linjc16/ctgov huggingface dataset:
Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache

Study Overview
=================
Brief Summary
-----------------
The primary objectives of the Registry are to: Monitor the transfer of the ATI Neurostimulation System and its safety/clinical performance to a larger number of centers in the post market phase and Collect additional evidence to support reimbursement and clinical acceptance and long term follow up

Official Title
-----------------
Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache

Conditions
-----------------
Cluster Headache

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject meets CE marked labeling for cluster headache. Subject's typical cluster headache bouts last a minimum of 16 weeks, in the opinion of the Investigator. Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency or dose except to manage tolerability) from Study Enrollment through the completion of the Therapy Evaluation Period. Subject has the ability to read, comprehend and to reliably record information as required by the Protocol. Subject is able to provide written informed consent prior to participation in the study. Exclusion Criteria: Subject has had a change in type, dosage or frequency of taking preventive headache medications < one (1) month prior to Study Enrollment. Per the CE marked labeling: In the opinion of the Investigator, subject has bony facial deformities, inappropriate surgical anatomy or has had facial surgery in the surgical area on the same side as the planned surgery that would prevent the proper placement of the ATI Neurostimulator. Subject has other significant pain problem that might confound the study assessments in the opinion of the Investigator.
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 |
| --- | --- | --- |
| Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following: | Implantation of ATI Neurostimulator within the pterygopalatine fossa Explant and lead-revision rates and reasons | Through study completion | 
| Characterization of patient response to therapy, as evaluated by the following: | Patient acceptance of the therapy Responder Analysis, where a responder is any patient who achieves Effective Therapy in at least 50% of evaluable attacks, a 50% attack frequency attack decrease relative to Baseline, or both Disability and Quality of Life as characterized by the HIT-6 and SF-36v2 compared to Baseline Subject Overall Evaluation of Therapy Change in use of acute medications compared to Baseline Change in preventive medication use and work status compared to Baseline | Through study completion |
A Study Evaluating the Sonendo GentleWave™ System

Study Overview
=================
Brief Summary
-----------------
A post market, observational study evaluating the treatment of 1st and 2nd molars indicated for root canal therapy and treated with the Sonendo GentleWave System and obturated with CPoint and BC Sealer in at least one canal.

Official Title
-----------------
An Observational Study Evaluating the Sonendo GentleWave™ System and the EndoTechnologies CPoint™ Obturation for Treatment of Molar Teeth Requiring Root Canal Therapy

Conditions
-----------------
Root Canal

Intervention / Treatment
-----------------
* Device: Sonendo GentleWave™ System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is 18 years of age or older The subject tooth has been treated for root canal therapy with the Sonendo GentleWave System and obturated with CPoint and BC Sealer in at least one canal The subject tooth is a 1st or 2nd molar Exclusion Criteria: Vertical fracture, horizontal fracture, or perforation extending below the Cemento-Enamel Junction (CEJ) of the subject tooth Subject tooth having previous or attempted pulpectomy or root canal therapy

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: Sonendo GentleWave™ System|The Sonendo GentleWave System is intended to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject teeth that are healed or are healing at the twenty-four month follow-up visit. | Healed is defined by absence of a radiographic indication of apical periodontitis (Periapical Index Score < 3) and absence of clinical signs and symptoms. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
requiring therapy, Teeth
Impact of Sustained Virologic Response on Glycemic Control Among Diabetic Patients With Hepatitis C Virus Related Liver Disease

Study Overview
=================
Brief Summary
-----------------
Hepatitis C virus (HCV) is a major cause of chronic liver disease. The World Health Organization has reported that 170 million people are chronically infected with HCV globally. The highest prevalence of HCV infection worldwide exists in Egypt (15%); 90% of infection among Egyptian patients is due to genotype 4

Official Title
-----------------
Impact of Sustained Virologic Response on Glycemic Control Among Diabetic Patients With Hepatitis C Virus Related Liver Disease

Conditions
-----------------
Hepatitis c

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic HCV infection will be diagnosed based on positive testing for serum HCV RNA and anti-HCV Ab. Diagnosis of type 2 DM will depend on fasting level of serum glucose more than 126 mg/dl and/or serum level of HbA1c more than 6.5 % on oral hypoglycemic therapy. Exclusion Criteria: Chronic hepatitis due to causes other than HCV infection Coinfection with HBV infection Hepatocellular carcinoma Child C stage of liver cirrhosis. Patients with type I diabetes mellitus. Cardiopulmonary diseases. Major illness. Patient receiving corticosteroids. Patient refused consent.
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 subjected to: Baseline investigations, end of treatment investigations and 3 months after treatment investigations. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of patients with glycemic control | Exploring the impact of achieving SVR by directly acting antiviral drugs on glycemic control among diabetic patients with HCV infection. | 3 months |
Study To Assess Long Term Safety Of Pazopanib

Study Overview
=================
Brief Summary
-----------------
This study was a rollover study to evaluate the long term safety of pazopanib and to continue to provide pazopanib to patients who participated in a GSK sponsored pazopanib study until pazopanib is available commercially.

