cyrilzakka/clinical-trials huggingface dataset:
Home Based Intervention Led by Nurse in Brazil

Home visits (HV) are one of the multidisciplinary approaches that has already shown to benefit the follow-up of Heart Failure (HF) patients. It is considered to be one of the most effective and humane approaches as it educates and takes care of the patient in his/her routine environment. In this study, the follow-up of HF patients in a home setting after being discharged from hospital will include the reinforcement, monitoring and re-evaluation of guidelines previously provided about the disease and self-care, compliance to prescribed medicines and, specially, the early recognition of decompensation signs and symptoms by patients and their caregivers.

The epidemiological overview of cardiovascular diseases in which HF turns out to be the main cause of re-hospitalizations in the Unified Health System, which has not changed over the years, impairs the management of the limited resources of the public health system. Additionally, HF leads to substantial damage to the quality of life of patients, many of them at a socially productive age, resulting in early retirements and absences. In this study, the objective is to evaluate the impact of the follow-up of heart failure patients at home, interspersed with telephone contacts, by the nursing team, after hospital discharge, regarding knowledge of the disease, self-care skills and quality of life improvement, compared with the conventional follow-up of patients in a 6-month period without this intervention, as well as to build a mobile-technology computer structure to make the use of cardiology nursing evaluation forms viable; correlate sociodemographic and clinical characteristics with treatment compliance and re-hospitalization rates in both; and ascertain home follow-up costs.

With this purpose, a two-center randomized clinical trial, blinded for the endpoints re-hospitalization and costs, was designed.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes
* Age equal to or above 18 years
* Diagnosis of heart failure with systolic dysfunction (ejection fraction ≤ 45%)
* Hospitalized for heart failure decompensation and who agree to participate in the study by signing a Free Informed Consent Form.

Exclusion Criteria:

* Patients presenting with communication barriers and suffering from degenerative neurological diseases.
* Patients who had Acute Coronary Syndrome (ACS) in the past 6 months before randomization
* Patients with renal/hepatic/pulmonary or systemic disease who may confuse the interpretation of findings or result in limited life expectancy
* Surgical or therapeutic treatment that may influence the follow-up
* Pregnancy
* Diagnosis of Heart Failure secondary to:

  * sepsis
  * myocarditis
  * acute myocardial infarction
  * peripartum cardiomyopathy and other acute cause
* No interest in receiving home visits
* Living more than 10 km away for the original hospital
* No possibility of telephone contact.
Prevalence of FGIDs and Probiotics Study

This is a study to evaluate the prevalence of FGIDs in infants using the Thai version of Rome IV diagnostic questionnaire for functional gastrointestinal disorders in infants and evaluate the efficacy of Limosilactobacillus reuteri DSM 17938 to prevent FGIDs in infants.

This is a randomized controlled trial study about the the efficacy of Lactobacillus reuteri DSM 1987 to prevent FGIDs in healthy infants and the effect to gut microbiota diversity. The incidence of FGIDs in Thai infant using Thai version of ROME IV questionnaire (authorized by Rome Foundation) for infant and toddler and the associated factors of FGIDs also evaluate.

Population: target and control populations are the healthy infants born at King Chulalongkorn Memorial Hospital, Bangkok, Thailand, and can come to follow up at the hospital at 1, 2, 4, and 12 months of age Inclusion criteria

1. Healthy and term (GA 37-41 weeks) infants
2. Appropriate weight for age
3. APGAR score more than 8 at 10 minutes of life
4. Normal physical examination
5. Mothers have no previous probiotics use Methodology

   * Participants were double-blinded randomized using computer generation in block of four
   * Target population were received Limosilactobacillus reuteri DSM 17938 5 drops (0.185 mL) per day for 60 days
   * Control population were received mixture of sunflower oil and MCT oil 5 drop (0.185 mL) per day for 60 days
   * There were 5 visits at birth, 1, 2, 4, 12 months of life: the demographic data/Rome IV questionnaire for FGIDs in infant and associated factors with FGIDs record, physical examination and stool collection
   * Research assistance will telephone to them to take the Rome IV questionnaire for FGIDs at 3, 6, 9 months of life

