linjc16/ctgov huggingface dataset:
Hypertonic Solution in Off Pump Coronary Artery Bypass Graft Surgery

Study Overview
=================
Brief Summary
-----------------
This is a comparison between Hypertonic versus isotonic solution in a double blind randomized trial for off pump Coronary Artery Bypass Graft (CABG) surgery targeting the left marginal branch. Hypertonic solution should provide better tolerance for heart mobilization with less volume expansion and less drugs.

Official Title
-----------------
Use of Hypertonic Versus Isotonic Solutions in Off Pump Coronary Artery Bypass Graft Surgery Targeting the Left Marginal Branch

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Hypertonic solution
* Drug: Isotonic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Off pump CABG targeting the left marginal branch Exclusion Criteria: On pump surgery
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 |
| --- | --- |
| Active Comparator: Hypertonic<br>Use of Hypertonic solution during left marginal branch CABG surgery. | Drug: Hypertonic solution<br>* Use of Hypertonic solution 4 ml/Kg during left marginal branch CABG surgery.<br>|
| Placebo Comparator: Isotonic<br>Use of Isotonic solution during left marginal branch CABG surgery. | Drug: Isotonic<br>* Use of Isotonic solution 4 ml/Kg during left marginal branch CABG surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of vasoactive drugs in left marginal branch off pump CABG surgery | Comparison between hypertonic and isotonic solutions for need of vasoactive drugs with heart mobilization during left marginal branch off pump CABG surgery. Data will be collected respectively at 1, 5 and 10 minutes after beggining the left branch coronary anastomosis. Data will be type of drug need and dosage until the end os the anastomosis. | time related to left branch coronary anastomosis for drug need. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid balance | Comparison of fluid balance in the operative period between hypertonic and isotonic solutions. Data will be collected at the end of surgery and by next mornning. | Operative period and first operative day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Bypass, Off-Pump, Saline Solution, Hypertonic
Prospective Study on Rehabilitation Patients With Pulmonary Hypertension and Other Pulmonary Diseases

Study Overview
=================
Brief Summary
-----------------
This monocentric registry should provide information on the extent how patients with pulmonary diseases such as pulmonary hypertension will benefit from rehabilitation treatment. The data may provide a basis for further prospective studies showing the treatment of patients with pulmonary diseases especially by physical activation.

Conditions
-----------------
Pulmonary Diseases, Rehabilitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pulmonary Disease Exclusion Criteria: Inability or refusal to give written 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pulmonary disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection | Characterization of patients with pulmonary hypertension and other pulmonary diseases in a german rehabilitation clinic. | 12 Months |
Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns

Study Overview
=================
Brief Summary
-----------------
Symbiotic interaction between probiotics (Living alimentary microbials supplemental, affecting positively host by improving intestinal microbial equilibrium (Fuller, 1989)) and human digestive tract was amply experimented and seems to be an interesting solution to orientate neonates digestive flora. Many studies showed a probant efficiency of probiotic supplementation in neonates on ECUN, despite abnormally high ECUN incidence in control group. Nevertheless, our aim is to test clinical efficiency of two new probiotics strains. Bifidobacterium Longum and Lactobacillus GG on Oral Nutrition (volume at Day 14 and Day 21) and safety (Adverse Events) in very premature babies.

Official Title
-----------------
Digestive and Nutritional Effects of Probiotics (Bifidobacterium Longum and Lactobacillus GG) Supplementation in Premature Newborns

Conditions
-----------------
Duration of Parenteral Nutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG )


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newborns (< 2 weeks of life) 32 Weeks of Gestation, weight < 1500g, Enteral nutrition begun, Clinical stability, Signed consent form from both parents. Exclusion Criteria: newborns (>= 2 weeks of life), weight >= 1500g, pathology avoiding the start of the enteral nutrition, other pathologies of those due to premature and its complications, No signed consent form.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 2 Weeks

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG )|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition |  | at D14 and D21. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age when Enteral Nutrition reaches 50% of Nutritional needs. |  |  | 
| Incidence of Nosocomial Infections. |  |  | 
| Composition of Colic Flora. |  |  | 
| Fecal Calprotectin as Index of Inflammation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Digestive and Nutritional Effects, Safety and Growth, Feeding Tolerance
A Cohort Study of Patients Treated With Brachytherapy for Selected Desmoid Patients in Gardner Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the long-term outcome in a cohort of Gardner-Syndrome patients receiving prophylaxis and treatment for intestinal and non-intestinal tumors.

