cyrilzakka/clinical-trials huggingface dataset:
Understanding and Addressing Disparities in Cancer Therapy Induced Inflammation and Associated Endothelial Dysfunction

Very little is understood about the off-target vascular mechanisms of anti-cancer drug toxicity and the impact of exercise on these changes. Much of what has been learned about molecular pathways regulating vascular endothelial function has been established by logical expansion of knowledge obtained through experimental studies (e.g., discovery of endothelium-derived relaxing factor/nitric oxide). Within the last 10 years technological advancements of -omics approaches, such as RNA-sequencing and shotgun proteomics, have dramatically reduced the cost and technical challenge of accessing these tools for discovery-based research. Investigators are now able to obtain unbiased datasets showing changes in transcript or protein expression within complex samples. With cost and accessibility of sequencing is no longer being substantial bottleneck, one of major challenges researchers now face is determining how to meaningfully interpret profiles from large datasets. The extensive characterization of molecular pathways impacting inflammatory responses, endothelial function and angiogenesis, the pathway and network analysis tools will be an asset for identification molecular pathways relevant to alterations in microvascular endothelial function. The investigators preliminary studies on only a small number of samples highlights this potential of the proposed approach to lead to identify personalized medicine-based profiles that will predict patients are likely to develop microvascular endothelial dysfunction from CTx.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years) assigned female sex at birth
* Diagnosed with invasive non-metastatic breast cancer
* Receiving neo-adjuvant CTx (or adjuvant CTx and undergoing breast conserving surgery) that includes anthracyclines (such as DOX) and/or targeted anti-Her2 therapy
* Able to safely participate in moderate exercise and strength training based on MD approval
* Willing to complete all study activities
* Self-identifies as Black/African American or non-Hispanic White

Exclusion Criteria:

* Unintentional weight loss \> 10% in the past 6 months
* Current pregnant and lactating patients. Must have completed lactation prior to study start
* Metastatic disease
* Diagnosed cardiovascular disease as evidenced by cardiomyopathy (reduced regional or global LV contractility), diastolic dysfunction grade 2 or above, symptomatic coronary - artery disease, ejection fraction below 50%
* History of prior chemotherapy or targeted H2N Treatment received less than 3 years ago
* Non-English speaking
Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Female

The purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in female who are reversed with sugammadex or neostigmine.

Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.

Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

* BMI \> 30 kg/m2, respiratory infection, uncontrolled hypertension
Primary Prevention of Patients With Hepatocellular Carcinoma and Concomitant Esophageal Varices

Randomized comparison within the endoscopic esophageal varices ligation versus non-selective beta-blocker in the primary prevention of esophageal variceal bleeding in patients with HCC.

Gastroesophageal variceal bleeding is a major complication of cirrhosis and has high rate of rebleeding and mortality. In these 20 to 30 years, medical advances have significantly improved the prognosis of variceal bleeding. Nevertheless, the mortality of gastroesophageal variceal bleeding is still nearly 20 to 30%.

Hepatocellular carcinoma (HCC) is one of the most common malignancy in Asian, and is also the special group in portal hypertension. Studies in Italy, more than 50% of patients diagnosed with HCC are concomitant with esophageal varices. HCC and portal thrombosis caused by HCC itself are all independent risk factors of gastroesophageal bleeding. Once the bleeding, rebleeding rate is up to 50% even if early use of vasoconstrictor agents and endoscopic therapy, which is generally 2 times in patients with cirrhosis.

According to 2010 Baveno V recommendations, non-selective beta-blockers (NSBB) or endoscopic variceal ligation (EVL) are first choice for primary prevention of first variceal bleeding in cirrhotic patients. However, risk factors of variceal bleeding caused by HCC or cirrhosis are different, and portal hypertension is particularly high in patients with HCC and may be combined with portal vein thrombosis. NSBB sufficient to decreased portal hypertension to prevent variceal bleeding is not clear. In Hepatology 2010, Lebrec claimed that NSBB used for cirrhotic patients with refractory ascites had poor prognosis, the main cause of death were the progression of HCC and sepsis, although the impact of NSBB for HCC patients are not entirely clear, but this issue remind clinicians to careful use of NSBB in these patients. Since NSBB possible adverse effects, the use of EVL to prevent bleeding in patents with HCC is superior to NSBB? These need further study to clarify. So we designed this study to evaluate the feasibility and effectiveness of using EVL or NSBB to prevent first bleeding in patients with HCC concomitant with esophageal varices.