Biological specimen collection Stool will be collected by rectal stimulation in each visit. The amount of \>5 gm stool will be preserved in DNA and kept at -80 °C. All stool specimen will be processed the DNA extraction (DNA \> 40 microlitre with concentration \>50 ng/L). The DNA extraction for further amplification 16S rRNA using Illumina. The rest of the specimen will be kept up to 10 years for further evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy and term (GA 37-41 weeks) infants
2. Appropriate weight for age
3. APGAR score more than 8 at 10 minutes of life
4. Normal physical examination
5. Mothers have no previous probiotics use

Exclusion Criteria:

1. not willing to anticipate in the study
2. cannot come to follow-up until 1 year of age
Imaging Study of Neurovascular Coupling in Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL)

The aim of this study is to investigate using fMRI methods, EEG and dedicated mathematical models, the potential alterations of neurovascular coupling in CADASIL.

Comparison study of parameters derived from mathematical models of neurovascular coupling and obtained using fMRI (Bold signal, ASL and EEG).

Eligibility Criteria:
Inclusion Criteria:

* CADASIL group: typical NOTCH3 mutation, age less than 60 years, rankin score at 0-1, active social insurance

Exclusion Criteria:

* MRI contra-indications and use of any treatment known to interfere with neurovascular coupling, pregnancy, lack of informed consent
A Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine (SUZ) for Acute Pain After Selected Surgeries

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of SUZ for acute pain after laparoscopic procedures of the intraperitoneal or retroperitoneal cavities or arthroscopic orthopedic procedures.


Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of greater than or equal to (≥) 18.0 to less than or equal to (≤) 40.0 kilogram per meter square (kg/m\^2)
* Scheduled to undergo a procedure that is in one of the following categories that would typically be treated with opioid therapy for at least 72 hours postoperatively such as

  * Laparoscopic intraperitoneal or retroperitoneal procedure
  * Arthroscopic orthopedic procedure

Key Exclusion Criteria:

-Participated in previous study with Suzetrigine or received Journavx

Other protocol defined Inclusion/Exclusion criteria will apply.
Group Cognitive Behavior Sessions (CBCSM) to Decrease Distress in Cancer Patients

This clinical trial tests how well cognitive behavioral cancer stress management (CBCSM) group sessions work to decrease psychological distress in cancer patients. CBCSM teaches patients how to recognize and reduce the impacts of cancer associated stress on the biological, psychological, and social life domains.

PRIMARY OBJECTIVE:

I. To reduce psychological stress.

SECONDARY OBJECTIVES:

I. To increase post-traumatic growth (PTG). II. To increase patient self-efficacy in utilizing therapy skills. III. To estimate patient acceptability and feasibility of conducting CBCSM within the clinical setting.

IV. To estimate differences of conducting CBCSM virtually during the Public Health Emergency (PHE) versus in person pre-PHE.

V. To estimate differences of conducting CBCSM post PHE virtually with limitation to Minnesota patients only.

VI. To explore the difference using the same therapy in patients with advanced, metastatic disease in a individual setting versus patients without the advanced, metastatic disease in a group setting.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP I: Patients participate in five CBCSM group sessions on study. Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.

GROUP II: Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for the cognitive behavioral cancer stress management (CBCSM) clinical service
* Cancer diagnosis with predicted survival \> 1 year
* Cancer treatment within past 1 year or treatment planning in progress
* Age \>= 18-years
* Moderate distress screen, indicated by Impact of Event Scale-Revised (IES-R) score \>= 14 or clinical judgment
* Written informed research consent

Exclusion Criteria:

* Inability to actively participate in and learn from group therapy (e.g., psychotic symptoms, neurological condition, personality pathology) as determined by clinical judgment in clinical consultation (Individual therapy or alternative group therapy will be offered)
Soy Protein and Breast Cancer Risk Reduction

Soy consumption has been associated with reduced risk for developing breast cancer. Ovarian hormones and breast density are considered breast cancer risk markers. We propose to test the hypothesis that consumption of soy protein reduces ovarian steroid hormones and results in a corresponding reduction in breast density comparing to casein protein.

