cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Shear Wave Elastography in Parkinson's Disease

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by motor symptoms including muscle rigidity as one of major motor symptoms affecting quality of life of Parkinson's disease patients, thus we aim to assess and quantify muscle stiffness in those patients using Ultrasound shear wave elastography .

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by motor symptoms like tremors, bradykinesia, muscle rigidity, and postural instability, as well as various non-motor symptoms . While the exact cause of Parkinson's disease is not fully understood, it is thought to result from a combination of genetic and environmental factors, leading to the degeneration of dopamine-producing neurons in the brain . PD is the second most common neurodegenerative disorder after Alzheimer's disease, primarily affecting those over 60, with a higher prevalence in men . The disease significantly impacts quality of life due to progressive motor and non-motor disabilities, and while treatments can alleviate symptoms, there is currently no cure . Disease progression and prognosis vary, with advanced stages often leading to severe disability and reduced life expectancy .

Muscle rigidity, one of the major motor symptoms, refers to the increased resistance when muscles are passively stretched . Accurate assessment of muscle stiffness is essential for monitoring disease progression and evaluating therapeutic interventions .

Traditionally, clinical assessment tools like the Unified Parkinson's Disease Rating Scale (UPDRS), part III, are used to evaluate rigidity severity in PD patients . These assessments, involving manual joint movement and muscle palpation by professionals, are subjective and prone to error . Thus, there is a growing need for noninvasive, quantitative tools to assess muscle stiffness in PD patients .

Tools like electromyography (EMG) and myotonometry offer quantitative measurements . Ultrasound shear wave elastography (SWE) is another non-invasive technique that measures tissue stiffness by analyzing shear wave propagation. While SWE shows promise for various conditions, its application in PD-related muscle rigidity remains relatively unexplored .

Eligibility Criteria:
Inclusion Criteria:

* patient diagnosed with Parkinson's disease
* Age between 40-85 years
* No other neurological or musculoskeletal disorders affecting the examined limb muscles.

Exclusion Criteria:

* History of other neurological or musculoskeletal disorders affecting the examined limb muscles.
* History of significant trauma or surgery in the examined limb within the last year.
* patients with contraindications to ultrasound( such as open skin wounds or severe skin conditions in the area of interest).
Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)

The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip once a day in patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are defined as "definite ALS," "probable ALS" or "probable-laboratory-supported ALS," met diagnostic criteria revised EL Escorial for Airlie House.
* Patients who can eat a meal, excrete, or move with oneself alone, and do not need assistance in everyday life.
* Patients of less than 3 years after the onset of ALS.
* Patients whose progress of the condition during 12 weeks before administration meet other requirements.

Exclusion Criteria:

* Patients judged to be inadequate to participate in this study by their physician, because those patients' general condition deteriorated to the point that they need to be hospitalized for severe hepatic disease, severe heart disease, severe renal disease and so on, or they need to be administered antibiotics to infection.
* Patients who complain the difficulty in breathing caused by deteriorating the respiratory function.
* Patients with such complications as Parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication, and patients who have the anamnesis of hypersensitivity to edaravone.
* Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception.
* Patients who have participated in other trials within 12 weeks before consent, or who are participating in other clinical trials at present.
* In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.
PLAYwithHEART: PLAY With Happiness, Engagement, Acceptance, and Respect With Your Team

This investigation aims to apply and test the feasibility of a structured Program for young athletes. PLAYwithHEART is a program for promoting acceptance and cooperation skills in adolescent athletes. This group application program comprises eight weekly sessions and aims to decrease levels of sport anxiety, and increase the psychological quality of life of young athletes, by promoting skills inherent to an affiliation mentality (mindfulness, acceptance, and compassion), as an alternative to a social ranking mentality (based on maladaptive processes, such as shame and self-criticism), to deal with the challenges and demands of the sport context.

The sample will include young athletes of different sports with ages ranged 12 to 18 years old. The principal investigator will recruit participants through contact with different sports clubs in Portugal. Athletes who demonstrate interest will go through a Screening interview (previously authorized by your legal guardian) by a licensed psychologist that aims explain the structure and arms of the investigation, to collect demographic data, and whether the athlete meets the inclusion criteria for the study. Athletes who meet the inclusion criteria and demonstrate interest in participating in the study, will sign an informed consent.

All ethical requirements for research with humans are guaranteed. Afterwards, participants will be allocated in two groups (experimental and control group). Additionally, the experimental group will enroll in the PLAYwithHEART programme, also provided by a licensed psychologist and a co-therapist.

Both groups will concurrently complete a protocol of self-report measures (to measure: a) psychological processes; b) quality of life and sports anxiety. These assessments will occur in three different times: before the start of the PLAYwithHEART programme (M0), after the final session of the programme (M1), and 6 months after that (M2).

