linjc16/ctgov huggingface dataset:
The Effect Site Concentration of Remifentanil for Conscious Sedation During Awake Nasotracheal Fiberoptic Intubation

Study Overview
=================
Brief Summary
-----------------
Remifentanil provides analgesia, suppresses airway reflex, has little effect on cognitive function. It can be used for conscious sedation during awake nasotracheal fiberoptic intubation. Target-controlled infusion is more reliable technique for maintaining optimal infusion rate than manual controlled infusion. The aim of this study is to determine the effect site concentration of remifentanil for successful conscious sedation during awake nasotracheal fiberoptic intubation.

Official Title
-----------------
The Effect Site Concentration of Remifentanil for Conscious Sedation During Awake Nasotracheal Fiberoptic Intubation

Conditions
-----------------
Cervical Disc Herniation, Cervical Spinal Stenosis, Cervical Spine Damage

Intervention / Treatment
-----------------
* Drug: Remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing cervical spine surgery Age 20-65 American Society of Anesthesiologists physical status classification I or II Exclusion Criteria: Patients' refusal allergy to any drug used unable to cooperate Severe hepatic or renal disease coagulation disorder chronic use of opioids or sedatives increase risk of pulmonary aspiration.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Remifentanil|After topical airway anesthesia with 10 % lidocaine in nostril and oropharyx, 1.5 2.0 mg of IV midazolam is injected. Awake nasotracheal fiberoptic intubation is performed with target-controlled infusion of remifentanil. Initial effect site concentration is 3.0 ng/ml. Smooth intubation is defined as absence of persistent cough with head elevation and defensive movement of extremities. In case of smooth intubation, effect site concentration is decreased by 0.5 ng/ml for the subsequent case. If intubation is not smooth, effect site concentration is increased by 0.5 ng/ml for the subsequent case. EC50 of remifentanil is determined using Dixon's up-and-down method.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EC50 of remifentanil for preventing persistent cough and defensive movement using Dixon's up-and-down method |  |  |
Study in Non-responder Hepatitis C Genotype 1 Patients With EMZ702, Pegylated Interferon and Ribavirin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1.

Detailed Description
-----------------
In this study, 28 patients with chronic hepatitis C genotype 1 who have failed previous treatment with pegylated interferon plus ribavirin will be treated. The study treatment will consist of the same type and doses of pegylated interferon and ribavirin to which the patient failed to respond plus EMZ702. EMZ702 will be administered intravenously twice a week during the first 12 weeks of treatment. Thereafter and according to viral response, patients will continue to receive pegylated interferon and ribavirin only for up to 36 weeks.

Official Title
-----------------
An Open Label, Dose Escalation Study of EMZ702 in Combination With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C Genotype 1 Non-responsive to Prior Therapy With Pegylated Interferon and Ribavirin

Conditions
-----------------
Chronic Hepatitis C, Hepatitis, Viral, Human

Intervention / Treatment
-----------------
* Drug: EMZ702


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hepatitis C virus (HCV) genotype 1 Previous therapy with pegylated interferon and ribavirin Documented previous treatment failure Exclusion Criteria: Hepatic dysfunction Coinfection with hepatitis B or HIV Other unrelated liver diseases Liver cancer

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EMZ702|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the viral response and pharmacokinetic profile of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis C, genotype 1, non-responders, viral hepatitis
Assessment of a Tool for Decision Making in Case of Worsening Condition of Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Observational two year study to evaluate the utility of a decision-support sheet on how to proceed in case of aggravation of a patient's condition with advanced disease.

Detailed Description
-----------------
Prospective and multicenter study conducted in the Rhône-Alpes-Auvergne area. All patients suffering from lung cancer admitted to a pulmonology unit in 2014 will be included. This document will be used if a decision to withhold life-sustaining treatment is decided. Investigators will assess the relationship between the planned intensity of care and those established when the patient develops an organ failure. Patient characteristics and factors associated with proposed levels and types of care will be analyzed. Patient and family opinions will be obtained after 3 months. The number of subjects is 468.

