linjc16/ctgov huggingface dataset:
Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL in Healthy Adult Male Volunteers

Study Overview
=================
Brief Summary
-----------------
To investigate the bioavailability of ESR 1150 CL by the time course determination of plasma concentration (pharmacokinetics) of no-transformed ESR 1150 after single administration to healthy adult male volunteers. Secondary objective is to investigate the safety of ESR 1150 CL.

Official Title
-----------------
Absolute Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL 1 mg Capsule Compared to 0.015 mg Solution i.v. as Single Administration in Healthy Male Subjects (Open-labelled, 2-way Cross-over Study)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ESR 1150 CL, Capsule, oral
* Drug: ESR 1150 CL, solution, intravenous


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male subjects age: >= 20 and <= 35 years weight: >= 50 to <= 80 kg and within +/- 20 % of standard weight blood pressure: systolic 100 - 138 mmHg and diastolic of less than 84 mmHg pulse rate: 45 to 80 beat/min volunteer whose participation in the trial is judged valid by the investigator based on the results of preliminary check-up and pre-administration check-up Exclusion Criteria: history of diseases including cardiac, pulmonary, hepatic, renal or gastrointestinal disease history of drug allergy history of drug dependency, alcohol dependency, etc. use of other trial drug within 6 months before study drug administration use of any drugs within 7 days before study drug administration

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESR 1150 CL capsule<br> | Drug: ESR 1150 CL, Capsule, oral<br> <br> |
| Experimental: ESR 1150 CL ampoule<br> | Drug: ESR 1150 CL, solution, intravenous<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma drug concentration-time curve from time zero to infinity |  | up to 16 hours after drug administration | 
| maximum drug plasma concentration (Cmax) |  | up to 16 hours after drug administration | 
| time to achieve maximum drug plasma concentration (tmax) |  | up to 16 hours after drug administration | 
| elimination half-life (t1/2) |  | up to 16 hours after drug administration | 
| mean residence time (MRT) |  | up to 16 hours after drug administration | 
| total clearance (CL) |  | up to 16 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of adverse events |  | up to day 22 |
Correlation of PaCO2 to the Inspired and Expired Oxygen Gradient

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether a correlation exists between the partial pressure of carbon dioxide existing within arterial blood and the gradient between inhaled and exhaled fractions of oxygen.

Official Title
-----------------
Correlation of PaCO2 to the Inspired and Expired Oxygen Gradient

Conditions
-----------------
Neurosurgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 65. Scheduled for surgical procedure that will last at least 2 hours. Arterial cannulation is planned because of either the complexity of the surgery or patient comorbidity. At least two arterial blood gas analyses are planned during the surgery. Exclusion Criteria: No arterial cannulation is necessary or planned for the procedure.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Correlate the level of carbon dioxide within arterial blood to inspired and expired oxygen gradient. | Compare the levels of carbon dioxide found in the patient's blood to the amounts of carbon dioxide and oxygen in the air that the patient inhales and exhales. If a relationship exists between the levels of carbon dioxide in the blood and the levels of carbon dioxide and oxygen inhaled and exhaled by the patient, anesthesiologists will be able to use this relationship to adjust ventilators during anesthesia without having to take blood from an artery. | At least 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arterial cannulation, Blood gas, Carbon dioxide, Arterial blood, Oxygen, Oxygen fractions
Topotecan Plus Paclitaxel and Carboplatin in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the feasibility and toxicity of the combination of paclitaxel, carboplatin, and topotecan in patients with previously untreated, stage III or IV epithelial ovarian carcinoma or primary peritoneal carcinoma. We will also make a preliminary evaluation of the efficacy of this three drug regimen in the initial treatment of these patients.

Detailed Description
-----------------
Upon determination of eligibility, all patients will be receive: Paclitaxel + Carboplatin + Topotecan a maximum of six courses of chemotherapy will be given at 21 day intervals

Official Title
-----------------
A Phase II Study of a Three-Day Schedule of Topotecan Plus Paclitaxel and Carboplatin on Day Three in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma

Conditions
-----------------
Ovary Cancer

Intervention / Treatment
-----------------
* Drug: Topotecan
* Drug: Paclitaxel
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be included in this study, you must meet the following criteria: Epithelial ovarian carcinoma or primary peritoneal carcinoma Willing to consider second-look surgery to evaluate response if necessary No previous treatment with chemotherapy or radiation therapy Ability to perform activities of daily living with minimal assistance Adequate bone marrow, liver and kidney function Written informed consent Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age < 18 years Brain metastases Recent history of significant heart disease within 6 months Other significant medical conditions Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Topotecan|nan|
|Drug: Paclitaxel|nan|
|Drug: Carboplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovary Cancer
Screening and Assessing the Risk Factors and Complications of Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The study is an observational, cross-sectional study aimed at screening and accessing risk factors and complications for Chinese chronic kidney disease (CKD) patients. To investigate the prevalence of hypertension, cardiovascular and cerebrovascular diseases, protein energy malnutrition（PEM）, cognitive impairment and other complications in the CKD patients. To develop biomarkers of CKD.

