linjc16/ctgov huggingface dataset:
Treatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT

Study Overview
=================
Brief Summary
-----------------
To compare the effect and side effects of photodynamic treatment and traditional topical steroid treatment in female genital erosive lichen planus

Detailed Description
-----------------
To assess the feasibility, efficacy and safety of hexyl 5-aminolevulinate-hydrocloride (HAL)-PDT in GELP in women.

Official Title
-----------------
A Study of Topical Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) and a Phase III Comparative Treatment Study of HAL PDT in Female Genital Erosive Lichen Planus (GELP)

Conditions
-----------------
Genital Lichen Planus

Intervention / Treatment
-----------------
* Drug: clobetasol propionate 0,05% ointment
* Drug: hexaminolevulinate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with symptomatically genital ELP, clinically verified by at least one doctor attended to the Vulva clinic. Untreated for ELP for at least 4 weeks. Written Informed Consent signed Age 18 or above Exclusion Criteria: Current pelvic inflammatory disease, genital malignancy, or gynecological infection. Known or suspected porphyria Known allergy to hexaminolevulinate or similar compounds (e.g. hexaminolevulinate or aminolevulinic acid) Pregnancy and lactation Participation in other clinical study either concurrently or within the last 30 days

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ELP active<br>one PDT treatment with 2 ml hexaminolevulinate 6 mg/ml gel | Drug: hexaminolevulinate<br>* one PDT treatment<br>|
| Active Comparator: topical steroids<br>treatment with clobetasol propionate 0.05% ointment used daily for 6 weeks | Drug: clobetasol propionate 0,05% ointment<br>* continuously daily treatment for 6 weeks<br>* Other names: Dermovate 0.05% ointment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change of GELP score and/or VAS score 6 weeks after start of treatment. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change of GELP score and/or VAS score 6 months after start of treatment. |  | 6 months |
A Clinical Trial of Infliximab for Uveitis

Study Overview
=================
Brief Summary
-----------------
This project is designed to test the hypothesis that inhibition of binding between tumor necrosis factor alpha (TNF-alpha) and its receptors using Remicade (infliximab, chimeric mouse/human IgG1K monoclonal antibody directed against human TNF-alpha, Centocor, Malvern,PA) is clinically useful for patients with uveitis that is refractory to other forms of systemic immunosuppressive therapy.

Official Title
-----------------
The Use of Remicade (Infliximab) in the Management of Vision-threatening Uveitis That is Refractory to Other Modes of Systemic Immunosuppression

Conditions
-----------------
Uveitis

Intervention / Treatment
-----------------
* Drug: Remicade (infliximab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study group will include patients suffering from treatment-resistant vision-threatening uveitis who attend the Uveitis Clinic at Casey Eye Institute. We plan to enroll 32 patients. Exclusion Criteria: Patients with ocular or systemic infection. Patients with the subtype of uveitis termed pars planitis who have MRI scan evidence of demyelination. There is a theoretical risk of adverse outcome of TNF-alpha inhibition on the clinical course of multiple sclerosis. Patients who suffer from pars planitis are at increased risk of developing multiple sclerosis. Children under the age of 9. Patients with known sensitivity to mouse proteins. Remicade is a chimeric protein with human and murine components. Patients with history of cancer (exception- skin cancers which are curatively resected), organ transplantation (exception- cornea), recent drug or alcohol addiction, or inability to keep appointments. Patients with other serious systemic diseases that could interfere with participation in the study. It is specifically noted that pregnant women and nursing mothers will be excluded from this study.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Remicade (infliximab)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Suprachoroidal Hemorrhage Associated With Pars Plana Vitrectomy

Study Overview
=================
Brief Summary
-----------------
To analyze the characteristics, related risk factors, and prognosis of suprachoroidal hemorrhage (SCH) associated with pars plana vitrectomy (PPV).

Official Title
-----------------
Suprachoroidal Hemorrhage Associated With Pars Plana Vitrectomy

Conditions
-----------------
Suprachoroidal Hemorrhage (Diagnosis), Pars Plana Vitrectomy

Intervention / Treatment
-----------------
* Procedure: Suprachoroidal hemorrhage associated with pars plana vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suprachoroidal hemorrhage associated with pars plana vitrectomy Exclusion Criteria: Patients with eye trauma-related Suprachoroidal hemorrhage were excluded.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Suprachoroidal hemorrhage associated with pars plana vitrectomy|SCH has a higher incidence rate after a second intraocular surgery in a vitrectomized eye which is associated with the lack of vitreous support and easier fluctuation of intraocular pressure. SCH associated with PPV is more localized and has a relatively good prognosis; high myopia and aphakic/ pseudophakic eyes are risk factors. Active treatment can effectively improve visual prognosis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathogenesis | pathogenesis of PPV-related SCH and incidence of PPV-related SCH | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vision acuity | the final vision acuity | up to 7 weeks |
Ceprotin Treatment Registry

Study Overview
=================
Brief Summary
-----------------
The overall objective is to collect and assess data on the treatment, safety, and treatment outcomes of subjects prescribed, receiving and participating in the Ceprotin treatment registry.

