cyrilzakka/clinical-trials huggingface dataset:
Fit For Function: A Community Wellness Program for Persons With Stroke

Building on an earlier pilot study, this randomized controlled trial will compare the effectiveness of a 12 week community YMCA-based wellness program specifically designed for people with stroke (Fit for Function) to a standard YMCA membership.

The program will be delivered through a partnership between McMaster University, the YMCA and Hamilton Health Sciences/ the Brant Community Healthcare System/ the Niagara Health System. Participants will exercise three times a week and receive weekly education about how to take care of themselves after a stroke. The YMCA staff who deliver the program will have specialized training about how to help people with a stroke exercise safely and effectively. The hospital within each region will provide specialized on-site physiotherapy consultative support. The comparator standard YMCA membership will include typical sessions with a wellness coach who has basic safety training regarding stroke and exercise.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with stroke
* 18 years of age or older
* community dwelling
* able to walk 10m independently, with or without an assistive device
* medically approved by a physician to participate
* able to tolerate 60 minutes of activity with rest intervals
* able to independently follow instructions

Exclusion Criteria:

* involved in an active rehabilitation program
Assessing Cement-bone Incorporation and Adjacent Segment Degeneration Following Cement Augmentation; an MRI-PET Follow-up

3-year PET-MRI follow-up after vertebral balloon kyphoplasty aiming to investigate cement incorporation.


Eligibility Criteria:
Inclusion criteria

* Men and women aged 18 to 70 years
* Minimum 3-year follow-up
* Single-level vertebral kyphoplasty
* Index surgery at UniversitätsSpital Zürich
* MRI-scan during initial treatment
* Informed consent provided

Exclusion criteria

* Combined with other operative procedure on the spine (e.g. dorsal instrumentation)
* Intraoperative intradiscal cement leakage
* Previous history of spinal surgery except on the cervical spine
* Metastatic disease with skeletal involvement
* Known chronic diseases of the bone metabolism other than osteoporosis
* Documented pregnancy (see also 6.3)
* Presence of implants not suited for MRI (pacemaker, neuro-stimulators, pain pumps, insulin pumps, Cochlea implants, metallic foreign bodies like bullet fragments)
Evaluation of Respiratory Parameters and Functional Capacity in Coronary Artery Patients

The purpose of this study is to evaluate respiratory parameters and functional capacity in coronary artery patients.

Decreased pulmonary function as measured by forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), or peak expiratory flow (PEF) has been associated with an increased risk of cardiovascular mortality and morbidity. A low MIP value may generally indicate weak muscle strength and therefore be an indicator of general poor health. Respiratory muscle weakness and decreased respiratory muscle endurance affect exercise tolerance in individuals with chronic disease, including cardiovascular disease. Studies have supported the association of grip strength with frailty, physical activity, diabetes, functional limitation, nutritional status, metabolic syndrome, and mortality.

The study will evaluate respiratory parameters and functional capacity in coronary artery patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery disease
* Volunteering to participate in the research

Exclusion Criteria:

* Having a musculoskeletal problem
* Having unstable cardiac disease
* Having chronic heart failure (NYHA III-IV)
* A history of acute coronary syndrome or surgical revascularization less than 3 months ago
* Having arrhythmia
* Having the last stage of kidney disease
* Having active myocarditis or pericarditis
Choice of Valve Substitute in the Era of Oral Anticoagulation Self-Management

The optimal valve substitute for patients between 60-70 years is controversial. We compared anticoagulation-related adverse events (ARAE) in patients receiving mechanical heart valve replacement (MHVR) on INR self-management vs. stentless bioprosthesis, to assess whether the risk of structural valve deterioration (SVD) is still out-weighted by the benefit of not requiring permanent anticoagulation.


Eligibility Criteria:
Inclusion Criteria:

* heart valve replacement

Exclusion Criteria:

* CABG
* Afib
Periodontal Status and Pregnancy or Delivery Complications in Type 1 Diabetes Mellitus Pregnant Women

The results of contemporary studies suggest an association between inflammatory periodontal disease and pregnancy and delivery complications. The aim of this study was to assess the association between periodontal disease, clinical periodontal parameters and pregnancy or delivery complications in type 1 diabetes mellitus and non-diabetic pregnant women.

