linjc16/ctgov huggingface dataset:
Beta Cell Function Tests Over Time In Patients With T2dm Randomized To Metformin Or Rosiglitazone

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether markers of b-cell function can predict changes in B-cell function over time in patients with type 2 diabetes mellitus (T2DM) randomized to treatment with metformin or rosiglitazone.

Detailed Description
-----------------
The study terminated on 17-Jul-07 due to concerns about long-term cardiovascular safety of Avandia and slow patient enrollment. There were no specific safety issues raised within the trial.

Official Title
-----------------
Analyzing Beta Cell Function Tests Over Time In Patients With Type 2 Diabetes Mellitus Randomized To Metformin Or Rosiglitazone

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

Intervention / Treatment
-----------------
* Drug: Rosiglitazone
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female with type diabetes mellitus (diagnosed via ADA criteria), newly diagnosed or treatment-naive (other than diet and exercise) and HbA1c range of 7 to 9%. 45-70 years of age. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated, asymptomatic, seasonal allergies).

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosiglitazone|nan|
|Drug: Metformin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study will examine whether biomarkers of B-cell function measured early in the study (1, 3, and/or 6 months) will predict long-term changes in B-cell function (as represented by HOMA-B). |  |  |
Clinical Isolation Syndrome of Spinal Cord and Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the factors that influence the progression of patients with clinically isolated spinal cord syndrome to multiple sclerosis.

Detailed Description
-----------------
This study included patients who were first diagnosed with clinically isolated spinal cord syndrome admitted to the Department of Neurology, Peking University Third Hospital between January 2010 and November 2020. According to the result of the outcome is divided into multiple sclerosis and outcome group, analyzing the characteristics of the age, sex, clinical manifestations, imaging features, evoked potential, blood immune antibody results, rate of cerebrospinal fluid routine biochemical synthesis oligoclonal band IgG, extension, nerve dysfunction score spinal cord clinically isolated syndrome and the influence factors, such as the relationship between the outcome of multiple sclerosis.

Official Title
-----------------
Clinical Isolated Spinal Cord Syndrome Was Identified as Multiple Sclerosis Associated Risk Factor Analysis

Conditions
-----------------
Clinical Isolation Syndrome of Spinal Cord, Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis time and place: Department of Neurology, Peking University Third Hospital from January 2010 to November 2020 Diagnosed as a patient with clinically isolated spinal cord syndrome for the first time Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| multiple sclerosis group<br> | |
| non-prognosis group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progressed to multiple sclerosis | Progressed to multiple sclerosis | 3 years |
Effects of Roxithromycin on Quality of Life and Physiological Outcomes in Bronchiectasis

Study Overview
=================
Brief Summary
-----------------
roxithormycin 300 mg per day for 12 weeks could improve quality of life and physiological outcomes in bronchiectasis

Detailed Description
-----------------
A randomized, double blinded, placebo controlled study was conducted to evaluate the effects of a 12-week administration of roxithromycin 300 mg once daily and a 12-week follow-up period in symptomatic stable bronchiectasis

Official Title
-----------------
Effects of Roxithromycin on Quality of Life and Physiologic Outcomes in Bronchiectasis Patients During Treatment and Posttreatment Period

Conditions
-----------------
Quality of Life, Respiratory Function Tests

Intervention / Treatment
-----------------
* Drug: Roxithromycin 300 MG
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
minimum 15 year maximum 75 years Criteria inclusion Criteria: Symptomatic bronchiectasis Stable clinical bronchiectasis Exclusion Criteria: Adverse drug reaction to macrolide Recent exacerbation within 2 weeks History of macrolide therapy within 2 weeks active malignancy and end stage diseases 5. not perform lung function tests Females who were lactating

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
Interventional Model Description: randomised control study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: roxithromycin<br>roxithromycin 300 mg oral per day | Drug: Roxithromycin 300 MG<br>* Roxithromycin 300 mg oral per day<br>* Other names: Roxithromycin;|
| Placebo Comparator: placebo<br>placebo one tablet per day | Drug: Placebo<br>* Placebo one table oral once dialy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SGRQ scores | SGRQ scores | for 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function tests | FEV1 | 24 weeks | 
| sputum volumes | sputum volume per day | 24 wekse | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchiectasis, quality of life, pulmonary function tests
Postprandial Hemodynamics

Study Overview
=================
Brief Summary
-----------------
To study the postprandial alterations in hemodynamics and blood pressure in relation to gastric emptying rate, postprandial blood glucose, plasma concentrations of insulin, satiety in healthy subjects.

Detailed Description
-----------------
Ingestion of a meal increase blood flow to the gastrointestinal organs and affects the heart rate, blood pressure, and cardiac output. It is not known through wich mechanisms the heart function changes affects after a meal.

