cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat

The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir in a fixed-dose combination with cobicistat with that of atazanavir coadministered with cobicistat as single agents.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy men and women, ages 18 to 49 years
* Body mass index 18 to 32 kg/m\^2, inclusive
* Women of childbearing potential (WOCBP) who were not pregnant or breastfeeding
* WOCBP and men who are sexually active with WOCBP must use acceptable contraceptive methods

Key Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) gastrointestinal tract disease
* Any major surgery within 4 weeks of study drug administration
* Any gastrointestinal tract surgery (including cholecystectomy) that could have an impact on the absorption of study drug
* Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
* Blood transfusion within 4 weeks of study drug administration
* Inability to tolerate oral medication, to be venipunctured, or to tolerate venous access
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination or electrocardiogram (ECG) findings, vital sign measurements, or results of clinical laboratory tests, beyond what is consistent with the target population
* Any of the following 12-lead ECG findings prior to study drug administration, confirmed by repeat testing

  * PR ≥210 msec
  * QRS ≥120 msec
  * QT ≥500 msec
  * QTcF ≥450 msec
* 2nd- or 3rd-degree A-V block or clinically relevant abnormalities in ECG findings
* Positive result on urine screening for drugs of abuse
* Positive result on blood screening for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 or -2 antibody
* Laboratory test results indicating levels outside of the ranges specified below:

  * Alanine aminotransferase \>upper limit of normal (ULN)
  * Aspartate aminotransferase \>ULN
  * Total bilirubin \>ULN
  * Serum creatinine \>ULN
Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections

A national data registry of patients receiving the rescue fecal microbiota transplantation for the refractory intestinal infections from the China Microbiota Transplantation System was designed to assess the short-term and long-term safety and efficacy.

This registry will enroll national patients with refractory intestinal infections (including clostridioides difficile infection, other infections with known or unknown pathogens) receiving rescue fecal microbiota transplantation (FMT) from the the China Microbiota Transplantation System. The improved methodology of FMT based on the automatic washing process and the related delivering consideration was named as washed microbiota transplantation (WMT) by the consensus statement from the FMT-standardization study group in 2019.12. Data of demographic characteristics, symptoms of intestinal infections, previous medicine treatment and clinical outcomes will be collected retrospectively abstracted from the electronic medical records or prospective follow-up. All the patients will be followed up for at least 12 weeks post-FMT. Information on follow-up will be designed to assess the short-term and long-term adverse events.

Eligibility Criteria:
Inclusion Criteria: National patients with refractory intestinal infections receiving rescue FMT from the China Microbiota Transplantation System from September 2015 to December, 2029 will be included.

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Exclusion Criteria: Patients will be excluded from the analysis if they are not followed up for at least 12 weeks post-FMT.

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COvid-19 aNd TechNology - thE Impact on Clinical Trial Patients

This is a 2 part qualitative study involving a questionnaire (part 1) and focus group discussions (part 2).

The purpose of the study is to evaluate how patients' attitudes to technology in the oncology clinical trials setting since the start of the Coronavirus pandemic in 2020, and to assess how their use of technology has changed during this time.

Part 1 of the study will be conducted via a self-report questionnaire to 100-140 cancer patients involved in clinical trials at The Christie NHS Foundation Trust over a 2 month period. Following this, three focus groups with a maximum of 8 participants in each group will take place to further assess patients' experiences with technology during the pandemic.

Participants may take part in part 1 or part 2 only, or in both.

Clinical trial involvement is more resource-intensive than receiving standard of care treatment and often results in more frequent hospital visits for patients. To reduce the risk of patients to COVID-19, there has been a shift towards reducing on-site visits with increased use of technology e.g. virtual visits. Patients may have also been using devices at home to aid in their care, including digital devices, mobile applications, smart watches and, rarely, trial-specific devices, to monitor aspects of their own health.

Our project will explore the impact that the coronavirus pandemic has had on clinical trial patients and how they feel technology could help or create barriers in their future care.

In order to quantify how clinical trial visits have changed and to evaluate patient's attitudes to the increasing use of technology in clinical trials, we will be disseminating questionnaires to 100 patients currently on clinical trials over a 2 month period. We will follow these up with three virtual focus group discussions with 8 participants in each to delve further into patients' experiences.

