cyrilzakka/clinical-trials huggingface dataset:
Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt

This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.

Non-cirrhotic subjects were directly enrolled into Arm A. Cirrhotic subjects were randomized to either Arm B (12 weeks of treatment) or Arm C (24 weeks of treatment).

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C, genotype 4-infection (hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] level greater than 1,000 IU/mL at Screening)
* Subjects must meet one of the following:

  * Treatment-naive: Subject has never received antiviral treatment for HCV infection OR
  * Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegylated-interferon \[pegIFN\]/RBV);
* Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
* In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or Fibroscan
* In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening and confirmed absence of hepatocellular carcinoma

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
* HCV genotype performed during screening indicating unable to genotype or co-infection with any other HCV genotype
* abnormal laboratory tests
* self-reports current drinking more than 2 drinks per day
* current enrollment in another investigational study
* previous treatment with a direct acting antiviral agent (DAA) containing regimen
* In substudy 1, evidence of liver cirrhosis
* In substudy 2, evidence of current or past Child-Pugh B or C classification and confirmed presence of hepatocellular carcinoma
Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation

The purpose of the proposed pilot study is to determine if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival.

This is a small scale pilot study to evaluate if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival. This prospective, randomized study will include 20 patients diagnosed with COVID-19, and undergoing mechanical ventilation for the treatment of respiratory failure. Patients will be randomized in a 1:1 fashion with 10 patients (Group A) randomized to undergo core warming, and the other 10 patients (Group B) serving as the control group who will not have the ensoETM device used. Patients randomized to Group A will have core warming initiated in the ICU or other clinical environment in which they are being treated after enrollment and provision of informed consent from appropriate surrogate or legally authorized representative.

Eligibility Criteria:
Inclusion Criteria:

* Patients above the age of 18 years old.
* Patients with a diagnosis of COVID-19 on mechanical ventilation.
* Patient maximum baseline temperature (within previous 12 hours) \< 38.3°C.
* Patients must have a surrogate or legally authorized representative able to understand and critically review the informed consent form.

Exclusion Criteria:

* Patients without surrogate or legally authorized representative able to provide informed consent.
* Patients with contraindication to core warming using an esophageal core warming device.
* Patients known to be pregnant.
* Patients with \<40 kg of body mass.
* Patients with DNR status.
* Patients with acute stroke, post-cardiac arrest, or multiple sclerosis.
Comparison of Proliferative Potential of H-PBSC Based on Demographics and Cryopreservation Time

The goal of this observational study is to observe stored stem cells and determine their capability to grow based on several factors. The main two factors focused on in this study are as follows:

* Time stem cells have spent in cryopreservation
* Demographic factors (gender, race, age)

This study is a secondary, correlational, single-center laboratory study involving the analysis of previously obtained PBSC samples at the Andrews Research \& Education Foundation (AREF). Individuals who previously provided samples for a primary study that has a concluded will be reconsented for this study. No manipulation of samples will occur until Broad Informed Consent has been obtained. Upon Broad Informed Consent being granted, the samples will be removed from cryopreservation and analyzed in a laboratory setting.

Each sample's total nucleated cell count (TNC), cell viability, and proliferative potential will be analyzed. Measurements will be performed at different time intervals and the results will be recorded in a password protected system.

These parameters will be followed for each available PBSC sample regardless of time spent in cryopreservation to examine if variation in time spent under cryopreservation had an impact on overall cell viability and proliferative potential.

Following conclusion of the cell viability data acquisition stage of the study, the data will be further analyzed to determine if there are any statistically relevant correlations between various demographic factors and the viabilities of the PBSC samples. The secondary, demographic factors to be examined include the sample patient's age, sex, and race. The data analysis will determine whether these factors in addition to length of time spent under cryopreservation influenced the PBSC samples' viability and proliferative potential upon the samples being removed from cryopreservation and prepared for analysis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Prior primary study at Andrews Research \& Education Foundation must be completed
* Additional biospecimens continue to be in a cryopreserved state at Andrews Research \& Education Foundation Regenerative Medicine Center (RMC)
* Subject is willing and able to provide Broad Informed Consent for secondary study

Exclusion Criteria:

* Subjects whose biospecimens did not maintain primary study sample labels
* Subject is not willing and able to provide Broad Informed Consent for secondary study
Cost of Using FLUOrescence to Green of Indocyanine for the Detection of Breast Cancer.

