cyrilzakka/clinical-trials huggingface dataset:
Clusterin Level and Polycystic Ovary Syndrome

Clusterin, a protein involved in metabolic syndrome, insulin resistance, and metabolic disorders associated with inflammation and oxidative stress such as atherosclerosis, Alzheimer's and some malignancies, has elevated levels in metabolic syndrome, PCOS, and the combination of these two groups. Clusterin could be used as an inflammatory marker to predict PCOS and metabolic syndrome.

The study included 118 women diagnosed with PCOS according to the Rotterdam criteria and 62 age-matched healthy women without cardiovascular risk factors. The patients diagnosed with PCOS were also classified into phenotypes. No interventional examination was requested for patients A, B, C, and D, except for hormonal tests and blood collection for Human Clusterin. The demographic and clinical characteristics of all patients were compared, with the primary outcome being blood Clusterin levels. The secondary outcomes are blood Clusterin levels in women with and without metabolic syndrome in addition to PCOS, the relationship between PCOS phenotypes and Clusterin levels, and the relationship between Clusterin levels and clinical and laboratory parameters.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 and 45,
* natural bilateral ovaries and no functional cysts on transvaginal ultrasound.

Exclusion Criteria:

* who have hyperandrogenism/hyperandrogenemia
* who have non-classical congenital adrenal hyperplasia (17 OHP value \>2 nmol/L)
* who have thyroid disease (TSH \>5 mlU/L),
* women with hyperprolactinemia (Prolactin\>30 mlU/mL)
* patients taking hormonal drugs or ovulation induction agents.
Spontaneous Healing of ARticular Cartilage (SHARC)

SHARC is an observational study of cartilage patients who are treated with surgery that involves obtaining a harvest biopsy. SHARC will study the natural healing process of the harvest biopsy site based on histological and biochemical analyses of repair tissue biopsies, synovial fluid biomarkers, medical imaging (MRI) and gait analysis.

Osteoarthritis (OA) is a very common disease of the joints, for which in the United Kingdom alone almost 9 million people have sought treatment. This painful disease affects the cartilage and bone inside the joint. Many factors are known to increase the risk of getting osteoarthritis, or the rate at which it gets worse. Very important among these factors is an injury or a defect of the cartilage. It was believed for hundreds of years that cartilage, once injured, does not heal.

Research from the past 10 years is now throwing doubt on this old certainty, as researchers who took regular scans of volunteers over time noted that sometimes these defects come and then go. A Japanese group of surgeons decided to look again after a year to see what had happened to these defects, and noted that about half of them had got better! Cartilage defects in human therefore can heal, but nobody knows how this works.

For many years, our Center has helped patients who have knee cartilage damage by using the patients' own cartilage cells to help repair areas of damaged cartilage. This cell therapy starts by taking a piece of cartilage (10 mm) from the patient's knee, and this created defect always heals after a year. Thus, our proposal is to use our cell therapy patients as a human experimental model of natural cartilage healing using a wide range of techniques including Magnetic Resonance Imaging (MRI), visual inspection of the joint itself during knee joint surgery, examining biopsies of repair tissue down the microscope and measuring various kinds of molecules researchers think are important. The information gathered from these tests will help bridge the gap in our understanding of the mechanisms involved in the cartilage tissue regeneration.

Eligibility Criteria:
Inclusion Criteria:

* Being able to provide signed and dated informed consent form.
* Scheduled for one of the following surgical treatments

  * Surgery that involves the harvest of cartilage tissue as part of the treatment, thus creating a fresh cartilage defect, which is then left to heal naturally. Examples of such surgery are autologous chondrocyte implantation (ACI) and mosaicplasty.
  * Autologous stromal cell implantation (ASCI), as part of the ASCOT randomised clinical trial.

