cyrilzakka/clinical-trials huggingface dataset:
A Multi-Site Trial of the Impact of Assistive Technology With Assistance Users and Their Caregivers

Many individuals with mobility limitations, especially those who are older and have more severe impairments, use a combination of assistive devices and personal assistance to meet their needs. Assistive technology (AT), which includes devices such as wheelchairs, walkers, bathroom grab bars, and dressing aids, helps facilitate day-to-day activities and social participation (basic and instrumental activities of daily living) among these individuals and may decrease their dependence on human assistance. Although some research has reported beneficial outcomes of AT use, few studies have used controlled experimental designs. Furthermore, the results are often difficult to interpret because the AT interventions are only vaguely described. Another concern is that many individuals receive help from others, but scant attention has been paid to the impact of AT on caregivers. This neglect produces an incomplete portrayal of the effect of AT interventions. The proposed study addresses these deficiencies by evaluating the effects of a formalized dyadic AT intervention on individuals with mobility limitations and on their caregivers. The Assistive Technology Provision, Updating and Training (ATPUT)intervention involves a detailed in-home assessment of participants' current AT; the negotiation and implementation of a personal AT plan with the participants and their caregivers; and the provision of AT devices, non-structural home modifications, and device training.

Objectives:

1. To determine the efficacy of the Assistive Technology Provision, Updating and Training intervention for assistance users and for their caregivers.
2. To explore how the intervention is experienced by these individuals and to help explain the study findings.

General Hypotheses:

The investigators anticipate this intervention will increase the daily activities and social participation of individuals with mobility limitations; decrease the psychological and physical demands on caregivers; and reduce the amount of caregiving required.

Methodologies:

This research will use a combination of quantitative and qualitative methods. The quantitative portion will be an experimental, single-blinded study in which the investigators randomly assign participants to either the ATPUT or a customary care group.


Eligibility Criteria:
Inclusion Criteria:

* daily activity and/or mobility disability
* referred to homecare
* have an unpaid informal caregiver who is above the age of consent and willing to participate in the study
* can communicate in English or French.

Exclusion Criteria:

* cognitive impairments that are likely to prevent them from reliably completing the study questionnaires.
Exercise and Physical Activity in Children with Pediatric Acquired Brain Injury

Exercise and physical activity in children with pediatric acquired brain injury

Although emerging approaches have emerged in the design of interventions that promote an orientation towards physical activity scientific evidence on their efficacy in this particular population remains limited. This underscores the need for further research to evaluate the efficacy of these intervention approaches in the context of pediatric ABI.

Eligibility Criteria:
Inclusion Criteria:

* Be under 18 years of age and present a medical diagnosis of pediatric acquired brain injury.
* Have the informed consent completed and signed
* Present a state that allows following indications for the practice of exercise and physical-sports activity.

Exclusion Criteria:

* Have medical comorbidities that contraindicate the safe performance of the program (i.e., cardiac or respiratory instability, uncontrolled seizures).
* Have additional disabling conditions, such as cognitive impairment and/or an inability to communicate with the researcher verbally, in writing, or through an emissary.
* Non-attendance and/or non-collaboration at 70% of the sessions of the program.
DETERMINE-preserved - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Preserved Ejection Fraction

International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients with Preserved Ejection Fraction (HFpEF)


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent prior to any study specific procedures
* Male or female, aged ≥40 years
* Established documented diagnosis of symptomatic HFpEF (NYHA functional class II-IV), which has been present for at least 8 weeks
* LVEF\>40% and evidence of structural heart disease
* Elevated NT-proBNP levels
* Patients should receive background standard of care as described below: All patients will be treated according to locally recognised guidelines on standard of care treatment for patients with HFpEF. Therapy should have been individually optimised and stable for ≥4 weeks (this does not apply to diuretics) and include (unless contraindicated or not tolerated) treatment of co morbidities (including high blood pressure, ischaemic heart disease, atrial fibrillation/flutter).
* 6MWD≥100 metres and ≤425 metres at enrolment and randomization

