cyrilzakka/clinical-trials huggingface dataset:
Effects of Roaccutane on Ca, P, PTH and Vitamin D Metabolites in the Treatment of Sever Acne

serum levels Ca, P, PTH and vitamin D metabolites before and after treatment with isotretinoin for sever acne

few studies has been done of serum levels Ca, P, PTH and vitamin D metabolites in patients receiving isotretinoin .In this study we measured serum levels Ca, P, PTH and vitamin D metabolites before and after treatment with isotretinoin for sever acne in 30 patients . the patients had no kown skeletal, endocrine ,renal and gastrointestinal disorders.

Eligibility Criteria:
Inclusion Criteria:

* sever acne

Exclusion Criteria:

* renal disorders
* gastrointestinal disorders
* skeletal disorders
* endocrine disorders
* drugs such as glucocorticoids , thiazide diuretics, mineral multivitamins, anti acids, tetracyclines
Videoconferencing Between Ambulances and Physician at the Emergency Medical Dispatch Center, Effects on On-Site Patient Treatment and Patterns of Referral

The prehospital resources are limited. The emergency medical dispatch center (EMDC) is manned by qualified health care personnel around the clock. The investigators believe that the EMDC is an unexploited resource in the prehospital treatment of patients. By the use of videoconferencing the investigators will activate this resource.

Mobile videoconferencing between ambulances and physician at the EMDC enables patient consultation at a distance. Video consultation between patient and the physician at the EMDC can take place when the patient is at home or in the ambulance.

The primary aim of this study is to examine the effect of video consultation between physicians at the EMDC and patients receiving treatment by ambulance personnel on the number of patients receiving final treatment on-site in the pre hospital setting.


Eligibility Criteria:
Inclusion Criteria:

* Less ill/slightly injured patients receiving prehospital care by ambulance personnel

Exclusion Criteria:

-
Rectal Indomethacin Versus Rectal Indomethacin and Sublingual Nitrate for PEP Prevention

Patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) are at risk for post-ERCP pancreatitis (PEP), which is associated with adverse outcomes. Combination prophylaxis strategies are increasingly investigated to prevent PEP more effectively, and studies have confirmed the benefits. Two randomized controlled trials revealed that combination prophylaxis with rectal NSAIDs and sublingual nitrate has reduced PEP rates to 5.6%-6.7% in average-risk patients. However, there was concern regarding the safety of sublingual nitrate with reports of significant increasing the risk of hypotesion (rate of 54.9%) and headache (rate of 4.1%) as compared with placebo.

As a safety drug, rectal administration of one dose NSAIDs is recommended as basic chemoprophylaxis in common or high-risk patients in guidelines. Results from previous studies showed rectal administration of NSAIDs significantly reduced PEP rate to 4-5.3% in average-risk patients. Although the difference in demographics, study design and outcomes definition, evidence was obtained that rectal NSAIDS was associated with similar PEP rate as combination prophylaxis with rectal NSAIDs and sublingual nitrate. However, evidence is lacking from large, randomized clinical trials indicating that efficiency of PEP prevention with rectal NSAIDs alone is not inferior to with combination prophylaxis. The investigators conduct this trial to investigate the hypothesis that rectal NSAIDs alone is non-inferior to the combination prophylaxis in terms of PEP prevention, but with reduce side effect.


Eligibility Criteria:
Inclusion Criteria:

* Patients (age, 18-80 y) with native papilla planned for diagnostic or therapeutic ERCP were eligible for enrollment in the study.

