cyrilzakka/clinical-trials huggingface dataset:
Primary Mitral Regurgitation Repair

This longitudinal cohort study evaluates the relationship of myocardial tissue markers characteristics assessed by cardiac MRI, with clinical measures of symptoms and functions in adults with primary mitral regurgitation. Participants are followed conservatively or may choose to undergo surgical repair at the discretion of their clinical team.

The transition from compensated to decompensated chronic primary mitral regurgitation remains poorly understood in the clinical setting. Changes at the myocardial tissue level, such as scar formation and decreased contractility, have been implicated in the end stage, decompensated phase of this disease entity.

Advances in cardiac MRI (CMR) have enabled non-invasive characterization of the myocardial tissue components, such as cardiomyocyte volume and extracellular matrix, and tissue contractility. These measures have been well validated in various cardiac pathologies with biopsy studies but only at single time points.

In this study, adults with isolated chronic primary regurgitation will be followed conservatively over at least a year to determine the natural progression of these CMR-derived markers over time and to investigate the prognostic potential of these markers for clinically assessed functional capacity and symptoms. These participants may elect to undergo any valvular intervention at the discretion of their treating clinical team.

Alongside this arm, similar adults with isolated chronic primary regurgitation will be recruited, who have elected upfront to undergo surgical repair. These patients will be similarly studied to determine reverse remodeling of these CMR-derived markers over time and to investigate the prognostic potential of these markers for the same clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Isolated mitral regurgitation

   1. of any primary mechanism and
   2. of moderate-to-severe (Sellers 3+) or greater severity, assessed by any imaging modality (echocardiography, angiography, cardiac MRI)
3. Able to receive gadolinium-based contrast agent (estimated glomerular filtration rate \>30 mL/min/1.73 m2, no prior allergy to gadolinium contrast agents)

Exclusion Criteria:

1. Refusal to consent
2. Pregnancy during the study
3. Hemodynamically or clinically unstable
4. Inability to undergo a CMR scan, which can include the following reasons: severe claustrophobia, ferromagnetic implants, implanted defibrillator, pacemaker, or abandoned pacemaker leads, cochlear implants, unable to lie flat
5. Other diseases known to influence myocardial fibrosis development (coronary artery disease, diabetes mellitus, uncontrolled hypertension, infiltrative cardiomyopathy, myocarditis, hypertrophic cardiomyopathy, any cardiac tumors, moderate or more valvular heart disease other than primary mitral valve regurgitation)
Neuromuscular Warm-up Intervention to Improve Postural Control in Female Handball Players

Female handball athletes are at a particular risk of sustaining lower extremity injuries. The study examines time-dependent adaptations of static and dynamic balance as potential injury risk factors to a specific warm-up program focusing on neuromuscular control.


Eligibility Criteria:
Inclusion Criteria:

* Gender: Female
* Handball players
* Actively participated in competitions
* Uninjured at study enrollment

Exclusion Criteria:

-
Long-term Follow-up Study of Risdiplam in Participants With Spinal Muscular Atrophy (SMA)

A multi-center, longitudinal, prospective, non-comparative study to investigate the long-term safety and effectiveness of risdiplam, prescribed based on clinician judgment as per the Evrysdi® U.S. Package Insert (USPI) in adult and pediatric participants with SMA. In this study, participants will be followed for the duration of the study or until withdrawal of consent, loss to follow-up, or death. Participants who discontinue risdiplam may still remain in the study, if they agree to continue participating in the follow-up assessments.

An optional sub study will assess the feasibility, acceptability, and adherence of remote assessment of motor and bulbar functions in participants with SMA using wearable and smartphone-based biosensors. Approximately 39 participants from the main study are planned to be enrolled in the sub study.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of SMA
* Prescribed or continued risdiplam based on clinical judgment of prescriber, as per the Evrysdi® USPI, after U.S. FDA approval (07 August 2020)

Sub study:

Participants in the main study (ML43702) are eligible to be included in the sub study only if all of the following criteria apply:

* Age ≥ 10 years at the time of signing Informed Consent Form
* Willingness and ability to use smartphone technology
* Fluency in English (written and spoken as per the judgment of the investigator)
* Willingness and ability to complete all aspects of the sub study, including respiration and swallowing measurements using respiratory inductance plethysmography (RIP) belts and surface electromyography (sEMGs)
* Hammersmith Functional Motor Scale-Expanded (HFMSE) \> 10
* Functional Oral Intake Scale (FOIS) \>1
* Willingness to be video recorded during in-clinic SMA-DAT tasks and ADAM sensor assessments and training
* Availability of a caregiver who is willing to participate throughout this sub study

Exclusion Criteria:

