cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study

The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.

This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Kuwait in a clinical practice patient population.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve or -experienced adult male or female participants with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with the current local label.
* If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).
* Participant must not be participating or intending to participate in a concurrent interventional therapeutic trial.

Exclusion Criteria:

* Participant must not be participating or attending in a concurrent interventional therapeutic trial.
Gut Microbiota and Alzheimer's Diseases

The investigator will perform clinical studies to test a hypothesis that participants who have Alzheimer's disease will have different gut/oral microbiota profile as compared to the participants who do not have Alzheimer's disease. The investigators will also check the microbiome of their partners in this study. The investigators plan to perform the studies in 150 participants in Shanghai Tenth's People's Hospital and also in the houses in Shanghai city. Investigators will also measure the beta-amyloid in the feces of the participants. Finally, the investigators will determine cognitive function in these participants.

Studies have shown that gut/oral microbiome and beta-amyloid in body may have a significant impact on the behavior and brain pathology consistent with Alzheimer's disease (AD) neuropathogenesis. The objective of this study is to assess whether the gut/oral microbiome and feces beta-amyloid of AD patients are different from those of the participants without AD and their partners. The investigators plan to recruit 150 subjects, including three groups of normal elders, AD patients and the partners of the AD patients. The cognitive function will be assessed and the feces and oral samples will be collected to determine whether there are differences or correlations.

Eligibility Criteria:
Inclusion Criteria:

* aged 60 and older

Exclusion Criteria:

* with other acute gastrointestinal diseases
* with other severe neuropsychiatric disorders
Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis

This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee

Exclusion Criteria:

* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs
* Other protocol defined inclusion/exclusion criteria may apply.
Evaluation of Glucose Monitoring Methods: Characterizing Glycemic Control in Subjects With Diabetes

Evaluate the usefulness of continuous glucose monitoring devices in terms of their ability to identify periods throughout the day when glucose varies significantly.

Many CGM systems use a surrogate for blood glucose--tissue glucose or interstitial glucose. Interstitial fluid (ISF) is the medium for these approaches. A physiological lag in ISF glucose relative to capillary blood glucose has been noted, probably due to relatively low blood perfusion at the sampling site. 9 This physiological lag can result in an accuracy error, manifesting as a significant bias between blood and tissue glucose, particularly during periods of rapid glucose change. This lag error might be particularly meaningful when glucose is rapidly dropping towards hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* adult
* A1c \>7.4 within last 4 months
* type 1 or 2 diabetes treated with basal/bolus insulin

Exclusion Criteria:

* under 18 years of age
* unable to read/write english
* allergy to adhesives
* employee of CGM company
Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept™2 Trial

This study is conducted globally. This study describes pharmacogenetic testing of saliva samples from patients who participated in the NN1731-3562 trial (adept™2) (NCT01392547). The objective is to determine the HLA (human leukocyte antigen) type and polymorphisms in the FVII gene in patients previously exposed to rFVIIa analogue.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before collection of saliva samples
* Previous participation in adept™2 trial with 5 or more exposure days to rFVIIa analogue
CMA-676 in Treating Older Patients With Acute Myeloid Leukemia in First Relapse

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of CMA-676 in treating older patients who have acute myeloid leukemia that has recurred for the first time following at least 3 months of complete remission.

OBJECTIVES: I. Assess the efficacy of CMA-676 in elderly patients with acute myeloid leukemia in first relapse in terms of the number of patients attaining a complete remission. II. Assess the safety of CMA-676 in this patient population.

OUTLINE: This is an open label, single arm, multicenter study. Patients receive 1 course of CMA-676 IV over 2 hours on day 1 followed by a 6 hour observation period. Patients may receive 1 additional course of therapy 15 to 28 days later. There is a 28 day follow-up period after the last dose of study medication. Patients are followed for an additional 6 months, then every 3 months for 18 months, and then every 6 months until relapse and/or death.

PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study within 12 months. Enrollment will then be extended for up to an additional 55 patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS: CD33 positive acute myeloid leukemia in first relapse At least 3 months of complete remission No history of a secondary leukemia evolving from a known prior myelodysplastic syndrome or resulting from exposure to chemotherapy or toxins No active CNS leukemia

PATIENT CHARACTERISTICS: Age: 60 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC less than 30,000/mm3 at time of CMA-676 administration Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: No uncontrolled cardiac disease Pulmonary: No uncontrolled pulmonary disease Other: No other active malignancy No uncontrolled, life-threatening infections Able to obtain bone marrow aspirate HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow and peripheral blood stem cells transplantation No prior anti-CD33 antibody therapy Chemotherapy: Prior cytotoxic chemotherapy for AML allowed No prior chemotherapy for AML in first relapse except hydroxyurea At least 24 hours since prior hydroxyurea Recovered from prior antineoplastic therapy (except alopecia) No concurrent cytotoxic chemotherapy Endocrine therapy: No concurrent immunosuppressive therapy Radiotherapy: Not specified Surgery: Not specified Other: At least 4 weeks since prior investigational agents No other concurrent antileukemic therapy
The Role of Substance P on Perception of Breathlessness During Resistive Load Breathing

Substance P is released from sensory nerves and transmits pain information into the central nervous system. As pain and dyspnea share many characteristics, including similar neurological pathways, it is possible that substance P may contribute to the sensation of dyspnea. The hypothesis of the study is that patients with chronic obstructive pulmonary disease (COPD) will provide lower ratings of breathlessness during resistive load breathing with oral aprepitant, a medication that blocks the activity of substance P, compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* 50 years of age or older
* diagnosis of COPD
* former smoker \> 10 pack-years
* clinical diagnosis of chronic bronchitis
* post-bronchodilator forced expiratory volume in one second (FEV1) 30 - 80% predicted
* FEV1/forced vital capacity ratio less than or equal to 70%

Exclusion Criteria:

* current smoker
* pregnant women
* concomitant disease that might interfere with study procedures
* peripheral vascular disease or cold hypersensitivity
* drugs that might interfere with aprepitant
The Influence of an Acute Exacerbation During Pulmonary Rehabilitation in COPD Patients Awaiting Lung Transplantation

Data from chronic obstructive pulmonary disease patients awaiting lung transplantation which performed a pulmonary rehabilitation program will be analyzed retrospectively. Acute exacerbations occur frequently in these patients and have a major impact on the course of the disease. This study investigates the prevalence and the impact of acute exacerbations during pulmonary Rehabilitation in patients with severe chronic obstructive pulmonary disease patients awaiting lung Transplantation that continued the Rehabilitation program despite an acute exacerbation. Data will be taken from the internal database of the reference center (Schoen Klinik Berchtesgadener Land, Schoenau, Germany) where these data were collected during clinical routine.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of chronic obstructive pulmonary disease including patients with alpha-1 antitrypsin deficiency
* listed for lung Transplantation or in the Evaluation process for lung transplantation
* performed a pulmonary rehabilitation program at the reference center

Exclusion Criteria:

* patients that discontinued the pulmonary Rehabilitation program due to any reason and could therefore not perform assessement tests at the end of regular Rehabilitation program
Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma

Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.

The dose escalation parts (Part A with CC-93269 administered intravenous (IV) and Part C subcutaneous (SC)) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered IV or SC, to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-93269. The expansion parts (Part B and D) will further evaluate the safety and efficacy of CC-93269 administered IV or SC at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the Recommended Phase 2 dose (RP2D).One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 5 years for subjects maintaining clinical benefit, or until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.

Eligibility Criteria:
Inclusion Criteria:

* History of multiple myeloma with relapsed and refractory disease
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Must have measurable disease as determined by the central laboratory

Exclusion Criteria:

* Symptomatic central nervous system involvement of multiple myeloma
* Prior autologous stem cell transplant ≤ 3 months prior
* Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior
* History of concurrent second cancers requiring active, ongoing systemic treatment

Other protocol-defined inclusion/exclusion criteria apply
Study of Nebulized Ampion for the Treatment of Adult COVID-19 Patients With Respiratory Distress

This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of nebulized Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who have respiratory distress.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, ≥ 18 years old.
2. Diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-CoV-2, or suspected COVID-19 diagnosis based on radiological clinical findings.
3. Respiratory distress as evidenced by at least two of the following:

   * Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.)
   * Recording of SpO2 ≤ 90% or the patient is requiring supplemental oxygen to maintain an SpO2 ≥ 90%
   * Requiring supplemental oxygen
   * Diagnosis of mild, moderate, or severe ARDS by Berlin definition
4. A signed informed consent form from the patient or the patient's legal representative must be available.

