cyrilzakka/clinical-trials huggingface dataset:
The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition

Emerging evidence suggests that microorganisms acting via the Brain-Gut axis may have potential benefits for the management of stress-related conditions. The majority of studies have focused on animal models. Preclinical studies have identified the Lactobacillus Rhamnosus JB-1 strain as a putative psychobiotic with an impact on stress-related behaviours, physiology and cognitive performance. Whether such preclinical effects could be translated to healthy human volunteers remains unknown.

30 healthy male volunteers will be recruited in a randomized single blind placebo controlled cross over trial. Study participation will involve a screening visit followed by a baseline cognitive test battery, EEG and stress visit (socially evaluated cold-pressor test). These measures will be repeated after 4 weeks of daily probiotic and placebo capsules.

Eligibility Criteria:
Inclusion Criteria:

* able to give informed written consent
* able to speak English

Exclusion Criteria:

* having a significant acute or chronic illness
* following a diet or taking a medication that would interfere with study objectives
* pose a safety risk or confound the interpretation of the study results
* evidence of immunodeficiency, bleeding disorder or coagulopathy
* English not being participant's first language
* colour blindness
* dyslexia or dyscalculia
* taking any probiotic products or antibiotics in the last 4 weeks
* receiving any treatment involving experimental drugs
Strength After Elbow Fractures in the Elderly

Elderly patients strength and function, specifically the ability to rise from a seat after either operative or non operative treatment of an mayo type 2 olecranon fracture.

Elderly patients with an olecranon fracture will receive appropriate treatment as determined by the treating surgeon. Patients will then be assessed at 6 weeks, 6 months and 12 months post treatment. Assessments include, range of motion, patient reported outcomes and a strength test.

Eligibility Criteria:
Inclusion Criteria:

1. ≥65 years of age
2. Mayo type II olecranon fracture
3. Ambulatory (with or without the use of walking aides)

Exclusion Criteria:

1. Additional injuries to the affected arm or contralateral arm
2. Associated nerve injury
3. Dementia or cognitive impairment that inhibits the collection of outcome measures
4. Likely problems, in the judgement of the investigator, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged, patients without adequate support, etc.)
5. Injury or previous deficit to the contralateral arm
6. Currently enrolled in any other research study involving drugs or medical devices
7. Open fractures
8. Inability to provide informed consent
Self-Compassionate Writing for Caregivers of Older Adults

The goal of this study was to test an online writing intervention to encourage a self-compassionate mindset in family caregivers of older adults. The main aims were to answer the questions:

* Writing with self-compassion would increase self-compassion.
* Writing with self-compassion would improve mood. Researchers compared self-compassion components (self-kindness, which involves a gentle and non-judgemental approach to oneself at times of difficulty; common humanity, which includes recognising one's difficulties as part of a shared human experience; mindfulness, which includes noticing difficult feelings without becoming overwhelmed by them) to see which combinations achieved the best outcomes.

Participants wrote with different combinations of self-compassion components together, such as mindfulness and common humanity or mindfulness and self-kindness. Participants also wrote with self-kindness, common humanity, or mindfulness separately.

After being informed and consenting to participate in the study, participants were allocated to a self-compassion or control condition. The study was designed to target state self-compassion and mood. The research was carried out over three studies, with refinements being made each time based on previous outcomes. In Studies 1 and 2, participants were tested for self-compassion and mood (guilt, sadness, and serenity). after the writing tasks. In Study 3, participants were asked to complete measures for these both before and after the writing tasks. The experiments were carried out online for all three studies.

Eligibility Criteria:
Inclusion Criteria:

* Family carer.
* Caring for a person over 65 years of age.
* Participants over 18 years of age.

Exclusion Criteria:

* Professional carers.
* Caring person under 65 years of age.
* Participants under 18 years of age.
HEALthy Brain and Child Development Study - COVID-19 Supplement

The purpose of this study is to advance the scientific understanding of how a prenatal COVID-19 infection and associated psychological distress influences infant neurodevelopment. This project will aim to shed light on how families and child development are impacted by the current COVID-19 pandemic and will work to better support these families and children as they grow.

