linjc16/ctgov huggingface dataset:
Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma With 6 Months Follow-up

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of photodynamic therapy (PDT)in treatment of Basal cell carcinoma (BCC) and recurrence rate after 6 months.

Detailed Description
-----------------
Background and Aim: Basal cell carcinoma (BCC) is the most common skin cancer .Photodynamic therapy _as a novel , non-invasive therapeutic approach _may be considered a valuable strategy. This study was designed with the aim of the evaluation of efficacy of PDT in treatment of BCC and recurrence rate after 6 months . Materials and Methods: This was a clinical trial which was done on 28 BCCs. Patients were treated with ALA-PDT monthly for 1-6 sessions and evaluated for clinical response,cosmetic results,recurrence rate and probable side effects.

Conditions
-----------------
Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Radiation: photodynamic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven BCCs Exclusion Criteria: Rodent ulcer Morphea type ANA + History of photosensitivity or photodermatosis or ingestion of phototoxic drugs during last month Pregnancy Breast feeding Age< 18 History of another therapeutic intervention for bcc during last 6 months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCC, ALA-PDT<br>Patients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT | Radiation: photodynamic therapy<br>* 5-ALA cream 20% topical administration + photodynamic therapy (red light) 120 j/cm2<br>* Other names: PDT 1200L Waldman Medizintechnik, Villengen; Schwenningen, Germany;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate(regarding clinical and/or pathological examination) after 6 months of follow up |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
basal cell carcinoma, photodynamic therapy, photo chemotherapy, basal cell epithelioma
Investigation of Microbiome-based Prognostical Biomarkers in Patients With Morbid Obesity and Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
Morbid obesity leads to non-alcoholic fatty liver disease (NAFLD), and not all NAFLD cases benefit from weight loss e.g. after bariatric surgery. Our aim is to find out, which intrahepatic factors and / or biomarkers might be beneficial or can be identified as prognostic factors for remission of NAFLD after weight loss. As other factors such as the microbiome or muscle and fatty tissue also influence the development of obesity and liver diseases, it is planned to examine these parameters before and after bariatric surgery as well. Tissue biopsies will therefore be taken during the surgery, and blood as well as stool samples will be collected and compared for suitable biomarkers before and after the intervention.

Official Title
-----------------
Investigation of Microbiome-based Prognostical Biomarkers in Patients With Morbid Obesity and Bariatric Surgery

Conditions
-----------------
NAFLD, Obesity, Morbid, Bariatric Surgery Candidate, Microbiome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI above 40 kg/sqm or BMI above 35 kg/sqm and comorbidities related to morbid obesity (e.g. type 2 diabetes, hypertension, coronary heart disease, dyslipoproteinemia, sleep apnea, and others Exclusion Criteria: BMI below 35 kg/sqm no informed consent patient not suitable for bariatric surgery (severe psychological disorder, pregnancy, drug abuse, active malignant or other consuming disease

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 |
| --- | --- |
| Adip1<br>Patients with morbid obesity (i.e. BMI >35 kg/sqm) and age >18 scheduled for bariatric surgery (all standard procedures included) | Procedure: Bariatric surgery<br>* Any bariatric operation that is considered as a standard procedure in bariatric surgery (i.e. sleeve gastrectomy, roux-en-y gastric bypass, mini-gastric / one anastomosis gastric bypass, redo and revisional bariatric surgery).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of microbiome after bariatric surgery | Collection of stool sample before and after (3 and 6 months) the operation | at time of operation, 3 and 6 months after the operation | 
| Changes of microbiome after bariatric surgery | Collection of blood sample before and after (3 and 6 months) the operation | at time of operation, 3 and 6 months after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of fatty liver in obese patients | Surgical liver biopsy during laparoscopy | during the operation |
Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917

Study Overview
=================
Brief Summary
-----------------
This study will compare glucose lowering with CS-917 compared to placebo after 3 months of treatment

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of CS-917 as Monotherapy for Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: CS-917
* Drug: metformin hydrochloride
* Drug: pioglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Drug naive or newly diagnosed type 2 diabetic subjects: Never received oral antihyperglycemic or insulin therapy or No oral antihyperglycemic or insulin therapy for more than 6 months since original diagnosis and No insulin therapy within one year of screening, with the exception of use during hospitalization or for use in gestational diabetes and No antihyperglycemic therapy for more than three consecutive days, or a total of of seven non-consecutive days, during the 8 weeks prior to screening. HbA1C>6.7% and < or = to 10% at screening Exclusion Criteria: Current insulin therapy Symptoms of poorly controlled diabetes History of diabetic ketoacidosis or hyperosmolar, nonketonic coma within one year of screening Serum bicarbonate < or = to 19 meq/L Serum creatinine (Scr) > 1.4 mg/dL (females) or 1.5 mg/dL (males) Contraindication to metformin

