cyrilzakka/clinical-trials huggingface dataset:
An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens

This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/=18 years of age
* chronic hepatitis C
* participation in Roche DAA treatment protocol for CHC infection
* DAA-associated resistant mutations persisting through to last evaluation in donor protocol , or partial viral response or viral load rebound while on RO5024048 treatment, or sustained virological response \>/= 20 weeks after last dose of study medication in donor study

Exclusion Criteria:

* For patients participating in DAA resistance monitoring: Initiation of treatment after participation in the donor protocol for which there is evidence of cross-resistance to donor protocol DAA
* For patients participating in DAA SVR durability: Treatment with any anti-HVC therapy since establishing SVR in the donor study
Ultrasound Guided Lateral Sphincterotomy: Long Term Results

Ultrasound guided placement of the knife intersphincteric increases accuracy and safety during sphincterotomy. Secondly 3-D ultrasound visualizes that the internal anal sphincter is divided.


Eligibility Criteria:
Inclusion Criteria:

Patients undergoing lateral sphincterotomy for chronic anal fissure

Exclusion Criteria:

* Previous diltiazem treatment og botox injections were not performed
AC-OLE-01-VA Tolerability Study in Healthy Participants Under Different Dosing Conditions

This is an open-label, 3-arm study to compare tolerability of three different titration and dosing schedules of the AC-OLE-01-VA formulation of tricaprilin.

Following a screening of up to 28 days, eligible participants will be initially randomised to one of 2 arms (Arm 1 or Arm 2). Arms 1 and 2 will be completed in advance of Arm 3 with all subsequent participants allocated to Arm 3.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy (in the opinion of the Investigator) as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
* Body weight ≥45 kg and body mass index (BMI) within the range 18.0 - 32.0 kg/m2 (inclusive).

Exclusion Criteria:

* History of, or current gastrointestinal (GI) conditions constituting a risk when taking the study treatment; or interfering with the interpretation of data, based on the Investigator's judgement.
* Participants on a ketogenic diet, low-fat diet or actively using medium chain triglycerides, ketone esters, or other ketogenic products within 3 months prior to screening.
When Distance is an Act of Love: Exploring the Use of Video Diaries for Family Members of Intensive Care Patients

Due to Covid-19, intensive care (ICU) patients are not allowed visitors or have severely restricted visiting. After being admitted to ICU most patients are unconscious or extremely weak and therefore cannot speak on a phone or video call to a family member. Before these visiting restrictions, family members of patients admitted to ICU as a result of being critically ill were already known to suffer significant psychological distress and may now face increased distress given they are unable to visit a loved one.

Previous research demonstrates that keeping a paper diary has been found to be helpful for ICU patients and families. When lockdown measures were announced, NHS Scotland introduced video diaries as an emergency measure to try to support communication with families and reduce distress. vCreate is an NHS Trusted secure video messaging service that helps patients, families and clinical teams stay connected throughout their care journey. The use of video diaries may have a positive impact for family members but there is a risk that they could also have negative effects for some people. There is a need to explore both ICU healthcare professionals and family members' experiences of using video diaries. At the same time it is also important to test the feasibility and acceptability of measures of distress and psychological well-being on family members during and after their experience of video diaries. In doing so, some initial recommendations about video diaries can be made and a larger subsequent study planned to test their effect on family members and healthcare professionals.


Eligibility Criteria:
Inclusion Criteria:

- (i) Family Members in Lothian aged ≥16 years receiving a video diary for an ICU patient who stays in ICU for ≥24 hours or more. If the patient dies, family members will be invited to continue in the study.

(ii) ICU healthcare staff in NHS Lothian who have experience of using the video diary to support family members during lockdown.

Exclusion Criteria:

Prisoners Family members lacking capacity to consent Family members aged under 16 years
Collaborative Cardiac Care Project

Data from VA-funded studies and the broader literature indicate that chronic stable angina (CSA) is prevalent, under recognized, under treated and associated with reduced quality of life. There are substantial opportunities for improving care of patients with this debilitating and potentially fatal problem. Because primary care providers manage most patients with CSA, efforts to improve care must necessarily involve the primary care delivery system. C3P is composed of a set of interventions employing a Collaborative Care Team model, which has been shown to be effective in managing other chronic illnesses in the primary care setting.

Objectives of the proposed project are to: 1) ascertain whether a collaborative approach to managing CSA in primary care results in better symptom control and quality of life than routine care; 2) assess whether the practice of providers assigned to the intervention group is more consistent with national clinical practice guidelines than that of control providers; 3) assess satisfaction of both patients and providers with this approach to management; and 4) assess marginal cost-effectiveness.

