cyrilzakka/clinical-trials huggingface dataset:
The Safe Teen Study

The study examines (1)the incidence of preventive health services provided by family physicians to adolescent patients, and (2)barriers and facilitators of prevention discussions between family physicians and their adolescent patients.

This study used a card study design to allow volunteer physicians to record research data in the context of providing clinical care. The method was brief, simple, and convenient for busy practicing clinicians.

Volunteer resident physicians and faculty carried data collection checklists in their pockets and completed one for every adolescent patient seen during a randomly selected two week period. Physicians attempted to collect data on ten consecutive encounters with teen patients aged 11-21 years. The checklist documented patient characteristics (age, gender and ethnicity), reason for visit, parent presence, and types of prevention issues discussed during the visit. Patient and visit information was collected to assess its influence on physician prevention discussions. Finally, the checklist asked open-ended questions related to barriers to and facilitators to teen prevention discussions.

The study involved five clinical sites comprising approximately 140 faculty and resident family physicians. The investigators sought 10-15 volunteer physicians from each site (60-90 physicians), and asked them to complete data checklists on 10 consecutive adolescent patients (600-900 visits). After a training session, each site randomly selected data collection periods.

Physicians provided usual care for adolescent patients and recorded on the checklists any prevention discussions during the visit.

Eligibility Criteria:
Inclusion Criteria:

* Family Medicine Residency physicians and faculty in six residency programs in Texas

Exclusion Criteria:

* Physicians not in the residency programs
Slow-release Locally Administered 0.02% Hypochlorite Formulation

Aim: The presence of bacterial plaque is associated with the development of periodontal inflammation. The aim of this single-blind randomized clinical study was to prospectively evaluate the efficacy of two different agents in a staged approach for nonsurgical periodontal treatment in terms of clinical and patients related outcomes in a cohort of patients with periodontitis: NitrAdine® based disinfectant formula (PerioTabs®) vs Chlorhexidine 0.12 toothpaste and mouthwash 0.20.

Material and methods: Patients with a diagnosis of periodontal disease (stage I-III) scheduled for non surgical periodontal treatment were randomly allocated to the preparatory home use of a chlorhexidine mouthwash or a NitrAdine® based brushing solution called PerioTabs® for 10-15 days. Active decontamination with ultrasonic scalers was performed after the completion of the preparation period. Clinical and patient-related outcomes were recorded at baseline, at the moment of professional intervention, and after 30 and 90 days from baseline.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 y.o,
* systemically healthy,
* with a clinical diagnosis of periodontitis

Exclusion Criteria:

* alcohol or drug abuse,
* regular drug use of bisphosphonates,
* non-steroidal or steroidal anti-inflammatory,
* daily antacid therapy,
* selective serotonin reuptake inhibitors and other therapy that might affect periodontal health,
* antibiotics during the previous 6 months,
* smoking more than ten cigarettes per day;
* pregnancy;
* lactation;
* previous periodontitis treatment within the last 6 months,
* radiotherapy to the head or neck, current chemotherapy.
The Effects of CO2 Pneumoperitoneum at Different Temperature in Laparoscopic Surgery

Objective: It is recommended to heat and humidify CO2 in laparoscopic surgery to prevent postoperative pain and hypothermia but information about its effects on hemodynamic and respiratory parameters is limited. The investigators aimed to investigate the effects of standard and heated-humidified CO2 on hemodynamic and respiratory parameters.

Study design: One hundred patients who underwent laparoscopic hysterectomy for benign pathology were divided into two groups: Group CD (cold-dry) patients were administered standard CO2, while Group HH (heated-humidified) patients were administered 95% humidified insufflation at 37°C. Hemodynamic and respiratory parameters, body temperature, pain score and blood count parameters were recorded.

