cyrilzakka/clinical-trials huggingface dataset:
Ecological Momentary Determinants of Sedentary Behavior

A two phase trial to understand the personal, behavioral, environmental, and contextual factors that underpin sedentary behavior and to systematically test a series of contextual prompt characteristics that may lead to subsequent change in sedentary behavior.

Phase 1: This is an observational study that will utilized Ecological Momentary Assessment, to determine which personal (e.g. fatigue, mood, and stress level), behavioral (e.g. watching TV, working at desk, and eating meals), environmental (e.g. being at home or work, time of the day, and weather) and contextual factors were associated with sedentary behavior. Three EMAs per day will be sent randomly sent to participants on weekdays (Monday to Friday), for four consecutive weeks (total of 20 days). During these days, participants will also wear an activPAL device to objectively measure sedentary behavior. The purpose of the study is to identify the combination of factors most likely to precede and proceed short (\<30 min) and long (≥30 min) bouts of sedentary behavior.

Phase 2: A micro-randomized trial will be used to evaluate the efficacy of an email-based prompt to elicit a proximal effect (e.g., a postural response defined as a transition from seated to standing or seated to moving within 5 minutes to interrupt prolonged sitting) compared to a no prompt condition. A secondary aim of this study is to determine whether prompts that encourage standing are more likely to elicit a response than those that encourage moving. An exploratory aim is to examine whether varying the content of the stand or move prompt to include combinations of short term goals and employer approval, influence the magnitude of response.

Eligibility Criteria:
Inclusion Criteria:

* Full-time employees
* Males or females
* Ages 18-65
* Sedentary working habits (as indicated by \>7 hrs/day of sedentary time at work in the Sedentary Behavior Questionnaire)
* Willing to engage in the study assessment and intervention for 10 weeks.

Exclusion Criteria:

* Non-ambulatory, pregnant
* Non-English speaking
* Diagnosis of psychiatric problems or taking psychiatric medications
* Medical history that prohibits prolonged standing.
DEP-Ru Regimen as a Salvage Therapy for HLH

This study aimed to investigate the efficacy and safety of ruxolitinib together with liposomal doxorubicin, etoposide and methylprednisolone (DEP-Ru) as a salvage therapy for refractory/relapsed hemophagocytic lymphohistiocytosis.


Eligibility Criteria:
Inclusion Criteria:

1. meet HLH-04 diagnostic criteria;
2. treated with HLH-94 no less than 2 weeks before enrollment and did not achieve at least PR; or relapsed patients after remission；
3. Life expectancy exceeds 1 month;
4. Age≥1 year old and ≤70 years old, gender is not limited；
5. Before the start of the study, total bilirubin ≤ 10 times the upper limit of normal; serum creatinine ≤ 1.5 times normal；
6. Serum HIV antigen or antibody negative；
7. HCV antibody is negative, or HCV antibody is positive, but HCV RNA is negative；
8. Both HBV surface antigen and HBV core antibody were negative. If any of the above is positive, peripheral blood hepatitis B virus DNA titer should be detected, and less than 1×103 copies/ml can enter the group；
9. Echocardiographic examination of LVEF ≥ 50%;
10. Informed consent.

Exclusion Criteria:

1. Heart function above grade II (NYHA)；
2. Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2；
3. Pregnancy or lactating Women；
4. Allergic to Pegaspargase, doxorubicin or etoposide；
5. Active bleeding of the internal organs；
6. uncontrollable infection；
7. Serious mental illness;
8. Non-melanoma skin cancer history;
9. Patients unable to comply during the trial and/or follow-up phase;
10. Participate in other clinical research at the same time.
Service Users' Perspective of Reasons for Detention Under Section 136 of the Mental Health Act 1983

Section 136 of the Mental Health Act (MHA) 1983 allows the police to detain someone in a public place if there are reasons to believe that they may be suffering from a mental disorder and to be in need of care or control. For a significant number of psychiatric patients, detention under section 136 and accessing psychiatric services via the police remains an important, and sometimes the only pathway to care. Approximately 17400 people were detained under section 136 of the MHA 1983 during the year 2005-2006 (Independent Police Complaints Commission, 2008).

