cyrilzakka/clinical-trials huggingface dataset:
DISH Data Analysis Study

To perform extensive analyses of data from the Dietary Intervention Study of Hypertension (DISH)..

BACKGROUND:

DISH was a multicenter, controlled, randomized study conducted in 1980-1983 of 496 patients, who were formerly participants in the Hypertension Detection and Follow-up Program and who had their blood pressure well controlled with medication. At DISH baseline they were randomized to continue medication or to be withdrawn from antihypertensive medication to determine if weight reduction or sodium restriction/potassium increase interventions could maintain these people under blood pressure control without drugs. Only the main findings regarding diastolic blood pressure control under the different diet regimens, were analyzed and reported during the course of DISH funding. Many questions which could be uniquely addressed by this comprehensive data base remained unexplored.

DESIGN NARRATIVE:

The investigators explored the questions dealing with demographic, clinical and physiologic predictors of relapse to the hypertensive state. They also analyzed the mortality experience of this cohort five years post DISH in relation to the DISH randomization groups and in relation to success in remaining off drugs during DISH. They did this by querying the National Death Index to determine who of the DISH participants died following the termination of DISH.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Study of Lithium Carbonate to Treat Niemann-Pick Type C1 Disease

This study is planned to study whether lithium carbonate has protective effect on the brain of Niemann-Pick disease type C1.


Eligibility Criteria:
Inclusion Criteria:

1. aged from 7 years to 40 years
2. onset of neurological symptoms prior to 15 years of age
3. confirmed diagnosis of NPC1 determined by either two NPC1 mutations or one NPC1 mutation with elevated plasma 7-ketocholesterol
4. ability to walk either independently or with assistance
5. Subject or parent/guardian able to communicate with investigator, understand and abide the rules of this clinical trial.
6. parent/guardian able to accompany the subjects to participate in the clinical trial
7. Subject or parent/guardian must provide written informed consent

Exclusion Criteria:

1. One NPC clinical severity scale score reached 5
2. Female in pregnancy or breastfeeding
3. The predicted life span less than 1 year
4. Severe liver insufficiency (defined as hepatic laboratory parameters, AST and/or ALT greater than three-times the upper limit of normal
5. Renal insufficiency, with the serum creatine greater than 1.5 times the upper limit of normal
6. Free with neurological symptoms
7. Take antidiuretic hormone
Unknown Cause of Acute Liver Failure

The purpose of the study is to evaluate the outcome and to determine predictive factors of patients admitted in a context of acute liver failure without identified cause.

Methodology: Multicentric French national cohort with prospective collection of data and constitution of biobank, in patients hospitalized in a context of acute liver failure without known cause at admission. Follow-up during 3 months for each patients. The primary objective is to determine predictive factors of early mortality. This study is an observational cohort and patients will received standard care during the follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Acute liver failure defined by a PT\<50% or INR\>1.5;
* with or without hepatic encephalopathy;
* without cause identified at admission, and non A non B hepatitis;
* age\>18 year old;
* signed an informed consent.

Exclusion Criteria:

* chronic liver disease;
* Patient under guardianship
Therapeutic Strategy in Patients Treated With Methotrexate for Rheumatoid Arthritis

This is a longitudinal, observational, prospective, multicentre study conducted in metropolitan France, among a representative sample of office-based or mixed practice rheumatology doctors.

The aim of this study is to describe in real life, the therapy strategy when faced with a patient treated with methotrexate as a monotherapy consulting for rheumatoid arthritis and the impact on the progression of the disease at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient, ambulatory, seen in a rheumatology consultation.
* With a confirmed diagnosis of RA (ACR 1987 or ACR/EULAR 2010 criteria) receiving a disease-modifying treatment with methotrexate as a monotherapy.
* With clinical, functional, structural and/or therapeutic disease progression, for whom the rheumatologist intends to change the therapeutic treatment of the RA .
* Informed about the computer processing of their medical data and their right of access and correction.

Exclusion Criteria:

* Patient not treated with methotrexate for their RA.
* Already treated with a biotherapy or receiving other synthetic DMARDs (disease-modifying antirheumatic drugs) in combination with methotrexate .
* Participating in a clinical trial in rheumatology.
Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years

GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. The current study will provide pivotal data in support of extending the age range for Boostrix vaccine to include adults 19-64 years of age.


