cyrilzakka/clinical-trials huggingface dataset:
Move@NUS: a Digital Intervention Cohort Promoting Healthy Movement Behaviours

The aim of the Move@NUS pilot study is to determine the feasibility of establishing a digital intervention cohort to monitor and improve the health and wellbeing of students by encouraging them to engage in healthy movement behaviours (i.e., physical activity, sleep, and limiting smartphone-based recreational screentime).

The digital intervention cohort consists of:

* 6-months of continuous monitoring of movement behaviours, wellbeing and related factors via an Apple Watch and repeated bursts of ecological momentary assessments (EMAs).
* 3x embedded randomised controlled trials (RCTs) evaluating the efficacy of small-scale smartphone-based interventions designed to nudge participants toward participating in healthier movement behaviours.

Good overall mental and physical health and wellbeing can be promoted by engaging in healthy movement behaviours - getting adequate sleep, being physically active, and minimising recreational time spent watching a screen or being sedentary. The objectives of this study are to determine the feasibility of:

* establishing a digital cohort study and continuously monitoring health behaviours and wellbeing (and related factors) for 6 months, and
* rapidly evaluating the effects of ecological momentary interventions (EMIs; small-scale interventions that provide support in real-time, delivered via the smartwatch and app) for promoting healthy movement behaviours via a series of embedded RCTs.

The investigators will enrol up to 150 first-year university students into an innovative hybrid study that combines a digital cohort with embedded randomised controlled trials (RCTs). The digital cohort consists of 6 months of continuous observations of movement behaviours, wellbeing, and related factors via a smartwatch (Apple Watch) and repeated bursts of smartphone-based ecological momentary assessment (EMA) surveys. Throughout the 6-month monitoring period, participants are enrolled in 3 embedded RCTs evaluating the effects of EMIs that, in turn, target sleep, physical activity, and smartphone-based recreational screentime. For each embedded-RCT we assess engagement and acceptability outcomes (e.g., whether a push notification is opened, whether it is responded to), and preliminary efficacy (i.e., whether there is a between group difference in the target behaviour from pre- to post-intervention). Participants also complete traditional questionnaires at baseline, 3-, and 6-month follow-up.

Eligibility Criteria:
Participants are eligible to join the study if they:

* are enrolled in the first year of an undergraduate degree at the National University of Singapore,
* own or use an Apple smartphone with a data plan,
* are willing to download and use a smartphone app, and
* have an Apple smartwatch (Series 6/SE or newer) and are willing to wear it continuously for the 6-month study duration.

Participants will be excluded if they are:

* pregnant, or
* planning to be overseas for more than 6 weeks (per trip) during the upcoming semester.
Efficacy of Topical Morphine in the Treatment of Severe Local Pain of Chronic Wounds

This phase III study aims to show that topical morphine low doses treats localized pain in chronic wounds, intense and rebellious to systemic analgesics included or not opioids.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged over 18 years
* Painful chronic wounds (bedsores, wound tumor, arterial ulcers, venous or mixed diabetic ulcer if systolic pressure index \>0.8, necrotic angiodermatitis not graftable), a bottom surface 300 cm² and does not require more than 15 ml of gel by application. When patient has multiple painful chronic wounds, the wound having only the highest pain intensity is considered for evaluation.
* Ineffective systemic analgesic with or without opioid analgesic established and maintained at the same dose for 3 days before inclusion. If treatment includes morphine, the daily dose should not exceed 60 mg of morphine equivalent and this treatment must be a treatment exclusive background.
* Patient requiring an analgesic equilibration for intense and rebellious local pain, with a daily average score greater than or equal to 5, on a graduated numerical scale of 0 to 10. The score is defined at the inclusion and corresponds to the pain intensity felt locally by the patient under treatment systemic analgesic with or without co-analgesics.
* If analgesics to treat systemic pain is ongoing, it must have been introduced for more than 3 days (according to criteria 3)
* If antidepressant treatment is in progress, it must have been established for over a month for a tricyclic and for more than 15 days for other classes of antidepressants.
* If an anti-epileptic treatment analgesic is in progress, it must have been established for over 15 days.
* Signing of the informed consent form.
* Patient able to respond the self-assessment questionnaires (sufficient understanding assessments, proficiency in French).
* Patient affiliated to an health insurance plan

