linjc16/ctgov huggingface dataset:
Primary Anatomical Versus Primary Electrophysiological Approach in Circumferential Pulmonary Vein Ablation

Study Overview
=================
Brief Summary
-----------------
Randomized comparison between 2 techniques of circumferential pulmonary vein ablation in paroxysmal atrial fibrillation: Primary anatomical ablation with secondary closure of possible electrical gaps versus primary electrophysiological ablation at the sites of atrio-venous electrical breakthroughs with secondary circumferential ablation around the pulmonary vein orifice

Official Title
-----------------
Circumferential Pulmonary Vein Ablation in Paroxysmal Atrial Fibrillation: Randomized Comparison Between a Primary Anatomical Versus a Primary Electrophysiological Approach

Conditions
-----------------
Paroxysmal Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: primary electrophysiological approach
* Procedure: primary anatomical approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: paroxysmal atrial fibrillation age over 18 years Exclusion Criteria: persistent atrial fibrillation reversible cause of atrial fibrillation inability to comply with follow-up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: 1<br>primary electrophysiological approach | Procedure: primary electrophysiological approach<br>* primary ablation of atrio-venous breakthrough sites followed by circumferential ablation around pulmonary vein orifice<br>|
| Active Comparator: 2<br>primary anatomical approach | Procedure: primary anatomical approach<br>* primary circumferential ablation around the pulmonary vein orifice followed by ablation of possible conduction gaps<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial tachyarrhythmias at 6-months follow-up |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of procedural characteristics (duration, fluoroscopy time, ablation time, ablation energy, complications) |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, paroxysmal, symptomatic, drug-refractory
Impaired Wound Healing in Diabetic Foot Ulceration

Study Overview
=================
Brief Summary
-----------------
An observational study to gather information about people who may have certain abnormalities in skin microcirculation and muscle metabolism and to determine whether these abnormalities affect wound healing. The study also examines the association of a specific type of cell with the rate of wound healing.

Detailed Description
-----------------
An observational study which entails: medical history; physical examination; blood tests; MRI; microcirculation tests (two noninvasive tests: 1) a procedure that measures the resting blood flow of the skin and 2) a technique that introduces acetylcholine and sodium nitroprusside in the skin and measures the ability of the skin's vessels to dilate and increase blood flow); and macrocirculation tests (noninvasive ultrasound of arm). This study also involves 2 Visits to the Beth Israel Deaconess Medical Center in Boston, MA. (Joslin-Beth Israel Deaconess Foot Center, Lowry Outpatient Laboratory, MRI Suite).

Official Title
-----------------
Impaired Wound Healing in Diabetic Foot Ulceration

Conditions
-----------------
Diabetes Mellitus, Healthy Volunteers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current diagnosis of Type I or Type II Diabetes Mellitus. Ulcer present for minimum 4 weeks Have adequate circulation to the foot Can return for follow-up visits Be able to read and sign the Informed Consent form before enrollment Exclusion Criteria: Active Charcot's foot ulcer on the foot to be studied Presence of any serious disease that can affect wound healing including end stage renal failure requiring hemodialysis or renal transplantation, active malignant disease requiring treatment, hepatic, hematologic, neurologic, or immune disease Alcohol or drug abuse problems Treatment with oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents Presence of infectious disease that can preclude EPC measurements (including HIV, Hepatitis B and C) Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |
Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia

Study Overview
=================
Brief Summary
-----------------
Validate pulse oximeter sensor SpO2 accuracy from 70-100% during induced hypoxia.

Detailed Description
-----------------
The testing is conducted on 10 healthy, consenting, non-smoking subjects in accordance with the IRB approved Protocol. The subjects shall be distributed across both genders and a range of skin tones as equally as practical. An arterial line will be placed in the radial artery of each subject's right arm, and sensors will be attached to each subject. The subjects will be placed in a semi-supine position and allowed to breathe through a mouthpiece while the nose is blocked with a nose-clip. Hypoxia will be induced by on each subject, as levels of oxyhemoglobin saturation (between 70% and 100%) are achieved by breathing mixtures of nitrogen, room air and carbon dioxide. Inspired O2 concentration will be adjusted breath-by-breath using a computed saturation, based on end-tidal PO2 and PCO2, as sampled by a mass spectrometer. Predicted levels of oxyhemoglobin saturations will be attained and held stable. At a minimum of sixty seconds into each plateau, a 0.5cc waste blood draw through the arterial line, followed by the first 1.0cc sample blood draw. After approximately thirty additional seconds, the second 1.0cc sample blood draw will be taken. The samples will immediately be analyzed by a Radiometer OSM-3 multi-wavelength co-oximeter and recorded. The SpO2 data from the oximeters will be collected via a laptop computer. Concurrent with the end of each blood draw, a marker will be generated on the laptop computers to identify the event.

