linjc16/ctgov huggingface dataset:
A User Study of SYNUS Pain Relief Made by Tivic Health Systems

Study Overview
=================
Brief Summary
-----------------
Demonstrate the ability of subjects suffering from sinus pain to self-treat with the SYNUS Pain Relief device and to obtain pain relief compared to a sham/placebo device.

Detailed Description
-----------------
A prospective study of at least 58 recruited subjects suffering from sinus pain. At least 30 of the subjects will be randomly selected to use the SYNUS Pain Relief device, a device that uses micro-currents to stimulate major nerve fibers passing from the sinus passages through various foramina to the facial skin. Subjects will read manufacturer's provided Instructions-For-Use (IFU's) and without help from staff will proceed to self-perform the treatment. The other subjects will follow the same procedure but use a sham/placebo device with no stimulating current. Subjects will be blinded as to the device they use. Prior to and 10 minutes following the stimulation, subjects will score their pain level on a visual analogue scale.

Official Title
-----------------
A User Study of SYNUS Pain Relief Made by Tivic Health Systems

Conditions
-----------------
Sinus; Inflammation

Intervention / Treatment
-----------------
* Device: SYNUS Pain Relief device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be 18 years of age and older Present with symptoms of sinus pain and pressure Have an initial sinus pain score of 4 or more on the visual analogue scale Be able to read and understand English Agree to participate in the study Be able and willing to provide Informed Consent Exclusion Criteria: Do not meet Inclusion Criteria Have currently a dental infection Have currently abnormal cranial nerve or other neurological findings or symptoms that would require prompt medical attention Be currently pregnant Have implanted electrostimulation devices including a pacemaker, a DBS or a cochlear implant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active device users<br>Users will use an active SYNUS Pain Relief device | Device: SYNUS Pain Relief device<br>* SYNUS Pain Relief is a handheld micro-current TENS device used for the temporary relief of sinus pain.<br>|
| Sham device users<br>Users will use a sham SYNUS Pain Relief device that is not providing treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | Average decrease in pain score of the SYNUS device is greater than the average decrease is pain score for the sham/placebo device. | 10 minutes |
Training Model on Insertion Techniques for Postplacental Intra Uterine Device

Study Overview
=================
Brief Summary
-----------------
This study aimed to compare special guided training model with standard procedure on insertion technique for post-placental intra uterine device that provides IUD location close enough to fundal part of uterus to prevent expulsion

Detailed Description
-----------------
The standard of insertion IUD postplacental can not provide prevention of expulsion. Special techniques on insertion IUD is needed for preventing expulsion. This training model is consisted of the special techniques to provide intra uterine device post placental close enough to fundal part of uterus to prevent expulsion

Official Title
-----------------
Study of Special Guided Training Model on Insertion Techniques for Postplacental Intra Uterine Device to Prevent Expulsion

Conditions
-----------------
Intra-uterine Device Complication

Intervention / Treatment
-----------------
* Behavioral: Training
* Behavioral: No Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 37-42 weeks gestation pregnancy women in delivery, singleton pregnancy, without any uterine anomaly Exclusion Criteria: Any bleeding and infection complication

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IUD new technique<br>Training | Behavioral: Training<br>* Training model is consist of effort to provide intra uterine device post placental by organising a special guided training model for post-placental IUD insertion by pushing the head of IUD using index and middle finger close enough to fundal part of uterus to prevent expulsion.<br>|
| Experimental: No Training<br>No Training | Behavioral: No Training<br>* Control of Training model is without training on effort of pushing the head of IUD using index and middle finger to uterine fundus.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with IUD total or partial expulsion | Transabdominal ultrasonography examination was done by researcher right after insertion. Ultrasonography examination was done using longitudinal and transversal scan, with client in supine position using real time convex 2 probe with 3,5 Mhz frequency. While transvaginal ultrasonography examination was done when the client come after 6 weeks, 6 months and 12 months after insertion. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with retained skill and knowledge |  | 12 Months |
Effect of the Extract of the Flour Fermented With Bacillus Subtilis Var Natto DC-15 on Postprandial Glucose

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to evaluate the effect of the extract of the flour fermented with Bacillus subtilis var natto DC-15 on postprandial glucose level in subjects with prediabetes.

Official Title
-----------------
A Randomized, Double-blind, Placebo Controlled, Crossover Study to Determine the Effect of the Flour Fermentation Products by Bacillus Subtilis Var Natto DC-15 on Postprandial Glucose Profile in Prediabetic Subjects.

