linjc16/ctgov huggingface dataset:
STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea

Study Overview
=================
Brief Summary
-----------------
Currently there is an ongoing clinical trial for patients with chemotherapy induced diarrhea. This trial is being conducted to evaluate the efficacy of two dose levels (30 mg and 40 mg) of an investigational drug in reducing the occurrence of severe (Grade 3 or 4) diarrhea during chemotherapy. Eligible patients must either have experienced NCI Common Toxicity Grade 1 - 4 chemotherapy-induced diarrhea during previous chemotherapy treatment or be experiencing Grade 1-4 chemotherapy-induced diarrhea currently. In order to participate in this clinical trial, patients must be male or female 18 years of age or older. Inclusion into this investigational drug trial is based on the protocol entry criteria and a detailed evaluation from a participating trial investigator

Conditions
-----------------
Neoplasms, Diarrhea

Intervention / Treatment
-----------------
* Drug: Sandostatin LAR Depot


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion criteria: male or female patients of 18 years of age or older, scheduled or expected to receive at least two cycles of chemotherapy over at least a two- month period as primary or adjuvant therapy for any malignancy, have experienced NCI Common Toxicity Grade 1 - 4 diarrhea during previous chemotherapy treatment or are currently experiencing Grade 1-4 diarrhea due to chemotherapy treatment Key Exclusion criteria: females who are pregnant or lactating, current use of anticoagulants, except for those who are receiving 1 mg/per day of Coumadin for port maintenance, known hypersensitivity to Sandostatin, Sandostatin LAR ® Depot or other related drug or compound, history or presence of Crohn™s disease, ulcerative colitis, sprue, or known C. difficile infection, or any other diarrheal syndrome, WBC < 3000 /L, Platelets < 75,000 /L, serum creatinine >2.0 mg/dL

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

| Intervention/Treatment |
| --- |
|Drug: Sandostatin LAR Depot|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chemotherapy induced diarrhea, diarrhea, CTID, colorectal cancer, Sandostatin LAR Depot, Sandostatin, adverse events, side effects
Application of Miglustat in Patients With Niemann-Pick Type C

Study Overview
=================
Brief Summary
-----------------
To evaluate the changes in cognitive function after miglustat treatment in Niemann-Pick type C patients.

Detailed Description
-----------------
Patients with Niemann-Pick C disease will be treated with Miglutat 200mg tid. Neurologic evaluation and safety will be monitored periodically.

Official Title
-----------------
Application of Miglustat in Patients With Niemann-Pick Type C

Conditions
-----------------
Niemann-Pick Disease Type C

Intervention / Treatment
-----------------
* Drug: Miglustat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirm diagnosis of Niemann-Pick C disease Symptomatic including motor or mental symptoms Exclusion Criteria: Unknown severe diarrhea for more than 7 day Allergy to miglustat
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: Miglustat<br>miglustat 200mg tid | Drug: Miglustat<br>* miglustat 200mg tid for adult. For children surface area correction will be made. A lower dose may be used initially to decrease side effect.<br>* Other names: Zavesca;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swallowing | videofluoroscopic swallowing study (VFSS), or NP-C functional disability rating scale if VFSS can not be performed due to safety issue | 12th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental | IQ test or Mini-Mental Status Examination if a full IQ test can not be performed | 12th month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Niemann-Pick disease type C, miglustat
Stress During Elective or Emergency Cesarean Operations

Study Overview
=================
Brief Summary
-----------------
We investigated a correlation between maternal anxiety and age, body mass index (BMI), parity-gravidity, patient satisfaction, antenatal care, postoperative pain according to emergent or elective C/S under general anesthesia.

Official Title
-----------------
The Evaluation of the Effects of Stress During Elective or Emergency Cesarean Operations; Prospective, Randomized Clinical Trial

Conditions
-----------------
Anxiety

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women aged ≥18 years (gestational age: 37-40 weeks) underwent emergent or elective C/S. Exclusion Criteria: patients with cardiopulmonary, renal, hepatic or psychiatric disease, obstetric-fetal anomaly and weighing ≥ 100 kg were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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 |
| --- | --- | --- |
| correlation between maternal anxiety and age according to emergent or elective C/S under general anesthesia. |  | during operation | 
| correlation between maternal anxiety and body mass index according to emergent or elective C/S under general anesthesia. |  | during operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between maternal anxiety and parity-gravidity according to emergent or elective C/S under general anesthesia. |  | during the operation | 
| correlation between maternal anxiety and patient satisfaction according to emergent or elective C/S under general anesthesia. |  | during the operation | 
| correlation between maternal anxiety and postoperative pain according to emergent or elective C/S under general anesthesia. |  | during the operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cesarean operation, Spielberger State Trait Anxiety Inventory, pain
Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS

Study Overview
=================
Brief Summary
-----------------
This study was designed to assess the effectiveness of dutasteride in the actual clinical practice of prostate assessment clinics in the UK in accordance with best practice over a 12-month period.

