linjc16/ctgov huggingface dataset:
Safety Study of APR-246 in Patients With Refractory Hematologic Cancer or Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the highest feasible dose (HFD) of intravenous (IV) APR-246 when given to patients with refractory hematologic malignancies or prostate carcinoma.

Official Title
-----------------
An Open-label Phase I Dose Escalating Study of APR-246 for Infusion in Patients With Refractory Hematologic Malignancies or Prostate Carcinoma

Conditions
-----------------
Hematologic Neoplasms, Prostatic Neoplasms

Intervention / Treatment
-----------------
* Drug: APR-246


Participation Criteria
=================
Eligibility Criteria
-----------------
Summary criteria for participant selection: Inclusion Criteria: Male or female ≥ 18 years of age. Any below mentioned advanced disease, which is not eligible for other therapies. The diagnosis should have been confirmed either histologically or cytologically: Acute myeloid leukemia. Acute lymphoid leukemia. Chronic lymphocytic leukemia. Chronic myeloid leukemia. Chronic myelomonocytic leukemia. Multiple myeloma. Non Hodgkin's lymphoma. Hodgkin's lymphoma. Myelodysplastic syndrome. Myelofibrosis. Hormone refractory, metastatic prostate 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: APR-246|Intravenous infusion. Dose escalating. Dosing will be conducted with three patients at each dose level.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-Limiting Toxicity (DLT) is reached and HFD is defined accordingly, OR the dose, which is expected to result in maximum plasma concentration close to, but not exceeding 35 μg/ml in any single patient without showing signs of DLT. |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the toxicity and safety profile of APR-246 based on safety parameters from the entire study period. |  | continuously during 21 days | 
| Determination of the PK profile for up to 22 hours after the last APR-246 infusion. Cmax (maximal plasma concentration), AUC (area under the curve), t1/2 (half-life) and clearance will be determined. |  | continuously, during 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hematologic malignancy, Prostate carcinoma, Hematologic cancer, Prostate cancer
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects With Partly Controlled Atopic Asthma

Study Overview
=================
Brief Summary
-----------------
This study is to examine the safety, tolerability, pharmacokinetics and functional activity of ADC3680B administered once daily for 28 days in subjects with partly controlled atopic asthma.

Official Title
-----------------
A Randomised, Placebo-Controlled, Double-Blind, Parallel Group Phase II Study to Assess the Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects With Partly Controlled Atopic Asthma

Conditions
-----------------
Atopic Asthma

Intervention / Treatment
-----------------
* Drug: ADC3680B oral
* Drug: Placebo oral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Partially controlled mild-moderate atopic asthma Receiving inhaled corticosteroids Non-smoker or former smoker Males and females aged 18 to 55 years inclusive If female, must be of non-childbearing potential Exclusion Criteria: History of acute severe asthma attacks History of COPD Other serious respiratory or other medical condition which may interfere with the outcome of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Experimental: ADC3680B oral<br> | Drug: ADC3680B oral<br>* Once daily for 28 days<br>|
| Placebo Comparator: Placebo oral<br> | Drug: Placebo oral<br>* Once daily for 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the change in frequency and severity of adverse events as a measure of safety and tolerability |  | Baseline to Day 35 | 
| Evaluation of the change in incidence of routine haematology and biochemistry abnormalities as a measure of safety |  | Baseline to Day 35 | 
| Evaluation of the change in vital signs as a measure of safety |  | Baseline to Day 35 | 
| Evaluation of the change in Pulmonary function as a measure of safety and tolerability |  | Baseline to Day 35 | 
| Assessment of the change in asthma symptoms using the Asthma Control Questionnaire as a measure of safety and tolerability |  | Baseline to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of concentrations of ADC3680B in plasma |  | Days 1-2 and Days 28-30 | 
| Exploratory assessment of exhaled nitric oxide and selected markers of inflammation in blood |  | Day 1 and Day 28 |
Effects of Thai Massage on Patients With Wrist Extensor Muscles Latent Myofascial Trigger Points

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the effect of Thai massage on pressure pain threshold, pain intensity, wrist range of motion, grip strength and patient satisfaction in patients with wrist extensor muscles latent Myofascial trigger points.

