linjc16/ctgov huggingface dataset:
Use of MRI for Assessing Stomach Relaxation in Response to a Meal

Study Overview
=================
Brief Summary
-----------------
This study is being done to test new way of measuring the relaxation of the stomach after a meal (called gastric accommodation) by using a MRI scan. This new test will be compared with the standard test of measuring stomach relaxation that uses radioactive tracers. These tests will be compared in healthy volunteers and people with upper abdominal symptoms (known as dyspepsia).

Official Title
-----------------
Dynamic MRI - A Novel Approach for Measuring Gastric Accommodation

Conditions
-----------------
Dyspepsia, Healthy Volunteers

Intervention / Treatment
-----------------
* Procedure: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria for Dyspeptic patients (30 required) One or more of eight postprandial dyspeptic symptoms i.e. fullness, bloating, epigastric discomfort, early satiety, nausea, vomiting, belching, pain for a minimum of 3 months, OR Patients fulfilling the ROME-II criteria for functional dyspepsia, AND no symptom improvement after standard dose PPI treatment, AND normal upper gastrointestinal endoscopy within six months prior to the study Inclusion Criteria for Healthy Controls (20 required) • Absence of current abdominal symptoms or depression Exclusion Criteria for all Participants Known structural upper GI disorder (e.g. peptic ulcer disease, esophagitis, malignancy); Abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, tubal ligation, or inguinal hernia repair; Medications that may alter gastrointestinal motility, e.g., serotoninergic agents, alpha adrenergic agonists, calcium channel or beta blockers; stable dose of thyroxine will be permitted; Pregnant or breast-feeding females; Known claustrophobia; Any metal objects in the body (e.g. metal implants, pacemaker, AICD)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: MRI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric Volume (fasting and postprandial) |  |  | 
| Antral Contractility |  |  |
Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma

Study Overview
=================
Brief Summary
-----------------
Endoscopic thyroidectomy has been used to treat thyroid diseases in China. However, whether this technique is rational to treat thyroid carcinoma is still in controversy. The diagnosis of thyroid carcinoma is predominantly made according to intra-operative frozen section pathological examination in China. In this research, the investigators want to compare clinical index (blood loss, operation duration, number of lymph nodes dissected, complication rates, etc) between patients underwent endoscopic thyroidectomy ( total thyroidectomy) and those underwent conversion to open procedure. The investigators want to evaluate the technical feasibility of endoscopic thyroidectomy for treating thyroid carcinoma.

Detailed Description
-----------------
intra-operative diagnosis of thyroid carcinoma is usually considered the indication of conversion to open surgery. with accumulation of experience of endoscopic thyroidectomy, the investigators want to evaluate the technical feasibility, completeness and safety of endoscopic thyroidectomy.

Official Title
-----------------
Comparison of Effectiveness and Safety of Thyroidectomy for Thyroid Carcinoma in Patients Undergo Endoscopic Surgery and Those Receive Conversion

Conditions
-----------------
Thyroid Carcinoma

Intervention / Treatment
-----------------
* Procedure: thyroidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lesion diameter less than 1 cm by ultrasound Exclusion Criteria: frozen section diagnosis indicates benign lesion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: conversion<br> | Procedure: thyroidectomy<br>* total thyroidectomy via endoscopic approach and that convert to open procedure<br>* Other names: totally endoscopic thyroidectomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the completeness of thyroid resection and clearance of lymph nodes in the central compartment, and to observe the complications such as RLN palsy and hypocalcemia |  | 1 year after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopic thyroidectomy, thyroid carcinoma
Evaluation of Cirrhosis and Malignant Hepatic Lesions Using Novel MR Contrast Agents

Study Overview
=================
Brief Summary
-----------------
This study aims to determine whether or not gadoxetate disodium (Eovist) enhanced magnetic resonance imaging (MRI) has a higher sensitivity for detecting hepatocellular carcinoma (Liver Cancer) comparison to multi-detector computed tomography (CT).