* Hypersensitivity to risdiplam
* Participated in a registrational trial for risdiplam (i.e., Firefish \[NCT02913482\], Sunfish \[NCT02908685\], Jewelfish \[NCT03032172\], and Rainbowfish \[NCT03779334\])

Sub study:

Potential participants will be excluded from the sub study if they meet any of the following criteria:

* Current respiratory infection that, in the opinion of the investigator, would interfere with the conduct of the sub study
* History or known presence of any significant psychiatric disorder such as schizophrenia, bipolar disorder, or substance use disorders
* Current active clinically significant anxiety or depressive disorder, as judged by the investigator, that is likely to impede a participant's ability to participate in the sub study
* Wearing a pacemaker (due to incompatibility with the ADAM sensor)
* Inability to tolerate the performance of sub study procedures
Foot Reflexology and Abdominal Massage

to determine and compare the effects of foot reflexology and abdominal massage applied to elderly individuals on constipation

This randomized controlled study examined the effects of foot reflexology and abdominal massage on constipation in 90 elderly individuals from three nursing homes. Participants were divided into three groups: reflexology, abdominal massage, and control. The intervention groups received eight sessions over three weeks, while the control group received no treatment.

Eligibility Criteria:
Inclusion Criteria:

Being 65 years or older Having no movement restrictions Not using pharmacological laxatives Being diagnosed with constipation according to the ROMA IV criteria Voluntarily agreeing to participate in the study

Exclusion Criteria:

Individuals having a condition that prevents cognitive, affective and verbal communication Having a disorder related to the nervous system and circulatory system Having an injection applied to the abdominal region during the application process Having a systematic disorder related to the GIS (diarrhea, irritable bowel syndrome, fecal impaction, incontinence, etc.) Having physiological and structural disorders that may prevent evacuation in the anus region (rectal fissure, etc.) Having any negativity in the sensory function examination test performed with a sharp-blunt hard object on the sole of the foot and abdomen Having any physiological and structural disorders related to the foot/sole of the foot
Effects of Lumbopelvic Manipulation on Neuromuscular Activity of Back & Hip Muscles in Adults With Chronic Low Back Pain

The purposes of this study are:

1. To examine the within-day and between-day test-retest reliability of a testing protocol measuring the back and hip muscles fatigability using EMG median frequency
2. To examine the immediate and the carry-over effects of the lumbopelvic manipulation on the EMG median frequency of the lumbar multifidus (MULT), gluteus medius (GMED) and gluteus maximus (GMAX) muscles in patients with chronic low back pain (CLBP)
3. To compare the fatigability levels of the MULT, GMED and GMAX muscles by measuring the EMG median frequency between the participants who will receive lumbopelvic manipulation.

The research hypotheses are:

1. The testing protocol using EMG median frequency as a fatigue indicator for MULT,GMED and GMAX muscles will have good (ICC ≥ 0.80) within-day and between-day test-retest reliability.
2. The fatigability level of the MULT, GMED and GMAX muscles will significantly decrease immediately after the lumbopelvic manipulation and will be maintained over two to four days following the manipulation.
3. The fatigability of the MULT, GMED and GMAX muscles will significantly decrease after the intervention in the manipulation group while no change will occur in the placebo group.


Eligibility Criteria:
Healthy subjects or the reliability phase:

Inclusion Criteria:

* Subjects without any history of back problems
* Subjects without any known pathology.

Exclusion Criteria:

* Any serious spinal condition such as tumor, fracture, or infection,
* Signs of nerve root compression (i.e. straight leg- raise ≤ 45° or diminished reflexes, sensation or lower extremity strength),
* Structural deformity,
* Spondylolithesis ,
* Ankylosing spondylitis
* Spinal stenosis,
* Osteoporosis,
* Previous surgery to the back or the hip, and
* Current pregnancy.

Subjects with Chronic low back pain for both the reliability and the manipulation phases:

Inclusion Criteria:

* Participants should be between the age of 20 to 60 years.
* Have had complaints of chronic low back pain for at least three months.

Exclusion Criteria:

* Any serious spinal condition such as tumor, fracture, or infection,
* Signs of nerve root compression (i.e. straight leg- raise ≤ 45° or diminished reflexes, sensation or lower extremity strength),
* Structural deformity,
* Spondylolithesis ,
* Ankylosing spondylitis
* Spinal stenosis,
* Osteoporosis,
* Previous surgery to the back or the hip, and
* Current pregnancy
Postoperative Heme Oxygenase Induction and Carbon Monoxide Production as a Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy

The study will monitor carbon monoxide production in patients undergoing liver resection. Carbon monoxide will be checked from arterial blood gas obtained routinely as a part of the postoperative care as well as from the exhaled air of the patient through a CO detector commercially available and used as smokerlyzer helping people to stop smoking. The results of the surgical resection will be collected from the patient routinely ordered tests after liver resection including pathology of the resected part of the liver, laboratory and radiology tests. The study aims to identify the relationship between CO production and recovery after liver resection. Results of this study may help in predicting and improving results of liver resection.

