linjc16/ctgov huggingface dataset:
The Paleolithic Diet and Male Factor Infertility

Study Overview
=================
Brief Summary
-----------------
Prospective studies concerning diet and male fertility are lacking. Observational studies suggest that a diet rich in fruits, vegetables and meats may be associated with higher sperm counts. The investigators wanted to see if a paleolithic diet consisting of meat, fish, fruits vegetables and nuts and lacking grains, legumes and dairy products can improve sperm counts.

Official Title
-----------------
The Impact of a Paleolithic Diet on Sperm Parameters for Men Suffering From Male Infertility

Conditions
-----------------
Male Infertility

Intervention / Treatment
-----------------
* Other: paleolithic diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men with male infertility willingness to make dietary change for three months willingness to be blinded to sperm test results until the end of the experiment Exclusion Criteria: High fever or abdominal or scrotal surgery during three months prior to intervention Change in diet, drinking or smoking habits in three months prior to intervention regular consumption of more than two servings of alcohol a day background ailment preventing dietary change

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paleolithic diet<br>Subjects will adhere to a paleolithic diet for the duration of three months | Other: paleolithic diet<br>* The diet consists of unlimited quantities of meat and fish, fruits and vegetables, eggs, nuts and water. Foods to be avoided include grains, wheat products, legumes, soy, potatoes and corn, rice, legumes, processed meats, soft drinks, dairy products and sugar. Allowed in moderation include coffee, alcohol,cooking oil, honey, salt, dried fruit.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm Parameters | volume, concentration, motility, morphology | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomedical Indexes | Weight, blood pressure, CBC, liver enzymes, kidney function, lipid prophile, fasting glucose, HgbA1c, CRP, Testosterone, LH, FSH, Estradiol, TSH, Prolactin. | 3 months |
Pediatric Difficult Airway Prediction Using Ultrasonography

Study Overview
=================
Brief Summary
-----------------
Recognition of difficult airway is purported to be the most important factor in successful management of difficult airway. The incidence of difficult airway in pediatrics is much less than in adults; however, airway related complications can lead to hypoxic brain damage or even death especially in younger age groups as neonates and infants.The aim of this work is to evaluate the feasibility and accuracy of ultrasound measurements (hyomental distances, tongue measurements, and anterior neck soft tissue thickness at the level of hyoid bone, thyrohyoid membrane, and thyroid cartilage) in predicting difficult laryngoscopy and difficult mask ventilation in pediatric patients undergoing elective surgery under general anesthesia.

Official Title
-----------------
Pediatric Difficult Airway Prediction Using Ultrasonography

Conditions
-----------------
Difficult Intubation, Difficult Mask Ventilation

Intervention / Treatment
-----------------
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gender both males and females ASA Class I and II Age 1month to 10 years Children undergoing elective surgery under general anaesthesia Exclusion Criteria: congenital upper airway malformation, head and neck swellings, scars, radiation to the neck, tracheotomy, Neurosurgical or cardiac procedures ENT surgeries

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 10 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ultrasound|The following ultrasound measurements will be assessed: DS-HB, HMDR, TT, TT-S, TW, EW, ET, DS-E, and DS-V.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity of DS-HB to predict difficult laryngoscopy | The ability of DS-HB ultrasound measurement to predict difficult airway in pediatrics | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Difficult airway, pediatric, Airway ultrasound
Patient's Satisfaction of Bispectral Index-guided Monitored Anesthesia Care

Study Overview
=================
Brief Summary
-----------------
The investigators will evaluate the effect of bispectral index-guided titration of sedation during ear surgery under monitored anesthesia care on participant's satisfaction with anesthesia, as well as side effects caused by the anesthetics.

Official Title
-----------------
A Prospective Randomized Controlled Trial on the Patient's Satisfaction of Bispectral Index-guided Monitored Anesthesia Care

Conditions
-----------------
Bispectral Index, Monitored Anesthesia Care

Intervention / Treatment
-----------------
* Device: Titration under the guidance of BIS
* Diagnostic Test: Titration under the guidance of OAA/S


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving ear surgery with ASA physical status 1 or 2 Exclusion Criteria: Age under 19 years Pregnancy Cognitive disorder affecting daily activity Patients who cannot participate in the survey Allergy to the medication History of sedative abuse

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OAA/S<br>The patients in the control group will receive MAC titrated according to observer's assessment of anesthesia/sedation(OAA/S) score. | Diagnostic Test: Titration under the guidance of OAA/S<br>* The infusion rate of dexmedetomidine is increased by 0.1mcg/kg/h if OAA/S is greater than 3; The infusion rate is decreased by 0.1mcg/kg/h if OAA/S is less than 3.<br>|
| Active Comparator: BIS<br>The patients in the control group will receive MAC titrated according to bispectral index(BIS). | Device: Titration under the guidance of BIS<br>* The infusion rate of dexmedetomidine is increased by 0.1mcg/kg/h if BIS is greater than 80; The infusion rate is decreased by 0.1mcg/kg/h if BIS is less than 60.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iowa Satisfaction with Anesthesia Scale(ISAS) | Patient's satisfaction with MAC | within 30 minutes after the end of surgery (in the PACU) |
Simultaneous Injection of Propofol and Rocuronium in Inducing General Anesthesia

Study Overview
=================
Brief Summary
-----------------
This study is conducted to evaluate the efficacy of simultaneous injection of propofol and rocuronium in inducing general anesthesia.

