cyrilzakka/clinical-trials huggingface dataset:
Caregiver Study Dr. Phillips

This study will examine whether a performing arts class will improve the well-being of primary unpaid caregivers of people with dementia

This study used sample size analysis to determine the adequately sized intervention group and control group, well-defined statistical methodology, and a well-documented intervention that can be easily replicated. The intervention has been developed by Dr. Phillips Center for the Performing Arts leadership with assistance from AMS Planning \& Research.

Eligibility Criteria:
Inclusion Criteria:

* Primary, unpaid caregiver of person with dementia OR
* Person with Dementia.
* Live independently in the community.
* Care recipient has a Functional Assessment Staging Test (FAST) Score of 4-6b.
* Caregiver does not display symptoms of emotional, cognitive, or mental impairment.
* Caregiver must be able to produce adequate saliva sample.
* Caregiver/care recipient can travel to program.
* Caregiver/care recipient agree to participate in all aspects of study intervention and assessments.
* Caregiver is 18 years of age or older.
* Care recipient is 65 years of age or older
* Access to home phone or mobile phone

Exclusion Criteria:

* Unable to understand either spoken and/or written English.
* Caregiver is a paid employee of care recipient's legally appointed representative
Electrical Stimulation on Erbs Palsy Infants

This study examined the effect of reciprocal electrical stimulation (RES) across elbow flexors and extensors on the reaction of degeneration percentage and motor function in Erbs palsy infants.

Forty infants with Erb's palsy aged between 2-5 months were randomly allocated to one of two equal groups: the control group (A) received standard physical therapy, the study group (B) received traditional physical therapy plus a 15-minute RES through elbow flexors and extensors. For three months, interventions were carried out three times each week. The percentage of degeneration and motor function reaction were assessed pre-and post-treatment using electromyography and Toronto active motion scale, respectively.

This study examined the effect of reciprocal electrical stimulation (RES) across elbow flexors and extensors on the reaction of degeneration percentage and motor function in Erbs palsy infants.

Forty infants with Erb's palsy aged between 2-5 months were randomly allocated to one of two equal groups: the control group (A) received standard physical therapy, the study group (B) received traditional physical therapy plus a 15-minute RES through elbow flexors and extensors. For three months, interventions were carried out three times each week. The percentage of reaction of degeneration and motor function were assessed pre-and post-treatment using electromyography and the Toronto active motion scale respectively.

Eligibility Criteria:
Inclusion Criteria:

* Infants with OBPI limited to nerve roots C5, C6, with/without involvement of C7, partial lesion as determined by electrophysiological examinations, age between two to five months, and willingness of the infant's family to take part in the study.

Exclusion Criteria:

* Infants with clavicular or humeral fractures, complete transection of nerve roots, other neurological co-morbidities such cerebral palsy, congenital musculoskeletal deformities, or recommendation against electrical stimulation by the attending neuro-pediatrician.
Mindfulness Training for Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and Mindful Parenting

This study evaluates the effectiveness of an 8-week mindfulness group training for children (8-16 years old) with ADHD in combination with a parallel mindful parenting training for their parents. Half of the participants will be randomly assigned to the mindfulness training in addition to care-as-usual (CAU); the other half to CAU-only.

The hypothesis is that compared to care-as-usual only, the addition of the mindfulness training will improve self-control of youth with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Child has a clinical diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders; DSM-IV or DSM-5 system, and confirmed by a structured interview (The Schedule for Affective Disorders and Schizophrenia for school-Age Children (K-SADS)).
* Child receives CAU and has remaining ADHD-symptoms (average score \> 1.0 on the investigator-rated DSM-5 items from the Conners' ADHD rating scale).
* Child is between 8 and 16 years old.
* At least one parent is willing to participate.
* ADHD medication dose is stable, or there is an informed decision on not taking ADHD medication.
* Psychiatric comorbidities are allowed except psychosis, bipolar illness, active suicidality, untreated posttraumatic stress disorder or substance use, provided ADHD is the primary diagnosis in the child; similarly, psychopathology in the parents is allowed except psychosis, bipolar disorder, active suicidality, untreated posttraumatic stress disorder or substance use.
* Child and parent have an estimated intelligence quotient (IQ) ≥ 80.
* Child and parent have adequate mastery of Dutch language.

