linjc16/ctgov huggingface dataset:
S(+)-Ibuprofen Effects on Asprin Treated Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to determine whether S(+)-ibuprofen affect the platelet inhibition under steady state acetylsalicylic acid conditions.

Official Title
-----------------
Double Blind, Randomised, Parallel Group, Placebo Controlled Clinical Trial of S(+)-Ibuprofen Effects on TxB2 Concentrations and Platelet Aggregation in Aspirin-treated Healthy Adult Volunteers

Conditions
-----------------
Drug Interactions

Intervention / Treatment
-----------------
* Drug: S(+)-ibuprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy caucasian volunteer Must be able to swallow tablets Exclusion Criteria: Underlying diseases Ulcus pepticum in history Abuse of alcoholic beverages (40g/d) Hypersensitivity to investigational medicinal products

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

| Intervention/Treatment |
| --- |
|Drug: S(+)-ibuprofen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of inhibition of TxB2 after 1, 3, 7 and 10 days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of subjects with >90% inhibition of TxB2, CEPI-CT and CADP-CT measured by PAF100, |  |  | 
| prostacyclin metabolite |  |  |
Insulin Resistance in Women With Prolactinoma

Study Overview
=================
Brief Summary
-----------------
Prolactin is suggested to influence insulin resistance, but scarce data is available on the metabolic profile of patients with prolactinoma. The purpose of the protocol was to evaluate cardiovascular disease risk factors in women with prolactinoma treated with dopamine agonists and to study the influence of disease control and anthropometry on their metabolic profile.

Detailed Description
-----------------
A cross-sectional study was performed in non-obese premenopausal women with prolactinoma treated with dopamine agonists evaluated regarding glucose, insulin, Homeostasis Model Assessment (HOMA), lipid profile, C reactive protein (CRP), body mass index (BMI), waist circumference, prolactin, estradiol, testosterone, and sex hormone binding globulin (SHBG). They were compared with control women of similar age and BMI distribution.

Official Title
-----------------
Insulin Resistance and Lipid Profile in Non-Obese Women With Prolactinoma Treated With Dopamine Agonists

Conditions
-----------------
Prolactinoma, Insulin Resistance, Hyperlipidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prolactinoma Female gender Premenopausal Exclusion Criteria: Obesity (BMI ≥ 30 kg/m²) Diabetes mellitus Hypertension GH deficiency Hypothyroidism Primary hypogonadism Adrenal insufficiency Pituitary surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 Years

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

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
-----------------
Insulin, glucose, lipids, prolactinoma, hyperprolactinemia
A Phase I Study of G3139 Subcutaneous in Solid Tumors

Study Overview
=================
Brief Summary
-----------------
Genasense® is currently administered to subjects in clinical studies as a multiple-day continuous intravenous infusion. Subjects are treated on an outpatient basis and carry a pump that delivers the drug through a peripheral or central intravenous line. The route of administration limits the convenience of treatment, and catheter-related complications have been reported. This study is designed to evaluate the pharmacokinetics and safety of G3139 administered by subcutaneuous injection.

Official Title
-----------------
A Pharmacokinetic and Safety Assessment of G3139 Administered by Subcutaneous Injection to Patients With Solid Tumors

Conditions
-----------------
Tumors

Intervention / Treatment
-----------------
* Drug: G3139, Oblimersen sodium, Bcl-2 antisense oligonucleotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A Confirmed diagnosis of a solid tumor malignancy, not to include lymphoma, that has failed standard therapy or for which no standard therapy is available. Patients with a history of brain metastasis will be eligible if there is no evidence of cerebral edema or treatment with steroids. Adequate organ function as determined < 7 days prior to starting study medication Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 At least 3 weeks and recovery from effects of major prior surgery or other therapy including radiation therapy, immunotherapy, cytokine, biological, vaccine and chemotherapy Exclusion Criteria: Significant medical diesese History of leptomeningeal disease Coexisting condition that would require the subject to continue therapy during the treatment phase of the study with a drug known to alter renal function. Use of any investigational drug within 3 weeks prior to starting study medication Known hypersensitivity to phosphorothioate-containing oligonucleotides Pregnancy/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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: G3139, Oblimersen sodium, Bcl-2 antisense oligonucleotide|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
-----------------
ECOG, MRT, NCI CTC, SAE, Short Intravenous Infusion to Patients with Solid Tumors
Correlation Between Upper Airway Endoscopy and Physiological Traits of Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES To train and test a mathematical model to predict complete concentric collapse at the level of the palate (CCCp, primary) and other sites of upper airway collapse (secondary) during drug-induced sleep endoscopy (DISE) using the data captured during a diagnostic polysomnography (PSG). HYPOTHESIS The site, pattern and degree of upper airway collapse is associated with distinct flow features as captured during a baseline PSG. STUDY DESIGN Retrospective trial. STUDY POPULATION 200 patients with moderate to severe obstructive sleep apnea (OSA, AHI ≥ 15/h) who underwent both a DISE and a diagnostic PSG at the Antwerp University Hospital (UZA) between January 2018 and December 2020. OUTCOME MEASURES: Raw data as captured during a diagnostic PSG, including electroencephalography (EEG), flow, electrocardiography (ECG), electromyography (EMG), oxygen desaturation and breathing effort. SAMPLE SIZE / DATA ANALYSIS Data of 200 patients will be retrospectively included into this study protocol. Different machine learning techniques will be adopted to select features, train the model and test the model. TIME SCHEDULE January 30, 2021 - November 30, 2021