Official Title
-----------------
Assessment of a Tool for Decision Making in Case of Worsening Condition of Cancer Patients

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Other: observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient with lung cancer, hospitalized in pulmonology unit in one of the participating centers. Patient who requires a decision to withhold life-sustaining treatment One patient can be included at each hospitalization. Exclusion Criteria: Minor patient Refusal of participation of the patient in the study

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 |
| --- |
|Other: observational study|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergent Serious Adverse Events | The main objective of this study is to assess the relationship between the planned intensity of care and those established when the patient develops organ failure. The agreement will be assessed using Cohen's kappa coefficient . | 1 year and a half | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient feeling assessment using phone interview questionnaire | Patients will be contacted by the investigator, to evaluate their feeling according to the collect of their opinion and wishes using a phone interview questionnaire within 30 minutes duration | 3 months after patient inclusion | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | assessment at inclusion | first day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
decision-support sheet
Effect of Some Drugs on Rheumatoid Arithritis Activity

Study Overview
=================
Brief Summary
-----------------
Effect of Some Drugs on Rheumatoid Arithritis Activity.

Detailed Description
-----------------
The study aims at evaluating the effect of Some Drugs on Rheumatoid Arithritis Activity.

Official Title
-----------------
Clinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid Arithritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Rupatadine
* Drug: Montelukast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid arthritis Exclusion Criteria: liver or renal disease

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 |
| --- | --- |
| No Intervention: No intervention<br>No intervention | |
| Active Comparator: Rupatadine<br>Rupatadine 10 mg once daily. | Drug: Rupatadine<br>* Rupatadine 10 mg daily<br>|
| Active Comparator: Montelukast<br>Montelukast 10 mg daily | Drug: Montelukast<br>* Montelukast 10 mg daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| se level of IL-17 | change in level of IL-17 | 6 months |
Study About Lymphocytes Change During Menstrual Cycle in Women of Child-bearing Age

Study Overview
=================
Brief Summary
-----------------
The investigators are going to select the normal child-bearing period women as the study subjects and draw their peripheral blood to observe and analyze the change of quantity and percentage of lymphocyte subsets along with the change of menstrual cycle. Recording their BMI\menstrual history\and childbearing history, the investigators would select 300 healthy women in 6 different age groups which are aged 20-24, aged 25-29, aged 30-34, aged35-39, aged 40-44 and aged 45-49, then draw 1-2 ml blood form their peripheral vein (adding EDTA for anti-coagulation). The investigators are going to perform routine examination on the blood samples and detect T\B\NK lymphocyte through flow cytometry (FCM), thus calculating the absolute number of every species of lymphocyte. The investigators make assessment for the cellular immune function of the women during child-bearing period via comparing distinction in percentage and absolute number of every lymphocyte subset among reproductive-age women in different ages.

Conditions
-----------------
Lymphocyte Subsets in Women of Child-bearing Age

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 20-49; Having a regular menstrual cycle of which the menstrual period is between day 3-7, and the period between day 25-35; Excluding internal and surgical disease (after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine). Exclusion Criteria: Having experienced severe allergies, trauma history and/or operation history within 3 months; With a history of mental illness and/or family history of mental illness; Limb disabled; Taking medicine within one month; Suffering major events or having mood swings.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 49 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observational group<br>Observational Study about Lymphocytes Change during Menstrual Cycle in Women of Child-bearing Age | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of lymphocyte subsets |  | through study completion, an average of 1 year |
The ATLAST Long-Term Study

Study Overview
=================
Brief Summary
-----------------
The Study is a multi-center, prospective, open label, single-arm, three-month, long-term study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea (OSA). The objective of the study is to monitor long-term use of the Attune Sleep Apnea System.

