linjc16/ctgov huggingface dataset:
Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition

Study Overview
=================
Brief Summary
-----------------
The benefit of anti-worm therapy as part of the case management of severe acute malnutrition (SAM) in the outpatient setting has not previously been studied. This study will compare recovery rates of children with SAM treated in the community with locally-produced ready-to-use therapeutic food (RUTF) with and without prescribed albendazole as part of their case management.

Official Title
-----------------
Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Benefit of Antihelminthic Therapy in the Community-Based Treatment of Severe Acute Malnutrition in Malawian Children

Conditions
-----------------
Kwashiorkor, Marasmus

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Albendazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12-59 months old Kwashiorkor and/or Marasmus Qualified for home-based therapeutic feeding with RUTF Exclusion Criteria: Obvious congenital or other malformation that makes child a poor candidate for feeding with RUTF Unable to consume test-dose of RUTF in clinic Parent refusal to participate and return for follow-up

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 59 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo given once<br>|
| Experimental: Albendazole<br> | Drug: Albendazole<br>* single dose albendazole given at the time of enrollment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nutritional recovery | Weight-for-Height Z-score (WHZ) > -2 without bipedal pitting edema | 12 weeks | 
| mortality |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| malnutrition relapse | acute malnutrition, either moderate (WHZ < -2) or severe (WHZ < -3 and/or bipedal pitting edema) | 6 months | 
| height and weight gain |  | 6 months |
Cirrhotic Patients With Septic Shock

Study Overview
=================
Brief Summary
-----------------
Cirrhotic patients have a poor outcome in intensive care unit (ICU). Septic shock is a leading cause of ICU admission and death in this specific population. We performed a monocentric retrospective study; all cirrhotic patients admitted in the ICU with septic shock from 2002 to 2013 were included. The aim of the study was to identify prognostic factors for both short- and long-term mortality in these patients. Demographic, clinical and biological data, organ supports, and outcomes were collected. Univariate and multivariate analysis were carried out regarding both ICU and one-year mortality.

Official Title
-----------------
Cirrhotic Patients Admitted to the ICU With Septic Shock: Factors Predicting Short and Long-term Outcome

Conditions
-----------------
Septic Shock, Cirrhosis

Intervention / Treatment
-----------------
* Other: Measure of short- and long-term mortality and analysis of independent predictors of short- and long-term mortality.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 or older diagnosis of cirrhosis diagnosis of septic shock at ICU admission Exclusion Criteria: prior liver transplantation

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cirrhotic patients with septic shock<br>All consecutive adult cirrhotic patients admitted to the ICU with septic shock from 2002 to 2013. | Other: Measure of short- and long-term mortality and analysis of independent predictors of short- and long-term mortality.<br>* Data were collected regarding medical background, medical condition and management, both at admission and during the ICU stay. These included demographics, clinical, biological and therapeutic data. Outcome at ICU discharge and at one year were also recorded.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term outcome: analysis of independent predictors of ICU mortality rate. | The predictors assessed independently are the clinical data, site of infection, biological data, liver scoring systems, organ failure, organ support and simplified acute physiology score (SAPS II), expressed in percentage of patients. The mortality rate is expressed in percentage of patients. | Between ICU admission (from January 2002 to December 2013) and ICU discharge | 
| Long-term outcome: analysis of independent predictors of one-year mortality rate. | The predictors assessed independently are the independent predictors found to be related to the short-term mortality rate, expressed in percentage of patients. The mortality rate is expressed in percentage of patients. | At one year after ICU admission (from January 2002 to December 2013) |
Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
To determine the pharmacodynamic and safety of MBA-P01 in Healthy Male Volunteers

Official Title
-----------------
A Randomized, Double-blind, Active-controlled, Single-center, Phase 1 Study to Determine the Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: MBA-P01
* Drug: BOTOX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male adults aged between 20 and 45 years Exclusion Criteria: Subjects not appropriate for participating in this study according to the investigator's opinion

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: botulinum toxin 1U<br> | Drug: MBA-P01<br>* injection of MBA-P01 into the muscle of each contralateral foot in equal doses<br>Drug: BOTOX<br>* injection of BOTOX into the muscle of each contralateral foot in equal doses<br>|
| Experimental: botulinum toxin 5U<br> | Drug: MBA-P01<br>* injection of MBA-P01 into the muscle of each contralateral foot in equal doses<br>Drug: BOTOX<br>* injection of BOTOX into the muscle of each contralateral foot in equal doses<br>|
| Experimental: botulinum toxin 15U<br> | Drug: MBA-P01<br>* injection of MBA-P01 into the muscle of each contralateral foot in equal doses<br>Drug: BOTOX<br>* injection of BOTOX into the muscle of each contralateral foot in equal doses<br>|
| Experimental: botulinum toxin 30U<br> | Drug: MBA-P01<br>* injection of MBA-P01 into the muscle of each contralateral foot in equal doses<br>Drug: BOTOX<br>* injection of BOTOX into the muscle of each contralateral foot in equal doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to estimate the pharmacodynamic aspects of muscle | percentage of reduction of CMAP amplitude of the muscle from baseline | day 3, 14, week 4, 8, 12 |
Copeptin in Normal- to Hyperosmolar States