Despite the large number of patients accessing mental health services via the police, there is no research available to identify the service users' perspective of what led them to come into contact with police and to identify the reasons for care not being accessed by conventional routes. Royal College Psychiatrists (RCP, 2008) and Independent Police Complaints Commission (IPCC, 2008) found that there was lack of research into the service users' perspective and recommended research into this area.

The investigators have devised this research project to help themselves and the wider research and clinical community understand the service users' perspective of how they came to be detained by the police, whether the community services had failed and explore their views to understand what can be done to improve the service provisions.

Fieldhead hospital, Wakefield provides acute inpatient care for psychiatric patients. Those who are detained under section 136 of the MHA in Wakefield area are taken to a place of safety and following assessment they may be admitted formally or informally to Fieldhead hospital for assessment and treatment. Those who are detained under section 136 of MHA and subsequently admitted as inpatients to Fieldhead hospital will be included in this study.


Eligibility Criteria:
Inclusion Criteria:

* Those who have been detained under Section 136 of the Mental Health Act 1983 and subsequently admitted to Fieldhead Hospital, Wakefield
* Those service users aged between 18 and 65 years
* Those service users who have the capacity to consent to the interview

Exclusion Criteria:

* Those service users who are under 18 years old and over 65 years old at the time of the study
* Service users who are assessed to be incapacitated to consent to the study
* Adults with dementia
* Those who cannot understand and/or speak English sufficiently to participate in interview
* Service user's who are currently experiencing crisis
Cubii Vital Sign and Range of Motion Study

The purpose of this study is to evaluate the effect of a seated compact elliptical on vital signs and range of motion (of knees and ankles) following thirty minutes of activity.

The purpose of this study is to evaluate the effect of 30 minutes of exercise on a seated compact elliptical on vital signs and range of motion (ROM). A convenience sample of 40 patients will be recruited for this study in two phases. The first phase from younger 18-30 staff from Kaizo Health who currently engage in a program or aerobic exercise greater than 90 minutes per week and report no previously diagnosed chronic health problems. Phase two will take place among the patient population of Kaizo Health consisting of men and women between 30-70. The purpose of recruiting in two phases is generate a more diverse sample. Participants must be able to perform all study procedures in order to participate. Exclusionary criteria will include less than 18 years of age, pregnancy, cancer, or the any of the conditions on the ACSM absolute and relative contraindications to exercise. After explanation of the study and consent is obtained, participants will complete the demographics form, medication questionnaire, the Self-Administered Comorbidity Questionnaire, and International Physical Activity Questionnaire short form. After completing the initial paperwork, participant's vital signs (blood pressure, heart rate, and oxygen saturation) and ROM of the ankle and knee will be assessed (T1). Following baseline measures, participants will perform a one-minute warm-up, thirty minutes of activity, and a two-minute cool-down on the Cubii®, a seated compact elliptical. During all activity, heart rate and oxygen saturation will be recorded every minute. Following the cooldown, blood pressure, heart rate, oxygen saturation, and ROM will be reassessed (T2). At the end of T2, steps, elliptical strides, distance, time, and calories burned will be recorded from the Cubii®. Additionally, all participants will complete a satisfaction questionnaire about the Cubii®.

Eligibility Criteria:
Inclusion Criteria:

* currently engage in a program or aerobic exercise greater than 90 minutes per week
* report no previously diagnosed chronic health problems
* patient population of Kaizo Health
* perform all study procedures in order to participate

Exclusion Criteria:

* less than 18 years of age
* pregnancy
* cancer
* any of the conditions on the ACSM absolute and relative contraindications to exercise
Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors

This study compare the efficacy of conventional photodynamic (PDD) guided transurethral bladder tumor resection in the operating theatre with outpatient PDD guided laser destruction of bladder tumors through flexible cystoscopes.

A prospective randomized two-part clinical trial comprising patients with recurrent pTa low grade bladder tumors.