Official Title
-----------------
Efficacy of Neuromuscular Blockade Before Facemask Ventilation in Inducing General Anesthesia

Conditions
-----------------
Anesthesia; Functional

Intervention / Treatment
-----------------
* Drug: administration of propofol and rocuronium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective surgery requiring endotracheal intubation ASA I, II, and III above 20 years Exclusion Criteria: refuse to enroll patients with risk of aspirating gastric contents patients in whom NMBs are contraindicated patients with predictors of difficult mask ventilation

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simultaneous administration of propofol and rocuronium<br>In this group, the investigator will administrate propofol (2ml/kg) and rocuronium (0.6mg/kg) simultaneously, and start facemask ventilation after patient loss consciousness to induce general anesthesia. The investigator will measure the mean tidal volume (TV) applied during facemask ventilation for 1 minute. | Drug: administration of propofol and rocuronium<br>* compare the tidal volume applied from starting facemask ventilation under 15cmH2O of PCV for 1 minute according to administrating propofol and rocuronium simultaneously, or ordinally<br>|
| Experimental: ordinal administration of propofol and rocuronium<br>In this group, the investigator will administrate propofol (2ml/kg) first, and follow injection of rocuronium (0.6mg/kg) after patient loss consciousness and confirming facemask ventilation. The investigator will measure the mean tidal volume (TV) applied during facemask ventilation for 1 minute. | Drug: administration of propofol and rocuronium<br>* compare the tidal volume applied from starting facemask ventilation under 15cmH2O of PCV for 1 minute according to administrating propofol and rocuronium simultaneously, or ordinally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean tidal volume | mean tidal volume of facemask ventilation in 1 minute | from starting facemask ventilation for 1 minute |
FLOR3 Gene Polymorphism in Predicting Outcomes of Tyrosine Kinase Inhibitor（TKI）Stopping in Chronic Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
For patients with chronic myeloid leukemia in chronic phase (CML-CP) who have achieved a stable deep molecular response (DMR) using BCR-ABL1 tyrosine kinase inhibitors (TKIs), treatment-free remission (TFR) following TKI cessation is an emerging goal. However, about half of the patients relapsed after TKI discontinuation. There is no definite examinations to predict the outcome of TKI discontinuation. Investigators aim to study the relationship between FLOR3 SNP rs139130389 and the outcome of TKI discontinuation.

Detailed Description
-----------------
Investigators aim to detect FOLR3 SNP rs139130389, and establish its correlation with patients' treatment response, remission time, TKI resistance and the outcome of TKI stopping.

Official Title
-----------------
A Multicenter Prospective Cohort Study of FLOR3 Gene Polymorphism in Predicting Outcomes of TKI-stopping in Chronic Myeloid Leukemia

Conditions
-----------------
Folate, CML, Treatment-free Remission

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient signs the informed consent form Age over 18, male or female The patient was diagnosed as chronic phase of CML. ECoG score 0-2 Receive TKI treatment for at least 4 years and continuously obtain MR4 or mr4.5 for at least 3 years. The subjects fully understand and comply with the requirements of the research scheme and are willing to complete the research as planned. Exclusion Criteria: NA

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment-free remission or relapse | Observe whether the patients were in remission or relapse 1 year after drug withdrawal | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FOLR3, CML, TFR
Open-Label Natalizumab Safety Extension Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the safety and the immunogenicity of extended treatment with natalizumab when administered at a dose of 300 mg intravenously (IV) to subjects with multiple sclerosis (MS) who have completed natalizumab Studies C-1801, C-1802, or C-1803.

