cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Management of Tramadol Use Disorders

In France, In recent years, there has been a steady increase in reports of abuse and dependence on tramadol. Over 50% of tramadol withdrawal syndromes involve taking tramadol in therapeutic doses, sometimes for short periods of less than a week. Physical dependence can develop when a therapeutic maintenance dose is prescribed for the treatment of mild to moderate pain. Due to its mixed mechanism of action, tramadol withdrawal syndromes are not only characterized by classic signs of opioid withdrawal (muscle pain, mydriasis, sweating, nausea and vomiting, tearing, rhinorrhea, yawning, fever, insomnia, etc.). The properties of this substance on serotonin explain the effects which are added to the morphine-mimetic withdrawal of tramadol. Analysis of spontaneous reports shows "psychological and psychic" signs of withdrawal. Currently, there is no validated protocol for the management of tramadol withdrawal. The main objective is to assess the different options for managing tramadol withdrawal: opioid maintenance therapy and symptomatic treatments, in relation to the addictive and psychiatric co-morbidities in patients. The study also provides insight into the different types of withdrawal syndromes experienced by patients in order to raise awareness among doctors when prescribing tramadol.


Eligibility Criteria:
Inclusion criteria:

* \>18 years old
* Tramadol actual misuse/addiction
* Patients hospitalized for Tramadol withdrawal

Exclusion criteria:

* \<18 years old
* History of misuse or addiction for tramadol
Study for the Recording of Adherence to Treatment With Perindopril/Indapamide/Amlodipine Fixed Dose Combination

The main objective of this study is to record, in routine clinical practice, patients' adherence to treatment with Perindopril/Indapamide/Amlodipine fixed dose combination, during 4 months treatment.

This is a non-interventional study aiming to record adherence to treatment with Perindopril/Indapamide/Amlodipine fixed dose combination. In parallel blood pressure levels will be recorded, as well as safety and tolerability of this fixed dose combination.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, ambulatory patients \>18 years old.
* Clinically diagnosed essential arterial hypertension.
* Under treatment with Perindoril/Indapamide/Amlodipine fixed dose combination.
* The patient has given his/her written consent after being informed, before his inclusion in the study.

Exclusion Criteria:

* Secondary arterial hypertension.
* Serious end stage diseases, severe neuropsychiatric diseases, cerebrovascular event with serious residual lesions, scheduled procedure or surgical operation or hospital admission.
* Pregnancy, lactation or intention to become pregnant.
Cohort Study of HIV-1 Incidence Among Clients of the Thai Red Cross AIDS Research Center, Bangkok, Thailand

The purpose of this study is to assess populations in Thailand at high risk for HIV-1 infection for potential efficacy trials of candidate HIV vaccines to include:

1. assess incidence of HIV-1 and volunteer retention
2. describe early viral load and CD4 counts
3. assess participant willingness to participate in HIV vaccine efficacy trials and other HIV prevention trials
4. describe volunteer risk behavior

Prospective cohort study of HIV-negative participants who will receive voluntary counseling and testing (VCT) for HIV-antibody in conjunction with questionnaires on risk behavior, willingness to participate in HIV vaccine trials and other HIV prevention trials at 4 month intervals for a period of 1 year. This study will follow 1000 HIV-negative volunteers with an expected minimum of 15-20 incident HIV-infections based on a minimum incidence rate of 1.5/100 person-years. Weighted incidence estimates will be calculated with exact 95% confidence intervals.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged 18-50 years
* Willing to provide location or contact information and allow contact
* Thai citizenship as identified by Thai National Identification card
* Ability and willingness to provide consent
* Availability for follow-up for the planned study duration

Exclusion Criteria:

* Persons who have a history of a medical or psychiatric disorder, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent
* Persons who are known to be HIV-positive
Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation

In Korea, oral chloral hydrate is still widely used for pediatric procedural sedation. The primary objective of the study is to evaluate the effect of intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) on the success rate of rescue sedation after failed sedation (PSSS=4,5) with chloral hydrate (50mg/kg) The hypothesis of this study is that the intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) will improve the success rate of rescue sedation (PSSS=1,2,3) within 15 minutes. This is a prospective, parallel-arm, single-blinded, multi-center, randomized controlled trial comparing the effect of intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) with oral chloral hydrate (50mg/kg) in pediatric patients after failed sedation attempt with oral chloral hydrate. Prior to the procedure, each patient will be randomized in the control arm (oral chloral hydrate) or study arm (intranasal dexmedetomidine and ketamine).


