cyrilzakka/clinical-trials huggingface dataset:
A Study Evaluating the Pharmacokinetics of Doravirine (MK-1439) in Participants With Severe Renal Impairment (MK-1439-051)

This study will evaluate the effect of severe renal impairment on the pharmacokinetics of doravirine.


Eligibility Criteria:
Inclusion Criteria:

* is a non-smoker or moderate smoker
* has a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m\^2
* other than renal impairment, participant is judged to be in good health based on medical history, physical examination, vital signs, and laboratory safety tests
* female informed of the risks of pregnancy, agree not to become pregnant while participating in this study. Female of childbearing potential must either be sexually inactive for 14 days prior to dosing and throughout the study, or uses one acceptable birth control method
* female of non-childbearing potential must have undergone sterilization procedures at least 6 months prior to dosing.
* Participants with severe renal impairment only: has baseline estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m\^2

Exclusion Criteria:

* is mentally or legally incapacitated or has significant emotional problems
* has a history or presence of clinically significant medical or psychiatric condition or disease
* has history or presence of alcoholism or drug abuse within the past 2 years
* has history or presence of hypersensitivity or idiosyncratic reaction to the study drug, any inactive ingredients, or related compounds
* has history or presence of renal artery stenosis
* has had a renal transplant or nephrectomy
* has rapidly fluctuating renal function as determined by historical measurements
* female is pregnant or lactating
* has positive results for the urine or saliva drug and urine or breath alcohol screen at screening or check-in
* has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
* is unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing and throughout the study. Certain medications including those to treat kidney disease will be permitted. Other medications may be permitted following consultation with the Sponsor Clinical Monitor.
* is unable to refrain from or anticipates the use of inducers of cytochrome P450 3A (CYP3A) or permeability glycoprotein (P-gp) transporters for at least 28 days prior to dosing and throughout the study.
* has been on a diet incompatible with the on-study diet, within 28 days prior to dosing, and throughout the study
* has donated blood or had significant blood loss within 56 days prior to dosing
* has donated plasma within 7 days prior to dosing
* has participated in another clinical trial within 28 days prior to dosing
Effect of G6PD Deficiency on Red Blood Cell Storage

The proposed study will determine whether G6PD-deficient RBCs store differently than normal RBCs under standard blood banking conditions. The investigators plan to screen a large number of healthy male volunteers for G6PD deficiency in order to identify 10 G6PD deficient and 30 matched normal individuals using a blood sample obtained from a finger-stick. The identified individuals will then be asked to donate a unit of blood that will be stored for up to 42 days and various tests will be performed on these units during storage. At 6 weeks of storage a portion of the unit will be radioactively labeled and re-infused into the volunteer. Blood samples will be drawn before, during, and after the infusion to measure how well or poorly the red blood cells survive after transfusion.

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is the most common enzyme deficiency, affecting approximately 400 million people world-wide. It manifests as red blood cell (RBC) destruction in response to oxidative stress, which can be precipitated by infection, and by the ingestion of certain medications and foods. The prevalence of G6PD deficiency varies among populations and is most commonly found in individuals from sub-Saharan Africa, the Mediterranean region, and south-east Asia. Although in most studies G6PD-deficient individuals have normal RBC survival at steady-state, this may vary based upon the G6PD variant present, and some individuals may have shortened RBC survival. While it is not routine practice to screen blood donors for G6PD deficiency, G6PD deficient donor RBCs may store more poorly than normal RBCs. In addition, the transfusion of stored G6PD-deficient RBCs may result in decreased RBC survival after transfusion compared to RBCs from normal donors.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Weight greater than 110 pounds
* Hemoglobin greater than 11.5 g/dL
* African (e.g., Afro-American, Afro-Caribbean, Sub-Saharan), Asian, Hispanic, Middle Eastern, or Mediterranean (e.g., Italian, Greek) based on mother's ancestry
* English speaking

Exclusion Criteria:

* Presence of hemoglobin variant
* Ineligible for donation based on the New York Blood Center donor autologous questionnaire
* Systolic blood pressure \>180 or \<90 mm Hg, diastolic blood pressure \>100 or \<50 mm Hg
* Heart rate \<50 or \>100
* Temperature \>99.5°F prior to donation
* Temperature \>100.4°F or subjective feeling of illness prior to transfusion (this criterion is to avoid concurrent illness affecting post-transfusion measurements)
* Positive results on standard blood donor infectious disease testing
Retrospective Multicenter Clinical Evaluation of Complications for Single or Multilevel VEO® Lateral Access and Interbody Fusion System and eXtreme Lateral Interbody Fusion (XLIF®) Subjects

The purpose of this retrospective clinical evaluation is to compare VEO® single or multilevel results to XLIF® single or multilevel results relative to the safety endpoints. This study will collect retrospective data on subjects who were treated with VEO® and XLIF® at least 3 months prior to the initiation of this study. Given that fusion generally takes at least 6 months to determine, the aim of this study is not to determine fusion but to consider the short-term (out to 6 months) reported adverse events between the two cohorts.