Eligibility Criteria:
Inclusion Criteria:

* Between 20 and 80 years old
* Hepatocellular carcinoma (HCC) associated with esophageal varices
* F2 or F3 esophageal varices (Beppu et al classification)
* Hepatocellular carcinoma (HCC) associated with portal thrombosis

Exclusion Criteria:

* History of esophageal variceal bleeding
* Had received endoscopic variceal ligation (EVL) or endoscopic injection sclerotherapy (EIS)
* Pregnancy, or the patients with other terminal illness (such as other terminal cancers, heart failure, renal failure...)
* Propranolol contraindications (such as atrioventricular block, heart failure, chronic obstructive pulmonary disease, asthma, poorly controlled diabetes, severe peripheral arterial disease...)
Comparison of Single vs Group Embryo Culture in Micro-well Group Culture Dish

Does group culture using micro-well group culture dishes improve human blastocyst development compared to single embryo culture?


Eligibility Criteria:
Inclusion Criteria: female age uner 40, male age under 60 patients undergoing IVF-treatment with oocyte collection after ovarian hyperstimulation having signed the study-specific consent form patient fulfilling clinic's standard criteria for blastocyst culture minimum 5 normally fertilized oocytes at the time of fertilization check

Exclusion Criteria: use of any type of surgically retrieved sperm cells patients undergoing any kind of genetic diagnosis at any developmental stage

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Functional Scaffold Transplantation Combined With Epidural Electrical Stimulation for Spinal Cord Injury Repair

The study is designed to assess the role of functional neural regeneration collagen scaffold transplantation combined with epidural electrical stimulation in spinal cord injury patients.


Eligibility Criteria:
Inclusion Criteria:

The enrolled participants are divided into three categories:

1. Participants had complete functional scaffold transplantation in previous study and had motor functional recovery
2. Participants With Acute Complete SCI: (1) Classification ASIA A, occurring within past 14 days; (2) Completely spinal cord injury at neurological level C4- T12/L1; (3) No serious complications
3. Participants With Chronic Complete SCI: (1) Classification ASIA A, greater than 6 months post injury and no significant further improvement within past 3 months; (2) Completely spinal cord injury at neurological level C4- T12/L1; (3) Peripheral nervous system in good condition; (4) No serious complications

Inclusion Criteria For All The Participants

1. Men or non-pregnant women, 18-60 years old
2. Ability and willingness to regular visit to hospital and follow up during the protocol Procedures
3. Accompanied by a family member
4. Signed informed consent

Exclusion Criteria:

1. Obvious muscle atrophy or fibrosis
2. Decline in peripheral nerve function
3. A current diagnosis of diseases affecting spinal cord injury recovery or rehabilitation training (e.g., brain injury, cerebral hemorrhage, cognitive impairment, other central nervous system diseases)
4. Having serious health problems, (e.g., cardiovascular disease, diabetes, autoimmune diseases, tumors or severe hypertension) or serious complications (e.g. severe bedsores, pulmonary infection, respiratory disorders)
5. Pregnancy or lactation
6. History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders
7. No family member accompany or can not get in touch with family members
8. Poor compliance, difficult to complete the study
9. Any other conditions that might increase the risk of participants or interfere with the clinical trial
Balance, Aerobic Capacity, Mobility and Strength in Patients Hospitalized for Heart Failure (BAMS-HF) Program