Eligibility Criteria:
Inclusion Criteria:

* adolescent competitive athletes
* presentation of the informed consent signed by the participant and respetive legal guardian
* availability to participate in the 8 sessions of the PLAYwithHEART Programme
* inexistence of cognitive difficulties that interfere in completing self-response measures
* not being under psychological / psychiatric appointments

Exclusion Criteria:

* no presentation of the informed consent signed by the participant and respetive legal guardian
* unavailability to participate in the 8 sessions of the PLAYwithHEART Programme
* existence of cognitive difficulties that interfere in completing self-response measures
* being under psychological / psychiatric appointments
Rapid Diagnostic Assay for Gonorrhea and Chlamydia

This study is a pilot randomized controlled trial evaluating the use of either a) rapid 30-minute desktop assay or b) point-of-care gram stain (current standard of care) to guide the clinical management of patients with symptomatic urethritis or cervicitis evaluated in the Massachusetts General Hospital Sexual Health Clinic. Patients presenting with symptoms of urethritis or cervicitis and meeting inclusion criteria will be randomized to have diagnostic specimens tested during the clinical encounter using either the 30-minute desktop assay or point-of-care gram stain. Patients randomized to the intervention arm of the study will also have a gram stain created, which will be held for interpretation by the clinician following the clinical encounter. Patients will not be followed longitudinally. Recruitment will conclude when 100 participants enroll in the study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Presenting with symptoms of acute urethritis or cervicitis
* Willing to provide urine or additional vaginal swab specimen

Exclusion Criteria:

* Younger than 18 years old
* Presenting with symptoms not consistent with urethritis or cervicitis
* Unwilling or unable to provide urine or vaginal swab specimen
* Pregnant
* Contact of index patients with Gonorrhea or Chlamydia
* Known exposure to Gonorrhea or Chlamydia
* Reporting concurrent symptoms at a non-genital site
* Suspected or confirmed to have Monkeypox
Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta

The primary objective of this study is to evaluate the pharmacokinetics (PK) profile following multiple subcutaneous (SC) doses of romosozumab in children and adolescents with Osteogenesis Imperfecta (OI).


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory male or female children 5 to less than 18 years of age upon entry into screening
* Clinical diagnosis of OI defined as a clinical history consistent with type I-IV OI as determined by presence of expected phenotype and lack of additional features unrelated to type I-IV OI

Exclusion Criteria

* History of an electrophoresis pattern inconsistent with type I to type IV OI
* History of known mutation in a gene other than collagen type I alpha 1/collagen type I alpha 2 (COL1AI/COL1A2) causing OI or other metabolic bone disease
* History of other bone diseases that affect bone metabolism (eg, osteoporosis pseudoglioma syndrome, idiopathic juvenile osteoporosis, osteopetrosis, hypophosphatasia)
* History of Kawasaki disease, rheumatic myocarditis, ischemic cardiomyopathy, inherited cardiomyopathies, nephrotic syndrome, familial hypercholesterolemia, stroke, or any thromboembolic disorder
* Unhealed fracture as defined by orthopedic opinion
* Symptoms associated with skull abnormalities such as basilar invagination, basilar impression or Chiari malformation
* Prior treatment with anti-sclerostin antibody, fluoride or strontium, parathyroid hormone (PTH) within 12 months prior to screening, denosumab within 12 months or zoledronic acid within 6 months prior to first dose
* Less than 2 evaluable vertebrae by DXA evaluation in the region of interest, L1 - L4, as confirmed by the central imaging laboratory.
* Clinically significant valvular heart disease based on local echocardiogram (ECHO) results.
Transition of Renal Patients Using AlloSure Into Community Kidney Care

Patients undergoing kidney transplantation alone (either de-novo or re-transplant) at a participating hospital are routinely surveyed with interval blood tests as part of standard post-operative care through outpatient consultation. These tests include serum creatinine, blood sugar as well as DSA testing at various intervals. The ability to screen patients to better identify those who may be at risk of developing an adverse event using AlloSure cfDNA is likely to be advantageous, with the potential to improve graft survival and outcomes for transplant patients. The addition of AlloSure to the interventional group will be the focus of this study. Patients will have quarterly AlloSure cfDNA testing (every 3 months) and DSA as part of their post-transplant surveillance for a period of 5 years.Participants will attend outpatient visits/follow-up visits as part of their standard care, these will include appointments where they will have blood tests taken as part of post-transplant surveillance. For AlloSure cfDNA and DSA, blood will be taken quarterly.


Eligibility Criteria:
Inclusion Criteria:

* Participants with single kidney transplant (de-novo or re-transplant) who are ≥ 6 months and ≤ 36 months post-transplant. Participants and will need to have a draw in this time period .
* Participant is willing and able to give informed consent for participation in the trial.
* Male or Female, aged 12 years or older.
* In the Investigator's opinion, is able and willing to comply with all trial requirements.

