cyrilzakka/clinical-trials huggingface dataset:
Olanzapine Versus Active Comparator in the Treatment of Depression in Patients With Schizophrenia

This is a research study comparing the safety and efficacy of two active study medications


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18-60 years of age
* Female subjects of childbearing potential must be using a medically accepted means of contraception
* Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol
* Subjects must be considered reliable

Exclusion Criteria:

* Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry
* Female subjects who are either pregnant or nursing
* Uncorrected hypothyroidism or hyperthyroidism
* Narrow-angle glaucoma
Diagnostic Impact of Low-dose Dobutamine Echocardiography in Low-flow Low-gradient Aortic Stenosis

When aortic valve-area is \<1.0cm2 and transvalvular mean-gradient is \>40mmHg, the diagnosis of severe aortic stenosis (AS) is straightforward. However, some patients present with an apparently reduced valve-area, despite transvalvular-gradient \<40mmHg; Low-flow, low-gradient aortic stenosis (LFLG AS). When a patient with LFLG AS also presents with LVEF \<50%, guidelines recommends performing a Low-Dose Dobutamine-echocardiography (LDDE) to confirm true-severe AS. However, nearly 30% of patients with LFLG AS do not show an adequate respond to Dobutamine. More commonly, patients present with the combination of LFLG AS, despite LVEF≥50%. In this group of patients the use of LDDE remains undisclosed.

The purpose of this study is to examine the safety and diagnostic usefulness of LDDE in patients with LFLG AS with LVEF≥50%. Furthermore we will examine factors associated with inadequate response to LDDE.

150 symptomatic and/or asymptomatic patients with LFLG and LVEF≥50% and a control group with LVEF\<50% will be enrolled at the Department of Cardiology, OUH. Patients will undergo clinical evaluation including LDDE, blood analyses, CT-scan and cardiac Mri.

Only a limited number of studies examine the possible use of LDDE in patients with LFLG AS and LVEF≥50% and no study has been performed documenting the safety and feasibility.


Eligibility Criteria:
Inclusion Criteria:

1. Low-flow (SVi\<35 ml/m2) low-gradient (mean gradient \<40 mmHg) AS with estimated AVA\<1.0 cm2 referred to the Department of Cardiology, Odense University Hospital.
2. Age \> 18 years.
3. Signed informed consent.

Exclusion Criteria:

1. Other moderate-severe valvular heart disease.
2. Unwilling to participate in the study.
3. Poor echocardiographic window.
4. Inability to follow-up due to temporary citizenship Registration Number (CPR-Number) or emigration within the study period.
5. Pregnant women.
6. Patients with severe chronic renal failure (eGFR\<40 ml/min) will not undergo cardiac MRi or CT angiography.
7. Known contrast allergy.
Half-life of Plasma Phytosterols in Very Low Birth Weight Preterm Infants With Parenteral Nutrition-associated Cholestasis

Parenteral nutrition-associated cholestasis (PNAC) is one of the most common complications resulting from administration of parenteral nutrition in neonates. Excess intravenous intake of vegetable oil-based lipid emulsions containing phytosterols is felt to be a major contributing factor. To date, no information is available on plasma phytosterols half-lives in very-low-birth-weight (VLBW) preterm infants with PNAC. In a prospective cohort study, plasma phytosterols (campesterol, stigmasterol and sitosterol) of VLBW preterm infants with PNAC will be measured by gas chromatography-mass spectrometry (GC-MS) during PN administration and also after the stop of intravenous lipid infusion. Plasma phytosterols half-lives will be calculated from the monoexponential decay curves. Blood samples will be weekly collected from 1st to 12th week of life during routine metabolic tolerance analysis or gas-analysis in order to avoid burden of additional phlebotomy. Samples will be collected in ethylenediaminetetraacetic acid-tubes and immediately centrifugated. Plasma will be stored in pyrogallol added-tubes at -20°C until analysis. Saponification reaction will be done using 5-alpha-cholestane as internal standard.


