cyrilzakka/clinical-trials huggingface dataset:
Depression and Health Outcomes in Refractory Epilepsy

To define the benefits of antidepressant treatment or cognitive behavior therapy on mood, function, and quality of life in persons with depression and refractory epilepsy.

This randomized clinical trial will be conducted to compare the drug sertraline to cognitive behavioral therapy on symptoms of depression, antiepileptic medication compliance, seizure frequency, and quality of life outcomes in persons with depression and a seizure disorder or epilepsy. Approximately 140 persons will be enrolled in this study over a period of five years. Individual participation will last approximately 16 weeks. Study participants will be chosen randomly to receive either the study medication (sertraline) or cognitive behavior therapy for 16 weeks. Sertraline is approved by the Food and Drug Administration (FDA). Subjects who receive cognitive behavior therapy will be provided with a one-hour individual session with a licensed clinical psychologist each week for 15 weeks. All study participants will attend scheduled clinic visits every 4 weeks for 16 weeks.

Eligibility Criteria:
INCLUSION:

* Must have a seizure disorder.
* Must meet the DSM-IV criteria for major depression.
* Must be willing to provide written informed consent.
* Must be age 21 to 75 years old.
* Must be compliant, cooperative, reliable, and able to follow instructions, and to visit the clinic on schedule.

EXCLUSION:

* Have active suicidal or homicidal ideation.
* Have current alcohol or other substance abuse disorders or a history of bipolar depression or any psychotic disorder.
* Are pregnant or lactating.
* Are known to be hypersensitive to sertraline.
* Have a progressive central nervous system disorder (such as a tumor or multiple sclerosis), or severe hepatic or renal disease (serum creatinine \>3 mg/dl).
* Currently taking an antidepressant medication or seeing a therapist regularly.
Immunotherapy of Gastric Cancer With Autologous Tumor Derived Heat Shock Protein gp96

The purpose of this study is to evaluate the safety and effectiveness of autologous gp96 treatment of gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Disease characteristics: Histologically confirmed gastric carcinoma: clinical stage III (according to the Japanese gastric cancer classification), must have undergone radical resection
2. Able to read and understand the informed consent document, must sign the informed consent
3. Age: 18 to 75 years old
4. Availability of at least 0.5 g tumor sample
5. ECOG ≤1；life expectancy \>=12 weeks, able to comply with study-related procedures
6. Adequate bone marrow function including the absence of lymphopenia (ANC \> 1,500/ mm3; Hemoglobin \> 10g/dL ; platelet count \>100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase \[AST\], alanine amino transferase \[ALT\] \<2.5 times institutional upper limit of normals \[IULNs\] and bilirubin (total) \<1.5 times IULN), and adequate renal function (BUN and creatinine \<1.5 times IULNs)
7. Normal heart function
8. NOT participate in ANY other clinical trials within 4 weeks prior to vaccination.

Exclusion Criteria:

1. Unable to get the informed consent
2. Female patients who are pregnant or breastfeeding
3. Progression prior to treatment as determined by the principal investigator
4. Transplant recipient
5. Patients currently diagnosed with Human Immunodeficiency Virus or other active uncontrolled infection
6. Unstable or severe intercurrent medical conditions
7. Patient with allergic constitution
8. Patients with any systemic disease needed to be treated with immunosuppressant or Corticosteroids.
Novel Equation for Estimating Resting Energy Expenditure

The energy and nutrition states are closely associated with CKD patients complications and outcomes.To reach the energy balance target, we need the accurate resting energy expenditure level of patients. Traditional equations are not applicable to CKD patients,so we aim to develop and validate a equation for estimating resting energy expenditure in CKD patients.


