linjc16/ctgov huggingface dataset:
The Effect of Motilin on the Frequency and Amount of Food Intake

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators aimed at evaluating the role of motilin in the regulation of food intake. Motilin, a gastrointestinal hormone, is a hunger signal in healthy volunteers and is significantly increased in obese patients. Its role in food intake regulation might contribute to the pathogenesis of obesity.

Official Title
-----------------
Influence of Erythromycin on ad Libitum Food Intake and the Evaluation of Motilin in Food Timing in Healthy Volunteers and Patients

Conditions
-----------------
Healthy, Obesity

Intervention / Treatment
-----------------
* Drug: Erythromycin
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI < 30 kg/m² for lean volunteers BMI > 30 kg/m² for obese volunteers Subject is capable and willing to give informed consent Female volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception Exclusion Criteria: Female volunteer is pregnant or breastfeeding GI diseases, major abdominal surgery Major psychiatric illnesses Volunteers that use drugs affecting the GI tract or the central nervous system Volunteers suffering from endocrine diseases such as diabetes, Cushing's disease, Addison's disease, hypothalamic tumor Volunteers that have undergone surgical procedure for weight loss

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erythromycin<br>40 mg of erythromycin will be administered intravenously over a period of 20 min in a saline solution of 100 ml | Drug: Erythromycin<br> <br> |
| Placebo Comparator: Placebo<br>a saline solution of 100 ml will be administered intravenously over a period of 20 min | Drug: Saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in food intake, assessed by caloric intake, after intravenous administration of erythromycin compared to placebo |  | Caloric intake will be assessed 1 hour after the start of infusion and the start of ad libitum food intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of food intake correlated with motilin plasma levels |  | Assessment will be done over a period of 5 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Motilin, Erythromycin, Food intake
Study of Safe Blood Transfusion Volumes to Correct Acute Severe Anaemia

Study Overview
=================
Brief Summary
-----------------
Greater volume of whole blood(30mls/kg compared to 20mls/kg) following standard calculations, given to children with severe anaemia will be beneficial in haematological correction and can be given safely since respiratory distress and haemodynamic changes result from acidosis and compensation in these children rather than from biventricular failure.

Detailed Description
-----------------
Severe anemia (SA, hemoglobin <6 g/dl) is a leading cause of pediatric hospital admission in Africa, with significant in-hospital mortality. The underlying etiology is often infectious, but specific pathogens are rarely identified. Guidelines developed to encourage rational blood use recommend a standard volume of whole blood (20 ml/kg) for transfusion, but this is commonly associated with a frequent need for repeat transfusion and poor outcome. Evidence is lacking on what haemoglobin threshold criteria for intervention and volume are associated with the optimal survival outcomes. We evaluated the safety and efficacy of a higher volume of whole blood (30 ml/kg; Tx30: n = 78) against the standard volume (20 ml/kg; Tx20: n = 82) in Ugandan children (median age 35.5 months (interquartile range (IQR) 12.5 to 52.5)) for 24-hour anemia correction (hemoglobin >6 g/dl: primary outcome) and 28-day survival.

Official Title
-----------------
Phase II Trial of Transfusion Volumes in Children With Acute Severe Anaemia

Conditions
-----------------
Severe Anaemia

Intervention / Treatment
-----------------
* Other: Whole blood
* Other: Whole blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe anaemia(HB less than 6g/dl)at admission Guardian or parent willing/able to provide consent Exclusion Criteria: Malignancy Surgery Acute trauma Severe malnutrition

Ages Eligible for Study
-----------------
Minimum Age: 60 Days
Maximum Age: 12 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 20ml/kg of whole blood transfusion<br>Standard care recommended by WHO | Other: Whole blood<br>* 30mls/kg transfused over fours hours<br>Other: Whole blood<br>* 20mls/kg transfused over four hours<br>|
| Experimental: 30ml/kg of whole blood<br>Higher volume than currently recommended | Other: Whole blood<br>* 30mls/kg transfused over fours hours<br>Other: Whole blood<br>* 20mls/kg transfused over four hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correction of severe anaemia. | Correction of severe anaemia to a Hb >6g/dL at 24 hours. | 24 hours |
Effects on Glutamine on the Outcome of Allogeneic Bone Marrow Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this project is to investigate if addition of glutamine, an amino acid, to standard parenteral nutrition, may improve the clinical outcome of the bone marrrow transplantation reducing the occurrence of veno-occlusive disease and severity of mucositis.

