cyrilzakka/clinical-trials huggingface dataset:
CA 125 Levels in Treating Patients With Relapsed Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Who Are Receiving Tamoxifen

RATIONALE: Estrogen may cause the growth of ovarian cancer cells. Hormone therapy using tamoxifen may fight ovarian cancer by blocking the use of estrogen by the tumor cells. Measuring CA 125 levels may help doctors predict a patient's response to tamoxifen and help plan the best treatment.

PURPOSE: This phase II trial is studying CA 125 levels in treating patients with relapsed advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who are receiving tamoxifen.

OBJECTIVES:

* Determine the percentage of patients with relapsed advanced ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma who have a log linear rise in CA 125 levels.
* Determine whether the log linear part of the curve is consistent enough to allow comparison of the slope before and after introduction of a new therapy.
* Compare the serial doubling time before and after commencing tamoxifen citrate treatment.
* Determine the number of patients required to detect a significant difference in CA 125 doubling time before and after starting tamoxifen citrate treatment.

OUTLINE: Patients undergo blood collection once a month to measure CA 125 levels. Once the CA 125 level goes above the upper limit of normal (ULN) or has started to rise from its nadir level (if not previously normal), CA 125 levels are measured every 2 weeks. When CA 125 levels reach 4 times the ULN or 4 times the nadir level (if not previously normal), patients begin oral tamoxifen citrate once daily for 3-6 months in the absence of disease progression or unacceptable toxicity. CA 125 levels will continue to be measured every 2 weeks during treatment.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed advanced ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma
* Completed therapy for first relapse

  * Had an elevated CA 125 level before starting relapse therapy with ≥ 50% fall by completion of that therapy or response according to RECIST criteria
* No significant cancer-related symptoms requiring urgent treatment

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy \> 3 months
* Hemoglobin \> 10 g/dL
* WBC \> 2,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Creatinine \< 2 times upper limit of normal (ULN)
* AST/ALT \< 2 times ULN
* Bilirubin \< 1.5 times ULN
* No evidence of significant clinical disorder or laboratory finding that would preclude study participation
* No psychiatric disorder that would preclude informed consent
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

* No other concurrent hormonal therapy, except hormone-replacement therapy
* Other concurrent medications allowed provided dose is stable
Canadian Treat and Extend Analysis Trial With Ranibizumab

This is an observational study to will evaluate and compare two Ranibizumab treatment regimens (Standard of care) in patients with neovascular (wet) age-related macular degeneration (wAMD) aiming to achieve and to maintain a maximum visual function benefit. The results will be used to generate further recommendations on the timing of treatment administration for patients with neovascular (wet) age-related macular degeneration (wAMD). In this context, the study will use the anatomical imaging (for example, optical coherence tomography \[OCT\]) to evaluate wAMD disease activity impacted by the recurrence of disease instability and for decision making in the treatment decision algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Infomed consent,
* Male and Female, 50 years of age or older
* Diagnosis of treatment-naive CNV secondary to age-related macular degeneration(AMD) in the study eye,
* BCVA score between 78 and 19 letters inclusive,

Exclusion Criteria:

* Patients with structural foveal damage in the study eye,
* Patients with confounding severe oculare diseases,
* Patients with suspicion of ( Polypoidal Choroidal Vasculapathy PCV) in the study eye,
* Patients with active or suspected or periocular infections in either eye or active intraocular inflammation in either eye,
* Patients who had previous subfoveal laser photocoagulation in the study eye or history of vitrectomy surgery in the study eye,
* Patients who had any prior treatment in the study eye, e.g., with Visudyne\*, Avastin\*, prior Ranibizumab treatment, Ozurdex\*, external radiation therapy, transpupillary thermotherapy (TTT), or any intravitreal injection,
* Patients with a known sensitivity to Ranibizumab or any component of its formulation,
* Patients who have used any investigational agent in the last 30 days,
* Concurrent participation in a clinical trial or within 30 days prior to enrollment,
* Patients having received systemic treatment with any other anti-vascular endothelial growth factor (VEGF) therapy ≤ 60 days prior to enrollment
* Patients with physical or mental disabilities that prevent accurate vision testing,
* Patients physically unable to tolerate intravenous fluorescein angiography,
* Pregnant or breastfeeding female patients,
* Any patient with recent history of new onset cardiac disease or thromboembolic central nervous system (CNS) event (within 12 months of Baseline Visit),
* Patients with any other condition which, in the opinion of the Investigator, would require treatment that would significantly impact the treatment assessments during this study.
Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation

The purpose of this study is to learn if a voice analysis smartphone app which detects anxiety and depression could be used along with cardiac rehabilitation to improve results compared to cardiac rehabilitation alone.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in cardiac rehabilitation program to start within 3 months from hospital discharge.
* Owns a smartphone.
* Willing to download and use a smartphone app.
* Able to read, write, and speak English.

Exclusion Criteria:

* Actively treated for an anxiety or depressive disorder through psychotherapy or pharmacologic treatments.
* Cardiac transplant.
* Active substance use.
* Neurocognitive disorder.
* Active psychosis.
* Mania diagnosis.
* Active suicidality
Nicotine Patch - Multidose Bioequivalence Study

The purpose of this study is to compare the relative bioavailability of nicotine following repeated applications of a new transdermal formulation to that of a reference formulation.

Up to day 7


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject aged 18 to 45 years (inclusive)
* Current Smoker of \>or = 5 and \< or = 15 cigarettes/day
* Fagerström score \< or =5 at selection
* Absence of any clinically significant abnormal finding at physical, vital sign, Electrocardiogram ECG, biological examinations in the investigator's opinion.

Exclusion Criteria:

* Presence of any significant medical finding or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator
* Any visible skin disorder, abnormal skin pigmentation or dermatologic disease liable to interfere with use or assessment of transdermal patch
Thymidine Kinase 1 in Risk Assessment for Hereditary Breast /Ovarian Cancer

This study aimed to compare the activity of Thymidine Kinase 1 in serum of two groups of woman at high and normal risk for breast/ovary cancer.

Hereditary breast/ovarian cancer syndrome is associated with mutations in tumor suppressor BRCA1 and BRCA2 genes. Products of these genes play an important role in the repair of DNA double-strand breaks. Mutations in BRCA1 and BRCA2 genes could impair DNA repair. In resting or G1 cells, where the de novo synthesis of DNA precursors is absent, the salvage pathway is the sole provider of deoxyribonucleotides to be used in DNA repair. For this process a sufficient supply of deoxynucleotides and activity of Thymidine Kinase 1 are essential. TK1 is an important component of adaptive response of cells to DNA damage. Mutations in genes directly engaged in the DNA repair process could lead to the accumulation of DNA damage and in turn cause an adaptive cell reaction manifesting as permanently increased Thymidine Kinase 1 activity.

A recently developed new high-sensitive assay DiviTum® allows to investigate the contribution of this enzyme to DNA repair processes and to make a comparison of Thymidine kinase 1 activity in women with normal and impared DNA repair system.

Eligibility Criteria:
Inclusion Criteria:

* women from family with more than two breast cancer cases and one or more cases of ovarian cancer diagnosed at any age;
* women from family with more than three breast cancer cases diagnosed before the age 50;
* women from family withsister pair in which one of the following combinations was diagnosed before the age of 50: two breast cancers, two ovarian cancers, or a breast and ovarian cancer.

Exclusion Criteria:•

* pregnant women;
* women with generalized CMV and HZV infections;
* women with severe B12 deficiency and megaloblastic anaemia;
* women with severe rheumatoid arthritis.
Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD

The objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring in patients with COPD.


