cyrilzakka/clinical-trials huggingface dataset:
Mind-body Wellness Intervention in Primary Biliary Cholangitis (PBC)

The investigators have designed a guided, online, multicomponent, mind-body intervention for participants with primary biliary cholangitis. The ability of the online intervention to impact the primary and secondary outcome measures will be assessed as compared to control.

Persons with primary biliary cholangitis (PBC) experience significantly higher rates of fatigue, stress, anxiety, depression, and impaired health related quality of life (HRQOL) as compared to the general population. Online wellness programming ranging from physical activity to mindfulness interventions has been shown to be effective in decreasing fatigue and improving mental wellness in a variety of chronic disease populations. To date, no large-scale studies have been conducted to discern whether programming of this nature impacts measures of wellbeing in PBC.

Building upon a 12-week, online, mind-body wellness program that our team previously co-developed with the Canadian PBC Society and launched as a feasibility and acceptability trial to a group of 30 individuals with PBC, the primary aim of this research project is to carry out a randomized controlled trial to assess the efficacy of the online intervention provided with brief study follow-up phone calls performed weekly by study personnel as compared to a control arm. The ability of the online program to impact the primary outcome measure of anxiety and depression as measured by the hospital anxiety and depression scale (HADS), and a range of secondary outcomes including perceived stress, fatigue, resilience, health related quality of life, physical functioning will be assessed as compared to control.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ 18 years)
* Identified diagnosis of PBC
* Ability to communicate (read, write, speak) in English
* Access to an internet connected device at home.

Exclusion Criteria:

* Inability to provide informed consent
* Unsafe to participate in a low-intensity online activity program (e.g. uncontrolled angina or arrhythmia, myocardial infarction or stroke within the last 3 month, other major medical comorbidity of concern)
* Severe psychiatric disorders (HADS score \>10)
Effects and Safety of Clonidine Patch on Young and Middle-aged Smokers With Mild Hypertension

The optimal antihypertensive treatment strategy in young and middle-aged hypertensive adults remains undefined. Clonidine controlled-release patches administered once a week might have the advantage of convenience. ECLIPSE trial is intended to explore the effect and patient tolerability of clonidine controlled-release patches (one patch per week for a total of 8 weeks) in the treatment of hypertension in young and middle-aged adults, compared with long-acting antihypertensive drug amlodipine. Clonidine patch was demonstrated ameliorating the early withdrawal symptoms during smoking cessation. This trial is also intended to observe its effect on smoking cessation in young and middle-aged male smokers.

The young and middle-aged hypertensive population is growing, but the optimal antihypertensive treatment strategy remains undefined. Young and middle-aged adults have poor adherence to antihypertensive medications and are prone to missed doses, and weekly formulations may be potentially advantageous. As a centrally acting antihypertensive agent, clonidine exerts sustained antihypertensive effects by agonizing alpha2-adrenoceptors. Clonidine controlled-release patches have the advantage of convenience in that they are administered once a week through a transdermal controlled-release technique to achieve a smooth and sustained action of clonidine. However, there is a lack of evidence from clinical trials on its efficacy and tolerability in the treatment of hypertension in young and middle-aged people. ECLIPSE trial is intended to explore the effect and patient tolerability of clonidine controlled-release patches (one patch per week for a total of 8 weeks) in the treatment of hypertension in young and middle-aged adults, compared with long-acting antihypertensive drug amlodipine. Clonidine patch was demonstrated ameliorating the early withdrawal symptoms during smoking cessation and recommended by American Cancer Society to help people quit smoking. Therefore, this trial is also intended to observe its effect on smoking cessation in young and middle-aged male smokers at the same time.

Eligibility Criteria:
Inclusion Criteria:

1. 18-60 years old male with mild hypertension (systolic blood pressure (BP) 140-159 mmHg and/or diastolic BP 90-99 mmHg).
2. History of smoking and a desire to quit.
3. Signed informed consent form.

