cyrilzakka/clinical-trials huggingface dataset:
Study To Evaluate Upper Arm Autologous Fat Transfer

The objective of this pilot study is to observe the utility of autologous transfer of fat collected using ultrasonic assisted liposuction into the upper arms with ultrasonic visualization.


Eligibility Criteria:
Inclusion Criteria:

1. Is male.
2. Is between 20 and 50 years of age, inclusive, on the day of enrolment.
3. Is to undergo abdominal liposuction.
4. Wishes to undergo autologous fat transfer to the upper arms.

Exclusion Criteria:

1. Currently enrolled in another device or drug study that has not completed the required follow-up period, or has completed all other study-required follow-up less than 30 days before enrolment in this study.
2. Undergoing body contouring for reconstruction following injury or disease.
3. Deemed inappropriate candidates for the surgical procedures for any reason.
4. Are unwilling to undergo the study procedures or participate fully in all follow-up.
DP-R213 Phase 1 Pharmacokinetics Study

A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each component administered alone in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* IBW ±20%
* Signed the informed consent form prior to the study participation

Exclusion Criteria:

* Clinically significant disease
* Previously donate whole blood within 2 months or component blood within 1 month
* Clinically significant allergic disease
* Taken IP in other trial within 3 months
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result
InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology

The objective of the study is to evaluate the feasibility of the BioSpy System sensor to differentiate tissues that are encountered during bronchoscopic biopsy of endobronchial tumors and peripheral lung nodules and masses.

Participants in this study require a lung biopsy to confirm if they have a lung tumour. A biopsy is a procedure where a piece of lung tissue is removed for testing. Current biopsy techniques cannot guarantee the exact location of lung tumours, so biopsies can be taken from healthy tissue.

The BioSpy System (BSS) is a device with a probe, which is placed inside a normal biopsy needle. The tip of the probe contains sensors, that will scan the composition of the tissue which is in contact with the sensors.

The INSPECT study aims at collecting the sensor data, with the goal of being able to differentiate the different tissues.

All study participants will have a biopsy with the BSS. Participants will have a hospital visit for the procedure, and will have to stay up to 16 hours after their procedure as per normal hospital practice.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Subjects with lesions eligible for lung biopsy under general anesthesia.
3. Lesion localization:

   1. Central or proximal lesions ≥ 10 mm in diameter confirmed by imaging (CT scan and/or PET scan) and/or endobronchial visual control; or
   2. Peripheral lesions ≥ 20 mm in diameter confirmed by imaging (CT scan and/or PET scan) and/or ultrasound analysis (RP EBUS with central localization of the ultrasound probe) during the procedure.
4. Written Informed Consent to participate in the study.

Exclusion Criteria:

1. Target lesion \<10 mm for central and \<20 mm for peripheral lesions (as determined on previous imaging)
2. Contra-indication to bronchoscopy procedures
3. Contra-indication to general anesthesia
4. Any subject that is, according to the discretion of the investigator, not eligible for study participation
5. Known lactating or confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)
Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma

Phase 1 is an open-label, dose finding, multicenter study of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.

Phase 2b is a randomized, double-blind, multicenter study of ibrutinib or placebo, in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.

Bruton's tyrosine kinase (Btk) is an enzyme that is present in hematopoietic cells other than T cells and is necessary for downstream signal transduction from various hematopoietic receptors including the B cell receptor as well as some Fc, chemokine, and adhesion receptors, and is crucial for both B cell development and osteoclastogenesis. Although down-regulated in normal plasma cells, Btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. Ibrutinib is a potent and specific inhibitor of Btk currently in Phase 2 and 3 clinical trials. The current study is designed and intended to determine the safety and efficacy of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with relapsed/refractory MM who have received at least two prior lines of therapy including lenalidomide and either bortezomib or carfilzomib and have demonstrated disease progression on or within 60 days of the completion of the most recent treatment regimen.
* Measurable disease defined by at least ONE of the following:

  1. Serum monoclonal protein (SPEP) ≥1 g/dL.
  2. Urine monoclonal protein (UPEP) ≥200 mg by 24 hour urine.
* Adequate hematologic, hepatic, and renal function
* ECOG performance status of ≤ 2

Exclusion Criteria:

* Subject must not have primary refractory disease
* Plasma cell leukemia, primary amyloidosis or POEMS syndrome
* Unable to swallow capsules or disease significantly affecting gastrointestinal function
* Requires treatment with strong CYP3A inhibitors
* Women who are pregnant or breast feeding.
Optimal Predilatation Technique for BVS Implantation

The purpose of this study is to determine the optimal way of predilatation for BVS implantation.

Randomized, single-center study. Forty-five patients with intended BVS implantation will be randomized in ratio of 1:1:1 to different predilatation strategies(non-compliant balloon/Emerge NC™, Boston Scientific, cutting balloon/Flexitome™, scoring balloon/Scoroflex™,Orbus). Predilatation is intended to be done in a vessel:balloon ratio of 1:1. If the device is not able enter the lesion, it will be replaced with a conventional semicompliant balloon with the same predilatation strategy (a vessel:balloon ratio of 1:1) After a successful predilatation, the BVS (Absorb™, Abbott) will be implanted and this procedure will be accomplished by a high pressure postdilatation with a non-compliant balloon (Emerge NC™, BSCI). The MLA of the Absorb stent will be evaluated with optical coherence tomography (OPTIS, St.Jude).

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing percutaneous coronary intervention (PCI)
* lesion no more than 25 mm in length with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment

Exclusion Criteria:

* patients with acurate myocardial infarction (STEMI)
* patients with specific complex lesion features (left main, aorto ostial, bifurcation with side branch ≥ 2 mm in diameter, extreme angulation proximal or within the target lesion, moderate or heavy calcification proximal or within the target lesion, chronic total occlusion)
Positron Emission Tomography (PET) Using Hormone Receptor Ligands in Breast Cancer

The purpose of this study is to find a way to learn the hormone receptor status of a tumor before surgery is done. By testing for the hormone receptor proteins, doctors can find out if the breast cancer uses hormones to grow. This is important since the hormone receptor status of a tumor helps doctors decide if extra treatment like chemotherapy or pills are needed.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female patients
* Aged 18 or older at the time of breast cancer diagnosis
* Patients with invasive breast cancer at least 1 cm in size. Patients who have had a prior surgical excision are eligible provided there is a residual of at least a 1 cm area suspected on imaging studies.
* Histopathologic review at MSKCC confirming diagnosis of invasive breast cancer (ductal, lobular, or inflammatory breast cancer).
* Patients who are operative candidates. Patient will have surgery to include either mastectomy or lumpectomy. Radiologic assisted excisions such as needle localization are also eligible.
* Patients with bilateral breast cancer are eligible.
* Patients with metastatic cancer, provided they need surgical biopsy.
* Patients who are undergoing sentinel node mapping (day before or sameday mapping).
* Patient must sign informed consent.

Exclusion Criteria:

* Previous or concurrent malignancy (except basal and squamous skin cancer and stage 0 cervical cancer)
* Patients who are pregnant or nursing
* Patients unable to tolerate PET or PET/CT
* Patients with known active infection, autoimmune or inflammatory disease such as sarcoidosis, and rheumatoid arthritis.
* Patients with non invasive breast cancer such as DCIS.
* Patients who have received prior radiation therapy to the affected breast.
* Patients who have received prior chemotherapy, including neoadjuvant chemotherapy or hormonal therapy for breast cancer.
* Patients living in a residential care or correctional facility.
Study of Tenofovir Alafenamide Fumarate Tablets (TAF) in Blocking Mother-to-child Transmission of Hepatitis B Virus

