cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome

RITuximab AntiphosPholipid Syndrome (RITAPS) Study is designed to evaluate whether a medication called rituximab would reduce the signs and symptoms of antiphospholipid antibody (aPL) -related certain clinical problems.

Persistently antiphospholipid antibody (aPL)-positive patients, age 18 - 75 years of age, with anticoagulation-resistant manifestations of APS and fulfilling protocol defined study inclusion criteria will receive two doses of Rituximab, and will be followed for 6 and 12 months for clinical and safety outcomes, respectively.

Patients are eligible to take part in this study if their blood test is persistently positive for aPL and they have one or more of the aPL-related clinical problem(s) listed below: low platelet (blood cells involved in the prevention of bleeding) count; anemia (deficiency of red blood cells); heart valve disease; skin ulcers; kidney smal vessel blood clots; and/or memory problems.

Eligibility Criteria:
Inclusion Criteria:

* - Positive aPL profile defined as:

  * Positive lupus anticoagulant test as defined by the International Society on Thrombosis and Haemostasis, on two or more occasions, at least 12 weeks apart and/or
  * Positive anticardiolipin antibody (aCL) immunoglobulin G(Ig)G/M/A isotype, present in \> 40U, on two or more occasions, at least 12 weeks apart and/or
  * Positive anti-β2-glycoprotein-I (aβ2GPI) IgG/M/A isotype, present in \> 40U, on two or more occasions, at least 12 weeks apart

AND

- Clinical features attributable to aPL that are resistant to warfarin and/or heparin:

* Persistent thrombocytopenia and/or
* Persistent autoimmune hemolytic anemia and/or
* Cardiac valve disease and/or
* Chronic skin ulcers and/or
* Renal thrombotic microangiopathy and/or
* Cognitive dysfunction with/without white matter changes

Exclusion Criteria (selected):

* \> 4/11 American College of Rheumatology Classification Criteria for SLE
* Acute thrombosis
* History of stroke (only for patients with cognitive dysfunction)
* Positive Hepatitis B or C serology
* History of positive HIV
* Acute or chronic pancreatitis
* Treatment with any investigational agent within 4 weeks of screening
* Receipt of a live vaccine within 4 weeks prior to randomization
* Previous Treatment with Rituximab (MabThera® / Rituxan®)
* Previous treatment with Natalizumab (Tysabri®)
* Known active bacterial, viral fungal mycobacterial, or other infection
* Pregnancy
* Concomitant malignancies or previous malignancies, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* History of psychiatric disorder that would interfere with normal participation in this protocol
* Significant cardiac or pulmonary disease
The Relationship Between Scapular Endurance, Core Endurance, and Functional Performance in Adolescent Tennis Players

This study aims to examine the relationship between scapular endurance, core endurance, and upper extremity performance in adolescent tennis players. The hypothesis of this study is that better scapular/core endurance in adolescent tennis players is associated with better upper extremity performance. Establishing this relationship will contribute to identifying the exercise training necessary to improve upper extremity performance in tennis players.

Tennis is a sport characterized by coordinated, repetitive, and powerful movements along the kinetic chain. Being both overhead and rotational, achieving a good shot in tennis involves transferring high forces and energy from the lower extremities to the upper extremities through the trunk. In this context, core muscles play a crucial role in athletic performance by stabilizing the shoulder girdle, pelvis, and spine, acting as a pivot point for extremity movements. Therefore, good core strength is essential during a stroke. Additionally, as the acceleration of the ball is influenced by both maximum external and internal rotation of the shoulder, tennis players require good shoulder mobility and stability. In this regard, the scapula in the shoulder girdle provides a stable foundation for the glenohumeral mobility necessary for the shot. Both the core and scapular regions serve as pivot points for upper extremity functional activities. Therefore, this study aims to examine the relationship between scapular endurance, core endurance, and upper extremity performance in adolescent tennis players. The hypothesis of this study is that better scapular/core endurance in adolescent tennis players is associated with better upper extremity performance. Establishing this relationship will contribute to identifying the exercise training necessary to improve upper extremity performance in tennis players.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent tennis players

Exclusion Criteria:

* Athletes with a history of musculoskeletal injury or surgery in the last year that would prevent the tests from being performed
* Athletes who feel pain in the trunk and lower extremities during the tests
Individualized Bowel Preparation for Colonoscopy

A randomized control trial comparing a standard bowel preparation for colonoscopy with an individualized bowel preparation strategy based on patient characteristics


Eligibility Criteria:
Inclusion Criteria:

* elective out-patient diagnostic or therapeutic colonoscopy

Exclusion Criteria:

* pregnant women; refusal to participate; significant comorbidities (ASA score 3 or above); suspicion of bowel perforation;
Aberrant Myeloid Lineage Differentiation in HIV/AIDS Patients

The investigators included 782 HIV-infected patients from January 2016 to October 2020 Zhongnan Hospital of Wuhan University, whose AIDS diagnosis criteria met the "AIDS Diagnosis and Treatment Guide (2018 edition)" of Chinese Medical Association.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infection

Exclusion Criteria:

-
Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)

The LOOK-UP is an investigator-initiated clinical study with the aim of monitoring the post-marketing safety of the medicine Rinvoq™ (upadacitinib), which is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease. The Marketing Authorisation Holder is AbbVie Deutschland GmbH \& Co. KG.

