cyrilzakka/clinical-trials huggingface dataset:
Pediatric Speech Therapy Session Frequency and Speech Outcomes

The goal of this clinical trial is to compare speech therapy outcomes in children ages 18 months to 16 years who participate in weekly speech therapy with home programming versus every-other week speech therapy with home programming in outpatient speech therapy. The main question it aims to answer is: Does a change in how often speech therapy sessions are delivered show an increased benefit in language and articulation standardized test scores? Participants will be randomly assigned to either (1) weekly or (2) every-other-week speech therapy for a total of 8 sessions. Researchers will compare these two groups to see if there are differences in speech outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Medical order for speech therapy
* Patients eligible for speech therapy at Connecticut Children's (qualify for receptive, expressive language and/or articulation therapy)
* Diagnosis of communication disorder.ICD-10 codes will be utilized pertaining to expressive, receptive language and articulation disorders (ICD-10 code specific to patient: F80.0, F80.1, F80.2, F80.4, F80.9, R47.89, R41.841)
* Patient recommended for individual (i.e. not group) treatment
* 18 months to 16 years of age
* Completed 1 plan of care (POC) with a duration of 8 sessions
* Attended at least 80% of scheduled visits during their plan of care period (still completing 8 sessions of therapy, may have extended time to completion).
* Services for a full 8-session plan of care.

Exclusion Criteria:

* - Seeking speech therapy care for treatment of disorders related to diagnosis of voice, feeding, fluency, and/or cognition
* Patient unable to complete standardized tests (EOWPVT-4, ROWPVT-4, GFTA-3, REEL-4)
* Patients in group speech therapy
* Patients younger than 18 months or older than 16 years of age
* Not willing to complete a full POC (8 sessions)
* Unable/unwilling to attend 80% of scheduled visits
Bortezomib, Rituximab and Dexamethasone (BORID) for Relapsed/Refractory Mantle Cell Lymphoma

Mantle cell lymphoma (MCL) remains difficult to treat by standard treatment approaches. Novel drugs have shown promising results in early clinical evaluations. In the current trial, we investigate a combination of bortezomib (a proteasome inhibitor), rituximab (a monoclonal antibody), and dexamethasone in patients with MCL, who have already been pretreated by standard chemotherapy and show again signs of disease progression. The study objectives include remission rates, safety of this drug combination, and survival time.

Description of the treatment regimen: Bortezomib: 1.3 mg/m2 as i.v. bolus injection, given on days 1, 4, 8, and 11 of each treatment cycle; Rituximab: 375 mg/m2 infusion, day 1 of each cycle; Dexamethasone: 40 mg per day orally (days 1 - 4) of each treatment cycle. Treatment will be given for a total of 6 cycles (every 21 days), followed by maintenance treatment with rituximab (375 mg/m2 every two months for 4 times)

Eligibility Criteria:
Inclusion Criteria:

* mantle cell lymphoma at stage II - IV, previously treated with at least one line of prior therapy (CHOP or CHOP-like), measurable disease, age 19 - 75 years, adequate cardiac, liver and renal function tests, patient's written informed consent

Exclusion Criteria:

* second malignancy, evidence for CNS involvement, clinically significant peripheral neuropathy (grade II or higher), HIV positivity, pregnancy
KLOS Study - Korean Medicine Registry for Low Back Pain Patients, a Prospective, Observational, Multicenter, Pilot Study

The Purpose of this trial is to define the characteristics of the in/outpatients with low back pain in traditional Korean medicine rehabilitation clinic. This information will create a registry that will help us to compare similarities and differences in patients and their symptoms. The more patients the investigators are able to enter into the registry, the more the investigators will be able to understand the low back pain and learn better ways of caring for patients.

