linjc16/ctgov huggingface dataset:
Novel Serum Markers for Monitoring Response to Anti-Cancer Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the levels of serum proteins and other biomarkers in cancer patients and in patients suspected of having cancer. We believe that some of these markers may be useful for confirming the diagnosis or for selecting patients for specific types of cancer therapies. These markers may also help to predict response to therapy, relapse after therapy, and survival after therapy.

Detailed Description
-----------------
This is a blood serum collection study at Stanford University for patients with cancer at a variety of disease sites. The purpose of this study is to collect and store blood serum from patients before, during, and after anti-cancer therapy to find new biomarkers that signal disease or response to anti-cancer therapy. The collection and analysis of these biomarkers may lead to improved diagnostic and treatment therapies for certain cancers in the future. We are also interested in collecting blood serum from healthy individuals such as the spouses, relatives, and friends of cancer patients to obtain healthy controls for comparison

Official Title
-----------------
Development of Novel Serum Markers for Monitoring Response to Anti-Cancer Therapy

Conditions
-----------------
Carcinomas (Including Squamous Cell and Adenocarcinoma), Neoplasms

Intervention / Treatment
-----------------
* Procedure: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Age > or = 18; for the samples collected under the NIH grant, no subjects below the age of 20 will be enrolled. Prior diagnosis of cancer or suspected of having cancer Karnofsky performance status of greater than 70 Standard pretreatment evaluation Signed Stanford University Human Subjects Committee consent

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: blood draw|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers for disease |  | Day one |
A Study of Acute Kidney Injury in Care Transitions

Study Overview
=================
Brief Summary
-----------------
This research is being done to develop materials and processes that will help facilitate education and kidney care coordination for AKI survivors.

Official Title
-----------------
AKI in Care Transitions (ACT) Trial

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Behavioral: AKI in Care Transitions (ACT) program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Participants will be recruited from those identified by a developed electronic health record list of patients with stage III AKI (severe) during a hospitalization based on serum creatinine rise or urine output decline from Olmsted County. Exclusion Criteria: Dementia. Non-English speaking. Expected to be dismissed to a skilled nursing facility or hospice at discharge. Expected to need dialysis at discharge. Primary Care Transitions Program enrollment. Transplant recipients within 100 days of transplant. Can only have one time enrollment.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AKI in Care Transitions (ACT) Group<br>Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will participate in the ACT program which provides standardized education and assists with coordination of follow up care after hospital stay. | Behavioral: AKI in Care Transitions (ACT) program<br>* Multicomponent transitional support bundle that includes consultation from nurse educators before discharge to deliver kidney health education and coordination of appointments post-discharge.<br>|
| No Intervention: Usual Care Group<br>Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will receive standard of care from their inpatient and outpatient care teams. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects to complete the ACT program | Total number of subjects to complete the full ACT program intervention | 30 days after hospitalization |
Safety and Effectiveness of Zintevir (AR177) Given to HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to give zintevir (AR177) to asymptomatic (no symptoms) HIV-infected patients. Zintevir belongs to a new class of anti-HIV drugs, the integrase inhibitors. HIV uses the protein integrase to infect a cell. Integrase inhibitors block integrase and may stop replication of HIV.

Detailed Description
-----------------
Zintevir belongs to a new class of anti-HIV drugs, the integrase inhibitors. The HIV-1 virus uses the protein integrase to incorporate its genetic material into the infected host cell. Integrase inhibitors block integrase and may stop replication of the HIV-1 virus. In this open-label, Phase I/II study, 3 groups of HIV-positive patients (12 patients total) receive escalating doses of intravenous zintevir for 14 consecutive days.