Exclusion Criteria:

* Presence of any condition that precludes exercise testing
* Participation in a structured exercise training programme in the 1 month prior to screening or planned to start during the trial
* Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
* Type 1 diabetes mellitus
* eGFR \<25 mL/min/1.73 m2 (CKD-EPI formula) at enrolment, unstable or rapidly progressing renal disease at time of randomisation
* Systolic BP \<95 mmHg on 2 consecutive measurements
* Systolic BP ≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements
* Current acute decompensated HF or hospitalisation due to decompensated HF \<4 weeks prior to enrolment
* MI, unstable angina, coronary revascularization ablation of atrial fibrillation/flutter, valve repair/replacement, implantation of a cardiac resynchronization therapy device within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization.
* Stroke or transient ischemic attack within 12 weeks prior to enrolment.
* Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD.
* Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
* HF due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular disease
Efficacy and Safety of Long Term Use of hCG or hCG Plus hMG in Males With Isolated Hypogonadotropic Hypogonadism (IHH)

This study will evaluate the efficacy and safety of long term use of hCG alone or hCG plus hMG in the treatment of male patients with isolated hypogonadotropic hypogonadism (IHH). One third of the participants will receive hCG treatment alone and the other third of the participants will receive hCG treatment alone for six months, then the hMG will be added. And the last third of the participants will receive hCG and hMG treatment since the beginning of the treatment.

The efficacy of hCG alone or hCG plus hMG in the treatment of male IHH patients was reported in some studies. However, these studies were mostly non-randomized controlled studies with small size of samples and short follow-up time. There was also no reported study which aimed to compare the efficacy and safety of long term use of hCG or hCG plus hMG in the treatment of male patients with IHH. So the difference in the efficacy and safety between long term use of hCG alone and hCG plus hMG in the treatment of IHH is unknown. In different reported studies, the hCG plus hMG treatment had two regimens: using hCG alone for six month, then hMG was added and using hCG plus hMG since the beginning of the treatment. The difference in the efficacy and safety between the above two regimes is also unknown.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18, ≤ 45 years old;
2. Adolescent dysplasia or loss of puberty: Genital Tanner score ﹤ 5, pubic hair Tanner score ﹤ 5;
3. Serum FSH and LH levels are low or in normal low value, testosterone was lower than normal range (1.75ng / ml, the lower limit of the normal blood testosterone reference range of Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology);
4. With or without olfactory loss/reduction;
5. Other pituitary hormone levels are normal;
6. Head MRI examination is normal;
7. Fertility is desired currently or will be desired in the future;
8. Understand and sign the informed consent form.

Exclusion Criteria:

1. Primary hypogonadism;
2. Acquired hypogonadotrophic hypogonadism;
3. A history of treatment with pulsed GnRH, hCG and FSH related hormones;
4. Receive testosterone replacement therapy for more than 6 months;
5. History of cryptorchidism or cryptorchidism;
6. The sperm density before treatment ≥1×10\^6/ml;
7. Moderate or severe liver and kidney dysfunction (ALT\>120IU/L, AST\>80IU/L, CR\>115μmol/L);
8. The karyotype is 45,X or 47,XXY and 48, XXXY and other abnormal karyotypes;
9. True hermaphroditism and pseudohermaphroditism;
10. Sex hormone abnormalities caused by adrenal lesions;
11. Hypogonadism secondary to other systemic diseases;
12. Abnormal secretion of hormones caused by brain lesions (such as pituitary tumors);
13. There are other hormone abnormalities in the pituitary;
14. There are contraindications for the treatment with hCG or hMG.
Study Evaluating Bazedoxifene Dose-Response in Japanese Patients With Postmenopausal Osteoporosis.

