cyrilzakka/clinical-trials huggingface dataset:
The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery

Sleep deprivation is known to affect brain function but is often ignored in the sickest patients including those in the intensive care unit after major surgery. In these patients, the levels of melatonin can also be altered. Melatonin is a hormone secreted in the brain that maintains the body's sleep-wake, or circadian, cycle. The investigators want to test whether improving sleep quality affects the risk of developing confusion (delirium) in patients having clot removed from their lung (open heart surgery). In order to improve sleep quality, the investigators will conduct a study of Ramelteon, a medication that mimics the activity of melatonin and measure its effects on levels of melatonin and monitor sleep.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) who are admitted to UCSD for a planned PTE surgery.
* Age \> 18 years

Exclusion Criteria:

* Pregnancy
* Cirrhosis of any etiology
* Current use of any atypical antipsychotic including Fluvoxamine (contra-indicated with Ramelteon)
* Any contraindication to EEG/Sleep recording
* Non-English speaking (who are unable to complete delirium questionnaires)
Effect of Plant Stanols on Cholesterol Absorption

This study aims to measure the effect of three different doses of plant stanols in margarine on the cholesterol absorption efficiency in subjects with mildly to moderately increased serum LDL cholesterol concentrations

Serum cholesterol lowering effect of plant sterols is well established and it is also known that plant stanols inhibit the absorption of cholesterol. However, there is lack of dose-response studies directly measuring the cholesterol absorption efficiency during prolonged consumption of plant stanols. Therefore this study aims to measure the cholesterol absorption efficiency at different plant stanol consumption levels using a stable isotope tracer method.

Subjects will be randomized in their study groups that consume 20 g of margarine with different doses of plants stanols (0.8, 1.6 and 2.0g) based on cholesterol absorption efficiency at screening (high and low absorbers randomised separately). Cholesterol absorption test with cholesterol tracer will be conducted twice: at baseline and after 2-3 weeks margarine consumption period.

Cholesterol absorption efficiency will also be examined by indirect method i.e. by following the concentrations of serum cholesterol precursors and plant sterols in blood. In addition serum total, LDL and HDL cholesterol and triglycerides are followed.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults with mild to moderate hypercholesterolemia

Exclusion Criteria:

* lipid lowering medication
* pregnancy or lactation
* severe diseases (inc. diabetes, unstable CVD, malignant diseases)
* severe obesity
* regular plant sterol consumption
AMX0035 in Adult Patients With Wolfram Syndrome

This study is an open label Phase II study to evaluate the safety and efficacy of AMX0035 in adults with Wolfram syndrome.

AMX0035 is a combination therapy designed to reduce neuronal death through blockade of key cellular death pathways originating in the mitochondria and endoplasmic reticulum (ER). This clinical trial is designed to demonstrate that treatment is safe, tolerable, and to evaluate the effect of AMX0035 on residual beta cell functions by monitoring c-peptide levels during a 0-240 minute mixed-meal tolerance test. The trial will also assess the effects of AMX0035 on changes to diabetic measurements including daily insulin dose, time in good glucose range, and HbA1c levels. Effect on best-corrected visual acuity in both eyes will also be evaluated.

Eligibility Criteria:
Key Inclusion Criteria:

* Definitive diagnosis of Wolfram syndrome
* Insulin dependent diabetes mellitus due to Wolfram syndrome
* At least 17 years of age
* Participant must be willing to wear a CGM device for the duration of the study

Key Exclusion Criteria:

* Presence of pathologies that can alter the enterohepatic circulation of bile acids (e.g., ileal resection and stoma, regional ileitis)
* Any history of heart failure per New York Heart Association (NYHA)
* History of or family history of breast and/or ovarian cancer
* Participant under severe salt restriction where the added salt intake due to treatment would put the patient at risk, in the Investigator's judgment
* Received treatment with any investigational drug or device within the 30 days (or 5 half-lives, whichever is longer) prior to first dose at Day 1
* Previous treatment with gene or cellular therapy
Ridge Augmentation Comparing a Block Allograft to a Demineralized Bone Matrix Allograft.