Official Title
-----------------
Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia

Conditions
-----------------
Hypoxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-smoker 18 years or older Meet the requirements of the investigator's medical history questionnaire criteria which described family history, present symptoms, smoking history, risk factors, nutrition, exercise levels and stress levels Understand and provide signed consent for the procedure Exclusion Criteria: Smoker User of illegal drugs Hypertension Respiratory disease Known allergy to Lidocaine or its derivatives Those suffering from upper respiratory infection on the day of study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 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 |
| --- | --- | --- |
| SpO2 Accuracy Verification Study (Arms) of ≤ 3.0% between 70-100% |  | During Analysis - data were collected for all subjects on one day |
Autologous Blood for Full-thickness Macular Hole

Study Overview
=================
Brief Summary
-----------------
Autologous blood for primary and recurrent holes

Detailed Description
-----------------
Utilizing whole autologous blood for closing both primary and recurrent holes. Here, we apply a drop of the taken whole blood over the hole, and the access blood will be aspirated on the macula with a silicon-tipped active back-flash cannula, to abolish all the possibilities of the fibrinogenic behavior of the whole blood composition, which might cause traction and recurrent hole formation. Therefore, only the hole will be filled with blood. The blood will be taken under completely sterile and aseptic conditions. The air infusion will be raised after the valve of one of the trocars will be removed, to allow the air current to dry the clot inside the hole rapidly. Then air gas exchange will be performed to allow the clot to remain away from intraocular fluids for one to two weeks and abolish the possibility of the clot being dissolved.

Official Title
-----------------
Autologous Whole Blood for Closing Full-thickness Macular Hole

Conditions
-----------------
Ophthalmopathy

Intervention / Treatment
-----------------
* Other: Pars-plana vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary and recurrent holes Exclusion Criteria: Lamellar and pseudoholes
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: Utilizing autologous whole blood for the full thickness macular hole<br>It is an interventional study by performing pars-plana vitrectomy | Other: Pars-plana vitrectomy<br>* Pars-plana vitrectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical outcome | OCT | The fourth week post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome | Best corrected visual acuity | The fourth week post-operatively. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Full Thickness Macular Hole, Blood Clot, Whole blood, Pars-pana vitrectomy
Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar

Study Overview
=================
Brief Summary
-----------------
Determine if there is a difference in treatment response for adults with ADHD who are treated with Strattera versus those treated with a combination of Strattera and buspirone

Official Title
-----------------
Eight-Week, Double-Blind, 3-Arm Parallel, Placebo-Controlled, Randomized Efficacy And Safety Trial Of Atomoxetine, Atomoxetine Plus Buspirone, And Placebo In Adults With Attention Deficit Hyperactivity Disorder

Conditions
-----------------
Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
-----------------
* Drug: Atomoxetine
* Drug: Buspirone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with ADHD Exclusion Criteria: Other Axis I Psychiatric Disorders

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

| Intervention/Treatment |
| --- |
|Drug: Atomoxetine|nan|
|Drug: Buspirone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of Atomoxetine-Buspirone (ATX-BSP) vs placebo (PBO) and atomoxetine (ATX) monotherapy in adult patients with ADHD as measured by the mean change across 7 weeks in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the safety over 8 weeks of ATX-BSP as compared to PBO and ATX monotherapy. To assess the response rate for the 3 treatment groups based on AISRS and CGI scores. |  |  |
Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures

Study Overview
=================
Brief Summary
-----------------
This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.

Official Title
-----------------
An Open-label, Exploratory, Multicenter, Dose-escalation Study Examining the Efficacy, Safety and Tolerability of Ucb 44212 Used at Doses of 10 mg, 20 mg, 40 mg and 80 mg b.i.d. (Total Daily Dose of 20 to 160 mg) in Adult Subjects (18-65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures (Whether or Not Secondarily Generalized) and Treated With 1, 2 or 3 Approved Antiepileptic Drugs

Conditions
-----------------
Epilepsy, Partial

Intervention / Treatment
-----------------
* Drug: Seletracetam (ucb 44212)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males/Females from 18 to 65 years of age (minimum body weight of 40 kg) Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized. Subjects who have been treated for epilepsy for ≥6 months and are currently uncontrolled while being treated with 1-3 concomitant AED(s). Female subjects without childbearing potential; Female subjects with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method Exclusion Criteria: Seizures occurring in clusters. Status epilepticus within 6 months of Visit 1. History of non-epileptic seizures Subjects on vigabatrin Subjects on felbamate, unless treatment has been continuous for >2 years Ongoing psychiatric disease other than mild controlled disorders. Subjects with clinically significant organ dysfunction Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients Pregnant or lactating women. Subjects currently taking levetiracetam (LEV). Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant AEDs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Seletracetam (ucb 44212)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in seizure frequency over 11-week treatment period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy: partial onset seizures, seletracetam
Measuring the Effect of Radiation Therapy on Patient Activity Levels

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to measure the effect of radiation therapy on the activity levels of patients. This will be achieved by tracking their activity levels during a treatment course of radiation therapy.