The LOOK-UP study is an investigator-initiated clinical study conducted by INFARMED, the Portuguese Authority of Medicines and Health Products, I.P., and coordinated by the Porto Pharmacovigilance Centre at the Faculty of Medicine, University of Porto. The study aims to monitor the post-marketing safety of Rinvoq™ (upadacitinib), a medicine indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease. Rinvoq™, a selective and reversible Janus Kinase (JAK) 1 inhibitor, has been under additional monitoring by the European Medicines Agency (EMA) since its approval in December 2019, necessitating active safety surveillance in real-world settings.

The primary objective of the LOOK-UP study is to quantify the incidence of adverse events in patients prescribed Rinvoq™, with a focus on serious adverse events such as malignant neoplasms, non-melanoma skin cancer, major adverse cardiovascular events, venous thromboembolism, serious and opportunistic infections, gastrointestinal perforations, liver injuries, bone fractures, and all-cause mortality. Secondary objectives include describing the incidence of adverse events among specific subgroups, such as very elderly patients, patients with moderate hepatic impairment, and patients with severe renal impairment. Additionally, the study aims to characterize patient-reported adverse events using MedDRA terms. An exploratory objective is to evaluate adherence to risk minimization measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) for the safe use of Rinvoq™.

The study is designed as a Phase 4 post-authorization safety study (PASS), utilizing an observational cohort approach that is both multicentric and ambispective. This design includes prospective and retrospective monitoring of patients, ensuring comprehensive safety analysis. The study will be conducted exclusively in hospital settings within the Porto district, reflecting the prescription and usage constraints of Rinvoq™.

Eligibility Criteria:
Inclusion Criteria:

* Prescription of Rinvoq™ from January 1, 2024;
* 18 years of age or older at the time of recruitment; and
* Expressed consent to participate in the study.

Exclusion Criteria:

* They have any degree of cognitive impairment that prevents them from responding to a questionnaire administered by telephone;
* They are participating in a phase I, II, or III clinical trial;
* They have a life expectancy of less than 1 month; or
* They do not have a valid telephone contact.
Efficacy of Different Doses of Amino Acids in 5AA+CrPic Water on Glucose Homeostasis in a Healthy Population.

It has previously been shown that a carbonated water including a defined amount of amino acids and chromium can decrease the postprandial glucose response. In this study, the effect of three different doses of amino acids on glucose excursions after a standardized test meal will be evaluated in healthy subjects. The study will be conducted in a randomized, single center, crossover, double-blinded, placebo controlled design including 25 participants. The primary endpoint of the study is the incremental area under the curve for capillary blood glucose (iAUC) within 180 minutes after ingestion of the meal.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 18-25 (±0.5) kg/m²
* Agree to maintain consistent dietary habits and physical activity levels for the duration of the study
* Healthy as determined by medical history and information provided by the volunteer
* Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits
* Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

* Pregnancy or lactation
* Known Type I or Type II diabetes
* Undetected Type I or Type II diabetes (fasting blood glucose \< 6.1 mmol/L at first test day)
* Use of antibiotics
* Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
* Allergy to test product or placebo ingredients
* Participants restricted to a vegetarian or vegan diet
* Intolerance to lactose or gluten
* Acute infection
* Individuals who are averse to venous catheterization or capillary blood sampling
* Alcohol or drug abuse
* Currently active smokers (tobacco products, and e-cigarettes)
* Participation in other clinical research trials
* Individuals who are cognitively impaired and/or who are unable to give informed consent
* Any other condition which in the PI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
* Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the PI
* Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the PI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless recommended by their physician.
Stellate Ganglion Block on Tourniquet Response

To investigate the influence of stellate ganglion block on tourniquet response during surgery in patients undergoing elective lower limb Department of orthopedics.

Select elective general anesthesia in 100 cases of lower extremity Department of orthopedics surgery patients were randomly divided into SGB group and control group, SGB group received anesthesia before the right stellate ganglion block intervention, the control group underwent right deltoid muscle injection, changes in hemodynamics in two groups were recorded in heart rate, blood pressure, and before anesthesia, after intubation 3min 1H, a tourniquet, tourniquet release before and after tourniquet release 3min, 30min, changes in blood physiological analysis. The effect of stellate ganglion block on tourniquet response during perioperative period was observed.