This study with compare the ridge dimension changes for a block allograft vs. a demineralized bone matrix moldable allograft.

The patients' treatment will be randomly assigned by coin toss done by the mentor immediately after flap reflection. The examiner will be blinded to the treatment and will not have access to information indicating treatment assignment. The examiner will never see the patient between the time of grafting and complete healing at 4 months. The surgical procedure will consist of the reflection of a split-thickness flap to expose the alveolar ridge. Following complete exposure of the surgical site, vertical measurements will be taken with the acrylic occlusal stent in place, and horizontal measurements with a specially designed digital caliper. After initial surgical measurements, numerous cortical perforations will be performed with a round bur in the area of the augmentation. The control group will receive a block graft and bone screw for stabilization, with voids being filled by the Optecure+CCC®. The test group therapy will include graft with the Optecure+CCC® and the use of Bone Pin® for space maintenance. Horizontal dimension will be established by graft dimensions, bone screws, or bone pins when necessary, for each planned implant area. Longer span edentulous spaces will be divided into individual sites as follows: 5 mm from natural teeth to future mid-implant sites and 7 mm between two future mid-implant sites. The bone pins and bone blocks with bone screws will be placed to allow enough exposure for augmentation to achieve 9 mm horizontal width available for implant placement. Vertical and horizontal measurements will again be taken with the acrylic occlusal stent and calipers prior to flap closure. An resorbable membrane will cover both test and control groups. A monofilament suture material will be used. The surgical procedures will be documented with clinical photographs.

Eligibility Criteria:
Inclusion Criteria:

* At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
* Healthy person that is at least 18 years old.
* Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

* Patients with debilitating systemic diseases, diseases that significantly affect the periodontium, or psychological problems that would interfere with treatment.
* Previous head and neck radiation or chemotherapy within the previous 12 months.
* Patients with known allergy to any of the materials that will be used in the study.
* Smokers.
* Patients who need prophylactic antibiotics prior to dental procedures.
* Patients on long-term steroid therapy or oral bisphosphonates \> 3 years or any IV bisphosphonates.
* Patients who are pregnant
The Effect of Binasal Occlusion on Balance Following a Concussion

This study evaluates the effect of binasal occlusion (BNO) glasses on balance and eye movement in adults with dizziness after a concussion. Participants will stand on a force plate while rapidly reading a series of numbers both with and without the BNO glasses. It is thought that the BNO glasses will improve both balance and the time to read the numbers.

While most individuals will recover within the first month after concussion, a significant number will continue to experience dizziness, balance problems, cognitive deficits, and vision problems. Single-task measures of static balance may not be sensitive enough, however, to capture mild postural changes still associated with incomplete recovery. Increasingly there is an interest in dual-task paradigms of balance assessment as a more accurate representation of functional postural control associated with activities of daily living and sport participation. Binasal occlusion (BNO) has been proposed as a means of providing visual stabilization to improve postural control in individuals with vision-related balance problems following a concussion.

Eligibility Criteria:
Inclusion Criteria:

Forty adults with persistent symptoms one month or more following a concussion will be recruited for the study. Individuals will be considered eligible if they have been diagnosed with a concussion as defined in the 2016 Berlin consensus statement (McCrory et al., 2017) as a traumatic brain injury induced by biomechanics forces, which was caused by either a direct or indirect blow to the head, face, neck or elsewhere on the body with an impulsive force transmitted to the head, which may or may not have involved loss of consciousness, and included one or more of the following clinical domains:

* Symptoms (e.g. headache, nausea, fatigue, feeling like in a fog, difficulty concentrating or remembering, and/or emotional lability)
* Physical signs (e.g. loss of consciousness, amnesia, neurological deficit);
* Balance impairment (e.g. gait unsteadiness)
* Behavioural changes (e.g. irritability)
* Cognitive impairment (e.g. slowed reaction times)
* Sleep/wake disturbance (e.g. somnolence, drowsiness) Participants must also meet the following inclusion criteria: (1) aged 18-65 years; (2) sustained the concussion 4 or more weeks ago; (3) report persistent dizziness or balance problems not accounted for by a pre-existing musculoskeletal, neurological, or vestibular condition; (4) have normal vision or visual impairments that can be corrected with contact lenses; (5) are proficient in English or French; (6) are able to provide informed consent.