This study is a single-group, multi-center and prospective clinical study designed to assess the efficacy and safety of TAF in blocking mother-to-child transmission of hepatitis B virus.Pregnant women whose HBsAg and HBeAg are positive are included in the study.Eligible hepatitis B pregnant women are given TAF antiviral therapy at 24-28 weeks of gestation to block mother-to-child transmission and followed up during pregnancy and after delivery.The study will be initiated with approval by the central ethics committee.Subjects will start screening after signing the informed consent form. Those who meet the criteria will start taking TAF (25mg, oral, 1/day) at 24-28 weeks of gestation until one month after delivery.At that time, chronic hepatitis B carrier will stop taking antiviral therapy, and patients with chronic hepatitis B decide whether to continue the therapy according to the patient's condition.The babies born are immunized according to the national standard immunization program,, that is, 100 IU of hepatitis B immunoglobulin (HBIG) and 10 μg/0.5 ml of hepatitis B vaccine are given within 12 hours after birth. And the same dose of hepatitis B vaccine is given at 1 month and 6 months of age.


Eligibility Criteria:
Inclusion Criteria:

* maternal age: 20 to 35 years
* 20-24 week of gestation
* HBsAg-positive more than 6 months and HBeAg-positive
* HBV DNA\> 1000,000 IU/ml
* both husband and wife voluntarily sign informed consent
* with good compliance and comply with follow-up programs

Exclusion Criteria:

* mother with co-infection of hepatitis C virus,human immunodeficiency virus
* evidence of decompensated liver disease
* combined with important organ lesions which will affect patient compliance and follow-up plans, pregnant women who are expected to be difficult to complete the study
* have a history of spontaneous abortion, or have a birth defect or congenital malformation in the last pregnancy
* mother treated with antiviral therapy within 6 months prior to enrollment(except those treated with antiviral therapy in the last pregnancy to prevent mother-to-child transmission)
* have a history of kidney injury, creatinine clearance \<50ml/min, urine protein positive (\>300mg/L)
* combined with other chronic diseases and need to take immunomodulators, cytotoxic drugs or hormonal drugs during pregnancy
* the infants' biologic father is a chronic HBV infected person
* symptoms of threatened abortion during early pregnancy
* evidence of hepatic cell carcinoma
* alanine aminotransferase (ALT) \> 10 x upper limit of normal(ULN ), or total bilirubin (TBIL) \> 3 x ULN or glomerular filtration rate (GFR) \< 90 mL (min\*1.73 m2), or serum Albumin (ALB) \< 25 g/L before enrollment
* fetal malformations detected by B-ultrasound
* participants in other research
Study for Novel Coronavirus Pneumonia (NCP)

To develop practical and effective clinical diagnosis and treatment schemes for the control of novel coronavirus pneumonia.

By retrospectively analyzing the clinical epidemiological characteristics of the novel coronavirus pneumonia and the current diagnosis and treatment schemes, as well as in-depth analyzing the disease development process and outcome trends of NCP patients to develop practical and effective clinical diagnosis and treatment schemes and provide guarantee for the rapid control of the epidemic.

Eligibility Criteria:
Inclusion Criteria:

* Patients confirmed with novel coronavirus pneumonia. The Diagnostic criteria refer to "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5)";

Exclusion Criteria:

* Physician judged the patient was not suitable for this clinical trial.
Neurodegeneration Markers and Neurological Course in Severe Covid-19 Infection

Emergence of Covid-19 virus is associated with high frequency of extremely severe clinical pictures, with minor signs of CNS impairment (e.g. anosmia, headache). Since neurotropism is a common feature of coronavirus infection in animals, the investigators examine if indirect signs of CNS lesion are observed in association with severe Covid-19 infection.

In animals, coronavirus infection is commonly associated with CNS involvement:

epilepsy and ataxia are observed during Feline Infectious Peritonitis (FIP) and virus is recovered in CSF, CNS is involved with strain-dependent severity in mice and rats infected by murine hepatitis virus, and murine infection with MHV A59 strain is a model of multiple sclerosis (MS). Mice encephalitis occurs through infection of olfactory bulb and spreads along the axonal pathway. Viral antigens and neuronal apoptosis are observed in brainstem and hypothalamus, without minimal or absent inflammation.