Eligibility Criteria:
Inclusion Criteria:

* 24 weeks \< gestational age \< 32 weeks;
* 500 g ≤ birth weight \< 1250 g;
* parenteral nutrition with vegetable oil-based lipid emulsions from the first hours of life;
* diagnosis of cholestasis during vegetable oil-lipid infusion (plasma conjugated bilirubin value \> 1 mg/dl)
* parental consent;

Exclusion Criteria:

* severe malformations;
* inborn errors of metabolism;
* severe congenital sepsis;
* normal liver functions (plasma conjugated bilirubin under 1 mg/dl during vegetable oil-lipid infusion).
22G-ProCore vs 22G-Standard Needle in Diagnosis of Lymphadenopathy by EBUS-TBNA

The aim of this study is to compare the performance of 22G-ProCore and 22G-Standard needle in diagnosis of mediastinal and hilar lymphadenopathy via EBUS-TBNA with the purpose to explore the optimal technique for obtaining diagnostic material.

EBUS-TBNA is an important minimally invasive tool for the diagnosis of mediastinal and hilar lymphadenopathy. The investigators will explore the performance of two kinds of needles and different methods to obtain tissues via EBUS-TBNA in the study. The study is designed as a prospective, single-center, randomized controlled trial, 600 patients will be expected to enroll in the study and randomly assigned to two groups, the 22G-ProCore group and the 22G-Standard group. The primary aim is to compare the diagnostic yields of the two types of needles. The secondary endpoint is to assess the quality of histologic specimen. Meanwhile, stylet slow-pull or negative suction techniques and different agitations (10, 20, 30 times) that each pass includes will be evaluated in the study as well.

Eligibility Criteria:
Inclusion Criteria:

1. Imaging examination indicates enlarged intrathoracic lymph nodes need pathological diagnosis (any lymph node has a short diameter \> 1 cm in CT or PET-CT SUV value \> 2.5).
2. Accessible mediastinal and hilar lymphadenopathy to EBUS-TBNA.
3. Inform consent signed.

Exclusion Criteria:

1. Contraindications of EBUS-TBNA. Such as use of anticoagulant therapy or presence of a coagulopathy (platelet count \< 50000 or INR \> 1.5).
2. Severe cardiopulmonary dysfunction and other indications that can't tolerate bronchoscopy.
3. Life expectancy less than 6 months.
4. Uncooperative patients.
5. Patients representing vulnerable populations (prisoners, pregnant women, etc).
6. Researchers consider it inappropriate to participate in this study.
[18F]Fluciclatide-PET, Pazopanib and Paclitaxel in Ovarian Cancer

The purpose of this study is to assess \[18F\] -fluciclatide as a biomarker of response to pazopanib and to evaluate the efficacy and safety of the combination of pazopanib and paclitaxel in platinum-resistant ovarian cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of relapsed ovarian cancer
* Responded to at least on one line of prior platinum based therapy
* Relapsed within platinum resistant interval (≤6months)
* Eastern Cooperative Oncology Group (ECOG) performance status of \<2
* Measurable disease defined as a lesion that can be accurately measured in at least one dimension with the longest diameter ≥25mm using conventional techniques
* Satisfactory baseline haematologic and organ function:

  * Haematologic: Absolute neutrophil count \> or = 1.5 X 10\^9/L; Platelets \> or = 100 X 10\^9/L; Haemoglobin \> or = 9g/dL; PT or INR \< or = 1.2 x ULN; PTT \< or = 1.2 x ULN
  * Hepatic: Bilirubin \< or = 1.5 X ULN; AST or ALT \< or = 2.5 X ULN
  * Renal: Serum creatinine \< or = 1.5 mg/dL; Or if \>1.5 mg/dL, calculated creatinine clearance \> or = 50mL/min; UPC \<1

Exclusion Criteria:

* Poorly controlled hypertension \[defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg\]. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be \<140/90 mmHg in order for a subject to be eligible for the study.
* Treatment with any of the following anti-cancer therapies:

  * radiation therapy 28 days prior to the first dose of pazopanib OR
  * surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
  * chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
* Treatment with anti-angiogenic therapy
* Presence of gross ascites
* Clinically significant peripheral neuropathy
* Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study
PREDIGA 2: Spanish Acronym of "Educational and Diagnostic Project for Gaucher and ASMD"

The study of splenomegaly, and the follow-up of splenectomized patients, is one of the causes of referral of these patients to pediatric gastroenterology and oncohematology clinics, and adult internal medicine and hematology. It has been described that 0.3% of hospital admissions is for this reason.