Exclusion Criteria:

1. In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
2. Patient has a do-not-resuscitate (DNR) or do-not-intubate (DNI) order in place
3. Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.).
4. Patient is on chronic immunosuppressive medication.
5. As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.
6. A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
7. Patient has known pregnancy or is currently breastfeeding.
8. Participation in another clinical trial (not including treatments for COVID-19 as approved by the FDA through expanded access or compassionate use).
9. Baseline QT prolongation.
Acute Combined Care for Seniors in Southern Denmark

the elderly population (+ 65 years) is increasing. Acute medical conditions often leads to hospital admissions in this age group. However hospital admission is linked to adverse events. like confusion, medication errors or new infections.

the ACCESS project aims to examine alternatives to acute admissions for senior medical patients.

the aims are:

1. How many patients will be admitted to hospital due to acute medical conditions if cared for by their own General Practitioner (GP) versus a hospital intern specialist ?
2. how many patients will be admitted to hospital due to acute medical conditions if cared for by acute team in their home versus in specialised care centres ?


Eligibility Criteria:
Inclusion Criteria:

* acute medical condition requiring immediate intervention.

Exclusion Criteria:

* GP not available next days
* absolutely admission requiring condition
* no informed consent obtainable
* nursing home resident
* inclusion in ACCESS within the last 3 months
* home care capacity limit reached
CT Image-assisted Detection Software for Focal Liver Lesions

To evaluate the safety and effectiveness of the developed and produced CT image-assisted detection software for focal liver lesions before being put into the market.


Eligibility Criteria:
Inclusion Criteria:

* doctors have liver CT scanning experience more than 1 year;

Exclusion Criteria:

* persons don't have the license of practicing physician; doctors don't have liver CT scanning experience or have liver CT scanning experience less than 1 year;
Comparing a Horizontal Ultrasound Technique With a Palpation Technique for Localising the Cricothyroid Membrane

The investigators will be comparing a traditional palpation (feeling) technique with an ultrasound technique for finding a specific part of the neck.

This study compares a traditional palpation (feeling) technique with an ultrasound technique for finding a specific part of the neck. Finding this part of the neck is important for anesthesiologists in emergencies and can sometimes be difficult. We would like to determine if using ultrasound is easier and more reliable than examining the neck by hand. Newer methods using ultrasound have not been studied in detail in the pregnant population.

This study aims to describe a simple technique for identifying the cricothyroid membrane. The secondary aim is to determine how ultrasound compares to palpation in pregnant women at term.

Eligibility Criteria:
Inclusion Criteria:

* term pregnancy
* 19yrs and older

Exclusion Criteria:

* preterm pregnancy
Paleolithic Diets vs T2D and Improvements in the Metabolic Syndrome

This study proposes to evaluate the physiological effects of eating Paleolithic type diet ("hunter-gatherer's diet") on Type 2 diabetic patients. The diet essentially consists of fruits, vegetables, nuts, lean meats, excludes dairy products and grains.Subjects will be randomized into taking either ADA (American Diabetic Association) recommended diet or Paleolithic diet for 21 days. The research kitchen will provide all food items and total calories in both groups will be adjusted to maintain baseline weight. Blood and urine test will be done in the first 3 days, last 3 days and 1 month after the study period to study and compare the effects of the two diets on subjects glucose control, lipid profile and other parameters of cardiovascular physiology.

We hypothesize that a palaeolithic diet in subjects with Type 2 diabetes mellitis, will result in improvement in above parameters and lead to improvement in glucose control with less need for diabetes medicines (either lower doses or fewer medications) to a greater extent than in subjects fed with ADA diet, without any change in weight. We also expect a beneficial effect on blood vessel function, lipid profiles and blood pressure.