Exclusion Criteria:

* Allergy to morphine or carboxymethylcellulose or history of intolerance to morphine
* Analgesic at baseline including systemic morphine to greater than 60 mg equivalent dose of morphine treatment
* Fistulated wound
* Heavily exuding wound
* Wound bleeding (spontaneous bleeding)
* Ongoing radiotherapy on chronic wound
* Creatinine \> 110 µmol/L, Total bilirubin \> 20 µmol/L
* Not communicating patient
* Unable to comply with requirement of the protocol (11 days)
* Patient pregnant or of childbearing age without contraceptive therapy or lactating
* Person deprived of liberty or under guardianship
* Only for pharmacokinetic analysis: analgesics at baseline including morphine or hydromorphone or oxycodone or codeine. Fentanyl is allowed
Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management

Patients who are scheduled for: elective oesophageal tumour resection, total gastrectomy, pancreas resection, major vascular, total cystectomy will be recruited.To investigate effects of central venous pressure (CVP) and central venous saturation (ScvO2) guided fluid management on intraoperative haemodynamic parameters, volume and vasopressor requirement, and postoperative organ function and postoperative inflammatory response.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing the following elective major abdominal surgery: oesophagectomy, total gastrectomy, radical cystectomy, aorta-bifemoral bypass or elective operation of abdominal aortic aneurysm.
* after surgery patients were admitted to our intensive care unit.

Exclusion Criteria:

* patients younger than 18 years
* chronic organ insufficiency: "Acute Physiology and Chronic Health Evaluation (APACHE) II" scoring system: New York Heart Association Class IV, chronic hypoxia or hypercapnia, chronic renal failure requiring renal replacement therapy, biopsy proven cirrhosis or portal hypertension and immunodeficiency.
* preoperative anaemia (haemoglobin\<100g/L)
* coagulation abnormality
* and patients with chronic use of corticosteroids and non-steroid anti-inflammatory drugs
* patients requiring an operation due to malignant disease where the tumour then proved to be inoperable.
A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with chronic lymphocytic leukemia (CLL) who have relapsed after or were refractory to treatment with a purine nucleoside analogue-containing regimen. The trial will enroll in two phases: a Phase I dose-escalation portion and a Phase II expanded treatment cohort, with enrollment of additional patients in order to expand safety experience and collect preliminary anti-leukemia activity data.


Eligibility Criteria:
Inclusion Criteria:

* Documented history of histologically confirmed B-cell CLL
* Relapsed or refractory CLL with history of prior treatment with purine nucleoside analogue-containing regimen
* Eligible for treatment of their CLL based on criteria adapted from the National Cancer Institute-Working Group (NCI-WG) Response Criteria for CLL
* For patients of reproductive potential (males and females), use of a reliable means of contraception
* For females of childbearing potential, a negative serum pregnancy test

Exclusion Criteria:

* Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab)
* Prior use of any non-CD20 targeted monoclonal antibody therapy within 6 months of enrollment
* Current or recent CLL treatment
* History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
* Evidence of acute/active autoimmune hemolytic anemia or other autoimmune complications of CLL
* Use of hematopoietic growth factors or RBC and/or platelet transfusions
* Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
* Evidence of myelodysplasia or myelodysplastic changes on bone marrow examination
* History of cancer other than CLL)
* Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics
* A major episode of infection requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening or oral antimicrobials within 2 weeks of screening
* Positive hepatitis B or C serology
* Positive human immunodeficiency virus (HIV) serology
* Active cytomegalovirus (CMV) disease by antigen or polymerase chain reaction testing
* Pregnancy or lactation
* CNS leukemia
* Recent major surgery, other than diagnostic surgery
Evaluation of Blood Brain Barrier Integrity and Structural Abnormalities in MPS IIIB Patients Using Multimodal Magnetic Resonance Imaging

The purpose of the study is to characterize structural abnormalities in the brain and the integrity of the blood brain barrier in patients with mucopolysaccharidosis type IIIB (MPS IIIB).


