linjc16/ctgov huggingface dataset:
Pre-treatment Exercises Versus Post-treatment Exercises for Dysphagia

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to determine if pre-treatment swallowing exercises can improve post-treatment swallowing function in patients undergoing radiation with or without chemotherapy for advanced squamous cell carcinoma of the head and neck.

Official Title
-----------------
Determining the Efficacy of Pre-treatment Swallowing Therapy as a Means to Improve Dysphagia Quality of Life When Compared to Post-Treatment Therapy.

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

Intervention / Treatment
-----------------
* Other: Pre-treatment swallowing exercises
* Other: Post-treatment swallowing exercises.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage III or IV squamous cell cancer of teh pharynx and larynx Patients who will be receiving chemoradiation Age 19 years of age or older Must sign informed consent. Exclusion Criteria: Prior cancer diagnosis Metastatic disease Cognitive Impairment

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients will receive pre-treatment swallowing exercises. | Other: Pre-treatment swallowing exercises<br>* Swallowing exercises will be started pre-treatment with radiation.<br>|
| Active Comparator: 2<br>Post-treatment swallowing exercises. | Other: Post-treatment swallowing exercises.<br>* Patients to start swallowing exercises after completion of radiation therapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test whether pre-treatment swallowing exercises compared with usual care (where exercises are taught post-treatment) improves quality of life in patients undergoing chemoradiation therapy for advanced head and neck cancer. |  | 8 weeks, 6 months, 12 months post radiation treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test whether pre-treatment swallowing exercises compared with usual care improves secondary outcome measures related to dysphagia in this patient population. |  | 8 weeks, 6 mnths and 12 months post radiation. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Dysphagia, Radiation, Patients with H&N cancer who will be receiving chemoradiation
Effect of SBG in Patients With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This study is set up to determine whether soluble beta-glucan (SBG) has unfavourable side effects beneficial treatment effects when given in combination with standard antibody and chemotherapy to patients with breast cancer.

Official Title
-----------------
A Phase I/II Study to Assess the Effect of Soluble Beta-1,3/1,6-glucan in Combination With Standard Therapy in Patients With Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: SBG (Soluble beta-glucan)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with histologically/cytologically confirmed locally advanced or metastatic breast cancer Primary tumor or metastases are HER2-ICH3+ or FISH+ Measurable or non-measurable disease The patients must not have received treatment with the combination trastuzumab and vinorelbine previously Expected lifetime of more than 12 weeks Age ≥ 18 years Performance status ≤ 2 according to World Health Organization (WHO) scale The patient must be able to comply with the protocol Verbal and written informed consent Exclusion Criteria: Women who are pregnant or breast-feeding. A negative pregnancy test must be provided during the screening period for fertile women. Fertile women must use effective contraceptive methods Clinical symptoms indicating central nervous system involvement Other current or former malignant disease, with the exception of adequately treated and cured carcinoma in situ cervicis uteri and basocellular skin carcinomas Left ventricular ejection fraction (LVEF) < 50% of normal range Reduced bone marrow function defined by leukocyte counts < 3.0 x 109/l and neutrophil counts < 1.5 x 109/l, or thrombocyte counts ≤ 100 x 109/l Reduced liver function defined by bilirubin > 3 x upper normal limit and/or ASAT/ALAT > 3 x upper normal limit and/or alkaline phosphatase > 3 x upper normal limit. Reduced renal function defined by serum creatinine > 2 x upper normal limit

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

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

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

| Intervention/Treatment |
| --- |
|Drug: SBG (Soluble beta-glucan)|Oral administration, three dose levels, administered day 1-8 in each 3-weeks treatment cycle, 4 treatments cycles.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asess the safety of SBG in combination with standard antibody and chemotherapy treatment |  | 21 weeks |
Cardio-Respiratory Response of a Training Session Versus an Adapted Physical Activity Session

Study Overview
=================
Brief Summary
-----------------
the aim of this study is to show that training session with nintendo WII requires the same cardiorespiratory demand than training session on ergocycle or treadmill, traditionally used in pulmonary rehabilitation program.