Eligibility Criteria:
Inclusion Criteria:

* A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday) at the time of study vaccination.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding administration of study vaccine, or planned use during the active phase of the study.
* Chronic administration of immunosuppressants or within six months prior to administration of study vaccine.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of study vaccine (with the exception of an influenza vaccine).
* Administration of a diphtheria-tetanus (Td) booster within previous five years.
* Administration of Tdap vaccine at any time prior to study entry. History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.
Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis

This randomized,controlled, multicenter, 2-arm, parallel-group, double-blind, prospective, Phase 1 study is designed to demonstrate comparable pharmacokinetics in terms of AUC0-last and Cmax (after second infusion) between CT-P10 and MabThera in patients with active RA concomitantly treated with MTX during the Core Study Period.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has a diagnosis of RA according to the revised 1987 ACR classification criteria (Arnett et al 1987) for at least 6 months prior to randomization.
2. Patient has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed) and 6 or more tender joints (of 68 assessed), and serum CRP ≥1.5 mg/dL or an ESR ≥28 mm/hour.

Exclusion Criteria:

1. Patient is unresponsive or intolerable to more than 2 biologic agents.
2. Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins.
3. Patient has current or past history of chronic infection with hepatitis B, hepatitis C, or infection with human immunodeficiency virus (HIV)-1 or -2 or who has a positive result to the screening test for these infections.
Dexmedetomidine Versus Midazolam-Fentanyl for Analgesia and Sedation

Postoperative sedation is an essential component in recovery of the patient undergoing cardiac surgery. It facilitates the patient's unawareness of the environment as well as reduce the discomfort and anxiety caused by surgery, intubation, mechanical ventilation, suction, and physiotherapy.

Despite the advances in anesthesia and surgical techniques, the duration of mechanical ventilation (MV) may be prolonged after cardiac surgery, due to the classic high-dose narcotic-based cardiac anesthesia.

In recent years, fast-track extubation (FTE) protocols have been developed to reduce the long period of intubation and complications that may occur due to the long duration of MV. Potential advantages of FTE protocols following surgery for congenital cardiac disease are reduced ventilator-associated pulmonary complications and the negative effects of positive pressure ventilation, reduced nosocomial infections, postoperative atelectasis, reduced requirements of sedatives and analgesic drugs, early enteral feeding, rapid patient mobilization, and shorter intensive care unit (ICU) stay.

The ideal analgesic-sedative agents would keep the patient comfortable without anxiety. It would effectively provide adequate sedation, but also allow neurologic evaluation of the patient, ideally without stopping administration of the drug. It would have minimal hemodynamic and respiratory depressant effects. It also would have a rapid onset and offset of action without drug accumulation or active metabolites, making it easily titratable and allowing rapid recovery with a prompt return to normal activity after discontinuation.

Opioids and benzodiazepines are the most frequently used analgesic-sedative agents after cardiac surgery. Although opioid can provide excellent analgesia, the doses for effective pain relief may lead to undesirable side effects, such as respiratory depression requiring prolonged MV, hemodynamic instability, tolerance, and significant withdrawal symptoms that also delay patient recovery.

Dexmedetomidine is a highly selective α2-adrenoreceptor agonist. Presynaptic activation of α2-adrenoreceptors at sympathetic nerve endings inhibits catecholamine release. The major effect of dexmedetomidine is maintaining sedation-analgesia without a respiratory depressant effect. It has relatively few cardiovascular side effects and produces sleep-like sedation without narcosis or respiratory depression.

Indeed, current guidelines recommend lighter levels of sedation to manage ventilated patients preferably using nonbenzodiazepine sedatives. Nevertheless, there is currently no consistent recommendation regarding which nonbenzodiazepine sedative agents should be used.

Eligibility Criteria:
Inclusion Criteria:

- This study will include patients undergoing elective adult valvular cardiac surgeries

Exclusion Criteria:

* Patient refusal.
* Emergent valve cardiac surgeries.
* Patients with known hypersensitivity to study drugs.
* History of uncontrolled diabetes or hypertension.
* Impaired kidney or liver functions.
* Perioperative hemodynamic instability.
A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics

The purpose of this Phase I study is to determine the safety of a drug called dexmedetomidine (DEX) as part of a balanced general anesthetic and sedative strategy for neonates and infants undergoing corrective cardiac surgery that requires the use of cardiopulmonary bypass for congenital cardiac problems. This study will also design and validate a dosing schema for the use of DEX as described above.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age 0 to 180 days at the time of surgery.
2. Diagnosis of: D-transposition of the great arteries (with or without ventricular septal defect), or tetralogy of Fallot, or ventricular septal defect (with or without associated atrial septal defect and/or patent ductus arteriosus)
3. Scheduled for complete corrective two-ventricle surgical repair with cardiopulmonary bypass.