Official Title
-----------------
A Phase I/II Multiple Dose Study to Evaluate the Safety, Pharmacokinetic Profile and Virologic/Immunologic Activity of Zintevir (AR177) in HIV-1 Patients

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Zintevir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria You may be eligible for this study if you: Are HIV-positive, but do not have any symptoms of HIV infection. Have a CD4 count greater than 200 cells/mm3. Have a viral load (level of HIV in the body) greater than 4,000 copies/ml. Are at least 18 years old. Exclusion Criteria You will not be eligible for this study if you: Tend to have abnormal bleeding or other blood problems. Have an active AIDS-defining illness. Have a history of serious disease or illness. Abuse alcohol or drugs. Have received certain medications.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zintevir|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
-----------------
HIV-1, Dose-Response Relationship, Drug, HIV Integrase Inhibitors, HIV Integrase
Statin Therapy Results in the Real World Practice in the Czech Republic

Study Overview
=================
Brief Summary
-----------------
Statins are the first choice treatment of dyslipidemia, a major contributor to cardiovascular diseases. Statins also have enough evidence to demonstrate decrease of morbidity and mortality from cardiovascular diseases. Even though statin therapy is effective treatment of dyslipidaemia not all patients reach the goal levels. The aim of the study is to estimate proportion of patients who achieved the therapeutic goal (LDL-C. total cholesterol, HDL-C and triglycerides levels) after at least one year of a statin therapy.

Official Title
-----------------
Statin Therapy Results in the Real World Practice in the Czech Republic

Conditions
-----------------
Dyslipidaemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented statin therapy for at least 12 months Available two LDL-C values: one at the beginning of statin therapy or at the time when patient comes to a specialist; and the other one at least after 12 months of treatment. The latter value should not be older than 6 months. 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol |  | one year | 
| HDL-C |  | one year | 
| triglycerides |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
statin therapy, treatment goal, dyslipidaemia
Prehospital Severe Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to measure the effect of Finnish physician-staffed EMS unit treatment methods on traumatic brain injury (TBI) patient prognosis. In the second part of the study the gathered data will be combined with the data from an earlier study (NCT01454648) for regression analysis. The aim of the second study is to identify prehospital factors influencing the prognosis of prehospital TBI patients.

Detailed Description
-----------------
A secondary aim is to identify out-of-hospital treatment factors that can be influenced by education and protocols.

Official Title
-----------------
The Effect of Different Emergency Medical Systems on the Prognosis of Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TBI with GCS ≤ 8 or unconsciousness verified by an on-call neurosurgeon during admission to the hospital Exclusion Criteria: Multiple trauma
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FH30<br>Patients treated by Pirkanmaa physician-staffed emergency medical service (EMS) unit | |
| FH10<br>Patients treated by Helsinki and Uusimaa physician-staffed emergency medical service (EMS) unit | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow outcome score |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Traumatic Brain Injury
Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis

Study Overview
=================
Brief Summary
-----------------
This protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated estrogen cream (PVC) given vaginally in postmenopausal women with atrophic vaginitis.

Official Title
-----------------
Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administered Vaginally in Postmenopausal Women With Atrophic Vaginitis

Conditions
-----------------
Atrophic Vaginitis, Atrophy, Vaginitis

Intervention / Treatment
-----------------
* Drug: PVC (daily for 21 days, 7 days off)
* Drug: PVC (twice weekly)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy postmenopausal women with symptoms of atrophic vaginitis including vaginal dryness, vaginal itching, vaginal burning, and/or painful intercourse. The subject must have a clinical diagnosis of atrophic vaginitis and an intact uterus. Exclusion Criteria: Women who do not have a clinical diagnosis of atrophic vaginitis.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

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

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: PVC (daily for 21 days, 7 days off)|nan|
|Drug: PVC (twice weekly)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postmenopause, Vaginitis
Role of Cryotherapy in Reduction of Post Operative Endodontic Pain Following Single Visit Root Canal Therapy

Study Overview
=================
Brief Summary
-----------------
AIM : To determine the efficacy of cold saline irrigation in reduction of post operative pain following root canal therapy. METHODOLOGY : Forty patients requiring root canal treatment on permanent single rooted teeth were included. The patients were assigned randomly into two groups of 20 patients each. The teeth in Group1 (n = 20) were irrigated using normal saline solution, whilst those in Group 2 (n = 20) were irrigated with cold saline solution stored at 4 degrees centigrade. A Heft Parker visual analog scale was used to measure pre-operative pain and post-obturation pain at 12, 24,48 and 72 hours after obturation. Chi square tests and Mann Whitney U tests were used for statistical analysis.

