linjc16/ctgov huggingface dataset:
Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if changes in ocular signs and symptoms occur in patients with ocular hypertension or glaucoma when they switch from latanoprost 0.005% (Xalatan) to preservative free Tafluprost eye drops.

Official Title
-----------------
Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops

Conditions
-----------------
Ocular Hypertension, Open-Angle Glaucoma

Intervention / Treatment
-----------------
* Drug: tafluprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of ocular hypertension or open angle glaucoma for which the patient has been using latanoprost 0.005% as his/her prior medication. - Evaluable patients must have ocular surface related symptoms and/or signs with their prior medication.

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1 arm<br>Open-lable study with one arm. | Drug: tafluprost<br>* prostaglandine analoque<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from screening in ocular symptoms and signs |  | at week 6 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Quality of life parameters. |  | From Screening (visit 1) to visits at week 2, 6 and 12. |
Physical Activity in Youth: Implications for Reversing Risk Factors for Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
In this randomized controlled trial, we will examine the effect of a 3-month exercise training (aerobic exercise versus resistance exercise) without calorie restriction on total and regional adiposity, and risk of type 2 diabetes in overweight children and adolescents.

Official Title
-----------------
Physical Activity in Youth: Implications for Reversing Risk Factors for Type 2 Diabetes

Conditions
-----------------
Abdominal Obesity

Intervention / Treatment
-----------------
* Other: Control
* Other: Resistance Exercise
* Other: Aerobic exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy overweight (BMI >-95th) youth between 12 and 18 years of age Waist circumference >-75th percentile Sedentary (no structured exercise >2 times/week for past 6 months) Non-smokers, non-diabetic, no medical conditions Weight stable for past 3 months Exclusion Criteria: Smokers, diabetic, psychiatric disorders, syndromatic obesity

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

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

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

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 |
| --- | --- |
| Other: Control<br>Standard care control | Other: Control<br>* Standard care control (no exercise)<br>|
| Active Comparator: Aerobic Exercise<br> | Other: Aerobic exercise<br>* Supervised aerobic exercise using treadmills, bikes, and ellipticals<br>|
| Active Comparator: Resistance Exercise<br> | Other: Resistance Exercise<br>* Supervised resistance exercise using stack weight equipments.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal obesity, visceral fat |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity and secretion, glucose tolerance |  | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Childhood obesity, Abdominal obesity, Visceral fat, Insulin resistance, Liver fat, Skeletal muscle lipid, Fitness
Robotic Versus Hybrid Assisted Ventral Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Laparoscopic ventral hernia repair (LVHR) may be associated with chronic pain, seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence and poor quality of life (QoL). Our study evaluates whether robotic-assisted ventral hernia repair (rVHR) diminish these complications compared to LVHR with primary closure of the defect (hybrid).

Detailed Description
-----------------
Thirty patients undergoing incisional ventral hernia operation with fascial defect size from 3 to 6 cm will be recruited. Fifteen patients undergo rVHR and fifteen undergo hybrid operation.The main outcome measure is postoperative pain, evaluated with visual analogue scale (VAS: 0-10) preoperatively, at 1-week, at 1-month and at 1-year. Hernia recurrence will be evaluated with ultrasound examination at 1-year and QoL using the generic SF-36 short form questionnaire preoperatively, at 1-month and at 1-year.

Official Title
-----------------
Robotic Assisted vs. Laparoscopic Hybrid IPOM Ventral Hernia Repair: a Prospective Randomized Study Comparing Postoperative Outcomes

