cyrilzakka/clinical-trials huggingface dataset:
An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

The purpose of this study is to assess the efficacy and safety of CNTO6785 in participants with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.

This is a randomized (participants are assigned to treatment by chance), double-blind (participants and study personnel will not know which treatments are being given), placebo-controlled (a placebo appears identical to a study drug but has no active ingredients), multicenter study. The study will consist of 3 phases: a screening phase, a treatment phase, and a follow-up phase. Approximately 250 participants with active RA despite MTX therapy will be randomly assigned to receive placebo or CNTO 6785 during the double-blind treatment phase. The maximum period of active treatment will be 28 weeks. The maximum duration of study participation will be 44 weeks. Participant safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the American Rheumatism Association) and have had RA for at least 6 months prior to the date of signing the informed consent at screening
* Have active RA defined study as persistent disease activity with both of the following criteria: at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline; and serum C-reactive protein (CRP) ≥ 0.8 mg/dL at screening or erythrocyte sedimentation rate (ESR) ≥ 28 mm in the first hour at screening or baseline
* Have been treated with and tolerated methotrexate (MTX) treatment at dosages from 7.5 to 25 mg/week, inclusive, for a minimum of 6 months prior to screening and must have a stable MTX dose for a minimum of 6 weeks prior to the first dosing with study agent

Exclusion Criteria:

* Has inflammatory diseases other than RA, that might confound the evaluation of the benefit of study agent therapy
* Has a diagnosis of fibromyalgia
* Has a recent history (within 12 months prior to screening) of uncontrolled, chronic disease including, but not limited to, pulmonary, psychiatric, and metabolic disturbances, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, or urological diseases that the investigator believes are clinically significant
* At screening, the results of laboratory tests must meet protocol-specified criteria
* Has ever received any approved or investigational biologic agent for a rheumatic indication
A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents

Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subject ≥ 18 years of age.
* Subject meets DSM-IV criteria for a primary diagnosis of schizophrenia or schizoaffective disorder.
* Subject must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to insufficient efficacy and/or safety or tolerability concerns.

Exclusion Criteria:

* Presence of an Axis I or Axis II disorder other than schizophrenia or schizoaffective disorder that is the primary focus of treatment prior to screening.
* Subject has experienced persistent lack of improvement in psychotic symptoms despite adequate trials (at least 6 weeks at standard doses), of two or more antipsychotic agents in the 12 months prior to screening.
* Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or property. Subject has suicidal ideation at baseline or has attempted suicide within 90 days prior to randomization (even without hospitalization).
Mother's Gift Project

This prospective randomized evaluation of pneumococcal vaccine immunization of pregnant mothers, followed by pneumococcal conjugate immunization of their children is designed to assess the effects of these strategies on the immunogenicity and safety of both vaccines. We hypothesize that maternal followed by infant immunization will be safe and will provide higher levels of antibody from birth through 12 months of age.

This is a randomized vaccine evaluation in 4 groups of mothers and their infants, to assess the effect of maternal immunization on the infants' response to pneumococcal vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Mothers from 18 to 14 years of age in the third trimester of pregnancy,
* with normal medical and obstetric history,
* who plan to deliver their infant in Dhaka city and remain there for 12m

Exclusion Criteria:

* Maternal history of systemic disease,
* Maternal history of previous complicated pregnancies, preterm delivery, abortions, or birth with congenital anomalies.
* Maternal hypersensitivity to any vaccination, or
* Maternal receipt of pneumococcal vaccine in the last 3 years.
Evaluation of the Satisfaction of the Patients Operated for a Mild Hyperplasie of the Prostate by Laser in Ambulatory Surgery

Every year more than 70 000 interventions for prostatic adenoma are realized. Several type of surgery are realized going of the ambulatory to longer hospital lengths of stay. There are also several techniques.However it appears that ambulatory surgery is less costly. The arguments of surgeons are patients reluctance or the difficulty to manage in case of complication.

The aim of the study is to show that there is a good acceptance from patient with a good level of satisfaction at day 30.


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18
* patient with benign prostatic hyperplasia
* ambulatory eligibility

Exclusion Criteria:

* recused for ambulatory surgery
* Patients operated by surgeons not having ended their learning curve.
Metabonomics to Investigate Effects of Healthy Diets on Blood Pressure: the OmniHeart Study

To compare the urinary metabolomes on individuals undergone three different healthy diets--a carbohydrate-rich diet, a protein-rich diet, or a diet rich in unsaturated fat.

