linjc16/ctgov huggingface dataset:
Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the present investigation will be to determine whether a combination of clown doctor and parental presence is more effective than a combination of sedative premedication and parental presence for reducing anxiety in children and their parents and for improving parental satisfaction.

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: midazolam
* Other: clown doctor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children aged 2 to 12 yr, scheduled for minor surgery under general anesthesia will be included in the present study. Exclusion Criteria: Children with prematurity, development delay, previous anesthetic experience will be excluded from this study

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 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: midazolam<br> | Drug: midazolam<br>* Children in this group will be premedicated with oral midazolam syrup (0.3 mg.kg) at least 15 minutes before the surgical procedure and one of the parents will be present throughout the anesthesia induction process.<br>|
| Active Comparator: clown doctor<br> | Other: clown doctor<br>* Children will interact with clowns before entering the operating room and will stay with them and one of the parents throughout the anesthesia induction process.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative anxiety |  | Prior to induction of anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children, surgery, anxiety
Weight Watchers and Families

Study Overview
=================
Brief Summary
-----------------
Research suggests that when one spouse loses weight, the other spouse does too. This study will examine whether a ripple effect is observed in untreated spouses and children of individuals participating in a nationally available weight loss program. Participants will be randomly assigned to either receive Weight Watchers immediately or at the end of a 6-month waiting period. Participants and untreated spouses (and any children in the home) will be assessed at baseline, 3, and 6 months.

Official Title
-----------------
Ripple Effect of a Nationally Available Weight Loss Program on Untreated Family Members

Conditions
-----------------
Overweight and Obesity

Intervention / Treatment
-----------------
* Other: Self guided handout
* Behavioral: Weight Watchers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body mass index between 27.0-40.0 kg/m2 married or living with a significant other who had a BMI > 25 kg/m2 Exclusion Criteria: currently in a weight loss program, dieting, or taking medications that might affect weight had participated in a weight loss program in the past year lost > 5% of their body weight in the past 6 months were planning to or had undergone weight loss surgery had any orthopedic limitations or contraindications to physical activity were pregnant, lactating, or less than 6 months postpartum, or were planning to become pregnant in the next year reported uncontrolled hypertension, history of coronary heart disease, stroke, or peripheral arterial disease; reported chronic gastrointestinal disease endorsed having hepatitis B or C, cirrhosis, or HIV had a history of cancer within the past 5 years reported a significant psychiatric illness that might interfere with completion of the study.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Access to Weight Watchers in-person meetings and online tools. | Behavioral: Weight Watchers<br>* Access to Weight Watchers in-person meetings and online tools<br>|
| Other: Self-Guided Control Group<br>Received handout with basic weight management advice. | Other: Self guided handout<br>* Written handout with basic weight management strategies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | body weight measured in kg | 0, 3, and 6 months |
The Role of CGRPand Nociceptin in Migraine

Study Overview
=================
Brief Summary
-----------------
The release of the neuropeptide calcitonin gene-related peptide (CGRP) is thought to play a causative role in migraine. Nociceptin immunoreactivity and ORL-1 mRNA have been detected in human trigeminal ganglia where it was co-localized with CGRP. It may play a role in migraine pathogenesis. We are collecting the blood samples of migraineurs for analysis of these neuropeptides.

Detailed Description
-----------------
The release of the neuropeptide calcitonin gene-related peptide (CGRP) is thought to play a causative role in migraine. Nociceptin immunoreactivity and ORL-1 mRNA have been detected in human trigeminal ganglia where it was co-localized with CGRP. It may play a role in migraine pathogenesis. We are collecting the blood samples of migraineurs for analysis of these neuropeptides.

Official Title
-----------------
The Role of Calcitonin Gene-Related Peptide(CGRP)and Nociceptin in the Pathogenesis of Migraine

Conditions
-----------------
Migraine, Headache

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with headache - Exclusion Criteria: fever, congenital anomaly, CNS organic lesions -

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 50 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
migraine, CGRP, nociceptin
Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether 100mg erlotinib had similar effect compared with 150mg erlotinib in NSCLC patients with EGFR mutation in China.

Detailed Description
-----------------
In China it was confirmed that 150mg Erlotinib was effective in NSCLC patients wtih EGFR mutation, but reducing dose occurring in some patients because of the drug related side-effects. Thus, we sought to investigate that in Chinese patients with EGFR mutation whether low dose (100mg) Erlotinib had similar efficacy but lower toxcities compared with standad dose (150mg) Erlotinib.

