cyrilzakka/clinical-trials huggingface dataset:
Monocular-Camera-Based Mobile Exergame for Type 2 Diabetes Prevention

Exergames have demonstrated potential as effective interventions for promoting physical activity and preventing type 2 diabetes (T2D), particularly among older adults. Kinect-based exergames, in particular, have been associated with improved adherence to exercise regimens and positive health outcomes. However, widespread implementation is limited by the high cost and reduced accessibility of the required hardware, restricting their use in home-based settings. Recent advances in computer vision have enabled the development of exergames using monocular camera systems, which may represent a cost-effective and scalable alternative. This study investigates the feasibility of monocular-camera-based exergames as a cost-effective and convenient alternative for home-dwelling individuals.

A total of 45 community-dwelling older adults aged 60-74 years, identified as high risk for T2D were recruited through local community health centers. Participants were randomly assigned to one of three groups (n = 15 per group): (1) Control group (traditional offline exercise with printed instructions), (2) Kinect group (Kinect-based exergames targeting aerobic capacity, balance, and strength), and (3) Monocular group (monocular-camera-based exergames using real-time 2D pose estimation). The intervention lasted six weeks, with participants completing three 30-minute sessions per week at home. Primary outcomes included exercise performance (completion rate and movement accuracy) and intrinsic motivation. Secondary outcomes included perceived enjoyment, challenge, and usability. Data were analyzed using one-way ANOVA.


Eligibility Criteria:
Inclusion Criteria:

1. age between 60-74;
2. a score of 25 or higher on the Chinese Diabetes Risk Score;
3. community-dwelling individuals, not reside in assisted living or long-term care facilities;
4. physically capable of engaging in light to moderate exercise, as determined by self-report and/or physician clearance;
5. normal cognitive function that enable the participant to complete the experiment independently or with minimal assistance;
6. Written informed consent provided by participants or their families.

Exclusion Criteria:

1. diagnosis of type 1 or type 2 diabetes;
2. current participation in another exercise intervention study;
3. severe cognitive impairment with MMSE \< 24;
4. major mobility limitations such as severe osteoarthritis and recent orthopedic surgery.
A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease

The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.

This is a post-approval registry which is required by of the approval under PMA P150038/S006 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral thalamotomy in the treatment of medication refractory Tremor Dominant Parkinson's Disease (TDPD). Subjects participating in this registry will have received a unilateral thalamotomy (ventralis medius) prior to enrollment using the commercially available Exablate Neuro for the treatment of Essential tremor and TDPD.

The following assessments will be collected at Baseline,1, 3, 6, and 12 months post Exablate procedure and annually thereafter for 5 years:

* Adverse Events (AEs) (does not apply to Baseline Visit)
* Medication usage
* Clinical Rating Scale for Tremor (CRST) ON medication
* Unified Parkinson's Disease Rating Scale Part III ON medication
* EQ-5D-5L
* WPAI-GH

Eligibility Criteria:
Inclusion Criteria:

1. Men and women, age 30 years and older
2. Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care.
3. Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits
4. Subject has signed and received a copy of the approved informed consent form

Exclusion Criteria:

Subject does not agree to participate or is unlikely to participate for the entirety of the study.
A Registry for Participants With Chronic Hypoparathyroidism

The main aim of this study is to find out the long-term safety and effectiveness profile of recombinant human parathyroid hormone (1-84) (rhPTH\[1-84\]) treatment in participants with chronic hypoparathyroidism under conditions of routine clinical practice.

Participants will be treated according to their clinic's standard practice determined by the treating doctors. Each participant will fill out a study questionnaire during a routine doctor visit.


Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with chronic hypoparathyroidism, that is, hypoparathyroidism with a duration of longer than 6 months, including:

  1. Adult participants (greater than or equal to \[\>=\] 18 years of age) who are receiving for chronic hypoparathyroidism any of the following options: standard therapy, standard therapy plus rhPTH(1-84), or rhPTH(1-84) therapy alone.
  2. Pediatric participants (less than \[\<\] 18 years of age) who are receiving for chronic hypoparathyroidism any of the following options: standard therapy, standard therapy plus rhPTH(1-84), or rhPTH(1-84) therapy alone.

Exclusion Criteria:

* Participants or legally acceptable representatives unable to provide informed consent.
* Participants using rhPTH(1-34) or who used rhPTH(1-34) for more than 2 years are excluded. Participants who had been treated with rhPTH(1-34) within 3 months of enrollment are also excluded as are participants currently using rhPTH(1-34).

FOR US SITES ONLY: Participants treated with rhPTH(1-84) prior to the US recall may use rhPTH(1-34) only while rhPTH(1-84) is unavailable due to the recall.

