linjc16/ctgov huggingface dataset:
Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy

Study Overview
=================
Brief Summary
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Hemostasis will be achieved during Pediatric Tonsillectomy/Adenoidectomy with the use of QuickClot.

Detailed Description
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The Quickclot dressing contains Kaolin, a natural mineral that promotes the body's clotting process. This dressing will be applied for one minute to the area where the tonsils/adenoids were. The investigators are hoping to develop a standard of practice where Quickclot is a key addition for tonsillectomy surgery.

Official Title
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Hemostatic Control After Adenotonsillectomy- Open Label QuikClot Study.

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: QuickClot


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: diagnosis of adenotonsillar hypertrophy causing obstructive sleep disorders Exclusion Criteria: Patients with signs or symptoms of obstructed breathing recurrent pharyngitis history of bleeding disorder history of prior adenotonsillectomy

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 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
Interventional Model Description: Quickclot
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QuickClot<br>QuickClot sponge will be applied for one minute each site of tonsillectomy and Adenoidectomy. | Device: QuickClot<br>* 1 application of treatment to each tonsil/adenoid removal area<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds | After removal of the adenoids, a tonsil pack wrapped in QuikClot will be placed in the nasopharynx. The investigators will then perform tonsillectomy with the Microdebrider. A QuikClot roll will be placed in the tonsil fossa, and pressure applied via tonsil sponge for one minute. The contralateral tonsil will then be addressed with the same technique. The QuikClot adenoid pack is then removed and residual adenoidal bleeding is addressed with suction electrocautery, followed by placement of a second QuikClot adenoid pack. The tonsil rolls are sequentially removed, followed by control of residual hemostasis with suction electrocautery. A second set of tonsil rolls are placed. After adenoid pack is removed from nasopharynx and bleeding controlled, tonsil rolls are removed, followed by suction electrocautery for any residual hemostasis is performed. | at the time of surgery, 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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tonsillectomy, adenoidectomy, obstructive sleep apnea
Evaluation of a Non-Invasive Electrocardiogram-Assisted Blood Pressure Monitor

Study Overview
=================
Brief Summary
-----------------
Approximately one billion people suffer from hypertension worldwide. At least 10% of this population, that is, 100 million people, also suffers from associated chronic conditions namely, atrial fibrillation (AF), obesity, arterial stiffness (AS), and heart failure (HF). Personal interaction with medical practitioners (doctors) and review of published clinical research confirms that current non-invasive automatic blood pressure (BP) monitors that rely on BP pulse analysis alone cannot provide accurate measurement due to the unpredictable/weak nature of BP pulses in the above-mentioned chronic conditions. Lack of accuracy in BP estimation can lead to wrong diagnoses and hence to complications such as stokes and heart attacks. The Sponsor is developing a novel non-invasive BP monitor that is similar to existing automatic monitors yet is capable of acquiring and analyzing electrocardiogram (ECG) data in conjunction with BP pulse data to provide better and more accurate measurements in the above chronic conditions. The objective of this clinical trial is to evaluate the performance of this ECG-assisted BP monitor against invasive BP measurements in a small group of patients who suffer from the above conditions.

Official Title
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Evaluation of a Novel Non-Invasive Electrocardiogram-Assisted Blood Pressure Monitor Against Invasive Intra-Arterial Pressure Monitoring - A Pilot Study

Conditions
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Hypertension, Atrial Fibrillation, Obesity, Heart Failure, Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
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Inclusion: Patients undergoing an angiography in the catheterization lab who also suffer from at least one of the following chronic conditions: Established diagnosis of AF. Obesity characterized by a BMI > 40 (extremely high, Class III). Established diagnosis of AS. Established diagnosis of HF. Age ≥ 18 years. Exclusion: Patients unwilling or unable to comply with study requirements. Failure to sign the informed consent form. Age < 18 years.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Accurate and Consistent Blood Pressure Measurement | We expect to demonstrate that our automated non-invasive ECG-assisted BP monitoring technology can provide accurate and consistent diastolic & systolic pressure measurements in chronic patient conditions (namely AF, obesity, AS, and HF) in which current non-invasive oscillometric technologies tend to be unreliable. | 12 months |
Investigation of the Accuracy of a Low-cost, Portable, Autorefractor to Provide Well-tolerated Eyeglass Prescriptions

Study Overview
=================
Brief Summary
-----------------
At the Aravind Eye Hospital (AEH) in Madurai, India, patients ages 18-40 receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and objective refraction, by way of the QuickSee autorefractor. Patients will then be randomized into one of two treatment plans: receive glasses from objective measure first then subjective measure second, and vice versa. After one week of wearing the first pair of glasses, patient preferences are assessed, and glasses are switched. After a week of wearing the second pair of glasses from the alternate measurement method, patient preferences are again assessed. Patients may then decide which pair patient like best. This is a double blind, case-crossover clinical trial.