Exclusion Criteria:

* contraindications to ERCP;
* allergy to nitrates or NSAIDs;
* currently on nitrate medication;
* receiving NSAIDs within 7 days;
* not suitable for indomethacin eg, gastrointestinal hemorrhage within the past 4 weeks, renal dysfunction (creatinine level \>1.4 mg/dL) or the presence of coagulopathy before the procedure (international normalized ratio \> 1.5);
* acute pancreatitis within 3 days;
* pregnant or breastfeeding women;
* unwilling or inability to provide consent.
iNO300 Therapy in Critically Ill Patients With Pneumonia

The goal of this clinical trial is to learn the formation and recovery rate of methemoglobin (MetHb) in severely sick patients with pneumonia who receive high doses of inhaled nitric oxide (iNO) therapy at 250 parts per million (ppm), not exceeding 300 ppm. Meanwhile, the benefits of the therapy to treat severely sick patients with pneumonia will be explored. Patients who are 18 years or older, newly diagnosed with pneumonia, and severely sick with requirement of a breathing machine could be included. The main questions it aims to answer are:

How does methemoglobin change through the iNO treatment? Does iNO therapy increase the number of patients recovering from pneumonia? Researchers will compare iNO treatment to placebo, which means using the same device as the treatment group without delivering the study drug.

Participants will:

* Receive iNO treatment starting at 250 ppm, not exceeding 300 ppm, 40 min, every 6 hours, from day 1 to day 5
* Be followed up for 60 days

This study is designed as a pilot, double-blinded, randomized controlled trial to investigate levels of methemoglobin in the treatment group versus the control group and efficacy of high dose inhaled NO among critically ill patients with pneumonia. We will enroll 34 adult patients with newly diagnosed pneumonia and invasive mechanical ventilation who are admitted to the ICUs at Massachusetts General Hospital.

After enrollment, participants will be randomized in 1:1 ratio to intervention group or control group. Baseline characteristics will be collected.

During treatment period, patients allocated to the intervention group will receive high dose inhaled NO starting at 250 ppm (not exceeding 300 ppm), 40min, 4 times daily, for 5 days. The control group will receive sham intervention. Both groups will receive standard therapy.

During follow-up period, we will follow participants for a total duration of 60 days. Methemoglobin kinetic levels and efficacy outcomes will be collected.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Intubated and mechanically ventilated
* Within 72h of diagnosis of community- or hospital-acquired pneumonia
* Written informed consent obtained from patients or legally authorized representatives

Exclusion Criteria:

* Obvious signs of pregnancy (the third trimester) or active lactation.
* Baseline methemoglobin 3% or higher
* Genetic diseases including glucose-6-phosphate dehydrogenase deficiency, cytochrome b5 reductase deficiency, sickle cell disease
* Oxygen saturation \< 88% on 100% inspired fraction of oxygen
* Anemia with hemoglobin \< 7.0 g/dl
* Documented history of left ventricular ejection fraction less than 30%
* Acute cardiogenic shock requiring inotropic or mechanical support with an ejection fraction less than 20%
* eGFR \< 30 ml/min/1.73m\^2 or use of continuous renal replacement therapy
* Platelet count less than 30,000/μl and/or high risk of bleeding
* A decision to do-not-resuscitate
* Enrollment in another experimental antimicrobial treatment protocol
A Study Conducted Over 3 Periods to Look at the Drug in the Body

A study conducted over 3 periods to look at the drug in the body.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated written informed consent before any study specific procedures including consent for genetic research exploring genetic variations in CYP3A5
* suitable veins for cannulation or repeated venepuncture
* Subjects should have a body mass index (BMI) between 18 and 30 kg/m2

Exclusion Criteria:

* Abnormal vital signs (blood pressure and pulse) after 10 minutes supine rest, as judged by the investigator
* Prolonged QTcF \>450 msec or shortened QTcF \<350 msec or family history of long QT syndrome
* Suspicion of known Gilbert's disease
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee Osteoarthritis

The purpose of this study is to determine if Bone Marrow Concentrate may be successful in the treatment of osteoarthritis. Bone Marrow Concentrate is known to contain a community of cells that has been shown to have "regenerative" properties. This study is designed to evaluate the short-term clinical and x-ray outcomes of injections for hip and knee osteoarthritis.