Devices used in both systems are cleared for use and conform to US regulatory requirements. The study employs these procedures and devices for uses that are consistent with their 510(k), legally cleared, labeling.


Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years of age or older;
* Male or female VEO® subjects that had previously received the single or two level LLIF procedure using the VEO® or XLIF® systems as an adjunct to fusion at L2-S1 to treat degenerative disc disease (DDD) at the treated level;
* Subject that was treated no less than 3 months prior to this evaluation with the LLIF procedure using the VEO® or XLIF® system by the participating surgeons.

Exclusion Criteria:

* Subject who did not receive LLIF procedure using the VEO® or XLIF® system for fusion of L2-S1;
* Subjects with less than 3 months of follow-up data.
Positive ER Expression Assessed by 18F-FES PET/CT in the MBC with ER-negative Primary Tumor

To investigate the treatment pattern and efficacy of patients with negative primary ER lesion but positive ER expression in MBC using a novel convenient way of 18F-fluoroestradiol positron emission tomography/computed tomography (18F-FES PET/CT).


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with breast cancer (according to International Classification of Diseases 10th Revision) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a nonmetastatic stage.
* MBC patients who underwent 18F-FES PET/CT at the Fudan University Shanghai Cancer Center between 2012 and 2023
* Patients diagnosed with primary ER-negative tumor and who were yet to receive any systemic therapy during the advanced stage

Exclusion Criteria:

Patients with incomplete medical records and those diagnosed with secondary primary tumors
Benefit of Ethanol Sclerotherapy of Endometriomas Before Ovarian Stimulation on Pregnancy Rates in IVF/ICSI

Evaluation of progressive pregnancy rates (with an embryo with cardiac activity at 12 weeks), on a first attempt at IVF/ICSI (fresh and frozen embryo transfers) following the discovery of one or two endometrioma(s) of 30 to 80 mm, without a history of cystectomy, and comparison between the two groups: ethanol sclerotherapy and therapeutic abstention


Eligibility Criteria:
Inclusion Criteria:

* Infertile women aged 18 to 43,
* Presenting one or 2 endometriotic cysts of 30 mm to 80 mm long axis, confirmed by ultrasound and/or pelvic MRI and without signs of atypia,
* With indication of IVF/ICSI, first IVF/ICSI after the discovery of endometriosis cyst(s),
* Having given their consent.

Exclusion Criteria:

* A history of ovarian cystectomy,
* A non-homogeneous cyst that cannot be punctured (risk of incomplete aspiration),
* Complex adnexal image that cannot exclude an associated hematosalpinx (communicating hematosalpinx, tissue component),
* A recent tubo-ovarian infection,
* An active, untreated vaginal infection,
* Anticoagulant treatment at a therapeutic dose,
* All adult patients protected by law (under guardianship or curatorship),
* Problems understanding the French language,
* Participation in intervention research,
* All patients not affiliated to the social security system.
Evaluation of Predictive Factors for Psoas Tendinitis After First-line Total Hip Arthroplasty

Evaluation of predictive factors for psoas tendinitis after first-line total hip arthroplasty.

A single-centre retrospective study of medical data from the medical records of patients undergoing total hip arthroplasty.

From the medical records of a series of patients operated on for total hip arthroplasty:

Main objective: To assess individual and surgical factors associated with the development of psoas tendinitis.

Secondary objectives:

* To describe the frequency of occurrence of psoas tendinitis
* To describe the outcome of patients who underwent tenotomy.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older, having been informed of the research
* Patient who has had a total hip replacement implanted for at least six months as a first-line treatment
* Patient who has been regularly monitored since the operation and for whom all clinical and radiological data are available during follow-up visits

Exclusion Criteria:

* Patient undergoing revision surgery
* Patient who has indicated his opposition to the use of his medical data
* Patient under legal protection, guardianship or curators
IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) Patients

The main purpose of this study is to evaluate safety and tolerability in patients diagnosed with asymptomatic antibody-mediated TTP with low ADAMTS13 activity after receiving single intravenous dose of IdeS.

Immunoglobulin G-degrading enzyme of Streptococcus pyogenes (IdeS) is an IgG specific endopeptidase which cleaves IgG molecules and efficiently neutralizes Fc-mediated activities. IdeS-mediated IgG degradation constitutes a novel therapeutic principle for the treatment of IgG-driven human diseases.