Eligibility Criteria:
Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Patients have to be 18 years of age or older.
2. Patients have to be currently enrolled on a phase I, II or III cancer related clinical trial within the Christie NHS Foundation Trust

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. Unable to understand and converse in English for the focus group session.
2. Patient not currently involved in a phase I, II or III clinical trial
EFFECTIVENESS OF A PROGRAM OF DOMICILIARY EXERCISES AGAINST HABITUAL CLINICAL PRACTICE IN THE RECURRENCE OF ACUTE LOW BACK PAIN: RANDOMIZED CLINICAL TRIAL

Introduction: Low back pain is a frequent and universally distributed symptom that affects people of any age and both sexes. Approximately 80% of the population will present it at some point in their life. Acute low back pain lasts less than 4 weeks, subacute 4 to 12 weeks and chronic more than 12 weeks.

Hypothesis: Treatment with an exercise program combined with the usual treatment decreases the recurrence of acute low back pain, as well as improvements in pain, functionality, and quality of life of patients.

Principal Objective To evaluate the decrease of recurrence of low back pain in the medium-long term of the patients who perform an exercise program compared to those who do not, with both groups receiving the same pharmacological treatment and information of the postural hygiene guidelines endorsed by the current scientific societies.

Methods: Patients between 18 and 65 years of age who come to the emergency room with acute low back pain and who meet the eligibility criteria proposed for this study. At the first visit, patients in a control group and intervention group will be randomized. Pharmacological treatment and postural hygiene guidelines will be indicated for both groups, adding the exercise table to the intervention group. The variables chosen are the questionnaires Oswestry for functionality, Goldberg, EuroQol-5D for the quality of life, and VAS for pain; which will be measured in the first consultation, at one month, at three and at six months.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 65 years old.
2. Low back pain of non-traumatic origin.
3. Signature of informed consent.
4. Availability for compliance with the intervention and commitment to send the study questionnaires.
5. A correct domain of the Spanish language.

Exclusion Criteria:

1. Pregnant women and breastfeeding
2. Any underlying pathology that contraindicates the use of the drugs (NSAIDs, paracetamol) included in this study.
3. Rheumatological diseases that cause spinal involvement (e.g., spondyloarthritis)
4. Low back pain with clinical or associated neurological deficit
5. History of active cancer or remission less than one year
6. Pathological previous image test that shows a causal relationship with the episode under study (e.g. fracture-vertebral crush, herniated disc, etc.)
7. Low back pain associated with other systemic pathologies (eg urinary infection, retroperitoneal hematomas, pancreatitis, etc.)
8. Fever
9. Patients with usual analgesic treatment superior to the 1st step of WHO.
10. Major psychiatric pathology diagnosed not stable (pharmacological treatment not stable in the last 6 months) except depression
11. Neuromuscular pathology diagnosed
12. Having some of the following diseases: fibromyalgia, chronic fatigue syndrome, chronic low back pain diagnosed
Prometra's Utilization in Mitigating Pain (PUMP)

Clinical evaluation of the safety and efficacy of the Prometra Programmable Infusion Pump to accurately supply drug to the intrathecal space for the treatment of chronic pain.

Chronic conditions of pain and spasticity are and have been major challenges to traditional medical treatment. Chronic pain and spasticity seriously reduce the quality of life and restrict normal daily activities for many people. The first line of defense is normally oral medications. However, a significant number of these patients require additional or alternative therapy due to the side effects of the oral medications or the intractable nature of the condition.

In 1979, Wand et. al. found that small amounts of morphine, when injected into the sub-arachnoid space, had significant affect in reducing pain. Since that time a number of drug products and infusion pumps have been developed to address this condition. The primary drug used for this purpose in preservative-free morphine sulfate solution which is delivered via an implanted intrathecal catheter. The Prometra Intrathecal Pump System is only the second programmable pump to be used in the treatment of chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* suffering from chronic pain
* 18 years of age or older
* life expectancy \>6 months
* failure to respond to less invasive methods
* patient undergone successful morphine trial
* patient agrees with Protocol requirements
* patient considered good subject per clinician

Exclusion Criteria:

* Existing spinal problems that prevent treatment
* systemic infection
* patient is pregnant or breast feeding
* known allergy or sensitivity to materials
* coexisting medical condition that precludes pump usage
* subject requires MRI post procedure
* subject unwilling/unable to comply
IPS/Peer Support Intervention in the DTES

Individual placement support (IPS) is an evidence-based supported employment model for people with severe mental illness, designed to achieve employment in mainstream competitive jobs, either part-time or full-time. The aim of this study is to assess the (i) effectiveness of embedding the (IPS)/Peer Support intervention as part of the primary care centre in securing employment of adults living in the downtown eastside in comparison to the usual treatment WorkBC (control group). (ii) effectiveness of IPS/Peer Support versus the usual treatment (WorkBC) in improving mental illness, quality of life and personal recovery through participation in employment.

