linjc16/ctgov huggingface dataset:
Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function

Study Overview
=================
Brief Summary
-----------------
The knowledge of the health effects of CLA on the human body is limited. However, CLA supplements are sold over the counter in several countries and various techniques are used to increase the content of CLA in food. The CLAxon-study will be performed to investigate wether high doses of CLA can be safely given to healthy human volunteers.

Detailed Description
-----------------
Each volunteer receives CLA enriched products for a total of 3 weeks containing approximately 20g CLA per day. A control group is not needed. If three subjects or more show one or more blood values for liver and kidney function above predefined limits the study will be terminated.

Official Title
-----------------
The Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function in Healthy Volunteers (CLAxon-Study)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Procedure: consumption of CLA enriched food


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-60 years serum total cholesterol < 8.0 mmol/L serum triglycerides < 3.0 mmol/L ALAT < 45 IU/L ASAT < 41 IU/L amylase 35-130 U/L alkaline phosphatase 40-125 U/L bilirubin < 17 µmol/L gamma-glutamyltranspeptidase > 75 U/L (men) and < 40 U/L (women) lactate dehydrogenase 230-485 U/L creatinine clearance >= 90 mL/min fasting glucose levels 70-115 mg/dL fasting insulin levels 5-30 mU/L Exclusion Criteria: use of cholesterol lowering medication high alcohol intake BMI > 30 chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction) pregnancy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: consumption of CLA enriched food|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALAT |  |  | 
| ASAT |  |  | 
| amylase |  |  | 
| bilirubin |  |  | 
| alkaline phosphatase |  |  | 
| gamma-glutamyltranspeptidase |  |  | 
| lactate dehydrogenase |  |  | 
| creatinine clearance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total cholesterol |  |  | 
| HDL cholesterol |  |  | 
| LDL cholesterol |  |  | 
| triglycerides |  |  | 
| fatty acids |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLA, liver, kidney
A Trail of CDK4 / 6 Inhibitor and MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors

Study Overview
=================
Brief Summary
-----------------
This is a prospective, open, phase I clinical study to evaluate the safety and tolerability of a CDK4 / 6 inhibitor and a MEK inhibitor in the treatment of metastatic digestive system tumors

Official Title
-----------------
Phase I Clinical Study on the Safety and Tolerability of a CDK4 / 6 Inhibitor and a MEK Inhibitor in the Treatment of Metastatic Digestive System Tumors

Conditions
-----------------
Digestive System Tumors

Intervention / Treatment
-----------------
* Drug: a CDK4 / 6 inhibitor and a MEK inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-75 years; ECOG score ≤ 1; Patients with advanced KRAS mutation or metastatic digestive system tumor confirmed by histology or cytology and imaging diagnosis; According to Recist1.1, there was at least one measurable lesion; The expected survival time was more than 12 weeks; Exclusion Criteria: Patients who received any anti-tumor treatment within 4 weeks before enrollment, including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, or participated in another intervention clinical trial; Previous treatment with targeted BRAF, MEK, ERK or CDK family related inhibitors; The third space effusion (such as massive pleural effusion or ascites) with clinical symptoms that cannot be controlled by drainage or other methods; Allergy to any test drug and its excipients, or serious allergic history, or contraindication of the test drug; Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a CDK4 / 6 inhibitor and a MEK inhibitor<br>Participants will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment | Drug: a CDK4 / 6 inhibitor and a MEK inhibitor<br>* Participant will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment to determine the maximum tolerated dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum tolerated dose of a CDK4 / 6 inhibitor and a MEK inhibitor therapy |  | Up to approximately 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | the Objective Remission Rate | Up to approximately 24 months |
A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare healing times and subjective pain level responses of nepafenac to placebo after photo refractive keratomileusis (PRK) surgery.

