linjc16/ctgov huggingface dataset:
Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-003)

Study Overview
=================
Brief Summary
-----------------
The purpose of this phase III study is to determine the safety and efficacy of difluprednate in the management of inflammation following ocular surgery.

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Drug: Difluprednate
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for unilateral ocular surgery. Exclusion Criteria: Systemic administration of any corticosteroid or immunosuppressive drug in the 2 weeks prior to study enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 2 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: 1<br>Difluprednate | Drug: Difluprednate<br>* Difluprednate<br>|
| Placebo Comparator: 2<br>Vehicle | Other: Placebo<br>* Vehicle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with an anterior chamber cell grade of 0 and a flare grade of 0 on Day 14, compared between difluprednate and placebo groups |  | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with an anterior chamber cell grade of 0 and a flare grade of 0 on Day 7, compared between difluprednate and placebo groups. |  | Day 7 |
Neuropsychological Indicators of SCD Progression

Study Overview
=================
Brief Summary
-----------------
Some patients with subjective cognitive decline (SCD) progress to neurocognitive disorders (NCD), whereas others remain stable; however, the neuropsychological determinants of this progression have not been identified. The investigators objective was to examine baseline neuropsychological indicators that could discriminate between people in whom the SCD progressed to a mild or major NCD and people in whom the SCD remained stable. The investigators retrospectively included patients consulting for SCD at a university medical center's memory center (Amiens, France) and who had undergone three or more neuropsychological assessments at least 6 months apart. The relationship between domain-specific scores and the global cognitive score (GCS, as a function of final status (stable SCD vs. progression toward a mild or major NCD)) was examined using a generalized linear mixed model.

Official Title
-----------------
In Individuals With Subjective Cognitive Decline, Age, Memory and Action Speed Scores at Baseline Predict Progression to Cognitive Impairment

Conditions
-----------------
Biomarkers, Cognitive Assessment, Cognitive Decline, Neurocognitive Disorders, Neurodegenerative Diseases, Subjective Cognitive Decline

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who had been referred to the memory center at Amiens University Medical Center (Amiens, France). patients who had undergone three neuropsychological assessments at least 6 months apart, from 2005 patients who met the criteria for SCD. Exclusion Criteria: patients who didn't meet the criteria for SCD

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Variation of neuropsychological indicators (global congnitive score) between NCD et SCD patients | subjective cognitive decline (SCD) neurocognitive disorders (NCD) neuropsychological indicators could discriminate between people in whom SCD progressed to a mild or major NCD and people in whom SCD remained stable. A global cognitive score was created using all 5 tests : Alice Heim 4-I tests inductive reasoning ; Short-term verbal memory was assessed with a 20-word free-recall test; Two measures of verbal fluency were used: phonemic and semantic; Vocabulary was assessed using the Mill Hill Vocabulary test. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomarkers, Cognitive assessment, Cognitive decline, Neurocognitive disorders, Neurodegenerative diseases, Neuropsychological assessment, Risk of progression, Subjective cognitive decline
Gene Polymorphisms Influencing Steroid Synthesis and Action

Study Overview
=================
Brief Summary
-----------------
The extend of steroid biosynthesis and action is mainly dependent on underlying genetic polymorphisms and gene mutations. These sequence variations in multiple genes involved in steroid biosynthesis and action cause different diseases (for example congenital adrenal hyperplasia or disorders of sex development). In addition, sequence variations in several other genes may influence the severity of a genetically caused disease of steroid biosynthesis or action. By this, the differences in an observed phenotype may be explained. Within the study all genes necessary for adrenal and gonadal steroid biosynthesis and several genes which are known to influence the action of steroid hormones will be analysed in patients with congenital disorders of adrenal and gonadal steroid biosynthesis, disorders of steroid action and disorders of sex development. The primary aim is to set up a correlation of the disease phenotype with the different genotypes detected.

Official Title
-----------------
Investigation of Gene Polymorphisms Influencing Steroid Synthesis and Action in Patients With Deficient Steroid Biosynthesis and Disorders of Sex Development

Conditions
-----------------
Intersex, Disorders of Sex Development, Congenital Adrenal Hyperplasia, Congenital Adrenal Hypoplasia, Adrenal Insufficiency, Mineralocorticoid Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Disorders of Sex Development Congenital Adrenal Hyperplasia Congenital Adrenal Hypoplasia Adrenal Insufficiency Mineralocorticoid Deficiency Salt-loss
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 |
| --- | --- |
| 1<br> | |
| 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ghrelin Levels in Pancreatic Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The primary outcome measure for this study is plasma ghrelin level.

