cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Soft Robotic Glove Versus EMS on Hand Function and Quality of Life in Stroke Survivors (RCT)

This study will evaluate the effectiveness of soft robotic gloves versus electrical muscle stimulation (EMS) in improving hand function and quality of life in stroke survivors. Stroke often leads to impaired hand mobility, impacting daily activities and reducing overall quality of life. Soft robotic gloves, designed to assist with hand movement, will provide mechanical support and encourage voluntary muscle activity. EMS, on the other hand, will stimulate muscle contraction through electrical impulses, potentially enhancing muscle strength and coordination.

Participants will be divided into two groups: one will receive treatment using soft robotic gloves, and the other with EMS. Outcomes will be assessed using standardized hand function tests and quality-of-life questionnaires over a specified period. Results are expected to indicate that both interventions will improve hand function and quality of life, with the robotic gloves showing a marginally greater improvement in dexterity and grip strength, while EMS will yield benefits in muscle reactivation and endurance. Stroke survivors in the robotic glove group are anticipated to report greater ease in performing daily tasks, while the EMS group will note an increase in muscle engagement.

Eligibility Criteria:
Inclusion Criteria:

* Had ischemic or hemorrhagic stroke ≤6 months.
* Mini-mental status exam scores \> 24(7).
* GCS score 11 to 15(2)
* FMA-UE score \< 21(3)

Exclusion Criteria:

* Participants with severe vision or hearing impairment.
* Neurological disorders including epilepsy, Alzheimer's disease, vertigo, Parkinson disease, and , muscular disorders which limit functional activity (OA, RA, etc).
* Peripheral vestibular disorder.
* Medications that affect balance, severe cardiovascular conditions, recent lower limb injury or surgery.
* Contraindications for EMS: Patients with certain medical conditions, such as pacemakers, implantable cardioverter-defibrillators, or metal fragments in their body, that contraindicated the use of EMS were excluded.
Multimodality Evaluation of LAA Leaks Arising After Incomplete LAAC: Insights From the LAA-Leak Registry

Closure of peri-device leaks (PDL) after incomplete LAAC have shown early feasibility, however no comparison study of all the leak closure modalities exists. Therefore, this is an attempt to report the first 3-way observational comparison study to date, with results in 160 total patients in 3 arms including detachable embolization coils, vascular plugs/septal occluders and Radiofrequency ablation.

Left Atrial Appendage (LAA) Closure (LAAC) is a potent technique of LAA isolation and exclusion for stroke prevention in patients with atrial fibrillation, with evidence from the PROTECT-AF and PREVAIL-AF trials, including their 5-year follow-up assessments, solidifying LAAC as a viable option in these patients with comparable stroke reduction in comparison to oral anticoagulation (OAC) as well as a reduction in bleeding risk, hemorrhagic CVA, and mortality. However, the surge in the multiple methods of LAA exclusion has also brought to attention postprocedural complications specific to LAAC, namely, peri-device leaks (PDL). The stroke implication and classification of PDL itself still lacks consensus, with an increased thromboembolic (TE) potential due to PDL seen in patients with LARIAT and surgical ligation procedures, yet no statistically significant relationship seen in percutaneous and endocardial LAA closure approaches. PDL \> 5mm has been widely accepted as clinically significant, although there remains limited data with no current established guidelines. Placement of a septal occluder device such as Amplatzer Vascular Plug, Detachable embolization coils, Gore Cardioform Septal Occluder (CSO; W.L. Gore and Associates, Newark DE), and radiofrequency ablation (RFA) have all emerged as options to resolve residual PDL and post-surgical/ligation leaks. However, there exists no head-to-head comparison between these modalities. Given their emergence, this is a proposed a multi-center observational study to further assess and evaluate these three treatment modalities for their efficacy for leak closure, assessment of pre-, peri- and post-procedural characteristics after leak closure, TE events, and bleeding risk, and complication rates.

Eligibility Criteria:
Inclusion Criteria:

1. Patients at risk for stroke or thromboembolism that demonstrated any degree of the significant leak on follow up TEE imaging at least 4-6 weeks following either epicardial, endocardial, or surgical LAAC
2. Patients undergoing any form of eccentric or centric/central leak closure with available modalities (detachable embolization coils, vascular plus/septal/ASD occluders, or RF Ablation). Criteria for this was made based on the judgement of the operator, with no specific cutoffs for leak size, follow-up time from LAAC to leak closure, etc)
3. Age greater than 18 years

Exclusion Criteria:

1. Patients not undergoing leak closure after incomplete LAAC
2. Patients unable to complete 45 day follow-up imaging for reevaluation of LAA leak
3. Patients unable to consent
Effect of Probiotic Lozenge on Gingivitis and Periodontitis

The oral cavity is mostly influenced by general health. The oral microbiota which is as complex as the gastro-intestinal or vaginal microbiota are considered to be difficult therapeutic targets. The effects of probiotics in different fields of health care have resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been clinically proved effective in different fields of oral healthcare such as halitosis, oral candidiasis and tooth decay. They have also been inducted in the field of periodontal healthcare because of the current views on the etiology of plaque- related periodontal inflammation.