Eligibility Criteria:
Inclusion Criteria:

* CKD 3-5 stages
* Age:18-80 years old

Exclusion Criteria:

* Dialysis and kidney transplantation;
* Acute complications to hospitalization
* 1 month prior to the study;
* Acute or chronic infections, cancer and other wasting diseases in the past year;
* Thyroid dysfunction;
* Acute onset of podagra; Musculoskeletal diseases;
* Respiratory diseases (asthma, pleural effusion, pneumothorax, COPD);
* History of hormonal drugs use;
* During pregnancy or lactation
Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal

Chronic Obstructive Pulmonary Disease (COPD) is the fourth most important cause of death worldwide and is one of the commonest non-communicable diseases (NCDs) in Nepal. The presence of risk factors like indoor and outdoor air pollution, the high prevalence of smoking and lack of general awareness of COPD makes it a serious public health concern. However, no attempt has been made in Nepal to estimate its burden and address the disease at the community level. This community-based cluster randomized controlled study aims to fulfil that gap through mobilization of Female Community Health Workers (FCHVs) who will be trained to perform a certain set of health promotion activities aimed at prevention of the disease and its progression. Baseline and follow-up surveys will be conducted to compare the intervention and control groups. This study has the potential to generate evidence in helping address NCDs in Nepal and also other similar resource-limited countries.


Eligibility Criteria:
Inclusion Criteria:

* Capable of performing spirometry
* Aged greater than and equal to 40 years
* Full time residents in the study area and will be in the study area for at least one year

Exclusion Criteria:

* Younger than 40 years of age
* Self-reported pregnancy
* having active pulmonary tuberculosis or being on medications for pulmonary tuberculosis
* thoracic, abdominal or eye surgery in the last six months
* History of Mental illness
* MI in past 8 weeks prior to study
* Hospital admission in the past six months for cardiac illness
* Those who decline to provide consent to the study will be excluded.
Comparison of Three Different Doses of Intrathecal Morphine for Analgesia After Cesarean Section

In our study, It was aimed to determine the dose of morphine that provides the most effective analgesia with the least incidence of side effects in the postoperative period.

Spinal anesthesia is a widely used method in cesarean section operations. It has become a popular practice to add opioids to local anesthetic agents to improve the quality and prolong the duration of intraoperative and postoperative analgesia. Morphine and fentanyl are commonly used opioids for this purpose. In cesarean sections, intrathecal morphine (ITM) is preferred for postoperative analgesia due to its slow onset and long-term analgesia, and intrathecal fentanyl is preferred for intraoperative analgesia due to its faster onset of action.

ITM can cause side effects such as nausea, vomiting, itching, sedation and respiratory depression. The quality of analgesia and the incidence of side effects may vary depending on the ITM dose used. There are studies indicating that reducing the dose of ITM results in good quality, long-term analgesia with a low incidence of side effects. However, the ideal dose of ITM providing optimal postoperative analgesia with the lowest incidence of side effects for cesarean section has not been determined yet in the literature. For this purpose, in this study it was compared the postoperative analgesia efficiency and incidence of side effects of three different ITM doses in order to contribute to the literature.

Patients were divided into three groups:

Group 1: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 80 mcg intrathecal morphine was administered.

Group 2: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 120 mcg intrathecal morphine was administered.

Group 3: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 160 mcg intrathecal morphine was administered.

All patients received iv Patient Controlled Analgesia (PCA) prepared with fentanyl postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing cesarean section
* Between the ages of 18-40,
* ASA II,
* Pregnant women with gestational week \> 36

Exclusion Criteria:

* Not accepting regional anesthesia,
* İnfection at the injection site,
* Coagulopathy, bleeding diathesis,
* Severe hypovolemia,
* İncrease in intracranial pressure,
* Pregnant women with problems such as severe aortic stenosis, severe mitral stenosis for which spinal anesthesia is contraindicated,
* Patients with a history of allergy to any drug included in the study protocol
p53 Gene in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer

The study objective is to investigate the efficacy and safety of p53 combined with chemotherapy (cisplatin and paclitaxel) in treatment of recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer.

The study objective is to investigate the efficacy and safety of p53 combined with chemotherapy (cisplatin and paclitaxel) in treatment of recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer.

study design: open-labeled, active controlled, randomized, phase 2 treatments: experiment group will consist of intraperitoneal p53 (2 x 10\^12 viral particles) plus cisplatin 150 mg/m\^2, and Paclitaxel 175 mg/m\^2 IV over 3 h on day 1; every 21 d for 6 cycles.

study end points: response rate, progression-free survival, overall survival and Karnofsky score（KPS).