Conditions
-----------------
Quality of Life, Pain, Recurrence

Intervention / Treatment
-----------------
* Device: robotic
* Device: hybrid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ventral hernia size 3-6 cm Exclusion Criteria: previous ventral hernia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: Robotic<br>Fifteen patients undergo rVHR operation. | Device: robotic<br>* fifteen patients undergo robotic operation<br>|
| Experimental: hybrid<br>Fifteen patients undergo hybrid operation. | Device: hybrid<br>* fifteen patients undergo hybrid operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Robotic-assisted ventral hernia repair vs hybrid. Change in pain | VAS scale from 0 to 10. Zero in VAS is no pain and number ten is the highest possible pain | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Robotic-assisted ventral hernia repair vs hybrid. Change in the social functioning status. | SF-36. Scale from 0 to 100. For all scales, higher scores (100) represent better function or outcome | 1-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventral hernia, Laparoscopy, Robot-assisted, pain
Brain Connectivity in Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
This study is to determine how cognitive deficits (e.g.,verbal fluency deficit) in patients with Age-Related Macular Degeneration (AMD) relate to specific aspects of brain and function. The study team will assess whether the brain signatures associated with specific cognitive deficits differ in older adults with and without AMD.

Official Title
-----------------
Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AMD - Vision loss attributable to AMD Controls Age match (± 5 yrs) Gender match Education match (± 4yrs) Normal macular exam Exclusion Criteria: AMD Other significant eye pathology Mod/severe dementia Communication barrier that precludes testing Controls Other significant eye pathology Mod/severe dementia Communication barrier that precludes testing MRI subset Devices or material incompatible with 3.0 Tesla MRI Conditions that may interfere with interpretation of fMRI (e.g. history of stroke, brain tumor or previous brain surgery; psychoactive medications; seizure disorder) Claustrophobia Left-handed Body weight > 300 lbs Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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 |
| --- | --- |
| AMD controls<br> | |
| AMD cases<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration | All Participants will receive neurocognitive testing, health and lifestyle surveys, audiometry and eye exams. Brain MRIs will be obtained on half the cohort, as this will provide sufficient power to accomplish the Aims that involve neuroimaging data. These MRIs will be obtained while participants are in the resting state meaning they are awake but not instructed to perform specific scanner. Two years after baseline exams, participants will return for repeat data collection. Participants who received an MRI at baseline will receive repeat resting-state, brain MRI at 2-year follow-up, unless they have developed contradictions to MRI scans in the interim. | Baseline, anticipated 2 years |
Diagnosing Pulmonary Aspergillosis in Patients With Hematological Malignancies: A Multicentre Prospective Evaluation of an Aspergillus PCR Assay and a Galactomannan ELISA in Bronchoalveolar Lavage Samples

Study Overview
=================
Brief Summary
-----------------
Diagnosing invasive pulmonary aspergillosis (IPA) remains a challenge in patients (pts) with hematological malignancies. The clinical significance of testing bronchoalveolar lavage (BAL) samples both with polymerase chain reaction (PCR) and Aspergillus galactomannan (GM) ELISA is unclear, and the BAL cutoff for GM has not been clearly defined yet. Using a validated nested PCR assay and a GM ELISA, we prospectively examine BAL samples from hematological patients at high risk of PA.

Official Title
-----------------
Diagnosing Pulmonary Aspergillosis in Patients With Hematological Malignancies: A Multicentre Prospective Evaluation of an Aspergillus PCR Assay and a Galactomannan ELISA in Bronchoalveolar Lavage Samples

Conditions
-----------------
Invasive Aspergillosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - hematological patients with lung infiltrates at high risk for invasive aspergillosis Exclusion Criteria: - patients without informed consent

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 80 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 |
| --- | --- |
| Hematological patients with proven or probable aspergillosis<br> | |
| Hematological patients with possible aspergillosis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis |  | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of diagnostic and therapeutic intervention concerning antifungal treatment with regard to outcome (overall survival, in months) of a fungal infection |  | up to 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pcr, aspergillosis, bronchoalveolar lavage, galactomannan, hematological patients
Study Evaluating IMA-638 in Healthy Japanese

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and drug levels for single, ascending doses of IMA-638 in healthy Japanese subjects.

Official Title
-----------------
An Ascending Single Dose Study of the Safety and Pharmacokinetics of IMA-638 Administered to Healthy Japanese Subjects

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

Intervention / Treatment
-----------------
* Drug: IMA-638


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First generation healthy Japanese men and women of non-childbearing potential.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: IMA-638|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be measured by evaluating physical examinations, vital signs, electrocardiograms (ECGs), and clinical laboratory test results. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug levels and associated biomarkers will be evaluated. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy subjects
Pazopanib (GW786034) In Subjects With Relapsed Or Refractory Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how effective and safe a new investigational drug is in treating patients with relapsed or refractory multiple myeloma. The treatment involves daily dosing. A patient may continue to receive the treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.

