linjc16/ctgov huggingface dataset:
Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2

Study Overview
=================
Brief Summary
-----------------
Partially HLA-matched irradiated donor lymphcyte infusion alone resulted in 27% overall response rate (ORR) in advanced renal cell carcinoma without significant toxicities. In addition, high-dose interleukin-2 (IL-2)showed an ORR of 6-21% in metastatic melanoma or renal cell carcinoma with a durable response in patients who achieved complete remission. Therefore, irradiated donor lymphocyte infusion plus high-dose IL-2 might show a synergistic anti-tumor activity agaist relapsed or metastatic melanoma or renal cell carcinoma.

Official Title
-----------------
Phase II Study of Irradiated Donor Lymphocyte Infusion Plus High-dose Interleukin-2 in Patients With Metastatic Malignant Melanoma and Renal Cell Carcinoma

Conditions
-----------------
Metastatic Malignant Melanoma and Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Biological: Irradiated donor lymphocyte infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed malignant melanoma or renal cell carcinoma At stage IV or relapse At least one prior chemotherapy including targeted agents At least one haploidential or partially matched-HLA donor ECOG performance status 0-1 Age 18-75 years Measurable lesion Adequate bone marrow, liver, and renal functions Exclusion Criteria: Chemotherapy within 4 weeks Stem cell transplantation Active CNS metastasis Hypersensitivity to IL-2

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dose IL-2<br> | Biological: Irradiated donor lymphocyte infusion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-week modified immune-related response rate |  | 12-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-week modified immune-related response rate |  | 6-week | 
| Overall response rate based on RECIST v1.1 |  | 6/12-week | 
| Progression-free survival |  | 6-month | 
| Overall survival |  | 1-year | 
| Immune-related adverse events |  | 12-week |
The Use of Narrative in Public Health Research and Practice: Patient Experience of Wellness Acupuncture

Study Overview
=================
Brief Summary
-----------------
This study examined the experiences of individuals undergoing acupuncture to gather information on patient-provider communication and on the therapeutic effects of acupuncture.

Detailed Description
-----------------
Authentic voice is a approach involving the use of first-hand narratives from members of a target population in order to accomplish public health goals. In the first paper, a discussion of the potential of using narratives from the target population as 1) a direct intervention; 2) a form of persuasive communications; and 3) a source of information for research into various topics. The main premise is that traditional narrative methods can be adapted to the public health context by providing the narrator with the topic of the narrative. The second paper examines the patient experience of acupuncture using narrative drawn from interviews with and letters from acupuncture patients using a content oriented approach. The third paper examines the importance of meaning shift over the course of acupuncture treatment and demonstrates the usefulness of patient narratives as a data source for examining meaning. Findings include the need for intervention studies comparing authentic voice approaches to existing health communication tools for effectiveness in creating attitude and behavior change efficiently. Authentic voice approaches also need to be researched to understand and systematize concepts such as validity in relation to target-group derived narratives. Effectiveness of authentic voice for advocacy and research should also be further tested. Concerning acupuncture, the second and third papers show that acupuncture patients report a variety of benefits far wider than previously reported in the literature. Study designs should consider this wide range of benefits when assessing acupuncture outcome. Meaning shift is also reported by acupuncture patients and may play an important (but non-specific) role in the healing associated with acupuncture.

Official Title
-----------------
The Use of Narrative in Public Health Research and Practice: Patient Experience of Wellness Acupuncture

Conditions
-----------------
Pain, Depression, Fatigue

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: individuals seeking acupuncture from private practice in Baltimore/Washington metro area. Exclusion Criteria: prior patients

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

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
acupuncture, patient narratives, qualitative methods
Validation of Hand Held Indirect Calorimeter in Overweight and Obese Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine, in a group of overweight or obese volunteers, if a handheld indirect calorimeter can accurately measures oxygen consumption to determine resting metabolic rate compared to a portable indirect calorimeter.

Detailed Description
-----------------
Background and Rationale: With the growing number of overweight and obese Americans, health professionals need accurate and convenient tools to help personalize weight loss programs. Portable indirect calorimetry measurements are more expensive than handheld devices and often limited to research setting only, making them impractical for clinical use. Additionally equations used to estimate resting metabolic rate may be significantly inaccurate in overweight patients. Several studies have been conducted to determine the accuracy of handheld devices, however none have been done in the overweight and obese populations. If handheld calorimeters can accurately measure resting metabolic rate in overweight and obese patients, these tests may be used to improve and personalize weight management programs. Key Objectives: To determine in a group of overweight or obese volunteers if a handheld indirect calorimeter can accurately measures oxygen consumption to determine resting metabolic rate.

