cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients

The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to branded tacrolimus (Prograf) in stable renal transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Able to participate and willing to give written informed consent and to comply with the study visits and restrictions.
* Patient who has received a primary or secondary kidney transplant
* Patient who is at least 6 months post transplant and on a stable dose of tacrolimus as defined by physician, one tacrolimus trough level within the physician defined target range within past 6 months and one additional trough level during the screening period within 30% of the physician defined target range.
* Body mass index (BMI) greater than or equal to 19 but less than or equal to 35
* Patients who are taking tacrolimus (generic, Sandoz) or Prograf

Exclusion Criteria:

* Evidence of any acute rejection
* Patients who require dialysis within 6 months prior to study entry
* Recipients of antibodies blood group (ABO) incompatible allograft or positive crossmatch
* Recipients of multiple organ transplants
* Patients who have tested positive for hepatitis B surface antigen (HBsAG) or human immunodeficiency virus (HIV), or who are recipients of organ from donors who are known to be HBsAG or HIV positive. Virology screening at the time of transplant was acceptable unless more recent tests were available.
* History of malignancy, treated or untreated, within the past 2 years with the exception of carcinoma in situ or excised basal cell carcinoma
* Glomerular filtration rate ≤35 ml/min measured by modification of diet in renal disease (MDRD4)
* No anticipated change in the immunosuppressive regimen during patient participation other than that required by the protocol
* Initiation of any medications that could interfere with tacrolimus blood levels, including over the counter medications, herbal supplements, grapefruit or grapefruit juice.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\> 5 mIU/mL)
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are

  * women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
  * women whose partners have been sterilized by vasectomy or other means
  * using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs); periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
* Patients who are taking a generic tacrolimus product other than tacrolimus (generic, Sandoz).
Physiotherapy Treatment of Shoulder Rotator Cuff Tendinopathies. Global Postural Reeducation or Aerobic Exercise?

The goal of this clinical trial is to compare in participant population (patients with rotator cuff tendinopathy of the shoulder) the effect of a Global Postural Reeducation (GPR) program vs. a nonspecific therapeutic (aerobic) exercise program

Participants who meet the inclusion criteria will be randomly distributed between group 1 "GPR", group 2 "exercise", or group 3 "no physical therapy intervention".

Group 1 participants will receive a physical therapy treatment using the GPR method for 6 weeks consisting of 1 weekly session lasting 40 min performing "frog on the ground" and "sitting" poses. Patients in this group will also perform self-postures at home daily for 10 minutes.

Group 2 participants perform training for 6 weeks using non-specific aerobic exercise consisting of a daily 20-minute walk at a speed of 4-5 km/h.

Group 3 participants will not receive any physical therapy treatment and will serve as a control group.

Eligibility Criteria:
Inclusion Criteria:

* Shoulder pain with duration of at least 3 months
* Positive painful arc test during abduction
* At least one positive of the following tests: Hawkins-Kennedy test, Neer's sig, empty can test, drop arm or lift-off test

Exclusion Criteria:

* Cervical radiculopathy
* Moderate or severe degenerative arthropathy
* Complete rotator cuff tear
* History of shoulder or neck surgery
* History of shoulder fractures or dislocation
* Frozen shoulder or adhesive capsulitis
* Previous interventions with steroid injections or physiotherapy 2 months before the start of the program
Assessment of Clinical Onset of IV Heparin in Interventional Cardiology and Cardiac Surgery

The efficiency and promptness of heparin anticoagulation is necessary during the structural heart procedures to minimize time from insertion of cannulae to valve deployment in cardiac surgery. The goal of this study is to determine how rapidly the adequacy of heparin induced anticoagulation occurs using two different point of care activated clotting time technologies (iSTAT and Hemochron).

Adequate anticoagulation is achieved in cardiac surgery and interventional cardiology procedures with intravenous (IV) administration of unfractionated heparin. The Activated clotting time (ACT) is routinely measured to assess adequacy of anticoagulation to prevent clotting/thrombotic complications from placement of foreign materials used during cardiac surgery and cardiology procedures. Alternative methods to measure adequacy of anticoagulation such as measurement of Anti-Xa level and Reaction (R) time as assessed by Thromboelastrography (TEG) have also been suggested. However, their use in clinical practice is limited by lack of Point of Care (POC) technology and need for additional expertise to run these tests.