This is a pilot randomized trial of the BAMS-HF (Balance, Aerobic capacity, Mobility and Strength in patients hospitalized for Heart Failure) Program versus usual care. The BAMS-HF Program pilot study is an initial step in eventually creating a comprehensive, patient-centered, primarily home-based rehabilitation intervention aimed at preventing worsening disability and dependence among older adults hospitalized for HF. The BAMS-HF Program will enroll patients hospitalized for HF (or with HF as an active problem during hospitalization) within the past 4 weeks and will engage patients during the vulnerable post-discharged period. The objective of this pilot study is to test the feasibility, acceptability and preliminary effect of the BAMS-HF Program in older (\>/= 65 years) adults hospitalized for HF. The BAMS-HF Program will begin within 4 week of hospital discharge and be administered 3 times weekly for 12 weeks in the patient's home upon discharge. Patients who are able to safely complete the program without in-person assistance will transition to telehealth (aka telerehabilitation) visits. The BAMS-HF Program is innovative because it is home-based, and will utilize rigorous, progressive exercises across multiple domains of physical function. The estimated preliminary effect size will be measured with the Short Physical Performance Battery (SPPB), a well-validated measure that predicts incident mobility/disability and falls in the geriatric population.

Aim #1: To assess the feasibility of the BAMS-HF Program by measuring 1) study enrollment rate, 2) proportion of prescribed sessions that were actually performed, 3) proportion of patients completing full baseline assessment and outcome measures

Aim #2: To assess the acceptability of the BAMS-HF Program with qualitative interviews of participants in the intervention arm that will ask about their experience in the program, any aspects of the intervention they recommend changing and whether patients would recommend the program to others. Reason for declining or stopping participation in the study will also be recorded and considered in adjusting the study protocol.

Aim #3: To estimate the preliminary intervention effect by investigating the difference in change in SPPB between the BAMS-HF Program arm and the usual care arm.


Eligibility Criteria:
Inclusion Criteria:

* 55 years old or older
* Hospitalized for HF or with HF as an active problem during hospitalization
* SPPB \>/=10

Exclusion Criteria:

* Irreversible orthopedic or neurologic disease that severely limits mobility
* Active cancer diagnosis except non-melanoma skin cancer
* Dementia
* Life expectancy of \< 6 months
* Uncontrolled/untreated ventricular tachycardia or ventricular fibrillation
* Advanced heart failure with expectation of left ventricular assist device or transplant in the next 6 months
* Any major surgery in the past 30 days or planned in the next 10 weeks
* Discharge to a skilled nursing facility and/or home with home healthcare physical therapy (home health care nurse or occupational therapist is ok)
Application of Antiosteoporosis Therapy in Osteolysis

To report the postoperative complications and limb function of patients with osteolysis after surgery for bone tumors of the extremities who received anti-osteoporosis therapy in Henan Cancer Hospital in the next 10 years.

A total of 100 patients with osteolysis after surgery for bone tumors of the four extremities who received anti-osteoporosis treatment in Henan Cancer Hospital in the next 10 years were reported. The basic information, treatment methods, postoperative complications and limb function of these patients were collected.

Eligibility Criteria:
Inclusion Criteria:

1. No age restriction, male or female.
2. A subtype of bone tumor (including benign, malignant, and metastatic cancer) was confirmed in the pathology department of the research institution.
3. Received excision of bone tumor in research institution.

Exclusion Criteria:

Not applicable.
Shear Wave Elastography Versus Strain Elastography With Histogram Analysis in Solid Pancreatic Lesions

to assess the diagnostic value of strain elastography EUS and shear wave EUS in solid pancreatic lesions

Three measurements of strain ratio elastography and three measurements of shear wave elastography with VPN\> 20% will be performed in the same solid pancreatic lesions. The results will be compared in the groups of adenocarcinomas, neuroendocrine tumors and benign solid pancreatic lesions.

Eligibility Criteria:
Inclusion Criteria:

* patients with solid pancreatic masses \> 2 cm in diameter at CT scan for EUS assessment

Exclusion Criteria:

* Patients with inconclusive pathology results
* patients with cystic component \> 20%
Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.