Exclusion Criteria:

* Child or the participating parent(s) have participated in a mindfulness programme in the past year or ever in a Mindful Parenting training.
* Child or parent is participating in another intervention study.
Flutiform® Compared With Seretide® in the Treatment of COPD

The purpose of this study is to investigate whether flutiform® is effective and safe in the treatment of chronic obstructive pulmonary disease (COPD).

A multi-centre, randomised, double-blind, double dummy, active-controlled, parallel-group study in male and female subjects conducted to assess the efficacy and safety of flutiform in the treatment of COPD. Subjects will be randomised to one of three treatment groups in a 1:1:1 ratio. Throughout the study subjects will be assessed on a mixture of symptom based and lung function measurements to monitor their progress in the study.

Eligibility Criteria:
Inclusion:

1. Male or Female subjects aged ≥ 40 years at screening visit.
2. Diagnosis of COPD
3. Willing and able to replace current COPD therapy with study medication.
4. Able to demonstrate correct use of a pMDI with or without a spacer and Accuhaler.
5. Willing and able to attend all study visits and complete study assessments.
6. Able to provide signed informed consent.

Exclusion:

1. Ongoing moderate or severe exacerbation of COPD in the 2 weeks before screening.
2. Current diagnosis of asthma.
3. Documented evidence of α1-antitrypsin deficiency as the underlying cause of COPD.
4. Other active respiratory disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, cystic fibrosis, bronchiolitis obliterans.
5. Previous lung resection.
6. Use of long-term oxygen therapy (LTOT) or mechanical ventilation. Note: LTOT is defined as \>15 hours use per day
7. Chest X-ray or CT scan that reveals evidence of clinically significant abnormalities not believed to be due to COPD.
8. Evidence of uncontrolled cardiovascular disease.
9. Evidence of clinically significant renal, hepatic, gastrointestinal, or psychiatric disease.
10. Current malignancy or a previous history of cancer which has been in remission for \< 5 years (basal cell or squamous cell carcinoma of the skin which has been resected is not excluded).
11. Clinically significant sleep apnoea requiring use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
12. Participation in the acute phase of a pulmonary rehabilitation programme within 4 weeks prior to screening or during the study.
13. Known or suspected history of drug or alcohol abuse in the last 2 years.
14. Requiring treatment with any of the prohibited concomitant medications.
15. Known or suspected hypersensitivity to study drug or excipients.
16. Received an investigational drug within 30 days of the screening visit (12 weeks if an oral or injectable steroid).
Amphetamine Induced Adult Respiratory Distress Syndrome

Methamphetamine and amphetamine has various cardiovascular and central nervous system effects. Long-term use is associated with many adverse health effects including cardiomyopathy, hemorrhagic, and ischemic stroke. Death is usually caused by cardiovascular collapse and while amphetamine abuse has been considered as a potential cause of acute respiratory distress syndrome, the reports are usually anecdotal. This investigation considers reviewing individuals with few to zero medical conditions who develop acute respiratory distress syndrome and are methamphetamine positive

Methamphetamine and amphetamine has various cardiovascular and central nervous system effects. Initially prescribed in the 1930s for respiratory ailments such as asthma, current clinical indications of amphetamine range from treatment of attention deficit hyperactivity disorder to narcolepsy. The mechanism of action is primarily potentiation of release of monoamine neurotransmitters, mainly dopamine and norepinephrine, from presynaptic nerve endings into the synaptic space, in addition to attenuation of monoamine metabolism by inhibiting monoamine oxidase. This in turn leads to an increase in sympathetic tone by alpha and beta adrenergic receptor activation, resulting in elevations in heart rate, respiratory rate, and vascular tone. Long-term use is associated with many adverse health effects including cardiomyopathy, hemorrhagic and ischemic stroke. Other long-term associations include increased violent behavior, documented increased motor vehicle accidents, and clandestine manufacturing of the drug.

