cyrilzakka/clinical-trials huggingface dataset:
Efficacy of a Physical Rehabilitation Program Using Virtual Reality in Patients With Chronic Tendinopathy (Virtendon-Rehab)

Chronic tendinopathies (CT) have a high prevalence (30% of musculoskeletal injuries), causing pain, decreased physical activity and functionality, as well as limitations in daily life. Virtual reality (VR) fosters patient recovery through playful activities that promote competitiveness, stimulates motivation and continuous attention, allows individualizing the exercise program, objectively assessing the execution of the treatment and monitoring the patient's evolution. Therefore, the VIRTENDON-REHAB project aims to conduct a low-risk randomized controlled clinical trial to analyze the efficacy of a VR-based physical rehabilitation program in a population diagnosed with CT on pain, functionality, range of motion, strength, muscle activation pattern, kinesiophobia, quality of life, adherence to treatment and patient satisfaction with the use of the system, compared to a control group. Likewise, the aim is to characterize the clinical profile of this population and to know the relationships between the previous variables. Measurements will be taken at the beginning of the intervention, at the end (12 weeks) and 3 months after the end of the intervention. A descriptive analysis will be performed, inter- and intra-group differences will be analyzed by means of t-Student, Wilcoxon, Mann-Whitney U and mixed ANOVA tests. Cohen's d will be used to determine the effect size. Relationships between variables will be analyzed using structural equations. The results obtained will allow improving knowledge on the management of CT using VR, as well as improving clinical care and reducing healthcare costs.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of tendinopathy (shoulder rotator cuff tendinopathy, epicondylitis/epicondylitis, patellar tendinopathy, achilles tendinopathy).
* Duration of symptoms: greater than 6 weeks.

Exclusion Criteria:

* People who have any pathology that prevents them from performing physical exercise.
* Persons who have undergone surgery.
* Persons who have an illness that may be a contraindication to the proposed procedure.
* Persons who have received exercise therapy in the last 3 months.
* Persons who have received corticosteroid injections in the last 3 months.
Thol'Impilo: Bringing People Into Care

The main objective of this study is to compare the effectiveness of combinations of three patient-oriented strategies, compared to the standard of care, to increase the proportion of patients who enter-into-care for HIV within 90 days of testing HIV positive.

Background:

Mortality remains high among individuals with HIV in South Africa largely due to low CD4 at initiation of combination antiretroviral therapy (cART) or failure to initiate cART altogether. The problem of advanced HIV at the time of entry-into-care persists despite increases in CD4 count initiation thresholds and higher CD4 counts among individuals testing HIV positive at HIV counselling and testing services (HCT). A reason for the discord between CD4 at HCT and CD4 at cART initiation is a failure to effectively link people who test positive into HIV care; less than half of individuals testing HIV positive enter HIV care within 3-6 month of HIV diagnosis. However, not only do these delays increase HIV associated mortality, delays from testing positive to entry-into-care for HIV also reduces the ability of test-and-treat strategies to reduce HIV transmission through HIV treatment.

Study Design:

Thol'impilo is an open (non-masked) individually-randomized implementation science evaluation of the effectiveness and cost-effectiveness of combinations of three strategies to increase timely entry-into-care for HIV compared to the standard of care. Participants are randomly assigned to one of four arms to increase timely entry into care: (1) standard of care, (2) point-of-care CD4 and transport assistance, (3) point-of-care CD4 and care facilitator and (4) point-of-care CD4 alone.

Sample size:

The study aims to enrol 2500 participants (i.e. 650 participants per arm).

Setting:

The study is built onto the current community-based HIV Counselling and Testing (HCT) services. The HCT units serve peri-urban townships and informal settlements, rural farm workers, and both urban and rural communities.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years and older, diagnosed HIV positive at enrolling mobile HCT units, no prior self-reported registration at a health care facility for HIV care, provide consent for participation

Exclusion Criteria:

* self-reported prior or current registration as an HIV patient at a healthcare facility
Increasing Stroke Treatment Through Interventional Change Tactics Study

The purpose of this study is to evaluate a standardized, system-based, barrier assessment and interactive educational intervention to increase appropriate t-PA use for stroke.

