linjc16/ctgov huggingface dataset:
HPA Axis Study in Japanese Adults

Study Overview
=================
Brief Summary
-----------------
A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.

Detailed Description
-----------------
Assessment of the adrenal suppression potential, safety, efficacy and pharmacokinetics of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.

Official Title
-----------------
A Multicenter, Open-label Study to Evaluate the Adrenal Suppression Potential of Mapracorat 0.1% Ointment in Japanese Adults With Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis, Eczema

Intervention / Treatment
-----------------
* Drug: Mapracorat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Male or female subject aged >= 20 years Diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria Investigator's Global Assessment (IGA) score of 3 (moderate) to 4 (severe) at baseline Normal ACTH response before start of treatment Exclusion Criteria: Pregnancy or lactation Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results Concomitant medical or dermatological disorder(s), which could interfere with the investigator's ability to evaluate the subject's response to the investigational product Clinically manifest immunosuppressive disorder or known history of malignant disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Mapracorat<br>* Application of the investigational product on the affected skin areas<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of subjects with adrenal suppression |  |  |
Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the treatment of subjects with prostate cancer.

Official Title
-----------------
Non-comparative, Opened Multicenter Study to Assess the Efficacy and Safety of ELIGARD 22.5mg in the Treatment of Subjects With Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: ELIGARD 22.5mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male of 20 years or above Subject with prostate cancer with TNM stage T2 4NxMx Blood testosterone concentration ≥ 100ng/dl Bilirubin ≤ 1.5xULN, transaminase ≤ 2.5xULN WHO ECOG performance status ≤ 2 Signed written informed consent Exclusion Criteria: Hormone-Refractory Prostate cancer Brain metastasis Another primary malignant tumor except for prostate cancer Other conditions which in the opinion of the investigator preclude enrollment into the study

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

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: ELIGRAD 22.5mg<br>a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks | Drug: ELIGARD 22.5mg<br>* a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks<br>* Other names: ELIGARD;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg |  | 4weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dL until 24weeks |  | 24weeks | 
| Ratio of subjects whose blood testosterone concentration exceed 50ng/dL until 24weeks |  | 24weeks | 
| Change in self assessment scale grade |  | 0,4, 8, 12, 24 weeks | 
| Ratio of subjects whose blood testosterone concentration is below 20ng/dL at 4weeks and 24weeks |  | 4, 24 weeks | 
| Change in ECOG performance status |  | 0,4,8,12, 24weeks | 
| Change in blood prostate-specific antigen |  | 0,4,8,12,24 weeks | 
| Change in QoL_EPIC grade |  | 0,12, 24weeks | 
| Change in penile length |  | screening, 12, 24weeks | 
| Change in testicular volume |  | screening, 12, 24weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ELIGARD, Prostate cancer
Parkinson's Disease Genetics Database

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to develop and organize an effort to identify genes that determine an individual's risk for developing Parkinson's disease (PD). To ascertain, study and establish a repository of DNA samples that will allow for the identification of known and yet-to-be-identified genetic markers associated with the development of PD. To create a database with clinical, genetic (HLA, genome screen) and medical history information that will facilitate the search for PD susceptibility genes. To provide a centralized DNA repository to allow for targeted studies of genetic factors contributing to the onset, heterogeneity and progression of PD. To evaluate opportunities to extend the results of research to develop methods of risk prediction, prevention and therapy for PD.

Official Title
-----------------
Parkinson's Disease Genetics Database

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Genetic: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have a diagnosis of Parkinson's Disease as determined by standard neurological criteria. Patients ≥18 years of age who are able to provide informed consent Patients ≥ 18 who are decisionally impaired for whom informed consent can be obtained by a legally authorized representative. Exclusion Criteria: Patients without a diagnosis of Parkinson's 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: blood draw|The blood collection is designed to obtain blood samples as a source of DNA for genotyping and to establish a plasma and serum storage repository for future assays. GCRC nurses will perform all blood draws associated with this study. The following procedures are designed to standardize sample collection: Blood will be collected with the participant in the seated position with the reclining position reserved for those with a history of fainting during blood collection. Participants will be instructed to drink plenty of water (e.g., at least 8 large glasses of water) prior to the clinic visit as this facilitates easier collection. No fasting, activity or medication restrictions are required prior to or following blood collection. Blood collection will follow completion of the questionnaires. They will be performed by a nurse or technician with documented class time and experience in phlebotomy. Technician certification will occur prior to blood collection.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the current protocol is for establishment of the registry only and not for particular analyses of its contents |  | 5 years |
Topical Voltaren in Otitis Externa

Study Overview
=================
Brief Summary
-----------------
Voltaren being a Non-steroidal anti-inflammatory drug (NSAID) drug may be used as a single drug therapy in otitis externa being both therapeutic and analgesic thus reducing consumption of oral analgesia.

