linjc16/ctgov huggingface dataset:
Evaluation of a Desipramine Ceiling in Cocaine Abuse - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm whether a blood level ceiling exists on desipramine effect in cocaine abuse.

Official Title
-----------------
Evaluation of a Desipramine Ceiling in Cocaine Abuse

Conditions
-----------------
Cocaine-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Desipramine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Desipramine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving |  |  | 
| Retention |  |  | 
| Cocaine use |  |  | 
| Depression |  |  | 
| Anxiety |  |  | 
| Mood indicators |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Myeloid Suppressors in Inflammation

Study Overview
=================
Brief Summary
-----------------
Myeloid-derived suppressor cells (MDSC) have been studied for their ability to suppress T cell responses in vivo and in vitro. As a result, MDSC can regulate cellular responses to chronic inflammatory conditions such as cancer, leading to the induction of tolerance and, ultimately, tumor escape from immune surveillance.

Official Title
-----------------
Myeloid Suppressors in Inflammation

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Ages eligible for study: 18 to 60 years Genders eligible for study: male and female Signed and dated written informed consent is obtained prior to study blood draw. Subjects being actively treated for chronic moderate to severe asthma based on National Heart Lung and Blood Institute guidelines (figure 1). Subjects must carry the diagnosis of asthma (made by a physician) for a minimum of six months. Subjects within the first seven days of an acute asthma exacerbation, as determined by the referring physician. Able to give informed consent. Exclusion Criteria: Use of systemic corticosteroids within the previous two weeks. Pregnant and/or lactating females. Current tobacco use. Severe psychiatric illness. Current illicit substance abuse or dependence and/or abuse of alcohol. Current use of anti-microbial medications. Primary or secondary immunodeficiency. Any clinically significant uncontrolled medical condition that would put the patient's safety at risk.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| acute asthma exaecerbtion patients<br>Patients experiencing acute exacerbation of their asthma | |
| chronic asthma group<br>Two groups are being enrolled. The first group is chronic asthma patients with FEV1 below 80% and FEV1/FVC ratio reduced by 5% | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify and characterize specific cell types (human dendritic cells, myeloid-derived suppressor cells and T lymphocytes) that are present in acute and chronic asthma. |  | one year from start of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma
Measurement of MSFP and Stressed Volume With CardioQ+®

Study Overview
=================
Brief Summary
-----------------
To study the reliablity of MSFP and stressed volume to follow volume loading and to predict fload loading responsiveness in patients after elective coronary artery bypass grafting (CABG) surgery.

Detailed Description
-----------------
In this study the oesophageal Doppler monitor (CardioQ+), arterial pulse wave analysis (via the CardioQ+ and Flotrac device) and central venous pressure (CVP) will be used to estimate mean systemic filling pressure (MSFP) with the inspiratory hold method. Furthermore the MSFParm will be determined using a rapid cuff inflator. From MSFP vascular compliance (Csys) and stressed volume (Vs) will be calculated. The accuracy of Vs to follow a 500 increase in volume will be studied. The accuracy of MSFP and Vs to to predict fluid loading responsiveness will be assessed in 42 patients after elective coronary artery bypass grafting (CABG) surgery. The effect of a standardised fluid loading on parameters of intrinsic contractility and afterload will be determined. The effect of fluid loading on inertia, resistance and elastance will be assessed

Official Title
-----------------
Measurement of Mean Systemic Filling Pressure & Stressed Volume With CardioQ+® Oesophageal Doppler Measurement

Conditions
-----------------
Cardiac Surgery, CABG

Intervention / Treatment
-----------------
* Diagnostic Test: MSFP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years and older planned for CABG Exclusion Criteria: Contraindication for fluid loading Pregnancy, morbid obesity Hemodynamic instability with a mean arterial pressure (MAP) < 55 mm Hg and/ or a cardiac index < 1.5 L•min-1 Severe arrhythmias Intra-cardiac shunts Symptomatic peripheral vascular disease Symptomatic pulmonary disease Significant valvular regurgitation Poor pre-operative left or right ventricular function Core temperature < 36 °C Contra-indication to the rapid cuff inflator Contra-indication to oesophageal Doppler probe insertion.

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 |
| --- |
|Diagnostic Test: MSFP|MSFPhold and MSFParm|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSFPhold | Mean systemic filling pressure | Before and after fluid administration (2 minutes and 10 minutes) | 
| MSFParm | Mean systemic filling pressure | Before and after fluid administration (2 minutes and 10 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stressed volume | Vs | Before and after fluid administration (2 minutes and 10 minutes) |
Mannitol Improves Cerebral Oxygen Saturation

Study Overview
=================
Brief Summary
-----------------
Decreased cerebral oxygen saturation (rSO2) was reported to occur during insufflation for laparoscopic procedures due to increased Intracranial pressure (ICP) with resultant decrease in cerebral perfusion pressure.

