cyrilzakka/clinical-trials huggingface dataset:
Continues Positive Airway Pressure Treatment for Patients With Dilated Cardiomyopathy and Obstructive Sleep Apnea

The aim of this randomized controlled study is to investigate the effect of continues positive airway pressure (CPAP) treatment in patients with dilated cardiomyopathy (DCM) and concomitant obstructive sleep apnea (OSA). The primary endpoint is left ventricular function measured by magnetic resonance (improvement of at least 4%) after six months treatment with CPAP.

The secondary endpoints include diastolic dysfunction, cardiovascular biomarkers and quality of life.

Sleep apnea, either obstructive (OSA) and central (CSA), occurs in more than half of all patients with heart failure (HF), and is associated with poor prognosis in these individuals.

Dilated cardiomyopathy (DCM) is the most common type of cardiomyopathy and is defined as the presence of the left ventricle dilatation and left ventricular systolic dysfunction without concurrent valvular or coronary artery disease. Its etiology is unclear, but a genetic component is present in at least 25% of cases. In younger individuals, the etiology is more heterogeneous, where a rare type of cardiomyopathy may occur in women in connection with pregnancy, s.c. peripartum cardiomyopathy. Other underlying causes include alcohol, drugs, pharmaceuticals, endocrine disorders, systemic diseases and general muscle. These factors account for approximately half the cases of DCM in younger and other half designated as idiopathic (IDCM).

The relationship between cardiomyopathies and OSA is insufficiently studied so far. In a smaller population of 20 individuals with DCM, sleep apnea (OSA or CSA) had 16, ie 80% of patients. The first-line treatment of OSA is continues positive pressure breathing mask (CPAP) during sleep in patients with daytime sleepiness. Effect of CPAP therapy in patients with DCM and OSA is completely unknown, because many of them do not report daytime sleepiness. The fact that patients with heart failure and reduced pumping function usually have symptoms of including fatigue, it becomes difficult to distinguish what is fatigue due to heart failure and what is related to sleep apnea. Interpretation of the Epworth Sleepiness Scale (ESS) is thus difficult and possibly unsure why all patients with DCM and OSA will be randomized to treatment with CPAP.

Eligibility Criteria:
Inclusion Criteria:

Patients with newly diagnosed or previously known DCM, treated and followed at cardiology outpatients clinic, stable in their symptoms and functional class at least 2 weeks after the last medicine change.

* Consent for the study.
* EF ≤ 45%.
* OSA diagnosis (Apnea-Hypopnea index\> = 15 in the sleep recording below).

Exclusion Criteria:

* Patients already treated with Continues Positive Airway Pressure.
* Patients with claustrophobia
A Crossover Study Assessing the Pharmacokinetics, Pharmacodynamics, and Safety of Recombinant Human Insulin

The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, and safety of recombinant human insulin. The study will consist of 2 phases.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Male Subjects
* Age between 18 and 40 years of age

Exclusion Criteria:

* History of Diabetes
* Subjects with clinically significant active disease
* Known allergy to insulin
Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in CRC

This study select the diagnosis of postoperative colorectal cancer patients with stage II/III to adjuvant chemotherapy, and received 2 weeks and 3 weeks xelox adjuvant treatment process until disease progression or patients died or lost to follow-up. To analyze the difference in efficacy and safety of xelox in 2 weeks and 3 weeks of postoperative adjuvant therapy for colorectal cancer, so as to find a better postoperative adjuvant treatment model.


Eligibility Criteria:
Inclusion Criteria:

* Carcinoma of the intestine confirmed histologically or cytologically
* Radical surgical resection was performed after diagnosis and the post operative stages were high-risk II or III patients
* The ECOG PS score less than or equal to 2 points
* No chemotherapy of any kind has been performed in the past
* Neutrophils acuity 1.5x10e9/L, platelets more than 100x10e9/L, college blood red protein more than 9g/dL
* liver function transaminase is less than or equal to 2.5 ULN, alkaline phosphatase is less than 2.5 ULN, and total bilirubin is less than 1.5 ULN

Exclusion Criteria:

* Patients with unresectable CRC
* Patients who have any form of chemotherapy before
* Participating in or having participated in clinical studies of other drug
* Patients have second primary malignant tumors of have other malignant tumors in the past five years
* There is evidence of allergic reaction to drugs in this study
* A history of ischemic heart disease in the past 1 year or patients with high risk factors for heart failure, or uncontrolled arrhythmias
* Severe active inflammation, including tuberculosis and HIV
* Long-term immunization or hormone therapy, except hormone replacement therapy at physiological dose
* Drug or alcohol addiction
* Get pregnant or breastfeed
* The investigator considers that the patient is not suitable for this clinical study due to any clinical or laboratory abnormalities or compliance problems
Optimizing the Temperature for Embryo Culture in In Vitro Fertilization

Many human and animal studies over the past 40 years have revealed that ovaries and Fallopian tubes have a lower temperature than core body temperature, especially around the time of ovulation and early embryo development. Whether average core body temperature, 37 degrees Celsius, is ideal temperature for culture has not been prospectively evaluated. The purpose of this study is to determine whether lowering the incubator temperature by 1 degree Celsius will result in meaningful improvements in embryo development and pregnancy rates.