This 18-month mixed methods study consists of an effectiveness multi-site randomized controlled trial of the IPS/peer support intervention plus an embedded qualitative exploration of participants' experiences. All clients receiving primary care services from one DTES clinical site who are employment ready and are not receiving mental health services will be randomly assigned to IPS \& Peer Support (experimental group) or WorkBC (control group). Clients are required to participate in the intervention for 16 weeks and will be assessed at baseline, 1-, 3-, and 6-months post study intervention start-date for both groups. Assessments will include the 5 questionnaires administered at baseline which cover the following: Employment Quality, Employment Sustainability, Education Quality and Quantity, Quality of Life, Community Engagement and Clinical significant levels of depression and anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Adults, age 19 and over, accessing primary care services at the primary care centre listed in this study (CH Pender Community Health Centre)
* At least one visit to VCH Pender Community Health Centre
* Currently unemployed and not in school or post-secondary training.
* Able to provide informed consent and fluent in English (intervention is currently offered in English only).
* Not hospitalized at the time of recruitment.

Exclusion Criteria:

• Adults, age 19 and over who have access to mental health services
Use of a Novel Drug in People With Non-alcoholic Steatohepatitis (NASH) or Non-alcoholic Fatty Liver Disease (NAFLD)

Does the novel drug decrease liver fat in subjects with NASH or NAFLD as compared to placebo

We propose to evaluate hepatic fat and hepatic fibrosis using magnetic resonance elastography (MRE) liver (pre vs. post). We will also establish glucose tolerance status by our established labeled oral glucose tolerance test (OGTT) (6,6 ²H2 glucose). Following baseline evaluation subjects with biopsy/MRE proven NASH will be randomized to one of two groups and treated either with active drug (AZ compound) or placebo for 12 weeks (plus or minus 1 week). Subjects with history suggestive of non-alcoholic fatty liver disease (NAFLD) or NASH will be invited to participate. If they meet criteria following initial screening they will be included in the study. OGTT, liver MRE will be repeated. Liver enzymes \[aspartate aminotransferase (AST), alanine aminotransferase (ALT),alkaline phosphatase (ALP)\] as well as other safety tests \[creatine phosphokinase (CPK), thyroid stimulating hormone (TSH), international normalized ratio (INR),total bilirubin\] will be measured before, monthly during therapy and at one month following therapy. Furthermore, we will also do the subgroup analysis in NASH/NAFLD subjects with and without diabetes to see the effect of the drug.

Eligibility Criteria:
Inclusion Criteria:

* Age: 21-75
* Body Mass Index (BMI) \>19 kg/m\^2
* Subjects with biopsy/MRE proven NASH \[MRE liver fat ≥ 5%, with elevated liver enzymes ALT \<5x upper limit normal (ULN)\].
* Subjects with NAFLD and MRE shows F0 or greater fibrosis
* Subjects with history suggestive of NAFLD/NASH
* Total bilirubin must be \< 1.5 x ULN and INR must be \< 1.3 at baseline screening.
* TSH and CPK will be within normal limits (WNL) at screening.
* Subjects with type 2 diabetes who are on stable doses of medications (except pioglitazone) to control hyperglycemia and have baseline HbA1c of 10% or lower.
* Hemoglobin must be greater than or equal to 12.0 in males and 11.0 in females.

Exclusion Criteria:

* Medications that may affect glucose metabolism such as corticosteroids, opiates, barbiturates, and anticoagulants.
* Subjects with anemia, and symptoms suggestive of undiagnosed illness, overt hepatic disease, stroke, Alzheimer's disease, autoimmune hepatitis, alcoholism or increased alcohol consumption over the American Diabetes Association (ADA) guidelines.
* Any disorder that may potentially impact the outcome measures.
* Pregnant women and children.
* Subjects planning weight loss or in any weight loss program.
* Subjects taking TZD's, Atazanavir, Indinavir, Ketoconazole, Valproic acid, Silybum marianum and Valeriana officinalis.
Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants

The management of pain related to venipuncture remains insufficient in very preterm infants (VPI. The separation between the mother (father) and her(his) child can aggravate the short-term painful experience of the newborn. Accurate diagnosis and treatment of pain is necessary to preserve the well-being and brain development of VPI. A better understanding of the development of pain pathways and the cortical integration of nociceptive messages is essential to reach this goal.


Eligibility Criteria:
Inclusion Criteria:

* Experimental group: VPIs of gestational age less than or equal to 33 weeks on the day of birth and hospitalized in the neonatal intermediate care unit or the neonatal intensive care unit of the Neonatal department of the Hautepierre Hospital (Strasbourg University Hospital)

  * Control group: Healthy full-term babies (\> 37 weeks gestational age) hospitalized in the maternity ward of Strasbourg University Hospital
  * Consent obtained from both parents
  * Subject affiliated to a social health insurance plan.