Stroke is a major public health problem. Only 1 to 3 percent of people with stroke patients in community settings are receiving tissue plasminogen activator (t-PA) therapy ten years after it was approved by the Food and Drug Administration (FDA). Data from academic stroke teams, stroke patient arrival times, and thrombolytic therapy (clot-dissolving) in myocardial infarction suggest substantially higher treatment rates are possible. The development and implementation of educational interventions to motivate physicians, other healthcare providers, and healthcare organizations, to learn the principles of acute stroke care is a high-priority.

Limited prior work found a combination of community and professional education increased thrombolytic therapy for stroke from a pre-intervention rate of 2.2 percent to a post-intervention rate of 11.3 percent, with the data suggesting the professional education was the critical element for increasing use.

The Increasing Stroke Treatment through Interventional behavioral Change Tactics (INSTINCT) trial is designed to evaluate a standardized, system-based barrier assessment and interactive educational intervention (BA-IEI) for increasing appropriate t-PA use in people with stroke. This multi-center, randomized, controlled study will be conducted at 24 hospital sites nationwide.

The intervention, BA-IEI, targets emergency departments and is based on adult education and behavior change theory. BA-IEI is designed for replication in community health initiatives. It incorporates local stroke champion development, hospital-specific barrier evaluation, mixed CME targeting identified barriers, performance feedback, protocol development, and academic detailing. The primary endpoint will be the increase in appropriate use of t-PA for stroke with evaluations of change in emergency physician knowledge on t-PA use.

The primary aims of this study are to determine if a BA-IEI is effective in increasing appropriate t-PA use in stroke, and if BA-IEI improves emergency physician knowledge, beliefs, and attitudes regarding the use of t-PA for acute stroke.

Results from this study may lead to an effective method for increasing the use of t-PA for stroke.

Eligibility Criteria:
Inclusion Criteria:

* Physician staffed emergency department at all times
* 24/7 CT scanning availability
* Computerized pharmacy dispensing system for the emergency department or thrombolytic use log
* Agreement to participate and identified site investigator

Exclusion Criteria:

* Primary children's, psychiatric, or long-term (convalescent) care hospital
* Established academic comprehensive stroke center (Detroit Receiving Hospital, Henry Ford Hospital, University of Michigan)
* Annual emergency department volume greater than 100,000 patients per year (only one hospital)
Study of the Link Between Psychosocial Treatments and the Need of Pharmacological Treatments in Children With Attention Deficit Hyperactivity Disorder

The Attention Deficit and Hyperactivity Disorder (ADHD) is a frequent disorder in children and adolescents. The diagnosis is clinical with the input of several informants (child, family, teachers, ...). ADHD is a risk factor for academic difficulties, school dropout, social isolation, injury, oppositional behaviour. In school-age children and adolescents having moderate to high or persistent impairment despite psycho-educational support and environmental modification, the first-line treatment is methylphenidate. Group or individual cognitive behavioural therapy for parents and/or children and adolescents is recommended for co-occurring disorders and persistent impairment. In France, the initiation of methylphenidate requires an annual hospital prescription by a paediatrician or psychiatrist, and a regular medical supervision (weight, heart rate, blood pressure, ...). At least once a year, the indication of methyphenidate needs to be re-evaluated and confirmed at the hospital. In case of lack of efficiency and/or poor tolerance, therapeutic alternatives including non-psychostimulants should be considered.

A randomized controlled trial evaluated the dose of methylphenidate received over a period of 13 months. It was observed that the "combined treatment" group (methylphenidate + psychosocial treatments) received a lower average dose of methylphenidate than the "methylphenidate alone" group. These results are difficult to extrapolate to the general population, due to the study protocol (regular monitoring of ADHD symptoms with the aim of total remission).