The results of contemporary studies suggest an association between inflammatory periodontal disease and pregnancy and delivery complications. The aim of this study was to assess the association between periodontal disease, clinical periodontal parameters and pregnancy or delivery complications in type 1 diabetes mellitus and non-diabetic pregnant women. Methods: 15 type 1 diabetes mellitus and 15 non-diabetic primiparous women were enrolled in the prospective "case-control" study. Investigators compared periodontal status, levels of glycosylated haemoglobin (HbA1c), high sensitivity C-Reactive Protein (hs-CRP), gestational week of birth, birth weight of a newborn and pregnancy or delivery complications (C-section, pre-eclampsia) between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Pregnant Women
* Pregnant Women with Diabetes Mellitus type 1
* Healthy Pregnant Women with signs of Periodontal Disease
* Pregnant Women with Diabetes Mellitus type 1 and signs of Periodontal disease

Exclusion Criteria:

* Smokers
* Former smokers who had stopped smoking less than five years before participation
* Pregnant women with other systemic diseases
Safety and Efficacy Study of CD22 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia

This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD22 CAR-T cell in the treatment of recurrent or refractory B-ALL

The CARs consist of an anti-CD22 single-chain variable fragment（scFv）, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

The Main research objectives:

To evaluate the safety and efficacy of CD22CAR-T in patients with recurrent or refractory B-ALL

The Secondary research objectives:

To investigate the cytokinetic characteristics of CD22CAR-T in patients with recurrent or refractory B-ALL

Eligibility Criteria:
Inclusion Criteria:

1. Patients with relapsed and refractory acute B-lymphoblastic leukemia who have any of the following:

   1. B-ALL patients with relapse (including bone marrow morphological relapse 1 and minimal residual relapse 2) after remission by chemotherapy or autologous stem cell transplantation;
   2. Primary B-ALL patients who can not be completely relieved by more than two times of repeated chemotherapy;
   3. High risk primary B-ALL patients who have not been relieved but are not suitable for re intensive therapy after 1-2 times of chemotherapy;
2. Flow cytometry (FCM) showed CD 22 positive in bone marrow or peripheral blood;
3. There should be at least one assessable lesion in B-ALL patients with simple extramedullary recurrence;
4. The activity state score of the Eastern Cooperative Oncology Group (ECOG) was less than or equal to 2;
5. The estimated survival time is more than 3 months;
6. Need to sign informed consent.

Exclusion Criteria:

1. Serious cardiac insufficiency；
2. Has a history of severe pulmonary function damaging;
3. Other malignant tumors;
4. Serious infection or persistent infection and can not be effectively controlled；
5. Merging severe autoimmune diseases or immunodeficiency disease;
6. Patients with active hepatitis (HBV DNA or HCV RNA positive);
7. Patients with HIV infection or syphilis infection;
8. Has a history of serious allergies on Biological products (including antibiotics);
9. Being pregnant and lactating or having pregnancy within 12 months;
10. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study（including a history of serious mental illness, substance abuse and addiction）
Molecular Imaging of Plaque Vulnerability

Accumulating data in the literature suggests that radiolabeled-choline (18F-choline) is a sensitive molecular tracer for PET imaging that is taken up in activated cells and, as such, is able to identify active inflammatory sites. The investigators hypothesize that 18F-choline is also highly taken up in vulnerable plaques in comparison to the stable ones.

Accumulation and subsequent activation of inflammatory cells in the atherosclerotic plaques play an essential role in transforming a stable plaque into a vulnerable plaque at risk to rupture. On this basis, the study aims to evaluate the diagnostic performance of 18F-choline PET in identifying ongoing inflammation within atherosclerotic plaques. The investigators hypothesize that 18F-choline PET is efficient in detecting intraplaque inflammation and identify vulnerable plaques that are prone to rupture in comparison to the stable ones.

