cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus Erythematosus

The purpose of this study was to explore the clinical and immunological efficacy of belimumab plus low dose IL-2 in systemic lupus erythematosus.

Given that belimumab and low dose interleukin-2 (IL-2) have been widespreadly applied in the treatment of systemic lupus erythematosus (SLE), this study designed a randomised, single center, prospective study to investigate the effects and safety of combined utilization of belimumab and low dose IL-2. SLE patients were allocated in each group randomly (n=10) and regularly administered belimumab (10mg/kg) with or without IL-2 (1 million IU). Then, we evaluated the improvement of clinical and laboratory indexes and monitored the changes of immune cell subsets and cytokines.

Eligibility Criteria:
Inclusion Criteria:

- 1. Male or female \>18 years of age at screening visits 2. Patients meet the American-European Consensus Group 2002 classification criteria 3. The patient must be informed in writing of the consent to participate in the trial and the patient is expected to be able to comply with the requirements of the study follow-up plan and other protocols.

4. Dosing of antimalarials, prednisone or equivalent, cholinergic stimulants, and topical cyclosporine required to be stable for at least 4 weeks before screening and during study; maximum doses allowed:

* Hydroxychloroquine, 400 mg/day;
* Prednisone, 10 mg/day

Exclusion Criteria:

* 1. Any subject meeting any of the following criteria should be excluded: 1. Laboratory abnormality: • Hb≤9 g/dl • Neutrophil 10 mg/d) within 1 month.

  2. Serious complications: including heart failure (≥ New York Heart Association (NYHA) class III), renal insufficiency (creatinine clearance ≤ 30 ml/min), liver dysfunction (serum Alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of normal, or total bilirubin greater than Normal upper limit) 3. Known allergies, hyperreactivity or intolerance of tofacitinib or its excipients.

  4. Have a serious infection needing hospitalization (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, Epstein-Barr virus (EBV), tuberculosis infection), or use intravenous antibiotics to treat infection in 2 months before the enrollment.

  5. Infection with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If seropositive, it is recommended to consult a doctor who has expertise in treating HIV or hepatitis C virus infection.

  6. Any known history of malignancy in the past 5 years (except for nonmelanoma skin cancer, non-melanoma skin cancer or cervical tumor without recurrence within 3 months after surgical cure prior to the first study preparation).

  7. Uncontrolled mental or emotional disorders, including a history of drug and alcohol abuse over the past 3 years, may hinder the successful completion of the study.

  8. Pregnant, lactating women (WCBP) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.
Proprioception and Eye-head Coordination for the Cervical Spine

Specific aims of this project were as follows:

1. To investigate the eye-head coordination of patients with cervical spine degeneration.
2. To investigate the relationship of these impairment measurements (range of motion, muscle power, proprioception, sensory threshold, eye-head coordination) and functional outcome (neck disability index, quality of life evaluation).
3. To develop a computer assistant device and software for the proprioceptive training and eye-head coordination.
4. To provide a treatment and prevention program emphasized on proprioception treatment and coordination for employee with neck-shoulder complaints.


Eligibility Criteria:
Inclusion Criteria:

* Group one: participants without degenerated disease in cervical spine
* Group two: participants with degenerated disease in cervical spine

Exclusion Criteria:

* Grade III, IV degenerated cervical spine
Hemostasis With QuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access

To evaluate the efficacy and safety of the QuikClot® Radial® pad on hemostasis after transradial access (TRA), compared to the standard of care TR Band®, to hopefully develop a safe and efficacious technique to achieve more rapid patent hemostasis after TRA, and improve patient care by optimizing radial hemostasis management.

The QuikClot® Radial® (QC) pad will be applied over the radial artery access site covered with either a Coban™ bandage or a Tegaderm™ dressing after TRA. Firm manual compression will then be applied over the QC pad after the sheath is removed for 5 minutes. The Coban™ cohort will then have the Coban™ bandage removed after an additional 25 minutes, then be covered with a Tegaderm™ dressing. The Tegaderm™ only cohort will be closely observed for 25 minutes after release of manual pressure. Both cohorts will remove the Tegaderm™ dressing the following morning.

