linjc16/ctgov huggingface dataset:
A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare injection skin (injection site) reactions when an antihistamine (Zyrtec®) or placebo is taken prior to performing daily Copaxone® injections. Patients will be assigned (like a flip of a coin) to take either a placebo or an antihistamine (Zyrtec®) prior to performing their daily Copaxone® injections. The patient and physician will be unaware whether they are taking a placebo or antihistamine during the study.

Official Title
-----------------
A Double-Blind, Randomized, Placebo Controlled Study of An Oral Antihistamine on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® Using Autoject® 2 for Glass Syringe.

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

Intervention / Treatment
-----------------
* Drug: glatiramer acetate injection with oral cetirizine hydrochloride
* Drug: glatiramer acetate with placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years of age or older Diagnosis of RRMS Beginning or recently (within < 3months) began self-injecting Copaxone® Exclusion Criteria: Taking any other immunomodulatory therapy in conjunction with Copaxone® Unable to perform subcutaneous self-injection Pregnant or trying to become pregnant, or breast feeding during the study Previously participated in this study or in another clinical trial in the past 30 days

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 |
| --- | --- |
| Active Comparator: Copaxone® with Zyrtec<br> | Drug: glatiramer acetate injection with oral cetirizine hydrochloride<br>* Copaxone® injection 20 mg, Oral Zyrtec® 10 mg tablet<br>* Other names: Copaxone®, Zyrtec®;|
| Experimental: Copaxone® with placebo<br> | Drug: glatiramer acetate with placebo<br>* Copaxone® injection 20 mg, oral placebo<br>* Other names: Copaxone®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection Site Reaction | Injection site reaction after taking antihistamine | 5 weeks |
Rifaximin Use in Severe Alcoholic Hepatitis

Study Overview
=================
Brief Summary
-----------------
This study aimed to investigate the effect of decontamination by rifaximin in severe alcoholic hepatitis patients. Patients who take corticosteroid or pentoxifylline will be randomly allocated to rifaximin group or control group.

Official Title
-----------------
Effect of Gut Decontamination Using Rifaximin in the Patients With Severe Alcoholic Hepatitis

Conditions
-----------------
Severe Alcoholic Hepatitis

Intervention / Treatment
-----------------
* Drug: Rifaximin
* Drug: Corticosteroid or pentoxifylline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heavy alcohol drinking within 3 months (Over 40 g/day) Maddrey's discriminant function ≥ 32 AST/ALT ration ≥ 2 Bilirubin level ≥ 5mg/dL Any one of the following additional criteria : hepatic encephalopathy, enlarged, tender liver, or peripheral leucocytosis Age : 19-75 Jaundice within 3 months Exclusion Criteria: Other causes of chronic liver disease (HBV, HCV, or autoimmune hepatitis) Antibiotics or probiotics use within 8 weeks Drug induced hepatotoxicity Acute viral hepatitis (HAV or HEV) Hepatic abscess or cholagitis Hepatocellular carcinoma of modified UICC stage II, III or IV Malignant tumor other than HCC Pregnancy Severe chronic extrahepatic disease Type I hepatorenal syndrome Hepatic encephalopathy grade II or IV Severe infection

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 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: Rifaximin group<br>Corticosteroid or Pentoxifylline for 28 days Rifaximin 400mg tid for 28 days | Drug: Rifaximin<br>* 400mg three times per day for 28 days<br>Drug: Corticosteroid or pentoxifylline<br>* Corticosteroid 40mg/day or pentoxifylline 400mg three times per day for 28 days<br>|
| Active Comparator: Control group<br>Corticosteroid or Pentoxifylline for 28 days | Drug: Corticosteroid or pentoxifylline<br>* Corticosteroid 40mg/day or pentoxifylline 400mg three times per day for 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 6-month |
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany

Study Overview
=================
Brief Summary
-----------------
This is a Pilot/ feasibility study for a population-based Screening in all children 2 to 6 years in Lower Saxony, Germany during the compulsory (U7 (from the age of 2) U7a, U8, U9) routine check-ups and any voluntary visits to the pediatricians office.