Prenatal exposure to maternal illness and stress has been widely associated with adverse neurodevelopmental outcomes, including deficits in cognition and socioemotional development. The principal goal of this project utilizes Magnetic Resonance Imaging (MRI), Electroencephalography (EEG), and a variety of behavioral measures to assess brain maturation and neurodevelopment among infants exposed prenatally to COVID-19 and associated high levels of stress. The planned experiments are effective in identifying brain markers that may contribute to resiliency in young infants, determining measures of stress response in relation to a maternal COVID-19 diagnosis, and characterizing the neurodevelopment of those infants born to mothers with a COVID-19 infection.

Specific goals include:

1. To determine the prevalence of psychological distress in pregnant women with a confirmed COVID-19 diagnosis and to examine the extent to which existing high risk environments play a role in the susceptibility of heightened psychological distress.
2. To examine the effects of prenatal distress and maternal illness/inflammation related to a maternal COVID-19 diagnosis on early structural and functional brain development.
3. To characterize neural networks that may have been impacted by a maternal COVID-19 infection and related stress during pregnancy.
4. To assess the early neurodevelopment outcomes of infants exposed to elevated prenatal stress related to a maternal COVID-19 diagnosis during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish- speaking of any ethnicity
* Women, aged 18 or older
* Women who received COVID-19 diagnoses during pregnancy OR Women without any SARS-CoV-2 positive test during pregnancy, any suspected COVID illness (even if not tested) or who received a negative COVID-19 test result during pregnancy

Exclusion Criteria:

Participants will be excluded if the child:

* is born at less than 34 weeks or if birth weight is not appropriate for dates
* has an identified genetic, metabolic, syndromic or progressive neurological disorder (e.g., Down Syndrome, Rett Syndrome, Tuberous Sclerosis, Neurofibromatosis, Fragile X Syndrome) at birth or within the first year
Effects of Band Exercises Added to the Warm-Up on Shooting and Viscoelastic Properties of Muscles in Handball Players

Today's handball has become a fast and fluid handball that expects superior performance from athletes. The aim of handball is to put the ball into the opponent's goal, so one of the most important parameters of sports performance is shooting performance.

Studies show that warm-up programs have a positive effect on sports performance. Warm-up programs are used to prevent possible injuries and to increase sports performance by increasing temperature and flexibility in muscle and connective tissue. Warm-up programs may also cause changes in muscle viscoelastic properties and thus affect performance.

Recently, new approaches have begun to be used in warm-up programs. Some of these are warm-ups with a resistance tire, a medicine ball, and a weight vest. When the literature was examined, the effects of the warm-up program with resistance bands on adolescent handball players were generally examined in the lower extremity, but no study was found examining the effects on the upper extremity. For this reason, the study was designed to examine the effect of elastic band exercises applied to the upper extremity in addition to the traditional warm-up program on shooting performance in adolescent female handball players and the change in the viscoelastic properties of the upper extremity muscle groups.

30 female handball players with an age range of 12-18 years will participate in the research. Athletes will be divided into two equal groups as control and experimental groups in a controlled, randomized manner. The control group will be given a traditional warm-up program 6 days a week for 6 weeks. The experimental group will be given a traditional warm-up program under the same training conditions and additional elastic band exercises. In order to examine the effects of the warm-up programs to be applied in the chronic period, goal shooting, Modified Push Up test, Medicine Ball Throwing test, Upper Extremity Y Balance Test will be performed before training and at the 6th week and muscle viscoelastic properties will be evaluated. At the same time, in order to examine the acute effects, the goal shooting and muscle viscoelastic properties will be evaluated after the first warm-up training.The investigators hope that our study will help coaches and physiotherapists working in this field during the training process by ensuring the active use of a warm-up program with elastic bands in handball players.