Official Title
-----------------
Correlation Between Upper Airway Endoscopy and Physiological Traits of Obstructive Sleep Apnea: a Retrospective Study

Conditions
-----------------
Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older. Diagnosis with symptomatic moderate to severe OSA (AHI ≥ 15/h). Underwent DISE at UZA as part of the clinical pathway for non-continuous positive airway pressure (CPAP) therapies Underwent a baseline diagnostic PSG at UZA max 2 years before DISE Exclusion Criteria: Medication use related to sleeping disorders Central Sleep Apnea Syndrome. Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, periodic leg movements, narcolepsy). Seizure disorder. Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient). Pregnancy <4 h of data recording during the baseline PSG night

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 |
| --- | --- | --- |
| Airflow [l/s] | The primary outcome of this study is the effect of DISE site, degree and pattern of collapse on the airflow [l/s] as measured during the baseline polysomnography | Retrospective, measured during the baseline polysomnography study |
Alternatives to Hand Therapy for Hand Surgery Patients

Study Overview
=================
Brief Summary
-----------------
Patients will be asked to use a mobile phone app to conduct their hand therapy after having hand surgery.

Detailed Description
-----------------
Patients who are undergoing the included procedures will be informed of the study & consented. They will be given information on how to download the app & input their surgery date. The app will guide the patient through various hand therapy exercises and ask them to record their QuickDASH, PSFS and VAS Pain weekly.

Official Title
-----------------
Alternatives to Hand Therapy for Hand Surgery Patients

Conditions
-----------------
Carpal Tunnel Syndrome, Trigger Finger, Ganglion Cysts, Distal Radius Fracture, Finger Fracture, De Quervain Syndrome

Intervention / Treatment
-----------------
* Other: Mobile App


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing the following procedures: carpal tunnel release, trigger finger release, distal radius fracture fixation, de quervains release, cyst excision, finger fracture fixation smart phone that is compatible with the app Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>All patients will be given information about a mobile app to use during the recovery period to assist with hand therapy activities | Other: Mobile App<br>* a mobile app that demonstrates hand therapy exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QuickDASH | The QD is a short form of the DASH, which measures disability of the arm, shoulder and hand. it is scored 0-100, with higher scores indicating higher disability | once a week for 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Specific Functional Scale | the PSFS is a validated measure of disability, that is scored on a 0-10 scale with lower scored indicating higher disability. | once a week for 6 weeks | 
| VAS Pain | VAS pain is a validated measure of pain, scored 0-10, with higher scores indicating higher pain | once a week for 6 weeks |
Pharmacokinetics of Lenalidomide (Revlimid®) in Patients With Multiple Myeloma and Impaired Renal Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the pharmacokinetic profile of Revlimid® in patients presenting with Multiple Myeloma and impaired renal function, the safety of Revlimid® in the enrolled patients population. and evaluate the efficacy of Revlimid®-Dexamethasone combination in patients presenting MM and impaired renal function at completion of 3 cycles of treatment.

Conditions
-----------------
Multiple Myeloma, Impaired Renal Function

Intervention / Treatment
-----------------
* Drug: lenalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of relapsed or refractory multiple myeloma (MM). Age > 18 years at the time of signing the informed consent form Stable renal function Exclusion Criteria: Documented amyloidosis Any prior use of Revlimid ® Any contraindication to Revlimid ® and especially: Lack of acceptable method of birth control for female of childbearing potential (FCPB) Men who don't agree to use condom during the study and 4 weeks after the last study drug intake if their partner is a FCPB. Pregnant or breast feeding women

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1 to 5<br> | Drug: lenalidomide<br> <br> |

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
-----------------
Multiple Myeloma, impaired renal function
Research of Resistance to Antiplatelet Agents and Development of Tailored Treatment Model for Patients With Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the prognosis of patients with resistance to antiplatelet agent and develop tailored treatment model for patients with coronary artery disease.

