linjc16/ctgov huggingface dataset:
Muscle Preservation Hamstring Graft for ACL Reconstruction

Study Overview
=================
Brief Summary
-----------------
Muscle derived stem cell is a better source of stem cells than a tendon tissue Preservation of muscle derived stem cell may enhance bone-tendon integration and ligamentization of ACL hamstring graft

Official Title
-----------------
Muscle Preservation Hamstring Graft for ACL Reconstruction: Randomized Controlled Trial

Conditions
-----------------
Graft Healing

Intervention / Treatment
-----------------
* Procedure: Muscle preservation
* Procedure: No muscle preservation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary ACL reconstruction using autogenous hamstring graft Exclusion Criteria: Combined meniscal or ligament surgery Combined osteoarthritis (KL grade II or more) chondral injury more than grade 2 Refuse to undergo MRI

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 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: Muscle preservation<br>Muscle preservation for hamsting graft | Procedure: Muscle preservation<br>* Muscle preservation during graft preparation of hamstring graft<br>|
| Active Comparator: None preservation<br>No muscle preservation for hamstring graft | Procedure: No muscle preservation<br>* No muscle preservation during graft preparation of hamstring graft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNQ value of MRI | signal of ACL graft-signal of quadriceps tendon/singal of background | 6 months |
Gemcitabine/Platinum Containing Regimens as Preoperative Chemotherapy for Patients With Non Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
To study the efficacy and tolerability of gemcitabine/platinum chemotherapy in non small cell lung cancer

Official Title
-----------------
A Randomized Phase II Trial of Gemcitabine Containing Regimens (Gemcitabine/Carboplatin and Gemcitabine/ Cisplatin)When Used as Preoperative Chemotherapy for Patients With Stage I and II NSCLC

Conditions
-----------------
Carcinoma, Non Small Cell Lung

Intervention / Treatment
-----------------
* Drug: gemcitabine
* Drug: carboplatin
* Drug: cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically of cytologically confirmed non small cell lung cancer No prior chemotherapy or radiation No prior malignancy Exclusion Criteria: Pregnant or breastfeeding Serious concomitant systemic disorder

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 |
| --- |
|Drug: gemcitabine|nan|
|Drug: carboplatin|nan|
|Drug: cisplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete pathological response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate, disease free survival, toxicity including pulmonary toxicity,operative mortality and quality of life. |  |  |
Epidemiological Analysis of Vitamin D and Breast Cancer Risk in Saudi Arabian Women

Study Overview
=================
Brief Summary
-----------------
This is an analysis of de-identified data collected from 240 Saudi Arabian women, 120 with breast cancer and 120 control women, to evalyate if vitamin D status is associated with breast cancer risk.

Detailed Description
-----------------
Background: The role of vitamin D in breast cancer prevention is equivocal. Saudi Arabian women are thought to be at greater risk for vitamin D deficiency due to darker skin type and greater likelihood for reduced UVB radiation exposure. However, there is a lack of data regarding the vitamin D status of Saudi Arabian women and how this may relate to breast cancer risk. Objective: The purpose of this research was to evaluate the association between circulating concentrations of 25(OH)D and breast cancer risk in Saudi Arabian women. Design: A case-control study was conducted among 120 breast cancer cases and 120 controls. The study population was drawn from patients admitted to King Fahd Hospital in Jeddah, Saudi Arabia from June to August 2009. Participants completed questionnaires on diet and medical history and serum samples were collected from all women to measure circulating 25(OH)D concentrations.

Official Title
-----------------
Vitamin D Status and Breast Cancer in Saudi Arabian Women: Case Control Study

Conditions
-----------------
Breast Cancer, Vitamin D Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Invasive breast cancer (cases) or healthy women (controls), receiving standard medical check-ups at the women's clinic Female, between the ages of 18 and 75 years BMI ≤ 40 kg/m2 residence in Saudi Arabia for more than 5 years absence of chronic diseases that could affect vitamin D metabolism, including renal, hepatic, endocrine, or autoimmune disease. Exclusion Criteria: receiving standard medical check-ups at the women's clinic Male, less than 18 or greater than 75 years of age BMI > 40 kg/m2 Not a resident of Saudi Arabia for more than 5 years Presence of chronic diseases that could affect vitamin D metabolism, including renal, hepatic, endocrine, or autoimmune disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| breast cancer cases<br>breast cancer cases versus controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum vitamin D | assessed serum vitamin D in cases versus controls | cross-sectional from May 2009-August 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, vitamin D, 25 OH vitamin D
Levosimendan in High Risk Heart Valve Surgery

Study Overview
=================
Brief Summary
-----------------
Prospective, randomized, double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery. Study hypothesis: Levosimendan diminishes the need for adrenergic inotropic drugs and morbidity and may improve survival after heart valve surgery.