Exclusion Criteria:

1. History of cardiopulmonary and vascular disease.
2. Severe liver or kidney disease.
3. Night shift workers, drivers, and those who work at height.
Role of Cbc Indices in Acute Lymphoblastic Leukemia Patients

Role of cbc indices in acute lymphoblastic leukemia patients to explore the prognostic role of them in prediction the response to induction chemotherapy

Role of neutrophil to lymph ratio , lymphocyte to monocyte ratio and platelet to lymphocyte in acute lymphoblastic leukemia adults and pediatric patients to explore the prognostic role of them in prediction the response to induction chemotherapy

Eligibility Criteria:
Inclusion Criteria:

* patients newly diagnosed ALL

Exclusion Criteria:

* others malignanices
* ALL on therapy
Post-marketing Safety Study of GSK Biological's Pediarix™ Vaccine

Pre-licensure studies of GSK Biologicals' PEDIARIX vaccine have shown it to be generally safe and unlikely to result in vaccine-associated serious adverse events. This post-licensure study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort.

* The outcomes to be assessed include the occurrence of all seizures (with or without fever), medically-attended fever, seizures associated with fever, allergic reactions, outpatient visits and hospitalizations for any cause, and all deaths.
* Data collection through utilization of automated databases at the study site with subset medical record review. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility Criteria:
Inclusion criteria:

Primary study cohort

The primary study cohort will include all infants from SCKP who have begun their primary course of vaccine with PEDIARIX co-administered with Prevnar and for whom at least one dose of PEDIARIX was administered prior to the infant's 9-month birthday and safety follow-up information is available.

Control cohorts

Three control cohorts will be evaluated.

1. The historical cohort will include age-, gender- and area-matched infants from SCKP who received at least one dose of DTaP vaccine co-administered with Prevnar prior to the infant's 9-month birthday and for whom safety follow-up information is available. This cohort will include infants vaccinated between January, 2002 and March, 2003.
2. The self-control cohort is defined for the study subject as the 20-day post-vaccination period from Day 21 to Day 41 for each infant in the primary cohort (PEDIARIX co-administered with Prevnar as the primary vaccination course).
3. The "delayed PEDIARIX use clinic" cohort will include all infants from SCKP who, during the enrollment period for the primary cohort, began their primary course of vaccination with DTaP vaccine and for whom at least one dose of DTaP vaccine was co-administered with Prevnar prior to the infant's 9-month birthday and safety follow-up information is available. The size of this cohort will depend on how quickly individual SCKP clinics and medical centers use PEDIARIX once it is made available. The size of this cohort, therefore, is not immediately predictable.

Exclusion Criteria: none
Effects Of Detrol LA On Memory And Cognition In Elderly Population

The primary purpose of the trial is to show that tolterodine ER has no effect on memory and other cognitive abilities in an elderly population


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with age of 65 - 75 years
* Having a score of greater than or equal to 26 on the Mini-Mental State Exam (MMSE)

Exclusion Criteria:

* Current or history of bladder outlet obstruction. Previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to randomization
* Significant hepatic or renal disease, defined as twice the upper limit of the reference ranges regarding serum concentrations of AST, ALT, ALP, urea nitrogen, or creatinine
Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis

The study will include 10 adult patients with cystic fibrosis. The aim of the study is to evaluate whether Tobramycin 300 mg aerosol once-a-day for 28 days can reduce the bacterial load in the airways. Secondary end-point is the evaluation of variation in bacterial susceptibility during and at the end of study period.

Ten adult patients with cystic fibrosis will be enrolled in a stable phase and will received prophylaxis with aerosol of Tobramycin 300 mg once a day for 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients, male and female, age range 18-45 years
* Diagnosis of cystic fibrosis
* FEV1 \>50% predicted.
* sputum samples available
* Chest x ray negative for pneumonia and tuberculosis
* Informed consent

Exclusion Criteria:

* Allergy to tobramycin
* Use of systemic steroids in the previous 2 weeks
* Pregnancy or breast feeding
* Treatment with other experimental drug in the previous 3 months
Cold Snare Endoscopic Resection for Duodenal Adenomas

Non-ampullary sporadic duodenal adenomas (SDA) are rare lesions, incidentally discovered in up to only 5% of patients during routine endoscopy. In any case, these lesions require treatment due to their potential malignant transformation because of the adenoma-carcinoma sequence, occurring in 30-85% of cases. Endoscopic resection (ER) of SDA represents an attractive alternative to surgical resection in appropriately selected patients, with lower morbidity and mortality rates.