Official Title
-----------------
A Phase II, Open-Label Study of Pazopanib (GW786034) in Patients With Relapsed or Refractory Multiple Myeloma

Conditions
-----------------
Carcinoma, Renal Cell

Intervention / Treatment
-----------------
* Drug: GW786034


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Must have diagnosis of relapsed or refractory multiple. bone marrow function [ANC (absolute neutrophil count) greater than 1000/mm3]; platelet count greater than or equal to 75,000/mm3. renal function (calculated creatinine clearance >50 mL.min, albumin less than or equal to 500 mg). Exclusion criteria: Failed more than 3 prior lines of therapy including stem cell transplant. Females who are pregnant or nursing. Unstable blood pressure. Significant heart conditions or history of thrombosis. Any unstable, pre-existing major medical condition or history of other cancers. Have received an investigational drug, chemotherapy, radiation treatment or surgery within 28 days prior to entering the study.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: GW786034|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and tolerability of GW786034 in patients with relapsed or refractory multiple myeloma (MM). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate time-to-tumor progression (TTP), time to response, and duration of response. Characterize the pharmacokinetics of GW786034 in patients with MM. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pazopanib(GW786034), Solid Tumors, Myeloma
Nivolumab in the Real World: Analysis of the Expanded Use in Spanish Patient

Study Overview
=================
Brief Summary
-----------------
The investigators will be retrospectively review the case note of patients registered in the EAP of Nivolumab. A standard anonymous data collection form will be used to collect data and to analyze it. Patients with advanced Non-Small Cell Lung Cancer previously treated and included in the SPANISH expanded access programme of nivolumab.

Detailed Description
-----------------
This study will help to understand the efficacy of Nivolumab in the real world setting within the SPANISH expanded access programme. The main objective of this study is to evaluate nivolumab efficacy in terms of Overall Survival (OS), Progression Free Survival (PFS), Overall Response Rate (ORR) and safety in the clinical practice. The efficacy variables will be assessed for patients (squamous vs non-squamous) who received second line therapies or third lines and subsequent lines and also, long responders will be evaluated.

Official Title
-----------------
A Retrospective, Multicenter and Observational Study of Nivolumab Monotherapy Treatment in Subjects With Advanced or Metastatic Squamous (Sq) or Non-Squamous (Non-Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimens for the Treatment of Stage IIIb/IV NSCLC Within the Expanded Access Program (EAP) in SPAIN

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Nivolumab 10 MG/ML


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Squamous or Non-Squamous, non small cell lung cancer (NSCLC), Stage IIIb/IV (histologically or cytologically confirmed), relapsed after 1 prior platinum-based systemic treatment and who received treatment within the SPANISH expanded access programme of nivolumab (EAP) Alive patients must have signed and dated an IRB/IEC-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care Exclusion Criteria: Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form Patients who were accepted in the EAP but do not receive treatment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nivolumab 10 MG/ML|nivolumab 3 mg/kg as an intravenous infusion every 2 weeks until progression|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free survival | time from inclusion to progression | At 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response rate | Percentage of patient reaching a complete, partial or stable disease | At 12 months |
Comparison of Uterine Exteriorization Versus in Situ Repair at Cesarean Section: a Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
There is no difference between extra-abdominal or in situ suture of the uterus in cesarean section.

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Procedure: suture techniques


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication of cesarean section gestational age > 24 weeks Exclusion Criteria: two or more cesarean sections chorioamnionitis hemorrhagic complications unable to consent previous abdominal surgery

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 44 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: suture techniques|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometritis |  | within the first 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nausea and vomiting during surgery, mean operative time, estimated intraoperative blood loss, number of surgical sutures for uterine repair, pain postoperative, number of postoperative analgesic doses, surgical site infection |  | from surgery to 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uterus, abdominal delivery, suture techniques