linjc16/ctgov huggingface dataset:
Pathway CH-1 Long-Term Follow-Up

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for stimulation of the sphenopalatine ganglion (SPG) in cluster headache subjects.

Official Title
-----------------
Long-Term Follow-Up for the Pathway CH-1 Trial: Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has been implanted with an ATI Neurostimulator as a part of the Pathway CH-1 trial. Subject has completed the Pathway CH-1 Open Label Final office visit and remains implanted with an ATI Neurostimulator. 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 or requires a pacemaker/defibrillator or other implantable device having a sense amplifier that is programmed 'On.' Subject is not suitable for the study for any reason in the judgment of the Investigator.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pathway CH-1 Subjects<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for the stimulation of the SPG in CH Subjects. |  | Long-Term |
Study of Efficacy and Safety of Investigational Treatment in Patients With Nail Psoriasis

Study Overview
=================
Brief Summary
-----------------
Part 1 is a randomized, double-blind, placebo-controlled phase 1b study to evaluate AT193 in approximately 34 patients with nail psoriasis for 16 weeks. Part 2 is an open-label extension phase where all patients will receive active drug for an additional 16 weeks followed by a 2 week nontreatment period.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Phase 1b Study Followed by an Open-Label Extension to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Topical AT193 in the Treatment of Patients With Nail Psoriasis

Conditions
-----------------
Nail Psoriasis, Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: AT193


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of nail psoriasis for at least 3 months preceding study entry Diagnosis or history of plaque psoriasis or psoriatic arthritis A female participant of childbearing potential must use appropriate contraceptive measures during the study period A female participant of childbearing potential must have a negative urine pregnancy test result at screening Written informed consent must be obtained before any study procedure is performed Exclusion Criteria: Pregnant or breastfeeding Diagnosis of other active skin or nail diseases or skin or nail infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis History or evidence of a clinically significant disorder, condition, or disease that would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion in the judgment of the investigator

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AT193<br>Topical applied daily | Drug: AT193<br>* Topical applied to affected areas daily<br>|
| Placebo Comparator: Placebo<br>Topical applied daily | Drug: AT193<br>* Topical applied to affected areas daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events |  | 16 weeks |
Lived Experiences of Adolescents in the Treatment Process of Cancer and the Impact on Occupations

Study Overview
=================
Brief Summary
-----------------
The purpose of this phenomenological study is to discover and illuminate the experiences of adolescents in the treatment process of cancer and the meanings they attach to these experiences, while maintaining their daily routines. The focus area of interest lies in the impact side-effects (psychological and physical) which these treatments may have on an individual's ability to participate with peers, maintain social activities, and be involved in daily occupation(s).

Detailed Description
-----------------
This study will explore the following research questions: 1. How do adolescent patients in the treatment process of cancer perceive and describe their experience of engaging in occupational routines? 2. What effect does the treatment process of cancer have on an adolescent's ability to participate in life situations such as creating and maintaining relationships with family, friends, peers, students, or people with similar backgrounds? By doing this study, researchers hope to gain information so that occupational therapists can increase the profession's present body of knowledge and better understand these individuals at a transitional period in their lives.

Official Title
-----------------
Lived Experiences of Adolescents in the Treatment Process of Cancer and the Impact of Occupations

Conditions
-----------------
Pediatric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric cancer patients

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 19 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 |
| --- | --- | --- |
| Lifestyle changes | Participants will be interviewed for observations of disease effect. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lived Experiences, Adolescents, Cancer Treatment, Occupations
Evaluation of Gastrointestinal Motility With SmartPill

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the clinical usefulness of a capsule (SmartPill ) measuring pH, pressure and temperature from within the entire GI tract to determine gastric emptying time, combined small and large bowel transit time and total transit time. In addition, the Capsule will characterize pressure patterns and provide motility indices for the antrum and duodenum. It is believed that the condition of your digestive system can have a large impact on your overall physical health. Therefore,the investigators would like to assess whether using the pill device helps to determine any functional problems in patients in the ICU. The investigators are studying ICU patients because any change in their condition can have a large impact on their recovery.

