cyrilzakka/clinical-trials huggingface dataset:
Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B

The primary objective of the study was to evaluate the safety of recombinant coagulation factor IX Fc fusion protein (rFIXFc, BIIB029) in previously untreated patients (PUPs) with severe hemophilia B. Secondary objectives were to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes in PUPs, and to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes in PUPs.


Eligibility Criteria:
Key Inclusion Criteria:

* Weight \>=3.5 kilogram at the time of informed consent.
* Severe hemophilia B was defined as less than or equal to (\<=)2 International Units per deciliter (IU/dL) (\<=2 percent \[%\]) endogenous FIX documented in the medical record or as tested during the Screening Period.

Key Exclusion Criteria:

* History of positive inhibitor testing. A prior history of inhibitors was defined based on a participant's historical positive inhibitor test using the local laboratory Bethesda value for a positive inhibitor test (that is equal to or above lower limit of detection).
* History of hypersensitivity reactions associated with any rFIXFc administration.
* Exposure to blood components or injection with a coagulation factor IX (FIX) concentrate (including plasma derived) other than rFIXFc.
* Injection with commercially available rFIXFc more than 28 days prior to Screening.
* More than 3 injections of commercially available rFIXFc prior to confirmation of eligibility.
* Other coagulation disorders in addition to hemophilia B.
* Any concurrent clinically significant major disease that, in the opinion of the Investigator, would have made the participant unsuitable for enrollment (example HIV infection with cluster of differentiation 4 (CD4) lymphocyte count less than (\<)200 cells/microliter (mcL) or a viral load greater than (\>)200 particles/mcL, or any other known congenital or acquired immunodeficiency).
* Current systemic treatment with chemotherapy and/or other immunosuppressant drugs. Use of steroids for treatment of asthma or management of acute allergic episodes or otherwise life-threatening episodes was allowed. Treatment in these circumstances should not have exceeded a 14-day duration.
* Participation within the past 30 days in any other clinical study involving investigational treatment.
* Current enrollment in any other clinical study involving investigational treatment.
* Inability to comply with study requirements.
* Other unspecified reasons that, in the opinion of the Investigator or Bioverativ, would have made the participant unsuitable for enrollment.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Acetabular Fractures of Both Columns

The purpose of this research is to study a specific acetabular (hip socket) fracture pattern and how its treatment affects the functional, clinical, and x-ray outcomes. There are no experimental procedures involved.

This study will identify a small subset of patients that fall outside the Letournel classification system of acetabular fractures. The fracture pattern, its influence on the surgical treatment decision making process, and the radiographic and outcomes will be detailed. In particular, both-column acetabular fractures with significant posterior deformity have been correlated with poor functional outcomes, increased arthritis radiographically, and worse prognosis in general. Despite these findings, there has been no specific study evaluating these injury patterns to date. We present ten patients with both column acetabular fractures and an associated posterior column/wall piece and their clinical outcomes in an effort to help guide surgical treatment and offer prognostic guidance.

Eligibility Criteria:
Inclusion Criteria:

* All patients that underwent surgical fixation of the hip at Hershey Medical Center between June 2006 and May 2007 by Dr's J. Spence Reid and David Goodspeed.
* They will include patients that are admitted directly from the field or are transferred from outside hospitals.

Exclusion Criteria:

* will be those acetabular fractures of non-traumatic etiology (e.g.: secondary to malignancy or fatigue)
* fractures that have not undergone operative fixation
* pediatric populations under the age of 18
* mentally compromised patients
* those that do not give consent for the clinical evaluation.
Study Evaluating Sirolimus (Rapamune™) in Solid Organ Transplant Recipients

To evaluate the safety of long-term administration of sirolimus oral solution for up to 5 additional years, or until the tablet formulation is commercially available (whichever occurs first) in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical trials with sirolimus (with or without cyclosporine (CsA). To evaluate the pharmacokinetics and safety of long-term administration of sirolimus tablets administered for up to 5 years, or until the tablet formulation is commercially available in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical trials with sirolimus (with or without CsA) or who are currently enrolled in protocol 0468E1-306-US.