Inclusion Criteria:

* Subjects must be scheduled for an autologous bone marrow hip or knee injection
* Subjects must have a diagnosis of hip or knee osteoarthritis
* Subjects must be between the ages of 18 and 85
* Subjects must be willing and able to sign Informed Consent
* Subjects must be willing and able to return for scheduled follow-up evaluations

Exclusion Criteria:

* Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment
* Subjects for whom baseline data is not available


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be scheduled for an autologous bone marrow hip or knee injection
* Subjects must have a diagnosis of hip or knee osteoarthritis
* Subjects must be between the ages of 18 and 85
* Subjects must be willing and able to sign Informed Consent
* Subjects must be willing and able to return for scheduled follow-up evaluations

Exclusion Criteria:

* Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment
* Subjects for whom baseline data is not available
Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis

This study is to test a new treatment method, arterial embolization of the shoulder (AES), to reduce the severity of pain and improve range of motion (ROM), and to see if it can be performed safely.

Purpose: The primary aims of this study are to determine if arterial embolization of the shoulder will reduce the severity of pain as well improve Range of Motion (ROM) caused by adhesive capsulitis and if it can be performed safely. The secondary aim is to determine if AES can result in the decreased necessity for ongoing conservative therapies, such as medication therapy and joint injections.

Participants: Twenty patients with adhesive capsulitis, resulting in shoulder pain that is refractory to conservative therapies, who are not planning to undergo surgery within 6 months.

Procedures (methods): This will be an open label 24-month pilot study with a small population undergoing AES to determine safety and efficacy. Clinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for arterial embolization of the shoulder, and follow-up visits at 24 hours, 1, 3 \& 6 months. An MRI will be performed at the 1-month visit to detect a change in capsular vascularity and to exclude complication.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe shoulder pain (VAS greater than 40mm), and
* diagnosis of adhesive capsulitis, and
* age \> 21, and
* pain refractory to at least 30 days of conservative therapy (pain medications, physical therapy, etc.)

Exclusion Criteria:

* current local infection, or
* life expectancy less than 6 months, or
* known advanced atherosclerosis, or
* rheumatoid or infectious arthritis, or
* prior shoulder replacement surgery, or
* uncorrectable coagulopathy as defined by INR \> 2.5 or platelets \< 30,000, or
* iodine allergy resulting in anaphylaxis, or
* renal dysfunction as defined by GRF of \< 45, or
* contraindication for magnetic resonance imaging, or
* known complete full thickness tear of rotator cuff, or
* currently pregnant
Paracoracoid Subscapularis Plane Block Versus Iso Block for Shoulder Surgery for Shoulder Surgery

Shoulder surgery is the second orthopedic operation cause post operative pain Interscalene block is the standard block for shoulder surgery but it cause phrenic nerve block and diaphragmatic hemipareses Iso block is the block used to block the brachial plexuses cord and suprascapular nerve And paracoracoid subscapularis block supra scapular nerve in supra scapular fosa and axillary nerve as it curves around humeral head

Two groups Group S for paracoracoid subscapularis block Group I for iso block Twenty patients for para coracoid subscapularis block with ultra sonography 50 mm 22G needle inserted anterior to the fascia and 15ml o.5% bupivicaine injected another twenty patients for iso block a linear probe of ultrasound is placed in the infraclavicular region to identify the cords the needle is inserted 2-3cm superior to the clavicle and advanced in.plane posterior to the clavicle toward the cods and 25ml local anaesthesia is injected

Eligibility Criteria:
Inclusion Criteria:

* male or female patient \>20year for shoulder surgery American Society of anaesthesiologist physical state 1 to2

Exclusion Criteria:

* refusal of patient Systemic infection Local infection Neurological or respiratory disease
Transient Receptor Potential Vanilloid One (TRPV1) Receptor Expression in Children With Retrosternal Pain

We would like to evaluate the changes in nerve innervation and TRPV1 receptor expression along with microscopic changes associated with heart burn and abdominal pain

Approximately 5% of children between 10-17 years of age report symptoms of heart burn, epigastric pain or regurgitation. This study will evaluate the changes in nerve innervation and TRPV1 receptor expression in children having upper endoscopy for evaluation of heart burn and abdominal pain.