The sample consisted of 100 American Society of Anesthesiologists (ASA) physical status I-II patients aged 40-65 who underwent laparoscopic hysterectomy for benign pathology. The patients were divided into two groups according to a randomization scheme created by a computer: Group CD (cold-dry) patients were administered dry CO2 via insufflator at room temperature (21°C), while Group HH (heated-humidified) patients were administered 95% humidified CO2 insufflation at 37°C. The study was planned as a randomized and double-blind study, where patients were not informed of their group.During the operation and in the postoperative period, the patients were followed up by two different anesthetists. All patients were given information and training on the anesthesia method, the use of the patient-controlled-analgesia (PCA) device and the visual analog scale (VAS) the day before the operation. The patients' demographic data (age, weight, height, etc.) and their basal systolic, diastolic and mean blood pressures and heart rates were measured prior to the operation and recorded on the case report form.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-II patients aged 40-65 who underwent laparoscopic hysterectomy for benign pathology.

Exclusion Criteria:

* Patients with chronic obstructive pulmonary disease, asthma, advanced liver and kidney disease, infection, bleeding disorder and drug allergies
A Prospective/Retrospective,Randomized Controlled Clinical Study of Interferon Atomization in the 2019-nCoV Pneumonia

At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of two therapeutic schemes(abidol hydrochloride,abidol hydrochloride combined with interferon atomization)in the treatment of 2019-nCoV viral pneumonia, so as to provide reliable evidence-based medicine for the treatment of viral pneumonia caused by 2019-nCoV.


Eligibility Criteria:
Inclusion Criteria:

1)2019-nCoV nucleic acid test was positive. 2)CT of the lung conformed to the manifestation of viral pneumonia.

Exclusion Criteria:

1. Patients who meet any of the contraindications in the experimental drug labeling
2. Patients who do not want to participate in this clinical study
Health Literacy in the General Population in Belgium

The aims of the study are:

* To measure health literacy (HL) levels in a sample composed of members of a health mutual (Solidaris), and its potential associations with several determinants (health, health services consumption, health behaviours...)
* To identify potential groups at risk of a lower HL
* To identify the determinants of HL level


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more
* Affiliated to Solidaris (health mutual), with a valid phone number
* Consent to participate

Exclusion Criteria:

* None
ZIKAlliance Natural History Study

Study to enroll up to 1000 adult patients (\>18 years) presenting with febrile or rash illness of short duration (\<72h) in designated clinics in the State of Sao Paulo, Brazil.

* Study to enroll up to 1000 adult patients (\>18 years) presenting with febrile or rash illness of short duration (\<72h) in designated clinics in the State of Sao Paulo, Brazil.
* Following enrolment (day 0), patients will be followed up at days 2-3, 7, 14, 21, 30, 90, 180 and 360 with clinical and biological procedures (blood and urine samples).
* For patients with proven ZIKA Virus (ZIKV) infection, follow-up samples will include blood, saliva, urine and genital samples.
* For non-ZIKV infected patients, follow-up samples will include serological monitoring at days 14, 30, 180 and 360, and for men, possible assessment of genital fluids at day 180.
* All patients will be evaluated for impact on disability up to one year. Household adult contacts of ZIKV patients will be invited for ZIKV evaluation including collection of blood and urine samples.

Eligibility Criteria:
Inclusion Criteria:

* Rash or Fever illness
* within 72 hours of symptom onset

Exclusion Criteria:

* presence of symptoms or complications indicative of a bacterial infection
Increasing Water Access and Appeal in Community Recreation Centers

This study is a cluster randomized controlled trial with n=28 City of Philadelphia recreation centers (14 matched pairs) designed to determine the effectiveness of a comprehensive multi-level intervention to increase water access and appeal in community recreation centers on 1) center-level water intake as measured by water meters, and 2) purchase of outside beverages as measured by observations of recreation center youth.


