cyrilzakka/clinical-trials huggingface dataset:
Hepassocin Levels in Patients With Polycystic Ovary Syndrome

The investigators aimed to investigate hepassocin levels in patients with polycystic ovary syndrome (PCOS). There are 3 groups aged between 18 and 35 years as non-obese healthy women, non-obese women with PCOS, and obese women (BMI\>30) with PCOS.

Hepassocin, also known as Fibrinogen-like-protein or hepatocyte-derived fibrinogen-related protein 1, is a new marker for obesity and insulin resistance. In hepatic injury, it protects liver cells and promotes regeneration. High levels of hepassocin was shown to be independently associated with HOMA-IR and diabetes. Since insulin resistance is known to be seen in patients with PCOS, it may be expected that hepassocin levels may be higher in this group of patients.

Eligibility Criteria:
Inclusion Criteria:

* 60 patients with PCOS aged between 18 and 35 and age-matched 30 healthy women with BMI\<30

Exclusion Criteria:

Premature ovarian failure (FSH \>30 mIU/mL), tumors secreting androgens, non-classical congenital adrenal hyperplasia, Cushing syndrome and irregular menses due to thyroid dysfunction (TSH \>5 mIU/L ), hyperprolactinemia, more than twofold high transaminase levels (\>70 U/L), patients with cigarette smoking, alcohol consumption, oral contraceptives use, medications that are affecting liver function test, insulin metabolism and lipid metabolism, patients with a history of chronic diseases such as diabetes mellitus, hypertension, chronic liver disease, chronic kidney disease, autoimmune disease, inflammatory disease, malignant disease, bleeding disorders, and thrombosis were also excluded. All the patients were beta-HCG, hepatitis B surface antigen, and hepatitis C antibody negative.

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Counteracting Age-related Loss of Skeletal Muscle Mass (CALM)

Up to 66 healthy elderly individuals (at least 65 years old) are recruited as subjects. They will be recruited as a subgroup to protocol ID: H-4-2013-070.

Upon inclusion, each individual will be randomized into one of the five groups stratified according to gender (M/F) and 30s chair stand (\<16 OR ≥16). The five groups are: Heavy Resistance Training (N=12), Light Intensity Training (N=12), Protein Whey (N=15), Protein Collagen (N=15) and Carbohydrate (N=12). The individuals randomized into one of the supplementation groups (Protein Whey, Protein Collagen or Carbohydrate) will be blinded to the supplement content.

Assessments will be performed at Baseline (before intervention start) and after 12 months of intervention.

The primary outcomes are measures of muscle protein synthesis rate measured as the fractional synthesis rate from Baseline to 12 months of intervention.

The hypotheses are i) that basal and protein-stimulated muscle protein synthesis rates are elevated in the exercise training groups after 12 months of intervention. ii) prolonged intake of protein of different quality will improve the muscle protein synthetic response to protein intake after 12 months of intervention.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, independently living
* Age at least 65 years

Exclusion Criteria:

* Subjects dependent on help/nursing etc.
* Chronic medical diseases: diabetes mellitus, clinical knee or hip osteoarthritis, other types of arthritis or connective tissue disorders, active cancer, renal diseases, severe chronic obstructive pulmonary disease, cardiac arrhythmias or known decreased left ventricular ejection fraction, lactose or gluten intolerance, chronic inflammatory bowel diseases, non-treated hyper/hypothyroidism, dementia
* Surgical diseases: Bone, muscle, tendon or joint injuries compromising participation in exercise regimens
* Implanted magnetic devices incompatible with MRi-scanning
* Weekly alcohol consumption \> 21 units (1 unit equals 4 g of ethanol) for men and \> 14 for women
* Medicine except acetylsalicylic acid, paracetamol, thyroid function hormones, statins in doses above 40 mg/day or if combined with subjective myalgia, ACE-inhibitors, angiotensin II blockers, beta-blockers, calciumantagonists, proton-pump inhibitors, thiazides, potassium-sparring diuretics and loop diuretics
* 1 hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation
Vitamin D Level and Emergence Delirium in Children

In our study, we aimed to evaluate the relationship between vitamin D levels and postoperative delirium in children who had undergone tonsillectomy and/or adenoidectomy.

