linjc16/ctgov huggingface dataset:
Study of the Blood Levels and Effects of ATL-962 on Fat Excretion in Obese Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the amount of metabolites of ATL-962 in the blood and to investigate the effect of ATL-962 on the amount of fat that is excreted in the faeces in subjects who are obese

Detailed Description
-----------------
Obesity is a significant and increasing clinical problem. There is a need for effective therapeutic agents to help people reduce weight. ATL-962 is a lipase inhibitor which could reduce the amount of fat absorbed from a person's diet, leading to weight reduction.

Official Title
-----------------
Randomized, Double Blind, Parallel Group, Repeat Dose Pharmacokinetic and Pharmacodynamic Study of Four Doses of ATL-962 (40mg, 80mg, 120mg 240mg) in Otherwise-Healthy Obese Volunteers

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: ATL-962


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese, otherwise-healthy subjects Body mass index 30-45kg/m2 Exclusion Criteria: Women who are pregnant or breast feeding Any drug treatment within 2 weeks of commencement of dosing in this study

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ATL-962|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of metabolites of ATL-962 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of ATL-962 on faecal fat excretion |  |  | 
| Safety and tolerability of ATL-962 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Pharmacokinetics, Pharmacodynamics
A Long-term Observational Study Cohort in Patients With Advanced Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the protocol is to assess the rate of castration resistance, disease progression and overall survival over a 3-year period post-androgen deprivation therapy (ADT) induction in a study cohort of patients with advanced disease.

Official Title
-----------------
A Prospective Observational Study Cohort to Assess the Rate of Castration Resistance, Disease Progression and Overall Survival Over a 3-year Period Post-androgen Deprivation Therapy Induction in Patients With Advanced Prostate Cancer Who Have Previously Participated in the Triptocare Study (Http://Clinicaltrials.Gov/ct2/Show/Study/NCT01020448)

Conditions
-----------------
Advanced Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have participated and received study treatment in the Triptocare study Be aware of the investigational nature of this observational study cohort and must give written (personally signed and dated) informed consent Exclusion Criteria: Absence of written informed consent from the patient

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

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

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 |
| --- | --- | --- |
| Castration-resistant prostate cancer (CRPC) |  | Over a 3-year period post-androgen deprivation therapy induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression (DP) rate post-androgen deprivation therapy induction |  | Over a 3-year period post-androgen deprivation therapy induction | 
| Overall survival |  | 3-years post-androgen deprivation therapy induction | 
| Serum prostate specific antigen |  | Over a 3-year period post-androgen deprivation therapy induction | 
| Serum testosterone |  | Over a 3-year period post-androgen deprivation therapy induction |
Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the increase in spine bone mineral density that has been generally observed in previous clinical studies involving the study drug can be maintained or even increased if followed with raloxifene HCl. All qualifying study participants will receive the study drug followed by treatment with raloxifene HCl or placebo. All study participants will receive raloxifene HCl in the third phase of the study.

Official Title
-----------------
Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: teriparatide
* Drug: raloxifene HCl
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be diagnosed with osteoporosis Must be female, age 55 through 80 Must be at least 5 years postmenopausal Must be free of other severe or chronically disabling conditions Must be able to properly use injection device. Exclusion Criteria: Must not have bone diseases other than osteoporosis Must not have history of certain cancers Must not have certain medical diseases (inflammatory bowel disease, malabsorption syndrome, kidney or bladder stones, venous thrombi or emboli, recent vaginal bleeding due to unknown causes) Must not have treatment with particular medications (warfarin, estrogens, androgens, steroids, calcitonins, fluorides, biphosphonates) Must not have known allergy to the study agent or raloxifene HCl

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: teriparatide|nan|
|Drug: raloxifene HCl|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The study is designed to compare the effect of 1 year of raloxifene treatment with the effect of placebo on maintaining teriparatide-induced increases in spine and hip BMD. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An open-label treatment phase will extend the study for 1 year beyond the primary endpoint. During this final year of the study all patients will receive raloxifene. |  |  | 
| The purpose of lengthening is to assess the differences in response to raloxifene when it is administered immediately following versus 1 year after(with and without a washout period) withdrawal from teriparatide. |  |  |
Clinical Efficacy of In-situ Thrombolysis in Case of Intraventricular Haemorraghia by Aneurysm Rupture

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the impact of in situ fibrinolysis on the mortality at 30 days in case of subarachnoid hemorrhage.