Exclusion Criteria:

* - Any malformation known before inclusion
* Cerebral lesions discovered on cerebral ultrasound performed as part of the standard management of newborns (Intra-Ventricular Hemorrhages of grade III or IV of the Papile classification, Periventricular Leucomalacia)
* Unstable clinical status according to the investigator's judgment
* Expected transfer of the child to another hospital before the term of 40 weeks PMAs.
Cost Information on Carpal Tunnel Syndrome Treatment Decisions

The purpose of this study was to determine whether the provision of societal cost information affects patients' decisions whether or not to undergo surgical management in carpal tunnel syndrome, using a hypothetical scenario.

Given the large societal costs of carpal tunnel surgery and existence of a relatively inexpensive treatment option, carpal tunnel release provides fertile ground for testing whether societal costs can influence patient decision-making in hand surgery. Such work would inform future efforts to reduce societal healthcare costs by elucidating whether appeals to societal cost are effective at driving stewardship of limited healthcare resources at the patient level. In this study, the investigators aimed to answer this question by presenting participants with a hypothetical scenario in which the participants had to choose between surgery and wrist bracing for carpal tunnel syndrome. Participants were randomized into two cohorts and societal cost information was presented to the intervention group. The effect of societal cost information on treatment choice is assessed, along with participants' healthcare attitudes.

Eligibility Criteria:
Inclusion Criteria:

* English speaking upper extremity patients
* Nontraumatic condition

Exclusion Criteria:

* Traumatic condition
HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy

The purpose of this study is to determine whether the use of lower doses of busulfan and the elimination of cyclosporine will further reduce transplant-related side effects for patients with Fanconi Anemia (FA). Patients will undergo a transplant utilizing mis-matched related or matched unrelated donors following a preparative regimen of busulfan, fludarabine, anti-thymocyte globulin and cyclophosphamide.

The trial proposed is a three arm phase II treatment protocol designed to investigate the safety and efficacy of risk-adjusted chemotherapy-based cytoreductive regimen plus a CD34+ selected T-cell depleted peripheral blood stem cell (PBSC) stem cell transplant for the treatment of patients with Fanconi anemia and severe hematologic disease. Candidates for this trial will include patients with Fanconi anemia presenting with severe marrow failure (transfusion dependent) or myelodysplastic syndrome, or acute myelogenous leukemia for whom an allogeneic stem cell transplant is indicated.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of Fanconi anemia
* Patients must have one of the following hematologic diagnoses:

  1. Severe Aplastic Anemia (SAA), with bone marrow cellularity of \<25% OR Severe Isolated Single Lineage Cytopenia and at least one of the following features:

     1. Platelet count \<20 x 109/L or platelet transfusion dependence\*
     2. ANC \<1000 x 109/L
     3. Hgb \<8 gm/dl or red cell transfusion dependence\*
  2. Myelodysplastic Syndrome (MDS) (based on WHO or IPSS Classification
  3. Acute Myelogenous Leukemia (untreated, in remission or with refractory or relapsed disease)
* Donors will be either human leukocyte antigen (HLA) compatible unrelated or HLA-genotypically matched related donors (no fully matched sibling donor).
* Patients and donors may be of either gender or any ethnic background.
* Patients must have a Karnofsky adult, or Lansky pediatric performance scale status \> 70%.
* Patients must have adequate physical function measured by:

  1. Cardiac: asymptomatic or if symptomatic then 1) left ventricular ejection fraction (LVEF) at rest must be \> 50% and must improve with exercise or 2) Shortening Fraction \> 29%
  2. Hepatic: \< 5 x upper limit of normal (ULN) alanine transaminase (ALT) and \< 2.0 mg/dl total serum bilirubin.
  3. Renal: serum creatinine \<1.5 mg/dl or if serum creatinine is outside the normal range, then CrCl \> 50 ml/min/1.73 m2
  4. Pulmonary: asymptomatic or if symptomatic, DLCO \> 50% of predicted
* Each patient must be willing to participate as a research subject and must sign an informed consent form.
* Female patients and donors must not be pregnant or breastfeeding at the time of signing consent. Women must be willing to undergo a pregnancy test prior to transplant and avoid becoming pregnant while on study.

Exclusion Criteria:

* Active CNS leukemia
* Female patients who are pregnant (positive serum or urine HCG) or breast-feeding.
* Active uncontrolled viral, bacterial or fungal infection
* Patient seropositive for HIV-I/II; HTLV -I/II