linjc16/ctgov huggingface dataset:
Bioimpedance Analysis in Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate whether the objective measurement of fluid overload by bioimpedance analysis (Body Composition Monitor-BCM) in patient with acute decompensated heart failure would improve the diuretic therapy.

Official Title
-----------------
Role of the Bioimpedance Analysis in Guiding the Diuretic Therapy in Chronic Heart Failure - A Randomized Controlled Trial

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Body Composition Monitor (BCM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with known or newly discovered chronic heart failure admitted to hospital because of the clinical signs of acut cardiac decompensation Exclusion Criteria: High level of fatigue (the patient cannot stand on a scale) Amputated upper and/or lower limb(s) The BCM analysis is not possible technically (e.g. open wounds on the limbs) Severe obesity (>130 kg) Patients on chronic hemodialysis or peritoneal dialysis Severe fluid volume in the transcellular space Patients with a unipolar pacemaker whose sensitivity threshold is very low Pregnancy, lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCM group<br>The patients are measured by Body Composition Monitor (BCM) and both the patient and the physician know the results and adjust the diuretic therapy accordingly. | Device: Body Composition Monitor (BCM)<br>* In the experimental group, the diuretic therapy adjusted according to the result of the BCM analysis.<br>|
| Placebo Comparator: Control group<br>The patients are measured by Body Composition Monitor (BCM) but neither the patient nor the physician know the results, the physician adjusts the diuretic therapy as usual, according to the protocols. | Device: Body Composition Monitor (BCM)<br>* In the experimental group, the diuretic therapy adjusted according to the result of the BCM analysis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-hospitalization rate |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Bioimpedance analysis, Fluid overload
High Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
To assess the role of autologous hematopoietic cell rescue in the treatment of multiple myeloma.

Detailed Description
-----------------
To assess the toxicity and efficacy of sequentially administered high dose cyclophosphamide and VP-16 followed by total body irradiation or BCNU and high dose mephalan and autologous stem cell rescue in the treatment of multiple myeloma.

Official Title
-----------------
High Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Procedure: high dose chemotherapy then autologous hematopoietic cell transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- received cytoreduction prior to transplant adequate organ function Exclusion Criteria:- previous transplant smoldering MM or benign monoclonal gammopathy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: high dose chemotherapy then autologous hematopoietic cell transplant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity and efficacy of sequentially administered high dose chemotherapy and autologous hematopoietic cell transplantation |  | Patients will have a daily CBC with platelet count, and chemistries until engraftment, then as indicated clinically. Chest x-rays will be done weekly until engraftment, then as indicated clinically. Patients will be restaged for abnormal proteins (SPIE) |
ST-2; a Non-invasive Fibrosis Marker for Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
IL-33 is a recently identified number of the IL-1 family. Hepatic over-expression of IL-33 has been recently linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. We aimed to determine ability of ST2 to predict fibrosis in chronic hepatitis B.

Detailed Description
-----------------
ST-2 is an IL-1 receptor family member and exists in both a membrane-bound isoform and a soluble (sST2) isoform. It has a functional ligand (Interleukin-33) and via ST-2/IL-33 inflammation and immunity is regulated. Hepatic over-expression of IL-33 has been recently linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. We aimed to determine ability of ST2 to predict fibrosis in chronic hepatitis B.

Official Title
-----------------
The Ability of Prediction of Fibrosis for ST-2 as a Non-invasive Marker in Chronic Hepatitis B

Conditions
-----------------
Sequela of Chronic Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of chronic hepatitis B or liver cirrhosis Exclusion Criteria: Accompanying chronic inflammatory disease

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 |
| --- | --- |
| Chronic Hepatitis B Group<br>Patients with chronic hepatitis B | |
| Cirrhosis<br>Patients with liver cirrhosis | |
| Control Group<br>Control Group: Healthy Volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ST-2, IL-33, prediction, fibrosis, hepatitis B
Cancer Information Your Way: Get What You Need to Make Your Decisions

Study Overview
=================
Brief Summary
-----------------
People diagnosed with cancer may face many difficult decisions regarding their care and preferences. This may be particularly challenging when the cancer cannot be cured. It is therefore hugely important that patients have the information they need so that they can be involved in these decisions and in their care. This qualitative interview study aims to hear from patients who might have found that the information they were given wasn't easy to understand, or who haven't been able to get involved in their care as much as they would have liked. We hope to learn from these experiences in order to improve the way patients are given information and supported to become involved in their care.

