linjc16/ctgov huggingface dataset:
Sugammadex Administration in Pregnancy

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators aimed to evaluate the maternal and fetal effect of sugammadex in pregnant patients undergoing a non-obstetric surgery. The investigators mainly focused on the short- and long-term adverse effects such as an abortion or a teratogenic effect and that may occur in fetus and the adverse effects that may be seen in mother.

Detailed Description
-----------------
Since the approval in Europe in 2008, sugammadex has been widely studied among pregnant patients in the context of cesarean deliveries. However, the use of sugammadex in pregnant patients undergoing a non-obstetric surgery is not clearly defined. The package insert indicates that there are no data on its use in pregnant women regarding the drug-associated risks. There are some questions raised, and answers needed from the scientific community about the maternal and fetal effect of sugammadex administered in pregnant patients. This is a retrospective case-control cohort study which was conducted in a single-center territory university hospital. The investigators used the hospital information management system for determining the patients that are eligible for inclusion. Patients operated between January 2017 and june 2022 were included in the study. Patient data was obtained by manual review of anesthesia charts of eligible patients. Pregnant patients who underwent a non-pregnancy surgical intervention within the study period were included in the study.

Official Title
-----------------
Maternal and Fetal Outcomes of Sugammadex Administration During Pregnancy: A Retrospective Cohort Study

Conditions
-----------------
Sugammadex, Pregnant, Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women who were operated under general anesthesia during pregnancy and who used sugammadex during the awakening phase. Exclusion Criteria: Patients with severe hepatic and renal impairment Patients with missing data Patients with fetal anomaly detected before the procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Fetal outcome | Determined by using APGAR score. | one week postoperatively | 
| Preterm labor | Labor that starts before 37 completed weeks of pregnancy. | Labor that starts before 37 completed weeks of pregnancy |
Extended Work Schedules, Sleep Loss and Health

Study Overview
=================
Brief Summary
-----------------
This study aims to determine whether abnormal bodily rhythms contribute to elevate the risk of diabetes, independently of the amount of sleep loss.

Official Title
-----------------
Extended Work Schedules and Health: Role of Sleep Loss

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Behavioral: Fixed restricted bedtimes
* Behavioral: Sleep restriction with circadian misalignment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal healthy men and women between the ages of 21 years and 39 years (inclusive) with normal weight (i.e., body mass index under 28 kg/m2 in men, 27 kg/m2 in women) normal findings on clinical examination, normal results on routine laboratory tests, normal EKG, normal glucose tolerance test, negative pregnancy test for women no personal history of psychiatric or endocrine illness no personal history of sleep disorder, usual total sleep time of at least 7 hours only female volunteers with normal ovulatory cycles will be included Exclusion Criteria: subjects with irregular life habits (shiftworkers and subjects having traveled across time zones less than one month prior to the beginning of the baseline study) subjects taking any medication (including hormonal contraceptive therapy), and smokers are excluded subjects with significant sleep apnea (apnea index above 10) or significant arousal-associated periodic leg movements are excluded

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 39 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep loss and circadian alignment<br>Sleep restriction without circadian misalignment | Behavioral: Fixed restricted bedtimes<br>* Sleep restricted to 5 hours per night for 8 nights<br>|
| Experimental: Sleep loss and circadian misalignment<br> | Behavioral: Sleep restriction with circadian misalignment<br>* Sleep restricted to 5 h per day for 8 days, alternating night sleep and day sleep<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shift work, diabetes, Affects of shift work and sleep loss on health
The Impact of Anti- Asthmatic Medications on Salivary pH and Dental Caries Pattern in a Group of Egyptian Children With Bronchial Asthma

Study Overview
=================
Brief Summary
-----------------
The impact of Anti- Asthmatic medications on salivary pH and dental caries pattern in a Group of Egyptian Children with Bronchial Asthma.

Detailed Description
-----------------
Due to lack of published studies about the impact of anti-asthmatic medications on salivary pH and dental caries pattern among the Egyptian children diagnosed with Bronchial Asthma, this study will be conducted to cover this point.