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CS-917|nan|
|Drug: metformin hydrochloride|nan|
|Drug: pioglitazone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in HbA1C after 12 weeks compared to placebo |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of efficacy of CS-917 |  |  | 
| Safety and tolerability of CS-917 |  |  | 
| Changes in other relevant glycemic and metabolic measures |  |  | 
| Proportion of subjects achieving therapeutic response |  |  | 
| Proportion of subjects discontinuing or requiring rescue for continued or worsening hyperglycemia |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, Type 2, High blood sugar, Hyperglycemia, Antihyperglycemic agents, CS-917
Sleep Quality in Healthcare Personnel During COVID-19

Study Overview
=================
Brief Summary
-----------------
Coronavirus disease 2019 (COVID-19), represents a medical and psychological challenge to healthcare workers to the limits that it affects their quality of sleep and their general health.

Official Title
-----------------
Sleep Quality and Effect on General Health in Healthcare Personnel During COVID-19 Pandemic

Conditions
-----------------
COVID-19, Sleep Quality, General Health

Intervention / Treatment
-----------------
* Other: Web Based Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All healthcare personnel actively working during the pandemic Exclusion Criteria: non healthcare workers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthcare workers<br>Physicians, Nurses, Laboratory workers, radiology technicians | Other: Web Based Survey<br>* On line survey distributed electronically<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure sleep quality in healthcare worker | Pittsburgh sleep quality index (0-21) higher means worse quality | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of covid-19 pandemic on general health | general health questionnaire (0-12) higher means worse | 40 days | 
| correlate between sleep quality and general health | web based survey | 40 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, corona virus disease, Pittsburgh sleep quality index, General health questionnare, Healthcare worker
Mucopolysaccharidosis I (MPS I) Registry

Study Overview
=================
Brief Summary
-----------------
The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will provide information to better characterize the natural history and progression of MPS I as well as the clinical responses of patients receiving enzyme replacement therapy, such as Aldurazyme (Recombinant Human Alpha-L-Iduronidase), or other treatment modalities. The objectives of the Registry are: To evaluate the long-term effectiveness and safety of Aldurazyme® (laronidase) To characterize and describe the MPS I population as a whole, including the variability, progression, and natural history of MPS I To help the MPS I medical community with the development of recommendations for monitoring patients and reports on patient outcomes to optimize patient care

Detailed Description
-----------------
The MPS I Registry is an international program; in addition to the central contact information provided under the Location heading, patients may contact: In Asia-Pacific - Vivian Liu, +65-6431-2548, Vivian.liu@genzyme.com In Europe - +31-35-699-1232, europe@mpsiregistry.com In Latin America - +617-591-5500, help@mpsiregistry.com In North America - +617-591-5500, help@mpsiregistry.com

Official Title
-----------------
Mucopolysaccharidosis I (MPS I) Registry

Conditions
-----------------
Mucopolysaccharidosis I (MPS I)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with a confirmed diagnosis of MPS I are eligible for inclusion. Confirmed diagnosis is defined as: A. documented biochemical evidence of a deficiency in alpha (a)-L-iduronidase enzyme activity and/or B. mutation(s) in the gene coding for a-L-iduronidase, or measurable clinical signs and symptoms of MPS I For all patients there should be a completed patient authorization form Exclusion Criteria: No exclusion criteria for participation in the MPS I Registry. NOTE: Registry participation does not exclude participation in other clinical studies.
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 |
| --- | --- | --- |
| To evaluate the long-term effectiveness of Aldurazyme |  | Approximately 17 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hurler's Syndrome, Hurler-Scheie Syndrome, Scheie Syndrome
The Effects of COX-inhibiting Drugs on Skeletal Muscle Adaptations to Resistance Exercise in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
In this study, healthy human subjects (18-35 yrs) are be randomised to consume 1200 mg ibuprofen or 75 mg acetylsalicylic acid daily during a training period of 8 weeks. During these weeks, subjects perform 2-3 supervised strength training sessions (knee extensions). Before and after training, muscle volume is measured by MRI, and muscle strength is assessed by isokinetic and isoinertial ergometers. Muscle biopsies are obtained from m. vastus lateralis to study gene and protein expression of markers regulating muscle protein turnover and prostaglandin synthesis.

