linjc16/ctgov huggingface dataset:
the Correlation Between Non-invasive Indicators in Patients With Biliary Atresia

Study Overview
=================
Brief Summary
-----------------
we propose this study and try to find out possible clinical applicable non-invasive imaging indices or its combination with the laboratory indices to predict the status of hepatic fibrosis in BA patients.

Official Title
-----------------
the Correlation Between Hepatic Fibrotic Scores and ADC and Other Non-invasive Indicators in Patients With Biliary Atresia

Conditions
-----------------
to Find Out Non-invasive Indices to Predict the Status of Hepatic Fibrosis in BA Patients.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathological proved diagnosis of biliary atresia, and without other distinct abnormality or malformations. All had undergone Kasai portoenterostomy. All of them received abdominal MRI study. Exclusion Criteria: absence of laboratory data required.

Ages Eligible for Study
-----------------
Minimum Age: 10 Days
Maximum Age: 30 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 |
| --- | --- | --- |
| pathologic METAVIR fibrosis score |  | 1 month |
WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to sulfonylurea alone or in combination with other anti-diabetic drugs.

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetics With Inadequate Glycemic Control on Sulfonylurea Monotherapy or Sulfonylurea Therapy in Combination With Other Oral Anti-Diabetic Agents

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Colesevelam hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 years, inclusive Diagnosed with type 2 diabetes Stable dose of sulfonylurea alone or in combination with other anti-diabetic medications for 90 days Hemoglobin A1c value 7.5% to 9.5%, inclusive C peptide > 0.5 ng/mL Prescribed ADA diet Exclusion Criteria: History of type 1 diabetes or ketoacidosis History of pancreatitis Uncontrolled hypertension Allergy or toxic response to colesevelam or any of its components Serum LDL-C < 60 mg/dL Serum TG > 500 mg/dL Body mass index (BMI) > 45 kg/m2

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

| Intervention/Treatment |
| --- |
|Drug: Colesevelam hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the additional lowering of HbA1c achieved by addition of colesevelam hydrochloride to current antidiabetic therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the fasting plasma glucose and fructosamine lowering efficacy; |  |  | 
| To assess glycemic control response rate; |  |  | 
| To assess the improvement in insulin sensitivity; |  |  | 
| To assess the effect on C reactive protein; |  |  | 
| To assess lipids and lipoproteins; |  |  | 
| To assess the safety and tolerability of colesevelam hydrochloride as add-on therapy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus
Lactated Ringers vs Normal Saline in Patients With Acute Pancreatitis: A Bias-Adjusted Meta-analysis

Study Overview
=================
Brief Summary
-----------------
This study aims to compare NS and LR in terms of outcomes in patients with acute pancreatitis while addressing the current methodological issues with available meta-analyses on the topic. Such comparison combined with bias adjustment will assist with identifying the optimal fluid rehydration therapy in acute pancreatitis, since most of the available data is conflicted around the topic. A database search will be conducted to identify studies comparing normal saline and ringer's lactate. Existing meta-analyses will be assessed. The results will be discussed in the light of their strengths and limitations and then any deficiencies will be addressed through a new synthesis as a final step of this umbrella review. The primary outcome will be SIRS at 24 hours. OR and 95% confidence intervals will be generated using the quality effects model. Heterogeneity will be evaluated using the I2 statistic. Publication bias will be assessed using the Doi Plot.

Official Title
-----------------
Lactated Ringers vs Normal Saline in Patients With Acute Pancreatitis: A Bias-Adjusted Meta-analysis

Conditions
-----------------
Acute Pancreatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RCTs and observational studies that compared NS vs LR in AP patients. Studies reviewed must report data as effect estimates or provide raw data sufficient to calculate effect estimates. Exclusion Criteria: Studies involving animal studies, pediatric patient populations, and cell lines will be excluded. All studies will be reviewed in full form by each author to determine eligibility. In case of disagreement, determination of inclusion will be reached via consensus.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lactated Ringer's (LR) solution<br> | |
| Normal Saline (NS)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic inflammatory response syndrome (SIRS) | SIRS is defined as two out of the following four criteria: a) Temperature<36˚C (96.8˚F) or >38˚C (100.4˚F) b) Heart rate>90/min c) Respiratory rate>20/min d) WBC(<4000/mm3) (>12,000/mm3) or 10% bands. | at 24 hours |
Evaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
Evaluation of surgical excision of cardiophrenic lymph nodes in patients with advanced ovarian cancer

Detailed Description
-----------------
The role of cardiophrenic lymph node assessment and excision in advanced ovarian cancer is still debatable , correlation of radiological finding with pathological findings after reaction of radiological positive lymph nodes and its impact in diseases free survival and over all survival