Official Title
-----------------
Cardio-Respiratory Response of an Exercise Training Session With Ergocycle or Treadmill Compared to an Adapted Physical Activity Session on a Wii, in Patients With Pulmonary Disease

Conditions
-----------------
Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with pulmonary disease Exclusion Criteria: exacerbation of the pulmonary disease Weight >150Kg Refusal to participate People in pre and post surgical rehabilitation

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 |
| --- | --- | --- |
| compare heart rate between a training session on cycle or treadmill and a training session on Nintendo WII | heart rate (pulse per minute) at the end of each session | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare dyspnea between a training session on cycle or treadmill and a training session on nintendo WII | dyspnea (borg scale) at the end of each session | one day | 
| compare lower limb muscle fatigue between a training session on cycle or treadmill and a training session on nintendo WII | lower limb muscle fatigue (borg scale) at the end of each session | one day | 
| compare pulse oxymetry (SpO2) between a training session on cycle or treadmill and a training session on nintendo WII | SpO2 at the end of each session | one day | 
| Compare the felt pleasure between a training session on cycle or treadmill and a training session on nintendo WII | felt pleasure (likert scale) at the end of each session | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary rehabilitation, exercise, physical activity
A Study To Investigate The Elimination Of PF-06273588 From The Body Following A Single Low Dose.

Study Overview
=================
Brief Summary
-----------------
To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose via both intravenous and oral routes.

Official Title
-----------------
An Exploratory, Open Label, Fixed Sequence Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-06273588 In Healthy Male Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: PF-06273588
* Drug: PF-06273588


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs). Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). A positive urine drug screen. History of regular alcohol consumption exceeding 21 drinks/week for males.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 microgram PF-06273588 intravenous<br>Subjects will receive a single intravenous microdose of PF-06273588 in period one | Drug: PF-06273588<br>* Intravenous, 50 microgram, single dose<br>|
| Experimental: 50 microgram PF-06273588 oral<br>Subjects will receive a single oral microdose of PF-06273588 in period two | Drug: PF-06273588<br>* Oral solution, 50 microgram, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with Adverse Events as a measure of Safety and tolerability. |  | 3 days | 
| Pharmacokinetics : peak plasma concentration |  | 3 days | 
| Pharmacokinetics : time of peak plasma concentration |  | 3 days | 
| Pharmacokinetics : area under plasma concentration-time curve |  | 3 days | 
| Pharmacokinetics : Terminal plasma half life |  | 3 days | 
| Pharmacokinetics : Plasma Clearance |  | 3 days | 
| Pharmacokinetics : plasma volume of distribution |  | 3 days | 
| Pharmacokinetics : oral bioavailability |  | 3 days |
NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR and impedance.

Detailed Description
-----------------
The aim of the study is to examine how suitable a hand-held measuring probe (DDD-probe) using NIR (near infrared light) as well as impedance (conductivity), is to detect early signs of diabetic neuropathy. The DDD-probe is put directly on the skin and is measuring by the use of light and impedance.

Official Title
-----------------
NIR (Near Infrared)- Spectroscopy and Multifrequent Impedance Spectroscopy on the Skin to Detection of Sensory and Autonomic Neuropathy Among Patients With Type 1 Diabetes

Conditions
-----------------
Diabetic Neuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men with type 1 diabetes (WHO criteria) age 35-50 years duration of diabetes > 10 years Exclusion Criteria: P-creatinine> 120 micromol/l other acute or chronic disease, or type of treatment that makes the patient unsuitable to participate, valuated by the investigator non intact skin on the measuring spots the patient is unable to understand the informed consent

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic neuropathy<br>Male participants, type1 diabetic with diabetic neuropathy | |
| Diabetes without neuropathy<br>Male participants, type1 diabetic without diabetic neuropathy | |
| Non diabetic control<br>Male participants, control group non diabetic | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| near infrared spectroscopy | Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe | one time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Near infrared light, Diabetic neuropathy, Sensory neuropathy, Autonomic neuropathy, Vagus, Sudomotor function, Monofilament, Impedance
To Explore The Potential For PF-04531083 To Effect The Blood Concentrations Of Simvastatin And Its Main Acid Metabolite Following Co-Administration Of Both Medications

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to quantify the effect of multiple doses of PF-04531083 on the pharmacokinetics (PK) of co-administered single dose simvastatin.

Detailed Description
-----------------
observational- quantify any effects of PF_04531083 on the PK of Simvastatin

Official Title
-----------------
A Phase 1, Open Label, Fixed Sequence Study To Investigate The Effect Of Multiple Doses Of PF-04531083 On Simvastatin And Simvastatin Acid Pharmacokinetics Following Single Dose Of Simvastatin in Healthy Volunteers

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Drug: PF-04531083
* Drug: simvastatin
* Drug: PF-04531083
* Drug: simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: young healthy male and female volunteers Exclusion Criteria: Elderly Patients