Eligibility Criteria:
Inclusion Criteria:

* History of COPD, FEV1 less than or equal to 65%, FEV1/FVC less than or equal 70%
* Smoking history greater than or equal to 10 pack years
* Not history of clinical diagnosis of asthma and/or atopy
* A history of thoracotomy with pulmonary resection
* Patients requiring the use of supplemental oxygen therapy for \>12 hours per day
* Chronic use of systemic corticosteroids in an unstable daily dose
* Patients with a recent history of myocardial infarction
* A known hypersensitivity to anticholinergic drugs
Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans

Investigate the effects of milk fat with or without milk fat globule membranes (MFGM) on blood lipid profile, vascular function, insulin sensitivity, inflammation and gene expression. Overweight subjects will be randomized to one of 2 groups with different types of dairy products: 1)butter oil; 2) cream (milk fat with MFGM).

Dairy foods are a major component of the nordic diet. Epidemiological data suggest potential health effects of dairy foods with regard to obesity related disorders. Low-fat dairy foods have shown to be protective, but also high-fat products have been linked to reduced risk in some studies. It is well known that dairy products increase LDL-cholesterol in blood, but effects on glucose metabolism are unclear. Intervention trials are needed to clarify the health effects of dairy foods. Some data have indicated that cheese and milk may have less hypercholesterolemic effect compared with butter. Our hypothesis is that milk fat globule membranes (MFGM), present in all dairy products except butter, can affect blood lipid profile, vascular function, insulin sensitivity, inflammation and gene expression. Such idea might explain why different dairy products could have different effects on cholesterol levels. The investigators aim to conduct a controlled study to investigate this. Overweight subjects will be randomized to one of 2 groups with different types of dairy products: 1)butter oil; 2) cream (milk fat with MFGM).

Eligibility Criteria:
Inclusion Criteria:

* BMI 25-37
* LDL-cholesterol 2.0-4.5 mmol/l

Exclusion Criteria:

* Use of lipid lowering drugs
* Diagnosed cardiovascular disease or diabetes
* Use of extreme diets
* Food allergies relevant to the study
* Pregnancy or active lactation
Effect of Rib Mobilization on Weaning Parameters From Mechanical Ventilator in Patients With Pneumonia

this study will be conducted to distinguish between effect of rib mobilization and routine chest physiotherapy on weaning parameters from mechanical ventilator in patients with pneumonia •

HYPOTHESES:

It will be hypothesized that there may be significant effect of rib mobilization on weaning parameters from mechanical ventilator in patients with pneumonia.

RESEARCH QUESTION:

Does rib mobilization have an effect on weaning parameters from mechanical ventilator in patients with pneumonia? measuring weaning parameters: on screen of mechanical ventilator : measuring respiratory rate, Tidal volume (TV), FiO2.

* Arterial blood gases (ABG) analyzer machine ABG is recorded daily (PH- PaO2 - PaCO2)
* Length of ICU stay: calculated by (admission date - discharge date
* Weaning success rate

Ventilator-associated pneumonia (VAP) represents a significant sub-set of (HAP) remains the most frequent intensive care unit (ICU)-acquired infection its incidence ranges from 9% to 27% of ventilated patients ,VAP is associated with an increased length of stay, mortality and health care costs, Pneumonia can result in chest wall stiffness, decreased mobility, limiting the range of motion during breathing and decreased lung compliance and impaired respiratory function , Rib mobilization: is an articular , non-invasive, passive technique that can be useful with acutely ill, hospitalized patients emphasizes the placement of a repetitive force to increase the range of motion of the posterior rib articulations and chest wall , lessening somatic dysfunction of the spine, stretches myofascial structures and improve respiratory mechanics So, this study will be conducted to distinguish between effect of rib mobilization and routine chest physiotherapy on weaning parameters among intubated pneumonic patients on mechanical vent.

