linjc16/ctgov huggingface dataset:
Effect of Intense Multi-modal Training on Bone Health and Quality of Life in Persons With Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
Bone loss is a common secondary complication of spinal cord injury (SCI), and treatments used to reverse this condition have equivocal effectiveness. The aim of this study is to determine the effect of intense multi-modal training on bone health, body fat, and quality of life in persons with SCI. Participants will complete 6 months of training during which various measures will be obtained at 0, 3, and 6 months. Control subjects are also being recruited to complete testing but not participate in training.

Official Title
-----------------
Effect of Intense Multi-modal Training on Bone Health and Quality of Life in Persons With Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injury, Obesity

Intervention / Treatment
-----------------
* Other: Exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable spinal cord injury below C2 doctor's permission to participate in the study non-pregnant Exclusion Criteria: see above

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise intervention<br>6 months of intense multimodal training. | Other: Exercise training<br>* 6 months of intense multi-modal exercise consisting of vibration exercise, gait training, electrical stimulation, etc.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density | Bone mineral density of the total body, knee, hip, and spine will be assessed via dual energy x-ray absorptiometry. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat | Total-body and regional depots of fat and fat-free mass will also be assessed in this study. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
paralysis, paraplegia, obesity
A Study of Mircera in Anemic Patients With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
This study will investigate the efficacy, safety and pharmacokinetics of Mircera in adult anemic patients with multiple myeloma. In the first stage of the study, patients will be randomized to receive subcutaneous injections of Mircera once every 3 weeks, at doses of 2.0, 3.5 or 5.0 micrograms/kg. Following the administration of 2 doses, an evaluation of hemoglobin increase will be made at week 6. In the second stage, further groups of patients will receive additional doses of Mircera,at doses of 1.0, 6.5 or 8.0 micrograms/kg, depending on efficacy, safety and pharmacokinetic considerations.The anticipated time on treatment is 3-12 months, and the target sample size is <100 individuals.

Official Title
-----------------
Open Label, Randomized, Exploratory Study to Investigate the Hemoglobin Dose-response, the Safety and the Pharmacokinetic Profile Following Subcutaneous Administration of Mircera Once Every Three Weeks to Anemic Patients With Multiple Myeloma

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: C.E.R.A.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; confirmed diagnosis of multiple myeloma; anemia (hemoglobin <=11g/dL at screening visit). Exclusion Criteria: transfusion of red blood cells during 2 months prior to first planned dose of study medication; therapy-resistant hypertension; relevant acute or chronic bleeding within 3 months prior to planned start of study treatment; recombinant human erythropoietin or erythropoiesis-stimulating drug therapy within 3 months prior to planned start of study treatment.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: C.E.R.A.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin level, and change from baseline, at week 6 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Hematocrit, and change from baseline; reticulocyte count. PK:AUC at weeks 4-6; Safety: AEs, laboratory parameters, blood pressure |  |  |
The Reduction in Glucose Stimulated Insulin Secretion Induced by Cytokines May be Prevented by Copper Addition - Studies in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
In the CDs rat model, beta-cell dysfunction and pancreatic exocrine damage are triggered and prevented by altering dietary Cu content suggesting a chronic and acute role for Cu. These abnormalities become apparent when the CDs rats are exposed to high sucrose low copper diet, triggering a vicious sequence of events: exocrine damage, recruitment of macrophages expressing IL-1beta leading to oxidative stress and even more reduction in the activity of Cu-dependent enzymes (chronic effect). When Cu levels are re-established (acute effect) they may prevent the inhibitory effect of IL-1beta on insulin release and may restore the activity of enzymes inhibited by IL-1beta. In this study we will identify humans with marginal Cu status that may benefit from copper supplementation to normalize their GSIS. These patients will be given a daily Cu supplement (3mg/d), or placebo for a period of 6 months. GSIS, pancreatic dysfunction and biomarkers of marginal Cu status will be measured in different blood components before and every 4 weeks during treatments or placebo.

Official Title
-----------------
This Study is a Small Preliminary Study to Evaluate the Possibility of Performing a Phase 1 Study.

Conditions
-----------------
Hyperglycemia, Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: copper sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic subjects with BMI < 33 HbA1C < 8 plasma copper levels of < 90 ul/dl Exclusion Criteria: patients with bad physical conditions

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

| Intervention/Treatment |
| --- |
|Dietary Supplement: copper sulfate|copper sulfate 3mg/d for a period of 6 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify humans with marginal Cu status that may benefit from copper supplementation and normalize their GSIS. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glucose stimulated insulin secretion, copper, cytokines, diabetes, Reduction in insulin secretion
REsearching Covid-19 Outcomes in Diabetes (RECODE)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe any changes that may occur to certain organs following a confirmed diagnosis of COVID-19 in people with and without diabetes.