Eligibility Criteria:
Inclusion Criteria:

* Recreation center is located in a low-income neighborhood in the City of Philadelphia, defined by ≥20% of the residents in the zip code at or below Federal Poverty Level
* Recreation center includes both summer and after-school programming
* Recreation center is willing to comply with City of Philadelphia Healthy Vending standards and discourage sugar sweetened beverage consumption
* Recreation center has water lines appropriate for installing indoor hydration stations

Exclusion Criteria:

* Unwilling to accept randomization
STHLM3 - Prostate Cancer Diagnostic Trial

STHLM3 is a paired diagnostic trial aiming to assess whether a panel of biomarkers for prostate cancer can substantially reduce the proportion of men referred to biopsy whilst maintaining sensitivity for aggressive prostate cancer


Eligibility Criteria:
Inclusion Criteria:

* Age 50-69
* Residential address in Stockholm County

Exclusion Criteria:

* Previous Prostate Cancer Diagnosis
* Not able to comprehend inform consent material
Randomized Trial Comparing PrePex Day 7 Foreskin Removal Procedure (FRP) to a Day 0 PrePex FRP .

A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings.

Study Objectives:

To compare the safety and acceptability of PrePex Day 7 Foreskin Removal Procedure (FRP) (herein: PrePex) versus PrePex Day0 FRP

Planned Subjects Population:

One hundred and fifty (150) subjects scheduled for voluntary medical male circumcision. The subjects will be randomly divided into two unbalanced study arms (2:1), Day0 FRP arm which will include hundred (100) subjects and PrePex arm which will include fifty (50) subjects.

Study duration per subject will be up to 7 weeks and will include a total of 9 visits.

Study Site: University of Nairobi, Illinois, and Manatoba (UNIM) Research and Training Centre, Kisumu, Kenya

Eligibility Criteria:
Inclusion Criteria:

* Ages - 13 to 49 years
* Uncircumcised
* Adequately vaccinated, or willing to be vaccinated, against Tetanus based on appropriate national guidance for male circumcision
* Willing to be circumcised
* Legal guardian consent to the procedure for ages 13-18 years
* Agrees to be circumcised by any of the study methods, Day0 FRP or Day7 FRP as will be determined randomly
* Able to understand the study procedures and requirements
* Agrees to abstain from sexual intercourse for 8 weeks after circumcision
* Agrees to abstain from masturbation for at least 2 weeks after Removal
* Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 6 weeks post removal (7 weeks total)
* Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study

Exclusion Criteria:

* Legal guardian withholds consent for ages 13-18 years
* Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
* Subject with the following diseases/conditions: phimosis, paraphimosis, adhesions, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
* Known bleeding / coagulation abnormality, uncontrolled diabetes
* Subject that to the opinion of the investigator is not a good candidate
* Subject does not agree to anonymous video and photographs of the procedure and follow up visits.
ED50 of Cis-atracurium for Laryngeal Mask Incubation in General Anesthesia

1. The muscle relaxants can improve the conditions of laryngeal mask incubation and reduce the related complications (such as laryngeal spasm and postoperative throat pain)
2. The dosages of muscle relaxants used in various researches vary greatly.
3. We are planning use the most classical method for determining the ED50 or half effective concentration of cis-atracurium using sequential method, which is also called " up and down method" and " ladder method".

The concordance of the current research is that muscle relaxants can improve the conditions of laryngeal mask incubation and reduce the related complications (such as laryngeal spasm and postoperative throat pain ) of laryngeal mask incubation. It is necessary to use muscle relaxants in laryngeal mask incubation under non-special circumstances. However, the dosages of muscle relaxants used in various researches vary greatly of normal endotracheal intubation. Previous studies have shown that the amount of muscle relaxant required for laryngeal mask intubation is smaller than that required for endotracheal intubation. Although the dosage of muscle relaxant required for tracheal intubation can ensure the smooth insertion of laryngeal mask airway, laryngeal mask airway is mostly used for short surgery, which is prone to postoperative muscle relaxation residue and prolongs the recovery. We planning use the most classical method for determining the ED50 or half effective concentration of cis-atracurium using sequential method, which is also called " up and down method" and " ladder method".

