cyrilzakka/clinical-trials huggingface dataset:
A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne

Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Adapalene 0.3% gel in combination to emulate real life practice.


Eligibility Criteria:
Inclusion Criteria:

i. Outpatient, male or female subjects of any race, and at least 12 years of age or older.

* Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (test must have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study:
* A female is considered of childbearing potential unless she is:

  1. postmenopausal for at least 12 months prior to study drug administration;
  2. without a uterus and/or both ovaries; or
  3. Has been surgically sterile for at least 6 months prior to study drug administration.
* Reliable methods of contraception are:

  1. Hormonal methods or intrauterine device in use \> 90 days prior to study drug administration;
  2. Barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
  3. Vasectomized partner (vasectomy must be performed 3 months prior to first study drug administration or in the alternative a zero sperm count will suffice).
* Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.

ii. Facial acne IGA score of 3 or 4.

iii. Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.

Exclusion Criteria:

i. Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.

ii. Allergy or sensitivity to any component of the test medications (Section 5.2).

iii. Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I).

iv. Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study.

v. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris vi. Evidence of recent alcohol or drug abuse. vii. History of poor cooperation, non-compliance with medical treatment, or unreliability.

viii. Exposure to an investigational drug study within 30 days of the Baseline Visit.
The Effect of Manual Therapy Versus Kinesio Taping on Tension-type Headache in Jouf University Female Students

Patients suffering from Tension Type Headache (TTH) report emotional and functional deficits (missing work, sleep disorders, emotional stability) and are susceptible to pharmaceutical abuse. Cervical muscle training, posture correction, spinal mobilization, and other physical therapy modalities may help alleviate symptoms.

This study will aim to compare the effect of manual therapy and kinesio taping on tension-type headache.


Eligibility Criteria:
Inclusion Criteria:

* Students between the ages of 18 and 25 will be enrolled in the study if they have tension type headache based on the IHS headache classification: A headache that occurs at least 15 days per month for more than 3 months (≥ 180 days per year) and lasts for hours or is continuous. The headache exhibits at least one of the following characteristics: 1. bilateral location, 2. pressing/tightening (non-pulsating) character, 3. mild or moderate intensity that is not exacerbated by routine physical activity such as walking or ascending stairs, and both of the following: 1. No more than one of photophobia, phonophobia, or mild nausea, and 2. No moderate to severe nausea or vomiting.

Exclusion Criteria:

* Reumatoid arthritis, suspected malignancy, pregnancy, regular use of triptans, ergotamines, or opioids on ≥ 10 days/month or simple analgesics on ≥ 15 days/month for ≥ 3 months, or physical therapy treatment within 2 months prior to enrollment in the study.
Weight Patterns in the Month After Birth

This is a prospective cohort study that will be conducted in four low income countries to describe newborn weight patterns in the first month after birth and their association with clinical and demographic factors including dietary intake.

Background: Worldwide, more than 50 million children under 5 are wasted (weight-for-length/height Z-score (WLZ) \<-2) and over 150 million children under 5 are stunted (length/height-for-age Z-score (LAZ) \<-2); such wasting and stunting often begin during infancy. Optimal early nutrition can prevent wasting and stunting. In low income countries, there is therefore a need to understand early weight patterns and how they relate to dietary intakes.

Objectives: The proposed study will assess the relationship between infant dietary intake and weight change in low income countries by characterizing neonatal weight loss/gain patterns, dietary intake, and growth.

Methodology: We will use a prospective cohort study design to describe early infant weight patterns and their relationship to dietary intake. Up to 880 newborns and their mothers will be enrolled in four countries: Guinea-Bissau, Nepal, Pakistan and Uganda (up to 220 newborns/site). Enrolled infants will be followed from birth until one month of age and will be assessed by anthropometry, dietary survey and hemoglobin measurement. Mothers will also be assessed for anthropometry and hemoglobin. Infants' fathers and next-oldest siblings will also be enrolled for anthropometry if available and willing to participate.

Descriptive statistics will be used to describe sample characteristics. We will use various regression modeling techniques to examine the links between individual, family, and community characteristics and early infant weight patterns. Logistic regression models will also be used to consider potential confounding.

Study findings will allow us to describe weight patterns in the first 30 days after birth and their relationship to the dietary intake during that time. We hypothesize that infants who lose 6% or more of their birth weight prior to beginning weight gain will have lower WAZ at 30 days of age. We also hypothesize that at 12 days of age, weight change relative to birth weight will be lower for infants born \<2500g then for infants born ≥2500g.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight ≥ 2000g.
* Mother ≥18 years of age and intends to breastfeed for at least 6 months.
* Mother anticipates availability for all study visits.