Official Title
-----------------
Clinical Efficacy of In-situ Thrombolysis in Case of Intraventricular Haemorraghia by Aneurysm Rupture

Conditions
-----------------
Aneurysm, Ruptured, Subarachnoid Hemorrhage

Intervention / Treatment
-----------------
* Procedure: fibrinolysis in situ
* Procedure: drainage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subarachnoid hemorrhage by aneurysm rupture severe intraventricular hemorraghia Exclusion Criteria: pregnant women hemostasis disturbance

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>drainage of hemorraghia | Procedure: drainage<br>* drainage<br>|
| Experimental: 1<br>Actylise | Procedure: fibrinolysis in situ<br>* intraventricular injection of actilyse<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of mortality |  | at 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of morbidity |  | at 6 months |
Immune Response to Covid-19 in 300 Health Care Workers With Mild Symptoms

Study Overview
=================
Brief Summary
-----------------
Three hundred healthcare workers with mild symptoms for Covid-19 will be followed during three months. Each two weeks, serological tests will be performed. Re-infection will be monitored by saliva-swabs.

Official Title
-----------------
Immune Response to Covid-19 in 300 Health Care Workers With Mild Symptoms

Conditions
-----------------
COVID-19, Serology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCW previous tested for Covid-19 with mild symptoms in Jessa Ziekenhuis, Belgium Exclusion Criteria: -

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of serological positive healthcare workers |  | three months | 
| Percentage of HCW with positive Saliva-sabs |  | three months |
Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess bone mineral density in patients switching from an oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.

Official Title
-----------------
A Study to Assess the Safety, Tolerability, and Efficacy of Switching Patients Currently on Oral Bisphosphonate to Zoledronic Acid

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-menopausal women between 45 and 79 years of age Must be osteopenic/osteoporotic Treatment with oral bisphosphonate for at least 1 year Exclusion Criteria: Any woman of child bearing potential Treatment with other bone active agents Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: zoledronic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare % change in Lumbar Spine BMD from Baseline to Month 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic post-menopausal women populations |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations |  |  | 
| To demonstrate continued bone remodeling by evaluation of bone biopsies in a subset of patients |  |  | 
| To assess patient preferences for annual i.v. therapy compared to weekly oral therapy through a patient questionnaire |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoporosis, osteopenia, post-menopausal, zoledronic acid
Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

Study Overview
=================
Brief Summary
-----------------
A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.

Official Title
-----------------
URG101 Pharmacodynamic and Safety Study: A Randomized, Double-blind, Placebo-controlled, Multi-center Cross-over Study to Investigate the Pharmacodynamic Profile of URG101 in Subjects With Pelvic Pain of Bladder Origin.

Conditions
-----------------
Painful Bladder Syndrome, Interstitial Cystitis

Intervention / Treatment
-----------------
* Drug: URG101
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female subjects >= 18 years of age moderate to severe symptoms of PBS/IC minimum pain/urgency/frequency scores female subjects on hormone therapy must be on stable dose for >= 3 months Exclusion Criteria: positive pregnancy test or pregnant or lactating narcotics or medical marijuana within 3 months use of any investigational drug or device within 30 days bacterial cystitis within 30 days

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 |
| --- | --- |
| Other: Crossover<br>Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2 | Drug: URG101<br>* Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week.<br>Drug: Placebo<br>* Liquid formulation without active URG101 drug components<br>|
| Other: Crossover 2<br>URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2 | Drug: URG101<br>* Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week.<br>Drug: Placebo<br>* Liquid formulation without active URG101 drug components<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average % Change in Daytime Bladder Pain Score |  | T0 - 12hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PORIS - Question 3 - ≥50% Overall Improvement |  | T 0.5hr | 
| Average % Change in Total Symptom Score (pain + urge) |  | T0 - 12hr | 
| Average % Change in Daytime Urinary Urgency Score |  | T0-12hr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bladder, pain, urgency, frequency
Survey Conducted Among Early Breast Cancer Patients Treated With Arimidex for Evaluation of Treatment Adherence

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the patient's perception about and willingness to take his or her medication and the influencing factors interfering with taking medication.