For a global consideration of children's needs, it is important to better understand the interactions between these two therapeutic approaches.

To participate in the study, parents will have to complete an online questionnaire. This questionnaire contains anamnestic data collection, questionnaires to assess ADHD symptoms and parenting practices.


Eligibility Criteria:
Inclusion criteria:

- Children 6-18 years of age, diagnosed with ADHD, treated with methylphenidate for at least 6 months. Parents' online response between may and june 2020.

Exclusion criteria:

- Exclusion of respondants not caring for the child , refusal to participate
The Role of Family Functioning in Promoting Adaptation in Siblings of Individuals With Duchenne Muscular Dystrophy (DMD)

Background:

We want to learn more about the relationship between the way families function and how children adapt to having a sibling with Duchenne muscular dystrophy (DMD). What we learn will help us design better interventions for families.

Objective:

* To learn more about how families with an individual with DMD function.
* To learn how siblings adapt in families with an individual with DMD.

Eligibility:

* One parent and one child, age 13-18, from a family where another child has DMD.
* The parent and the child must be able to read and write English.

Design:

* One parent from each family will complete a survey about how family members communicate and relate with each other. The parent will also answer questions about the behavior of the child without DMD. This survey will take you about 40 minutes to complete.
* One child from each family, either a boy or a girl, will also complete a survey. This survey asks about how he/she views him/herself. It also asks about how he/she interacts with peers and family members and how he/she behaves. The survey also asks how satisfied he/she is with how his/her family functions. This survey takes about 30 minutes to finish.

This study proposes to explore the role of family functioning in promoting adaptation in unaffected siblings of children with Duchenne muscular dystrophy (DMD). Although evidence suggests that family functioning may be a predictor of adaptation in caregivers of children with chronic illnesses, little research has been conducted on the relationships between aspects of family functioning and the adaptation of unaffected siblings. Evidence in the literature suggests that aspects of family functioning may play a key role in adaptation. Moreover, the role of DMD-specific communication in facilitating sibling adaptation has not yet been explored in the literature and further insight may be derived from exploring this relationship. The goals of this study are to better understand the relationship of family functioning with the adaptation of unaffected siblings, as well as to explore the timing, extent (depth and content), and the characteristics of initiation of discussion of parent-sibling communication around DMD. Currently, some evidence exists to direct the creation of interventions that reinforce a family-centered approach to facilitate adaptation of family members to living with a child with a chronic health condition. Nevertheless, more insight is needed to understand how family processes affect individual adaptation, especially that of the unaffected sibling, in order to maximize the effectiveness of future interventions with this population.

Eligibility Criteria:
* INCLUSION CRITERIA:

Parents/Caregivers:

* Parent or caregiver of child with DMD and child without DMD
* Lives with child that does not have DMD
* 18 or older
* Reads/Writes English

Siblings:

* Sibling of child with DMD
* Lives in same household as individual with DMD
* 13-18 years of age
* Reads/Writes English
Vitamin D Replacement in Statin-Induced Myopathy

Pretreating people with replacement doses of vitamin D will allow them to tolerate Statin medications that have caused muscle pain for them in the past.

Patients who have been unable to tolerate statin medications due to muscle pain will be randomly assigned to receive vitamin D or placebo for 6 weeks before reintroducing their statin medication. The investigators will judge whether vitamin D in the manner administered in the study reduces the myalgia with statins and allows patients to remain on these important medications.

Eligibility Criteria:
Inclusion Criteria:

* male and female adults
* identified by their physician as having myalgia with their statin medication.