Eligibility Criteria:
Inclusion Criteria:

* American Society of anesthesiologists Grade 1-3 Patients
* undergoing lower limb surgery under general anesthesia
* should be treated with tourniquet

Exclusion Criteria:

* Tourniquet application time is less than 1h, greater than 1.5h
* Abnormal coagulation function
* perioperative application of hormone
* lidocaine allergy
* can not cope with nerve block
* nerve block failure
* minimally invasive surgery
Extended Perioperative Administration of Fibrinolysis Inhibitors After Cardiac Surgery

PRIORITY is a pragmatic, multi-center, cluster crossover trial that aims to evaluate whether implementing a policy of routine extended (intraoperative and 4 hour after transfer to ICU) use of fibrinolysis inhibitors leads to a decrease in post-operative blood transfusion compared to a policy that only involves intraoperative use.

Routine use of fibrinolysis inhibitors is strongly recommended in cardiac surgery (recommendation level 1A). However, despite numerous studies on the pharmacodynamics and clinical effects of these drugs, there is still no consensus on the optimal dose and dosage regimen. As a result, there is wide variability in the use of fibrinolysis inhibitors across different clinics. Several studies have shown that peak activation of fibrinolysis occurs during cardiopulmonary bypass. However, elevated levels of markers of fibrinolytic activity in the blood plasma are observed for at least 2 hours after surgery and 4 hours after heparin neutralization. This suggests the potential for extended use of fibrinolysis inhibitors after surgery. There have been limited attempts to investigate the effectiveness of postoperative administration of fibrinolysis inhibitors, and these studies have been conducted on small samples or with retrospective designs. The authors of these studies were unable to identify the benefits of postoperative administration in terms of reducing bleeding risk and the need for blood transfusions. However, postoperative infusion of fibrinolysis inhibitors demonstrated a comparable safety profile. There is evidence suggesting that repeated administration of fibrinolysis inhibitors after cardiopulmonary bypass, rather than a single dose at the beginning of surgery, may be more beneficial. Due to uncertainty regarding the best approach (routine extended use of fibrinolysis inhibitors or no routine extended use of fibrinolysis inhibitors), we will compare the effects of a hospital policy that includes routine administration of fibrinolysis inhibitors 4 hours after surgery to a policy that avoids routine postoperative administration. The comparison will focus on the blood transfusion requirement during hospitalization among patients undergoing open heart surgery.

Eligibility Criteria:
Inclusion Criteria:

1. A hospital that performs a minimum of 250 open heart interventions per year.
2. Consent from hospital physicians regarding the prophylactic use of fibrinolysis inhibitors (more than 95% of physicians involved in the treatment of adult patients (\>18 years) agree to adhere to the strategy of using fibrinolysis inhibitors as prescribed by the study protocol).

Exclusion Criteria:

* Hospital does not meet inclusion criteria
Live Donors for Kidney Transplants

On a yearly basis there are approximately 12,000 kidney transplants in the United States. Presently there are approximately 40,000 patients awaiting a transplant with only 5,000 available donors. Due to the obvious difference between organ supply and demand, live donors have become a standard source of kidneys for transplantation.

Research has proven that kidneys from living donors are superior to cadaveric donors (kidneys harvested from a deceased individual). Kidneys from living donors are not exposed to extremely low temperature that could increase post-operative problems. They are less likely to experience rejection and there is a decreased likelihood that a patient will have to undergo post-operative dialysis.

The objective of this study is to promote the enrollment of healthy individuals to serve as kidney donors for patients undergoing research kidney transplantation at the NIH. Potential donors will be screened to make sure they are able to survive with a single kidney without significant medical risk. Additional tests will be taken to establish compatibility with the recipient. Compatible donors will be evaluated to determine which kidney is suitable for transplantation. Both the donation and transplantation procedure will be conducted on the same day. Appropriate post-operative care and follow-up will be provided at the Clinical Center.

This protocol is designed to facilitate the enrollment of healthy individuals to serve as renal allograft donors for subjects undergoing protocol renal transplantation at the NIH. Donation will be allowed for altruistic purposes only.

Eligibility Criteria:
* INCLUSION CRITERIA:

Willingness to donate without evidence of secondary gain, coercion, or conflict of interest.

Age greater than or equal to 18 years

ABO compatible with recipient

Normal renal function with a 24hr creatinine clearance greater than 80ml/min/1.73m(2).

Willingness and legal ability to give informed consent

Recipient is enrolled in a NIH protocol for transplantation or has been established as a candidate for receipt of an altruistic or paired donation through the Washington Regional Organ Procurement Agency donor program.

EXCLUSION CRITERIA:

Hypertension

Pregnancy

History of stroke

Active tuberculosis

History of active malignancies except basal cell carcinoma of the skin.

