cyrilzakka/clinical-trials huggingface dataset:
Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy

Trial to assess the bilateral deficit phenomenon during dynamic plantar flexion task in patients with haemophilic arthropathy Describe the differences in terms of the physical variables (muscular strength, range of motion and proprioception) in patients with hemophilia who have conducted a home treatment with a digital tool.

Bookmark the relationship between clinical history of joint bleeds and clinical manifestations in standing and walking.

* Assess the bilateral deficit phenomenon during dynamic plantar flexion task in patients with haemophilic arthropathy.
* Indicate the independent variables that influence the development of strength and contractile activity, with or without previous joint bleeds in haemophilia patients with minors.
* Observe the descriptive variables people influence the standing, the incorporation from sitting and jumping.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hemophilia A and B.
* With or without joint involvement clinically diagnosed, and with or without a previous history of hemarthrosis joint load legs.
* In prophylactic regimen with FVIII / FIX concentrates .
* Residents in the Autonomous Community of the Region of Murcia.

Exclusion Criteria:

* Patients without walking ability.
* Patients diagnosed with other congenital coagulopathy (von Willebrand disease, etc..).
* Patients with neurological or cognitive impairments that prevent understanding the questionnaires and physical tests.
* Patients whose parents or guardians have not signed the informed consent document.
Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human

This is an interventional study to investigate formation and pharmacokinetics of reactive carbonyl species adducts of apple polyphenols in human after a single dose of apple consumption.

A crossover design was used. Twelve healthy volunteers were recruited and asked to avoid the consumption of any apple products starting 1 week before intervention and continuing throughout the entire study for a total of 3 weeks.

On week 2, each of six participants received 600 g apple blends (seeds removal) in a single dose, and afterwards, urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h were collected. Meanwhile, other six participants received breakfast (without any apple products) only, and urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h were collected.

On the contrary, on week 3, six participants who received apple blends on week 2 received breakfast only, and six participants who were used as control on week 2 received apple blends. And urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h for both groups were collected.

Samples will be analyzed by LC-MS/MS. Pharmacokinetics of conjugates will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 17 and 30
* Have blood and urine biochemical markers in normal range
* Have no known allergy to apples
* Be not taking antibiotics for six months
* Be not currently taking medication
* Be nonsmoking
* Have no alcoholic intoxication
* Have no extensive exposure to industrial wastes
* Be not frequent charred meat consumption

Exclusion Criteria:

* Individuals with gout
* Individuals with heart diseases
* Individuals with peripheral vascular diseases
* Individuals with degenerative kidney
* Individuals with degenerative liver
* Cancer patients
* Patients with diabetes
* Individuals with GI disorders
* Individuals with endocrine disorders
Change of Nerve Conduction Properties in IVIg Dependent Neuropathies

IVIg exert a variety of different immunomodulatory effects and several mechanism of action have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in patients with immune-mediated neuropathies will be explored.

IVIg exert a variety of different immunomodulatory effects and several mechanism of action have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in patients with immune-mediated neuropathies will be explored

Eligibility Criteria:
Inclusion Criteria:

* immune neuropathy
* age above 18 y
* IVIg treatment

exclusion:

* no IVIg treatment
QStat in Liver Transplant

This study will assess the clinical performance of the Quantra System with the QStat Cartridge in the liver transplant population.

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic propoerties of a whole blood sample during coagulation. The Quantra QStat Cartridge was developed to monitor hemostasis in the trauma and liver transplant populations which may experience a range of coagulopathies of various etiologies including fibrinolytic defects.

This single-center, prospective, observational stuey will evaluate the performance of the Quantra System with the QStat Cartridge as compared to corresponding measures determined using the TEG 5000.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age
* Subject is undergoing deceased donor liver transplant and is a candidate for a TEG test to be performed to access coagulopathy during surgery.
* Subject is willing to participate, and is willing to consent (either prospectively or by deferred consent)

Exclusion Criteria:

* Subject is younger than 18 years of age
* Subject is known to have received antifibrinolytic therapy immediately prior to the start of liver transplantation surgery.
* Subject is unable to provide written informed consent (either prior to performing any study related procedures or by deferred consent)
* Subject is currently enrolled in a distinct study that might confound the results of the proposed study
* Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks
Deep Dive Randomized Control Trial

Compare two care management support program models on medical costs and utilization.