Study objectives and purpose:

* 1st Objective: To evaluate whether small pTa bladder tumours can be removed with diode laser in an outpatient department with similar efficacy as by TUR-BT resection in the operating theatre.
* 2nd Objective: To evaluate the patients experience of symptoms during laser treatment in the outpatient department (OPD) using quality of life (QOL) questionnaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation).
* 3rd Objective: To evaluate whether patients prefer standard transurethral bladder tumor resection (TUR-BT) in the operating theatre (OT) or laser treatment in the OPD.
* 4th Objective: To evaluate the safety after laser treatment in the OPD.

Efficacy:

* 1st Endpoint: Proportion of patients with no tumor tissue in the bladder after 4 months and 12 months.
* 2nd Endpoint: Visual Analog Scale Score (pain evaluation) in patients having tumor removed by laser in the OPD.

General urinary problems and QOL one week after the laser treatment. The Danish validated questionnaire (QLQ- BLS24) from EORTC will be used.

* 3rd Endpoint: Patients preference for either OPD laser treatment procedure or TUR-BT in the OT as inpatient procedure.
* 4th Endpoint: Character and severity of adverse events in relation to the outpatient treatment.

Study

Inclusion criteria:

1. Ta low grade bladder tumor recurrences
2. Up to a tumor size of 1,5 cm
3. Up to 6 tumors
4. Eligible patients for TUR-BT

Exclusion criteria:

1. Patients with porphyria
2. Known hypersensitivity to Hexvix® or porfhyrins
3. Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa
4. Dementia
5. Macroscopic hematuria
6. Pregnant or breast feeding women
7. Expected poor compliance estimated by the investigators
8. Patients \< 18 years
9. Patients who do not read or understand Danish

Eligibility Criteria:
Inclusion Criteria:

1. Ta low grade bladder tumor recurrences
2. Up to a tumor size of 1,5 cm
3. Up to 6 tumors
4. Eligible patients for TUR-BT in GA

Exclusion Criteria:

1. Patients with porphyria
2. Known hypersensitivity to Hexvix® or porfhyrins
3. Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa
4. Dementia
5. Macroscopic hematuria
6. Pregnant or breast feeding women
7. Expected poor compliance estimated by the investigators
8. Patients \< 18 years
9. Patients who do not read or understand Danish
Patient Derived Cancer Cell Lines in Identifying Molecular Changes in Patients With Previously Untreated Pancreatic Cancer Receiving Gemcitabine Hydrochloride-Based Chemotherapy

This pilot research trial studies patient derived cancer cell lines in identifying molecular changes in patients with previously untreated pancreatic cancer and are receiving gemcitabine hydrochloride-based chemotherapy. Cell lines refer to samples taken from the patient's tumor to grow for many months or years in a laboratory, and can therefore be studied scientifically. Studying cell lines in the laboratory may help doctors understand the genetic changes that occur to the tumor during chemotherapy that allows the tumor to resist or grow despite treatment.

PRIMARY OBJECTIVES:

I. Compare the genetic profile of the tumor after progression has occurred, to the tumor prior to treatment.

SECONDARY OBJECTIVES:

I. Additional molecular patterns, beyond genetics, will be analyzed, including ribonucleic acid (RNA) and protein expression.

OUTLINE:

Tissue and blood samples are collected for genetic analysis via sequencing from patients receiving gemcitabine hydrochloride intravenously or gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation. Chemotherapy is not part of the protocol. Per standard of care, patients receive gemcitabine hydrochloride (IV) the first 3 of 4 weeks (qw 3/4 wk) or gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation IV qw 3/4 wk in the absence of disease progression or recurrence.