Exclusion Criteria:

* 1. Less than 37 completed weeks' gestational age at birth for the Neonatal age group (0-21 days); less than 36 completed weeks' gestational age at birth for the Infant age group (22-180 days).

  2. Enrollment in the PHN Collaborative Learning Study, if tetralogy of Fallot 91-180 days of age only.

  3. Known or suspected hepatic dysfunction; AST and ALT \>3X upper limit of normal at the time of screening within 72 hours of operation.

  4. Known or suspected renal dysfunction; serum creatinine \> 0.8 mg/dL after 7 days of age, \>1.2 mg/dL if \<7 days of age, within 72 hours of operation.

  5. Preoperative administration of DEX or clonidine within 72 hours of operation.

  6. Major congenital anomaly(ies) outside the cardiovascular system that in the investigator's opinion would potentially affect safety or pharmacokinetics.

  7. Preoperative central nervous system injury resulting in clinical signs and symptoms: coma, seizures, hemiparesis.

  8. Planned period of deep hypothermic circulatory arrest. 9. History of second or third degree heart block. 10. Sinus or junctional bradycardia below 80 BPM sustained for greater than 15 minutes within 72 hours of operation. 11. Junctional rhythm sustained for greater than 15 minutes within 72 hours of operation.

  12. Hypotension defined as mean arterial blood pressure below 35 mm Hg for 0-21 day old neonatal patients, and below 40 mm Hg for 22-180 day old infant patients sustained for greater than 15 minutes within 72 hours of operation.

  13. History of cardiac arrest or ECMO cannulation.
Bedside Nursing Handovers in the Surgical Context

Nursing handovers are performed 2-3 times a day for each patient, with an approximate average of 2 million nursing deliveries per year in a hospital of medium size. Nursing handovers are considered essential for the continuity and safety of care. If the relevant clinical information is not shared in a precise and timely manner, it may worsen the patients' outcomes with an increase in adverse events, delays or inappropriate treatment until the omission of procedures.

The modality of nursing delivery presents, therefore, a gap of vulnerability where vital information could not be considered and systematically shared.

Patients should be involved in their care to promote a patient-centred approach. The involvement of patients in handovers is effective compared to other delivery methods.

To date, however, the best mode to deliver handovers was still unclear due to a systematic lack of studies to identify the best practice of nursing handovers. The studies in the literature lack of sound methodologies due to not randomized designs.

Thus an intervention to improve quality of handovers and to implement bedside handovers in surgical wards will be performed.

The following hypotheses were made:

* The introduction of nursing bedside handovers will improve the quality of the information exchanged.
* The educational intervention training intervention will positively modify the nursing handovers.
* There is a relationship between the qualitative level of nursing handovers and working status (expert vs novice) of the nurses.
* There is a relationship between the qualitative level of nursing handovers and the patients' characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Surgical patients
* All nurses working with surgical patients who attended the educational intervention

Exclusion Criteria:

* Nurses who did not participate in the educational intervention
* Nursed who did not operate stably in the surgical wards included in the study
* New hired nurses
An Open-Label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62% Applied to the Upper Arms and Shoulders and Use of a T-shirt Barrier

Single-center, single dose, open-label study in healthy male and female volunteers to further characterize the transfer potential of Testosterone Gel 1.62% formulation.

Single-center, single dose, open-label study in 12 healthy male and 12 healthy female volunteers to further characterize the transfer potential of Testosterone Gel 1.62% formulation.

Eligibility Criteria:
Inclusion Criteria

* BMI between 20-35 kg/m\^2 inclusive.

Exclusion Criteria

* Males: history, current or suspected prostate or breast cancer.
* Females: pregnant or lactating.
Cross-cultural Adaptation, Evaluation and Validation of Wang Qi's Constitution of TCM Questionnaire (For Old Person)

This is a cross-cultural adaptation, evaluation and validation study of Wang Qi's Constitution in TCM questionnaire (For Old Person) in Hong Kong to investigate the content validity, construct validity and reliability of the CTCMQ-C in Cantonese speaking Hong Kong Chinese elderly population.