Detailed Description
-----------------
Forty patients scheduled for laparoscopic cholecystectomy will be enrolled in this double blind, randomized controlled study. Patients will receive either 0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia (group M) or an equal volume of 0.9% normal saline instead (group C). Primary outcome measure is rSO2. Secondary outcome variables include extubation time, clinical assessment of consciousness recovery using the modified Observer's assessment of alertness/sedation scale (OAA/S) and the mini-mental state examination (MMSE) for cognitive evaluation after recovery.

Official Title
-----------------
Effect of Preoperative Mannitol Infusion on Cerebral Oxygen Saturation and Patients' Recovery After Laparoscopic Cholecystectomy

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: Mannitol
* Drug: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists physical status I or II aged between 25 and 50 years with a body mass index (BMI) 22-34 kg/m2 Exclusion Criteria: obstructive or restrictive pulmonary disease cardiac dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mannitol<br>Patients will receive 0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia | Drug: Mannitol<br>* 0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia<br>* Other names: mannite or manna sugar;|
| Placebo Comparator: Control<br>Patients will receive normal saline | Drug: Control<br>* Saline infusion<br>* Other names: Saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rSO2 |  | participants will be followed for the duration of surgery, an expected average of 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| extubation time | time from end of anesthesia to fulfilling extubation criteria | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesia, Recovery, laparoscopy, cholecystectomy
Socio-Economic Survey in Uganda

Study Overview
=================
Brief Summary
-----------------
This study will be conducted at Mulago Teaching Hospital. Patients coming to the ER with an orthopaedic injury will be approached. If a patient consents to be part of the study, they will complete a questionnaire. Participation in the study will end as soon as the questionnaire is completed.

Detailed Description
-----------------
All patients will be recruited from the orthopedics inpatient wards and emergency department at Mulago National Referral Hospital. Only patients who have sustained an orthopedics injury will be included in this study, and the severity will be recorded for future references. No Protected Health Information (PHI) will be collected throughout the study. Steps Identify patients from Mulago Teaching Hospital Enrollment of patients into survey study Administer survey to patients at 1st meet up Administer survey to doctor-in-charge? Compilations of survey results into excel spreadsheet. Participants will be assigned an ID. The study team does not intend to collect any PHI. Statistical Analysis.

Official Title
-----------------
Short Term Socio-economic Impact Due to Blunt Orthopedics Trauma on the Victims in Uganda

Conditions
-----------------
Orthopaedic Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subject is a male or female 18 years old or older. all patients presented at Mulago National Referral Hospital with orthopedics trauma injuries regardless of age and gender. Exclusion criteria: - patients presented with all other conditions other than orthopedics related injuries that may require long term care. Some examples are head injuries leading to long term damage, loss of sights, etc.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate social-economic impact of orthopedics trauma as measured by socio-Economic Questionnaire | A short socio-economic questionnaire will be provided to all enrolled patients | approximately 20 minutes |
The Reality of Nutritional Therapy in Brazil: Quality Assessment

Study Overview
=================
Brief Summary
-----------------
Nutritional status depletion is associated with complications such as increased morbidity and mortality, worsening of patients' quality of life and increased length of hospital stay. Thus, nutritional therapy defined as the set of therapeutic procedures for maintenance or recovery of the nutritional status of the patient, becomes a procedure of extreme importance in the hospital setting. It should be carried out by an interprofessional team, in order to ensure adequate patient care. Aim: This study intends to evaluate the reality of Nutritional Therapy in Brazil, 18 and 14 years after the introduction of the resolution n ° 272 and the RDC n ° 63, respectively, regarding the practice of this important therapy and the existence of interdisciplinary teams. Method: Descriptive, observational and national study. In each Brazilian state was selected the capital, and drawn a city of average and other one of small size. Next, a public, private and university hospital in each municipality was randomly selected. Data collection will be done by means of a questionnaire, based on the Secretary of Sanitary Surveillance of the Ministry of Health resolution n ° 272 and the RDC n ° 63. The questionnaire will be applied by the researchers, and directed to the health professionals involved in the Nutritional Therapy practice in each of the selected hospitals.