The purpose of this study is to analyze the average direct costs of each of these techniques, represented by the costs directly linked to the management of breast cancer, to the surgical intervention and to the techniques evaluated (Indocyanine Green and isotopes) which are: consultations, hospitalizations, resources consumed during the surgical intervention, as well as the time of the patients, transport...

The main objective is to evaluate the overall cost at 1 month of the sentinel lymph node detection technique using Indocyanine Green compared to the technique using isotopes in patients with breast cancer, from the point of view of health insurance and the hospital.

The chosen time horizon is up to 1 month post-intervention. The choice of this time horizon corresponds to the usual duration of follow-up for patients who have benefited from one of the sentinel lymph node detection techniques, in order to collect the main post-surgical complications.

This is a multicenter, prospective, observational, non-randomized study, aimed at comparing the overall cost of two sentinel lymph node detection techniques (Indocyanine Green and isotope) from a dual perspective (health insurance and hospital).

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or over, having given her oral non-objection ;
* Patient with histologically proven breast cancer ;
* Patient eligible for the sentinel lymph node technique by Indocyanine Green or isotopes.

Exclusion Criteria:

* Patient who has expressed her opposition to the use of her medical data ;
* Patient under legal protection, guardianship or curatorship ;
* Pregnant patient ;
* Patient not affiliated to a social security scheme.
Study of Nivolumab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) That Have Either Failed or Are Not Eligible for Autologous Stem Cell Transplant (CheckMate 139)

The purpose of this study is to determine whether Nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Confirmation of relapsed or refractory DLBCL or transformed lymphoma (TL)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 -1
* At least one lesion that measures \>1.5 cm
* Prior therapy and screening lab criteria must be met
* Appropriate contraceptive measures must be taken

Exclusion Criteria:

* Known central nervous system (CNS) lymphoma
* History of interstitial lung disease, prior malignancy, active autoimmune disease, positive test for hepatitis B or hepatitis C virus
* Prior allogeneic stem cell transplant (SCT), chest radiation ≤ 24 weeks from study drug, ≥1000 mg of Carmustine Bis-chloroethylnitrosourea (BCNU) as part of pre-transplant conditioning regimen, prior treatment with drug targeting T-cell costimulation or immune checkpoint pathways
* Women who are breastfeeding or pregnant
Sarcopenia is an Independent Prognostic Factor for Overall Survival in Patients With Pancreatic Adenocarcinoma

The primary objective of this study was to validate Total Psoas Area (TPA) measurement as an independent prognostic factor of overall survival in patients with pancreatic adenocarcinoma. Secondary objective was to describe the evolution of the TPA during the follow-up.


Eligibility Criteria:
Inclusion Criteria:

* All patients consecutive enrolled from January 2009 to December 2015 who underwent at least one chemotherapy for pancreatic adenocarcinoma, whatever the stage

Exclusion Criteria:

* A patient record captured outside the time frame from January 2009 to December 2015
Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer

The primary purpose of this study is to determine the effectiveness of SPI-1620 in combination with docetaxel in patients with advanced biliary cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed biliary tract or gallbladder cancer that have relapsed or are refractory after one prior gemcitabine-based chemotherapy regimen for advanced biliary cancer
* Evaluable disease
* ECOG PS ≤ 2
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* Treatment with more than one prior chemotherapy regimen
* Known, uncontrolled CNS metastases
* Baseline peripheral neuropathy ≥ grade 2.
* Significant circulatory disorders in the past 6 months
* Concomitant use of phosphodiesterase inhibitors
Effects of Two Aquatic Training Models in Physiological Parameters of Elderly Dyslipidemic Women.