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients who need procedural sedation (Age \< 7 years)
* ASA (American Society of Anesthesiologists) physical status 1-3
* Failed to induce sedation with oral chloral hydrate 50mg/kg

Exclusion Criteria:

* ASA (American Society of Anesthesiologists) physical status 4-5
* History of hypersensitivity to Dexmedetomidine, Ketamine, or Chloral hydrate
* Recent administration of Alpha 2 adrenergic receptor agonist or antagonist
* Cannot administrate oral medication (e.g. Swallowing difficulty)
* Cannot administrate intranasal medication(e.g. Excessive rhinorrhea)
* Unstable vital signs, Unstable arrhythmia
Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency

The purpose of this study is to evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and up
* Patients with maximum serum growth hormone concentration of less than 5 ng/ml
* Patients who can successfully complete this study based on appropriate medical judgment or who expect to benefit from this study
* Persons who have agreed in writing to participate in this study

Exclusion Criteria:

* Persons who are currently under treatment after being diagnosed with a malignant tumor
* Hepatosis
* Renal function disorder
* Intra-cranial hypertension
* Proliferative diabetic retinopathy
* Persons who carry acromegaly activity
* Fertile women who are not pregnant or who do not take appropriate contraceptive measures and whose urine tested positive for hCG (human Chorionic Gonadotropin)
* Mental patients and/or drug addicts and alcoholics
* Patients who had participated in the other drug study within the last 30 days prior to participating in this study
* Patients considered unfit for this study by the attending physician
Establishment of Natural History of Scorpion Envenomation

This retrospective study was conducted to collect data from approximately 100 patients from 6 months to 18 years of age who were stung by a scorpion but were not treated with antivenom. The study consisted of a review of hospital records of patients who were admitted for intensive care management of scorpion envenomation, at the only two hospitals in North America known to admit children routinely for scorpion sting management without antivenom. The standard of care consisted of symptomatic and supportive care, including airway maintenance, fluid and electrolyte support and, if necessary, sedation.

The study objective was to document the clinical syndrome of scorpion envenomation in the absence of antivenom treatment in pediatric patients. This was done to establish historical control data on the time from sting to the time of resolution of signs of envenomation. These historical control data are intended to be used for comparison with Alacramyn treated patients in two prospective studies being conducted in Mexico and the U.S.for which a control population could not otherwise be established.

The total duration of clinically important systemic signs of envenomation was determined based upon overall investigator assessment of the last signs of any respiratory compromise, any pathological agitation or other indicator of continuing illness (e.g., continuing need for sedative administration).

To facilitate comparison of these historical data with prospective open label trials, periodic assessments of the overall presence or absence of clinically important signs was performed. Periodic assessments were also performed for each individual component indicator of respiratory compromise and of pathological agitation, when available.

A research nurse reviewed hospital discharge diagnoses for all pediatric charts coded for "scorpion sting". For these cases demographic, diagnostic, and therapeutic data were entered on the case report form (CRF) as well as data necessary to assess compliance with study inclusion and exclusion criteria.

A physician subinvestigator reviewed the research nurse's findings for the key outcome indicators, which consisted of clinically important systemic signs of scorpion envenomation and adjunctive sedation treatment (dose and timing of dose) when medical judgment was required.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 6 months to 18 years of age
* Presenting for emergency treatment with clinically important systemic signs of scorpion sting envenomation

Exclusion Criteria:

* Use of any antivenom within the last month or concomitantly
* Signs and symptoms confined to local sting site
* Concurrent medical condition involving a baseline neurologic status mimicking envenomation (chorea, tardive dyskinesia, uncontrolled epilepsy)
* Incomplete or unavailable medical record
Function of Tamsulosin in Older Males Undergoing Surgery with Indwelling Catheter

This study is being done to answer the question: What is the impact of a medication called tamsulosin (also called Flomax) on the rate of postoperative urinary retention (POUR) and catheter-associated urinary tract infection (UTI)? One of the most common complications following surgery and associated with Foley catheters is post-operative urinary retention (POUR) after the catheter is removed. This is defined as being unable to urinate spontaneously within 8 hours following the removal of the indwelling Foley catheter (the catheter that sits in your bladder to drain urine after surgery). When this happens, it requires intermittent straight catheterization of the bladder (placing a temporary catheter in the bladder to drain the buildup of urine), which can cause a lot of discomfort and anxiety, as well as increase the risk of catheter-associated urinary tract infection (CAUTI).

All participants in this study will be males who are undergoing a planned surgery on their liver, gallbladder/biliary tract, pancreas, colon, or rectum for any reason. If able to obtain appropriate consent from a legal representative, cognitively impaired patients may be included. After having surgery where a catheter is placed in the bladder to drain urine (this is called a Foley indwelling catheter), the catheter eventually gets removed, and some of the most frequent problems that can happen after that are post-operative urinary retention (POUR) and catheter-associated urinary tract infection (CAUTI).

