linjc16/ctgov huggingface dataset:
A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in adult subjects with atopic dermatitis

Official Title
-----------------
A Multiple-Dose (0.3%, 1%, and 3% [w/w]), Randomized, Blinded, Vehicle- and Active Comparator-Controlled, Sequential Dose Cohorts, Multi-Center Trial to Assess the Safety, Pharmacokinetics, and Proof-of-Concept Efficacy of Topical OPA 15406 Ointment, Applied Twice Daily for 28 Days, in Adult Subjects With Atopic Dermatitis

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

Intervention / Treatment
-----------------
* Drug: OPA-15406
* Drug: Tacrolimus
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects 18-65 years of age Diagnosis of atopic dermatitis (AD) AD affecting at least 5% of total Body Surface Area (BSA) for Part 1 and at least 10% BSA for Part 2, not including face, neck, and head Have had a positive but inadequate response to one or more treatment course of standard AD therapy including topical steroids, UV light A, narrowband UV B, and UV light B. Exclusion Criteria: -Use of systemic or topical therapy for contact or atopic dermatitis within 30 days of screening

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Matching placebo. | Drug: Placebo<br> <br> |
| Active Comparator: Tacrolimus<br>Tacrolimus 0.1% ointment twice daily for 28 days. | Drug: Tacrolimus<br>* 0.1% concentration of tacrolimus.<br>* Other names: Protopic;|
| Experimental: OPA-15406<br> | Drug: OPA-15406<br>* 0.3%, 1%, or 3% OPA-15406 topical ointment, applied twice daily for 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with AEs, SAEs, and % of clinically relevant changes from baseline in Draize Scale, physical examinations, vital signs, laboratory assessments, and electrocardiograms. |  | 28 days | 
| Measurement of drug levels in the blood of treated patients |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment (IGA) of Disease Severity at Week 4 |  | 28 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic Dermatitis, Eczema
Study to Explore Pharmacokinetics and Pharmacodynamics of a Single Rising Dose of BI 135585 XX

Study Overview
=================
Brief Summary
-----------------
To investigate the pharmacokinetics and pharmacodynamics of BI 135585 XX following single dose administration.

Official Title
-----------------
Pharmacokinetics and Pharmacodynamics of BI 135585 XX Administered as Oral Dose in Healthy Male Volunteers (Open-label, Single-dose Trial)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: BI 135585 XX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy male subjects overweight or obese Exclusion criteria: 1. Any relevant deviation from healthy conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

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

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: BI 135585 XX<br>one single dose | Drug: BI 135585 XX<br>* one single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum measured concentration of the analyte in plasma) |  | up to 4 days postdose | 
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) |  | up to 4 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-8 of BI 135585 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |  | up to 4 days postdose |
Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i.v. was at least one year before study entry. This study is limited to four study centers in the US.

Official Title
-----------------
Multicenter, Open-Label, 24 Week Regimen of 8 mg Pegloticase i.v. in Symptomatic Gout Subjects Who Participated in Previous Studies of Pegloticase i.v.

Conditions
-----------------
Chronic Gout Refractory to Conventional Therapy

Intervention / Treatment
-----------------
* Drug: pegloticase 8 mg i.v.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous treatment in studies of pegloticase i.v. Last exposure to pegloticase i.v. greater than one year prior to study entry Symptomatic gout Documented hyperuricemic (SUA ≥ 7 mg/dL) Exclusion Criteria: Prior exposure to Elitek® (rasburicase) Unstable angina Uncontrolled arrhythmia or hypertension Non-compensated congestive heart failure End stage renal disease requiring dialysis Concomitant use of SUA lowering agents and use of other investigational drugs

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pegloticase<br> | Drug: pegloticase 8 mg i.v.<br>* pegloticase 8 mg i.v. every 2 weeks for 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event Profile | Number of participants reporting events | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Plasma Uric Acid | This endpoint assessed the change in mean PUA concentration from baseline after the first dose and after the third dose. Mean PUA was calculated from samples collected at 5 timepoints following each of those doses. For example, Mean PUA at Week 3 included 5 timepoints before dose 2 infusion. | Baseline, Week 3 and Week 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gout, Gouty Arthritis, Anti-Gout preparations
Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy

Study Overview
=================
Brief Summary
-----------------
This is a nonblinded Case-only study that evaluates the effects of Agmatine Sulfate on small fiber peripheral neuropathy. Patients will be started on Agmatine sulfate (a metabolite of Arginine) and monitored for two months. Improvement will be noted on their response to the Neuropathic Pain Questionnaire. Additionally the investigators will note improvement by performing autonomic function testing at the beginning and end of the study.