This study aims to compare the effects of two water-based training models in physiological parameters of dyslipidemic elderly women. Thus, a randomized controlled clinical trial will be conducted in parallel with the participation of 45 dyslipidemic elderly women.

The women will be randomly divided into three groups: water aerobics training (WA), resistance aquatic training (WR) and the third is the control group (who will perform relaxation sessions under water). The three groups will attend classes during 10 weeks, with two weekly sessions of 45 minutes each. The WA and WR groups will use the same four exercises in their training.

The WA group will be trained using the interval method, performing six blocks of five minutes each one, alternating four minutes at intensities corresponding to 90 to 100% of the heart rate corresponding to the second ventilatory threshold (HRVT2) and one minute at intensities between 80 and 90% HRVT2.

The WR group will perform four to eight sets of 20 to 10 seconds along the macrocycle, always at maximal speed execution of the exercises.

Will be measured, before and after the period of 10 weeks of intervention, biochemical, cardiorespiratory, neuromuscular and hemodynamic variables, parameters of quality of life and depressive symptoms in addition to the cardiovascular risk score of the participants of the three groups.

Data will be described by means values and lower and upper limits, with a 95% confidence interval. Comparisons between and within groups were performed using the method of generalized estimates of equations (GEE), with Bonferroni post hoc, adopting a 0.05 significance level.

Eligibility Criteria:
Inclusion Criteria:

* being female, aged between 60 and 75, sedentary (not practicing any kind of regular, supervised physical activity in the last three months), have any type of dyslipidemia.

Exclusion Criteria:

* women who are smokers, suffering from cardiovascular disease with associated complications and those with orthopedic diseases that prevented the practice of systematic physical exercise, users of hormone therapy drugs and lipid-lowering medications.
Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCUfor the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract


Eligibility Criteria:
Inclusion Criteria:

* Undergoing uncomplicated cataract surgery with or without a posterior chamber intraocular lens (IOL) implantation.
* If a contact lens is used for correction of post-operative aphakia, it must be a silicone elastomer lens or a rigid gas permeable lens (no water content).
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory, or other medical condition that could increase the risk to the subject as determined by the investigator.
* Has a post-traumatic cataract.
* Presence of active or suspected viral, bacterial, or fungal disease in the study eye.
* Ocular hypertension with an IOP in the study eye \>25 mmHg at Screening with or without treatment with anti-glaucoma monotherapy.
* Subjects who have received a periocular corticosteroid injection in the study eye in the 3 months prior to Screening.
* Subjects who have received any intravitreal corticosteroid delivery vehicle (eg, Retisert®, Ozurdex®, Iluvien®) in the study eye at any time.
* Other protocol-specified exclusion criteria may apply
The Association of Sex With Guideline-based Perioperative Care in Hip Fracture Surgery

The investigators will use multilevel multivariable regression analysis to measure the association of sex with provision of guideline-based perioperative care for hip fracture surgery in Ontario.

In 2013, the Ontario Ministry of Health and Longterm Care published a 'Quality Based Procedures' guideline for care of hip fracture patients. The adjusted association of sex with receipt of 5 perioperative processes of care that can be accurately measured in health administrative data within this guideline will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Non-elective hospital admission
* Hip fracture diagnosis
* Hip fracture surgery

Exclusion criteria

-None
A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections of Humalog® and Lantus® in Healthy Chinese Volunteers

This is a randomised, double-blind, double-dummy, active-controlled, three-period crossover euglycemic clamp trial in healthy Chinese volunteers.

Each subject will be randomly allocated to one of 6 treatment sequences. Each sequence comprises one single dose of BC Combo THDB0207, one single dose of Humalog® Mix25, or simultaneous administration of Humalog® and Lantus®.

Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.

Subjects will attend the study site in the morning in a fasted state and will be connected to an automated glucose clamp device (ClampArt). Prior to dose administration plasma glucose will be stabilised at a defined target level by means of an intravenous infusion of glucose or insulin. IMP administration will be done by an unblinded person by means of subcutaneous injections in the abdominal wall.

Following each dosing a euglycaemic glucose clamp procedure will be carried out for up to 30 hours.

