cyrilzakka/clinical-trials huggingface dataset:
Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients

To assess the efficacy and safety of 0.5mg Fingolimod (Gilenya) in Chinese patients with relapsing relapsing multiple sclerosis (RMS)

This is a 24-month, open-label, multicenter, interventional, single-arm study to collect efficacy and, safety of oral fingolimod 0.5 mg/day in approximately 100 relapsing multiple sclerosis (RMS) subjects in China.

The study will consist of three Phases:

Screening (up to 1 month): After signing informed consent, subjects will enter a Screening Phase to determine eligibility according to inclusion and exclusion criteria.

Treatment Period (24 months): On visit Day 1, all eligibility criteria will be confirmed, including a pre-dose ECG and vital signs. The first dose of study drug will be taken in the clinic on Day 1 and the subject will be monitored for 6 hours after the first dose administration before discharge. Participants will return to site for evaluation at month 1 and then every three months until the end of treatment up to 24 months.

Follow Up (2 months): Subjects who completed Treatment Period or discontinued from treatment will return for the Follow-up visit 2 months after the last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

* Participant 10 to 17 years old inclusive with weight \> 40kg.
* Participant 18 to 65 years old inclusive;
* Participants with relapsing multiple sclerosis
* Participants never used fingolimod before enrollment
* Subjects with Expanded Disability Status Scale (EDSS) score of 0 - 6.0 (inclusive) at Screening

Exclusion Criteria:

* Participants with certain cardiovascular conditions and/or findings in the screening ECG.
* Diagnosis of macular edema during screening visit.
* Increased risk for opportunistic infections
* Participants with known active malignancies.
* Participants who have been treated with teriflunomide within 3.5 months prior to baseline, except if active washout.
* Participants with severe active infections, active chronic infection.
* Participants with severe liver impairment.
* Pregnant confirmed by a positive pregnancy test or nursing (lactating) women.

Other protocol-specified inclusion or exclusion criteria may apply.
Protective Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants

The purpose of this study is to determine whether the intervention of delaying cord clamping for 30 to 45 seconds followed by one milking of the cord while simultaneously lowering the VLBW infants below the introitus will result in less bleeding in the brain and fewer infections while in the Neonatal Intensive Care Unit (NICU) and better motor skills at 7 months corrected age. The investigators will attempt to identify the mechanisms of effect through measurement of biologic markers.

The current obstetrical practice at birth in the United States is that the umbilical cord of the very low birth weight (VLBW) infant is clamped immediately. When immediate cord clamping occurs, up to 25% of the fetal-placental blood volume may be left in the placenta acutely increasing vulnerability to hypovolemia. Hypovolemia can precipitate a cascade of physiologic events including poor tissue perfusion, ischemia, and initiation of the fetal/neonatal inflammatory response. Intraventricular hemorrhage (IVH) is a major cause of brain injury for preterm infants and is a predictor of poor neurodevelopment outcomes. Late onset sepsis (LOS) is also associated with morbidity and mortality in the NICU and later developmental delay. Of the approximately 57,000 infants born annually at less than 1500 grams, 10% develop cerebral palsy and 25 to 50% show later cognitive and behavioral deficits affecting school performance with higher rates found in males. We propose a trial with a sample of 212 randomized infants to validate our prior findings that delaying the cord clamping lowers the incidence of intraventricular hemorrhage and late onset sepsis, and to identify the mechanisms of effect through the study of biologic markers including measurement of cytokines, circulating stem cells, and red cell volume. Enrolled women in preterm labor will be randomized at birth to the immediate cord clamping group or the delayed clamping group. Assessment of motor outcomes is planned at 7 months corrected age. This study will help to establish a scientific basis for the timing of cord clamping of VLBW infants. The innovation of this study is in the simplicity of delaying cord clamping for 30 to 45 seconds and lowering the VLBW infants at birth. This low-tech change in a clinical practice has the potential to reduce the risk of disease and disability and to improve the neonatal and early childhood outcomes for these most vulnerable preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 24 and 31.6 weeks gestation at risk of delivery
* Vaginal or cesarean birth

Exclusion Criteria:

* Congenital anomaly
* Multiple gestation
* Intent to withhold or withdraw care
* Severe or multiple maternal illnesses
* Mothers who are institutionalized or psychotic
A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 under two different dosing schedules with the objective of defining the dose limiting toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy. The Extension Study portion will allow active subjects to continue to receive ABT-263 for up to 11 years after the last subject transitions with less frequent study evaluations.


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory CLL and require treatment in opinion of investigator.
* Eastern Cooperative Oncology Group (ECOG) \<= 1.
* Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria.