Study Overview
=================
Brief Summary
-----------------
Kinetics of Copeptin in response to osmotic alterations in healthy volunteers

Detailed Description
-----------------
Construction of the standard area of copeptin release in the normo- and hyperosmolar state and its half-life based on ist decline during hypoosmotic Suppression in healthy volunteers.

Official Title
-----------------
Kinetics of Copeptin in Healthy Volunteers - a Prospective International Study

Conditions
-----------------
Copeptin Blood Values

Intervention / Treatment
-----------------
* Other: Hypertonic saline infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum Age 18 no severe comorbidities no medication (except contraceptives) baseline sodium Level 135-145mmol/l euvolemic status Exclusion Criteria: history of heart failure liver cirrhosis kidney disease (GFR <60ml/min) anemia uncontrolled Hypertension pregnancy Diabetes mellitus BMI >28kg/m2 other severe disease

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Copeptin values in normo- to hyperosmolar states<br> | Other: Hypertonic saline infusion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological relationship between Serum osmolality and Plasma copeptin release. | Copeptin and Blood osmolality will be measured concomitantly while hypertonic saline is infused. The infusion is continued until a hyperosmolar state is reached (defined with a sodium-level of 150mmol/l). Definition of an area of normality describing the physiological relationship between Serum osmolality and Plasma copeptin release in normo- to hyperosmolar states. | beginning and end of protocol, up to 8 hours | 
| Half life of Copeptin | Calculation of Copeptin half-life based on its decline during hypoosmotic suppression (oral waterload and glucose 5%-infusion) | beginning and end of protocol, up to 8 hours |
Influence of the COVId-19 Pandemic on the STRESS of Dental Surgeons (COVISTRESS - Dental Surgery)

Study Overview
=================
Brief Summary
-----------------
Coronavirus has caused containment of more than half of the world's population and a major and rapid reorganization of clinical and support services. The spread of coronavirus (COVID-19) has posed significant challenges for dental surgeons and associates who are at high risk of COVID-19 infection due to close face-to-face contact. However, there is currently no data on the influence of this epidemic on the practice and feelings of dental surgeons and associates

Detailed Description
-----------------
This is an observational study by REDCap questionnaire® via an internet link, which will be distributed to dental surgeons and associates by any means The self-survey will assess stress, working conditions and changes in practices related to the coronavirus outbreak. This Dental Surgery questionnaire includes 16 questions

Official Title
-----------------
Influence of the COVId-19 Pandemic on the STRESS of Dental Surgeons

Conditions
-----------------
Dental Surgeon

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All dental surgeons and associates volunteers to participate Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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 |
| --- | --- | --- |
| Stress measures | Attitudes and stress from dental surgeons will be measured via questionnaire | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic characteristics | Age, gender, qualification, personal work status, ethnicity and life characteristics will be assessed by questionnaires | Day 1 | 
| occupation perception | the perception about occupation will be assessed by questionnaires | Day 1 | 
| work conditions | work conditions will be assessed by questionnaires | Day 1 | 
| Changes in practices | changes in practices related to coronavirus pandemic will be assessed by questionnaires | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Dental surgery, Stress
Hyperbilirubinemia in Acute Appendicitis as a Predictor of Perforation

Study Overview
=================
Brief Summary
-----------------
It has recently been published that hyperbilirubinemia is a reliable marker for the preoperative diagnosis of perforated acute appendicitis. The investigators believe, based on their own previous publications, that C-reactive protein (CRP) with or without a white blood cell count and some other clinical parameters, are more specific markers for the preoperative diagnosis of perforated acute appendicitis. The purpose of this study is to prospectively compare the specificity and sensitivity of hyperbilirubinemia CRP, white blood cell count and other clinical parameters for the preoperative diagnosis of acute appendicitis.