Patients are assigned to one of two groups. Serum 25(OH)D level will be determined as \<12 ng/ml group 1, group 2 with ≥12 ng/ml. ASA I-II children aged 2-10 years who will undergo adenoidectomy and/or tonsillectomy surgery under general anesthesia will be included in the study. In the operating room, the patient will monitored using electrocardiography, pulse oximetry, noninvasive blood pressure measurements, capnography. Under anesthesia, blood samples were taken for serum 25(OH)D levels. After extubation, patients will be taken to the recovery room. Delirium will be evaluated using the PAED (Pediatric Anesthesia Emergence Delirium) scale at 10-minute intervals in the recovery unit. In our study, 25(OH)D level was measured.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I and II Tonsillectomy and/or Adenoidectomy Surgery

Exclusion Criteria:

* psychological disorders
* emotional disorders
* abnormal cognitive development
* developmental delay
* allergy to the drugs in our protocol
Development of Discharge Education Video for Solid Organ Transplant Recipients

Audiovisual teaching aids can play a significant role for the retention of new material and help overcome barriers such as the physical presence or time restrictions of an instructor. In a clinical setting, multimedia health education can offer an advantage over traditional didactic teaching by engaging patients through visual content and unlimited accessibility.

A critical factor to long-term survival of solid organ transplant recipients is compliance to post-transplantation medication and follow-up patient care. Transplant pharmacists serve on multidisciplinary care teams as the medication experts that provide discharge education to recipients and caregivers often at the bedside. The adoption of digital multimedia content for patient education can increase engagement of diverse learning styles while simultaneously reducing potential time conflicts in hospital practice. This study contributes to the literature by assessing the effectiveness of discharge education video(s) on patient satisfaction and knowledge levels which are currently limited.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are solid organ transplant recipients at Johns Hopkins Hospital
* Patients who are being managed by an adult solid-organ transplant surgical service
* Patients who can speak and read the English language

Exclusion Criteria:

* Patients with language access services needs will be excluded
* Patients who do not meet inclusion criteria
Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma

Sacrococcygeal teratoma (SCT) is the most common fetal and neonatal tumor. However, predicting factors of evolution, sequelae and relapse are still unreliable because of small-cohort studies. This study aims at identifying prenatal and postnatal prognostic factors of evolution of SCT during pregnancy, of postnatal relapse, and of medium and long-term sequelae (urinary, digestive, esthetic, psychologic) in order to improve parental counseling when the diagnosis of SCT is made during pregnancy.

Sacrococcygeal teratoma (SCT) is the most common fetal and neonatal tumor. Although mostly benign, SCT can lead to perinatal mortality and long-term sequelae.

Three main risks occur throughout the evolution of SCT:

1. A perinatal life-threatening risk related to the importance of vascularization since SCT can lead to a true arteriovenous fistula with the risk of cardiac failure
2. A risk of benign or malignant tumor recurrence
3. A risk of medium and long-term sequelae, mostly urinary and/or digestive disorders but also aesthetic and psychologic.

In most cases, a prenatal diagnosis is made for which physicians are expected to give a prognosis and counsel parents about medium and long-term complications. However, there is no robust data to date correlating prenatal and postnatal features to prenatal and postnatal evolution of the tumor. The situation is all the more delicate as the information given by the physician can lead to the parent's will to terminate the pregnancy. This retrospective multicentric study aims at identifying prenatal and postnatal prognostic factors of SCT evolution during pregnancy, the occurrence of postnatal relapse after surgical excision, and medium- and long-term sequelae. The primary goal of this study is to improve prenatal parental counseling when the diagnosis of SCT is made.