Official Title
-----------------
The Effects of COX-inhibiting Drugs on Skeletal Muscle Adaptations to Resistance Exercise

Conditions
-----------------
Skeletal Muscle Mass Regulation

Intervention / Treatment
-----------------
* Drug: Ibuprofen
* Drug: Acetylsalicylic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Considered healthy Moderately trained 18-35 yrs Exclusion Criteria: Cardiovascular disease Impaired kidney or liver function Lower limb injury Pregnancy Ulcer or gastrointestinal upsets Previous reactions to use of NSAID

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen<br>Resistance exercise 20 sessions during 8 weeks Daily consumption of 1200 mg ibuprofen (400 mg x 3) during 8 weeks | Drug: Ibuprofen<br> <br> |
| Active Comparator: Acetylsalicylic acid<br>Resistance exercise 20 sessions during 8 weeks Daily consumption of 75 mg acetylsalicylic acid (75 mg x 1) during 8 weeks | Drug: Acetylsalicylic acid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quadriceps muscle volume | Measured through MRI | Baseline and after 8 weeks training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle gene expression | Through quantitative PCR and microarray | Baseline, 4 weeks and after 8 weeks training | 
| Change in muscle protein expression | Through Western Blots | Baseline, 4 weeks and after 8 weeks training | 
| Change in Quadriceps muscle strength | Measured in strength dynamometers | Baseline and after 8 weeks training | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Muscle mass, strength, NSAID, Ibuprofen, resistance exercise
Robotic-assisted Left Hemicolectomy for Left Colon Cancer

Study Overview
=================
Brief Summary
-----------------
The main goal of this study is to clarify if Robotic-assisted surgery could become the standard approach in patients undergoing left colonic resection. Patient candidates to left colonic resection were randomly assigned to Robotic(RAL) or laparoscopic(LL) approach. The surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital days. Long-term morbidity, quality of life, and 5-year survival have also been evaluated

Detailed Description
-----------------
Robotic-assisted Left Hemicolectomy as advantages on showing the inferior mesenteric artery (IMA), protection of autonomic nerve compare to laparoscopic approach. Our experience found that operational flexibility was advantage without surgeon's position exchange.

Official Title
-----------------
Robotic-assisted Left Hemicolectomy for Left Colon Cancer With a Medial-to-lateral Approach Orientated by AMA or AMV

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Procedure: robotic assisted surgery
* Procedure: laparoscopic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colon cancer adenocarcinoma The tumor located between the descending colon and the right 1/3 of transverse colon Tumors T3,Т4а,b N0-2 Tolerance of chemotherapy ECOG 0-2 Exclusion Criteria: With distant metastases Tumors T1-2 Complications of tumor Women during Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: robotic-assisted left colonic resection<br>Standard left colonic resection assisted by Davinci Robotic | Procedure: robotic assisted surgery<br>* robotic assisted surgery was benefit to operation<br>|
| Active Comparator: laparoscopic left colonic resection<br>Standard laparoscopic left colonic resection | Procedure: laparoscopic<br>* conventional laparoscopic surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-years overall survival rate |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term morbidity rate |  | 30 days | 
| Anastomosis leakage rate |  | 6 months | 
| Operation Time |  | 1 day | 
| Blood loss during operation |  | 1 day | 
| Complication incident rate of surgery |  | 1 day | 
| C-reaction protein level |  | 7 days | 
| Recovery time after surgery |  | 60 days |
A Research Study to Test (2) Two Different Types of Feeding Tubes Used in the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the success rates of two types of feeding tubes, specifically the standard gastric feeding tube to a small bowel feeding tube.

Detailed Description
-----------------
Enteral nutrition has many advantages for critically ill patients including lower incidence of infections and a reduced hospital stay, however it is controversial whether enteral feeding via small bowel feeding tubes offers an advantage over gastric feeding tubes in terms of reducing aspiration risk, improving feeding tolerance or ensuring quicker attainment of nutritional goals. The advantages of a small bowel feeding tube over a gastric feeding tube is thought to be related to its post pyloric position, however the insertion of small bowel feeding tubes is technically challenging (most studies report a success rate of 15-30%), can take time and has complications not unlike those of the gastric feeding tube. Our hypothesis is that the small bowel feeding tube offers an advantage to the gastric feeding tube due to its ability to achieve post pyloric placement. Specifically we chose to compare the standard gastric feeding tube (Dubhoff) to a small bowel feeding tube which offers the advantage of having alternating flaps which allows the gut to drag this tube into the small bowel.

Official Title
-----------------
A Comparative Study of the Tiger Tube Frictional Nasal Jejunal Feeding Tube and the Dubhoff Tube

Conditions
-----------------
no Primary Disease; ICU Patient Who Require Enteral Nutrition

Intervention / Treatment
-----------------
* Device: Tiger Tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all ICU patients requiring enteral nutrition Exclusion Criteria: coagulopathy, esophageal or gastric, surgery, varices, trauma, ulcer, structure, rupture

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

| Intervention/Treatment |
| --- |
|Device: Tiger Tube|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success in placing feeding tube |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - rate of reaching nutritional goal, aspiration pneumonia, feeding tolerance, and pre-albumin |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
feeding tube, nutrition, gastric, jejunal