linjc16/ctgov huggingface dataset:
International Registry of Patients With Alpha Thalassemia

Study Overview
=================
Brief Summary
-----------------
This is an international prospective registry of patients with Alpha thalassemia to understand the natural history of the disease and the outcomes of fetal therapies, with the overall goal of improving the prenatal management of patients with Alpha thalassemia.

Detailed Description
-----------------
The aim of this registry is to prospectively and retrospectively collect data on patients who are diagnosed with alpha thalassemia major and other alpha thalassemia mutations. Data collected will be used to: Identify patient outcomes of therapies. Improve clinical management of patients with ATM. Improve medical decision making. Improve quality of care.

Official Title
-----------------
International Prospective Registry of Patients With Alpha Thalassemia

Conditions
-----------------
Alpha Thalassemia Minor, Alpha-Thalassemia, Alpha Thalassemia Major

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of alpha thalassemia (prenatal or postnatal) with genotype consistent with ATM or BHFS phenotype referred to the University of California, San Francisco Fetal Treatment Center for fetal diagnosis, management and/or evaluation for the ongoing in utero stem cell transplantation clinical trial 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 |
| --- | --- | --- |
| Survival to birth | Number of fetuses diagnosed with alpha thalassemia who survive to birth, compared to number of fetuses diagnosed with alpha thalassemia who have fetal demise or are terminated in utero. This is measured in number of fetuses alive at birth divided by number of all fetuses. | 6 months | 
| Vineland-3 Adaptive Behavior Scale | Results of neurodevelopmental testing using the Vineland Adaptive Behavior Scale version 3. The Vineland-3 scoring system is based on scores for three specific adaptive behavior domains: Communication, Daily Living Skills, and Socialization. The domain scores are expressed as standard scores with a mean of 100 and standard deviation of 15. | 10-15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at birth | Gestational age of the child at birth. This is measured in weeks. | 6 months | 
| Mechanical ventilation | Duration (if any) of requiring mechanical ventilation after birth. This is measured in days. | 1 year | 
| Length of hospitalization | Duration of the child's hospitalization after birth. This is measured in days. | 6 months-1 year | 
| Resolution of hydrops | Evaluate whether receiving fetal therapy leads hydrops fetalis to resolve. This is measured by ultrasound findings. | 6 months |
Study Evaluating the Efficacy of DVS-233 in Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if DVS-233 is safe and effective in the treatment of pain and other symptoms of fibromyalgia syndrome.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adaptive Design, Efficacy and Tolerability Study of 4 Fixed Doses of DVS-233 in Adult Outpatients With Fibromyalgia Syndrome

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Drug: DVS-233


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fibromyalgia according to 1990 American College of Rheumatology (ACR) criteria Exclusion Criteria: Other painful conditions that may make results difficult to interpret. Treatment with other drugs for fibromyalgia with 14 days of study start or during the study.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DVS-233|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be the change in the daily pain score from baseline to study day 105 of therapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Impact Questionnaire and the Patient Global Impression of Change |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibromyalgia, Adults, Outpatients, Adult, Double-Blind Method
Multicentric Registry for the Detection of C5 Palsy After Anterior Cervical Discectomy and Fusion

Study Overview
=================
Brief Summary
-----------------
Detect the reason for the frequently occurring C5 palsy after anterior cervical discectomy and fusion

Detailed Description
-----------------
A registry which includes all known and individually analyzed but even new factors are evaluated in order to perform a multivariate analysis for the detection of risk factors of C5 palsy after anterior cervical discectomy and fusion which is a very disabling and still cryptic complication.

Official Title
-----------------
Registry for the Detection of C5 Palsy After ACDF

Conditions
-----------------
Degenerative Cervical Spinal Stenosis, Cervical Disc Herniation, Suspected Cervical Spine Instability

Intervention / Treatment
-----------------
* Procedure: Patients undergo ACDF or cervical vertebral body replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ACDF or cervical vertebral body replacement due to herniated disc, spinal stenosis or trauma Exclusion Criteria: infectious disease or neurodegenerative disease
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ACDF or cervical vertebral body replacement<br> | Procedure: Patients undergo ACDF or cervical vertebral body replacement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C5 palsy | defined as deterioration on BMRC scale of C5 innervated muscles | 3 months |
Cycloplegic Delivery Investigation

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to compare the effectiveness of the administration of sequential drops, a combination drop and a combination spray for producing mydriasis and cycloplegia.