Official Title
-----------------
Research of Resistance to Antiplatelet Agents and Development of Tailored Treatment Model for Patients With Coronary Artery Disease

Conditions
-----------------
Cardiovascular Diseases, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >20 Patients with coronary artery disease Patients with peripheral artery disease Exclusion Criteria: Renal dysfunction Hepatic dysfunction Major surgery planned within 1 year Malignant tumor History of gastrointestinal bleeding low or high platelet count

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Major adverse event | Major adverse event : overall mortality, cardiovascular mortality, target vessel revascularization | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker | homocysteine, Lp(a), fibrinogen, PAI-1, NTpro-BNP, hs-CRP, matrix metalloproteinase-9, soluble CD40L, IL-6, serum amyloid A, AGE | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antiplatelet Agents, Drug Resistance
Randomised Controlled Trial PFC Versus CKS Total Knee Prostheses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the functional outcome of two different total knee prostheses in a prospective randomised study.

Official Title
-----------------
A Prospective Randomized Double-Blind Study to Assess the Functional Differences Between the PFC and CKS Knee Prostheses

Conditions
-----------------
Osteoarthritis, Knee

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients on the waiting list for a TKA due to an invalidating gonarthrose as a result of osteo-arthrosis or secondary to a rheumatic disease or a trauma. Exclusion Criteria: patient suffering from juvenile rheumatic disease patient suffering hemophilia patient on the waiting list for posterior stabilized TKA or hinge joint. patient who suffers from a lesion of the ligaments due to surgery patient who is legally not capable to make decisions patient who suffer from cancer
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 |
| --- | --- | --- |
Determination of Forces Used in Palpatory Diagnosis

Study Overview
=================
Brief Summary
-----------------
In this study, we are experimentally investigating the assessment of forces used by skilled clinicians and beginning practitioners in palpatory techniques. The study will assess pressure used during palpatory diagnosis of the paraspinal region.

Detailed Description
-----------------
The study will assess pressure used during palpatory diagnosis of the paraspinal region. The research hypothesis is that both experience and gender will affect the amount of pressure exerted with diagnostic springing. The data will be valuable in characterizing practice parameters of novice and skilled osteopathic clinicians in palpation and will provide data on skill maturation from novice to experienced clinician. It will also allow far more precise teaching of these skills to students, who can use the transducers to determine how much pressure they are using compared to skilled clinicians. For measuring the palpatory forces, a thin film pressure transducer will be used in the hand of the clinician. Data will be collected on a portable computer via an analog to digital interface.

Official Title
-----------------
The Effect of Experience and Gender on the Palpatory Forces Exerted by Novice and Experienced Osteopaths in Australia

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: osteopathic student first year or senior or experienced osteopathic clinician Exclusion Criteria: none
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 |
| --- | --- |
| 1<br>first year osteopathic students | |
| 2<br>fourth and fifth year osteopathic students | |
| 3<br>experienced osteopathic clinicians | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| palpatory force exerted with PA springing |  | 3 minutes |
The Influence of MCIMT (Modified Constrained Induced Movement Therapy), Bilateral Intensive Treatment, and NDT Approach on the UL Function in Children With Hemiplegic Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study was to compare unimanual training (CIMT) and bimanual training (HABIT) protocols aimed to improve ability of the involved hand in children with hemiplegia. Both protocols were conducted in an educational setting for 2 hours a day for 2 months, one-hour group session and one-hour individual therapy session conducted by occupational therapists or assistants. The children in the CIMT group practiced various tasks using their involved hand with the contralateral hand constrained with a mitt. The children at the HABIT group practiced various bimanual tasks without constraint. Twelve children (2 - 6.5 yrs.) participated in this study. The inclusion criterion included minimal extension movement of the involved wrist, and for the CIMT group, the ability to of tolerates the mitt. The children were matched in relation to cognitive level and MACS score and randomly divided into the two intervention groups. Each child's assessment included the Quality of Upper Extremity Skills Test (QUEST), the Assisting Hand Assessment (AHA), and the Blocks and Box for children above age 5 yrs old. Range of motion (ROM) was assessed using an electronic gonimeter, and muscle tone was recorded using surface EMG and the Tardiue scale. The Child Health Questioner (CHQ) was completed by the parents before, and 6 months after, the intervention. Children were assessed starting two month before, and two month after, the intervention.

Conditions
-----------------
Hemiplegic Cerebral Palsy

Intervention / Treatment
-----------------
* Behavioral: treatment approach - CIMT
* Behavioral: treatment approach - HABIT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with Hemiplegia Exclusion Criteria: No ability for a minimal extension movement in the wrist

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: treatment approach - CIMT|CIMT, 2 months, 2Hr per day|
|Behavioral: treatment approach - HABIT|HABIT-2 months, 2Hr per day|

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
-----------------
Improving the assisting hand function in children with Hemiplegic Cerebral palsy