Official Title
-----------------
Survey and Follow-up of the Treatment Adherence and Medication Habits of Early Breast Cancer Patients on Adjuvant Hormonal Therapy With the Aromatase Inhibitor Arimidex

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early breast cancer Post menopausal Adjuvant hormonal Arimidex therapy
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Percent of patients remaining adherent to therapy with Arimidex |  | Every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire for factors influencing adherence |  | Every 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adherence, early breast cancer, Arimidex, Therapy adherence
Reducing Readmission Rates by Providing a Comprehensive Transition Plan From Hospital to Home for Cardiac Surgery Patients.

Study Overview
=================
Brief Summary
-----------------
Patients who undergo cardiac surgery will be screened by a team member with the risk score once the patient has been admitted to the Cardiovascular Progressive Care Unit (CVPCU) after surgery. Participants will be randomized to the intervention or the control group. Both groups will receive standard discharge planning. In addition, the intervention group will have a nurse practitioner (NP) who will be responsible to verify that each essential step of the discharge process has been completed and will visit the patient in patient's home after discharge to complete a physical, review medications, titrate medications as needed, prescribe any necessary treatments, and perform education. The primary outcome variable will be a decrease in the 30 day readmission rate comparing high risk patients at pre and post intervention.

Official Title
-----------------
Reducing Readmission Rates by Providing a Comprehensive Transition Plan From Hospital to Home for Cardiac Surgery Patients.

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Behavioral: Home Visit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients 18 years of age or greater who have had cardiac surgery procedures including coronary artery bypass surgery (CABG), valve replacement, aortic aneurysm repair, and combined CABG and valve procedures. Exclusion Criteria: Patients who have undergone orthotopic heart transplantation, orthotopic lung transplantation, or orthotopic heart-lung transplantation Patients who have undergone ventricular assist device placement Patients who do not reside in Maryland Non English speaking patients Patients discharged to a facility.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home visit group<br>Will receive a home visit after discharge in addition to the standard discharge planning. | Behavioral: Home Visit<br>* Physical exam, medication dose titration<br>|
| No Intervention: Control group<br>Will receive only the standard discharge planning. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-Day readmission rate | Rate of readmissions within 30 days after discharge | Up to 30 days post discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reducing readmissions
Association Between Telomere Length and Cardiac Dysfunction

Study Overview
=================
Brief Summary
-----------------
Compelling epidemiological evidence indicates that alterations of relative telomere length (RTL) are associated with cardiac dysfunction caused by chemotherapy in children with acute leukemia (AL).The aim of this study was to explore association between RTL content in peripheral blood cells could be used as a risk predictor for severity of cardiac damage.

Official Title
-----------------
Association Between Relative Telomere Length and Severity of Cardiac Dysfunction

Conditions
-----------------
Cardiac Toxicity, Acute Leukemia, Childhood Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Relative telomere length


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. histological confirmed acute leukemia; 2. Preparing for chemotherapy; Exclusion Criteria: 1.history of other malignancy; 2.blood transfusion within one month or prior bone marrow transplantation; 3.patients who reluctant to sign informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 16 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| acute leukemia group<br>300 patients were recruited, who have diagnosed with acute leukemia by bone marrow biopsy | Diagnostic Test: Relative telomere length<br>* Relative telomere length in peripheral blood cell<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative telomere length | The ratio of RTL to hemoglobin contents was calculated for each sample from standard curves. After that, the ratio for each sample was normalized to a calibrator DNA in order to standardize between different runs, and then defined as the measurement of relative mtDNA contents.Relative expression of mtDNA were measured in young adults suffered from AL. | From date of admission until the date of discharging from hospital, assessed up to 5 days |