Official Title
-----------------
A Randomized Control Studies on the Effects of Glutamine on the Clinical Outcome of Bone Marrow Transplant Recipients With Special Reference to Veno-occlusive Disease and Mucositis.

Conditions
-----------------
Pulmonary Veno-Occlusive Disease, Hepatic Veno-Occlusive Disease, Mucositis

Intervention / Treatment
-----------------
* Drug: Glutamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allogeneic bone marrow transplant recipients using busulfan and cyclophosphamide as conditioning.

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Veno-occlusive disease |  | 1 month | 
| Mucositis |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay |  | 2 months | 
| Use of antibiotics |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Veno-occlusive disease, Mucositis
Gut Hormone, Nociceptors, Neurotrophic Factors Expression in Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
The pathophysiology of functional dyspepsia is still unclear but several peptides have been indicated in the etiological factors in FD. Ghrelin and leptin are involved in regulation of appetite and gut motility and serotonin is a typical neurotransmitter related with sensory and motor functions of gut. On the other hand, transient receptor potential vanilloid receptor 1 (TRPV1) has been proposed to be involved with functional gastrointestinal disorder, and expression of this receptor could be regulated by nerve growth factor (NGF) or glial cell-line derived neurotrophic factor (GDNF). The investigators aimed to determine whether expressions of ghrelin,leptin, serotonin,TRPV1,GDNF and NGF in blood or gastric mucosa of FD patients are different from those in healthy controls, and whether some changes of their expression correlate with certain dyspeptic symptoms. The investigators also investigated the effect of H. pylori infection by comparing their expressions before and one year after H. pylori eradication.

Official Title
-----------------
Ghrelin, Leptin, Serotonin, TRPV1, NGF and GDNF Expression in the Patients With Functional Dyspepsia

Conditions
-----------------
Functional Dyspepsia, H. Pylori Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who completed upper GI endoscopy and questionnaire about gastrointestinal symptoms Exclusion Criteria: Daily user of NSAID or anticoagulants with concomitant systemic diseases such as diabetes mellitus or any malignancy Participants with major depression, psychosis, eating disorder Participants with typical reflux symptom Patients with Benign gastric ulcer or duodenal ulcer Patients with past gastrointestinal surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Functional dyspepsia group<br>Patients who had epigastric pain or discomfort with normal upper endoscopy and no organic evidence for explaining these symptoms | |
| Control group<br>Subjects with normal endoscopic finding who do not have any gastrointestinal symptoms | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of fasting plasma acyl ghrelin |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of gastric mRNA ghrelin, leptin, TRPV1, NGF and GDNF expression and blood level of acyl ghrelin, leptin and serotonin |  | Baseline/ 1year | 
| Expression of gastric ghrelin, leptin, TRPV1, NGF and GDNF mRNA and blood level of des-acyl ghrelin and serotonin |  | Baseline |
Safety and Immunogenicity of a Inactivated Influenza Vaccine When Administered to Non Elderly Adults and Elderly Subjects.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of a Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2005-2006, when Administered to Non-Elderly Adults and Elderly Subjects

Official Title
-----------------
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2005-2006, When Administered to Non-Elderly Adult and Elderly Subjects

Conditions
-----------------
Influenza Disease

Intervention / Treatment
-----------------
* Biological: influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects 18 years of age or older Exclusion Criteria: Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine known or suspected (or high risk of developing) impairment/alteration of immune function

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: influenza vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection. |  |  | 
| Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection. |  |  | 
| Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza, non elderly adult and elderly, vaccine
Efficacy of Acupuncture on Induction of Labor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of acupuncture for the induction of labor in pregnant women at the 40 weeks + 4 days of gestation.

Detailed Description
-----------------
Women at 40+2-40+4 gestational age were allocated to receive acupuncture twice a week or observation in order to observe the efficacy of acupuncture in labour onset.