Dose-response in Japanese patients with postmenopausal osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Must be postmenopausal and diagnosed as osteoporosis based on bone mineral density and/or vertebral fracture.

Exclusion Criteria:

* Diseases which possibly induce secondary osteoporosis or osteopenia and affect on bone metabolism.
Examining the Feasibility of Wysa in Hindi

The principal objective of this study is to investigate the feasibility of including a digital mental health intervention (Wysa in Hindi) within pre-existing usual care to support adolescents and young adults with Type 1 Diabetes (T1D) who have mild and above mental health distress (operationalized as Patient Health Questionnaire-9: 5-14 scores; or Diabetes Distress Scale-17: \>2.0 mean score) with their mental health distress. This will be conducted through an exploratory randomized control study comparing Wysa in Hindi plus usual care with a control arm that just has usual care. The study further explores the effectiveness of the digital mental health intervention using the Patient Health Questionnaire (PHQ-9) and Diabetes Distress Scale (DDS-17).

Participants (13-25 years) with Type1 Diabetes are invited into the study. The intervention being studied is the Wysa in Hindi app. Participants will be recruited from Udaan (a Non-Governmental Organization (NGO) supporting individuals with Type1 diabetes). They will complete baseline research procedures and be randomly allocated to one of two groups.

Participants in the intervention arm will get access to the Wysa in Hindi app as well as access to usual care (individual and group sessions on motivation, mental health, and coping). The control arm will only have access to the usual care i.e. the individual and group sessions. At the end of 2 months, participants will be invited for follow-up to complete the endline assessments.

Eligibility Criteria:
Inclusion Criteria:

* Age between 13-25 years
* Diagnosis of Type1 diabetes
* Access to a smartphone with internet connection
* Can read and understand Hindi
* Mental health distress as demonstrated by elevated scores on any of the scales: Mild -moderate symptoms (between 5-14 score) on Patient Health Questionnaire (PHQ-9), moderate and above diabetes distress (mean score 2.0 and higher) on the Diabetes Distress Scale (DDS-17)

Exclusion Criteria:

* Do not own or have access to a mobile device
* Are identified to have risk of harm/ suicidality (as identified on PHQ-9)
* Are currently undergoing or have received psychiatric support
* Experience any mental or physical impairments that create accessibility barriers to the use of a smartphone or access to a digital mental health intervention
Mindfulness Based Stress Reduction App

African American caregivers of people living with HIV/AIDS (PLWHA) have unique needs because they are more likely to experience stressors related to intersecting sources of stigma, discrimination, and caregiving burdens specifically associated with caregiving for PLWHA. The proposed project will enhance and finalize Phase I app development and evaluate its effectiveness in a randomized controlled trial. The project has high public health significance because of its potential to provide an accessible, easy to use mindfulness-based support tool for African American caregivers that could reduce stress, mitigate the harm of intersecting stigmas, and strengthen the caregiver-care recipient relationship.

Building upon prior research regarding mindfulness-based stress reduction interventions, during Phase I, we successfully developed a prototype mobile application (app) for caregivers entitled Mindfulness Based Stress Reduction for African American Caregivers (MBSR-AAC). Based on the Health Stigma and Discrimination Framework, components of the app focus on decreasing stress associated with intersecting sources of stigma, discrimination, and caregiving burdens specifically associated with caregiving for people living with HIV/AIDS (PLWHA). In the present Phase II SBIR study, we will build on Phase I findings to incorporate research-driven enhancements to the app, conduct a feasibility trial of the enhanced app, and conduct a randomized clinical trial to examine the effectiveness of the app in reducing caregiver stress. If proven to be effective, the MBSR-AAC app could have a positive impact on the well-being of African American caregivers that serve as a critical pillar of support for many PLWHA.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* African American
* Currently a main unpaid caregiver (defined as providing emotional, physical, and financial support) to a person living with HIV/AIDS.

