linjc16/ctgov huggingface dataset:
A Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron in Patients With Thyroid Scan Indication

Study Overview
=================
Brief Summary
-----------------
Prospective, open label single site study to demonstrate the safety and efficacy of Tc-99m pertechnetate produced by high energy cyclotron at CHUS.

Detailed Description
-----------------
The proposed clinical trial will be a prospective, case-controlled Phase I, open label, single site study. The first 10 consecutively enrolled patients will receive CYCLOTEC standard procedure thyroid imagery and an additional whole-body scans, and 20 subsequent case-matched controls, will receive GPERT and will also have additionnal whole body scan.

Official Title
-----------------
A Phase I Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron (CYCLOTEC) in Patients With Thyroid Scan Indication

Conditions
-----------------
Autoimmune Thyroid Disease, Congenital Hypothyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prescribed thyroid scan Provided written informed consent prior to participation Biochemical parameters within 5 times of the normal limits for age WBC count > 3.0/μL ANC count 1.5/μL Platelets > 75,000/μL Haemoglobin > 10 g/dL Karnofsky Performance Scale score > 50 Exclusion Criteria: Nursing or pregnant females Biochemical parameters as measured outside 5 times the normal limits for age within 14 days of the scan WBC < 3.0/μL ANC < 1.5/μL Platelets < 75,000/μL Haemoglobin < 10 g/dL Unable and unwilling to follow instructions and comply with the protocol Unable or unwilling to provide written informed consent prior to participation in the study Karnofsky Performance Scale score < 50

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cyclotec<br>The first 10 consecutively enrolled patients will have thyroid and whole body scan with CycloTec | |
| generator produced Tc99m-pertechnetate<br>20 subsequent case-matched controls will have thyroid and whole body scan with conventional Tc99m-pertechnetate | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biodistribution of Tc99m produced by high-energy cyclotron (CycloTec) | Equivalence of biodistribution of Tc99m produced by high-energy cyclotron (CycloTec) will be compared to the biodistribution of the conventional Tc99m pertechnetated (Case match: 1 CycloTec patient vs. 2 conventional Tc99m-pertechnetate patients) | 6 months |
Evaluation of Risk Factors for Gestational Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study examines the relationship between the age at menarche and gestational diabetes mellitus (GDM). In this retrospective study, the sample included all pregnant women diagnosed with GDM in a pregnancy polyclinic in Kocaeli, Turkey between 2014 and 2019. The sample included 373 participants: 233 in the GDM group and 140 in the control group. The groups were compared in terms of age at menarche.

Official Title
-----------------
Evaluation of the Relationship Between Age at Menarche and Gestational Diabetes Mellitus

Conditions
-----------------
Diabetes, Gestational, Menstrual Cycle Abnormal

Intervention / Treatment
-----------------
* Other: oral glucose loading test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women with gestational diabetes Exclusion Criteria: Patients with hypertension and pregestational diabetes mellitus Patients with rheumatologic, nephrological, and hematological diseases Presence of active infection, corticosteroid use, acetylsalicylic acid, and anticoagulant use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patients with gestational diabetes mellitus<br>study group | Other: oral glucose loading test<br>* oral glucose loading test was performed to all participants. gestational diabetes and control group were compared in terms of menarche age.<br>|
| Placebo Comparator: healthy participants<br>control group | Other: oral glucose loading test<br>* oral glucose loading test was performed to all participants. gestational diabetes and control group were compared in terms of menarche age.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational diabetes mellitus risk faktors | It was evaluated whether the menarche age of pregnant women with gestational diabetes was different from pregnancy without gestational diabetes. | From the 24th week of pregnancy to the delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
menarche, gestational diabetes mellitus, cycle, menstrual
Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old

Study Overview
=================
Brief Summary
-----------------
To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer

Official Title
-----------------
Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: BAY987517
* Drug: Sunscreen Lotion (RB# T78-190B)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be healthy, males or females between 3 to 9 years of age with no medical conditions of the skin. Subjects must have Fitzpatrick Skin Type I, II, III or IV. Subjects must agree to restrict their sun exposure activities for at least five days immediately preceding participation in the study. Exclusion Criteria: Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions. Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn as determined by the baseline skin evaluation. Subjects must not have significantly tanned skin.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 9 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987517<br>2/3 of subjects testing the test article | Drug: BAY987517<br>* Applied liberally to the skin (Formulation: RB# Z16-071)<br>|
| Active Comparator: Sunscreen Lotion<br>1/3 of subjects testing the marketed control | Drug: Sunscreen Lotion (RB# T78-190B)<br>* Applied liberally to the skin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3 |  | From the beginning of the study until 24 hours after study |
Evaluating the Effect of Perioperative Caloric Restriction Program on Perioperative Outcomes in Patients With Obesity and Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
80% of endometrial cancer patients are overweight or obese. Preclinical and clinical data have shown that caloric restriction (CR) protects against organ injury and decreases perioperative morbidity. This is a feasibility trial to evaluate the effect of a 6 week perioperative CR on surgical and patient-reported outcomes in 20 obese newly diagnosed endometrial cancer patients. The intervention will provide individualized CR program, meal replacement products and nutritional counselling sessions.

Official Title
-----------------
Evaluating the Effect of Perioperative Caloric Restriction Program on Perioperative Outcomes in Patients With Obesity and Endometrial Cancer

Conditions
-----------------
Obese, Endometrial Cancer

Intervention / Treatment
-----------------
* Other: Perioperative Caloric Restriction Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed with Endometrial Cancer BMI30 kg/m2 18 year of age or older Scheduled for definitive surgical intervention (hysterectomy, bilateral salpingoopherectomy with or without lymphadenectomy) in the following 2-3 weeks as part of the standard of care Have ECOG performance status of 0-1 Have a life expectancy of at least 1 year Exclusion Criteria: Inability to communicate in English BMI30 kg/m2 Age18 Have any uncontrolled serious medical or psychiatric conditions that would affect their ability to participate in an intervention study, (e.g., severe/uncontrolled diabetes mellitus, severe cardiac and/or pulmonary disease and/or depression) Diagnosed with any other invasive malignancy currently, in the last five years or expected to undergo active treatment with either cytotoxic chemotherapy or radiation during the 6 week caloric restriction period

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Calorie Restricted (CR) program<br>The intervention will provide individualized CR program, meal replacement products and nutritional counseling sessions. | Other: Perioperative Caloric Restriction Program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of completed perioperative caloric restriction program in obese newly diagnosed endometrial cancer patients |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
newly diagnosed patients
Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle

Study Overview
=================
Brief Summary
-----------------
The company suggests a new concept of treatment for PE: Transient inhibition of striated muscle contraction by a transcutaneous stimulation device. This study aim is to evaluate the safety of delivering increasing electrical stimulation intensities to the subject's perineum, using a TENS technique and equipment, followed by a 72-hour postoperative follow-up.

Official Title
-----------------
Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle

Conditions
-----------------
Premature Ejaculation

Intervention / Treatment
-----------------
* Device: TENS Stimulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy Ability to follow study instructions and complete study assessment tools Exclusion Criteria: History of cardiovascular disorders Any type of implanted pacemaker/defibrillator Hypertension Diabetes Mellitus Local dermatological disease Local skin irritation/lesions Any neurological disorder Any psychiatric disease and/or psychiatric medications

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

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

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

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

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TENS stimulator<br>Single day Transcutaneous electrical nerve stimulations utilizing a commercial TENS stimulator (TensMed S82 ENRAF-NONIUS) | Device: TENS Stimulator<br>* Initial stimulation of arm (conditioning) followed by Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle<br>* Other names: TensMed S82 ENRAF-NONIUS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Pain sensation score given by all subjects, as well as their verbal description of what they sensed during the various stimulations | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-treatment Adverse Events | Post treatment safety evaluation completed by subjects (using safety questionnaire) | 72 hours |
Endoscopic Ultrasound-guided Fine Needle Aspiration of Solid Masses: Histological and Immunohistochemical Evaluation

Study Overview
=================
Brief Summary
-----------------
The aim of this retrospective single center study was to evaluate the clinical utility of histological and immunohistochemical analyses of specimens obtained by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA).