BACKGROUND:

This study based on the OmniHeart dietary intervention study, a randomized, three period cross-over feeding study that compared the effects on blood pressure and plasma lipids of three DASH-like diets: a carbohydrate-rich (CARB) diet pattern, a rich in protein (PROT) and a rich in unsaturated (MUFA) fat, predominantly monounsaturated fat diet (see full details of OmniHeart dietary intervention https://clinicaltrials.gov/ct2/show/record/NCT00051350).

This metabonomic study aims to evaluate the feasibility of identifying individuals showing variation in clinical response to three different healthy diets, with the purpose of reducing cardiovascular disease (CVD) risk, using proton nuclear magnetic resonance (NMR) based metabolic phenotyping approach.

Eligibility Criteria:
Inclusion Criteria:

* with pre-hypertension (systolic BP of 120 to 139 mmHg and/or diastolic BP of 80 to 89 mmHg) or stage 1 hypertension (systolic BP of 140 to 159 mm Hg and/or diastolic BP of 90 to 99 mm Hg) and without diabetes or prior CVD

Exclusion Criteria:

* CVD or diabetes
QLB Versus PVB for Acute Pain and Quality of Recovery After Laparoscopic Partial Nephrectomy

This trial is a prospective, randomized, single-center, open-label, parallel-arm, blinded-analysis trial, the objective of which is to evaluate the effect of transmuscular quadratus lumborum block (TMQLB) in the pain relief and quality of recovery in laparoscopic partial nephrectomy compared with thoracic paravertebral block (TPVB).


Eligibility Criteria:
Inclusion Criteria:

Age 18-70 yrs American Society of Anesthesiologists physical statusⅠ-Ⅲ Undergo laparoscopic nephrectomy Informed consent

Exclusion Criteria:

A known allergy to the drugs being used Coagulopathy, on anticoagulants Analgesics intake, history of substance abuse Participating in the investigation of another experimental agent Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
Noninvasive Determination of Cerebral Tissue Oxygenation in Pulmonary Hypertension

To study the effect of acute pulmonary vasodilatation on cerebral tissue oxygenation (CTO) and cerebral blood flow (CBF) as indicator for cerebrovascular autoregulation in comparison to the effects of supplemental oxygen, decreased carbon dioxide by hyperventilation and exercise in patients with pulmonary hypertension (PH) undergoing clinically indicated right heart catheterisation (RHC).

Oxygenation and hemodynamic parameters will be assessed during RHC according to standard procedures. Non-invasive near infrared spectroscopy (NIRS) and a nasal canula will be additionally applied to measure CTO, CBF and endtidal CO2 (EtCO2). All parameters will be obtained at rest breathing room air, during an oxygen challenge, during standardized hyperventilation, under vasodilatation testing and during exercise in random, single-blinded sequences (except for exercise and hyperventilation). Pulmonary, systemic and cerebral oxygenation parameters and hemodynamics will be correlated with each other and functional class, quality of life, exercise and cognitive assessments at the time of the RHC and after three month.


Eligibility Criteria:
Inclusion criteria: Inclusion criteria are age 18 years or older, to be scheduled for RHC due to suspected or known PH and the ability to give informed consent. Both genders will be accepted.

Exclusion criteria: Exclusion criteria are: inability to follow the study due to language or cognitive problems (e.g. a major active psychiatric disorders, prior traumatic brain injury, and neurologic disease), dementia on the basis of a Mini Mental State Test and pregnant women.
Pharmacist Management of Paxlovid eVisits

The goal of this cluster randomized trial is to compare two modes of management -- pharmacist care vs. pooled adult and family medicine physician care -- for electronically submitted requests (e-visits) for Paxlovid by adults with COVID-19. It will compare quality of care based on counseling for common potential drug-drug interactions and time to prescription, as well as the time and financial costs of care in the two groups.

Importance. Enhancing the management of messages from patients and providing virtual options for urgent care are top priorities for The Permanente Medical Group (TPMG) and Kaiser Foundation Hospitals/Health Plan (KFH/P).

Objective. To compare pharmacist management of e-visit requests for Paxlovid for COVID-19 with management by adult and family medicine physician pools regarding costs, time, clinical outcomes, and patient and clinician satisfaction.

Design, setting, and participants. This cluster randomized clinical trial will include adults from 17 medical facilities of Kaiser Permanente Northern California who make Paxlovid e-visits on weekdays from October 9 to December 11, 2023.