However, most endoscopists are not keen to resect larger lesions due to the risk of complications. Indeed, endoscopic resection in the duodenum has unique challenges: thin wall, high vascularity, very limited space and harmful effects of bile and acid both acting on the ER defect.

Cold snare endoscopic resection has been shown to be a viable method for removing colorectal lesions with comparable efficacy outcomes compared to conventional polypectomy/endoscopic mucosal resection (EMR) and a promising safety profile. As a matter of fact, adverse events associated with hot snare resection technique such as delayed bleeding, post-polypectomy syndrome, and perforation are all related to electrocautery-induced injury.

Performing cold snare piece-meal resection and avoiding the need of thermal therapy, may have a major impact in the duodenum where the risk of delayed bleeding and perforation is consistent.

The aim of this pilot study is to prospectively evaluate the feasibility and the efficacy in term of safety and efficacy of cold snare endoscopic resection.


Eligibility Criteria:
Inclusion Criteria:

• Patients able to give informed consent to involvement in trial.

Exclusion Criteria:

* Patient's with known strictures/stenosis
* Pregnancy
* Patients who did not consent to study
* Bleeding diathesis
* Anticoagulants
Psychosocial Intervention in Latino Patients with Advanced Cancer

Palliative Care focuses on symptom management and quality of life and helps patients with life-limiting illness match goals and preferences for care. While there has been interest in and acknowledgement that palliative care is an important part of training patient navigators, there have been no previous studies examining the effectiveness of a navigation intervention to improve palliative care for patients. This study will examine the feasibility to implement patient navigator and psychosocial interventions.


Eligibility Criteria:
Inclusion Criteria:

* Adults ages \> or = 18 years of age
* Must self-identify as Latino/a
* Have stage III/IV cancer
* Seeking or In treatment for their cancer (ie: not in hospice care)
* Not incarcerated
* Have at least moderate baseline distress (\> 4 on the NCCN Distress Thermometer) or positive screen for depression (PHQ-2 score \>=3) or anxiety (GAD-2 score \>=3)

Exclusion Criteria:

-No exclusion criteria listed
Intraoperative Functional Ultrasound

A wide spectrum of methods is used to image brain activation in vivo. It can be directly detected by neurons electrical activity imaging (cortical simulation mapping, calcium imaging, voltage sensitive dyes) or indirectly by imaging hemodynamic changes induced by the neurovascular coupling in the vessels surrounding the activated neurons (intrinsic optical imaging, photoacoustic imaging, positron emission tomography (PET), functional magnetic resonance imaging (fMRI)).

Ultrasound as the potential to complement these functional imaging techniques at low cost. Ultrasound imaging can do real-time in-depth imaging of brain. However, its use to imaging of major vessels has been limited until now due to its poor sensitivity. To overcome this limitation functional ultrasound (fUS) was developed in Institut Langevin since 2011. This technique enables high spatio-temporal resolution imaging of whole-brain microvasculature dynamics in response to brain activation without the need of contrast agent.

This fUS method relies on a new power Doppler imaging sequence sensitive enough to detect blood flow in most of cerebral vessels (arterioles, big venules and larger vessels). Repeating the acquisition of such ultrasensitive Doppler images over time enables to follow flow dynamics in such vessels modulated by local neuronal activity.

Applied to the rat brain, fUS was proved able to map brain activation at high spatiotemporal resolution and high signal to noise ratio. The aim of this study is now to apply fUS on human brain in intraoperative condition.

The main objective of this study is to find activation maps through intraoperative ultrasensitive Doppler compared to gold standard cortical simulation mapping and functional MRI.