Eligibility Criteria:
Inclusion Criteria:

* All employees, dependents and retirees in one of seven large employer groups, including a state university system, a state employee group, two manufacturing companies, a natural resource extraction company, a public educational service agency, and a nonprofit multiple employer association for independent colleges were eligible for inclusion.

Exclusion Criteria:

* no financial information was available from their facility and professional claims;
* they were in an employer sub-group ineligible for care support services;
* they asked not be to contacted or were deceased;
* gender information was missing from their eligibility files;
* their claims data from the year prior to the start of the study indicated diagnoses of HIV, AIDS, end-stage renal disease (ESRD), organ transplants, or necrotizing fasciitis (intended to improve the likelihood of a balanced distribution of costs and conditions); OR
* they were in an employer sub-group with less than four months of enrollment prior to the study start date (resulting in too little information for stratification).
PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence

Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer.

The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.

This is not an investigational study drug. Flotufolastat PET scan is FDA Approved for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. In this research study, the flotufolastat-PET scan will be repeated if the initial scan does not show cancer and if PSA further rises by greater than 0.1 ng/ml. Other currently used scans for this purpose do not detect cancer in all patients with low levels of rising PSA.

Eligibility Criteria:
Inclusion Criteria:

* History of localized adenocarcinoma of the prostate with prior curative intent radical prostatectomy.
* An elevated PSA test result that is greater than or equal to 0.1 ng/ml and less than 0.5

Exclusion Criteria:

* Patients who are planned to have an x-ray contrast agent or other PET radiotracer \&amp; less than 24 hours prior to the flotufolastat F-18 PSMA-PET scan.
* Patients currently receiving Androgen Deprivation Therapy (ADT).
A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Solid Tumors

This is a Phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in combination with durvalumab (MEDI4736) in participants with relapsed or refractory solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed: Non-small cell lung cancer (NSCLC, adenocarcinoma or squamous-cell carcinoma), Breast Cancer (HER2 positive or triple negative), Pancreatic Cancer (adenocarcinoma)
2. Relapsed or refractory disease (Stage III or IV): NSCLC or pancreatic cancer must have failed at least 1 prior treatment. Breast cancer must have failed at least 2 prior treatments.
3. Measurable lesion by RECIST 1.1
4. Adequate hematologic function:

   * ANC \>1500 cells/mm3
   * Platelet count \>100,000 cells/mm3
   * HGB \>9.0 g/dL
5. Adequate hepatic and renal function:

   * AST and ALT ≤2.5 x ULN for subjects without liver metastases and ≤3.5 x ULN for subjects with liver metastases
   * Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
   * Creatinine ≤2.0 x ULN and Creatinine Clearance ≥40 mL/min (Cockcroft-Gault or 24-hour creatinine clearance collection)
6. PT/INR \<1.5 x ULN and PTT/ aPTT \<1.5 x ULN

Exclusion Criteria:

1. Mixed small cell and NSCLC histology
2. A history of CNS involvement except as follows: Subjects with previously treated CNS metastases that are adequately treated with whole brain radiotherapy, that are neurologically stable, and do not require corticosteroids for symptomatic management for at least 14 days prior to first dose of study drug. There must be no clear evidence of radiographically active disease for at least 90 days prior to enrollment.
3. Anti-tumor therapy within 21 days of study Day 1
4. Prior treatment with ibrutinib or other BTK inhibitor anti-CD137 or CTLA-4 antibody. The following are exceptions to this criterion: Subjects previously treated with an anti-PD1, anti-PD-L1, or anti-PD-L2 antibody.
5. History of allogeneic organ transplant
6. Treatment with a strong cytochrome P450 (CYP) 3A inhibitor
Mechanisms of Alcohol Sensitivity in AERD

The purpose of this study is to determine what type of reactions in the body may be responsible for the respiratory symptoms that occur when patients with Aspirin Exacerbated Respiratory Disease (AERD) drink alcoholic beverages. These reactions are most often seen with red wine.

