linjc16/ctgov huggingface dataset:
Auricular Stimulation for Relief of Stress and Anxiety

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate whether auricular stimulation (percutaneous sensory stimulation of cranial nerves) as compared vs. no intervention (waiting list) reduces stress and anxiety in health care providers, working at the time of COVID-19 pandemic at the University Medicine of Greifswald.

Official Title
-----------------
Auricular Stimulation (AS) vs. Waiting List for Relief of Stress and Anxiety in Health Care Workers During COVID-19 Pandemic - a Prospective Controlled Investigation

Conditions
-----------------
Stress and Anxiety

Intervention / Treatment
-----------------
* Other: Auricular stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical care workers at the University Medicine of Greifswald Experiencing stress and anxiety in connection with COVID-19 pandemic Participants without previous anxiolytic medication Ability to understand and fill in the structured questionnaire (Appendix D & E) Written informed consent Exclusion Criteria: Recidivist alcoholics Local auricular skin infection Pregnant or lactating women Participants with prosthetic or damaged cardiac valves and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of AHA) Participants who are unable to understand the consent form History of psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Prospective investigation during 15 weeks of treatment for each participant with waiting list control group (no intervention). Waiting group will receive the intervention (auricular stimulation) after 15 weeks of investigation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>This group is constituted from patients who will receive the intervention first within 15 weeks | Other: Auricular stimulation<br>* Auricular acupuncture-like stimulation (percutaneous sensory stimulation of cranial nerves)<br>|
| No Intervention: Waiting list<br>This group is constituted from patients who will receive the intervention after 15 weeks | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | State anxiety | 15 weeks of investigation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trait anxiety |  | Before and after 15 weeks of intervention application | 
| Sleep quality |  | 15 weeks of investigation |
Milk Supplementation and Energy Balance.

Study Overview
=================
Brief Summary
-----------------
The aim of the project is to determine if milk supplementation during a caloric restriction program facilitates the lost of weight, improves the appetite control and attenuates the decrease of bone mineral content in low-calcium consumer women.

Detailed Description
-----------------
Calcium deficiency is related to a higher risk of obesity. Some studies showed a lost of weight by elevating the calcium consumption to reach the recommended level. Milk supplementation could be a good alternative to reach this objective, but its impact on weight loss and on appetite sensations has not been verified. Furthermore, losing weight leads to some negative consequences like a decrease of bone mineral content. Considering the benefits of milk on bone health, a higher intake of this food product during weight loss could represent a healthy strategy.

Official Title
-----------------
Impact of Milk Supplementation on Body Composition, Bone Density and Satiety in Women Following a Weight Loss Program.

Conditions
-----------------
Obesity, Osteoporosis

Intervention / Treatment
-----------------
* Dietary Supplement: Supplementation of milk (35% more calcium)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low-calcium consumer (less than 800 mg daily) BMI between 27 to 42 kg/m2 Sedentary Healthy Exclusion Criteria: In menopause Medications that alter the project's objectives Smoker Dietary supplement consumer High alcohol or caffeine consumer

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Supplementation of milk (35% more calcium)|The supplement provides 1000 mg of calcium and 250 kcal daily.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition (body weight, fat mass, anthropometric measurements) |  | Baseline, month 1, and month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density (DXA) |  | Baseline and month 6 | 
| Appetite sensations |  | Baseline, month 1, and month 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Milk, Calcium, Weight loss, Bone density, Appetite
Far Infrared Radiation Treatment for Bipolar Condition

Study Overview
=================
Brief Summary
-----------------
A preliminary study to determine the possibility of using far infrared radiation for the treatment of the Bipolar Condition

Detailed Description
-----------------
A 2000 study in the American Journal of Psychiatry reported that, in those with bipolar, two major areas of the brain contain 30 percent more cells that send signals to other brain cells. This fact explains why famous people with the Bipolar condition like astronaut Buzz Aldrin, financier Robert Campeau, British Prime Minister Winston Churchill, composer Mozart, scientist Isaac Newton, physician Sigmund Freud and media giant & entrepreneur Ted Turner, excelled in life due to the additional brain power! The excessive brain power, however, had to be controlled occasionally with mood stabilizers. Mood stabilizers include a number of anticonvulsants and Lithium. These medications, however, have adverse side effects on the kidneys. The proposed evaluation does not have any adverse health effects.