Official Title
-----------------
Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy

Conditions
-----------------
Peripheral Neuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and Women Ages 18-75 with symptoms of small Fiber Neuropathy and have been diagnosed via autonomic function testing and or skin biopsy Exclusion Criteria: Women who are pregnant or breast feeding, patients with history of substance abuse, and patients with myelopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Neuropathic Pain Questionnaire |  | After 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QSART & ANSAR testing |  | After 2 months |
Spontaneous Gastric Intramural Hematoma: Case Report and Literature Review

Study Overview
=================
Brief Summary
-----------------
Patient previously healthy found to have spontaneous gastric intramural hematoma

Detailed Description
-----------------
28 year old male patient previously healthy presented with diarrhea and diffuse abdominal pain of 1 week duration that exacerbated 1 day prior to presentation. CT showed anterior abdominal mass possibly from the outer gastric wall. Gastroscopy suspected a submucosal tumor in the body and antrum. Patient's pain exacerbated and developed drop in hemoglobin. Urgent CT scan showed a bleeding gastric tumor. Urgent laparotomy identified a bleeding gastric lesion at greater curvature. Partial gastrectomy done with abutting mesocolon resection. Surgical specimen pathology showed gastric intramural hematoma that was considered spontaneous.

Official Title
-----------------
Spontaneous Gastric Intramural Hematoma: Case Report and Literature Review

Conditions
-----------------
Gastric Hemorrhage

Intervention / Treatment
-----------------
* Procedure: Gastric wide local excision for bleeding mass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient presenting with gastric bleeding tumors Exclusion Criteria: patients on anticoagulants and patient with gastric medical history
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Gastric wide local excision for bleeding mass|Laparoscopic partial gastrectomy for gastric submucosal mass|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous gastric intramural hematoma | Spontaneous gastric intramural hematoma | 1 month |
Functional Communicative Profile of Children With Down Syndrome

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to verify the use of communicative functions by children with DS in two interaction conditions: interaction with therapist and interaction with parent.

Detailed Description
-----------------
Parents and caregivers' engagement on therapeutic process of children with Down syndrome (DS) is important for language and communication development. The identification of the communicative skills presented by these children as well as the context influence in their performance as interlocutors, will contribute to the design of therapeutic interventions. Pragmatics theories are helpful to language use studies, since it takes into account social and environmental aspects and considers adult-child interaction as a determinant factor for its occurrence.

Official Title
-----------------
Functional Communicative Profile of Children With Down Syndrome

Conditions
-----------------
Down Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: genetic diagnosis of Down syndrome good health conditions normal results on audiologic evaluation pediatric and ear, nose and throat periodic check ups. attend speech-language therapy at the Speech Language Pathology Laboratory in Syndromes and Sensorimotor Deficits (SLPL-SSD) of the School of Medicine of the University of São Paulo. Exclusion Criteria: submission to long term hospitalizations due to heart diseases and major respiratory airway infections, that may interfere in the child's global development presence of visual or auditory important deficits

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 8 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 |
| --- | --- |
| Research Group<br>15 children with Down syndrome, observed in two interaction conditions: playing with their therapist (A) and playing with their caregiver (B). | |

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
-----------------
Down syndrome, Pragmatics, Language Development
Surgical Management of Postpartum Haemorrhage Without Embolization

Study Overview
=================
Brief Summary
-----------------
Postpartum haemorrhage is the main cause of maternal mortality. The aim of investigators' study was to evaluate the practice of hemostatic surgery (arterial ligation, uterine compression or hysterectomy) when the embolization of uterine arteries wasn't be performed.

Official Title
-----------------
Surgical Management of Intractable Postpartum Haemorrhage When Arterial Embolization Can't be Performed : Feasibility an Complications.