This is a prospective trial of approximately 60 subjects with AERD to explore the mechanisms behind the physiologic reactions that occur when drinking alcoholic beverages. At various time points patients will be asked to ingest a variety of substances found in red wine after which blood and urine markers of the reaction will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Controls - must be 21 years or older
* Aspirin Tolerant Asthma and AERD arms must note a sensitivity to alcoholic beverages

Exclusion Criteria:

* Enzymopathies
* Mastocytosis
* Alcoholism
* Prior severe respiratory reaction to alcohol consumption
* Current pregnancy
* Monoamine Oxidase Inhibitor (MAOI) use
* Age under 21
* Use of leukotriene modifier 1 week before study intervention
* Having undergone and maintained aspirin desensitization
Kinectics of Donor-specific Anti-HLA Antibody After HLA-incompatible Allogeneic Haematopoietic Stem Cell Transplantation

Donor specific anti-HLA antibody (DSA) is closely related not only to primary graft rejection (GR) after HLA-incompatible transplantation, but also to the occurrence of primary PGF. Desensitisation therapy can reduce the level of DSA in patients and decrease the incidence of PGF after transplantation. However, most studies at home and abroad have focused on DSA levels in recipients before transplantation, risk factors and their effects on prognosis. Very few studies have focused on the rate of DSA positivity and its risk factors after transplantation. Therefore, this project aims to clarify the rate of DSA positivity after HLA-incompatible Allo-HSCT and reveal the influencing factors of post-transplantation DSA positivity with the help of a prospective, registry-based clinical cohort of HLA-incompatible transplant recipients, in order to provide a basis for the prevention and treatment of DSA-induced graft rejection or PGF.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis haematological disorders undergoing HLA-incompatible allogeneic haematopoietic stem cell transplantation Between 15 and 60 years-old Must sign the informed consent

Exclusion Criteria:

Withdraw of the signed informed consent for any reason Lack of ability to provide consent due to psychiatric or physical illness
Strengthening Exercises for Fibromyalgia

Objective: We evaluated the effectiveness of strengthening exercises using the Swiss ball in patients with fibromyalgia (FM).

Material and Method: Sixty FM patients were randomized into two groups: an intervention group (IG), in which patients performed muscle strength exercises using the Swiss ball, and a stretching group (SG), in which patients performed stretching exercises. All patients participated in 40-minute training sessions three times per week for 12 weeks. The IG performed the following eight strengthening exercises using a Swiss ball: lateral rise, simultaneous biceps curl, squat, two arms triceps extension, abdominal, one arm dumbbell row, reverse crucifix and crucifix. The SG performed exercises targeting the same muscle groups trained in IG. Outcome measures were as follows: visual analogue scale (VAS) for pain, 1 repetition maximum test for muscle strength; fibromyalgia impact questionnaire (FIQ) to evaluate disease impact, and short form health survey (SF-36) to assess quality of life. All participants underwent an evaluation at baseline, at 6 weeks and at 12 weeks of training. The assessor was blind to patient allocation.


Eligibility Criteria:
Inclusion Criteria:

* female with fibromyalgia according to the classification criteria of the American College of Rheumatology;
* aged between 20 and 65 years old.

Exclusion Criteria:

* uncontrolled hypertension;
* decompensated cardiac disease;
* history of syncope or exercise-induced arrhythmias and decompensated diabetes;
* severe psychiatric illness;
* history of regular exercise at least twice a week for the last 6 months;
* any other condition that could prevent the patient from performing physical exercises.
Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration

This open-label, randomized, Phase II research study will look to see whether an investigational treatment combining bromfenac ophthalmic drops with ranibizumab intravitreal injection is safe and effective for treating wet AMD as compared to ranibizumab alone.

Age Related Macular Degeneration (AMD) is the leading cause of blindness in adults over the age of 50 years. It can cause permanent loss of eyesight due to deterioration of the macula.

Ranibizumab monotherapy is currently the standard of care in neovascular AMD patients. Inflammation is believed to play an important role in AMD. Currently, MD's are investigating modulating the inflammation component of AMD with intra-ocular steroids although there is a high rate of steroid associated adverse events, such as glaucoma, cataracts and endophthalmitis.

