linjc16/ctgov huggingface dataset:
Carbon Monoxide-Saturated Medium for Islet Isolation

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine whether harvesting islets using carbon monoxide (CO)-saturated mediums can protect islet cell from death after autologous islet transplantation in patients with chronic pancreatitis.

Detailed Description
-----------------
Investigators plan to harvest human islets using carbon monoxide-saturated mediums. Survival and function of transplanted islets will be compared with islets harvested using regular mediums.

Official Title
-----------------
A Novel Approach to Harvest Islets for Autologous Islet Transplantation

Conditions
-----------------
Chronic Pancreatitis

Intervention / Treatment
-----------------
* Other: Carbon monoxide-bubbled mediums


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic pancreatitis patient selected for total pancreatectomy and islet autotransplantation. Age between 18-69. Exclusion Criteria: 1. Had prior pancreatic surgeries. Note: The study was initially designed only to enroll diabetes free patients. To increase enrollment, we extended the inclusion criteria by allowing patients who are pre-diabetic to participate the study. This revision was approved by the MUSC IRB on 11/10/2015.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbon monoxide-bubbled mediums<br>Islets will be harvested with Carbon monoxide-saturated mediums | Other: Carbon monoxide-bubbled mediums<br>* Islets will be harvested with carbon monoxide bubbled mediums<br>|
| No Intervention: Normal mediums<br>Islets will be harvested with regular mediums | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve during mixed meal tolerance test |  | 6 months |
Orthotics and Achilles Load in Runners

Study Overview
=================
Brief Summary
-----------------
Compare Customized arch support orthoses (CASO) and orthotic heel lift (HL) on the effect of ATL in recreational runners with pronated feet.

Detailed Description
-----------------
This was a controlled laboratorial, within subject, repeated measures study. The aim of this study was to compare two clinically applied treatment options: Customized arch support orthoses (CASO) and orthotic heel lift (HL) on the effect of ATL in recreational runners with pronated feet. It implicated to provide a better understanding of the types of foot orthoses for flatfeet runners and additional biomechanical evidence for the clinical field to guide orthotic prescription as well as selection for Achilles tendinopathy management.

Official Title
-----------------
Controlled Trial to Compare the Achilles Tendon Load During Running in Flatfeet Subjects Using a Customized Arch Support Orthoses vs an Orthotic Heel Lift

Conditions
-----------------
Achilles Tendinopathy, Flatfoot, Sports Injury

Intervention / Treatment
-----------------
* Device: CASO
* Device: HL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Foot Posture Index (FPI) was used as evaluating pronated foot posture. Subjects with FPI scores of 6-12 were recruited in the current study. All participants should be free of Achilles tendinopathy and triceps surae injury for 6 months. no previous surgery. not previously attempted any foot orthoses intervention before this study. Exclusion: leg-length discrepancy rigid forefoot varus deformity gastrocnemius equinus structural hallux limitus, or rigidus Any musculoskeletal or neurological disorders

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

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

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

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: Runner<br>Subject will undergo an assessment wearingeither the CASO or the HL. Sequence of CASO of HL will be randomly allocated. | Device: CASO<br>* Customized arch support orthoses (CASO)<br>Device: HL<br>* Orthotic Heel Lift (HL)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plantarflexion moment | 8-camera motion capturing system | Day 0 | 
| Peak Achilles tendon load | Piezoelectric force platform, computed using the Newton-Euler inverse-dynamics | Day 0 |
The Effects of Dairy Products on Energy Balance

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the long time effects of high and low intake of dairy products on fecal fat excretion, weight loss, blood pressure, lipid profile, lipid oxidation and appetite regulation in moderately overweight men and women over 24 weeks.

Official Title
-----------------
The Effects of Dairy Products on Energy Balance

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

Intervention / Treatment
-----------------
* Other: High Calcium intake from dairy products


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women, medium overweight (body mass index 28-36 kg/m2), 18-60 years old, low habitual calcium intake (<800 mg/d) Exclusion Criteria: milk allergy, infection diseases and diabetes, intake of dietary supplements, smoking, pregnancy and/or breast feeding, any medications known to affect the outcome measurements, weigh reducing diet, gastrointestinal diseases, participation in other intervention studies