KLOS, prospective, multi-center, patient registry pilot study will collaborate with 7 Korean medicine hospitals and plan to recruit low back pain patients into the registry. 150 eligible patients with new episode of LBP who visit Korean medicine hospital without any other treatment history will enroll to the registry. After enrollment, study collect the individual characteristics of patient's status such as pain intensity, LBP related daily disability, anthropometrics, HRQoL at baseline, 30 and 90 days. We also access to the patient's clinical and administrative electronic records to analyze the pattern of patients' resource utilization. Overall, the aims of KLOS are to: 1) explore the general characteristics of new episode of LBP patients and; 2) evaluate the efficacy and safety of various Korean medicine treatments on low back pain based on nationwide registry outcome collecting process.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients with chief complaint of low back pain in Korean medicine rehabilitation center
* Age greater than or equal to 19
* Ability to have normal communication
* Ability to give informed consent

Exclusion Criteria:

* Patients with low back pain which caused by other diseases(ex. lumbar herniated disc-surgery within past 3 months, vertebral fracture, inflammatory spondylitis, spinal infection, metastatic cancer etc.);
* Patient with musculoskeletal pain which is more severe than lower back pain;
* Patients with chronic disease may affect the results of clinical trial;
* Treated with medication for low back pain within past 4 months;
* Participated in other low back pain clinical trials within past 1 month;
* Patients who are Inability to communicate, such as alzheimer's disease or mild cognitive impairment;
* Pregnant women;
* Patients who are judged to be inappropriate for the clinical study by the researchers
St. Mary's Duluth Clinic (SMDC) Pacemaker Magnetic Resonance Imaging (MRI) Study

The purpose of this study is to monitor and follow non-pacemaker dependent patients with implanted permanent pacemakers, who undergo medically required Magnetic Resonance Imaging (MRI) scans.

Patients with pacemakers are currently excluded from obtaining MRI scans. MRI scanning is now the imaging of choice for a number of neurological, vascular, or musculoskeletal conditions.

Data suggests that patients with pacemakers, when properly monitored, can safely undergo MRI scanning, though the largest published study to date consists of 54 patients, and no long term follow-up has been published.

Though MRI cardiac scanning has been demonstrated to produce local tissue heating at the pacemaker lead tip, the long term effect of tissue heating on lead stability is unclear.

This study will evaluate patients with permanent pacemakers undergoing medically indicated MRI scanning.

Patients will be followed for one year at 3, 6, and 12 months. Data collected will evaluate change in pacing thresholds over time as well as cardiac troponin I, creatinine kinase MB function, and myoglobin levels within the first 12 hours following the scans, side effects, symptoms, the need to make pacemaker program changes, and possible artifacts created by the pacemaker on the MRI scan.


Eligibility Criteria:
Inclusion Criteria:

* Permanent pacemaker or ICD implanted for at least 6 weeks
* Referred for medically indicated MRI
* Age greater or equal to 18 years old

Exclusion Criteria:

* ICD market released before 2001 including GDT Ventak-AV, GDT MINI-II, GDT MINI-IV, GDT MINI-III, GDT Prizm-2 MDT GEM-I series
* Epicardial coronary sinus lead or subcutaneous array
* Unable to program all leads to bipolar configuration
* Pacemaker Dependent
* Device has reached elective replacement or end of life
* Other usual contraindications to MRI scanning
* The use of inotropic pharmacological agents, such as dobutamine, during the MRI
Feasibility and Acceptability of Group Medical Visits for Anxiety and Depression

The goal of this clinical trial is to evaluate the feasibility and acceptability of the intervention, Group Medical Visits (GMVs), for patients with depression and anxiety. It also aims to get some initial information on the effectiveness of GMVs on reducing depression and anxiety scores, which will help inform power calculations for a future larger randomized controlled trial (RCT). The main question it aims to answer is:

* Are GMVs feasible and acceptable to patients with depression and anxiety?

This study consists of a pilot RCT with an intervention and control arm. At enrollment, participants will be randomized to the intervention group, 6 months of GMVs, or to the control group, which consists of "standard client services". For the GMV group, participants will engage in a biweekly virtual group that is similar to a standard psychiatric follow-up. Participants in the control group will receive standard care after a psychiatric assessment, which includes follow-up with their primary care provider (family physician or nurse practitioner), individual psychiatric care if suggested by the psychiatrist who did their psychiatric assessment, and/or a referral to publicly funded therapy groups if interested.