Patients participating in this study will undergo routine in vitro fertilization (IVF) stimulation. Following egg retrieval, patients with at least 8 mature eggs will have those eggs divided randomly into two groups. Both groups will then under ICSI (intra-cytoplasmic sperm injection) to fertilize the eggs. The groups will randomly be assigned to control or study condition. The control condition group will be cultured at 37 degrees Celsius, the current standard of care. The study group will be cultured at 36 degrees Celsius. All other culture conditions will be kept identical and embryos will be assessed on day 3 and day 5 of development.

On day 5, all well-developed blastocysts will undergo biopsy for Comprehensive Chromosomal Screening (CCS), which will evaluate the chromosomal normalcy of the embryo . Patients will undergo transfer on the morning of day 6 and the highest quality, chromosomally normal embryo from each group (the 36 degree cultured embryos and the 37 degree cultured embryos) will be transferred. If only 1 embryo is available for transfer, the patient will have a single embryo transfer.

All embryos available for cryopreservation will undergo biopsy for CCS before being frozen. Some arrested embryos from each temperature group will also undergo genetic analysis to evaluate chromosomal normalcy or mosaicism.

The female patient will undergo a blood draw at 9 weeks gestation and buccal swabs will be obtained from the infant(s) after birth.


Eligibility Criteria:
Inclusion Criteria:

* No more than 1 prior failed cycle at RMA NJ facility; up to 2 prior failed cycles at another facility pending investigator review
* Female partner between 18 and 41 at onset of IVF cycle
* Normal day 3 FSH (\< or = 12) in RMA NJ laboratory
* Basal antral follicle count of at least 10
* Male partner with greater than 100,000 total motile spermatozoa per ejaculate (donor sperm is ok)
* BMI \< or = 32 kg/m2

Exclusion Criteria:

* Diagnosis of chronic anovulation (cycles occuring typically less often than every 90 days)
* Use of testicular aspiration or biopsy procedures to obtain sperm
* Unevaluated ovarian mass or diagnosis of surgically-confirmed stage IV endometriosis
* Presence of hydrosalpinges that communicate with the uterine cavity
* History of endometrial insufficiency
* Any contraindication to undergoing IVF or gonadotropin stimulation
* Prior poor fertilization rate- less than 50% of mature eggs
* Prior poor blastulation rate- less than 10% of 2PNs (day 1 embryos)
Evaluation of Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of Ravulizumab Administered Intravenously in Pediatric Participants With Generalized Myasthenia Gravis (gMG)

The primary purpose of this study is to characterize the pharmacokinetics and pharmacodynamics of treatment with ravulizumab intravenous infusion in pediatric participants with gMG.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of gMG confirmed by a positive serologic test for anti-AChR antibodies (Abs) obtained at Screening and/or during Screening Period
* Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to Class IV at Screening
* Participants receiving treatment must be on a stable dosing regimen of adequate duration prior to Screening and during the Screening Period.
* Eculizumab-experienced participants must have been enrolled and treated with eculizumab in Study ECU-MG-303 for at least 6 months (180 days) and must have been on a stable dose for ≥ 2 months (60 days) prior to Screening.
* All participants must be vaccinated against meningococcal infection

Exclusion Criteria:

Medical Conditions

* Any untreated thymic malignancy, carcinoma, or thymoma.
* Participants with a history of treated benign thymoma
* History of thymectomy, thymomectomy, or any thymic surgery within the 12 months prior to Screening
* History of N meningitidis infection
* Known to be human immunodeficiency virus (HIV) positive
* History of unexplained infections
* Known or suspected history of drug or alcohol abuse or dependence within 1 year prior to the start of the Screening Period
Therapeutic Education Program in Psoriasis

The primary objective of this research protocol is to assess the effect of a structured therapeutic education program on the quality of life of patients with moderate to severe psoriasis