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high calcium<br>Dietary intake of calcium   1500 mg/ d, including  1200 mg/d from dairy products | Other: High Calcium intake from dairy products<br>* High dietary intake of calcium from dairy products ( 1200 mg/d)<br>|
| Active Comparator: Low calcium<br>Low dietary intake of calcium, i.e.   <600 mg/d, including 0-1 portion of dairy products | Other: High Calcium intake from dairy products<br>* High dietary intake of calcium from dairy products ( 1200 mg/d)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal fat excretion |  | 24 weeks | 
| Body weight |  | 24 weeks | 
| body composition |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting energy expenditure |  | 24 weeks | 
| Blood pressure |  | 24 weeks | 
| Appetite regulation |  | 24 weeks | 
| Lipid profile |  | 24 weeks | 
| Intestinal micro flora |  | 24 weeks | 
| Metabolomics in urine, feces and blood |  | 24 week | 
| calcium excretion |  | 24 weeks | 
| bone markers |  | 24 weeks | 
| vitamin D status |  | 24 weeks | 
| calcium status |  | 24 weeks | 
| lipid metabolism |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, metabolic syndrome, fecal fat excretion, fecal calcium, weight loss, appetite regulation, intestinal micro flora, lipid profile, energy balance
Intravenous Colistin Versus Intravenous Colistin Plus Nebulized Colistin in VAP Due MDR Acinetobacter Baumannii

Study Overview
=================
Brief Summary
-----------------
Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant.

Detailed Description
-----------------
Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant.

Official Title
-----------------
Phase 3b Randomized Double Blind Controled Placebo Comparative Trial of Intravenous Colistin vs Intravenous Colistin Plus Nebulized Colistin in Patients With Ventilator-associated Pneumonia (VAP) Due Multiresistant Acinetobacter Baumanii

Conditions
-----------------
Cross Infection, Pneumonia, Bacterial

Intervention / Treatment
-----------------
* Drug: Colistin
* Drug: Colistin and saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnose of VAP due A. baumannii or A. baumannii and another microorganism carbapenems resistant. Clinical Pulmonary Infection Score (CPIS) > 6 Exclusion Criteria: Allergy to colistin. Asthma Shock status Diagnose of VAP due A. baumannii colistin resistant.

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: A<br>Intravenous colistin and nebulized colistin | Drug: Colistin<br>* intravenous colistin and nebulized colistin<br>|
| Placebo Comparator: B<br>intravenous colistin and saline solution nebulized | Drug: Colistin and saline solution<br>* intravenous colistin and nebulized saline solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acinetobacter baumanii, Ventilator-associated pneumonia
Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses of aspirin (325 mg) in normal healthy volunteers.

Official Title
-----------------
A Randomized, Single-Blind, Endoscopic Evaluation Of Upper GI Mucosal Damage Induced By PL-2200 Versus Aspirin In Healthy Volunteers

Conditions
-----------------
Upper Gastrointestinal Mucosal Damage

Intervention / Treatment
-----------------
* Drug: acetylsalicylic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is ≥50 to ≤75 years of age. Subject is healthy. Subject has a BMI between 20 and 32 If female and of child bearing potential, subject has a negative pregnancy test and is not nursing. Exclusion Criteria: Subject has abnormal screening/baseline laboratory parameters or endoscopic observations deemed clinically significant by the Investigator. Subject has an active Helicobacter pylori infection. Subject has a prior GI ulcer, bleeding, obstruction or perforation. Subject has taken aspirin or any aspirin containing product within the last 4 weeks, or a non-aspirin NSAID product within 2 weeks. Subject has taken any of the following medications within 2 weeks prior to enrollment: Any anti-platelet agents, anti-coagulants or selective serotonin reuptake inhibitors. Subject has used an investigational agent within the past 30 days. Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PL-2200<br>PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix. | Drug: acetylsalicylic acid<br>* 325mg once a day for 7 days<br>|
| Active Comparator: Aspirin<br>Immediate release 325mg aspirin | Drug: acetylsalicylic acid<br>* 325mg once a day for 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Subjects With Gastroduodenal Erosions and Ulcers. | Incidence of subjects with gastroduodenal composite scores of 3 or 4 (> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth). | After 7 days of study medication | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
To evaluate the acute gastrointestinal safety of PL-2100.
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Metastatic Triple-negative Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

Detailed Description
-----------------
To explore the progression-free survival of patients with metastatic triple-negative breast cancer treated with peripheral blood stem cell transplant (PBSCT) followed by high dose chemotherapy.