Detailed Description
-----------------
The Fr1dolin-Study will be presented to the parents of ca. 320,000 children living in Lower Saxony, Germany. The recruitment of subjects, collection of written consent, the capillary blood sample and the screening questionnaire will be done by the registered pediatricians in their local medical practices. After study enrolment 200 µl of capillary blood are be taken from the subject and are sent pseudo-anonymized to the lab. LDL-C and the diabetes-associated antibodies are identified. Based on the results a second blood sample will be required. In case of pre-type-1 diabetes or signs for a familial hypercholesterolemia the pediatrician will be informed. He will contact the parents and discuss the further procedure in cooperation with the study center. In case of a positive result by measuring diabetes-related antibodies and LDL-C the goal of this trial is to advise and educate the families appropriate and to treat them if necessary. In addition families should have the possibility to participate in prevention trials. All data will be registered in a study database. Follow-up pre-type 1 diabetes: During the first year, follow-up will be performed after 6 and 12 months and thereafter annually until the age of 12 years or up to 6 months after the clinical onset of type 1 diabetes. Follow-up familial hypercholesterolemia: During the first year, follow-up will be performed after 6 and 12 months and thereafter annually until the age of 12 years.

Official Title
-----------------
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany

Conditions
-----------------
Type 1 Diabetes, Familial Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children living in Lower Saxony (primary residence) Age between 2 and 6 years (both included) Written consent by at least one parent / legal representative Willingness to deliver 200 µl of capillary blood Willingness to complete a questionnaire Willingness to participate to the follow-up visits Exclusion Criteria: • none

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 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 |
| --- | --- | --- |
| number of familial hypercholesterolemia or pre-type-1-diabetes | identification of patients/ families with familial hypercholesterolemia or pre-type-1 diabetes | 18 month |
Meal Distribution Across the Day in Female Nurses Working Shifts

Study Overview
=================
Brief Summary
-----------------
This study assessed the meal distribution across the day (energy and macronutrient intake) and its relationship to the nutritional status of nursing professionals.

Detailed Description
-----------------
221 female nursing professionals from Brazilian University hospital were classified in three shifts: day shift (n=112), night shift (n=55), and day-night shift (n=54). Food intake assessment (3-day 24-hour recall); Anthropometric variables (weight, height, waist circumference and hip circumference); Sleep time on working days and day off.

Official Title
-----------------
Meal Distribution Across the Day in Female Nurses Working Shifts and Their Relationship With Nutritional Status

Conditions
-----------------
Shift Work Type Circadian Rhythm Sleep Disorder, Imbalance of Constituents of Food Intake

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible participants were regularly employed by the hospital, with 36-hours per week scheduke, not counting additional shifts and overtime work. Exclusion Criteria: Volunteers who did not supply the necessary information for the development of the research and who were pregnant or lactating.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| meal distribution | 3-Day 24-Hour Recall Questionnaire. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shift work, nutritional status, nursing professionals, meal distribution, food intake
Pre-operative Studies for Prediction of Lymph Nodes Involvement in Endometrial Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The study evaluates pre-operative prediction of the risk for lymph nodes involvement in endometrial cancer patients. Patients will undergo ultrasound exam (bi and three dimensional) and biomarker test - Ca 125, in addition to routine physical and laboratory exams, before surgery. The sonographic evaluation will include endometrial characteristics and myometrial invasion, pelvic findings and enlarged lymph nodes.

Official Title
-----------------
Preoperative Evaluation of Endometrial Cancer

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Device: ultrasound
* Other: blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Endometrial cancer patients Surgical candidates Exclusion Criteria: Fertility preservation therapy Contraindication for surgery Stage 2 and higher

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: all patients<br>all study patients will undergo ultrasound and blood test | Device: ultrasound<br> <br> Other: blood test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with positive nodes |  | 4 weeks after surgery (4-6 weeks from enrollment) |
[S,S]-Reboxetine Long Term Safety Study In Post-Shingles Pain.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the long term (up to 2 years) safety and tolerability of [S,S]-Reboxetine in patients with pain after shingles.

Official Title
-----------------
A Phase 2B Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Postherpetic Neuralgia (PHN).

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: [S,S]-Reboxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have pain present for more than 3 months after healing of the shingles skin rash. Patients at screening must have a score of >/=40mm on the pain visual analogue scale. Exclusion Criteria: Patients with significant hepatic impairment. Patients with other severe pain, that may impair the self-assessment of pain due to postherpetic neuralgia (pain after shingles).