Eligibility Criteria:
Inclusion Criteria:

1. ASA Ⅱ\~Ⅲlevel;
2. BMI18.5-30；
3. Those who intend to undergo short urological surgery ( operation time \< 1h );
4. Age 25\~75 years
5. Estimated amount of bleeding \< 5ml / kg.

Exclusion Criteria:

1. Neuromuscular diseases or metabolic diseases;
2. Preoperative complicated with water and electrolytes disorders ( such as hypokalemia and hypocalcemia );
3. Serious hepatic and renal insufficiency and serious heart and lung diseases;
4. Predictable difficult airway;
5. Take drugs ( such as aminoglycoside, polymyxin, phenytoin sodium, carbamazepine, etc. ) that affect the nerve-muscle transmission function or the efficacy of muscle relaxants before surgery;
6. Muscle relaxation drug allergy;
7. Previous history of alcoholism or drug abuse.
The Association Between Conditioned Pain Modulation and Pain Catastrophizing in Chronic Low Back Pain

This study evaluates the potential association between pain catastrophizing thoughts and the ability to dampen pain via endogenous descending inhibition. Half of the participants are persons with chronic low back pain and the other half are age and gender-matched controls

Pain catastrophizing is a cognitive feature commonly seen in various musculoskeletal pain population and is considered an important factor to account for in rehabilitation. The ability to dampen pain via endogenous pain modulatory mechanisms is likewise known to be reduced in musculoskeletal pain conditions.

Studies utilizing functional magnetic resonance imaging (fMRI) have demonstrated that the supraspinal areas involved in pain-related cognitive processing to a great extent overlap with those involved in endogenous pain modulation. Therefore, it is plausible that factors such as pain catastrophizing thoughts may affect the nervous systems ability to dampen pain.

Chronic low back pain is the single clinical problem with the biggest impact in the modern society. Previous studies have demonstrated that pain catastrophizing and reduced endogenous pain inhibition are part of the clinical picture. However, previous studies have never investigated a potential relationship between these two factors.

Eligibility Criteria:
Inclusion Criteria:

Low back pain group:

* chronic low back pain ( lasting more than 3 months)
* intensity of ≥ 3/10 on a numeric rating scale
* pain is located in the area between the gluteal folds below to the thoracolumbal junction above.

Controls:

No current or previous history of musculoskeletal pain of ongoing nature

Exclusion Criteria:

Applies for both groups:

* Signs of radicular pain or other specific medical conditions e.g. rheumatologic disease or diabetes
* Pregnancy
Corneal Opacities in Children

A prospective observational study on corneal opacities in infants and children (1 month to 18 years old) will be conducted at CHLA. Most of these cases will be due to congenital corneal opacity (e.g. Peter's anomaly, mucopolysacharidoses) or scarring due to infectious keratitis. Sixty (60) subjects will be recruited. The children will be examined under anesthesia with a portable slit-lamp and OCT. An iVue OCT system (Optovue) attached to an operating microscope-style mount at CHLA will be used for the intraoperative scans. Both cross-sectional and 3-D OCT scans will be performed to assess opacity depth, pachymetry map, endothelial defects, and any abnormal adhesion between the cornea, iris and lens. The anterior chamber angle will also be imaged with cross-sectional OCT to assess angle depth, trabecular meshwork, Schwalbe's line, and possible peripheral iridocorneal adhesion or posterior embryotoxon. OCT of the crystalline lens will be obtained to assess the presence of cataract. Slit-lamp photography will be obtained, and gonioscopy will be performed if indicated. Corneal diameter will be measured with a caliper, and intraocular pressure will be measured with a tonopen (Reichert).


Eligibility Criteria:
Inclusion Criteria:

* Infants and children (1 month to 18 years of age) with corneal opacity requiring a thorough eye examination.

