linjc16/ctgov huggingface dataset:
Laser Cataract Surgery With the Femtosecond Laser Technology

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to create a clear corneal incision during cataract surgery.

Official Title
-----------------
Laser Cataract Surgery With the Femtosecond Laser Technology

Conditions
-----------------
Cataracts

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study participants must have a cataract for which phacoemulsification extraction and posterior IOL implantation has been planned in at least one eye. Study participants should be capable of achieving better than 20/30 Snellen best corrected distance vision after cataract extraction and IOL implantation. The surgeon may use the Mento Potential Acuity Meter (PAM)laser interferometer, McIntyre Pinhole, or his/her judgement to estimate the patient's potential acuity. Exclusion Criteria: Concurrent participation or participation in the last 30 days in other clinical trials. Known steroid IOP responder. Taking medications that may affect vision, IOP, or ease of cataract surgery (e.g. Flomax, Glaucoma medications, etc.). Acute or chronic disease or illness that would increase risk or confound study results(e.g. uncontrolled diabetes mellitus, immunocompromised, etc.). Uncontrolled systemic or ocular disease. Corneal abnormalities (e.g. stromal, epithelial, or endothelial dystrophies) Pseudoexfoliation. Ocular hypertension (>or =20hg) or glaucomatous changes in the optic nerve.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Femtosecond Laser<br> | Procedure: Femtosecond Laser<br>* Using the Femtosecond Laser to make a clear corneal incision.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure | Measure the fluid pressure inside the eye. | three month | 
| Uncorrected and Best corrected Visual Acuity | Vision obtained with the best possible lens correction (Best corrected). Vision obtained without the use of glasses or contact lenses (Uncorrected). | three month |
Burn Scar Appearance After Treatment With Fractional Carbon Dioxide (CO2) Laser

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if fractional carbon dioxide laser treatment of a burn scar is a more effective method for improving the appearance of scars than the current available treatments.

Official Title
-----------------
Burn Scar Characteristics After Treatment With Fractional CO2 Laser: A Clinical and Histological Study

Conditions
-----------------
Scars

Intervention / Treatment
-----------------
* Device: Lumenis fractional carbon dioxide laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a mature burn scar and desire revision Fluent in English Must reside in the Los Angeles vicinity for the duration of the study Exclusion Criteria: Previous history of scar revision Non-English speakers Pregnant or cognitively impaired subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser treatment<br>Half of each subject's scar will be treated with a fractional CO2 laser. | Device: Lumenis fractional carbon dioxide laser<br>* Laser resurfacing of a burn scar<br>* Other names: Lumenis;|
| No Intervention: No treatment<br>Half of each subject's scar will not be treated. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of clinical improvement of burn scar appearance as determined by blinded-observer and patient ratings. |  | 2 weeks after each procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
burn scar, fractional carbon dioxide laser, scar revision
Anticoagulation in Gastroesophageal Varices and JAK2 Mutation

Study Overview
=================
Brief Summary
-----------------
Myeloproliferative neoplasms (MPNs), including polycythemia vera, essential thrombocythemia, and primary myelofibrosis, may lead to gastroesophageal varices. The quality of life, morbidity, and mortality of MPN patients mainly depend on disease-related symptoms, thromboembolic and hemorrhagic complications. Previous studies have shown that JAK2 V617F has a prominent role in vascular risk and MPN-associated gastroesophageal varices. The aim of this study is to evaluate the efficacy of anticoagulation in patients with JAK2 mutation and gastroesophageal varices.