Eligibility Criteria:
Inclusion Criteria:

* 12-18 years old
* Female Gender
* Participating in active training at least 3-4 times a week
* Athletes who volunteer to participate in the study
* Having a license in handball

Exclusion Criteria:

* People with orthopedic, neurological or congenital problems
* Athletes with chronic illnesses
* People with upper extremity surgery history within the last year
* People with cognitive problems
* People with problems that will prevent the application of tests
* Having had a sports injury that would affect upper extremity shooting performance within the last six months
Microbiome Fructan Metabolism and Symptoms in Childhood IBS

This study evaluates whether the gut microbiome is involved in determining whether children with irritable bowel syndrome (IBS) develop worsening GI symptoms (e.g. pain) when given fructans (a sugar often found in wheat). Participants will both receive a diet with fructans and a diet without fructans.

Fructans (fructo-oligosaccharides) are a type of carbohydrate which can not be hydrolyzed by humans. It is commonly found in wheat in the American diet. After ingestion they arrive essentially intact into the colon where they are metabolized by the colonic microbiome. Fructan avoidance has been found to help decrease gastrointestinal symptoms (e.g. pain) in those with IBS.

However not all individuals with IBS have worsening symptoms when eating fructans in their diet. This study seeks to evaluate whether the microbiome is involved in determining whether an individual with IBS has worsening symptoms with fructan ingestion.

Following a one week baseline period, participants will be randomized in a double-blind cross-over fashion to either a 72 hour meal period with fructans or a 72 hour meal period with maltodextrin (placebo). A washout period of at least 10 days will occur in between. Symptoms will be captured using a stool and pain diary. Stool specimens and urine specimens will be obtained at baseline and during the dietary interventions. Breath hydrogen testing will be obtained during the dietary interventions.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 7-17 years
* Children with IBS will meet Rome III criteria per the Rome III questionnaire
* Healthy children will not have chronic conditions
* English speaking and able to read/write in English

Exclusion Criteria:

* Previous bowel surgery
* Documented gastrointestinal disorder (e.g. ulcerative colitis)
* Serious chronic medical condition (e.g. diabetes)
* Weight and/or height are greater than or less than 2 standard deviations for age
* Chronic conditions with GI symptoms (e.g. cystic fibrosis)
* Antibiotics within the past 3 months
* Pregnancy
* Autism spectrum disorder and/or significant developmental delay
* Mood disorders (e.g. major depression)
* Known post-infectious etiology
HMGB1 Release From Hemorrhagic Shock Patients

It is reported that high mobility group box 1 (HMGB1), a non-histone nuclear protein, can serve as an alarmin with damage associated molecular patterns to activate immune responses in the early stages of hemorrhagic shock (HS). However, the origin of HMGB1 and how it is released following HS is poorly understood. In this study, we teased out this mechanism. We try to record the concentration of serum HMGB1 protein following HS in clinical patients.

The study was approved by the First People's Hospital of Chenzhou, Hunan, P.R. China. Consent was obtained from patients in their hospital course. Eighteen patients were enrolled for each group. In addition, Acute Physiological and Chronic Health Evaluation II (APACHE II) score was used to evaluate the severity and morbidity of HS patients Serial blood samples were collected at indicated time points on hospital admission for HS patients (0, 2, 4, 8, 24, and 72 h following HS). Levels of HMGB1 were detected by ELISA according to the kit manufacturer's instructions.

Eligibility Criteria:
Inclusion Criteria:

Hemorrhagic shock (HS) was defined as out-of-hospital systolic blood pressure (SBP) of 70 mmHg or less or SBP ranging 71 to 90 mmHg with a heart rate of 108 beats/min or more.

Exclusion Criteria:

pregnancy, \<18 years old, more than 2,000 mL of intravenous fluids or blood before enrollment, hypothermia, drowning, asphyxia, burns, isolated penetrating head injury, time of call received by dispatch to study intervention longer than 4 h, known prisoners, and transfer from another hospital
Intervention to Improve Social and Family Support for Caregivers of Dependent Patients. (ICIAS)

The purpose of this study is to determine wether a multi-factor intervention involving the primary caregiver of a dependent patient, with the goal of improving his or her social and family support and carried out by the professionals of the patient's regular PHCT, will decrease the burden and increase quality of life for the primary caregiver.