Official Title
-----------------
An Open-Label, Phase Ib Study to Assess the Long Term Safety Profile of Pazopanib in Cancer Patients

Conditions
-----------------
Carcinoma, Renal Cell

Intervention / Treatment
-----------------
* Drug: Pazopanib


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Participated or completed a GSK sponsored pazopanib study and remains eligible for continued treatment with pazopanib and lapatinib (if on combination therapy). Able to understand and provide written informed consent Women and men agree to use protocol specific birth control measures Key Exclusion Criteria: The subject has a treatment related serious adverse event that remains unresolved or unstable or had pazopanib permanently stopped in a previous study because of intolerate or because it was unsuccessful in treating your cancer If you are pregnant or breast feeding Your doctor does not think you would be a good candidate for the study Poorly controlled high blood pressure Subject is unwilling or unable to follow the procedures outlined in the protocol.

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications | Drug: Pazopanib<br>* Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the long-term safety of repeat daily doses of pazopanib in cancer subjects with solid tumors | To evaluate the safety assessments; adverse events, vital signs, physical examinations, electrocardiograms, multi-gated acquisition scans or echocardiograms (only for patients on pazopanib and lapatinib combination therapy), and clinical laboratory assessments. | Subjects will stay on the study as long as they are benefiting from treatment, have not met one of the stopping criteria, or experienced a toxicity up to 72 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic administration, monotherapy and combination therapies, solid, lapatinib (TYKERB, TYVERB), malignant tumor, Pazopanib, GW786034, cancer, safety
A Study Of Diflucan In Children With Ringworm Of The Scalp

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of fluconazole for the treatment of tinea capitis in pediatric patients aged 3 to 12 years.

Official Title
-----------------
An Open Label, Multicenter Trial Of Diflucan (Fluconazole) For 6 Weeks Given Once Daily To Pediatric Patients With Tinea Capitis

Conditions
-----------------
Tinea Capitis

Intervention / Treatment
-----------------
* Drug: fluconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients (aged 3-12 years) Clinical diagnosis of tinea capitis Direct microscopy (KOH) positive for fungal elements within or outside hair shaft Exclusion Criteria: Negative baseline KOH Liver disease

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 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: Arm A<br> | Drug: fluconazole<br>* Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined clinical and mycological outcome at Week 6 |  | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10 |  | Weeks 3, 6, and 10 | 
| Combined clinical and mycological outcome at Weeks 3 and 10 |  | Weeks 3 and 10 | 
| Mycological outcome based on culture results at Weeks 3, 6, and 10 |  | Weeks 3, 6, and 10 | 
| Culture results at Weeks 3, 6, and 10 |  | Weeks 3, 6, and 10 |
Comparison of Two-treadmill Test Protocols to Evaluate Endurance in People With Cancer

Study Overview
=================
Brief Summary
-----------------
During this study the investigators will compare the use of two treadmill tests in people diagnosed with cancer. The STEEP treadmill protocol is often used to evaluate the endurance of people diagnosed with cancer, however, since it is based on step increases in speed or ramp, it may not related to normal function. The new test, which is based on the body response to increased activity has not been used with people with cancer but may provide a better approximation of endurance demands during daily function. Our question is whether the new treadmill test can be used to evaluate aerobic function with people with cancer better than the STEEP treadmill test.

Official Title
-----------------
Comparison of Two-treadmill Test Protocols to Evaluate Endurance in People With Cancer.

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants are required to be adults (age 16 or over), Diagnosed with cancer, at any stage of treatment (during or after treatment), Able to follow instructions in English, and provide informed consent. Participants need to be considered well to participate. A well participant has been defined as a cancer survivor who is living at home, able to ambulate independently without a gait aid (single point cane is acceptable), has no acute medical conditions, and passes pre-exercise safety screening. Exclusion Criteria: Cancer survivors with metastatic disease. Cancer survivors who are defined as unwell.

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Treadmill test<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STEEP treadmill test | Treadmill test for endurance. Lasts approx 15 min with 45 min recovery | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treadmill, Exercise, Cancer, Validity, Reliability
Serum Pepsinogen After H. Pylori Eradication

Study Overview
=================
Brief Summary
-----------------
Helicobacter pylori has been recognized as a major pathogen in gastric carcinogenesis. Current guidelines recommend the H. pylori test-and-treat strategy for the purpose of primary and secondary gastric cancer prevention. Considering the point of no return theory, however, H. pylori eradication cannot reduce the risk of gastric cancer in subjects with gastric atrophy and intestinal metaplasia. The intragastric hypoacidic environment is associated with the risk of intestinal-type gastric cancer development. Recently, the secretory ability of the stomach can be measured using the serum pepsinogen (PG) assay.

Detailed Description
-----------------
This study aimed to evaluate the change of serum PGs after H. pylori eradication success and identify the optimal timing of eradication.