Official Title
-----------------
Ceprotin Treatment Registry

Conditions
-----------------
Protein C Deficiency

Intervention / Treatment
-----------------
* Biological: Protein C Concentrate (Human)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants for whom CEPROTIN therapy has been indicated and meeting the following criteria may be enrolled in this study: Signed and dated informed consent from either the participant or the participant's legally authorized representative prior to enrollment, as applicable Males and females of any age, including neonates, children, adolescents and adults Participant who received CEPROTIN or is initiating/receiving CEPROTIN treatment Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with severe congenital protein C deficiency<br>Registry subjects will be identified by working with Hemophilia Treatment Centers and Thrombosis Centers known to have subjects with severe congenital protein C deficiency, as well as by working with centers that use Ceprotin in emergency care situations. | Biological: Protein C Concentrate (Human)<br>* Commercially available Ceprotin will be prescribed, obtained and administered by the investigator according to local standard of care.<br>* Other names: Ceprotin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical diagnoses associated with Ceprotin treatment |  | 2 to 5 years, or until the Registry is terminated | 
| Ceprotin treatment regimens |  | 2 to 5 years, or until the Registry is terminated | 
| Safety information based on all serious adverse events (SAEs), related SAEs and related non-serious adverse events (AEs) |  | 2 to 5 years, or until the Registry is terminated | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment outcomes categorized by medical diagnosis | Evidence of halting or reversal of coagulopathy or thrombosis, end-organ damage, limb sparing, Length of Hospital Stay (LOS), and mortality | 2 to 5 years, or until the Registry is terminated | 
| CEPROTIN use and treatment outcomes in pregnancy, labor and delivery, surgery and invasive procedures, different age groups, and, in the presence of pre-existing renal and/or hepatic dysfunction |  | 2 to 5 years, or until the Registry is terminated |
ZD6474(Vandetanib) + Alimta Combo Study

Study Overview
=================
Brief Summary
-----------------
The main purpose of this trial is to look to see if adding ZD6474 (100 mg or 300mg tablets) to Alimta chemotherapy in patients with non-small cell lung cancer is safe and will help control their symptoms and disease better than the chemotherapy alone.

Official Title
-----------------
A Phase I, Open-Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With Pemetrexed (Alimta) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Prior Chemotherapy.

Conditions
-----------------
Carcinoma, Non-Small Cell Lung, Lung Cancer

Intervention / Treatment
-----------------
* Drug: ZD6474 (vandetanib) 100mg
* Drug: pemetrexed
* Drug: ZD6474 (vandetanib) 300mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed advanced or metastatic non-small cell lung cancer Failure of first-line chemotherapy 1 or more measurable lesion by RECIST Exclusion Criteria: Previous chemotherapy or radiotherapy within 4 weeks Significant cardiac events, arrythmias or other cardiac conditions Unacceptable laboratory measurements

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: ZD6474 (vandetanib) 100mg<br> | Drug: ZD6474 (vandetanib) 100mg<br>* once daily oral tablet<br>* Other names: ZACTIMA™;Drug: pemetrexed<br>* intravenous infusion<br>* Other names: Alimta®;|
| Experimental: ZD6474 (vandetanib) 300mg<br> | Drug: pemetrexed<br>* intravenous infusion<br>* Other names: Alimta®;Drug: ZD6474 (vandetanib) 300mg<br> <br> * Other names: ZACTIMA™;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the safety & tolerability of ZD6474 when administered in combination w/Pemetrexed (Alimta) to patients w/locally advanced or metastatic NSCLC after failure of prior chemo, by assessment of AEs, vital signs, lab, ECG and physical exam. |  | assessed at each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the pharmacokinetics of ZD6474 and Pemetrexed when given in combination to patients with locally advanced or metastatic NSCLC after failure of prior chemotherapy, by assessment of appropriate pharmacokinetic (PK) parameters. |  | assessed at each visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer, Non-small cell lung cancer, alimta, vandetanib, phase 1
Expanded Access for Bromodomain and Extra-Terminal (BET) Inhibitor

Study Overview
=================
Brief Summary
-----------------
This is an expanded access designed to provide access to Bromodomain and Extra-Terminal (BET) Inhibitor for eligible participants.

Intervention / Treatment
-----------------
* Drug: BET Inhibitor


Participation Criteria
=================

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: BET Inhibitor|Bromodomain and Extra-Terminal Inhibitor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Determining Whether Intra-Arterial Carboplatin Causes Hearing Loss in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out how often hearing loss occurs in patients with retinoblastoma after receiving treatment with intra-arterial carboplatin.