Objective: To assess whether an intervention designed to improve the social support for caregivers effectively decreases caregivers burden and improves their quality of life.

Methodology:

Design: Controlled, multicentre, community intervention trial, with patients and their caregivers randomized to the intervention or control group according to their assigned Primary Health Care Team (PHCT).

Study area: Primary Health Care network (9 PHCTs). Study participants: Primary informal caregivers of patients receiving home health care from participating PHCTs.

Sample: Required sample size is 282 caregivers (141 from PHCTs randomized to the intervention group and 141 from PHCTs randomized to the control group.

Intervention: a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support.

Control: Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request.

Data Analysis. Dependent variables: Caregiver burden (short-form Zarit test), caregivers social support (Medical Outcomes Study), and caregiver reported quality of life (SF-12) Independent variables: a) Caregiver: sociodemographic data, Goldberg Scale, Apgar family questionnaire, Holmes and Rahe Psychosocial Stress Scale, number of chronic diseases. b) Dependent patient: sociodemographic data, level of dependency (Barthel Index), cognitive impairment (Pfeiffer test)

Discussion:

If the intervention intended to improve social and family support is effective in reducing the burden on primary informal caregivers of dependent patients, this model can be readily applied throughout usual PHCT clinical practice.

Eligibility Criteria:
Inclusion Criteria:

Adults (older than 18 years) identified in the eCAP database as the primary caregiver for a dependent patient, and who act as caregivers without remuneration.

Both the caregivers and the dependent patients have an active clinical record in a participating primary care centre.

-

Exclusion Criteria:

- 1. Caregivers for intermittent periods, independently of the length of care provided.

2. Caregivers who have provided less than one year of ongoing care. 3. Caregivers with any communication problem (psychiatric disorders, etc.) that makes them difficult to interview
Biological Markers in Patients With Pancreatic Cancer Experiencing Weight Loss

RATIONALE: Learning about biological markers in patients with pancreatic cancer and cachexia may help doctors predict patient outcome and may help the study of cancer in the future.

PURPOSE: This laboratory study is examining biological markers in patients with pancreatic cancer experiencing weight loss.

OBJECTIVES:

* Compare levels of caspase-3 and phosphorylated Akt (pAkt) in the rectus abdominous muscle of patients with pancreatic cancer who are experiencing cachexia and are undergoing surgery for diagnosis or primary therapy with patients who have not lost weight and are undergoing abdominal surgery for nonmalignant conditions.
* Compare levels of urinary 3-methylhistidine (3-MH) in these patients.
* Evaluate possible correlations of caspase-3 activity, pAkt, and urinary 3-MH with early time to progression and subsequent lean body weight loss in patients with pancreatic cancer.
* Associate excretion of urinary 3-MH with higher levels of caspase-3 activity and pAkt to analyze the utility of 3-MH as a marker of skeletal muscle proteolysis.

OUTLINE: This is a pilot study.

During surgery, a muscle biopsy is performed and approximately 1 cm of rectus abdominous muscle is obtained for analysis. Caspase-3 activity and total/phosphorylated phosphatidylinositol-3 kinase and Akt are measured in muscle biopsies by western blot analysis. 3-methylhistidine activity is measured in urine samples.

After completion of study, patients with pancreatic cancer are followed postoperatively at 3 and 6 months.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Diagnosis or suspicion of pancreatic cancer

    * Any stage disease allowed
    * At least 5% weight loss within the past 6 months
    * Scheduled to undergo exploratory surgery
  * Scheduled to undergo exploratory surgery for suspected nonmalignant condition

    * No weight loss OR weight loss due to specific reason (e.g., bowel obstruction, infection, or nausea/vomiting)
* No cancer diagnosis other than primary pancreatic carcinoma

PATIENT CHARACTERISTICS:

* ECOG performance status 0-3
* Life expectancy ≥ 12 weeks
* No pacemakers or implanted defibrillators