Official Title
-----------------
Clinical Evaluation of SmartPill Capsule for Investigation of Total Intestinal Transit Time and Intestinal Pathology in Critically Ill Patients

Conditions
-----------------
Gastrointestinal Motility

Intervention / Treatment
-----------------
* Device: SmartPill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suffered from traumatic or non-traumatic intracranial hemorrhage and were admitted to an intensive care unit (ICU) at University of Louisville Hospital sedated and had tracheal intubation and mechanical ventilation older than 18 years Exclusion Criteria: younger than 18 years multiple injuries, especially abdominal trauma or inflammatory bowel disease history of complicated abdominal surgery or unknown type of abdominal surgery clinical evidence of ileus or suspected bowel obstruction a pacemaker

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill ICU patients<br>ICU patients with brain injuries who will be receiving a feeding tube. | Device: SmartPill<br>* Qualifying patients were assigned to the study within four days of hospital admission. They all received a gastro-duodenal tube and capsule. The motility capsule (SmartPill®) was placed into the capsule delivery device (AdvanCE™, US Endoscopy) and advanced blindly into the stomach and released<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transit time | The subjects were followed from the time of placement of the capsule in the stomach until the capsule was viewed in the stool or abdominal X-rays revealed it had passed from the body | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopy, Video Capsule, Motility, Gastrointestinal
A Bioequivalence Study Comparing Irbesartan/Atorvastatin Combination Tablet With Coadministration of Irbesartan and Atorvastatin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of Irbesartan and Atorvastatin in combination as HCP0912

Official Title
-----------------
Single Dose Open-label Comparative Pharmacokinetic Study to Assess the Pharmacokinetic Characteristics of Irbesartan and Atorvastatin Between Irbesartan/Atorvastatin Combination Tablet and Coadministration of Irbesartan and Atorvastatin Tablets in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: HCP0912 / Irbesartan and Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20 and 45 Signed informed consent form weight : over 45kg and in the range of ±20% of IBW Exclusion Criteria: Has a medical history of hypersensitivity to atorvastatin or irbesartan severe Hypotension Not eligible for subject in health examination within 28 days of IP administration

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCP0912<br>Irbesartan/Atorvastatin combination tablet | Drug: HCP0912 / Irbesartan and Atorvastatin<br>* Irbesartan and Atorvastatin combination tablet / coadministration of Irbesartan and Atorvastatin<br>|
| Active Comparator: Irbesartan and Atorvastatin<br>coadministration of irbesartan and atorvastatin | Drug: HCP0912 / Irbesartan and Atorvastatin<br>* Irbesartan and Atorvastatin combination tablet / coadministration of Irbesartan and Atorvastatin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of Irbesartan |  | 0-48 hrs | 
| AUC of Atorvastatin and 2-hydroxy atorvastatin |  | 0-48 hrs | 
| Cmax of Irbesartan |  | 0-48 hrs | 
| Cmax of Atorvastatin and 2-hydroxy atorvastatin |  | 0-48 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irbesartan, Atorvastatin, combination
Diagnosis and History Study of Patients With Different Neurological Conditions

Study Overview
=================
Brief Summary
-----------------
This protocol is a screening and natural history protocol, which allows for evaluation of patients and families where neurological conditions are present for enrollment into other studies and will also be used to screen healthy volunteers to create a pool of potential future HV matches for HMCS protocols. Through diagnostic evaluations, data will be collected for research use in this study. ...

Detailed Description
-----------------
This protocol is a screening and natural history protocol, which allows for evaluation of patients and families where neurological conditions are present for enrollment into other studies and will also be used to screen healthy volunteers to create a pool of potential future HV matches for HMCS protocols. Through diagnostic evaluations, data will be collected for research use in this study.

Official Title
-----------------
Diagnosis and Natural History Protocol for Patients With Different Neurological Conditions

Conditions
-----------------
Nervous System Disease, Healthy Volunteer

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Patients with neurological disorders and subjects with a family history of neurological conditions OR Healthy volunteers: People age 18 or older who are generally in good health. EXCLUSION CRITERIA: Patients <2 years old. Employees of HMCS in NINDS.

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| family members<br>Family Members who are 2 years old or older of people with a neurological disorder | |
| healthy volunteers<br>healthy volunteers age 18 and older | |
| patients<br>subjects with neurological disorders who are 2 years old or older | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to screen patients with neurological conditions and family members of patients with neurological conditions for enrollment in additional research protocols | The goal is to screen patients with neurological conditions and family members of patients with neurological conditions for enrollment in additional research protocols. No investigational treatments will be administered on this protocol and the NIH physicians will be playing a consultative role to the patient s primary physician. | ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteer, Nervous System Disease, Natural History
Safety and Efficacy of a Glaucoma Drug Delivery System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: High Dose Device
* Drug: Low Dose Device
* Device: Placebo Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman 21 years of age or greater must have open angle glaucoma or ocular hypertension. Corrected visual acuity in each eye of 20/200 or better. Exclusion Criteria: Previous glaucoma intraocular surgery or refractive surgery. Planned contact lens use during the study. Clinically significant ocular or systemic disease that might interfere with the study. Use of chronic corticosteroids by any route.