Conditions
-----------------
Postpartum Hemorrhage, Second Line Management, Uterine Arteries Embolization, Surgical Management of Haemorrhage

Intervention / Treatment
-----------------
* Other: Arterial embolization and/or surgical management.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age over 18 Postpartum haemorrhage Necessity of second line management No embolization performed Necessity of surgical management after embolization Exclusion criteria: Unnecessity of second line management Management by only embolization Incomplete medical files

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Arterial embolization and/or surgical management.|Arterial embolization and/or surgical management.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of each type of surgical management | Frequency of each type of surgical management | at delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of surgical interventions | Number of surgical interventions | at delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Embolization, surgery, hysterectomy, arterial ligation
Efficacy of Magnesium Sulfate on Reducing Renal Colic in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
To determine if magnesium sulfate paired with an analgesic medication will improve patient pain from renal colic compared with analgesic alone.

Official Title
-----------------
Efficacy of Magnesium Sulfate on Reducing Renal Colic in the Emergency Department

Conditions
-----------------
Renal Colic

Intervention / Treatment
-----------------
* Drug: Magnesium Sulfate
* Drug: D5W


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years old and <100 years old. Patients seen in the Emergency Department at Henry Ford Macomb hospital. Patients that are A+Ox3. Patients who have typical presentation for renal colic. Exclusion Criteria: Age <18 years. Patients with a history of dementia, acute delirium or altered mental status. Patients with inability to consent to study or inability to fill questionnaire independently. Patients with chronic kidney disease and allergies to study drugs. Patients that are pregnant (women who are of child-bearing potential will be screened with a urine BHCG). Patients with stroke activation or symptoms. Patients with trauma activations. Patients over the age of 100 years old are excluded as they make up a small percentage of the population and may become identifiable because of their age. Imaging study does not show evidence of ureteral stone.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: Treatment<br>Receiving Magnesium Sulfate | Drug: Magnesium Sulfate<br> <br> |
| Placebo Comparator: Placebo<br>Receiving Dextrose 5% in Water (D5W) | Drug: D5W<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score Change | We asked the patient's pain score on a scale of 0-10 with 10 being the highest amount of pain and 0 no pain, before and after treatment (approximately 1 hour). Primary Outcome was the change in score before and after treatment. | 1 hour after the completion of treatment medication (Placebo or Study Drug) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Requiring Opiates for Additional Pain Control | We analyzed how many patients required additional pain control with opiates between the two treatment groups. | Any opiate administration required after re-evaluation of pain score after initial treatment with either placebo or study drug |
Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical study is to determine impact of carbon ion radiotherapy (CIRT) treatment in combination with systemic therapy for oligo-metastatic prostate cancer. The primary objective: to determine disease biochemical progression-free survival in man with oligo-metastatic (M1a/b) prostate cancer undergoing systemic therapy with definitive radiotherapy of the primary tumor. The secondary objective: to determine local control, overall survival and quality of life in men with oligo-metastatic prostate cancer undergoing carbon ion radiotherapy

Official Title
-----------------
Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer

Conditions
-----------------
Metastatic Prostate Carcinoma

Intervention / Treatment
-----------------
* Radiation: CIRT with systemic therapy arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed adenocarcinoma of the prostate Age ≥ 20 and < 80 years of age ECOG PS 0 or 1 Life-expectancy ≥1 year Stage T1-4,N0-1,M1a/b disease on imaging, with a combined maximum of 3 synchronous lesions. Ability to understand and willingness to sign informed consent Exclusion Criteria: No pathologically confirmed adenocarcinoma of the prostate visceral metastasis Previous pelvic radiotherapy or prostatectomy Severe systemic disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: CIRT with systemic therapy arm<br>Carbon ion radiotherapy combined with systemic therapy | Radiation: CIRT with systemic therapy arm<br>* carbon ion radiotherapy to the prostate(59.2GyE/16Fx to prostate and seminal vesicle) Systemic therapy:Hormonal therapy (LHRH agonist and/or antiandrogens) or chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to PSA relapse |  | From the start of systemic therapy, a median of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | From the start of systemic therapy, a median of 2 years | 
| Overall survival |  | From the start of systemic therapy, a median of 2 years | 
| Quality of life |  | From the start of carbon ion radiotherapy, a median of 2 years |