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cohort 1<br> | Drug: PF-04531083<br>* PF-04531083: 100mg to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.<br>Drug: simvastatin<br>* Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.<br>|
| Experimental: cohort 2<br> | Drug: PF-04531083<br>* PF-04531083: a dose to be selected depending on results from Cohort 1 to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.<br>Drug: simvastatin<br>* Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of simvastatin. AUC, Cmax and half life. |  | days 1 and 14 of study | 
| Pharmacokinetics of simvastatin acid. AUC, Cmax and half life. |  | days 1 and 14 of study | 
| Trough concentrations of PF-04531083 2, 4, 7, 11 and 14 days post commencement of dosing |  | days 2, 4, 7, 11 and 14 of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability of PF-04531083 and simvastatin. Vital signs, laboratory tests and adverse events |  | days 1 and 15 of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, drug-drug interaction
Phase I Study of UCART123 in Patient With Adverse Genetic Risk Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
This is a Phase I, open-label, dose escalation study of UCART123 administered intravenously to patients with newly diagnosed CD123 positive adverse genetic risk acute myeloid leukaemia (AML) defined in the ELN adverse genetic risk group (2017). The purpose of this study is to evaluate the safety and clinical activity of multiple infusions of UCART123 and to determine the Maximum Tolerated Dose (MTD).

Official Title
-----------------
Phase I, Open Label Dose-escalation Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of Multiple Infusions of UCART123 (Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor) in Patients With Adverse Genetic Risk Acute Myeloid Leukaemia

Conditions
-----------------
Acute Myeloid Leukaemia

Intervention / Treatment
-----------------
* Biological: UCART123


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Patients newly diagnosed with CD123 positive adverse genetic risk acute myeloid leukaemia (AML) defined as per ELN guidelines (Döhner et al., 2017) Eastern Cooperative Oncology Group performance status of 0 or 1 No prior gene or experimental cellular therapy No organ dysfunction that in the opinion of the investigator precludes intensive induction chemotherapy or cellular therapy

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose escalation<br>Several tested doses of UCART123 until the Maximum Tolerated Dose (MTD) is identified. | Biological: UCART123<br>* Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AE/SAE/DLT [Safety and Tolerability] | Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Myeloid Leukaemia, Newly diagnosed AML, ELN adverse genetic risk group, Chimeric Antigen Receptor T-Cell (CAR-T) therapy, Allogeneic, Transcription Activator-Like Effector Nuclease (TALEN)
Micro-Health Insurance in Cambodia

Study Overview
=================
Brief Summary
-----------------
People who buy insurance are sicker and/or more risk averse than those who don't. Also, Micro-health insurance increases utilization of public health care facilities and protects against asset sales.

Detailed Description
-----------------
Randomly assign coupons giving a discounted price for insurance. Since coupon receipt is exogenous, use these coupons as an instrument for take-up of insurance.

Official Title
-----------------
A Randomized Control Trial of Micro-Health Insurance in Cambodia

Conditions
-----------------
Health Insurance Sale, Health Utilization, Asset Sales, Investment and Saving Behaviors

Intervention / Treatment
-----------------
* Behavioral: Savings Behavior and Consumer's Approach to Risk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be in a village where the health insurance program is being offered.
Sexes Eligible for Study
-----------------
All

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Savings Behavior and Consumer's Approach to Risk|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Better Understand Health Utilization Behavior in Cambodia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Better Understand asset sales, investment and saving behaviors |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health insurance, Health utilization rates, Saving Behavior, Risk aversion
Prospective Data Collection of Patients < 6 Months of Age Undergoing Thoracoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
The study is primarily a descriptive study examining the physiological, ventilatory, surgical, and recovery effects of patients ≤ 6 months of age who undergo thoracoscopic surgery and to determine the accuracy of transcutaneous CO2 (TC-CO2) and end-tidal CO2 (ET-CO2) during high frequency oscillatory ventilation (HFOV) and thoracoscopic procedures.

Conditions
-----------------
Congenital Diaphragmatic Hernia, Tracheoesophageal Fistula, Esophageal Atresia

Intervention / Treatment
-----------------
* Procedure: Thoracoscopic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting for thoracoscopic surgery Patients aged ≤ 6 months of age Exclusion Criteria: Patients presenting for any procedure other than thoracoscopic surgery Patients aged > 6 months of age

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thoracoscopic surgery<br>Infants undergoing thoracoscopic surgery. | Procedure: Thoracoscopic surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in transcutaneous CO2 |  | Duration of surgery, average of 3 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ET-CO2 | End-tidal CO2 | Duration of surgery, average of 3 hours. | 
| Change in heart rate |  | Duration of surgery, average of 3 hours. | 
| Change in blood pressure | Non-invasive and invasive. | Duration of surgery, average of 3 hours. | 
| Change in SpO2 | Oxygen saturation. | Duration of surgery, average of 3 hours. |