Official Title
-----------------
Efficacy of Acupuncture on Induction of Labor

Conditions
-----------------
Labor, Pregnancy

Intervention / Treatment
-----------------
* Procedure: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physiological pregnant women at 40 weeks + 4 days of gestation Exclusion Criteria: Fetal or maternal disease

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>acupuncture daily fo 7 days | Procedure: acupuncture<br>* acupuncture application<br>|
| No Intervention: 2<br>observation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the efficacy of acupuncture administered daily from 40 weeks + 4 days of gestation for induction of labor respect with placebo |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate safety of acupuncture |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
to evaluate acupuncture as possible alternative treatment for induction of labor, Induction, treatment, posterm
Rapid Prototyping Models for Patient Education

Study Overview
=================
Brief Summary
-----------------
Pre-made rapid prototyping models will be used to increase patient education versus current methodologies.

Detailed Description
-----------------
Post-partum women and their co-parent will have a medical condition explained to them first verbally, followed by a questionnaire, and then with the use of anatomical models created by rapid prototyping, followed by a questionnaire. The two questionnaires will then be compared.

Official Title
-----------------
Use of 3-D Printed Models to Improve Patient Understanding During the Informed Consent Process: A Pilot Study

Conditions
-----------------
Patient Education

Intervention / Treatment
-----------------
* Other: RP model explanation and questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mother Post-partum Atraumatic delivery of healthy, live infant at HMC Age > 18 Co-parent Co-parent Atraumatic delivery of healthy, live infant at HMC Age > 18 Exclusion Criteria: any pregnancy related issues fetal loss NICU stay > 6 hours Emergent cesarean section Post-partum hemorrhage Hysterectomy Any other condition requiring unplanned, medical intervention during labor and delivery Prior fetal loss or anomaly Inability to read or write English those who do not consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-partum Women<br>Post-partum women following an atraumatic pregnancy. | Other: RP model explanation and questionnaire<br>* Rapid prototyping models of anatomy will be used to demonstrate an anatomic and medical condition and participants will grade the experience on a questionnaire.<br>|
| Co-Parents<br>Co-parents to post-partum women following an atraumatic pregnancy. | Other: RP model explanation and questionnaire<br>* Rapid prototyping models of anatomy will be used to demonstrate an anatomic and medical condition and participants will grade the experience on a questionnaire.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in questionnaire score |  | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Age |  | through study completion, an average of 1 year | 
| Participant Education Level |  | through study completion, an average of 1 year | 
| Participant Gender |  | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient Care, Education
Safety and Effectiveness Evaluation of the Apotech® Diabetic Body Moisturizer

Study Overview
=================
Brief Summary
-----------------
Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications.

Detailed Description
-----------------
Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications. This study aim to address the target population, subjects with controlled diabetes, to verify the improvement of texture, elasticity, and general appearance of the skin through the application of the cosmetic product Apotech®.

Official Title
-----------------
Safety and Effectiveness Evaluation of a New Moisturizer Formulation With Antioxidant, Anti-inflammatory and Anti-microbial Effects in the Prevention of a Diabetic Skin Dryness and Complications

Conditions
-----------------
Skin Care, Skin Diseases, Metabolic

Intervention / Treatment
-----------------
* Other: Body moisturizer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with controlled diabetes Any phototype and all skin types Exclusion Criteria: Pregnant women Subjects that not match the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: This study aim to verify the improvement of texture, elasticity and general appearance of the skin through the application of the cosmetic product Apotech®.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Body moisturizer Apotech®<br>Instructions for use: Massage the product in the body twice a day (morning and evening) with gentle movements until completely absorption. Daily use for 28 days. | Other: Body moisturizer<br>* Daily body moisturizer application for skin protection and barrier.<br>* Other names: Apotech® SkinCare;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin general appearance | Standard guide for sensory claim substantiation - ASTM | 28 days | 
| Skin texture | Standard guide for sensory claim substantiation - ASTM | 28 days | 
| Skin hydration | Standard guide for sensory claim substantiation - ASTM | 28 days | 
| Skin elasticity and visible cracking | Standard guide for sensory claim substantiation - ASTM | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory evaluation of the product | Standard questions | 28 days |