cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection

This was a multicenter study evaluating the efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12 weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV treatment-experienced, cirrhotic HCV genotype 1b-infected adults.

The primary objective of this study was to assess the safety and efficacy (the percentage of participants achieving a 12-week sustained virologic response (SVR12), \[HCV ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks following treatment\]) of co-formulated ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/r) and dasabuvir co-administered with RBV for 12 weeks in HCV genotype 1b-infected adult participants with compensated cirrhosis. The secondary objectives of this study were to assess the number and percentage of participants with virologic failure during treatment and the percentage of participants with relapse post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at Screening)
* Evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening
* Participant had never received antiviral treatment (including pegIFN/RBV) for hepatitis C infection (treatment-naïve participant) or had documentation of meeting one of the defined categories of a treatment-experienced participants
* Absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) performed within 3 months prior to screening or a negative ultrasound at screening.
* Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
* Males must have been surgically sterile, or agreed to practice 2 effective methods of birth control throughout the course of the study.

Exclusion Criteria:

* Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
* Evidence of current or past Child-Pugh B or C classification
* Confirmed presence of hepatocellular carcinoma
* Abnormal laboratory tests
* Participant who self-reported on average drinking more than 2 drinks per day for current drinkers
* Previous treatment with a direct acting antiviral agent (DAA) containing regimen
* History of solid organ transplant.
Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received a liver transplant.


Eligibility Criteria:
Key Inclusion Criteria:

* History of chronic HCV infection (≥ 6 months)
* HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate
* Liver transplant ≥ 3 months prior to screening
* Male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis

Key Exclusion Criteria:

* History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol,
* Co-infection with HIV or hepatitis B virus
* Known hypersensitivity to study medication,
* Use of any prohibited concomitant medications as within with window before the Day 1 visit.
* De novo or recurrent hepatocellular carcinoma posttransplant

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Efficacy and Safety Study of a Recombinant Protein-Free Manufactured Factor VIII (rAHF-PFM) in Previously Untreated Hemophilia A Patients

The purpose of this study is to evaluate whether Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) is effective and safe in the treatment of hemophilia A patients who have not been treated with factor VIII (FVIII) before.


Eligibility Criteria:
Inclusion Criteria:

* The subject has severe or moderately severe hemophilia A as defined by a baseline factor VIII level \<= 2% of normal, as documented at screening
* The subject is \< 6 years of age
* The subject's legally authorized representative has provided written informed consent

Exclusion Criteria:

* The subject has a history of exposure to factor VIII other than rAHF PFM or more than 3 infusions of commercially available rAHF PFM (i.e., ADVATE) within 28 days prior to screening, as determined by the subject's medical history. Any infusion of factor VIII replacement products prior to the 28-day period excludes the subject from participation
* The subject has received more than 3 infusions of rAHF PFM (commercially available and/or study product) between screening and prior to the initial recovery infusion
* The subject has a detectable inhibitor to factor VIII, as measured in the screening sample by the Nijmegen assay in the central laboratory
* The subject has a history of inhibitor to factor VIII at any time prior to screening
* The subject has a known hypersensitivity to rAHF PFM
* The subject has any 1 of the following laboratory abnormalities at the time of screening:

  1. Platelet count \< 100,000/mm\^3
  2. Hemoglobin concentration \< 10 g/dL (100 g/L)
  3. Serum creatinine \> 1.5 times the upper limit of normal (ULN) for age
  4. Total bilirubin \> 2 times the ULN for age
* The subject has an inherited or acquired hemostatic defect other than hemophilia A (e.g., qualitative platelet defect or von Willebrand's disease)
* The subject is known to be seropositive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV), as determined by the subject's medical history
* At the time of enrollment, the subject has a clinically significant chronic disease other than hemophilia A
* The subject is currently participating in another investigational drug study, or has participated in any clinical study involving an investigational drug within 120 days of the screening visit
* The subject (or the subject's legally authorized representative) is identified by the investigator as being unable or unwilling to cooperate with study procedures
* The subject has received any blood product, including packed red blood cells (RBC), platelets, plasma, or cryoprecipitate
Alternating Pressure Air Mattress and Pressure Injury Prevalence

explore the correlation of accurate implementation of APAM and pressure injury prevalence


Eligibility Criteria:
Inclusion Criteria:

patients with pressure injury

Exclusion Criteria:

-
A Study of Lebrikizumab in Combination With Topical Corticosteroids in Patients With Atopic Dermatitis (AD) That Are Not Adequately Controlled With or Are Non-eligible for Cyclosporine

The main purpose of this study is to evaluate the efficacy of lebrikizumab compared with placebo in participants not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable up to Week 16.