Detailed Description
-----------------
anticipated advantages are: reduction of inflammation and edema, no fungal overpopulation- when steroids are employed, contains boric acid as an ingredient, high safety profile, can be switched to antibiotic therapy later, can be used in conjunction wit steroids

Official Title
-----------------
Topical Voltaren as an Alternative Treatment for Otitis Externa

Conditions
-----------------
Otitis Externa

Intervention / Treatment
-----------------
* Drug: diclofenac sodium
* Drug: dexotc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults having otitis externa as single diagnosis mild to moderate Exclusion Criteria: Diabetes Children Pregnant women Immune compromise Starting other treatment Moderate to severe otitis externa

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>voltaren ophta | Drug: diclofenac sodium<br>* topical solution used in ear 5 drops 8 3/day<br>* Other names: voltaren ophta;|
| Active Comparator: 2<br>dexotic | Drug: dexotc<br>* aural drops<br>* Other names: dexotic;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reducing oral analagestic use |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adding an alternative treatment for otitis externa |  | 1 week |
Pre-approval Single-patient Expanded Access for Abrocitinib (PF-04965842)

Study Overview
=================
Brief Summary
-----------------
Provide pre-approval single patient Expanded Access (compassionate use) of abrocitinib for patients with severe uncontrolled atopic dermatitis

Detailed Description
-----------------
In Expanded Access, treating physicians are the Sponsor. Expanded Access requests from treating physicians may be submitted at www.pfizercares.com ; availability will depend on location/country.

Conditions
-----------------
Severe Uncontrolled Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: abrocitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Must have severe uncontrolled atopic dermatitis refractory to other available treatments

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

Arms and Interventions

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

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
-----------------
AD, atopic dermatitis, Atopic eczema, JAK inhibitors
Long Term Prevention of Nausea and Vomiting in Gynecologic Laparoscopy

Study Overview
=================
Brief Summary
-----------------
To compare postoperative nausea and vomiting (PONV) and perioperative outcomes of gynecologic patients undergoing laparoscopic surgery after scheduled administration of intravenous Ramosetron during hospital stays. Randomized controlled arm : Placebo versus Ramosetron injection Administration schedule : immediate postoperative status, 12 hrs after surgery, 36hrs after surgery

Detailed Description
-----------------
Surgical outcomes including operative time, blood loss, Hb change, postoperative pain, nausea/vomiting scale, times of rescue therapy, and complications

Official Title
-----------------
A Randomized Prospective Study of Scheduled Intravenous Ramosetron for the Prevention of Nausea and Vomiting in Hospitalized Patients After Gynecologic Laparoscopy

Conditions
-----------------
Uterine Myoma, Ovary Neoplasm, Adenomyosis

Intervention / Treatment
-----------------
* Drug: Ramosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18< or =, = or <70 with benign gynecologic disease ASA-Class I-II No-definite malignancy by US, CT/MRI, CA 125 < 500IU/ml Non-smoker Exclusion Criteria: Conversion to laparotomy Hx of malignancy Smoker Suspicious malignancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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 |
| --- | --- |
| Active Comparator: Ramosetron<br> | Drug: Ramosetron<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence or intensity of PONV |  | during postoperative hospital stays (2 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reaction associated with Ramosetron injection |  | Postoperatvie 7 days (at OPD based) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ramosetron, postoperative nausea and vomiting, laparoscopy
Interrogation of Exosome-mediated Intercellular Signaling in Patients With Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to isolate and analyze exosomes, which are tiny carriers of important proteins and nucleic acids that serve as messenger systems in the blood and tissue. Blood and tissue from patients with pancreatic cancer will be compared with blood and tissue from patients with noncancerous pancreatic disease. Including patients without cancer will allow the investigators to establish normal values, which currently do not exist. The investigators will then look to see whether exosome activity has a connection to disease recurrence and outcomes in patients. The results of this study will be the basis for future studies exploring this area.