Exclusion Criteria:

* Birth weight \<2000g
* Respiratory distress including tachypnea, head nodding, nasal flaring, chest retractions or grunting
* Known major congenital anomalies including orofacial clefts, neural tube defects and congenital heart defects
* Contraindication to breastfeeding at each site as determined by a site's national or sub-national health authorities
* Twins and other multiples.
* Newborns whose birth weight was not obtained in the first six hours.
* Newborns whose mothers intend to move or otherwise become unavailable during the follow up period of 30 days after birth
The Efficacy of Transversalis Fascia Plane Block in Pediatric Inguinal Hernia Repair

In patients undergoing lower abdominal surgery, postoperative pain management is frequently provided with systemic opioids use or neuraxial methods. Ultrasound-guided TFP block is the preferred method to reduce the use of opioids and systemic analgesics for postoperative pain management. TFP block provides anesthesia and analgesia in the inguinal region by blocking the ilioinguinal and iliohypogastric nerves.

In this study, we aimed to evaluate the effects of ultrasound-guided TFP Block on postoperative pain scores in pediatric lower abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-II patients undergoing ınguinal hernia repair

Exclusion Criteria:

* American Society of Anesthesiologist's physiologic state III-IV
Evaluation of the Dose Received by the Prostate With in Vivo Dosimetry in Patients Treated With Daily IGRT Associated With IMRT Using Two Repositioning Techniques for Localized Prostate Cancer

This study evaluates the dose received by the prostate with in vivo dosimetry when delivering image guided radiation therapy (IGRT) associated with intensity modulated radiation therapy (IMRT) for patients with localized prostate cancer using two repositioning techniques: fiduciary markers or soft tissues.

10 participants will receive a cone beam computed tomography (CBCT) repositioning, while the other 10 will receive a kV imaging of fiducial marker repositioning. The principal objective is to evaluate and compare the dose received by the prostate using two repositioning techniques.

Eligibility Criteria:
Inclusion Criteria:

* male \> 18 years
* carcinoma of the prostate histologically confirmed
* OMS 0-1
* localized stage
* favorable, intermediate and unfavorable groups according to NCCN or D'Amico classification
* patients must have signed a written informed consent form
* patients must be affiliated to a Social Health Insurance.

Exclusion Criteria:

* metastasis
* indication for pelvic radiation
* anticoagulant therapy
* lateral or bilateral hip replacement
* patient receiving an adult protective services
* Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons
Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

The purpose of this study is to evaluate end of day (EOD) visual acuity (VA) at distance when wearing Precision1™ contact lenses compared to Acuvue® Moist contact lenses.

The expected duration of subject participation in the study is 1-8 days, with 3 scheduled visits (Screening, Dispense, Exit).

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign an approved Informed Consent form
* Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day
* Best corrected VA of logMAR 0.10 or better in each eye
* Willing to discontinue artificial tears and rewetting drops during the study
* Able to wear contact lenses within the protocol-specified sphere power range
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator
* History of ocular or intraocular surgery, including refractive surgery, and/or irregular cornea
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment
* Previous 3 years or current wearers of Acuvue Moist or DAILIES TOTAL1® contact lenses
* Other protocol-specified exclusion criteria may apply.
Shenfu Injection Improves Arterial Vascular Reactivity

Septic shock is a common and critical illness in ICU.The vascular dysfunction of septic shock is manifested by vasospasm and decreased arterial vascular reactivity . Current studies have shown that the main mechanisms of vasospasm and decreased arterial vascular reactivity include increased vasospasm and down-regulation of receptor sensitivity , and eventually cause a decrease in vascular smooth muscle contractility.A large number of vasodilators are released during septic shock, in which inducible nitric oxide synthase (iNOS) and prostacyclin (PGI2) are important vasodilators leading to septic shock vasospasm.At present, vasoactive drugs are widely used in clinically to improve vascular tone and are important means of circulation support. However, when the infection is heavier, the reactivity of the blood vessels to the vasoactive drugs is lowered, and it is difficult for the large doses of the vasoactive drugs to maintain the circulation stability. At this time, the use of vasoactive drugs alone does not benefit patients with septic shock and may require the combination of other drugs.From the perspective of Chinese medicine, shock is a disease of yang. Shenfu injection has the effect of rejuvenating the yang and replenishing the qi. This trial was designed to give patients with septic shock the use of Shenfu injection to determine the specific effects of Shenfu injection on vascular reactivity in patients with septic shock.


