linjc16/ctgov huggingface dataset:
AcrySof IQ Toric A-Code Post-Market Clinical Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population.

Detailed Description
-----------------
Patients will be examined pre-operatively to up to 3 years post-operatively. One eligible eye will be selected as a target eye for efficacy analysis. If both eyes are eligible, the eye in which the IOL is implanted first will be selected as the target eye.

Official Title
-----------------
AcrySof IQ Toric A-Code Post-Market Clinical Study

Conditions
-----------------
Astigmatism, Cataract

Intervention / Treatment
-----------------
* Device: AcrySof IQ Toric A-code IOL
* Procedure: Cataract surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cataracts with planned cataract removal by phacoemulsification Calculated lens power within the available range Able to sign informed consent and complete all study visits Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Eye conditions as specified in the protocol Uncontrolled glaucoma Pregnancy, current or planned Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Experimental: Acrysof IQ Toric A-code IOL<br>IOL implanted during cataract surgery | Device: AcrySof IQ Toric A-code IOL<br>* Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient<br>* Other names: Models SN6AT3, SN6AT4, SN6AT5;Procedure: Cataract surgery<br>* Removal of cataractous lens and implantation of IOL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4) | IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. No confirmatory hypothesis testing was conducted. | Visit 00 (Day 0 operative), Visit 4 (Day 120-180 postoperative) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phacoemulsification, toric, intraocular lens, vision
Neurofibromatosis Type 1 Patient Registry

Study Overview
=================
Brief Summary
-----------------
The Neurofibromatosis Type 1 (NF1) Patient Registry Initiative (NPRI) is a web-based registry that asks participants to fill out a 30-minute online questionnaire to collect information about the spectrum of medical and social problems experienced by children and adults with NF1. The information gained from your participation may one day help doctors develop personalized treatments for individuals living with NF1. We are currently enrolling individuals with NF1 who either (1) HAVE previously been diagnosed with a brain tumor younger than 18 years or (2) HAVE NEVER had a brain tumor. Please note: there is no therapy associated with this study. Individuals may participate in the registry by going to https://nf1registry.wustl.edu/

Official Title
-----------------
Neurofibromatosis Type 1 Patient Registry

Conditions
-----------------
Neurofibromatosis Type 1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals diagnosed by a healthcare provider with Neurofibromatosis Type 1 Exclusion Criteria: Individuals without a healthcare provider diagnosis of Neurofibromatosis Type 1
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 |
| --- | --- | --- |
| Neurofibromatosis Type 1 |  | ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NF1, neurofibromatosis, NF
A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare skin reactions with or without the use of warm compress prior to performing a Copaxone® injection.

Official Title
-----------------
An Open-Label, Randomized, Single Cross-over Study of Warm Compress Versus Usual Injection Site Preparation on Local Injection Site Reactions Among Persons With MS Who Perform Daily Injections of Copaxone®.

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: glatiramer acetate
* Procedure: Warm compress prior to injection of glatiramer acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female, 18 years or older, with a diagnosis of RRMS Willing and able to complete all procedures and evaluations related to the study. Willing to provide Informed Consent Exclusion Criteria: Taking any other immunomodulatory therapy in conjunction with Copaxone®. Has a significant medical illness other than MS which may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study. Any situation which the investigator or nurse feels may interfere with participation in the study. Pregnant, or trying to become pregnant, or breast feeding during the study. Previously participated in this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>skin reactions with the use of warm compress prior to performing a Copaxone® injection | Drug: glatiramer acetate<br> <br> * Other names: Copaxone;|
| Experimental: 2<br>skin reactions without the use of warm compress prior to performing a Copaxone® injection | Procedure: Warm compress prior to injection of glatiramer acetate<br> <br> * Other names: Copaxone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of local injection site reactions (LISRs) noted at 5-minutes post-injection |  | 2-week diaries kept by the patients for Period 1 and for Period 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total and partial number of LISRs noted at 2-minutes post-injection The total and partial number of LISRs noted immediately after injection |  | 2-week diaries kept by the patients for Period 1 and for Period 2 |
Efficacy of COMB (Comprehensive Behavioral) Model of Treatment of Trichotillomania