Secondly the investigators want to test sensitivity of this new Doppler mode. fUS method will be used for different types of stimuli and intensity and the investigators will do some control acquisitions. Blood vessel density observed with a conventional Doppler will be compared to the one measured with the ultrasensitive Doppler to prove that this new Doppler mode enhance micro vessel visualization.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, adults ( \> 18 years old)
* Participants who have to undergo brain surgery, awake or under general anesthesia, for tumor or lesion resection (all types of tumors and lesions, cortical or subcortical), with programmed intraoperative ultrasound and cortical simulation mapping.
* Consent form signed by the patient after being informed (written and oral) of the research protocol.
* Patient affiliate to the social welfare system

Exclusion Criteria:

* Minors ( \< 18 years old)
* Pregnant, parturient or breastfeeding women
* Protected persons, under guardianship, or under any administrative or legal right and liberty revocation procedure
* Patient without affiliation to the social welfare system
Study of 90Y-DOTA-hLL2 as a Consolidation Therapy After R-CHOP in Patients With Diffuse Large B-cell Lymphoma

Phase II, multi-centric, open-label, study.

Disseminated diffuse large B-cell lymphoma in patients older than 60: evaluation of fractionated radio-immunotherapy with 90Y-DOTA-hLL2 as a consolidation therapy after first line of chemotherapy.

Initial treatment: 6 courses of CHOP-R 14 with evaluation of response before C4 (observation of no change or progression at this time will get the patient off study).

Consolidation : fractionated RIT (8 weeks after the end of R-CHOP: 2 injections of 15 mCi/m2 of 90Y-DOTA-hLL2 and hLL2 at day 1 and day 8).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 60 and \< 80 years
* Non eligible for stem cell transplantation
* CD20 diffuse large B-cell lymphoma according to the WHO classification
* Bulky stage I and II \> ou =7 cm and stage III and IV
* Performance status 0 - 2
* Creatinine clearance \>ou = 50 ml/min (Cockroft formula).
* Serum bilirubin \< ou =30 mmol/l
* Leucocytes \> ou =3 G/l, granulocytes \> ou = 1,5 G/l, platelets \>ou= 100 G/L.
* HIV negative
* Written informed consent

Exclusion Criteria:

* Age \< 60 years and \> 80 years
* Other types of lymphomas except CD20+ diffuse large B-cell lymphoma according to the WHO classification
* Histologic transformation of low grade lymphoma (Involvement of the bone marrow by small B-cell lymphoma will not lead to exclusion of the patient)
* Primary lymphoma of the central nervous system and transformed gastro intestinal MALT lymphoma
* Meningeal involvement
* Bone marrow involvement \> 25% after R-CHOP
* Aggressive post-transplantation lymphoma
* Absence of CD20 expression on tumor cells
* Non bulky stages I et II
* HIV positive
* Active Hepatitis B or C
* Left ventricular ejection fraction \< 50%.
* Contra-indication to R-CHOP treatment
* Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 5 years
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Participation at the same time in another study in which investigational drugs are used
* Absence of written informed consent
Resilience and Exercise in Advanced Cancer Treatment

This is a pilot study to evaluate the feasibility of, adherence to, and early efficacy of Band Together, a strength-training and walking program (intervention arm) vs. education on the benefits of exercise (control arm) in patients with aggressive gastrointestinal (GI) malignancies (gastric, gastroesophageal, and pancreatic cancer) undergoing neoadjuvant therapy.

A growing body of evidence suggests host resilience (lack of frailty, skeletal muscle reserve, etc.) may impact early healing, recovery following neoadjuvant therapy and surgery, and long-term cancer-free survival. It is well-recognized that resilience is enhanced in individuals with proper diet, sleep habits, and exercise. However, it is unknown whether such resilience can be enhanced by training programs initiated at the time of cancer diagnosis. Although exercise interventions may contribute to these improvements, it is unknown how willing and able these patients are to comply with an exercise regimen during the neoadjuvant therapy period. The aim of this study, therefore, is to evaluate compliance with and the efficacy of Band Together, an exercise program combining strength-training and aerobic exercise, in patients with aggressive GI malignancies undergoing neoadjuvant therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. New diagnosis of potentially resectable or borderline resectable pancreatic adenocarcinoma, gastric adenocarcinoma, or adenocarcinoma of the gastroesophageal junction.
3. Patients must be evaluated at the Penn State Hershey Medical Center prior to receiving neoadjuvant chemotherapy or chemoradiation.
4. Patients must be deemed appropriate for neoadjuvant therapy by their treating health care providers.
5. The ability to speak and read English.
6. The ability to provide informed consent.