Exclusion Criteria:

* History or is clinically suspicious for cancer-related Central Nervous System disease.
* Receipt of allogenic or autologous stem cell transplant.
* Recent history (within 1 year of first dose) of underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
* Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
* Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose).
Deprescribing DRrugs for Overactive Bladder in General Practice (DROP)

The objective is to understand and evaluate the effectiveness of a deprescribing intervention in primary care, specifically targeting medications for overactive bladder in individuals aged 65 or older.

Potentially inappropriate medication is prescribed medications with an unfavorable risk-benefit profile, for which there might be better, safer, or more cost-effective alternatives. Anticholinergic drugs for Overactive Bladder (OAB) is an example of a potentially inappropriate medication in the elderly, calling for attention and possible deprescribing. Due to their crucial role in maintaining a patient's medication regimen, primary care settings are widely regarded as the optimal location for conducting medication reviews and deprescribing interventions.

This study utilizes a mixed methods explanatory sequential design, nested in a randomised controlled trial to explore deprescribing drugs for Overactive Bladder (OAB). General practices will be randomized into two groups. The intervention group will then be evaluated in a mixed methods setup and finish the study with a comparison to the control group. The mixed methods approach employs a quantitative approach following the intervention group and investigates the prevalence of deprescribing the drugs in question. Secondly, a qualitative approach will be used to delve into the experiences of general practitioners (GPs), support staff, and patients during the deprescribing process. Finally, the quantitative and qualitative findings are merged to gain a comprehensive understanding of deprescribing for OAB. This integrated approach enhances insights and informs future interventions and recommendations. After the mixed methods studies are completed the control group will be used in an overall comparison of the two groups using registry data

Eligibility Criteria:
Inclusion Criteria:

* patient must have been prescribed one of the following drugs for OAB within the last 14 months
* patient must be able to speak and understand Danish

Exclusion Criteria:

* too cognitively impaired to participate or otherwise unfit to participate as estimated by general practitioner
* receiving neurological or urogenital ambulatory care for their overactive bladder symptoms
Continuous Endotracheal Tube Cuff Pressure Monitoring

Tracheal tube cuff pressure in the range of 20 to 30 cmH2O is considered safe, but it is quite common to encounter cuff pressure outside this range in patients with tracheal intubation. Moreover, objective cuff pressure measurement and monitoring are not routinely applied, especially in general anesthesia practice. Overinflation of the cuff can potentially impair tracheal mucosal blood flow. This may lead to various tracheal injuries such as mucosal inflammation, mucosal ischemia, tracheal ulceration, tracheal stenosis, tracheoesophageal fistula, and tracheal rupture. Conversely, inadequate cuff inflation can lead to inadequate ventilation and microaspiration. The importance of routine cuff pressure measurement and pressure adjustment to keep the pressure in the desired range is emphasized in preventing such side effects in intubated patients. Despite this recommendation for routine intracuff pressure measurement, the methods used to measure and monitor cuff pressure vary from subjective estimation techniques to objective measurements, and there is a lack of specific protocols and documents in the current literature. For this purpose, in this study, it was aimed to perform continuous cuff pressure measurement monitoring using the transducer of the invasive pressure monitoring device, which is routinely used in arterial or central venous pressure monitoring, and to test the effectiveness of this method in reducing cuff-related complications including sore throat, hoarseness, and dysphagia compared to the intermittent monitoring method.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age adult patients
* Elective non-head-neck surgical procedures under nitrous oxide (N2O)-free general anesthesia
* Patients orally intubated with a cuffed endotracheal tube facilitated by neuromuscular blockers
* Surgeries with neutral head-neck position

Exclusion Criteria:

* Emergency surgery
* Laparoscopic surgery
* Head and neck surgeries including nose, mouth, pharynx, larynx and throat
* Surgeries with non-supine patient position
* Patients with preoperative sore throat, cough, hoarseness or dysphagia, history of smoking, asthma or COPD, severe cardiovascular disease, inability to obtain consent, having any lesions detected in the pharynx or larynx during laryngoscopy
* Use of double lumen tracheal tube
* Use of a naso- or orogastric tube or any pharyngeal catheter
* Intraoperative nitrous oxide use
* Difficult intubation or repeated endotracheal intubation attempt
* Patients who strain during endotracheal extubation
* High PEEP (greater than 5 cmH2O) application
Evaluating Patient Participation in Phase I Clinical Trials

RATIONALE: Understanding why patients participate in a phase I clinical trial may help doctors plan better treatment for cancer.

