linjc16/ctgov huggingface dataset:
Recruitment Maneuver After Bronchoalveolar Lavage in ARDS Patients

Study Overview
=================
Brief Summary
-----------------
ARDS caused by pneumonia is one of the main reasons for ICU admission in critically ill patients, and also a common complication in patients admitted to ICU with invasive mechanical ventilation. Bronchoalveolar lavage (BAL) is the main diagnostic method for these patients, which often leads to alveolar collapse and exacerbates hypoxemia. In clinical practice, recruitment maneuver (RM) is often used immediately after BAL to prevent such a situation, but there is a lack of data on RM after BAL.

Official Title
-----------------
Recruitment Maneuver After Bronchoalveolar Lavage in ARDS Patients

Conditions
-----------------
Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Other: Recruitment Maneuver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with invasive mechanical ventilation; Patients who diagnosed with ARDS according to the Berlin definition There are indications for bronchoalveolar lavage Exclusion Criteria: Patients with contraindications for EIT procedures; Patients with contraindications for RM; Previous chronic respiratory diseases (long-term home oxygen therapy for chronic respiratory diseases such as pulmonary fibrosis or COPD); Pregnancy; Refusal to sign informed consent

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RM after BAL<br>patients underwent RM after BAL | Other: Recruitment Maneuver<br>* RM after BAL<br>|
| No Intervention: Non-RM after BAL<br>patients did not undergo RM after BAL | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the ratio of tidal volume in the BAL side and the other side | distribution of tidal volume monitored by electrical impedance tomography from the BAL side to the other side | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| partial pressure of arterial oxygen (Pao2) to the fraction of inspired oxygen (Fio2) ratio | partial pressure of arterial oxygen (Pao2) to the fraction of inspired oxygen (Fio2) ratio | up to 24 hours | 
| respiratory system compliance (the tidal volume to the driving pressure ratio) | respiratory system compliance was calculated by dividing expiratory tidal volume by the driving pressure (plateau pressure minus positive end-expiratory pressure) | up to 24 hours |
Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1

Study Overview
=================
Brief Summary
-----------------
The effects of food additives on body weight in humans are largely unknown. This is a before-and-after feasibility study in 5 obese adults who will be followed for 5 months. Eligible participants will meet with the study team and will be taught how to limit the exposure to the studied food additives in their diet. Participants will also be asked to limit eating out to a maximum of 2 days per week. Primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.

Official Title
-----------------
Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Dietary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI>/=30 kg/m2 willingness and ability to follow the proposed dietary intervention informed consent Exclusion Criteria: previous or planned bariatric surgery in the next 1 year current or planned participation in any structured weight-loss programs in the next 6 months current or recent (within the last 6 months) use of weight-loss-inducing drugs or systemic steroids bipolar disorder or attention deficit hyperactivity disorder current use of anti-depressant or anti-psychotic medications eating disorder or any other active disorder that may lead to significant weight changes working night shifts pregnancy or planned pregnancy in the next 1 year uncontrolled diabetes mellitus or diabetes requiring treatment with >2 oral diabetes medications or with insulin

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary intervention<br> | Other: Dietary intervention<br>* Limiting dietary exposure to benzoic acid, sorbic acid, polysorbates and related food additives; limiting eating out to a maximum of 2 days per week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate |  | 0 months | 
| Retention rate |  | 5 months | 
| Adherence to the dietary intervention | Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls conducted at 2, 3 and 4 months | 2 to 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dietary modification
Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I in children with hyperinsulinism.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross-over study. Patients are randomized to receive recombinant human insulin-like growth factor I (IGF-I) or placebo subcutaneously twice daily for 4 weeks. After a 2 week washout period, patients are crossed over to the other regimen for an additional 4 weeks. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Hyperinsulinism

Intervention / Treatment
-----------------
* Drug: insulin-like growth factor I


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of hyperinsulinism (i.e., evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action) Suboptimal control of blood sugar (i.e., inability to fast at least 10 hours with a blood sugar of 60 mg/dL or greater) --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other major medical conditions No known adverse reaction to recombinant human insulin-like growth factor I

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum 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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin-like growth factor I|nan|

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
-----------------
endocrine disorders, hyperinsulinism, rare disease
Endocrine Regulation of Energy and Fluid Supplies in Alcoholic Patients