Eligibility Criteria:
Inclusion Criteria

* Patients with chronic mild to moderate periodontitis.
* Having Pocket depth \> 4mm.
* Mean loss of attachment, evaluated by measuring the distance from cement-enamel junction to the bottom of the probing pocket \> 4mm

Exclusion Criteria:

* Patients on probiotic supplements
* Patients who have allergy to lactose and fermented milk products
* Smokers
* Patients who are on antibiotic therapy or were on antibiotic therapy in the past 6 months
* Patients with advanced periodontal and/or periapical conditions which necessitate immediate treatment
* Patient suffering from any systemic illness
* Patients who are deemed to be un-cooperative
Bypass vs. Ecmo in Lung Transplantation (BELT)

This study seeks to compare outcomes of 2 different methods of cardiopulmonary support during lung transplant surgeries.

This study will compare use of extracorporeal membrane oxygenation (ECMO) and heart-lung bypass (CPB) during lung transplant procedures and their short and long term outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. The study population will be all patients requiring cardiopulmonary support while undergoing lung transplantation at our institution.

Exclusion Criteria:

1. Patients undergoing concomitant cardiac operations with indication for obligate use of cardiopulmonary bypass
2. Patient with specific anatomy that require full cardiac decompression such as severe pulmonary hypertension or large heart that are shifted severely into the left chest
3. Patients with high likelihood of significant pleural bleeding that will require returning the blood back into the cardiotomy reservoir
4. Patients bridged to transplant with ECMO
5. Cystic fibrosis/bronchiectasis/resistant infection patients where surgeon will need to remove both lungs prior to implantation
6. Patients who the surgeon feels would be better served with CPB rather than ECMO- These patients will be entered into a registry and followed.
Spinal Anesthesia Associated With General Anesthesia in Coronary Artery Bypass

CONTEXT: In patients eligible for coronary artery bypass surgery, anesthesia should provide a number of conditions that exceed the limits of cardiovascular stability, myocardial protection and other organs. Moreover, the combination of general anesthesia and spinal anesthesia lessens the homeostatic, metabolic, hormonal and immunosuppressive changes. The goal of this research was to evaluate the consumption of fentanyl citrate in intra-operative in Coronary Artery Bypass Grafting (CABG) surgery with cardiopulmonary bypass under spinal anesthesia associated with general anesthesia.

METHODS: Clinical, prospective, randomized and double covered study, approved by the Research Ethics Committee. Fifty-six patients candidates for CABG with CPB, after signing the Terms of consent, were randomized and divided into two groups: GI - General and GII - General + subarachnoid. General anesthesia was induced according to the weight of each patient and maintenance with isoflurane and fentanyl. Spinal anesthesia was induced with 20 mg of 0.5% hyperbaric bupivacaine and 200 mcg of morphine, the patient is placed in cephalo-position slope of 45 degrees for 10 minutes in Group II. In the statistical study was performed using the Mann-Whitney test; the level of statistical significance was set at 5%.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders
* Underwent cardiac artery bypass surgery with cardiopulmonary bypass, with
* No restriction on age
* No restriction on ethnicity
* No restriction on education or social class

Exclusion Criteria:

* Patients with sternotomy provided; those
* Urgent surgery and/or emergency
* Patient was with signs of shock
* Patients with chronic renal failure
* Patients with liver disorders
* Tracheostomy patients
* Patients with presence of use of mechanical ventilatory support;
* Patients with physical disabilities; bedridden and wheelchair users.
* Patients to withdraw the Consent and Informed
* Patients who eventually had to be re-operated in the presence also of the mechanical ventilatory support.
An Innovative Master Platform for Clinical Trials in Mood Disorders

Mood disorders such as depression and bipolar disorder affect over 350 million people around the world. While several effective treatments exist, it is often difficult to match the right treatment to an individual person. Repeated efforts to find the right treatment contribute to poor functioning, low quality of life, and prolongs the time it takes to get well. Most areas of medicine are able to use 'biomarkers' or clinical tests, blood tests, or imaging to help diagnose and treat illness. The search for biomarkers in mood disorders is advancing, but one roadblock to progress is the lack of large, standardized studies of mood disorders that are needed to accurately identify biomarkers. The aim of the ENABLE platform is to provide the Canadian neuroscience community a standardized way of collecting biomarker data from individuals with a range of mood disorders symptoms. In addition, this 'master clinical trial platform' framework will provide a pool of participants who can be recruited into biomarker-based clinical trials.

