cyrilzakka/clinical-trials huggingface dataset:
Targeted Literature Review and Subject Interviews in Wiskott-Aldrich Syndrome (WAS)

WAS is a rare primary immune deficiency disease caused by genetic mutation and is more common in males than females. The purpose of this study is to understand experiences of WAS subjects and caregivers to identify important concepts of interest that could be measured in future Phase IIIb trials. This is a qualitative cross-sectional study that will include a sample of approximately, 8 subjects with WAS and 13 caregivers of subjects with a diagnosis of WAS in the United States, United Kingdom and France. A 60 to 90 minute open-ended interview will be conducted over the telephone or video conference that will be audio-recorded for subsequent transcription. The aim of these interviews is to obtain subject and caregiver perspectives on the impact of WAS and its associated treatments on quality of life and experiences of living with WAS.


Eligibility Criteria:
Inclusion Criteria:

Subjects:

* Male adolescents or young adults ranging in age from 12 through 30 years old.
* Diagnosis of WAS defined by WAS genetic mutation with a clinical score \>=1 or self-reported disease severity.
* Subjects who are "conservatively managed" or have not received treatment for WAS; a maximum of 5 subjects who have received a hematopoietic stem cell transplant within the preceding two years.
* Able to read, speak, and understand English or French sufficiently to complete all assessments.
* Willing and able to participate in an audio-recorded, telephone or video conference session, including adherence to the interview instructions and completion of all questionnaires.
* Parent/guardian/patient signed informed consent.

Caregivers:

* Caregivers of children \>=2 years of age diagnosed with WAS; at least 5 caregivers of subjects under the age of 8.
* Caregivers of subjects with a diagnosis of WAS defined by WAS genetic mutation with a clinical score \>=1 or self-reported disease severity.
* Caregivers of subjects who are "conservatively managed" or have not received treatment for WAS; At least 2 caregivers of subjects who have received a hematopoietic stem cell transplant within the preceding two years.
* Caregivers are defined as primary caregiver.
* Able to read, speak, and understand English or French sufficiently to complete all assessments.
* Willing and able to participate in an audio-recorded, telephone or video conferencing interview session, including adherence to the interview instructions and completion of all questionnaires.
* Caregivers of Wiskott-Aldrich patients can be of any age or gender and do not have to follow the patient inclusion criteria, as long as their child/patient meets the inclusion criteria, as outlined.

Exclusion Criteria:

Subjects

* Subjects who have previously received gene therapy treatment Caregivers
* Caregivers of subjects who have previously received gene therapy treatment
* Professional caregivers (that is, at home nurse or equivalent).
Consumption of Probiotics on Salivary Bacteria Causing Dental Caries

Dental caries is a multifactorial disease effecting majority of the human population.One of the etiological factor causing dental caries is salivary mutans streptococci. Reducing the levels of this bacteria in the saliva can significantly reduce the incidence of dental caries. A non-invasive intervention, such as the administration of probiotics reduced the salivary mutans streptococci levels.

40 candidates were selected from a pre-determined group and were randomly assigned to two groups. Group A (n=20) was administered probiotic drink and Group B (n=20) was administered placebo for 14 consecutive days. Saliva was collected on day 1 and day 15 to compare the salivary mutans streptococci levels.

Eligibility Criteria:
Inclusion Criteria:

* Decayed Missing Filled Surfaces less than or equal to 6
* Brushes twice daily

Exclusion Criteria:

* undergoing orthodontic treatment
* topical fluoride therapy in the past 2 yrs
* using sugar free gums
Head & Neck Cancer Survivorship: Physical and Functional Status

RATIONALE: Early physical therapy may be effective in improving range of motion of the neck and shoulders in head and neck cancer survivors who are undergoing chemotherapy and radiation therapy.

PURPOSE: This phase I trial is studying how well early physical therapy works in improving physical and functional well-being in head and neck cancer survivors receiving chemoradiotherapy.

OBJECTIVES:

* Describe the physical and functional well-being of head and neck cancer (HNC) survivors undergoing physical therapy during adjuvant chemoradiotherapy.
* Describe clinical measure of range of motion for the cervical spine and shoulder of HNC survivors undergoing physical therapy during adjuvant chemoradiotherapy.
* Determine the feasibility of an early physical therapy intervention (prior to and during adjuvant treatment) targeting the physical needs of HNC survivors.