Ages Eligible for Study
-----------------
Minimum Age: 21 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose Device<br>device worn continuously for 14 days | Drug: High Dose Device<br>* inserted for 14 days<br>|
| Experimental: Low Dose Device<br>device worn continuously for 14 days | Drug: Low Dose Device<br>* inserted for 14 days<br>|
| Placebo Comparator: Placebo Device<br>device worn continuously for 14 days | Device: Placebo Device<br>* inserted for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity - Right Eye | This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | at 14 days | 
| Visual Acuity - Left Eye | This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | at 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) |  | from baseline to 14 days |
A Study of Olynth Saline/Ectomed Nasal Drops/Spray Based Upon Previous Usage

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to proactively collect customer feedback on the performance aspects and risk factors of Olynth Nasal Saline Drops/Spray and Olynth Ectomed Nasal Spray.

Official Title
-----------------
A Non-Interventional Clinical Study to Assess the Risk and Performance Aspects of Olynth Saline/Ectomed Nasal Drops/Spray Based Upon Previous Usage

Conditions
-----------------
Common Cold, Sinusitis, Hypersensitivity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or older who has personally used or administered the nasal drops/spray to a child Has personally used or administered to a child, the Nasal Drops/Spray at least once within the past 6 months Able to read, write, speak, and understand German Has internet access to complete an on-line survey Intends to complete the survey Individual has signed the informed consent document (ICD) Exclusion Criteria: - Is an employee/contractor or immediate family member of the principal investigator (PI), Schlesinger group, product perceptions limited (PPL) Insights or sponsor of this study

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 |
| --- | --- |
| Olynth Nasal Saline Drops/Spray and Olynth Ectomed Nasal Spray<br>Participants who have personally used or administered the Olynth Nasal Saline Drops/Spray and Olynth Ectomed Nasal Spray to a child at least once within the past 6 months will provide feedback via electronic survey on the prior use of the Drop/Spray. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Feedback on the Performance Aspects of Olynth Nasal Saline Drops | Participant feedback on the performance aspects of Olynth Nasal Saline Drops will be assessed via electronic survey. | Up to 1 month and 14 days | 
| Participant Feedback on the Performance Aspects of Olynth Nasal Saline Spray | Participant feedback on the performance aspects of Olynth Nasal Saline Spray will be assessed via electronic survey. | Up to 1 month and 14 days | 
| Participant Feedback on the Performance Aspects of Olynth Ectomed Nasal Spray | Participant feedback on the performance aspects of Olynth Ectomed Nasal Spray will be assessed via electronic survey. | Up to 1 month and 14 days | 
| Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in participants, users or other persons, whether or not related to the investigational device. | Up to 1 month and 14 days |
Tolerability of Switching to Duloxetine for the Management of Diabetic Nerve Pain

Study Overview
=================
Brief Summary
-----------------
This study is to compare the tolerability of different methods for switching from another medication to duloxetine for the management of diabetic nerve pain. The primary objective is to compare the most gradual method with the most abrupt method, to see if they have different tolerability.

Official Title
-----------------
A Comparison of Strategies for Switching Patients From Amitriptyline to Duloxetine for the Management of Diabetic Peripheral Neuropathic Pain

Conditions
-----------------
Diabetic Neuropathy, Painful

Intervention / Treatment
-----------------
* Drug: duloxetine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You must have been diagnosed with Diabetic Peripheral Neuropathic Pain. You must have been taking the same dose of amitriptyline once daily at bedtime for at least four (4) weeks. You must have stable glycemic control. You must be able to visit the doctor's office once a week for ten (10) weeks. Exclusion Criteria: You are in the acute recovery phase following myocardial infarction. You have Major Depressive Disorder, an Anxiety Disorder, or some other psychiatric illnesses that the doctor will ask you about. You are allergic to amitriptyline or duloxetine. You are currently taking an anticonvulsant, cisapride (Propulsid), or if you have taken an opioid for three or more consecutive days during the 14 days prior to Visit 2. You have uncontrolled narrow angle glaucoma.

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: duloxetine hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subscale of the UKU side effect rating scale to be measured during the switch period. The weeks during which the switch occurs are blinded. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily: 24 hr avg pain, worst pain, night pain; NSAID & acetaminophen use. |  |  | 
| Weekly: Leeds Sleep Evaluation Questionnaire, Brief Profile of Mood States, Clinical Global Impression of Severity. Visits 2, 7, 11: Treatment Satisfaction Questionnaire for Medic |  |  |