The efficiency and promptness of heparin anticoagulation is necessary during the structural heart procedures to minimize time from insertion of cannulae to valve deployment in cardiac surgery. The time required to prevent major complications is on the order of seconds to minutes. The goal of this study is to determine how rapidly the adequacy of heparin induced anticoagulation occurs using two different point of care ACT technologies (iSTAT and Hemochron). It is hypothesized that anticoagulation can be determined by the iSTAT ACT device 30 seconds after administration of heparin. Measuring heparin effectiveness at 30 or 90 seconds instead of the usual 3-minute time period may allow for earlier cardiac intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adult cardiac surgery patients presenting for elective valvular surgery
* Interventional cardiology patients presenting elective Transcatheter Aortic Valve Replacement (TAVR)

Exclusion Criteria:

* Preoperative IV heparin administration within 12 hours of surgery
* Preoperative oral anticoagulant use within 24 hours of surgery
* Platelet count \<120,000U/ml within 24 hours of surgery
Management of Cerebral Vascular Spasm in Posttraumatic Subarachnoid Hemorrhage Using Combination Therapy

To evaluate the efficacy and safety of oral Nimodipine and IV milrinone combination therapy for management of cerebral spasm after aneurysmal subarachnoid hemorrhage.

after being informed about the study and potential risks. All patients giving written consent will be randomized by double-blind manner into 2groups each one containing 15 patients.

Group 1(n =15 ):the patients will receive nimodipine (60 mg/4 hours) orally or via nasogastric tube In group 2(n =15 ): the patients will receive Oral Nimodipine (60 mg/4) will be given orally or in the gastric tube also from the first day of admission, then after the diagnosis of vasospasm is confirmed, start milrinone.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to our surgical ICU
* aged between (18-60) years old
* World Federation of Neurological Surgeons grades 1-3 Grades

Exclusion Criteria:

* Aneurysmal SAH
* SAH with Fisher Grade I and IV,
* World Federation of Neurological Surgeons grade IV \& V
* No informed consent,
* peripheral vascular disease
* Cardiac disease (heart block, severe valvular stenosis, cardiomyopathothy , ejection fraction\<40%), Renal impairment (serum creatinine ≥ 1.4 mg.L-1), Hemodynamic instability
The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate

The purpose of this study is to study the effects of Paricalcitol (Zemplar) on kidney functioning. The investigators hypothesize that the increase in serum creatinine observed in recent paricalcitol trials is a function of reduced creatinine secretion and not an actual reduction in kidney function. 16 patients will have kidney function measured via iothalamate clearance at baseline, after 7 days of paricalcitol treatment and after 7 days of being washed off the paricalcitol.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Stage 3 or 4 CKD
* Ability to give informed consent

Exclusion Criteria:

* Serum Calcium \> 10 g/dL
* Serum Phosphorous \> 6 g/dL
* On \> 400 units/d Vitamin D therapy
* Receiving cimetidine, triamterene, or trimethoprim, drugs that block creatinine secretion
* On vitamin D receptor activators (paricalcitol, calcitriol or Zemplar)
* Allergic to radiocontrast dye
The Efficacy of SGLT-2 Inhibitor in Patients With CAD and DM Undergoing PCI.

The study is to compare the effects of SGLT-2 inhibitors and other oral hypoglycemic agents in patients with coronary heart disease and diabetes mellitus undergoing percutaneous coronary intervention.

This is a single center, observational study designed to evaluate the efficacy of SGLT-2 inhibitors and other oral hypoglycemic agents in patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention (PCI). 1424 subjects will be enrolled. All patients were divided into the SGLT-2 inhibitors group and other oral hypoglycemic agents group according to whether they were discharged with SGLT-2 inhibitors or not. The primary endpoint is adverse cardiovascular and cerebrovascular events (MACCE), composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and unplanned coronary revascularization at 12 months after the index PCI. The key secondary endpoints are changes in insulin resistance index and platelet reactivity at 3 months and change in glucose and lipid metabolism at 12 months after the index PCI.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention.
3. Patients were provided informed consent before the procedure.