Methamphetamine has also been associated with deleterious effects on society as a whole; it is credited as a cause of increase in rates of crime, abuse, and unemployment, and associated with great economic burden. A significant portion of healthcare resources consumed are rooted in the emergency department, particularly in trauma. Studies previously performed have demonstrated that methamphetamine use among patients that present to trauma centers has been continually increasing. Death is usually caused by cardiovascular collapse and while amphetamine abuse has been considered as a potential cause of acute respiratory distress syndrome, the reports are usually anecdotal. This investigation considers reviewing individuals with few to zero medical conditions who develop acute respiratory distress syndrome and are methamphetamine positive

Eligibility Criteria:
Inclusion Criteria:

* Total body surface area burns between 20% and 60% admitted to the burn unit

Exclusion Criteria:

* Under 18 years of age
* Burns outside of the inclusion ratio
Intermittent Fasting Following Acute Ischemic Stroke

Despite numerous kinds of evidence on functional health and CNS protection of intermittent fasting after injuries were found in many brain-, and spinal cord-damaged animal models, there has yet to be any clinical study of intermittent fasting after acute ischemic cerebral infarction. The aim of this study is to evaluate the neurological, functional and clinical efficacy of intermittent fasting in patients after acute ischemic stroke.

In order to verify the validity and clinical efficacy of intermittent fasting for neurological and functional effects of ischemic cerebral infarction, the first ischemic stroke (diagnosed within 1 year through brain MRI / CT) patients will be randomly assigned to intermittent fasting group or control group. In both groups, physical therapy, occupational therapy and speech therapy will be provided during 3 hours in total a day. The intermittent fasting group should maintain intermittent fasting for no less than 12 hours or more every day during the rehabilitation period (at least 1 week), and the control group is able to eat all of the hospital meals and all the participants want without any time limit. The efficacy of intermittent fasting is to be verified by performing the electro-physiological tests and functional evaluations before participation, 1st week, 2nd weeks after participation, before discharge, 3 months, and 6 months after the stroke onset.

Eligibility Criteria:
Inclusion Criteria:

* Patients who was diagnosed first ischemic stroke within preceeding 1 year through brain MRI/CT

Exclusion Criteria:

* Musculo-skeletal disease with limbs malformation or joint contracture
* Weigh more than 135 kg or taller than 195 cm
* Diabetes mellitus
* unstable patient in neurology
* Refusal of participation
A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1

The primary purpose of this study is to assess the antiviral activity of VH3739937 in Human Immunodeficiency Virus Type-1 (HIV-1) infected treatment naive (TN) participants during monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy (other than HIV infection) as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
* Positive HIV antibody test
* Treatment-naïve: No Antiretrovirals (ARVs) (in combination or monotherapy) received after the diagnosis of HIV-1 infection
* Body weight ≥50.0 kilogram (kg) (110 pounds \[lbs\]) for men and ≥45.0 kg (99 lbs) for women and BMI for all participants within the range 18.5-35.0 kilogram per meter square (kg/m\^2).
* Capable of giving signed informed consent
* Participant must be willing and able to start Combination Antiretrovial Therapy (cART) as selected with the Investigator on Study Day 8 (except in the case of early termination, clinically relevant AE/SAE, lab abnormality, the withdrawal of consent, lost to follow-up, etc., where circumstances could dictate otherwise).