Study Overview
=================
Brief Summary
-----------------
This study is about the endocrine regulation of energy and fluid supplies in alcoholic patients. A large proportion of energy and fluid is supplied by alcohol beverages in alcoholic patients. In this study, we evaluated the importance of these supplies with a detailed questionnaire, a nutrition software that evaluated the importance of each macro- and micronutrients and correlated these values with several hormones such as Leptin, Insulin, Cortisol, Ghrelin, and PYY involved in the regulation of energy balance or AVP involved in the regulation of plasma osmolality

Detailed Description
-----------------
This study was conducted in a stepwise manner : study of the energy supplies first, of water supplies next. Interviews and samples were performed or collected at two times of alcohol withdrawal to evaluate the possibility of parallel changes in craving for alcohol, supplies and endocrine function.

Official Title
-----------------
Etude Des déterminants Endocrinologiques Des Apports énergétiques et Fluides Des Patients Alcooliques en Cours de Sevrage

Conditions
-----------------
Alcoholism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alcoholic patients still under the effect of alcohol at entry Exclusion Criteria: Other type of addiction

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcoholism, nutrition, craving, energy supplies, water supplies
Bone Marrow Autotransplantation in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This project evaluates the effectiveness of the administration of autologous bone marrow blood in patients with brittle type 1 diabetes mellitus to restore insulin secretion. After mobilization of hematopoietic progenitors (G-CSF) during 3 days, 50 to 90 mL of bone marrow blood will be obtained by multifunction in the posterior iliac crest. The material obtained will be implanted into the pancreas through the magna pancreatic artery after femoral catheterization.

Official Title
-----------------
Regeneration of Insulin Production in Patients With Type 1 Diabetes by Autologous Bone Marrow Blood Infusion

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Biological: administration of autologous bone marrow blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetes type 1 patients 18 to 50 years of age more than 5 years of evolution of the disease brittle diabetes (HbA1c > 8.5 % with intensified treatment or severe hypoglycemia episodes Exclusion Criteria: history of cancer hematologic alterations infectious disease positivity (HIV, HCV etc.) diabetic nephropathy cardiac failure liver disease autoimmune systemic disease allergy to iodine contrast or anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: administration of autologous bone marrow blood|administration of autologous bone marrow blood through magna pancreatic artery after femoral catheterization once during 12-month study period|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate glycosylated hemoglobin 1,3,6, and 12 months after autologous bone marrow blood administration. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate number of hypoglycemias 1,3,6, and 12 months after autologous bone marrow blood administration. |  | 12 months | 
| Evaluate insulin dose 1,3,6, and 12 months after autologous bone marrow blood administration. |  | 12 months | 
| Evaluate GADab titers and treatment tolerance 1,3,6, and 12 months after autologous bone marrow blood administration. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes type 1, bone marrow transplantation
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-3 - 6

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in healthy, non-drug dependent volunteers.

Detailed Description
-----------------
not available at this time

Official Title
-----------------
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-3

Conditions
-----------------
Heroin Dependence, Opioid-Related Disorders

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals must be healthy, non-drug dependent volunteers, be at least 18 years of age, and have no prior history of drug or alcohol abuse or dependence. Subjects must have had some minimal experience with opioids (e.g. at least two prior exposures) Exclusion Criteria: Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g., liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Drug<br>Test drug to prevent heroine withdrawal | Drug: Test Drug<br> <br> * Other names: test drug o;|
| Placebo Comparator: Placebo Pill<br>Placebo drug | Drug: Placebo Drug<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed withdrawal rating |  |  | 
| Pupil diameter |  |  | 
| Drug effect characteristics |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heroin Dependence
Dynepo Long-Term Safety Study

Study Overview
=================
Brief Summary
-----------------
To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.