Eligibility Criteria:
Inclusion Criteria:

1. Patient's age ranged from 40- 50 years old from both genders.
2. Diagnosed with pneumonia and need invasive mechanical ventilation support.
3. Stable oxygen saturation (SpO2 more than 85, (FiO2) 0.6 or less, PEEP less than 10 Cm H2O).
4. mean arterial pressure \> 75 mmHg and urine output \> 1 mL/kg/h;
5. Patients with Glasgow coma scale (GCS) \> 8T
6. Unconscious and semi-conscious patients. -

Exclusion Criteria:

1. Unstable hemodynamics
2. Unstable neurological problems e.g. (epileptic seizures -hyperthermia).
3. Unstable chest wall e.g. (multiple rib or vertebral fractures)
4. Increase intracranial pressure (\>20 mmHg for \>5 min).
5. Undrained pneumothorax, recent pulmonary surgery
Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity

The purpose of this study is determine if the combination of zonisamide SR and bupropion SR are is more effective than either drug given alone or placebo in the treatment of obesity.


Eligibility Criteria:
Inclusion Criteria:

* Female or male subjects, 18 to 65 years of age
* Have body mass index (BMI) ≥ 30 kg/m2 and ≤ 45 kg/m2 for subjects with uncomplicated obesity, and BMI of ≥ 27 kg/m2 and ≤ 45 kg/m2 for subjects with obesity and dyslipidemia and/or controlled hypertension
* Non-smoker and no use of tobacco or nicotine products for at least 6 months prior to screening
* Normotensive (systolic ≤140 mm Hg; diastolic ≤90 mm Hg). Anti-hypertensive medications are allowed with the exception of adrenergic blockers and clonidine. Medical regimen must be stable for at least 6 weeks prior to randomization
* Triglycerides \<400 mg/dL. Medications for treatment of dyslipidemia are allowed with the exception of cholestyramine and cholestypol as long as medical regimen has been stable for at least 6 weeks prior to randomization
* No clinically significant laboratory abnormalities
* Negative urine drug screen
* Negative serum pregnancy test in women of child-bearing potential
* Women of child-bearing potential must be non-lactating, and agree to use acceptable contraception throughout the study period and for 30 days after discontinuation of study drug
* Able to comply with all required study procedures and schedule
* Able to speak and read English
* Willing and able to give written informed consent

Exclusion Criteria:

* Obesity of known endocrine or genetic origin (e.g., untreated hypothyroidism, Cushing's syndrome, polycystic ovary syndrome)
* Serious medical condition
* History of malignancy within the previous 5 years, with exception of non-melanoma skin cancer or surgically cured cervical cancer.
* History of suicide attempt or serious psychiatric illness
* History of Major Depressive Disorder within the past 2 years
* In need of medications for the treatment of a psychiatric disorder (with the exception of short-term insomnia) within the previous 6 months prior to randomization
* Type I or Type II diabetes
* History of alcohol or drug abuse or dependence as determined by the Investigator within 1 year prior to randomization
* History of surgical or device (e.g. gastric banding) intervention for obesity
* History of seizures or predisposition to seizures
* History of hypersensitivity to sulfonamides ("sulfa"), bupropion, or zonisamide
* History of treatment with bupropion SR (Wellbutrin, Zyban) or zonisamide (Zonegran) within previous 12 months
* History of nephrolithiasis (renal calculi)
* Loss or gain of more than 4.0 kg within 3 months prior to randomization
* Women of child bearing potential not adhering to a medically acceptable form of contraception
* Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug
The Effects of a Spread With Added Plant Sterols and Omega-3 Fatty Acids on Blood Lipids

The main aim of the study is to investigate the effect of daily consumption of a margarine enriched with plant sterol esters and fish oil on fasting triglycerides (TG) concentrations.

The study also aims to investigate the effect of plant sterols and fish oil on fasting total cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C), High-density lipoprotein cholesterol (HDL-C) and non-HDL-C.

At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations will be explored.

The main aim of the study is to investigate the effect of daily consumption of a margarine enriched with plant sterol esters and fish oil on fasting TG concentrations.

The study also aims to investigate the effect of plant sterols and fish oil on fasting TC, LDL-C, HDL-C and non-HDL-C.

