linjc16/ctgov huggingface dataset:
Collection of Tumor Tissue, Blood and Spinal Fluid From Patients With Brain or Spine Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to collect samples of brain or spine tumors. Memorial Sloan-Kettering Cancer Center would then store them for use by researchers who study brain or spine cancer and try to find better ways of treating it. We will also collect blood and spinal fluid from patients with brain or spine tumors. The blood and spinal fluids are also used for research studies of cancer and its treatment.

Detailed Description
-----------------
The main objective of the protocol is the establishment of a repository of central nervous system (CNS) tumors or metastases to the CNS and related tissues as an invaluable resource for current or future research studies of the etiology, pathogenesis and treatment of human central nervous system tumors. The database will be established through the intra-operative acquisition of brain or spine tumors as well as the collection of blood and spinal fluids from consenting CNS tumor patients.

Official Title
-----------------
Collection of Tumor Tissue, Blood and Spinal Fluid From Patients With Brain or Spine Tumors

Conditions
-----------------
Primary or Metastatic Central Nervous System (CNS) Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For acquisition of intra-operative brain or spine tumor specimens, blood specimens and spinal fluid specimens, all patients who undergo surgery for resection or biopsy qualify for inclusion in this protocol. If spinal fluid is not accessed as part of the operative procedure, it will not be collected. All patients must be under the care of one or more members of the MSKCC CNS disease management team at the time of tissue acquisition. Patients may have been previously diagnosed and/or treated at another institution. Subjects are eligible regardless of sex, age or race. Parental or guardian consents will be obtained in the case of minors (less than 18 years of age) Exclusion Criteria: Patients or their guardians, in case of a minor, may choose to be excluded at any time. If a patient, or guardian, decides to withdraw after some or all of the tissues have been collected, such tissues will be destroyed at their request. Patients or their guardians will be counseled at the time of obtaining their consent, of the possibility of withdrawing from the protocol.
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 |
| --- | --- | --- |
| To establish a repository of CNS tumors or metastases to the CNS and related tissues for current or future studies. |  | conclusion of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
central nervous system (CNS) tumor, tissue collection
Bibliotherapy for Patients With Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the efficacy of a self-help workbook in enhancing a sense of empowerment, coping, quality of life and reducing distress for patients with cancer.

Official Title
-----------------
Feasibility, Acceptability and Efficacy of Bibliotherapy for Patients With Cancer: a Randomized Control Trial

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: Self-help book


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18+ years of age been diagnosed with cancer can read English Exclusion Criteria: -participating in the Think Smart, Live Well group

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-help book<br> | Other: Self-help book<br>* Participants have 6 weeks to complete a 12 chapter self-help workbook. The workbook addresses: (i) The enhancement of a sense of personal control; and (ii) The learning of emotional and instrumental coping responses<br>|
| No Intervention: Usual Care Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Health Education Impact Questionnaire scores |  | pre-intervention (week 0), post intervention (week 6), follow-up (week 10) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Ways of Coping Questionnaire - Cancer Version & Hospital Anxiety and Depression Scale scores |  | pre-intervention (week 0), post intervention (week 6), follow-up (week 10) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
self-help book, support service
Post Surgically Treated Peritonitis Complications

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to investigate the management and the complications associated wtih surgically treated peritonitis. Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

Detailed Description
-----------------
Anonymous data will be collected by study coordinators in a secured e-database. Cross audit will be performed to check data.

Official Title
-----------------
A Prospective Cohort of Patients Hospitalized in West French Intensive Care Units for Peritonitis Surgically Treated

Conditions
-----------------
Peritonitis

Intervention / Treatment
-----------------
* Other: Collection of medical data from ICU patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nosocomial surgically treated Peritonitis Or Community-Acquired surgically treated Peritonitis Or Post-operative surgically treated Peritonitis Exclusion Criteria: Consent withdrawal

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU patients<br>Collection of medical data of Patients with peritonitis (nosocomial or community-acquired) or Patients with post-operative peritonitis | Other: Collection of medical data from ICU patients<br>* Medical data collected on a electronic secured data base<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In ICU stay main complications | Nosocomial Infections (epidemiology, risk factors, antibiotic susceptibility of pathogens) Organ failures (incidence, risk factors) | Within the first 28 days after ICU admission date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation |  | In ICU (up to 90 days) | 
| ICU length of stay |  | In ICU (up to 90 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nosocomial Peritonitis, Community-acquired Peritonitis, Post-operative Peritonitis
Osteoporosis and Colles Fracture

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the retrospective study is to determine the incidence of osteoporosis in women with previous Colles Fracture. Secondly, to determine to which extent Colles Fracture has led to a diagnosis and/or treatment of osteoporosis. The primary purpose of the prospective study is to determine the incidence of osteoporosis in women with an actual Colles Fracture. Secondly, to investigate the consistency between prospective and retrospective data.

