linjc16/ctgov huggingface dataset:
Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout

Study Overview
=================
Brief Summary
-----------------
D-0120 is being tested in combination with Allopurinol in adult subjects with Gout.

Official Title
-----------------
A Randomized, Open-Label, Multiple-Dose Phase II Study to Evaluate Efficacy and Safety of D-0120 Administered in Combination With Allopurinol in Subjects With Gout

Conditions
-----------------
Gout

Intervention / Treatment
-----------------
* Drug: D-0120
* Drug: Allopurinol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gout subjects meeting 2015 ACR/EULAR Gout Classification Criteria with inadequate urate-lowering response Subject has reported at least 2 gout flares in the previous 12 months. Body Mass Index (BMI) between 18.0 and 40.0 kg/m2 (inclusive). Male and Female Subjects must agree to abstain or use effective contraception methods from the time of signing ICF and for the duration of study participation through 30 days after the last dose of study drug. Subjects must have adequate clinical laboratory and ECG results as assessed by the Principal Investigator Exclusion Criteria: Subjects with significant comorbidities, inadequate lab function, current (and within the past 5 years) diagnosis of cancer or any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study. Women who are pregnant or breastfeeding

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized , Open Label, Multiple Dose
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A<br>week 1: D-0120 low dose in combination with Allopurinol week 2-12: D-0120 increased dose in combination with Allopurinol | Drug: D-0120<br>* increasing dose of D-0120<br>Drug: Allopurinol<br>* standard dosing<br>|
| Experimental: Cohort B<br>week 1: D-0120 low dose in combination with Allopurinol week 2: D-0120 increased dose in combination with Allopurinol week 3-12: D-0120 high dose in combination with Allopurinol | Drug: D-0120<br>* increasing dose of D-0120<br>Drug: Allopurinol<br>* standard dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • To assess the efficacy of D-0120 in combination with allopurinol to reduce serum urate levels in treatment of patients with gout by week 12 |  | 12 weeks |
Safety and Efficacy Evaluation of IM23 CAR-T Cells (IM23CAR-T)

Study Overview
=================
Brief Summary
-----------------
Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor to Patients With CD123+ AML

Detailed Description
-----------------
Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor to Patients With CD123+ AML and determine the best dosage.

Official Title
-----------------
Safety and Efficacy Evaluation of IM23 CAR-T Cells On CD123+ AML Patients

Conditions
-----------------
AML

Intervention / Treatment
-----------------
* Drug: IM23


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with CD123+ Refractory or Relapsed AML To be aged 3 to 80 years Expression of CD123 in Blast ≥90% ECOG score ≤2 Voluntary participation in the clinical trials and sign the informed consent. Exclusion Criteria: Intracranial hypertension or unconsciousness Respiratory failure CD19 negative Disseminated intravascular coagulation ALT /AST>3 x normal value; Creatinine> 1.5 x normal value; Bilirubin >2.0 x -normal value Hematosepsis or Uncontrolled active infection Uncontrolled diabetes Abalienation; Patients in pregnancy or breast-feeding period Previously treatment with any gene therapy products Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 80 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: IM23 CART<br>All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD123 CAR will be infused 24-96 hours later. | Drug: IM23<br>* T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of study related adverse events | defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2 | 2 years |
Trial of Wireless Capsule Endoscopy in the Evaluation of Obscure Gastrointestinal Bleeding

Study Overview
=================
Brief Summary
-----------------
This study compares wireless capsule endoscopy (patients swallow a pill-size camera that sends pictures of the intestine to a recorder worn on their belt) to an x-ray study (called dedicated small bowel contrast radiography) in patients who have bleeding from the gastrointestinal tract without a source of the bleeding identified on routine endoscopic examinations of the esophagus (food pipe), stomach, small intestine, and large intestine. The investigators hope to determine if the capsule is a better test in terms of decreasing further bleeding, decreasing the need for further diagnostic testing, and decreasing the need for blood transfusions and time spent in the hospital.