Detailed Description
-----------------
200 patients are prospectively randomized in a double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery. Levosimendan/placebo is administered as 24 hour continuous infusion beginning after anesthesia induction. Primary endpoint being adrenergic inotrope need after cardiopulmonary bypass and secondary endpoints hospital and 6-month mortality and major organ failure.

Official Title
-----------------
Efficacy of Levosimendan in Cardiac Failure After Heart Valve Surgery

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: levosimendan
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible for cardiac valve or combined CABG and cardiac valve surgery: Clinical signs of cardiac insufficiency Exclusion Criteria: Endocarditis

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Levosimendan | Drug: levosimendan<br>* Intravenous infusion, blus 24 mcg/kg in 30-minutes followed by 0.2 mcg/kg/min up to 24 hours<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart failure necessitating inotropic drug administering after heart valve surgery |  | Postoperative hospital period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital morbidity and mortality |  | Postoperative hospital period | 
| Postoperative mortality at six months |  | Six months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, levosimendan, cardiac surgery
INNO-105 in Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The safety, tolerability and pharmacokinetics of INNO-105, an investigational anticancer drug, are being studied in patients with solid tumors.

Official Title
-----------------
A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Weekly Intravenous INNO-105 in Adult Patients With Advanced Solid Malignancies

Conditions
-----------------
Tumors

Intervention / Treatment
-----------------
* Drug: INNO-105


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a histologically or cytologically confirmed diagnosis of a solid malignancy (patients may have either measurable or nonmeasurable disease). Be ≥18 years old. Not eligible for effective therapy likely to provide clinical benefit. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2. Acceptable pretreatment clinical laboratory results. Life expectancy of greater than 12 weeks. Exclusion Criteria: Have received previous treatment with INNO-105. Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment. Are pregnant or lactating. Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up. Have received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 2 weeks of treatment in this study. Have not recovered from acute toxicity of all previous therapy prior to enrollment. Have symptomatic or untreated central nervous system (CNS) metastases. Have a susceptibility to hypotension, bradycardia, and/or hypopnea, such as patients with known coronary heart disease, arrhythmias, cerebral vascular disease, and chronic obstructive airways disease (CO2-retaining).

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

| Intervention/Treatment |
| --- |
|Drug: INNO-105|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Factor XIII and Pulmonary Embolism in Neurosurgical Patients

Study Overview
=================
Brief Summary
-----------------
Two studies (Gerlach et al. 2000; Gerlach et al. 2002) described the impact of factor XIII on the risk of prospective hemorrhage for patients undergoing craniotomy. Since then, factor XIII is measured and substituted in various centers. Few reports support the idea of factor XIII being involved in the formation of deep venous thrombosis and pulmonary embolism. In this prospective observational study, patients undergoing craniotomy for brain tumors or vascular lesions are investigated concerning the incidence of postoperative pulmonary embolism in respect of possible risk factors (factor XIII activity levels, standard coagulation parameters, tumor entity, blood loss).

Official Title
-----------------
Risk Factors for Perioperative Pulmonary Embolism in Neurosurgical Patients in Respect of Factor XIII Activity

Conditions
-----------------
Brain Tumor, Vascular Lesion, Factor XIII Deficiency, Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preoperatively low Factor XIII activity neurosurgical procedure (craniotomy) substitution of Factor XIII postoperative occurence of pulmonary embolism Exclusion Criteria:
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with low Factor XIII<br>Postoperative occurence of pulmonary embolism in patients scheduled to undergo a neurosurgical procedure with laboratory-confirmed low levels of Factor XIII | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pulmonary embolisms following Factor XIII substitution |  | 38 months |
Bronchoreversibility Test in Asthmatic Children and Correlation With Diagnostic Criteria Proposed by the GINA Guidelines