Exclusion Criteria:

• Inability to provide informed consent (e.g., compromised comprehension).
The Boston Pace Study

Right ventricular (RV) pacing can cause left ventricular systolic dysfunction in 10- 20% of patients. Biventricular pacing had previously been shown to prevent left ventricular systolic dysfunction. However, implantation of coronary sinus lead increases procedural risk and can be limited by higher threshold and phrenic nerve capture. HIS pacing has been evaluated as an alternative pacing strategy, but its routine use was limited by difficulty of the procedure, success rate and high pacing threshold.

Left bundle branch area pacing (LBBAP) is a promising physiologic pacing technique that has been proposed as a pacing strategy to prevent pacing induced cardiomyopathy and for treatment of desynchrony in heart failure. LBBAP has been adopted widely and performed routinely on patients with AV block. Currently, it is up to the discretion of the proceduralist whether LBBAP is performed given that there is lack of evidence to guide pacing strategies.

This pilot trial is a feasibility study that will assess for efficacy, safety and success rate of left bundle branch area pacing. The study will also examine the recruitment rate at 2 major tertiary hospitals.

The study will examine if the use of LBBAP can prevent the occurrence of pacing induced cardiomyopathy (PICM) compared to RV pacing among patients with normal left ventricular function and high-grade AV block.

The investigators hypothesize that the rate of pacing induced cardiomyopathy is lower with LBBAP compared to RV pacing in patients with normal left ventricular function requiring high burden of RV pacing.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18
2. Patients with complete AV block, high-grade AV block with an anticipated ventricular pacing rate of more than 40%
3. Left ventricular ejection fraction of 50% or more.
4. Echocardiogram within the last 3 months

Exclusion Criteria:

1. History of systolic dysfunction with LV EF of less than 50%
2. Prior myocardial infarction
3. Obstructive coronary artery disease
4. Severe valvular dysfunction
5. Life expectancy of less than a year
6. Pregnancy
Rehabilitation of Single Aesthetic Areas Using Narrow Diameter Implants

The scientific literature does not provide scientific evidence on how to manage patients suffering from monoedentulism with ridges having a reduced bone thickness or a reduced mesio-distal space. Narrow diameter implants could be a solution to rehabilitate patients suffering from these clinical conditions while avoiding longer, more complex and sometimes even multidisciplinary therapies. However, there is a lack of clinical studies analyzing the outcomes of rehabilitation with narrow diameter implants.

Dental implants are considered a predictable rehabilitation option in the event of tooth extraction or missing tooth. In some cases, the inevitable resorption of the alveolar ridge after tooth extraction can make the insertion of dental implants difficult or even impossible without the use of more advanced bone regeneration procedures. Narrow diameter implants represent an alternative treatment option in areas with limited ridge width. Narrow alveolar ridges and limited interdental or inter-implant spaces continue to pose a challenge to the clinician. In the case of a narrow ridge, two options are available: the first option is to insert a standard diameter implant following bone augmentation procedures; the second option is to use an implant with a narrow diameter. Regarding the mesio-distal gap, an adequate distance between teeth and implants is necessary to reduce subsequent bone resorption and recession of the papillae. Difficult clinical situations with limited mesio-distal space or reduced ridge width can be overcome by using narrow diameter implants. Correct three-dimensional implant positioning is the key factor to obtain, in addition to good integration, favorable prosthetic results and a good long-term aesthetic result. To optimize the insertion of the implants, reducing the intrinsic imprecision of the conventional free-hand technique, computer-guided static surgery protocols can be used to plan the angulation, position and depth of the implant with a digital software. Narrow diameter implants therefore have their own indication for the replacement of lateral incisors of the maxilla and for the incisors of the mandible.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone implant surgery to perform implant rehabilitation of single edentulism in the anterior region to insert a reduced diameter implant;

  * ASA I and ASA II patients;
  * Age \> 18yr;
  * Non-smokers or smokers ≤ 5 cig/day;
  * Achievement of FMPS and FMBS ≤ 15%;
  * Signing of the written informed consent to participate in the study.