Official Title
-----------------
Phase 3 Study of Erlotinib 100mg or 150mg in Treating EGFR Mutated Patients With Non-small Cell Lung Cancer

Conditions
-----------------
NSCLC, EGFR Mutation

Intervention / Treatment
-----------------
* Drug: Erlotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological diagnosis of NSCLC with phase IIIB or IV disease; Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method) Never received anti-tumor therapies for the advanced stage; Never used EGFR inhibitors; Measurable disease by RECIST criteria; Male or female patients >=18 years of age; ECOG karnofsky performance 0 3, life expectancy is greater than 12 weeks; Patients must be accessible for treatment and follow-up; Exclusion Criteria: Previously used EGFR inhibitors Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer; Allergic to erlotinib; Non-measurable lesions Pregnant or lactating women; Patients having other factors that preventing researchers from enrollment them.

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: Erlotinib 100mg<br>Erlotinib 100mg | Drug: Erlotinib<br>* 100mg vs. 150mg<br>* Other names: tarceva;|
| Active Comparator: Erlotinib 150mg<br>Erlotinib 150mg | Drug: Erlotinib<br>* 100mg vs. 150mg<br>* Other names: tarceva;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 2 years after the initial dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective response rate |  | Patients will be followed for an expected average of 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
erlotinib, EGFR mutation
Micromegaly and Discrepancy Between Growth Hormone and IGF1 at the Diagnosis and Follow-up of Acromegalic Patients

Study Overview
=================
Brief Summary
-----------------
The diagnosis and the follow-up of acromegalic patients are based on the mesurement of Growth hormone (GH) and IGF1 rates. However, the literature described some cases of patient for whom the investigators observed a discrepancy between GH and IGF1 rates. Since the acromegaly is a rare disease and this phenomenon concerns about 30% of these patients, there is a lack of investigations about consequences that this discordance may induces. In this study, the investigators aimed at assessing if patients with discordance between GH and IGF1 rates present a different risk of recurrence and complications related to acromegaly, from patients with concordant results.

Official Title
-----------------
Micromegaly and Discrepancy Between Growth Hormone and IGF1 at the Diagnosis and Follow-up of Acromegalic Patients : What About Their Consequences ?

Conditions
-----------------
Acromegaly

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Acromegaly followed up in one of the center (Montpellier, Nimes or Béziers hospital, independent endocrinologist) between 2010 and 2021 Age over 18 years old Measurement of GH and IGF1 rates at the last visit control available Exclusion criteria: Lost to follow-up Status about complications related to acromegaly unknown

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Occurrence of complications and/or recidivism related to acromegaly | The investigators check in the patient file if there is complications or pathology recidivism detected at the last full check-up of the disease, assessed by blood-control and complementary exams | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease's specificity | The investigators collected datas about disease's diagnosis (IRM characteristic, GH/IGF1 rates, clinical presentation) to evaluate if there is a different initial presentation between groups. | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endocrinology, Acromegaly, Discrepancy, Complications
Evaluation of Serum Amyloid A in Early Diagnosis of Spontaneous Bacterial Peritonitis

Study Overview
=================
Brief Summary
-----------------
One of the most common and serious complications in decompensated cirrhotic patients (DCPs) is bacterial infection.The most common infections in DCPs are cases of spontaneous bacterial peritonitis (SBP), which account for 40% 70% of cases, followed by urinary tract infections, pneumonia and cellulitis. Serum amyloid A (SAA) and C-reactive protein (CRP) are acute-phase proteins predominantly produced and secreted by hepatocytes. Other cells including lymphocytes, monocytes, and macrophages can also produce these proteins. The induction of SAA and CRP synthesis is triggered by a number of cytokines, chiefly IL-6, which is released from a variety of cell types, but mainly from macrophages and monocytes at inflammatory sites

Detailed Description
-----------------
Increased serum CRP and SAA levels have been found in a number of disorders, including bacterial infections, malignancies tissue injuries and tissue rejection. Therefore, new studies of early diagnosis, prevention and treatment are needed to improve clinical outcomes.