Eligibility Criteria:
Inclusion Criteria:

1. diagnosed as septic shock according to 2016 SSC Guidelines;
2. The dose of norepinephrine required to maintain MAP\>65mmHg ≥0.5μg/kg.min;
3. SVRI \<800 dyns/cm5.m2;
4. CI\>2.5L/min/m2;
5. The patient or the patient's family signed the informed consent form for this trial.

Exclusion Criteria:

1. septic shock occurs more than 24 hours;
2. Age \> 85 years old or \<18 years old;
3. pregnant or lactating women;
4. There are shock patients caused by other causes such as cardiogenicity and neurogenicity;
5. The terminal state of malignant tumor end-stage disease or the patient who is expected to die within 24 hours.
Evaluation of Retinal Microstructure Detected With Intraoperative Optical Coherence Tomography During Vitrectomy

We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings will affect postoperative visual outcome.

We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings will affect postoperative visual outcome.

Eligibility Criteria:
Inclusion Criteria: Eyes with macular hole or lamellar macular hole -

Exclusion Criteria: Eyes with retinal detachment, retinal vascular disease, glaucoma

-
Or v IV Antibiotics for Infection

Management of periprosthetic joint infection (PJI) commonly includes 6 weeks of intravenous (IV) antibiotics after surgical treatment. However, there is little evidence to suggest that oral (PO) therapy results in worse outcomes. This study aims to determine whether or not PO antibiotics are non-inferior to IV antibiotics in treating PJI. The study is a multicenter, parallel-group, randomized (1 : 1), open-label, non-inferiority trial. The non-inferiority margin will be set at 10%. Adults with a clinical diagnosis of PJI according to the International Consensus Meeting (ICM) criteria who would ordinarily receive at least 6 weeks of antibiotics and have received ≤ 7 days of IV therapy from surgery will be included. A total of 308 participants will be centrally computer-randomized to PO or IV antibiotics to complete the first 6 weeks of therapy. Follow-on PO therapy will be permitted in either arm. The primary outcome is the proportion of participants experiencing treatment failure within 1 year. An associated cost-effectiveness evaluation including complications, resource utilization and quality-of-life data will be performed.


Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 18 years
* willing and able to give informed consent
* primary THA or TKA diagnosed with PJI based on International Consensus Meeting criteria

  1. A sinus communicating with the prosthesis OR
  2. Two positive cultures obtained from the prosthesis OR
  3. 3 of 5 criteria:
* Elevated ESR (\>30mm/hr) and CRP (\>10mg/L)
* Elevated synovial leukocyte count (\>3000 cells/µL) or change of ++ on leukocyte esterase strip
* Elevated synovial neutrophil percentage (\>80%)
* One positive culture
* Positive histological analysis of periprosthetic tissue (\>5 neutrophils per high power field in 5 high power fields x400)
* PJI treated by debridement and implant retention, or excision of the prosthetic joint (with or without planned reimplantation)
* received ≤ 7 days of IV therapy after an appropriate surgical intervention

Exclusion Criteria:

* Previously treated for native septic arthritis or PJI in the same joint
* S. aureus bacteremia on presentation or within the previous month
* clinical, histological or microbiological evidence of mycobacterial, fungal or parasitic etiology of the infection
* any other concomitant infection that, in the opinion of the clinician responsible for the patient, requires a prolonged course of IV antibiotic therapy (e.g. bacterial endocarditis, mediastinal infection, central nervous system infection)
* septic shock or systemic features that, in the opinion of the clinician responsible for the patient, requires a course of IV antibiotic therapy (the patient could be re-evaluated if these features resolved)
* an infection for which there are no suitable antibiotic choices to permit randomization between the two arms of the trial (e.g. when organisms are only sensitive to IV antibiotics or PO antibiotics)
* unlikely to comply with trial requirements following randomization in the opinion of the investigator
Effect of Early Systemic Stabilization Therapy on Recent Onset Vitiligo

Vitiligo is a distressing disorder of depigmentation. In spite of multiple successful therapeutic regimens, disease relapse remains a challenge to patients and physicians. Most guidelines consider systemic treatments only in rapidly progressive disease with wider surface areas. This delay in halting the immune attack, may give the chance for further disease progression as well as establishment of resident memory T cell population predisposing to future disease relapses. The aim of this study was to assess the ability of early systemic therapy of localized (\<2% BSA), recent onset (\<6 months) vitiligo to control disease activity and minimize the possibility of recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 6 years old of both genders
* Early onset vitiligo (˂6m duration)
* Body surface area (BSA) affected ≤2%

Exclusion Criteria:

* Patients who received any previous treatment for vitiligo
* Pregnant and lactating females
* Patients with other cutaneous or systemic autoimmune diseases
* Patients with contraindication to systemic corticosteroids
EPIMix Versus CT Brain Pediatric Study

This study aims to assess the diagnostic feasibility and diagnostic performance of a new fast MR sequence EPIMix for neuroradiological evaluation in comparison to computed tomography of brain in pediatric population.