Eligibility Criteria:
Inclusion Criteria:

Providers:

* Staff (MD, PA, NP) or resident (R1, R2)
* at least 1 participating patient

Patients

* assigned to participating provider
* diagnosis consistent with IHD
* 2 visits in past year
* frequent angina symptoms (SAQ freq. score less than 70)

Exclusion Criteria:

Providers:

- No participating patients

Patients:

* cognitive impairment (inability to complete questionnaires and phone interviews)
* non-participating provider
* life expectancy of less than 24 months
Steroid Sparing Treatment With in Newly Diagnosed Transplant Ineligible Patients With Multiple Myeloma

The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.

This is an open label, phase 2 study consisting of daratumumab, lenalidomide and dexamethasone, given upfront in newly diagnosed, transplant ineligible patients with myeloma. Patients participating in the study will be recruited from the Wilmot Cancer Institute, University of Rochester in Rochester, New York and all University of Rochester community affiliates.

Patients will be treated with 1800 milligrams of Daratumumab subcutaneously or 16 milligrams/kilograms daratumumab intravenously (IV) weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks. Patients will be treated with 25 milligrams of Lenalidomide days 1-21 out of a 28 day cycle (dose adjustments for creatinine clearance) and 20 milligrams of Dexamethasone at least 60 minutes prior to first infusion of daratumumab. Each cycle consists of 28 days (4 weeks).

Response assessments by International Myeloma Working Group criteria for myeloma will be performed every 4 weeks while on therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple myeloma with diagnosis
* Must not have received previous therapy for multiple myeloma
* Newly diagnosed and not considered candidate for high-dose chemotherapy
* Adequate organ system function
* A performance status ≤ 3
* Ability to swallow and retain oral medication
* Female subjects of child bearing potential must be surgically sterile, be post-menopausal

Exclusion Criteria:

* A diagnosis of primary amyloidosis; monoclonal gammopathy of undetermined significance, smoldering multiple myeloma; non-secretory myeloma
* A diagnosis of Waldenström's disease
* Receiving cancer therapy
* Radiation therapy within 14 days of enrollment
* Major surgery within 2 weeks before enrollment
* Human immunodeficiency virus -infected patients must be on effective anti-retroviral therapy with undetectable viral load within the past 6 months
* Seropositive for hepatitis B, or seropositive for hepatitis C
* Ongoing systemic bacterial, fungal or viral infection
* Severe and/or uncontrolled medical conditions
* Malignancy within 2 years of study enrollment
* Women who are pregnant or lactating
* Contraindications to required prophylaxis for deep vein thrombosis and pulmonary embolism.
Protein Consumption in Critically Ill Patients

A retrospective study of protein intake and needs as well as outcomes in critically ill adult patients. Data will be collected for up to 7 days of ICU stay.

This retrospective study of critically ill adults receiving enteral nutrition will assess the ability to meet estimated protein and energy needs via enteral nutrition.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥18 years)
* Admitted to the ICU
* Administered at least one dose of enteral formula

Exclusion Criteria:

* Receiving exclusive oral or exclusive parenteral nutrition
: Identification of Non-alcoholic Steato-hepatitis Cases in a Sample of Type 2 Diabetes Patients, with a Disruption of the Liver Function Tests, At the Pointe-à-Pitre University Hospital

Non-alcoholic steatohepatitis (NASH) develops on insulin resistance, especially in patients with carbohydrate tolerance. NASH may progress to more extensive fibrosis, including cirrhosis, but also to HCC with or without cirrhosis in 10 to 20% of cases. The main objective of our research is to identify the prevalence of NASH in a sample of 100 patients with type 2 diabetes mellitus (T2DM), consulting in the PAP hospital and having a liver function disorder

In Guadeloupe, the prevalence of T2DM is estimated to be 20%, among the highest in the French departements. NASH is probably present in our patients with T2DM but we do not know its prevalence. There is no data on the development of NASH in the Afro-Caribbean population, but in the United States, it has been observed that NASH was less prevalent among African-Americans compared to Caucasian and Hispanic Americans, and this could be explained by differences genetics in fat metabolism. In view of the emergence of NASH worldwide as a cause of chronic liver disease, it is necessary to carry out a pilot study to determine the presence or absence of NASH in T2DM patients in Guadeloupe. This will necessitate a systematic evaluation of liver function, usually performed during the T2DM assessment but not necessarily followed by specialized advice to confirm or invalidate the diagnosis of NASH. For each patient, an abnormality of liver function will be assessed by usual serum tests (transaminases, GGT, PAL). Prescription for a fibrotest / actitest + NASHtest and the NAFLD fibrosis score, will be perfomred as well as ultrasound and blood tests to eliminate other causes of liver disease (viral B or C, alcoholic, autoimmune, hemochromatosis) will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus patient with impaired hepatic function (transaminases and / or PAL and / or gamma-GT\> Norm)
* Age ≥18 years
* Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
* Affiliate or beneficiary of a social security scheme.