Eligibility Criteria:
Inclusion Criteria:

1. histopathologically diagnosed ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer
2. recurrent
3. 18 years or older
4. with normal tests of hemogram, blood coagulation, liver and kidney function
5. signed the informed consent form.

Exclusion Criteria:

1. Serious blood coagulation disorder, bleeding tendency, platelet \< 6 \* 1000000000/L;
2. have serious heart, lung function abnormalities or severe diabetes patients;
3. active infection;
4. severe atherosclerosis;
5. AIDS patients;
6. serious thrombotic or embolic events within 6 months;
7. renal insufficiency requiring hemodialysis or peritoneal dialysis;
8. pregnant or lactating women;
9. mental disorder or disease.
Grape Polyphenols and Second-meal Effect

The aim of this is study is to evaluate the effects of a single intake of grapes (a polyphenol-rich food) in postprandial metabolism in subjects with obesity, including a first intake (high-fat breakfast) after overnight fasting a second one (medium-fat lunch). Studies on the effects of polyphenols on postprandial (glucidic and lipidic) metabolism have commonly been performed in animal models and have used grape extracts, ignoring the whole pool of polyphenols present in grapes (extractable and non-extractable polyphenols). Besides, the contribution of polyphenols to the so-called second-meal effect has not been explored. It should be highlighted that this study aims to explore the potential beneficial role of fresh grapes, consumed as fruit; in order to ensure the stability of the product, they will be provided as freeze-dried milled material, but the amount received by the subjects could be incorporated into a common diet, being equivalent to 300 g of fresh grapes.

Twenty-five subjects with obesity will be were recruited. Detailed inclusion and exclusion criteria are provided below.

The subjects will receive, after overnight fasting, either a monodose of freeze-dried grapes (equivalent to 300 g of fresh grapes) or isocaloric placebo solved in water, together with a high-fat breakfast. Blood samples will be collected before the intake, up to 5 h after breakfast, then a medium-fat lunch will be provided and blood samples will be collected for three additional hours. Both interventions will be separated by two weeks. The following determinations will be performed in blood samples collected at different periods: glucose, insulin, triglycerides, uric acid, viscosity, antioxidant capacity. Additionally, a satiety test will be provided. It is expected that grape supplementation, as compared with an isocaloric placebo, causes significant modifications in all the parameters indicated. Nevertheless, the primary outcome of this study is the area under the curve for glucose after the second meal (300-420 min from basal time).

Eligibility Criteria:
Inclusion Criteria:

* Obesity (BMI = 30-40 kg/m2).

Exclusion Criteria:

* Subjects with a pharmaceutical treatment set to modify blood pressure, lipid profile or glucose.
* Subjects with diagnoses of type 2 diabetes, cardiovascular diseases or thyroid diseases.
* Values above the following ones: glucose, \> 115 mg/dL; triglycerides, \> 350 mg/dL; total cholesterol, \> 280 mg/dL; systolic blood pressure, \> 150 mmHg; diastolic blood pressure, \> 100 mmHg
* Previous bariatric surgery.
* Volunteers participating in other studies (currently or during last year) or weight loss plans.
* Pregnant or breastfeeding women.
* Adherence to vegetarian diets or usual consumption of dietary supplements.
Population Pharmacokinetics of Linezolid

Linezolid is the first of a new class of antibacterial drugs, the oxazolidinones. It has a specific inhibitory activity against Gram positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

Dosage of 600 mg discontinuous administration twice a day was about studies in safety volunteers. The intensive care units patients, with mechanical ventilation, and with severe sepsis, represent highly heterogeneous population responsible of hight variability in pharmacokinetics parameters (augmentation in total volume of distribution, modification in glomerular filtration) wich can lead to antibiotic inefficacy.

In a first time, this study describe the pharmacokinetics of Linezolid in intensive care units patients with severe MRSA infection. The aim of this study is to define and validate a population pharmacokinetic model including the influence of patients' characteristic on the pharmacokinetics of Linezolid.

The demographic, clinical and biological parameters are collected. Patients receive Linezolid as 600 mg twice a day during an administration of 60 minutes.

Blood sampling are collected on the second day after beginning of treatment at the following time : H1, H2, H3, H6 and H12.

The population pharmacokinétics analysis will be carried out using Monolix, a software for the analysis of nonlinear mixed effects models.

Eligibility Criteria:
Inclusion Criteria:

* In-patient stay in intensive care
* Over 18 years old
* Presenting with MRSA nosocomial pneumonia or bacteraemia with a strain thought to be sensitive to Linezolid
* Simplified Acute Physiological Score (SAPS) II \> 20
* Expected duration of life \> 7 days.

Exclusion Criteria:

* History of allergy to linezolid or any of the antibiotics used
* Isolation of MRSA resistant to linezolid
* Lack of seeds
* Pregnancy and lactation
Calcium (ca),Phosphorus( P) and 25-hydroxyvitamin D(25OHD)] in Infants Born ≤ 32 PMA Gestational Weeks (GA)

It has not yet been established the optimal dose of vit. D for preterm infants in Poland. It is not known what dose of vit. D will provide the correct concentration of vit. D and the optimal development of the skeleton of the premature.

The study will try to determine the optimal supplementation of vitamin D and the supply of Ca and P for normal growth and development of a child born prematurely.

In addition, the investigators will evaluate any risk factors for deficiency and excess of vitamin D and the consequences of its deficiency and overdose. Simultaneously the study would make possible the determination of an optimal schedule for controlling the Ca-P levels in the group of the youngest infants born prematurely. In addition, the study will assess the relationship between maternal and newborn vitamin D resources right after birth, and the incidence of vitamin D deficiency in infants born prematurely. Preterm infants will be randomized in 3 groups assigned to different doses of vit. D. The study will investigate the metabolism of calcium, phosphorus, the health of bones and development of the premature babies till the age of 2.

The participants of the study will be prematures, born ≤32 GA, hospitalized in the Department of Neonatology, in the neonatal intensive care unit. Hospitalized patients who meet the inclusion criteria will be randomized in 3 groups assigned to different doses of vit. D (400, 800 or 1200 units(UNT) of vitamin D).

At defined age points of postnatal life, parameters of calcium and phosphorus metabolism and vitamin D level will be tested, along with the health of bones, health status and development.

Eligibility Criteria:
Inclusion Criteria:

* gestational age ≤32 weeks at birth
* hospitalization in the department no later than at the age of 7 days (for infants born outside the center)
* No birth defects or diseases permanently affecting the ability to accept enteral feeding
* Anticipated possibility of continuous monitoring of the course of treatment in hospital until discharge
* Consent of Parents / legal guardians for the participation in the study.

Exclusion criteria

* gestational age\> 32 weeks at birth
* the beginning of hospitalization in the department later than the age of 7 days (for infants born outside the center)
* presence of congenital defects or diseases permanently affecting the ability to accept enteral feeding (e.g.oesophageal atresia, anal atresia, congenital umbilical hernia, gastroschisis, syndromes genetically determined)
* significant interruption (\> 1 week) of the hospitalization in the center
* lack of consent of the Parents / legal guardians to participation in the study
At-risk Intervention and Mentoring Evaluation

The purpose of this study is to determine if a hospital-based violence intervention programs can make sustainable behavior changes in at-risk youth using two key components, brief intervention at the hospital bedside and case management.

This study will be a randomized controlled trial. Youth presenting to the emergency department with an intentional injury (gunshot wound, stab wound, or assault) will be given a behavioral assessment. Participants will be categorized according to risk (low, moderate, high). Only moderate or high youth will continue in the study and be randomized. Low risk youths will receive the medical standard of care and be re-assessed at 18 months.

Randomization will place participants in one of two arms. Arm 1 will receive the standard of care PLUS a brief intervention with AIM outreach workers. Arm 2 will receive standard medical care PLUS a brief intervention PLUS case management.

Every randomized youth will be assessed for risk and protective factors and have have data collected at 6-month intervals (0, 6, 12, 18 months).

Eligibility Criteria:
Inclusion Criteria:

* 14-24 years of age , Intentional Injury (Gunshot Wound, Stab Wound, Assault)

Exclusion Criteria:

* Younger than 14, 25 or older, non-English speaking, unable to give informed consent/assent, sexual assaults, domestic violence, child neglect/abuse.
Characteristics of NAFLD Among Type 2 Diabetes Patients

Type 2 diabetes patients have a high risk of developing NAFLD. This was confirmed during previous research, a high prevalence of NAFLD among type 2 diabetes mellitus patients was found. The investigators want to determine the characteristics of this population.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years,
* having type 2 diabetes,
* able to understand Dutch,
* able to understand the informed consent

Exclusion Criteria:

* excessive alcohol abuse,
* other liver disease,
* secondary causes of steatosis
Liquid Biopsy System Intracoronary Blood Sampling and Analysis to Characterise Disease Biomarkers in Patients With Coronary Disease

The aim of this research, proposed and funded by PlaqueTec and co-ordinated by Papworth Trials Unit Collaboration, is to demonstrate the performance of the coronary artery blood sampling device (Liquid Biospy System, LBS) and establish its usefulness to collect a range of disease biomolecules from the coronary artery of interest. Using the data generated from extensive analysis of the blood samples, key biomarker data will be generated that will close a knowledge gap and facilitate the development of tailored treatments for coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

Stage 1 screening inclusion:

1. ≥18 years of age, have capacity and be willing to provide informed consent to participate
2. Clinical evidence of obstructive coronary artery disease and be scheduled for either:

   1. Elective coronary angiography +/- proceed for stable angina OR
   2. Elective PCI for stable angina with known bystander disease not for PCI OR
   3. Angiography +/- proceed for Troponin negative unstable angina

Stage 2 screening inclusion:

Suitable lesion identified meeting angiographic criteria for LBS deployment and Cardiologist comfortable to deploy OCT and LBS on study lesion before carrying out PCI on any other lesion

Exclusion Criteria:

Stage 1 screening exclusion:

1. Myocardial Infarction within 30 days of procedure.
2. Chronic renal failure (eGFR\<30ml/min/1.73m2).
3. Contrast allergy.
4. Hypotension, shock or haemodynamic instability.
5. Ventricular arrhythmia.
6. Chronic Heart Failure (NYHA ≥ 3) or LVEF ≤ 30%.
7. Immunocompromised or receiving immunosuppressant therapy.
8. Any active disease that in the opinion of the investigator makes the subject unsuitable for the research procedure or subject life expectancy less than 1 year.
9. Active infection or sepsis (significant CRP elevation and/or requiring antibiotics).
10. Active systemic inflammatory condition.
11. Inability to receive anticoagulants or antiplatelets or uncorrected bleeding disorder or deranged platelet count.
12. Is pregnant.
13. Deemed high clinical risk or unsuitable for the procedure for any reason by the treating clinician.

Stage 2 screening exclusion:

1. Target lesion is in the left main coronary artery.
2. Target lesion requires PCI
3. In same vessel as lesion requiring PCI
4. Unsuitable coronary anatomy (vessel tortuosity \[\>45 degree bend\], moderate/ severe calcification angiographically, ostial disease).
5. Presence of thrombus in the target vessel.
6. Prior PCI or stent in vessel identified for LBS sampling
The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia

The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with Hypertriglyceridemia.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) ≤ 45 kg/m2
2. Fasting Triglycerides (TG) ≥ 500 mg/dL (≥ 5.7 mmol/L) at Screening.
3. If on statin or fibrate, participants must be on stable, labeled dose for at least 3 months prior to screening. Participants not receiving these drugs within 4 weeks prior to screening are also eligible.

Exclusion Criteria:

1. Type 1 diabetes mellitus
2. Newly diagnosed type 2 diabetes mellitus (within 12 weeks of screening) or HbA1c ≥ 9.0% at Screening
3. Acute pancreatitis within 3 months of screening
4. Acute Coronary Syndrome within 6 months of screening
5. Major surgery within 3 months of screening
6. Prior exposure to ISIS 304801
7. Have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study