Exclusion Criteria:

* Inadequate understanding of verbal explanations or written information given in English, or having special communication needs.
* Chronic severe renal insufficiency
* Anything that would preclude the individual's full compliance with or completion of the study.
Youth Metacognitive Therapy Feasibility Trial

One in eight children and young people (CYP) suffer mental health problems needing support or treatment and 5% have more than one such problem. The effects can be major, affecting CYP emotionally and functionally, impacting progress at school, relationships with others and increasing long term risk of mental health problems. Parents, schools, policy makers and the NHS often struggle to find the best way to help, especially within their limited budgets. The UK Government and the NHS have highlighted the need to improve mental health in CYP.

The most common treatment is cognitive behavioural therapy; however this can be time consuming, needs to be delivered over many weeks, must focus on the most upsetting problem first and is not very effective. One way to overcome this is to evaluate a group therapy that can treat multiple mental health problems at once. This new treatment is called Metacognitive Therapy (MCT).

The aim of the study is to see if participating in a randomized trial of Group MCT is a feasible and acceptable treatment for CYP suffering with anxiety, stress, depression, or a combination in comparison to usual care. This allows us to test key questions about recruitment and drop-out rates, test the protocol, and gain information about MCT including training and supervision needs of clinicians and the experience of patients receiving it.


Eligibility Criteria:
Inclusion Criteria:

* Seeking treatment for emotional disorder symptoms (i.e. generalized anxiety disorder, panic disorder, agoraphobia, post-traumatic stress disorder, obsessive compulsive disorder, social anxiety and/or depression).
* Native fluency in English language
* Medication permitted but must be stabilised for 6 weeks.

Exclusion Criteria:

* Presence of significant risk or safeguarding concerns
* Head injury/organic impairment
* Formal diagnosis or under assessment for Autism Spectrum Disorder or Attention Deficit-Hyperactivity Disorder
* Eating Disorder
Occupational Therapy and Registered Dietitian Services to Reduce Fall Risk Among Home Delivered Meal Clients

The purpose of this study is to determine which of the following four service models is most effective for reducing fall risk among home-delivered meal clients: (1) meals alone, (2) meals + registered dietitian services, (3) meals + occupational therapy services, (4) meals + registered dietitian + occupational therapy services.

Home delivered meal programs provide essential health and nutritional support to community-dwelling older adults in the United States. Without this support, nearly three million older adults would be at even greater risk for malnourishment and subsequent health decline, leading to potential hospitalizations and nursing home placements. Despite the reported value of home delivered meals, the increasingly complex health needs of the older adult population warrant new, innovative approaches that enhance home-delivered meal services. In our prior work, we identified that the majority of home delivered meal clients are at high risk for malnutrition, increasing clients' risk of falling and warranting the need for registered dietitian services to attenuate health decline. Additionally, our other work has identified that 80% of home delivered meal clients are at elevated risk for falling,6 and over 40% have experienced a fall in the past year. The high prevalence of fall risk factors among home delivered clients suggests that additional services - such as occupational therapy - are also needed to optimize clients' ability to safely remain living in their own homes and communities. In response to home delivered meal clients' need for more enhanced and specialized services, the present study will test four different service models to determine which model is most effective for reducing fall-related outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Eligible to receive meals according to LifeCare Alliance's standard in-take criteria (Over the age of 60; unable to safely and independently leave the home; does not have access to a caregiver who can prepare meals)
* Has a working freezer to store between 7-14 frozen meals/week
* Has a working microwave or oven to reheat meals
* Lives within LifeCare Alliance's 5-county service area

Exclusion Criteria:

* Individuals already receiving home-delivered meals from LifeCare Alliance or other meal agency (within the past 40 days)
* Individuals residing in residential care or a skilled nursing facility
* Individuals whose dietary restrictions prohibit them from eating meals from LifeCare Alliance's frozen meal selection
* Individuals at home on hospice care
* Unable to independently answer LifeCare Alliance's in-take questions
Stem Cell Therapy for Chronic Kidney Disease

The purpose of this study is to assess the safety and tolerability of allogeneic mesenchymal stem / stromal cell therapy in individuals with chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-80 years.
* Estimated glomerular filtration rate (eGFR) 25-55 ml/min/1.73m\^2
* Spot urine albumin:creatinine ≥30 mg/g unless on Renin-angiotensin-aldosterone system (RAAS) inhibition.
* Ability to give informed consent.