Exclusion Criteria:

* Pregnancy or breast-feeding
* No diabetes or type 1 diabetes
* Chronic hepatopathy of other origin: viral B, C, alcohol, hemochromatosis, α1-antitrypsin deficiency, Wilson's disease, autoimmune hepatitis
Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers

The purpose of this study is to determine the excretion kinetics and mass balance of fenebrutinib in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects, between 18 and 60 years of age, inclusive
* Within body mass index range 18 to 32 kg/m2, inclusive
* In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs, and physical examination
* For males who are sterile: agreement to use a condom with a fertile or pregnant female partner from Day -1 until 90 days following Study Completion; for males who are fertile: agreement to use a condom with spermicide with a fertile or pregnant female partner from Day -1 until 90 days following Study Completion

Exclusion Criteria:

* History or symptoms of any significant disease
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
* History of stomach or intestinal surgery or resection, except appendectomy, hernia repair, and cholecystectomy
* History of malignancy, except for non-melanoma skin carcinoma with 3-year disease-free follow-up
* Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to Day -1
* Exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Day -1
* Participation in a radiolabeled drug study in which exposures are known to the Investigator within 4 months prior to Day -1, or participation in a radiolabeled drug study in which exposures are not known to the Investigator within 6 months prior to Day -1. The total 12-month exposure from this study and a maximum of 2 other studies must be within the Code of Federal Regulations (CFR) recommended levels considered state (per 21 CFR 361.1), e.g. less than 5,000 mrem whole body annual exposure
Comparison of the Effects of Green Exercise Programs Including Resistance and Aerobic Exercises

It was aimed to evaluate the effects of aerobic exercise and resistance exercises performed together with aerobic exercise, applied in the concept of green exercise with a multidisciplinary team (specialist doctors physiotherapists, nurses) on senior fitness, aerobic capacity and IC in individuals aged 65 and over.

The study is a multicenter, parallel three-group, randomized controlled study conducted to examine the effects of aerobic and resistance exercises applied within the framework of green exercise concept on physical fitness, aerobic capacity and intrinsic capacity. In this study, it was aimed to evaluate the effects of aerobic exercise and resistance exercises performed together with aerobic exercise, applied in the concept of green exercise with a multidisciplinary team (specialist doctors physiotherapists, nurses) on senior fitness, aerobic capacity and IC in individuals aged 65 and over.

Eligibility Criteria:
Inclusion Criteria:

* After the cardiology examination, it was decided that it was suitable for exercise,
* The Mini Mental Test score was above 24 points
* Had adequate communication skills

Exclusion Criteria:

* Individuals with uncontrollable arrhythmia and/or hypertension,
* neuromuscular disease,
* orthopedic injury that interferes with walking,
* severe sensory deficit, visual and/or hearing problems
RCT: The Effect of an Electronic Clinical Decision Support Application on Perioperative Medication Errors.

The purpose of this study is to assess the effect of a novel clinical decision support application on the rate of perioperative medication errors and preventable adverse medication events. The investigators hypothesize that the perioperative clinical decision support application will reduce the incidence of perioperative medication errors and adverse medication events compared to the standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Anesthesia clinician (anesthesiologists, certified registered nurse anesthetists (CRNAs), student nurse anesthetists, fellows and residents) at Massachusetts General Hospital.

Exclusion Criteria:

* Study staff
Aggrastat Truncated Length Against Standard Therapies in Percutaneous Coronary Intervention

The purpose of this study is to determine whether the efficacy of tirofiban (a 25mcg/kg i.v. bolus followed by a 0.15mcg/kg/min i.v. infusion during a percutaneous coronary intervention (PCI) plus two hours after the procedure) is more effective than placebo in the setting of standard therapies (e.g. aspirin, a thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing PCI, as assessed by the incidence of adverse cardiac ischemic events defined as death, myocardial infarction (MI), and urgent target vessel revascularization (uTVR) within 48 hours following study drug initiation.