Exclusion Criteria:

1. History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
2. History of one or more severe hypoglycemic episode within 6 months before screening
3. Ongoing, inadequately controlled thyroid disorder.
4. History of hepatitis B surface antigen or hepatitis C antibody positive
5. Any history of or planned bariatric surgery.
6. Current use of a corticosteroid medication or immunosuppressive agent, or likely to require treatment with a corticosteroid medication.
Timing of Surgery And Outcome in Burn Patients ( EARLYBURN )

The prognostic of burn patients has improved over the last decades. Early excision of full thickness burns is thought to be one of the key factors which have led to prognostic improvement. Best timing for burn excision remain uncertain, however. In this multicenter observational study, we aim at exploring the impact of timing of surgery on outcome in severely ill burn patients using a propensity analysis.

The first aim of the study is to explore the impact of timing of the first surgery on outcome of severely ill burn patients. Because a randomization would not be feasible in this setting, we will use a propensity analysis in matching patients receiving early surgery and those receiving late surgery. Secondary aims are to evaluate the impact of the timing of surgery on morbidity (organs failure, infections, sepsis) but also to assess the diagnostic and prognostic value of plasma and urine biomarkers in severely ill burn patients

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Admission to a burn unit within 72 hours from a burn injury
* Total burned surface area (TBSA)\>20%(2nd degree or 3rd degree) for any type of burn
* Patient covered by the social security
* Non-opposition to participate to the study and to the constitution of the biological collection

Exclusion Criteria:

* Decline to participate
* Decision not to resuscitate order before surgery
* Pregnant or breastfeeding patiente
* Decision to limit therapies in the first 24 hours
* Patient not resident in France
* Patient deprived of liberty
Emergency Contraception and Body Weight: Pilot Study

The purpose of this research study is to determine how body weight changes the drug level of an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This emergency contraceptive is available to women without a prescription, but has recently been found to not work as well to prevent pregnancies in women of higher body weight. The overall goal of this research is to improve the effectiveness of contraception for women, no matter their weight.

To determine if differences exist in the pharmacokinetics (PK) of levonorgestrel-based emergency contraception (LNG-EC) in obese and normal body mass index (BMI) users and test whether doubling the dose of LNG-EC in obese women increases total and free LNG serum concentrations.

We enrolled healthy, reproductive-age women with obese and normal BMIs received 1.5 mg LNG orally and then in a subsequent menstrual cycle, the obese group also received 3 mg LNG. Total and free LNG PK parameters were obtained via serum samples through an indwelling catheter at 0, 0.5, 1, 1.5, 2, and 2.5 h. The primary outcome was the difference in total and free LNG concentration maximum (Cmax) between ECx1 and ECx2 in the obese group.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are between the ages of 18 and 35
* Subjects are in good general health
* Subjects have regular menstrual cycles (between 21 and 35 days)
* Subjects are willing to use condoms (if you are sexually active with a male partner), subjects are willing to not have sex with men during the study, or subjects have had a tubal ligation (or have a partner who has had a vasectomy) or subjects have a copper intrauterine device (IUD).

Exclusion Criteria:

* Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome
* Impaired liver or renal function
* Actively seeking or involved in a weight loss program (must be weight stable)
* Pregnancy, breastfeeding, or seeking pregnancy; recent (8 week) use of hormonal contraception
* Current use of drugs that interfere with metabolism of sex steroids
* Smokers.
Evaluate the Safety, Efficacy and Dose Response of GSK573719 in Combination With Fluticasone Furoate in Subjects With Asthma

Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control.

Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms on large and small airways. Most of the experience with older anti-cholinergics had been with acute use and little is known about their effect in chronic use in asthma. This is a multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3 treatment periods per subject. The total duration of subject participation is approximately 14 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient
* 18 years of age or older at Visit 1
* Diagnosis of Asthma
* Male or eligible Female
* Pre-bronchodilator FEV1 of 40-80% of the predicted normal value at Visit 1
* Demonstrated reversibility by ≥12% and ≥200mL of FEV1 within 40 minutes following albuterol at Visit 1
* A need for regular controller therapy (i.e., inhaled corticosteroids alone or in combination with a long-acting beta-agonist, or leukotriene modifier etc.,) for a minimum of 8 weeks prior to Visit 1.

Exclusion Criteria:

* History of Life threatening asthma
* Respiratory infection not resolved
* Asthma exacerbation
* Concurrent respiratory disease
* Current Smokers
* Other diseases that are uncontrolled disease or disease state that, in the opinion of the investigator, would put the safety of the patient at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study
* A positive Hepatitis B surface antigen or positive Hepatitis C antibody and/or HIV
* Visual clinical evidence of oropharyngeal candidiasis
* Drug or milk protein allergies
* Concomitant medications affecting course of asthma
* Use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer)
* Previous use of GSK573719
* Any disease preventing use of anticholinergics
* Any condition that impairs compliance with study protocol including visit schedule and completion of daily diaries
* Any subject with a history of alcohol or substance abuse
* Any affiliation with Investigator's site
Effectiveness of Two Simulation-Based Functional Nasopharyngoscopic Velopharyngeal Assessment Trainings

The aim of this clinical trial was to compare the effectiveness of functional nasopharyngoscopic velopharyngeal assessment training given to undergraduate speech and language therapy students on a 3D printed endoscopy training model and a ready-made endoscopy training model.


Eligibility Criteria:
Inclusion Criteria:

* To be a 4th year undergraduate student of speech and language therapy
* To have taken the course of cleft lip and palate or an equivalent course

Exclusion Criteria:

* Receiving previous hand-on flexible endoscopy training
* Having any health problem in the upper extremities
Treatment of Cervical Spinal Cord Injury With Imatinib - a Safety and Feasibility Study

This is a phase II, single center, open-label, non randomized clinical study to assess the uptake, safety and tolerability of Imatinib in acute Cervical Spinal Cord Injury patients. The aim is to determine if Imatinib reaches sufficient blood levels when given to patients with cervical spinal cord injury, via a gastric feeding tube, and also evaluate the safety and tolerability of this drug treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 18-80 years
2. Clinical signs of cervical spinal cord injury due to trauma.
3. In otherwise good health condition as determined by past medical history, physical examination, laboratory tests and vital signs
4. Patient that is conscious and oriented x 4 (regarding date/time, localisation, situation and personal details), with higher level of consciousness, i.e. Glasgow Coma Scale \> 14, and is assessed to be competent to give informed consent.

Exclusion Criteria:

1. Diabetes (type I and II)
2. Ongoing cancer treatment
3. Known allergy to study drug Imatinib or its excipients
4. On current therapy with drugs which may interfere with Imatinib, (e.g. paracetamol, ketoconazole, itraconazole, erythromycin, clarithromycin, dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidon, Hypericum perforatum).
5. Female subjects lactating or with positive pregnancy test
6. Known liver or kidney disease
7. Any relevant surgical or medical condition which in the opinion of the investigator may interfere with the conduct of the study or the scientific results. This includes hemorrhagic conditions.
An Assessment of Voluntary Adolescent Mental Health Screening and Referral in a Children's Hospital Emergency Department

The purpose of this study is to compare the TeenScreen intervention to usual care for adolescents who screen positive for mental health problems in a pediatric emergency department. It is anticipated that adolescents receiving the TeenScreen intervention will be more likely to attend a first session of outpatient mental health services within 60 days of the initial screening than those receiving the usual care.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 11 and 17 years old
* Medically stable and presenting with a non-psychiatric complaint
* English speaking
* Parent/guardian present for consent
* Insurance coverage by Medicaid
* Hamilton County residents
* Not currently receiving mental health treatment

Exclusion Criteria:

* Less than 11 years or greater than 17 years old
* Parent/guardian not present at time of visit
* Medically unstable
* Non-English speaking
* Insurance other than Medicaid
* Presenting complaint is a mental health problem
* Currently receiving mental health treatment