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

Intervention / Treatment
-----------------
* Procedure: Mydriasis/cycloplegia via different modes of administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients ages 8 to 30 with best corrected acuity of 20/30 or better in both eyes at distance and near will be recruited. Exclusion Criteria: vision not correctable to 20/30 or better

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 30 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Mydriasis/cycloplegia via different modes of administration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Registry on Hypomethylating Agents in Myeloid Neoplasms

Study Overview
=================
Brief Summary
-----------------
This registry is set up to collect real-world experience in the management of patients with myeloid neoplasms, in particularly in patients with MDS, CMML or AML, treated with hypomethylating agents in Austria and potentially other participating countries. This registry will collect data in a retrospective as well as in a prospective manner at various sites. The aim is to gain valuable insights on both efficacy and toxicity of these drugs in a routine clinical setting in patients with various comorbidities.

Official Title
-----------------
Registry on Hypomethylating Agents in Myeloid Neoplasms, Including Myelodysplastic Syndromes (MDS), Chronic Myelominocytic Leukemia (CMML) and Acute Myeloid Leukemia (AML)

Conditions
-----------------
Chronic Myelomonocytic Leukemia, Myelodysplastic Syndromes, Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Other: non interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with MDS, CMML, and AML who begin with or already have received treatment with with a hypomethylating agent who are willing to provide informed consent Exclusion Criteria: Due to the non-interventional design of this program there are no specific exclusion criteria.

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 |
| --- | --- |
| Hypomethylating Agents<br>Patients treated with hypomethylating agents | Other: non interventional<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response evaluation | hematological response, marrow response, cytogenetic response (if data is available), quantification of reduced need for transfusions, median response duration | up to 10 years | 
| Overall survival |  | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of adverse events and toxicities |  | up to 10 years | 
| Number of treatment cycles |  | up to 10 years | 
| Number and reasons of dose reductions |  | up to 10 years | 
| Uni/multivariate analysis of various factors known or thought to influence overall survival in order to establish prognostic markers |  | up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CMML, MDS, AML, registry, Vidaza
Evaluation and Management of Parturients' Pain Intensity

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to examine the effects of Attentional Bias Modification (ABM) on the labor pain in parturients. One-third of the participants will undergo ABM training away from affective pain stimuli. One-third of the participants will undergo ABM training away from sensory pain stimuli. The rest of participants will be the control group.

Detailed Description
-----------------
In recent years, significant attention has been paid to the attentional bias in patients with chronic pain. Studies found that Attentional Bias Modification (ABM) could reduce the pain intensity in participants with chronic pain. The investigator's goal is to evaluate the effects of ABM on labor pain and patient satisfaction with the labor and delivery experience.

Official Title
-----------------
Evaluation and Management of Parturients' Pain Intensity

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Behavioral: ABM affective pain stimuli
* Behavioral: ABM sensory pain stimuli
* Behavioral: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parturients who are at 36 weeks gestation (at time of starting the study) Exclusion Criteria: Any patient who refuses Patients with impaired decision-making capacity Patients who are blind or extremely visually impaired Patients who cannot understand or read English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Affective pain stimuli group<br>affective/neutral word pairs | Behavioral: ABM affective pain stimuli<br>* Patients undergo ABM training to shift attention away from affective pain stimuli<br>|
| Experimental: Sensory pain stimuli group<br>sensory/neutral word pairs | Behavioral: ABM sensory pain stimuli<br>* Patients undergo ABM training to shift attention away from sensory pain stimuli<br>|
| Placebo Comparator: Control group<br>affective/neutral and sensory/neutral word pairs | Behavioral: Placebo<br>* Patients undergo ABM training to receive affective/neutral and sensory/neutral word pairs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of Attentional Bias Modification (ABM) on labor pain | Change in pain threshold and labor pain as measured by Fear of Pain Questionnaire (FPQ), Brief Pain Inventory (BPI) and McGill Pain Questionnaire (MPQ) before and after the ABM training. | 4 weeks (starting from 36-week gestation) |
Monopolar Scissors vs Bipolar Vessel Sealer vs Ultrasonic Shears: A Prospective Randomized Study in Laparoscopic Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
Monopolar electro surgery scissors (MES), electro thermal bipolar vessel sealer (BVS) and ultrasonically coagulating shears (UCS) are all applied in laparoscopic colorectal surgery. We aimed to compare the different devices with regard to dissection time, blood loss, technical aspects and costs. Trial with surgical intervention

Conditions
-----------------
Colorectal Disease

Intervention / Treatment
-----------------
* Device: Laparoscopic colectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: All patients undergoing laparoscopic left-sided colorectal resection. Exclusion criteria: < 18 years no informed consent restricted communication abilities (language, mental illness)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- |
|Device: Laparoscopic colectomy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dissection time |  |  |
Glycemia in Diabetic Elders Trial

Study Overview
=================
Brief Summary
-----------------
This study is a pilot randomized controlled trial of 30 elderly type 2 diabetes patients conducted at the MODEL Clinical Research (MODEL), Research Division of Bay West Endocrinology Associates in Baltimore, Maryland. The investigators hypothesized that compared to a regimen base solely on traditional drugs, a regimen including newer drugs will achieve glycemic target faster and induce less hypoglycemia, weight gain, and other side effects, over the short run.