The aims will be tested by conducting a randomized, double-blind study, with two arms and 100 women in each arm. Premenopausal women will be recruited and randomly allocated to take one of two different dietary supplements daily for 2 years. The two test diets soy protein drink and caseinate protein drink. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary intervention period and analyzed for ovarian hormones. At baseline and after the intervention period, breast density, and bone density will be assessed by radiological techniques at baseline and 1 yr and 2 yr after protein drink supplementation. The efficacy of the dietary intervention will be determined by comparing mean changes of ovarian steroids, and density of the breast and bone tissues over the 2 year dietary intervention period in the two diet groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soya dietary supplements will reduce breast density, which will be explained by individual hormonal changes.

Eligibility Criteria:
Inclusion Criteria:

* healthy premenopausal women
* 30 to 40 years old
* normal mammograms
* regular menstrual cycles

Exclusion Criteria:

* abnormal mammograms
* first degree relatives with breast cancer
* pregnant or lactating
* peri- or post-menopause
* breast augmentation, reduction, and lifting
* on oral contraceptive medications or exogenous hormones
* medically prescribed diets
* allergic reaction to soy or cow's milk
Safety and Efficacy of AEB071 and EVEROLIMUS in Patients With CD79-mutant or ABC Subtype Diffuse Large B-Cell Lymphoma

Study of the safety and efficacy of AEB071 and EVEROLIMUS in patients with CD79-mutant or ABC subtype Diffuse Large B-Cell Lymphoma.

The trial did not progress into Phase II due to the suboptimal tolerability of the combination treatment of sotrastaurin and everolimus in the Phase Ib part of the study. There were no serious safety concerns associated with this combination.

This is a Phase Ib dose escalation and Phase II study in patients with DLBCL harboring mutations in CD79A/B or of the ABC subtype. Pre-screening for mutations in CD79A/B or the ABC subtype will be required, as it is anticipated that both patient groups may receive clinical benefit from the combination of AEB071 and EVEROLIMUS.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years of age.
* Diffuse DLBCL with activating mutations in CD79 (A or B subunits) or ABC-subtype DLBCL (CD79 wildtype or CD79 mutant). DLBCL that arose from transformed indolent lymphoma is allowed.
* Prior treatment and relapse following chemotherapy and autologous bone marrow or stem cell transplant. Patients who are not transplant eligible or who did not respond to chemotherapy may be considered for the study following a single regimen of chemotherapy such as R-CHOP or R-EPOCH. There is no limit to number of prior therapies allowed.
* May be treated with localized radiation as long as measurable or evaluable disease remains at untreated sites.
* WHO performance status of ≤ 2.
* A representative FFPE tumor sample must be available for molecular testing along with a corresponding pathology report. An archival tumor sample may be submitted. However, if not available, a new tumor biopsy obtained for the purpose of this study must be submitted instead.

Exclusion Criteria:

* Treatment with strong inducers or inhibitors (medications and herbal supplements) of cytochrome P450 3A4/5 (CYP3A4/5), or CYP3A4/5 substrates with a QT prolongation risk that cannot be discontinued at least 7 half-lives (or if the half-life is unknown,14 days) prior to study drug treatment.
* Impaired cardiac function or clinically significant cardiac diseases.
* Impairment of GI function or GI disease that could interfere with the absorption of AEB071 or everolimus.
* Severe systemic infections, current or within the two weeks prior to initiation of AEB071.
* Kown history of HIV.
* Poorly controlled diabetes as defined by a fasting serum glucose \> 2.0 x ULN.
* Evidence of current CNS involvement.
* Significant symptomatic deterioration of lung function.
Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Pre-psychosis

The primary objective of this study is to determine whether aspirin is effective in alleviating symptoms of the clinical high risk (CHR) syndrome for psychosis. The investigators further aim to determine whether it may delay or prevent the onset of psychosis in those currently experiencing CHR symptoms. As secondary measures the investigators aim to collect laboratory studies of inflammation markers and genetic samples to determine whether certain genetic profiles correlate with risk for psychosis, or response to aspirin treatment.