Major anticipated illness or organ failure incompatible with survival after nephrectomy

Functionally significant coronary artery disease.

Active kidney stones

Proteinuria (greater than 250mg/24hr)
Targeted Food Incentives to Improve Diet Quality and Health Among Adults

The purpose of this study is to test whether individual-level targeted price incentives for healthier foods can improve the diet quality of grocery purchases made by adults in comparison to a "one size fits all" approach. To test this, the investigators plan to implement a 8-month randomized controlled cross-over trial. The intervention group will receive a small discount for using their loyalty card and weekly coupons for healthier foods (e.g. fruits, vegetables, whole grains, lean meats and seafood, low-fat dairy) that are selected based on the individual's past purchase history, dietary preferences, their baseline diet quality, and their estimated likelihood of using the coupon. Individualized coupons will be automatically sent to customers' loyalty cards each week, and separate emails with appropriate nutrition education and information about the coupons will be sent to participants weekly. The control group will receive a small discount for using their loyalty cards during the first phase of the study (3-months), occasional untargeted coupons, and weekly emails with untargeted nutrition education. Following phase1, there will be a 2-month washout period, and then the intervention and control groups will cross over for the remaining 3-months of the study. The investigators will collect purchase data from all participants as well as food frequency questionnaires and other self-reported behavioral and health questions at baseline, after phase 1 completion, and after phase 2 completion. The investigators hypothesize that participants in the intervention group will meaningfully improve the overall quality of their food purchases (measured using the Grocery Purchase Quality Index-2016) as well as their overall diet quality (measured using the Healthy Eating Index 2010.

A detailed description of Eligibility and outcome measures is entered elsewhere

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Speaks English
* Non-store employee
* Primary shopper in the household
* Purchases at least half of weekly groceries at supermarket
* Not pregnant or planning on becoming pregnant before April 2019

Exclusion Criteria:

* Younger than 18 years of age
* Does not speak English
* Employee at supermarket
* Pregnant or planning to become pregnant before April 2019
* Not primary shopper for household
* Purchases less than half of weekly groceries at supermarket
Intervention Study of Drugs in Patients Osteopenia and Osteoporosis

This is a 12 months, randomized, multicenter, open-label, parallel-group study in postmenopausal women and male aged 50 years or old with osteoporosis or osteopenia in China to evaluate the efficacy and safety of different anti-osteoporpsis intervention strategies.

This is a 12 months,randomized, multicenter, open-label, pragmatic-group study in postmenopausal women and male aged 50 years or old with osteoporosis or osteopenia in China to evaluate the efficacy and safety of different anti-osteoporpsis intervention strategies, including

* Group1: Basic treatment group (elemental calcium 600mg/ day + vitamin D 1000IU/day)
* Group2: Basic treatment+ anti-osteoporosis drug group (alendronate, zoledronate, tripopeptide, denosumab, activated vitamin D, menatetrenone soft capsules according to the patient's condition)
* Group3: Basic treatment + non-drug treatment group(diet, exercise, rehabilitation therapy).

Eligibility for participation will be determined by medical history, physical examination, and laboratory results obtained during a screening visit. About 180 postmenopausal women and elderly male with osteoporosis or osteopenia will be included in this study.

All subjects will be given informed consent before starting any examination and test. The following data of all subject will be collected: liver and kidney function, HbA1c, fasting blood glucose, fasting lipid profile, serum calcium, serum phosphate, parathyroid hormone, 25-hydroxy vitamin D, bone turnover markers(BTMs) (inculding serum procollagen type I N-propeptide, serum C-terminal telopeptide of type I collagen,osteocalcin and alkaline phosphatase), thoracic and lumbar spine X-ray, bone mineral density(BMD) by dual energy X-ray.

Then they will be randomized into three groups at a 1:1 ratio. Every group will be given calcium carbonate and vitamin D. In the group 2, the medication will be decided by the doctor according to the patients' condition. Particularly, denosumab has not been approved for male adaptation, we will sign an additional informed consent.

All subjects will be followed by visiting clinic every three months and complete the examinations to assess the safety and efficacy. Safety indexes: liver and kidney function, urine routine test and 24-h urine calcium. Efficacy indexes: BMD change, BTMs changes and fracture reduction. All subjects will be followed 12 months and data will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities
* Postmenopausal women and male aged 50 years or old
* Osteoporosis by DXA or fragility fracture history
* Osteopenia with more than one osteoporotic risk factors

Exclusion Criteria:

* Secondary osteoporosis
* Renal insufficiency (Ccr\< 35ml/min)
* New fractures \< 3 months, prior bilateral hip fractures or surgical replacement.
* Other medication contraindications
* Malignant tumors
* Mobility-impaired individuals