Official Title
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Investigation of the Accuracy of a Low-cost, Portable, Autorefractor to Provide Well-tolerated Eyeglass Prescriptions

Conditions
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Refractive Errors

Intervention / Treatment
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* Other: QuickSee refractive error assessment + glasses


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Participants- who visit a Vision Center for their eye check-up who are aged between 18 years and 40 years Exclusion Criteria: Participants- whose refractive error is not within the detection range of the QuickSee device: -10 to +10 D who have a cylindrical power greater than 3 D who have to travel long distances (beyond 10kms) to the hospital who choose to buy spectacles that are priced more than Rs. 2000/- per pair who have speech or hearing impairment who do not speak the local language, Tamil who do not want to purchase spectacles from AEH

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: OR Eyeglasses, then SR<br>Objective Refraction (OR) Eyeglasses, then Subjective Refraction (SR) | Other: QuickSee refractive error assessment + glasses<br>* QuickSee refractive error assessment + glasses<br>|
| Other: SR Eyeglasses, then OR<br>Subjective Refraction (SR) Eyeglasses, then Objective Refraction (OR) | Other: QuickSee refractive error assessment + glasses<br>* QuickSee refractive error assessment + glasses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Preference | Patients are asked the question Which eyeglasses did you prefer?. Patient response is then recorded. | 2 years |
Defining Reference Ranges for Cerebral Oxygenation In Neonates (COIN) During Immediate Neonatal Transition After Birth

Study Overview
=================
Brief Summary
-----------------
Especially in neonates non-invasive methods are required for monitoring the complex changes during immediate transition after birth to improve assessment of neonate and eventually resuscitation. During this period especially, the brain is vulnerable and monitoring the brain and possible influencing factors of cerebral oxygenation and perfusion are of great interest. To initiate and guide therapies based on cerebral oxygenation, it is important to define reference ranges.

Official Title
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Defining Reference Ranges for Cerebral Oxygenation In Neonates (COIN) During Immediate Neonatal Transition After Birth - a Prospective Observational Study

Conditions
-----------------
Neonatal Adaptation

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term and preterm neonates observed routinely at the resuscitation desk Decision to conduct full life support Written informed consent Neonates who require no respiratory or medical support Exclusion Criteria: No decision to conduct full life Support No written informed consent Congenital malformation Neonates who require respiratory and/ or medical support

Ages Eligible for Study
-----------------
Minimum Age: 0 Minutes
Maximum Age: 15 Minutes

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 |
| --- | --- |
| Term neonates<br> | Other: No Intervention<br>* no intervention<br>|
| Preterm neonates<br> | Other: No Intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of cerebral tissue oxygen saturation (crSO2) level | To measure cerebral oxygenation with Root (O3 regional oxymetry, Masimo, USA) non-invasively and continuously during the first 15 minutes after birth and establish the reference ranges in term and preterm neonates. | At each minute from minute 1 to minute 15 after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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percentile, cerebral oxygenation, neonate, immediate after birth
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring

Study Overview
=================
Brief Summary
-----------------
The Carevive registry collects patient characteristics, patient symptoms, and treatment experience data from patients receiving cancer treatment for breast, lung, GI or multiple myeloma. For this study, a core set of variables is collected on each patient in the Carevive platform. Patients will complete a baseline survey in person using a secured device or remotely using their own electronic device in a location of their choice. Weekly electronic Patient Reported Outcome surveys are collected from the patients using the Carevive platform for a minimum of 12 weeks. Patients may continue weekly surveys as long as they are receiving treatment.

Official Title
-----------------
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring

Conditions
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Lung Cancer, Breast Cancer, Gastrointestinal Cancer, Multiple Myeloma

Intervention / Treatment
-----------------
* Other: survey


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: All participants must be 18 years of age or older. Subjects may be any stage and anywhere in the treatment continuum. Subject participants must have a diagnosis of breast, lung, GI or ovarian cancer or multiple myeloma. Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer. All participants must be able to understand English. Exclusion Criteria: Any patient who cannot understand written or spoken English. Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer. Any patient on a treatment clinical trial. Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: survey|Patients will complete a baseline survey in person using a secured device or remotely using their own electronic device in a location of their choice. Weekly electronic PRO surveys are collected from the patients using the Carevive platform for a minimum of 12 weeks.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Create data set | Project outcome measures for this project are the prevalence, frequency, and severity of symptoms in each disease group, longitudinal change in symptom experience, and time on treatment from enrollment to next treatment. | 12 weeks |
Safety and Exploratory Efficacy Study of UCMSCs in Patients With Fracture and Bone Nonunion

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with fracture and bone nonunion.