The study includes two steps. Firstly, translation of the questionnaire into Cantonese, followed by cross-cultural adaptation. Ten Chinese Medicine Practitioners (CMPs) and 30 patients will be recruited from the community and the outpatient clinics of Hong Kong Baptist University (HKBU) to evaluate the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C) for content validity by the cognitive debriefing interviews. The content validity indices (CVI) of clarity, relevance and appropriateness of each item of the questionnaire rated by CMPs and patients will be quantified. The interpretations of items and suggestions of rewording by the patients and CMPs will be analyzed qualitatively to identify any item of the questionnaire that is not valid for the Chinese population in Hong Kong. Secondly following the validation study, 264 patients will be recruited. A validated CTCMQ-C will then be generated and will be endorsed by expert panel to use in the subsequent cross-sectional and cohort studies to evaluate the preventive effect with Chinese Medicine approaches. The psychometric properties including construct validity by scaling assumptions, confirmatory factor analysis (CFA) and reliability of the CTMCQ-C will also be tested.

Eligibility Criteria:
Inclusion Criteria:

* aged 65 and above;
* Hong Kong residents;
* capable of consenting and have agreed to participate.

Exclusion Criteria:

* not fulfill the above inclusion criteria;
* having serious diseases with undesirable conditions that unable to complete the survey;
* having serious mental and behavioral disorders.
Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy

The purpose of this study is to evaluate the effect of subcutaneous administration of immunoglobulin compared to intravenous treatment, for multifocal motor neuropathy

NB. ONLY RECRUITING FROM DENMARK

Introduction Intravenous immunoglobulin (IVIG) treatment is the only established treatment modality in Multifocal Motor Neuropathy (MMN). In order to maintain neuromuscular performance patients require lifelong treatment. Hospital-based treatments have high cost and inconveniences to patients, particularly in chronic disorders. Immunoglobulin preparations are now available for subcutaneous use as IgG replacement therapy. The safety and efficacy of subcutaneous infusion is reported to be comparable to i.v. preparations, and has been applied successfully in other autoimmune disorders. However patients with MMN have not previously been treated with subcutaneous immunoglobulin.

Hypothesis:

Subcutaneous immunoglobulin treatment is efficacious and safe with less patient inconvenience.

Primary endpoint:

Isokinetic muscle strength at the end of treatment A vs B (subcutaneous vs i.v.)

Secondary endpoint:

Medical research council score (MRC-score), 9-hole peg test, 10m walking, Nerve conduction parameters, SF-36.

Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of multifocal motor neuropathy, supported by electrophysiological findings

Exclusion Criteria:

* Other severe medical conditions
* Pregnancy and lactation
* Anti-coagulation therapy
A Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or the Buttock Muscle in Patients With Schizophrenia

The purpose of this study is to evaluate the safety and tolerability of intramuscular injections (to the buttocks or to the shoulders) of paliperidone palmitate in patients with schizophrenia.

To date, all prior trials involving intramuscular injection of paliperidone palmitate were conducted with buttock administration. This is a randomized, multicenter, crossover design study in evaluating safety and tolerability of paliperidone palmitate in two different injection sites. The study hypothesis is that there will be no difference in safety and tolerability between buttock injection compared to shoulder injection at any of the three different doses of paliperidone palmitate. The patients will receive intramuscular injections of paliperidone palmitate in either their buttocks or in their shoulders

Eligibility Criteria:
Inclusion Criteria:

* The patient must have signed an informed consent
* The patient must meet the diagnostic criteria for schizophrenia
* Female patient must be postmenopausal for at least 2 years or have negative pregnancy test result at screening
* The patient must be able to perform study requirements (e.g. answer questionnaire)

Exclusion Criteria:

* Primary, active diagnosis other than schizophrenia
* Psychiatric inpatient hospitalization for relapse of symptoms of schizophrenia in the past 90 days
* Change in their antipsychotic medication in the past 45 days
* Diagnosis of active substance dependence within 3 months
* History of treatment resistance
* History of concurrent significant or unstable diseases (e.g. heart, lung, or liver diseases)