Official Title
-----------------
An Open-Label, Phase IV, Multi-Centre Study to Investigate the Long-Term Safety and Efficacy of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease

Conditions
-----------------
Anemia, Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Drug: Dynepo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who complete Dynepo study SPD490-301. Patients who continue to require epoetin (EPO) treatment and have had a Hb level of 10g/dL between Weeks 16 and 24 of study SPD490-301. Exclusion Criteria: Withdrawal, before Week 24, from study SPD490-301. Pregnant or lactating women. Uncontrolled hypertension. Thrombocytopenia (platelet count <75,000/mm3). Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or genitourinary tract bleeding). Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to enrolment in this study. Androgen therapy in the 30 days immediately prior to enrolment in this study. Known Human Immunodeficiency Virus (HIV) infection. History of hypersensitivity to Dynepo. Known to have Ab against EPO.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynepo (Epoetin delta)<br>Subjects received Dynepo (Epoetin delta) either twice weekly (BIW), once weekly (QW), once every 2 weeks (Q2W) or once every 4 weeks (Q4W) based on what is appropriate for the subject | Drug: Dynepo<br>* Subcutaneous injection either BIW, QW, Q2W or Q4W based on what is appropriate for the subject<br>* Other names: Epoetin delta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Emergence of Treatment Emergent Adverse Events (TEAEs) |  | Over the course of 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years |  | Baseline and 2 years | 
| Change From Baseline in Hematocrits at 2 Years |  | Baseline and 2 years |
Non-Interventional Study on the Tolerability and Efficacy of IVIG

Study Overview
=================
Brief Summary
-----------------
Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%

Detailed Description
-----------------
A Non-Interventional Study on the Tolerability and Efficacy of Octagam 5% or 10% or panzyga. Patients with any indication (replacement and immonomodulation) as prescribed by the treating physician. Marketed Octagam 5% or 10% or panzyga will be used according to the investigator prescription; intravenous (iv) administration.The primary objective is to detect and evaluate adverse drug reactions (ADRs) occurring during or after the administration of Octagam or panzyga in any indication, age group or treatment regimen, where a causal relationship to the administration of Octagam or panzyga is suspected.

Official Title
-----------------
Non-Interventional Study on the Tolerability and Efficacy of IVIG

Conditions
-----------------
Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG

Intervention / Treatment
-----------------
* Biological: Octagam IVIG 5% or 10%
* Biological: Panzyga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient who needs to be treated with a product of this class because of his/her medical condition and whom the treating physician decides to prescribe Octagam or panzyga regularly, may be included. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Octagam<br>Patient receiving Octagam 5% or 10% IVIG | Biological: Octagam IVIG 5% or 10%<br>* Octagam IVIG 5% or 10%<br>|
| Panzyga<br>Patient receiving panzyga | Biological: Panzyga<br>* Panzyga<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Drug Reactions | Number of patients with adverse drug reactions | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection Occurrence | Pool of PID/SID Patients: Influence of IVIG/SCIG Treatment. Frequency, intensity, and duration of infectious episodes assessed. At the last available assessment, the influence of study IVIG on the frequency, intensity, and duration of the infections. | Up to one year |
Rifaximin in Patients With Diabetic Gastroparesis

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to determine if subjects with diabetic gastroparesis and symptoms of bloating will have a greater improvement in bloating symptoms when treated with rifaximin.

Official Title
-----------------
Evaluating the Therapeutic Efficacy of Rifaximin in Patients With Diabetic Gastroparesis Using Bloating as the Primary Endpoint.

Conditions
-----------------
Crohn Disease, Diabetic Gastroparesis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Men and women adult patients, aged 18-75, with diabetic gastroparesis Diagnosis of diabetic gastroparesis will have been made previously using a combination of symptoms (e.g., nausea, vomiting, bloating, early satiety, abdominal pain), the absence of mechanical obstruction, and delayed gastric emptying using a 4-hour, solid phase scintigraphic study (GES; > 20% remaining at 4 hours) Exclusion Criteria Prior surgery to the stomach or esophagus Known mechanical obstruction of the GI tract Current or recent (< 4 weeks) use of opioids Current/active use of cannabis Current or recent (< 4 weeks) use of antibiotics Current or recent use of antifungal agents (< 4 weeks) Prior treatment with rifaximin (< 1 year) Uncontrolled diabetes with a HgbA1c > 12 Severe uncontrolled or untreated anxiety or depression.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Intervention Treatment<br>Subjects diagnosed with gastroparesis will receive Rifaximin | Drug: Rifaximin<br>* 550 mg by mouth three times daily for 14 days<br>* Other names: TD-1473;|
| Placebo Comparator: Placebo Group<br>Subjects diagnosed with gastroparesis will receive a placebo | Drug: Placebo<br>* By mouth three times daily for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in bloating | Change is the self reported bloating questionnaire comprised of 45 questions addressing symptoms of bloating/distention | Week 2, week 4, week 8 |