To our knowledge little is known about the effects of Gilenya (Fingolimod) on the autonomic nervous system. We do know of rare, but potentially clinically and therapeutically relevant cardiovascular adverse events of Gilenya (Fingolimod). From a scientific point of view the mechanisms by which this is mediated are of interest. Maybe a better understanding of these mechanisms might even be of clinical relevance (e.g. risk stratification).

The impact of Gilenya (Fingolimod) on the autonomic nervous system is quantitavely measured, using a state-of-the-art technique. Non-invasive blood pressure measurement is performed with the Finometer Pro (Finapres Medical Systems, NL) under different paradigms (breathing at rest, deep breath, valsalva maneuver, active standing). In addition the sympathetic skin reaction is performed. The non-invasive blood pressure measurements are done by continuous, plethysmographic blood pressure measurement at the index finger, while the patient is performing the tasks mentioned above. By interpreting the blood pressure curve, heart rate and blood pressure variability are calculated. The sympathetic skin reaction consists of measuring the change of electric conductibility of the skin (palms and soles) after an electric stimulus of a peripheral nerve. These parameters allow to assess the functionality of four important autonomic functional systems (orthostasis, sympathetic adrenergic, sympathetic cholinergic, parasympathetic cholinergic). Normative data has been acquired in our lab.

Our hypothethis is, that there will be a change of heart rate variability at t4,5h compared to baseline (t0) for the parameter "RMSSD" under "normal breathing".


Eligibility Criteria:
Inclusion Criteria:

* indication for treatment with Gilenya according label
* treatment with Gilenya intended
* no contraindications for the treatment with Gilanya
* all safety-aspects have been fullfilled
* age between 18 and 60 years
* written consent is given

Exclusion Criteria:

* relapse during the last 30 days befor randomization
* steroids within 30 days before randomization
* heart rhythm disturbance
* new or currently changed dose (last 4 weeks) of bata-blockers, calcium antagonists, antidepressants or antiarrhythmics
* diabetes mellitus
* polyneuropathy
* missing consent
* pregnancy
* lactation period
Influence of Obesity on Endogenous Oxalate Synthesis

There is increasing evidence that obesity is associated with increased urinary oxalate excretion, an important risk factor for calcium oxalate stone formation. By the administration of a controlled low oxalate diet the investigators will estimate endogenous oxalate synthesis in both non-obese and obese non-kidney-stone forming adults. This study seeks to thusly increase the understanding of the relationships between obesity and endogenous oxalate synthesis to serve as a platform to develop novel therapies for stone prevention.

Calcium oxalate stone disease results in billions of dollars in healthcare costs per year, creates large economic losses due to decreased work productivity, and produces significant pain and suffering in affected individuals impacting quality of life. Almost 9% of the population in the United States may now experience a stone event at least once in their lifetime and that figure is increasing. Although stone removing treatments have advanced in the last few decades with a variety of minimally invasive procedures such as shock wave lithotripsy, ureteroscopy and percutaneous nephrolithotomy, our knowledge of how stones form and how to prevent them has not kept pace. Approximately 70-80% of the stones formed contain oxalate. Oxalate is an end product of metabolism and an ubiquitous element of human diets. Small increases in urinary oxalate can increase calcium oxalate crystal formation and thus stone disease. Urinary oxalate levels are affected by both dietary and endogenous components, complicating the discrimination between the two sources. Multiple epidemiological and clinical studies have demonstrated a link between body mass index (BMI) and kidney stone disease and also an increased urinary oxalate excretion.

The interpretation of studies suggesting a link between obesity and the amount of urinary oxalate excreted is confounded by the failure in most studies to use diets controlled in calcium and oxalate. Adult humans without a history of kidney stones will be placed on controlled low oxalate diets to estimate the contribution of endogenous oxalate synthesis to the urinary oxalate pool. In addition, oral doses of 13C2-glycolate and 13C6- vitamin C will be used to determine their conversions to 13C2-oxalate and provide an index of endogenous oxalate production. Body morphometric indices, markers of oxidative stress, and insulin resistance will be assessed in these subjects.They will also be evaluated with DXA and MRI to define body fat content and distribution.