Detailed Description
-----------------
The primary outcome measure for this study is plasma ghrelin level, and the two primary comparison are: Patients with cachexia versus patients without cachexia Patients with cachexia versus healthy controls

Official Title
-----------------
Assessment of Plasma Ghrelin Levels in Patients With Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological proof of pancreatic adenocarcinoma The control are will include healthy age-matched patients without cancer The test arm will include patients with pancreatic cancer and they will divided into two groups: those with and without weight loss Patients must have recovered from any major infections and/or surgical procedures Exclusion Criteria: Patients with other serious medical illness like congestive heart failure, thyroid disease,liver disease or renal failure - conditions that will alter their nutritional state Patients on appetite stimulant and those receiving total parenteral nutrition Patients who have undergone gastrectomy or those who have gastric ulcers Patients receiving active chemotherapy No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or for which patient has been disease free for at least five years.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Pancreatic cancer patients | Procedure: Blood draw<br>* One blood draw prior to first treatment<br>|
| 2<br>Healthy controls | Procedure: Blood draw<br>* One blood draw prior to first treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate plasma ghrelin levels in patients with pancreatic cancer and compare with age matched controls |  | prior to treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the role of ghrelin in pathophysiology of cancer cachexia |  | prior to treatment | 
| To generate hypotheses for future studies and treatment based on the findings |  | prior to treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ghrelin
The Effect of Dexamethasone Dosing on Post-tonsillectomy Hemorrhage

Study Overview
=================
Brief Summary
-----------------
This is a retrospective chart review looking at the effect of dexamethasone dosing on post-tonsillectomy hemorrhage.

Conditions
-----------------
Tonsillectomy, Adenotonsillectomy

Intervention / Treatment
-----------------
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing a tonsillectomy Patients undergoing an adenotonsillectomy Exclusion Criteria: All patients with a known history of bleeding or clotting disorders, as well as those patients who had presented to Nationwide Children's Hospital main operating room for control of PTH but had their initial tonsillectomy/adenotonsillectomy at an outlying facility will be excluded from the study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non post-tonsillectomy hemorrhage<br>Children who do not have post-tonsillectomy hemorrhage. | Drug: Dexamethasone<br> <br> |
| Post-tonsillectomy hemorrhage<br>Children return to the hospital after surgery with post-tonsillectomy hemorrhage. | Drug: Dexamethasone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dexamethasone Dosage |  | once at start of surgery |
Factors Associated With High Mortality of Gastric Adenocarcinoma in Thailand Versus Japan

Study Overview
=================
Brief Summary
-----------------
The differences in patient's clinicopathological characteristic between high and low prevalence of gastric cancer region should be further examined to elucidate factors that associate with poor survival rate of patients with gastric cancer. Therefore, this study aimed to evaluate characteristics of patients with gastric adenocarcinoma and factors associated with different outcome in Thailand and Japan to find a clue to improve patients' survival in low prevalence country such as Thailand. This is a retrospective cohort study. It was conducted at King Chulalongkorn Memorial Hospital, Thailand and Osaka Medical Center for Cancer and Cardiovascular Disease, Japan. Eligible cases were selected by using standardized search protocols: formal computer searches of all patients seen at out-patient clinic and/or hospitalized for gastric cancer between 2010 and 2014.Two physicians, who were informed the definition of each variable, individually reviewed chart of patients.

Official Title
-----------------
Factors Associated With High Mortality of Gastric Adenocarcinoma in Thailand Versus Japan

Conditions
-----------------
Risk Factor

Intervention / Treatment
-----------------
* Other: Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients seen at out-patient clinic and/or hospitalized for gastric cancer between 2010 and 2014. Exclusion Criteria: Age < 18 years Incomplete data Miss diagnosis of gastric adenocarcinoma Died from other causes (not related to gastric adenocarcinoma).

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 |
| --- | --- |
| Thailand<br>Thai patients who diagnosed gastric cancer | Other: Treatment<br>* Observe the treatments of gastric cancer in each group<br>|
| Japan<br>Japanese patients who diagnosed gastric cancer | Other: Treatment<br>* Observe the treatments of gastric cancer in each group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors that associated with mortality rate in Thailand compared to Japan |  | 2010-2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric cancer, Thailand, Japan
Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of a topical antifungal formulation, Luliconazole Solution, 10%, in the treatment of adults with onychomycosis of the toenails.