A secondary objective of this study is to assess whether tirofiban (a 25mcg/kg i.v. bolus followed by a 0.15mcg/kg/min i.v. infusion during a PCI plus two hours after the procedure) is safe compared to placebo in the setting of standard therapies (e.g. aspirin, a thienopyridine, and unfractionated heparin or bivalirudin) among patients undergoing PCI, as assessed by the incidence of non-CABG-related TIMI major bleeding within 48 hours following study drug initiation.

Patient enrollment is pending.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years of age
2. Scheduled to undergo PCI with an approved device
3. Written informed consent

Exclusion Criteria:

1. Primary PCI for ST-elevation myocardial infarction (STEMI)
2. Prior PCI within 30 days
3. Prior GPIIb/IIIa use within 14 days
4. Prior enoxaparin use within 4 days
5. Prior STEMI within 30 days
6. In non-elective subjects, a rising troponin defined as a most recent pre-PCI sample greater than the sample immediately preceding it, as long as the two samples are separated by four or more hours and have been analyzed in the same hospital laboratory.
Follow up of Increased Nuchal Translucency :Study of 2010 to 2018 of Limoges Hospital

The ultrasound of the first trimester allows to determinate the pregnancy beginning, the type of pregnancy and also to detect increased nuchal translucency (NT). Fetuses with common chromosomal abnormalities (trisomies 21, 18 and 13 and monosomy X) and structural abnormalities (particularly cardiac defects) and single-gene disorders frequently show increased NT. The purpose of this study is to evaluate in the population of Limousin, the type and frequency of these abnormalities.

Increased NT superior than 95th percentile (Nicolaides curves) during the ultrasound of the first trimester, are associated to common chromosomal abnormalities. It's therefore necessary to make amniocentesis and to analyze karyotyping and Genomic microarrays, also known as chromosomal microarrays (CMA). In euploid foetus, increased NT is also associated with structural defects or genetic syndromes. Additionally, the overall long-term growth of euploid children with increased NT is not much known. The majority (98%) of euploid children with a normal second trimester ultrasound is apparently healthy in the short run. The investigator's objective is to evaluate in a retrospective way, different events (structural defects, chromosomal or genetic abnormalities) during these pregnancies. In a prospective way, the neurodevelopmental disorders in euploid children will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Increased nucal translucency (NT) \> 95e percentile on the pregnancy's first trimester
* Monofoetal pregnancy
* Twin pregnancy (biamniotic bichorial)
* Adult patients

Exclusion Criteria:

* Increased NT \< 95e percentile on the pregnancy's first trimester
* Increased NT \> 95e percentile on the pregnancy's second trimester
* Twin pregnancy (biamniotic monochorial), triple or more gestation
* Underage patients
Gut Hormones and Roux en Y Gastric Bypass

The purpose of this study is to assess whether the changes in gut hormones seen following Roux en Y Gastric Bypass surgery are responsible for some of the beneficial effects seen post-operatively.

This study is designed to investigate whether chronic elevation of glucagon-like peptide-1 (GLP-1), oxyntomodulin and peptide YY (PYY) in combination is responsible for the majority of the metabolic effects of Roux-en-Y gastric bypass (RYGB) including improved glycaemia, increased energy expenditure, reduced food intake, weight loss, reduced preference for high calorie foods and reduced activation in brain reward areas in response to visual food cues.

Eligibility Criteria:
Inclusion criteria

* Aged 18 - 70 years.
* Male or female.
* Eligible for bariatric surgery under the NHS.
* Diagnosed with impaired glucose regulation or type 2 diabetes, according to WHO 2011 criteria.
* Those with diabetes should be stable and well controlled with either diet or one oral hypoglycaemic agent.
* HbA1c ≤9.0% or 74.9 mmol/mol.

Exclusion criteria

* History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the volunteer.
* Without access at home to a telephone or other factor likely to interfere with ability to participate reliably in the study.
* Pregnancy or breastfeeding.
* Smokers.
* Unable to maintain adequate contraception for the duration of the study and for one month afterwards.
* History of hypersensitivity to any of the components of the subcutaneous infusions.
* Donated blood during the preceding 3 months or intention to do so before the end of the study.
* Insulin treatment.
* Uncontrolled hypertension.
* Any other co-morbidity that would compromise the validity of the study or the safety of the participant such as heart failure, clinically apparent cardiovascular disease.
* Volunteers on anti-coagulants such as warfarin and factor Xa inhibitors will not undergo adipose tissue biopsy.
* Unable to give informed consent.
* Previous bariatric surgery.
* Unable to undergo fMRI due to:

  * Claustrophobia.
  * Pacemaker, metal implant, clips, implanted device, shrapnel or bullet, metal in eyes that precludes magnetic resonance imaging.
  * Significant structural abnormality on magnetic resonance brain scan