linjc16/ctgov huggingface dataset:
Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Refractory and/or Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
In this phase I study we will characterize the safety, tolerability, maximum tolerated dose and dose-limiting toxicity of weekly bolus topotecan when administered in combination with two different dosing schedules of carboplatin. We will also evaluate any antitumor activity of these combination regimens.

Detailed Description
-----------------
Upon determination of eligibility, patients will be receive: Topotecan + Carboplatin In order to determine the most appropriate dosing regimen to progress into future phase II trials, two different dosing schedules of topotecan and carboplatin will be utilized (ARM I and ARM II). Patients will be accrued to both treatment arms simultaneously.

Official Title
-----------------
A Phase I Study of Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Patients With Refractory and/or Advanced Solid Tumors

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be included in this study, you must meet the following criteria: Adult patients at least 18 years old Advanced solid tumors refractory to conventional therapy ECOG performance status must be 0 or 1 Patients may have received no more than 3 prior chemotherapy regimens Adequate bone marrow, liver and kidney function Able to understand the nature of the study and give written informed consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Active concurrent infections or serious underlying medical conditions Known HIV positivity Female patients who are pregnant or lactating Received both topotecan and carboplatin 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
-----------------
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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting toxicity |  |  | 
| All over response |  |  |
Duration of Vitamin D Stores After Prolonged Vitamin D Substitution

Study Overview
=================
Brief Summary
-----------------
Ingested or skin produced vitamin D is either hydroxylated in the liver to 25-hydroxyvitamin D (25(OH)D), metabolized and excreted in the urine, or stored in adipose and other tissues. The capacity for vitamin D storage in adipose tissue is not known, nor the importance of such storage which may potentially be of vital importance when intake or solar exposure is limited. In the present study we will include 76 subjects who have participated in an intervention study with vitamin D (20.000 IU per week) versus placebo for the prevention of type 2 diabetes, and who have completed the study after 5 years or who have been excluded because of diagnosed type 2 diabetes or for other reasons. If vitamin D is stored to any extent in the body the subjects given 20.000 IU vitamin D per week for 2-5 years will have a considerable amount of stored vitamin D and accordingly, a slow decline in serum 25(OH)D during the following year without vitamin D substitution, which will be measured in the present study. If our hypothesis is correct, that vitamin D can be stored in significant amounts when the supply is abundant; current advice on vitamin D supplementation mainly during winter should be changed to year around in order to build up sufficient stores for the months without sufficient sun light.

Official Title
-----------------
Duration of Vitamin D Stores After Prolonged Vitamin D Substitution

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previously participated in a vitamin D study Exclusion Criteria: pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 85 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 |
| --- | --- |
| subjects previously given placebo<br> | |
| subjects previously given vitamin D<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| half-life of serum 25-hydroxyvitamin D |  | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D, fat, biopsy
Impact of Morning Symptoms in Clinical Control of Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
Observational study to know the Impact of morning symptoms in clinical control of COPD patients. 1200 patients will be included by General practitioners (GPs) and pneumologists. Objective: establish if there are differences in the impact of COPD on daily activities and morning symptoms measured through questionnaires of daily life activity (Capacity of Daily Living during the Morning (CDLM), Global Chest Symptoms Questionnaire (GCSQ))

Official Title
-----------------
Impact of Morning Symptoms in Clinical Control of COPD

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has signed informed consent form Patients of both sexes,> 40 years. Patients diagnosed with COPD according to global consensus on the definition, classification and management of the disease (GOLD) criteria: post-bronchodilator forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC) <70% post-bronchodilator FEV1 <80% (stage II, III and IV) Exclusion Criteria: Participating in an epidemiological study or clinical trial Patient with other respiratory disease than COPD (eg bronchial asthma, cystic fibrosis, severe bronchiectasis, restrictive lung disease, cancer, etc.). Patients with mild COPD: FEV1> 80%

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| Determine if there are differences in the impact of COPD on patients according to the characteristics of the disease. To measure the impact of specific self-administered questionnaires used in COPD: CDLMQ, GCSQ and CCQ | Capacity of Daily Living during the Morning Qustionnaire (CDLMQ), Global Chest Symptoms Questionnaire (GCSQ)and COPD Control Questionnaire (CCQ) | Retrospective, (previous 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess comorbidities as a risk factor for frequent exacerbations |  | Retrospective, (previous 24 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
morning symptoms COPD
Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI

Study Overview
=================
Brief Summary
-----------------
Pacemaker requirement in the immediate post procedure phase following TAVI is approximately 20% depending on device type and patient characteristics. There is a signal from recent studies suggesting increased risk of sudden cardiac / unexplained death in the first 30-60 days. This study aims to address whether there is a mortality advantage to having a pacemaker in the short term