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

| Intervention/Treatment |
| --- |
|Drug: [S,S]-Reboxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs |  |  | 
| Physical examination |  |  | 
| 12-lead ECG |  |  | 
| Hematology/Biochemistry |  |  | 
| Adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Visual Analogue Scale |  |  | 
| Patient Global Impression of Change |  |  | 
| Neuropathic Pain Symptom Inventory |  |  | 
| Modified Brief Pain Inventory - Short Form |  |  | 
| SF-12 Health Survey |  |  | 
| EQ-5D |  |  | 
| Analgesic Treatment Satisfaction Scale |  |  | 
| Pain-related Medication Utilization |  |  |
Exercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036)

Study Overview
=================
Brief Summary
-----------------
To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).

Official Title
-----------------
A Multicenter, Double-Blind Placebo-Controlled Crossover Study to Investigate the Effects of an Inhaled Corticosteroid on Cardiopulmonary Exercise Parameters in Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Drug: Fluticasone
* Drug: Comparator: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 40 years and older Clinical diagnosis of COPD for greater than one year History of cigarette smoking Exclusion Criteria: Other lung diseases (not including COPD), such as asthma A condition that could interfere with your ability to perform exercise tests

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Arm 1: drug, crossing over to Pbo comparator | Drug: Fluticasone<br>* fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.<br>|
| Other: 2<br>Arm 2: Pbo comparator, crossing over to drug | Drug: Fluticasone<br>* fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.<br>Drug: Comparator: Placebo<br>* Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized Dyspnea Score at Isotime During Exercise | Difference in standardized dyspnea rating at isotime during constant load exercise in patients with COPD between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period. Isotime is the duration of the shortest exercise test on all treatment days (or the longest exercise time point common to all constant-load exercise tests). The standardized dyspnea score will be measured with the modified 10-point Borg Scale (0 [Best] - 10 [Worst] ). | 2 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Endurance Time | Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period. | 2 Weeks |
Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.

Detailed Description
-----------------
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study comparing DPSG to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne Vulgaris.

Official Title
-----------------
A Single-center, Double-blind, Randomized, Parallel-group Study, Comparing DPSG to a Placebo Control in the Treatment of Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: DPSG 7.5%
* Drug: Aczone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or non pregnant female aged ≥ 12 years with a clinical diagnosis of acne vulgaris. Exclusion Criteria: Female Subjects who are pregnant, nursing or planning to become pregnant during study participation

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DPSG 7.5%<br>DPSG 7.5% (Taro Pharmaceuticals USA) Topical, twice daily on the face for 84 days. | Drug: DPSG 7.5%<br>* topical gel<br>* Other names: dapsone;|
| Placebo Comparator: Vehicle Gel<br>Placebo product (Taro Pharmaceuticals Inc.) Topical, twice daily on the face for 84 days. | Drug: Placebo<br>* topical gel<br>* Other names: Vehicle;|
| Active Comparator: Aczone<br>dapsone 7.5 Topical, twice daily on the face for 84 days. | Drug: Aczone<br>* topical gel<br>* Other names: dapsone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inflammatory lesion counts | Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts | 12 weeks | 
| Change in non-inflammatory lesion counts | Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response of success | The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment | 12 weeks |
The Change of NK Cell Activity After Head and Neck Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
Cellular immunity can be changed after surgery and anesthesia. Tissue injury by surgical procedures significantly reduces the immune function in proportion to the degree of tissue injury. In addition, the use of opioids as analgesics during the perioperative period depress cellular immunity, in particular the activity of the natural killer (NK) cells. This perioperative immunosuppression may cause deleterious consequences on postoperative outcome in cancer patients. The aim of this study is to confirm the presence or extent of the change of NK cell activity between before and after head and neck surgery. Additionally, investigators will identify the clinical or genetic factors related to the change of NK cell activity.

Conditions
-----------------
The Patients Undergoing Head and Neck Surgery Including Tumor Removal and Reconstruction With Flap

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) The patients undergoing head and neck surgery including tumor removal and reconstruction with flap Exclusion Criteria: patients refusal patients not able to read, or understand the consent form History of Active viral or bacterial infection History of use of immunosuppressive drugs within the last six months History of chemotherapy History of autoimmune disorders Known HIV, Hepatitis B, or Hepatitis C infection Female who is pregnant, nursing ethnicity, other than asian

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| The change of NK cell activity | Preoperative NK cell activity will be measured using the NK vue diagnostic test before surgery and anesthesia. Postoperative NK cell activity will be measured using the NK vue diagnostic test after 24 hours since stopping the use of intravenous remifentanil as analgesics during anesthesia in the operating room or sedation in the intensive care unit. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
natural killer cell, head and neck cancer, opioid