It is likely that by correlating the inflammatory status of an atherosclerotic plaque (on 18F-choline PET) with the presence of other vulnerable plaque features (on MR imaging) would be of high clinical relevance for clinical diagnosis of vulnerable plaques.

Eligibility Criteria:
Inclusion Criteria:

* Patients known with symptomatic carotid artery stenosis (≥2 mm carotid plaque on duplex ultrasound), who are scheduled in the clinical setting to undergo a carotid endarterectomy or who are referred to conservative therapy;
* Age 18 years and older (no maximum age);
* Informed consent by signing informed consent form regarding this study.

Exclusion Criteria:

* Dementia, pregnancy, nursing mothers;
* Serious neurological deficits at symptomatic side (hemi paralysis, complete aphasia);
* Severe heart failure NYHA III-IV and severe pulmonary dysfunction dependent on oxygen supply;
* Patients with contra-indications for MRI (ferromagnetic implants like pacemakers or other electronic implants, metallic splinters in the eyes, vascular clips, claustrophobia, etc.).
Goal Directed Fluid Therapy and Postoperative Ileus

Despite Goal Directed Fluid Therapy (GDFT) has shown a reduction of hospitalization and overall complications in patients undergoing abdominal surgery, there is a need to address the effect of implementing GDFT on the incidence of specific surgical complications and in a context of en enhanced recovery program (ERP). Specifically, studies investigating the impact of GDFT on primary postoperative ileus (POI) in patients undergoing laparoscopic colorectal surgery and using an ERP are missing.

It is hypothesized that the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving Standard Fluid Therapy (SFT) after elective laparoscopic colorectal surgeries with an ERP program.

Randomized Controlled Trial. Study population: elective laparoscopic colorectal resections with an Enhanced Recovery Program (ERP) Sample size: 128 patients (140 accounting for drops out)

Two arms:

GDFT: patients will receive GDFT esophageal doppler guided; SFT: patients will receive SFT based on standard anesthesia formula and international guidelines to calculate fluid requirements.

Study Hypothesis: the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving SFT after elective laparoscopic colorectal surgeries with an ERP program.

ERP: all patients will receive the same perioperative care according to the Enhanced Recovery After Surgery ERAS® program guidelines. Intravenous fluid will be stopped the first day after surgery. Patients will be allowed to have clear fluids the same day of surgery and diet, as tolerated, the first day after surgery.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing elective laparoscopic colorectal resection with an Enhanced Recovery Program

Exclusion Criteria:

1. Age \<18 yr
2. Emergency surgery
3. Patients who do not understand, read or communicate in either French or English
4. Patients who had undergone esophageal or gastric surgery
5. Esophageal pathology (esophageal varices or cancer)
6. Patients with coarctation of the aorta or aortic stenosis
7. Chronic atrial fibrillation

7. Preoperative bowel obstruction 8. Coagulopathies 9. Chronic use of opioids
Study Investigating the Pharmacokinetic Properties of the Drug Lu AF35700 in Subjects With Liver Impairment and in Healthy Subjects

The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of a single oral dose of Lu AF35700


Eligibility Criteria:
Inclusion Criteria:

* Subjects with hepatic impairment disease stage Child-Pugh's Criteria A (mild) or Child-Pugh's Criteria B (moderate) and healthy subjects with normal hepatic function
* Subjects have a body mass index between 18.5 and 34 kg/m2 (inclusive)

Exclusion Criteria:

* Subjects previously been dosed with Lu AF35700

Other protocol defined inclusion and exclusion criteria may apply
A Trial of Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite (D. Pteronyssinus) Allergy

Allergic diseases represent a major health issue worldwide. Mainstay treatment is allergen avoidance and pharmacotherapy for symptom relief. Allergen immunotherapy offers the advantages of specific treatment with long lasting efficacy, and can modify the course of disease. However, use of this treatment is restricted by the high risk of adverse events especially in asthmatics. Other, better tolerated, routes of allergen administration than the current conventional subcutaneous route (SCIT) have been investigated including sublingual (SLIT). However, the immune parameters of SLIT have not been examined. We propose conducting a randomised, placebo-controlled study of a commercially-available SLIT for house dust mite (HDM) allergy to investigate induction of relevant T cell regulatory immune mechanisms. The first year will be followed by an optional open label extension period. Immunoregulatory cytokine synthesis and T cell phenotype and function (real time PCR and flow cytometry) will be examined. This project will provide important fundamental knowledge on which to base improved and greater application of this potentially curative treatment for allergy. SLIT has the potential advantage of home administration and suitability for patients with asthma who are currently unable to access many of the allergen desensitising regimens.