Official Title
-----------------
Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI

Conditions
-----------------
TAVI

Intervention / Treatment
-----------------
* Device: Pacemaker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients post TAVI Exclusion Criteria: Nil

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 |
| --- | --- |
| Those with pacemaker at discharge<br>Landmark analysis of early mortality dependant on pacemaker status at discharge | Device: Pacemaker<br> <br> |
| Those without pacemaker at discharge<br>Landmark analysis of early mortality dependant on pacemaker status at discharge | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day mortality |  | 30 dyas | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 60 day mortality |  | 60 days |
Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the benefit of lidocaine perfusion in cancer related visceral pain resistant to morphinics. It is an efficacy study in adults and children and a randomized prospective study.

Official Title
-----------------
Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics: Efficacy Study in Adults and Children. Randomized Prospective Study With Direct Individual Benefit

Conditions
-----------------
Cancer, Pain

Intervention / Treatment
-----------------
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from cancer of any type, at any stage, hospitalized at the Institut Gustave Roussy Aged from 6 to 14 years old (group A) and from 15 to 70 years old (adults) Presenting visceral pain due to neurotoxic chemotherapy, due to the tumoral mass or to peritoneal carcinosis Pain resistant to morphinic treatment Exclusion Criteria: Cardiac troubles, clinical cardiac insufficiency, or history of myocardial infarction (MI) of less than 3 months Neurological: non-controlled epilepsy, encephalopathy, or dementia Severe hepatic insufficiency Severe renal insufficiency Respiratory insufficiency Patients having surgery or in postoperative period Known deficit in G6PD, alanine exposure, or sulphamide treatment Porphyria Weight > 80 kg

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lidocaine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine prospectively the lidocaine efficacy in 2 types of patient populations with cancer (group A: children from 6 to 14 years old and group B: adults from 15 to 70 years old) |  | continuous intravenous perfusion for 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To confirm the tolerance of the lidocaine |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer Related Visceral Pain Resistant to Morphinics
Buprenorphine in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
This is a pilot randomized control trial randomizing patients presenting in opioid withdrawal to the emergency department to receive either one of clonidine (usual standard of care) or buprenorphine for their opioid withdrawal. Primary treatment outcome is attendance at a rapid access addiction medicine clinic within a few days of emergency room presentation. Secondary treatment outcome is treatment status with respect to opioid agonist treatment at one month post emergency room visit.

Official Title
-----------------
Buprenorphine in the Emergency Department: Buprenorphine Versus Clonidine for Opioid Withdrawal

Conditions
-----------------
Opioid Withdrawal, Opioid-use Disorder

Intervention / Treatment
-----------------
* Drug: Buprenorphine
* Drug: Clonidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presenting to the ED in opioid withdrawal or soon to be in withdrawal Minimum age 16 English speaking Active phone number Ontario Health Insurance Program card Exclusion Criteria: Pregnant Currently enrolled in a methadone or buprenorphine maintenance Benzodiazepine addiction (or taking >50mg of valium equivalent/day) Acute hepatitis or liver failure

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buprenorphine<br>Patient receives buprenorphine in the emergency room based on a clinical trial protocol as well as a take home prescription for buprenorphine | Drug: Buprenorphine<br>* The participant receives buprenorphine<br>|
| Active Comparator: Clonidine<br>Patient receives clonidine in the emergency room based on a clinical trial protocol and also receives a take home prescription for clonidine | Drug: Clonidine<br>* The participant receives clonidine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants attending the rapid access clinic | The number of participants who attend a rapid access clinic assessment after initial enrollment | 2-5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who are on opioid agonist treatment | The number of participants who are maintained on some form of opioid agonist treatment at the one-month mark | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emergency department, buprenorphine
DSA Risk Factors in MMF-based Immunosuppressed Post-transplanted Patients

Study Overview
=================
Brief Summary
-----------------
Kidney transplantation is the best therapy method for patients with uremia. The main factors affecting the long-term survival of the graft were chronic antibody-mediated rejection and the death of the patients. Newborn donor special antibody (DSA) is a major risk factor for chronic antibody-mediated rejection (AMR) and poor transplantation outcomes. Detection of mycophenolate mofetil (MMF) trough concentration can help estimate its exposure. Deficient exposure of MMF can lead to AMR after transplantation surgery. The aim of this study is to estimate the risk factors of one-year DSA after transplantation.