Non-interventional (observational) cohort prospective real life study with primary and secondary data collection from patients on adjuvant treatment with dabrafenib + trametinib in patients with completely resected high-risk stage III (stage IIIA \[lymph node \> 1mm\], IIIB, IIIC and IIID according to AJCC 8th edition) melanoma in Turkey.

The prospective registration of completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting will be based on collaboration with centers of excellence on melanoma patients treatment. Pre-identified centers (up to 12) considered as the most advanced according to their knowledge and experience, will take part in the patients recruitment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with complete surgical resection of histologically confirmed AJCC (8th edition) clinical stage III (stage IIIA \[lymph node \> 1mm\],, IIIB, IIIC, IIID) melanoma, in whom a decision for adjuvant treatment with dabrafenib and trametinib has been made before entering the study;
* V600E mutation-positive cutaneous melanoma;
* ≥ 18 years of age;
* Written informed consent signed.

Exclusion Criteria:

* Lack of basic demographic and staging data.
* Current active participation in an interventional clinical trial for treatment of melanoma.
* Pregnancy or breastfeeding women.
* Current primary diagnosis of a cancer other than melanoma, that requires systemic or other treatment.
Cohort Study in Senegal Comparing Artesunate + Amiodaquine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine, based on the first malaria attack of each subject.

Secondary objectives:

For the first attack: To compare the two groups of treatment in terms of:

* D14 efficacy
* Parasitological and fever clearance
* Clinical and biological tolerability
* Evolution of gametocyte carriage
* Cardiac tolerability (QTc)

For the repeated attacks: To compare the two groups of treatment in terms of:

* D14 and D28 clinical and parasitological effectiveness (PCR adjusted)
* Clinical and biological tolerability
* Proportion of patients without fever at D3
* Proportion of patients without parasite at D3
* Compliance
* Impact on anaemia

During the total follow-up of the cohort: To compare the two groups of treatment in term of:

* Treatment incidence density
* Impact of repeated treatment on clinical and biological safety
* Impact of repeated treatment on hearing capacity


Eligibility Criteria:
Lists of Inclusion and Exclusion criteria:

Inclusion Criteria:

* adults or children weighting more than 5 kg
* axillary temperature \>=37.5°C at D0 or history of fever within the previous 24hrs
* confirmed Plasmodium falciparum monoinfection, with parasitemia\>1000mcl
* negative urinary pregnancy test for women of child bearing age before each new administration of treatment

Exclusion Criteria:

* presence of any serious or clinical danger sign of malaria: prostration, consciousness disorders, recent and repeated convulsions, respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic BP\< 70 mmHg in adults or \< 50 mmHg in children, spontaneous bleeding, inability to sit or stand
* severe concomitant disease
* allergy to one of the investigational drugs.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus

The purpose of this study is to compare a needle-free treatment of hypoglycemia with nasal glucagon (study drug) to a marketed glucagon administered by the intramuscular (IM) route, in participants with type 1 diabetes mellitus (T1DM).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 2 years and receiving daily insulin since the time of diagnosis

Exclusion Criteria:

* Have a history of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs
* Have a history of pheochromocytoma (that is, adrenal gland tumor) or insulinoma
* Occurrence of an episode of severe hypoglycemia (defined as requiring the assistance of another person in the 1 month prior to enrolling in the study)
* Have a history of epilepsy or seizure disorder
* Are women who are pregnant or lactating
* Have, except for the current regimen of insulin therapy and concomitant medication, regular use of or intended use of any over-the-counter or prescription medications or nutritional supplements that treat hyperglycemia or insulin resistance or that promote weight loss within 14 days before dosing
* Daily use of systemic beta-blocker, indomethacin, warfarin or anticholinergic drugs
* Require daily insulin treatment greater than (\>)1.5 unit/kilograms (U/kg)/body weight
A Study of Letermovir (MK-8228) to Evaluate Efficacy and Safety for Prevention of Cytomegalovirus Infection in Chinese Hematopoietic Stem Cell Transplant Recipients (MK-8228-045)

The purpose of this study is to evaluate the efficacy and safety of a once-a-day oral or intravenous (IV) dose of Letermovir (MK-8228) in Chinese adult hematopoietic stem cell transplant (HSCT) recipients for the prevention of clinically significant cytomegalovirus (CMV) infection.


