linjc16/ctgov huggingface dataset:
Prognostic Markers of Patients With STEMI

Study Overview
=================
Brief Summary
-----------------
To analyze the relationship between the clinical data and the outcomes of STEMI patients.

Official Title
-----------------
Prognostic Markers of Patients With ST-segment Elevation Myocardial Infarction

Conditions
-----------------
STEMI - ST Elevation Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with ST-segment elevation myocardial infarction(STEMI). Exclusion Criteria: Patients with concurrent infection or any documented inflammatory illness, such as arthritis or connective tissue diseases,or any other malignancy. Pregnant women. Severe hepatic dysfunction. Uncontrolled hypertension.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with STEMI<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 3 years |
Aquatic Therapy and Autism Spectrum Disorders

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of one-on-one versus group-based aquatic therapy on the social interactions, behaviors and physical activities of children with autism spectrum disorders (ASDs).

Official Title
-----------------
Aquatic Therapy and Autism Spectrum Disorders

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Other: Aquatic Physical Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligibility criteria: DSM-V diagnosis of Autism Spectrum Disorder or DSM-IV diagnosis of Asperger's syndrome or high functioning atypical autism or pervasive development disorder - not otherwise specified or else the typical clinical findings and suspicion of an ASD Treatment naïve to prior aquatic therapy Exclusion criteria: Not willing to undergo an investigational treatment Unable to cooperate well enough to safely participate in aquatic therapy under the protocol guidelines Known allergies to pool chemicals Other significant co-morbidities which may include (but is not limited to): severe cerebral palsy with low motor function, advanced pulmonary disease, home oxygen requirement, spina bifida with low motor function, permanent feeding tubes, poorly controlled seizure disorder, chronic indwelling urinary catheters or any condition causing severe cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 17 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observation<br> | |
| Active Comparator: One-on-one Aquatic Therapy<br> | Other: Aquatic Physical Therapy<br>* Swim Whisperer's Aquatic Therapy Sessions<br>|
| Experimental: Group Aquatic Therapy<br> | Other: Aquatic Physical Therapy<br>* Swim Whisperer's Aquatic Therapy Sessions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PedsQL Score | Survey | Baseline and 10 weeks after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aquatic therapy, hydrotherapy
Sun Protection Factor Assay

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 on Minimal Persistent Pigment-Darkening Dose.

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY 987517)


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 Signed and dated Informed Consent Form Signed and dated HIPAA Form An unambiguous MED 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 dianoses 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Each test site area is divided into test subsite 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: Coppertone (BAY 987517)<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-SR15-68_R84-089)<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 |
Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

Study Overview
=================
Brief Summary
-----------------
This phase I clinical study was designed to evaluate the safety of novel recombinant HPV 16/18 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women 18-55 years of age at enrolment. Approximately 30 study subjects will receive the novel HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.

Official Title
-----------------
An Open-Label, Single-dose, Non-Randomized, Safety and Tolerability Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 55 Years

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Biological: HPV 16/18


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent from the subject prior to enrolment; Female between, and including, 18 and 55 years of age at the time of enrolment; Subjects must be free of obvious health problems; Not pregnant and having no plan for pregnancy; Exclusion Criteria: Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7); Previous vaccination against HPV; Having severe allergic history or other immunodeficiency; Chemotherapy and other immunosuppressive agents using;

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

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

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: HPV 16/18<br>Participants in this arm would intramuscularly receive 90mcg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses. | Biological: HPV 16/18<br>* Participants would intramuscularly receive 90mcg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure injection-site complaints within 7 days after each vaccination; Measure systematic adverse reactions within 1 month after vaccination; Measure serious adverse experience; Measure blood, liver and kidney functions pre- and 3 days post vaccination. |  | 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
human papillomavirus vaccine
Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral administration.