The goal of this proposal is to elucidate the role of HO-1 induction in hepatic regeneration after partial hepatectomy (PH). There is a growing body of evidence that HO-1 induction through CO production has an important role in cellular protection and regeneration. To test this concept, we will monitor endogenous CO production in patients who undergo PH and analyze the relationship between CO production and hepatic regeneration. Using this approach we will test the following two hypotheses: (1) HO-1 induction after PH is proportional to the extent of the surgical resection, and (2) failure to appropriately induce HO-1 is associated with impaired hepatic regeneration.

Specific Aim 1: To monitor the extent of HO-1 induction (by measuring endogenous CO production) in relationship to the extent of hepatic resection 1.1 Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH 1.2 Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH 1.3 Analyze the relationship between CO production and the extent of hepatic resection assessed by computed scans liver volumetric study at one and three months after PH, size and weight of the resected specimen and operative report.

Specific Aim 2: To analyze the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration after PH 2.1 Analyze the relationship between CO production and the quantity and quality of hepatic regeneration assessed by computed scans liver volumetric study at one and three months after PH and liver function tests after PH.

2.2 Determine the relation between postoperative liver related morbidity in patients undergoing PH and the extent of postoperative HO-1 induction.

Eligibility Criteria:
Inclusion Criteria:

* Patients plan to have partial liver resection for primary liver pathology or metastatic disease.
* Patients able to comprehend and willing to sign the written consent form.

Exclusion Criteria:

* Patients age less than 18
* Patients not having pathology proven liver malignancy
* Patient not able to comprehend or sign written consent form.
Air Polishing Effect on Biological, Clinical and Patient-reported Experience Among Epileptic and Non-epileptic Children

In epileptic and non Epileptic children, the full dentition of each patient was split into four quadrants, starting from the upper right quadrant (1) and moving clockwise until the lower right quadrant (4). Bundled into two groups: quadrant (1+3) vs. (2+4). After randomization, each of these pairs of quadrants had the same treatment modality; test quadrants received treatment with airflow to remove soft biofilm, and ultrasonic scaler for areas with calculus deposits, and control quadrants were treated with conventional rubber cup polishing to remove soft biofilm and ultrasonic scaler for calculus deposits.

The treatment of each quadrant was administered sequentially, beginning with the upper right quadrant. Treatment duration was measured in seconds from the start of treatment in each quadrant until the removal of all disclosed biofilm and calculus. This process was repeated for each quadrant individually. And intra-oral photographs were taken before, immediately after treatment, and at follow-up time.

Conventional treatment was conducted after biofilm disclosure by a rubber cup and prophylaxis paste spearmint (Kemdent Works, Purton. Swindon, Wiltshire. SN5 4HT, UK). The power setting was between 70% and 100%. The rubber cup was used until all biofilm was removed, then, if present, calculus was removed by Electro Medical Systems (EMS) ultrasonic scaler with a power setting between 3-6 on the Airflow control panel.

For Airflow, treatment was conducted after biofilm disclosure. The powder chamber of the air polishing device was filled with low-abrasive erythritol powder, according to the manufacturer's instructions. The tip of the handpiece was positioned at an angle of 70° to the surface of the tooth to be polished at 3 mm from the tooth surface. Once activated, a non-stop movement from mesial to distal and distal to mesial in a smiley face shape starting from the gingival sulcus and moving upwards coronally to the incisal to cover the entire clinical crown was performed, with a power setting ranging from 3-6 on the control panel of the airflow device. EMS ultrasonic scaler was used to remove calculus if present with a power ranging from 3-6.

Eligibility Criteria:
Inclusion Criteria:

* children aged 5 to 15 years with epilepsy
* on anti-epileptic drugs (AED) for at least 3 months
* periodontal pockets depths not exceeding 3mm
* full-mouth plaque scores over 50%, and having 5 teeth per quadrant.
* The non-epileptic group included healthy non-epileptic children meeting similar criteria for age, periodontal health, and plaque scores

Exclusion Criteria:

* coexisting neurological illnesses other than epilepsy, medical conditions impacting oral health, periodontitis, asthma, swallowing difficulties, intellectual disabilities, and non-ambulatory status
Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types)

To investigate the pharmacodynamics, pharmacokinetics and safety of 7-day-repeated doses of FYU-981 administered orally to male hyperuricemic patients with uric acid-overproduction or uric acid-underexcretion type.