Exclusion Criteria:

* Hemoglobin A1c greater than or equal to 11%.(in individuals with diabetes mellitus)
* Anemia (hemoglobin less than 9g/dL)
* Body weight greater than 150 kg or BMI greater than 50
* Uncontrolled hypertension: sustained systolic blood pressure (SBP) greater than 155 mmHg at screening exam (a maximum of 3 screening visits will be allowed for demonstration of blood pressure control)
* Chronic hypotension: sustained SBP less than 85 mmHg at screening exam.
* Glomerulonephritis not in partial or complete remission for 6 months (or estimated/measured proteinuria greater than 10 grams/day)
* Active glomerulonephritis (glomerular disease) include: ANCA associated glomerulonephritis, post-infectious glomerulonephritis, lupus nephritis, amyloidosis, or other monoclonal gammopathy of renal significance.
* Nephrotic syndrome defined as proteinuria greater than 3.5g per 24 hours, plus hypoalbuminemia (serum albumin less than or equal to 2.5g/L) and edema
* Autosomal dominant or recessive polycystic kidney disease
* Kidney failure requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation)
* Active immunosuppression therapy (including prednisone greater than or equal to 10mg daily)
* Kidney transplantation history
* Solid organ transplantation history
* Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure) within 6 months or uncontrolled cardiac arrhythmias
* Liver cirrhosis
* Chronic obstructive pulmonary disease, asthma
* History of blood clotting disorder (thromboembolism; pulmonary embolism, deep venous thrombosis)
* Pregnancy
* Active malignancy
* Active infection
* Active hepatitis B or C, or HIV infection
* History of allergic reaction to cellular products (ie. blood transfusions, platelets)
* Active tobacco use
* Illicit drug use and excessive alcohol use presence of psychosocial issues (e.g., uncontrolled mental illness, unpredictable childcare or eldercare responsibilities, irregular/inflexible work schedule) that may interfere with the ability to complete all study procedures
* Subjects anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits
* Inability or unwilling to have magnetic resonance imaging (MRI) or computed tomography (CT) studies
* Inability to give informed consent
Buprenorphine's Dose Response Curve

This is a residential study that looks at the effects of buprenorphine in persons who abuse but are not dependent on opioids. Animal studies show that very high doses of buprenorphine produce less effects than mid-range doses. This suggests that buprenorphine can be a very safe medication. However, no studies in humans have tested higher doses in a similar way. The goal of this study is to show the effects of single doses of buprenorphine, across a range of doses, in persons who are not physically dependent on opioids (but do abuse opioids).

Preclinical studies have demonstrated for a variety of measures that buprenorphine has a bell-shaped dose response curve. However, human studies with buprenorphine have not shown such an effect, although controlled studies have generally not tested higher acute doses of buprenorphine. Current clinical recommendations generally place an upper limit of daily buprenorphine dosing at 32 mg of sublingual tablets, although considerably higher acute doses have been administered to humans (primarily in clinical studies of less than daily dosing). Determining the relationship between higher doses of buprenorphine in humans and effects produced would be valuable; it would be scientifically interesting to demonstrate a bell-shaped curve in humans, and it would help guide clinical practice (for example, with respect to dosing, safety, and side effect considerations. The purpose of this study is to characterize the dose response curve for buprenorphine in humans, utilizing acute single doses of parenteral buprenorphine.

Eligibility Criteria:
Inclusion Criteria:

1. current opioid abuse but not physically dependent on opioids

Exclusion Criteria:

1. evidence of significant medical (e.g., insulin dependent diabetes) or psychiatric (e.g., schizophrenia) illness
2. anemia defined as a hematocrit less than 30%
3. females are required to provide a negative pregnancy test prior to study participation
4. baseline electrocardiogram (ECG) showing prolongation of the corrected QT interval (QTc)
5. current significant alcohol or sedative/hypnotic drug use
6. Forced expiratory volume at one second (FEV1) of less than 50% at the time of screening
7. applicants seeking treatment for their substance abuse will not be admitted to the study, and should be provided information about treatment services available
Secondary Prevention of coRonary Events After Discharge From Hospital (SPREAD)

This is a randomized, open trial comparing post discharge interventions by community health workers (CHW) to standard care in acute coronary syndrome (ACS) patients.