Patients will be randomly assigned to either active treatment (aspirin) or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Age 19 - 35
* Must have a SIPS interview
* CHR subjects must meet at least one of 3 CHR syndromes defined by SIPS
* Must demonstrate adequate decisional capacity

Exclusion Criteria:

* Under age of 19
* Have pre-existing gastrointestinal disease, heart disease
* Have kidney disease
* Taking non-steroidal anti-inflammatory medications
* Hypersensitive to NSAID (non-steroidal anti-inflammatory medications)
* Have coexisting unstable major medical illness
* Are pregnant or breastfeeding
* Consume more than 2 drinks of alcohol per day
* Have a blood clotting disorder
* Are taking ACE inhibitors, acetazolamide, anticoagulants, anticonvulsants, beta blockers, diuretics, methotrexate, oral hypoglycemic or uricosuric agents
* Have a history of substance abuse in past three moths or dependence in past 6 months
Head Injury Retrieval Trial

The study hypothesis is that advanced interventions as provided by a physician at an accident scene will decrease the death rate and the rate of severe disability in survivors of severe head injury. Extended interventions by advanced level prehospital providers may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.

A randomised, controlled trial examining prehospital management of persons with severe blunt head injury, in the Sydney region. Treatments examined will be the current system consisting principally of paramedic management (standard care) compared with management by a retrieval team lead by a consultant anaesthetist, emergency physician or intensive care specialist. Patients for inclusion in the study will be identified by a paramedic screening all "000" calls to the ambulance service and identifying persons likely to have severe head injury. The principal outcome measure will be their degree of disability measured at 6 months post injury.

Eligibility Criteria:
Inclusion Criteria:

* Glasgow Coma Scale score of 3 to 8 due to blunt trauma as measured at the accident scene by the first prehospital team to arrive at the site.

Exclusion Criteria:

* Penetrating trauma
* Age less than 16 years
* No more than 5 casualties at the scene
Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)

In a prospective, non-interventional, monocentric observational study the pharmacokinetic properties of selected antiinfective drugs during sustained low-efficiency dialysis (SLED) will be analyzed.

Antibiotic concentrations are measured whilst patients receive SLED for renal replacement therapy. The plasma specimens will be quantified using high Performance liquid chromatography (HPLC).

Primary endpoint:

- Plasma levels of antiinfectives during SLED

Secondary endpoints:

* mortality
* length of stay at the intensive care unit (ICU) and hospital
* clinical cure of infections

Inclusion criteria:

* age: \> 18 years
* patients under SLED
* antiinfective treatment

exclusion criteria:

- missing informed consent

Eligibility Criteria:
Inclusion Criteria:

* age: 18 or older
* patients receiving SLED and either meropenem or ceftazidim

Exclusion Criteria:

* missing informed consent
Study in Patients With Asthma

The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control drug.


Eligibility Criteria:
Inclusion Criteria:

-Require regular use of an inhaled Beta-2-selective adrenergic agent

Exclusion Criteria:

* Active acute or chronic disorders of the respiratory system within one month prior to screening
* Smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history
* Recent surgical interventions such as lung lobectomy or resection (\< one year), or cardiothoracic interventions
* Life-threatening systemic and debilitating diseases.
Low Dose CT Distal Radius Fractures

This study is a prospective, departmental funded study examining the outcomes of Low Dose CT scans compared to Conventional Dose CT scans in patients who present to Duke University with a Distal Radius Fracture.