Official Title
-----------------
The Reality of Nutritional Therapy in Brazil: Quality Assessment

Conditions
-----------------
Nutritional Therapy Quality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitals with nutritional therapy Exclusion Criteria: Hospitals with no nutritional therapy
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Reality of Nutritional Therapy in Brazil | The adequacy will be assessed using proper questionnaire prepared up from Resolution of Collegiate Board of the National Health Surveillance Agency Nº 63/2000 and portaria n° 272 of the Ministry of Health. | December, 2017. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of interdisciplinary teams of nutritional therapy | The performance will be assessed using proper questionnaire prepared up from Resolution of Collegiate Board of the National Health Surveillance Agency Nº 63/2000 and portaria n° 272 of the Ministry of Health. | December, 2017. | 
| Number of patients in nutritional therapy in hospitals | Own Checklist | December, 2017. |
Niclosamide In Moderate COVID-19

Study Overview
=================
Brief Summary
-----------------
This is a Phase 2, multicentre, randomized, double blind, 2 arm placebo-controlled study in adults with moderate COVID-19 with gastrointestinal signs and symptoms.

Official Title
-----------------
Phase 2, Multicentre, Randomized, Double Blind, 2 Arms Placebo-controlled Study in Adults With Moderate COVID-19 With Gastrointestinal Signs and Symptoms

Conditions
-----------------
COVID

Intervention / Treatment
-----------------
* Drug: Niclosamide Oral Tablet
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients hospitalized for treatment of COVID-19 with or without pneumonia, who are expected to remain in hospital at least seven days after the randomization and who accept continuing to be assessed for the study procedures (home or outpatient unit) up to 6 weeks in case of discharge. Patients who prior to developing COVID-19 usually have normal bowel habits defined as at least 3 stools per week and no more than 3 stools per day. SARS-CoV-2 infection confirmed by RT-PCR in rectal swab (or stool test) ≤2 days before randomization by local or central lab. Diarrhea defined as at least 3 watery stools in the last 24 hours prior to enrolment Exclusion Criteria: At the time of randomization patients requiring ICU admission or patients with severe respiratory insufficiency requiring mechanical ventilation or with rapid worsening of respiratory function leading to expectation for mechanical ventilation or ICU admission. Evidence of rapid clinical deterioration or existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Niclosamide<br>Continued SOC therapy together with Niclosamide tablets for 14 days | Drug: Niclosamide Oral Tablet<br>* Continued SOC therapy together with niclosamide TID for 14 days<br>|
| Placebo Comparator: Placebo<br>Continued SOC therapy together with placebo tablets matching niclosamide | Drug: Placebo<br>* Continued SOC therapy together with placebo tablets matching niclosamide for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the rate of faecal SARS-CoV-2 virus clearance (rectal swab or stool sample) assessed by RT-PCR in the niclosamide group, compared to the placebo group |  | From Day 1 to 42 |
A Comprehensive Assessment and Follow up Descriptive Study on Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the reliability and validity of the bipolar index (BPX) to diagnosis bipolar disorder, and to verify the stability of it in identifying bipolar disorder; the secondary purpose was to understand the dynamic changes of bipolar disorder in natural status.

Conditions
-----------------
Bipolar Disorder, Unipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 years old； Be able to understand the content of assessment and cooperate； Currently patients are depressive episode, and / or manic / hypomanic episode, also can be mood stable； Currently according to diagnostic criteria of the U.S Diagnostic and Statistical Manual Fourth Edition of Mental Disease (DSM-IV) of bipolar disorder (Type I, II, rapid cycling, mixed episodes)； Currently according to diagnostic criteria of the U.S Diagnostic and Statistical Manual Fourth Edition of Mental Disease (DSM-IV) of depressive disorder； No other mental illness or a history of physical disease，or patients with physical disease; Not received modified ECT at least four weeks or more before entering the group. Exclusion Criteria: Can not understand the content of assessment and cooperate； Meet the diagnosis criteria of schizophrenia and other psychotic disorders; Meet the diagnosis criteria of Diagnosis of mental retardation or pervasive developmental disorder; Clinically significant neurological disease or loss of consciousness more than one hour of traumatic brain injury；

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bipolar Disorder<br> | |
| Unipolar Disorder<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test-retest reliability of the scale |  | one year later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cronbach's α coefficient of the scale |  | one year later |
Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To determine the bioequivalence between the clinical batch process and the new processes for manufacturing LNG/EE. Secondary Objective: To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women.

Official Title
-----------------
An Open-label, Single-dose, Randomized, 2-period, Crossover, Bioequivalence Study to Compare Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: levonorgestrel/ethinyl estradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 18 - 35 years of age Non-smokers Exclusion Criteria: History of thromboembolic disease Prior adverse experiences with oral contraceptives

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: levonorgestrel/ethinyl estradiol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic sampling over the course of 4 days following two different formulations of the same compound |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional safety--clinical labs |  |  | 
| electrocardiograms (ECGs) |  |  | 
| vital signs |  |  | 
| and adverse event recording over 4 days following administration of each formulation (LNG/EE) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral contraceptive, therapeutic equivalency, contraceptives, oral, combined