Exclusion Criteria:

* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* Participants with primary HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion
* Myocardial infarction, acute coronary syndrome, unstable angina, stroke, transient ischemic attack, or intermittent claudication in the past 3 months
* The participant has received an investigational HIV vaccine (immunotherapeutic or immunomodulatory)
* Regular use of drugs of abuse
* Sensitivity to heparin or heparin-induced thrombocytopenia
The Value of Memory B Cells Marker (CD27) and Howell Jelly Bodies Detrection in Critically Ill Patients

A total of ninety - five patients (54men and 41women) were included in the study. Fifty-eight patients developed septic complication during ICU stay (sepsis group). Forty seven patients were critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis were measured. Routine cultures were obtained. The attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. Memory B cells and Heinz bodies were monitored.

The patients staying in ICU for more than 24 hours were enrolled in the study. Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure; patients received massive blood transfusion; patients with radiation therapy and patients with previous organ transplantation were excluded from the study. At admission, patient's age, sex, weight and height were recorded. Patients data that include the clinical status; sequential organ failure assessment (SOFA) score; temperature; heart rate; respiratory rate; blood pressure; central venous pressure; laboratory analysis (complete blood count, blood urea nitrogen, blood sugar, serum sodium, potassium, calcium, aspartate aminotransferase, alanine aminotransferase, prothrombin time, albumin and CRP) and arterial blood gas analysis were measured. Routine cultures of suspected sites, blood and urine were obtained to determine the presence of infection. We attempted to maintain the patient hemoglobin level at 10-12g/dl and central venous pressure at 8-12 cmH2o. When needed, intravascular fluid replacement, blood products and inotropic or vasopressor agents were administered. Each day the attending physician evaluated all the study patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients with manifestation of sepsis or SIRS

Exclusion Criteria:

* Patients received anti-inflammatory drugs or corticosteroids before admission, who had immunosuppressive illness, who had chronic organ failure; who had received massive blood transfusion; those with radiation therapy, previous organ transplantation were excluded from the study.
CircaHealth Development and Evaluation

This study evaluates the feasibility, acceptability, and efficacy of an online education course about circadian rhythms and health. Half of participants will be enrolled into the online course and the other half will receive materials on sleep hygiene as a control.

This is a pilot randomized controlled study that aims to develop CircaHealth: an online course on practices, known as circadian hygiene, that promote circadian rhythm alignment and minimize circadian rhythm misalignment. The project also will determine the feasibility, acceptability, and preliminary effects of CircaHealth in improving circadian rhythm related measures in University of Miami Miller School of Medicine medical students.

The educational videos will be incorporated into a six-module online course which contains additional educational and behavior modification tools. Medical students (n = 40) will be recruited via email and randomized to receive CircaHealth or materials from the National Sleep Foundation and/or the American Academy of Sleep Medicine. Sleep, mood, and circadian hygiene knowledge, behaviors, and attitudes will be assessed at baseline and four weeks post intervention. Feasibility will be determined by CircaHealth module completion rates, and acceptability will be assessed via a self-report survey. Changes in sleep quality measures between groups will determine the preliminary efficacy of CircaHealth.

Eligibility Criteria:
Inclusion Criteria:

* Medical students, 1st through 4th year, at the University of Miami Miller School of Medicine willing to participate in surveys and the CircaHealth course.
Prospective Multicenter Study on Mitral Annular Disjunction

Observational cohort prospective multicenter study on patients with mitral annular disjunction (MAD). MAD is defined as a separation (≥1 mm) between the atrial wall-mitral valvular junction and the left ventricular free wall during end-systole

Mitral annular disjunction (MAD) is a structural abnormality of the mitral annulus, defined as a separation (≥1 mm) between the atrial wall-mitral valvular junction and the left ventricular free wall during end-systole. This abnormality is significantly associated with the presence of mitral valve prolapse (MVP), but it can also be observed in normal hearts. MAD-related hypermobility of the mitral apparatus and the consequent posterior systolic curling determine a mechanical stress of the infero-basal wall and papillary muscle. This phenomenon leads to myocardial hypertrophy and fibrosis, creating an arrhythmogenic substrate and a source of electrical instability. For this reason, the analysis of left ventricle by cardiac magnetic resonance plays a pivotal role in the identification of predictors of fatal arrhythmic events, such as sudden cardiac death (SCD). Taking into account that MAD could be present without MVP, some studies analyzed the association between MAD and arrhythmic events. They showed that MAD itself is a risk marker of electrical instability supporting the existence of an emerging clinical entity: the MAD arrhythmic syndrome. An in deep analysis of MAD patients and their characteristics in terms of EKG, types of arrhythmia, echocardiographic parameters and cardiac magnetic resonance (CMR) data and long-term events is lacking.