Official Title
-----------------
Endoscopic Ultrasound-guided Fine Needle Aspiration of Solid Masses: Histological and Immunohistochemical Evaluation

Conditions
-----------------
Pancreatic Mass, Peripancreatic Mass

Intervention / Treatment
-----------------
* Procedure: EUS-FNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We retrospectively reviewed medical records of patients who underwent EUS-FNA to evaluate solid pancreatic or peripancreatic lesions from January 2009 to July 2010 Exclusion Criteria: Patients with unavailable data

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| EUS-FNA<br> | Procedure: EUS-FNA<br>* tissue samples were harvested from 116 patients undergoing EUS-FNA of solid masses for cytologic smear and histological analysis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the diagnostic accuracy of cytology, histology, and combined analysis of specimens obtained by EUS-FNA for pancreatic or peripancreatic solid masses | The first, pre-op checked each diagnostic accuracy of cytology, histology, and combined analysis by EUS-FNA. and then, finaly diagnosis following surgery or clinical follow up for at least 6 months was re-check with diagnosic accuracy of cytology, histology, and combined analysis pre-diagnosed by EUS-FNA | at least 6 months after surgery or clinical follow up |
Effect of Ulnar Styloid Fracture on the Outcome of Distal Radial Fractures Treated With External Fixation

Study Overview
=================
Brief Summary
-----------------
Untreated ulnar styloid fracture may affect the outcomes of distal radial fracture patient treated with external fixation.

Conditions
-----------------
Fracture of Distal End of Radius, Fracture of Ulnar Styloid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unstable distal radial fracture fixed with external fixator Exclusion Criteria: multiple fracture open fracture nerve injury vascular injury

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| wrist motion range | extension, flexion, radial deviation, ulnar deviation, forearm pronation and forearm supination | 3 months, 6 months, and 1 year | 
| ulnar sided pain | presence of ulnar-sided wrist pain during daily activities was recorded | 3 months, 6 months, and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiographic analysis | Standard anterior-posterior and lateral radiographs were obtained at each time point to evaluate fracture healing and the alignment of the distal part of the radius. Radial inclination, volar tilt, and radial height were measured | 6 weeks, 3 months, and 1 year |
Evaluation of a Six-session Psycho-education Group Program

Study Overview
=================
Brief Summary
-----------------
The aim of this project is to analyze the impact of a psycho-educational group program on the family members and close friends of persons with eating disorders and co-morbid personality disorders.

Detailed Description
-----------------
The aim of this project is to analyze the impact of a six session psycho-educational group program on the family members and close friends of persons with eating disorders and co-morbid personality disorders. Measurements: General health, perceived caregiver burden, and relation to the patient at the following point of time: pre -, post- and follow up, with waiting list control.

Official Title
-----------------
Evaluation of a Six-session Psycho-education Group Program Delivered to Family Members and Close Friends of Patients Suffering From Eating Disorders and Co-morbid Personality Disorders

Conditions
-----------------
Eating Disorders, Personality Disorders

Intervention / Treatment
-----------------
* Behavioral: psycho-education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relatives and close friends to persons receiving treatment for their eating disorder and comorbid personality disorder. > 18 years, Speak and understand norwegian language, and Informed consent to participate for both relative and patient.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: psycho-education<br>six session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders | Behavioral: psycho-education<br>* six session psycho-educational group program for family members and close friends of persons with eating disorders and co-morbid personality disorders<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on perceived caregiver burden (Experience of Caregiving Inventory [ECI]) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on general health and relational variables |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psycho-education, Eating disorders, Personality disorders, Relatives and close friends, Caregiver burden
A Study of the Inflammatory Pathways Associated With Chronic Obstructive Pulmonary Disease Exacerbations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe how the inflammatory pathways differ in subjects with chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD (AECOPD).

Detailed Description
-----------------
This is an observational study in adult male and female subjects with COPD to collect blood, endobronchial tissues and BAL to investigate the inflammatory genes/pathways associated with AECOPD at the time of exacerbation (ie, active disease) and at 6 weeks later (ie, stable disease).

Official Title
-----------------
An Exploratory Study of the Cellular Inflammatory Mechanisms Associated With Chronic Obstructive Pulmonary Disease Exacerbations

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physician-diagnosed acute exacerbations of chronic obstructive pulmonary disease Current or ex-smoker with a tobacco history of 15 or more pack years Females of childbearing potential must use birth control for the duration of the study. Exclusion Criteria: Evidence or history of clinically significant disease Subjects with asthma Subjects taking anti-leukotriene medications

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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 |
| --- | --- |
| COPD subjects<br>Adult male and female subjects with COPD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of how inflammatory pathways differ in COPD subjects | Identify how inflammatory pathways differ in subjects with COPD during an acute exacerbation relative to when the disease is stable. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker Sample Repository | Establish a biomarker sample repository to support future target validation for the treatment of subjects with COPD. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Obstructive Pulmonary Disease, COPD, Acute Exacerbation of COPD, AECOPD