OUTLINE: Patients undergo physical therapy weekly for 10 weeks beginning 1 week prior to initiating adjuvant chemoradiotherapy and continuing until 2 weeks after the completion of adjuvant chemoradiotherapy.

Patients undergo range of motion assessment and complete a Cancer Survivorship Survey (CSS) at baseline and in weeks 4, 8, 9, and 10 of physical therapy.

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS:

* Head and neck cancer survivor
* Planning to receive adjuvant chemoradiotherapy for head and neck cancer

  * Has not yet initiated adjuvant therapy
* Referred to rehabilitation oncology physical therapy program

Exclusion Criteria:

* No metastatic disease
* No CNS cancer

PATIENT CHARACTERISTICS:

* Speaks English
* No significant history of cardiovascular or neurovascular disease involving disability

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Not currently in hospice care
Project Health Link: Connecting Patients With Services

The proposed study will compare three alternative interventions in the emergency department (ED) to promote linkage to substance abuse assessment, referral and treatment entry for those who meet abuse/dependence criteria for stimulants, cannabis, and/or non-injected opioids: (1) a 5-session Strengths-Based Case Management (SBCM) model; (2) a 2-session Brief Motivational Enhancement (BME); or (3) a one-time Brief Informational Feedback (BIF) session. The primary outcome variables for this trial include receiving an assessment and referral and treatment entry. Other outcomes include degree of treatment completion, substance-related measures, health service utilization, health status changes, and psychosocial factors.


Eligibility Criteria:
Inclusion Criteria:

* (1) adults age 19-60 presenting to the Hurley Medical Center ED within 24 hours of an injury; (2) ability to provide informed consent.

Additional inclusion criteria for intervention study: meets criteria for substance abuse or dependence for stimulants (cocaine powder, crack cocaine, methamphetamine, amphetamine), cannabis (marijuana, hashish), and or opioids (noninjected heroin, other opioids such as hydrocodone and oxycodone) in the previous year.

Exclusion Criteria:

* (1) adult patients who do not understand English; (2) prisoners; (3) adults classified by medical staff as "Level 1 trauma"; (4) adults deemed unable to provide informed consent as stated above (e.g., intoxication, mental incompetence); (5) patients treated in the ED for suicide attempts and sexual assaults; (6) patients who have been in treatment for substance abuse in the past six months; (7) patients who are triaged to psychiatric emergency services; and (8) patients who report injecting heroin or other opiates in the past year.
Adaptation and Validation of a Nutrition Literacy Assessment Instrument

The purpose of this study is to develop a tool to help researchers better understand what diet information people know and what skills they use to make diet choices.


Eligibility Criteria:
Inclusion Criteria:

* Able to speak and read English
* Have 1 or more of the following diseases: diabetes, hyperlipidemia, hypertension, and/or overweight/obesity

Exclusion Criteria:

* Visual acuity insufficient to read the testing instrument
* Cognitive impairment
* Weight \> 500 pounds
Anaesthetic and Pediatric Living Related Liver Transplantation

To study the effect of different anaesthetic methods on pediatric neurocognitive development and cerebral injury during pediatric living related liver transplantation .

Since the 1960 s, with the successful development of liver transplantation, it has become an important method for the treatment of patients with end-stage liver disease.Biliary atresia1 is the most frequent causes of pediatric end-stage liver disease,.The morbidity of congenital biliary atresia is 1/8000-18, 0002 ,which influence the patients' overall growth and development situation. The rising of living donor liver transplantation has provide children with the chance of a timely treatment since the 1980 s, It is no doubt that pediatric liver transplantation is facing with many complications, including the most importance of neurocognitive development .Now the researches of neurological complications is less .According to statistics, the incidence of neurological complications after pediatric liver transplantation was 8% - 46% . So it is necessary to research the neurological complications and brain protection strategy .Previous studies have studied that some anaesthetic have uncertain affect on the development of children.

Eligibility Criteria:
Inclusion Criteria:

* Children with end-stage liver disease Children with biliary atresia

Exclusion Criteria:

* pre-existing cerebral disease second liver transplantation
Evaluation of Neopterin Levels in Pre and Post-menopausal Women With Periodontitis Following Non Surgical Therapy

Neopterin has been identified as a marker of cellular immune system activation. It is synthesized by macrophages upon stimulation with the cytokine interferon-gamma and is indicative of a pro-inflammatory immune status. Neopterin concentration increases with increasing severity of periodontal disease in diverse body fluids like Urine, Saliva and Plasma. Hence Neopterin can be considered as an important inflammatory marker in periodontal disease as well as other systemic diseases.

