linjc16/ctgov huggingface dataset:
The Effect of Cataract Extraction on the Contractility of Ciliary Muscle

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the changes in the pilocarpine-induced ciliary body movement before and after cataract extraction in order to determine the effect of lens sclerosis on the ciliary muscle contractility.

Detailed Description
-----------------
The functional changes in the ciliary body in presbyopia are not only important in a study of the mechanism for presbyopia but are also a key to various procedures or devices used to restore accommodation. Therefore, it is becoming increasingly important to quantify the in vivo accommodative changes in the aging ciliary muscle with and without a lens. We are going to evaluate the changes in the pilocarpine-induced contractility of the ciliary muscle in eyes with presbyopia before and after cataract extraction using ultrasound biomicroscopy (UBM).UBM will be performed with and without instilling 2 % pilocarpine, as well as before and 2 months after cataract extraction. Images of the ciliary body will be compared visually using Adobe Photoshop 7.0.

Official Title
-----------------
The Effect of Cataract Extraction on the Contractility of Ciliary Muscle

Conditions
-----------------
Presbyopia, Cataract

Intervention / Treatment
-----------------
* Other: UBM with pilocarpine in presbyopia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age : same or more than 55 years Patients with senile cataract who are going to get cataract surgery Exclusion Criteria: Age : less than 55 years Previous ocular disease other than cataract.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>ultrasound biomicrocopic examinations and pilocarpine instillation | Other: UBM with pilocarpine in presbyopia<br>* ultrasound biomicroscopic examination in both eyes 30 minutes after one drop of 2% pilocarpine hydrochloride (Ocucarpine®, Samil Pharm., Seoul, Korea) instillation before and two months after cataract surgery<br>* Other names: UBM with pilocarpine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ultrasound biomicroscopic findings (ciliary body axial length) |  | 2 months before and after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
presbyopia
Vitamin D Supplementation in Adult Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether vitamin D supplementation is effective in the prevention of relapse in Crohn's disease.

Official Title
-----------------
Vitamin D and Immunomodulation: Effects in Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D3
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients must fulfill the clinical criteria for diagnosis of Crohn's disease. Subjects must have inactive CD as defined by CDAI < 150 CRP </=10 mg/L. Exclusion Criteria: Pregnant and lactating women. Known hypersensitivity to vitamin D. Hypercalcaemia Current supplemental intake of vitamin D3 >800 IU/D. Diagnosis of any of the following: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, renal failure or malignancy, active TB, sarcoidosis, lymphoma. Participation in a concurrent clinical trial.

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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vitamin D<br>Capsule, one taken daily | Dietary Supplement: Vitamin D3<br> <br> |
| Placebo Comparator: Placebo<br>Capsule, one taken daily | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Relapse: defined as a CDAI of 150 or more and an increase in CDAI of more than 70 compared with baseline during the 12 month follow-up period. |  | 12 Months |
A Study Of AL101 In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

Study Overview
=================
Brief Summary
-----------------
This is a Phase 2, non comparative, open label, multicenter study of AL101 in patients with recurrent or metastatic ACC who harbor NOTCH 1,2,3,4 activating mutations.

Official Title
-----------------
A Phase 2, Open-Label, Multi-center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

Conditions
-----------------
Adenoid Cystic Carcinoma

Intervention / Treatment
-----------------
* Drug: AL101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed Adenoid Cystic Carcinoma with known NOTCH 1/2/3/4 activating mutation that is recurrent or metastatic, not amenable to potentially curative surgery or radiotherapy. Evidence of radiographic or clinical disease progression within 6-months of signing informed consent; newly diagnosed metastatic patients will be allowed. Patients must have Formalin-fixed, Paraffin-embedded tissue available . Must have at least 1 target lesion that is measurable for patients with nodal or visceral metastasis. Exclusion Criteria: Diagnosed with a malignancy other than ACC in the past 2 years. Uncontrolled, Active Infection Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel disease (IBD)] Symptomatic central nervous system (CNS) metastases. Unstable or severe uncontrolled medical condition Eastern Cooperative Oncology Group (ECOG) performance status ≥2. Abnormal organ and marrow function

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SINGLE-ARM<br>AL101 is an inhibitor of gamma secretase-mediated Notch signaling. | Drug: AL101<br>* AL101 is a small-molecule that inhibits gamma secretase, an enzyme which plays a key role in the activation of the Notch signaling pathway by releasing the Notch intracellular domain (NICD) of all four Notch receptors from the membrane. In patients with aberrant Notch signaling, AL101 may inhibit Notch signaling and potentially impede tumor growth.The drug is administered intravenously<br>* Other names: BMS 906024;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR; complete response [CR] and partial response [PR]) by RECIST v1.1 |  | Up to 36 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency, duration and severity of adverse events (AEs) and serious adverse events (SAEs); |  | Up to 36 month |
Validation of Serum Creatinine Dosage and Renal Clearance

Study Overview
=================
Brief Summary
-----------------
This study has an open study design. The GFR will be measured using the renal clearance of inulin (Inutest) in volunteers with different stage of renal disease or without renal disease. A blood sample will be obtained for measuring serum creatinine in different laboratories.