Eligibility Criteria:
Inclusion Criteria:

* Completion of sirolimus/blinded therapy in solid organ clinical trials (with or without CsA) with satisfactory compliance and an adequate safety profile.
* Women of childbearing potential who have a negative pregnancy test before enrollment into this study and who agree to practice either a hormonal or barrier method of birth control throughout the treatment period and for 3 months following discontinuation of sirolimus may be enrolled into the study.
* Signed and dated informed consent

Exclusion Criteria:

* Unstable disease states, which in the opinion of the investigator would present a risk to the patient.
* Known hypersensitivity to macrolide antibiotics
A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-insulin Treated Type 2 Diabetes

This randomized, parallel group study will determine whether the use of episodic, intensive glucose monitoring via the Accu-Chek 360 view blood glucose analysis system has a positive effect on overall glycemic control. Patients will be randomized into either the 'usual care' group, or the 'interventional group' supplemented with the Accu-Chek 360 view blood glucose analysis system. The effect of each treatment regimen on glycemic control will be assessed by measurement of change in baseline HbA1c values at 12 months. The anticipated time on study treatment is 1 year, and the target sample size is 504 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>= 25 years of age
* Type 2 diabetes for \>= 1 year
* Hemoglobin A1c \>= 7.5% and \<=11%
* Diabetes managed by exercise and diet, prescription oral medication or an injectable incretin mimetic

Exclusion Criteria:

* Type 1 diabetes
* On any type of insulin therapy at start of study
CABG REVEAL: Atrial Fibrillation After Coronary Artery Bypass Graft

Atrial Fibrillation is an abnormal heart rhythm that can occur after coronary heart bypass graft operations. How often this happens and what other problems occur for a person after these operations needs to be better understood. This study uses a device called the Reveal XT, a small device that records heart rhythms to track a patient's heart rhythms after the bypass surgery. The device is implanted at the time the bypass graft is made. The information that is gathered for this study will help physicians to provide better treatment and follow-up of the patients under their care.

We will utilize the Reveal XT implantable loop recorder (ILR) in order to monitor the incidence of AF in our post-CABG patients. The Reveal XT has been shown to be superior in comparison to the more commonly used sporadic ECGs.6 Unfortunately, the occurrences of arrhythmias tend to be "unpredictable" and often paroxysmal. Observers are unlikely to have the opportunity to record ECGs at the time of event until it is too late. The ability of the Reveal XT to continuously record ECGs over long periods of time has made it a superior and powerful diagnostic tool in patients with arrhythmias and arrhythmia related complications.

This was evident in the large multicenter PICTURE study whereby a large number of diagnostic tests were undertaken in patients with unexplained syncope without providing conclusive data, but in the same study with the Reveal ILR, the mechanism of syncope in the vast majority of these patients were established often at first onset of an arrhythmia.7

"The equivalent efficacy", if not superiority, of Reveal ILRs above conventional ECGs and Holter-monitors in detecting AF was established in the "XPECT" trial.8 Its sensitivity in detecting events not seen with ECGs and Holter monitoring post COX MAZE procedure (surgical procedure for AF) and post ablations for paroxysmal AF and persistent AF is well established.

Eligibility Criteria:
Inclusion Criteria:

* 60 years of age or older
* Presenting for elective Coronary Artery Bypass Graft at Saint Thomas West Hospital

Exclusion Criteria:

* Patients \<60 years of age
* Prior cardiac surgery
* Emergent surgery
* Need for concomitant cardiac surgery other than PFO closure
* Prior history of AF or Atrial flutter
* Prior atrial ablation
* Prior cardioversion
* Patients with prior permanent pacemaker
* Ejection fraction \<35%
* Prior history of thyroid disease
* Prior history of a cardiomyopathy
* Patients without telephonic access
Fine Tuning of Neuro-muscular Blockade in Robot-assisted Prostatectomy

Assessing the routinely used protokoll for deep NM Block during robot-assisted prostatectomy in general anesthesia. The protocoll contains the repeated dosing of rocuronium according to the results of relaxometry performed with a TOFcuff relaxometer (RGB Medical, Madrid) during pneumoperitoneum. This is done by keeping the block level between 1 to 6 PTC (post tetanic counts). The scope of the study was to find out, to which percentage this protocoll permits the maintenance of block level inside of the desired range.

Robot-assisted urological interventions require sufficiently deep neuromuscular relaxation (NMR) during the phase of pneumoperitoneum. This is achieved by repeated administration of the non-depolarizing neuromuscular relaxant rocuronium, which is used in clinical routine. The level of relaxation is usually measured with the TOF-Watch relaxometer. This device has limitations in its usability and accuracy in this setting because it is unreliable when the monitored arm of the patient is not accessible for the anaesthetist for visual or tactile assessment of finger movements. The novel TOF-Cuff relaxometry equipment is by design intended to provide constant and reliable quantitative and in vivo calibrated relaxometric values independently of the arm position. The combination of frequently adjusted neuromuscular relaxation in a standardised mode in combination with a reliable relaxometry by TOFcuff promises an improved surveillance of neuromuscular relaxation and a higher safety standard. This investigation aims to test and to define the combined use of the best available drug with the best available relaxometer for general anesthesia in robot-assisted urological surgery.