Exclusion Criteria:

* Participant who is pregnant, lactating or planning pregnancy during the trial.
* Significant hepatic impairment (determined by the PI).
* Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
* Participant with life expectancy of less than 6 months, or inappropriate for diagnostic monitoring through regular blood sampling.
* \< 6 months and \> 36 months post-transplant
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
* Multi-organ transplant (e.g., Kidney-Pancreas).
Neuropathy Evaluation Using the Vibration of a Mobile Phone

A single centre validation/method comparison study of the experimental NERVE device for the measurement of vibration perception threshold against the established 'Neurothesiometer' device, evaluating agreement and reliability. It will also include collecting feedback from patients, carers and clinicians on the usability of the device


Eligibility Criteria:
Inclusion Criteria:

* Formally Diagnosed With Diabetes

Exclusion Criteria:

* 1. Un- willing or un-able to provide free informed consent (no time limit)
* 2. Un-willing or un-able to comply with all protocol requirements including study assessments;
* 3. Bilateral foot ulcers
Tianjin Gestational Diabetes Prevention Program (TGDPP)

A total of 1,180 women diagnosed with Gestational Diabetes Mellitus (GDM) from 2005 to 2009 and their children have and continues to be randomly assigned to either the intervention group or the control group. A total of 83 women with prior GDM and newly diagnosed diabetes at baseline survey have the nine-month lifestyle intervention program. GDM women in the intervention group will have five consulting sessions with a dietician during the first year and two sessions during the second year. The intervention group are given detailed advice about how to achieve the five goals of the intervention. The primary aim will test whether lifestyle intervention can reduce incident Type 2 Diabetes (T2D) in women with prior GDM. The second aim will test gene-intervention interactions through fine-mapping established genes for glucose, IR, lipids, obesity and T2D in relation to metabolic traits for T2D in GDM women. The third aim will evaluate the effects of the nine-month lifestyle intervention program on cardiovascular risk factors in women with prior GDM and newly diagnosed diabetes. The forth aim will assess if a lifestyle intervention targeting both GDM mothers and their offspring can greatly improve offspring's cardimetablic risk (body weight, glucose and lipid metabolism).


Eligibility Criteria:
Inclusion Criteria for mothers:

1. Age 20-49 years
2. Women diagnosed with GDM between 2005 and 2009.

Inclusion Criteria for children: age 1-5 years at baseline survey.

Exclusion Criteria:

1. Age \< 20 and ≥ 50 years
2. Newly diagnosed diabetes in the screening visit
3. The presence of any chronic diseases that could seriously reduce their life expectancy or their ability to participate in the trial
4. Unable or unwilling to give informed consent or communicate with study staff
5. Currently pregnant, or planning to become pregnant in the next four years
Real-life Experience of the Use of Isomers as METPURE XL (S (-) Metoprolol Succinate) for Evaluation of Efficacy, Safety and Tolerability in the Management of Cardiovascular Disease in Colombian Patients

This is a Phase 4, observational, open study in patients who their doctor has prescribe METPURE XL (S (-)metoprolol succinate)by clinical practice. No medication was provided by the sponsor. The planned observation time is 8 weeks. The 8 weeks of observation involves an evaluation of baseline followed by information gathered from the assessment visits at week 4 and week 8.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were prescibed with s(-)metoprolol succinate(25mg, 50mg), depending on their clinical condition and use locally approved will be eligible to participate in this study
Evaluation of a Digiphysical Screening Method to Identify and Diagnose Familial Hypercholesterolemia

Longitudinal and observational registry-based cohort study of individuals participating in the national digiphysical screening program for Familial Hypercholesterolemia. The information collected in the screening process will be combined in pseudo-anonymous form with data from the National Board of Health and Welfare (registries: Cause of Death, Diagnoses according to International Classification of Diseases (ICD) and Prescribed drugs) and Statistic Sweden (Longitudinal integrated database for health insurance and labour market studies). Primary analysis: association between Familial Hypercholesterolemia and cardiovascular disease. Secondary analysis: efficacy and health economic aspects of digiphysical screening for Familial Hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Swedish personal identification number

Exclusion Criteria:

* Decline informed consent
Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload

This is a pilot study looking at the safety and efficacy of giving combination chelation with deferasirox and deferoxamine. The hypothesis is that combination chelation is safe in decreasing overall iron in patients with thalassemia.

This was a phase two pilot clinical trial designed to evaluate the safety and efficacy of the combination of deferasirox and deferoxamine in transfusion dependent thalassemia with a range of systemic iron burden. The duration of combined therapy was 12 months. Changes in liver iron concentration, ferritin, myocardial iron, and serum creatinine was monitored.