Most COVID-19 patients with neurologic impairment displayed expected complications of severe infections (e.g. neuropathy and muscle loss, stroke) but encephalitis remained exceptional, as previously observed in SRAS. It is argued that central lesions may explain some of the clinical features ventilation failure, or disproportionate residual fatigue and cognition impairment in survivors of severe COVID infection. According to data obtained from various coronavirus infections in animals, the investigators ask if severe COVID infection in human could be associated with sub-clinical encephalitis. This clinical trial examines highly sensitive blood biomarkers of brain dysfunction in correlation with late clinical outcome. Biomarkers are neurofilament light chain (NFL) and GFAP. Clinical outcomes are death, signs of central neurologic sequellae, and fatigue. Clinical examination and blood samples will be obtained at inclusion (d0), which is mostly the entrance in intensive care unit (ICU), at day 7 (between day 4 and exit from ICU) and at day 60.

Eligibility Criteria:
Inclusion Criteria:

* Infection with Covid-19 (proven or probable) AND
* possible encephalitis (at least confusion, epilepsy) OR
* clinical severity requiring invasive ventilation.

Exclusion Criteria:

* brain stroke
* minor CNS dysfunction (isolated smell loss or headache),
* absence of Covid infection.
Pediatric Acute Kidney Injury (AKI) Retrospective, Real-Time and Repository Research

This proposal will incorporate statistical models developed by the investigators to predict risk for acute kidney injury into our electronic medical record system, enabling an alert to notify providers of the risk status. Pediatric inpatients will be randomly assigned to be in the intervention group, for whom the notification will be implemented, or in the control group, who will receive usual care (no notification). The investigators believe the notification will increase appropriate screening for acute kidney injury and reduce the severity of acute kidney injury in the intervention group.

This proposal will incorporate a logistic regression models developed by the investigators to predict risk for acute kidney injury in pediatric intensive care unit and pediatric ward patients into the electronic medical record system, enabling personalized decision support. Real-time surveillance using the risk prediction models will identify pediatric inpatients at increased risk for acute kidney injury. When patients exceed the threshold risk for acute kidney injury, the electronic medical record system will notify providers. Patients will be randomly assigned to be in the intervention group, for whom the notification will be implemented, or in the control group, for whom the notification will not display. The risk notification will be assessed for its impact on outcomes including rates of screening for acute kidney injury and the severity of acute kidney injury.

Eligibility Criteria:
Inclusion Criteria:

* All admissions to the pediatric intensive care unit or pediatric wards at the Monroe Carell Junior Children's Hospital at Vanderbilt

Exclusion Criteria:

* Prior diagnosis of chronic renal disease, including dialysis and transplant
* Admission to the Neonatal Intensive Care Unit during the current admission
Orange Juice Consumption and Cognitive Function

This study is investigating the effect of 8 weeks of orange juice supplementation on executive function in healthy older adults. The study is a controled, double-blind, crossover trial and involves a 8 week supplementation with a high flavonone orange juice and a carbohydrate-matched control. Volunteers consume 500ml of either the test juice or the control juice per day for an 8 week period. There is then an 8 week washout period before subjects proceed to the other arm of the study. Subjects are randomly assigned to either arm at the beginning of the study. Measures of cognitive function will be administered pre and post both test and control interventions. Blood pressure will also be measured and blood and urine samples will be collected to assess absorption of from the juice. A sub-sample of volunteers will undergo MRI imaging pre- and post intervention to acquire cerebral blow flow information.


Eligibility Criteria:
Inclusion Criteria:

* In good general health i.e. no major health condition such as diabetes
* BMI \< 30
* Cholesterol \< 6 and BP \< 150/90
* Not on blood pressure medication or blood thinning medication such as aspirin - No learning difficulty such as dyslexia

Exclusion Criteria:

* Diabetes
* Gastro-intestinal disease
* High BMI
* Cholesterol and BP
* Smoker
* On blood pressure medication or blood thinning medication such as aspirin
* Dyslexic/dyspraxic
* Depression or history of depression
ICBT for Mental Health Problems Related to the Coronavirus Pandemic

The study seeks to investigate the effects of a guided internet-based cognitive behavioral therapy (ICBT) programme a on adult mental health problems related to the current coronavirus pandemic. ICBT will be compared to a wait-list control group.