Eligibility Criteria:
Inclusion Criteria:

1. Suspected or confirmed pancreatic adenocarcinoma, any stage
2. \>18 years of age
3. No prior systemic chemotherapy for pancreatic cancer, or currently undergoing first-line treatment for pancreatic cancer, or completed only first-line treatment for pancreatic cancer
4. A plan to undergo gemcitabine-based chemotherapy at Thomas Jefferson or a collaborating institution
5. Abdominal/pelvic CT scan or MRI within 4 months of the study
6. Signed study-specific informed consent

Exclusion Criteria:

1. Pregnancy
2. Prior systemic chemotherapy for pancreatic cancer
3. Gender/Minority/Pediatric Inclusion for Research
High Intensity Interval Training vs Moderate Intensity and Continuous Training in Chronic Heart Failure

Purpose: Exaggerated sympathetic nervous system (SNS) activity associated with low heart rate variability (HRV) is considered as a trigger of cardiac arrhythmias and sudden death. Regular exercise training is efficient to improve autonomic balance. In 2013, the investigators published that a single session of an optimized short-high intensity interval exercise with passive recovery (HIIT) protocol was efficient in chronic heart failure (CHF) patients for enhancing vagal tone and to decrease arrhythmias in the 24-h post exercise period when compared to a single session of moderate intensity continuous exercise (MICT). Nevertheless the effects of HIIT training performed on several weeks have never yet been studied on the parameters described by Coumel's triangle (the arrhythmogenic substrate, the trigger factor as premature ventricular contraction and the modulation factors of which the most common is the autonomic nervous system). The aim of this study was to verify the superiority of HIIT to enhance parasympathetic activity, cardiorespiratory fitness and cardiac function when compared to MICT in a short and intense cardiac rehabilitation program.

Before and after the Rehabilitation Program (RP), all patients underwent a 24-hour ECG recording, an echocardiography, a cardiopulmonary exercise test.

The RP consisted of 2 types of exercise training according to the randomization:

1. a short-high intensity interval exercise with passive recovery
2. a classical moderate and continuous exercise training at 60% of peak power output

The RP lasted 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* stable chronic heart failure with NYHA functional class from I to III
* stable left ventricular ejection fraction (LVEF) \< 45% over at least 6 months
* stable optimal medical therapy including a beta-blocker and an angiotensin-converting enzyme inhibitor or angiotensin receptor blockers for at least 6 weeks
* ability to perform a maximal cardiopulmonary exercise test
* admitted to the Rehabilitation Centre for a comprehensive Cardiovascular Rehabilitation Program

Exclusion Criteria:

* any relative or absolute contraindications to exercise training according to current recommendations
* fixed-rate pacemaker with heart rate limits set lower than exercise training target
* major cardiovascular event or procedure within the 3 months preceding enrolment
* chronic atrial fibrillation
* heart failure secondary to significant uncorrected primary valve disease (except for mitral regurgitation secondary to left ventricular dysfunction)
* heart failure secondary to congenital heart disease or obstructive cardiomyopathy.
A Virtually Delivered Memory Rehabilitation Protocol in Older Adults

The investigators conducted a feasibility study of a virtually-delivered adaptation of an ecologically oriented neurorehabilitation of memory (EON-Mem) in improving memory for healthy older adults. The primary purposes of this study included determining the feasibility of conducting EON-Mem virtually with older adults and whether a randomized control trial using EON-Mem in older adults is of value.

Twenty-five older adults aged 55 years and older were recruited for participation in the EON-Mem training program adapted and administered virtually. Measures of emotional functioning and cognitive functioning were administered before and following the intervention. Participants attended one virtual treatment session per week for a total of six weeks with daily homework assignments. A priori, feasibility was set at an 80% completion rate. To address questions regarding feasibility, the investigators calculated descriptive statistics on sample information.

Eligibility Criteria:
Inclusion Criteria:

* Individuals 55 and older

Exclusion Criteria:

* Evidence of cognitive dysfunction on the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) as evidenced by a score of 3.3 or more
* History of moderate-to-severe TBI
* History of stroke
* Dementia/neurological diagnoses
* Current chemotherapy or radiation
* Current or history of brain cancer
* Poor sensory function including uncorrected vision, hearing, or speaking impairments that could interfere with learning the intervention, including nonnative English speakers.
Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)

Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy. The shock wave therapy will be done in 3 sessions with one week interval. The outcome parameters are: change in pain, size of the calcinosis, of possible ulcers and intake of painkillers.

