linjc16/ctgov huggingface dataset:
Individual Patient Compassionate Use of Crenolanib

Study Overview
=================
Brief Summary
-----------------
Compassionate use of crenolanib for patients with serious life-threatening illness that have exhausted all available therapies used to treat the disease, with no other viable therapy options, who is not eligible for clinical trials. This program is designed to evaluate the requests on a patient by patient basis. Patients must have documented evidence of a point mutation in position 842 in platelet derived growth factor receptor alpha (PDGFRA-D842V) or amplification of PDGFRA or internal tandem duplication within the FMS-like tyrosine kinase 3 (FLT3-ITD) or point mutations within the tyrosine kinase domain (TKD) of FLT3 (FLT3-TKD)

Detailed Description
-----------------
This program is being offered on a patient by patient basis while phase 3 studies with crenolanib are ongoing. Institutional Review Board-/Independent Ethics Committee approval must be granted before, The experimental intervention will be administered over 28-day cycles. Compassionate use of crenolanib will be limited such that it does not interfere with the supply need for phase 3 studies. There must be adequate understanding of the indication for the requested use.

Official Title
-----------------
Compassionate Use of Crenolanib for Cancers With Platelet Derived Growth Factor Receptor Alpha (PDGFRa) Mutations, PDGFRa Amplifications or Fms-like Tyrosine Kinase 3 (FLT3) Mutations

Conditions
-----------------
FLT3-ITD Mutation, FLT3/TKD Mutation, PDGFR-Alpha D842V, PDGFRA Gene Amplification

Intervention / Treatment
-----------------
* Drug: Crenolanib besylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have a serious life threatening cancer with FLT3/PDGFRa mutation or PDGFRa amplification who has exhausted all other treatment options Subject and their partner (if adults) must use 2 forms of contraception during study and for 3 months following last dose of study drug Exclusion Criteria: Subject is eligible for enrollment in an ongoing clinical trial Subject has any condition which, in the investigator's opinion makes the subject unsuitable for participation
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Crenolanib besylate|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
-----------------
Compassionate use
Left Ventricular Capture Management (LVCM) Software Download Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. Left Ventricular Capture Management (LVCM) refers to the overall method for determining left ventricular thresholds (level of energy needed to effectively pace the tissue in the lower left chamber of the heart) by measuring, analyzing, and adjusting energy delivered from the CRT device to the pacing lead. The purpose of the Left Ventricular Capture Management Software Download Clinical Trial was to evaluate the accuracy of the Left Ventricular Capture Management (LVCM) feature to support LVCM feature approval in future cardiac resynchronization therapy with defibrillation (CRT-D) devices

Official Title
-----------------
Left Ventricular Capture Management (LVCM) Software Download Clinical Trial

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Left Ventricular Capture Management Software


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who successfully underwent implantation of an InSync II Marquis system Exclusion Criteria: Subjects who are post-heart transplant Subjects enrolled in a concurrent study that may confound the results of this 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Left Ventricular Capture Management Software|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the accuracy of left ventricular capture management (LVCM) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare left ventricular capture management (LVCM) measurements to a similar measurement taken automatically when subjects are completing normal daily activities |  |  | 
| To evaluate subject rhythm and rate immediately following an LVCM measurements |  |  | 
| To characterize all adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac resynchronization therapy
Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole

Study Overview
=================
Brief Summary
-----------------
The investigators propose the evaluation of posaconazole and benznidazole in humans for the treatment of Chagas disease chronical infection. Exploratory trial of posaconazole antiparasitic activity against Trypanosoma cruzi.