Eligibility Criteria:
Inclusion Criteria:

* allergic rhinitis and/or
* mild stable asthma
* house dust mite allergic
* positive HDM-specific IgE as determined by skin prick test (wheal diameter \>6 mm to D. pteronyssinus) or CAP-Pharmacia score \> 2

Exclusion Criteria:

* Immunodeficiency diseases
* Severe or uncontrolled asthma
* Previous immunotherapy with House dust mite (HDM) extract within the last five years or ongoing immunotherapy with HDM or other allergens
* Continuous oral corticosteroids
* Subjects on treatment with beta-blockers
* Pregnant women
Evaluate Pharmacokinetics and Safety of BMS-986177 in Participants With Normal Renal Function and With Moderate or Severe Renal Impairment

Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in participants with normal renal function and moderate to severe renal impairment.


Eligibility Criteria:
Inclusion Criteria:

* Participants in Groups B and C will be classified by renal function by eGRF at screening and confirmed on Day -1
* Participants in Group A will be healthy participants as determined by no significant deviations in normal medical and surgical history and assessments
* Participants in Group A must have a body mass index of 18.0 to 32.0 kg/m2, inclusive
* Females must be of non-childbearing potential

Exclusion Criteria:

* Participants in Groups B and C cannot have an indwelling catheter for hemodialysis
* Participants in Groups B and C cannot have had, nor be waiting for, an organ transplant

Other protocol defined inclusion and exclusion criteria could apply
Adjuvant Immune Checkpoint Inhibitors in Postoperative Hepatocellular Carcinoma

Though hepatectomy is the best treatment for patients with hepatocellular carcinoma (HCC), the 5-years recurrence-free survival is lower than 30%. In recent years, several immune checkpoint inhibitors have been approved in advanced HCC. No study about the safety and efficacy of adjuvant immune checkpoint inhibitors for patients with HCC after hepatectomy was reported.

Hepatic resection is the best treatment for patients with early stage hepatocellular carcinoma (HCC) or selected intermediate or advanced disease. However, the postoperative 5-years recurrent rate is up to 70%, for whom recurrence is a major cause of death. In recent years, several immune checkpoint inhibitors have been approved in advanced HCC by official guidelines. At the same time, four randomizead controlled trials about adjvuant immune checkpoint inhibitors for postoperative HCC are ongoing. However, no study about the safety and efficacy of adjuvant immune checkpoint inhibitors for such patients in clinical practice was reported. Therefore, the investigators plan to investigate the safety and efficacy of adjuvant immune checkpoint inhibitors for patients with high-risk factor of HCC recurrence after curative hepatectomy in a prospective cohort study.

Eligibility Criteria:
Inclusion Criteria:

* Underwent curative hepatectomy;
* Diagnosis of HCC was confirmed by postoperative histopathology;
* Liver function Child-Pugh A or B;
* Performance status score 0 or 1
* With high risk factor of HCC recurrence, such as tumor size ≥ 5 cm, multinodular, macrovascular invasion or microvascular invasion; Receive immune checkpoint inhibitors based adjuvant therapy.

Exclusion Criteria:

* Receive neoadjuvant immune checkpoint inhibitors therapy.
Upper Extremity Rehabilitation With Virtual Reality in Parkinson's Disease Patients

Upper extremities are the first part of the body to be affected by Parkinson's disease. Although studies have shown that virtual reality-assisted rehabilitation methods are effective on gait and balance, studies on their use for upper extremity rehabilitation are limited. For this reason, the aim of the project is to examine whether virtual reality supported upper extremity position matching exercises, which will be specially prepared according to joint ranges of motion, will provide functional improvement in the upper extremities of individuals with Parkinson's disease.

Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor disorders. Difficulties in using the upper limbs caused by these motor impairments are common with the disease. Upper limb motor impairments in PD include slowness of movement, difficulties in performing sequential tasks and limitations in upper limb function. Studies show that the upper extremities are usually the most affected body region in the early stages of PD. Despite this, the number of rehabilitation methods that can be used for upper extremity rehabilitation is limited. Impairments in upper extremity motor function constitute a leading problem in the lives of individuals with PD by affecting their ability to perform activities of daily living. Virtual reality applications stand out as an innovative approach in neurorehabilitation. Previous studies have reported positive effects of virtual reality on gait function and balance in PD. However, the number of studies designed with virtual reality for the upper limb is limited. Therefore, this project aims to fill the gap in the literature by examining the effectiveness of virtual reality-based rehabilitation in PD with a particular focus on upper extremity motor function and proprioception.

Eligibility Criteria:
Inclusion Criteria:

* Accepting to participate in the research
* Being diagnosed with Parkinson's Disease by a neurologist
* Continuing anti-parkinsonian medication
* Hoehn-Yahr (H-Y) stage 3 and below
* Ability to walk independently
* To have full range of motion in shoulder abduction and elbow extension movements

Exclusion Criteria:

* Presence of additional neurological diseases other than Parkinson's Disease
* Scores below 21 on the Montreal Cognitive Assessment Scale
* Change in medication dosage in the last 1 month
* Severe visual impairment or complete hearing impairment in both ears
* Having a rheumatologic, musculoskeletal, etc. disease that may affect upper extremity functions
* The occurrence of severe tremors or dyskinesias due to the end of the drug dose
* Failing the Titmus butterfly test
Image Characteristic and Longitudinal Follow up of 18F-PMPBB3 (APN-1607) PET for Progressive Supranuclear Palsy

The study will enroll 20 PSP and 8 normal subjects with complete neurological examination, 18F-PMPBB3 (APN-1607) PET and MRI assessment. To explore: (1) whether 18F-PMPBB3 (APN-1607) can detect the 4R tau protein in the brain of PSP patients; (2) whether 18F-PMPBB3 (APN-1607) can distinguish the clinical characteristics of PSP; (3) Whether the distribution of tau deposition is related to disease severity, progression, and prognosis.

Progressive supranuclear palsy (PSP), also known as Steele-Richardson-Olszewski syndrome, has a similar incidence in men and women. The pathophysiology of PSP is remaining unclear, but it is known to be related to the abnormal accumulation of 4R tau protein in the brain. Recently, new generation of novel radiotracer 18F-PMPBB3 (APN-1607), which can be labeled with 4R PHF-tau without significant off-target binding, has been successfully developed. The study will enroll 20 PSP and 8 normal subjects with complete neurological examination, 18F-PMPBB3 (APN-1607) PET and MRI assessment. To explore: (1) whether 18F-PMPBB3 (APN-1607) can detect the 4R tau protein in the brain of PSP patients; (2) whether 18F-PMPBB3 (APN-1607) can distinguish the clinical characteristics of PSP; (3) Whether the distribution of tau deposition is related to disease severity, progression, and prognosis. The research results will help to understand the potential of 18F-PMPBB3 (APN-1607) as a biomarker for diagnosis and therapeutic assessment tool for progressive nuclear paralysis as well as other tau proteinopathy.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Patients fulfill the criteria of NINDS-SPSP clinical criteria for the diagnosis of PSP "as possible" or "probably" PSP, and healthy volunteer with no clinically relevant finding on physical examination at screening visit.
3. Age range 20-90 years

Exclusion Criteria:

1. Implantation of metal devices including cardiac pacemaker, intravascular metal devices.
2. Major systemic diseases including coronary arterial disease, heart failure, uremia, hepatic failure, prominent strokes, acute myocardial infarction, poorly controlled diabetes, previous head injury, intracranial operation, hypoxia, sepsis or severe infectious diseases
3. Major psychiatric disorders, drug or alcohol abuse and major depression
4. Pregnant women or breast- feeding women