cyrilzakka/clinical-trials huggingface dataset:
Palmitic Acid in the Sn-2 Position of Triacylglycerols and Postprandial Lipemia

The purpose of this study is to determine whether high-fat meals rich in palmitic acid in the sn-2 position decrease lipaemia in men aged 40-70 y with higher than optimal fasting triacylglycerol concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Non-smokers
* Aged 40-70 years
* Fasting TAG concentrations ≥1.5 mmol/L.

Exclusion Criteria:

* Reported history of CVD (myocardial infarction, angina, venous thrombosis, stroke), impaired fasting glucose/uncontrolled type 2 diabetes (or fasting glucose ≥ 6.1 mmol/L), cancer, kidney, liver or bowel disease.
* Presence of gastrointestinal disorder or use of drug, which is likely to alter gastrointestinal motility or nutrient absorption.
* History of substance abuse or alcoholism (previous weekly alcohol intake \>60 units/men)
* Current self-reported weekly alcohol intake exceeding 28 units
* Allergy or intolerance to any component of test meals
* Unwilling to restrict consumption of any source of fish oil for the length of the study
* Weight change of \>3kg in preceding 2 months
* Body Mass Index \<20 and \>35 kg/m2
* Fasting blood cholesterol \> 7.8 mmol/L
* Current cigarette smoker.
* Current use of lipid lowering medication
Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-007)

The purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in the treatment of dry eye syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe dry eye syndrome with or without Sjogren's syndrome or other autoimmune disease

Exclusion Criteria:

* Intraocular or refractive surgery in the study eye within 3 months prior to study start
* Unwilling to discontinue use of contact lenses during the run-in and duration of the study
* Pregnancy or lactation
Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Abdominal Surgery

The purpose of this study is to determine whether the early identification and more precise intervention of goal-directed intraoperative plasma volume expansion and catecholamine therapy using arterial pressure based cardiac output (APCO) measurement in addition to normal vital signs will improve postoperative organ function, in particular renal function, in patients undergoing major abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled for elective major abdominal surgery and has two or more risk factors according to the Lee classification scheme.
* Patient can sign informed consent before surgery.
* Patient is able to comply with the study procedure.
* Patient must require an indwelling radial or a femoral artery catheter.
* Patient must be 20 years old or older.
* Patient must be 40kg or heavier.
* Patients height and weight can be accurately obtained prior to study start.

Exclusion Criteria:

* Emergency surgery.
* Patients with aortic or mitral valve regurgitation.
* Renal insufficiency requiring hemodialysis.
* Liver dysfunction (alanine/aspartate aminotransferase \>40 U/L).
* Patient with contraindications for the placement of radial, femoral or other arterial cannulae.
* Patient being treated with an intraaortic balloon pump.
* Female patients with a known pregnancy.
* Patient is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
The Bialystok Bariatric Surgery Study

The Bialystok Bariatric Surgery Study (BBSS) is a prospective observational cohort study of patients undergoing bariatric surgery at the First Clinical Department of General and Endocrine Surgery at the Medical University of Bialystok. The BBSS consists of a battery of baseline tests established one month prior to the surgery and repeated at one, three, six, twelve and twenty four-month follow-up clinical visits.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 40 kg/m2, or BMI ≥ 35 and at least one or more obesity-related co-morbidities such as type 2 diabetes (T2D), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease.
* Inability to achieve a healthy weight loss sustained for a period of time with prior weight loss efforts
* Patient consent for participation in research project
* Willingness in participation in follow-up visits

Exclusion Criteria:

* substance abuse,
* uncontrolled psychiatric illness
* expected lack of compliance
* advanced-stage cancer

Non-obese control group:

* BMI \<30
Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees

The purpose of this study is to test how tolerable and effective acamprosate is when used to prevent alcohol relapse in criminal justice supervisees (those on probation, parole, or in drug court).

Acamprosate has been an available treatment for alcohol dependence outside the United States and has recently been approved by the U.S. Food and Drug Administration as an effective therapy for alcohol dependence. In the past ten years, drug court programs have been implemented as one possible solution to reduce the burden placed on state and federal correctional systems. These programs are generally focused on non-violent drug dependent offenders and are offered as an alternative to incarceration. However, the use of acamprosate has never been examined for alcohol relapse prevention among a drug court population, or among those on probation or parole.

Comparison: Alcohol-dependent criminal justice supervisees who receive acamprosate, compared to participants who do not receive acamprosate.

Eligibility Criteria:
Inclusion Criteria:

* History of alcohol dependence in the year before entering criminal justice supervision
* Currently under criminal justice supervision (drug court, probation, or parole) in central Virginia

Exclusion Criteria:

* Pregnant or nursing a baby
* Known sensitivity to acamprosate
* Elevated serum creatinine level or other evidence of kidney problems
* Symptoms of severe depression or suicidal ideation
* Non-English speaking such that they cannot provide informed consent
* Cognitive impairment such that they cannot provide informed consent
High Protein and Energy Diet for Better Coughing in COPD Patients

Chronic Obstructive Lung Disease (COPD) is one of the leading death causes worldwide. COPD is a disease that is characterized by chronic inflammation which leads to irreversible damage of airways and lung tissue. This intervention investigates the effects of a diet high in protein and energy for the improvement of coughing capacity and lung function of COPD patients. The patients will be recruited as part of a lung rehabilitating programme which takes place in Bispebjerg and Hvidovre Hospital. The intervention group receives individual nutritional guidelines whereas the control group continues their usual diet. Blood tests will be performed at baseline and the end of the study. Other anthropometric measures include spirometry for lung function, hand grip strength and fat free mass to assess muscle waisting.

40 patients with COPD randomized to diet with protein 1.3 g/kg/day or habitual intake:

Primary endpoint (before-after): Leicester Cough Questionnaire Secondary endpoints: ADL-score, no. daily cough periods, development in FEV1 and FVC, hand-grib-strenght, use of respiratory medications, smoking, appetite, admissions to hospital, antibiotics and/or steroids, oxygen saturation, FFM (BIA), Coughs tests in spirometer and peak-flow-meter

Study period: 2 months

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with COPD
* Participating in ongoing lung rehabilitating programme at Hvidovre and Bispebjerg Hospital
* over 18 years

Exclusion Criteria:

* Plasma creatinin over 200 mikrog/l
* dementia
* unable to read or speak danish
Discovering Factors in the Clinical Study Journey of Patients With OCD

This research aims to collect comprehensive data on the clinical trial experience of OCD patients. Its goal is to identify the factors that limit patients' ability to join or complete a trial successfully. Clinical trial participation often favors specific demographic groups, and limited research exists on the impact of trial attributes on participation. Therefore, this study aims to analyze data from various demographic groups and identify any recurring trends that could provide valuable insights for future OCD patients.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
* Participant has a diagnosis of OCD.
* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

Exclusion Criteria:

* Pregnant or lactating woman
* Enrolled in another research study
* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop

This study is designed to look at how snacking during exercise may help prevent low blood sugars while subjects are on the "closed loop artificial pancreas." This system uses a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the sensor glucose level.

This study will be a randomized cross-over study as subjects will be studied under both study conditions - Closed Loop (CL) alone vs. CL + proactive snacking protocol). Differences in the nadir blood glucose levels during exercise between the two study conditions will be the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

1. Age 13-45 years
2. Clinical diagnosis of T1D (formal antibody and/or genetic testing will not be required)
3. Duration of T1D ≥ 1 year
4. HbA1c ≤ 9 %
5. Treated with continuous subcutaneous insulin infusion (pump) for at least 3 months
6. Body weight \> 40 kg (to accommodate phlebotomy)
7. Able to tolerate a 75-minute exercise period of moderate intensity
8. Be willing to wear 2 subcutaneous glucose sensors (placed under the skin like a pump site) simultaneously during the inpatient portions of this study.
9. Be in good general health without other acute or chronic illness that in the judgment of the investigator could interfere with the study or jeopardize subject safety
10. Normal hematocrit
11. Able to give consent (for children \<18 years, permission from parents and subject assent will be required)
12. Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods.

Exclusion Criteria:

1. Insulin resistant (defined as requiring \> 1.5 units/kg/day at time of study enrollment)
2. Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
3. Use of any medications (besides insulin) known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 2 weeks of the closed loop admissions. Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites.
4. Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
5. History of hypoglycemic seizure within last 3 months
6. Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
Expanded Access Study of TJ004309 in Patients With Advanced or Metastatic Cancer

This expanded access protocol was designed to provide TJ004309 in combination with atezolizumab to the remaining three patients with advanced or metastatic cancer who plan to continue with treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Participation in the Tracon sponsored 4309ST101 or I-Mab sponsored TJ004309STM103 study and thought to have potential to derive clinical benefit from continued treatment in the opinion of the parent study investigator from dosing of TJ004309 in combination with atezolizumab.
2. Willing or able to comply with study treatment and standard of care testing and procedures.

Exclusion Criteria:

1. Any unresolved ongoing toxicity or clinical event that would make continued treatment with TJ004309 inappropriate.
2. Current treatment in another clinical study or treatment with other standard of care therapy.
3. Currently pregnant.
4. Current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might interfere with the patient's participation or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
Liver Function Assessment - Feasibility and Dosing Study

The purpose of this study is to 1) determine the feasibility of using Cardiox Liver Function Assessment System (LFA) to measure indocyanine green (ICG) clearance; 2) determine an adequate dose based on LFA technology and 3) determine an adequate time period for LFA determination.

Four cohorts of subjects will be enrolled. The fist two cohorts will receive fixed doses of ICG dye (2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg) followed by 20 minutes of LFT monitoring. The final two cohorts will receive weight based doses of ICG dye (0.1 mg/kg, 0.5 mg/kg) followed by 20 minutes of LFT monitoring. Additionally the final two cohorts will have serial blood draws before the ICG dose and at 5, 10, 15 and 20 minutes post ICG dose.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged 18 to 75 years, inclusive
* Informed consent documentation understood and signed.

Exclusion Criteria:

* Known allergy or sensitivity to the ICG or to iodide contrast dye
* Pregnant women or those nursing babies
Atlas of Intracranial Recordings on Cortical Responses After Functional tACS

By analyzing the SEEG recordings, we explore the range of cortical functional responses to strings of 77.5Hz stimulations delivered by tACS,


Eligibility Criteria:
Inclusion Criteria:

* All epileptic patients that would receive the implantation of SEEG electrodes, regardless of the seizure locations;
* There was no metal implantation before;
* Eligible for MRI examination;
* No other lesional neurological disorders;
* Could be well informed by the study protocols.

Exclusion Criteria:

* Suffered from any other mental illnesses prior to the enrollment;
* Those suffering from the serious or unstable organic diseases;
* Pregnant or lactation women, and those who have a plan of pregnant;
* Patients with central nervous system tumors, acute brain injury or infection;
* Skin injured, or allergic to the exposure of the conductive gel;
* Those with implanted devices;
* Those who received modified electrical convulsive therapy, or TMS within the recent one month;
* The score of item 3 (suicidal item) in HAMD-17 equal or greater than 3;
* Enrolled in any other on going trials;
* Other situations evaluated by the researchers as inappropriate to the enrollment
Right Ventricular Function During Exercise in Highlanders/Lowlanders

The purpose of the current study is to evaluate the right ventricular function during graded cycling on an ergometer by transthoracic echocardiography in Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a cross-sectional case-control study.


Eligibility Criteria:
Inclusion Criteria:

* high altitude pulmonary hypertension confirmed by clinical presentation and mean pulmonary artery pressure \>30 mmHg measured by echocardiography at altitude of residence.
* healthy subjects (high altitude controls)
* Both genders
* Age \>16 y
* Kyrgyz ethnicity
* born, raised and currently living at \>2500 m
* healthy subjects currently living at \<1000 m (low altitude controls)

Exclusion Criteria:

* Pulmonary hypertension from other causes, in particular from left ventricular failure as judged clinically and by echocardiography
* Excessive erythrocytosis
* Other coexistent disorders that may interfere with the cardio-respiratory system and sleep
* Regular use of medication that affects control of breathing
* Heavy smoking
Continuous Monitoring of Vital Parameters for Early Detection of Clinical Deterioration in Hospitalized Patients

For patients admitted to the medical ward, it is often difficult to predict if their clinical condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 24/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients condition progress beyond the point-of-no-return, where adverse events are inevitable. The WARD project aims to determine the correlation between cardiopulmonary micro events and clinical adverse events during the first four days after hospital admission.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years
* Acute hospitalization or discharge from Intensive Care Unit (ICU) after an admission of at least 24 hours.
* Early Warning Score (EWS) ≥4 at least once from admission and until inclusion
* One of the following tentative diagnoses as the primary reason for admission: Pneumonia, Dyspnea, Acute myocardial infarction, heartfailure or sepsis
* Inclusion conversation possible within 12 hours of admission or discharge from ICU

Exclusion Criteria:

* Patients that cannot cooperate
* Patients that cannot give informed consent
* Patients with EWS≥4 that is not of presumed physical origin
* Patients with allergies to plaster or silicone
* Patients with pacemaker or ICD
* Patients with treatment limitations (no resuscitation or no admission to ICU)
* Patients with expected discharge within 24 hours
* Patients that have been included in the WARD-COPD study (H-18026653)
Antisecretory Factor Glioblastoma Phase 2

This is a randomised, double blinded and multiple center , Phase 2 study in patients with newly diagnosed glioblastoma. Participants will receive an egg powder enriched for antisecretory factor (AF), Salovum, or a placebo egg powder daily from 2 days before concomitant radio-chemo therapy or chemotherapy until 14 days after finalisation plus during adjuvant chemotherapy.The primary aims of are overall survival at 6 and 12 months after diagnosis

Glioblastoma (GB) is the most common primary brain tumor and also has the worst prognosis with a mean survival time below 1 year and a 5-year survival rate of less than 2%. AF is a 41kilodalton endogenous and essential protein with antisecretory and anti-inflammatory effects. Endogenous AF activity increases after exposure to bacterial toxins and endogenous triggers of inflammation. The active amino-terminal portion of AF has been synthesized as a 16 amino acid peptide (AF-16) and has been used in animal experimental studies. Salovum® is a product based on egg yolk powder B221® and contains high levels of AF. Salovum® is classified as food for special medicinal purposes (FSMP) by the European Union an din other countries.

Many tumors show elevated interstitial fluid pressure (IFP) compared to the surrounding tissue due to vascular leakage, providing a barrier for drug uptake in solid tumors, as well as poor perfusion, resulting in hypoxia and relative resistance to radiochemotherapy.

AF-16 was reported to significantly reduce the IFP in xenotransplanted human glioblastoma by inhibiting an ionic pump, NKCC1, in the tumor tissue. Both Salovum® and AF-inducing specific processed cereals (SPC) prolonged survival in the same models. Systemic temozolomide treatment combined with AF inducing SPC completely blocked tumor growth in GBM xenografts. Likewise, SPC treatment abrogated 90% of pre-established syngeneic tumors in immune competent animals.

Intratumoral delivery of AF-16 potentiated the effect of intratumoral temozolomide in an experimental model of glioblastoma.

Mechanistically, it remains unclear whether AF's effect in tumor models is mediated through decrease of IFP and/or immunomodulation. Also, an effect on the complement system through modulation of circulating complement complexes with proteasome units has been proposed.

Salovum® has been administered to patients with various diseases as, inflammatory bowel disease, Mb Ménière and mastitis and traumatic brain injury without signs of any adverse effects.

In a completed phase1-2 trial in participants with primary gliobalstoma the add on of Salovum during concomitant radiochemotherapa was considered safe and feasible.

The current study is aimed at assessing the efficacy of Salovum in a RCT (randomised controlled trail).

Eligibility Criteria:
Inclusion Criteria:

1. Pathology verified glioblastoma or astrocytoma grade 4
2. Age 18-75 years
3. Surgical treatment-resection.
4. Scheduled concomitant radiochemotherapy, or only chemotherapy.
5. Informed consent

Exclusion Criteria:

1. No informed consent
2. Egg yolk allergy
3. Only surgical biopsy
4. Only radiotherapy
Efficacy of Endocell® vs Conventional Medium in the Treatment of Infertility

The aim of this study is to demonstrate the efficacy of a single embryo transfer at blastocyst stage (Day 5) after co-culture on Autologous Endometrial Cell Culture (AECC) versus transfer of a single embryo at Day 3 after culture in conventional medium. Efficacy will be assessed in terms of clinical pregnancy rate 5 to 8 weeks after embryo transfer.


Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥ 18 and ≤ 36
* Undergoing ovarian stimulation for an In Vitro Fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI)
* Having experienced no more than 1 Embryo Transfer failure
* With basal FSH level ≤ 12 IU/l within the 6 months prior to the study
* Endometrial biopsy during the menstrual cycle preceding the ovarian stimulation (6 to 12 days after a documented ovulation)
* Negative serology for HIV 1 and 2, hepatitis B and C, HTLV 1 and 2, syphilis

Exclusion Criteria:

* Hypersensitivity to one of the culture media components
* Oocyte donation, sperm donation
* Thawed embryos transfer
* Women with endometriosis grade III and IV, chronic endometritis, hydrosalpinx, polycystic ovary, amenorrhoea, anovulation, uterus with malformation, uncontrolled prolactinaemia, uterine synechia, uterine fibroma, women exposed to distilbene, uterine polyps
* Women affected by pathologies associated with any contraindication of being pregnant
* Abnormal gynaecologic bleeding of undetermined origin
* Uncontrolled thyroid (TSH dosage) or adrenal dysfunction
* Neoplasias, any pathologies of the endometrium or the cervix
Evaluation of the Alveolar Recruitment Obtained During Non-invasive Ventilation After Cardiac Surgery

The great majority of cardiac surgery patients develop a degree of post-operatory respiratory failure. This is due to several factors. The predominant element in the onset of this respiratory impairment is the constitution of foci of pulmonary atelectasis, caused by peroperative hypoventilation (in the presence or absence of ECC). The incidence has been evaluated at between 54% and 92%, depending on the study. The use of NIV (non-invasive ventilation) might (through the application of continuous positive expiratory pressure) help to counter the development of these atelectasic foci.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* in the post-operative phase after elective cardiac surgery for aortic or mitral valve replacement, coronary revascularization or mixed surgery, hypoxemia or hypercapnia, with an indication for NIV,
* hemodynamic stability
* prior consent
* spontaneous ventilation
* social security coverage.

Exclusion Criteria:

* Under-18 patients
* complex cardiac surgery
* pregnancy
* pre-existing chronic obstructive respiratory disease (COPD \> stage II)
* legal guardianship
* incarceration