Eligibility Criteria:
Inclusion Criteria:

* Retrosternal and/or epigastric pain and esophagitis
* Retrosternal and/or epigastric pain but no macroscopic or microscopic esophagitis
* Gastrointestinal symptoms such as diarrhea, regurgitation, rumination, vomiting, feeding aversion, non-organic failure to thrive, celiac disease with no macroscopic or microscopic esophageal inflammation
Afluria Pregnancy Registry

The study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with Afluria during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

Enrollment and data collection will be coordinated through a coordination center (CC). The minimum eligibility criteria required for enrollment are as follows:

* Sufficient information to confirm that the exposure of interest occurred during pregnancy and at which date.
* Sufficient information to determine whether it concerns a prospectively enrolled subject, since retrospective cases are ineligible for enrollment.
* Reporter (e.g. HCP) contact information to allow for follow-up

Exclusion Criteria:

* N/A
Repetitive Transcranial Magnetic Stimulation as an Analgesic Treatment in Endometriosis Chronic Pain : Feasibility

Endometriosis is associated with different types of pain (acute, chronic, excess nociception, neuropathic) generated by different mechanisms in the nervous system. The rTMS could provide significant analgesia for refractory endometriosis pain.

The aim of the study is to evaluate the feasibility of transcranial magnetic stimulation (rTMS) for analgesia on chronic refractory endometriosis pain.

The first step consists of the inclusion of 12 patients followed by the filling by each patient of the RedCap software of five simple numerical scales for 4 weeks . Realization of a brain and medullary MRI to allow neuronavigation. Realization of 5 sessions of rTMS in 5 days during the first week then evaluation (physical examination, questionnaires) in consultation on post-stimulation. Then followed for 28 days in total through self-assessment of pain that will be filled daily on REDCap and last consultation on D28 for further evaluation

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal (presence of at least one of the two ovaries and absence of clinical signs of menopause),
* Not pregnant or breastfeeding;
* At least one painful symptoms related to the existence of endometriosis (dyspareunia, dysmenorrhea, pain with defecation or urination, neuropathic pain);
* Average VAS\> 4/10, at least 4 days out of 7 for at least 3 months;
* Hormonal treatment failure continued in association or not for pain control;
* A level of understanding and satisfying expression in French;
* Monitoring possible during the duration of the study (4 weeks).
* These patients should be affiliated to the French social security and should have signed a written consent after receiving clear information.

Exclusion Criteria:

* Prior treatment with rTMS,
* Industrial accident or notion of litigation
* Cons-indication for rTMS (cortical lesion within 2cm of the motor cortex, ECT treatment during previous month, epilepsy and / or a history of epilepsy, history of head trauma, intracranial hypertension;
* Metal clip; pacemaker,
* Pregnant or breastfeeding women;
* Pain lasting less than 3 months;
* Another pain more severe than that associated with endometriosis;
* Lack of filling of the computerized questionnaires on Redcap;
* Incapable of understanding about informed consent,
* Patient under guardianship.
Fluorescence Angiography: Planning and Monitoring of Perforator Flaps

The purpose of this study is to determine whether fluorescence angiography is an effectiveness technique for the localization of vascular perforators and their area of perfusion and for the postoperative monitoring of flap perfusion.

Reconstructive surgery is intended to replace amputated anatomical regions by autologous tissue taken from distant locations: flaps. The goal is to restitute ad integrum with minimal sequelae. Among the flaps available, perforator flaps have the advantage of being highly plastic, large and can be taken from accessory vessels the loss of wich does not compromise the vitality of the sampling site. However their more variable anatomy requires irradiating preoperative morphological assessment (CT angiography) or a doppler ultrasonography that is not always performed by the surgeon himself and does not distinguish between muscle perforator and skin perforator.