The pharmacodynamic assessment will be based on the time course of glucose infusion rate (GIR) and plasma glucose.

Plasma insulin concentrations will be measured using a specific validated bioanalytical method differentiating concentrations of insulin glargine, of its main metabolites insulin-glargine-M1 and insulin-glargine M2, and of insulin lispro. Pharmacokinetic insulin assessments will be based on total insulin concentration.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with Chinese origin. To qualify as a subject of Chinese origin (first-generation Chinese), the subject, the subject's biological parents, and all of the subject's biological grandparents are of exclusive Chinese descent and have been born in China.
* BMI between 18.5 and 30.0 kg/m2, both inclusive.
* Fasting plasma glucose concentration \<= 5.6 mmol/L (100 mg/dL).

Exclusion Criteria:

* Known or suspected hypersensitivity to IMP(s) or any of the excipients or to any component of the IMP formulation.
* Receipt of any investigational medicinal product within 3 months before randomisation in this trial.

Women of childbearing potential who are not using a highly effective contraceptive method.

* Any history or presence of a life-threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (including type 1 and type 2 diabetes mellitus, haematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator.
* Heart rate at rest outside the range of 50-90 beats per minute.
* History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants

The use of breast implants, both in cosmetic and restorative surgery, is common. It is a device consisting of a silicone elastomer envelope and the container of which may be silicone gel or saline. They can be texturing carriers (roughness) on the surface of their envelope.

If silicone is considered inert and biocompatible, several phenomena should be noted:

* Implant placement results in the formation of a periprosthetic capsule which is the product of the inflammatory reaction and will isolate it from adjacent breast tissue
* The periprosthetic capsule and adjacent breast tissue are chronically exposed to implant silicone.
* Silicone in implants, even intact, has been shown to diffuse through the shell into the periprosthetic compartment and adjacent breast tissue
* There is a phenomenon of erosion of the surface of the implants, particularly textured, responsible for the release of silicone particles within the periprosthetic capsule
* The rupture of the prosthetic envelope is a dreaded complication, due to the alteration of the aesthetic result and the possibility of leakage of silicone gel
* Since 2016, macrotextured implants have been implicated in the occurrence of anaplastic large cell lymphoma associated with breast implants (LAC-AIM) The presence of silicone in contact with tissues seems to promote an inflammatory environment, and this phenomenon seems increased if the implant is textured.

Chronic inflammation induced by these devices can therefore have harmful consequences in the long term. INFLAMA study interested in the consequences of the presence of a silicone implant on local inflammatory phenomena within the periprosthetic capsule.


Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 18 years old
* Requiring a change of unilateral/bilateral breast implants or breast expansion prosthesis for cosmetic surgery or breast reconstruction
* Subject not objecting to the use of personal data and/or biological samples
* Affiliation to or beneficiary of a French social security scheme.

Exclusion Criteria:

* Transgender men and patients
* Pregnant women, and nursing mothers
* Persons deprived of their liberty by a judicial or administrative decision;
* Persons undergoing psychiatric care under duress;
* Persons admitted to a health or social establishment for purposes other than research
* Persons of full age who are subject to a legal protection measure or who cannot express their consent
* Subject being in the period of exclusion from another study or foreseen by the "national volunteer file".
Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness

In this mono-center pilot trial, surgical patients who are at high risk to be admitted to intensive care will be screened and asked for participation. We are going to take blood and muscle samples at respecified time points to do metabolic, histological and molecular testing.

Aim of the study is to investigate (1) changes of the blood metabolome in patients with ICUAW (intensive care unit acquired weakness) and (2) identify metabolic components who are responsible for ICUAW or can be used as marker for ICUAW.


Eligibility Criteria:
Inclusion Criteria:

* invasive mechanically ventilated critically ill patient with expected intensive care unit stay \> 3 days
* postoperative patient
* ≥ 18 years old
* American Society of Anesthesiology (ASA) classification ≥ III

Exclusion Criteria:

* moribund patient
* non-curative care (comfort care)