Official Title
-----------------
REsearching Covid-19 Outcomes in Diabetes (RECODE)

Conditions
-----------------
Covid19, Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For Type 2 Diabetes (T2D) Male or female 18 years of age and older willing and able to give informed consent to participate in the study Confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged at least 2 months from hospital but not greater than 6 months). Diagnosis of T2D according to American Diabetes Association (ADA) criteria. Must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments. For participant without Type 2 Diabetes (T2D) Male or female 18 years of age and older willing and able to give informed consent to participate in the study Confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged at least 2 months from hospital but not greater than 6 months). Must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments. Exclusion Criteria: Symptoms of active respiratory viral infection: high temperature (over 37.8°C/100.4°F) cough (consistent for over an hour; 3 or more episodes in 24 hours) Any history of Type I diabetes The participant may not enter the study with any known contraindication to magnetic resonance imaging including Pregnancy, lactation or 6 months postpartum from the scheduled date of collection Metal implants (pacemaker, aneurysm clips) based on Investigator's judgment at Screening Unable to participate in MRI assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on Investigator's judgment at Screening Unable to tolerate MRI imaging or claustrophobia Any condition, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with and without diabetes who were previously diagnosed with COVID-19<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure and characterize organ volume change in patients with and without diabetes through use of summary statistics. | Patients recovering from the COVID-19 disease | 1 year |
ILUMYA in Combination With HALOG Ointment 0.1% for Plaque Psoriasis.

Study Overview
=================
Brief Summary
-----------------
Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment.

Detailed Description
-----------------
25 adult subjects with moderate to severe plaque psoriasis will receive Ilumya 100mg subcutaneously at weeks 0, 4 and 16. At week 16, patients with remaining BSA ˃3% will be given HALOG ointment 0.1% to apply BID for 4 weeks. Patients who have ≤3% BSA at week 16 will remain on Ilumya monotherapy. Patients will continue to be evaluated at weeks 20 and 24.

Official Title
-----------------
A Single Center Study to Evaluate the Effectiveness and Safety of ILUMYA in Combination With HALOG Ointment 0.1% for the Treatment of Moderate to Severe Plaque Psoriasis.

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Ilumya Injectable Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adult ≥ 18 years of age; Diagnosis of moderate-to-severe chronic plaque-type psoriasis as defined by BSA 10% PGA ≥3 PASI ≥12 Must be a candidate for phototherapy and/or systemic therapy Females of childbearing potential (FCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide. Exclusion Criteria: Non-plaque forms of psoriasis Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating Presence of significant uncontrolled medical condition that in the opinion of the investigator would affect patient safety during the trial. Active or untreated latent tuberculosis (TB)

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
Intervention Model: Single Group Assignment
Interventional Model Description: open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ilumya<br>Ilumya 100mg subcutaneous at weeks 0, 4 and 16. | Drug: Ilumya Injectable Product<br>* IL-23 injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body surface area | evaluation of body surface area percentage affected by psoriasis where 1 palm is equivalent to 1% | 16 weeks |
Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization

Study Overview
=================
Brief Summary
-----------------
This study evaluated the effectiveness and safety of Hybrid Coronary Revascularization in real-world practice.

Official Title
-----------------
Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization, a Non-randomized, Prospective, Open-label Registry in Real-world Practice

Conditions
-----------------
Percutaneous Coronary Revascularization, Coronary Stenosis, Coronary Artery Disease Progression, Coronary Artery Bypass Grafting

Intervention / Treatment
-----------------
* Procedure: Hybrid Coronary Revascularization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20 and more Hybrid coronary revascularization due to multivessel coronary artery disease(must include left anterior descending artery) Written consent Exclusion Criteria: Previous CABG(coronary artery bypass graft) Life expectancy ≤1 year