The ENABLE platform offers to the Canadian neuroscience community (1) standardized data collection methods with deep clinical and neurobiological phenotyping of individuals across the spectrum of mood disorder symptoms; (2) a recruitment pool for efficient launch of clinical trials; and (3) an open source of clinical and neurobiological data for discovery analyses and/or grant applications.

The assessments have been categorized into a tiered system, where participants must consent to complete tier 1 items in order to be enrolled in the platform. Tier 2 items will be optional measures, the absence of these measures will not compromise the inclusion in the platform. A separate written informed consent to be contacted regarding participation in future clinical trials associate with the ENABLE platform will also be offered.

At tier 1, individuals complete clinical assessments (clinician administered and self-report) and during their tier 2, they provide blood, undergo neuroimaging procedures (MRI and EEG); and are given an actigraphy device to wear for two weeks.

Eligibility Criteria:
Inclusion Criteria

Patients:

1. 16 years of age or older.
2. Meet criteria for bipolar or depressive disorders as defined by DSM-5.
3. Fluency in English, sufficient to complete the interviews and self-report questionnaires.

Inclusion Criteria

Healthy Comparison (HC) Participants:

1. 16 years of age or older.
2. No history of psychiatric disorders (according to DSM-5) or significant unstable medical conditions.
3. Fluency in English, sufficient to complete the interviews and self-report questionnaires.
Mapping 3D Bladder

This is a single centre, single arm feasibility study assessing the feasibility of using computer vision methods to recreate the 3D bladder shape and to then map the cystoscopy images onto this bladder shape. If feasible, this 3D reconstructed shape would be spatially registered to radiological images (CT, MR) that are then used during radiation treatment planning. This analysis would not be used for making any clinical treatment decisions on the patient.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Clinical suspicion or histologic diagnosis of bladder tumour suitable for endoscopic evaluation.
* Intention to treat using external beam radiation therapy as part of standard of care.
* Ability to provide written informed consent to participate in the study.

Exclusion Criteria:

* Prior complete or partial radiation therapy to bladder.
* Contraindications to radiation therapy as determined by the treating physician.
* Concurrent illness or condition that precludes subject from undergoing endoscopy or CT scanning.
A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis

The purpose of this study is to investigate the safety of subcutaneous (SC) interferon beta therapies with regard to frequency of injection site reactions (ISR) and flu-like symptoms (FLS) as reported by the relapsing-remitting multiple sclerosis (RRMS) participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Ability to understand the purpose of the study and provide signed and dated informed consent
* Diagnosed relapsing-remitting multiple sclerosis
* Currently receiving a SC interferon beta treatment (label conform)
* Stable on SC interferon beta treatment for three months or longer (switch between SC interferon beta treatments possible).

Key Exclusion Criteria:

* Contraindications according to the Fachinformation (German equivalent to Summary of Product Characteristics \[SmPC\])
* Treatment with Glatiramer acetate and intramuscular (IM) interferon beta-1a
* Participation in a non-interventional or interventional clinical study of Biogen
Sintilimab and Nab-paclitaxel in Second-line Treatment of Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma

To evaluate the efficacy and safety of Sintilimab (PD-1 inhibitor) and nab-paclitaxel in second line treatment of advanced gastric and gastro-esophageal junction adenocarcinoma. This is a prospective, multi-centers, single arm phase II trial with primary objective overall response rate and second objective of safety and other efficacy endpoints.