Detailed Description
-----------------
This is a randomized, 2-arm, parallel group, open-label study to evaluate the safety and efficacy of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise or with oral anti-hyperglycaemic agent. The patients will receive either TA-7284-Low or TA-7284-High orally alone or in combination with oral anit-hyperglycaemic agent for 52 weeks.

Official Title
-----------------
An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of TA-7284 in Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: TA-7284-Low
* Drug: TA-7284-High


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women age ≥20 years old Diagnosed with Type 2 diabetes mellitus at least 3 months before screening HbA1c of ≥7.0% and ≤10.0% (monotherapy group) HbA1c of ≥7.0% and ≤10.5% (combination therapy group) Exclusion Criteria: Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus Past or current history of severe diabetic complications Fasting plasma glucose > 270 mg/dL before treatment start History of hereditary glucose-galactose malabsorption or primary renal glucosuria Patients requiring insulin therapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TA-7284-Low<br> | Drug: TA-7284-Low<br>* TA-7284-Low<br>|
| Experimental: TA-7284-High<br> | Drug: TA-7284-High<br>* TA-7284-High<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events |  | 54 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | Week 52 | 
| Change in Fasting Plasma Glucose |  | Week 52 | 
| Change in Body Weight |  | Week 52 | 
| Change in Blood Pressure |  | Week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TA-7284, JNJ-28431754, Canagliflozin, Sodium Glucose Co-Transporter (SGLT2 inhibitor)
Influence of the Implant Connection on Facial Tissues Maturation

Study Overview
=================
Brief Summary
-----------------
The substitution of a tooth with a fixture often induces undesired morphological changes, resulting in a deterioration of the aesthetic appearance. The purpose of this study is to compare the soft tissue behavior next to two different implant connections: 5° (group 1) and 35° hexed (group 2), conical, internal with switching platform design after 12 months of functional provisionalization

Official Title
-----------------
Influence of the Implant-Abutment Connection on the Ratio Between Height and Thickness of Tissues at the Buccal Implant Zenith: a Perspective Randomised 3d Comparative Analysis on 188 Implants

Conditions
-----------------
Bone Loss, Periodontal Bone Loss, Implant Tissue Failure

Intervention / Treatment
-----------------
* Biological: implantology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Missing teeth good oral hygiene good systemic health Exclusion Criteria: lactation pregnancy heavy smoking (more than 20 cigarettes/day) severe medical conditions that could affect periodontal health and peri-implant tissue response use of drugs correlated to periodontal hypertrophy bone volume that required bone augmentation procedures before implant placement as well as soft tissue graft or any kind of peri-implant tissue engineering

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Anyridge (Mega'Gen, Korea) 5° conical internal hexed connection | Biological: implantology<br>* placing of implant<br>|
| Active Comparator: Group 2<br>Core (Bioimplant, Italy) 35° conical internal hexed connection (screw-vent style) | Biological: implantology<br>* placing of implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| height of the peri-implant mucosa (MH) | This measurement (MH) corresponds to the depth of the implant referred to the most coronal point of the buccal mucosa measured according to the main implant axis digitally calculated by 3D software Gom. | after 12 months | 
| The width (MT) of the peri-implant mucosa | was calculated from the vestibular shoulder of the analogue to the external mucosa point perpendicular to the implant major axis digitally calculated by 3D software Gom. | 12 months |
Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes

Study Overview
=================
Brief Summary
-----------------
The overall objective and Primary Aim of this Limited Competition: Small Grant Program (R03) is to address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by conducting a pilot randomized clinical trial to evaluate the efficacy of Blood Glucose Awareness Training, which has been adapted for, but never evaluated in adolescents with Type 1 Diabetes (T1D) and their parents.

