linjc16/ctgov huggingface dataset:
Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis

Study Overview
=================
Brief Summary
-----------------
The overall objective of this research study is to determine the effect of a pre-operatively placed nasogastric tube compared to no nasogastric tube, on post-operative emesis rates and postoperative length of stay in infants with a primary diagnosis of pyloric stenosis treated with pyloromyotomy. This study will also examine the feasibility data of the pilot data to develop estimates of treatment effect of a pre-operative nasogastric tube on post-operative rate of emesis and length of stay to be used to determine the sample size of the definitive trial.

Official Title
-----------------
Post-Operative Impact of Nasogastric Tubes on Rates of Emesis in Infants Diagnosed With Pyloric Stenosis: A Prospective, Randomized Controlled Pilot Trial

Conditions
-----------------
Pyloric Stenosis

Intervention / Treatment
-----------------
* Device: Nasogastric Tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female infant ≤ 6 months of age Primary diagnosis of Pyloric Stenosis confirmed by ultrasound Amendable to circumumbilical pyloromyotomy Amendable to a minimum size 10 French nasogastric tube Able to undergo general anesthesia Parent or legal guardian able to give free and informed consent Exclusion Criteria: Contraindicated for circumumbilical pyloromyotomy Contraindicated for a size 10 French nasogastric tube Prematurity before 35 weeks' gestation Bronchopulmonary dysplasia Viral infection in the past 7 days Cardiac malformation Patent ductus arteriosis Previous abdominal surgery Concurrent surgical procedure scheduled Parent or legal guardian unable to read, speak and understand English Co-enrolled in a different interventional trial

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nasogastric Tube<br>10 French Nasogastric Tube inserted before surgery | Device: Nasogastric Tube<br>* Insertion of a 10 French Nasogastric tube prior to surgery<br>|
| No Intervention: No Nasogastric Tube<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative length of stay |  | 1 year | 
| rates of post-operative emesis |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pyloric stenosis, nasogastric tube, pyloromyotomy
Can Thyroidectomy be Considered Safe in Obese Patients?

Study Overview
=================
Brief Summary
-----------------
Obesity is a growing public health concern in most western countries. More and more patients with high body mass index (BMI) are undergoing surgical procedures of all kinds and, in this context, obese patients are undergoing thyroid surgery more than ever before. This study showed that obesity, in the field of thyroid surgery, is not associated with any increase of postoperative complications. Thus, it is possible to conclude that thyroidectomy can be performed safely in obese patients.

Detailed Description
-----------------
Background: Obesity is a growing public health concern in most western countries. More and more patients with high body mass index (BMI) are undergoing surgical procedures of all kinds and, in this context, obese patients are undergoing thyroid surgery more than ever before. The aim of the present study was to evaluate whether thyroidectomy can be considered safe in obese patients. Methods: Patients undergoing thyroidectomy in our Unit between January 2014 and December 2018 were retrospectively analysed. Patients were divided into 2 groups: those with BMI < 30 kg/m2 were included in Group A, while those with BMI ≥ 30 kg/m2 in Group B.

Official Title
-----------------
Can Thyroidectomy be Considered Safe in Obese Patients? Retrospective Cohort Study

Conditions
-----------------
Obesity, Thyroid, Surgery--Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients submitted to thyroidectomy in our Unit Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese patients<br> | |
| Non-obese patients<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Occurrence of postoperative complications | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Evaluation of operatives times | 1 day |
Attenuation of Pain in Men and Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine opioid and endocannabinoid mechanisms of exercise-induced analgesia in men and women.

Official Title
-----------------
Attenuation of Pain in Men and Women: Mechanisms of Exercise-Induced Analgesia

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Naltrexone, then placebo
* Drug: Placebo, then Naltrexone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women - Exclusion Criteria: current cardiac or other chronic diseases (e.g., cancer, diabetes, hypertension, kidney disease); routine use of prescriptive medications; history of vasovagal response to phlebotomy; an allergy to naltrexone; pregnancy; current smokers; current use of recreational drugs; history of substance abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Men<br> | Drug: Naltrexone, then placebo<br>* 50 mg of naltrexone<br>Drug: Placebo, then Naltrexone<br>* sugar pill<br>|
| Active Comparator: Women<br> | Drug: Naltrexone, then placebo<br>* 50 mg of naltrexone<br>Drug: Placebo, then Naltrexone<br>* sugar pill<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for Subject to Reach Pain Threshold |  | Baseline |
Dermal and Gynecological Acceptability (Irritability and Sensitization in the Genital Mucosa) of an Investigational Product and Evaluation of Moisture Efficacy by TEWL and Perceived Efficacy.

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety of an investigational product through the verification of signs of irritability and sensitization of the genital mucosa, as well as the instrumental moisturizing efficacy by TEWL and barrier integrity analysis, in addition to the efficacy perceived by the volunteers.

Official Title
-----------------
Dermal and Gynecological Acceptability (Irritability and Sensitization in the Genital Mucosa) of an Investigational Product and Evaluation of Moisture Efficacy by TEWL and Perceived Efficacy.