Intervention. In the intervention group, a regional team of pharmacists will manage Paxlovid e-visits following a standard protocol; in the comparison group, adult and family medicine physicians (AFMs) will manage these visits according to medical center-based protocols.

Main Outcomes and Measures. The primary outcome is whether a patient with one or more common drug-drug interactions received counseling for any drug-drug interaction. Secondary outcomes are the hours from the e-visit request to the prescription among patients who receive one and the clinician time and cost per visit managed.

Potential Results. We will test the hypotheses that Pharmacist Care compared with AFM Pool Care will have higher quality of care and lower costs based on the receipt of counseling for common drug-drug interactions, faster time to prescriptions, and lower clinician time and cost per visit managed.

Potential Conclusions and Relevance. If pharmacist management has better or similar outcomes compared with AFM pool management, this will provide support to continue this practice for Paxlovid e-visits and to evaluate possible expansion of pharmacist management for similar clinical situations.

Eligibility Criteria:
Inclusion Criteria:

* Patients making Paxlovid e-visits on weekdays from 8:00 am to 4:30 pm during the study period

Exclusion Criteria:

* None
Misoprostol for Cervical Priming Prior to Vacuum Aspiration

Despite of the widespread use, and extensive studies, the optimal route of administration of misoprostol before surgical abortion remains to be defined. Following administration of 400 mcg vaginally as per clinical guidelines, the time for optimal priming seems to be 3 hours, but the longer the interval the greater the risk or bleeding and expulsion of the uterine contents before the surgical evacuation. Sublingual administration seems to give adequate plasma concentration and cervical priming faster than oral or vaginal administration. This may allow a shorter waiting time with maintained efficacy, less side effects and logistic advantages.


Eligibility Criteria:
Inclusion Criteria:

* women opting for first trimester surgical abortion
* nulliparous
* able and willing to provide informed consent

Exclusion Criteria:

* unwilling to participate,
* unable to communicate in Swedish and English and
* minors (i.e. women \< 18 years of age),
* contraindications to misoprostol
* women with pathological pregnancies
Structured Aerobic and Resistance Exercise and Gestational Diabetes

Gestational diabetes mellitus (GDM) is defined as impaired glucose tolerance of various degrees first manifested during pregnancy. The primary aim of treating GDM is to optimize glycaemic control and improve pregnancy outcomes. Also, as part of treatment, it is recommended to continue or initiate exercising with moderate intensity. However, available data on the effects of physical activity on GDM are based on a small number of trials. The aim of the trial is to examine and add new scientific evidence on possible health-related effects of application of structured programme consisting of aerobic and resistance exercises on the course and outcomes of GDM. Primary goal of research is to determine how proposed exercise programme effects glycaemic control, rate of complications during pregnancy, labour, delivery, immediate after delivery and health status of newborn. Main hypothesis is that parameters of glycaemic control, course of GDM, complications during delivery and birth outcomes directly and significantly correlate with participation in structured programme of exercise. Research will be conducted as experimentally designed randomized controlled trial. Participants will be pregnant women diagnosed with GDM, age between 20 and 40, without comorbidities. Women in the experimental group will be included in exercise programme two times per week with duration of 50 minutes. Training sessions will start right after the diagnosis and will be performed until the end of the pregnancy. The training protocol will follow international guidelines (ACOG, 2001; ACOG, 2002; ADA, 2008; NICE, 2008; ADA 2011). Women in the control group will receive standard medical care.


Eligibility Criteria:
Inclusion Criteria:

* established diagnosis of gestational diabetes,
* age between 20 and 40,
* otherwise healthy pregnancy

Exclusion Criteria:

* pharmacological treatment with oral hypoglicemics and/or insulin therapy introduced prior to trial enrollment,
* existing comorbidities and
* contraindications for exercise
Power of Growth - Digitally Assisted Intervention for the Early Childhood Educators' Self-efficacy Teamwork and Children's Behavioral Challenges.

This is an RCT study investigating the efficacy of digital intervention focusing on enhancing positive directing skills for teams of early childhood education (ECE) professionals. The aims are to study 1) changes in the ECEs' self-assessed self-efficacy experience in the intervention group compared to the control group; 2) changes in the behavioral challenges of the children in the ECEs' groups assessed by the parents in the intervention group compared to the control group; and 3) changes in the ECEs' guidance methods in the intervention group compared to the control group. We will also study changes in the wellbeing of ECEs and teamwork in both treatment groups. The sample size will consist of approximately 64 teams of ECEs. Hence, altogether there will be approximately 200 study subjects.