Official Title
-----------------
The Impact of Anti- Asthmatic Medications on Salivary pH and Dental Caries Pattern in a Group of Egyptian Children With Bronchial Asthma: A Cohort Study

Conditions
-----------------
pH

Intervention / Treatment
-----------------
* Drug: Aironyl syrup(Terbutaline sulfate) + Epidrone syrup(Dexamethone)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Children aged 6-12 years old diagnosed with Bronchial asthma (Mixed dentition stage). Control group : a matched group aged 6-12 years old Patients taking regular medications for the treatment of Bronchial asthma at least for 1 year back Both male and female patients will be included. Exclusion Criteria: No other systemic Diseases.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asthmatic children<br>Aironyl syrup(Terbutaline sulfate ................. 1.5mg) 0.075-0.29 mg/ kg body weight 3 times daily Apidone syrup(Dexamethone) (0.02 to 0.3 mg per kilogram (kg) of body weight per day, divided and taken 3 or 4 times a day). | Drug: Aironyl syrup(Terbutaline sulfate) + Epidrone syrup(Dexamethone)<br>* Aironyl syrup(Terbutaline sulfate ................. 1.5mg) 0.075-0.29 mg/ kg body weight 3 times daily Apidone syrup(Dexamethone) (0.02 to 0.3 mg per kilogram (kg) of body weight per day, divided and taken 3 or 4 times a day)<br>|
| Non-Asthmatic children<br>no intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pH of Saliva | Digital pH electrode meter | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pattern of Dental caries | DMFs/defs index | 1year |
Evaluate Artificial Tear Efficacy in Moderate to Severe Dry Eye

Study Overview
=================
Brief Summary
-----------------
Comparison of two Dry Eye products

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: Systane
* Other: Optive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Have a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question; see Section 8.5.1. Have a sodium fluorescein corneal staining sum of ≥ 3 in either eye; see Section 8.5.10. Have a best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed using an ETDRS chart; see Section 8.5.7. Exclusion: Have a history or current evidence of the following: epithelial herpes simplex keratitis (dendrictic keratitisis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; acute or chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye. Use of Restasis® (cyclosporine ophthalmic emulsion, 0.05%) within 30 days of Visit 1. Use of systemic medications that may contribute to dry eye if the dosing regimen has not been stable for at least 30 days prior to Visit Additionally, the dosing regimen must remain stable throughout the study period. Medications known to contribute to dry eye include, but are not limited to, cold and allergy treatments, tricyclic antidepressants, and hormone replacement therapies. Presence of ocular conditions such as active acute blepharitis, conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of the test article. Unwilling to discontinue contact lens wear at least 7 days prior to Visit 1 and during the study period. Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).

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 |
| --- | --- |
| Active Comparator: Systane<br>Systane | Other: Systane<br>* Dry Eye relief eye drops<br>|
| Active Comparator: Optive<br>Optive | Other: Optive<br>* Dry Eye relief eye drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Break-up time |  | 42 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye, Corneal Staining
Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to study orbital structures in Graves´ Disease using multidetector computed tomography and color doppler imaging. Some changes in orbital structures detected by imaging exams could predict severity of the ocular Graves´disease. Thus the study could be useful in improve medical management of patients with Graves´ Disease.

Detailed Description
-----------------
Morphometric analysis of orbital structures in Graves´ Orbitopathy using multidetector computed tomography scan and color doppler imaging: Patients with Graves´ orbitopathy are evaluated by a complete ophthalmic examination.A prospective study with Multidetector CT scan and Color Doppler of these patients are made to develop parameters capable to predict Dysthyroid Optic Neuropathy (DON).

Official Title
-----------------
Morphometric Analysis of Orbital Structures in Graves´ Orbitopathy Using Multidetector Computed Tomography Scan and Color Doppler Imaging.

Conditions
-----------------
Dysthyroid Orbitopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Graves´Orbitopathy diagnosed based on previously reported criteria Age above 20 years Good cooperation for performing Visual Field test Spherical refraction within ± 5 D and cylinder correction within ± 3 D Exclusion Criteria: Graves´Orbitopathy not diagnosed

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| 1Patients with Graves´orbitophathy.<br>Patients with Graves´orbitophathy. | |
| 2 Patients with detected DON<br>Patients with Graves´orbitophaty and detected dysthyroid optic neuropathy (DON) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| screening indexes for dysthyroid optic neuropathy |  | indexes above 60% of orbital apex crowding were high suspected for DON | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dysthyroid Optic Neuropathy, multidetector computed tomography, color doppler, Grave´s Orbitopathy, Grave´s Disease, morphometric analysis
Observational Study of the Prognosis in Treated Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
Observational study of life time prognosis for persons medically treated for arterial hypertension, according to current WHO-guidelines.

Official Title
-----------------
Observational Study of the Prognosis in Treated Arterial Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: antihypertensive drugs according to current guidelines


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypertension according to WHO-defined criteria Exclusion Criteria: age < 18 years pregnancy

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

| Intervention/Treatment |
| --- |
|Drug: antihypertensive drugs according to current guidelines|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)

Study Overview
=================
Brief Summary
-----------------
The primary objective of the the study is to investigate the changes in bone remodeling during Velcade treatment.

