linjc16/ctgov huggingface dataset:
Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)

Study Overview
=================
Brief Summary
-----------------
The purpose of this surveillance is to collect more safety and efficacy data in non-study patients during concomitant and adjuvant temozolomide therapy.

Official Title
-----------------
Post Marketing Surveillance of Radiotherapy With Concomitant and Adjuvant Chemotherapy With Temozolomide for Patients With Newly Diagnosed and Operated Glioblastoma Multiforme

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Procedure: Primary surgical treatment
* Radiation: Radiotherapy
* Drug: Temozolomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have newly diagnosed and operated glioblastoma multiforme with postoperative residual tumor <=1.5 cm by magnetic resonance imaging (MRI). Age >=18 years. Hemoglobin >=10 g/dL. White blood cell count >=1.5x10^9/L. Platelet count >=100x10^9/L. Blood urea <=1.5 x upper limit of normal values (ULN). Creatinine <=1.5 x ULN. Bilirubin <=1.5 x ULN. Aspartate aminotransferase <=3 x ULN. Alanine aminotransferase <=3 x ULN. Alkaline phosphatase <=2 x ULN. Exclusion Criteria: Tumor-specific pretreatment. Contraindication against radiotherapy and/or chemotherapy. Malignomas other than basaliomas. Existing or planned pregnancy or lactation or inadequate contraception. Psychiatric disease. Simultaneous participation in another clinical trail or participation in another clinical trail in the last 30 days before recruitment.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with newly diagnosed and operated glioblastoma multiforme. | Procedure: Primary surgical treatment<br>* Primary surgery for tumor resection.<br>* Other names: Surgery;Radiation: Radiotherapy<br>* Radiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics.<br>* Other names: Radiation therapy;Drug: Temozolomide<br>* Temozolomide is first given with concomitant radiotherapy, and then as monotherapy (adjuvant chemotherapy). Dosing according to European Summary of Product Characteristics.<br>* Other names: SCH 052365;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme |  | After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide |
Special Survey of Production of Insulin Aspart Specific Antibody

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Japan. The aim of this study is to collect data of production of insulin aspart specific antibody under normal clinical practice conditions.

Official Title
-----------------
Special Survey of Production of Insulin Aspart (IAsp) Specific Antibody

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetes requiring insulin therapy Exclusion Criteria: Patients who had a treatment history of NovoRapid® (insulin aspart)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Insulin Aspart<br> | Drug: insulin aspart<br>* Injected subcutaneously (s.c., under the skin). Prescribed by physician as a result of normal clinical practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody titre findings |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemic events |  |  | 
| Adverse events |  |  | 
| HbA1c (glycosylated haemoglobin) |  |  |
Non-adherence to Pain Medication Increases Risk of Postoperative Frozen Shoulder

Study Overview
=================
Brief Summary
-----------------
Background: Postoperative Frozen-Shoulder (FS) or adhesive capsulitis is a relatively frequent complication (5-20%), even after simple arthroscopic shoulder surgeries. The pathophysiology is still unclear, but psychological factors may play a pivotal role. From clinical experience, the investigators hypothesized that participants, who are reluctant to take medications, particularly pain-killers, have an increased incidence of postoperative FS. The investigators retrospectively compared participants with and without postoperative FS by their attitude towards medication and by depression scale questionnaires.

Official Title
-----------------
Non-adherence to Pain Medication Increases Risk of Postoperative Frozen Shoulder: A Case Control Study

Conditions
-----------------
Frozen Shoulder, Depression

Intervention / Treatment
-----------------
* Procedure: Arthroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Shoulder arthroscopy Exclusion Criteria: Active frozen shoulder
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study Group<br> | Procedure: Arthroscopy<br>* Shoulder Arthroscopy<br>|
| No Intervention: Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-developed questionnaire | Adhereance to pain medication | 1 to 4 years postoperatively | 
| PHQ 4 (Patient Health Questionnaire-4) | Depression scale | 1 to 4 years postoperatively | 
| SMS (Self-Medicating Scale) | Patient's beliefs about self-medication | 1 to 4 years postoperatively |
Long-term Effectiveness, Safety, and Performance of the Evoke Closed-Loop SCS System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

Study Overview
=================
Brief Summary
-----------------
The objective of this multicountry, multicentre, prospective study is to evaluate the long-term clinical effectiveness, safety, and performance of the Evoke System in the treatment of chronic pain of the trunk and/or limbs in a real-world population.

Official Title
-----------------
A Prospective Study to Evaluate the Long-term Effectiveness, Safety, and Performance of the Saluda Medical's EvokeTM Closed-Loop Spinal Cord Stimulation System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Device: Evoke Spinal Cord Stimulation (SCS) System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible for therapy according to the Evoke System indications for use statement and labelling requirements Willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits Baseline VAS pain rating ≥60 mm in the primary area of pain Exclusion Criteria: No further exclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ECAP-controlled, closed-loop SCS<br>Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude | Device: Evoke Spinal Cord Stimulation (SCS) System<br>* A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Visual Analogue Scale (VAS) Pain | Visual Analogue Scale (VAS) to rate pain intensity (0mm [no pain] to 100mm [worst pain imaginable]) | 3-months post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of device- and procedure-related adverse events |  | through 60-months post-implant | 
| Measurement of ECAPs by the Evoke SCS System |  | through 60-months post-implant |
Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation

Study Overview
=================
Brief Summary
-----------------
To evaluate programming modalities at various targets for focal foot, knee pain, and groin pain relief.