Official Title
-----------------
Relationship Between Postprandial Alterations in Hemodynamics, Blood Pressure, Blood Glucose, Insulin Concentrations, Gastric Emptying, and Satiety

Conditions
-----------------
Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Exclusion Criteria: history of gastrointestinal disease, abdominal surgery or diabetes mellitus

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Oral Care of Patients Treated With Anti-RANK-ligand Antibodies for a Giant Cell Tumour

Study Overview
=================
Brief Summary
-----------------
Giant cell tumors are mostly benign tomoral processes, most often responsible for areas of osteolysis in the metaphysoepiphyseal area of long bones, representing 5-6% of primary bone tumors. The bone weakening induced by these beaches leads to pain and risk of fracture, and this is what leads the patient to consult. These tumors are found particularly in the young adult population between 20 and 40 years old, are locally aggressive, but malignant transformations and metastases (pulmonary) are quite rare. In this study, the investigators wish to retrospectively study the oral care of patients who presented with a giant cell tumor and were treated with Denosumab at the University Hospital of Strasbourg and their associated oral follow-up

Official Title
-----------------
Oral Care of Patients Treated With Anti-RANK-ligand Antibodies for a Giant Cell Tumour: Retrospective Study at the University Hospitals of Strasbourg

Conditions
-----------------
Giant Cell Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult subject, having presented a giant cell tumor treated with adjuvant or neoadjuvant denosumab at the HUS from 01/01/2014 to 08/31/2022. Subjects who have not expressed their opposition to the reuse of their data for scientific research purposes. Exclusion criteria: Subject having expressed their opposition to the retrospective reuse of their data for scientific research purposes Pathology finally labeled other than giant cell tumour. Treatment with denosumab was not initiated because of death, change in treatment protocol, etc. Absence of oral follow-up element.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Number of Decayed, Missing, and Filled Permanent Teeth (DMFT) |  | Files analysed retrospectively from from January 01, 2014 to August 31, 2022 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Giant Cell Tumors, Anti-RANK-ligand antibodies
The Effect of Radiofrequency Ablation of Genicular Nerves on Postural Stability in Patients With Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
In advanced knee osteoarthritis, postural stability is also disturbed. There are some concerns about performing radiofrequency ablation to genicular nerves since this may further decrease the postural stability of the patient. The aim of this study is to see if application of genicular radiofrequency causes a significant change in postural stability.

Official Title
-----------------
The Effect of Radiofrequency Ablation of Genicular Nerves on Postural Stability in Patients With Knee Osteoarthritis

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Procedure: radiofrequency ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage 3 and 4 knee osteoarthritis according to Kellgren-Lawrance scale Knee pain more than 3 months Exclusion Criteria: Neurological diseases such as polyneuropathies Presence of severe psychiatric disorders Hemodynamic instability History of any surgery from the knee

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
Interventional Model Description: Patients with knee osteoarthritis with Kellgren-Lawrance scale stage 3-4 will receive radiofrequency ablation to their genicular nerves and will be evaluated before treatment, 3 weeks and 3 months after treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genicular RF<br>Patients who will receive genicular radiofrequency ablation | Procedure: radiofrequency ablation<br>* radiofrequency ablation of the genicular nerves<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | The change of pain will be evaluated with 10 cm visual analogue scale will be applied to the patients, 0 being no pain while 10 being intolerable pain | 3 weeks and 3 months after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural stability | The change of weight bearing indexes of both feet will be measured | 3 weeks and 3 months after the treatment | 
| WOMAC | Western Ontario & McMaster Universities Osteoarthritis Index | 3 weeks and 3 months after the treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis, radiofrequency ablation
Impact of Age on Surgical Outcome of Adolescent Idiopathic Scoliosis

Study Overview
=================
Brief Summary
-----------------
This is a study prospectively enrolling adolescent idiopathic scoliosis (AIS) patients and try to find how the age will impact the surgical outcome of AIS.