Eligibility Criteria:
Inclusion Criteria:

* Subject and/or subject's parent or legal guardian provides informed consent
* Subject is ≥5 years of age.
* Subject has a definitive diagnosis of MPS IIIB, as determined by either a documented deficiency in alpha-N-acetylglucosaminidase (NAGLU) enzyme activity or documented functionally-relevant mutations in both alleles of the NAGLU gene.

Exclusion Criteria:

* The subject has any internal or non-removable external metal items that may present a safety risk (for MRI), or any other medical condition or circumstance in which an MRI is contraindicated.
* The subject has a known or suspected hypersensitivity to anaesthesia, a bleeding disorder, or any other medical condition or circumstance in which a lumbar puncture (for collection of CSF) is contraindicated.
* Previous allergic reaction to gadolinium-based MRI contrast media.
An Acceptance-Based Behavioral Intervention vs. Nutritional Counselling for Weight Loss in Psychotic Illness

Obesity occurs at 2-3 times the general population rate in persons living with a psychotic illness. The risk of obesity-related serious medical conditions like diabetes and heart disease are also two to three times higher in this population. Traditional behavioral weight management approaches help more than half of these individuals to lose weight, but a significant proportion are not helped. This pilot study is intended to determine the feasibility, efficacy, acceptability, and potential clinical utility of an intervention that integrates mindfulness, acceptance, distress tolerance, and motivation and commitment combined with traditional behavioral strategies for weight loss. This is the first study to investigate such an acceptance-based behavioral intervention for weight loss in psychotic illness. The results from this study will help to determine whether future research in this area is warranted with a larger sample, over a longer period of time.

Primary hypothesis: Weight loss will be greater in individuals who receive the acceptance based behavioral intervention, relative to those who receive nutritional counseling.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 25.0
* Diagnosed psychotic illness (i.e., schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, major depressive disorder with psychotic features, substance-induced psychotic disorder, and psychotic disorder not otherwise specified).

Exclusion Criteria:

* Inability to provide informed consent
* Prediabetes or type 2 diabetes mellitus
* Current enrollment in another formal weight management program
* Brief Psychiatric Rating Scale (BPRS) ratings of 4 or more on any one of Grandiosity (Item #6), Suspiciousness (Item #7), Hallucinations (Item #8), Unusual Thought Content (Item #9), or Conceptual Disorganization (Item #10), or a BPRS total score of 80 or more.
Fluoxetine Versus Fluoxetine Plus DU125530 in Major Depressive Disorder

The purpose of this study is to examine whether the speed of the clinical antidepressant action of fluoxetine can be accelerated by administering DU125530 a full 5-HT1A antagonist.

SSRI acts by blocking the serotonin transporter (5-HT), increasing the availability of serotonin at the synaptic cleft averting its reuptake. The increment of serotonin activates 5-HT1A presynaptic autoreceptors, resulting in a modulation in the release of serotonin by the presynaptic neuron. It is proposed that 5-HT1A receptor antagonism could accelerate the clinical effect of antidepressants by preventing this negative feedback.Preclinical data obtained with selective 5-HT1A antagonists, such as pindolol, and with mice lacking 5-HT1a receptors supports this hypothesis. Results on partial antagonists (pindolol) are conclusive in accelerating SSRI. It is reasonable to call into question whether a total antagonism of 5-HT1a receptors could imply a more rapid antidepressant response. To test this hypothesis we conducted a double blind, randomised, controlled trial with DU 123550 added to fluoxetine 20 mg/day

Eligibility Criteria:
Inclusion Criteria:

* Consecutive eligible patients aged 18 to 70
* Diagnosis of unipolar major depression using DSM-IV criteria with moderate to severe symptoms (score e 18 on the Hamilton Depression Rating Scale-HDRS- of 17 items).
* There was a wash-out of 1 week of any antidepressant drug (specifically 28 days for fluoxetine) prior entering the study.
* Written informed consent was obtained from all participants.