Eligibility Criteria:
Inclusion Criteria:

* Transfusion Dependent Thalassemia
* If iron between 5-15 mg/g dry liver by SQUID, subject must have a documented endocrinopathy or cardiac finding
* Older than 8 years

Exclusion Criteria:

* Participating on another interventional clinical trial
Long-term Effects ReSet Your Mind - Mechanisms

See: ClinicalTrials.gov ID: NCT05402150

Relevant for this Paper:

This investigation aims to evaluate the stability of the effectiveness of different two-week online interventions in a four months follow-up regarding reward sensitivity, anhedonia and depression.

The authors will further investigate factors influencing treatment success regarding reward sensitivity. The investigators assume that the more depressive expectations and stress improve during our online intervention, the more change in reward insensitivity is experienced at follow-up. In addition, it is hypothesized that the more people engaged in physical activities and social encounters during the two-week online intervention, the more change in reward insensitivity is experienced at follow-up.

See for main study: ClinicalTrials.gov ID: NCT05402150.

A possible maintaining role in depressive symptoms plays reward hyposensitivity. Therefore, treatments should include evidence-based psychological interventions that target and modify reward insensitivity. Prior research lacks studies investigating reward sensitivity as main outcome measure, especially in the web-based format. This is why this study investigated an online intervention with the following groups regarding effectively increasing reward sensitivity compared to a waitlist control condition:

a) mindfulness-based interventions, b) behavioral activation, c) a combination of both.

The daily exercises were supported via videos and worksheets. Here, the investigators explore the effects after a four-months follow-up. In addition, this paper will deal with the long-term prediction of reward sensitivity, a feature not considered in our main paper preregistered with the ID NCT05402150. Factors, which are considered to play a big role in reward sensitivity are perceived stress, depressive expectations, physical activity and the frequency of social encounters.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above
* Fluent in German
* Informed consent
* Depressive symptoms (PHQ-9 \> 5)

Exclusion Criteria:

* suicidality, severe depression
* current or lifetime: substance use disorder, psychotic disorders, bipolar I or II
* current psychotherapy
* if antidepressant medication: has not been stable over the last 4 weeks
Oral Health Related Quality of Life

As oral health has a major impact on general health and quality of life, good oral health are essential. The aspects of oral health that are most important for each individual vary, and quality of life is subjective, and influenced by the person´s experiences, perceptions, expectations and ability to adapt to circumstances. FDI World Dental federations definition of oral health is; "Oral health is multifaceted and includes the ability to speak, smile, smell, taste, touch, chew, swallow, and convey a range of emotions through facial expressions with confidence and without pain, discomfort, and disease of the craniofacial complex.


Eligibility Criteria:
Inclusion Criteria: Read and understand Swedish -

Exclusion Criteria:

-
Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Obsessive Compulsive Disorder

This study will evaluate the possible therapeutic effects of repetitive transcranial magnetic stimulation(rTMS) in obsessive-compulsive disorder (OCD) in OCD patients who have not fully responded to pharmacotherapy, and the underlying neural mechanism by EEG.

The purpose of study is to examine the efficacy of rTMS over different brain areas, including the bilateral supplement motor Area (SMA), the right dorsal lateral prefrontal cortex (DLPFC) and SMA+DLPFC in the treatment of OCD. 120 OCD patients will be randomized into four groups. Continuous theta burst stimulation (cTBS) stimulation will be performed once a day, five times a week, for four weeks. The investigators will assess improvement after four weeks of cTBS. Though the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS), the Barratt Impulsiveness Scale-11 (BIS-11), the Beck Depression Inventory(BDI), the Beck Anxiety Inventory (BAI), Perceived Stress Scale(PSS), Pittsburgh sleep quality index(PSQI), the Obsessive-Compulsive Inventory-Revised(OCI-R) and side effects will be obtained by a trained investigator. The patients will also receive magnetic resonance imaging scan and electroencephalography (EEG).

Eligibility Criteria:
Inclusion Criteria:

* age\>18 years old;
* DSM-5 criteria for OCD;
* Y-BOCS total score \> or = 16, despite treatment with an adequate trial of a serotonin reuptake inhibitor (SRI) and currently using adequate, stable dose of SRI at least 4 weeks. An adequate SRI trial is defined as treatment for at least 12 weeks on the SRI, that meets or exceeds the recommended dosage level for OCD;
* \>or＝9 yrs education

Exclusion Criteria:

* any additional current psychiatric comorbidity, except for obsessive-compulsive personality disorder
* serious suicide risk;
* the inability to receive rTMS because of metallic implants, or history of seizures，or history of head injury, or history of neurosurgery;
* any major medical disease;
* pregnancy or nursing of an infant;
* participation in current clinical study;
* current use of any investigational drug;
* TMS/DBS treatment at any point in their lifetime;
* history of long-time use of benzodiazepines