cyrilzakka/clinical-trials huggingface dataset:
A Study on Efficacy and Safety of iNK Cells for CAEBV /EBV-HLH After Allo-HSCT

To evaluate the efficacy and safety of iNK cells infusion in patients with chronic active Epstein-Barr virus infection (CAEBV) and EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) after allogeneic hematopoietic stem cell transplantation (allo-HSCT)

It is a prospective, open-lable study to evaluate the efficacy and safety of iNK cell infusion in CAEBV/EBV-HLH patients after allo-HSCT. The study will enroll fifteen subjects who will receive ongoing least 4 doses of iNK cells intravenously infusion after allogeneic hematopoietic stem cell transplantation. All subjects will assess the incidence of disease relapse and EBV-DNA reactivation up to one year.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with CAEBV or EBV-HLH who are eligible for allogeneic hematopoietic stem cell transplantation meet one of the following criteria:

   ①EBV-DNA (PBMC or plasma) was still more than 103 before transplantation；②Positive for Cerebrospinal fluid EBV-DNA；

   ③Abnormal phenotypic lymphocytes could still be detected in bone marrow immunotyping；

   ④Measurable EBV-related lesions on imaging；
2. ≤65 years，ECOG :0-2；
3. Cardiac EF≥40%, creatinine clearance ≥50%; aminotransferase（ALT/AST）\<200U/L。；
4. In patients with HLH, HLH efficacy ≥Partial Response after prior treatment is required；
5. Estimated survival time is longer than three months；
6. Agree to sign the Informed Consent Form。

Exclusion Criteria:

1. Patients with evidence of grade II or more serious heart disease according to the New York Heart Association (NYHA) score (including Grade II) ; Clear diagnosis of cirrhosis；
2. Active infections other than EBV that have not yet been controlled；
3. Positive for hepatitis B virus or hepatitis C virus；
4. Active massive hemorrhage of internal organs (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.)；
5. Also participation in other interventional clinical studies within 4 weeks
Intensity Modulated Radiotherapy for Breast Cancer

This study delivers radiation therapy to any residual breast tissue and the chest wall plus lymph node areas around the breast. These lymph node areas are under the arm, around the collar bone, and under the sternum (breastbone).

IMRT treatment uses a computer-controlled x-ray (CT) to deliver radiation beams at several different angles and strengths to deliver precise doses to the regions at risk for recurrence of breast cancer while reducing or sparing the dose to critical structures (heart, lungs) and nearby normal tissue.

Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Age ≥ 18 years
* Invasive primary female breast cancer
* Pathologically proven regional nodal metastasis
* Status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection.
* Signed study specific consent form

Exclusion Criteria:

* Distant metastasis
* Currently Pregnant
* Psychiatric or addictive disorders that preclude informed consent
* Time from initial diagnosis to the start of radiation therapy \> one year
* Estimated life expectancy judged to be \< one year
* Prior radiation to the ipsilateral breast or chest wall
* Primary breast cancer is lymphoma or sarcoma
* Patients being treated with concurrent chemotherapy.
Clinical Study and Economic Analysis of an Intraoperative Navigation System for Total Hip Arthroplasty

This study will assess the clinical and health economic value of an intraoperative navigation system for total hip arthroplasty in one Ontario hospital. The results of this study will be used to generate evidence-based recommendations on the use and funding of the device in public hospitals and inform the development of a provincial healthcare innovation pathway.


Eligibility Criteria:
Inclusion Criteria:

* Receiving primary THA
* Elective THA
* Provision of informed consent

Exclusion Criteria:

* Unable to obtain informed consent
* Receiving revision THA
* THA is to treat trauma (i.e. hip fracture and/or dislocation)
* Patient is undergoing simultaneous bilateral hip replacement
* Performing surgeon is not participating in the study
* Hip fracture
* Hip dislocation
* Severe osteoporosis
* Trochanteric osteotomy
* Suspected or actual infection
* Existing implanted hardware
* Severe deformities of the femoral or pelvic bone
* High Body Mass Index (BMI)\*
Does a Complex Care Discharge Planning Initiative Reduce Unplanned Hospital Readmissions? (G78717-Readmits)

Unplanned hospital readmissions are associated with increases in morbidity, mortality, cost and patient dissatisfaction,. Policymakers continue to seek effective policy solutions to avoid readmissions in order to improve quality of care and reduce unnecessary expenditures,. One attempt to reduce readmissions was implemented on June 1 2012, when the Specialist Services Committee of British Columbia (a partnership of Doctors of BC and the Ministry of Health) introduced the new "G78717" fee code for physicians. The objective of the fee code was to create a financial incentive for physicians to provide a point-of-care supplemental discharge summary to patients and their primary care providers prior to discharge from hospital. Initially, only urgent hospital admissions were eligible for this incentive payment but on Nov 1 2015 the incentive was extended to include elective admissions as well. The other eligibility criteria remained unchanged.