Detailed Description
-----------------
In this study we will investigate the correlation between the GFR as measured by inulin clearance (golden standard) and the estimated GFR as measured by laboratories which used different serum creatinine assays in patients without renal disease and in patients with different stage of kidney failure.

Official Title
-----------------
Validation of Serum Creatinine Dosage and Renal Clearance

Conditions
-----------------
Kidney Failure

Intervention / Treatment
-----------------
* Procedure: Calculation of inuline clearance
* Procedure: Measuring serum creatinine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal weight as defined by a Body Mass Index of 18 to 30 kg/m2. Subject is competent and willing to sign informed consent form after being given all the detailed information about the study. Informed consent form signed voluntarily. The subjects must be in stable clinical condition, with stable serum creatinin at least for 6 months. Persons with different stage of chronic renal disease and without kidney disease (living donors) who need an evaluation of the GFR or Admitted volunteers who easily obtain urine samples. Exclusion Criteria: Transplant patients Medication that will influence the serumcreatinine. Morbid obesity Pregnant, lactating females or females with childbearing potential without adequate contraception (use of oral contraceptives, IUD or condoms with spermicide). History of allergy or hypersensitivity to inulin Donation of blood in the 60 days preceding the first visit. Liver disease, heart failure, nephrotic syndrome. Patients in critically ill conditions. Malnutrition Postrenal kidney failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Calculation of inuline clearance|Calculation of inuline clearance.|
|Procedure: Measuring serum creatinine|Measuring serum creatinine.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular filtration ratio |  | At time T0 | 
| Serum creatinine |  | At time T0 |
Predictive Factors for Exacerbation Outcome in Severe Refractory Asthmatics

Study Overview
=================
Brief Summary
-----------------
Asthma is a chronic inflammatory disease, affecting up to 10 % of the general population in developed countries. Corticosteroids are necessary to control symptoms, but induce adverse events sometimes intolerable. In severe asthma, which represent 5 to 10% of global asthma, corticosteroids frequently fail to prevent severe exacerbations, leading to emergency care, hospitalization and sometimes death. The aim of this study is to identify predictive factors specific for exacerbation outcome which will lead to a minor increase in treatment in order to prevent exacerbations, while minimizing drug adverse effects.

Official Title
-----------------
Predictive Factors for Exacerbation Outcome in Severe Refractory Asthmatics

Conditions
-----------------
Asthma, Chronic Inflammatory Diseases

Intervention / Treatment
-----------------
* Other: spirometry, and blood taken


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Male or female adults aged ≥ 18 years, who have signed an Inform Consent Form prior to initiation of any study-related procedure Patients with severe asthma with at least 2 exacerbations during the last 12 months that necessitated oral cortico-therapy or increase in oral cortico-therapy Exclusion criteria : Pregnant or nursing women Patients with other chronic inflammatory lung disease Current smoker or a smoking history of 10 pack years or more

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: spirometry, and blood taken|each month during one year|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of predictive factors for exacerbation outcome in severe asthmatics. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of predictive factors identified in the study, in order to prevent exacerbations. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Severe asthma, exacerbation, predictive factors, Severe
Steroid Injection in De Quervain Tenosynovitis

Study Overview
=================
Brief Summary
-----------------
This study is carried out to find out the degree of pain relief achieved with standard treatment as steroid injection as well as its time to onset. It will recruit 50 subjects over a period of 18 months.

Detailed Description
-----------------
The aim of the study is determine how effective these injections are and when will the patient start feeling relief of his/her symptoms.The aim of the study is not to change the current practice, but provide hand surgeons enough data to clarify their patients the expected outcomes and onset timing of the treatment performed.