Official Title
-----------------
Evaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Procedure: cardiophrenic lymph nodes resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Ovarian cancer patient (FIGO stage III-IV) Preoperative CT showing CPLN with short axis diameter > 5mm. Anathestically fit patient (ASA score I or II). Accepted pulmonary function test. Patient who received neoadjuvant chemotherapy or recurrent cases may be enrolled Written informed consent. Achievement of optimal cytoreduction intra-abdominal( No residual disease more than 1 cm ) Exclusion Criteria: Anathestically unfit patient Unresectable disease Patient refusal No detected CPLN by preoperative radiology

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

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

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: cardiophrenic nodes excision in ovarian cancer<br>We are going to evaluate the comorbidites and impact of cardiophrenic lymph nodes excision in cases of advanced ovarian cancer with positive cardiophrenic lymph nodes | Procedure: cardiophrenic lymph nodes resection<br>* surgical resection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of CPN retrieved/pathological nodes | correlation of radiological active lymph nodes with pathological findings | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | 2 years progression without disease recurrence | up to 2 years following the end of study |
In-Vitro Maturation of Oocytes From Polycystic Ovarian Patients Undergoing IVF

Study Overview
=================
Brief Summary
-----------------
Retrieval of immature oocytes from women with polycystic ovaries, their in-vitro maturation, fertilization and embryo transfer can prevent hormonal treatment that can lead to ovarian hyperstimulation. In addition, it can decrease discomfort and side-effects of routine daily administration of hormones and it can be cost-effective. Thirty healthy women with Polycystic Ovarian Syndrome aged 20-35, with BMI 18-30 kg/msq will be included in the study. Their immature oocytes will be retrieved from small follicles without any hormonal treatment. The oocytes will be fertilized post in-vitro maturation. The developed embryros will be transferred to the patients as in a routine IVF cycle.

Official Title
-----------------
In-Vitro Maturation of Oocytes From Polycystic Ovarian Patients Undergoing IVF

Conditions
-----------------
Polycystic Ovarian Syndrome

Intervention / Treatment
-----------------
* Other: In-vitro maturation oocytes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women diagnosed with Polycystic Ovarian Syndrome with BMI 18-30 kg/sqm, aged 20-35 Exclusion Criteria: Every one else

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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: Observational<br> | Other: In-vitro maturation oocytes<br>* Immature oocytes (development stage GV or M1) will be matured in-vitro in IVM culture medium for approximately 28-32 hours. The oocytes will be routinely observed and when they reach maturation (M2) they will be fertilized. The developed embryo will be transferred to the patient 24 hours post-fertilization.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maturation rate of oocytes, their fertilization rate, cleavage rate and embryo quality. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate and successful delivery. |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCO/PCOD, IVM, Immature Oocytes
Adherence to Continuous Positive Airway Pressure Among Obstructive Sleep Apnoea Patients.

Study Overview
=================
Brief Summary
-----------------
Prospective study designed to identify factors that would predict patient adherence to CPAP (Continuous Positive Airway Pressure) therapy.

Detailed Description
-----------------
Prospective study designed to identify factors that would predict patient adherence to CPAP therapy. Comparison between data recorded among patients and the data of the CPAP microchip.

Official Title
-----------------
Adherence to Continuous Positive Airway Pressure Among Obstructive Sleep Apnoea Patients. An Anaesthetic Algorithmic Approach to Prevent Postoperative Complications.

Conditions
-----------------
Sleep Apnea, Obstructive

Intervention / Treatment
-----------------
* Other: Comparison between groups


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (> 18 patients) All patients under CPAP (Continuous Positive Airway Pressure) therapy coming for annual visit in the Sart-Tilman Sleep Study Center Exclusion Criteria: Patient refusal

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 |
| --- | --- |
| Adherent Patients<br>Comparison between groups | Other: Comparison between groups<br>* Comparison between the two groups (adherent and non-adherent patients) in order to discover criteria of non-adherence<br>|
| Non-adherent patients<br>Comparison between groups | Other: Comparison between groups<br>* Comparison between the two groups (adherent and non-adherent patients) in order to discover criteria of non-adherence<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hours of CPAP use by night | Analyse of the data recorded by the CPAP microchip in order to assess the adherent or non-adherent status to the patient (adherent: CPAP use > 4 hours per night, non-adherent: less than 4 hours) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lickert's scale to assess criteria of non-adherence | Evaluation of 72 criteria by a Lickert's scale in order to assess characteristics associated with non-adherence to CPAP therapy | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Apnea, Obstructive, Continuous Positive Airway Pressure, Perioperative Period
Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to determine if treatment with Ramelteon will help to improve insomnia in older adults with co-existent insomnia and sleep apnea. The primary study objective is sleep latency (a measure of insomnia). The hypothesis is that sleep latency will be reduced in subjects taking Ramelteon relative to the placebo arm. The secondary study objective is to determine if subject compliance with CPAP treatment of their sleep apnea is improved in subjects taking Ramelteon (their compliance may be improved because they would have less insomnia due to Ramelteon treatment when using their CPAP). The hypothesis is that compliance with CPAP will be improved in subjects taking Ramelteon relative to the placebo arm.