Study Overview
=================
Brief Summary
-----------------
This pilot study is being conducted in order to help make the case for later, more systematic research on the effectiveness of the Comprehensive Behavioral (COMB) model of treating trichotillomania (compulsive hair pulling). The goals are to standardize COMB treatment techniques in the form of a clear written manual for therapists; determine whether therapists can use these guidelines in a consistent manner in making treatment decisions; develop and test the reliability of measures of how well therapists are conducting the treatment; and collect preliminary data on the acceptability of the treatment to patients.

Official Title
-----------------
Treatment Development Study of the COMB Model of Trichotillomania

Conditions
-----------------
Trichotillomania, Hair-Pulling Disorder

Intervention / Treatment
-----------------
* Behavioral: COMB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Primary Diagnostic and Statistical Manual, Fifth Edition (DSM-5) diagnosis of Trichotillomania (TTM) Exclusion Criteria: Current suicidality or severe depression Current psychosis Current alcohol or substance abuse Concurrent psychotherapy for TTM Psychotropic meds (for any disorder) that have not been stable for >4 weeks

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 |
| --- | --- |
| Experimental: COMB<br> | Behavioral: COMB<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Massachusetts General Hospital Hairpulling Scale (MGH-HS) | Improvement in hair pulling symptoms | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trichotillomania, Hair pulling, Behavior therapy
Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Peripheral Neuropathy Receiving Paclitaxel for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This research trial studies whole exome sequencing in finding causative variants in germline deoxyribonucleic acid (DNA) samples from patients with peripheral neuropathy receiving chemotherapy for breast cancer. Studying samples of germline DNA in the laboratory from patients with peripheral neuropathy receiving paclitaxel for breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to peripheral neuropathy.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To identify, using next generation sequencing, rare variants of large effect size that impact the risk of peripheral neuropathy in patients of African and European descent in the clinical trial ECOG-5103 (E5103). OUTLINE: Previously collected germline DNA samples are analyzed via whole exome sequencing.

Official Title
-----------------
Exploratory Next Generation Sequencing to Identify Causative Variants for Taxane-Induced Peripheral Neuropathy From Breast Cancer Study E5103 Germline DNA Samples

Conditions
-----------------
Breast Carcinoma, Neuropathy

Intervention / Treatment
-----------------
* Other: Laboratory Biomarker Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: European American patients with DNA available and designated case or control African American patients with DNA available and designated case or control status Patients who developed grade 2-4 for African American (AA) and grade 3-4 for European American (EA) peripheral neuropathy during their treatment with paclitaxel and who did not develop peripheral neuropathy following a full course of treatment with paclitaxel
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-Correlative (whole exome sequencing)<br>Previously collected germline DNA samples are analyzed via whole exome sequencing. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of rare coding variants of large effect that predict the risk of peripheral neuropathy | Assess by Burden analysis. | Baseline |
Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the effect of Sunitinib on tumor vascularization and necrosis in patients with metastatic renal cell cancer.

Detailed Description
-----------------
Sutent is an angiogenesis inhibitor used in the treatment of renal cell cancer. Very often tumor necrosis is seen after the start of the treatment. It is unknown after how many days this effect starts. In patients with renal cell cancer with metastases, who will be treated with Sutent, 3 MRIs will be made. Kep, R2*, b-coefficient (perfusion, hypoxia, blood volume and necrosis) will be measured.