Eligibility Criteria:
The key inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Male/Female Chinese adult participant of an allogeneic Hematopoietic Stem Cell Transplant (HSCT).
* Has documented positive Cytomegalovirus (CMV) serostatus (CMV immunoglobulin G \[IgG\] seropositive) for recipient (R+) at the time of screening.
* Is receiving a first allogeneic HSCT.
* Is within 28 days post-HSCT at the time of randomization.
* Female participant is not a Woman of Child Bearing Potential (WOCBP) or is a WOBCP who agrees to use acceptable contraception during the treatment period and for ≥28 days after the last dose of study drug.

Exclusion Criteria:

* Received a previous allogeneic HSCT.
* Has a history of CMV end-organ disease within 6 months prior to randomization.
* Has evidence of CMV viremia at any time from HSCT procedure until the time of randomization.
* Has severe hepatic insufficiency.
* Is a) on renal replacement therapy (e.g., hemodialysis, peritoneal dialysis) OR b) has end stage renal impairment with a creatinine clearance \<=10 mL/min within 5 days prior to randomization.
* Has both moderate hepatic insufficiency AND moderate to severe renal insufficiency.
* Has an uncontrolled infection on the day of randomization.
* Has rapidly progressing disease that requires mechanical ventilation or is hemodynamically unstable.
* Has a documented positive result for a human immunodeficiency virus antibody (HIV-Ab) test at any time prior to randomization, or for hepatitis C virus antibody (HCV-Ab) with detectable HCV ribonucleic acid (RNA), or hepatitis B surface antigen (HBsAg) within 90 days prior to randomization.
* Has active solid tumor malignancies except localized basal cell or squamous cell skin cancer or the condition under treatment (e.g., lymphomas).
* Has received any prohibited medications within 2 days prior to initiation of treatment with Letermovir.
* Is anticipated to be treated with Traditional Chinese Medicine or herbal medicine during the study treatment period and for 14 days after study medication.
Effects of Adherence to a Mediterranean Diet Style on Cardiovascular Risk

Evaluation of the effect of adherence to Mediterranean Diet on some surrogate vascular markers and on gene expression of some cardiometabolic genes

The investigators have designed a study project to evaluate in a sample of patients with high cardiovascular risk:

1. The effects of adherence to Mediterranean Diet on serum levels of some metabolic variables (glucose blood levels, serum LDL cholesterol, serum total cholesterol, serum triglycerides)
2. The effects of adherence to Mediterranean Diet on serum levels of some ceramides and of adiponectin and resistin at 6 and 12-month follow-up
3. The effects of adherence to a Mediterranean Diet style on some surrogate markers of vascular damage such ad endothelial function measured by means of the evaluation of reactive hyperemia index (RHI) and arterial stiffness markers (PWV, AIX) at 6 and 12-month follow-ups
4. The effects of adherence to Mediterranean Diet on the genetic expression of some cardiometabolic and atherothrombotic candidate genes at 12-month follow-up
5. The effects of the Mediterranean diet adherence on the incidence of cardio and cerebrovascular events at 12 and 18 month follow-ups considering respectively:

   1. composite endpoint: myocardial infarction, ischemic stroke and death from cardiovascular causes
   2. secondary endpoint: myocardial infarction, stroke, death from cardiovascular causes

Eligibility Criteria:
Inclusion Criteria:

* at least two of the following eligibility criteria:

  1. Type 2 diabetes mellitus
  2. Arterial hypertension
  3. BMI ≥ 25
  4. Active smoking
  5. Family history of early cardiovascular disease
  6. Previous cardiovascular or cerebrovascular events (\> 6 months)

Exclusion Criteria:

* All patients with recent (\<6 months) cardiovascular or cerebrovascular events were excluded.