Detailed Description
-----------------
Since 1978, we have been following a family of 105 descendants with Gardner Syndrome (GS). Mutation carriers were screened by endoscopy, and colorectal resection was performed upon pending malignancy. Resectable desmoid tumors were excised, whereas large tumors of the abdominal wall were treated by a combination of brachytherapy (BT) and radiotherapy (RT). Outcome was analyzed with respect to length of tumor-free survival, and morbidity from surgery or radiotherapy. Results: 37 of 105 family members have GS. Preventive colorectal resections were performed in 16 patients (15%), with one death due to subsequent gastric cancer. In 4 patients who denied screening endoscopy, invasive tumors of the colon (3 patients) and stomach (one patient each) developed. Of 33 desmoid tumors, 10 (30%) were located in the mesentery, 17 (52%) in the abdominal wall, and 6 (18%) in extra-abdominal sites. Excision of 12 desmoids was performed in 8 patients (36%), and 4 were treated by a combination of BT and RT. Following BT/RT, all patients showed full or partial remission.

Official Title
-----------------
In Modern Era, Recurrent Desmoids Determine Outcome in Patients With Gardner Syndrome: A Cohort Study of Three Generations of an Adenomatous Polyposis Coli (APC-) Mutation-Positive Family Across 30 Years

Conditions
-----------------
Gardner Syndrome, Colorectal Carcinoma, Desmoid Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: family with an identical adenomatous polyposis coli (APC-) germ line mutation Exclusion Criteria: negative testing for adenomatous polyposis coli (APC-) germ line mutation
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 |
| --- | --- | --- |
| mortality |  | 1978-2010 (as long as patients live) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of colorectal carcinoma |  | 1978-2010 (entire patient life) | 
| Incidence of desmoid tumors |  | 1978-2010 (entire patient life) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gardner syndrome, colorectal carcinoma, desmoid tumor, resection, colon
A Study of the Effect of Plasmaexchange in Patients With Acute Liver Failure

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine if high-volume plasma exchange has a positive effect on mortality in patients with acute liver failure.

Official Title
-----------------
European Multicenter Plasma Exchange Trial (Empet): A Controlled, Open, Randomised, Multicenter Study In Patients With Acute Liver Failure

Conditions
-----------------
Acute Liver Failure

Intervention / Treatment
-----------------
* Procedure: High volume plasma exchange
* Procedure: Standard medical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute liver failure in encephalopathy grade 2-4 Exclusion Criteria: alcoholic hepatitis primary non function liver graft or graft dysfunction known chronic liver disease known malignancies clinical suspicion of brain death

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High volume plasma exchange<br>3 successive plasma exchanges over 3 days | Procedure: High volume plasma exchange<br>* 3 high volume plasma exchanges over 3 days<br>* Other names: HVP;Procedure: Standard medical treatment<br>* Standard medical treatment<br>* Other names: SMT;|
| Placebo Comparator: Standard medical treatment<br> | Procedure: Standard medical treatment<br>* Standard medical treatment<br>* Other names: SMT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | at day 3, day 7 |
Induced Hypoxia Study for Validation of SpO2 Accuracy

Study Overview
=================
Brief Summary
-----------------
Validate Non-Motion SpO2 Accuracy from 70%-100% of various pulse oximeter/ sensor combinations and various OEM pulse oximeter modules and sensor combinations during induced hypoxia (desaturation).

Detailed Description
-----------------
The testing is conducted on 12 healthy, consenting, non-smoking subjects in accordance with the IRB approved Protocol. The subjects shall be distributed across both genders and a range of skin tones as equally as practical. An arterial line will be placed in the radial artery of each subject's right arm, and sensors will be attached to each subject. The subjects will be placed in a semi-supine position and allowed to breathe through a mouthpiece while the nose is blocked with a nose-clip. Hypoxia will be induced by on each subject, as levels of oxyhemoglobin saturation (between 70% and 100%) are achieved by breathing mixtures of nitrogen, room air and carbon dioxide. Inspired O2 concentration will be adjusted breath-by-breath using a computed saturation, based on end-tidal PO2 and PCO2, as sampled by a mass spectrometer. Predicted levels of oxyhemoglobin saturations will be attained and held stable. At a minimum of sixty seconds into each plateau, a 0.5cc waste blood draw through the arterial line, followed by the first 1.0cc sample blood draw. After approximately thirty additional seconds, the second 1.0cc sample blood draw will be taken. The samples will immediately be analyzed by a Radiometer OSM-3 multi-wavelength co-oximeter and recorded. The SpO2 data from the oximeters will be collected via a laptop computer. Concurrent with the end of each blood draw, a marker will be generated on the laptop computers to identify the event.

Official Title
-----------------
Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia

Conditions
-----------------
Hypoxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-smokers Healthy; no known blood disorders Finger sizes within the sensor specifications Minimum 18 years of age Exclusion Criteria: Artificial nails or fingernail polish

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- | --- |
| SpO2 Accuracy Verification Study (Arms)of ≤3 between 70 & 100% |  | During Analysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Induced hypoxia, Pulse oximeter, Nonin Medical, Verification of SpO2 accuracy
Study of Maggot Therapy in Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
This study was a Kind of clinical trial with equal randomization, that have been done from January 2009 to June 2011 in the AFZALIPOOR hospital endocrine ward in Kerman-Iran on 128 diabetic patient who had foot wounds.Replacement of conventional therapy by new methodes is one of the more important aims for health professional specially for nurses.One of this new treatment is maggot therapy.