Official Title
-----------------
Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Device: Spinal Cord Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Average unilateral foot, or knee or groin pain intensity of 6 or greater on a 0-10 numerical rating scale at Baseline Visit based on 7-day average NRS score Subject signed a valid, EC-approved informed consent form (ICF) Willing and able to comply with all protocol-required procedures and assessments/evaluations 18 years of age or older when written informed consent is obtained Key Exclusion Criteria: Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidates to participate in the study Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dorsal Column (DC) Perception<br>Use of DC Perception based programming | Device: Spinal Cord Stimulation<br>* Patients eligible for SCS<br>|
| Active Comparator: Dorsal Root (DR) Perception<br>Use of DR Perception based programming | Device: Spinal Cord Stimulation<br>* Patients eligible for SCS<br>|
| Active Comparator: Dorsal Root (DR) Sub-perception<br>Use of DR sub-perception based programming | Device: Spinal Cord Stimulation<br>* Patients eligible for SCS<br>|
| Active Comparator: Dorsal Column (DC) Sub-perception<br>Use of DC sub-perception based programming | Device: Spinal Cord Stimulation<br>* Patients eligible for SCS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity | Change in pain intensity from Baseline to end of each Period (knee/foot). Pain scores are measured on a scale of 0 - 10 where 0 is no pain and 10 is maximum pain possible. | up to 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Cord Stimulation, Chronic Pain
Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients

Study Overview
=================
Brief Summary
-----------------
To determine the safety and IOP-lowering ability of a test compound in patients with open-angle glaucoma or ocular hypertension.

Official Title
-----------------
Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Glaucoma therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; logMAR visual acuity not worse than 0.6. Exclusion Criteria: Clinically relevant ophthalmic or systemic conditions may be excluded.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Glaucoma therapy|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
-----------------
open-angle, glaucoma, ocular, hypertension, POAG
Sun Protection Factor Assay (339/2016)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987516
* Drug: SPF Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form. Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPF evaluation<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987516<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z43-090)<br>Drug: SPF Control<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Multi-modality MRI Study on Differences in Conversion of aMCI Patients With APOEε4 to AD

Study Overview
=================
Brief Summary
-----------------
This study is to find out the imaging marker and the changing laws of the marker during the course of the disease. The final purpose is to provide scientific evidence for new prevention, diagnosis and treatment of Alzheimer's disease.

Detailed Description
-----------------
It is an urgent problem in the field of cognitive neuroscience to tell the conversion progression of amnestic mild cognitive impairment(aMCI) patients with Apolipoproteinε4(APOEε4) to Alzheimer's Disease(AD). Based on our preliminary work, we will study the special group of aMCI patients with APOEε4 with multi-modality magnetic resonance imaging (resting-state functional MRI, structural MRI and diffusion tensor imaging) longitudinally. Besides, we will also detect the APOE genotype of each sample and enlarge the sample size. According to situation of the conversion or non-conversion and differences in the conversion progression, we will analyze the data between the inter-groups and intra-groups, compare the imaging data of baseline and follow-up, find the prediction imaging marker of AD and optimize the reliability and validity.

Conditions
-----------------
Mild Cognitive Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complaint about memory loss and confirmed by an informant Cognitive impairment in single or multiple domains, adjusted for age and education Normal or near-normal performance on general cognitive function and no or minimum impairment of daily life activities A Clinical Dementia Rating (CDR) score is 0.5 Failure to meet the criteria for dementia Carrying susceptible gene APOEε4 Must be able to accept examination of MRI, sight and hearing allow to complete test Exclusion Criteria: Other diseases that cause cognitive impairment,such as thyroid disease,stroke and so on people who have severe visual and hearing impairment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| aMCIp,aMCIs<br>progressive aMCI,stable aMCI | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the conversion of aMCI patients with APOEε4 to AD | According to situation of the conversion or non-conversion and differences in the conversion progression, we will analyze the data between the inter-groups and intra-groups, compare the imaging data of baseline and follow-up, find the prediction imaging marker of AD and optimize the reliability and validity. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
APOEε4
Expanded Access to Provide Selitrectinib for the Treatment of Cancers With a NTRK Gene Fusion

Study Overview
=================
Brief Summary
-----------------
Selitrectinib expanded access is for minor and adult patients with cancer having a change in a particular gene (NTRK1, NTRK2, or NTRK3 gene fusion). The patients are ineligible for an ongoing selitrectinib clinical trial or have other considerations that prevent access to selitrectinib through an existing clinical trial. Expanded access is intended to treat individual patients with different types of cancers with a NTRK gene fusion, including blood cancers, who have previously received tropomyosin receptor kinase (TRK) inhibitor therapy.

Official Title
-----------------
Expanded Access to Provide Selitrectinib (BAY2731954) for the Treatment of Cancers With a NTRK Gene Fusion.

Conditions
-----------------
Solid Tumors Harboring NTRK Fusion

Intervention / Treatment
-----------------
* Drug: Selitrectinib (BAY2731954)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cancer with a NTRK1, NTRK2, and NTRK3 gene fusion Previous treatment with a kinase inhibitor with known activity on TRK inhibition Unable to participate in an ongoing selitrectinib clinical trial Medically suitable for treatment with selitrectinib Exclusion Criteria: Currently enrolled in an ongoing clinical study with a TRK inhibitor

Ages Eligible for Study
-----------------
Minimum Age: 1 Month

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Selitrectinib (BAY2731954)|Selitrectinib is administered as capsules or liquid formulation.|

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
-----------------
NTRK2, NTRK3, Fusion Positive, Children, Loxo-195, Metastatic cancer, Advanced cancer, Neurotrophic tyrosine receptor kinase (NTRK), NTRK1