Official Title
-----------------
Effects of Thai Massage on Patients With Wrist Extensor Muscles Latent Myofascial Trigger Points

Conditions
-----------------
Patients With Latent Myofascial Trigger Point

Intervention / Treatment
-----------------
* Other: Thai massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Age between 18 - 40 years old The participants have at least one latent trigger point in the wrist extensor groups muscles. The participants will be able to follow instructions. Good communication and cooperation. Exclusion Criteria: Contraindications of traditional Thai massage Tennis elbow or Golf's elbow Poor skin sentation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thai massage<br>The participants will receive a thirty minutes session of Thai massage onto the wrist extensor groups muscle for 9 sessions | Other: Thai massage<br> <br> |
| Sham Comparator: Sham Ultrasound therapy<br>The participants will receive a thirty minutes session of sham ultrasound therapy onto the wrist extensor groups muscle for 9 sessions | Other: Thai massage<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Pain Threshold as a measure by algometry |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores on visual analog scale |  | 5 weeks | 
| Wrist Range of motion as a Measure by goniometer |  | 5 weeks | 
| Grip strength as a measure by hand-held dynamometer |  | 5 weeks | 
| Patient satisfaction level |  | 5 weeks |
Anesthesia for Pars Plana Vitrectomy (PPV) With Insulin Needle

Study Overview
=================
Brief Summary
-----------------
Periocular blockade with 12.5 mm needle is as effective as block with 25 mm needle for patients undergoing Pars Plana Vitrectomy.

Detailed Description
-----------------
The author wants to see the effect of short needle in patients undergoing retinal surgery.

Official Title
-----------------
Anesthesia for PPV Using Insulin Needle

Conditions
-----------------
Retinal Disorders

Intervention / Treatment
-----------------
* Device: needle
* Device: needle
* Procedure: Pars Plana Vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients undergoing pars plana vitrectomy under local anesthesia Exclusion Criteria: Patients allergic to local anesthetic solutions With local sepsis Serious impairment of coagulation Orbital abnormalities Unable to cooperate in maintaining a relatively motionless supine position Who refused the anesthetic technique

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Control | Device: needle<br>* Peribulbar blockade with standard (25 mm) needle<br>* Other names: Peribulbar blockade with standard needle;Procedure: Pars Plana Vitrectomy<br>* Peribulbar block<br>* Other names: Extraconal block;|
| Active Comparator: Group 2<br>Block with short needle | Device: needle<br>* Peribulbar blockade with short (12.5 mm) needle<br>* Other names: Peribulbar blockade with short needle;Procedure: Pars Plana Vitrectomy<br>* Peribulbar block<br>* Other names: Extraconal block;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of insulin needle. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Efficiency, Pars, Plana, Vitrectomy
Diagnosis et Treatment of Asthma in Athlete : Boundary Between Disease and Doping

Study Overview
=================
Brief Summary
-----------------
This study will determine the pharmacokinetic profile of the salbutamol concentration in the urine while athletes are resting or during exercise.

Official Title
-----------------
Diagnosis et Treatment of Asthma in Athlete : Boundary Between Disease and Doping

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

Intervention / Treatment
-----------------
* Other: blood sample
* Other: urine sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient who hold a license in a sport federation, and do at least 8 hours of sport each week asthmatic patient Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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: athlete under asthma treatment<br>athlete suffering from asthma blood sample urine sample | Other: blood sample<br>* blood sample<br>Other: urine sample<br>* urine sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of exercise on pharmacokinetics profile | impact of exercise on pharmacokinetics profile of salbutamol concentration in urine | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, athlete
Correction of Breech Presentation With Laser Acupuncture

Study Overview
=================
Brief Summary
-----------------
Acupuncture-type interventions (such as moxibustion and acupuncture) at Bladder 67 (BL67, Zhiyin point) have been proposed to have positive effects on breech presentation. However, the role of laser acupuncture for Breech presentation remains unknown. The aim of this study is to evaluate the effectiveness and safety of laser acupuncture in correcting breech presentation.

Official Title
-----------------
Correction of Breech Presentation With Laser Acupuncture: a Randomized Controlled Trial

Conditions
-----------------
Breech Presentation

Intervention / Treatment
-----------------
* Procedure: Laser acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breech presentation or non-cephalic presentation gestation age 28 34 weeks singleton Exclusion Criteria: uterus anomaly uterus tumors risk of preterm labor

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 36 Years

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

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 |
| --- | --- |
| Experimental: Laser acupuncture<br>Laser acupuncture with knee-chest position | Procedure: Laser acupuncture<br>* Laser acupuncture is a low-level laser technique with no invasive procedure<br>|
| No Intervention: No intervention<br>usual care with knee-chest position | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cephalic presentation at gestation age (GA) of 36 weeks | numbers of cephalic presentation confirmed by ultrasound | at gestation age (GA) 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cephalic presentation at labor | confirmed by ultrasound | numbers of cephalic presentation at labor (an average of GA 38 weeks) |
Xanthine Oxidase and Uric Acid Origin in Preeclamptic Women

Study Overview
=================
Brief Summary
-----------------
Findings regarding the presence of xanthine oxidase and uric acid in different blood locations is important in preeclamptic women. We aim to detecting Xanthine oxidase and uric acid levels in both umbilical cord artery and vein as well as maternal blood (3 locations) in pregnant women with and without diagnosis of preeclampsia. The study population will be divided into groups matching the three locations in order to describe and compare outcome levels.