Official Title
-----------------
Serum Pepsinogen After Helicobacter Pylori Eradication for the Gastric Cancer Prevention

Conditions
-----------------
Helicobacter Pylori Eradication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gastroscopy can be performed Serologic markers including serum pepsinogen can be measured Exclusion Criteria: Age < 20 or > 70 years Anemia (serum hemoglobin level < 10 g/dL) Severe systemic disease Advanced chronic liver disease Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics History of H. pylori eradication History of gastric surgery Recent history of upper gastrointestinal bleeding

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Serum pepsinogen change after H. pylori eradication | Serum pepsinogen recovery | after 8 weeks |
Turmeric for Patients With Basal Joint Arthritis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess whether the use of a commercially available nutraceutical, turmeric, is an effective option to manage pain and stiffness in patients with basal joint arthritis. To conduct a pilot Randomized Controlled Trial evaluating the impact of turmeric on basal joint arthritis.

Official Title
-----------------
A Randomized Controlled Trial Using Turmeric for Patients With Basal Joint Arthritis

Conditions
-----------------
Thumb Osteoarthritis

Intervention / Treatment
-----------------
* Dietary Supplement: Turmeric
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 40 years of age or older English fluency and literacy Seeking care for basal joint pain Tender over basal joint Positive distraction rotation test (rotation of the thumb metacarpal base while applying axial traction) Radiographic evidence of Eaton stage 1 and 2 only Exclusion Criteria: Secondary gains (litigations or worker compensation) procedures that may interfere with patients' motivation for treatment Inability or unwillingness to participate in a trial study Rheumatoid Arthritis or other inflammatory disorder diagnoses Post-traumatic osteoarthritis Patients on Coumadin/Steroids/NSAIDs/Tylenol Diabetes Mellitus Pregnant or lactating women Basal joint arthritis of Eaton stage 3 Patients seeking other treatment for their basal joint arthritis (splint, corticosteroid injection, surgery)

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Turmeric<br>Subjects in this group will receive turmeric (100 mg pastille) 3 times per day for 6 weeks. | Dietary Supplement: Turmeric<br>* Subjects will receive turmeric (100 mg pastille) 3 times per day for 6 weeks.<br>|
| Placebo Comparator: Control<br>Subjects in this group will receive a placebo pill 3 times per day for 6 weeks. | Other: Placebo<br>* Subjects in the control group will receive a placebo 3 times per day for 6 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline pain intensity | 0-10 ordinal rating of pain intensity | Enrollment, 6 weeks, and 3 months | 
| Change in baseline disability | Disability measured by the QuickDASH | Enrollment, 6 weeks, and 3 months |
Retrospective Study to Review Patients at Risk for VTE at Hospital Discharge

Study Overview
=================
Brief Summary
-----------------
An investigator initiated study exploring VTE prophylaxis at the time of hospital discharge.

Detailed Description
-----------------
It appears likely that many patients will remain at risk for VTE at the time of hospital discharge. These risks will go unrecognized, and discharge prophylaxis orders will not be prescribed. To test this hypothesis, we will perform a retrospective review of approximately 2,500 patients at Brigham and Women's Hospital at risk for VTE at the time of hospital discharge to determine what proportion received VTE prophylaxis. We will correlate the implementation of discharge VTE prophylaxis with the occurrence of symptomatic DVT and pulmonary embolism within 90 days of hospital discharge. We will also conduct a substudy of this patient population to determine adherence to VTE prophylaxis among hospitalized patients.

Official Title
-----------------
VTE Prophylaxis Across the Continuum of Care: High Risk Patients at Hospital Discharge

Conditions
-----------------
Venous Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acutely ill medical and surgical patients with a risk score of 4 or greater without prophylaxis or a risk score of 4 or greater with anticoagulation at hospital discharge. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- |
| 1<br>Acutely ill medical and surgical patients who were hospitalized at BWH, and at-risk for VTE, but were not treated with prophylaxis at hospital discharge. | |
| 2<br>Acutely ill medical and surgical patients who were at risk for VTE at time of hospital discharge and prescribed a prophylaxis strategy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic PE/DVT within 90 days of hospital discharge. |  | 90 days |
Vascular Inflammation and Cholesterol Lowering Therapy

Study Overview
=================
Brief Summary
-----------------
This study aim to detect change in vascular inflammation following intense lipid lowering therapy

Official Title
-----------------
Vascular Inflammation and Cholesterol Lowering Therapy

Conditions
-----------------
Lipid Lowering, Vascular Inflammation

Intervention / Treatment
-----------------
* Drug: Evolocumab or Alirocumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: treatment with PCSK-9 inhibitors Exclusion Criteria: Infection Pregnancy Severe claustrophobia Weight >140 kg

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipid lowering<br> | Drug: Evolocumab or Alirocumab<br>* All patients are treated with PCSK-9 inhibitors (Evolocumab or Alirocumab) to lower cholesterol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vascular inflammation | Change in standard uptake value (SUV) of flourdeoxyglucose (FDG) before and after initiation of lipid lowering therapy | 12 weeks |