The study and management of splenomegaly is well described among the different medical specialties to which these patients arrive. After the application of the different algorithms and the different studies that are carried out, these splenomegaly are identified as being of hepatic, infectious, inflammatory, congestive, hematological origin and primary causes. Despite these studies of splenomegaly, approximately 10-15% of these patients still remain undiagnosed.

The objective of the present study is to increase the diagnostic sensitivity of these unknown splenomegalys, or unknown splenomegaly patients who remain in consultations, using the usual diagnostic clinical procedures of unknown splenomegaly and unknown splenectomy patients, where the investigators include the extraction of a blood sample for dry drop test (DBS), where the determination of the enzymatic/genetic activity will be carried out for Gaucher disease (GD) and acid sphingomyelinase deficiency (ASMD) , analysis of LisoGl1 and LisoSM.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both sexes.
* Patients who present signs, assessed instrumentally or with laboratory tests, of unknown splenomegaly, defined as a palpable spleen ≥ 1cm from the costal margin or diagnosed by ultrasound, magnetic resonance imaging (MRI) or computed tomography (CT) of the spleen.
* Splenectomy patient with no diagnosis of the origin of the splenomegaly of unknown origin.
* Patients with splenomegaly or splenectomy without diagnosis but identified with ITP (Idiopathic Thrombocytopenic Purpura)
* Patient who gives his consent to participate in the study.

Exclusion Criteria:

* Splenomegaly due to portal hypertension (documented by abdominal ultrasound or other instrumental test) due to liver disease
* Hematologic malignancy \[documented by positive physical exam + blood smear or fine needle aspiration (FNA) or bone marrow biopsy\]
* Hemolytic anemia and/or thalassemia
* Patients who cannot meet the requirements of the protocol due to mental and/or cognitive alterations, uncooperative patients, educational limitations and understanding of written language
* Refusal of the patient to participate in the study
A Study to Assess the Disturbances in Calcitonin Gene in Patients With Gum Disease and Osteoporosis

Osteoporosis and Periodontitis are multifactorial diseases which share common risk factors.The aim of the present study is to ellucidate polymorphisms in Calcitonin receptor gene? in patients with Osteoporosis and Periodontitis.

Periodontitis is a polymicrobial inflammatory disease which includes various modifiable and nonmodifiable risk factors. The non modifiable risk factors include genetic polymorphisms like metabolism associated genetic polymorphisms ( Vitamin D and Calcitonin).

Osteoporosis is a systemic skeletal disease characterized by low bone mass and micro-architectural deterioration of bone tissue with consequent increase in bone fragility and susceptibility to fractures.

Bone loss is a common feature shared between periodontal disease and osteoporosis.

Out of all genetic factors Calcitonin gene polymorphism contributes to the development of both osteoporosis and chronic periodontitis.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female
* Patients aged between 35.00 Year(s) to 60.00 Year(s) diagnosed with Osteoporosis and Chronic Periodontitis who are willing to participate in the study

Exclusion Criteria:

* Patients who are Systemically compromised and under medications such as steroids.
* Patients who smoke.Pregnant and lactating mothers are excluded from the study
EEG Detection of Delirium

VEEGix is a portable device developed by NeuroServo for simplifying electroencephalograms at the bedside. It is an easy-to-use device that only requires the operator to place an adhesive strip of electrodes on the patient's forehead, connected to the device. The goal of this study is to determine EEG thresholds for the diagnostic of delirium.

Methods : This prospective observational study includes patients undergoing orthopedic or degestive surgery. Each subject will have an EEG reading before surgery and twice daily after surgery until discharge or up to 5 days. Patients will be monitored for post operative delirium using the 3D-Confusion Assessment Method. Delirium diagnostic will be confirmed by a geriatrician. EEG relative power reading will be compared between patient with and without a delirium diagnostic.