Psoriasis is a chronic inflammatory skin disease affecting 1 to 3% of the French population. Moderate to severe psoriasis has a significant impact on quality of life. Psoriasis is associated with an increased risk of depression, social isolation, unemployment. In addition, it has recently be shown that patients with moderate to severe psoriasis have an increased incidence of cardiovascular risk factors such as hypertension, overweight, hyperlipidemia and exposure to tobacco and alcohol. These so-called comorbidites may have a negative impact on psoriasis management. They also may account for the reduced life expectancy reported in patients with severe psoriasis. Therapeutic education is a structured process whose objective is to help patients to acquire or to maintain competencies that are required to live with a chronic disease. Therapeutic education is an important process to be integrated into the therapeutic strategy. It has to take into account co-morbidities, social and psychological context and its priorities need to be defined with the patient.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe psoriasis defined as patients receiving a systemic psoriasis treatment including methotrexate, cyclosporine, PUVA, retinoids or a biological agent and with significant impact on quality of life defined as a Skindex \> 18
* Patients with palmo-plantar or erythrodermic psoriasis may be included if they can be classified as moderate to severe according the above described definitions

Exclusion Criteria:

* Patients not able to give informed consent,
* Patients not able to follow the program,
* Patients without social security affiliation.
Cerebral Perfusion in Hypothermic Circulatory Arrest

Selective antegrade cerebral perfusion (sACP) during aortic arch surgery in hypothermic circulatory arrest (HCA) is an established method for intraoperative neuroprotection. Although sACP is established as a beneficial method to reduce secondary neurological side effects due to brain-malperfusion, there are several parameters like sACP flow rate, perfusion pressure or temperature of the perfusate, where the optimal values remain unclear. The flow rate of the sACP-perfusate is increased according to center-specific standard-procedures. The optimal sACP flow rate, monitored by near infrared spectroscopy (NIRS), is to be investigated in this single center clinical prospective observational study. 40 Patients are enrolled over an estimated period of 14 months.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Elective cardiac surgery with cardiopulmonary bypass
* Hypothermic circulatory arrest
* General informed consent signed

Exclusion Criteria:

- Severe stenotis in cerebral arteries
Personalized B-fructan Diet in Inflammatory Bowel Disease Patients

This study aims to examine patient tolerability of personalized dietary fibre consumption recommendations (high-pectin diet versus high-B-fructan diet based on personalized responses), provided by an IBD dietician, based on our novel translational research findings.


Eligibility Criteria:
Inclusion Criteria:

* Children (age 6-17) or young adults (age 18-39).
* Known or suspected UC or IBDU \[there will be 2 control group: non-IBD (undergoing colonoscopy but found not to have IBD; and healthy (no GI symptoms, so not required to have colonoscopy; could be family members)\]
* For UC: Remission-mild-moderate disease: Mayo score \<10
* Clinical indication for sedated colonoscopy
* Disease location: E2-E4
* Stable treatment (not on steroids; biologics or immunomodulator not changed in last month)
* High likelihood that patients will be able to collect all samples and provide all data

Exclusion Criteria:

* Use of antibiotics for a week or more over the last 3 months
* Use of probiotics or prebiotics at pharmacological doses (adding fibre sources to food or probiotics in yogurt, for example, are allowed)
* History of abdominal surgery, including appendectomy
* Documented enteric infection during the 3 months prior to endoscopy
* Presence of non-IBD bowel conditions (e.g., celiac), anatomical or mucosal abnormalities, motility disorder
* Presence of a systemic disease requiring treatment (cancer, ischemic heart disease, kidney failure, etc)
* Proctitis (E1)
* Systemic steroids (above 10 mg/day of Prednisone)
* Topical therapy within 1 week of endoscopy
* Recent change in IBD treatment (started biologics or IM over the last month)
* Pregnancy or planning to become pregnant during the study
* Inability to understand or sign the consent
Telithromycin, Treating Adult Outpatients With Mild to Moderate Community-acquired Pneumonia (CAP) in High Bacterial Resistance Areas

Demonstrate efficacy of telithromycin over single-agent oral antibiotics usually prescribed by local guidelines ("usual care") for treating adult outpatients with mild to moderate community-acquired pneumonia (CAP) in high bacterial resistance areas.


Eligibility Criteria:
Inclusion Criteria:

* Adult outpatients with mild to moderate CAP. Diagnosis of CAP was based on the presence of fever and/or hyperleucocytosis and the new and sudden onset of at least two clinical signs and symptoms of pneumonia (cough, dyspnea or tachypnea, chills, pleuritic chest pain, purulent sputum or change in sputum character, auscultatory findings). Clinical diagnosis of CAP had to be confirmed by chest X-ray findings (e.g. presence of presumably new infiltrate). Specimens for microbiological documentation had to be collected within 24 hours prior to enrollment.