* Participants currently enrolled in an interventional clinical study (whether or not the study is related to hypoparathyroidism); note that this does not include participants enrolled in other observational registries.
* History of hypoparathyroidism resulting from impaired responsiveness to PTH (pseudohypoparathyroidism).
Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes

This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin detemir plus insulin aspart and NPH insulin plus human soluble insulin both in a basal bolus regimen with or without metformin in Chinese patients with type 2 diabetes.

The trial adopts a group sequential design, where the analysis of the primary efficacy endpoint will be performed at the interim analysis, in addition to the final formal analysis. The decision to continue or stop the trial will be based on the result of the interim analysis.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (diagnosed clinically) for at 12 months or longer
* Currently treated with basal insulin once daily or premixed insulin twice daily for at least 3 months with or without OAD(s), and total daily insulin dose less than 1.4 IU (U)/kg (If treated with metformin, unchanged total daily dose of at least 1000 mg for at least 3 months)
* Body Mass Index (BMI) equal to 40 kg/m\^2 or below
* HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.0% by central laboratory analysis
* Plan to be admitted for optimising glycaemic control at least 2 days prior to the randomisation

Exclusion Criteria:

* Treatment with thiazolidinediones (TZD) or Glucagon-Like Peptide-1 (GLP-1) receptor agonists within the last 3 months prior to the screening
* Anticipated change after the randomisation in concomitant medication known to interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers and mono amine oxidase (MAO) inhibitors
* Previous participation in this trial (participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period.)
Coronary Flow Reserve in Patients With Bio-active Stent or Everolimus-eluting Stent Implanted in Acute Coronary Syndrome

The aim of the trial is to assess coronary artery reactivity using adenosine-induced coronary flow reserve (CFR) by transthoracic echocardiography in patients with Bio-active stent (BAS) and Everolimus-eluting stent (EES) distal to the original culprit lesion at 6-8 months.

Objective: The aim of the trial is to assess coronary artery reactivity using adenosine-induced coronary flow reserve (CFR) by transthoracic echocardiography in patients with Bio-active stent (BAS) and Everolimus-eluting stent (EES) distal to the original culprit lesion at 6-8 months.

Design: BASE-CFR is a substudy of the larger randomized multicenter BASE-ACS trial comparing bio-active Titan stent to everolimus-eluting stent in patients with acute coronary syndrome. CFR assessment will be performed at 6-8 months after stent implantation at the same time with OCT assessment. In-stent restenosis will be ruled out using OCT.

Primary endpoint: CFR at 6-8 months after stent implantation.

Secondary endpoint: Coronary flow velocity at baseline and during adenosine-induced hyperemia 6-8 months after stent implantation..

Association of CFR to unendotheliazed stent struts and stent malapposition.

Enrollment: 40 patients (20 receiving BAS and 20 receiving EES).

Clinical site: Satakunta Central Hospital, Finland Turku University Hospital, Finland

Eligibility Criteria:
Inclusion Criteria:

* The patient is enrolled to the BASE-ACS trial. Treated culprit lesion is in the proximal or middle LAD
* Patient or the patient's legal representative has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Ethics Committee of the respective clinical site

Exclusion Criteria:

* Diabetes mellitus
* Treated stent position other than LAD proximal or middle.
* EF\<30%
* Bifurcation lesions
* Renal impairment (creatinine \>120 mmol/L)
* No suitable anatomy for OCT scan or CFR measurement
Sleep Ergonomics in Low Back Pain

The aim of this study is to investigate the effect of sleep ergonomics guidance given by physiotherapist on pain and disability in patients with low back pain. In this randomized controlled trial participants are assigned either into the intervention or the control group. The intervention group will receive detailed instruction on sleeping ergonomics whereas the control group will only be instructed to avoid painful sleeping posture. The initial hypothesis is that in the intervention group pain and disability will decrease more compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Low Back Pain
* Pain during sleep or

Exclusion Criteria:

* Fibromyalgia
* Inflammatory rheumatic disease
* Severe depression or other psychiatric diagnosis
* Previously received specific guidance in sleep ergonomics
Stratifying Critically Ill Patients for Novel Ferroptosis or Pyroptosis Intervention Strategies