Official Title
-----------------
Impact of Age on Surgical Outcome of Adolescent Idiopathic Scoliosis

Conditions
-----------------
Scoliosis

Intervention / Treatment
-----------------
* Procedure: posterior correction and fusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescent idiopathic scoliosis patients; undergoing posterior correction surgery; with minimum 5 years follow-up; with full-spine radiography. Exclusion Criteria: with spinal tumor; with hip disease; without quality of life measurements.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 25 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 |
| --- | --- |
| Other: Age before and after 18 years old<br>Surgical treatment before and after skeletal maturity | Procedure: posterior correction and fusion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of coronal Cobb angle | Cobb angles, including thoracic and lumbar Cobb angle, are measured from coronal radiographs with validated software (Surgimap). | From immediate post-operative until at least 10 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of sagittal profile | Sagittal profile, described sagittal radiographic parameters such as thoracic kyphosis and lumbar lordosis, is measured with validated software (Surgimap). | From immediate post-operative until at least 10 years follow-up | 
| Health-related quality of life (HRQOL) | HRQOL measurements include Short Form 36 (SF-36), Scoliosis Research Society (SRS) 22 questionnaire and Visual Analogue Scale (VAS). | From immediate post-operative until at least 10 years follow-up |
YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if patients who take YM598 in addition to mitoxantrone and prednisone (standard therapy) experience improvement in the pain associated with prostate cancer metastases in the bone.

Conditions
-----------------
Hormone-Refractory Prostate Cancer, Prostatic Neoplasms

Intervention / Treatment
-----------------
* Drug: YM598


Participation Criteria
=================

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

Sexes Eligible for Study
-----------------
Male

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: YM598|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Androgen-independent prostate cancer
Pain in Newborn Heel Blood Collection

Study Overview
=================
Brief Summary
-----------------
This study was conducted to evaluate the effect of white noise and therapeutic touch on pain in newborn heel blood collection.Questions including the sex of the newborns, postnatal age, gestational age, birth weight, height, head and chest circumference, feeding style, nutritional status in the last half hour, and previous heel blood collection were collected with the Information Form.The Newborn Infant Pain Scale (NIPS) was used to evaluate the pain levels of newborns.

Official Title
-----------------
The Effect of White Noise and Therapeutic Touch on Pain in Newborn Heel Blood Collection

Conditions
-----------------
Infant, Newborn, Disease, Pain, Acute

Intervention / Treatment
-----------------
* Other: White Noise
* Other: Yakson Touch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestational week 37 and above, fasting time < 1 hour, without comorbidity and congenital anomalies, not receiving oxygen or mechanical respiratory support, no analgesic sedation before the procedure neonates with stable physiological findings before the procedure Exclusion Criteria: • newborns whose heel blood cannot be taken at once

Ages Eligible for Study
-----------------
Minimum Age: 37 Weeks
Maximum Age: 42 Weeks

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: White Noise<br> | Other: White Noise<br>* Orhan OSMAN's song Don't Let Your Baby Cry-2 from the Kolik album was used.<br>|
| Experimental: Yakson touch<br> | Other: Yakson Touch<br>* In order to transfer the Ki energy to the baby, he took a deep breath and gathered the universal energy in his palms, intending the baby's well-being and healing. The researcher applied the Yakson touch by covering the abdomen and chest of the newborn with his right hand (dominant hand) while the newborn was in the supine position, and supported the baby's back and hips with his left hand.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Newborn Infant Pain Scale (NIPS) | The Newborn Infant Pain Scale (NIPS) was used. NIPS: Scale Lawrence et al. (1993) was developed to evaluate the behavioral and physiological pain responses of preterm and term infants. The scale consists of five behavioral factors (facial expression, crying, arousal, arm and leg movements) and one physiological (breathing pattern) factor. The crying factor is given 0-1-2 points, the other factors are given 0-1 points, and the total score is between 0-7. A high score indicates greater severity of pain. | 12 week |
Open Lung Approach Versus Standard Protective Strategies

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to compare the effects of adding a recruitment maneuver (RM) to low tidal volume (VT) ventilation, with or without an individualized post-RM positive end-expiratory pressure (PEEP) setting in lung-healthy patients during anesthesia.

Official Title
-----------------
Open Lung Approach Versus Standard Protective Strategies: Effects on Driving Pressure and Ventilatory Efficiency During Anesthesia

Conditions
-----------------
Lung Collapse

Intervention / Treatment
-----------------
* Procedure: OLA
* Procedure: RM-5


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I-III undergoing elective major abdominal surgery including pancreatic-duodenectomy, gastrectomy and liver resection Exclusion Criteria: i) laparoscopic surgery, ii) patients with previous respiratory 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OLA<br>recruitment maneuver + individualized PEEP | Procedure: OLA<br>* PEEP titration trial for best Cdyn after the alveolar recruitment maneuver<br>|
| Active Comparator: RM-5<br>recruitment maneuver + fixed standard PEEP | Procedure: RM-5<br>* Fixed standard PEEP after the alveolar recruitment maneuver<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| driving pressure | The driving pressure is a physiological ventilatory parameter measured as platteau pressure minus PEEP. This parameter may be associated with postoperative pulmonary complications | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilatory efficiency | Ventilatory efficiency measured with volumetric capnography which includes dead space and tidal elimination of carbon dioxide. | intraoperative |