Eligibility Criteria:
Inclusion Criteria:

* Age 25-60 years
* Body Mass Index (BMI) \<50

Exclusion Criteria:

* history of kidney stones
* history of diabetes, hepatic disease, renal disease including Chronic Kidney Disease (CKD), bowel disease or other endocrine disorders
* pregnant or lactating women, or those with the intention to become pregnant in the near future
* abnormal liver enzymes
* hemoglobin A1C \> 6.5
Childhood Obesity Management Using Innovative Digital Technology

The project will evaluate the short- and long-term effects of a 10-week Family Healthy Living Program (FHLP). The program is designed for families with children ages 8-12 years old who are at risk for being above a healthy weight and who would like support with healthy living habits such as physical activity and healthy eating.

Families will participate together, with both parents and children being involved in the program. FHLP participants will receive 9 weekly 2-hour online group sessions with a facilitation team as well as additional web-based resources. They will be compared to a control group of participating families who will be offered only the self-guided web-based resources. This will help us see the impact of offering facilitated FHLP group sessions versus only offering resources online. The FHLP is 10 weeks long, but participants will be followed for 12 months in total so that researchers can look at the long-term impact of participation.

All participating families from both groups will be asked to complete surveys and provide child height and weight measurements at four timepoints: before beginning the program, immediately after completing the program, at 6-months post-program, and at 12-months post-program. Children will also be given FitBit activity watches to measure their daily step counts at each timepoint.

Researchers will compare survey responses, child growth patterns, and FitBit step counts between the FHLP participants and the control group to see whether participating in the FHLP helps families improve their healthy living habits more than only offering a similar curriculum of healthy living resources online for families to access on their own.


Eligibility Criteria:
Inclusion Criteria:

* Children must be aged 8-12 years with at least one primary caregiver who agrees to participate with them. More than one child per parent will be able to participate if the child meets the inclusion criteria.
* Children must have a BMI ≥ 85th percentile for age and sex.

Exclusion Criteria:

* Children below the 85th percentile BMI.
* The inability to communicate (speak, read, and write) in English.
* Any conditions that prevent children from being physically active.
The Association Between Albumin Administration and Short-term Rebleeding Risk in Cirrhosis Patients With Acute Variceal Hemorrhage and Stable Hemodynamics

The impact of albumin administration in cirrhotics with acute variceal hemorrhage (AVH) is controversial. We aim to investigate the short-term rebleeding risk associated with albumin administration in a retrospective study of hospitalized cirrhotics with AVH with stable hemodynamics. This retrospective analysis includes clinical data of cirrhosis patients with acute variceal bleeding admitted to our hospital from January 2021 to October 2023. Propensity score matching will be performed to account for potential confounders associated with albumin use for outcome analysis. According to the outcome, patients will be divided into rebleeding group and non-rebleeding group. To investigate the impact of albumin infusion on the rebleeding risk in the propensity-matched cohort, patients will be divided into albumin user group and albumin non-user group. The primary outcome is the rebleeding risk within 30 days after discharge.


Eligibility Criteria:
Inclusion criteria (1) Patients were diagnosed with liver cirrhosis with esophageal and gastric varices; (2) Patients were presented with any evidence or signs of acute upper gastrointestinal bleeding within 3 days before admission, including hematemesis, melena, and positive fecal occult blood. (3) Endoscopy or imaging data suggested the presence of AVB.

Exclusion criteria

(1) Patients with unstable hemodynamics (patients whose sBP\<90mmHg or heart rate \>120 bpm at admission). (2) Patients who were initially treated at other facilities but later transferred to our hospital without comprehensive medication records. (3) Ages \<18 years old or ages \>85 years old. (4) Patients with incomplete data.