In order to better determine which therapy is best for patiënts which present with organ falure during the course of their stay in the intesive care unit (ICU) , one has to determine which underlying mechanism is causing this organ falure. We will determine levels of so called "biomarkers" for ferroptosis (a mechan ism of iron-related cell death) in the peripheral blood and biological fluids of criticaly ill patients admitted to the ICU with a catastrrophy (severe infection, trauma ...) . Why ? If it turns out that this ferroptosis plays a role in the ocurrence of organ failure in the critially ill, this will lead to new therapies in the future as drugs become more and more available which can influene this biochemical "pahway". of iron-relatd death.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the ICU of UZA
* Critically ill and predicted to be hospitalised in the ICU for \> 48 hours (i.e. mostly patients admitted for sepsis, trauma, haemorrhagic shock, neurological catastrophe ... which means at risk to develop mono-or multiple organ failure)
* With arterial line in place (for blood sampling)

Exclusion Criteria:

* Refusal of consent by patient or closest relative
* Postoperative patients after major surgery in whom prolonged ICU stay is not foreseen (i.e. elective cardiac surgery
Improving Pediatric Asthma Care Through Inhaled Steroids in Schools

Asthma is the most common chronic pediatric disease in the United States, and is the most common cause of school absenteeism due to a chronic disease. Socioeconomically disadvantaged minority children receive disproportionately poor asthma care and incur a disproportionate share of asthma-related morbidity. The District of Columbia is particularly severely affected, with a lifetime asthma prevalence rate among children 0-17 years of age in 2010 of 22%, more than double the national average.

One of the major challenges in treating asthma is poor adherence to daily controller medications, particularly inhaled corticosteroids (ICS) which are the cornerstone of the NIH guidelines for asthma management. In an attempt to overcome poor compliance, investigators in Rochester, New York have partnered with primary care providers in their community to arrange for ICS administration at school by school nurses, and this approach yielded significant improvements in several asthma outcomes.

The investigators propose to collaborate in a pilot research project with the overall goal of improving asthma outcomes through reducing barriers to medication adherence. Specifically, the investigators aim to improve adherence to controller medications (inhaled corticosteroids - ICS) among DC children with asthma through the following activities:

1. A pilot prospective randomized clinical trial of home vs. school administration of ICS among DC children in grades kindergarten-8 with persistent asthma.
2. Qualitative interviews with nurses from DC public and public charter school to identify key barriers to administration of daily controller medications in the school setting


Eligibility Criteria:
Inclusion Criteria:

* Current enrollment in one of the grades K-8 at a DC public school (DCPS) or DC public charter school (DCPCS)
* Active public insurance
* Persistent asthma
* An Asthma Action Plan including daily ICS
* Child's primary asthma caregiver present, meaning the person who usually takes care of his/her asthma at home and can answer questions about his/her medical history.

Exclusion Criteria:

* Chronic disease of the cardio-pulmonary system other than asthma
* Non-English speaking parent/guardian
* Currently enrolled in in another asthma study
MIPO Versus Conventional Approach in Volar Locking Plate for Close Fractures Distal End Radius Under WALANT

The goal of this clinical trial is to compare the Minimally Invasive Plate Osteosynthesis (MIPO) approach with conventional methods in volar locking plate treatment for distal end radius fractures under the Wide Awake Local Anesthesia No Tourniquet (WALANT) technique. The main question it aims to answer is: Does the MIPO approach provide better pain control than the conventional approach of volar locking plate fixation in distal radius fractures under WALANT? Participants will be requested to record their pain on the Visual Analog Scale (VAS), assess their functional scores, and undergo postoperative radiographic evaluations. Researchers will compare the MIPO group and the conventional group to determine the postoperative pain VAS scores, shedding light on the comparative effectiveness of the two approaches.

Gap of knowledge

* No comparison of conventional Versus MIPO technique under WALANT
* No result in acute post-operative pain

Eligibility Criteria:
Inclusion Criteria:

* isolated closed fractures of the distal end radius requiring surgery
* aged 18 years and older

Exclusion Criteria:

* Patients with bone fractures lasting more than 21 days
* open fractures
* articular multi-fragmentary comminuted fractures of the distal radius
* not suitable to undergo volar approach surgery
* individuals with combined carpal fractures or dislocation
* ulna fractures
* associated injuries
* a history of previous wrist surgery
* diabetes mellitus
* chronic wrist inflammation
* wrist bone deformities
* the use of anticoagulation drugs
* uncooperative behavior
* those refusing to participate in the research
GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers

The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 Diabetes
* Chronic ulcer (present for ≥4 weeks, but not more than 52 weeks)
* Index ulcer located below the malleoli on the plantar or dorsal surface of the foot
* Index ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone or joint capsule
* Adequate circulation to the foot (documented by ABI or TBI)

Exclusion Criteria:

* Gangrene present on affected foot
* Index ulcer is over a Charcot deformity
* Patient is receiving dialysis
* Patient has 2 or more previous amputations
* Patient has HbA1c \>12% or random blood sugar \>450 mg/dl
* Chronic oral steroid use
* Use of IV corticosteroid, immunosuppressive, or cytotoxic agents
* IV antibiotics
* Another ulcer within 5cm of the Index ulcer
* Cellulitis, evidence of infection, or osteomyelitis
Study of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors

The main purpose of this study was to assess the safety,efficacy and pharmacokinetic when combining SHR-1701 and BP102 in participants with advanced or metastatic non-squamous non-small cell lung cancer. To explore the immunogenicity of SHR-1701 and the relationship between corresponding biomarkers and therapeutic effect.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer.
2. Failed with prior systemic treatments.
3. Measurable disease, as defined by RECIST v1.1
4. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1
5. Life expectancy ≥ 3 months
6. Adequate hematologic and end-organ function as defined in the protocol

Exclusion Criteria:

1. Histologically or cytologically confirmed mixed SCLC and NSCLC.
2. Symptomatic, untreated or active central nervous system metastases.
3. Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment
4. With any active autoimmune disease or history of autoimmune disease.
5. Inadequately controlled hypertension.
6. Tumor infiltration into the great vessels on imaging.
7. History of hemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment.
8. Uncontrolled tumor-related pain.
9. Patients with active hepatitis B or hepatitis C
10. Severe infections within 4 weeks prior to initiation of study treatment.
11. Active tuberculosis within one year prior to initiation of study treatment.
Feasibility Study: Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and Neck

All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.

This is a prospective, single-center clinical trial to evaluate the efficacy of the Ulthera® System to provide a customized, high-density, vectored Ultherapy™ treatment to lift and tighten the skin of the face and neck. Skin laxity changes from baseline will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 25 to 60 years.
* Subject in good health.
* Skin laxity in the area(s) to be treated.
* Understands and accepts the obligation not to undergo any other procedures in the area(s) to be treated through the follow-up period.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the area(s) to be treated.
* Excessive skin laxity on the area(s) to be treated.
* Significant scarring in area(s) to be treated.
* Open wounds or lesions in the area(s) to be treated.
* Severe or cystic acne on the area(s) to be treated.
* Presence of a metal stent or implant in the area(s) to be treated.
* Inability to understand the protocol or to give informed consent.
* BMI equal to and greater than 30.
Trastuzumab Combined With Chemotherapy or Endocrine Therapy to Treat Metastatic Luminal B2 Breast Cancer

The primary objective of this study is to compare progression-free survival (PFS) of patients with metastatic Luminal B2 breast cancer subtype randomised to treatment with Trastuzumab Combined With Chemotherapy or Endocrine Therapy.

This is a non-inferiority study to examine Trastuzumab combined with chemotherapy or endocrine therapy in patients with metastatic Luminal B2 breast cancer subtype. The main purposes of this study are to test the safety and clinical benefit of Trastuzumab combined with chemotherapy or endocrine therapy in treating Luminal B2 breast cancer (hormone receptor positive and human epidermal growth factor receptor (HER2) positive or amplification). This multicentre, randomized study is designed to recruit up to 392 subjects to identify 196 research subjects for each study treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older.
2. Patients with an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
3. Histologically confirmed metastatic or local recurrence of breast cancer.
4. ER positive and/or progesterone receptor (PR) positive, HER-2+ defined as immuno-histochemistry3+ staining or FISH+.
5. Prior adjuvant Trastuzumab therapy is permitted, but disease-free interval (DFI) must be more than 12 months.
6. Patients must have measurable or evaluable disease.
7. Adequate bone marrow reserve with neutrophils \> 1000 and platelets \> 100,000.
8. Adequate renal function with serum creatinine \< 2.0.
9. Adequate hepatic reserve with serum bilirubin \< 2.0, alanine transaminase(ALT) \< 3 times the upper limit of normal, and alkaline phosphatase \< 5 times the upper limit of normal.
10. Adequate cardiac reserve with at least 45% of Left ventricular ejection fraction (LVEF) by echocardiogram.
11. Able to give informed consent.
12. Life expectancy of at least 12 weeks.

Exclusion Criteria:

1. Pregnant or breast feeding.
2. ECOG score ≧2
3. DFI \<12 months.
4. LVEF \< 45% by echocardiogram.
5. Uncontrolled medical problems.
6. Evidence of active acute or chronic infection.
7. Hepatic, renal, or bone marrow dysfunction as detailed above.
8. Concurrent malignancy or history of other malignancy within the last five years except as noted above.
9. Known severe hypersensitivity to Trastuzumab.
10. Patients were unable or unwilling to comply with program requirements.