Exclusion Criteria:

* Unexplained CK \> 4X upper limit of normal, at study entry, or on a statin medication in the past.
* Severe myositis
* Consumption in excess of 14 alcoholic beverages per week
* Situations which will cause difficulty in interpreting the vitamin D and / or PTH.

examples:

* Present consumption of vitamin D supplements \> 1000 iu daily
* Renal impairment (Estimated creatinine clearance \< 70 ± 14 mL/min/m2 in Males; and \< 60 ± 10 mL/min/m2 in Females)
* Chronic liver disease or impaired liver function
* Any contraindication for statin re-challenge Example: rhabdomyolysis or allergy to statins
Cross-linked CMC and Silk Proteins in Corneal Re-epithelization

Data analyses and revision of the corneal re-epithelization in patients who underwent either PRK (Photorefractive Keratectomy), CXL (Corneal Cross-Linking), PTK (phototherapeutic keratectomy), or experienced a corneal abrasion. A novel ophthalmic solution containing cross-linked CMC (CX-CMC) and Silk Proteins (SP) has been made available on the market. Both molecules have been widely studied for their wound healing properties in the ophtalmic field. This new ophthalmic solution is the first on the market formulated with a CX-CMC and SP.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had undergone surgical procedures involving de-epithelialization, which included CXL, PRK, and PTK, as well as those with a first diagnosis of corneal abrasion

Exclusion Criteria:

* patients with known allergies or hypersensitivity to any components of the tested formulations or standard therapies, or those requiring different treatments compared to the rest of the study population
Effects of Continuous Airway Pressure on the Ability to Heat and Humidify Air

We hypothesize that continuous positive pressure applied to the airway will decrease the ability of the nose to warm and humidify inspired air compared to zero or negative pressure.

We will use continuous positive airway pressure (CPAP), a device commonly used to treat patients with sleep apnea, to vary the pressure in the airway and determine if increased pressure decreases the ability to warm and humidify inspired air. If our hypothesis is correct, it may explain the reason why CPAP is poorly tolerated in patients with sleep apnea; i.e., less ability to warm and humidify air leading to more nasal mucosal irritation.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females between 18 and 55 years of age.
2. A clinical history suggestive of normal nose and upper airway, other than during a cold.
3. Willingness of the subject to participate in and complete the study, and the ability to understand the purpose of the trial.

Exclusion Criteria:

1. Physical sign or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Women of childbearing potential who are pregnant, trying to become pregnant or nursing a child.
3. Subjects treated with systemic steroids during the previous 30 days.
4. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 15 days.
5. Subjects treated with oral antihistamine/decongestants during the previous seven days.
6. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.
7. Subjects treated with immunotherapy.
8. Subjects on chronic anti-asthma medications.
9. Subjects with polyps in the nose or a significantly displaced septum.
10. Subjects who have incurred an upper respiratory tract infection within 14 days of the start of the study.
Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction

This study intends to determine if any correlation exists between administration of TXA or not to musculoskeletal oncology patients undergoing endoprosthetic reconstruction and blood loss and blood transfusion rates.

Resection of bony and soft tissue tumors with endoprosthetic reconstruction often presents a significant risk of perioperative blood loss requiring transfusion. Tranexamic acid (TXA) is an antifibrinolytic that is commonly used to reduce blood loss in orthopedic procedures, most often arthroplasty. The aim of this study is to determine in a randomized controlled fashion if there is any difference in perioperative blood loss and blood transfusion rates when TXA is used compared to when it is not used in patients undergoing radical resection of bone and soft tissue sarcomas with endoprosthetic reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing wide resection of a malignant bony tumor of the lower extremity with endoprosthetic reconstruction.
* Patients undergoing a resection of soft tissue sarcoma measuring \> 5cm.

Exclusion Criteria:

* Patients undergoing revision endoprosthetic reconstruction
* Patients with known coagulopathy
* Known history of DVT or embolic disease
* Benign tumors
* Patients with allergy to TXA
* Those refusing blood products
* Those concurrently on anti-coagulant therapy
* Pregnant and/or nursing women
* Vulnerable populations as defined by the KUMC IRB
Effect of Photobiomodulation in Patients With Temporomandibular Dysfunction Refractory to Botulinum Toxin Treatment.