Official Title
-----------------
Interrogation of Exosome-mediated Intercellular Signaling in Patients With Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer, Benign Pancreatic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients ≥ 18 years of age undergoing pancreaticoduodenectomy, partial or complete pancreatectomy, and duodenal ampullectomy for presumed ductal adenocarcinoma, intraductal papillary mucinous neoplasm (IPMN) or pancreatic neuroendocrine tumors, without an invasive component; or other benign pancreatic disease will be eligible. Exclusion Criteria: The presence of metastatic disease or disease that precludes resection Receipt of neoadjuvant chemotherapy or radiation for the index cancer within 6 months of being enrolled in the study INR >2 Known clotting factor deficiency or hypercoagulable state Any patient with the need or anticipated need for full anti-coagulation during hospitalization for the resection. Receipt of antiplatelet agents (other than aspirin) in the preceding week prior to resection. IPMN or pancreatic neuroendocrine tumors by radiographic imaging with high suspicion for invasive component Additionally, if at the discretion of the operating surgeon, blood collection would lead to undue morbidity, the patient will be excluded and replaced

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful isolation of exosomes | isolation of at least 100,000 microvesicles is needed for exosomes purification for down stream applications such as proteomics and RNA sequencing. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of the liver microenvironment | for alterations in cellular infiltrate and ECM using IF and IHC | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exosomes, 15-015
Platelet-rich Plasma Use as Prophylactic of Low Back Pain Post-spinal Following Gynecological Surgery

Study Overview
=================
Brief Summary
-----------------
Platelet-rich Plasma Use as Prophylactic of Post-operative Low Back Pain Following gynecological surgery.

Official Title
-----------------
Platelet-rich Plasma Use as Prophylactic of Low Back Pain Post-spinal Following Gynecological Surgery

Conditions
-----------------
Platelet-rich Plasma in Low Back Pain

Intervention / Treatment
-----------------
* Other: Platelet-rich Plasma
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective gynecological surgery. Exclusion Criteria: Spinal Pathology

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Platelet-rich Plasma<br>30 patients will receive platelet-rich plasma post-spinal anesthesia | Other: Platelet-rich Plasma<br>* The active group will receive Platelet-rich Plasma following spinal injection<br>|
| Placebo Comparator: Control<br>30 patients will receive sterile saline post-spinal anesthesia | Other: Control<br>* The control group will receive saline as a placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale |  | 7 days |
Drug Abuse Prevention Among Girls Through a Mother-Daughter Intervention

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine a computer- and family-based drug abuse prevention program is able to reduce drug use among early adolescent girls.

Detailed Description
-----------------
This study longitudinally tested a computerized, parent-involvement substance abuse prevention program for adolescent girls and their mothers. The prevention program aimed to strengthen and sustain the mother-daughter bond while equipping girls with the necessary information and skills to increase protective factors and reduce risk factors associated with tobacco, alcohol, and other harmful substance use.

Official Title
-----------------
Drug Abuse Prevention Among Girls Through a Mother-Daughter Intervention

Conditions
-----------------
Substance Use

Intervention / Treatment
-----------------
* Behavioral: Prevention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English-speaking New York City (NYC) area girls Ages 11 - 13 years Must have private access to a computer with high-speed connectivity Exclusion Criteria: Non-English-speaking girls who do not live in the NYC area Younger than 11 or older than 13 years of age Those who lack of private access to a computer with high-speed connectivity

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 13 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention Program<br>Girls and their mothers who are assigned to participate in a tobacco, alcohol, and other drug use prevention program aimed at young girls. | Behavioral: Prevention<br>* 9-session computerized cognitive behavioral program that young girls and their mothers interact with on a weekly basis in the privacy of their home. Girls and their mothers will watch and interact with 10 compact disc (CD) intervention sessions to learn skills to help girls avoid substance use.<br>|
| No Intervention: No Prevention Program<br>Girls and their mothers who are assigned to participate in questionnaires only. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Substance Use | Measured 30-day alcohol, tobacco, and other illicit drug use among girls. | Annually | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drugs, youth, parent, computer, prevention