At baseline - plasma, urine and saliva samples were collected and analysed for neopterin levels from the pre and post-menopausal women with periodontitis . Followed by scaling and root planing done in both the groups. After 3 months again these 3 samples were collected and analysed for post treatment neopterin levels

Eligibility Criteria:
Inclusion Criteria:

* moderate to chronic periodontitis
* non-smokers
* minimum 15 natural teeth present

Exclusion Criteria:

* patients on long term steroid medication
* with gross oral pathology or tumors
* undergoing hormone replacement therapy
* not undergone periodontal therapy in past 6 months
* under medication in past 6 months
* systemic disorders and drugs which influence the periodontium
Treatment of Symptomatic BPH Patients Undergoing Anticoagulant Therapy Using the PlasmaButton Vaporization Electrode

The purpose of this observational study is to evaluate the outcomes of using the PlasmaButton electrode in the treatment on Benign Prostatic Hyperplasia (BPH) while on anticoagulation medication.


Eligibility Criteria:
Inclusion Criteria:

* Men with obstructive symptoms due to benign prostatic hyperplasia who are also on anticoagulant regimen.
* Anticoagulant regiments include: Aspirin 81mg, Aspirin 325mg, Adenosine diphosphate (ADP) receptor inhibitors, Cilostazol, Dabigatran, Dipyridamole, or Warfarin. The patient will be stable on their dosage regimen for at least 3 months.
* Maximum flow rate \<15ml/s by uroflowmetry.
* International Prostate Symptom Score (IPSS)≥10.

Exclusion Criteria:

* Patients with coagulopathy, INR exceeding 3.
* Anti-coagulation dose changes within 3 months of surgery.
* Patients not medically cleared to undergo surgery for medical reasons.
* Patients with neurogenic bladder (bladder affected due to a neurologic cause).
* Urethral stricture, obstruction due to stricture.
* Suspected bladder or prostate cancer.
* Prostate size greater than 80 cc.
Safety and Efficacy Study of HuCNS-SC in Subjects With Neuronal Ceroid Lipofuscinosis

The purpose of this Phase Ib study is to determine if "Human Central Nervous System Stem Cells"(HuCNS-SC) is safe to be transplanted in subjects with infantile and late infantile neuronal ceroid lipofuscinosis. The study will also measure post-transplantation disease progression.

Participation in this study will involve screening assessments, surgery to implant HuCNS-SC, medication to suppress immune system and a series of follow-up assessments.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 months to 6 years
* Male or female
* Clinical diagnosis of Infantile neuronal ceroid lipofuscinosis or late infantile neuronal ceroid lipofuscinosis
* CLN1 or CLN2 mutation

Exclusion Criteria:

* Previously received an organ, tissue or bone marrow transplantation
* Previously participated in any gene or cell therapy study
* Infection with hepatitis virus, cytomegalovirus, Epstein-Barr virus, or Human Immunodeficiency Virus (HIV)
* Current or prior cancer
* Bleeding disorder
* Unable to have an MRI scan
Effect of Slope Time in PCV Mode on Mechanical Power Calculation and Oxygenation in Covid-19 ARDS Patients.

The investigators are planning to investigate the effect of each 5% slope time change on mechanical power and SPO2 of the patients with Covid 19 ARDS diagnosis which are on mechanical ventilation PCV mode support.