Official Title
-----------------
Observational Sutdy to Assess the Effectiveness of Avodart in Subjects With Benign Prostatic Hyperplasia in Day to Day Clinical Practice

Conditions
-----------------
Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Procedure: IPSS Questionnaire
* Procedure: EQ-5D Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who not have received any pharmacological treatment or surgical interventions for BPH (Benign Prostatic Hyperplasia). Patients should be prescribed dutasteride in compliance with the UK SmPC and BAUS guidelines on the treatment of BPH. Patients must only enter the study after the decision to prescribe dutasteride has been undertaken. Exclusion criteria: None specified
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: IPSS Questionnaire|nan|
|Procedure: EQ-5D Questionnaire|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
-----------------
BPH, Avodart, IPSS, dutasteride, EQ-5D, Observational
Relaxation Music to Lower Heart Rate Prior to Cardiac CT

Study Overview
=================
Brief Summary
-----------------
To acquire low radiation dose and good quality cardiac CT images requires scanning at low heart rates which is usually done with beta-blockers. However, in some patients beta-blockers have little effect. This is thought to be due to a different mechanism of action which continues to maintain the heart rate despite administration of beta-blockers. This study aims to look at the effect of music or relaxation tracks to reduce patient heart rate as anxiety is thought to play a role in maintaining high heart rates. This study will randomise patients into a normal standard of care group compared to a normal standard of care group with music/ relaxation track and compare heart rate, radiation dose, image quality, amount of beta-blocker used and patient experience via a State-Trait Anxiety Inventory (STAI) questionnaire.

Official Title
-----------------
Relaxation Music to Lower Heart Rate Prior to Cardiac CT

Conditions
-----------------
Coronary Artery Disease and Cardiac Anatomy, Patients Undergoing Coronary CT Angiogram, Patients Undergoing CT Pulmonary Vein Angiogram, Patients Undergoing CT Calcium Score

Intervention / Treatment
-----------------
* Other: Relaxation Music


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18 years and above All patients coming in for non-contrast enhanced calcium score CT, pulmonary vein angiogram, or coronary CT Angiogram Exclusion Criteria: Deaf CT for Transcatheter aortic valve implantation (TAVI) or congenital heart disease patients Poor english literacy Pacemaker Post CABG Post heart transplant

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Group plus normal standard of care<br>Patients will listen to music prior and during the scan | Other: Relaxation Music<br> <br> |
| No Intervention: Control Group - Normal standard of care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Heart Rate | Unit of measure - beats per minute | Same day as CT scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation Dose | Unit of measure - millisieverts | Same day as CT scan | 
| Image Quality | Measurement tool - Likert Scale. Review of images by two highly experienced cardiac radiologists | Same day as CT scan | 
| IV metoprolol dose | Unit of measurement - milligrams | Same day as CT scan | 
| Patient Satisfaction | Measurement tool - Modified state-trait anxiety inventory (STAI) questionnaire | Same day as CT scan |
Tobacco Smoking Among Crosslinked-keratoconus Patients

Study Overview
=================
Brief Summary
-----------------
Certain studies reported that cigarette by-products may make the cornea more rigid, suggesting that it could lead to natural CXL of collagen fibers, hence a protective effect for KC. Others have reported that cigarette smoking causes no significant changes in the corneal biomechanics. The aim of this study was to assess a possible link between keratoconus (KC) occurrence and patients' smoking habits.

Detailed Description
-----------------
a telephone Survey was performed among 80 KC patients who were treated from March 2014 until September 2017 by accelerated crosslinking (A-CXL) within the ophthalmology department. From the 80 people we phoned, 62 answered. Our questions were regarding family history, allergic history, and smoking habits. Family history was considered positive if a first-degree or second-degree relative had been diagnosed with KC. Allergies toward any kind of external factors were marked as positive. Patients' smoking habits were recorded and classified into regular, occasional, ex-smoker and non-smoker. The results were confronted to those of the general population by indirect standardization over age and sex according to the Baromètre Santé 2010 INPES survey (French Nation Institute for Prevention and Health Education).

Official Title
-----------------
Tobacco Smoking Among Crosslinked-keratoconus Patients

Conditions
-----------------
Keratoconus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients suffering from Keratoconus and needing Cross-linking therapy Exclusion Criteria: none
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 |
| --- | --- | --- |
| Percentage of smokers | Percentage of smokers among Cross-linked Keratoconus patients | After 2 years |
Continuing Care and Treatment for Patients With Cancer/AIDS/Skin Disease

Study Overview
=================
Brief Summary
-----------------
This protocol is to provide continuing medical/surgical/radio-therapeutic care, treatment and follow-up for NCI patients not currently entered on an active research protocol. No investigational treatments will be administered on this protocol.