Participants will be recruited in Sweden with a nationwide recruitment.

The study is set up as a randomized controlled trial. Quality of life, depressive symptoms, anxiety, sleep problems and traumatic stress will be measured. Given uncertainties regarding the psychological effects of Covid-19 pandemic a transproblematic tailored treatment approach will be used that has been tested in several previous trials. However, the present program has been adapted for the target population of people who are affected by the societal and individual consequences of the pandemic. The study does not focus on people who have or have had the corona virus.

Eligibility Criteria:
Inclusion Criteria:

* Experience mental health problems that are caused or exacerbated by the corona pandemic and/or its consequences
* 18 years or older.
* Adequate ability to understand and speak Swedish.
* Access to the internet and a smartphone/computer.

Exclusion Criteria:

* Other ongoing psychological treatment or counselling that interfere with trial treatment.
* Recent (within the past 3 months) changes in the dose of psychotropic medication.
* Any severe psychiatric or somatic conditions that would interfere with trial treatment
Clinical Study of Neoadjuvant Therapy Outcome Prediction of Muscle-invasive Bladder Cancer Based on PTC Drug Sensitivity Detection

In this study, investigators plan to conduct the 3D in vitro culture PTC drug sensitivity testing of fresh tumor specimen which obtained by endoscopic biopsy or other methods. Through assessing the consistency between the testing results and the patients' neoadjuvant treatment outcomes, they would evaluate the accuracy of PTC drug sensitivity testing and its application value in the individualized precision medicine for muscle-invasive bladder carcinoma.

This is a prospective observational study. In this study, researchers propose to enroll 40 participants above 18 years of age with muscle-invasive bladder carcinoma, who are going to receive the neoadjuvant therapy before surgery. Collecting fresh tumor samples for PTC drug sensitivity testing, conducting neoadjuvant therapy for the subjects simultaneously. By combining PTC prediction results with the patients' clinical treatment process and medication feedback, researchers could estimate the accuracy of PTC drug sensitivity testing. Completion of this research would provide real-world figures to support for the clinical application for PTC drug sensitivity testing, and a method is going to be established to guide the clinical treatment regimen for patients with muscle-invasive bladder carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* 1 The lesion of biopsy was diagnosed as muscle-invasive bladder cancer
* 2 Age ≥ 18 years old, regardless of gender
* 3 Treatment plan of bladder removal surgery
* 4 Neoadjuvant therapy before surgery
* 5 Adequate fresh tumor tissue can be obtained by endoscopic biopsy for PTC drug sensitivity testing
* 6 ECOG 0-1, expected survival is more than 3 months
* 7 Normal or stable hepatic, renal, and hematopoietic function
* 8 Normal or stable blood pressure
* 9 The subjects are willing to participate, sign an informed consent form, and have good compliance

Exclusion Criteria:

* 1 Patients with incomplete clinical data
* 2 Central nervous system metastasis
* 3 The presence of other malignant diseases was discovered during treatment, which is going to interfere the study
* 4 Researchers believe that the patient is not suitable for participation after comprehensive evaluation
* 5 Refuse the treatment or follow-up plans
Gatorade/Miralax With or Without Bisacodyl Versus NuLytely for Colonoscopy Preparation

The purpose of this study is to compare Nulytely (or Trilyte) with a Gatorade and Miralax combination for cleaning out the colon before colonoscopy. A laxative pill called Bisacodyl may also be used with the Gatorade and Miralax to see if it helps with the clean out process. We are trying to find out if either of these methods is more acceptable to the patient and does a better job cleaning out the colon for a colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients at least 18 years old planning to undergo an elective colonoscopy.

Exclusion Criteria:

1. Patients who are allergic or intolerant to any on the study drugs.
2. Pregnant patients.
3. Patients who required multiple day colon preparation in the past.
4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.