Official Title
-----------------
Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes

Conditions
-----------------
Type1diabetes, Fear of Hypoglycemia

Intervention / Treatment
-----------------
* Behavioral: Fear of Hypoglycemia
* Other: Treatment As Usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adolescents aged 10-17 years and their parent(s) or legal guardian; T1D duration >1 year; insulin pump use >6 months; agreement of both parent and adolescent to participate in intervention sessions; elevated scores on the Parent Hypoglycemia Fear Survey - Behavior Subscale. Exclusion Criteria: developmental disability or reading disorder that prevents understanding of the intervention materials; and non-English speaking adolescents and parents.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fear of Hypoglycemia Intervention<br>Cognitive behavioral therapy based psychological intervention occurring every other week for 12 weeks. | Behavioral: Fear of Hypoglycemia<br>* Participants will receive exposure and response prevention and/or hypoglycemia awareness training.<br>|
| Other: Treatment As Usual<br>Control group completes questionnaires but does not receive any study intervention. Receives medical care as usual. | Other: Treatment As Usual<br>* Treatment As Usual<br>* Other names: Standard of Care;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in scores on the Hypoglycemia Fear Survey | To address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by evaluating the efficacy of Blood Glucose Awareness Training as compared to treatment as usual. | Baseline, 3 and 6 months |
Safety of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke

Study Overview
=================
Brief Summary
-----------------
This study will determine if NXY-059 is safe in patients with an acute stroke caused by bleeding in the central nervous system. The primary objective was to assess the safety and tolerability of NXY-059 compared to placebo.

Official Title
-----------------
CHANT (Cerebral Hemorrhage And NXY Treatment) A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter, Phase IIb Study to Assess the Safety and Tolerability of Intravenous Infusion of NXY-059 in Adult Patients With Acute Intracerebral Hemorrhage (ICH)

Conditions
-----------------
Intracerebral Hemorrhage

Intervention / Treatment
-----------------
* Drug: NXY-059


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females Intracerebral Hemorrhage as the cause of stroke symptoms Onset of symptoms within 6 hours Full functional independence prior to the present stroke Exclusion Criteria: Unconsciousness Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition. Severe illness with life expectancy less than 6 months. Known severe kidney disorder. Current known alcohol or illicit drug abuse or dependence. Pregnant or breast-feeding. Treatment with acetazolamide and methotrexate is not permitted during the infusion Participation in a previous clinical study within 7 days. Meets all other exclusion criteria

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: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NXY-059|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global disability on modified Rankin scale at 90 days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH stroke scale |  |  | 
| Barthel Index |  |  | 
| Stroke Impact Scale |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, cerebral vascular accident, CVA, Hemorrhage, Intracerebral Hemorrhage (ICH), Brain Attack, Cataplexy
Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma

Study Overview
=================
Brief Summary
-----------------
The aim of the trial is to improve disease control after an allogeneic stem cell transplantation (alloSCT) for relapsed or refractory classical Hodgkin lymphoma (rrHL, cHL) with consolidation therapy by Brentuximab Vedotin (BV) for up to one year. The primary objective of the trial is to show efficacy of the experimental consolidative treatment strategy. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.

Official Title
-----------------
Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma

Conditions
-----------------
Classical Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Drug: Brentuximab Vedotin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with relapsed/refractory cHL who receive an allogeneic stem cell transplantation Histologically proven cHL in the most recent tumor biopsy Absolute neutrophil count ≥ 500/mm³ ECOG ≤2 Age ≥ 18 years Exclusion Criteria: Presence of nodular lymphocyte-predominant HL (NLPHL) or grey-zone lymphoma Progressive disease as last documented response prior to alloSCT Any peripheral neuropathy ≥ grade 2 Any other serious disease or organ dysfunction which might impair protocol treatment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maintenance<br>Brentuximab Vedotin will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions | Drug: Brentuximab Vedotin<br>* BV will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions<br>* Other names: BV;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year Cumulative incidence of relapse (CIR) | 1-year Cumulative incidence of relapse (CIR) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1- and 2-year Progression-free survival (PFS) | 1- and 2-year Progression-free survival (PFS) | 1 and 2 years |