In this study, with inspiration/expiration 1:2 and 1:1 time ratios in pressure controlled ventilation mode with different slope times mechanical power will be calculated in covid ARDS patients. In this way, the effect of every 5% slope time change in PCV on mechanical power and SPO2 will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with Covid-19 Acute Respiratory Distress Syndrome (ARDS) diagnosis
* intubated Covid-19 ARDS patients
* Covid-19 ARDS patients on mechanical ventilator support

Exclusion Criteria:

* heart failure disease
* Chronic Obstructive Pulmonary Disease (COPD)
* hemodynamically unstable patients
* pregnancy
Diffusion MRI-1 Imaging Database

The purpose of the dMRI-1 data collection study is to establish a database of clinical images and limited medical history information from patients that have previously received a dMRI scan. All data collected will be de-identified. No safety or effectiveness assessments will be completed.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is either ≥ 18 years and has previously received an acceptable dMRI scan(s) with at least 30 unique gradient directions or \< 18 years who has previously received an acceptable dMRI scan of any number of unique gradient directions and who is allowed to participate in this type of research project (e.g., IRB/EC approval with waiver of consent) per IRB/EC
2. Acceptable dMRI scan was completed prior to site activation in the study

Exclusion Criteria:

None
ST Elevation Myocardial Infarction Hemodynamic OutComes: Role of Non-Invasive Cardiac System (SHOCk-NICaS) Study

Proposed novel solution for high-risk heart disease Overall in-hospital mortality among ST elevation myocardial infarction (STEMI) patients is 3-4%, but \>50% patients experiencing cardiogenic shock (CS) secondary to STEMI die in the hospital. Evidence suggests early diagnosis and treatment of CS results in improved outcomes, albeit, there is no tool to diagnose CS reliably in a timely fashion in STEMI patients through the continuous monitoring. We hypothesize that bioimpedance-derived hemodynamic measures obtained using the Non-Invasive Cardiac System (NICaS) can facilitate early detection of CS, predict outcomes, and revolutionize the STEMI patient management. The objectives of SHOCk-NICaS study in STEMI patients are to: a) identify the CS early, using NICaS derived cardiac index of ≤1.8L/min/m2 or ≤2.2L/min/m2 with the use of vasopressor and/or inotropes, and compare it with the incidence of CS based upon lactate level ≥2mmol/L, and systolic blood pressure \<90mmHg; b): determine the impact of primary percutaneous coronary intervention (PPCI), using NICaS derived hemodynamic measures (stroke volume, cardiac index, cardiac power index, etc), by comparing pre- and post-angioplasty; and c) identify outcome-associated hemodynamic markers. A composite score of death during hospital stay, prolonged hospitalization due to heart failure (\>72hrs), and use of inotropic or mechanical circulation support is a primary outcome.

Methodology This is a multi-center, double-blind, prospective cohort study enrolling STEMI patients aged ≥18years visiting at 4 cardiac centers (St Boniface, St. Michael's, McGill University Hospital). Using validated NICaS protocol, hemodynamic parameters will be recorded at baseline, during the PPCI procedure, and within 24-hour post PPCI without altering the standard care. Statistical analysis: Baseline data will be reported as mean±SD or median±interquartile range. The outcomes will be assessed using multivariable logistic regression. We will analyze the impact of age, sex, gender, and ethnicity on hemodynamic measures. The targeted 500 patients will ensure a margin of error of 5% at a 95% CI. So far recruited 76 STEMI patients mark the study feasibility.

Significance This novel study in high-risk STEMI patients will provide a promising cost-effective, rapid, and non-invasive tool to identify CS early; a prompt intervention may curtail the high morbidity and mortality. The meticulously designed pragmatic study outcomes may revolutionize STEMI patient management.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years, presenting with EKG confirmed diagnosis of STEMI
* Able to understand, and consent to participate in the study

Exclusion Criteria:

* Patients unwilling to participate in the study
* Patients with any life-threatening medical condition with an expected life span of ≤1 year (e.g., metastatic cancer, terminal COPD)
To Compare Anterior Knee Pain Between Non Severe and Severe Patellofemoral Arthritis After Oxford UKA

The aims of this study is to compare the results between patients without severe patellofemoral arthritis and patients with severe patellofemoral arthritis after mobile bearing UKA.

The investigators prospective compute the results including anterior knee pain, knee society score, pain score, functional score, range of motion, operative time, blood loss, and component alignment.

The patients were performed surgery. The Oxford UKA was applied for all patient.