Eligibility Criteria:
Inclusion Criteria:

* 65 years and older
* Had a orthopedic or digestive surgery
* Good undersanding of French or English
* Consent to participate in the study

Exclusion Criteria:

* History of seizure or epilepsia
* Structural brain damage
* intelectual deiciency
* Severe major neurocognitive disorder
* incapacity to respond to the questionnaire
* Hospitalised in intensive care or intubated
New Antigens Against Glioblastoma

In this study the investigators will select and develop potential therapeutic monoclonal antibodies (mAbs) for glioblastoma (GB). Activities include tissue microarray (TMA) to test monoclonal antibodies specificity and target distribution, selection of glioblastoma specific functional monoclonal antibodies, identification of candidate targets.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years;
* Written informed consent

Exclusion Criteria:

* Not-availability of informed consent
Women's Healthy Lifestyle Project: Cardiovascular Risk Factors and Menopause

To determine if the increase in low density lipoprotein (LDL) cholesterol at the time of menopause could be ameliorated or prevented by an intensive dietary intervention. Also, to prevent the increase in body weight and associated changes in insulin, glucose, blood pressure, triglycerides, and high density lipoprotein cholesterol during the peri- to postmenopausal period.

BACKGROUND:

Coronary heart disease causes almost as many deaths in women as it does in men, with approximately 90 percent of the deaths in women occurring after the age of 50. There are substantial increases in coronary heart disease risk factors at the time of the menopause, especially increases in total cholesterol and low density lipoprotein cholesterol, that may well contribute to the increased risk of coronary heart disease.

DESIGN NARRATIVE:

A total of 275 premenopausal women were randomized to a control group and 260 women into a lifestyle intervention group, a cognitive-behavioral program which was designed to reduce total dietary fat to less than 25 percent of calories, saturated fat to less than 7 percent of calories, and cholesterol to less than 100 mg. All women were given a weight loss goal of five to 15 pounds, depending on baseline weight status and asked to reduce calorie intake to 1300 kcal until weight goal was achieved. The intervention included an intensive group program during the first six months and follow-up individual/group sessions from six through 54 months. The primary endpoints of the trial were difference in the change in LDL cholesterol and weight between intervention and assessment-only groups at the end of the trial. The intervention also compared whether the dietary intervention could prevent the increase in low density lipoprotein cholesterol and the weight gain observed at this period of a woman's life; whether dietary intervention affected the age of menopause or the percent of women using hormone therapy or having hysterectomy; and whether the dietary intervention had adverse effects on menopausal symptomatology, endogenous hormones, and bone mineral density.

The Office of Research on Women's Health provided supplemental funds to measure hemostatic factors, including fibrinogen, factor VIIc and antigen, antithrombin III and PAI-1 in plasma samples for all subjects at baseline. The supplement allowed a longitudinal description of changes in hemostatic factors that appeared to occur during the perimenopausal transition and an investigation of whether diet and diet intervention altered the pattern of hemostatic changes observed at menopause.

Beginning in February 1996, the trial was extended for four years through January 2000 to provide for data analysis and an additional follow-up of at least 4.5 years for all participants.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
Premenopausal women, ages 45-50 at entry.
Core Stability Program in Colorectal Cancer Survivors

The purpose of this study is to determine the effects of physical training program to improve deep stabilizer muscle in colorectal cancer survivors

Background: Colorectal cancer is the third most common cancer when considering both genders. Musculoskeletal alterations have been described related to techniques used during surgery, that it produces an inhibition of deep abdominal muscles. These muscles are in charge of lumbopelvic stabilization muscle linked to reduced ability to maintain independence in daily activity life that could have affected their quality of life

Objective: The aim objective will be evaluated short and long-term effects of physical activity program for muscle stabilization.

Methods: 20 colorectal cancer survivors will be recruited from the Department of Oncology of Clínico San Cecilio Hospital. Patients will be randomized in physical activity program group and usual care group. Physical activity groups will receive an eight week program form improve the muscle stabilization.

Discussion: Researchers attempts to increase the fitness level and reduce musculoskeletal disorders in colorectal cancer survivors through a physical activity interventions focusing in muscle stabilization.