The effectiveness and cost-effectiveness of the fee code intervention is unknown. This study will address important questions relevant to this policy intervention using rigorous methods and empirical data.

This study will employ two methods for measuring changes in readmission risk. First, we will use interrupted (multivariate) time series to measure whether there was a temporal change in provincial readmission risk associated with the implementation of the new fee code.

We will complement the above analyses with a stronger design, comparing hospitalizations for which the fee code was charged (intervention group) with a cohort of clinically similar hospitalizations for which the fee code was not charged (control group). For this approach, multivariate logistic regression will be the primary statistical method. Using this analytic strategy, 30-day readmission risk between the intervention and control group will be measured over time, adjusted for patient-, provider-, and hospitalization-level covariates.


Eligibility Criteria:
Inclusion Criteria:

The study population will be comprised of all hospital discharges in British Columbia between 1 Jan 2002 and 30 June 2017.

Exclusion Criteria:

We will exclude separations with the following International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Canada (ICD-10-CA) codes as the Most Responsible Diagnosis:

* Codes O00 - O99 \[Pregnancy, childbirth and the puerperium\]
* Codes P00 - P96 \[Certain conditions originating in the perinatal period\]
Anorexia Nervosa and Its Effects on Brain Function, Body Metabolism and Their Interaction

The neuromolecular and metabolic underpinnings of Anorexia Nervosa (AN) are studied using multi-modal molecular (positron emission tomography with two different radioligands) and functional (functional magnetic resonance imaging) neuroimaging in a prospective design. Subjects with AN and normal weight adolescents will be studied with PET and MRI and followed for five years.

A total of sixty females (30 with AN, 30 healthy controls) are recruited into this prospective study. The subjects will undergo physical examination, body tissue composition measurement, functional and structural MRI of the brain and body, and positron emission tomography (PET) with ligands \[18F\]-FDG, and \[11C\]carfentanil. Subjects' weight and physical condition will be followed up for 5 years. The study will start in August 2020 and end in the fall of 2028.

Eligibility Criteria:
Inclusion Criteria for AN:

1. Female sex
2. Age 18-32 3 years
3. BMI \< 17.5 kg/m2
4. Currently fulfilling modified DSM-IV diagnosis of AN with or without amenorrhea, onset age before 25 years
5. Diagnosed less than 2 years ago

For controls:

1. Female sex
2. Age 18-32 3 years
3. BMI 19 20-25 kg/m2
4. No lifetime history of obesity (BMI ≥\> 30) or eating disorders

Exclusion Criteria:

1. Any chronic disease or medication that could affect glucose metabolism or neurotransmission
2. History of psychiatric disorders (excl. AN for the corresponding study group)
3. Smoking of tobacco, taking of snuffs, or use of narcotics
4. Abusive use of alcohol
Oxygen Reserve Index: Utility as Early Warning for Desaturation in Morbidly Obese Patients

The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to partial pressure of oxygen (PaO2) values of 100 mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200 mmHg and above. This is clinical study designed to evaluate the clinical utility of the Oxygen Reserve Index (ORI) as an early warning for arterial hemoglobin desaturation during the induction of general anesthesia and tracheal intubation in obese patients undergoing elective surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* BMI\>30, \<40 m/kg2
* Control group only: BMI \>18.5 m/kg2, \<25 m/kg2
* Scheduled for an elective surgical procedure requiring general anesthesia and endotracheal intubation

Exclusion Criteria

* Age less than 18 years
* Adults unable to give primary consent
* Pregnancy
* Prisoners
Irish Omega-3 Study

The Irish Omega-3 study is a clinical trial designed to investigate the potential of Omega-3 fatty acids in the reduction of risk of psychosis.

The study is being coordinated by the HRB Clinical Research Facility at University College Cork. The Principal Investigator is Dr Maeve Rooney, Consultant Psychiatrist in the Mercy University Hospital, Cork. The study will be carried out in collaboration with the HRB Clinical Research Facility in Dublin in prior to rolling out to other centres around Ireland.

The Study is funded by Stanley Medical Research Institute, a non-profit organization supporting research on the causes of, and treatments for, schizophrenia and bipolar disorder. It is the largest provider of funding for research in serious mental illness outside of the U.S. government.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be aged between 13 and 50 years.
* Written informed consent will be obtained from subjects, or, in the case of those under - eighteen, from their parent or guardian, with the assent of the participant.
* Subjects meet the criteria of UHR, according to the Structured Interview for Prodromal Syndromes (SIPS) (Cannon et al., 2008, Woods et al., 2009).