Official Title
-----------------
Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Bipolar Condition

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Radiation: Far infrared


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons with Bipolar Condition, Depression, Anxiety, Stress and Insomnia Exclusion Criteria: Persons with severe mental illness that are confined to mental hospitals etc. as defined by the USA Diagnostic and Statistical Manual of Mental Disorders (DSM) are excluded from this clinical trial.
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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Radiation: Far infrared<br>* Far infrared radiation (5μm to 15μm wavelength)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point is to determine the therapeutic effects of far infrared radiation on bipolar condition. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary end point of the study is to evaluate the therapeutic effects of far infrared radiation on other related mental illness including Depression, Anxiety, Stress and Insomnia. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Affective Psychosis, Bipolar, Depression, Bipolar, Mania, Manic Disorder, Manic State, Manic-Depressive Psychosis, Psychoses, Manic-Depressive, Psychosis, Manic-Depressive
Genetic Polymorphisms & The Risk for Sepsis After Trauma

Study Overview
=================
Brief Summary
-----------------
The specific aim of this is to establish a cohort of severely injured patients admitted to our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from 3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms (SNP) (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death.

Detailed Description
-----------------
The specific aim of this is to establish a cohort of severely injured patients admitted to our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from 3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms (SNP) (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death

Official Title
-----------------
Genetic Polymorphisms & The Risk for Sepsis After Trauma

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Other: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to the Intensive Care Unit (ICU) at Harborview Medical Center after suffering a traumatic injury ability to obtain a 5 ml blood sample Expected to be in the ICU for more than 24 hours Exclusion Criteria: We will exclude subjects with chronic medical conditions for the reasons stated above as well as vulnerable populations (children, pregnant females, and prisoners)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| trauma patients<br>trauma patients 18 years or older requiring treatment in the ICU >24 hours. All subjects will undergo blood sampling. | Other: blood sampling<br>* 5 ml blood sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigators aim to identify up to 100 single-nucleotide polymorphisms (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death. | The investigators will be studying whether baseline genetic difference can be used in the future to identify patients at high risk and conversely those at low risk for complicated post-traumatic infections. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trauma, Sepsis
Social Media Use in Sickle Cell Patients

Study Overview
=================
Brief Summary
-----------------
Surveys of patients to identify primary social media sources for health news.

Official Title
-----------------
Social Media Use in Sickle Cell Patients

Conditions
-----------------
Survey, Family Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sickle cell disease diagnosis Exclusion Criteria: negative sickle cell disease diagnosis

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Media Use in Sickle Cell Patients | Surveys. The survey will have a variety of social media options and ask participants to select the medium used to receive information on health, news, and entertainment. | six months |
Treatment of Venous Malformation

Study Overview
=================
Brief Summary
-----------------
Vascular malformations are birth defects that happen when different stages of angiogenesis shut down. 44 - 64% of all vascular malformations are venous malformations (VMs). Sclerotherapy is the first treatment line for VMs. It acts by getting rid of the vascular endothelial cells in the lesion. One of the most common and well researched sclerosing agents for VMs is polidocanol, which is a popular counterpart for concentrated ethanol.

Official Title
-----------------
Treatment of Venous Malformation by Direct Puncture Repair: Ethanol Versus Polidocanol

Conditions
-----------------
Venous Malformation

Intervention / Treatment
-----------------
* Procedure: Direct Puncture Repair / Ethanol
* Procedure: Direct Puncture Repair / Polidocanol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with venous malformation of both genders and age above one year. Exclusion Criteria: Age below one year. Patients had any other vascular malformations. Indication for contrast material or Alcohol and polidocanol injection. Unfit for general anesthesia. 5) Pregnancy. 6) Skin infection, inflammation, and ulcers. Pulmonary embolism. Acute Ischemia, and acute DVT.

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 36 Years

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct Puncture Repair / Ethanol<br> | Procedure: Direct Puncture Repair / Ethanol<br>* Ethanol is an organic compound that will be injected in the venous malformation as a sclerotherapy by Direct Puncture Repair<br>|
| Active Comparator: Direct Puncture Repair / Polidocanol<br> | Procedure: Direct Puncture Repair / Polidocanol<br>* Polidocanol is a sclerosing agent that will be injected in the venous malformation by Direct Puncture Repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heaviness questionnaire | Heaviness of the affected part may be unchanged, or decreased or disppeared, or relapsed | 6 months post operative | 
| Disfigurement questionnaire | Disfigurementof the affected part may be unchanged, or decreased or disppeared, or relapsed | 6 months post operative | 
| size of venous malformation | it assess the size of malformations after injection; which may be unchanged, or decreased or disppeared, or relapsed | 6 months post operative | 
| Degree of satisfaction | It may be; Very satisfied, or satisfied, or not satisfied, or Dissatisfied. | 6 months post operative |
Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures

Study Overview
=================
Brief Summary
-----------------
The standard heart-lung machine is a major trigger of systemic inflammatory reactions, hemodilution, coagulopathy or organ failure. The strict reduction of blood-artificial surface and blood-air contact might represent meaningful improvements of the extracorporeal technology with respect to organ preservation. The aim of this study is the evaluation of potential differences between a minimal extracorporeal circuit (MECC) and a conventional cardiopulmonary bypass (MOPS) system.