Eligibility Criteria:
Inclusion Criteria:

* Fetuses and infants (\< 1 year) diagnosed with benign sacrococcygeal teratoma
* Cared for between January 2007 and December 2017 in the participating centers

Exclusion Criteria:

* Currarino syndrome
* Other benign sacrococcygeal teratoma discovered after 1 year old or malignant sacrococcygeal tumors
Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps

Chronic rhinosinusitis is a common disease that effects millions of people world wide. Despite its frequency it is unclear what treatment options are the best for these patients. Typically patients with chronic rhinosinusitis without nasal polyps (CRSsNP) are given a long term antibiotic (3 weeks), nasal steroid sprays, saline nasal irrigation and occasionally oral steroids. Oral steroids benefit patients with chronic rhinosinusitis with nasal polyps (CRSwNP) however their role in non polyp patients is less clear. It is the goal of this study to see if oral steroids benefit the treatment outcomes in those patients with chronic rhinosinusitis without nasal polyps. In addition this study will look to see if a short course (5 day burst) versus a longer course (21 day taper) of oral steroids make a difference in outcomes.

The investigators will compare patients with CRSsNP who are treated with antibiotics/nasal steroid sprays, and compare them to chronic sinusitis patients who receive antibiotics/nasal steroid spray along with a course of oral steroids. The goal is to determine if oral steroids have a role in CRSsNP, and if so, the most effective dosage.

Eligibility Criteria:
Inclusion Criteria:

1. They have three-months of persistent symptoms meeting criteria for chronic rhinosinusitis as defined by the taskforce on rhinosinusitis.
2. They have a CT-scan in the clinic or have a viewable recent (\< 3 weeks prior to clinic visit) CT-scan with a Lund Mackay score of 6 or greater. A Lund Mackay score of 6 or greater is felt to be indicative of at least moderate CRS.
3. They do not have nasal polyps on initial clinic nasal endoscopy
4. They are willing to participate in a clinical study
5. They are between the ages of 18 to 80.

Exclusion Criteria:

1. They have a condition in which the use of systemic corticosteroids is contraindicated such as diabetes will be excluded.
2. They are unable to or unwilling to take the prescribed antibiotics or steroids will excluded.
3. They have been treated with a \> 3 week course of antibiotics and/or systemic steroids will also be excluded.
4. They have variants of chronic sinusitis known to be refractory to medical therapy such as Wegener's granulomatosis, primary ciliary dyskinesia or sarcoidosis.
5. They have sinusitis secondary to prior surgery, a dental procedure or anatomical variants.
6. They have nasal polyps on physical exam.
7. They are pregnant. Subjects who are possibly pregnant will be excluded based on history. Pregnancy testing is not standard of care for diagnostic imaging.
8. They have a Lund-Mackay score on CT scan of \< 6
9. They are \< 18 or \> 80 years old
Impact of Mulstidisciplinary Medication Assessment Review in Surgery Departments

The presence of a clinical pharmacist (for their pharmacological expertise) and a general practitioner (for their somatic expertise) in surgery departments would contribute to improve the management of medications in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* The patient (or their representative) has given his consent and signed the consent form.
* The patient is affiliated to a health insurance programme.
* The patient is at least 65 years old (≥) treated by at least (≥) five medications for at least (≥) 6 months
* The patient is available for a follow-up of 3 months.
* The patient is hospitalized in the surgery department.
* Patient with a Trivalle score greater than or equal to 2 (≥).
* Patient living in a nursing home or going back home after hospitalization.

Exclusion Criteria:

* The subject is participating in another category I interventional study.
* The subject is in an exclusion period determined by another study.
* The subject is under safeguard of justice.
* It is not possible to give the patient (or his/her trusted-person) informed information.
* Palliative care
Letrozole and Metronomic Capecitabine in ER-positive HER2 Negative Advanced Breast Cancer (B-001 Study)

A phase II clinical trial designed to test the effect of combining endocrinal therapy (Letrozole) with chemotherapy (Capecitabine) in first line treatment of advanced cases of female breast cancer with ER positive disease.