Official Title
-----------------
A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief of Patients Status Post-Photorefractive Keratectomy: A Double-Masked Randomized Prospective Study

Conditions
-----------------
Photorefractive Keratectomy

Intervention / Treatment
-----------------
* Drug: nepafenac 0.1%
* Other: ketorolac 0.4%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 years or older with healthy ocular status and pre-operative refractive anisometropia of less than 2.000 diopters between eyes undergoing bilateral PRK surgery. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Those desiring PRK in only one eye, those in need of additional topical eye medications, those with history of drug/alcohol abuse, women breastfeeding or pregnant. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Nevanac<br>One drop, three times daily, in the assigned eye for the first three postoperative days | Drug: nepafenac 0.1%<br>* Nepafenac 0.1% randomly assigned to one eye, with ketorolac 0.4% in the fellow eye for contralateral post-surgical use.<br>|
| Placebo Comparator: Acular LS<br>One drop, three times daily, in the assigned eye for the first three postoperative days | Other: ketorolac 0.4%<br>* Keterolac 0.4% randomly assigned to one eye, with nepafenac 0.1% in the fellow eye for contralateral post-surgical use.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective pain |  | Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of epithelial healing |  | Time to event | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Photorefractive Keratectomy
IMAGE-Endocarditis: Resonance Magnetic Imaging at the Acute Phase of Endocarditis

Study Overview
=================
Brief Summary
-----------------
Patients with definite or possible infective endocarditis are included in this protocol, at the acute phase of the disease.

Detailed Description
-----------------
Patients with definite or possible infective endocarditis are included in this protocol, at the acute phase of the disease. Resonance magnetic imaging (head and abdomen) will be performed systematically before Day 7. The impact on the diagnosis and therapeutic options will be assessed, as compared to pre resonance magnetic nuclear (RMN) imaging declaration.

Official Title
-----------------
Resonance Magnetic Imaging at the Acute Phase of Endocarditis: Diagnostic and Therapeutic Impact

Conditions
-----------------
Endocarditis, Bacterial

Intervention / Treatment
-----------------
* Behavioral: Modification of therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute phase of infective endocarditis Exclusion Criteria: Contra indication to RMN
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br> | Behavioral: Modification of therapy<br>* Modification of the surgery date if adapted, modification of the antibiotics if adapted, based on RMI results<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modification of therapeutic project |  | As soon as RMI is performed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modification of diagnostic classification (Duke modified criteria) |  | As soon as RMI is performed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endocarditis, RMI, Impact measure
Silver Alloyed Urinary Catheters and Incidence of Catheter Acquired Urinary Tract Infections (UTI)

Study Overview
=================
Brief Summary
-----------------
This study is a single blinded (Outcome Assessors), multicenter randomized controlled study designed to investigate if a silver alloyed urinary catheter with antibacterial properties can reduce the incidence of catheter acquired urinary tract infections in patients undergoing elective surgery. Patients requiring urinary catheterization will be randomized into two groups and receive either the silver alloyed catheter (test) or a silicone catheter (control).

Official Title
-----------------
A Comparative Study to Investigate if Silver Alloyed Urinary Catheters Can Reduce the Incidence of Catheter Acquired Urinary Tract Infections in Patients Undergoing Elective Surgery

Conditions
-----------------
Urinary Tract Infection

Intervention / Treatment
-----------------
* Device: Bactiguard Infection Protection (BIP) Cathter.
* Device: Silicone Urinary Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults in elective surgery requiring urinary catheterization Exclusion Criteria: Patients who has or recently (within 3 weeks) had a urinary catheter Signs of urinary tracts infection Previous radiation therapy in lower pelvis Latex allergy Cognitive impaired Do not understand Swedish language.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silver alloyed urinary catheter<br> | Device: Bactiguard Infection Protection (BIP) Cathter.<br> <br> |
| Placebo Comparator: Silicone urinary catheter<br> | Device: Silicone Urinary Catheter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether a silver alloyed catheter with antibacterial properties will decrease the incidence of catheter associated urinary tract infection in patients undergoing elective surgery. |  | At catheter withdrawal (normally 1-3 days after catheter insertion). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient´s evaluation of the catheterization and overall satisfaction. |  | At catheter withdrawal and 7-10 days after catheter withdrawal. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Catheterization, Urinary Tract Infection, Elective Surgery
Comparison of a Locally Produced RUTF With a Commercial RUTF in the Treatment of SAM

Study Overview
=================
Brief Summary
-----------------
In order to make Cambodia independent from importing a product for the treatment and prevention of malnutrition, UNICEF, DFPTQ Fisheries Administration and IRD have started a collaboration for the development of a range of products for the treatment and prevention of malnutrition. To reduce costs of the product, and to adapt the taste to local circumstances, the protein source of the usual RUTF (milk powder) has been changed to fish (Trey Riel). The main objective of this sub-study is to test the efficacy of the newly developed RUTF on the recovery of children suffering from severe acute malnutrition. As comparison, the current treatment of SAM with BP-100 will be used.