Exclusion Criteria:

* Inability to give informed consent.
* Inability to maintain stable fixation for OCT imaging.
* Inability to commit to required visits to complete the study.
High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus

The purpose of this study is to evaluate the therapeutic response to fluconazole in patients with cutaneous leishmaniasis caused by and L.(V.)guyanensis and L.(V.) braziliensis.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
* Number of lesions: 1 to 3 ulcerative lesions.
* Lesion´s diameter: 1 to 5 cm.
* Disease duration: up to three months.

Exclusion Criteria:

* Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
* Immunodeficiency or antibody to HIV
* Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
* Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months

  * Lack of suitability for the trial:
* Negative parasitology (aspirate/biopsy/PCR)or negative Montenegro test
* Any history of prior anti-leishmania therapy
* Any condition which compromises ability to comply with the study procedures

  * Administrative reasons:
* Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
* Anticipated non-availability for study visits/procedures
A Safety, Efficacy and Tolerability Study of SEP-225289

To determine the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder

This is a randomized, placebo-controlled, double-dummy, multi-center study of the safety, efficacy and tolerability of SEP-225289 in male and female subjects with MDD. Subjects meeting DSM-IV criteria for Melancholic or Atypical Features specifier are eligible for participation. The study will consist of a screening period, which may last up to 2 weeks, an eight week (56 day) double-blind treatment period, a two week (14 day) wash-out, and a one week (7 day) follow up. Total subject participation will be approximately 91 days (13 weeks). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Inclusion Criteria:

* The duration of the current episode must be at least 1 month but not longer than 12 months.
* Subjects must have a primary diagnosis of Major Depressive Disorder.
* Subjects must have had at least one previous, diagnosed episode of MDD in the past 5 years.
* MDD must be the condition that was chiefly responsible for motivating the subject to seek treatment.
* Subject is in general good health.

Exclusion Criteria:

* Subject is participating in, has participated in, or plans to participate in any investigational drug study.
* Subject who has donated blood within the last 30 days or plans to donate blood during and 30 days following participation.
* Known failure to respond (in the past 5 years) to two adequate (dose and duration) antidepressant medications with distance mechanisms of action including tricyclics.
* Subjects who have undergone Electroconvulsive Therapy treatment.
* Treatment with fluoxetine, in the 6 weeks before baseline.
* Subject with psychotic disorders, anorexia nervosa, bulimia or post-traumatic stress disorder.
* Subject with a history or presence of bipolar disorder (i.e., current or past history of manic episode).
* Subjects with Obsessive Compulsive Disorder.
* Subjects with a lifetime diagnosis of Panic Disorder.
* Subject received treatment with antidepressants within 2 weeks.
* Subject with lifetime history of suicidal attempts, alcohol dependence or abuse, drug(s) dependence or abuse (excluding nicotine and caffeine) or has a positive urine drug screen.
* Subject has a history of significant risk of suicide or homicide.
* Bereavement - Defined as death of a loved one within 3 months.
* Subject has a documented history of HIV, hepatitis B or hepatitis C.
TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

This is a randomized, double-blind, double-dummy, multicenter, global Phase 3 study of IV to oral TR-701 FA 200 mg once daily for 6 days versus IV to oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Patients are to start treatment with at least 2 IV doses and may receive IV therapy for the entire treatment duration.

Approximately 100 to 140 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment.

The primary objective is to determine the noninferiority (NI) in the early clinical response rate of intravenous (IV) to oral 6 day TR-701 free acid (FA) compared with that of IV to oral 10-day linezolid treatment at 48-72 hours after the first infusion of study drug in the intent-to-treat (ITT) analysis set in patients with acute bacterial skin and skin structure infections (ABSSSI).

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring IV antibiotic therapy and with systemic signs of infection diagnosed with ABSSSI.
* Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

Exclusion Criteria:

* Uncomplicated skin infections
* Severe sepsis or septic shock
* ABSSSI solely due to gram-negative pathogens