cyrilzakka/clinical-trials huggingface dataset:
Single Low-dose Primaquine Efficacy and Safety.

Background: The World Health Organization has recommended addition of a 0.25 mg/kg single-dose primaquine (PQ) to standard artemisinin-based combination therapy (ACT) for elimination of malaria in low transmission-settings and for containment in areas threatened by artemisinin resistance. However, PQ metabolism is dependent on a highly polymorphic cytochrome P450 (CYP) 2D6 isoenzyme which probably compromises the drugs' safety and efficacy, particularly in individuals with reduced isoenzyme activity. This trial therefore, aims to assess the safety and efficacy of 0.25 mg/kg single-dose PQ when added to standard artemether-lumefantrine regimen for clearance and sterilization of Plasmodium falciparum gametocytes in patients with CYP450 2D6 reduced/null activity as compared to those with normal/increased enzyme activity.

Methods: On hundred and fifty-five children aged between 1 and 10 years and with uncomplicated P. falciparum malaria will be enrolled, treated with standard artemether-lumefantrine regimen plus a 0.25 mg/kg single-dose of PQ and then followed up on days 0, 1, 2, 3, 7, 14, 21 and 28 for clinical and laboratory assessment. Primaquine will be administered together with the first dose of artemether-lumefantrine. Safety assessment will be performed using the Primaquine Roll Out Monitoring Pharmacovigilance Tool (PROMPT). Gametocytes will be detected and quantified by microscopy and Pfs25 mRNA quantitative nucleic acid sequence based amplification (QT-NASBA) on days 0 and 7. For a subset of 100 participants, post-treatment infectiousness will be assessed by mosquito feeding assays on day 7. The CYP2D6 status will be determined using a polymerase chain reaction (PCR) followed by a restriction fragment length polymorphism (RFLP). The primary outcome will be the safety of single low-dose primaquine in patients with CYP2D6 reduced/null compared to those with normal/increased activity.

Expected outcomes: The findings will provide the much-needed information on the safety and efficacy of single low-dose primaquine for clearance and sterilization of P. falciparum gametocytes in individuals with reduced/null compared to those with normal/increased CYP450 2D6 isoenzyme activity prior to the implementation of the treatment policy particularly in Africa.


Eligibility Criteria:
Inclusion Criteria:

* Age from 1 to 10 years
* Weight ≥ 10 kg
* Body temperature ≥ 37.5°C or history of fever in the last 24 hours
* Microscopy confirmed P. falciparum mono-infection
* Parasitemia level of 2000 - 200000/µL
* Ability to swallow oral medication
* Ability and willingness to abide by the study protocol and the stipulated follow up visits
* Written proxy informed consent from a parent/guardian.

Exclusion Criteria:

* Evidence of severe malaria or danger signs
* Known allergy to trial medicines
* Reported antimalarial intake ≤ 2 weeks
* Hemoglobin \< 5 g/dL
* Blood transfusion within last 90 days
* Febrile condition other than malaria
* Known underlying chronic or severe disease
Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fed Conditions

This is a single Dose Two-Way Crossover Fed Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80mg, Bristol Myers Squibb in Healthy Volunteers.

Single Dose Two-Way Crossover Fed Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80 mg, Bristol Myers Squibb in Healthy Volunteers.

A total of 24 non-smoking subjects (18 men and 6 women) were included in this study, of which 23 finished the study according to the protocol.

The washout period (7 days) between the two periods of the study and with an equal number of subjects randomly assigned

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females at least 18 years of age inclusive.
* Informed of the nature of the study and given written informed consent.
* Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs. (Appendix I and II).

Exclusion Criteria:

* Hypersensitivity to Pravastatin (pravachol®), or similar compounds.
* Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
* Recent history (within 1 year) of mental illness, drug addiction, drug abuse or alcoholism.
* Donation of greater than 500 m1 of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
* Received an investigational drug within the 4 weeks prior to study dosing.
* Currently taking any prescription medication, except oral contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins, or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
* Tobacco use (\>5 cigarettes per day) in the 3 months prior to study dosing.
* If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods. Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
The Effect of Vagus Nerve Stimulation on Cycling Ergometry and Recovery

It is aIt is aimed to examine the possible benefits and effects of the use of Transcutaneous Auricular Vagus Nerve Stimulation to be applied in healthy individuals for sportive purposes on recovery and sportive performance level.

The 90 people between the ages of 18-35 will be included in the study. Each participant will be randomly divided into 3 groups to be homogeneous after the necessary calculations are made by evaluating with age, gender, weight, height and body mass index before starting the study.