Detailed Description
-----------------
Colles Fracture is known to be connected to decreased bone mineral density (BMD). Thus, it can be an early sign of osteoporosis and therefore an increased risk of new fractures. The results of earlier studies have not been unambiguous in the respect of what extent decreased BMD in the wrist of women with Colles Fracture is synonymous of osteoporosis in the spine and the hip. An earlier enquiry to the Danish Orthopedic Departments in 1995 showed that only 18 % of the departments diagnosed or referred patients with possible osteoporosis. The two study designs enhance the possibilities of evaluating the relevance of Low Energy Fractures in the wrist to avoid new fractures and their relation to bone mineral density. The results could also be a useful tool in quality assurance of the osteoporosis diagnostics.

Official Title
-----------------
Low-energy Fracture of the Wrist (Colles Fracture) and Osteoporosis. A Ten Year Follow-up and a Prospective Study

Conditions
-----------------
Previous or Actual Colles Fracture

Intervention / Treatment
-----------------
* Procedure: DEXA scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colles Fracture Women over 40 years Informed consent- Exclusion Criteria: High Energy Fracture Deceases or conditions that makes the participant unable to contribute to the investigation-

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: DEXA scan|orto|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of Osteoporosis ten years after a Colles Fracture |  | years | 
| The incidence of Osteoporosis in women with an actual Colles Fracture |  | years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colles Fracture, Osteoporosis, BMD, Quality assurance
Postoperative Cognitive Dysfunction After Total Knee or Hip Replacement Surgery in Fast-track Set-up

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to quantify the incidence of postoperative cognitive dysfunction in the elderly patient (>60y) after total hip or knee replacement surgery. The hypothesis is that the fast-track methodology with a mean hospital stay less than 3 days will help to minimize this reduction in memory and concentration.

Official Title
-----------------
Postoperative Cognitive Dysfunction After Total Knee or Hip Replacement Surgery in Fast-track Set-up

Conditions
-----------------
Postoperative Cognitive Dysfunction

Intervention / Treatment
-----------------
* Other: no intervention, descriptive study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 60 years of age or above ASA classification 1-4 undergoing fast-track hip or knee replacement Exclusion Criteria: anaesthesia within the past 90 days daily consumption of sleep or anxiety medication more than 35 units of alcohol per week lack of proper verbal and reading skills, Danish Serious hearing or visual impairment Mini mental status evaluation (MMSE) < 24 Parkinsons Disease or other neurological disease causing functional impairment

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Surgery<br>This group (n=220) consist of patients undergoing hip or knee replacement in a fast-track setup and they are tested 3 times for postoperative cognitive dysfunction. | Other: no intervention, descriptive study<br>* no intervention, descriptive study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Understanding COVID-19 Infection in Pregnant Women and Their Babies

Study Overview
=================
Brief Summary
-----------------
This national study will recruit expectant mothers with and without positive nasopharyngeal swabs for SARS-CoV-2, and aims to determine the seroepidemiology of SARS-CoV-2 amongst expectant mothers and their infants in the U.K.

Official Title
-----------------
Understanding COVID-19 Infection in Pregnant Women and Their Babies

Conditions
-----------------
Corona Virus Infection, Pregnancy Related, Neonatal Infection, Breastfeeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent form Any woman pregnant in selected hospitals in England who has no signs or symptoms of COVID-19 disease during pregnancy and is rtPCR negative at delivery Any woman pregnant in any hospital in England who tests positive by rtPCR at any point during pregnancy from 24 weeks gestation onwards, regardless of signs and symptoms Exclusion Criteria: If the pregnant woman is under 18 years in prison or unable to make an informed consent for other reasons (e.g. learning difficulties, language barriers)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed<br>Expectant mothers with a positive nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation regardless of antibody status. | |
| Seropositive<br>Expectant mothers with a negative nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation but positive IgM/IgG antibodies against SARS-CoV-2. | |
| Unexposed<br>Expectant mothers with a negative nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation and negative IgM/IgG antibodies against SARS-CoV-2. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody concentrations in maternal and cord blood in pregnant women in England and in infant blood if mothers are rtPCR positive for SARS-COV-2 |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibodies specific to SARS-CoV-2 in breastmilk |  | At birth and 6 weeks postpartum | 
| Mother-infant pairs who are both rtPCR positive in blood or secretions at birth |  | At birth | 
| Breastmilk samples that are rtPCR positive |  | At birth and 6 weeks postpartum | 
| Placental samples that are rtPCR positive |  | At birth | 
| Placental samples in whom the virus can be grown in vitro |  | At birth | 
| Breastmilk samples in whom the virus can be grown in vitro. |  | At birth and 6 weeks postpartum | 
| Mother-infant pairs at six weeks in whom the virus can be grown in vitro |  | At 6 weeks postpartum |
Metabolic Changes in Prostate Cancer Patients With Androgen-ablation Therapy (AAT)