Eligibility Criteria:
Inclusion Criteria:

* Adults and adolescents (aged greater than or equal to (\>=) 12 to \<18 years at the time of Informed Consent Form (ICF)/Informed Assent Form (IAF) and weighing \>=40 kilograms).
* Chronic AD that has been present for \>=1 year before the Screening visit.
* EASI score \>=16 at the Baseline Visit.
* IGA score \>=3 (moderate) (scale of 0 \[clear\] to 4 \[severe\]) at the Baseline visit.
* \>=10% BSA of AD involvement at the Baseline visit.
* Inadequate response to existing topical medications
* Failure to cyclosporine or non-medically advisable to receive/continue receiving cyclosporine
* Signed ICF (and informed assent for adolescents as required)

Exclusion Criteria:

* Treatment with TCS within 1 week before the Baseline visit.
* Treatment with topical calcineurin inhibitors, phosphodiesterase-4 inhibitors such as crisaborole, or cannabinoids within 2 week before the Baseline visit.
* Treatment with interleukin 4 (IL-4) or interleukin 13 (IL-13) antagonists biological therapies before the Baseline visit. Exception: previous treatment with dupilumab will be allowed in a subset of patients
* Treatment with immunosuppressive/immunomodulating drugs, phototherapy and photochemotherapy within 4 weeks before the Baseline visit
* Uncontrolled chronic disease that might require bursts of oral corticosteroids
* Serious, opportunistic, chronic or recurring infections within 3 months of Screening or before randomization
* Current or chronic infection with hepatitis B virus, current infection with hepatitis C virus, known liver cirrhosis and/or chronic hepatitis of any etiology
* Known or suspected history of immunosuppression, history of HIV infection or positive HIV serology at Screening
* Any clinically significant laboratory test results obtained at the Screening visit
* Presence of skin comorbidities that may interfere with study assessments
* Have had an important side effect to TCS that would prevent further use.
Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients

The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate bromide) for the treatment of COPD patients.

A Multinational, Multicentre, Randomised, Double Blind, Placebo-Controlled, 2-way Crossover Study to Evaluate the Efficacy and Safety of Glycopyrrolate Bromide Administered Via pMDI (CHF 5259), for the Treatment of Patients With Chronic Obstructive Pulmonary Disease

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults (40 ≤ age ≤ 80 years) with a diagnosis of COPD
* Current smokers or ex-smokers
* A post-bronchodilator FEV1 \< 60% of the predicted normal value and a post-bronchodilator FEV1/FVC \< 0.7
* Positive response to the reversibility test at screening defined as change in FEV1 ≥ 5%.
* BDI score ≤ 10
* Patients free of exacerbations for at least 1 month

Exclusion Criteria:

* Pregnant or lactating women
* Diagnosis of asthma
* Patients treated for exacerbations in the 4 weeks prior to screening visit
* Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN
* Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
* Known respiratory disorders other than COPD
* Patients who have clinically significant cardiovascular condition
Effects of Acupuncture in the Treatment of Infant Colic

Standardized acupuncture treatment for infant colic is a common treatment in general practice for doctors educated in medical acupuncture.

The investigators plan to study whether the perceived opinion on positive results can be verified in a multi-center clinical trial. The investigators aim to measure the effect of standardized acupuncture treatment, three repeated sessions, on infant colic in a randomized singe blinded prospective multi-center study, starting September 2009. The study will be done in thirteen locations in Norway by specialists in General Practice trained in acupuncture.

The investigators intend to include a total of 130 patients, 65 in the intervention group and 65 in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Infants under 3 months of age with birth weight over 2500 g and/or over 36th week of gestation.
* Further fulfilling Wessel et al criteria for infant colic: "Paroxystic uncontrollable crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying per day for more than 3 days a week for more than 3 weeks."

Exclusion Criteria:

* Infants over 3 months of age with birth weight under 2500 g and/or under 36th week of gestation.
* Not fulfilling Wessel et al criteria for infant colic: "Paroxystic uncontrollable crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying pr.day for more than 3 days a week for more than 3 weeks."
Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms

Colorectal cancer is the third most common cancer worldwide and its progression-free survival is still low, around 10 months. Thirthy to 50% of patients do not respond to chemotherapy upon initiation of treatment, suggesting that early development of chemoresistance mechanisms remains a major challenge. In order to better characterize these mechanisms, the aim is to develop a model of tumoroids derived from patients with a colorectal tumors prior to any systemic anti cancer treatment. This project will both allow us to study the role of the immunological microenvironment in chemoresistance and identify new predictive markers of tumor response. It will then serve to develop innovative personalized medicine strategies by targeting the newly identified mechanisms. This study should in fine help to improve the cancer patient's care.