Eligibility Criteria:
Inclusion Criteria:

* Adult Central Intake patients (patients referred for psychiatric consultation by their primary care provider) whose primary mental health issue is an anxiety disorder (social anxiety, generalized anxiety, or panic disorder) or depression (major depressive disorder or persistent depressive disorder)
* Able to participate in English language group with up to 10 participants
* Able to commit to a virtual biweekly group for about 1.5 hours each group
* Able to do virtual group from a private location with camera access
* Live in community in Manitoba and plan to stay for 6-month period

Exclusion Criteria:

* Patients with Bipolar 1 or 2 Disorder (even if current episode depression)
* Primary diagnosis of a personality disorder leading to anxiety/depression symptoms (personality disorder traits are not an exclusion criteria)
* Patients who already have established longitudinal care with a psychiatrist
* Received ECT treatment within past 6 months
* Any diagnosis that would significantly impact ability to participate in the group. For example:
* Moderate-to-severe substance use disorders (in particular substance use throughout day or inability to attend group without using substances before)
* Current psychotic symptoms
* Moderate-to-severe intellectual disability or neurocognitive disorder
* Current significant eating disorder symptoms (for example resulting in significant weight loss/malnutrition or that take up a significant part of the day either mentally or physically)
* Self harm behaviour requiring medical/psychiatric attention or active suicidal ideation/suicide attempts within the past 6 months
* Concern about safety of other group members/facilitators if this patient were to join
Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1

The goal of this pilot study is to examine both efficacy and tolerability in patients with HCV genotype 1 and mild decompensation with Child-Pugh-Turcott score of 6 or lower. The CPT score is used to assess the prognosis of chronic liver diseases, as well as the required strength and treatment and necessity of liver transplantation. A higher CPT score denotes higher necessity of liver transplantation.

Key objectives of this study include:

1. To describe efficacy (SVR) in a special population of patients with chronic hepatitis C who are not willing or not candidates for IFN-based therapy.
2. To describe safety, tolerability, and treatment persistency in this patient population with advanced liver disease.

Eligibility Criteria:
Inclusion criteria:

1. Adult 18-72 years
2. Cirrhosis: defined by stage 4 on biopsy or noninvasive tests or presence of splenomegaly and platelet of 130K or lower, or presence of shrunken nodular liver on CT or MRI, or presence of varices or encephalopathy or ascites.
3. HCV genotype 1 or indeterminate and later assessed at Screening and confirmed as genotype 1

Exclusion criteria:

1. Uncontrolled ascites, uncontrolled hepatic encephalopathy, or uncontrolled esophageal/gastric varices
2. Co-infection with HIV or hepatitis B (HBV)
3. CPT 7 or above, or MELD \>10
4. Total bilirubin 4.0 mg/dL or above
5. CrCl (creatinine clearance) \< 30 mL/min
6. Any unstable active medical illnesses.
7. Active use of illicit substances, alcohol, or smoking.
8. Any malignancy within last 5 years except for basal cell skin cancer that has been adequately treated or HCC within Milan or UCSF criteria, which will be acceptable
9. Any prior treatment with direct acting antivirals (approved or investigational), including HCV protease inhibitors, such as SMV. Patients who received prior treatment with SOF, and/or NS5A inhibitors (e.g. ledipasvir or Daclatasvir) can be included in this study
10. Platelet \< 30 K/uL
Stereotactic Body Radiotherapy (SBRT) With Concurrent Boost for Low- and Intermediate-Risk Prostate Cancer

The purpose of this study is to determine whether stereotactic body radiation therapy (SBRT) with simultaneous boost (higher radiation dose) to areas within the prostate with more prominent cancerous growth (intraprostatic lesions) utilizing intensity modulated radiotherapy (IMRT) planning techniques is a safe and effective treatment in patients with low- and intermediate-risk localized prostate cancer.