PURPOSE: This clinical trial is studying to determine the reasons for participation, perceptions, and expectations of patients receiving treatment for cancer in phase I clinical trials.

OBJECTIVES:

* Describe the motivations, perceptions, and expectations of patients enrolled in a phase I clinical trial.
* Assess the influence of age, education, and gender upon the perception of these patients.
* Compare the difference in perceptions, motivations, and expectations of patients who have previously participated in a phase I clinical trial vs those who have not.
* Determine whether patients' perceptions, motivations, and expectations change while enrolled in a phase I clinical trial.
* Validate an interviewer-administered tool measuring the perceptions, motivations, and expectations of these patients.
* Assess patients' perception of the information they were given while enrolled in a phase I clinical trial.

OUTLINE: Patients are interviewed over the phone to evaluate their perceptions, motivations, and expectations of phase I clinical trials. Patients complete a questionnaire comprising 24 questions over 30-45 minutes. Interviews are conducted within 1 week after enrolling in a phase I clinical trial (prior to the first dose of study agent) and then again 2 months later (or at the time the patient stops treatment). The first 10 patients enrolled complete an additional 6 questions over 15 minutes during the first interview to validate the questionnaire, but do not complete a second interview.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Enrolled in a phase I clinical trial within the past week

  * Signed an informed consent for a phase I trial

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Able to follow basic verbal instructions as witnessed by the investigator or a representative
* Able to understand and speak English as determined by the investigator or a representative
* Access to a telephone

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* Prior participation in a phase I clinical trial allowed
Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Type 2 Diabetes Patients

Worldwide, health systems and practitioners are facing obesity epidemics. High blood pressure, dyslipidemia and diabetes prevalence will explode during the 21st century.

The two main objectives of this 2-year controlled prospective study are:

1. to demonstrate that, for patients with high blood pressure, diabetes and dyslipidemia, dietician conducted survey and management in combination with annual endocrinologist follow-up enable both attainment and maintenance of recommended blood pressure, glycemic and lipid goals, as well as smoking cessation;
2. to demonstrate that dietician management is more cost effective than conventional care provided by general practitioners and endocrinologists.

Results are expected to show significantly different cardiovascular risk profiles (BMI and waist circumference, systolic and diastolic blood pressure, LDL-C, triglycerides and Total cholesterol/HDL ratio, HbA1c, smoking) between baseline and after 2 years follow-up. Sample size was determined in order to show statistically significant differences between the two groups.

Results will document for the benefit of care givers, health economists and policy makers alike an innovative and integrated model of care which is expected to be effective at the patient level as well as cost effective with respect to the increasing financial burden of diabetes on the health system.


Eligibility Criteria:
Inclusion Criteria:

* HbA1c \> 7%
* More than 2 follow-up visits
Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder

The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD).


Eligibility Criteria:
Inclusion Criteria:

* Subjects provides written informed consent
* Screening intact PTH (iPTH) ≥ 350 pg/mL and corrected calcium ≥ 8.5 mg/dL
* Hemoglobin ≥ 8.5 g/dL
* Serum transaminases (alanine transaminase \[ALT\], aspartate transaminase \[AST\]) less than 2.5 times the upper limit of normal
* Adequate hemodialysis three times per week

Exclusion Criteria:

* History or symptomatic ventricular dysrhythmias
* History of angina pectoris or congestive heart failure
* History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months
* History of or treatment for seizure disorder within the last 12 months
* Postdialysis systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 90 mmHg
* Serum magnesium below the lower limit of normal at screening
HIV, Buprenorphine, and the Criminal Justice System (STRIDE2)

STRIDE2 is a longitudinal, non-randomized study of individuals living with HIV who are dependent on opioids. This study is funded by the National Institute on Drug Abuse (R01DA030768, Altice, PI; Taxman \& Lawson, Co-PIs) and is being conducted by George Mason University, Yale University, and Howard University.

STRIDE2 will assist in identifying and monitoring individuals' HIV risk behaviors and provide resources to seek treatment for their HIV care and substance use. The goal of STRIDE2 is to examine if there are differences in HIV, drug use, and other outcomes between individuals receiving treatment versus individuals actively using, not actively using and not in treatment, and individuals on Methadone, Suboxone, or in some other treatment.

Eligibility Criteria:
Inclusion Criteria:

1. HIV+, confirmed by rapid HIV test
2. Meet DSM-IV criteria for opioid dependence
3. 18 years or older
4. Have health insurance that is accepted at Lab Corp.