Official Title
-----------------
DSA Risk Factors in Chinese Kidney Transplant Patients Using MPA-based Immunosuppression Protocol: A Multi-center Clinical Study

Conditions
-----------------
Antibody-mediated Rejection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: years 18-65 single organ transplantation first time to accept kidney transplantation Triple immunosuppression protocol based on MMF, tacrolimus and glucocorticoid PRA negative before transplantation not pregnant for female Exclusion Criteria: Not accept MMF multi-organ transplantation pregnancy or lactation period female mental illness past tumor, peptic ulcer, severe cardiopulmonary disease, active liver disease history Cannot regular follow up

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MMF group<br>Post-transplant patients accept immunosuppression protocol based on MMF for at least 12 months. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DSA 12 month | newborn DSA in recipient serum in the first 12 month after transplantation | 2021.5-2023.5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DSA 6 month | newborn DSA in recipient serum in the first 6 month after transplantation | 2020.12-2022.12 | 
| DSA risk factors | risk factors of newborn DSA | 2020.5-2023.5 | 
| MPA-AUC | trough concentration of MMF in recipients' serum | 2020.5-2023.5 | 
| AR | AMR after transplantation | 2020.5-2023.5 | 
| allograft function | serum creatinine and creatinine clearance in 1 year after transplantation | 2021.5-2023.5 |
Study of Flavocoxid (Limbrel) vs Naproxen in Subjects With Mod-Severe Osteoarthritis of the Knee

Study Overview
=================
Brief Summary
-----------------
Randomized, double-blind, placebo controlled parallel group, multi center study in subjects with moderate-severe osteoarthritis.

Detailed Description
-----------------
This will be a randomized, double blind, placebo controlled, parallel group, multi-center study in subjects with moderate-severe OA. Subjects will be randomized to receive flavocoxid 250 mg bid, flavocoxid 500 mg bid, naproxen 500 mg bid or placebo in a 2:2:2:1 ratio. Subjects will take study materials twice daily for twelve (12) weeks. After the 12 week visit subjects in the placebo arm will be re-randomized to the two flavocoxid arms. All subjects will then continue on the study for an additional 12 weeks. Subjects will keep a diary noting date of onset of symptom change (better or worse), adverse events and cost of all aspects of medical care related directly or indirectly to osteoarthritis. Laboratory studies for inflammatory markers will be drawn and archived at baseline and at the 12 week visit. In addition, a subgroup of subjects will have arthrocenteses performed at baseline and the 12 week visit and the synovial fluid archived for study of intra-articular inflammatory markers.

Official Title
-----------------
A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi Center Study of Flavocoxid ( Limbrel) vs Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Naproxen
* Dietary Supplement: flavocoxid 250 mg
* Dietary Supplement: flavocoxid 500 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OA of the Knee K-L Grade 2-3 Positive response to NSAIDS Exclusion Criteria: K-L grade 1 0r 4 OA of the knee History of GI Bleed within past 5 years Chronic bleeding disorder

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 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: flavocoxid 250 mg<br>flavonoid mixture | Dietary Supplement: flavocoxid 250 mg<br>* flavonoid mixture<br>* Other names: Limbrel 250 mg;|
| Active Comparator: flavocoxid 500 mg<br>flavonoid mixture | Dietary Supplement: flavocoxid 500 mg<br>* flavonoid mixture<br>* Other names: limbrel 500 mg;|
| Active Comparator: naproxen<br>nonsteroidal antiinflammatory drug | Drug: Naproxen<br>* nonsteroidal anti-inflammatory drug<br>* Other names: naprosyn;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya

Study Overview
=================
Brief Summary
-----------------
This study will determine if an education program about hygiene and child feeding practices, taught by local village community health workers, will improve child growth and decrease the prevalence of childhood malnutrition in a rural region of Kenya.

Official Title
-----------------
A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya

Conditions
-----------------
Child Nutrition Disorders

Intervention / Treatment
-----------------
* Behavioral: nutrition and hygiene education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child of a mother living in the catchment area of the study who delivered during the enrollment period

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 6 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>nutrition and hygiene education by community health workers | Behavioral: nutrition and hygiene education<br>* Monthly education sessions about child feeding and hygiene for mothers of young children, conducted by local Kenyan community health workers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| malnutrition prevalence | Child malnutrition rates, as measured by the prevalence of underweight, wasting, and growth stunting of the children in each group | Measured when children are 24 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child growth | Child growth as measured by change in z score of the children in each group | Measured when children are 24 months of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infant nutrition disorder, Child nutrition disorders, Malnutrition, Protein-energy malnutrition