Exclusion Criteria:

* Do not meet criteria stipulated in the inclusion criteria
Interest of CALR Allele Burden in Diagnosis and Follow-up of Patients With CALR Mutated Myeloproliferative Syndromes (CALRSUIVI)

Prospective study to evaluate the relevance of CALR allele burden monitoring as a molecular marker of disease progression.

A first local study on 45 patients showed the prognostic impact of CALR mutation quantification in follow-up, independently of the European LeukemiaNet (ELN) prognostic score validated in this group of patients.

This study aims to evaluate a multicenter cohort of 260 patients, including all types of CALR-mutated MPNs and several follow-up samples, to model the temporal evolution of CALR allele burden.

Blood of MPN patients will be collected, at the time of diagnosis and for 3 years (max 1 sample/year), for the quantification of the CALR allele burden. During follow-up, a clinicobiological score to define the progression or not of the disease for each patient will be evaluated in Essential Thrombocythemia (ET) and MyeloFibrosis (MF).

Eligibility Criteria:
Inclusion Criteria:

* adults (age ≥18 years),
* affiliated to the national social security system,
* with CALR mutated myeloproliferative neoplasm diagnosed between 2006 - 2020,
* for which at least one sample is available at the time of diagnosis or before cytoreductive treatment,
* who signed the consent to participate in the study,
* included, or consenting to be included, in the national clinical-biological database of France Intergroupe Syndrome Myéloprolifératifs (FIM).

Exclusion Criteria:

* patient with another active hematological disease or cancer at the time of diagnosis,
* person subject to legal protection scheme or incapable of giving consent.
LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)

The purpose of this research study is to measure the depigmenting effect of a serum product called Liftactiv B3 in patients with mild to moderate facial PIHP (Post Inflammatory Hyper Pigmentation)


Eligibility Criteria:
Inclusion Criteria:

* Multiethnic subjects
* 18 to 50 YO
* Phototype III-VI
* All skin types
* 50% with sensitive skin (declarative)
* Symmetrical mild to moderate facial post-acne PIHP lesions with IGA scale
* Mild active acne (less than 10 retention and 5 inflammatory lesions)
* Agreeing not to change their lifestyle during the study period.
* Capable of reading the documents presented to them, of adhering to the study regulations and accepting the limitations.
* Available to follow the study
* Agreeing to participate and having signed the informed consent

Exclusion Criteria:

* Moderate to severe active acne
* Patients under topical or systemic retinoids
* Patients under systemic immunosuppressants
* Patients under active treatment of PIHP (including topicals or procedures) within the last 3 months
* Patients treated with facial procedures within the last 3 months
* Pregnancy
* Patient with a recent change in contraception (since less than 6 months)
* Known allergy to any component of tested product
* Not presenting with the conditions needed to comply with the protocol.
* Unable to give their informed consent
* Not available to follow the study in its entirety
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Comparison to Mycophenolate Mofetil (MMF) in de Nove Heart Patients

This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in de novo heart recipients.