Official Title
-----------------
PROTOCOL FOR PHASE II CLINICAL TRIAL, RANDOMIZED AND OPEN FOR ETIOLOGICAL TREATMENT OF CHRONIC CHAGAS DISEASE WITH POSACONAZOLE AND BENZNIDAZOLE

Conditions
-----------------
Chagas Disease

Intervention / Treatment
-----------------
* Drug: Benznidazole
* Drug: Posaconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consenting patients with serological evidence of Chagas infection and positive PCR real time 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?
-----------------

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: Benznidazole<br> | Drug: Benznidazole<br>* Standard dosage<br>|
| Experimental: Posaconazole, low dose<br> | Drug: Posaconazole<br> <br> |
| Experimental: Posaconazole, high dose<br> | Drug: Posaconazole<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parasitological cure measured by a real time PCR in blood sample | PCR negative at the end of follow up | 12 months after starting treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parasitological cure measured by real time PCR in blood sample | substained parasitological response | End of treatment, weeks 8, 16, 24 and 40 after treatment | 
| Safety and tolerability of both drugs |  | First 2 months |
Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous FL058 Administered in Healthy Subjects(SAD)

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of FL058 in healthy Chinese subjects.

Official Title
-----------------
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FL058 for Injection in Healthy Chinese Subjects.

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

Intervention / Treatment
-----------------
* Drug: FL058
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults aged between 18 and 45 years (inclusive). Body mass index (BMI) ranges from 19 to 26 kg/m2 (inclusive), and the body weight is ≥50kg. Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests. Provide voluntary written informed consent prior to any study procedures and are willing and able to comply with the prescribed treatment protocol and evaluations. Exclusion Criteria: Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders. Positive screen result for HBsAg, HCV-Ab, or HIV-Ab at screening. History of clinically significant food or drug allergy. A QT interval corrected using Fridericia's formula >450 msec. eGFR<90mL/min/1.73m2.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FL058<br>a single ascending dose (SAD) of intravenous (IV) FL058(50mg 2000mg) | Drug: FL058<br>* 50mg、250mg、500mg、1000mg、1500mg、2000mg<br>|
| Placebo Comparator: Placebo<br>FL058 Placebo | Drug: Placebo<br>* empty bottle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events [Safety and Tolerability] |  | Day 1 to Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FL058 -Cmax | To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects. | Up to 48 hours post-dose | 
| FL058 -AUC | To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects. | Up to 48 hours post-dose | 
| FL058 -t1/2 | To evaluate the PK of single intravenous doses of FL058 in healthy adult human subjects. | Up to 48 hours post-dose |
Cardiaplication: A Novel Antireflux Operation

Study Overview
=================
Brief Summary
-----------------
Gastro-Esophageal Reflux is a commonly encountered problem in infants. After failure of medical therapy, many children are referred for surgical intervention. Techniques have evolved over the last 50 years; however, benefits in children remain the center of debate in many surgical forums. This is primarily owing to the high incidence of recurrence of reflux and need for revisions later in life. Some clinicians theorize that the pathophysiology of reflux in infants is different from that of the population at large, and that the traditional operation may not be the best suited for this patient population. We propose a study to test an alternative plication technique for modifying the gastro-esophageal junction at the Angle of Hiss. By plicating the cardia of the stomach, we hypothesize that we will create a valve which will limit reflux without disrupting the diaphragmatic crura, thus reducing the incidence of recurrent hiatal hernia and limiting the incidence of fundoplications which are too tight.

Official Title
-----------------
Cardiaplication: A Prospective Observational Trial

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Procedure: Cardiaplication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients under 12 months old who are scheduled to undergo an operative intervention for medically refractory GERD. Exclusion Criteria: Inability to obtain consent Surgeon preference

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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: Cardiaplication<br> | Procedure: Cardiaplication<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine pH impedance probe results of Cardiaplication | We will perform a pH impedance probe on all patients at 3 months post-op (+/- 30 days). We are looking for a statistically significant improvement in per-cent time the pH is <= 4. | At 3 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate elongation of the intra-abdominal esophagus as a mechanism for outgrowing GERD in infants | Radiographs at 1 year will be compared to post-op chest x-ray to determine vertical length between clips placed intra-operatively at the GE junction and on the diaphragmatic crus. | 1 year post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, fundoplication, cardiaplication, reflux
A Cohort Study on Biomarkers of Hypertension in Guangdong Province(GDP Study)

Study Overview
=================
Brief Summary
-----------------
Hypertension is the most common chronic diseases and a most important risk factor for cardiovascular and cerebrovascular diseases, and also a substantial public health problem. The purpose of the study is to investigate the association between biomarkers and adverse outcomes in patients with hypertension.