Official Title
-----------------
Glycemia in Diabetic Elders Trial

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Standard Treatment
* Drug: Incretin-Based Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetics diagnosed for at least 6 months Patients ages ≥ 65 years and older Active patients in the Bay West Endocrinology practice Inadequately controlled on oral agents and/or basal insulin with HbA1c between 8.0% and 12% Eligible for randomization to either treatment group Patients willing to follow either treatment arm including regimen using one or more injectables Patients to have an English Reading Level of Grade 6 or above Patients residing at home Exclusion Criteria: Unwilling to use a regimen that may contain using one or more injections Using short acting insulin prior to the study Using GLP-1 in past 10 weeks History of hypoglycemia unawareness or episodes needing emergency intervention End-stage renal disease Dementia Blindness Terminal illness

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Active Comparator: Standard Treatment<br>A regimen with traditional drugs only | Drug: Standard Treatment<br>* traditional drugs only<br>* Other names: TZDs;|
| Experimental: Incretin-based Treatment<br>A regimen including incretin-based drugs | Drug: Incretin-Based Treatment<br>* incretin-based drugs<br>* Other names: amylin analogues;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Achieve Glycemic Target (HbA1c <7.5%). | Data not analyzed due to n=1 each arm. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Hypoglycemia Measured by Glucose Meter | Data not analyzed due to n=1 each arm. | 6 months |
Community Oncology Setting Cost Analysis and Disease Outcomes of Taxane Use in Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a retrospective medical record abstraction study. It is a review and evaluation of up to 300 metastatic breast cancer patients treated with Abraxane or other taxanes such as paclitaxel and docetaxel to determine the overall cost of care for Abraxane compared to other taxanes in the first-line metastatic cancer setting and the cost of care for Abraxane compared to other taxanes when broken down by individual components of cost. In addition, the investigators will review the following patient outcomes: response rate, duration of therapy, toxicity, and survival.

Official Title
-----------------
Community Oncology Setting Cost Analysis and Disease Outcomes of Taxane Use in Metastatic Breast Cancer

Conditions
-----------------
Metastatic Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that have received Abraxane chemotherapy greater than three months from the time of chart review. Patients that have received taxane chemotherapy greater than three months from the time of chart review.

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

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

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 |
| --- | --- | --- |
| Describe patient demographics, disease and treatment characteristics. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe detailed treatment and response characteristics. |  | 6 months | 
| Describe resource utilization and cost variables. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Breast Cancer, Breast Cancer, MBC, Abraxane, Paclitaxel, Taxol, Docetaxel, Taxotere
Pharmacokinetics and Safety Profiles After Administration of DA-5211 and Co-administration of DA-5211-R1 and DA-5211-R2 in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetics and safety Profiles after administration of DA-5211 and co-administration of DA-5211-R1 and DA-5211-R2 in healthy adult volunteers

Official Title
-----------------
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DA-5211 and Co-administration of DA-5211-R1 and DA-5211-R2 in Healthy Adult Volunteer

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

Intervention / Treatment
-----------------
* Drug: DA-5211
* Drug: DA-5211-R1 + DA-5211-R2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers BMI between 18 and 30 kg/m2 Body weight: Male≥50kg, Female≥45kg Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study Exclusion Criteria: Subjects with allergy or drug hypersensitivity Subjects with clinically significant medical history Subjects with history of drug abuse or addicted

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br> | Drug: DA-5211<br>* single dose administration (DA-5211 one tablet once a day)<br>Drug: DA-5211-R1 + DA-5211-R2<br>* single dose administration (DA-5211-R1 one tablet once a day + DA-5211-R2 one tablet once a day)<br>|
| Experimental: Sequence B<br> | Drug: DA-5211<br>* single dose administration (DA-5211 one tablet once a day)<br>Drug: DA-5211-R1 + DA-5211-R2<br>* single dose administration (DA-5211-R1 one tablet once a day + DA-5211-R2 one tablet once a day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | area under the curve | pre-dose 72 hours post-dose | 
| Cmax | maximum plasma concentration | pre-dose 72 hours post-dose |