In addition, to investigate the additive effects of the combination of FYU-981 and topiroxostat administered orally to male hyperuricemic patients with uric acid-overproduction type.


Eligibility Criteria:
Inclusion Criteria:

* Japanese adult subjects
* Serum urate level: \>= 7.0mg/dL in patients
* Disease Type: Uric acid-overproduction Type or Uric acid-underexcretion Type

Exclusion Criteria:

* Gouty arthritis within a year before start of study treatment
* Mixed type in the classification of hyperuricemia
Peer Support Program in Cancer Patients Elkar Laguntza

In cancer patients, social support provided by partners, family and/or friends plays a key role in coping with the disease and reducing treatment-related distress. However, research indicates that some of the needs of patients, such as coping with the disease, reducing isolation or managing guilt, often go unmet. With the aim of trying to meet these types of needs of people with cancer, the present research will evaluate the effectiveness of a peer support program in cancer patients, based on the support provided or exchanged by people who have faced similar challenges or problems. The intervention will consist of 8 face-to-face sessions of social peer support, involving a cancer patient and a volunteer who is in a stable phase and who has undergone the same diagnosis and medical treatment. To evaluate the effectiveness of the social support program, the immediate and long-term effect of participation in the program on both psychological (anxious-depressive symptoms, quality of life, perception of the disease, coping strategies, perception of social support,...) and biological (endocrine and immune system) variables will be analyzed.

The general aim of the present research will be to evaluate the effectiveness of a peer social support intervention in cancer patients at the Onkologikoa Foundation of Guipuzcoa. Specifically, the immediate and long-term effect that such intervention will have on symptoms of psychological distress, quality of life, coping strategy, perception of social support, perception of the disease and emotional regulation will be evaluated. As a secondary aim of this study, we intend to evaluate the immediate and long-term effect of the peer social support intervention on the immune system (through the determination of the levels of cytokines IL-1β, IL-2, IL-6, IL-8, IL-10, IFN-γ and TNF-α), on the monoaminergic system (through the determination of plasma levels of serotonin, tyrosine, phenylalanine, tryptophan, quinurenine, quinurenic acid and 3-HK), on the HPA axis (through the measurement of the diurnal cycle of cortisol), and on sex hormones (through the measurement of estradiol and testosterone levels), systems that have been related both to the development of anxious-depressive symptoms and to the development, progression and recurrence of cancer.

In addition, it will be studied at what time the application of the program is most effective, being applied in newly diagnosed patients (experimental group 1) and in patients who have just finished medical treatment (experimental group 2).

Eligibility Criteria:
Inclusion Criteria:

* having received the diagnosis of cancer in the last month; not having started medical treatment; the tumor type and medical treatment coinciding with any of the volunteers.

Exclusion Criteria:

* relapse; suffering or having suffered from a severe mental disorder (according to DSM-V criteria).
commd7 Gene Expression in ALL

* study the expression pattern of COMMD7 gene in acute lymphoblastic leukemia.
* investigate correlation between the expression level of COMMD7 gene with other diagnostic parameters and prognosis in ALL .

Acute lymphoblastic leukemia (ALL) is a neoplastic disorder of lymphoid progenitor cells characterized by diverse cytogenetic and molecular abnormalities with peaks of prevalence for 2-5-year-old patients and those older than 50. Treatment strategies using risk-adapted chemotherapy cure more than 80% of childhood cases, but around 20 to 30% relapse developing serious complications including death.( 1) In the past decade, the available treatments for patients with acute lymphoblastic leukemia (ALL) have rapidly expanded, in parallel with an increased understanding of the genomic features that impact the disease biology and clinical outcomes.(2) The copper metabolism MURR1 domain (COMMD) protein family involved in tumor development and progression in several types of human cancer, but little is known about the function of COMMD proteins in hematological malignancy. (3) COMMD7, a member of the COMMD, which is located on chromosome 20q11.21, has been reported associated with tumor progression in human solid cancers \[4\]. COMMD7 is overexpressed in pancreatic ductal adenocarcinoma (PDAC) cells, associated with poor prognosis. \[5\]. Another study revealed that COMMD7-overexpressed hepatocellular carcinoma (HCC) cells promoted the proliferation of naïve HCC cells (6) A recent study was found that high expression of COMMD7 is a potential biomarker for adverse outcomes and poor prognosis in AML. (7)

. However, to date, the expression of COMMD7 in acute lymphoblastic leukemia and its prognostic value remain unclear.

Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed with acute lymphoblastic leukemia , male or female at any age.

Exclusion Criteria:

* history of anti-neoplastic therapy, such as chemotherapy or radiotherapy.
* Any other types of cancers.
* Any clinically systemic acute or chronic inflammatory disease/s within one months.