Conditions
-----------------
Prediabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Bacillus subtilis var natto DC-15


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting plasma glucose 110-125 mg/dL Exclusion Criteria: Taking anti-diabetic drugs Taking drugs or functional food that may affect blood glucose level Pregnant or nursing a child Participation in any clinical trial within 90 days of the commencement of the trial Renal or hepatic dysfunction Heart disease History of severe disease and/or major surgery

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo (flour)<br>5 placebo capsules for each test (4.88 kcal/5 cap) | Dietary Supplement: Placebo<br> <br> |
| Experimental: Bacillus subtilis var natto DC-15<br>5 experimental capsules for each test (4.96 kcal/5 cap) Extract powder of the flour fermented with Bacillus subtilis var natto DC-15 | Dietary Supplement: Bacillus subtilis var natto DC-15<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in plasma glucose profile including AUC and Cmax after taking 50 g carbohidrate. |  | Overall 3 hours |
Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Hepatocellular carcinoma (HCC) is one of the most common malignant disease worldwide with an increasing incidence in industrialized countries. For patients with advanced HCC no efficient treatment is currently available. The objective of this study is to assess the efficacy and safety of octreotide in patients with advanced hepatocellular carcinoma.

Official Title
-----------------
Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma

Conditions
-----------------
Advanced Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Octreotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years HCC diagnosis : histologically or cytologically proven HCC or association of the three following criteria: cirrhosis typical measurable mass (> 3cm, by 2 methods) serum alpha-foetoprotein (AFP) ≥500 µg/L Cancer Liver Italian Program (CLIP) score : 0 to 3 Not eligible for specific treatment (surgery, percutaneous ablation or chemo-embolization) Exclusion Criteria: Glycemia > 2.5 g/L or hypoglycemia Extra hepatic life-threatening disease Serum creatinin> 120 µmol/L Prothrombin time < 50 % Platelet count < 50.000 /µL Symptomatic cholelithiasis Non-measurable tumor

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
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Octreotide<br> | Drug: Octreotide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response |  |  | 
| Survival without progression |  |  | 
| Digestive bleeding |  |  | 
| Renal insufficiency |  |  | 
| Quality of life |  |  | 
| · Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Octreotide, hepatocellular carcinoma
Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether powdered ginger root (encapsulated ginger) is effective for reducing the frequency, duration and severity of both acute and delayed nausea and vomiting.

Official Title
-----------------
Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens

Conditions
-----------------
Nausea, Vomiting

Intervention / Treatment
-----------------
* Dietary Supplement: Ginger
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be able to give written informed consent. Have a diagnosis of cancer and currently receiving chemotherapy containing cisplatin (any dose). Scheduled to receive antiemetics: granisetron (kytril), hydrocortisone. Must be able to complete study questionnaires. Must be able to swallow capsules. Exclusion Criteria: Have no clinical evidence of current or impending bowel obstruction. Concurrent radiotherapy that is classified as high or intermediate risk of causing emesis. Pregnant or lactating. Patients taking therapeutic doses of coumadin (individuals on low-dose to maintain peripheral or central venous catheters are allowed), aspirin (individuals taking low-dose 80mg aspirin are allowed), or heparin. Patients with a history of a bleeding disorder(s) in past 6 months and those experiencing thrombocytopenia.

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Dietary Supplement: Ginger<br>* Capsule, 1000 mg, BID, 3 days<br>|
| Placebo Comparator: 2<br> | Dietary Supplement: Placebo<br>* Capsule, 1000 mg, BID, 3 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea, Vomiting |  | 3 days |
Continuous Glucose Monitoring During Intecorse in Young Adults With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Determine the incidence of hypoglycemia during / after sexual intercourse among young adults with type 1 diabetes using continuous -type sugar meter IPRO for a week.

Detailed Description
-----------------
Determine the incidence of hypoglycemia during / after sexual intercourse among young adults with type 1 diabetes using continuous -type sugar meter IPRO for a week.