Exclusion Criteria:

1. Are \<18 years old;
2. Are HIV negative;
3. Are Unable to communicate in English;
4. Are not able to provide informed consent;
5. Do not meet DSM-IV criteria for opioid dependence;
6. Plan to leave the DC area
Multiple Disseminated Hydatidosis With Rare Locations

Hydatid disease is an anthropozoonosis due to the development of the larval form of Echinococcus granulosus in the human body, which constitutes a 'dead-end' host. It's a common parasitosis in North African countries and constitutes a public health problem in Morocco. The liver and lung are the most affected while the mediastinum, pancreas and pelvis are rarely affected. We report the case of a 40-year-old patient operated 15 years ago for cerebral and cervical hydatid cysts and who was hospitalized for generalized mucocutaneous jaundice. On exploration, we discover the presence of disseminated abdominal hydatidosis with association of 3 rare locations: mediastinal, pancreatic and pelvic. Indirect diagnostic tests were positive: indirect hemagglutination (IHA) and Elisa. The Western blot test also showed the presence of specific bands, thus making it possible to retain the diagnosis of hydatidosis.

The hydatid cyst with mediastinal, pancreatic and pelvic location is rare and their association is very exceptional. It is essential to evoke the hydatid origin of any cystic lesion in a patient staying in an endemic area.


Eligibility Criteria:
Inclusion Criteria:

* none

Exclusion Criteria:

* none
Statins and Selective Cyclooxygenase-2 Receptor Inhibitors in Blunt Chest Trauma

Background: Lung contusion affects 17%-25% of adult blunt trauma patients, and is the leading cause of death from blunt thoracic injury. Statins are lipid-lowering drugs with recently suggested anti-inflammatory and antioxidant properties. Cyclo-oxygenase-2 (COX-2) is a key enzyme in the production of prostaglandins (PG), and evidence suggests that COX-2 plays an important role in the pathogenesis of acute lung injury (ALI).

Aims: The current study aims at evaluating the beneficial effects of statins and COX-2 receptor inhibitors on ALI elicited by blunt trauma to the chest.

Methods: After approval by the institutional ethics and a scientific committee, and obtaining informed consent , patients admitted to the emergency department (ED) due to blunt trauma with a diagnosis of lung contusion will be enrolled in the study.The effects of statins and COX 2 inhibitors on ALI will be assessed by recording clinical parameters and measuring inflammatory mediators levels in the serum and in the bronchoalveolar space.

Expected results: The investigators expect to find that the proposed treatment will be effective in reducing ALI burden. The investigators also suppose that using a combination of those drugs will synergistically potentiate their effect on ALI.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age
* Diagnosis of lung contusion by physical examination, chest xrays, history by the patient, accompanying persons or police.
* Ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation.
* Admission to ward

Exclusion Criteria:

* Penetrating trauma
* Current use of lipid-lowering therapy, use of non steroidal anti-inflammatory drugs.
* Current use of postmenopausal hormone-replacement therapy
* Evidence of hepatic dysfunction (an alanine aminotransferase level more than twice the upper limit of the normal range), a creatine kinase level more than three times the upper limit of the normal range.
* Creatinine level higher than 2.0 mg/dl
* Known uncontrolled hypertension (systolic blood pressure \>190 mm Hg or diastolic blood pressure \>100 mm Hg
* History of uncontrolled hypothyroidism (thyroid-stimulating hormone level\> 1.5 times the upper limit of the normal range)
* Psychiatric disorders
* Pregnancy
* Known allergy or intolerance to one of the protocol drug
The Effects of Thrust Joint Manipulation on the Resting and Contracting Thickness of Transversus Abdominis in Subjects With Low Back Pain

The primary aim of this study is to examine how different physical therapy interventions affect the resting state and contraction state of a certain abdominal muscle in patients with low back pain.

Patients with low back pain (LBP) will undergo ultrasound imaging of the transversus abdominis to measure the muscle thickness at rest and at the contracted state prior to intervention and again immediately after intervention. In this randomized controlled trial, patients will be randomized into one of two groups. One group will receive the intervention of thrust joint manipulation of the lumbar spine and the other group will receive the intervention of non-thrust joint manipulation of the lumbar spine.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 18-70 years of age with primary symptom of LBP, with or without referral into lower extremity.
* Subjects must be able to read and write in English.

Exclusion Criteria:

* Presence of serious pathology.
* Diagnosis of spinal stenosis or symptoms in both lower legs (changes in sensation, muscle weakness).
* Any history of low back surgery, rheumatoid arthritis, osteoporosis, osteopenia, scoliosis, or ankylosing spondylitis.
* Pregnancy
* Pending legal action.
* Prior surgery to the lumbar spine or fractures of the lumbar spine.