Conditions
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Fracture, Bone Nonunion

Intervention / Treatment
-----------------
* Biological: UCMSCs
* Biological: Percutaneous


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every patient with non union in the site of bone fracture and nonunion. Age more than 18 and less than 60 years old. Nonunion or delayed union. Exclusion Criteria: Diagnosis of cancer. Pregnancy or breastfeeding. Patient positive by serology or PCR for HIV, hepatitis B or C infection the patient with Accompanied fracture such as hip fracture that could not weight bearing. Any medical or psychiatric condition that in the researcher´s opinion could affect the patient´s ability to complete the trial or hamper the participation in the trial. Patients do not sign the consent forms

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UCMSCs<br>Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) in patients with fracture and bone nonunion. | Biological: UCMSCs<br>* Transplatation of umbilical cord mesenchymal stem cells<br>|
| Placebo Comparator: Placebo<br>The patients with fracture and bone nonunion who underwent percutaneous injection of placebo. | Biological: Percutaneous<br>* Percutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological progression of bone fusion | After patients receiving mesenchymal stem cells or placebo, imaging control by X-ray and CT, and then analysis by software(ImageJ ) at 1, 6 and 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the rate of complications between the 2 groups |  | 12 months | 
| Incidence of increased temperature sensitivity by questionnaire |  | 6 months | 
| Incidence and severity of infections at grafting sites by questionnaire |  | 6 months |
The Effect of Cognitive Function Training Program for Community Elderly

Study Overview
=================
Brief Summary
-----------------
Background. Recently, cognitive function training program has been shown to improve cognitive function in elders. However, the effects of cognitive function training program on elderly living in the community have not been thoroughly evaluated. Objective. The purpose of this study is to construct and evaluate the effects of cognitive function training program on cognitive function for community elderly. Design. This is a randomized controlled study. Study subjects are elderly living in community. Subjects will be randomized into experimental group or active control group. The evaluation of the program will be evaluated at baseline, immediate after, 3 months, 6 months, and 1 year after the last session. The primary outcome indicators of the training is cognitive function, assessed by MMSE and MoCA. Expected contribution. With rigorous design and long term follow-up, the effectiveness of cognitive function training program in Chinese population in Taiwan can be evaluated. Results of the current study will determine the value of the cognitive function training program and provide valuable information for future utilization of this protocol.

Official Title
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The Effect of Cognitive Function Training Program for Community Elderly

Conditions
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Cognitive Function 1, Social

Intervention / Treatment
-----------------
* Other: Cognitive training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 years old Exclusion Criteria: TBI

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive traiinig<br> | Other: Cognitive training<br>* cognitive related training bu virtual reality system<br>|
| Active Comparator: Active control<br> | Other: Cognitive training<br>* cognitive related training bu virtual reality system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMSE | cognitive function | 12 weeks | 
| MoCA | cognitive function | 12 weeks |
COVID-19 Infection in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
It was observed during the last period of COVID-19 pandemic that diabetic patients had a worse prognosis and more deteriorated clinical features than other patients

Detailed Description
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Diabetic patients infected with SAR-COV-19 were reported to have worse prognosis and faster deterioration in addition to higher rate for ICU admission when compared to other infected patients. In this study authors aim to investigate the certain cause for their case deterioration to be modified for better prognosis

Official Title
-----------------
Clinical Features of Diabetic Patients With COVID-19 Infection

Conditions
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Covid19, Diabete Type 2, Non Diabetic Patients, Chest CT Scan

Intervention / Treatment
-----------------
* Other: no intervention as it is an observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients infected with COVID-19 male or female 30 years old or more inpatients Exclusion Criteria: have othe comorbidities other than type 2 diabetes mellitus pregnant women below 30 years old

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 |
| --- | --- |
| control group<br>COVID-19 infected patients with no other comorbidities and they take the routine protocol from the Egyptian ministry of health | Other: no intervention as it is an observational study<br>* both groups will be monitored for the disease progress or deterioration and mortality rate<br>|
| diabetic group<br>COVID-19 infected patients with diabetes comorbidity and they receive the routine protocol for covid treatment in addition to their hypoglycemic drugs | Other: no intervention as it is an observational study<br>* both groups will be monitored for the disease progress or deterioration and mortality rate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigation of bad prognosis cause for covid-19 diabetic patients | number of diabetic patients with deteriorated case and to find the best hypoglycemic drug used for diabetic patients with covid-19 infection | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, prognosis, mortality rate, Diabetes Mellitus