Eligibility Criteria:
Inclusion criteria

* Male or female cardiac patients 18-65 years old undergoing primary heart transplantation treated with CS-ME and corticosteroids as basic immunosuppression.
* Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
* Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

Exclusion criteria

* Patients with donor hearts greater than 60 years of age and/or with cold ischemia time of more than 6 hours and/or donor hearts which have obvious coronary disease or are known to have heart disease at time of transplant.
* Patients on Left Ventricular Assist Device who have received any immunotherapy prior to transplantation or who are scheduled to receive immunotherapy thereafter.
* Patients with Panel Reactive Antibodies (PRA) 25%.
* Patients with serum creatinine 3.0mg/dL..
* Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
* Patients with a history of significant coagulopathy or medical condition requiring long term anti-coagulation after transplantation (low aspirin treatment is allowed).

Other protocol-defined inclusion/exclusion criteria may apply
Early Pregnancy Sample Collection Study

Female volunteers, wishing to become pregnant will be offered the use of Clearblue ovulation prediction products to help identify their most fertile time and aid conception. Volunteers will provide SPD with a daily urine sample throughout the study period, which will be used for the development and validation of SPD products related to pregnancy and fertility.

In order to develop and validate new and existing products SPD needs to maintain a sample bank of early pregnancy urine samples from the beginning of the cycle in which pregnancy is achieved, and throughout pregnancy.

This generic study will be initiated to maintain the SPD sample bank, the study will run continuous to replenish the sample bank, as samples are used.

To obtain these samples, volunteers wishing to become pregnant will be offered the use of a Clearblue ovulation prediction product to enable them to pinpoint their most fertile time and aid conception. Whilst on the study volunteers will be asked to collect daily urine samples and return them to SPD on a regular basis in addition to keeping a daily record of menstrual cycle details and test results. Women who become pregnant during the course of the study will be asked to continue collecting daily urine samples for a minimum of a further 4 weeks. Each volunteer will be on the study for a minimum of 1 and a maximum of 3 cycles. Volunteers will not be allowed to re-enter the study once they have completed without achieving pregnancy

It is anticipated that any one of SPD's marketed ovulation prediction products may be used in this study to aid the conception rate, this may include, but not be limited to the Clearblue fertility monitor and Clearblue digital ovulation test.

It is anticipated SPD will have to recruit approximately 600 volunteers to achieve each 100 pregnancies and that approximately 500 volunteers will be participating at any one time. The study size may be increased or decreased to meet sample demands.

Eligibility Criteria:
Inclusion Criteria:

* Female, age 18-45
* Have menstrual bleeds
* Seeking to become pregnant
* Willing to provide written, informed consent

Exclusion Criteria:

* Known condition to contra-indicate pregnancy
* Having treatment for infertility.
Fatty Liver and Pancreatic Steatosis

The goal of this observational study is to determine the prevalence of pancreatic steatosis in patients with fatty liver and determine the prevalence of exocrine pancreatic insufficiency (EPI) in these patients.

Participants with fatty liver and metabolic syndrome will undergo fecal elastase measurement and endoscopic ultrasound (EUS).

The purpose of this study is to evaluate the association between non-alcoholic fatty liver disease and non-alcoholic pancreatic steatosis and to describe cytokine levels in the context of a global epidemic of obesity and metabolic syndrome, which could represent a new treatment target in previously underdiagnosed patients with pancreatic insufficiency and pancreatic steatosis.

Patients over 18 years old with a diagnosis of MAFLD (Metabolic Dysfunction-Associated Fatty Liver Disease) will undergo the following assessments:

* Exocrine Pancreatic Insufficiency Questionnaire (PEI-Q)
* Measurement of weight, height, and abdominal circumference
* Fecal elastase (Fel-1)
* Pro-inflammatory and anti-inflammatory cytokines in serum
* Hydrogen and methane breath tests to evaluate small intestinal bacterial overgrowth (SIBO)
* Endoscopic ultrasound with sedation
* Fibroscan Exocrine pancreatic insufficiency (EPI) will be defined as a fecal elastase-1 (Fel-1) concentration of \< 100 µg/g or Fel-1 between 100 and 200 µg/g with alterations in additional pancreatic pathology tests, such as serum albumin, vitamin E, vitamin D, vitamin A, folic acid, iron, transferrin, calcium, magnesium, and/or malnutrition identified through anthropometric measurements conducted by an expert nutritionist. Fel-1 ≥ 200 µg/g will be considered normal.