Official Title
-----------------
Screening and Assessing the Risk Factors and Complications of Chronic Kidney Disease：a Cross - Sectional Study

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Other: blood sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age≥18 years clinical diagnosis of CKD signed informed consent Exclusion Criteria: End-stage renal disease(ESRD) or dialysis Acute kidney injure(AKI) history of solid organ or bone marrow transplantation active malignancy within 24 months prior to screening or metastatic cancer HIV infection or AIDS acute inflammation

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

| Intervention/Treatment |
| --- |
|Other: blood sample collection|blood sample collection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of CKD complications | hypertension, cardiovascular and cerebrovascular diseases, protein energy malnutrition(PEM), cognitive impairment | baseline | 
| Biomarkers of kidney function |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic analyses | circulating microRNA | baseline | 
| Questionnaire assessing cognitive function | Montreal Cognitive Assessment-Basic Chinese Version | baseline | 
| Questionnaire assessing depression | Beck Depression Inventory scores | baseline | 
| Questionnaire assessing risk of malnutrition | Malnutrition-Inflammation Score | baseline | 
| Questionnaire assessing dietary intake | Food Frequency Questionnaire | baseline | 
| Questionnaire assessing quality of life | Activity of daily living（ADL）and kidney disease quality of life （KDQOLTM-36） | baseline |
Prospective Study of the Perception of Palliative Care by Relatives of Patients Treated in Oncology

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate (thanks to analysed interview) the perception of palliative care by relatives of patients treated in oncology.

Official Title
-----------------
Prospective Study of the Perception of Palliative Care by Relatives of Patients Treated in Oncology

Conditions
-----------------
Palliative Care Perception

Intervention / Treatment
-----------------
* Other: interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: man or woman of age who is a relative of a patient treated in oncology subject who signed the informed consent subject without any legal protection measure and having health coverage Exclusion Criteria: Relatives of patients already followed in the palliative care departement Subjects with cognitive impairment or expression; Not french spoken subjects Pregnant or breastfeeding women

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: interview<br> | Other: interview<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of palliative care evaluated by an interview with the investigator | The interview takes place the same day the subject signs the informed consent ; it lasts around 1 hour | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analysis of main elements to be used in the early information to patients and their families about palliative care. |  | 1 day |
Multi-Parametric MRI Assessment of the Liver in the Dallas-FortWorth Metroplex Population

Study Overview
=================
Brief Summary
-----------------
To build a Registry of volunteers by inviting them to get a LiverMultiScan(LMS)and collecting their contact information to seek interest in participating in future studies.

Detailed Description
-----------------
This is a Registry where there will be no intervention to the standard of care.Participants will be required to attend a single visit that will involve having a multi-parametric MRI at no cost to them. In addition, the invesigators will collect contact information of participants including their email address, phone number and house address so that they can be contacted to discuss possible participation in future studies which may be sponsored by Perspectum or third parties, such as pharmaceutical companies, the participants personal information shall never be shared with these third-parties. Additionally, the contact information of the participants medical providers shall be collected so that, if requested, their LMS reports can be used in their diagnostic pathway. Imaging will be performed at two Touchstone Imaging locations, one in downtown Dallas and the other in Southlake. A total of 100 participants will be enrolled over a period of 1 year.

Official Title
-----------------
Multi-Parametric MRI Assessment of the Liver in the Dallas-FortWorth Metroplex Population

Conditions
-----------------
Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Device: Liver MultiScan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female volunteers aged 18 years and over• Participant willing and able to give informed consent for participation in the registry. Exclusion Criteria: The participant may not enter the Registry if they have any contraindication to magnetic resonance imaging (standard MR exclusion criteria at the imaging center including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).