Official Title
-----------------
Role of Cryotherapy in Reduction of Post Operative Endodontic Pain Following Single Visit Root Canal Therapy

Conditions
-----------------
Effects of; Cold

Intervention / Treatment
-----------------
* Other: cryotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 18 years of age Healthy patients without any medical conditions Exclusion Criteria: root canal retreatment pregnancy teeth with open apices a history of intolerance to nonsteroidal anti-inflammatory drugs immunosuppressed patients those under 18 years old patients requiring antibiotic prophylaxis patients with pacemakers.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold saline<br>Saline stored at 4 degrees centigrade | Other: cryotherapy<br>* Role of cryotherapy in reduction of post operative pain<br>* Other names: Cold saline;|
| Experimental: Normal Saline<br>Saline stored at room temperature | Other: cryotherapy<br>* Role of cryotherapy in reduction of post operative pain<br>* Other names: Cold saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post endodontic pain measure at different time intervals using heft parker visual analog scale |  | 12,24,48,72 hours |
AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in Patients With Advanced Solid Malignancies

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to assess the safety, tolerability and pharmacokinetics of a capsule of AZD6244 in patients with advanced solid malignancies.

Official Title
-----------------
A Phase I, Open Label, Multi-centre Study to Assess the Safety, Tolerability and Pharmacokinetics of a Solid Oral Dosage Formulation (Capsule) of AZD6244 in Patients With Advanced Solid Malignancies

Conditions
-----------------
Tumor, Cancer

Intervention / Treatment
-----------------
* Drug: AZD6244


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cancer which is refractory to standard therapies WHO performance status 0-2 evidence of post-menopausal status or negative pregnancy test Exclusion Criteria: Radiotherapy/chemotherapy within 21 days prior to entry brain metastases/spinal cord compression unless stable off steroids/anticonvulsants evidence of severe/uncontrolled systemic disease participated in an investigational drug study within 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: AZD6244<br> | Drug: AZD6244<br>* oral capsule<br>* Other names: ARRY-142886;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetics of the solid dose form of AZD6244 |  | each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety and tolerability of solid dose form of AZD6244 |  | assessed at each visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Malignancy, Cancer Eligibility, Malignancy
Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults.

Official Title
-----------------
A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHD

Conditions
-----------------
Growth Hormone Disorder, Adult Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe adult growth hormone deficiency Exclusion Criteria: Known or suspected allergy to study product(s) or related products Previous participation in the study Diabetes Mellitus Presence of malignant tumor(s) Pregnant or likely to get pregnant
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Norditropin®<br> | Drug: somatropin<br>* Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, and a Quality of Life form is completed by the patient, at visits 1 to 5.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and type of suspected serious adverse drug reactions (SADRs) during the study period |  | after 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of impaired glucose tolerance events during the study period |  | evaluated after 3 months, 6 months, 1 year and between 2-5 years | 
| Number of other types of adverse events (AEs) during the study period |  | evaluated after 3 months, 6 months, 1 year and between 2-5 years | 
| Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density) |  | evaluated after 3 months, 6 months, 1 year and between 2-5 years | 
| Effects of insulin-like growth factor-1 (IGF-I) levels |  | evaluated after 3 months, 6 months, 1 year and between 2-5 years |
Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease

Study Overview
=================
Brief Summary
-----------------
This is a phase 2, randomized, double-blind, multicenter study to assess the therapeutic efficacy, safety, and mechanisms of omilancor (BT-11) in patients with moderate to severe Crohn's Disease (CD).

Official Title
-----------------
A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: BT-11
* Drug: Active comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Male and female subjects age 18 to 75 years, inclusive. Diagnosis of CD for at least 6 weeks prior to screening Moderate to severely active CD as defined by all of the following: CDAI score of 220-450 PRO-2 stool frequency (SF) ≥ 4 and/or abdominal pain (AP) ≥ 2 SES-CD ≥ 6 ( ≥4 for isolated ileitis) scored by a blinded central reader Key Exclusion Criteria: Participant has ulcerative colitis Participant is at imminent risk of ileo-colectomy Prior enrolment in the current study and had received study treatment.

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BT-11 880 mg<br>Oral once daily tablet | Drug: BT-11<br>* Oral once daily tablet<br>|
| Active Comparator: Standard of care<br>Biologic | Drug: Active comparator<br>* Biologic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of reponse |  | 12 weeks |