Eligibility Criteria:
Inclusion Criteria:

* Male and female over 18 years old.
* Managed at the CHUGA for a colorectal adenocarcinoma
* With an indication for immediate surgical resection as part of the care.
* Patient naive from neo-adjuvant chemotherapy
* Patient did not object to the CRC-ORGA-2 study

Exclusion Criteria:

* Patients protected by law (pregnant or breastfeeding women, minors, patients under guardianship or trusteeship, persons deprived of their liberty or hospitalized under duress).
* Patients with positive HIV, HBV, HCV serology.
Racial Differences in Vagal Control of Glucose Homeostasis

The investigators will test the hypothesis that acute central acetylcholinesterase inhibition will restore PNS activity and reduce oxidation in AAW compared to whites.

Obesity has a greater detrimental impact on the health of African American women (AAW) than on any other racial or gender group. Nearly 80% of AAW are overweight or obese. Reduced insulin sensitivity is more prevalent among AAW as compared to white women and men of both races. This condition puts AAW at increased risk for the development of type 2 diabetes mellitus. The exact mechanism underlying these pathophysiological differences remains unknown. The investigators have found that obese AAW have decreased parasympathetic nerve (PNS) activity compared to whites and recent studies in animal models showed that the PNS confers protection against oxidative stress. In our AA cohort, PNS activity was directly correlated with insulin sensitivity in obese AAW even after controlling for differences in age, blood pressure and visceral adiposity. Equally important, the investigators also showed that the decrease in insulin sensitivity was associated with increased oxidative stress as measured by plasma levels of F2-isoprostanes. Taken together these findings lead us to hypothesize that the decreased PNS activity in obese AAW compared to white women has deleterious effects on oxidative stress and insulin sensitivity.The investigators will test the hypothesis that acute central acetylcholinesterase inhibition will restore PNS activity and reduce oxidation in AAW compared to whites.

Eligibility Criteria:
Inclusion Criteria:

* Female
* African American or white (race will be self-defined, but only subjects who report both parents of the same race will be included)
* 18-60 years old
* BMI 30-45 Kg/m2
* Not pregnant or breastfeeding

Exclusion Criteria:

* Pregnant or breastfeeding
* Diabetes diagnosis (defined by the American Diabetes Association (ADA) criteria)38
* Cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy.
* Arrhythmia (first-, second-, and third-degree atrioventricular (AV) block)
* Significant weight change \>5% in the past 3 months
* Impaired hepatic function (AST and/or Alanine transaminase (ALT) \> one and one half times (1.5X) upper limit of normal range)
* Impaired renal function (eGFR \<60ml/min)
* Users of strong inhibitors of Cytochrome P450 3A4 (CYP3A4) or cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6)
* Users of other acetylcholinesterase inhibitors such as pyridostigmine or bethanechol
* History of alcohol or drug abuse
* Mental conditions rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Pelvic Floor Muscle Activity in Primary Dysmenorrhea

This study will be conducted to assess the pelvic floor muscle (PFM) activity in primary dysmenorrhea (PD).

Dysmenorrhea, marked by painful menstrual cramps, often involves increased PFM tension, spasms, and inflammation, affecting females' quality of life and productivity. The traditional focus has been on investigating the abdominal region in women with PD. However, this new perspective considers that the hormonal changes experienced during the menstrual cycle in PD patients may lead to a heightened sensitivity of the PFM, not just the abdominal area. This suggests that the pain associated with PD may have a more widespread impact on the pelvic region rather than being localized to the abdomen. Pelvic floor myofascial trigger points (MTrPs) may also exacerbate menstrual pain through the neural pathway.

There is a critical gap in the literature regarding the nature of the association between dysmenorrhea and PFM activity in this population. Yet, it is unknown whether the pain is a cause or result of increased PFM tone, and the nature of the association between menstrual pain and PFM tone in women with PD is also unknown.

So, this study utilizes transabdominal ultrasound (TAU) to examine PFM activity in PD, aiming to clarify how PFM activity contributes to menstrual pain. Understanding these dynamics could lead to preventive strategies and educational efforts highlighting the role of pelvic floor interventions in managing dysmenorrhea, potentially improving treatment methods and overall women's health management.

Eligibility Criteria:
Inclusion Criteria:

* They should be virgin, healthy female physiotherapy students with PD.
* They have regular menstruation (3-8 days in duration, with 21-35 days in between).
* Their ages will range from 18 to 25 years old.
* Their body mass index (BMI) will range from 18 to 24.9 kg/m2.
* Their waist-to-hip ratio will be less than 0.8.

