linjc16/ctgov huggingface dataset:
Study of 0417 Ointment in the Treatment of Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The aim of this trial is to assess the efficacy of 0417 Ointment in the Treatment of Atopic Dermatitis. Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 4 weeks.

Official Title
-----------------
Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0417 Ointment

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: 0417
* Drug: Vehicle of 0417 test product
* Drug: Tacrolimus Ointment 0.03%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Atopic Dermatitis Good health with the exception of Atopic Dermatitis Percent Body Surface Area minimum requirements Exclusion Criteria: Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. Subjects who have any systemic or dermatological disorders with the exception of Atopic Dermatitis

Ages Eligible for Study
-----------------
Minimum Age: 8 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Test product that contains the active pharmaceutical ingredient | Drug: 0417<br>* Topical 0417 test product applied twice daily for 4 weeks<br>|
| Active Comparator: Reference<br>Reference product that contains the active pharmaceutical ingredient | Drug: Tacrolimus Ointment 0.03%<br>* Reference product for 0417 test product. Apply twice daily for 4 weeks<br>|
| Placebo Comparator: Vehicle<br>Placebo that contains no active pharmaceutical ingredient | Drug: Vehicle of 0417 test product<br>* Vehicle of 0417 test product applied twice daily for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region |  | Baseline, 4 weeks | 
| The Mean Change From Baseline in Pruritus |  | Baseline, 4 weeks | 
| The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA) |  | Baseline, 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic Dermatitis
Study on Pre-menopausal Patients With Advanced ER and PR + BC Treated With Arimidex Plus Zoladex

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy and tolerance of the association of two drugs already marketed and used to treat your disease: Arimidex® 1 Mg per day per os and Zoladex® 3,6 Mg in injections under cutaneous once per month in subjects with breast cancer.

Official Title
-----------------
An Open, Phase II Trial Assessing the Objective Response Rate After Combination of Arimidex® 1mg Per os/Day and Zoladex® 3.6 mg Sub Cut/Monthly as 1st Treatment for Premenopausal Receptor Positive Advanced or Metastatic Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Anastrozole and goserelin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, premenopausal women 18 years or older, histologically or cytologically confirmed locally advanced or metastatic breast cancer, suitable for endocrine treatment, no curative treatment available,, one or more measurable lesions, life expectancy more than 6 months, normal biological parameters. Exclusion Criteria: Presence of life-threatening metastases, previous endocrine therapy or chemotherapy for advanced or metastatic disease, any previous treatment with hormone (LH-RH) severe or uncontrolled systemic disease, pituitary adenoma, High risk of medullar compression.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anastrozole and goserelin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the feasibility and efficacy of the combination of these 2 drugs in these patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess clinical benefit rate, time to progression, duartion of response and safety in patients treated with the combination of these 2 drugs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premenopausal, Advanced Breast Cancer, Metastatic Breast Cancer
Cost of Off-label Antibiotics in Osteoarticular Infections

Study Overview
=================
Brief Summary
-----------------
Due to the emergence of multidrug-resistant micro-organisms in patients with bone and joint infection (BJI), the prescription of off-labeled antibiotics seem to be more and more common as part of routine care. These new antibiotics are, however, more expensive, and there are no precise data in France regarding the volume and cost of such off-label prescriptions in hospital, in the post-acute care structures, and in the outpatient setting. The objective of this study is to estimate the cost of using these antibiotics over 2 years for patients in a reference center for the management of complex bone and joint infection (CRIOAc)

Official Title
-----------------
Cost of Off-label Antibiotics in Osteoarticular Infections: Prospective Study Over 2 Years in a Reference Center for the Management of Complex Bone and Joint Infection

Conditions
-----------------
Bone Infection, Joint Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients having had off-label antibiotics between 2014 and 2015 to treat bone and/or joint infection, with or without implant and managed at the CRIOAc Lyon Exclusion Criteria: None