Detailed Description
-----------------
Participants will be identified by healthcare professionals and invited to take part in a single interview either by phone or video call, lasting around an hour. Interviews will be semi-structured and follow a topic guide, exploring how participants have been given information, how decisions have been made, and any particular challenges they may have faced. Consent will also be sought for collection of demographic and disease data from the participant's medical record

Official Title
-----------------
Cancer Information Your Way: Get What You Need to Make Your Decisions - a Qualitative Study of Decision Making by Patients With Lower Health Literacy Receiving Care for Incurable Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of incurable malignancy of any site (as identified by their treating oncologist and may be characterised by eligibility for or receipt of treatment with palliative intent) Identified by a member of the healthcare team as potentially having difficulties with health literacy Capacity to provide informed consent English as the main language

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Semi-structured interviews | To explore how best to support decision making by patients with lower health literacy receiving care for incurable cancer, acknowledging the implications COVID-19 will have for future care delivery. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health literacy
Resistant Starch on Glycemic Response in Older Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine how blood glucose changes after eating energy bars containing resistant starch type 4 compared with bars made with puffed wheat in healthy older adults.

Detailed Description
-----------------
To measure the blood glucose response, we collected blood samples before eating and 15, 30, 45, 60, 90 and 120 minutes after eating each bar. The incremental area under the curve was used to calculate glycemic index.

Official Title
-----------------
Resistant Starch Type 4 on the Glycemic Response in Older Adults

Conditions
-----------------
Hyperglycemia

Intervention / Treatment
-----------------
* Dietary Supplement: Resistant Starch Type 4
* Dietary Supplement: Dextrose
* Dietary Supplement: Puffed wheat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Apparently healthy (not diagnosed with disease) Over 60 years of age Exclusion Criteria: Diagnosed with diabetes or other metabolic disorder Allergies to wheat Non-smokers

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Dietary Supplement: Resistant Starch Type 4<br> <br> |
| Active Comparator: 2<br> | Dietary Supplement: Dextrose<br> <br> |
| Placebo Comparator: 3<br> | Dietary Supplement: Puffed wheat<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Response |  | 2-hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aging, Diabetes, Diet, Fiber
Malnutrition Screening in Acute Aged Care

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the impact of malnutrition screening and nutrition intervention on acute aged care patient outcomes.

Official Title
-----------------
Malnutrition Screening and Intervention in Hospitalised Older Patients: A Randomised Controlled Trial

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Other: Early referral to Dietitian for assessment and nutrition support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admitted under a geriatrician into one of 2 acute geriatric medicine wards of the hospital Exclusion Criteria: expected length of stay less than 72 hours palliative (not for active treatment) unable to be nutritionally assessed (non english speaking, severe dementia/confusion and non cooperative/refused) already seen by dietitian during current admission enrolled in the study during previous admission
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Early nutrition intervention<br> | Other: Early referral to Dietitian for assessment and nutrition support<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay |  |  |
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-8554 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-8554 in healthy Caucasian subjects.

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

Intervention / Treatment
-----------------
* Drug: MT-8554
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy and free from clinically significant illness or disease Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65 A body weight of ≥60 kg male and ≥50 kg female Exclusion Criteria: Participation in more than three clinical studies involving administration of an Investigational Medicinal Product (IMP) in the previous year, or any study within 12 weeks. Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder. Clinically relevant abnormal medical history, physical findings or laboratory values

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single ascending dose, MT-8554 or Placebo<br> | Drug: MT-8554<br> <br> Drug: Placebo<br> <br> |
| Experimental: Multiple ascending dose, MT-8554 or Placebo<br> | Drug: MT-8554<br> <br> Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as measured by vital signs |  | up to Day14 | 
| Safety and Tolerability as measured by ECG |  | up to Day14 | 
| Safety and Tolerability as measured by continuous lead II ECG monitoring |  | up to Day14 | 
| Safety and Tolerability as measured by laboratory safety assessments |  | up to Day14 | 
| Safety and Tolerability as measured by physical examination |  | up to Day14 | 
| Safety and Tolerability as measured by number of participants with adverse events |  | up to Day14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK profile (Cmax, tmax, t½, AUC) | Cmax, tmax, t½, AUC | 240 hours post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase 1, Healthy subjects, Pharmacokinetics of MT-8554
Immune Modulation Therapy for Pompe Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess anti-recombinant human acid α-glucosidase (anti-rhGAA) antibody titers after treatment with immune modulation therapy in patients of Pompe disease.