Official Title
-----------------
Randomized Controlled Trial of Wireless Capsule Endoscopy in the Evaluation of Obscure Gastrointestinal Bleeding

Conditions
-----------------
Obscure Gastrointestinal Bleeding (Occult or Overt)

Intervention / Treatment
-----------------
* Other: Capsule endoscopy
* Other: Dedicated small bowel contrast radiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Iron deficiency anemia in men or post-menopausal women and positive fecal occult blood test in pre-menopausal women with nondiagnostic upper endoscopy, colonoscopy, and push enteroscopy. Persistent or recurrent melena or hematochezia with nondiagnostic upper endoscopy, colonoscopy, and push enteroscopy. Exclusion Criteria: Known or suspected GI tract obstruction Severe motility disorders (e.g., achalasia, gastroparesis, pseudoobstruction) Pregnancy Cardiac pacemaker or implanted electro-medical devices

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Capsule Endoscopy | Other: Capsule endoscopy<br>* Capsule endoscopy<br>|
| Active Comparator: 2<br>Dedicated small bowel contrast radiography | Other: Dedicated small bowel contrast radiography<br>* Dedicated small bowel contrast radiography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further bleeding |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Capsule endoscopy, gastrointestinal hemorrhage
Perioperative Factors Impacting Surgical Risk and Outcomes in Children

Study Overview
=================
Brief Summary
-----------------
This prospective study will measure various factors in children coming in for ambulatory surgery and attempt to create a scoring system that would be able to predict post-operative outcomes.

Official Title
-----------------
Perioperative Factors Impacting Surgical Risk and Outcomes in Children

Conditions
-----------------
Surgery, Orthopedic Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: Spirometry
* Diagnostic Test: Reaction Time


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients aged 6-18 years old having ambulatory orthopedic surgery with or without planned postoperative admission. Patients need to be cooperative to under spirometry testing and reaction time measurement. If unable to perform, we will assess why they were not able (non-cooperative, inability, etc) Exclusion Criteria: Spinal fusion

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- |
| Orthopedic surgery<br>Pediatric patients presenting for ambulatory orthopedic procedures | Diagnostic Test: Spirometry<br>* Lung volumes will be measured using spirometry.<br>Diagnostic Test: Reaction Time<br>* PVT-192 Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-anesthesia care unit (PACU) length of stay | The investigators hypothesize that spirometry performance will be associated with reduced PACU length of stay | Immediately post-op |
Feasibility of Ultra-sound Guided Radiofrequency Ablation in the Management of Head and Neck Neoplasia.

Study Overview
=================
Brief Summary
-----------------
To study the feasibility of Radiofrequency ablation (RFA) via ultrasound guidance in the management of head and neck neoplasia.

Detailed Description
-----------------
The study evaluates the feasibility of radio-frequency ablation in the management of head and neck neoplasia.

Official Title
-----------------
Feasibility of Ultra-sound Guided Radiofrequency Ablation in the Management of Head and Neck Neoplasia.

Conditions
-----------------
Head and Neck Neoplasia

Intervention / Treatment
-----------------
* Procedure: Ultra-sound guided radio-frequency ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with head and neck neoplasia. Exclusion Criteria: When the patient does not meet the inclusion criteria. When the patient has a contra-indication of surgery or anesthesia. If the patient refuses involvement in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Ultra-sound guided radio-frequency ablation<br> | Procedure: Ultra-sound guided radio-frequency ablation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Technical success is defined as the ability to successfully enter the thyroid nodule via ultrasound guidance and apply the RFA. Assessed via surgeon self report | Length of the procedure, up to 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radio-frequency ablation; Head and Neck neoplasia.
Arnogene: A Phosphocalcic Study in Dialysis

Study Overview
=================
Brief Summary
-----------------
Searching for high morbi-mortality risk Klotho variants in dialysis patients

Official Title
-----------------
Genetic Determinants of Phosphocalcic Metabolism in Hemodialysis Patients

Conditions
-----------------
Dialysis

Intervention / Treatment
-----------------
* Genetic: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every adult > 18 years old and treated by dialysis in centers located in the Rhone Alpes area in France.

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 |
| --- | --- |
| hemodialysis patients<br>Adult patients undergoing maintenance dialysis since at leat three months | Genetic: blood sample<br>* Searching for Klotho variants in DNA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing morbi-mortality based on Klotho variants |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival and serum phosphocalcic parameters |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Klotho, calcium, phosphate, parathormone, survival, dialysis, Adult patients undergoing maintenance dialysis since at leat three months
Effect of Cinnamon on Glucose and Lipid Levels in Non-Insulin Dependent Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of cinnamon on serum glucose and lipid levels in people with non-insulin dependent type 2 diabetes mellitus.

Detailed Description
-----------------
Forty people with non-insulin dependent type 2 diabetes mellitus will be randomized to receive either cinnamon or placebo for three months. The dose of cinnamon will be one gram daily. Fasting serum glucose, triglyceride, total cholesterol, LDL, HDL, and insulin levels will be measured at baseline and at 1, 2, and 3 months. HbA1c levels will be measured at baseline and at 3 months. Patients will be monitored for compliance, adverse effects, and dietary changes.