Official Title
-----------------
Effectiveness of Steroid Injection in Treating Pain in De Quervain Tenosynovitis

Conditions
-----------------
De Quervain Disease

Intervention / Treatment
-----------------
* Procedure: Corticosteroid Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >21 years old Exclusion Criteria: Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Corticosteroid Injection|Steroid injection effectiveness will be determined by relief of pain scored by patient using Visual Analogue Scale (VAS). Data will be collected during clinic visit and contacting patients in a determined protocol for the following 6 weeks after steroid injection.After approval of the study, data will collected from participants over a period of 6 weeks follow up; the whole study will be conducted over a total of 2 years.Since the study will not conduct any further test to participants and follow up regimen will only state pain related to the specific condition (De Quervain tenosynovitis) and quick-DASH score, it will not result in any anticipated/unanticipated incidental findings, therefore participants will not be recontacted.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine efficacy of steroid injection | a single steroid injection over first dorsal compartment for patients diagnosed with de Quervain tenosynovitis will make effect within 7 days from injection, relieving pain to less or equal than 1 in Visual Analogue Scale (VAS) | 7 days |
Truncal Vagotomy in Patients Undergoing Revisional Sleeve Gastrectomy to Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy of performing a truncal vagotomy along with a sleeve to bypass revision surgery in reducing the severity and/or incidence of gastroesophageal reflux disease (GERD) post-surgery.

Official Title
-----------------
Truncal Vagotomy in Patients Undergoing Revisional Sleeve Gastrectomy to Gastric Bypass

Conditions
-----------------
GERD

Intervention / Treatment
-----------------
* Procedure: Truncal vagotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participating subjects will need to be >18yrs of age and eligible for sleeve to bypass revision bariatric surgery. Undergoing sleeve to bypass revision bariatric surgery. Exclusion Criteria: Patients who are under the age of 18. Not eligible for sleeve to bypass revision bariatric surgery.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Truncal Vagotomy<br>Truncal vagotomy will be performed during other routine procedure. | Procedure: Truncal vagotomy<br>* Truncal vagotomy will be performed in 50% of patients during other routine procedure.<br>|
| No Intervention: No Truncal Vagotomy<br>No truncal vagotomy will be performed during other routine procedure. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD-HRQL scores | GERD-HRQL scores | approximately 6 months post operation | 
| Esophageal pH monitoring | Esophageal pH monitoring | approximately 6 months post operation | 
| Reflux symptom index questionnaire | Reflux symptom index questionnaire | approximately 6 months post operation |
Disruption of Circadian Rhythm and Healthcare-related Infection in Patients With Severe Trauma

Study Overview
=================
Brief Summary
-----------------
Circadian rhythms, which play crucial roles in physiology, are emerging as important regulators of specific immune functions. Hospitalization in intensive care unit leads to a deep impairment of circadian rhythm. Infection is a frequent event during ICU hospitalization. The investigators hypothesis is that in trauma patients the lack of circadian rhythm variations is associated with the occurrence of infection. The primary aim of the study is to assess the circadian variations of plasma Bmal1 in the occurrence of healthcare related infection during the 30 days after inclusion. The secondary aims are to assess the plasma expression of circadian genes (Clock, Cry1, Per3, and Rev-erba), the production of cytokines in plasma, and the concentration of cortisol, according to the occurrence of an infection.

Official Title
-----------------
Disruption of Circadian Rhythm and Healthcare-related Infection in Patients With Severe Trauma

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Other: blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Trauma patients with an injury severity score > 15, requiring mechanical ventilation for at least 24 h during the first 48 h and an arterial catheter. Exclusion Criteria: Pregnant and lactating women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trauma patients<br>Blood samples will be collected every 4 hours during 24 h, between day 2 and day 4 after inclusion | Other: blood samples<br>* Blood samples will be collected every 4 hours during 24 h<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| area under the curve representing the maximal expression of Bmal1 gene during the first 24 h following inclusion |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infection in ICU
Multimodal Assessment of Knee Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess both osteoarthritis and other pathological knee conditions from the combination of signals that are known to provide information on the knee joint.

Official Title
-----------------
Multimodal Assessment of Knee Conditions

Conditions
-----------------
Osteoarthritis, Injury of Anterior Cruciate Ligament, Knee Injuries and Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 45 - 65 Exclusion Criteria: Rheumatoid arthritis Weight over 110 kg Previous total knee replacement surgery Contraindications to MRI

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 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 |
| --- | --- |
| Controls<br>Controls | |
| ACL subjects<br>Subjects with anterior cruciate ligament injuries. | |
| OA1, doubtful OA<br>Subjects with doubtful osteoarthritis. | |
| OA2, mild OA<br>Subjects with mild osteoarthritis. | |
| OA3, moderate OA<br>Subjects with moderate osteoarthritis. | |
| OA4, severe OA<br>Subjects with severe osteoarthritis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of osteoarthritis (confirmed using X-ray and magnetic resonance imaging) |  | 6 months |