The groups are; It will be in the form of Unilateral Stimulation (n=30), Bilateral Stimulation (n=30) and Bilateral Sham Stimulation (n=30) groups.

After the initial assessment, participants in all groups will be asked to do 30 minutes of cycling exercise at maximum performance under the same wattage load. Cycling will be re-evaluated after exercise. After the assessment is complete, stimulation will be given with Vagustim for 20 minutes non-invasively. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated.

After the pain and fatigue rating scale, the evaluation will be completed by determining the lactate level in the blood with the Lactat Scout. Vagus nerve stimulation will be applied with the Vagustim device for 20 minutes, keeping it biphasic, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current where the participant feels the current comfortably.

At the end of the Cycling Ergometer Test and Vagus nerve stimulation, the Autonomic Nervous System, pulse and blood pressure will be evaluated with Polar H10 within 5 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals between the ages of 18-35,
* Willingness to participate in the study
* Having signed the informed consent form

Exclusion Criteria:

* Cases do not want to continue the study.
* Having regular sports habits or starting in the working process,
* Having a disease related to the respiratory system and starting to use drugs
* Having a disease related to the cardiac system and starting to use drugs
* Presence of any chronic disease and using a drug related to it
Burn Healing and Analgesia With Propranolol

The purpose of this study is to investigate the ability of propranolol to decrease pain and improve recovery in burn patients with a common genotype.


Eligibility Criteria:
Inclusion Criteria:

* Thermal burn
* Greater than or equal to 18 years of age
* Less than 60 years of age
* Able to speak and read English

Exclusion Criteria:

* Intubated
* Clinically unstable
* Other substantial comorbid injury (e.g. long bone fracture)
* Heart block greater than first degree (EKG)
* History of coronary artery disease
* History of congestive heart failure
* Asthma (within past 10 years, induced by a beta-blocker, or receiving current treatment)
* Pregnant
* Prisoner
* Psychotic, suicidal, or homicidal
* Diabetic
* Hepatic failure (acute or chronic)
* Renal failure (acute or chronic)
* History of hyperthyroidism unless taking synthroid or other thyroid hormone replacement
* Exceeds daily acceptable chronic opioid use prior to burn
* Interacting medication
* Received propranolol within the last 6 months
* Multiple severe allergic reactions
* On daily methylphenidate or similar stimulant medication
* Unwilling to use medically acceptable birth control (if childbearing potential)
* Breastfeeding
* Severe peripheral vascular disease or vasospastic disorder
* Bradycardia that in the opinion of the investigator would constitute too great a risk when considered in the context of the patient's medical comorbidities and health history
* Other criteria that in investigator's opinion makes participant poor candidate for the trial
* Cancer (except basal cell cancer)
Assessment of Microfragmented Adipose Tissue Loaded on Bovine Graft Versus Bovine Graft Only on Ridge Preservation.

Evaluation of maxillary alveolar ridge changes (bone quantity and quality as revealed by Radiographic and Histomorphometry) utilizing microfragmented adipose tissue loaded on bovine graft versus bovine graft only for maxillary posterior ridge preservation.

All patients involved in this study will be divided into two groups; each group will receive a different graft of bone augmentation: Adipose tissue loaded on bovine graft will be utilized for the study group and bovine raft only for the control group.

After 6 months, patients will be evaluated histomorphometrically via core biopsy at the time of implant placement and radiographically via assessment of ridge height on CBCT.

Radiographic assessment that will be achieved by CBCT scan will be used to calculate the changes of bone height from base line (1week) to 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring implant treatment after tooth extraction due to either unrestorable caries lesions or affected periodontium.

  * Age group: above 21 years
  * Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.

Exclusion Criteria:

* General contraindications to implant surgery.

  * Subjected to irradiation in the head and neck area less than 1 year before implantation.
  * Poor oral hygiene and motivation.
  * Severe bruxism or clenching.
  * Systemic, immunologic, or debilitating diseases that could affect normal bone healing \& local pathosis.
  * Treated or under treatment of intravenous amino bisphosphonates.
  * Active infection or severe inflammation in the area intended for implant placement.
  * Patients participating in other studies if the present protocol could not be properly followed.
  * Heavy smokers
Post Market Clinical Follow-Up of Acetabular Titan-Augment Structan®

Implant Survival as well as clinical and radiological Follow-Up of acetabular Titan-Augment Structan®


Eligibility Criteria:
Inclusion Criteria:

* Minimum age 18 years
* Indication for cementless hip arthroplasty with acetabular defects that need Allograft or titanium augment
* Patient consent for study participation
* Physical and mental willingness to participate in the follow-ups