Eligibility Criteria:
Inclusion Criteria:

* pathological confirmed advanced gastric and gastro-esophageal junction adenocarcinoma;
* progression after first-line treatment of fluoropyrimidine and platinum, allow patients progressed on/within 6 months of neoadjuvant/adjuvant treatment; allow local radiotherapy after 21days later;
* 18-75 years old;
* ECOG: 0 or 1;
* has adequate organ function
* writen ICF;

Exclusion Criteria:

* previous treated with taxanes (including paclitaxel, nab-PTX, lipo-PTX, and docetaxel etc..);
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody;
* has known active central nervous system metastatases;
* has received a live vaccine within 4 weeks prior to the first dose of study treatment with any acitve autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatititis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
* clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), orventricular arrhythmia which need medical intervention.
* hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg. coagulation abnormalities (INR \> 1.5 or APTT \> 1.5×ULN), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
Roadmap for Succeeding in Bundled Payment for Orthopedic Joint Replacements

The objective of the study is to provide a road map that can help organizational leaders understand how to sequence their financial and human capital investments related to bundled payment arrangements. Although specific strategies will vary between organizations, providing evidence from a health system with extension experience bundling care for orthopedic joint replacements can be instructive for other providers entering new building arrangements. Insights from the experience of the health system can help other organizations prioritize effort and focus energy around strategies that increase the likelihood of succeeding under Comprehensive Care for Joint Replacement (CJR) and other bundled payment contracts.

This study will analyze data from a health system with the longest standing experience with bundled payments for orthopedic procedures. The goal of this work is to provide insights from this health system's six years of experience and offer a road map that other organizations around the country can use as they plan and implement their own bundled payment programs. The investigators will conduct a retrospective analysis on quality and cost data from a health system with extensive experience with bundled payments for orthopedic joint replacements. The study design will consist of three parts: first, the team will report trends in quality and cost outcomes over time using descriptive statistics; second, the team will perform multi-variable regression analyses on the data to identify significant predictors of different quality and cost outcomes and provide statistical tests on the trends; third, the team will evaluate changes in physician and hospital level variation along the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* participants in this study will be physicians participating in the bundled payment arrangement at the health system in question. All physicians will be included in the analysis.

Exclusion Criteria:

* no exclusion criteria
A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)

Primary Objective:

-To demonstrate that sarilumab added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Japanese RA participants with an inadequate response to MTX.

Secondary Objective:

-To assess the safety of sarilumab added to MTX in Japanese RA participants with an inadequate response to MTX.

The total duration of study was expected up to 62 weeks (screening period of 4 weeks, treatment period of 52 weeks, and a 6-week post treatment observation).

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of RA, according to the American College of Rheumatology/The European League Against Rheumatism (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria with \>=3 months disease duration.
* Moderately to severely active RA defined as:
* At least 8 of 68 tender joints and 6 of 66 swollen joints at screening visit.
* High sensitivity C-Reactive Protein (hs-CRP) \>=6mg/L at screening visit.

Exclusion criteria:

* Participants \<20 or \>75 years of age.
* Treatment with any Disease-modifying antirheumatic drug (DMARD) other than MTX or biologic agent without the appropriate off-drug period prior to screening.
* Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Effect of Probiotics on Chronic Periodontitis in Smoker and Non- Smokers

Periodontitis is one of the most common chronic inflammatory disease with the etiology of bacterial plaque and is associated with a number of putative bacterial species. The periodontal destruction is substantially mediated by the host, driven by the bacterial challenge. The presence of pathogenic bacteria with the absence of so-called "beneficial bacteria" and the susceptibility of the host are the main aetiological factors of periodontal diseases.


Eligibility Criteria:
Inclusion Criteria:

* Patients free from any systemic illness
* Previously untreated moderate to severe generalised chronic periodontitis.
* Patients free from adverse reactions to lactose or fermented milk products
* Patient unwilling to quit smoking and smokers over the past one year ( Smoker arm).

Exclusion Criteria:

* Previous history of antibiotic usage over past 6 months
* Patients who are eligible for antibiotic usage during the treatment course
* Patients who are pregnant, lactating, alcoholic or who had undergone any surgical or nonsurgical therapy within 6 months.
* Acute oral lesions or necrotising ulcerative periodontitis
Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer

The main purpose of this study is to compare progression free survival in patients treated with AZD8931 given in combination with anastrozole versus anastrozole alone. The secondary objective is to investigate the safety and tolerability of AZD8931 given in combination with anastrozole.


Eligibility Criteria:
Inclusion Criteria:

* Patients that have locally advanced or metastatic breast cancer. Lesions should not be amenable to surgery or radiation of curative intent
* Hormone therapy-naive
* Estimated life expectancy of more than 12 weeks

Exclusion Criteria:

* Last dose of prior anti-cancer therapy received within 14 days (or longer if required)
* Any eye injury or corneal surgery within 3 months prior to receiving first dose of study drug.
* Currently receiving (and unwilling to discontinue) oestrogen replacement therapy. (last dose \<7 days prior to randomisation)