Detailed Description
-----------------
20 patients will be included in the study over a 2 year period. Before, during and after treatment we will measure NTX-I, CTX-I, CTX-MMP, bALP, DKK-1, PINP, TRAcP and PTH. NTX, CTX and CTX-MMP are measured to estimate bone degradation. TRAcP is measured to estimate the activity of the osteoclasts. bALP and DKK-1 is measured to evaluate the activity of the osteoblasts and PINP is measured as a marker of new bone formation. PTH is measured in order to evaluate if the positive effects that is observed in bone formation in relations to velcade treatment is due to the pulsative way velcade is administered. The effect of the velcade treatment will be evaluated by x-ray, bone marrow and m-component.

Official Title
-----------------
The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: bortezomib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously untreated multiple myeloma Exclusion Criteria: Use of bisfosfonates

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bortezomib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bone markers during treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in osteolysis during treatment |  |  |
Cigarette Reduction Using the Quitbit Digital Lighter and Mobile Application for Smoking Cessation: a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The study is designed to evaluate the efficacy of a cigarette reduction intervention using a novel device called the Quitbit, a digital lighter paired with a smartphone mobile application, to enhance self-regulatory techniques for reducing cigarettes smoked per day toward cessation.

Official Title
-----------------
Cigarette Reduction Using the Quitbit Digital Lighter and Mobile Application for Smoking Cessation: a Randomized Controlled Trial

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: Gradual Cessation
* Behavioral: Gradual Cessation w/ Quitbit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age cigarette smoker wanting to quit in the next 30 days preference to quit gradually (vs. abruptly) or having no preference access to an iPhone (iOS only) completion of a run-in period Exclusion Criteria: no major change in number of cigarettes per day in the past month (+/- 20%) no major health diagnoses that could impact study attrition

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gradual Cessation<br> | Behavioral: Gradual Cessation<br> <br> * Other names: Cigarette Reduction;|
| Experimental: Gradual Cessation w/ Quitbit<br> | Behavioral: Gradual Cessation w/ Quitbit<br> <br> * Other names: Cigarette Reduction w/ Quitbit;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saliva cotinine level |  | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
technology, cigarette reduction, digital health, mobile health, Quitbit, mHealth, smoking cessation, quit smoking, self-regulation
Treatment of NAFLD With Two Different Diets

Study Overview
=================
Brief Summary
-----------------
The impact of popular diets on liver-related health is unclear. In this randomized, controlled trial, patients with NAFLD will be randomized to one of two popular diets or a placebo diet.

Detailed Description
-----------------
Subjects will include patients with MRI-verified NAFLD, with no concurrent liver diseases. Randomization will be done to either a control diet, the 5:2 diet or a low-carb-high-fat diet. The subjects will follow the diet for three months, after which a new MRI is performed. Main outcomes measure is reduction in liver fat.

Official Title
-----------------
Treatment of NAFLD With Two Different Diets

Conditions
-----------------
NAFLD

Intervention / Treatment
-----------------
* Behavioral: 5:2 diet
* Behavioral: LCHF
* Behavioral: Placebo diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Known NAFLD Exclusion Criteria: Other forms of liver disease Bolus insulin treatment Cirrhosis
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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo diet | Behavioral: Placebo diet<br>* Placebo diet: normal dietary advice<br>|
| Experimental: 5:2<br>5:2 diet | Behavioral: 5:2 diet<br>* Dietary intervention according to 5:2 diet during three months.<br>|
| Experimental: LCHF<br>LCHF diet | Behavioral: LCHF<br>* Dietary intervention according to LCHF diet during three months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver fat | MRI-measured liver fat content | Three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reduction of liver fat
Epidemiology of Sexually Transmitted Infections and Its iMpAcT on fEmale Infertility

Study Overview
=================
Brief Summary
-----------------
A longitudinal study to investigate the prevalence of sexually transmitted infections among young women and determine the role of the female genital tract microbiome in fertility

Official Title
-----------------
Epidemiology of Sexually Transmitted Infections and Its iMpAcT on fEmale Infertility

Conditions
-----------------
Sexually Transmitted Infection

Intervention / Treatment
-----------------
* Other: vaginal swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-22 years informed consent Exclusion Criteria: pregnancy sterilization not capable of giving informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 22 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: vaginal swab|self-sampling, vaginal swab|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of young women with STIs | longitudinal analysis of STIs and the female genital tract microbiome | at enrollment | 
| monitoring of STIs and their impact on infertility | obtain a better understanding for the emergence of infectious infertility and the impact on the pathogenicity | through study completion, an average of 5 years |