The goal of this study is to see if a medicine called tamsulosin (also called Flomax) can decrease the rate of POUR, which means not being able to urinate spontaneously like normal, and CAUTI, which means an infection in the urinary tract. This study is important because POUR and CAUTI can cause harm to patients, including discomfort if a temporary catheter has to be placed back in the bladder to get the urine out, infection, anxiety, and stress, and it's known that these complications can also increase hospital charges.

Eligibility Criteria:
Inclusion Criteria:

* Planned for elective surgery for any reason (benign, malignant, or indeterminate lesion) with either an open or minimally invasive approach (hepatobiliary, pancreatic, and colorectal operations)
* Male and age ≥50 years
* Deemed physically fit for surgery

Exclusion Criteria:

* Inability to obtain informed consent
* Age \<50 years
* Female
* Baseline creatinine \>1.5x upper limit of normal
* Tamsulosin therapy as a home-medication
* Procedure involving the prostate, bladder, ureters, or kidneys
* Planned Foley catheter removal on the same day of surgery
* Planned nasogastric tube retention on postoperative day 1
* Individuals taking daily phosphodiesterase 5 (PDE5) inhibitors (due to the risk of symptomatic hypotension if given with tamsulosin)
MR Imaging Study of TBI in Children

This project will combine the data collected from structural and functional MRI scans and neuropsychology performance post-TBI in children. Patients will be followed for a year, in order to examine the brain and cognitive recovery post head injury.

Traumatic brain injury in childhood has an cumulative effect that leads to impairments in cognitive functions such as deficits in memory, executive functions and attention. The cognitive impairment is the main cause of disabilities in the injured population, and has a different effect depending on the type and severity of the injury.

Imaging after brain trauma serves as a useful diagnostic tool in identifying the head trauma's results. Therefore, in recent years, using imaging methods, studies have tried to find measures which will be able to predict the functional outcome after brain injury in children, and assist in developing a personalized rehabilitation program. The combination of advanced imaging techniques with neuropsychological assessment within the early stage of the injury and during a year of followup, will allow us to establish the relationship between those measures and the functional recovery result of the children. This multi-analysis will enable us to have a deeper understanding of the neuroplasticity process and the functional recovery after brain injury in the developing young brain.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 9-18 years old, which are/were hospitalized in the Pediatric Rehabilitation Department, Sheba Medical Center
2. Glasgow coma scale score of 3-15.
3. Hebrew as mother-tongue

Exclusion Criteria:

1. History of neurological disorders, mental retardation or a previous head injury.
2. Current diagnosis or history of psychiatric disorders.
3. Cardiovascular instability.
4. Metabolic instability (water, electrolytes, sugar).
5. Fever or evidence of microbiological pollutant.
6. Uncontrolled seizures. 7 . Hydrocephalus.

8. Deafness or blindness. 9. Renal failure.
Open Label Trial of Rapastinel (Formerly GLYX-13) in Individuals With Obsessive-Compulsive Disorder

This research study tests whether GLYX-13 - an experimental drug that acts on a brain receptor called NMDA - can decrease symptoms of OCD within hours. This is not a treatment study. Results from this study will allow doctors and researchers to better understand if you and others with OCD may respond to a class of medications that target the NMDA brain receptor.


Eligibility Criteria:
Inclusion Criteria for Patients with No medication Washout:

* Age 18-55
* Physically healthy and not currently pregnant
* Primary Diagnosis of OCD
* currently off all psychotropic medications and other drugs
* Able to provide informed consent

Exclusion Criteria for Patients with No Medication Washout:

* Psychiatric conditions that make participation unsafe (schizophrenia \[either self or first degree relative e.g. siblings, parents\], history of violence, severe depression, eating disorder, substance abuse in prior year\[including nicotine\], lifetime substance dependence disorder \[except nicotine\])
* Female patients who are either pregnant or nursing
* Enrolled in or planning to enroll in Cognitive Behavioral Therapy.
* Medical conditions that make participation unsafe (e.g., high blood pressure, head injury)
* Currently on medications that make participation unsafe
* History of allergy, sensitivity, or intolerance to N-methyl-D-aspartate receptor (NMDAR) ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.

Inclusion Criteria for Patients with Medication Washout:

* Age 18-55
* Physically healthy and not currently pregnant
* Primary Diagnosis of OCD
* Currently on adequate dose of medication for treatment of OCD, but have not achieved at least partial remission and able to handle a medication washout.
* Able to provide informed consent

Exclusion Criteria for Patients with Medication Washout:

* Psychiatric conditions that make participation unsafe (schizophrenia \[either self or first degree relative e.g. siblings, parents\], history of violence, severe depression, eating disorder, substance abuse in prior year\[including nicotine\], lifetime substance dependence disorder \[except nicotine\])
* Female patients who are either pregnant or nursing
* Enrolled in or planning to enroll in Cognitive-Behavioral Therapy.
* Patient judged unlikely to be able to tolerated a medication washout.
* Medical conditions that make participation unsafe (e.g., high blood pressure, head injury)
* Currently on medications that make participation unsafe
* History of allergy, sensitivity, or intolerance to N-methyl-D-aspartate receptor (NMDAR) ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.
Epidemiology of Hepatitis C Virus Infection Among Opioid Substituted Patients

The aim of the present study is to estimate the national annual prevalence and incidence of current hepatitis C virus (HCV) infections among opioid dependent individuals in opioid substitution treatment (OST) based on a representative sample of approximately 2,500 outpatients in 100 substitution facilities across Germany. Furthermore, the study aims to describe factors influencing HCV therapy initiation and seroconversion during OST.