Exclusion Criteria:

* Subjects requiring parenteral antibiotic treatment.
* Subjects with severe CAP requiring hospitalization. The CAP was to be considered as severe in the presence of any of the following conditions:
* chest X-ray showing a multilobar consolidation (\> 1 lobe)3 and/ or an increase in the size of the opacity by greater than or = to 50% within 48 hours of the current evaluation
* shock
* altered mental status (disorientation to person, place or time that is not known to be chronic, lethargy, stupor or coma)
* total peripheral white blood cell count \< 4,000/mm3
* requirement for mechanical ventilation
* requirement for vasopressors
* acute renal failure

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of fluorouracil with or without mitomycin in treating patients who have peritoneal cancer.

OBJECTIVES: I. Compare the efficacy of adjuvant systemic fluorouracil with intraperitoneal mitomycin vs systemic fluorouracil alone in terms of survival in patients with peritoneal cancer originating from the colorectum.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and mode of surgery. Patients are randomized to one of two treatment arms. Arm I: Patients undergo complete resection of tumor on day 0. Patients then receive mitomycin intraperitoneally (IP) over 23 hours on day 1 and fluorouracil IP over 24 hours on days 2-5. Patients then receive one of three systemic chemotherapy regimens for 6 months: Regimen I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2. Treatment repeats every 2 weeks. Regimen II: Patients receive fluorouracil IV continuously for 7 weeks. Treatment repeats every 8 weeks. Regimen III: Leucovorin calcium and fluorouracil are administered as per standard procedure. Arm II: Patients receive treatment as in arm I but without early intraperitoneal chemotherapy. Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: At least 90 patients (45 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven peritoneal cancer that is amenable to total resection Originated as colorectal adenocarcinoma or cancer of the appendix No diffuse (unresectable) tumors No microscopic cancer only No hepatic, lymph node, or extraabdominal metastases on the preoperative work-up No primitive peritoneal mesothelioma No peritoneal pseudomyxomas or ascites No cancer that originates as ovarian or neuroendocrine cancer, especially sarcomas (intra- or retroperitoneal) Complete resection of tumor deposit No originating cancer of unknown origin

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC greater than 1,500/mm3 Platelet count greater than 100,000/mm3 No chronic hematologic disorder No coagulation disorder Hepatic: Not specified Renal: Creatinine less than 1.36 mg/dL Other: No significant medical condition that would preclude study

PRIOR CONCURRENT THERAPY: See Disease Characteristics
The Effects of Topical Almond Oil and Tretinoin on Facial Wrinkles

Investigate the topical use of almond oil, almond oil augmented with 0.5% vitamin E, 0.025% tretinoin oil augmented with castor oil on the appearance of facial fine lines and wrinkles, pigmentation, hydration, trans-epidermal water loss, and sebum excretion rate.

The natural cosmetic market is a multi-billion dollar industry. Nutraceuticals and food-based cosmetics are a growing trend within dermatology. Almonds are a rich dietary source of a range of fatty acids, phytochemical polyphenols, and antioxidants. Our previous study was a double blinded study that compared almond consumption interventions to a calorie matched intervention over 16 weeks. The study determined that that there was a statistically significant 8.41% improvement in wrinkle severity in the women that received almond supplementation. This proposal aims to now understand how the topical application of almond oil may influence the appearance of wrinkles and facial tone in post-menopausal women. Almond oil is rich in fatty acids and alpha-tocopherol. Tocopherol inhibits melanogenesis in melanocytes and topical alpha tocopherol has been shown to improve skin antioxidants and hyperpigmentation. A challenge of almond oil is that it is prone to oxidation due to its high unsaturated fatty acid concentrations. However, tocopherol has also been shown to improve almond oil stability.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women of Fitzpatrick skin types 1, 2, and 3
* Individuals with facial fine lines and wrinkles

Exclusion Criteria:

* Individuals who are pregnant or breastfeeding
* Prisoners
* Adults unable to consent
* Those with a nut allergy or tocopherol allergy
* Current smokers, those that have smoked within the past year, and former smokers with greater than a 10-pack- year history of smoking
* Those with an autoimmune photosensitive condition or a known genetic condition with a deficiency in collagen production (such as Ehlers-Danlos syndromes)
* Those who have undergone any cosmetic procedures to the face in the 3 months prior to enrollment in the opinion of the investigator. People that have undergone deeper chemical peels (TCA based peels) within 1 year prior to enrollment
* Individuals who are unwilling to discontinue vitamin E containing supplements and food sources such as all nuts, sunflower seeds or sunflower oil during the washout and intervention
* Individual who are unwilling to discontinue topical cosmetic products during the duration of the study or unwilling to undergo a 2-week washout of topicals that are known to modulate collagen and pigment:
* Retinoids such as tretinoin, adapalene, retinol, except as provided by the study.
* Antioxidant ingredients such as vitamin C or vitamin E.
* Pigment reducing agents such as hydroquinone, azelaic acid, kojic acid, or a retinoid except for the retinol that is provided in this study.
* Topicals that contain a nut oil or nut extract as part of their ingredient list.