In addition to assessing the safety and tolerability of IdeS the study will also assess the efficacy of IdeS to significantly increase the ADAMTS13 activity and decrease the anti-ADAMTS13 antibody levels in patients diagnosed with asymptomatic antibody-mediated TTP with low ADAMTS13 activity.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or above
* Diagnosed with acquired TTP with ADAMTS13 levels of ≤ 10 % in clinical remission and with measurable or previously confirmed ADAMTS13 antibodies

Exclusion Criteria:

* Prior malignancy within 5 years
* Test positive for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV)
* Ongoing infectious disease including P-CRP \>10
* Test positive for IgE antibodies against IdeS
* Secondary cause of TTP
* Rituximab treatment or other antibody-based therapy within 7 days prior to IdeS dosing
* Treatment with investigational medicinal product within the last 12 weeks proceeding screening
* Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure \> NYHA (New York Heart Association) grade 3, unstable coronary disease or oxygen dependent COPD
* History of any other clinically significant disease or disorder which may either put the patient at increased risk because of participation in the study, or influence the results or the patient's ability to participate in the study
* Hypogammaglobulinemia defined as any values of P-total IgG less than 3 g/L
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to IdeS (e. g. streptokinase and/or staphylokinase)
* Substance abuse or other concurrent medical condition that could confound study interpretation or affect the patient's ability to tolerate or complete the study
* Breast feeding women or women with a positive pregnancy test
* Previously received IdeS treatment
Metrological Characteristics of the Inertial Unit "FOX HiKoB©" in Comparison With the Reference System for the Adaptive Trigger System "Functional Electrical Stimulation" of Foot Elevators in Hemiplegic Post-stroke Patients

The main objective of this study is to evaluate the metrological characteristics of the data processing algorithms from inertial sensors (FOX © HiKoB) for the reconstruction of movement relative to the reference system (VICON) for measurement of dorsiflexion at the beginning of a step and in the middle of the oscillating phase.

The secondary objectives of this study are:

1. / - to assess the metrological characteristics of the data from inertial sensors (FOX © HiKoB) for the reconstruction of the movement in comparison with reference systems (GaitRite or Zebris systems, VICON) in terms of:

   A. Ability to determine the walking speed, stride length, the acceleration of plantar flexion at the beginning of the weight-bearing phase B. Ability to objectify performance reduction during a 6 minute test. C. Ability to identify different types of movement: simple walking, turn, obstacle clearance, staircase.
2. / - to analyze the EMG signal upon voluntary dorsiflexion of the foot of the paretic side from a sitting position before and after a fatigue test (objective D)

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Stroke, ischemic or hemorrhagic, supra-tentorial, regardless of the post-stroke period
* The patient can walk 10m without human help, with or without a cane and has a foot elevator deficit requiring the use of technical assistance or causing a walking defect

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient or his/her representative refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant or breastfeeding
* The patient has cognitive impairment
* Presence of permanent plantar flexion of the ankle joint with ankle dorsiflexion, knee straight, lower than 0°.
* Uncontrolled epilepsy
Clinical Performance Evaluation of the Hativ P30

Hativ P30 is intended to record, store, and transfer one-and two-channel ECG rhythms, and analyze them based on an artificial intelligence (AI) algorithm. In single channel mode, Hativ P30 can record lead-I. In two-channel mode, Hativ P30 can record lead-I and lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. The ECG signal measured through the device's electrode is converted into a digital signal and transmitted via Bluetooth to an Android or iOS-based smart device with a mobile app installed. The ECG signal and analysis result can be checked through the screen of the smart device.

The aim of this clinical study is to assess the safety and efficacy of the Hativ P30 ECG recording device, as well as to gather data to support an FDA submission through the 510(k) process for the device's commercialization.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older
* Able to provide written informed consent
* Able to remain in the same position for an ECG recording for at least 20 minutes using a standard 12-lead ECG recorder and the Hativ P30 device
* NSR cohort only: no history of arrhythmia
* NSR cohort only: no history of cardiovascular diseases, including but not limited to hypertension, hyperlipidemia, coronary artery disease, heart failure, peripheral artery disease, and stroke
* NSR cohort only: being in NSR at the time of screening ECG
* Arrhythmia cohort only: documented persistent, permanent, or chronic arrhythmia (AF or flutter, sinus rhythm with APB, sinus rhythm with VPB)
* Arrhythmia cohort only: being in arrhythmia (AF or flutter, sinus rhythm with APB, sinus rhythm with VPB) at the time of screening ECG

Exclusion Criteria:

* Subjects with an implantable pacemaker device, implantable cardioverter-defibrillator device, or internal simulator that would generate internal interference with the recording of the Hativ P30 device or a standard 12-lead ECG recorder
* Any medical or cognitive condition that would interfere with the consenting process and study-related procedures as determined by the Investigator
* Any known clinical condition (e.g., body tremors, non-healed chest wound, limb absence, etc.) that would preclude appropriate placement of the leads and/or compromise study measurements in the opinion of the Investigator
* Poor 12-lead screening ECG quality
* Pregnant at the time of enrollment
* Participation in other interventional clinical studies that includes active treatment for the last three (3) months (observational studies and long-term follow-up \[no active treatment\] will be allowed)
* Screening ECG record resulting in a significant arrhythmia out of the scope of the study, such as Supraventricular Tachycardia, Ventricular Tachycardia, Ventricular Fibrillation, Neurocardiogenic Syncope, among others
Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery

The study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for restoration and maintenance of hemodynamics during the investigational period in patients undergoing major elective surgery. Up to 50 mL 6% hydroxyethyl starch/kg body weight will be administered from start of surgery until two hours after end of surgery. The study hypothesis is that 6 % hydroxyethyl starch 130/0.4 will have a reliable volume effect and can be safely administered up to the dose limit.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing major elective surgery
* Adults patients (≥20 years of age): expected blood loss of ≥ 1000mL Pediatric patients (\<20 years of age): expected blood loss ≥ 15 mL/kg
* Adult patients: Routine measurement of Central Venous Pressure (CVP)

Exclusion Criteria:

* Known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs
* ASA classification ≥ IV
* Adult patients: renal failure with oliguria (\<400 mL urin /24hours) and anuria Pediatric patients: renal failure with oliguria and anuria not related to hypovolemia
* Known bleeding disorders
* Other contra-indications according to the current SmPC of Voluven 6% solution for infusion.
Leptin and Liver Enzymes Responses to Aerobic Training in Hepatitis c Patients

Exercise is one of the most vital components of health maintenance. Exercising regularly maintains the cardiovascular system health, promotes the health of liver, and declines the risks of complications induced by CHCV. Since overweight is the main risk factor for IR and type 2 DM which may speed the liver disease progression among HCV patients, exercise is very important for maintenance and loss of weight. Further, exercise can relieve the side effects of medications of HCV, improve immunity, promote a sense of well-being, reduce levels of chronic fatigue, improve blood oxygen levels and increase the endorphins excretion which makes the patients fully energized (Elgendi, Shebl A, Sliem M, and Gary FA, 2018).

Studies on exercise effect in patients with CHCV are quite scarce (de Sousa Fernandes et al., 2019). Decreased leptin levels by exercise positively modulate insulin signaling and inhibit pathology progression (Anaruma et al., 2019). Since studies investigated physical activity effect on regulating HCV related leptin levels are very little, the present study aimed to explore the response of serum leptin and liver enzymes to aerobic exercise in nondiabetic overweight men with CHCV.

The study group (n=20) received three sessions of aerobic walking exercise per week for 3 months. Every session was done on an electronic treadmill with no inclination started with 5 minutes warm-up then 30 minutes of moderate-intensity aerobic training with 60-75% of target heart rate then followed or ended by 5 minutes cool down. The control group (n=20) will receive no training.

Eligibility Criteria:
Inclusion Criteria:

* Men with hepatitis C patients at least from 6 months
* BMI ranged ≥ 25 to \< 30 kg/m2.
* fasting blood glucose level (FBG) \< 100 mg/dl.
* waist circumference \< 102 cm.

Exclusion Criteria:

* Besides the excluded individuals who participated in any form of physical training in the last 6 months, excluded patients by a physician will be patients with acute or other hepatitis types, cirrhotic or hepatocellular carcinoma, renal or respiratory problems, cardiovascular and neurologic diseases, and hypertension
Effects of Exercise in the Functional Capacity, Central Artery and Rigidity Ankle Brachial Index

The Peripheral Arterial Disease prevalence is around 3-10 % of the world population. Exercise plays an important role in treating these patients.

Objective: To investigate the effects of training Combined Aerobic - Strength versus aerobic functional capacity, ankle brachial index (ABI ) and central arterial stiffness in patients with peripheral arterial disease

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DAP and CI .
* Stage I or II of Fontaine .
* intermittent claudication symptoms for at least 3 months with ankle brachial index (ABI ) at rest ≤ 0.90 in 1 or 2 legs.

Exclusion Criteria:

* Ischemia criticism in one of the lower limbs.
* moderate or severe ulcers on one of the lower limbs.Orthopedic issues that prevent pratical of the exercises or conducting evaluations .
* Participation in other studies with rehabilitation.
* decompensated hypertension .
* decompensated diabetes .
* Cardiovascular events less than three months .
* severe lung disease .