In this non-interventional, observational, longitudinal study, data is collected at two time points. The primary outcome measures HCV prevalence and incidence will be based on documentation from routine patient care at baseline and 12-month follow-up. Secondary outcome measures will be investigated by means of surveys of opioid substituted patients and their clinicians (completed at baseline), as well as data from routine patient care.

The sample size calculation is based on the primary outcome variable of HCV incidence among OST patients. The literature reports an HCV incidence of about 4/100 person-years +/- 2 new infections per 100 person-years in this target group. For a partial sample size of (at least) 32 patients with HCV seroconversion and an observation period of 1 year, 800 HCV antibody-negative patients are needed as an initial group for observation. Assuming an HCV antibody prevalence of 68% among OST patients, 2500 patients are needed in total (32% corresponds to N = 800).

Recruitment of clinicians is conducted via the national Substitution Registry in which all clinicians in Germany, who hold a qualification to prescribe substitution medication, are registered. To ensure that all substituting clinicians in Germany are considered in the present study, the investigators sent study invitations to all 3,356 addresses in the Substitution Registry as of 31.12.2013. Of the clinicians eligible for participation, a representative sample of clinician is drawn according to two criteria: 'German Federal State' (GFS) and 'Number of Patients Per Clinician' (PPC). Using the SPSS Complex Samples Procedure, clinicians are stratified by GFS and PPC, such that each GFS is represented at least once, and such that the same proportions of clinicians per GFS and per PPC category are achieved (to the best of our ability) as in the total sample of clinicians registered in the Substitution Registry.

Eligibility Criteria:
Inclusion Criteria:

* minimum age 18
* diagnosed opioid dependence according to the ICD-10
* currently in opioid substitution treatment

Exclusion Criteria:

* severe mental impairment
* insufficient German reading and writing skills
The Effect of Fatima Ana's Hand on Birth Pain and Duration

Research Question: Does the Anastatica Hierochuntica have an effect on labor pain and duration? Methods: This study was planned as a a double blind randomized controlled experimental study. The study was conducted with 60 pregnant women who were randomized between February 2019 and November 2020 at a university and private hospital located in Anatolia, Turkey.

Complementary treatment methods during the birth process are supportive therapies. It is applied to meet the physical and psychological care needs, to help cope with pain during childbirth, to increase the quality of life of pregnant women. Mind-body methods, alternative medical methods, biological-based treatment methods, manipulative and body-based methods, and energy therapy methods are used as complementary treatment methods in labor. The focus applied within the scope of mind-body methods is based on the principle of revealing the mental skill that improve bodily functions. One of the methods applied in this direction is Anastatica Hierochuntica.

Anastatika Hierochuntica is a herbaceous plant that can live 1000-2000 years, with dry leaves resembling a fist-closed hand in which it stores its seeds. Known as "Fatma Ana Eli" or "Meryem Ana Eli". This dry ball-shaped plant in the deserts of Namibia comes alive in the rain and turns to green color by opening the folds. After the rain, the leaves of the plant, which stores some water to pass through a new drought period, close again and take a dry appearance.

The plant Anastatica Hierochuntica is known to have a facilitating effect on labor and is frequently used for this purpose during labor. During childbirth, the Anastatica Hierochuntica plant is dropped into a bowl of water. It is believed that as the plant opens, labor will be easier, and the baby will flow like water.

Despite its frequent use, when the literature is examined, no studies hasve been found on the effect of Anastatica Hierochuntica on birth. For this reason, the study was conducted to evaluate the effect of Anastatica Hierochuntica on labor pain and duration.

Eligibility Criteria:
Inclusion Criteria:

* Having a singleton pregnancy at 38-42 weeks,
* Pregnant women who had spontaneous labor,
* Pregnant women with a healthy fetus,
* Pregnant women without any complications that may cause dystocia during labor,
* Pregnant women who did not receive analgesia and anesthesia during the first phase of labor,
* Planned vaginal delivery, pregnant women who volunteered to participate in the research

Exclusion Criteria:

pregnant women with high-risk pregnancies, Planned caesarean delivery, pregnant women with chronic diseases