Exclusion Criteria:

1. Angina (stable or unstable)
2. Paraplegia or quadriplegia
3. Joint or muscle conditions that prevent the patient from being able to grip and or lift resistance bands.
4. Patients who have already started neoadjuvant chemotherapy at other institutions.
5. Presence of metastatic disease.
6. Gastric or pancreatic histologies other than adenocarcinoma.
7. Pregnant women.
8. Prisoners
9. Patients screening positive on the Physical Activity Readiness Questionnaire (PAR-Q)
Neuroprognostication Using Optic Nerve Sheath Diameter

This study investigates the relationship between optic nerve sheath diameter and increased intracranial pressure and its effect on neurologic outcome in post-cardiopulmonary arrest patients.

This study involves patients who have experienced either an in-hospital or out-of-hospital cardiopulmonary arrest, and who meet the 2015 American Heart Association (AHA) inclusion/exclusion criteria for targeted temperature management \[i.e., they are comatose or exhibit no meaningful response to verbal commands with return of spontaneous circulation (ROSC) after cardiac arrest\]. After induction of hypothermia protocol after cardiopulmonary arrest (i.e., targeted temperature management), patients will undergo ocular ultrasound at three time points.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years of age
* Patient has experienced either an in-hospital or out-of-hospital cardiopulmonary arrest
* Patient is comatose or exhibits lack of meaningful response to verbal commands with return of spontaneous circulation (ROSC) after cardiopulmonary arrest
* Patient must meet all inclusion criteria as deemed by physician and the 2015 American Heart Association standards for targeted temperature management (TTM) following cardiopulmonary arrest

Exclusion Criteria:

* Patient \< 18 years of age
* Patient does not meet inclusion criteria for targeted temperature management (TTM)
* Unable to obtain consent from Legal Authorized Representative (LAR)
* Patient has a Do Not Resuscitate (DNR) order or a Do Not Intubate (DNI) order at the time of consent
* Patient has uncontrollable bleeding
* Patient is able to follow verbal commands
* Patient has another medical condition creating increased ocular pressure, as deemed by physician
PHARM-S.A.V.E.S: Suicide Prevention Training

This is a pilot Randomized Controlled Trial (RCT) in which 150 pharmacy staff members will be randomized to an experimental or control group and data on suicide prevention communication and secondary outcomes will be collected over the course of the RCT.

This is a prospective pilot RCT that will evaluate the impact of suicide prevention gatekeeper training (Pharm-SAVES) on 150 pharmacy staff member communication behaviors (primary outcome). Data will be collected at baseline, immediately after training is completed, and at 1-month follow up. Data sources include simulated patient observations (to rate quality of communication) and survey data (for self-reports of knowledge, self-efficacy, and referral behaviors).

Eligibility Criteria:
Inclusion Criteria:

Staff must:

* be at least 18 years of age;
* read and speak English; and
* be currently employed as a pharmacist or pharmacy technician at a community pharmacy

Exclusion Criteria:

* Individuals will be excluded if they hold floater status (non-staff pharmacists or technicians).
A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture

This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone mass and a recent pertrochanteric hip fracture.

The study has 3 periods: a screening phase, a double-blind, double-dummy treatment phase from the time of randomization to the 26 weeks visit, and an open-label treatment phase of approximately 12 month duration, where participants will continue treatment with the same study drug that they were randomized to.

Eligibility Criteria:
Inclusion Criteria:

* Men and postmenopausal women aged ≥50 who have sustained a unilateral, fracture of the trochanteric region
* Lumbar spine BMD and/or femoral neck BMD and/or total hip BMD measurement of the contra lateral hip at least 2.0 SDs (standard deviation) below the average bone mass for young women and men

Exclusion Criteria:

* Clinically significant abnormal laboratory values
* History of unresolved skeletal diseases that affect bone metabolism
* Polytrauma participants and participants with fractures at more than one site