The present study is ideated and conducted to fill this gap and collect information regarding management and outcome of patients with MAD

Eligibility Criteria:
Inclusion criteria:

* Subject aged ≥18 years and \<65 years
* Evidence of MAD during routine echocardiography clinically indicated by treating physician for any reason
* Written informed consent

Exclusion criteria:

• Patient's refusal
RC48 for Neoadjuvant Chemotherapy of HER2 Positive Breast Cancer

This is a single-arm exploratory study to explore the effect of RC48 in HER2-positive neoadjuvant therapy and evaluate the non-inferiority of RC48 by comparing the latest reported data of T-DM1 in neoadjuvant therapy.

A single-arm exploratory study was conducted in 20 patients with HER2-positive breast cancer to explore the effect of RC48 in HER2-positive neoadjuvant therapy (treatment regimen: RC482.0 mg/kg, intravenous drip, once every 2 weeks). After 4-6 cycles, surgery was performed to evaluate the effect of neoadjuvant chemotherapy. The latest reported data of T-DM1 in neoadjuvant therapy were compared to evaluate the non-inferiority of RC48.

Eligibility Criteria:
Inclusion Criteria:

1. Enrolled were ≥ 18 years of age and \< 80 years of age
2. Female or male breast cancer
3. Patients with early or locally advanced breast cancer who are HER2-positive, have a tumor larger than 2 cm and/or have lymph node metastasis: HER2-positive is defined as 3 + by immunohistochemistry, or 2 + by immunohistochemistry, with a positive FISH test.
4. Left ventricular score ≥ 55%
5. ECOGPS score 0 or 1
6. Able to understand the test requirements, willing and able to comply with the test and follow-up procedures
7. Adequate organ function

Exclusion Criteria:

1. cardiac, hepatic, renal, or psychiatric disease history
2. History of other malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
CBT vs RTW Intervention for Patients With Common Subclinical Mental Illness in Primary Care

Background: Common mental illness, such as anxiety disorders and depression, is the main cause for sick leave in Sweden. Cognitive behavior therapy (CBT) has been shown to be effective in alleviating target symptoms of these disorders, but its effect on sick leave rates has not been sufficiently addressed. The investigators have developed an intervention called return to work (RTW), which is based in cognitive behavioral theory, that has a primary aim of helping sick-listed patients with common mental illness return to work. This new treatment has not been evaluated in a randomized controlled trial.

Aims: The aim of this study is to investigate the effect of CBT and RTW for subclinical common mental illness in a randomized controlled trial conducted in primary care. Participants will be randomized to diagnosis specific CBT (n=50), RTW (n=50. Main outcomes are days of sick leave and clinician severity rating of psychiatric symptoms. This study could contribute to new knowledge regarding how to best treat patients on sick leave with mild common mental illness.


Eligibility Criteria:
Inclusion Criteria:

* Have been on sick leave (at least 50%) for at least 1 month and not more than 6 months
* Have subclinical levels of anxiety disorder diagnosis (obsessive compulsive disorder, social phobia, panic disorder, generalized anxiety disorder, post-traumatic stress disorder, specific phobia), or/and major depression, or/and maladaptive stress reaction, or/and primary insomnia. Severity measured by clinical severity rating (CSR) 2-3 for mild subclinical level

Exclusion Criteria:

* A higer score than 3 on the Clinician severity rating scale
* A lower score than 2 on the Clinician severity rating scale