This trial will be conducted in 10 hospitals in India/different parts(both secondary and tertiary care). A total of 800 patients will be recruited, with equal allocation to SPREAD interventions and control groups (usual care)

Inclusion criteria:

Consenting patients being discharged after an acute coronary event such as unstable angina, acute myocardial infarction, or after coronary intervention (CABG surgery or PCI).

Exclusion criteria:

Patients with other terminal/ debilitating illness, (e.g., advanced cancer, disabling stroke) those not expected to survive for the study duration, those with dementia and psychiatric illness or patients unlikely to comply with study requirements, including regular follow up.

OUTCOME MEASURES:

1. Feasibility
2. Difference in adherence to specific medications for secondary prevention of CAD (Coronary Artery Diseases) compared to the control group, at one year.

Eligibility Criteria:
Inclusion Criteria:

* Consenting patients being discharged after an acute coronary event such as unstable angina, acute myocardial infarction, or after coronary intervention (CABG surgery or PCI).

Exclusion Criteria:

* Patients with other terminal/ debilitating illness, (e.g., advanced cancer, disabling stroke) those not expected to survive for the study duration, those with dementia and psychiatric illness or patients unlikely to comply with study requirements, including regular follow up
Self-Management Interventions for Chronic Pain Relief With Cancer Survivors

Cancer survivors who suffer from chronic pain would benefit from a low-cost, self-management intervention they can use at home. This study will evaluate the efficacy of a recorded hypnosis intervention in reducing chronic pain among cancer survivors and will explore its biological and psychological mechanisms.

The purpose of this randomized controlled trial is to evaluate if a 4-week recorded hypnosis intervention (RHI) works for reducing chronic pain in 100 adult cancer survivors who have completed active treatment. The RHI will be compared to an attention control condition (relaxation recording). qEEG measurement will be obtained while listening to the RHI at weeks 0, 2, and 4 to explore if brain states are related to hypnotic analgesia during the 4-week study period in 20 study participants.

The study has the following specific aims:

Aim 1: Does the RHI work? Evaluate the efficacy of RHI in reducing self-reported pain intensity (primary outcome), pain interference, anxiety, depression, fatigue and sleep disturbance (secondary outcomes) at 4 weeks compared to the attention control condition (relaxation recording). Hypothesis: RHI will significantly reduce pain intensity, pain interference, anxiety, depression, fatigue, and sleep disturbance at 4 weeks.

Aim 2: For whom does the RHI work? Examine if psychological factors (hypnotic suggestibility, mental absorption, treatment outcome expectancy, fear of cancer recurrence, resilience, self-efficacy) influence the relationship between RHI and pain intensity at weeks 0, 2, and 4.

Aim 3: How does the RHI work? a. Compare brain activity as measured by electroencephalogram (EEG) in cancer survivors with chronic pain (n=30) receiving the RHI relative to the attention control condition (relaxation recording) at weeks 0, 2, and 4. b. Explore the effects of brain activity on pain intensity at weeks 0, 2, and 4. In addition, structured interviews will be conducted with participants to understand facilitators and barriers associated with undergoing EEG at three time points and perceptions on how the intervention works to reduce pain.

Eligibility Criteria:
Inclusion Criteria:

* self-reporting moderate or higher pain on average during the last week (\> 3 on a 0-10 pain intensity numeric scale)
* self-reporting experiencing pain at least half of the days in the past 4 weeks
* self-reporting chronic pain related to cancer or its treatment
* completed active cancer treatment other than maintenance therapy
* being \> 18 years of age
* functional fluency in English
* mentally and physically able to participate and complete surveys

Exclusion Criteria:

• has a psychiatric condition or symptoms (i.e., diagnosis of paranoid schizophrenia or active paranoid delusional thoughts, as determined via a telephone or in-person screening assessment) that would interfere with study participation.