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 |
| --- |
|Device: Liver MultiScan|The LiverMultiscan is a quick 15 minute, contrast free, non-invasive MRI scan that provides 3 liver metrics|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To build a Registry of volunteers by inviting them to get a LiverMultiScan(LMS)and collecting their contact information to seek their interest in participating in future studies |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To use multi-parametric MRI (LMS) of the liver to assess the volunteer's liver health |  | 12 months |
Gait Evaluation in Haemophiliac Patients

Study Overview
=================
Brief Summary
-----------------
Joint damage secondary to recurrent haemarthroses and chronic synovitis represents the commonest clinical manifestation of haemophilia. Incapacitating pain, loss of joint stability and mobility, axial deviation, deterioration and decreased function are the most frequent complains in patients with severe haemophilic arthropathy In this context, the purpose of our study is to examine and analyse specific changes in gait in patients suffering from haemophilic arthropathy and determine the impact on health-related quality of life in terms of conceptual components of pain and stiffness, psychosocial stress, disability, and activity limitations as recommended by the International Classification of Function (ICF) recently published by the World Health Organization.

Official Title
-----------------
Gait Evaluation in Haemophiliac Patients

Conditions
-----------------
Hemophilia A, Hemophilia B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: haemophilia A or B aged more than 4 years Exclusion Criteria: impossibility to walk on a treadmill recent joint haemarthrosis or muscle haematoma

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| haemophiliacs A and B<br>haemophiliacs A and B mild, moderate or severe from 4 to 80 years old, with or without inhibitors. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate specific changes in gait in patients suffering from haemophilic arthropathy |  | from inclusion in the study until 1 year after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gait, haemophilia, arthropathy
Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients With Prolymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving fludarabine and cyclophosphamide together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with rituximab works in treating patients with B-cell prolymphocytic leukemia.

Detailed Description
-----------------
OBJECTIVES: Determine the overall and progression-free survival of patients with B-cell prolymphocytic leukemia treated with immunochemotherapy comprising fludarabine, cyclophosphamide, and rituximab. Determine the toxic effects of this regimen in these patients. OUTLINE: This is a non-randomized, open-label, multicenter study. Patients receive fludarabine IV and cyclophosphamide IV on days 1-3. Patients also receive rituximab IV on day 0 in course 1 and on day 1 in courses 2-6. Treatment repeats every 28 days for up to 6 courses. PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.

Official Title
-----------------
Phase II Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab in Patients With B-PLL

Conditions
-----------------
Prolymphocytic Leukemia

Intervention / Treatment
-----------------
* Biological: rituximab
* Drug: cyclophosphamide
* Drug: fludarabine phosphate


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of B-cell prolymphocytic leukemia Previously treated disease All Binet stages allowed PATIENT CHARACTERISTICS: Life expectancy > 3 months ECOG/WHO performance status 0-3 PRIOR CONCURRENT THERAPY: No more than 3 prior treatment regimens

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: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: rituximab|nan|
|Drug: cyclophosphamide|nan|
|Drug: fludarabine phosphate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Progression-free survival |  |  | 
| Toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prolymphocytic leukemia
Spinal Manipulative Therapy: Dual-Task Performance

Study Overview
=================
Brief Summary
-----------------
The purposes of this study is to determined the effects of instrument applied spinal manipulative therapy upon dual-task performance involving complex postural and cognitive task.

Detailed Description
-----------------
This study sought to determine whether a 2-week regimen of spinal manipulative therapy could improve postural control under 2 conditions. Condition one was a complex postural task which consisted of a shoulder width stance on a compliant surface with eyes closed to remove visual input. Condition 2 was as above with the addition of visio-spatial cognitive task (serial 7s subtraction). These tasks were performed on a force-place designed to capture center of pressure data. Data was captured prior to the onset of therapy and then again after 6 treatment sessions (2-week period). Data was also collected 1 week post treatment to note any lasting effects following therapy. This pilot study utilized a repeated measures designed with no control group.

Official Title
-----------------
Influence of Instrument-Applied Spinal Manipulative Therapy on Dual-Task Performance Involving Complex Postural and Cognitive Tasks

Conditions
-----------------
Balance

Intervention / Treatment
-----------------
* Device: Pro-adjuster mechanical spinal manipulative device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy participants Exclusion Criteria: No injuries No surgeries No visual, vestibular, or somatosensory disorders capable of affecting balance

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pro-adjuster mechanical spinal manipulative device|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sway velocity using a NeuroCom Balance Master Forceplate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dual-task, postural control, cognitive