Standard external beam radiation therapy (EBRT) for low- to intermediate-risk prostate cancer involves several weeks of daily treatment sessions. Stereotactic body radiation therapy (SBRT) is a newer form of EBRT that gives fewer treatments but higher doses of radiation per treatment. In many patients there are certain areas within the prostate with more prominent cancerous growth (intraprostatic lesions), which may require higher doses of radiation (boost) to treat effectively. This study will treat the prostate with simultaneous boost(s) to intraprostatic lesion(s) in 5 treatments over 10-14 days.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of prostate adenocarcinoma within one year
* Gleason Score 2-7
* Clinical T-stage T1b-T2c (AJCC 7th Edition)
* Clinical Nx or N0, and Mx or M0
* PSA \< 20 ng/mL
* Low or intermediate risk according to NCCN guidelines: Low: Clinical Stage (CS) T1b-T2a and Gleason 2-6 and PSA \< 10 ng/ml; Intermediate: CS T2b-T2c and Gleason 2-6 and PSA \< 10 ng/ml, or CS T1b-T2a and Gleason 7 and PSA \< 10 ng/ml, or CS T1b-T2a and Gleason 2-6 and PSA 10-20ng/mL
* ECOG performance status 0 or 1
* Has had a pre-treatment PSA drawn within a month of the beginning of protocol therapy
* If androgen-deprivation therapy (ADT) has been initiated, must have a documented pre-ADT PSA; this baseline PSA should not be obtained during following periods: 1) 10-day period following prostate biopsy; 2) within 30 days after discontinuation of finasteride; or 3) within 90 days after discontinuation of dutasteride.
* Has completed a baseline health-related quality of life assessment Extended Prostate Cancer Index Composite questionnaire (EPIC-26)
* Has had a history and physical examination (including digital rectal examination and a formal morbidity assessment via the ACE-27) within 60 days
* Morbidity score (via the ACE-27) of none (0), mild (1) or moderate (2)
* Willing and able to use adequate contraception during protocol treatment and for 3 months after the completion of protocol treatment

Exclusion Criteria:

* Invasive (carcinoma in situ is allowed) solid or hematologic malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
* Prior prostatectomy or cryotherapy of the prostate
* Prior radiotherapy to the prostate or lower pelvis
* Prior or concurrent cytotoxic chemotherapy for prostate cancer (prior chemotherapy for a different cancer is allowed)
* Implanted hardware near the planning target volume that would prohibit appropriate treatment planning or treatment delivery in the investigator's opinion
Physical Activity Levels and Statin Therapy

Rationale: Combining statin treatment and physical activity is very effective for the prevention of cardiovascular diseases. Statins are well-tolerated by most patients, but may cause statin-associated muscle symptoms (SAMS).

Objective: To identify predictors for SAMS in statin users and to objectively assess physical activity levels and sedentary time between symptomatic and asymptomatic statin users.

Combining statin treatment and physical activity is very effective for the prevention of cardiovascular diseases. Statins are well-tolerated by most patients, but may cause statin-associated muscle symptoms (SAMS). Physical activity may exacerbate SAMS, producing decreased physical activity levels or statin nonadherence. However, it is unknown if daily activity patterns differ between symptomatic and asymptomatic statin users.

In this cross-sectional observational study the investigators will assess if physical activity levels and sedentary time differ between symptomatic and asymptomatic statins users. Secondly, questionnaires will be used to assess predictors of SAMS.

Eligibility Criteria:
Inclusion Criteria:

* Mentally able to give informed consent
* Statin treatment for at least 3 months

Exclusion Criteria:

* Known hereditary muscle defect
* Known mitochondrial disease
* Other diseases known to cause muscle symptoms (e.g. m. Parkinson or rheumatic diseases)
Concordance Between Echocardiographic Assessment Performed in the Initial Phase of Decompensated Cirrhosis With Edema and Ascites by an Expert Intensive Care Physician and a Non-expert Gastroenterologist

The investigators hypothesize that trans-thoracic ultrasound performed by non-specialist gastroenterologists with a standard training by intensive care doctors will give equivalent results to those achieved by experts for a simple evaluation of hemodynamic status.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be an adult at least 18 years old
* Patient has known or suspected cirrhosis (diagnosed by biopsy or based on recognized clinical/biological/radiological criteria)
* Admitted to the gastroenterology service for odematous-ascitic decompensation defined by edema of the lower limbs, and/or ascites, anasarca, associated or not with weight gain.