Exclusion Criteria for Optional EEG Measurement:

* a history of seizure condition within the last year
* a significant brain injury or skull defect
* a history of brain cancer.
Spironolactone Safety in Dialysis Patients

Cardiovascular disease is the leading cause of death and disproportionately prevalent in patients with kidney disease. Spironolactone has been shown to improve survival in the general population with heart failure by up to 30%. We wish to study the safety and tolerability of aldosterone blockade with spironolactone on cardiac function in a high risk population of patients on hemodialysis. We will study and closely monitor subjects over a period of 12 months, during which they will be receiving spironolactone for a period of 6 months.


Eligibility Criteria:
Inclusion Criteria:

* They must be at least 18 years of age.
* They must understand the study purpose and give their written informed consent.
* They must have been stable on chronic hemodialysis for at least three months before enrollment into the study.
* Hemodialysis subjects will be included if they have had a left ventricular ejection fraction measured within the past six months with a value no more than 45 percent. A repeat, standardized echocardiogram will be used to confirm left ventricular ejection fraction.

Exclusion Criteria:

* Subjects with primary operable valvular heart disease.
* Subjects with a congenital heart disease.
* Subjects with unstable angina.
* Subjects with primary hepatic failure.
* Subjects with active cancer or any life-threatening disease (other than heart failure or end-stage renal disease).
* Subjects who have undergone heart transplantation or who are awaiting heart transplantation are also ineligible.
* Subjects on a renal transplant list will be accepted into the study until the time of successful renal transplantation and termination of dialysis.
* Subjects with habitually difficult to control hyperkalemia (serum potassium \>6.0 meq/L) in the previous month while on dialysis will be excluded.
* The inability to complete the 6-minute walk test will not be a reason to exclude subjects from this study.
Effect of Tranexamic Acid Based on Pharmacokinetics in Pediatric Patients Undergoing Craniosynostosis Surgery: Randomized Controlled Trial

Massive bleeding is expected when performing distraction osteotomy for craniosynostosis patients. Since such operation is performed at very young age, many efforts are performed in order to reduce the total amount of bleeding and the transfusion during and after the surgery. Our study aims at correcting the coagulopathy from massive bleeding and transfusion during distraction osteotomy using continuous infusion of antifibrinolytic agent, tranexamic acid. Tranexamic acid infusion is determined according to the pharmacokinetic model, and the changes in coagulopathy will be defined using thromboelastography.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for distraction osteostomy under the diagnosis of Craniosynostosis.
2. Patients aged from 2 months to 6 years, either of whose patients had consented
3. ASA class 1 or 2

Exclusion Criteria:

1. Coagulopathy with either PT \> INR 1.5 or PLT \< 50,000/dL
2. Patients took any NSAIDs within 2 days, or aspirin within 14 days prior to surgery
3. History of convulsive seizure, epilepsy, any brain surgery
4. Known drug allergic reaction to tranexamic acid
How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolved According to Propulsion: Control With Each mm of Advancement

The OAMMM study is a mono-centrer , non interventional, prospective study, carried out in CH Valence

Oral Appliance is indicated for first line moderate sleep Apnea Syndrome or severe sleep Apnea Syndrome after failure of positive airway pressure (CPAP).

Clinical impact of each mm advancement of Oral Appliance is imperfectly assessed.

The study aim to assess clinical and paraclinical efficacy of an oral Appliance on each mm of advancement.

Oral appliance will be delivered with a propulsion at 50% of the maximum advance and the investigator will titrate the advance according to the usual method

Polygraphy and clinical effectiveness of the Oral appliance will be evaluate

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Moderate sleep apnea diagnosis with clinical signs
* Severe sleep apnea with failure continuous positive airway pressure( CPAP)

Exclusion Criteria:

* previous sleep apnea treatment for Moderate sleep apnea
* refusal to participate in research
* Patient under guardianship, deprived of liberty, safeguard of justice