Additionally, for those patients with fecal elastase levels below 200 µg/g, the following measurements will be conducted:

* Proteinogram
* Vitamin E, vitamin D, vitamin A, vitamin K
* Folic acid, B12
* Calcium, magnesium, zinc
* Iron profile
* Nutritional assessment with anthropometry

For those with exocrine pancreatic insufficiency (EPI):

* IgG4
* Alpha-1 antitrypsin
* Endoscopic ultrasound (EUS) with biopsies

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old with a diagnosis of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).

Exclusion Criteria:

* - Alcohol consumption \>20 g/day in women, \>30 g/day in men
* Chronic hepatitis B or C infection
* Autoimmune liver diseases: autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis
* Hereditary hemochromatosis
* Wilson's disease
* Alpha-1 antitrypsin deficiency
* Celiac disease
* Uncontrolled thyroid disease
* Active or chronic infectious disease
* Active cancer or ongoing treatment
* Chronic renal insufficiency
* Pregnancy/lactation
* Insufficient data
* Patients who do not complete follow-up
Effect of Intervention on Progesterone Levels Before Euploid Embryo Transfer in Pregnancy Outcomes.

Transferring an euploid embryo avoids one of the main reasons of miscarriage and implantation failure (1), overcoming confounding factors such as embryo ploidy or maternal age. Frozen Euploid Embryo Transfer (FEET) is routinely performed under standard hormone replacement therapy (HRT) and could be considered the best model for evaluating the impact of the endometrial preparation in clinical pregnancy rate and also in miscarriage rate.

Recently several authors have paid attention to serum progesterone (P) as a possible factor influencing Frozen Embryo Transfer (FET) outcomes. P plays an important role in endometrial gland formation, embryonic implantation and pregnancy maintenance. Labarta et al. (2) described in blastocyst FET performed under HRT that serum P \<9.2 ng/mL measured on the transfer day is associated to significantly lower ongoing pregnancy rate (OR 0.297, 95% CI:0.113-0.779).

Recently the investigators have analyzed 244 FEET performed under HRT in a retrospective study (3). Preimplantation genetic testing for aneuploidies (PGT-A) was carried out as previously described (4). Embryos that reached the blastocyst stage were biopsied and frozen immediately afterwards using the vitrification method (5). Euploid embryos were transferred in a subsequent cycle under HRT. Serum P was analyzed the day previous to FEET. Patients with serum P \<10.6 ng/mL had significantly higher miscarriage rate (26.6% vs 9.5%, p=0.007) and lower live birth rate (47.5% vs 62.3 %, p= 0.029) than those with serum P \>10.6 ng/mL. The investigators also observed that patients with serum P \>13.1 ng/mL had the lowest miscarriage rate (9.1%) and the highest live birth rate (65.6%). The worst outcomes were observed when serum P was \<8.06 ng /mL (41% live birth rate and 32.4% miscarriage rate).

As miscarriage was higher among FEET cycles with serum P \<10.6 ng/ml, the investigators hypothesize that altering the progesterone supplementation scheme could potentially reduce miscarriage rates and increase live birth rate. The purpose of this study is to modify the standard progesterone supplementation in FEET under HRT (vaginal micronized progesterone 200 mg every 8 hours) (6) according to serum P measured not only on the day prior to transfer but also on Beta subunit of Human Chorionic Gonadotropin (β-hCG) analysis day, and to probe if this intervention reduces miscarriage rate and increases pregnancy outcome.


Eligibility Criteria:
Inclusion Criteria:

* FEET of at least one single embryo
* HRT
* Endometrial thickness \>= 6 mm measured day 4 of progesterone supplementation

Exclusion Criteria:

* Patients with mosaic embryos.
* Uterine abnormality.
* Natural cycle protocol