Exclusion Criteria:

* Previous psychotic episode of at least one week's duration.
* Previous manic episode of at least one week's duration.
* Acute suicidal or aggressive behaviour.
* Substance dependence.
* Lactose intolerance/Milk allergy
* Intellectual disability, which in the opinion of the investigator would affect the person's ability to participate in the trial.
* Previous treatment with an antipsychotic or mood stabiliser for a psychiatric indication longer than 2 weeks in the previous three months.
* Consumption of over the counter or prescribed omega-3 fatty acids supplements within 12 weeks of entering the trial.
* Pregnancy/breast-feeding.
* Severe inter-current illness that may affect the ability of the participant to take part in the trial.
The Relationship Between School Readiness and Sensory Processing Disorder in Preterm Preschooler

The study aims investigate sensory processing disorders and school readiness in pre-school preterm children and the relationship between sensory impairment and school readiness

A convenience of preterm and term preschoolers recruiting from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation. Each group contains 30 children. First, sociodemographic information and histories of children are obtaining. Ages and contact information of the parents are recording. Prenatal and natal risk factors of the mothers are querying. Gestational ages and height, weight, and head circumferences of babies at birth are recording. Number of pregnancies, live births and abortions, type of delivery, multiple pregnancies for mothers as well as consanguinity between parents are asking. Marmara Primary School Readiness Scale is using to evaluate mental-language development, socio-emotional development, physical development, self-care skills,math skills, science skills, voice exercises, line exercises and labyrinths. Sensory profile caregiver questionnaire screen for the senses (sensory processing), adjustment (modulation), behavioral and emotional responses. . All examination wiil be finished in the same day.

Eligibility Criteria:
Inclusion Criteria:

* No neurological diagnosis
* gestational age \< 37 weeks
* 60-78 months of age

Exclusion Criteria:

* Have a neurological diagnosis (such as cerebral palsy)
* Grade III or grade IV intraventricular hemorrhage
* Have undergone major surgery in neonatal period
* Mental retardation
The Safety and Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Fecal Incontinence

This clinical trial aims to assess the effectiveness of Ramosetron compared to Psyllium, a gold standard therapy, in patients with fecal incontinence. The primary questions it seeks to answer are:

1. Does Ramosetron improve the symptoms of fecal incontinence?
2. Is Ramosetron superior to Psyllium in terms of symptom improvement and its impact on quality of life?

Participants will be randomly assigned to one of two groups, either taking Ramosetron or Psyllium for one month. They will be asked to complete a questionnaire. Researchers will then compare the Fecal Incontinence Severity Index between the Ramosetron and Psyllium groups to determine whether Ramosetron provides superior symptom relief compared to Psyllium.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with fecal incontinence (patients with 2 or more symptoms of fecal incontinence per month for at least 3 months).
2. Patients who are able to understand and comply with this study.
3. Individuals who are agreeable to being on contraception for the duration of the study.

Exclusion Criteria:

1. Patients who have difficulty swallowing medications
2. Patients with gastrointestinal deformities due to surgery
3. Patients with malabsorption
4. Patients with inflammatory bowel disease (IBD)
5. Patients undergoing treatment for cancer of the gastrointestinal tract
6. Patients who are allergic to the study drug
7. Patients with overflow incontinence and fecal impaction on rectal residual examination (DRE) or Bristol Stool Scale of 3 or less.
8. Patients taking medication for fecal incontinence within 1 month of study entry.
9. Pregnant or lactating women.
10. Patients with contraindications to any of the study drugs (i.e., intestinal obstruction, intestinal stones, acute abdomen, undiagnosed abdominal pain/nausea/vomiting, gastrointestinal stenosis and dysphagia, patients with megacolon syndrome, severe diabetes, etc.).
11. Patients taking an agent that is contraindicated in combination with either study drug.
12. Patients deemed by the investigator and staff to be unsuitable for participation in the study.
MENTOR Wellness Program

This randomized trial aims to determine the effectiveness a virtual wellness intervention program in individuals with traumatic brain injury (TBI). Participants will be randomized at enrollment into two groups: immediate treatment (IT) and delayed treatment (DT) group. This study will also provide insights into the impact of these intervention's components in helping emotional, physical, and nutritional outcomes post-injury in the context of social determinants of health (SDOH).