Official Title
-----------------
The ATLAST Long-Term Study. A Multicenter, Prospective, Long-Term Study of the Attune Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)

Conditions
-----------------
Obstructive Sleep Apnea (OSA)

Intervention / Treatment
-----------------
* Device: Attune Sleep Apnea System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject participated in the ATLAST Study, and completed the 28-day take-home period Subject understands the Study protocol and is willing and able to comply with Study requirements and sign the informed consent form. The study physician and investigator believe that study participation is appropriate for the subject. Subject has at least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower). Exclusion Criteria: Female subjects who are pregnant or intend to become pregnant during the study period. Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed. Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the Attune Sleep Apnea System History of any OSA surgical treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Subjects that completed the ATLAST Study | Device: Attune Sleep Apnea System<br>* Observation of Attune Sleep Apnea System for use during sleep.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of hours per night of device use over a 3-month period | Nightly use will be monitored over a 3-month take-home period. | Each night's use |
Preoperative High Protein vs Immunodiet in Surgical Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Immunomodulating nutrition is supposed to reduce the number of complications and the legnth of the hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study is to assess the clinical effect of immunomodulating oral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients.

Detailed Description
-----------------
Between March 1, 2019, and December 31, 2020, a group of 300 well-nourished patients will be enrolled to the study and randomly assigned two one of two groups: A-high protein oral supplements (ONS) and B- immunomodulating ONS. The study is designed to test the hypothesis that immunonutrition and reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.

Official Title
-----------------
Preoperative Use of the High Protein ONS vs Immunoenhancing ONS in Gastrointestinal Cancer Patients Undergoing Surgery

Conditions
-----------------
General Surgery, Cancer of Colon

Intervention / Treatment
-----------------
* Drug: IMPACT
* Drug: resource protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: resectable GI cancer written consent Exclusion Criteria: inoperable GI cancer known allergy to the drug

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Protein<br>Provision of 400 ml per day of high protein oral nutritional supplements | Drug: resource protein<br>* Administration of oral high-protein oral supplement<br>|
| Experimental: Immuno ONS<br>Provision of 400 ml per day of immunostimulating oral nutritional supplements | Drug: IMPACT<br>* Administration of oral immunostimulating oral supplement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious complications | Number and type of infectious complications | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications | Number and type of surgical complications | 6 months | 
| Length of stay | Hospital length of stay | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immunonutrition, preoperative nutrition
Pregnancy/Implantation Rates Using a Day 3 Score Versus Graduated Embryo Score Plus a Biochemical Marker (sHLA-G)

Study Overview
=================
Brief Summary
-----------------
Objective: To compare pregnancy rates and implantation rates when embryos are selected based on a single Day 3 (D.3) score vs. a GES score plus sHLA-G expression.

Detailed Description
-----------------
Comparing pregnancy rates and implantation rates when embryos are selected using the most common criteria for embryo selection on day 3 - the morphology-(number of blastomere, their shape and size and the percentage of fragmentation)vs a graduated embryo score accumulated over 72 hours and the expression of sHLA-G at 44-46 hours post fertilization.

Official Title
-----------------
Pregnancy and Implantation Rates When Embryos Are Selected Based on a Single Day 3 Score (Day 3)vs Graduated Embryo Score(GES) Plus Soluble Human Leukocyte Antigen-G Expression.

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

Intervention / Treatment
-----------------
* Drug: Human derived FSH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self paying ART patients Exclusion Criteria: Abnormal uterus Specific Immunologic factors

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 40 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A<br>Embryo selection for transfer based on a Day 3 score only. | Drug: Human derived FSH<br>* Customized for each patient<br>* Other names: Bravelle;|
| Active Comparator: B<br>Embryos for transfer by first selecting any embryos that had a positive sHLA-G expression of OD = 190 ±6 and correlating such with the highest GES score available. | Drug: Human derived FSH<br>* Customized for each patient<br>* Other names: Bravelle;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy and implantation rates |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miscarriage rates |  | 9 months | 
| Miscarriage rates |  | 9-11 day until βhCG | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, implantation, miscarriage, sHLA-G