Exclusion Criteria:

* Severe general medical pathologies;

  * Immunodeficiency states;
  * Radiotherapy in the head and neck region;
  * Uncontrolled diabetes or hypertension;
  * Smokers \>5 cigs/day;
  * Impossibility to carry out homogeneous and continuous follow-up;
  * Documented allergy to the biomaterials used;
  * Pregnancy or breastfeeding;
  * Inability to provide written informed consent.
PERFORM = Pentaglobin® Registry For Outcome Report and Monitoring

International registry on the use of Pentaglobin® in patients with severe bacterial infections; multicentric, international registry, non-interventional trial

Aim of the Pentaglobin® registry of adult critically ill patients with severe infections is primarily to assess the effects of IVIgAM on the aforementioned outcome parameters and its side effects under real-life conditions based on a prospective, high-quality data documentation

* Age ≥ 18 years
* Diagnosis of severe bacterial infection
* Pentaglobin® use
* signed informed consent for data collection

Exclusion criteria None

Primary endpoints

* Comparison APACHE II and SAPS II predicted mortality vs. observed hospital mortality and
* Difference in SOFA scores, baseline vs. posttreatment (24 h after last application) assessment

Secondary endpoints

* In-hospital mortality total and in subgroups according to baseline IgM serum levels (\< 80 mg/dL vs. ≥ 80 mg/dL) and baseline CRP (\< 70 mg/L vs. ≥ 70 mg/L)
* Change in MOF score from the day before treatment start till 24 h after last application of Pentaglobin
* Course of laboratory markers (concentration-difference): CRP, procalcitonin, IL-6, IgM, IgA, IgG before treatment start till 24 h after last application as far as available in the centers
* Duration of ICU stay (days)
* Duration of hospital stay (days)
* Time from onset of severe bacterial infection to start of treatment

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years

* Diagnosis of severe bacterial infection
* Pentaglobin® use
* signed informed consent for data collection -

Exclusion Criteria:

-
Effects Of Vitamin D On Bone, Muscle, And Adipose Tissue In Obese Subjects

Obesity has emerged as a risk factor in the onset of bone, muscle and adipose tissue impairments that are further aggravated by vitamin D deficiency. A link of an active bone-muscle-adipose axis is represented by Wnt pathway. This study will test the hypothesis that vitamin D improves bone, muscle, and adipose tissue health through a positive modulation of Wnt pathway. It will be carried out a double-blind, placebo-controlled study of cholecalciferol supplementation in vitamin D-deficient obese adults. Specific aims will be: 1) to test the direct effect of vitamin D on Wnt signaling in bone, muscle, and adipose tissue; 2) to evaluate muscle mass and strength; 3) to assess changes in vitamin D status across different administration strategy (weekly, fortnightly, monthly).

This study will provide not only insight of new mechanisms involved in the pathophysiology of obesity-related musculoskeletal impairments but also evidence for new treatment recommendations for vitamin D deficiency in obesity.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory willing and able to provide informed consent;
* post-menopausal women (55-75 y.o.) and age-matched men;
* BMI 30 \>= kg/m2;
* serum 25OHD \< 20 ng/ml
* hip replacement surgery due to osteoarthritis according to orthopedic clinical decision

Exclusion Criteria:

* eGFR \<40 ml/min/1.72 m2 by EPI formula (21);
* hypercalcemia (\>10.5 mg/dL);
* osteoporosis (hip or vertebral t-score \>-2.5);
* conditions affecting bone
* vitamin D and/or calcium metabolism (chronic liver disease, renal failure, malabsorption, hypercortisolism);
* medications altering bone metabolism (e.g. denosumab, bisphosphonates, teriparatide, glucocorticoids, aromatase inhibitors, estrogen);
* enrollment in an interventional clinical trial in the previous 3 months.