Detailed Description
-----------------
Study population includes subjects who are hypertension, of any race or ethnicity, 18 or older years of age, and have provided written informed consent to provide whole blood specimens at one or more study visits. Physical examination, questionnaire survey and biological sample collection will be conducted at baseline and the incidence of all-cause and cardiovascular mortality will be investigated during follow-up.

Official Title
-----------------
Establishing Biobank in a Cohort Study for Hypertensive Patients in Guangdong Province(GDP Study)

Conditions
-----------------
Hypertension, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: Non-interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years old In accordance with the diagnosis of hypertension (including Blood pressure ≥140/90mmHg and/or taking antihypertensive drugs and/or self-reported hypertension) Exclusion Criteria: <18 years old Unsigned informed consent Pregnant Women and Lactation

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

| Intervention/Treatment |
| --- |
|Other: Non-interventional study|This is an observational, non-interventional study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-Cause Mortality | All-cause mortality was confirmed through a combination of hospital medical records, telephone contacts with patients or family members, and death registration at the Guangdong Provincial Center for Disease Control and Prevention. | From date of inclusion until the date of death from any cause, assessed up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Mortality | Cardiovascular mortality was defined as death attributable to an ischemic cardiovascular cause (including fatal MI, stroke). | From date of inclusion until the date of death from any cause, assessed up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mortality, Hypertension, Cardiovascular Diseases, Biomarker
Quadratus Lumborum Block III Versus Peritubal Local Infiltration

Study Overview
=================
Brief Summary
-----------------
Investigators compare post operative analgesic efficacy of peritubal local infiltration versus Quadratus Lumborum Block III . In patients undergoing Percutaneous Nephrolithotomy operation

Official Title
-----------------
Postoperative Analgesic Efficiency of Quadratus Lumborum Block III Versus Peritubal Local Infiltration in Patients Undergoing exPercutaneous Percutaneous Nephrolithotomy Operation : a Randomized Comparative Study

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: Quadratus block versus peritubal local infiltration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with pelvic renal stone less than 2 cm Americans society of Anesthesiologists physical status I, II BMI<35 Exclusion Criteria: patient refusal to participate in the study Americans society of Anesthesiologists physical status III or above major hepatic, renal or cardiovascular disease BMI > 35 coagulopathy psychological disorders.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Q<br>Patients in this group receive Quadratus Lumborum Block with 20 ml bupivacaine 0.5% | Procedure: Quadratus block versus peritubal local infiltration<br>* Quadratus lumborum block III versus peritubal local infiltration in patients undergoing Percutaneous Nephrolithotomy operation<br>|
| Active Comparator: Group L<br>Patients in this group receive peritubal local infiltration at 6 and 12 o'clock position with 20ml bupivacaine 0.5% | Procedure: Quadratus block versus peritubal local infiltration<br>* Quadratus lumborum block III versus peritubal local infiltration in patients undergoing Percutaneous Nephrolithotomy operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesia | Postoperative pain measured by visual analogue scale from 0 to 10 measured over 24h where 0 is better and 10 means worst pain | 24 hours | 
| Analgesic requirement | Investigators measured the total dose of morphine consumption in mg over 24hour | 24 hours |
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the effectiveness and safety of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to placebo, a treatment without activity.

Official Title
-----------------
A Phase 3, 12-week, Randomized, Double-blind Placebo-controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Drug: TD-4208
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a male or female subject 40 years of age or older Exclusion Criteria: Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TD-4208-1<br>88 mcg | Drug: TD-4208<br> <br> * Other names: revefenacin;|
| Active Comparator: TD-4208-2<br>175 mcg | Drug: TD-4208<br> <br> * Other names: revefenacin;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Trough FEV1 on Day 85 |  | Baseline and Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85 |  | Days 15 to 85 | 
| Summary of Change From Baseline to Peak FEV1 After First Dose |  | 0-2 hours after First Dose Day 1 | 
| Summary of Rescue Medication Use: Puffs Per Day |  | 1-3 Months | 
| St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85 | A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units | Day 85 | 
| Percentage of Albuterol Rescue-free 24-hour Periods |  | 1-3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Obstructive Pulmonary Disease, COPD