* Trial with medical device

Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy (medical device). The shock wave therapy will be done in 3 sessions with one week interval. The outcome parameters are: change in pain (questionnaire), size of the calcinosis (ultrasound and CT), new ulcers and intake of painkillers.

Eligibility Criteria:
Inclusion criteria:

* Age of 18
* Calcinosis cutis due to connective tissue disease
* information about ESWT given
* Patient understands the study and signs the informed consent

Exclusion criteria:

* No ESWT done
* cuagulopathy
* sepsis
* pregnancy
* pace maker
* severe disease in the opinion of the investigator
* cardiac risk with NYHA III-IV
* Ehlers-Danlos-Syndrome
HD-tDCS Over the dACC in High Trait Impulsivity

Psychological disorders characterized by impulsivity often show alterations in dorsal anterior cingulate cortex (dACC) activity. Recent research has therefore focused on non-invasive neurostimulation therapies for the modulation of functional activity in the dACC. To date there has only been one proof-of-concept study providing evidence for modulating dACC activity with non-invasive electrical neurostimulation (e.g. transcranial electrical stimulation). Since transcranial Direct Current Stimulation (tDCS) is relatively safe, tolerable, and mobile as compared to other neurostimulation techniques, it is worthwhile looking further into the effects of tDCS on functional dACC activity. The aim of the present research is to explore whether HD-tDCS can induce changes in the dACC in individuals with high trait impulsivity (N=20) in a double-blind cross-over study. Functional changes in dACC activity will be measured by the error related negativity (ERN), which is an event related potential generated by the dACC. The ERN is less pronounced in people that score high on impulsivity. It is therefore expect enhanced ERN amplitudes after HD-tDCS over the dACC. In addition, performance on the multisource interference task will be used as measure of dACC activity. It is hypothesize that increased dACC activity will be related to decreased impulsivity in high impulsive individuals as shown by improved inhibitory control on the Go/NoGo task. The results of the study may have implications for patient populations that are characterized by impulsivity.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* Score \> 46 on SUPPS-P

Exclusion Criteria:

* Score low on trait impulsivity as determined by a score of \< 47 on the SUPPS-P short form
* History of DSM-5 defined neurological illness, mental illness or traumatic brain injury,
* Currently taking any psychoactive medications,
* Have metal anywhere in the head, except the mouth. This includes metallic objects such as screws, plates and clips from surgical procedures.
* Currently pregnant or lactating,
* Being left-handed
Reducing the Need for In-Clinic Follow-Up for Medical Abortion in Moldova and Uzbekistan

The purpose of this study is to determine whether an alternative method of follow-up after medical abortion is acceptable and feasible for use in Moldova and Uzbekistan.

Medical abortion using mifepristone and misoprostol is a highly effective procedure, but access to it may be impeded by the fact that not all women can afford or want to return for a follow-up visit. This often results in a high loss to follow-up rate. Additionally, with medical abortions of those women who do return for follow-up, higher costs are borne by both the woman and the healthcare system.

This study compares two methods of follow-up after medical abortion: standard of care versus alternative follow-up. The former involves a routine clinic visit two weeks after misoprostol administration. The latter consists of a low-sensitivity pregnancy test and a self-administered questionnaire. Based on the results of the test and questionnaire, women may be flagged as needing in-clinic follow-up or discharged from the study if their abortion is complete.

Eligibility Criteria:
Inclusion Criteria:

* Reproductive-age woman seeking a medical abortion
* Woman in good general health
* Woman with an intrauterine pregnancy less than or equal to 63 days gestation on the day of mifepristone administration
* Woman able and willing to sign consent forms
* Woman eligible for medical abortion according to clinician's assessment
* Woman agreeing to be followed up with, by phone or at a clinic visit

Exclusion Criteria:

* Woman with a pregnancy greater than 63 days gestation on the day of mifepristone administration