Conditions
-----------------
Female Dry Genital Mucosa

Intervention / Treatment
-----------------
* Other: Intimate Lubricant Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female sex with active sex life; Age group: between 45 and 65 years old; Menopause for at least six months; Whole skin in the region of product analysis; No history of reaction to products of the same category Understanding, agreement and signature of the Term of Free and Informed Consent. Exclusion Criteria: Gestation or risk of gestation; Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study); Active cutaneous pathologies (local and / or disseminated) in the evaluation area; Pathologies that cause suppression of immunity, such as diabetes, HIV, etc.; Endocrine pathologies such as thyroid disorders, ovarian or adrenal gland disorders; Any infection in the region of analysis of the product diagnosed at the time of inclusion; Other conditions considered by the investigating physician as reasonable for disqualification of the individual from the study participation.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Other: Intimate Lubricant Gel<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the product's efficiency as a moisturizer through subjective evaluation |  | 30 days |
Correlation Between CYP2C19 Genotype, Level Of Clopidogrel Metabolite And Platelet Inhibition Status

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to check correlation between CYP2C19 genotype level of clopidogrel metabolite in plasma and platelet inhibition status.

Detailed Description
-----------------
THE FIRST PHASE OF THE RESEARCH WILL INVOLVE PATIENTS RECRUITMENT AND INFORMED CONSENT FOR GENETIC TESTING.THE MAJORITY OF PATIENTS WILL BE RECRUITED FROM EMERGENCY DEPARTMENT. EVERY PATIENT WILL BE ASKED ABOUT HIS AND HIS PARENT'S ETHNICITY (ASHKENASI OR SEPHARDY JEW) AND ADDITIONAL DRUGS HE TAKES. IF PATIENT AGREES TO PARTICIPATE IN THE STUDY , HIS BLOOD SAMPLE WILL BE COLLECTED FOR 3 KINDS OF TESTS: GENETIC (FOR CYP450 2C19) PLATELET MAPPING TEST ( BY THROMBOELASTOGRAPH ASSAY) CLOPIDOGREL INACTIVE METABOLITE DETERMINATION BY CHROMATOGRAPHIC METHOD

Conditions
-----------------
PRIMARY FOCUS:PATIENT THAT TAKE CLOPIDOGREL

Intervention / Treatment
-----------------
* Other: BLOOD COLLECTION


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 OLD PATIENTS THAT TAKE CLOPIDOGREL MORE THAN 1 WEEK Exclusion Criteria: PREGNANCY CHRONIC LIVER DISEASES

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: BLOOD COLLECTION|BLOOD SAMPLE WILL BE COLLECTED FOR 3 KINDS OF TESTS|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the optimal dose of sodium nitrate administered during resuscitation to achieve a plasma level of 10 μM by hospital arrival. Pharmacokinetic modeling from human cardiac arrest studies suggest that a single 25 mg IV dose of sodium nitrite will achieve the optimal (based on preclinical studies) neuroprotective plasma levels of 10 μM. In this phase-1 open-label dose finding study in 100 patients, we will determine whether 25 mg IV administered during resuscitation will achieve plasma nitrite levels of at least 10 μM by hospital arrival. Dose adjustments, either decreasing or increasing, will be made if necessary permitting us to determine the optimal nitrite dose needed to achieve the 10 μM plasma target. Safety data will also be collected

Official Title
-----------------
Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

Conditions
-----------------
Out-Of-Hospital Cardiac Arrest

Intervention / Treatment
-----------------
* Drug: Sodium Nitrite


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intravenous access/intraosseous access Cardiac arrest, either VF or non-VF patients receiving ACLS by Seattle Medic One paramedics. Age 18 years or older Comatose Exclusion Criteria: Traumatic cause of cardiac arrest Prisoner, pregnancy, age less than 18 (special population/vulnerable population) Known DNAR Drowning as cause of arrest.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sodium Nitrite|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma level of sodium nitrite at hospital arrival |  | 15-45 minutes after dose has been given | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of re-arrest |  | 15-120 minutes after dose has been given | 
| Need for pressor support before hospital arrival |  | 15-120 minutes after dose has been given |
Immunochromatography Versus Microscopy for Diagnosis of Entamoeba Histolytica/Dispar Infection.

Study Overview
=================
Brief Summary
-----------------
Amoebiasis, an infection by the protozoan parasite Entamoeba histolytica is globally considered as the third leading parasitic cause of human mortality besides malaria and schistosomiasis. It is estimated that E. histolytica may infect half a billion people annually. Moreover, it was estimated that 100,000 patients per year died due to the clinical complications of the disease. Laboratory diagnosis of E. histolytica/dispar is usually achieved by microscopic detection of trophozoites or cysts in stool samples. Microscopy is time consuming and requires an experienced observer to identify the organism. Furthermore, it must be performed on three stool samples to increase sensitivity leading to decreased patient compliance and delay in the final diagnosis. Therefore, a few the commercially available copro-antigen assay have been developed for E. histolytica/dispar diagnosis including the enzyme immunoassay and non-enzymatic immunochromatographic (ICT) assays that do not depend on microscopy skills and increase laboratory efficiency by reducing time and cost. The aim of the study is: to evaluate the efficacy of commercially available rapid immunochromatographic Copro-antigen assay (RIDA® QUICK Entamoeba) in comparison with conventional microscopic examination for the diagnosis of E. histolytica /dispar infection. to estimate the prevalence of E. histolytica /dispar infection in outpatients in Sohag.