Official Title
-----------------
Evaluation of Cirrhosis and Malignant Hepatic Lesions Using Novel MR Contrast Agents

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: MRI Scan of the Liver enhanced with Eovist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alpha-feto protein > 400 ng / mL or prior ultrasound with mass suspicious for hepatic malignancy or. clinical risk of hepatocellular carcinoma or prior multi-detector CT with mass suspicious for possible hepatocellular carcinoma Exclusion Criteria: Glomerulo-filtration rate < 50 mL/ min/1.73 m2 based on a creatinine measurement within three months of the MR study Previous diagnosis of hepatic malignancy Any conditions that would discount the ability to have an MRI scan

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 |
| --- | --- |
| Suspected Liver Disease<br>Alpha-feto protein > 400 ng / mL or prior ultrasound with mass suspicious for hepatic malignancy or. clinical risk of hepatocellular carcinoma or prior multi-detector CT with mass suspicious for possible hepatocellular carcinoma | Procedure: MRI Scan of the Liver enhanced with Eovist<br>* 10mL of gadoxetate disodium administered intravenously while being scanned via the MRI. Images will be attained on a 5, 10 and 20 minute delay. Expected scan time is 45 minutes total<br>|

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
-----------------
HCC, Hepatocellular Carcinoma, MRI, Liver
Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia

Study Overview
=================
Brief Summary
-----------------
A prospective, non-interventional, natural history study to assess the occurrence of higher FNAIT risk across a broad population of different racial and ethnic characteristics and the occurrence of HPA-1a alloimmunization in these women.

Official Title
-----------------
A Prospective, Natural History Study to Assess the Occurrence of HPA-1a Alloimmunization in Women Identified at Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Conditions
-----------------
Fetal and Neonatal Alloimmune Thrombocytopenia

Intervention / Treatment
-----------------
* Other: Clinical data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women (≥ 18 years of age) who have provided informed consent for the study. Exclusion Criteria: Participants with prior history of FNAIT

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br>Women with higher risk of FNAIT | Other: Clinical data collection<br>* Laboratory tests, Vital assessments, Maternal and fetal genotype testing, Antibodies Testing will be performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with higher FNAIT risk characterized by race and ethnicity |  | At inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of anti-HPA-1a maternal alloimmunization |  | At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event | 
| Pregnancy outcomes: incidence of live births, spontaneous abortion, elective abortion, still birth, and premature birth |  | At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event | 
| Occurrence of neonatal thrombocytopenia |  | At birth or at the time of the pregnancy terminating event | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alloimmunization, HPA-1a, Fetal and Neonatal Alloimmune Thrombocytopenia, Neonatal thrombocytopenia, Pregnant women
Abo Follow-up Study

Study Overview
=================
Brief Summary
-----------------
The aim of the project is to identify an efficient and effective policy or procedure for identifying complications from surgical abortions through follow-up phone calls.

Detailed Description
-----------------
The aim of the project is to identify an efficient and effective policy or procedure for identifying complications from surgical abortions through follow-up phone calls. Key questions include, what is our complication-detection rate from these phone calls? How many patients are contacted? How many attempts are made and how much effort is expended by staff in routine follow-up practices? Additionally, the research would attempt to answer the question, is there any way to predict problems or complications? This study will help to determine if excessive resources and time are being expended on follow-up phone method to detect complications. This study will consist of a retrospective chart review identifying the outcome of follow-up phone calls after an induced abortion.

Official Title
-----------------
Abortion Follow-up Study

Conditions
-----------------
Pregnancy Termination

Intervention / Treatment
-----------------
* Other: Retrospective Chart Review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Reproductive-aged women women who have had an induced abortion, and are contacted by a clinical nurse for a follow-up phone call. Exclusion Criteria: -
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Retrospective Chart Review|There is no intervention in this research. This research project is a retrospective chart review.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up Phone Calls | Key questions include, what is our complication-detection rate from these phone calls? How many patients are contacted? How many attempts are made and how much effort is expended by staff in routine follow-up practices? | 2 years |
Post-operative Radiotherapy With Cisplatin Alone or in Combination With Iressa in Upper Aerodigestive Tract Carcinomas

Study Overview
=================
Brief Summary
-----------------
This trial will be an open multicentric randomized phase II study comparing post-operative radiotherapy + cisplatin associated or not with Iressa in upper aerodigestive tract carcinomas.