Official Title
-----------------
Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures

Conditions
-----------------
Postoperative Bloodloss

Intervention / Treatment
-----------------
* Device: MECC
* Device: MOPS
* Device: Super MOPS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: extracorporeal circulation age > 18 years old

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MECC<br>Minimal extracorporeal circuit | Device: MECC<br>* Minimized extracorporeal circulation<br>|
| Placebo Comparator: MOPS<br> | Device: MOPS<br>* Modified and optimized perfusion system Frankfurt<br>|
| Placebo Comparator: Super MOPS<br> | Device: Super MOPS<br>* Super modified and optimized perfusion system Frankfurt<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bloodloss | Count of red blood packages | postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minimizing Cardiopulmonary Bypass MECC damage organ failure
Early Embryo Cleavage And Multiple Pregnancies After ICSI

Study Overview
=================
Brief Summary
-----------------
To observe whether Number of early cleavage embryos can be a predictor for multiple pregnancies after ICSI.

Detailed Description
-----------------
A total of 193 infertile couples, attending the ART unit, International Islamic Center for Population Studies and Research (IICPSR), -Al- Azhar University in the period from December 2010 to September 2012, were included in this study. The controlled ovarian hyperstimulation protocol was performed according to a long GnRH agonist protocol starting in the midluteal phase (day 21) of the preceding cycle. Embryos were assessed at 25 - 27 hr after ICSI for early cleavage. Embryos which reached the two cell stage at this interval were classified as Early Cleavage (EC) embryos, and the remaining as Non Early Cleavage (NEC) embryos. Embryos were assessed again at 64 - 68 hours post-ICSI for day-three embryo morphology. Day 3 embryo transfer was done. The best two or three embryos, according to day 3 embryo morphology were transferred. The patients were subdivided into two subgroups; one will transfer early cleavage embryos (EC) and the other will transfer non early cleavage embryo (NEC).

Official Title
-----------------
Early Embryo Cleavage And Multiple Pregnancies After ICSI

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: transfer early cleavage embryos
* Procedure: transfer non early cleavage embryo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >25 - 30 kg/m2 Have two ovaries Regular cycles first ICSI cycle Long midluteal GnRH protocol. Exclusion Criteria: uterine factor as a cause of female factor infertility pelvic masses or diseases (e.g: endometriosis, fibroids, hydrosalpnix, ...) history of medical disorders (e.g: hypertension, D.M, thyroid dysfunction, liver diseases, renal diseases,...) azoospermia as a cause of male factor infertility

Ages Eligible for Study
-----------------
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transfer early cleavage embryos (EC)<br>transfer early cleavage embryos | Procedure: transfer early cleavage embryos<br>* transfer early cleavage embryos<br>|
| Active Comparator: transfer non early cleavage embryo (NEC)<br>transfer non early cleavage embryos | Procedure: transfer non early cleavage embryo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| multiple pregnancy |  | 8 weeks |
Early Detection of noctUrnal hypoglyCemiA in TypE 2 Diabetes Using Pulse Rate Variability Measured by a Smartwatch(EDUCATED-Smartwatch)

Study Overview
=================
Brief Summary
-----------------
In patients with type 2 diabetes, it is necessary to identify and manage nocturnal hypoglycemia as early as possible, so as to reduce the damage caused by nocturnal hypoglycemia.We explore whether smartwatches can provide early warning of nocturnal hypoglycemic events in patients with type 2 diabetes by detecting changes in pulse variability.

Official Title
-----------------
Early Detection of noctUrnal hypoglyCemiA in TypE 2 Diabetes Using Pulse Rate Variability Measured by a Smartwatch(EDUCATED-Smartwatch)

Conditions
-----------------
Hypodlycemia

Intervention / Treatment
-----------------
* Device: Huawei Watch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. ≥18 years old 2.continuous glucose monitoring in patients with type 2 diabetes 3.Agreed to research into the group, and be able to sign the informed consent Exclusion Criteria: 1.Arrhythmia, such as sinus arrest, sick sinus syndrome, atrial fibrillation, atrial flutter 2.Such as acute or chronic infectious diseases,hyperthyroidism and thyroid function did not return to normal pregnancy 3.nursing mothers

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Huawei Watch|pulse rate variability measured by a smartwatch|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nocturnal hypoglycemia | hypoglycemia occuring during 0AM to 6AM | 8 months |