Official Title
-----------------
Immunochromatography Versus Microscopy for Diagnosis of Entamoeba Histolytica/Dispar Infection in Sohag.

Conditions
-----------------
Dysentery Amebic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients complaining of dysentery or diarrhea with any age & sex groups. Exclusion Criteria: Patients taking amoebicidal drugs.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the efficacy of immunochromatographic Copro-antigen assay for diagnosis of Entamoeba histolytica/ dispar. | comparing the sensitivity and specifity with conventional microscopy for diagnosis of Entamoeba histolytica/ dispar infection. | 16 weeks following the startpoint of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detect the prevelance of Entamoeba histolytica/ dispar in Sohag. | By examining stool samples from 100 patients, the number of cases with Entamoena histolytica/dispar infection is recorded. | 16 weeks following the startpoint of the study. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dispar, dysentery, diarrhea, Entamoeba, histolytica
Contacting Authors to Retrieve Individual Patient Data

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to examine the impact of incentivizing authors of RCTs that are eligible for a systematic review and meta-analysis, versus usual contact strategies to obtain original IPD

Official Title
-----------------
Contacting Authors to Retrieve Individual Patient Data: Protocol for a Randomized Controlled Trial

Conditions
-----------------
Response Rates

Intervention / Treatment
-----------------
* Other: Financial Incentive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Corresponding authors of RCTs included in our previous and updated systematic reviews Exclusion Criteria:
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Incentive<br>Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive | |
| Experimental: Incentive<br>Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and they will be given a financial incentive. | Other: Financial Incentive<br>* money<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Authors Who Provided Complete IPD | We contacted authors of eligible studies from June 2016 to October 2016. Authors were first contacted in June 2016, where we sent: a) an email requesting their IPD, b) email reminders (4 in total) at 2, 6, 10, and 14-week intervals after the initial email, c) reminders by post in week 7, and d) reminders via telephone in week 15. | June 2016 - October 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Taken to Obtain the IPD Between Initial Request and Authors' Provision | We contacted authors of eligible studies from June 2016 to October 2016. Authors were first contacted in June 2016, where we sent: a) an email requesting their IPD, b) email reminders (4 in total) at 2, 6, 10, and 14-week intervals after the initial email, c) reminders by post in week 7, and d) reminders via telephone in week 15. | June 2016 - October 2016 | 
| The Completeness of the IPD Received | We contacted authors of eligible studies from June 2016 to October 2016. Authors were first contacted in June 2016, where we sent: a) an email requesting their IPD, b) email reminders (4 in total) at 2, 6, 10, and 14-week intervals after the initial email, c) reminders by post in week 7, and d) reminders via telephone in week 15. | June 2016 - October 2016 |
Drug Use Investigation for PAXIL Tablet

Study Overview
=================
Brief Summary
-----------------
This post-marketing surveillance study is designed to detect adverse events (particularly clinically significant adverse drug reactions) occurring in clinical settings and to examine factors likely to affect the safety and efficacy of paroxetine.

Official Title
-----------------
Drug Use Investigation for PAXIL Tablet

Conditions
-----------------
Mental Disorders

Intervention / Treatment
-----------------
* Drug: Paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with depression/depressed state or panic disorder Exclusion Criteria: Patients who had been taking PAXIL since before the start of the survey Patients with hypersensitivity to paroxetine Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs Concomitant use in patients taking pimozide
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients prescribed PAXIL<br>Patients with depression/depressed state or panic disorder prescribed PAXIL during study period | Drug: Paroxetine<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice |  | 8 weeks | 
| Presence/absence of concomitant use of drugs metabolized by CYP2D6 | PAXIL inhibits drug-metabolizing enzyme CYP2D6, and it takes about 1 week following discontinuation of PAXIL for this CYP2D6 function to recover from the inhibiting effect. Since it requires attention if drugs that are metabolized by CYP2D6 are administered during this recovery period, it was decided to investigate the presence/absence of use of drugs metabolized by CYP2D6 within 2 weeks after discontinuation of treatment in patients for whom treatment with PAXIL was discontinued, as well as the safety thereof. | Within 2 weeks after discontinuation or completion of treatment | 
| Presence/absence of concomitant use of products containing Saint John's Wort (Hypericum perforatum; SJW, hereinafter) | Although the action mechanism for this is not clear, SJW has been reported to have the action of inhibiting reuptake of serotonin, noradrenaline and dopamine, and to exhibit an antidepressant effect. Since PAXIL also acts to inhibit serotonin reuptake, concomitant use of products containing SJW is thought to have an effect upon the serotonin reuptake inhibiting action of PAXIL, so it was decided to check for concomitant use of products containing SJW and investigate the safety of such concomitant use. | 8 weeks |