Official Title
-----------------
Safety and Efficacy of Luliconazole Solution, 10% With Two Dosing Regimens in Distal Subungual Onychomycosis of the Toenails: A Randomized, Double-Blind, Vehicle-Controlled, Phase 2B/3 Study

Conditions
-----------------
Distal and Lateral Subungual Onychomycosis

Intervention / Treatment
-----------------
* Drug: Luliconazole Solution, 10%
* Drug: Vehicle Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects of either gender, any race and between the ages of 18 and 70 inclusive Subjects with a clinical diagnosis with culture confirmation of distal subungual onychomycosis (DSO) - Subjects must be free of any disease that in the Investigator's opinion might interfere with the study evaluations or jeopardize the subject's safety Exclusion Criteria: Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the solution Subjects who are currently participating or have recently participated in another investigational medication or device study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Luliconazole Solution, 10% Regimen 1<br> | Drug: Luliconazole Solution, 10%<br>* Topical<br>|
| Experimental: Luliconazole Solution, 10% Regimen 2<br> | Drug: Luliconazole Solution, 10%<br>* Topical<br>|
| Placebo Comparator: Vehicle Solution Regimen 1<br> | Drug: Vehicle Solution<br>* Topical<br>|
| Placebo Comparator: Vehicle Solution Regimen 2<br> | Drug: Vehicle Solution<br>* Topical<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who achieve complete cure of the target great toenail |  | Week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Onychomycosis, Toenail Fungus, luliconazole, Antifungal, Topical
Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this work is to evaluate which of the two types of operation (traditional/open and laparoscopic) has more impact on patients who were operated electively due to their chronic calculous cholecystitis.

Detailed Description
-----------------
The prospective, single center, randomized study includes 120 patients who are operated electively - 60 patients operated laparoscopically and 60 patients operated traditionally. Biohumoral and endocrine parameters of response to trauma are determined from 24 hour urine and blood: adrenalin, noradrenalin, metabolites of corticosteroid hormone - 17- hydroxyl and 17- keto steroid (HPLC method), C reactive protein and albumin, glycemia, creatine phosphokinase, lactate dehydrogenase, sedimentation of erythrocytes and serum concentration of potassium.

Official Title
-----------------
Extent of Surgical Trauma in Open and Laparoscopic Cholecystectomy

Conditions
-----------------
Chronic Calculous Cholecystitis

Intervention / Treatment
-----------------
* Procedure: Laparoscopic cholecystectomy
* Procedure: Open Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Calculous Cholecystitis Exclusion Criteria: Previous Biliary Surgery Cholangitis Obstructive jaundice
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: Laparoscopic cholecystectomy<br> | Procedure: Laparoscopic cholecystectomy<br> <br> |
| Active Comparator: Open cholecystectomy<br> | Procedure: Open Surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine biohumoral and endocrine parameters of response to trauma | Urine and blood biochemical analyses: adrenalin, noradrenalin, metabolites of corticosteroid hormone - 17- hydroxyl and 17- keto steroid (HPLC method), C reactive protein and albumin, glycemia, creatine phosphokinase, lactate dehydrogenase, sedimentation of erythrocytes and serum concentration of potassium | first 24h after the surgical intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholecystectomy, Cholecystitis, Laparoscopy, Cholelithiasis, Operative trauma
Investigating the Frequency and Phenotype of Headaches Associated With Fasting During the Month of Ramadan.

Study Overview
=================
Brief Summary
-----------------
Headaches are more common in the month of Ramadan in patients who already suffer from migraine. The object of the present study is investigate the frequency in the Ramadan month .

Official Title
-----------------
Headache in Ramadan.

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

Intervention / Treatment
-----------------
* Other: There is no intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-60 years. expectation of fasting for at least 21 of 30 days during the month of Ramadan. understand and answer the questionnaire sent out in Danish. Exclusion Criteria: non-compliance with the headache calendar (defined as non-registration of at least 21 days per 30 days).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heathy participants<br> | Other: There is no intervention.<br>* No intervention.<br>|
| migraine patients<br> | Other: There is no intervention.<br>* No intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache frequency | The frequency of headaches is higher in the first half of Ramadan month compared to the last half. | Daily headache diary in three months. | 
| Headache frequency | The frequency of headaches is higher in the month before Ramadan compared to the month after ramadan. | Daily headache diary in three months. |