The intervention is aimed at ECE teams and its goal is to strengthen and unify the team positive guidance practices in children's groups. The intervention includes self-learning material and teams online coaching in which the entire team participates simultaneously. The self-material includes 360 videos of everyday situations in the daycare and videos can be watched with VR glasses. The participants practice the skills systematically with their group of children. The duration of the intervention is approximately 12 weeks and team coaching are carried out approximately every two weeks.


Eligibility Criteria:
Inclusion Criteria:

Participant is working in a daycare centre team that is participating to the study. Sufficient knowledge in Finnish language.

Exclusion Criteria:

-
Screening for Lung Health by a Mobile Device

Respiratory diseases are a common cause of mortality and disability at the worldwide and national levels. Many of them are characterized by underdiagnosis and diagnosis in advanced stages of the disease, and in most of them, forced spirometry is one of the fundamental tools to assess the diagnosis and seriousness of the disease.

To help in improving the detection of respiratory diseases and the understanding of the respiratory health of the general population, one possible solution would be to develop a mobile application that could assess respiratory health by using the sound signal of exhaled air recorded by a mobile microphone.

This project will aim to validate a mobile application (WebApp) for the detection of pulmonary function disorders. It is planned to recruit 267 subjects, with and without respiratory disease, who are attended in pulmonary function laboratories of 10 Spanish hospitals, to compare the sensitivity of this application in the diagnosis of pulmonary function disorders (either obstructive patterns or PRISm) versus the gold standard (spirometry). Ease of use and user satisfaction with the application will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with age range between 18 and 80 years old
* Signing the informed consent form
* Subjects scheduled for respiratory function tests at the pulmonary function laboratory for clinical reasons
* Having a cell phone and be willing to install the application

Exclusion Criteria:

* Contraindication to perform any of the protocol procedures
* Inability to answer the study questionnaires.
Hospital Ederly Life Program for Surgical Patients

Frailty is the clinically recognizable medical condition, also called syndrome or phenotype, that is, the result of processes leading to an increased vulnerability for serious deteriorations in health and the diminished ability to cope with physical stressors. Recently, frailty has emerged as a significant risk factor for adverse postoperative outcomes. It is related to declines in energy, strength, and function as well as to an increased inflammatory state, including elevated levels of interleukin 6 (IL-6), C-reactive protein (CRP), and anelevated white blood cell count . Frailty, as defined Frailty, as defined in the landmark paper by Fried, included at least three of five of the following criteria: unintentional loss of weight, low physical activity, low energy, low grip strength, and a slowed walking speed. Since then, various frailty scoring lists have been designed to optimize the predictive value. One of these is the Edmonton Frail Scale (EFS), an instrument that can be assessed quickly, using only a simple questionnaire which usually does not require more than five minutes to be completed and which covers most domains of functioning, making it easy and fast to get a reliable impression of the degree of frailty.The aim of this study was to determine which factors,with emphasis on frailty, significantly influence postoperative outcome after elective noncardiac surgery as measured by the Comprehensive Complication Index (CCI).


Eligibility Criteria:
Inclusion Criteria:

* elective noncardiac surgery

Exclusion Criteria:

* patients who don't cooperate
Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer

The aim of the present feasibility study of a new short palliative radiotherapy regime that apply to patients with metastatic hormone refractory prostate cancer (HRPC) presenting with a dominating debilitating symptom. Diffusion weighted magnetic resonance imaging (DWI) will apply to identify both the lesion and the most aggressive part of the lesion. The symptomatic lesions will be treated with a dose of 4 x 5 Gy, while for the most aggressive part of the lesion the dose will be escalated to 4 x 7 Gy using a simultaneous integrated boost (SIB) technique.

Please refer to uploaded Study Protocol

Eligibility Criteria:
Inclusion Criteria:

1. Patients with hormone refractory biopsy proven prostate cancer
2. Presenting with a dominating debilitating symptom
3. Expected median survival of 12 months
4. Focal irradiation of lesion is feasible
5. Systemic therapy according to guidelines
6. age ≥18 years
7. Legal capacity, able to understand consequences of the trial
8. Written informed consent

Exclusion Criteria:

1. Relevant comorbidity (limiting radiotherapy according to protocol)
2. Prior radiotherapy limitations to administer radiotherapy according to protocol
3. No large metal implants in vicinity of lesion
4. Department dose constraints for normal tissue can't be met
5. Large bony lesions with extensive osseous destruction
6. Patients symptoms do not correlate with MR findings