Fluorescence angiography is a superficial exploration technique of vascularization. After intravenous injection of a tracer (indocyanine green ICG), fluorescence angiography provides useful surface angiographic imaging in real-time. It can also help in monitoring intraoperative and postoperative quality of vascular anastomoses. Although fluorescence angiography has numerous applications (ophthalmology, neurosurgery, liver transplantation...), its usefulness in surgical flaps is only supported by a few publications. None really validate its clinical value by comparing it to reference investigations (CT angiography or doppler ultrasonography).

40 candidate for reconstructive surgery will be included in this study. The day before surgery, in addition to the usual technique used to locate perforator flaps, the patient will receive an injection of 0.025 mg / kg Infracyanine® (indocyanine green) and the area of interest of the flap will be explored with the Fluobeam™ camera.

Two hours after the surgery, during the usual clinical monitoring of the vitality of the flap, a new injection of Infracyanine® will test perfusion of the flap by measuring fluorescence intensity of the target area. These measurement will then be repeated every 6 hours for 4 days.

Eligibility Criteria:
Inclusion Criteria:

* perforator flap reconstruction whatever the indication (cancer, trauma, malformations). The main targets are the fibula flaps, anterolateral thigh flaps and inferior epigastric flaps
* consenting patient

Exclusion Criteria:

* known indocyanine green allergy
* pregnant woman, parturient woman or nursing woman
Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers

This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of itraconazole or rifampin on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.


Eligibility Criteria:
Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
* Female subjects must be of non-childbearing potential.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease.
* Pregnant or nursing females.
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
* A positive urine drug screen at screening or Day -1.
* Current tobacco smokers or use of tobacco within 3 months prior to screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
* History of regular alcohol consumption.
* Participation in a clinical trial within 30 days prior to the first dose of study drug.
Evaluation of Pharmaceutical Care in Depressed Outpatients

The study examines whether pharmacotherapeutic follow-up improves outcomes of treatment of depressed outpatients.


Eligibility Criteria:
Inclusion Criteria:

* women between 18 and 65 years, with diagnostic hypothesis of depression at the beginning of treatment or change in treatment unless 2 months (dosage or substance)

Exclusion Criteria:

* record of dependence on psychoactive substances, diagnosed schizophrenia,
* low education (illiterate) or cognitive impairment evident that compromise the completion of research instruments
Sedation and Ventilator Weaning Protocol in PICU

This research is a single-blinded, randomized controlled trial involving mechanically ventilated children in Pediatric Intensive Care Unit, Cipto Mangunkusumo Hospital, Indonesia. Subjects were divided into two groups: intervention vs control group. Primary and secondary outcomes will be measure pre, during, and post treatment.

As of today, there is no sedation and ventilator weaning protocol in our PICU. Decision for sedation and ventilator weaning were based on attending physicians clinical judgement, which greatly varies among individual. Previous study on the use of these protocols showed a favorable outcome. We aim to assess the safety and effectiveness of this protocol in our PICU.

Subjects were recruited consecutively and randomized into intervention and control group.

* Intervention group: sedation and ventilator weaning protocol
* Control group: no protocol

Primary outcomes:

* FLACC score
* COMFORT score
* Ventilator days

Secondary outcomes:

* Self extubation
* Reintubation
* PICU Length of stay
* Frequency of asynchrony
* NIRS value
* VIS score

Eligibility Criteria:
Inclusion Criteria:

* Patient who need mechanical ventilation for more than 12 hours

Exclusion Criteria:

* PICU admission due to post cardiac and respiratory arrest
Procalcitonin Monitoring Sepsis Study

The purpose of this study is to investigate the relationship between a procalcitonin decrease over 72 hours and outcome in patients who have severe sepsis or septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (i.e. \>18 years of age) diagnosed with severe sepsis or septic shock as defined in Appendix 1, who are already in the ICU or come from the ED, other wards or directly from out of hospital
* Blood sample collection within 12 hours after diagnosis "severe sepsis or septic shock"No prior enrollment into this study
* Written informed consent