Study Overview
=================
Brief Summary
-----------------
This is an observational, prospective, non-interventional and multi-centre study, to assess the impact of androgen ablation therapy in blood triglycerides, cholesterol and glucose, body fat distribution and fracture risk to ten years using FRAX model in patients with prostate cancer. The patients will be following for 12 months

Official Title
-----------------
Metabolic Changes in Prostate Cancer Patients With Androgen-ablation Therapy (AAT)

Conditions
-----------------
Prostatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate cancer patient requiring androgen-ablation treatment: LHRH analogs, surgical castration, antiandrogen treatment Provision of informed consent prior to conducting any study-related procedure Exclusion Criteria: Patient involved in a Clinical Trial

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 |
| --- | --- | --- |
| Metabolic syndrome |  | 3 months | 
| Metabolic syndrome |  | 6 months | 
| Metabolic syndrome |  | 12 months | 
| Diabetes |  | 3 months | 
| Diabetes |  | 6 months | 
| Diabetes |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture Risk Assessment Tool (FRAx) assessment |  | 0 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Observational, prospective, metabolic changes, metabolic syndrome, diabetes, prostatic cancer, risk fracture
Adherence in the Childhood Asthma Management Program

Study Overview
=================
Brief Summary
-----------------
To evaluate three adherence promoting interventions within the Childhood Asthma Management Program (CAMP), an eight center clinical trial that compared pediatric asthma therapies in children five to twelve years old.

Detailed Description
-----------------
BACKGROUND: The success of any therapeutic intervention, whether preventive or curative, is ultimately dependent on the individual's adherence to treatment. Unfortunately, the failure of a large percentage of patients to adhere to prescribed medical regimens is a widely recognized and well documented phenomenon. It has been estimated that as many as 50 percent of patients do not take their prescribed medications, and of those remaining, less than two-thirds take their medication as prescribed. The study was part of a two grant initiative, Evaluation of Adherence Interventions in Clinical Trials, developed by the Behavioral Medicine Branch staff and the Clinical Trials Branch staff and by members of the Clinical Applications and Prevention Advisory Committee Behavioral Medicine and Prevention Working Groups. The initiative, jointly sponsored by the NHLBI and the National Center for Nursing Research (NCNR), was released in September 1991 and awarded in September 1992. DESIGN NARRATIVE: All participants medication adherence was measured by self-report, canister weighing, and with the Nebulizer Chronolog, a microprocessor-based monitor of inhaler adherence that recorded the date and time of each inhaler use. The subjects were assigned to one of three adherence treatment groups; a control condition, an informed condition, and a feedback condition. Adherence outcomes were analyzed with respect to treatment assignment, as well as CAMP measures of asthma morbidity, pulmonary function, medication side effects, psychosocial development, and quality of life. Cost-effectiveness analyses were also conducted. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Asthma, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Prospective Procedural Data Collection for Continuous Improvement of the KODEX - EPD™ System Performance.

Study Overview
=================
Brief Summary
-----------------
The purpose of the KODEX EPD Field study is to evaluate the performance of the KODEX-EPD system and collect procedural data and medical images for Philips' internal research and development activities (R&D) related to the KODEX-EPD system, as well as for marketing and publication purposes. The KODEX-EPD system is an imaging system that will allow for real time visualization of the catheters in your heart during your procedure, as well as display cardiac images of your heart in several different formats.

Official Title
-----------------
Prospective Procedural Data Collection for Continuous Improvement of the KODEX - EPD™ System Performance

Conditions
-----------------
Cardiac Arrhythmia

Intervention / Treatment
-----------------
* Device: KODEX-EPD system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac Ablation Exclusion Criteria: There is no 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults<br>Patients who have cardiac arrhythmia | Device: KODEX-EPD system<br>* To evaluate the performance of the KODEX-EPD system and collect procedural data and medical images for Philips' internal research and development activities (R&D)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Images | The KODEX-EPD system is an imaging system that will allow for real time visualization of the catheters in your heart during your procedure, as well as display cardiac images of your heart in several different formats. | Through study completion, an average 1 year |