Official Title
-----------------
Continuous Glucose Monitoring During Intecorse in Young Adults With Type 1 Diabetes

Conditions
-----------------
Diabetes Mellitus Type 1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 1 diabetes Exclusion Criteria: type 2 diabetes other concomitant disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| Blood Glucose | Continuous glucose monitor for a week | week |
Intravitreal Bevacizumab for Management of Active Progressive Proliferative Diabetic Retinopathy (PDR)

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of intravitreal bevacizumab on the course of diabetic retinopathy in cases with the signs of active progressive PDR

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases of active progressive PDR with history of scatter laser photocoagulation Exclusion Criteria: history of vitrectomy
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: I<br> | Drug: bevacizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regression of diabetic retinopathy |  |  | 
| visual acuity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neovascularization |  |  | 
| fibrous proliferation |  |  | 
| traction retinal detachment |  |  | 
| vitreous hemorrhage |  |  | 
| pan retinal photocoagulation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neovascularization on disc (NVD), Proliferative diabetic retinopathy(PDR), Pan retinal photocoagulation (PRP), Vitreous hemorrhage, Traction retinal detachment, Neovascularization elsewhere (NVE), Fibrous proliferation on disc (FPD), Fibrous proliferaiton elsewhere (FPE)
Treatment of Peri-calcification Edema in Neurocysticercosis (NCC)

Study Overview
=================
Brief Summary
-----------------
Three-arm open, randomized comparative study of acetazolamide, dexamethasone, or no additional treatment to evaluate decrease in peri-calcification edema in neurocysticercosis

Detailed Description
-----------------
This study will evaluate 24 patients with calcified NCC and edema in three treatment arms to compare the reduction in edema volume

Official Title
-----------------
Open Controled Randomized Pilot Study on the Use of Acetazolamide and Dexamethasone for the Acute Phase of Perilesional Edema in Calcified Neurocysticercosis

Conditions
-----------------
Neurocysticercosis

Intervention / Treatment
-----------------
* Drug: Acetazolamide
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Calcified NCC Perilesional edema on CT or MRI Normal lab values Exclusion Criteria: Viable neurocysticercosis Status epilepticus Symptomatic intracranial hypertension Tuberculosis More than 7 days after seizure Pregnancy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetazolamide<br>750 mg acetazolamide p.o. divided in three dily doses, for 10 days | Drug: Acetazolamide<br>* As described above<br>|
| Active Comparator: Dexamethasone<br>8 mg p.o. divided in three daily daily doses, for 2 days followed by gradual tapering | Drug: Dexamethasone<br>* As described above<br>|
| No Intervention: No additional anti-edema treatment<br>No additional treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Volume of Perilesional Edema Between Baseline and Day 4 | MRI extension of edema | Baseline to Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Volume of Perilesional Edema Between Baseline and Day 8 | MRI extension of edema | Baseline to Day 8 | 
| Decrease in Volume of Perilesional Edema Between Baseline and Day 30 | MRI extension of edema | Baseline to Day 30 |
A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to estimate the safety and radiation dosimetry of a single dose of LMI1195 in healthy subjects and heart failure patients undergoing positron emission tomography (PET)

Official Title
-----------------
A Multi-Center, Single Dose, Phase I, Dosimetry, Biodistribution, and Safety Trial of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: LMI 1195-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Cohort 1 Inclusion: Healthy, age 18-40 Cohort 1 Exclusion: Significant or chronic medical illness Pregnant females Smoking within one month of enrollment Use of any prescription drugs within 4 weeks prior to dosing Cohort 2 Inclusion: 30-70 year old subjects with a diagnosis of NYHA Class II-III heart failure Ejection fraction less than or equal to 35% Rest SPECT imaging within 90 days prior to enrollment Cohort 2 Exclusion: Significant or chronic medical illness Pregnant females Known history of arrhythmogenic disorder or rhythm disorder

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Healthy Population | Drug: LMI 1195-101<br>* Single dose, bolus IV injection of LMI 1195<br>* Other names: LMI 1195-101 Clinical Trial;|
| Experimental: Cohort 2<br>Heart Failure Subjects with a documented ejection fraction of 35% or less, and a diagnosis of NYHA Class II-III heart failure, history of ventricular arrhythmia and ICD placement | Drug: LMI 1195-101<br>* Single dose, bolus IV injection of LMI 1195<br>* Other names: LMI 1195-101 Clinical Trial;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of LMI 1195 in terms of treatment-related adverse events | Number of study subjects exhibiting treatment-related adverse events | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation Dosimetry of a single dose of LMI 1195 | Radiation dose to organs defined by the MIRD model, in mGy/MBq | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, PET Imaging, Implantable Cardioverter-Defibrillator, Dosimetry