Consented subjects will be randomly assigned in the cardiac cath lab upon completion of their procedure into one of the following arms:

Arm 1 - Standard of Care with a TR Band®

Arm 2 - QC pad combined with a Coban™ bandage

Arm 3 - QC pad combined with a Tegaderm™ dressing. This arm was stopped after the enrollment of 73 patients and replaced by the QC/TR Band® arm

Arm 4- QC pad was applied on the radial arterial access site with 30 minutes of compression under a TR Band® inflated with 8-10 mL of air. Then the TR Band® was removed, leaving the QC pad covered with a Tegaderm™ dressing.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing cardiac catheterization (CC) and/or percutaneous coronary intervention (PCI) via the radial artery as part of their standard of care treatment
2. Patients able and willing to give written informed consent
3. Patient \> 18 years of age

Exclusion Criteria:

1. Patients presenting with acute ST-segment elevation myocardial infarction (STEMI)
2. Oral anticoagulation therapy as described below:

   1. If on a DOAC (direct-acting oral anticoagulants - ie dabigatran, rivaroxaban, apixaban, edoxaban), patients will be excluded if DOAC taken within 48 hours and eGFR \> 30 ml/min or DOAC taken within 72 hours and eGFR \< 30 ml/min.
   2. If the patient is on warfarin, excluded if INR \> 1.5
3. Liver Failure
4. Life-threatening illness that the patient would not be expected to live more than 6 months post-procedure
5. Major unanticipated event in the cardiac cath lab (i.e. cardiac arrest) of an already consented patient, but before randomization, where the operator believes participation in this trial is now inappropriate.
6. Thrombocytopenia, with a platelet count of \< 75,000.
The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

The purpose of this study is the examine the effect of taking exenatide on the blood levels (pharmacokinetics) of orally-administered contraceptives.


Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal female of child-bearing potential.
* Body Mass Index (BMI) between 19 and 35 kg/m\^2, inclusive.

Exclusion Criteria:

* On implanted contraceptives for 6 months, or injectable contraceptives for 12 months prior to the study.
* Evidence of diabetes mellitus.
* Participation in a study involving administration of an investigational compound within the past 3 months.
An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function

This is an investigational study to evaluate the experimental medication BMS-986036 in participants with different levels of kidney function.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* BMI ≥ 25 and ≤ 40 kg/m2

Exclusion Criteria:

* Presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
* Any bone trauma (fracture) or bone surgery (ie, hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
* Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
* Any major surgery (eg, abdominal, thoracal, or cranial procedures) within 6 weeks of study drug administration
* Donation of blood or plasma to a blood bank, or in a clinical study (except at the screening visit) within 6 weeks of study drug administration
* Inability to tolerate subcutaneous injections

Other protocol defined inclusion/exclusion criteria could apply
68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients

This is a prospective, open-label, single-arm, multicenter bridging study in Chinese patients with prostate cancer. This multicenter study is planned to be conducted in patients with biochemical recurrence (BCR) of elevated PSA after radical prostatectomy or radical radiotherapy. This study investigates how well 68Ga-PSMA-11 PET/CT works in detecting BCR prostate cancer in Chinese patient. 68Ga-PSMA-11, developed by Telix, is a new molecular entity tracer with the trade name Illuccix®, which is approved by FDA for the examination of: 1) patients with suspected metastatic PC who are scheduled for initial treatment; 2) patients with biochemical recurrence of elevated PSA levels after initial radical radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Are able to understand and provide written informed consent document.
2. Are Chinese males aged ≥ 18 years.
3. Have histopathologically confirmed prostate adenocarcinoma and have undergone radical prostatectomy and/or radical radiotherapy and experienced biochemical recurrence (PSA should be measured within 30 days of screening).

   1. Post radical prostatectomy (RP) PSA ≥0.2 ng/mL measured 6 weeks after RP
   2. Post radiation therapy - ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng/mL rise in PSA;
4. Have a Karnofsky performance status ≥ 60 (or ECOG/WHO equivalent).
5. Agree to practice a highly effective method of contraception for at least 28 days after 68Ga-PSMA-11 administration.
6. Are willing and able to comply with scheduled

Exclusion Criteria:

1. Have a prior history of any other malignancy within the last year, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
2. Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of 68Ga-PSMA-11.
3. Are participating or plan to participate in any drug or device clinical study during the study period.
4. Have a known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-11.
5. Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan.
6. Have prior history of salivary gland disease or Paget's disease.
7. Have a history of fracture and anemia within the last year.
8. Have abnormalities in physical examination, ECG, and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance.
9. Is deemed not suitable for participating in this trial in the opinion of the investigator.
To Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers

To evaluate the pharmacokinetics and the safety of ID14009 compared to coadministration of ID1805 with ID1803 in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers aged over 19 years
* Subjects who have over 50kg and BMI more than 18.5kg/m\^2 and less than 29.9kg/m\^2
* Subjects who are eligible for this study as determined by clinical laboratory test results, urine test results, vital sign measurements, 12-lead ECG results, and physical examination findings during screening.
* Subjects must agree to practice a medically acceptable method of birth control and should not donate sperm or eggs until 28 days after last dose of study drug.
* Subjects who provided written informed consent to participate in this study and voluntarily taken part in during the entire study period

Exclusion Criteria:

* • Subject with any clinically significant cardiovascular, respiratory, endocrinology, infectious disease, ophthalmology, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease

  * History of gastrointestinal disease (except for appendectomy or herniotomy) or surgery (ex. Crohn's disease, ulcer) that may affect the absorption of a given drug
  * Medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug
  * Subject with symptoms of acute disease within 28days prior to study medication dosing
  * Drugs or other drugs (aspirin, antibiotics, etc.) that contain the following drug categories or components of the same strain have an overactive or clinically significant history of hypersensitivity:
  * Subject with a history of drug abuse or urinalysis positive
  * Subject with clinically significant active chronic disease
  * Subject with genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
  * Genetic myopathic disorder or related family history
  * Positive test results for HBs Ab, HCV Ab, Anti HIV(AIDS), RPR Ab
  * Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
  * Subject who cannot take standard meal in hospitalization
  * Present history of hypothyroidism or clinically significant assay
  * Subjects who donated whole blood or partial blood within 2 or 1 month, respectively, prior to the first administration.
  * Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing
  * Smokers whose average daily smoking amount exceeds 10 cigarettes per day within 3 months before the first dosing day and those who can't quit from 48 hours before dosing to the time of the last blood sampling.
  * Subjects who judged ineligible by the investigator
Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)

To compare the efficacy and safety of FE 999049 (follitropin delta) and its personalized dosing algorithm in controlled ovarian stimulation for in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) using a long gonadotropin-releasing hormone (GnRH) agonist protocol versus a short GnRH antagonist protocol.


Eligibility Criteria:
Inclusion Criteria:

* Infertile women aged 18-40 undergoing their first IVF/ICSI cycle that are in good physical and mental health and that have been diagnosed with problems in the fallopian tubes, mild endometriosis or have partners with decreased sperm quality.
* The participants must have a regular menstrual cycle, a normal uterus and 2 normal ovaries.
* The allowed body mass index is 17.5-32 Kg/m\^2.

Exclusion Criteria:

* Women with very high ovarian reserve, strong preference for either treatment, severe endometriosis, history of repeated miscarriage, couples with known problems in the chromosomes, history or high risk of producing blood cloths, women known to have chronic diseases, women recently participating in trials with non-registered drugs.
Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial

The goal of this clinical trial is to assess whether the use of intermittent superficial parasternal intercostal plane blocks reduces opioid usage in patients undergoing cardiac surgery with median sternotomy.

Participants randomized to the intervention group will receive the blocks with 0.2% ropivacaine administered via catheters placed in the superficial parasternal intercostal plane bilaterally under ultrasound guidance. Researchers will compare this group with a control group given 0.9% saline through similarly placed catheters. The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion.

This trial is comparing the use of 0.2% ropivacaine and 0.9% saline through a parasternal intercostal plane block and to measure whether there are any tangible changes in:

1. cumulative postoperative opioid use from catheter insertion until hospital discharge - measured as Milligram Morphine Equivalent (MME)
2. median pain score - measured at rest and with coughing using a standardized numerical rating scale - over 72 hours post catheter insertion
3. delirium - assessed twice daily using institutional scores up to 72 hours following catheter insertion.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing cardiac surgery via median sternotomy

Exclusion Criteria:

* Redo sternotomy, or cardiac surgery performed through non-sternotomy approaches (minimally invasive procedures, thoracotomies, mini-sternotomy, hemi-sternotomy, etc.)
* Emergency procedures (surgery within 2 hours)
* Clinical instability which in the judgement of the investigator precludes enrollment or participation in the study
* Weight \< 50kg
* Active systemic bacterial infection including infective endocarditis or pre-existing sternal infections
* Surgery for infective endocarditis
* Pregnancy or nursing
* Chronic opioid/narcotic use \> 6 weeks, active use of illicit drugs, long-term opioid exposure or chronic pain disorder/syndromes
* Allergies to amide anesthetic agents or any components of study interventions
* Inability to comply with, or participate in, protocol (i.e. cognitive impairment/altered mental status/neurological deficit or disorder, inability to provide informed consent, inability to complete pain rating scales, etc.)
* Receipt of an investigational drug or device within past 7 days
VAlidity and Reliability of the Telephone Interview Form for Stroke Outcome Evaluation