The purpose of this study is to compare the use of a conventional dose computed tomography scan (C-CT) to a low dose computed tomography scan (L-CT) in the assessment of articular displacement, and development of a treatment plan for intraarticular distal radius fractures in an effort to reduce the radiation exposure to future patients with this injury pattern. Reviewers will be tasked with reporting data aimed at investigating 3 primary outcome measures: 1) Are L-CT images of sufficient quality to be used for diagnostic purposes, 2) Can accurate measurements of step and gap displacement be made on L-CT images, 3) Do proposed treatment plans change with the use of L-CT relative to those chosen based on C-CT images We hypothesize that reviewers will find L-CT images of sufficient image quality for diagnostic purposes, measurements of step and gap displacement will not be significantly different between L-CT and C-CT, and no significant differences in treatment options will be chosen based on the use of L-CT rather than C-CT for the same fracture. The secondary aim will be to evaluate the interobserver and intraobserver reliability of L-CT in evaluating intraarticular fractures of the distal radius.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be age 18 years or older.
* Subject must have sustained an intraarticular distal radius fracture which undergo closed reduction and application of a below-elbow splint.
* Subjects whos injury occurred less than 2 weeks prior to the time of enrollment.

Exclusion Criteria:

* Subject is under the age of 18 years.
* Subject is unable to speak English for completion of consent process.
* Subject sustained pathologic fracture.
* Subject sustained open fracture.
* Subject is a pregnant woman.
Proximal Humerus Fractures: Randomized Study Between Locking Nails and Locking Plates for Neer 2 and 3 Parts

The hypothesis of this study is to determine whether the technique of intramedullary locking nail presents clinical results comparable to the technique of locking plates, based on the Constant Score.


Eligibility Criteria:
Inclusion Criteria:

* Fracture with less than 21 days;
* Fractures of the proximal humerus classified as 2 or 3 parts of Neer, with involvement of the humeral head and one of the tuberosities;
* Fracture with unacceptable deviation for the non-surgical treatment, according to the criteria of Neer Neer: fractures with deviation greater than 45 ° or 1 cm for the fragment of the humeral head and fractures with a deviation of the tuberosity greater than 0.5 cm;
* Closed fractures;

Exclusion Criteria:

* Characteristics of the fracture:

  * fracture between the greater tubercle and the smaller, independent of the deviation;
  * Isolated fracture of the greater or lesser tuberosity
  * 4-part fractures of Neer;
  * Fracture involving the articular surface of the humeral head;
  * Fracture-dislocation of the proximal humerus
* Other criteria:

  * Neurological injuries in the affected limb;
  * previous surgery on the affected shoulder;
  * associated fractures in the affected limb;
  * pathologic fractures;
  * lesions of the rotator cuff tendons previously diagnosed;
  * Psychiatric illnesses or inability to understand preoperative questionnaires;
  * Active infection or previous infection on the shoulder;
School-based Group Acceptance and Commitment Therapy for Adolescents

The objective of the investigators' mental health promotion intervention premised on the Acceptance and Commitment Therapy (ACT) framework in secondary school settings aims to enhance young people's psychological flexibility and reduce their emotional distress. ACT is an evidence-based approach that encourages individuals to act in alignment with their identified values. The investigator's team will employ an ACT protocol for adolescents developed by Louise Hayes and Joseph Ciarrochi. The study includes a single-group study design. The investigator will compare the pre- and post-intervention data to assess the feasibility and potential effectiveness of the group intervention.


Eligibility Criteria:
Inclusion Criteria:

Eligible participants are adolescents who reported mild to moderate severity of psychological distress, including those who report:

* a score of 5-19 on the Patient Health Questionnaire (PHQ-9), or
* a score of 5-14 on the General Anxiety Disorder-7, or
* a score ≥14 on the Perceived Stress Scale.

Exclusion Criteria:

Adolescents will be excluded if they exhibit or report:

* violent or aggressive behavior, or
* active self-injurious or suicidal thought, or
* active psychotic symptom.