Eligibility Criteria:
Inclusion Criteria:

* Have a medically-documented (e.g., EMS report, hospital record, physician record) or per medical monitor review complicated-mild, moderate, or severe TBI requiring admission to an acute inpatient rehabilitation unit
* Be at least 12 months post-TBI
* Have access to the internet on a computer, tablet, and/or smartphone.
* Speak and understand English or Spanish
* Agree to participate
* Are medically cleared by their primary physician, physiatrist, neurologist, rehabilitation therapist, or other recognized health professional to participate in the study

Exclusion Criteria:

* No history of complicated-mild, moderate, or severe TBI
* Less than 12 months post-TBI
* In minimally conscious or vegetative state
* Beginning a new treatment regimen (e.g., physical therapy, occupational therapy, vestibular therapy, psychotherapy, and/or medication) at study start that can influence study findings in the judgment of the principal investigator and/or medical monitor (participants whose treatment regimens are stable will be eligible)
* In the judgment of the principal investigator, medical monitor, and/or study team member, presence of significant cognitive impairment (i.e. delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection
* In the judgment of the principal investigator, medical monitor, and/or study team member, significant or major disabling medical condition sufficient to preclude meaningful informed consent and/or data collection
Studying Blood Samples in Women With Breast Cancer or a History of Breast Cancer

RATIONALE: Studying samples of blood in the laboratory from patients with current or previous cancer may help doctors learn more about biomarkers related to cancer.

PURPOSE: This research study is looking at blood samples in women with breast cancer or a history of breast cancer.

OBJECTIVES:

Primary

* To compare peripheral blood (PB) concentrations of circulating endothelial cells (CEC) in women with measurable, active breast cancer to PB concentrations of CEC in a control population of women with a history of breast cancer who are currently without evidence of active disease.

Secondary

* To compare in women with measurable breast cancer the relationship between PB concentrations of CEC prior to and at 3 and 6 weeks following initiation of a new chemotherapy or hormonal therapy, and correlate these values with clinical response to treatment to determine if CEC can be used as a tumor marker or indicator of disease burden.
* To compare PB concentrations of CEC to levels of plasma proteins associated with angiogenesis, including vascular endothelial growth factor, in women with active or a prior history of breast cancer.

OUTLINE: Peripheral blood and plasma samples are collected for analysis of circulating endothelial cells (CEC) and angiogenic growth factor levels. Blood samples from patients initiating a new chemotherapy or hormonal therapy for breast cancer are collected at baseline and at 3 and 6 weeks following the start of treatment. CEC are quantified via flow cytometry and plasma angiogenic markers are assessed via ELISA.

PROJECTED ACCRUAL: A total of 100 patients with active, measurable breast cancer and 100 patients with a prior history of breast cancer will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Receiving treatment for measurable breast cancer at the Arizona Cancer Center Clinic
  * Being followed for a prior history of breast cancer (with no evidence of active disease) at the Arizona Cancer Center
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Improving Adherence and Commitment to Treatment in Diabetic Patients

In the IMPACT project, the investigators want to improve adherence and commitment to treatment.

In this study the investigators use 3 interventions in diabetic patients and one control, to find what is the best intervention to improve adherence to healthy life style and medication therapy. the 3 intervention as followed: 1) meetings and follow-up by the medical team; 2) meetings and follow-up by trained peers; 3) system for sending SMS, operate according to algorithm.

Eligibility Criteria:
Inclusion Criteria:

1. type 2 diabetes
2. age 30-70
3. Oral medication or insulin
4. According to the HbA1c test result, 0.5% above the target for the patient's personal balance and below the 10%, the most recent, but in any event not more than six months prior to the study patient recruitment
5. BMI\<35
6. Patients speak and read Hebrew
7. owners of a mobile phone that can receive text messages (SMS messages/ notifications) and have the ability to use the application (relevant for the SMS notification arm)

Exclusion Criteria:

1. Active malignant disease
2. creatinine levels above 2
3. Getting medicines that elevate sugar levels as steroids, chemotherapy
4. Three months after Myocardial Infraction (myocardial ischemia), surgical intervention, cardiac event
5. Patients who are planning major surgery
6. Patients who are planning a residential zone change
7. Patients with acute complications of diabetes under active treatment (such as limb amputation)
8. Patients diagnosed with unbalanced mental disorders
9. patients who can not sign the form on their own "informed consent"
10. patients suffering from dementia
11. Patients who are not mobile (dependent on the therapist)
Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies

The purpose of this study is to determine whether radioactive iodine, as compared to anti-thyroid medications, is a risk factor for the development or progression of thyroid-associated ophthalmopathy in patients with hyperthyroidism due to Graves' disease. The other aim of this study is to determine the incidence of the various ophthalmopathy subtypes and the utility of orbital antibodies in the diagnosis, classification and monitoring of patients with thyroid-associated ophthalmopathy.


Eligibility Criteria:
Inclusion Criteria:

* Graves' disease diagnosed in the last 3 months, regardless of the presence of ophthalmopathy

Exclusion Criteria:

* Pre-existing eye disease: e.g. orbital surgery, orbital irradiation or significant loss of vision
* Age \< 18 years
* Inability to consent to participation in the study
* Pregnancy
* History of radio-active iodine therapy