Eligibility Criteria:
Inclusion Criteria:

* Patients under partial colorectal resection to treat colon cancer
* Diagnosis of I, II or IIIa stage of colorectal cancer
* Completion of adjuvant therapy (except for hormone therapy)
* Medical clearance of participation

Exclusion Criteria:

Participants will be excluded if they presents with cancer recurrence or if they will have undergone previous abdominal surgeries or will be diagnosed with concomitant conditions, such as previous lower-back pain or musculoskeletal conditions (e.g., osteoarthritis, fibromyalgia or chronic fatigue syndrome).
Sildenafil Citrate of in Vitro Fertilization After Multiple IVF Failures Attributed to Poor Endometrial Development

The aim of this study is to evaluate the effect of sildenafil citrate on endometrial development in women with history of recurrent implantation failure after IVF

sildenafil citrate may increase endometrial thickness in women with recurrent IVF failure attributed to poor endometrial development

Eligibility Criteria:
Inclusion Criteria:

* (1) cases of infertility, older than 20 years of age and not older than 40 years.
* (2) Body mass index (BMI):20-29.
* (3) women have experienced two or more implantation failure attributed to inadequate endometrial development.

Exclusion Criteria:

* (1) Uterine abnormalities (e.g. septate, bicornuate and fibroid uterus, Asherman Syndrome).
* (2) Any contraindication to sildenafil citrate or any of the components of its formulation including:

  * Concurrent use of organic nitrites and nitrates.
  * Severe hepatic impairment.
  * Severe renal impairment.
  * Hypotension.
  * Recent stroke or heart attack.
Walking Meditation Exercise in Breast Cancer Patients

This study is to evaluate the effects of Walking Meditation on vascular function in breast cancer patients receiving Anthracyclines chemotherapy

Walking Meditation program will be based on aerobic walking exercise combined with Buddhist meditation. The subjects will perform walking while listening to the sound "Budd" and "Dha" and squeeze rubber balls according to the sound in order to practice mindfulness while walking. In phase 1 (week 1-6), Walking Meditation will be conducted at initial moderate intensity (41-50% heart rate reserve) 3 sets, 10 minutes per set and rest 3 minutes between set In phase 2 (week 7-12), the training intensity will be increased to ultimate moderate intensity (51-60% heart rate reserve) 3 sets, 15 minutes per set and rest 3 minutes between set. In both phases of the training, the frequency of Walking Meditation training is three times a week.

Eligibility Criteria:
Inclusion Criteria:

1. The inclusion criteria included stage 1-2 of Breast cancer patients after an operation with or without Hormone Receptor Positive and HER2 Positive.
2. All participants will be planned to use Anthracyclines chemotherapy in next 1 month by oncologist.
3. All participants did not participate in any exercise training in the past 6 months
4. All participants are free from acute or chronic renal failure, Heart Failure, Myasthenia gravis, pregnancy and history of smoke.

Exclusion Criteria:

1. Participants will be excluded if they dropped out or completed less than 80% of the training schedule.
Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patients With Structural Heart Disease

This is a prospective comparative study, conducted at Cardiology Department, Aswan University Hospital on AF patients with structural heart disease. Eplerenone 25 mg daily will be given and searching for AF recurrence among study population.

This is a prospective comparative study, conducted at Cardiology Department, Aswan University Hospital, on 100 patients with AF and structural heart disease. AF is confirmed by electrocardiography. The patients were divided into 2 groups:

Group A (study group): 50 patients received eplerenon 25 mg daily plus amiodarone and other medications not including non-dihydropyridine calcium channel blocker or digoxin.

Group B (control group): 50 patients received amiodarone and other medications not including non-dihydropyridine calcium channel blocker or digoxin.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-valvular AF who underwent cardioversion to sinus rhythm either medical, electrical or even spontaneously

Exclusion Criteria:

* Patients with rheumatic heart disease.
* Thyroid dysfunction.
* Wolf-Parkinson-White (WPW) syndrome.
* Renal impairment.
* Hyperkalemia.
* Acute coronary syndrome.
* Pregnancy.
* Left ventricular (LV) dysfunction with ejection fraction (EF) less than 40%.
* On current use of eplerenone.