The objective of this preliminary research was to identify the effect of low-level laser photobiomodulation therapy (LLLT-PBMT) in patients with myofascial temporomandibular disorders (TMDs), refractory to botulinum toxin (BTX) treatment.

Specifically, the hypothesis of LLLT-PBMT as a safe, low-cost, painless, and minimally invasive alternative therapy was proposed to improve complete muscle recovery and significantly reduce muscle paralysis in patients with masticatory muscle disorders previously treated with BTX. Additionally, different treatment alternatives were investigated, and a protocol was suggested for the application of LLLT-PBMT in myofascial TMDs and the pain associated with masticatory muscles, also analyzing its complications and negative effects


Eligibility Criteria:
Inclusion Criteria:

* Female patients diagnosed with TMDs. Presence of unilateral or bilateral painful symptoms. Associated conditions: Bruxism, hypertrophy of the masticatory muscles, headaches
* Previous treatment with BTX:

Minimum of 3 doses (100 IU) Applied in masticatory muscles and intracapsular area No favorable results obtained

Exclusion Criteria:

* Patients without prior treatment of this type.
* Patients receiving treatment in the Pain Unit.
* Patients undergoing invasive treatments: Open surgery in the cervicofacial region or TMJ arthrocentesis.
Taxane Induced Peripheral Neuropathy in Chinese Patients With Breast Cancer

The purpose of this study is to collect clinical data, blood samples, and self reported symptoms of peripheral neuropathy from Chinese patients with breast cancer after treatment with taxanes. This data will be used to develop predictive markers for neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast cancer
* Females aged 16 and older
* Planning to receive or previous treated with taxanes

Exclusion Criteria:

* Poorly controlled or insulin-dependent diabetes or other condition likely to predispose to neurotoxicity
Transcranial Doppler, Optic Nerve Envelope Diameter and Quantitative Pupillometry Measurements

Non-invasive neuromonitoring tools such as transcranial doppler, optic nerve envelope diameter measurement and quantitative pupillometry are routinely used in acute brain injured patients as part of multimodal neuromonitoring with the aim, among others, of detecting episodes of intracranial hypertension, each method allowing the study of one of the different pathophysiological mechanisms of its impact.

However, at present there is no data in the literature on the value of these non-invasive neuromonitoring tools in the management of patients undergoing controlled intracranial surgery.

The study aims to help the early detection of postoperative neurological deterioration.


Eligibility Criteria:
Inclusion Criteria:

* Regulated intracranial surgery: scheduled \> 48 hours
* French-speaking patient
* No opposition from the patient or a relative when the patient is unable to consent

Exclusion Criteria:

* Chronic subdural haematoma
* Isolated cerebral endovascular procedure
* Stereotactic biopsy
* Scheduled ventriculoperitoneal shunt or isolated ventriculocisternostomy
* Specific non-inclusion criteria for quantitative pupillometry: known pupillary abnormalities, glaucoma, cataract surgery and any ocular surgery.
Near Infrared Fluorescence Imaging for Bladder Cancer Detection

The primary outcome of this study is to determine the minimal dwell time needed for adequate detection of hexaminolevinulate HCL avid tumors using protoporphyrin IX (PpIX) near infrared fluorescence (NIRF).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bladder mass on office cystoscopy suspicious for malignancy, either newly diagnosed or a recurrent tumor.
* Planned transurethral resection of bladder tumor in the operating room.
* Ability to give informed consent.
* Willing to spend time for the study
* Men or women (age 18 or older)
* Any racial or ethnic origin

Exclusion Criteria:

* Pregnancy
* Nursing mother
* Diagnosis of porphyria
* Gross hematuria
* BCG immunotherapy or intravesical chemotherapy within the past 90 days
* Known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid