cyrilzakka/clinical-trials huggingface dataset:
BRS and Outcomes in Cardiothoracic Surgery

The purpose of this study is to determine whether baroreceptor sensitivity (the ability of your body to change your heart rate and/or blood pressure in response to a situation) has any effect on how likely you are to suffer certain events after heart or lung surgery. The postoperative events that the investigators will be studying are pain after surgery, atrial fibrillation (an irregular heart rhythm), and cognitive dysfunction (a decline in mental abilities).

The purpose of this study is to determine if preoperative baroreceptor sensitivity (BRS) correlates with major outcomes after cardiac and thoracic surgery, including acute and chronic pain, atrial arrhythmias, and cognitive function. To test this hypothesis, approximately 95 patients will be enrolled, and spontaneous baroreceptor sensitivity will be measured prior to surgery as well as immediately postoperatively. Outcomes will include acute pain using the numeric rating scale, Brief Pain Inventory, and Gracely Box Scale administered preoperatively, on postoperative days 1 and 2 and by phone at 6-weeks postoperatively. Chronic pain will be assessed at 6-month follow-up visit via hyperalgesia testing using Von Frey filaments. Postoperative atrial arrhythmias will be assessed by review of postoperative telemetry, the electronic medical record, and ECG performed prior to discharge. Finally, cognitive function will be assess via Mini-Mental State examination administered preoperative and at the 6-month follow-up visit. Association between BRS and the outcomes of interest will be tested with regression models adjusted for appropriate covariates. Significance threshold alpha will be adjusted for the number of statistical tests using the Bonferroni correction. Our hypothesis is that patients with impaired preoperative BRS will have an increased incidence of acute and chronic postoperative pain, atrial fibrillation, and cognitive decline after surgery.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age
* Undergoing cardiac (coronary artery bypass grafting \[CABG\], CABG + valve, or valve only) or thoracic (video-assisted thoracoscopic \[VATS\] approach to lobectomy) surgery

Exclusion Criteria:

* Any preexisting pain condition (defined as pain of \>=3 months duration prior to enrollment)
* Pain at the time of enrollment interview
* Need for preoperative analgesics
* Preexisting chronic or paroxysmal atrial fibrillation
* Preexisting atrial or ventricular arrhythmia
* Need for preoperative anti-arrhythmic medication
* History of symptomatic cerebrovascular disease (e.g., prior stroke) with residual deficits
* Alcoholism (\>2 drinks/day)
* Psychiatric illness (any clinical diagnosis requiring therapy)
* Drug abuse (any illicit drug use in the preceding 3 months before surgery)
* Hepatic insufficiency (liver function tests \> 1.5 times the upper limit of normal)
* Severe pulmonary insufficiency (home oxygen)
* Renal failure (serum creatinine \>2.0 mg/dL)
* Non-English speaking
* Unable to read
* Participants who score \<24 on baseline Mini Mental State examination
Efficacy and Safety of DEB-BACE Combined With PD-1 Inhibitors in Stage II/III NSCLC With Standard Treatment Failure

This study is a prospective, multi-center, randomized, open-ended, double-arm clinical study. All eligible patients were randomly assigned to DEB-BACE combined with PD-1 inhibitor (Sindilizumab) treatment group (test group) and DEB-BACE treatment group (control group), to explore the efficacy and safety of combination therapy for stage II/III NSCLC with standard treatment failure or intolerable patients.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years old, no gender limit.
* According to the Diagnosis and Treatment of Primary Lung Cancer (2018 edition), non-small cell lung cancer (NSCLC) was diagnosed by histopathology.
* Tumor Node Metastasis (TNM) staging is II-III.
* According to the National Comprehensive Cancer Network (NCCN) guidelines, patients who had failed, refused, or were not suitable for standard treatment (surgery, chemoradiotherapy, targeted) after consultation.
* Eastern Cooperative Oncology Group (ECOG), Performance Status (PS) Score ≤ 2.
* Estimated survival time is more than 3 months.
* The patient has signed informed consent.

Exclusion Criteria:

* The patient has previously received interventional therapy \[iodine seed implantation, ablation, bronchial arterial chemoembolization (BACE) therapy\], or received immunotherapy during the first-line standard treatment.
* The patient is accompanied by other malignant tumors and had not been cured.
* White blood cell \< 3×10\*9/L, absolute value of neutrophils \< 1.5×10\*9/L, neutrophil/lymphocyte ratio ≥ 3, platelet count \< 50×10\*9/L, hemoglobin concentration \< 90 g/L.
* Liver and kidney dysfunction (creatinine \> 176.8 μmol/L; aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2 times the upper limit of normal).
* Uncorrectable coagulopathy or active hemoptysis.
* Patient with active infections requires antibiotic treatment.
* Patient has uncontrollable hypertension, diabetes, and cardiovascular disease with obvious symptoms.
* Allergy to contrast agents.
* Women with pregnancy or lactation.
Hypertension Control Based on Home Blood Pressure

The aim of this trial is to study the effects of antihypertensive therapy based on home systolic blood pressure (BP) with different target levels using two classes of drugs.

The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. The study subjects are 40-79 years old hypertensive patients. After a 4 weeks of baseline period, subjects are randomly assigned to (1) modest control group (morning home BP \<140 mmHg) or (2) strict control group (morning home BP \<130 mmHg), and to (a) amlodipine group or (b) losartan group. Additional antihypertensive drugs can be used if home BP is not controlled. Home BP is measured in the early morning and late evening. The participants will be followed up for 5 years.

The aim of this trial is to study the effects of antihypertensive therapy based on home systolic blood pressure (BP) with different target levels using two classes of drugs.

The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. Inclusion criteria are 40-79 years old treated or untreated hypertensive patients without serious medical conditions. After a 4 weeks of baseline period, subjects are randomly assigned to (1) modest control group (target morning home BP \<140 mmHg) or (2) strict control group (morning home BP \<130 mmHg), and to (a) amlodipine group (2.5-5 mg od) or (b) losartan group (25-50 mg od). Additional antihypertensive drugs (diuretics, beta-blockers and alpha-blockers) can be used if home BP is not controlled. Home BP is measured in the early morning and late evening. Primary end point is combined cardiovascular events.The participants will be followed up for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hypertension

Exclusion Criteria:

* Severe hypertension (treated with 3 or more antihypertensive drugs)
* Unable to change antihypertensive drugs to a calcium antagonist or an angiotensin antagonist
* Serious medical conditions
* Women who may become to be pregnant
Efficacy Trial of the FMF Connect Mobile Health Intervention

The purpose of this study is to test a new smartphone "app" for parents/caregivers of children with fetal alcohol spectrum disorder (FASD). The app is called Families Moving Forward (FMF) Connect. The goal of the app is to provide parents/caregivers with useful information to help manage their children's condition and obtain peer support.


Eligibility Criteria:
Inclusion Criteria:

* Biological parent or other primary caregiver (e.g., foster or adoptive parent, relative, legal guardian) of a child with FASD or prenatal alcohol exposure (PAE)
* The parent/caregiver must be at least 18 years old
* The child must between the ages of 3 and 12 years old
* The child has a diagnosis of FASD or has confirmed PAE
* The child has lived with the parent/caregiver for at least 4 months and is expected to remain in the home for at least 1 year
* The parent/caregiver lives in the United States
* The parent/caregiver has a smartphone or ipad with iOS operating system

Exclusion Criteria:

* The parent/caregiver is not fluent in English (the FMF Connect app and pre-post measures are currently only available in English)
* There is another parent/caregiver of the same child or living in the home that is already enrolled in the study (couples are excluded to prevent dependence in the data)
* The family has previously received or is currently receiving the therapist-led Families Moving Forward (FMF) Program
Neuromodulation in Depressed and Schizophrenic Patients - Changing MEP (Muscle Evoked Potentials) by tDCS (Transcranial Direct Current Stimulation)

Muscle evoked potentials (MEP) are supposed to different in schizophrenic and depressed patients, compared to a sample of healthy volunteers. Transcranial Magnetic Stimulation (TMS)-evoked MEP are measured in all three groups at baseline and after tDCS (2 mA, 20 minutes). MEP amplitudes are supposed to normalize quickly in healthy volunteers, to stay diminished in depressed patients and to stay elevated in schizophrenic patients. These differences should disappear after regular pharmacological treatment. Outcome measures will be done in week 2 and week 4.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be in the condition to understand the patient-information, as well as the necessary examinations.
* He/she must be able to give a written consent.
* No medication at least three weeks before enrollment.

Exclusion Criteria:

* Existence of a care/legal incapacity
* Existing pregnancy
* Severe psychiatric illness (with exception of affective disorder)
* Acute suicidality
* Drug-, medication- or alcohol dependence
* Dementia according to DSM IV / ICD 10-criterions
* Severe brain infarctus in the anamnesis
* Indications of structural damage of the basal ganglia or the brain stem
* Severe neurological disorders (e.g. M. Parkinson, epilepsy, discus-prolapse, dementia, systemic neurological illnesses, normal pressure hydrocephalus, cerebrovascular diseases, elevated intracranial pressure, in the last 6 months, polyneuropathies).
* Severe other medical conditions, like manifest arterial hypertonia, severe heart disease, pacemakers, respiratory failure, malignant illnesses all type, also in the history, active infectious diseases, skeletal disorders (like M. Paget, osteoporosis with spontaneous fractures, fresh fractures) Other circumstances, that speaks against a participation of the patient pinion of Medical Doctor at this study.
Effect of Plasma Rich in Growth Factors on Semen Quality

The hypothesis is growing semen samples with plasma rich in growth factors (PRGF), because it could improve sperm motility in patients subsidiary TRA, ultimately improving pregnancy rates.

Platelet growth factors are a group of proteins involved in cellular communication modifying biological responses. Obtaining plasma rich in growth factors is already widespread and simple protocol technique that is being used in various areas of medicine with superb results. Described many of the growth factors present in the PRGF are related to sperm parameters, especially motility The described effects have been studied in mammalian and each growth factor individually. PRGF contains a pool of growth factors and therefore be interesting to analyze their effect on various sperm parameters.

One of those parameters is very important for fertilization sperm motility, since the lack of it will prevent displacement by the cervix to meet the egg in the fallopian tube.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 years
* more than 5 million sperm per milliliter

Exclusion Criteria:

* Not having genetic and infectious diseases
* Do not suffer mental illness
* Have a family study determined that there is no risk of hereditary diseases
* There have fathered more than 6 children in the country
Statin Impact on Hepatic Decompensation

The study aims to evaluate the impact of statin on hepatic decompensation.

Cirrhosis is the late stage of liver damage and possess two phases:. The shift from compensated to decompensated cirrhosis is characterized by the onset of complications) which are associated with substantial morbidity and negative Impact on quality of life (QOL)Cirrhosis and its complications have a substantial economic, social, and personal impact on affected patients, as well as their families and caregivers

Eligibility Criteria:
Inclusion Criteria:

* cirrhosis adult both sex

Exclusion Criteria:

* renal insufficiency
To Look or Not to Look at the Needle During Vaccination

It is common for people to advise individuals undergoing vaccination to look away from the needle to make them hurt less and be less scary. However, this advice is not backed up by research evidence. the purpose of this study is to learn about how looking away vs. looking at the needle during vaccination makes people feel. People will be randomized to 1 of 2 groups: look at the needle, look away. Then they will undergo vaccination and report on pain and fear experienced.

It is common for people to advise individuals undergoing vaccination to look away from the needle to make them hurt less and be less scary. However, this advice is not backed up by experimental research evidence. It is possible that looking away acts as a distraction and takes attention away from the needle, thus reducing pain. However, it is also possible that looking at the needle is better because it prevents people's imaginations from making them think it is worse than it actually is. To our knowledge, this is the first first randomized study to examine the effect of looking away vs. looking at the needle on pain and fear experienced during vaccinations. Adult university students undergoing routine flu vaccination will be included.

Eligibility Criteria:
Inclusion Criteria:

* undergraduate and graduate students at the University of Toronto's Leslie Dan Faculty of Pharmacy undergoing flu vaccination

Exclusion Criteria:

* less than 18 years of age or prior participation in the trial
Trial of Befizal® 200 mg for the Treatment of Leber Hereditary Optic Neuropathy

Study of the efficiency of Béfizal® 200 mg in 14 adult patients with a LHON that occurred for less than 5 years. Patient must have certain specific mutations

Study of the efficiency of Béfizal® 200 mg in 14 adult patients in whom the diagnosis of LHON obtained on anamnestic, clinical and ancillary testing / laboratory data. LHON should have occurred for less than 5 years and must be genetically proved with a 3460 or 11778 mitochondrial DNA mutation. Given the mode of transmission, genetic research may have been carried out in a maternal relative

Eligibility Criteria:
Inclusion Criteria:

* Adult patients in whom the diagnosis of LHON obtained on anamnestic, clinical and ancillary testing / laboratory data. LHON should have occurred for less than 5 years and must be genetically proved with a 3460 or 11778 mitochondrial DNA mutation. Given the mode of transmission, genetic research may have been carried out in a maternal relative

Exclusion Criteria:

* \* Any optic neuropathy for which the diagnosis of LHON is not formally confirmed or genetically proven;

  * LHON that started for more than 5 years;
  * LHON associated with another primary mutation than 3460 or 11778
  * Children or adult patients under guardianship or deprived of liberty by administrative or judicial decision;
  * Women of childbearing age ; pregnant or lactating women;
  * Patients who do not have affiliation to a social protection scheme (national or private insurance / beneficiary or assignee);
  * Patient who did not give its written, informed and signed consent;
  * Allergy to fibrate, bezafibrate and / or BEFIZAL® 200mg (Arrow Generiques) or one of these constituents;
  * Photosensitivity reactions related to fibrates;
  * Patient already receiving treatment with fibrates or HMG Co-A reductase inhibitors or anticoagulants;
  * Hepatic insuffisiency or dysfunction with increased of transaminases (AST and ALT) over 3 times of the normal;
  * Renal insufficiency with serum creatinine\> 15 mg / L (\> 135 mg / dL) Biliary pathology
A Study of Single Dose MK-3614 (MK-3614-001)(COMPLETED)

This study will determine if MK-3614, given as single doses, is safe and well tolerated in healthy males and male participants with mild to moderate hypertension.

Up to three planned panels of either 8 healthy participants (Panels A and B) or 8 participants with mild to moderate hypertension (Panel C) will be enrolled. In Panels A and B, 8 participants will alternately receive single rising doses of MK-3614 or placebo. All doses will be administered in the fasted state, except Panel A, Period 3 in which a standard high-fat breakfast provided approximately 30 minutes prior to dosing. Panel A will begin first. At least 3 days will elapse before participants in the alternate panel (Panel B) will receive the next higher dose. In Panel C, 8 mild to moderate hypertensive male participants will receive single rising doses of MK-8892 or placebo. For all panels, there will be at least 7 days washout between treatment periods for any given participant. Participants may only be enrolled in one panel of the study. All participants in periods of all panels (with exception of 0.25 mg fasted/fed periods) will be randomly assigned to either study drug or placebo, i.e., a participant could be assigned to receive study drug in one period and placebo in another. As per the protocol allocation plan, the same participants will receive 0.25 mg MK-3612 in a fasted and fed state.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants between 18 to 45 years of age; otherwise healthy participants between 18 to 55 years of age newly diagnosed with grade 1 or 2 hypertension
* Participant is in good general health
* Participant is a nonsmoker

Exclusion Criteria:

* Participant has a history of stroke, seizure or major neurological disease
* Participant has functional disability that can interfere with rising from a sitting position to a standing position
* Participant has a family history of a bleeding or clotting disorder
* Participant has a history of cancer
* Participant is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study
* Participant consumes excessive amounts of alcohol or caffeine
* Participant has had major surgery, donated blood or participated in another investigational study in the past 4 weeks.
Two Techniques for Root Coverage With a Xenogeneic Collagen Matrix

Gingival recessions are often successfully treated by coronally advanced flap technique (CAF) associated with subepithelial connective tissue grafts (SCTG). Currently the xenogeneic collagen matrix (CM) has been used as a substitute for SCTG associated with CAF technique for root coverage. CAF technique was not developed for use with CM and has shown limited results when applied to the CM. The aim of this study was to compare and show the benefits of the extended flap technique (EFT) compared to CAF technique using CM for root coverage.


Eligibility Criteria:
Inclusion Criteria:

* ages 25 to 50 years old
* bilateral gingival recession type Miller class I or II
* with 3 mm in height and less than 3mm of keratinized tissue
* non-molar teeth

Exclusion Criteria:

* diabetics
* pregnant women
* chronic use of medication
* periodontitis
An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis

The investigators are conducting this study to examine if a healthy diet based on the Alternative Healthy Eating Index (AHEI) influences pain symptoms, quality of life, and inflammatory markers measured in blood samples in women with endometriosis who are currently experiencing pain symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18-45
* Laparoscopically-confirmed endometriosis
* Premenopausal (at least one period in the past 6 months)
* VAS pain score of at least 7 out of 10 in the previous 3 months
* Score below 75 on the AHEI-2010

Exclusion Criteria:

* Postmenopausal
* Pregnant
* Have had a hysterectomy or oophorectomy
* Have chronic illnesses that are known to affect gastrointestinal absorption of nutrients (celiac disease, Crohn's disease, ulcerative colitis, or cystic fibrosis)
* A history of kidney stones, cancer (except basal cell carcinoma), or diabetes
Investigating Targetable Metabolic Pathways Sustaining Pancreatic Cancer

This clinical trial investigates the nutrients pancreatic cancers depend on in which to survive and the processes these tumors use (metabolism) to obtain these nutrients. Giving U-13C-glucose during surgery may allow doctors to trace the metabolic activity of pancreatic cancer in research experiments done in the laboratory. These experiments may help researchers understand how cancer cells manage their nutrients when compared to normal pancreatic cells.

PRIMARY OBJECTIVE:

I. To describe and discover new insights into the glucose, tricarboxylic acid (TCA) cycle, amino acid, and lipid metabolic dependencies of pancreatic ductal adenocarcinoma (PDAC) via liquid chromatography-mass spectrometry (LC-MS) analysis of in vivo uniformly-labeled \[13C\]glucose (U-13C-glucose) labeled pancreatic cancer biopsies.

OUTLINE:

Patients receive uniformly-labeled \[13C\]glucose intravenously (IV) over 10 minutes and then over up to 120 minutes until time of biopsy. Patients then undergo surgery and biopsy per standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \>= 18 years of age
* Pancreatic adenocarcinoma patients, previously diagnosed by biopsy, who are candidates for intended curative resection either with or without neoadjuvant chemotherapy
* Willing to undergo mandatory intraoperative small excisional and core biopsies (4-6 passes) of tumor and normal tissue for research purposes at the time of proposed pancreatectomy
* 16 patients will be enrolled including 8 with no prior treatment and 8 treated with at least 3 months of neoadjuvant chemotherapy
* All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry

Exclusion Criteria:

* Patients receiving any anti-cancer therapy (chemotherapy, immunotherapy, and/or biologic therapy) for 8 patients; the other 8 patients will be treated with neoadjuvant chemotherapy but no radiation, biologic or immunotherapy prior to surgery
* Is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study
* Concomitant active malignancy
* Is of child-bearing potential who has not had a recent negative pregnancy test done outside of this clinical trial (i.e., as part of standard preparation for diagnosis and treatment for her cancer)