Detailed Description
-----------------
Significance - findings regarding the presence of xanthine oxidase and uric acid in different blood locations may provide a scientific basis for understanding the source of them in preeclamptic women. Aim - detecting Xanthine oxidase and uric acid levels in both umbilical cord artery and vein as well as maternal blood (3 locations). Methods - samples will be collected from pregnant women with and without diagnosis of preeclampsia with blood uric acid > 6 mg/dL. Than the study population will be divided into groups matching the three locations. The investigators will describe and compare outcome levels (including Xanthine oxidase, uric acid).

Official Title
-----------------
The Origin of Xanthine Oxidase and Its Metabolite, Uric Acid, in Preeclamptic Pregnant Women - A Pilot Study

Conditions
-----------------
Pre-Eclampsia, Hyperuricemia

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preeclampsia and none-preeclampsia diagnosed pregnant women. Exclusion Criteria: Known or reported kidney disease.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Umbilical cord arterial blood<br>participant's umbilical cord arterial blood will be obtained | Other: No intervention<br>* No intervention<br>|
| Umbilical cord venus blood<br>participant's umbilical cord Venus blood will be obtained | Other: No intervention<br>* No intervention<br>|
| Maternal blood<br>participant's blood will be obtained | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uric Acid | mg/dL | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Xanthine oxidase, Uric acid
Retransfusion or Not of Cardiotomy Blood

Study Overview
=================
Brief Summary
-----------------
This randomised controlled trial has a non-inferiority design. The aim is to test if the blood loss (volume in mL and hemoglobin) is effected by heart and lung cardiotomy retransfusion, or not? Forty CABG (Coronary Artery By pass Grafting) patients will be allocated to either receive retransfusion (n=20) of cardiotomy blood via the heart and lung mashine, or no retransfusion (n=20).

Official Title
-----------------
Blood Loss With Cardiopulmonary Bypass, Re-transfusion or Not.

Conditions
-----------------
Blood Loss, Surgical

Intervention / Treatment
-----------------
* Procedure: No retransfusion of cardiotomy blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective CABG. Exclusion Criteria: Anaemia, infection, massive bleeding, CABG off pump.

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: Sequential Assignment
Interventional Model Description: Randomised controlled non-inferiority trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Retransfusion of cardiotomy blood or not<br>Intervention group does not get cardiotomy blood retransfusion via heart-and lung machine while control does. | Procedure: No retransfusion of cardiotomy blood<br>* No retransfusion of cardiotomy blood via heart- and lung mashine<br>|
| No Intervention: No retransfusion of cardiotomy blood<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss | Hemoglobin | During 5 days hemoglobin will be measured as the clinical rutine or as needed. | 
| Blood loss | Blood volume in millilitre (mL) | During 2 days or while surgical drains remains, blood volume in mL is measured. |
Analysis of Cutaneous and Hematologic Disorders by High-Throughput Nucleic Acid Sequencing

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to identify genetic changes associated with the initiation, progression, and treatment response of response of cutaneous and hematologic disorders using recently developed high-throughput sequencing technologies. The improved understanding of the genetic changes associated with cutaneous and hematologic disorders may lead to improved diagnostic, prognostic and therapeutic options for these disorders.

Official Title
-----------------
Analysis of Cutaneous and Hematologic Disorders by High-Throughput Nucleic Acid Sequencing

Conditions
-----------------
Cutaneous Lymphoma, Other Skin Disorders, Mycosis Fungoides, Cutaneous T-cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Patient meets the clinical and/or pathologic criteria for the cutaneous or hematologic disorder being examined. Patient is willing to provide skin biopsies and five 10 mL tubes of peripheral blood. Exclusion Criteria: - Less than 18 years of age

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

Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of mutations | Identify mutations, changes in DNA copy number, structural rearrangements, or altered coding and non-coding RNA expression | 2 years |