Detailed Description
-----------------
Randomized, double-blind, placebo-controlled, parallel arm clinical trial with two study arms.

Official Title
-----------------
Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)

Conditions
-----------------
Insomnia, Obstructive Sleep Apnea

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obstructive sleep apnea Insomnia Age>60 Exclusion Criteria: Cognitive impairment Active alcohol or substance abuse Active use of other sedative-hypnotic agents Active use of fluvoxamine (drug interaction with Ramelteon Evidence of hepatic dysfunction (Ramelteon contraindicated) on liver function panel Presence of Periodic Limb Movement Disorder or Restless Legs Syndrome Severe Chronic Obstructive Pulmonary Disease

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ramelteon<br>Ramelteon 8 mg oral before bedtime | Drug: rozerem<br>* Ramelteon (rozerem) 8mg oral before bedtime<br>* Other names: Ramelteon;|
| Placebo Comparator: sugar pill<br> | Drug: Placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Onset Latency | Time to sleep onset as determined by polysomnography | 4 weeks |
A Study of CM310 in Subjects With Chronic Pruritus

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM310 in subjects with chronic pruritus of unknown origin.

Detailed Description
-----------------
The study consists of a Screening Period (up to 4 weeks), Treatment Period (16 weeks) and Safety Follow-up Period (8 weeks). 50 subjects who meet eligibility criteria will be randomized 1:1 to receive either CM310 300 mg or matched placebo subcutaneously every two weeks (Q2W) for a total of 8 times. All subjects will receive mometasone furoate nasal spray (MFNS) on a daily basis as a background treatment throughout the study.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Chronic Pruritus of Unknown Origin

Conditions
-----------------
Chronic Pruritus of Unknown Origin

Intervention / Treatment
-----------------
* Biological: CM310


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old. With chronic pruritus of unknown origin. With the worst pruritus numerical rating scale (WI-NRS) ≥7. Contraception. Exclusion Criteria: Heavy drinking in the 3 months prior to screening. With severe hepatic and renal impairment. Previous history of autosensitivity dermatitis. Allergic to CM310/placebo. Vaccination with live attenuated vaccine within 12 weeks before randomization or during the planned study period.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM310<br>600 mg (first dosing) + 300 mg (subsequent dosing), once every two weeks | Biological: CM310<br>* 600 mg (first doing) + 300 mg (subsequent dosing), once every two weeks<br>|
| Placebo Comparator: Placebo<br>once every two weeks | Biological: CM310<br>* 600 mg (first doing) + 300 mg (subsequent dosing), once every two weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change of weekly average in the worst itching numerical rating scale (WI-NRS) | Change from baseline in the worst itching numerical rating scale at week 16 | at week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety parameters | Incidence of treatment-emergent adverse events (TEAEs). | Baseline up to Week 24 |
A Study to Determine the Safety and Efficacy of Atralin (Tretinoin 0.05%) Gel for the Treatment of Rosacea

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy and safety of tretinoin gel 0.05% to its vehicle when dosed once or twice daily in female subjects with rosacea.

Official Title
-----------------
A Pilot Study to Compare Tretinoin Gel, 0.05% to Tretinoin Gel Vehicle When Dosed Once or Twice Daily in Female Subjects With Classical Rosacea

Conditions
-----------------
Rosacea

Intervention / Treatment
-----------------
* Drug: tretinoin gel 0.05%
* Drug: vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age 18-65 Diagnosed with classical, centrofacial, erythemato-telangiectatic rosacea Exclusion Criteria: Male, females less than 18 years Females over 65 years No diagnosed rosacea

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

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

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 |
| --- | --- |
| Active Comparator: 1<br> | Drug: tretinoin gel 0.05%<br>* Apply tretinoin gel, 0.05% topically once or twice daily to female subjects with rosacea<br>|
| Placebo Comparator: 2<br> | Drug: vehicle<br>* Apply Atralin Gel vehicle topically once or twice daily to female subjects with rosacea.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in signs and symptoms of rosacea |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in various skin parameters |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tretinoin, efficacy, safety, rosacea