Eligibility Criteria:
Inclusion Criteria:

* consenting male adults undergoing elective robot-assisted urological surgery.

Exclusion Criteria:

* Emergency cases, Patients who don't understand the requirements of the study and don't agree to sign the informed consent. Contraindication to neuromuscular relaxation with rocuronium.
Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)

The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the following points that are in question and doubt:

* Incidence of adverse events under actual conditions of use (Serious and Nonserious Adverse Events);
* Adverse Drug Reactions not shown in the directions for use (will be stated as Unexpected Adverse Reaction);
* Adverse Event caused by misuse, abuse, or drug interactions;
* Other information concerned with safety or efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are prescribed with temozolomide by local labeling:

  * participants with newly diagnosed glioblastoma multiforme;
  * participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Exclusion Criteria:

* N/A
Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer

The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of subjects with advanced non-small cell lung cancer.

Preliminary signals of clinical activity of ganetespib as a single agent have been observed in NSCLC. A novel approach to treatment of NSCLC is the combination of Hsp90 inhibitors, such as ganetespib, and taxanes. Such combinations have shown potential for synergy in preclinical and clinical evaluations with other Hsp90 inhibitors. Preclinical studies with ganetespib and taxanes have indicated that the combination of these drugs was more effective than either drug alone at inducing cell death, and an ongoing phase 1 study indicates that the combination is well tolerated and warrants systematic evaluation in a larger study.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of NSCLC
* Stage IIIB or IV NSCLC
* ECOG Performance Status 0 or 1
* Prior therapy defined as 1 prior systemic therapy for advanced disease
* measurable disease
* Radiologic evidence of disease progression following most recent prior treatment.
* Adequate hematologic, hepatic, renal function

Exclusion Criteria:

* Active or untreated CNS metastases
* Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
* Serious cardiac illness or medical conditions
* Pregnant or lactating women
* Uncontrolled intercurrent illness
Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation

This study intends to determine whether steroid withdrawal or calcineurin inhibitor withdrawal is superior for graft function and graft survival. Secondary endpoints for this study are: incidence of tumors and cardiovascular events.

The primary objective: To assess if superior graft function (glomerular filtration rate (GFR) difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts of de novo kidney transplant patients treated with Myfortic-everolimus plus steroids compared to Myfortic-cyclosporine.

Methodology:

* A 5-year, multicentre, prospective, randomized, open-label, controlled study

  * Group 1: Simulect + cyclosporine + Myfortic + steroid stop at 3 months
  * Group 2: Simulect + cyclosporine (decrease dose in one week at month 3 and replace by everolimus) + Myfortic + steroid maintenance.
* In both groups MPA AUC monitoring will be done at 5-7 days and at 3 months, to ensure sufficient MPA protection.

Sample size calculations:

A total of 152 patients will be randomized (76 patients per group)

Population:

De novo kidney transplant recipients.

Study duration:

1.5 years inclusion+ follow-up during the first 5 years

Eligibility Criteria:
Inclusion Criteria:

* Male or female recipients of a de novo kidney transplant, aged above 18 years
* Women of childbearing potential must have a negative serum or urine pregnancy test with sensitivity equal to at least 50 mIU/ml
* Patients must be capable of understanding the purpose and risks of the study, and must sign an informed consent form

Exclusion Criteria:

* Multiple organ transplantation (e.g., Kidney-pancreas, kidney-heart, kidney- liver,...)
* Transplantation of a patient who got another organ transplant previously
* Recipients of a HLA-identical living-related renal transplant
* Patients with PRA \> 30%, patients who have lost a first graft from rejection within two years after transplantation, and African European patients.
* Patients with primary renal disease at risk for recurrence: FSGS, MPGN, HUS
* Pregnant or lactating women
* WBC \< 2.5 x 109/l (IU), platelet count \< 100 x 109/l (IU), or Hb \< 6 g/dl at the time of entry into the study
* Active peptic ulcer
* Severe diarrhea or other gastrointestinal disorder, which might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy
* Known HIV-1 or HTLV-1 positive tests
* The use of investigational drugs or other immunosuppressive drugs, as those specified in this protocol
* Patients receiving bile acid sequestrants
* Psychological illness or condition, interfering with the patient's compliance or ability to understand the requirements of the study
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).

Prospective, single arm, multi-center, Early Feasibility Study (EFS) to assess the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).