Bromfenac is a non-steroidal anti-inflammatory drug (NSAIDS) and is currently approved for the treatment of inflammation following cataract surgery. In combination with intravitreal ranibizumab, bromfenac may also provide anti-inflammatory effects and may be a safer alternative to steroids.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 50 years
* Patients with active neovascular AMD
* If the patient has bilateral disease and qualifies for the study, both eyes may be included

Exclusion Criteria:

* Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception.
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Current or recent participation in another simultaneous investigational drug trial may be exclusionary at the investigator's discretion
* Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)
* Previous intravitreal steroid or anti-VEGF therapy within last 3 months.
* Patients with a concurrent corneal epithelial disruption or erosion
* Patients with immune deficiencies that would affect the ability of the cornea to heal
* Patients with a known sensitivity to any component of the formulations under investigation
Prevention of the Procedural Pain in the Newborn

The aim of this study is to compare the impact of two non-medicinal strategies: the breast-feeding and saccharose to measure effects in cerebral cortex during pain using near infrared spectroscopy (NIRS)

Many studies of non-medicinal treatments(saccharose and breast-feeding)show a decrease of expression of pain in newborn. However Slater and al questioned these practices due to the absence of modification of the cerebral answer measured by evoked potential.

Eligibility Criteria:
Inclusion Criteria:

* Gestationnel age included between 37 and 42 weeks
* Born in the CHRU of Brest
* Breast-Fed
* Score of Apgar upper to 7
* No pathology malformative
* Absence of known chromosomal abnormality
* Consent of parents

Exclusion Criteria:

* Maternal drug use
* Morphinic treatment
* Barbiturate treatment
* Benzodiazépine treatment
A Clinical Investigation of the Balance® Microplasty™ Hip System

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Balance® Microplasty™ Hip System.


Eligibility Criteria:
Inclusion Criteria:

* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid arthritis.
* Correction of functional deformity.
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
* Revision of previously failed femoral head resurfacing component

Exclusion Criteria:

Absolute contraindications include:

* infection,
* sepsis,
* osteomyelitis.

Relative contraindications include:

* uncooperative patient or patient with neurologic disorders who are incapable of following directions,
* osteoporosis,
* metabolic disorders which may impair bone formation,
* osteomalacia,
* distant foci of infections which may spread to the implant site,
* rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
* vascular insufficiency, muscular atrophy, or neuromuscular disease.
Effect of Dietary Fat on Glycemic Control in Type 1 Diabetes

The purpose of this study is to determine if dietary fat alters insulin requirements in type 1 diabetes.

This cross-over prospective study will require a two day admission to the clinical research center. Subjects will undergo closed loop glucose control and will received a diet with controlled macronutrient content.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes using insulin pump and CGM

Exclusion Criteria:

* renal or hepatic failure
* cancer or lymphoma
* malabsorption or malnourishment
* hypercortisolism
* alcoholism or drug abuse
* anemia (hematocrit \< 36 in females and \<40 in males)
* eating disorder
* dietary restrictions
* Acetaminophen allergy
* Chronic acetaminophen use
* Glucocorticoid therapy
Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR

Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR


Eligibility Criteria:
Inclusion Criteria:

* male or female subjects ≥ 12 years
* 2 year history of seasonal allergic rhinitis
* documented hypersensitivity to local seasonal allergens (grass pollen)
* documented pollen-induced asthma
* without acute ongoing exacerbation of asthma or allergic rhinitis
* no continuous ongoing treatment for rhinitis or asthma

Exclusion Criteria:

* non-allergic rhinitis and anatomic abnormalities disturbing the analysis of nasal capacity
* symptomatic rhinitis or asthma due to tree pollens
* currently treated by specific grass pollen immunotherapy
* suffering from non-allergic asthma
* chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroid dependent asthma
* atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
* contraindication for salbutamol use
Use of BIP-Needles in Rheumatologic Injections

The study focuses on needle guidance in rheumatologic operations - glucocorticoid injections inside joint capsules specifically. The main purpose of the study is to assess and validate the clinical feasibility and performance of Bioimpedance Probe (BIP) Needles and assess the benefits, drawbacks and risks related to use of the BIP Needles.

Clinical device investigation

Eligibility Criteria:
Inclusion Criteria:

* Adult patients having an inflammatory rheumatic disease requiring an intra-articular glucocorticoid injection.

Exclusion Criteria:

* Exclusion criteria are the same as generally for intra-articular glucocorticoid injections (e.g. bacterial infection or recent surgical operation relating the joint).
* In addition for not giving (or not capable to give) the consent personally for any reason is an absolute exclusion criterion.
* In addition pregnant women are excluded