Exclusion Criteria:

* Patient not available for follow-up
* Increased anesthetics risks for the patient according to the "American Society of Anesthesiology": ASA IV
* Tumor
* Alcohol- or Drug abuse
* Permanent cortisone therapy
* Clinically relevant infection
* (Planned) pregnancy
Anticoagulant Therapy and 28-days Mortality in Critically Ill COVID-19 Patients

The aims of the study are to to associate anticoagulation (AC) regime with outcome in critically ill patients with Covid-19. This will be done by describe baseline characteristics and comorbidities before hospital admission, level of organ support and dose of AC treatment and associate this with 28 days survival, survival outside ICU, thromboembolic event and bleeding complications.


Eligibility Criteria:
Inclusion Criteria:

* laboratory confirmed positive test for SARS-CoV-2
* admitted to ICU because of critical illness due to covid-19

Exclusion Criteria:

* patients with treatment for thromboembolic complications at arrival to the ICU
* short ICU length of stay defined as discharged the same or the following day as ICU admission
Effect of CO2 Laser on Enamel White Spot Lesion Formation Around Orthodontic Brackets

This study aims to evaluate the clinical effect of CO2 laser on enamel resistance to white spot lesions formation around orthodontic brackets.

25 patients needing fixed orthodontic treatment will participate in the study, the CO2 laser will be applied in a split mouth design around orthodontic brackets in two contrast quarters of mouth in every patient and the other quarters will serve as a control. The white spot lesion formation will be monitored around the brackets during the orthodontic treatment after four and twelve weeks of irradiation with laser.

Prior to enrollment of each subject into the study, they will be examined completely to determine the orthodontic treatment plan. The operator will inform them about the aim of the study and ask them to provide a written informed consent.

Before brackets' bonding (T0) the operator will evaluate with intraoral clinical examination and take intraoral photographs and evaluate with DIAGNOdent. Then after brackets' placement on teeth, the CO2 laser will be applied to the area of enamel about 2 mm of width around orthodontic brackets in a split mouth design. To blind the intervention sides on patients the control sides will receive nontherapeutic light.

Then intraoral photographs will be taken and the teeth will be assessed with DIAGNOdent (T1).

All patients will be trained to brush their teeth with a tooth paste containing 1100 ppm of fluoride twice a day. After 4 weeks of irradiation (T2) the patients will be examined for white spot lesions formation by clinical examination using Geiger index, photographic examination using AutoCAD 2009 evaluating formation and area percentage of white spot lesions, and the degree of demineralization will be assessed with DIAGNOdent. The all exams will also be done after 12 weeks of irradiation (T3).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with permanent occlusion at age 15-25 years.
* No previous orthodontic treatment
* Good oral hygiene
* Need to orthodontic treatment with fixed appliances

Exclusion Criteria:

* Patients with systemic diseases or syndromes
* Patients with existence of enamel fluorosis
* Patients with existence of amelogenesis imperfecta or hypocalcified enamel
* Patients with existence of restorations or crowns or carious lesions on the labial surfaces of teeth.
* Patients who received fluoride treatment within the last three months prior to being enrolled in the study.
Worksite Phone Counseling for Smoking Cessation

Social support is poorly understood but likely to influence outcomes of behavior change efforts. Social support may take a directive or nondirective approach. In directive support, the person attempting a behavior change is told what to do and even what to think. In nondirective support, the person attempting the behavior change decides what to discuss. In some contexts, interactions of race or income with social support have been reported. This is a randomized controlled trial of directive and nondirective coaching in the context of a smoking quitline offered to employees of two large corporations.

BACKGROUND Given the association of smoking with low socioeconomic status, the potential of telephone counseling for smoking cessation to reach diverse audiences needs evaluation. In addition, different approaches to counseling have not been systematically examined, and may differentially affect reach, retention, and success.

PURPOSE To describe employee participation and outcomes in a trial of two counseling styles for telephone-based smoking cessation support.

APPROACH Employees and spouses of two large organizations are invited to participate in a trial of a telephone quitline. Participants are randomized to one of two coaching styles. A protocol-driven (Directive) coaching approach follows a script for each of seven calls over 9 weeks. A participant-centered (Nondirective) coaching approach allowed smokers to select topics of interest, with prompting by the coach as needed. A computer assisted telephone interview program and database provide topics in correct sequence for directive coaching, allow coaches to indicate topics during nondirective coaching, and track time spent on topics in both conditions.