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 |
| --- | --- | --- |
| Estimation of the cost of the off-label antibiotics | The molecule concerned are: daptomycin, ertapenem, linezolid, ceftaroline, tigecycline and / or colimycin. The characteristics of the patients, the type of bone and joint infection and the prescribing methods (dosage, duration) were collected throughout the care path (hospitalization in surgery and / or medicine at CRIOAc or in peripheral hospitals, in post-acute care structure and in the home). The duration of dispensation is about 50 days. Overall costs for off-label prescriptions were estimated taking account of variations in purchase price invoiced to the reference center. | 50 days |
Effect of Antidepressants on Back Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether different types of antidepressant medicines relieve back pain that has lasted at least six months on a daily basis. Study participants will be assigned to treatment with either a antidepressant acting on the serotonin system in the brain (fluoxetine), one acting on the noradrenaline system (desipramine, or to a control medication not expected to relieve pain (benztropine). Each participant will be seen at least nine times during their 12 weeks on medication. This is a phase 2/3, outpatient study.

Official Title
-----------------
Efficacy of Antidepressants in Chronic Back Pain

Conditions
-----------------
Back Pain, Sciatica

Intervention / Treatment
-----------------
* Drug: Desipramine
* Drug: Fluoxetine
* Drug: Benztropine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic back pain (pain on a daily basis for six months or longer) Age 18-65 No major medical illness Exclusion Criteria: medical contraindication to tricyclic antidepressants recent alcohol or substance use disorder bipolar disorder

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Desipramine, low, middle or high exposure | Drug: Desipramine<br>* Low exposure (40-70 ng/mL), Middle exposure (70-130 ng/mL), High exposure (130-200 ng/mL)<br>* Other names: Anafranil;|
| Experimental: Arm 2<br>Fluoxetine, low, middle, or high exposure | Drug: Fluoxetine<br>* Low exposure (200-399 ng/mL), Middle exposure (400-499 ng/mL), High exposure (500-700ng/mL)<br>* Other names: Prozac;|
| Placebo Comparator: Arm 3<br>Benztropine .125-.5mg daily | Drug: Benztropine<br>* Daily dose 0.125 to 0.5mg<br>* Other names: Cogentin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptor Differential Scale Pain Intensity |  | 12 weeks post baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
analgesia, Back pain, sciatica
Importance of Peritoneal Free Fluid Cultures in Acute Appendicitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the frequency of positive free fluid cultures in both perforated and non-perforated appendicitis. In addition predictors of positive free fluid cultures will be analyzed.

Detailed Description
-----------------
Prior to surgery, all patients will receive antibioprophylaxis. In case of free peritoneal fluid, a sample is aspirated and sent for microbiology. A lavage with saline is not necessary. The decision to start postoperative antibiotic is left at the discretion of the surgeon. The decision to leave an abdominal drain is left at the discretion of the surgeon. The use of a preoperative single dose administration of antibiotics has been extensively studied and found beneficial in the prevention of SSI in appendicitis. However, the use of continued postoperative antibiotics has barely been studied. The sparse evidence that exist does not seem to support its systematic use. During appendectomy the surgeon frequently encounters turbid free fluid, even in non-perforated appendicitis. It is common practice in Belgium to continue antibiotic prophylaxis for 5 days after aspiration and lavage. Although the aspect often seems purulent, it is unknown in what percentage this fluid is contaminated. Also, it is unknown whether after aspiration and lavage intra-abdominal drains are necessary.

Official Title
-----------------
Importance of Peritoneal Free Fluid Cultures in Both Perforated and Non-perforated Appendicitis

Conditions
-----------------
Appendicitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Appendicitis (Perforated/ Non-perforated) Free fluid Age: 6 - 90y Exclusion Criteria: Immunosuppression (recent chemotherapy, chronic use of immunosuppressive medication) Age < 6 and > 90y

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 90 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 |
| --- | --- |
| Appendicitis<br>Free fluid in perforated or non-perforated appendicitis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the frequency of positive free fluid cultures in both perforated and non-perforated appendicitis | In case of free peritoneal fluid, a sample will be aspirated and sent for microbiology. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appendicitis, Free fluid
A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis

Study Overview
=================
Brief Summary
-----------------
To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.