This is a randomized clinical trial that assigns patients with female breast cancer in the metastatic entity or advanced -beyond local disease treatment - entity into two arms. Arm A contains Letrozole with metronomic Capecitabine versus arm B that contains Letrozole alone. This is to be applied on ER positive HER2 negative tumours.

Eligibility Criteria:
Inclusion Criteria:

* Female sex
* Age 18-70
* ECOG-PS 0-II.
* Histopathological proof of breast cancer
* ER positive (Allred score of ≥3 out of 8), and HER2 negative by IHC (or ISH if HER2 +2).
* Metastatic/recurrent disease as proven by CT scan, bone scan or clinical examination (for skin lesions). Biopsy of the recurrent lesions is encouraged but not mandatory.
* Either hormone sensitive setting (Denovo metastatic disease or disease progression after more than 1 year of ending adjuvant endocrine therapy) or secondary resistance to tamoxifen therapy (disease relapse after more than 2 years of starting and less than 1 year of ending adjuvant endocrine therapy, or DP of metastatic disease after more than 6 months of first line tamoxifen).
* Adequate organ function.
* Signed informed consent

Exclusion criteria:

* Inadequate organ functions.
* Disease progression while on prior aromatase inhibitor therapy.
* Primary endocrine resistance.
* Double primary cancer (history of other malignancy apart from a non melanoma skin cancer).
* Refusal to sign consent.
Study of Brain Response to Emotional Pictures Using a fMRI While on Duloxetine

The purpose of this study is to find out what parts of the brain have increased or decreased activity when people are depressed and how antidepressant medicine changes this activity in depressed patients. The genetic samples collected are to look at variation in a gene (serotonin transporter gene), which affects the functioning of the chemical serotonin in the brain

This study will measure the activity in different parts of the brain, while the patients are seeing some pictures, using Magnetic Resonance Imaging (MRI) scan. For this study three MRI scans will be conducted. One before the patient begins on any medication, one during the study after 3 weeks of treatment and one after six more weeks of treatment with a standard antidepressant called duloxetine.

Eligibility Criteria:
Inclusion Criteria for Depressed Patients:

* Ages 18 - 60 years and able to give voluntary informed consent.
* Satisfy criteria for Major Depressive Disorder (MDD) and current depressed episode using the Structured Clinical Interview for DSM-IV (SCID-IV).
* 17-item Hamilton Depression Rating Scale (HDRS) score \> 18.
* Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire.
* Able to be managed as outpatients for initial assessment and during treatment as ascertained by the following:

  * Symptoms not worsening by more than 10 points on the HDRS during the course of the study.
  * No danger to self or others.

Exclusion criteria for patients:

* Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, bipolar disorder, atypical psychosis, mental retardation, or organic mental (including organic mood) disorder.
* Known hypersensitivity to duloxetine or any of the inactive ingredients.
* On monoamine oxidase inhibitors in the past 2 weeks.
* History of narrow angle glaucoma
* Lack of response of the current episode of depression to two or more adequate courses of antidepressant therapy at a clinically appropriate dose for a minimum of 4 weeks or, in the judgment of the investigator, the patient meets criteria for treatment-resistant depression.
* Use of neuroleptic in the past 2 weeks.
* Use of antidepressants in the past 2 weeks. If on fluoxetine in the past, then should not have been on this medication for 4 weeks.
* History of lack of response to duloxetine.
* Use of mood stabilizers in the past 2 weeks.
* Use of benzodiazepines in the past 2 weeks.
* Acutely suicidal or homicidal or requiring inpatient treatment.
* Meeting DSM-IV criteria for other substance dependence within the past year, except caffeine or nicotine. The criteria will be evaluated by interview and urinary toxicology screening initially and on test days.
* Use of alcohol in the past 1 week.
* No serious medical or neurological illness as assessed by physical examination and laboratory examination including CBC and blood chemistry.
* Current pregnancy or breast-feeding.
* Metallic implants.
* Previously known positive HIV blood test as reported by the subject.
Night Time Use of Thiazide Diuretics for Improved Reduction in Stone Risk in Stone Formers With Elevated Urine Calcium

Thiazide diuretics will be more effective in lowering urine calcium excretion if taken at night as compared to the daytime. It will therefore be more effective in reducing kidney stone recurrence in nephrolithiasis patients with elevated urine calcium who are known to have increased risk of kidney stones at night time.