Official Title
-----------------
Validation of Handheld Indirect Calorimeter in Overweight and Obese Patients

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at least 18 years (no upper limit). Able to fast overnight. Have a BMI no less than 25 kg/m2. Exclusion Criteria: All others

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>People who will have the portable measurement taken first and handheld measurement taken second | |
| B<br>People who will have the handheld measurement taken first and portable measurement taken second | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate handheld calorimeter against a portable device |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity
Cerebral Tissue Oxygenation Values in Newborns Measured Using Laser and LED NIRS Oximeters

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the values of cerebral tissue oxygenation measured simultaneously using laser light (FORE-SIGHT) and LED (INVOS) cerebral oximeters.

Official Title
-----------------
A Comparison of Cerebral Tissue Oxygenation Values in Newborns Measured Simultaneously Using Laser and LED NIRS Oximeters

Conditions
-----------------
Cerebral Oxygenation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically stable Spontaneously breathing newborns Exclusion Criteria: Congenital heart defects or anomalies of central nervous system Prematurity below 32 GA Respiratory distress

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Day

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| term newborns<br> | |
| Preterm Newborns (32-37 GA)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of variability and repeatability of the recorded cerebral tissue oxygenation signals between two groups of patients (clinical stable preterm and term newborns) | There are two FDA-approved near infrared cerebral oximeters: FORE-SIGHT- which uses laser light INVOS 5100- which uses light emmiting diode. Measurements in adult patients have showed that FORE-SIGHT provides more stable signal. Purpose of our study is to compare these two devices in newborn patients. | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral oxygenation, NIRS, tissue oximeters, near infrared spectroscopy, newborn
Postoperative Analgesia After Laparoscopic Living Donor Nephrectomy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate if perioperative administration of pregabalin vil reduce postoperative pain and the postoperative need for intravenous opioids compared with todays standard treatment which consist of paracetamol, corticoids and ketobemidone. In addition potential sideeffects as sedation and effect on cognitive function will be recorded.

Official Title
-----------------
Perioperative Administration of Pregabalin in Laparoscopic Living Donor Nephrectomy (L-LDN) - an Adjuvance to Peroral Analgetic Treatment - a Randomized Controlled Study

Conditions
-----------------
Living Donors

Intervention / Treatment
-----------------
* Drug: Pregabalin
* Drug: Sugar pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18, < 75 years healthy patients accepted for laparoscopic living donor nephrectomy Exclusion Criteria: not familiar to the Norwegian language (spoken and written) allergic to one or more of the medication given in the study

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin<br> | Drug: Pregabalin<br>* 150 mg x 2 daily for 2 days<br>* Other names: Lyrica ATC-nr.: NO3A X 160;|
| Placebo Comparator: Sugar pill<br> | Drug: Sugar pill<br>* 1 tablet x 2 daily, for 2 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption in milligrams Pain Score given as Numeric Rating Scale (NRS) |  | Daily troughout the hospital stay, approx. 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation and cognitive function |  | Daily troughout the hospital stay, approx. 6 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney
Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is early identification of asphyxiated newborns through eeg starting in the delivery room.

Detailed Description
-----------------
There is a need for a reliable detector of birth asphyxia so that newborns with birth asphyxia can have timely and accurate diagnosis to receive therapeutic hypothermia within 6 hrs of life, which has been shown to significantly reduce deaths and improve long term developmental outcomes. This study is designed to record EEG during birth transition through the first 10 minutes of life.

Official Title
-----------------
Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury

Conditions
-----------------
Encephalopathy, Asphyxia Newborns

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term infants Signed Informed consent Exclusion Criteria: Known congenital anomalies

Ages Eligible for Study
-----------------
Minimum Age: 36 Weeks
Maximum Age: 44 Weeks

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EES<br>Epidermal Electronic System | |
| Hydrogel Electrode<br>Hydrogel based EEG electrode | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG recorded | May be up to 60 minutes if applicable | Birth to 10 minutes of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin irritation from EES or hydrogel electrodes | Redness, excoriation | 60 minutes of life | 
| Successful adhesion of EES to skin | Redness, excoriation | 60 minutes of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perinatal depression
Physical Conditioning in Management of Chronic Venous Insufficiency

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to evaluate the efficacy of a structured program of physical therapy in ameliorating the adverse consequences of Chronic Venous Insufficiency (CVI). The study will also investigate the interrelationship among measure of chronic venous diseases: lower limb muscle strength, mobility, and other symptoms of CVI important to the quality of life. Sixty patients will be randomized to a 6 months physical therapy program or to a control group.