This study proposes to evaluate the physiological effects of eating Paleolithic type diet ("hunter-gatherer's diet") on Type 2 diabetic patients. The diet essentially consists of fruits, vegetables, nuts, lean meats, excludes dairy products and grains.Subjects will be randomized into taking either ADA (American Diabetic Association) recommended diet or Paleolithic diet for 21 days. The research kitchen will provide all food items and total calories in both groups will be adjusted to maintain baseline weight. Blood and urine test will be done in the first 3 days, last 3 days and 1 month after the study period to study and compare the effects of the two diets on subjects glucose control, lipid profile and other parameters of cardiovascular physiology.

We hypothesize that a palaeolithic diet in subjects with Type 2 diabetes mellitis, will result in improvement in above parameters and lead to improvement in glucose control with less need for diabetes medicines (either lower doses or fewer medications) to a greater extent than in subjects fed with ADA diet, without any change in weight. We also expect a beneficial effect on blood vessel function, lipid profiles and blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients
* Age \>= 18 yrs
* BMI \< 40 kg/m2
* Normal cardiac, renal and hepatic function

Exclusion Criteria:

* Subjects on thiazolidinediones ( Avandia, Actos) or other medications that interfere with the testing procedures
* Subjects unwilling or unable to follow the diet specified
* Pregnant women
* Subjects who are unable to understand the consent form
* Hematocrit less than 30
* Patients with defibrillators
Comparative PK Study of Econazole Nitrate Foam and Econazole Nitrate Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years

To compare the pharmacokinetics of Econazole Nitrate Foam with Econazole Nitrate Cream in subjects with interdigital tinea pedis aged 12 years to less than 18 years.

Based on the results of a previous clinical study evaluating the pharmacokinetics, safety and efficacy of EN Foam versus the reference listed econazole nitrate cream and the foam vehicle in adults, the current clinical study is being conducted to provide additional pharmacokinetic data for EN in the foam formulation in subjects ages 12 to less than 18 years with interdigital tinea pedis to support a clinical bridge for systemic safety to the RLD in this pediatric population. The study also includes clinical and safety endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Be between 12 years and less than 18 years of age and of either sex.
* Have a clinical diagnosis of interdigital tinea pedis
* Parent/guardian has provided written informed consent and the subject has provided written assent.
* Be willing and able to use the assigned study medication as directed and to commit to all follow-up visits for the duration of the study.
* Have microscopic evidence (positive KOH) of the presence of fungi and a positive fungal culture.
* Be in good health and free of any disease or physical condition which might, in the Investigator's opinion, expose the subject to an unacceptable risk by study participation.
* Females must be non-pregnant, non-lactating and not intending to become pregnant during the course of the study.

Exclusion Criteria:

* Is pregnant, nursing or planning a pregnancy during the study
* Has used topical antifungals or topical corticosteroids on the feet within 14 days prior to the start of the study.
* Has received systemic antifungal therapy within 12 weeks prior to the start of the study medication.
* Has used systemic antibacterials or systemic corticosteroids within 14 days prior to the start of the study.
* Has a history of uncontrolled diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
* Has concurrent moccasin-type tinea pedis (in the opinion of the Investigator).
* Has any other skin disease which might interfere with the evaluation of tinea pedis.
* Is currently enrolled in an investigational drug or device study.
* Has received an investigational drug or treatment with an investigational device within 30 days prior to entering this study.
* Is unreliable, including subjects with a history of drug or alcohol abuse.
* Has known hypersensitivity to any of the components of the study medications.
The Role of Lung Ultrasound During Perioperative Evaluation

Accurate pre-operative lung assessment is important to decide the most appropriate anesthesia plan. Until now, chest X-ray is considered the standard of care for lung assessment during perioperative evaluation. However, lung ultrasound is a rapid, simple, non-invasive, radiation-free imaging modality and can be used as an alternative to chest radiography for the diagnosis and follow-up of various lung diseases. Moreover, the decreased radiation exposure represents a considerable improvement in patient safety. Consequently, we decided to compare the data obtained from the lung ultrasound and the chest X-ray.


Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing elective general surgery;
* age \>18 years;
* ability to provide written consent;
* use of Chest radiography during the preoperative evaluation.

Exclusion Criteria:

* age \< than 18 year;
* pregnant patients;
* not use of Chest radiography during the preoperative evaluation.