Official Title
-----------------
Anticoagulation Treatment of Patients With Gastroesophageal Varices and JAK2 V617 Mutation

Conditions
-----------------
Gastroesophageal Varices, JAK2 Mutation, Myeloproliferative Neoplasm

Intervention / Treatment
-----------------
* Drug: Anticoagulation Agents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients aged 18-75 diagnosed as portal hypertension by contrast-enhanced computed tomography diagnosed as JAK2 positive Exclusion Criteria: not had portal contrast-enhanced computed tomography not had JAK2 mutation test other factors judged by the investigator that may affect the safety of the subject or the compliance of the trial. Such as serious illnesses (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anticoagulation group<br>Patients with JAK2 mutation and gastroesophageal varices receive anticoagulation agents. | Drug: Anticoagulation Agents<br>* Patients receive anticoagulation agents including low molecular weight heparin, warfarin, rivaroxaban, et al.<br>|
| Control group<br>Patients with JAK2 mutation and gastroesophageal varices who didn't receive anticoagulation agents. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of portal vein thrombosis | The changes of portal vein thrombosis including progression, disappear or unchanged. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of variceal bleeding | The occurrence of variceal bleeding including haematemesis and melena | 1 year | 
| Overall survival | Overall survival rate | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
portal hypertension, gastroesophageal varices, jak2 mutation, myeloproliferative neoplasm
Bariatric Surgery and Pharmacokinetics of Dexamphetamine

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on dexamphetamine are investigated.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics Dexamphetamine: BAR-MEDS Dexamphetamine

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Dexamphetamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dexamphetamine|Patients are tested for their normal prescription dexamphetamine medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dexamphetamine concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Dextroamphetamine
Protecting Health Care Workers During the COVID-19 Outbreak

Study Overview
=================
Brief Summary
-----------------
Preparing to deal with Covid-19 outbreak in Rajasthan, India, health care workers were given Ayurvedic Kadha (combination of ayurvedic herbal extracts) starting from the end of February 2020. Then, majority of these health care workers were put on front line managing screening, monitoring, quarantine and treating Covid 19 patients. This real-life study aimed to determine the experience of health care workers who had Ayurveda kadha before starting as front-line workers.

Official Title
-----------------
Protecting Health Care Workers During the COVID-19 Outbreak:Qualitative Study of AYUSH Initiative

Conditions
-----------------
Covid-19

Intervention / Treatment
-----------------
* Dietary Supplement: Ayurvedic Kadha


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health care workers posted in Covid-19 duties at front line Health workers who had Ayurveda herbs combination over for at least 10-days Exclusion Criteria: No willing to consent inability to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Ayurvedic Kadha|Kadha (also called Kwath and Kashaya) is a type of ayurvedic formulation prepared by boiling herbs in water. Water and herbs are main ingredients of these preparations. The preparation of Kadha uses dry herbs, which are dried under the sun or in the shade, as directed for the individual herb. Then, the herbs are pounded to form a coarse powder|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Health | Self-reported health issues | From baseline to 30-days | 
| Psychological Health | Self-reported psychological issues | From baseline to 30-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coping with distress | Self-reported coping with high demanding work in Covid-19 duties | From baseline to 30-days | 
| Self-Help | Self reported self-help measures used | From baseline to 30-days |
Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation

Study Overview
=================
Brief Summary
-----------------
To compare nitroglycerin and terbutaline for intrapartum fetal heart rate resuscitation

Official Title
-----------------
Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation

Conditions
-----------------
Fetal Distress

Intervention / Treatment
-----------------
* Drug: Terbutaline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:: nonreassuring fetal heart rate tracing Exclusion Criteria:- maternal cardiac disease, placental abruption, intrauterine growth restriction, prior cesarean section

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Terbutaline<br> | Drug: Terbutaline<br>* Terbutaline 250 micrograms intravenously for intrapartum fetal resuscitation. Nitroglycerine 400 micrograms intravenously for intrapartum fetal resuscitation.<br>|
| Active Comparator: Nitroglycerine<br> | Drug: Terbutaline<br>* Terbutaline 250 micrograms intravenously for intrapartum fetal resuscitation. Nitroglycerine 400 micrograms intravenously for intrapartum fetal resuscitation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resolution of abnormal fetal heart tracing |  | Administration of study medication to resolution of abnormal fetal heart tracing or operative delivery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cesarean section rate |  | Data analysis | 
| operative vaginal delivery rate |  | Data analysis | 
| neonatal outcomes |  | time of delivery to time of discharge |
Study of Insulin Pump Discontinuation in Adults With Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the rate of insulin pump discontinuation 18 months after initiation in patients with diabetes, and to determine factors associated with this discontinuation.