Official Title
-----------------
Maggot Therapy in Diabetic Foot Ulcers

Conditions
-----------------
DIABETIC FOOT ULCERS

Intervention / Treatment
-----------------
* Other: procedure:maggot therapy
* Other: conventional therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a chronic illness more than 7 weeks. The age of the patients between 40- 90 years old. Not having capillary disease (Blockage of artery, Rinold). Not user of anticoagulants and corticosteroids drugs. Patients without history of allergy to drugs and foods. Having diabetic type 2 Exclusion Criteria: patients who refer to critical clinical care unit patients who have amputation

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAGGOT THERAPY & conventional therapy T<br>Maggot therapy,ADMINISTERED TWO TIMES AS A NEW METHODS OF DRESSING in experimental group.conventional therapy ,administered two times in control group | Other: procedure:maggot therapy<br>* each times in maggot therapy continued for three days.wound assessment was done before and after any intervention<br>* Other names: larval therapy;Other: conventional therapy<br>* patients receive ordinary treatment for diabetic foot<br>* Other names: mechanical debridement;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 3days and change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 6 days |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MAGGOT THERAPY, DIABETIC FOOT, NURSING CARE, DRESSING
Hospital Intensive Monitoring of Adverse Drug Reactions of Qingkailing Injection In The Next Two Years

Study Overview
=================
Brief Summary
-----------------
To highlight the incidence of adverse reactions of Qingkailing Injection.

Official Title
-----------------
Intensive Hospital-based Adverse Drug Reaction Monitoring Study On Patients Treated By Qingkailing Injection In The Next Two Years

Conditions
-----------------
Adverse Drug Events, Adverse Drug Reactions

Intervention / Treatment
-----------------
* Drug: Qingkailing Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all the patients treated by Qingkailing Injection in the certain centers(hospitals) in the next 2 years. in accordance with ethics requirements. Exclusion Criteria: none.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 80 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 |
| --- | --- |
| Qingkailing Injection<br> | Drug: Qingkailing Injection<br>* Qingkailing Injection is a kind of natural product injection made from Chinese herbs, which has been used to treat cerebral ischemia for decades in China. The main bioactive ingredients of this injection include Baicalin, Jasminoidin, Ursodeoxycholic Acid, Concha Margaritifera,etc.<br>* Other names: Shineway Qingkailing Injection;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of severe adverse drug reactions |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse drug reactions |  | 2 years |
Results of Surgical Treatment of the Hepatobiliopancreatic Surgical Unit

Study Overview
=================
Brief Summary
-----------------
The main aims of this study are: - to evaluate post-surgical morbidity and mortality outcomes, following the criteria and the definitions from Claven-Dindo and ISGPS international classifications, of the patients operated by the HPB Surgical Unit. - to evaluate survival and disease-free survival rates of the patients operated by the HPB Surgical Unit due to tumoral cause.

Official Title
-----------------
Results of the Surgical Treatment of Patients From Hepatobiliopancreatic Surgical Unit at the Complejo Hospitalario de Navarra

Conditions
-----------------
Pancreas Disease, Liver Diseases, Surgical Procedure, Unspecified, Bile Duct Diseases

Intervention / Treatment
-----------------
* Procedure: Hepatobiliopancreatic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients operated by the HPB Surgical Unit in the last 10 years (retrospective) All patients being operated by the HPB Surgical Unit from January 2019 onwards who provide inform consent (prospective). Exclusion Criteria: Patients not eligible for surgery Patients not interested in taking part in the study

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Hepatobiliopancreatic surgery|Different surgical techniques tailored to each patient´s pathology|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patient with post-surgical morbidity and mortality operated by the HPB Surgical Unit | Morbidity and mortality outcomes are evaluated following the criteria and definitions from Claven-Dindo and ISGPS international classifications | 90 days post-surgery | 
| Survival rate of patients operated by the HPB Surgical Unit | These patients are operated due to tumoral cause | 5-years post-surgery | 
| Disease-free survival rate of patients operated by the HPB Surgical Unit | These patients are operated due to tumoral cause | 5-years post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of standardization of pre and post-surgical care |  | 90 days | 
| Evaluation of the result of the multimodal treatment |  | 90 days | 
| Assessment of the oncological quality standards of patients operated by HPB Surgical Unit due to tumoral cause |  | 5 years | 
| Assessment of the results from minimally invasive techniques in HPB surgery |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatobiliopancreatic surgery