Official Title
-----------------
Evaluation of Serum Amyloid A in Early Diagnosis of Spontaneous Bacterial Peritonitis

Conditions
-----------------
Spontaneous Bacterial Peritonitis

Intervention / Treatment
-----------------
* Other: serum amyloid A level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Decompansated cirrhosis with ascites, defined by a combination of any of the following: Laboratory findings Endoscopic results Ultrasound Histology Exclusion Criteria: Creatinine>1.5 mg/dl Other infection e.grespiratory,UTI ,gastrointestinal and skin infection. Hepatocellular carcinoma Other extrahepatic malignancy e.g ; chest Any significant psychiatric illness or other medical comorbidity. Any degenerative diseases.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Serum amyloid A level in SBP<br>serum amyloid A level | Other: serum amyloid A level<br>* serum amyloid A level (SAA)<br>|
| Serum amyloid A level in cirrhosis<br>Serum amyloid A level | Other: serum amyloid A level<br>* serum amyloid A level (SAA)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with elevated serum amyloid A |  | 6months |
Change in NLR and Survival Among Advanced Lung Cancer Patients Receiving ICIs With Immunomodulator

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate the change of neutrophil to lymphocyte ratio (NLR) after 6-week treatment of immune checkpoint inhibitors (ICIs) with or without immunomodulatory drugs and recognize the effect of post-treatment NLR and overall survival in advanced lung cancer patients by retrospective review.

Detailed Description
-----------------
In recent years, the therapeutic strategies for lung cancer have been enriched with small molecular targeted therapy and immunotherapy. In this retrospective study, we will observe the change in NLR and explore its possible association with survival among advanced lung cancer patients receiving Immune checkpoint inhibitors (ICIs) with and without such immuno-modulator, Astragalus Polysaccharide Injection. It can be used to understand the relationship between NLR values and the survival rate of lung cancer patients after ICIs treatment. Physicians can refer to this result to give patients the suitable treatment recommendations.

Official Title
-----------------
Change in Neutrophil to Lymphocyte Ratio (NLR) and Survival Among Advanced Lung Cancer Patients Receiving Immune Checkpoint Inhibitors With Immunomodulator: a Retrospective Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Aged 20 years and older. Patients who have been given a diagnosis of lung cancer. Previously advanced lung cancer patients first treated with ICIs from Oct 1, 2015 to Oct 31, 2019. Exclusion Criteria Patients who have no hematological laboratory data available at baseline (within 3 days prior to ICI treatment) and the 6th week (± 2 weeks) after ICI treatment initiation.

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 |
| --- | --- |
| Cohort 1：ICI treatment with immunomodulator<br>Lung cancer patients received immunological checkpoint inhibitors (ICIs) and any immunomodulatory drugs. | |
| Cohort 2：ICI treatment without immunomodulator<br>Lung cancer patients received immunological checkpoint inhibitors (ICIs). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutrophil to lymphocyte ratio (NLR) |  | Baseline, 4 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neutrophil to lymphocyte ratio (NLR), immunomodulator
Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease.

Official Title
-----------------
Phase I/II Prospective, Randomized, Double Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Compared to Placebo for the Treatment of Dry Eye Disease

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

Intervention / Treatment
-----------------
* Drug: DE-101 ophthalmic suspension
* Drug: DE-101 ophthalmic suspension
* Drug: DE-101 ophthalmic suspension vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed diagnosis of dry eye defined by protocol 18 years or older, and sign written informed consent negative pregnancy test and utilizing reliable contraceptive throughout study Exclusion Criteria: use of any topical ocular medications any ocular surgery within 90 days of study laser refractive surgery within one year of study ocular, lid disease/abnormalities that may interfere with the study corneal transplants uncontrolled systemic conditions females who are pregnant or nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception participated in another drug trial within 30 days prior to 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DE-101 ophthalmic suspension high dose<br> | Drug: DE-101 ophthalmic suspension<br>* Ophthalmic suspention; QID<br>|
| Experimental: DE-101 ophthalmic suspension low dose<br> | Drug: DE-101 ophthalmic suspension<br>* Ophthalmic suspention; QID<br>Drug: DE-101 ophthalmic suspension<br>* Ophthalmic suspension; QID<br>|
| Placebo Comparator: DE-101 ophthalmic suspension vehicle<br> | Drug: DE-101 ophthalmic suspension<br>* Ophthalmic suspention; QID<br>Drug: DE-101 ophthalmic suspension vehicle<br>* ophthalmic suspension vehicle; QID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fluorescein corneal staining |  | 8 weeks | 
| Ocular Symptom Severity |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry, Santen, Eye