Detailed Description
-----------------
Insulin pump discontinuation has been mostly studied in children and young adults living with diabetes, and rarely with a time-to-event analysis. We aim to evaluate the rate of insulin pump discontinuation after 18 months from initiation and factors associated with it in adults with diabetes. Knowing these factors would allow better support for patients in difficulty.

Official Title
-----------------
Probability and Factors Associated With Early Discontinuation of Insulin Pump Therapy in Adults With Diabetes at the Center Hospitalier Sud Francilien

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Medical data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients (adults and adolescents) with diabetes and an insulin pump initiation from 1 January 2015 to 30 June 2018 in the diabetes department of the Centre hospitalier sud francilien. Exclusion Criteria: Pregnant women (or women planning pregnancy in the short term) with an insulin pump initiation from 1 January 2015 to 30 June 2018 Patients hospitalized for an insulin pump replacement or change between 1 January 2015 and 30 June 2018. Patients with a history of insulin pump initiation within a period of less than 6 months before a new pump start between 1 January 2015 and 30 June 2018.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Medical data collection|Collection of medical data from patients'medical records|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Permanent discontinuation of insulin pump use. | Insulin pump discontinuation is considered permanent if > 6 consecutive months with patient back to insulin pen and no use of pump-related consumables during the 6 months. | at 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Age of patient at the moment of insulin pump discontinuation. | at day 0 | 
| Sex | Sex of patient | at day 0 | 
| type of diabete | type 1 or 2 | at day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, type 1, Diabetes mellitus, type 2, Insulin Infusion Systems, Patient Education
Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms

Study Overview
=================
Brief Summary
-----------------
In this project the investigators study the safety and efficacy of the pipeline embolization device with vantage technology in treatment of unruptured brain aneurysms

Official Title
-----------------
Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms

Conditions
-----------------
Brain Aneurysm, Intracranial Hemorrhages, Stroke

Intervention / Treatment
-----------------
* Device: Pipeline Embolization Device with Vantage Technology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients treated with Pipeline Embolization Device with Vantage Technology (PEDV) MRA and/or DSA (or tomographic angiography) available for follow up Exclusion Criteria: Insufficient background data available e.g., to determine size of aneurysm and pipeline device PEDV used for causes other than aneurysms, e.g., fistulas and dissection.

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

| Intervention/Treatment |
| --- |
|Device: Pipeline Embolization Device with Vantage Technology|Flow-diverter device occludes aneurysms through endoluminal reconstruction and remodelling of the parent artery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate 30-day morbidity rates | We will evaluate short term clinical outcome in the form of morbidity rates 30 days after the procedure | Done at 30 days post procedural | 
| Evaluate 30-day mortality rates | We will evaluate short term clinical outcome in the form of mortality rates 30 days after the procedure | Done at 30 days post procedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate 1-year morbidity rates | We will evaluate long term clinical outcome in the form of morbidity rates >30days up to 1 year after the procedure | Done at >30days up to 1 year post procedural | 
| Evaluate 1-year mortality rates | We will evaluate long term clinical outcome in the form of mortality rates >30days up to 1 year after the procedure | Done at >30days up to 1 year post procedural |
A 2-Year Study of an Investigational Drug in Obese Patients (0557-011)

Study Overview
=================
Brief Summary
-----------------
This is a 2-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of MK0557 in Obese Patients

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

Intervention / Treatment
-----------------
* Drug: MK0557


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese men and nonpregnant women at least 18 years of age with a specific body mass index (height and weight ratio) required by the study Exclusion Criteria: Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0557|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight after 1 year of treatment. Safety and tolerability for 2 years. |  | After 1 & 2 years of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Durability of weight loss over two years. |  | Over two years. |