Study Overview
=================
Brief Summary
-----------------
Since 2015, GINA (Global INitiative on Asthma) guidelines were modified and adapted to better fit the pediatric population. Asthma diagnosis is mainly based on the results of PFT (Pulmonary Function Tests) and broncho-reversibility test in adult. GINA guidelines modified the requirements to reach a diagnosis of Asthma in children, based on the reversibility test. GINA guideline propose an increase of 12% of the FEV1 is considered as the diagnostic criterium for asthma in pediatrics. Nevertheless, in clinical practice, most physicians base their diagnosis of asthma in children on the clinical signs presented by the patient and on the efficacy of the prescribed therapy. Also, the spirometric criterium is not sufficiently corroborated by clinical studies. No research has ever looked for the results of bronchoreversibility test in patients receiving a clinical diagnosis of asthma. For this reason, in children with a clinical diagnosis of asthma, the investigators want to look for the results of the bronchoreversibility test and validate that an increase of 12% of the FEV1 correlate with a physician-driven diagnosis of asthma in pediatrics. For further analysis the investigatorswill evaluate also the reversibility of small airways (FEF25-75) and the z-score of the results of the PFT in these children.

Official Title
-----------------
A Retrospective Study to Verify FEV1 Reversibility Criteria Proposed by the GINA Guidelines, in Asthmatic Children

Conditions
-----------------
Pediatric Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Children aged between 5 and 18 years Children with a diagnosis of asthma undergoing a PFT and a bronchoreversibility test on the day of the diagnosis Children evaluated at the University Hospital of Montpellier (France), or at the Pediatric Allergy Unit of the University Hospital of Pavia (Italy) Exclusion criteria: Children not able to perform a PFT Children taking drugs that could affect the results of a PFT Children included in other trials that don't allow them to be included in the present one

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum 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 |
| --- | --- | --- |
| value of FEV1 increase | Positive predictive value of FEV1 increase (%) in asthmatic children after bronchodilation test | 1 day | 
| value of FEF 25-75 | Positive predictive value of FEF 25-75 increase (%) in asthmatic children after bronchodilation test | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchodilation test, GINA, Reversibility criteria
Use of Somatropin in Turner Syndrome

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to study the dose-response relationship and effect of somatropin (Norditropin®) on final height in girls with Turner Syndrome.

Official Title
-----------------
The Use of Norditropin® in Turner's Syndrome

Conditions
-----------------
Genetic Disorder, Turner Syndrome

Intervention / Treatment
-----------------
* Drug: somatropin
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Turner Syndrome Not previously treated with growth hormone or androgen Well-documented height over the previous 12 months Informed consent of parents (and child if appropriate) Exclusion Criteria: Growth hormone (GH) deficiency based on a GH stimulation test

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 11 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br> | Drug: somatropin<br>* 2.9 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached<br>|
| Experimental: High dose<br> | Drug: somatropin<br>* 4.3 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final height in cm |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio between change in bone age and change in chronological age |  |  | 
| Age at onset of puberty |  |  | 
| Adverse events |  |  |
Validation of a Diagnostic Self-assessment Scale Non-motor Fluctuations at the Parkinson's Patient

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to validate a diagnostic tool severity of these common non-motor manifestations, disturbing and little recognized as a self-questionnaire. This assessment tool used on different subgroups of patients (free from any treatment at an early stage of the disease and the stage of motor complications) will better understand the natural history of the non-motor fluctuations (FNM)

Official Title
-----------------
Validation of a Diagnostic Self-assessment Scale Non-motor Fluctuations at the Parkinson's Patient

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: validation of a diagnostic tool severity of non-motor symptoms in Parkinson patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 30 or over Patient having an Parkinson's disease Patient hospitalized in one of the clinical sites participating in the project Patient have agreed to participate in the study subject that masters the French language and able to fulfill the self-questionnaire. Exclusion Criteria: Patient aged under 30 Patient can not answer the self-administered questionnaire Patient has not agreed to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: validation of a diagnostic tool severity of non-motor symptoms in Parkinson patients|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Self questionnaires with Beck Depression Scale | 2 years | 
| Quality of life | use of measurement scales Quality of Life; PDQ-39 it's a 39-item Parkinson's disease questionnaire (Record socio-demographic information) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Socio-demographic data | age, sex, socioeconomic status, | 2 years | 
| clinical evaluation | clinical form of the disease | 2 years | 
| clinical evaluation | current treatments and comorbidities | 2 years | 
| clinical evaluation | Questionnaire administered hetero Q1, Early questionnaire and UPDRS (Unified Parkinson's Disease Rating Scale) | 2 years |