The investigators combined the mRS questionnaire and BI questionnaire and then developed a telephone interview form as a simple questionnaire with internal rules. The main purpose of this study is to evaluate the validity and reliability of the telephone interview form when compared with face-to-face assessment in clinically stable patients with stroke.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of ischemic or hemorrhagic stroke.
* The course of 1 to 12 months.
* Patient or procuratorial caregiver has a good understanding so as to answer rater's telephone interview.
* Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

* Patients with psychological or mental disorders.
* Patients suffer from other so severe diseases that they can't complete the follow-up.
Evaluation and Management of Metabolic Bone Disease in Kidney Transplant Recipients

There is a well-documented increased risk for disordered mineral bone homeostasis in Kidney Transplant Recipients (KTRs) when compared to the general population, leading to a markedly increased risk for fragility fractures and their associated morbidity and mortality. A more uniform and rigorous evaluation of bone and mineral homeostasis,than is afforded to patients under "normal care", will result in better clinical outcomes in KTRs.

The aim is to comprehensively characterize the mineral metabolism and skeletal phenotype in kidney transplant recipients (KTRs) to being to identify risk factors for post-kidney transplant mineral bone disease (PKT-MBD); and to evaluate whether treatment of abnormalities in these parameters will improve skeletal health as quantified by bone mineral density (BMD), bone turnover markers (rate of skeletal remodeling) and Osteoprobe (a direct index of bone quality using reference point indentation technology.

Participants in the rigorous evaluation arm will be followed with a) Mineral metabolism: blood calcium, phosphorus, parathyroid hormone (PTH), 25(OH) vitamin D; b) Bone turnover markers: bone-specific alkaline phosphatase, cross-linked C-telopeptide of type I collagen (CTx), and N-terminal propeptide of type I collagen (PINP); c)Bone Mineral Density using a Dual energy x-ray absorptiometry which is the standard method by which bone mass is measured clinically.

NOTE: The use of the Osteoprobe was discontinued on 9/5/19 due to safety concerns from the FDA about the device in other trials/other sites.

The Control Cohort is essentially an historical control group who will have received standard of care for the 18 months ending just prior to the enrollment of our Intervention Cohort. A coincident Control Cohort will not be used because knowledge of the additional data to be collected in the Control Cohort will undoubtedly influence their care by their attending nephrologists and surgeons.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant subjects within the first 3 months after surgery (intervention cohort) and 18 months after surgery (control cohort)
* Age between 30 to 65 years old
* Estimated glomerular filtration rate (GFR) \> 35 ml/min/1.73 m2

Exclusion Criteria:

* Major acute post-operatory complications (infection, urine leak, delayed graft function)
* Living related-donor KTRs
* Estimated GFR ≤ 35 ml/min/1.73 m2
* Significant skin disorder, bruising, local edema, skin infection or are being treated with anticoagulants (such as warfarin, heparin, low molecular weight heparin or direct thrombin inhibitors) or have known or acquired clotting disorders since the OsteoProbe® procedure would be unsafe
* Patients who do not plan to be followed at Yale New Haven for at least 18 months
* Morbidly obese (BMI \>40)
* History of gastroparesis
Self Efficacy Levels, Attachment Style and Resiliency of Youth With Type 1 Diabetes

This project will assess self-efficacy levels(SE) ,resiliency and attachment style of adolescent with type 1 diabetes and their caregivers.SE and attachment style of patients and parents will be compared with each other as well as correlated with diabetes management as assessed by A1C and self inventory scale.


Eligibility Criteria:
Inclusion Criteria:

* T1DM patients age 12 - 18 yrs from Sick Kids Diabetes Clinic and a primary caregiver
* T1DM \> 1yr and able to communicate in English

Exclusion Criteria:

* Families who cannot communicate in English (read, write, speak)
* Diagnosed less than 1 year diabetes
* Transient form of Diabetes (such as medication induced diabetes)
* Exclude type 2 Diabetes and CFRD (cystic fibrosis related diabetes)