Official Title
-----------------
Phase II Study of Chemotherapy Followed by Peripheral Stem Cell Transplantation as First Line Therapy for Metastatic Triple-negative Breast Cancer

Conditions
-----------------
Carcinoma Breast Stage IV

Intervention / Treatment
-----------------
* Drug: Abraxane,Cyclophosphamide,Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) 0 or 1. Histologically or cytologically proven diagnosis of breast cancer with evidence of locally recurrent or metastatic disease. Documentation of estrogen and progestin receptor (ER/PR) negative status and HER2/neu receptor negative status (ie, FISH negative or immunohistochemistry 0 or +1). Obtained complete response or Good partial response after first line chemotherapy. Normal organ function required prior to study entry. Willingness to comply with treatment plans and other study procedures. Exclusion Criteria: Uncontrolled central nervous system (CNS) involvement with disease Fertile women unwilling to use contraceptive techniques during treatment Females who are pregnant Organ dysfunction. Patients may not be receiving any other investigational agents.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metastatic triple negative breast cancer<br>Abraxane,Cyclophosphamide,Carboplatin | Drug: Abraxane,Cyclophosphamide,Carboplatin<br>* High dose chemotherapy: Abraxane, Cyclophosphamide, Carboplatin<br>* Other names: Carboplatin 800 mg/m2;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free Survival |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autologous hematopoietic stem-cell transplantation, triple negative breast cancer
Natural Course for Renal Function After Heart Transplantation

Study Overview
=================
Brief Summary
-----------------
The outcome of heart transplantation has improved by years. The renal dysfunction is a major complication after heart transplantation.The natural course of renal function following orthotopic heart transplant is not clear in Taiwan. A retrospective study was conducted on patients who received a heart transplant at National Taiwan University Hospital between 1987 and 2015.

Detailed Description
-----------------
The investigators conducted a retrospective cohort study of patients who received a first heart transplant at the NTUH(Taiwan) between 1987 and 2015 . Clinical data were obtained and a retrospective chart review, and were collected up to 10 years . Data was collected from medical records and the heart transplant electronic database including: demographic parameters such as age and gender; etiology of heart failure; the presence of any of the following comorbidities: history of smoking, diabetes, hypertension, peripheral vascular disease and previous sternotomy; pre-transplant cholesterol levels; the use of any of the following pretransplant hemodynamic support measures:intravenous inotropes, intra-aortic balloon pump and ventricular assist device;creatinine levels; listing status according to the UNOS classification; waiting time; heart ischemic time;immunosuppression drug levels(cyclosporine,prograft or certican) and development of end stage renal disease requiring onset of dialysis therapy. Creatinine levels and GFRwere collected before transplantation and then the closest level to every month after heart transplant. The clinical outcomes of interest analyzed in this study included the development of post-transplant end stage renal disease and death.

Official Title
-----------------
Natural Course for Renal Function After Heart Transplantation

Conditions
-----------------
Creatinine Clearance Quantitative Trait Locus

Participation Criteria
=================
Eligibility Criteria
-----------------
This study included patients with a first HTx performed at NTUH between1987 and 2015. Patients were excluded if their first HTx was a combined transplant involving a KTx, they had renal replacement therapy prior to their HTx.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Natural course for renal function (ex blood creatine leveal ,eGFR) after heart transplantation | the outcome measure is assessed up to 10 years | patients who received a first heart transplant at the NTUH(Taiwan) between 1987 and 2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart transplant, renal insufficiency
Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction in Zanzibar

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of artesuante + amodiaquine four years after its introduction as first line treatment for uncomplicated childhood malaria in Zanzibar. The hypothesis is that the treatment has a polymerase chain reaction (PCR)adjusted parasitological cure rate of at least 85% 42 days after treatment.

Official Title
-----------------
Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction as New Treatment Policy for Uncomplicated Plasmodium Falciparum Malaria in Zanzibar

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Drug: artesunate + amodiaquine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age below 60 months Weight ≥5kg No general danger signs or severe malaria present (see 4.4.2.1 & 4.4.2.2) History of fever within 24 hours OR axillary temperature ≥ 37.5Cº No other cause of fever is detectable No severe malnutrition Presence of P. falciparum asexual parasite density between 2000- 200,000/ul Guardian/Patient has understood the procedures of the study and is willing to participate Patient able to come for stipulated follow up visits and has easy access to the Study Site Exclusion Criteria: Not able to drink or breastfeed Persistent Vomiting Recent history of convulsions Lethargic or unconscious Unable to sit or stand (as appropriate for age) History of allergy to test drugs History of intake of any drugs other than paracetamol and aspirin within 3 days

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: artesunate + amodiaquine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCR adjusted parasitological cure rate by day 42. |  |  |