Detailed Description
-----------------
The purpose of this research is to evaluate the efficacy of a structured program of physical therapy in ameliorating the adverse consequences of Chronic Venous Insufficiency (CVI). A secondary purpose is to investigate the interrelationship among measure of chronic venous diseases: lower limb muscle strength, mobility, and other symptoms of CVI important to the quality of life. Sixty patients will be randomized to a 6 months physical therapy program or to a control group. All subjects will undergo a complete hemodynamic and psychiatric assessment. Key measures will be repeated twice to quantify trend and stability of the baseline measures. Skin biopsies will be obtained in selected patients who demonstrate a response to the physical therapy to evaluate the ultrastructural response therapy. Physical therapy will be conducted 1-3 times per week. Participants will be visited at home and a program will be tailored for each individual to maximize compliance. Validated, standardized questionnaires (FIM, SF-36, OARS, CHART) and functional ratings will be employed at commencement,3,6 and 12 months. Evaluations of hydrodynamics, muscle strength, and ankle motion will be conducted monthly during active physical therapy. Participants in active therapy will be offered to wait listed control group after 6 months.

Official Title
-----------------
Physical Conditioning in Management of Chronic Venous Insufficiency

Conditions
-----------------
Venous Insufficiency

Intervention / Treatment
-----------------
* Procedure: Physical Conditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with severe form of chronic venous insufficiency

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Physical Conditioning|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
-----------------
Venous insufficiency, plethysmography, hypertension
Korean Transient Ischemic Attack eXpression Registry

Study Overview
=================
Brief Summary
-----------------
This study is to determine the clinical and neuroimaging characteristics of Transient Ischemic Attacks in Korean populations.

Official Title
-----------------
Transient Ischemic Attacks in Korean: Hospital-based, Multi-center Prospective Registry

Conditions
-----------------
Transient Ischemic Attack

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical symptoms and signs consistent with transient ischemic attack Subject who admitted hospital within 24 hours after symptom onset Subjects who underwent MRI (including diffusion-weighted images) and MRA (or CT angiography) Exclusion Criteria: Transient neurological symptoms due to Migraine aura Basilar migraine Seizures Syncope Peripheral vertigo Transient global amnesia

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| Vascular events including ischemic strokes, myocardial infarctions, cardiovascular deaths |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent transient ischemic attacks |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transient Ischemic Attack
Waiting Time to Operation for Hip-fracture Patients

Study Overview
=================
Brief Summary
-----------------
This study investigates the relationship between waiting time to surgery and the risk for medical complications and 1-year mortality in hip-fracture patients.

Official Title
-----------------
Waiting Time to Operation for Hip-fracture Patients

Conditions
-----------------
Hip-fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hip-fracture patient Exclusion Criteria: Periprosthetic fracture Pathological fracture
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hip-fracture patients<br>All the hip-fracture patients admitted to the Orthopaedic Depart of Danderyd Hospital between 1st June 2007- 1st June 2008 who fulfilled the inclusion criteria of the study. | |

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
-----------------
Hip-fracture
Micro-abrasive Blasting vs Acid Etching of Orthodontic Bracket Bases

Study Overview
=================
Brief Summary
-----------------
To describe a method of acid etching the base of a bracket, and to compare the bond failures between micro-abrasive blasted (sandblasted) brackets and acid etched brackets over an eighteen month period

Detailed Description
-----------------
The aims of this randomized control trial are: To describe a method to chemically etch the bases of stainless steel orthodontic brackets. To observe the changes in the micro-structure of the brackets with sandblasted bases and acid-etched bases under an electron microscope. To compare the failure of orthodontic brackets with a chemical etched base versus a sandblasted base bonded with composite using the conventional acid etch technique, over a follow-up of 18 months

Official Title
-----------------
Micro-abrasive Blasting vs Acid Etching of Orthodontic Bracket Bases: A Scanning Electron Microscope Study and an Eighteen Month Randomized Clinical Control

Conditions
-----------------
Orthodontic Appliances

Intervention / Treatment
-----------------
* Device: Acid etched brackets
* Device: Sandblasted brackets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients about to undergo fixed orthodontic therapy Exclusion Criteria: Patients with cavities, history of fixed orthodontic therapy, recent bleaching
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
Interventional Model Description: parallel-group, split mouth, triple blinded, randomized control trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acid etched brackets<br>Stainless steel bracket base etched with 10% Hydrofluoric acid for 1 minute | Device: Acid etched brackets<br>* The brackets will be bonded to the teeth with composite on the same patient in a split mouth design and observed for bracket debonding for 18 months<br>|
| Active Comparator: Sandblasted brackets<br>Stainless steel bracket sandblasted base | Device: Sandblasted brackets<br>* The brackets will be bonded to the teeth with composite on the same patient in a split mouth design and observed for bracket debonding for 18 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bond Failure Rate | To compare the bond failure rates between acid etched and sandblasted brackets. Done by calculating and comparing the percentages of bracket breakages between the acid etched and sandblasted bracket quadrants. | 18 months after placement of brackets on the teeth |