PRIOR CONCURRENT THERAPY:

* Prior or concurrent chemotherapy and radiotherapy allowed
* Prior or concurrent biological therapy and surgery allowed
* At least 4 weeks since prior corticosteroids or anabolic steroids
* Other concurrent anticancer therapy allowed
* No concurrent corticosteroids or anabolic steroids, thalidomide, eicosapentaenoic acid (EPA), or Juven for weight loss

  * Concurrent steroids (i.e., antiemetics) associated with chemotherapy allowed
* No concurrent nutritional supplements with EPA
High Dose of Quetiapine in Treating Subjects With Treatment Refractory Schizophrenia or Schizoaffective Disorder

This study will investigate the safety and efficacy of quetiapine in sub-optimally responding patients with DSM-IV schizophrenia using a double blind, randomized 12-week trial comparing oral doses of 1200 mg/d to 600 mg/d of quetiapine.

The study will be conducted at two sites: Manhattan Psychiatric Center (MPC), and the Clinical Research and Evaluation Facility at the Nathan S. Kline Institute for Psychiatric Research/Rockland Psychiatric Center (NKI). A total of 60 patients will be enrolled, 30 at each location. After a screening period of 1 week, all patients will be entering an open label, four-week quetiapine treatment period (run-in phase), during which quetiapine will be titrated to 600 mg PO daily and other adjunctive antipsychotics will be gradually tapered and discontinued. Other concomitant medications such as mood stabilizers will be maintained, if their dose has been stable for the preceding 2 months. Patients not responding to quetiapine treatment at 600 mg PO (defined as reduction of \< 15% change in Positive and Negative Syndrome Scale (PANSS) total score between start of run-in to end of week 4) during the run-in phase, will be eligible to enter the double blind phase. Study baseline will be Day 7 of Week 4 of the run-in phase. Patients qualifying for the double-blind phase will be randomly assigned to either high dose 1200 mg quetiapine daily (Group A) or to 600 mg quetiapine (Group B) daily and treated on the assigned dose in a double blind fashion for 8 weeks (Week 1 through Week 8 of double blind phase). Measures of extra-pyramidal side effects, psychopathology, and safety will be conducted throughout the trial.

Eligibility Criteria:
Inclusion Criteria:

1. DSM-IV criteria for chronic schizophrenia or schizoaffective disorder
2. Sub-optimal treatment-response
3. Total score \> 60 on the Positive and Negative Syndrome Scale (PANSS) at baseline of run-in phase and again at baseline of double blind phase
4. Age 18-64 years old
5. Signed informed consent
6. Patient is in good general medical health

Exclusion criteria:

1. History of failure to respond to 400 mg/day or more of clozapine for 8 contiguous weeks
2. History of failure to respond to quetiapine treatment at dosages \> 1200 mg daily for 6 contiguous weeks
3. History of quetiapine intolerance (e.g., clinically significant leukopenia or agranulocytosis, or severe dystonic reactions)
4. Significant recent history of violence or suicidal activity, which required \> 4 episodes of PRN anti-agitation medication per week
5. Mental retardation
6. Depot antipsychotic within 30 days before randomization
7. Significant medical illness requiring frequent dose adjustment or medication changes

Clozapine non-responders are explicitly excluded, as they would be unlikely to show a response in this study.
Cell-based Therapy for the Treatment of Kidney Disease

Endothelial progenitor cells derived from and delivered to the renal vasculature may be stimulated to initiate differentiation programs during episodes of injury. It is hypothesized that endothelial progenitor cells from the kidney can transition to a phenotype that promotes endothelial repair.

This is an interventional study involving patients that have a diagnosis of chronic kidney disease. Patients will have at least stage 3 chronic kidney disease stage or greater. Kidney-derived endothelial progenitor cells will have been obtained using associated protocols that are currently approved by the Partners Human Research Committee.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled patients will have endothelial progenitor cells previously acquired.

Exclusion Criteria:

* Patients without previously acquired endothelial progenitor cells will be excluded.