Official Title
-----------------
Effect of Cinnamon on Glucose and Lipid Levels in Non-Insulin Dependent Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Adult Onset

Intervention / Treatment
-----------------
* Drug: Cinnamon or placebo 500 mg capsule twice daily


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus HbA1C > 6.0% Age 18 and above Able to obtain consent Exclusion Criteria: Currently taking insulin Pregnancy End-stage renal disease Hemolytic anemia Cinnamon intolerance Inability or unwillingness to adhere to study protocol

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Cinnamon or placebo 500 mg capsule twice daily<br>* Cinnamon 500 mg capsule twice daily or placebo capsule twice daily<br>|
| Active Comparator: 2<br> | Drug: Cinnamon or placebo 500 mg capsule twice daily<br>* Cinnamon 500 mg capsule twice daily or placebo capsule twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Primary outcomes include HbA1c, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides levels. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cinnamon, Diabetes mellitus, Hyperlipidemia, Insulin Resistance
Markers of Airway Inflammation in BAL Fluid From Children With Asthma

Study Overview
=================
Brief Summary
-----------------
The study compares the biochemical markers in bronchoalveolar lavage samples from asthmatic children to those markers found in non-asthmatic children with other respiratory diseases. The investigators hypothesize that certain markers will be associated specifically with asthma.

Official Title
-----------------
Prospective Analysis of Markers of Airway Inflammation and Remodeling in Bronchoalveolar Lavage Fluid From Children With Asthma.

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or younger Scheduled for bronchoscopy at National Jewish Health for persistent asthma, persistent, poorly controlled wheezing, chronic cough, GERD, atelectasis, bronchopulmonary dysplasia, infection. Consent and assent from parent and patient [if appropriate]. Exclusion Criteria: Unwillingness to consent/assent to retrieval of BAL fluid for research analysis.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| 1 Asthma subjects<br>Children with asthma undergoing clinically indicated bronchoscopy at National Jewish Health. | |
| 2 Non-asthma subjects<br>Children with other respiratory diseases than asthma undergoing clinically indicated bronchoscopy at National Jewish Health. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The measurement of levels of lipopolysaccharides [LPS], which mediates airway inflammation, in bronchoalveolar lavage [BAL] fluid from children with asthma and comparison to LPS levels in children with non-asthma respiratory diseases |  | Single time point | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of the inflammatory cytokine and chemokine profiles in bronchoalveolar lavage [BAL] fluid in children with asthma and comparison to the profile for children with non-asthma respiratory diseases. |  | Single time point | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma inflammation bronchoscopy
Assessment of an Automated Telesurveillance System on Serious Falls Prevention in an Elderly Suffering From Dementia Specialized Care Unit: the URCC

Study Overview
=================
Brief Summary
-----------------
2 URCC in the Limousin region will be equipped with the automated telesurveillance system. Patient will be selected by ward's geriatrician and randomized into two groups after informed consent. One group will have cameras installed and the other will not and will act as a comparison group. Patient will be assessed twice during the study, at admission in (inclusion visit) and at outcome from the URCC (end of study visit). Each assessment implies a standard geriatric assessment, a fall questionnaire, a Neuropsychiatric inventory for behavioral disturbances and a quality of life questionnaire (EQ5D). Every fall will be considered as adverse events and will therefore be listed along the study and characterized in types and number.

Official Title
-----------------
Assessment of an Automated Telesurveillance System on Serious Falls Prevention in an Elderly Suffering From Dementia Specialized Care Unit: the URCC. GET-BETTER Study (Geriatric Environmental Telecare - Behavioral Engineering Technology To Enhance Rehabilitation)

Conditions
-----------------
Mentally Ill Old Subjects

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged more than 65 years old Patient admitted in Limoges or Brive's URCC Patient informed consent and/or proxy consent Patient covered by the French health insurance Exclusion Criteria: Patient without national health insurance coverage Patient with a short term prognosis pathology

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| intervention group<br>Rooms of the patient of the intervention group will be equipped of cameras | |
| reference group<br>Patient in the non-equipped group will have usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of the automated telesurveillance system | The impact of the automated telesurveillance system on the incidence rate of falls with serious outcomes between the two groups during their hospitalization in URCC. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of the system on the global rate of falls |  | 6 months |