Official Title
-----------------
An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Natalizumab in Subjects With Multiple Sclerosis Who Have Completed Studies C-1801, C-1802, or C-1803

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Natalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must give written informed consent. Must be an MS subject who has completed natalizumab Study C-1801, C-1802 or C-1803 Exclusion Criteria: History of, or available abnormal laboratory results, indicative of any significant disease that would preclude treatment. History of severe allergic or anaphylactic reactions or known drug hypersensitivity A clinically significant infectious illness within 30 days prior to study entry.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Natalizumab<br>Open-label natalizumab | Drug: Natalizumab<br>* Natalizumab 300 mg by IV infusion, every 4 weeks, for up to 24 months<br>* Other names: Tysabri;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety endpoints under consideration will be the incidence of adverse events, changes in laboratory evaluations, vital signs, and physical examinations. The incidence of development of antibodies to natalizumab will also be assessed. |  | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EDSS scores and assessments of relapse. |  | Month 24 |
Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout

Study Overview
=================
Brief Summary
-----------------
FYU-981 or Benzbromarone are administrated to hyperuricemia patients with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose regimen.

Official Title
-----------------
Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 for Hyperuricemia With or Without Gout to Evaluate the Safety and Noninferiority of FYU-981 (Phase III Study)

Conditions
-----------------
Hyperuricemia With or Without Gout

Intervention / Treatment
-----------------
* Drug: FYU-981
* Drug: Benzbromarone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hyperuricemic or gout patients Serum urate level: >= 7.0mg/dL in patients with history of gout, or >= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL Exclusion Criteria: Gouty arthritis within two weeks before start of study treatment Secondary hyperuricemia HbA1c: >= 8.4% Uric acid-overproduction type in the classification of hyperuricemia History of, clinically significant cardiac, hematologic and hepatic disease Kidney calculi or clinically significant urinary calculi Hepatic dysfuction, or AST: >=100 IU/L or ALT: >=100 IU/L at the pre-examination eGFR: < 30mL/min/1.73m^2 Systolic blood pressure: >= 180 mmHg Diastolic blood pressure: >= 110 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FYU-981<br> | Drug: FYU-981<br>* Oral daily dosing for 14 weeks<br>|
| Active Comparator: Benzbromarone<br> | Drug: Benzbromarone<br>* Oral daily dosing for 14 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction from baseline in serum urate level at the final visit | Percent reduction from baseline in serum urate level at the final visit | 14 weeks |
Rasagiline for Gait Treatment

Study Overview
=================
Brief Summary
-----------------
Gait disturbances are very common and are a major cause for losing of independency in patients with advanced Parkinson's Disease (PD). The medical treatment of gait disturbances in advanced PD is very difficult and in many cases the classical dopaminergic treatment has no clinical benefit or even can worsen the instability and increase falls. Rasagiline, a new MAO-B inhibitor who has recently been approved all over the world for the treatment of early and late stages PD has been suggested to have a special effect of gait in patients with advanced PD (LARGO sub-study).

Official Title
-----------------
Rasagiline for the Treatment of Gait Disturbances in Patients With Parkinson´S Disease (PD): an Open Label Study

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with PD who experience motor response fluctuations and have gait disturbances at ON and OFF (TUaG >10 secs in ON and 14 secs in OFF) treated with a stable dose of antiparkinsonian medications for the last month. Patients must be able to identify both situations Able to walk for 2 minutes at the OFF and ON state Non-demented (MMSE= or > to25) Exclusion Criteria: Severe orthopedic problems Orthostatic hypotension on basal visit Severe, troublesome ON dyskinesias Dementia (MMSE <25) Major depression Active psychosis or on anti-psychotic medications Patients who are unlikely to complete the full protocol. Patients who have tried rasagiline and stopped because of side effects or lack of symptomatic effect Treatment with selegiline for the last 2 months Any contraindication according SmPC

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
parkinson disease, gait
The Effects of Using Pathological- Based Guidelines for Arterial Blood Gas Analysis in Patients Aftercardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Blood gas analysis were routinely monitor every 4 hours in our surgical cardiac intensive care unit (SICU). These luxury investigations waste the resources. Therefore we develop a pathological- based guideline for arterial blood gas analysis in patients after cardiac surgery. We test the guideline for its safety and efficacy.

Official Title
-----------------
The Effects of Using Pathological- Based Guidelines for Arterial Blood Gas Analysis in Patients Aftercardiac Surgery

Conditions
-----------------
Blood Gas Analysis

Intervention / Treatment
-----------------
* Other: Control
* Other: Guideline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergone elective cardiac surgery with cardiopulmonary bypass Exclusion Criteria: Emergency surgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>The patient were retrospectively included according to the last digit of their admission number (odd number). The had arterial blood gas analysis every 4 hour during the ICU stay. | Other: Control<br>* The patient's ABGs were test according to a 4 - hour routine<br>|
| Active Comparator: Guideline<br>The patient were prospectively included and they had arterial blood gas analysis following the pathological- based guidelines for arterial blood gas analysis in patients aftercardiac surgery | Other: Guideline<br>* The patient's ABGs were test according to the guideline for requests Arterial Blood Gas status post cardiac surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ABG test | during intensive care stay | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of ABG testing on patients' outcome. | during intensive care stay | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arterial blood gas analysis