Detailed Description
-----------------
This study did not have a fixed duration, and the duration of individual subject participation was determined based on investigator assessment of subject tolerability and continued benefit until such time as either the drug was commercially available in the US, or an alternate treatment extension was available in non-US regions. For this reason, no subjects, therefore, were considered to have completed the study.

Official Title
-----------------
A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease

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

Intervention / Treatment
-----------------
* Drug: Pimavanserin tartrate (ACP-103)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has completed the treatment period of a previous blinded study of pimavanserin The subject is willing and able to provide consent Caregiver is willing and able to accompany the subject to all visits Exclusion Criteria: Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder Subject is judged by the Investigator to be inappropriate for the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pimavanserin tartrate (ACP-103)<br>Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects | Drug: Pimavanserin tartrate (ACP-103)<br>* Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) | Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug) | From first to last study drug dose plus 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's Disease Psychosis
Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia

Study Overview
=================
Brief Summary
-----------------
Achalasia is a primary esophageal motility disorder where the lower esophageal sphincter fails to relax in response to swallowing with no well understood underlying cause. Surgical myotomy represents an appropriate therapeutic option. The purpose of this study is to evaluate flexible endoscopic myotomy, a novel therapeutic approach to overcome the need for invasive surgery.

Detailed Description
-----------------
In this study, the investigators propose the use of a recent endolumenal technique for partial myotomy in patients suffering from esophageal achalasia. Under general anesthesia patients will have upper endoscopy. Submucosal injection and mucosal incision is created for entry into the submucosal space. A submucosal tunnel is then created using a needle knife or blunt dissection as appropriate. Dissection will continue distally beyond the lower esophageal sphincter. The inner circular muscle fibers will then be divided to achieve an adequate myotomy length. The mucosal entry is then closed appropriately. Results will be compared to historical data of conventional Heller myotomies.

Official Title
-----------------
Endoscopic Submucosal Tunnel Dissection for Endolumenal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia

Conditions
-----------------
Achalasia

Intervention / Treatment
-----------------
* Procedure: Per oral endolumenal myotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidate for elective Heller myotomy Ability to undergo general anesthesia Ability to give informed consent Exclusion Criteria: Previous mediastinal or esophageal surgery Contraindications for EGD

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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

| Intervention/Treatment |
| --- |
|Procedure: Per oral endolumenal myotomy|patient cohort having flexible endoscopic submucosal esophageal partial myotomy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal function testing | esophageal manometry test, pH test, upper endoscopy,barium swallow | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score | quality of life questionaire | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endolumenal myotomy, per oral endoscopic myotomy
Retrospective Chart Review of Subcutaneous IgG Use in Infants

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants less than two years old.

Official Title
-----------------
Retrospective Chart Review Study: Subcutaneous IgG in Children Under 2 Years of Age

Conditions
-----------------
Primary Immune Deficiency

Intervention / Treatment
-----------------
* Biological: Subcutaneous IgG (SCIG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants who received more than one dose of IgG by the subcutaneous route before the age of two years. Consent of parent/guardian if required by institution/IRB. Exclusion Criteria: Infants with protein losing conditions such as lymphangiectasis, nephrosis, S/P cardio-thoracic surgery requiring drainage tubes for more than 48 hrs, protein losing enteropathy. Concomitant treatment with plasma, other blood products or IGIV while on SCIG. Lack of consent by parent/guardian (if required by Institution/IRB). Any other condition or treatment which, in the opinion of the local investigator, would interfere with obtaining valid results for that subject.

Ages Eligible for Study
-----------------
Maximum Age: 2 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 |
| --- | --- |
| SCIG<br> | Biological: Subcutaneous IgG (SCIG)<br>* Administered according to normal clinical practice<br>* Other names: SCIG;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCIG use | To describe the use of SCIG in infants below the age of two years in major academic medical centers and immunologists' practices in the US | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infants who received more than one dose of SCIG, then continued receiving IgG by a route other than SC |  | 1 year |