The study aims to assess the feasibility of fast MR sequence for neuroradiological evaluation in comparison to computed tomography of brain in pediatric population. Imaging quality is analysed with regards to artefacts and lesion conspicuity as well as its diagnostic potential in rendering a probable diagnosis. The primary study aim is to define feasibility and the AUC for diagnostic performance of minute MRI compared to computed tomography.

Included patients are children age 4-18 with suspicion of cerebral pathology with referral to elective computed tomography of the brain.

Study participants are in addition to computed tomography investigated during same day at 3T MR.

Eligibility Criteria:
Inclusion Criteria:

* Age 4-18 years.
* Patient with suspicion of cerebral pathology.
* Referral to elective brain CT study.

Exclusion Criteria:

* CT planned with sedation
* known previous cerebral pathology (follow up study)
* Emergency CT
* Aborted MR exam
National Evaluation of PI-based 2nd Line Efficacy in Cambodia

Medium and long term efficacy of PI-based 2nd line antiretroviral (ARV) therapy in Cambodia is poorly documented when the numbers of patients on treatment and their duration are increasing. For patients in treatment failure , there is no alternative ARV regimen available to date.

This operational research aims to evaluate the Cambodian National Program PI-based 2nd line antiretroviral regimen to assess the proportion of treatment failure and drug resistance ;identify the structural and individual factors associated with treatment failure ; design alternative salvage ARV regimens.


Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* age above 18 years
* current PI based 2nd line ARV treatment since at least 6 months
* willing to participate and consent signature

Exclusion Criteria:

* ongoing PI based 2nd line regimen for less that 6 months at time of study intake
Frequency of Parasite Infection in Hyraxes and Sandflies During Outbreak of Leishmania Tropica Epidemic in The West Bank

The objective of the project is to study the pathogenesis of Leishmania tropica infection in a focus of infection, to learn about relationship of infection in humans with ecological factors such as infection in hyraxes reservoir hosts and vector sandflies


Eligibility Criteria:
Inclusion Criteria:

* People living on regular basis in Peduel (the site of current leishmania tropica epidemic)with and without cutaneous signs of leishmania infection

Exclusion Criteria:

* None
Effect of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects

The purpose of this study is to assess the GLP-1 and non-GLP-1 effects of LAF237 on glucagon secretion, using treatment observations of the overall glycemic response.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria - Type-2 Diabetes Patients

* Male or female patients aged 30 to 75 years with Type-2 Diabetes Mellitus (T2DM) and who are in otherwise good health
* Must have been diagnosed with T2DM at least 6 months prior to screening, and whose diabetes is controlled by diet and exercise alone or by stable dosage ( \> 3 months) of metformin
* HbA1c in the range of 6.5% to 9% at screening

Inclusion Criteria - Healthy Volunteers

* Male or female subjects aged 30 to 75 years, determined to be in good health
* Normal oral glucose tolerance test (OGTT) at screening
* Age, gender and weight matched to subjects with T2DM

Exclusion Criteria:

Exclusion criteria - Type-2 Diabetes Patients

* A history of:
* Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly
* Acute metabolic diabetic complications (such as ketoacidosis or hyperosmolar state (coma)) within the past 6 months
* Torsades de Pointes, ventricular tachycardia or ventricular fibrillation
* Any severe hypoglycemic episode within 3 months of screening
* Use of any of the following medications:
* Antihypertensive or lipid-lowering agents unless on a stable dose for at least 3 months prior to screening
* Chronic insulin treatment (\> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months
* Chronic oral/intramuscular/intravenous corticosteroid treatment ( \> 7 consecutive days of treatment) within 8 weeks prior to screening

Exclusion Criteria - Healthy Volunteers

* First degree relative of an individual with T2DM
* History of gestational diabetes
* Use of any prescription medication within 1 month prior to dosing. Use of over-the-counter medications or vitamins within 14 days prior to dosing.

Other protocol-defined inclusion/exclusion criteria may apply.