Detailed Description
-----------------
Background: It may be in the interest of the CCR to continue to follow and treat certain subjects after they have completed their treatment and participation on a research protocol. Objective: To provide continuing treatment and medical follow-up for CCR subjects who have completed their treatment and participation on a research protocol and who are not currently entered on or eligible for another active research protocol. Eligibility: Subjects who have been previously enrolled on and received treatment according to an approved CCR research protocol. (clinical trial) It is in the best interest of the subject and the CCR for the subject to continue to receive standard care and follow-up at the NIH. Design: Medical/surgical/radiotherapeutic care, treatment and follow-up is provided for CCR subjects who have completed their treatment and participation on a research protocol and who are not currently entered on an active research protocol. No investigational treatments will be administered. This protocol is not be used as a platform to perform pilot studies of off-label uses for standard agents.

Official Title
-----------------
Continuing Treatment for Children and Adults in the Center for Cancer Research

Conditions
-----------------
HIV, Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Subjects of any age who have been previously enrolled and treated on an approved CCR research treatment protocol. It is in the best interests of the subject and the CCR for the subject to continue to receive treatment and follow-up at the NIH. The subject or guardian signs the informed consent and agrees to the proposed treatment regimen. EXCLUSION CRITERIA: Subjects who have not been previously treated on a CCR research treatment protocol. Subjects who are receiving an investigational therapy.

Ages Eligible for Study
-----------------
Maximum Age: 99 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 |
| --- | --- | --- |
| To provide continuing treatment and medical follow-up for CCR subjects who have completed their treatment and participation on a research protocol and who are not currently entered on or eligible for an active research protocol. |  | Open-ended | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Follow-Up, Treatment
Results of Opening-wedge High Tibial Osteotomy Using Iliac Crest Allograft Compared to Iliac Crest Autograft

Study Overview
=================
Brief Summary
-----------------
The purpose of this RCT is to determine the results of opening-wedge high tibial osteotomy in patients with genovarum deformity using iliac crest allograft compared to the results when using iliac crest autograft.

Conditions
-----------------
Genovarum

Intervention / Treatment
-----------------
* Procedure: Iliac crest allograft
* Procedure: Iliac crest autograft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Varus malalignment of knee with of without osteoarthritis: the angle between the articular surface and anatomical axis of tibia< 82 degrees at least 7.5 mm opening wedge is needed in medial proximal tibia to correct the deformity assessed during pre-op planning Exclusion Criteria: symptomatic lateral compartment osteoarthritis of knee rheumatoid arthritis or other inflammatory joint diseases less than 100 degrees of knee range of motion grade III laxity in knee collateral ligaments history of surgery or fracture in the limb >15 degrees flexion contracture age <16 or >60 years >20 degrees varus deformity failure to attend follow-up visits sever bone loss in medial tibial plateau or medial femoral condyle >1cm joint subluxation presence of lateral trust during walking presence of patella baja skin derangements on medial proximal tibia any form of nicotine addiction

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Using Iliac crest allograft in high tibial osteotomy | Procedure: Iliac crest allograft<br>* Opening wedge osteotomy of proximal tibia with allograft from iliac crest<br>|
| Active Comparator: B<br>Using iliac crest autograft in high tibial osteotomy | Procedure: Iliac crest autograft<br>* open wedge osteotomy of proximal tibia using autogenous iliac bone graft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion of the knee |  | before op and at follow ups | 
| knee score (womac) |  | before op and at final follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genovarum, Medial opening-wedge high tibial osteotomy, allograft
Gas Exchange and CT Effects of PEEP in ARDS

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the association between effects of PEEP on gas exchange model parameters and CT scan results

Detailed Description
-----------------
In ARDS patients on mechanical ventilation, we will compare model-based estimation of gas exchange parameters (shunt, ventilation/perfusion mismatch) with CT-based estimation of effects of low and high PEEP

Official Title
-----------------
Does a Bedside Method for Describing Functional Gas Exchange Compare Well With Anatomical Description Via CT Scans, and Could it Predict the Effects of Recruitment and Ventilation/Perfusion Mismatch Improvement

Conditions
-----------------
ARDS

Intervention / Treatment
-----------------
* Diagnostic Test: ALPE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - ARDS patients requiring mechanical ventilation Exclusion Criteria: <18 years old Requirement of extracorporal life support Hemodynamic instability Barotrauma

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALPE-TAC<br>ARDS patients on mechanical ventilation. Measurement of CT scan at PEEP of 5, 20 and 45 cm H2O to evaluate potential for recruitment and measurement of gas exchange by model-based method and FiO2 titration at PEEP of 5 and 20 cm H2O | Diagnostic Test: ALPE<br>* Measurement of CT scan at PEEP of 5, 20 and 45 cm H2O Measurement of gas exchange by model-based method and FiO2 titration at PEEP of 5 and 20 cm H2O<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gas Exchange and lung recruitability at diferent PEEP levels | Gas exchange (At PEEP 5 and 20 cm H2O), CT scan (At PEEP 5, 20 and 45 cm H2O) | Approximately two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiologic Parameter 1 | Hemodynamic assessment at different PEEP levels | Approximately two hours | 
| Physiologic Parameter 2 | Respiratory mechanics at different PEEP levels | Approximately two hours |