Official Title
-----------------
CARISSA Trial - Multicenter Randomized Phase II Trial Comparing Post-operative Radiotherapy and Cisplatin Alone or in Combination With the EGFR Inhibitor ZD 1839 (Iressa) in Upper Aerodigestive Tract Carcinomas

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Drug: Iressa (Gefitinib)
* Radiation: chemoradiotherapy with cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with upper aerodigestive tract carcinomas (all sites included) having surgical resection and eligible for post-operative radiation + cisplatin. Patient having a tumoral biopsy (0.5 - 1 cm3) stored in liquid nitrogen at time of surgical resection (patients with small tumors located in larynx for instance will not be included) Patients receiving post-operative radiation (>=60 Gy on tumor bed and/or cervical area), associated with cisplatin, 6 weeks after surgery at the latest. Exclusion Criteria: previous history of cancer (except skin basal cell carcinoma)

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: postop chemoradio with cisplatin<br>postoperative chemoradiotherapy with cisplatin | Radiation: chemoradiotherapy with cisplatin<br>* postoperative chemoradiotherapy with cisplatin<br>|
| Experimental: postop chemoradio (cisplatin)+gefitinib<br>postoperative chemoradiotherapy with cisplatin + gefitinib | Drug: Iressa (Gefitinib)<br>* postoperative chemoradiotherapy with cisplatin + gefitinib<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 3 years |
Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma

Study Overview
=================
Brief Summary
-----------------
In this study the efficacy and tolerability of two approaches to treat and prevent hyperuricemia is tested in patients with acute lymphoblastic leukemia or high-grade lymphoma with high risk of tumor lysis syndrome. Both arms are compared by randomisation. In one arm patients receive during pre-phase chemotherapy conventional prophylaxis with allopurinol whereas in the other arm Rasburicase is used.

Official Title
-----------------
Randomised Phase III Trial of Effectivity and Safety of Rasburicase Compared With Allopurinol for Treatment of Hyperuricemia in Patients With Acute Lymphoblastic Leukemia or High-Grade NHL With High Risk of Tumorlysis Syndrome (> 15 Yrs)

Conditions
-----------------
Adult Acute Lymphocytic Leukemia, High-grade Lymphoma

Intervention / Treatment
-----------------
* Drug: Allopurinol
* Drug: Rasburicase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients of the GMALL B-ALL/NHL-Study 2002 patients of the GMALL-Study 07/2003 patients of the GMALL-Study Elderly 1/2003 which fulfill the following criteria: bulky disease (> 7.5 cm) high LDH (> 2 x UNL) uric acid >8 mg/dl/ >475µmol/L at diagnosis leukocytes > 30 000/µl Exclusion Criteria: exclusion Criteria of the GMALL B-ALL/NHL Study 2002 or the GMALL-Study 07/2003 or GMALL-Elderly 1/2003 and: asthma or severe, live-threatening atopic allergy in history hypersensitivity against Uric acid Glucose-6-Phosphate-Dehydrogenase deficiency pretreatment with Rasburicase or Urikozyme™

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Only 1 arm<br> | Drug: Allopurinol<br> <br> Drug: Rasburicase<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function, uric acid, electrolytes, adverse events and mortality in pre-phase and the two following cycles of chemotherapy, time and dose compliance of chemotherapy | after cycle 1 | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate, incidence of tumor lysis syndrome | after cycle 1 | 3 weeks |
A Phase 4, Observational Field Study to Evaluate TPOXX in Patients With Smallpox

Study Overview
=================
Brief Summary
-----------------
Phase 4, Observational Field Study in Patients Treated With TPOXX for Smallpox Disease

Detailed Description
-----------------
Phase 4, Observational Field Study to evaluate safety and clinical benefit of TPOXX (tecovirimat) in patients treated with TPOXX following exposure to variola virus and a clinical diagnosis of smallpox disease.