Official Title
-----------------
Comparison of a Locally Produced RUTF With a Commercial RUTF in the Treatment of SAM in Cambodia

Conditions
-----------------
Malnutrition, Children, Treatment

Intervention / Treatment
-----------------
* Dietary Supplement: 2 months of treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: discharged from hospital after admission for SAM WHZ <2.8 Z-score or MUAC<11.5 cm no complications passing the appetite test Exclusion Criteria: <6 mo of age complications related to SAM

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 5 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BP-100<br>standard treatment | Dietary Supplement: 2 months of treatment<br>* standard 2 months of treatment<br>|
| Experimental: Num Trey<br>locally produced RUTF | Dietary Supplement: 2 months of treatment<br>* standard 2 months of treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight gain | weight gain in g/kg/day | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition | changes in body composition obtained from skinfold thickness measurements over the treatment period | 2 months | 
| Fatty Acid composition | changes in serum concentrations of fatty acids over the intervention period | 2 months |
Family Planning Service Delivery Integration For HIV Positive And At-Risk Women In Botswana: A Hybrid Type 2 Clinical Intervention And Implementation Strategy

Study Overview
=================
Brief Summary
-----------------
The goal of this pilot study is to assess both implementation outcomes (acceptability, feasibility and adoption) and clinical efficacy (contraceptive method uptake by women wishing to avoid pregnancy) using a Hybrid Type 2 study design of a family planning program being piloted by the Cervical Cancer Prevention Program in Gabarone, Botswana.

Official Title
-----------------
Family Planning Service Delivery Integration For HIV Positive And At-Risk Women In Botswana: A Hybrid Type 2 Clinical Intervention And Implementation Strategy

Conditions
-----------------
Family Planning

Intervention / Treatment
-----------------
* Other: WHO Decision-Making Tool for Family Planning Clients and Providers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female English or Setswana speaking Receiving CCP services at the clinic 18-45 years of age Able to give informed consent to study procedures, as determined by research/clinic staff Exclusion Criteria: 1. Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Full group<br>Our goal is to assess the feasibility and acceptability of incorporating family planning (FP) service delivery, using a program validated by the World Health Organization (WHO), into the established Cervical Cancer Prevention (CCP) programs of Botswana. | Other: WHO Decision-Making Tool for Family Planning Clients and Providers<br>* Contraception decision-making tool<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provider acceptability rating | Likert scale 1-5, rating acceptability of offering family planning in this clinical setting. | 6 months | 
| Provider rating of feasibility | Likert scale 1-5, rating feasibility of offering family planning in this clinical setting | 6 months | 
| Provider report of adoption of the intervention | Comparing number of family planning methods offered by a provider pre- and post-intervention | 6 months |
Dysphagia Management During COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
The current study is aimed to determine the procedures applied in the dysphagia clinics during the COVID-19 pandemic period. A questionnaire consisting of 30 questions will be implemented. Each participant will be asked to answer the questions.

Detailed Description
-----------------
The current study is aimed to understand the current clinical conditions and current practice regarding dysphagia management during the pandemic period/normalization period. It is a cross sectional online survey study. The first part is the survey development and testing, the second part is determination of swallowing centers and last part is survey distribution by google forms. A coordinator will be selected for each center to discuss the survey with the entire team and reply the questions.

Official Title
-----------------
Experiences in Dysphagia Management During COVID-19 Pandemic

Conditions
-----------------
Dysphagia, Covid19

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Working on a dysphagia clinic from all over the world Exclusion Criteria: Not willing to participate Not working on a dysphagia clinic

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dysphagia clinicians<br>Clinicians from swallowing centers (from all over the world) | Other: Survey<br>* An online survey will be sent to each clinic to answer the survey questions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Online survey | An online survey will be designed to understand the current clinical conditions and current practice regarding dysphagia management during the pandemic period/normalization period | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dysphagia, COVID-19