Official Title
-----------------
Immune Modulation Therapy for ERT-naïve or ERT-treated Pompe Disease Patients

Conditions
-----------------
Pompe Disease

Intervention / Treatment
-----------------
* Drug: Rituximab
* Drug: intravenous immune globulin
* Drug: Bortezomib
* Drug: Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient (and/or patient's legal guardian if patient is < 18years) must provide written informed consent prior to any study-related procedures that are performed; The patient must have a confirmed diagnosis of Pompe disease defined as a documented acid α-glucosidase (GAA) enzyme deficiency from blood samples or 2 GAA gene mutations; The patient (and/or legal guardian) must have ability to comply with clinical protocol; Regimen A only: The patient is receiving enzyme replacement therapy, exhibits clinical decline, and has persistent high anti-recombinant human acid α-glucosidase (anti-rhGAA) antibody titers and/or tested positive for antibodies that inhibit enzymatic activity and/or uptake of Myozyme; Regimen B only: The patient is cross-reactive immune material (CRIM) -negative AND have not received Myozyme infusion prior to enrollment Exclusion Criteria: The patient is at risk of reactivation or is a carrier of Hepatitis B or Hepatitis C; The patient is at risk of reactivation of tuberculosis or has regular contact with individuals who are being actively treated for tuberculosis; The patient has used any investigational product (other than alglucosidase alfa) within 30 days prior to study enrollment; The patient is pregnant or lactating; The patient has had or is required to have any live vaccination within one month prior to enrollment.
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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITT<br>immune modulation therapy | Drug: Rituximab<br> <br> Drug: intravenous immune globulin<br> <br> Drug: Bortezomib<br> <br> Drug: Methotrexate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-recombinant human acid α-glucosidase (anti-rhGAA) antibody titers decrease |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immune modulation therapy, acid α-glucosidase, antibody
Validation of a Home-screening Test for Lactose Intolerance

Study Overview
=================
Brief Summary
-----------------
The hypothesis underlying this study is that whilst there is no home-screening test for lactose intolerance, this test would have significant value as lactose tolerance tests and breath hydrogen tests are expensive and time consuming. Therefore, it would be highly beneficial to validate a simple home-screening test. This study will validate a simple home-screening test that uses lactose and not milk.

Official Title
-----------------
A Study to Validate a Home-screening Test for Lactose Intolerant People

Conditions
-----------------
Lactose Intolerance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed lactose intolerance as demonstrated by a lactose tolerance test Diagnosed as not having lactose intolerance as demonstrated by a lactose tolerance test Exclusion Criteria: Pregnant Breastfeeding Unwillingness to comply with study outline

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lactose intolerance, Lactose, Home-screening test, Validate
Mononucleotide Autologous Stem Cells and Demineralized Bone Matrix in the Treatment of Non Union/Delayed Fractures

Study Overview
=================
Brief Summary
-----------------
The study is a prospective, trial to test the safety and feasibility of injecting autologous, isolated, sterile centrifuged NBMC, and Ignite® DBM in the treatment of high risk non union/delayed fractures. Another objective is to turn this procedure to a standard care protocol in our department .

Conditions
-----------------
Non Union/Delayed Fractures

Intervention / Treatment
-----------------
* Device: the Sepax is a tool to standardize adult stem cell. Ignite ®ICS injectable scaffold manufactured by Wright Medical Technology.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages: 18 to 65 Males- not involved in active military duty. Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent. Subjects must be available for follow-up for 1 year. 5Hard to heal fracture include the following: A. Fracture of the distal third of the tibial bone B. Segmental or open (II, IIIa an IIIB) fractures of the the tibia or femur diaphysis C.Articular fracture of the lower extremity (distal femur, tibial plateau and tibial pilon fractures) with significant metaphyseal comminution and/or bone loss. Exclusion Criteria: Active systemic or local infection. History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin) Pathological Fractures. Prior Fracture or Prior operation in the current fracture

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sepax, ignite, fracture healing<br>the mesenchymal cells will be separated by sepax separation system and demineralized bone matrix will be done using IGNITE INJECTABLE REPAIR GRAFT | Device: the Sepax is a tool to standardize adult stem cell. Ignite ®ICS injectable scaffold manufactured by Wright Medical Technology.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and radiological bony union at 3 months and 6 months. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subjects sustaining Non union/delayed fractures and requiring surgical intervention for treatment