Detailed Description
-----------------
Previously validated appendicitis score Time from onset of symptoms to diagnosis and to surgery Laboratory values: WBC, CRP, liver function test SIRS values Preoperative and postoperative diagnosis Length of hospital stay Postoperative complications Biopsy results

Official Title
-----------------
Prospective Study Comparing Hyperbilirubinemia, CRP, White Blood Cell Count, and Other Clinical Parameters for the Preoperative Diagnosis of Perforated Acute Appendicitis

Conditions
-----------------
Perforated Appendicitis

Intervention / Treatment
-----------------
* Other: Laboratory Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for appendectomies for acute appendicitis at the emergency unit of our institution Patients older than 15 years of age to 100 years of age Exclusion Criteria: Appendectomy performed incidentally or for other indications Patients younger than 15 years of age Alcoholism A history of viral hepatitis Gilbert's disease Dubin Johnson syndrome BRIC (benign recurrent intra-hepatic cholestasis) and other documented biliary Hemolytic or liver diseases associated with hyperbilirubinaemia

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| 1<br>Simple appendicitis | Other: Laboratory Test<br>* CRP, white blood cell count, hepatic function tests<br>|
| 2<br>Perforated appendicitis | Other: Laboratory Test<br>* CRP, white blood cell count, hepatic function tests<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRP, Appendicitis, Hyperbilirubinemia, Values of bilirubin, Values of liver function test, Values of white blood cells, Values of CRP
The Effects of Huang-Lian-Jie-Du-Tang（HLJDT) on the Survival of Patients With Multiple Myeloma in Maintain Therapy

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy of the combination of Thalidomide and Huang-Lian-Jie-Du-Tang on the patients with multiple myeloma in maintain therapy.

Official Title
-----------------
Phase 1 Study of the Effects of Huang-Lian-Jie-Du-Tang（HLJDT) on the Survival of Patients With Multiple Myeloma in Maintain Therapy

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Thalidomide
* Drug: HLJDT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients can take HLJDT Exclusion Criteria: patients can not take HLJDT

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Arm A: HLJDT 150ml three times per day for 6 months and Thalidomide 100mg once per day for 6 months | Drug: Thalidomide<br> <br> Drug: HLJDT<br> <br> |
| Active Comparator: B<br>Arm B: Thalidomide 100mg oral once per day for 6 months | Drug: Thalidomide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival of patients with multiple myeloma treated with Huang-Lian-Jie-Du-Tang（HLJDT) in maintain therapy |  | 6 months |
TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
Patients will be randomized into 2 groups: TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia IV: Patients receiving only intravenous Acetaminophen analgesia Postoperative pain 24 hours after surgery will be evaluated.

Detailed Description
-----------------
Patients will be randomized into 2 groups: TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia (1g/6h) IV: Patients receiving only intravenous Acetaminophen analgesia (1g/6h) Postoperative pain 24 hours after surgery will be evaluated, by a Visual Analogic Scale (VAS), ranging from 0 to 100mm.

Official Title
-----------------
Transversus Abdominis Plane (TAP) Blockade as Multimodal Analgesia for Pain Control in One-Anastomosis Gastric Bypass (OAGB)

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Procedure: Transversus abdominis plane blockade
* Drug: Intravenous analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing One-anastomosis gastric bypass (OAGB) as primary bariatric procedure Exclusion Criteria: Patients undergoing OAGB as revisional procedure Patients undergoing other bariatric procedures Patients undergoing additional surgical procedures during the same surgical act (band removal, cholecystectomy, hernioplasty, or hiatal hernia treatment) Patients with history of allegy to local anesthetic drugs

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transversus abdominis plain blockade<br>The patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia | Procedure: Transversus abdominis plane blockade<br>* Patients will undergo Transversus abdominis plane blockade with Bupivacaine 0.25% 30ml, applied in the plane between the internal oblique muscle and the trasnversus abdominis. The injection will be performed laterally to the port-sites, bilaterally at the same levels.<br>Drug: Intravenous analgesia<br>* Acetaminophen 1g/6h iv will be administered<br>|
| Active Comparator: Intravenous analgesia<br>The patients will receive intravenous analgesia with Acetaminophen (1g/6h) | Drug: Intravenous analgesia<br>* Acetaminophen 1g/6h iv will be administered<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Pain will be assessed 24 hours after surgery by a Visual Analogic Scale, ranging from 0 to 100mm | 24 hours after surgery |
Moderate Bleeding in Cardiac Surgery Post Operative

Study Overview
=================
Brief Summary
-----------------
Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population.

Detailed Description
-----------------
Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population. Secondary objectives: To evaluate the kinetics of moderate SPORT and its impact on anemia and postoperative transfusion. To evaluate the prognostic impact of the SPO moderate in terms of post-operative complications. Determine predictors of moderate SPO.

Official Title
-----------------
Bleeding Moderate Postoperative Cardiac Surgery and Prognostic Implications Anemia and Postoperative Transfusion: Prospective, Observational, Descriptive.

Conditions
-----------------
Heart Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the postoperative intensive care in cardiac surgery Exclusion Criteria: Patients who received a heart transplant, a heart surgery beating, cardiac support establishment of long duration, or have a disease that alters the coagulation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Evolution of blood loss per hour drains | Hourly blood loss in drains during the first twelve hours | Hourly blood loss in drains during the first twelve hours |