Official Title
-----------------
Determination of Hearing Status in Children Receiving Intra-Arterial Carboplatin for Intraocular Retinoblastoma

Conditions
-----------------
Intraocular Retinoblastoma, Hearing Loss

Intervention / Treatment
-----------------
* Diagnostic Test: Distortion product otoacoustic emission measurement (DPOAE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent indicating awareness of the investigational nature of the protocol. Children with RB aged 3 months and older who are scheduled to receive their first dose of IA carboplatin chemotherapy. Retinoblastoma is rarely seen in children over 8 years old, however we will not include an upper age range so as not to exclude any possible participants Exclusion Criteria: Children with known and documented preexisting hearing loss.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum 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 |
| --- | --- |
| Hearing evaluation DPOAE<br>Post IA hearing evaluation will be allowed up until 9 months after IA completion (or roughly one year from initiation of treatment). After completion of standard treatment for RB that included IA carboplatin. | Diagnostic Test: Distortion product otoacoustic emission measurement (DPOAE)<br>* Hearing will be measured at baseline and 3-9 months after completion of treatment with IA carboplatin chemotherapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the incidence of hearing loss | will be defined as a >10 db loss from baseline in any frequency, based on the lower threshold of the American Speech and Hearing Associations (ASHA) hearing change criteria. For children unable to cooperate for an audiogram, the DPOAE will be the primary measurement. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hearing Status, 18-529
The Impact of Heat Acclimation on Pro- and Anti- Inflammatory Cytokine Response

Study Overview
=================
Brief Summary
-----------------
There is growing evidence to conclude that part of the cascade leading to heatstroke is related to an inflammatory reaction triggered by the heat stress. The reduced ability to sustain heat stress - heat intolerance is also attributed to over-expression of inflammatory cytokines. Acclimation to heat improves human sustainability to heat and is a leading protective factor against heat stroke. The investigators hypothesize that the lower stress encountered during the process of acclimation to heat will be reflected by an over-ride in the expression of anti-inflammatory over the pro-inflammatory cytokines. This, in turn will attenuate the pathological cascade leading to heat stroke.

Official Title
-----------------
The Impact of Heat Acclimation on Pro- and Anti- Inflammatory Cytokine Response

Conditions
-----------------
Exposure to Heat

Intervention / Treatment
-----------------
* Other: exposure to heat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age:18-25 medically screened (healthy) Exclusion Criteria: BMI over 22 kg/m2 systolic blood pressure over 120 mmHg any febrile illness during the last week preceding the study any skin disease diabetes any heart conditions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: research arm<br> | Other: exposure to heat<br>* Dressed in shorts and tennis shoes the subjects will be exposed to exercise-heat stress for 12 consecutive days (excluding Saturday). Daily exposure will last 120 min, under the controlled environmental conditions of 40oC and 40% relative humidity. The exercise will consist of walking on a treadmill at a pace of 5km/h and 2% incline.<br>* Other names: acclimation to heat;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigating the variability in the levels of different cytokine and the kinetics in cytokine levels during the process of acclimation to heat. |  | 12 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acclimation, heat, cytokines, stress, inflammation
Intrauterine Device (IUD) Placement at the Time of Cesarean Section

Study Overview
=================
Brief Summary
-----------------
To evaluate the continuation of the Copper IUD at one year after placement through the cesarean incision into the uterus at the time of cesarean section.

Official Title
-----------------
Pilot Study of Copper IUD Placement at the Time of Cesarean Section

Conditions
-----------------
Intrauterine Device Placement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Desire an IUD post-partum and are willing to use the copper IUD. They will also need to be patients at one of our OBGYN clinics at the university of Kentucky. Exclusion Criteria: Post-partum hemorrhage, Chorioamnionitis (or a fever >101 at the time of cesarean), Women on antibiotic or immunosuppressive therapies, Cervical dilation > 5 cm at the time of c-section, OR Excessive intraoperative blood loss. Also women with contraindications to a copper IUD: Wilson's disease, unusual uterine shape or known uterine anomaly.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| women who have an IUD placed at the time of c-section<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuation at one year |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction with placement at time of cesarean |  | 4-6 months and 1 year | 
| bleeding profile |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-placental, IUD, Copper IUD, cesarean section, immediate post-partum, continuation
Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the efficacy and safety of OPC-249 by once daily inhalation at 0 (placebo), 30, 60 or 120 IU for 4 weeks in patients with pain due to osteoporosis.

Official Title
-----------------
Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis

Conditions
-----------------
Pain Due to Osteoporosis

Intervention / Treatment
-----------------
* Drug: OPC-249


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who fulfill all of the following items Patients with primary osteoporosis Patients who have existing 1-4 vertebral fractures Patients with back pain persisting for one week or more Postmenopausal women between 46 and less than 80 years of age

Ages Eligible for Study
-----------------
Minimum Age: 46 Years
Maximum Age: 79 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: OPC-249<br>* 1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)<br>|
| Active Comparator: 2<br> | Drug: OPC-249<br>* 1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)<br>|
| Active Comparator: 3<br> | Drug: OPC-249<br>* 1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)<br>|
| Active Comparator: 4<br> | Drug: OPC-249<br>* 1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (Subjective Symptom) | Change of pain measured by 100 mm visual analogue scale (VAS) at week4 from baseline. Regarding VAS (dotted onto a 100 mm line), 0 mm means No Pain and 100 mm means Worst Pain Imaginable. | Baseline and Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement Rate of Pain (Doctor's Judgment) | Percentage of participants qualified for improvement of pain by doctor's judgement. Qualification: stopped or almost stopped, alleviated, slightly alleviated, unchanged, worsend. Improvement defind by stopped or almost stopped or alleviated. | Baseline and Week 4 |