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient is pregnant or breastfeeding
* Patient already participated in the study
* Patient with cirrhosis admitted for a different decompensation (active digestive hemorrhage or sepsis)
* Poorly echogenic patient
* Patient withdraws consent
* Patient with anasarca of cardiac origin
* Ultrasound diagnosis of a severe cardiac pathology requiring specialized treatment in intensive care or cardiology (severe cardiac insufficiency, acute pulmonary edema, endocarditis, severe valvulopathy, cardiac tamponade, intracardiac thrombus)
Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants

The purpose of this study is to determine whether intravenous azithromycin is effective in eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks gestation.

The study design will be a double-blind, placebo-controlled clinical trial to test the efficacy and safety of azithromycin 20 mg/kg x 3 days to eradicate Ureaplasma spp from the respiratory tract of preterm infants 24 weeks 0 days to 28 weeks 6 days gestation exposed to positive pressure ventilation. The primary outcome will be survival with microbiological eradication of Ureaplasma defined as survival to discharge or transfer with 3 negative cultures obtained post-therapy. Secondary outcomes will include physiologic BPD at 36 weeks post-menstrual age (PMA), overall mortality, incidence of co-morbidities of prematurity such as intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, bacterial and fungal nosocomial infection, pulmonary air leak, patent ductus arteriosus, retinopathy of prematurity, number of days of positive pressure ventilation, number of days of oxygen supplementation, use of postnatal steroids, and use of non-study antibiotics. At 6 and 18 months adjusted age, a pulmonary outcome questionnaire will be administered by phone or in person interview. At 18-22 months adjusted age, neurodevelopmental outcomes will be assessed by 1) Bayley Scale of Infant and Toddler Development, 3rd edition (BSID-III); 2) Amiel-Tison neurologic examination; 3) Gross Motor Function Classification System; and 4) medical record review for hearing impairment with or without amplification and vision impairment (vision \<20/200).

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 24 weeks 0 days-28weeks 6 days by best obstetrical estimate
* \<72 h age
* Positive pressure ventilation for at least 1 hour duration during the first 72 hours of life
* Presence of indwelling intravenous line for drug administration

Exclusion Criteria:

* Any patient judged to be non-viable or for whom withdrawal of life support is planned
* Patients with major lethal congenital anomalies
* Triplets or higher order multiples
* Patients delivered for maternal indications (low risk of Ureaplasma colonization)
* Patients with EKG QT interval corrected for heart rate (Qtc) ≥ 450 ms
* Patients with significant hepatic impairment (direct bilirubin \>1.5 mg/dL)
* Patients exposed to other systemic macrolide
* Patients with clinically suspected Ureaplasma central nervous system (CNS) infection or other confirmed bacterial/viral infection
* Patients participating in other clinical trials involving investigational products.
Local Excision of Clinical T3 Rectal Adenocarcinoma Showing Major Response(ycT0-1) After Neoadjuvant Chemoradiotherapy

The purpose of this study is evaluation of the safety and the efficacy of transanal local excision in patients with cT3 rectal cancer which was downstaged into ycT0-1 after neoadjuvant chemoradiotherapy.

This study is a prospective multicenter single-arm phase II clinical trial. Rectal cancer patients with cT3 stage will receive neoadjuvant chemoradiotherapy, and be evaluated the response of the tumor in 6 to 10 weeks after completion of neoadjuvant chemoradiotherapy. For those who have good response (ycT0-1) will underwent transanal local excision under the patients' agree.

Eligibility Criteria:
Inclusion Criteria:

* age: more than 20 years
* biopsy-proven adenocarcinoma of the rectum
* clinical staging, cT3NxM0
* Rectal cancer located 8 cm from the anal verge
* Restaging in 6-10 weeks after completion of neoadjuvant chemoradiotherapy, ycT0-1N0M0
* ECOG performance status 2 or less

Exclusion Criteria:

* Synchronous colon cancer or other malignancy
* Obstructing rectal cancer
* Pregnant or breast-feeding
* Receiving any other study agents
* History of prior colorectal cancer or inflammatory bowel disease
* Hereditary colorectal cancer (FAP, HNPCC)