Detailed Description
-----------------
At the University of Pittsburgh (UPMC) St. Margaret and UPMC Shadyside, in the department of radiation oncology, breast, prostate, head and neck, and lung cancer patients will receive the standard treatment for their cancer and in no way will this study interfere with this treatment. Prior to initiation of radiation, consenting patients will be given Misfit activity tracking devices (accelerometers) to be worn on their wrist to track their activity levels throughout the course radiation therapy. Bracelets will be given to patients by the PI or co-investigators (MDs involved in patient's care) at date of consent and returned at completion of the study. The bracelets will track daily steps taken, calories burned, miles walked, and restful and restless sleep. Again, the purpose of the study is merely to measure the affect radiation therapy has on activity levels of patients.

Official Title
-----------------
Measuring the Effect of Radiation Therapy on Patient Activity Levels

Conditions
-----------------
Head and Neck Cancer, Prostate Cancer, Breast Cancer, Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Breast, Prostate, Lung or Head and Neck Cancer Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Ability to walk 100 feet without rest Signed informed consent Exclusion Criteria: Any other noncutaneous cancer diagnosis under active treatment Known metastatic disease

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 |
| --- | --- |
| Head and Neck<br>Subjects with head and neck cancer receiving radiation therapy. | |
| Prostate<br>Subjects with prostate cancer receiving radiation therapy. | |
| Breast<br>Subjects with breast cancer receiving radiation therapy. | |
| Lung<br>Subjects with lung cancer receiving radiation therapy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity level | Misfit activity tracking devices (accelerometers) will be worn by patients to track their activity levels 1 day to 4 weeks before radiotherapy, during radiotherapy, and for 1 day to 4 weeks after radiotherapy. | up to 15 weeks |
Evaluate the Auxiliary Diagnostic Value of Circulating Tumor Cells in Benign and Malignant Lung Nodules

Study Overview
=================
Brief Summary
-----------------
By testing the CTC number of new solitary pulmonary nodule patient, evaluating the correlation of CTC number and benign and malignant lung nodules auxiliary diagnosis, the correlation of CTC number and the size of lung nodules of the malignant patients, the correlation between the CTC number and subtypes of malignant lung nodules patients.The CTC and tumor markers will be detected before the patient received treatment. Tumor markers include Pro-GRP, NSE, CEA, CYFRA211, SCC.

Official Title
-----------------
Evaluate the Auxiliary Diagnostic Value of Circulating Tumor Cells(CTC) in Benign and Malignant Lung Nodules

Conditions
-----------------
Solitary Pulmonary Nodule

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New Solitary Pulmonary Nodule patients first visit patient Heart, liver and kidney function is normal. 18-80 years old. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Blood collection time is not in the scheduled time. The plasma sample hemolysis or condensation. Whole blood samples less than 3 ml. poor compliance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| The number of circulating tumor cells will be detected in baseline by Immunomagnetic negative screening and targeted polymerase chain reaction(PCR) method. | The 3 mL of blood will be taked with each patient for CTCs detection. | 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The concentration of the tumor marker of pro gastrin releasing peptide(Pro-GRP) will be detected in baseline by Electrochemical luminescence. | The 2 mL of serum will be extracted. | 1 months | 
| The concentration of the tumor marker of neurone specific enolase(NSE) will be detected in baseline by Electrochemical luminescence. | The 2 mL of serum will be extracted. | 1 months | 
| The concentration of the tumor marker of carcinoembryonic antigen(CEA) will be detected in baseline by Electrochemical luminescence. | The 2 mL of serum will be extracted. | 1 months | 
| The concentration of the tumor marker of cytokeratin 19 fragments(CYFRA211) will be detected in baseline by Electrochemical luminescence. | The 2 mL of serum will be extracted. | 1 months | 
| The concentration of the tumor marker of squamous cell carcinoma antigen(SCC) will be detected in baseline by Electrochemical luminescence. | The 2 mL of serum will be extracted. | 1 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CTC, PCR