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Multivessel coronary artery disease<br>must include left anterior descending artery | Procedure: Hybrid Coronary Revascularization<br>* Hybrid coronary revascularization (HCR) combines minimally invasive surgical coronary artery bypass grafting of the left anterior descending artery with percutaneous coronary intervention (PCI) of non-left anterior descending vessels.<br>* Other names: HCR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a composite event of death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke. | Patients who have experienced any one of the following events are considered to have experienced the composite outcome: death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All death |  | 5 years | 
| Cardiac death |  | 5 years | 
| Myocardial infarction |  | 5 years | 
| a composite event of all death or myocardial infarction |  | 5 years | 
| a composite event of cardiac death or myocardial infarction |  | 5 years | 
| TVR(Target Vessel Revascularization) |  | 5 years | 
| TLR(Target Lesion Revascularization) |  | 5 years | 
| Stent thrombosis | by an Academic Research Consortium (ARC) category | 5 years | 
| Cerebrovascular event |  | 5 years | 
| Procedural success | Procedural success is defined as < 30% final stenosis and the absence of in-hospital event including death, Q-wave myocardial infarction or urgent repeat revascularization. | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hybrid coronary revascularization
Conjugate Pneumococcal Vaccine in Ataxia Telangiectasia (AT)

Study Overview
=================
Brief Summary
-----------------
Ataxia Telangiectasia (AT) is an autosomal recessive inherited condition caused by mutations in the ATM gene1. Patients suffer from neuro-degenerative problems, usually commencing in the second year of life, and affecting predominantly the cerebellum. They also develop the characteristic superficial telangiectases. Between 60 and 80% of affected children are immunodeficient. This is associated with deficiency of immunoglobulin A (IgA ) 2, of IgG23 and of antibody responses to pneumococcal polysaccharides4. Patients suffer recurrent sino-pulmonary infections but a recent study suggests poor correlation between immune status and immunological parameters5. If uncontrolled, recurrent pulmonary infections can contribute to the development of chronic lung disease and bronchiectasis. Preventative management includes continuous prophylactic antibiotic treatment in some with the need for replacement immunoglobulin therapy in only a small proportion of cases. Antibiotics have been reasonably effective in this situation but the emergence of resistance amongst community acquired pneumococcal isolates is a cause for concern. Appropriate immunisation strategies may also have a role. This study is designed to look at antibody responses in a one versus two dose regimen in a cohort of AT patients recruited through the AT Society a national charitable organisation involved in providing support to families with this condition and in fostering education and research in the field.

Official Title
-----------------
Conjugate Pneumococcal Vaccine in Ataxia Telangiectasia (AT)

Conditions
-----------------
Ataxia Telangiectasia (AT)

Intervention / Treatment
-----------------
* Drug: Conjugated pneumococcal vaccine (Prevenar)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genetically confirmed diagnosis of AT

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

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

Design Details

Primary Purpose: Basic Science


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Conjugated pneumococcal vaccine (Prevenar)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of vaccine |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse reactions to vaccine |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ataxia telangiectasia,, Conjugated pneumococcal,, Prevenar,, Immunogenicity ,, Vaccine
Endometriosis: Sexual Dysfunction and Adaptation Strategies Among Couples

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the presence/absence and description of persistent sexual troubles following surgical treatment for endometriosis for women, and their partners.

Official Title
-----------------
Endometriosis: Sexual Dysfunction and Adaptation Strategies Among Couples

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient (and her partner) must have given his/her informed and signed consent The patient (and her partner) must be insured or beneficiary of a health insurance plan Couples for whom the woman has formerly undergone surgical treatment for endometriosis, and for the partner agrees to respond to questionnaires for this study Exclusion Criteria: The patient (or her partner) is participating in another study The patient (or her partner) is in an exclusion period determined by a previous study The patient (or her partner) is under judicial protection, under tutorship or curatorship The patient (or her partner) refuses to sign the consent It is impossible to correctly inform the patient (or her partner) The patient is pregnant The patient is breastfeeding The patient was surgically treated for endometriosis, but was single.

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 |
| --- | --- |
| The study population<br>All patients included according to state inclusion and exclusion criteria. | Other: Questionnaires<br>* All included couples (women and their partners) are required to fill out several questionnaires: 1. Questionnaire for women; 2. Self-questionnaire for women; 3. SFQ for women; 4. Questionnaire for men; 5. Self-questionnaire for men; 6. IIEF for men.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score for the SFQ questionnaire | Score for the SFQ questionnaire; varies from 0 to 5. | Day 1 | 
| Score for the IIEF questionnaire | Score for the IIEF questionnaire; varies from 0 to 75. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores for each sub-domain of the SFQ questionnaire | Scores for each sub-domain of the SFQ questionnaire; varies from 0 to 5. | Day 1 | 
| Scores for each sub-domain of the IIEF questionnaire | Scores for each sub-domain of the IIEF questionnaire; varies from 0 to 30. | Day 1 | 
| Sexual treatment request (yes/no) | Did the patients request treatment/help for sexual problems? yes/no | Day 1 |