PREDICTOR VARIABLES Demographics, smoking history and conventional self-reported measures of nicotine dependence, smoking urges, preference for patient-centric care, and depression are collected at baseline.

OUTCOMES The primary outcome measure is self-reported abstinence from smoking for 7 days at the time of last follow up, 6 or 12 months after baseline assessment.

ANALYSES Interactions of Race and Income with coaching approach are analyzed. Based on results with asthma patients, a positive interaction of low income with nondirective coaching is tested.

Eligibility Criteria:
Inclusion Criteria:

* Smoking employee or spouse in contemplation, action, or recently entering maintenance stage of change
* English speaking

Exclusion Criteria:

* Smoker in precontemplation stage of change
Speech Characteristics in Coronary Heart Disease

To improve the predictive validity of Structured Interview assessments of Type A behavior by comparing interviewer techniques in the Multiple Risk Factor Intervention Trial (MRFIT) and the Western Collaborative Group Study (WCGS). To assess whether there were interviewer differences in the predictiveness of Type A behavior and its components for coronary heart disease incidence in MRFIT and WCGS and if so, to assess whether the interviewer differences in disease predictiveness were related to interviewer stylistics.

BACKGROUND:

Individuals with Type A behavior are characterized as hard driving, competitive, and time urgent; when asked questions they are quick to answer with emphatic speech; they perceive themselves to be striving and competing and are prone to hostility. This core of behaviors is presumed to be on a continuum of intensity with well-developed Type A's at the upper end and well-developed Type B's at the lower end. Epidemiological studies have shown Type A's to have a higher prevalence and incidence of various forms of coronary heart disease than Type B's. The Structured Interview is a method of measuring Type A behavior in which a series of questions are administered about the individual's characteristic responses to situations relevant to the Type A behavior pattern, such as reaction to delay and reported frequency of anger. The Interview is delivered in challenging style designed to elicit Type A characteristics.

In 1960, the WCGS recruited 3,154 employed men, ages 39 to 59, who were initially free of coronary heart disease and followed them for 8.5 years for coronary heart disease incidence. In 1972 MRFIT began recruiting 12,866 men, ages 35 to 57, selected for elevation of one or more risk factors, but free from coronary heart disease and followed them for an average of seven years after randomization to a risk factor modification group or to a control group referred to their own physicians for treatment. Both studies used the Structured Interview to assess Type A behavior.

In 1981, Type A behavior was officially regarded as an independent risk factor for coronary heart disease, based largely on the findings of the WCGS. However, the MRFIT did not find Type A behavior to be related to coronary heart disease incidence. The manner of conducting the Structured Interview may have affected the predictive reliability of the Type A assessments.

DESIGN NARRATIVE:

Interviewer speech characteristics from the WCGS and MRFIT Structured Interview tape recordings were audited and analyzed. Each speech characteristic was scored with high reliability. Multiple logistic regression analyses were used to control for standard risk factors.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)

Biologics are routinely used for the treatment of rheumatoid arthritis (RA). Adalimumab is a human monoclonal antibody that inhibit the Tumor Necrosis Factor alpha (TNF-alpha). Identification of RA patients who respond to biologics is a challenging goal to avoid unnecessarily, costly and potentially harmful treatment.

The aim of the study is to address if 18 F FDG is a valuable biomarker for the assessment of the clinical response in RA with TNF-alpha blocking agent. Eight patients fulfilling the ACR (American College of Rheumatology) criteria will by enrolled. Patient will receive adalimumab according to the current guidelines i.e. 40mg /14 days sub cutaneously. The decision will stand on a high activity of the disease defined by the DAS 28 (Disease Activity Score) above 5.1. Positron emission tomography will be performed before, 2 and 12 weeks after the begin of the treatment. The response to adalimumab will by assessed by the SUV (standard Unit value) measured on the inflammatory joints of hands, wrist, ankle, feet and knees and compared to measurement of clinical (total swollen and tender joints count) echographic (synovium thickness and power doppler) and chemical biomarkers (erythrocyte sedimentation rate, C reactive protein).


Eligibility Criteria:
Inclusion Criteria: - Patients with active Rheumatoid arthritis PR définie selon les critères ACR (1987) (annexe 7) \[18\], Activité importante de la maladie (DAS 28 \> 5,1) (annexe 5) \[7\], Indication d'un traitement par adalimumab (en accord avec l'A.M.M.), Homme ou femme dont l'âge est supérieur ou égal à 18 ans, Acceptant de participer à l'étude et ayant donné son consentement éclairé, Affiliés ou bénéficiaire d'un régime de sécurité sociale.