At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations will be explored. This exploratory objective will only be analyzed if a relevant treatment effect on fasting triglycerides concentrations is observed.

Eligibility Criteria:
Inclusion Criteria:

* Fasting TG levels at screening: ≥ 1.40 and ≤ 5.60 mmol/L
* Fasting LDL-C levels at screening: ≥ 3.4 and ≤ 4.9 mmol/L

Exclusion Criteria:

* Recently (\<6 months) diagnosed with cardiovascular event(s), revascularization or systemic inflammatory conditions.
* Medical history which might impact study measurements, to be judged by the study physician
* Use of over-the-counter and prescribed medication which may interfere with study measurements
* Reported weight loss or gain of 3 kg or more during a period of 2 months prior to screening.
* Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.
Reconstructing Consciousness and Cognition

Currently it is unknown how the human brain reorganizes its network organization to generate conscious experience and cognitive activity after a period of unconsciousness. Therefore, the purpose of this study is to assess how cognitive activity is reconstructed after general anesthesia. The investigators hypothesize that the brain's transition from unconsciousness to consciousness and full cognition is a complex process that occurs over an extended period of time. Specifically, the investigators hypothesize the following order of cognitive reconstitution: responsiveness to command, attention, complex scanning and visual tracking, working memory, and executive function.

Volunteers will be healthy participants who are anesthetized with commonly used anesthetic drugs as well as a non-anesthetized group to control for circadian influences. A total of 60 subjects will be recruited for this study. All subjects (male and female) will perform basic tests for cognition on a laptop computer at 30-minute intervals during this study. The testing battery to be administered was assembled to assess multiple cognitive functions in order to determine whether and how cognitive processes return to baseline function. Electroencephalogram (measuring brain electrical activity) data will be monitored and recorded during both anesthesia and cognitive testing, for subsequent analysis.

This study is significant because it could lead to a better understanding of the neural correlates of human consciousness, as well as normal and abnormal conscious state transitions (including barriers to such transitions).


Eligibility Criteria:
Inclusion Criteria:

* Healthy 20-40 year old volunteers,
* American Society of Anesthesiologists Physical Status I or II (i.e., healthy),
* Body mass index \< 30 kg/m2,
* Easily visualized uvula,
* With anticipated equal recruitment of males and females.

Exclusion Criteria:

* Physical signs suggestive of difficult airway (e.g., mouth opening \<3cm, short distance between the chin and neck, poor mandibular subluxation, thick neck),
* History of obstructive sleep apnea,
* Reactive airway disease,
* Neuropsychiatric disorders,
* History or current use of psychotropic medications,
* Current tobacco and alcohol use,
* History of hypertension or current medication for blood pressure control, cardiovascular disease or arrhythmias,
* Positive urine toxicology screen,
* History of reflux,
* Pregnancy,
* Family history of problems with anesthesia (including but not limited to malignant hyperthermia),
* Sleep disorders,
* History of postoperative nausea/vomiting or motion sickness,
* Allergy to eggs, egg products or soy.
Muscle Oxygenation in Chronic Obstructive Pulmonary Disease

The aim of our study is to examine the Peripheral Muscle Oxygenations at rest and in motion on the 2nd day of hospitalized patients and before discharge in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease and to compare the results in the hospital periods by repeating the tests in the stable periods of the patients 1 month after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Being a COPD patient hospitalized with Severe Acute Exacerbation
* be between 40-80 years old
* Having a Body Mass Index below 35

Exclusion Criteria:

* Patients who do not want to participate in the study
* Patients requiring intensive care follow-up during their hospitalization Arthritis, neurological disease, deep vein thrombosis, peripheral arterial disease, muscle weakness, broken etc. patients with the condition
* Extensive parenchyma such as malignancy, pulmonary embolism, vasculitis, collagen tissue diseases, interstitial fibrosis, severe pneumonia patients with damage
* Patients with severe dyspnea and hemodynamic instability who cannot perform the sit-up test