Exclusion Criteria:

* Any urological or gynecological disorders in the previous 12 weeks (e.g., endometriosis, fibroids).
* Fibromyalgia.
* Severe psychiatric or psychological disorders.
* Those who had taken analgesics in the 12 hours before the assessment.
* Abdominal or pelvic surgery within the past six months.
Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis.

The aim of this study is to determine the safety and efficacy of daptomycin when used as an adjuvant agent to standard care in the treatment of proven native valve Enterococcal endocarditis. Patients with this disease will be offered the option of receiving daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving. The hypothesis of this study is that daptomycin added to standard therapy for Enterococcal endocarditis is safe and efficacious.

Patients who receive daptomycin + standard therapy will be compared to patients who receive standard therapy alone with respect to the following outcomes:

1. Safety.

   1. The frequency of any Grade 3 or 4 toxicity (DAIDS scale) will be measured.
   2. The frequency of muscle toxicity or renal toxicity, as determined by predefined criteria.
2. Efficacy.

   1. Clinical efficacy.

      * Time to clearance of bacteremia
      * Cure at 6 weeks following completion of antibiotic therapy
      * Mortality at 6 weeks following completion of antibiotic therapy
   2. Microbiologic efficacy.

      * Peak and trough serum bactericidal titers
      * The minimum bactericidal concentration of Enterococci to daptomycin

We expect to enroll 40 patients over 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* Definite Enterococcal endocarditis, as defined by modified Duke criteria
* Able to complete follow-up 3 and 6 weeks following completion of intravenous antibiotic therapy

Exclusion Criteria:

* Pregnancy or breast feeding
* Creatine phosphokinase levels over two times the upper limit of normal
* Renal insufficiency or dialysis requirement.
* Presence of chronic indwelling bloodstream catheters or foreign body devices suspected as primary or secondary sites of enterococcal infection unamenable to removal or replacement
* Inability to discontinue or abstain from use of a HMG CoA reductase inhibitor during the study period.
* Hypersensitivity to any of the study medications.
* Any condition that, in the investigator's opinion, may interfere with protocol compliance including, but not limited to, active substance abuse and/or dementia.
* Prosthetic valve endocarditis
Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax

This 6 month study seeks to compare the use of Intracanalicular Dexamethasone in conjunction with Restasis (cyclosporine ophthalmic emulsion) for the treatment of signs and symptoms of dry eye disease as compared to Restasis with Lotemax (loteprednol etabonate ophthalmic suspension 0.5%) and Restasis monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Signs and symptoms of Dry Eye Disease
* Consent to treat with topical immunomodulator
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form

Exclusion Criteria:

* Patients under the age of 18.
* Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
* Active infectious systemic disease
* Active infectious ocular or extraocular disease
* Altered nasolacrimal flow of either acquired, induced, or congenital origin
* Hypersensitivity to dexamethasone
* Patients who have been on topical immunomodulating agents in the previous 3 months to their baseline visit
* Patient being treated with either topical, oral, or intravenous immunosuppressive agents, immunomodulating agents, or steroid (including NSAIDS)
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Motivational Interviewing and Neuroimaging With Adolescents

This is a randomized controlled trial to examine the impact of two brief interventions on adolescent and young adult alcohol use behaviors and related brain response. The interventions being compared are motivational interviewing (MI) and brief adolescent mindfulness (BAM).


Eligibility Criteria:
Inclusion Criteria:

* within the specified age range
* \>= 1 past two month binge drinking episode
* right-handed
* proficient in English
* agree to be contacted for the 3, 6, and 12 month follow ups
* informed consent of a parent/guardian, if under 18 years old
* informed assent/consent of participating youth

Exclusion Criteria:

* \> 3 past-month instances of non-nicotine and/or non-cannabis substance use (e.g., methamphetamine)
* evidence of brain injury/illness or neurological disorder including psychosis
* lifetime loss of consciousness \>= 2 min
* unremovable metal on/in body, or other functional magnetic resonance imaging (fMRI) contraindications (e.g., pregnancy)
Robotic-assisted Versus Laparoscopic Sigmoid Resection

Retrospective multi-center comparative chart review of robotic-assisted versus laparoscopic sigmoid resection for both benign and malignant disease

The goal is to establish safety and effectiveness of robotic-assisted surgery in sigmoid resection for both benign and malignant disease by evaluation of short-term clinical outcomes through 30 days post index procedure.

Eligibility Criteria:
Inclusion Criteria:

* All patients that have undergone sigmoid resection for benign or malignant disease

Exclusion Criteria:

* Emergency Procedures