The study will be divided into three phases for every single patient, investigators will study 15-20 stone formers who have previously documented elevated urine calcium excretion, with a plan to measure their urine chemistries at baseline (if they currently use thiazide diuretics, they will come off of their respective thiazide for a 7-day washout period). Investigators will ask them to collect urine samples in two 12-hour intervals: on awakening, the 1st sample starts to before supper; 2nd sample begins after dinner and extends overnight with fasting after dinner, These measurements will be used as controls. Then patients will be started back on diuretics (25mg of chlorthalidone for the primary study; pending the results this may be repeated with 25mg of hydrochlorothiazide as a second substudy) which they will take in the daytime; after a 6-day acclimation period, two 12-hour urine samples will be collected as in the washout period. For the third study period, the patients will then begin taking the thiazide after dinner. After a 6-day acclimation period, the third set of urine collections will be done.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent calcium kidney stones (at least 2 episodes) and either a higher urine calcium excretion (urine Ca \>200 mg/d or \> 4 mg/kg body weight) or,
* In patients who currently take a thiazide diuretic, a history of elevated urine calcium prior to medication use;
* Also capable of signing consent and doing 24-hour urine collections repeatedly.

Exclusion Criteria:

* Patients with primary hyperparathyroidism, renal tubular acidosis, chronic kidney disease (serum creatinine \> 1.5 mg/dl), inflammatory bowel disease, gout,
* Patients taking thiazides with a history of hypertension,
* Patients with baseline systolic blood pressure less than 110mmHg
How to Predict Lung Recruitment at the Bedside in Patients Affected by Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS)

The investigators aim to compare four different lung recruitment techniques (described in literature) to Computed tomography scan analysis.

The investigators aim to compare four different lung recruitment techniques (described in literature) to Computed tomography scan analysis:

* stress index technique
* peep test
* recruitment technique used in the EXPRESS study
* recruitment technique used in the LOV study

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute lung injury/ acute respiratory distress syndrome
* Mechanical ventilation

Exclusion Criteria:

* Clinical diagnosis of chronic obstructive pulmonary disease
* Clinical diagnosis of pneumothorax
* Haemodynamic instability
A Study to Investigate of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle

The purpose of this study is to evaluate opioid dose effects on the ability of the diaphragm muscle to generate higher force behaviors.


Eligibility Criteria:
Inclusion Criteria:

- Adult male and female patients undergoing lower extremity orthopedic surgery at the study institutions (St. Mary Hospital and Rochester Methodist Hospital within the Mayo Clinic Rochester hospital system).

Exclusion Criteria:

* Patients who refuse research participation.
* Patients who are pregnant.
* Patients with known pulmonary pathology (COPD, asthma requiring routine treatment).
A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects

The primary purpose of this study is to determine if single doses of BMS-986166 are safe and well tolerated in healthy male subjects and female subjects of non-childbearing potential.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy female subjects of non-childbearing potential or male subjects as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations
* Ages 18 to 55 years
* Female subjects must provide documentation of an acceptable method of surgical sterilization or meet the protocol criteria for menopause

Exclusion Criteria:

* Any acute or chronic medical illness judged to be clinically significant by the Investigator and/or Sponsor medical monitor
* Any acute or chronic bacterial, fungal or viral infection, including tuberculosis, HIV, hepatitis B or hepatitis C, as defined in the protocol
* History of heart disease, neurological disease, eye disorders or gastrointestinal disorders or surgery (including cholecystectomy)
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs or clinical laboratory tests
* Smoking or nicotine use, drug or alcohol abuse within 6 months of starting the study

Other protocol defined inclusion/exclusion criteria could apply