Up to fifteen (15) patients at up to 10 US investigational sites and 3 German investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, and after 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years following the index procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patient has clinically significant TR graded as severe or greater
* Peak central venous pressure of ≥ 15mmHg
* Patient has NYHA functional classification of III or IV
* Patient is not eligible for standard-of-care surgical or interventional therapy or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic

Exclusion Criteria:

Patients will be excluded from participation if ANY of the following criteria apply:

* Severe RV dysfunction defined by TAPSE, RVEF, or RVFAC.
* Anatomical suitability according to CT scan.
* Systolic Pulmonary Artery Pressure \> 65mmHg
* Moderate or more mitral valve stenosis
* Greater than moderate mitral valve regurgitation or aortic valve stenosis/regurgitation
* Moderate mitral valve regurgitation combined with moderate aortic valve stenosis/regurgitation
* Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) \< 35 ml/min/1.73 m2 within 60 days prior to the index procedure or patient is on chronic dialysis
* Liver cirrhosis or moderate or severe liver disease (Child-Turcotte-Pugh class B or C, or a score of 7 or higher)
* Thrombocytopenia (Platelet count\< 80,000/mm3) or thrombocytosis (Platelet count \> 750,000/mm3) within 14 days of the index procedure
* In the opinion of the Investigator or the study eligibility committee, the patient's life expectancy \< 12 months
Expanded Access Treatment Protocol With DCA for Patients With PDCD

Expanded Access (EA) will provide a transition to continue therapy for those patients who are currently in the open label extension of the Phase III study, SL 1009-01, while also allowing new patients diagnosed with PDCD who meet the eligibility criteria to also have access to therapy that would be otherwise unavailable.

Expanded Access (EA) will provide a transition to continue therapy for those patients who are currently in the open label extension of the Phase III study, SL 1009-01, while also allowing new patients diagnosed with PDCD who meet the eligibility criteria to also have access to therapy that would be otherwise unavailable. The Expanded Access program (EAP) will also allow the sponsor to extend the collection of long term safety data for the current open label patients, while also expanding to an additional population of patients beyond those currently in the SL 1009-01 study.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 0 through adulthood
2. Presence of characteristic clinical or metabolic features of PDCD and
3. Presence of a known pathogenic mutation of a gene that is specifically associated with PDC (PDHA1, PDHB, DLAT, PDHX, DLD).
4. Females of reproductive age must be willing to use an effective method of barrier contraception for the duration of the study.-

Exclusion Criteria:

1. A genetic mitochondrial disease other than those stipulated under inclusion criteria
2. Primary, defined organic acidurias other than lactic acidosis (e.g., propionic aciduria)
3. Primary disorders of amino acid metabolism
4. Primary disorders of fatty acid oxidation
5. Secondary lactic acidosis due to impaired oxygenation or circulation (e.g., due to severe cardiomyopathy or congenital heart defects)
6. Malabsorption syndromes associated with D-lactic acidosis
7. Renal insufficiency, defined as 1) a requirement for chronic dialysis or 2) serum creatinine ≥ 1.2 mg/dl or creatinine clearance \<60 ml/min
8. Primary hepatic disease unrelated to PDCD
9. Pregnancy or breast feeding -
Effect of Time-restricted Eating on Cognitive Function and Other Biopsychosocial Factors in Menopausal Women Undertaking a 12-week Exercise Programme

The goal of this quasi-experimental study is to test effect of time-restricted eating on cognitive function and other biopsychosocial factors in menopausal women undertaking a 12-week exercise programme. The main questions to answer are:

1. What is effect of time-restricted eating on cognitive function in menopausal women undertaking a 12-week exercise programme?
2. What is effect of time-restricted eating on menopausal symptoms in menopausal women undertaking a 12-weeks exercise programme?
3. What is effect of time-restricted eating on metabolic health parameters in menopausal women undertaking a 12-weeks exercise programme?

Participants of both groups will have moderate intensity circuit mixed endurance and resistance exercise programme two times per week for 55 minutes for 12 weeks. Participants of one of two groups will not only exercise but also have a time-restricted eating following 16:8 protocol for 12 weeks.

Participants will have pre-tests and post-tests:

* blood samples collection (to measure level of brain-derived neurotrophic factor, glial cell derived neurotrophic factor, insulin, glucose, lipid profile),
* body composition analysis,
* Stroop test and N-back test,
* electroencephalography using Emotiv Epic X devices,
* One-repetition maximum test, Ruffier test,
* Questionnaire assessment (using Menopause Rating Scale and The Menopause-Specific Quality of Life Questionnaire).

Researchers will compare two groups - exercise group and combination group which will do both time-restricted eating and exercise to see if there is a modulating effect of time-restricted eating in participants undertaking exercise.


Eligibility Criteria:
Inclusion Criteria:

* perimenopause, menopause or post-menopause
* lightly physically active or physically inactive

Exclusion Criteria:

* using hormone replacement therapy or hormonal contraception
* having significant contraindications to physical exercise or time-restricted eating