Official Title
-----------------
Pilot Study on the Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma

Conditions
-----------------
Renal Cell Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with metastatic renal cell cancer for whom treatment with Sunitinib is planned histologically verified stage IV renal cell carcinoma of clear cell type measurable primary tumor or metastases (minimal diameter 2 cm) at other sites than the lungs Karnofsky score > 70% age > 18 year. written informed consent Exclusion Criteria: contra-indications for MRI contra-indications for treatment with Sunitinib previous systemic treatment within the last 30 days

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sutent, tumor necrosis, DCE-MRI (Dynamic enhanced magnetic resonance imaging)
Inflammatory Genetic Polymorphism and Acute Lung Injury After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Acute lung injury is a common complication of cardiac surgery with cardiopulmonary bypass, and it is significantly related to prolonged postoperative recovery, hospital stays and medical cost. Currently available predictors of acute lung injury after cardiac surgery are still limited within clinical data. Several genetic polymorphism of inflammatory mediators have been reported to be associated with severity of sepsis and ARDS, but the association of these inflammatory polymorphism and acute lung injury after cardiac surgery has never been reported. This study is performed to investigate the association of genetic polymorphisms including TNF -308A/G, IL-10 -1082A/G and IL-6 -572C/G and postoperative lung injury.

Official Title
-----------------
Association Study of Inflammatory Genetic Polymorphism and Acute Lung Injury After Cardiac Surgery With Cardiopulmonary Bypass

Conditions
-----------------
Acute Lung Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese Han unrelated population adult patients undergoing elective cardiac surgery with CPB Exclusion Criteria: malignant tumor autoimmune disease, immunodeficiency or immunosuppressive therapy chronic renal disease (glomerular filtration rate < 60ml/(min•1.73m2)) or liver dysfunction (Child Pugh classification>A) COPD, tuberculosis or other chronic pulmonary diseases anemia with hemoglobin lower than 90mmHg bleeding disorders postoperative pericardial tamponade requiring re-operation postoperative low cardiac output syndrome or acute pulmonary edema after left cardiac failure.

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 |
| --- | --- |
| ALI<br>patients with acute lung injury at 24h after cardiac surgery | |
| Control<br>patients without acute lung injury 24h after cardiac surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute lung injury after cardiac surgery with cardiopulmonary bypass |  | 24h after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| circulating level of CRP, TNF-alpha, IL-10, IL-6; APACHE Ⅱ score; postoperative kidney injury, duration of ventilation, ICU stay and hospitalization; death in 28 days |  | 24h and 1 month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Single Nucleotide Polymorphism, cardiopulmonary bypass, cardiac surgery
Effect of Solar Salt Diet in Elderly Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
High sodium intake causes hypertension. Various efforts for reducing salt consumption are proceeding all over the world. Solar salt contains reduced sodium and abundant mineral, such as calcium, potassium, and magnesium, comparing to ordinary salt. Use of solar salt, instead of ordinary salt, may have beneficial effects to blood pressure. The investigators are going to conduct a preliminary study that can support antihypertensive effect of solar salt intake.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Other: ordinary salt based- diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above 50 years elderly hypertensive patients possible oral intake Exclusion Criteria: dementia, GDS>6 terminal cancer patient

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: solar salt based-diet<br> | Other: ordinary salt based- diet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  |  |
Icotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in non-small cell lung cancer patients harboring uncommon EGFR mutation

Official Title
-----------------
Clinical Activity of Icotinib in Patients With Advanced Non-small-cell Lung Cancer Harbouring Uncommon EGFR Mutations: a Single-arm, Prospective, Phase 2 Study

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Icotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stage IIIB/IV non-small cell lung cancer Patients with uncommon epidermal growth factor receptor (EGFR) mutation Targeted-therapy-naive patients Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 Evaluable target lesions according to RECIST 1.1 for tumour response assessment Exclusion Criteria: Wild-type EGFR Positive 19 del and/or 21 L858R mutation Previous treatment with EGFR TKIs such as gefitinib, erlotinib, and afatinib Patients who have documented history of interstitial lung disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: icotinib<br>patients will be administered study drug (icotinib) until disease progression or unacceptable toxicity | Drug: Icotinib<br>* Icotinib will be given orally 250 mg thrice per day until disease progression, or untolerated toxicity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor response rate |  | 2 months | 
| overall survival |  | 24 months |