Eligibility Criteria:
Inclusion Criteria:

* anteromedial osteoarthritis knee,
* older than 40 years old,
* range of motion \> 90 degrees,
* varus deformity \< 25degrees,
* flexion contracture\< 20degrees,
* intact anterior cruciate ligament

Exclusion Criteria:

* younger than 40,
* osteonecrosis of knee,
* rheumatoid,
* posttraumatic arthritis,
* absent of anterior cruciate ligament
A Comparative Study Between Early Onset Colorectal Cancer and Late Onset Colorectal Cancer Patients

This study aims to investigate the clinical, socioeconomic, behavioral, genetic, and molecular factors characterizing Early Onset Colorectal Cancer (EOCRC) patients compared with Late Onset Colorectal Cancer (LOCRC) patients

Early Onset Colorectal Cancer (EOCRC), defined as a Colorectal Cancer (CRC) arising before the age of 50, is increasing and displays more aggressive features compared with Late Onset Colorectal Cancer (LOCRC, with a diagnosis after the age of 50). EOCRC patients have indeed a higher incidence rate of CRC recurrence after surgery compared with LOCRC, even at early CRC stages (stage I or II). The reasons underlying the more aggressive patterns are almost unknown but may span and can be represented by a combination of socioeconomic factors (including low economic income and access to screening programs, diagnosis, or therapy), behavioral and lifestyle factors (including diet, sedentary behaviors, or increased stress and anxiety), and molecular or genetic factors.

The aim of this study is to prospectively validate our previous retrospective findings, demonstrating a higher incidence rate of CRC recurrence in early stage EOCRC, and explore the possible association between lifestyle, dietary, socioeconomics, molecular and genetic factors and postoperative CRC survival.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 18 years old at the time of inclusion.
* Patients with a proven diagnosis of colorectal adenocarcinoma, as reported by the staging histological biopsies.
* Patients with a preoperative staging I-III.
* Patients scheduled for elective curative colorectal resection.
* Patients with rectal cancer who underwent neoadjuvant therapy can be included in the study.
* Patients able and willing to comply with the protocol requirements (samples' collection and questionnaires' compilation).

Exclusion Criteria:

* Patients with metastatic disease at diagnosis.
* Patients requiring an emergent procedure.
* Patients undergoing palliative surgery (for example, fecal diversion).
* Patients with a surgical indication for benign lesions (for example, adenoma or dysplasia).
* Patients with an intraoperative finding of a lesion other than adenocarcinoma will be withdrawn from the study.
* Patients with an intraoperative finding of distal metastasis or peritoneal carcinosis will be withdrawn from the study.
* Patients with a concomitant diagnosis of Inflammatory Bowel Disease.
* Patients with a known genetic syndrome (for example, Lynch syndrome or Familial Adenomatous Polyposis).
Measurement of Anti-Androgen Response Using Fluorine-18 Fluorocholine PET/CT in Androgen-Insensitive Prostate Cancer

The purpose of this study is to determine whether positron emission tomography / computed tomography (PET/CT) using fluorine-18 fluorocholine as an imaging agent can characterize regional responses to anti-androgen therapies in a manner that in the future aid in the customized planning of treatments for patients with androgen-insensitive prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent.
2. Men, over 18 years of age, with histologically-confirmed diagnosis of prostate cancer
3. History of treatment by complete androgen blockade for greater than 3 months prior to enrollment
4. Serum testosterone level \< 50 ng/ml. Castrate testosterone levels must be from orchiectomy or current therapy with leutinizing hormone-releasing hormone agonist.
5. Progressive disease evidenced by two consecutive rises in prostate specific antigen (PSA) above a nadir value, with the absolute value of the latest PSA \> 2. 0 ng/ml.
6. Patient will be undergoing a therapeutic intervention under the supervision of his treating physician (urologist, oncologist).

Exclusion Criteria:

1. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder.
2. Serious underlying medical conditions that would otherwise impair the patient's ability to undergo imaging.
3. Patient weighs over 350 lbs (due to scanner weight limit).
4. Clinical life expectancy \< 12 weeks.
5. Participated in other radioactive drug studies where estimated total cumulative dose within 1 year is \> 0.05 Sievert for whole body, active blood-forming organs, eye lens, gonads, or 0.15 Sievert for other organs.
6. Concurrent Therapy. Allowed: prior hormonal therapy; concurrent leuteinizing hormone releasing hormone (LHRH) agonist; prior surgery; prior or concurrent bisphosphonate. Not allowed: concurrent anti-androgen or secondary hormonal therapy, prior or concurrent chemotherapy, concurrent radiotherapy or radioisotope therapy (e.g., strontium). Other: Prior radiotherapy or radioisotope therapy must be \> 12 weeks since last treatment.