Official Title
-----------------
A Phase 4, Observational Field Study to Evaluate the Safety and Clinical Benefit of TPOXX (Tecovirimat)-Treated Patients Following Exposure to Variola Virus and Clinical Diagnosis of Smallpox Disease

Conditions
-----------------
Smallpox

Intervention / Treatment
-----------------
* Drug: TPOXX 200Mg Capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide informed consent or assent themselves or through a guardian or legally authorized representative, receiving or initiating treatment with TPOXX, and willing and able to adhere to the recommended procedures in the protocol. Determined, per the clinical definition of smallpox, that the patient presenting with a case of acute, generalized vesicular/pustular rash meets Centers for Disease Control and Prevention (CDC) criteria of having confirmed, suspected, or probable smallpox and/or is at high or moderate risk for developing smallpox. The CDC in coordination with the Department of Health and Human Services/Assistant Secretary for Preparedness and Response (ASPR) has released TPOXX to the physician or designated health authorities for patient treatment, and the CDC has provided physician contact information to PPD, the contract research organization. Exclusion Criteria: • Known allergy to tecovirimat and/or excipients of TPOXX.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TPOXX 200Mg Capsule|TPOXX 600 mg (three 200 mg.) capsules twice daily for 14 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess survival | To assess the overall survival at Day 44 following treatment with TPOXX | 44 days post first dose of TPOXX | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival status | Survival status after completion of 14 days of TPOXX treatment will be assessed by physician for inpatients and collected from patient via patient diary question or follow up telephone contact. | 14 days post first dose of TPOXX | 
| Time to death | Time to death after treatment with TPOXX | From date of treatment with TPOXX until the date of death from any cause, whichever came first, assessed up to 44 days after TPOXX treatment |
DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy

Study Overview
=================
Brief Summary
-----------------
This study is A Randomized, Double-blind, Placebo-controlled, Phase II Optimal Dose-finding Study to Determine the Safety and Efficacy of DWP450 in Subjects with Benign Masseteric Hypertrophy

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Phase Ⅱ Optimal Dose-finding Study to Determine the Safety and Efficacy of DWP450 in Subjects With Benign Masseteric Hypertrophy

Conditions
-----------------
Benign Masseteric Hypertrophy

Intervention / Treatment
-----------------
* Drug: Botulinum toxin type A
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subject over 18 years of age and written informed consent is obtained. Subject with Benign Masseter Hypertrophy Subject who has Bisymmetry of masseter at visual assessment. Subjects who meets thickness of Masseter muscle by ultrasonography. Subjects who can and will comply with the requirements of the protocol. Exclusion Criteria: Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function Subject who got any treatment, including double jaw surgery, laser, thread treatment etc. in 12 months. Subject who had previously received botulinum toxin within 3 months prior to the study entry Subject with known hypersensitivity to botulinum toxin Subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study period. Subjects who are not eligible for this study at the discretion of the investigator

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin type A<br>DWP450 | Drug: Botulinum toxin type A<br>* Botulinum toxin type A(DWP450)<br>|
| Placebo Comparator: Placebo<br>Normal Saline | Drug: Placebos<br>* Normal Saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction amount of masseter muscle thickness | Reduction amount of masseter muscle thickness by Ultrasonography | At 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction amount of masseter muscle thickness | Reduction amount of masseter muscle thickness by Ultrasonography | At 4,8,16 weeks | 
| Reduction amount of lower face volume | Reduction amount of lower face volume by 3D digital imaging | At 4, 8, 12, 16 weeks | 
| Overall satisfaction of subject | Overall satisfaction of subject by questionnaire | At 4, 8, 12, 16 weeks |