Exclusion Criteria:

* Concurrent psychiatric disorders (DSM IV axis I, II cluster A or B)
* Failure to respond to drug treatment in current depressive episode
* Previous resistance to SSRIs or other antidepressant drug
* Suicide risk score e 3 on the HDRS.
* Participation in other drug trials within the previous month
* Presence of delusions or hallucinations
* History of substance abuse (including alcohol) in the past three months
* Pregnancy or lactation
* Organic brain disease or history of seizures
* Serious organic illnesses such as hypo or hyperthyroidism,cardiac arrhythmias, asthma, diabetes mellitus.
* Myocardial infarction in the past 6 month
* Frequent or severe allergic reactions
* Concomitant use of other psychotropic drugs (benzodiazepines were allowed), lockers or catecholamine-depleting agents
* Current structured psychotherapy.
Testing the Protective and Caring Effect of a Water-in-oil Formulation in Patients Suffering From Urinary and/or Fecal Incontinence and Requiring Incontinence Care Products

The aim of this study is to test the protecting and caring effect of a protective balm on patients suffering from urinary and/or fecal incontinence and need incontinence care products.

Patients receive at least two applications of the test product in the application area daily for two weeks. An additional washing product is used during the entire application time. The caring and skin protecting effects, the skin tolerability and cosmetic efficacy of the test product will be assessed by a physician, a nurse and the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patient is capable of understanding the information given to them and providing informed consent
* 70 years of age and older
* Patients with incontinence (fecal and/or urinary), requiring incontinence protection material
* Skin type on Fitzpatrick scale: Between I to IV

Exclusion Criteria:

* Current cancer treatment such as chemotherapy, irradiation
* Documented allergies to skin care and / or skin cleansing products
* Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
* Incontinence-associated dermatitis (IAD) stage \>1a
* Active skin disease at the test area
* Any topical medication at the test area within the last 3 days prior to the start of the study and / or hroughout te entire course of the study
* Mini-Mental-Status-Test (MMST) \< 20
Benefit of Topical Hemostatic Powder Containing Hydrophilic Polymer With Potassium Ferrate for Hemostasis Following Nail Surgery

The purpose of this study is to assess the efficacy and safety of topical hemostatic powder containing hydrophilic polymer with potassium ferrate for bleeding control after nail surgical procedures


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Patients scheduled for any type of nail surgical procedure
* Willingness to participate in the study
* Ability to understand all instructions in the English language

Exclusion Criteria:

* Failure to have nail surgery performed
* Likely inability to comply with the study protocol or cooperate fully with the research team
Improving Exercise Capacity With Tailored Physical Activity in Lymphoma & Breast Cancer Patients Undergoing Tx

To provide critical participant enrollment data necessary to complete a larger definitive clinical trial in the future.

This study is a 2-arm, parallel design, single-blind randomized controlled pilot study designed to compare the effects of a tailored multi-level physical activity intervention (PAI) vs healthy living intervention (HLI) on exercise capacity, cardiovascular and cognitive function, health-related quality of life (QOL), strength and fatigue among lymphoma and breast cancer patients undergoing active treatment with anthracycline based chemotherapy (anthra-bC).

Eligibility Criteria:
Inclusion Criteria:

* Subjects age 18-85 years old
* Stage I-IV Hodgkin's (HL) or Non-Hodgkin's Lymphoma (NHL) or I-III Breast Cancer patients who are receiving (within 6 weeks of initiation) or are scheduled to receive potentially cardiotoxic systemic therapies (e.g. chemotherapy regimens \[anthracyclines, trastuzumab\]), immuno-therapies (immune checkpoint inhibitors \[ICI's\]), hormonal therapies (aromatase inhibitors) or radiation (within 8 weeks of completion).

Exclusion Criteria:

* Evidence of COVID19 within the last 60 days or recent (21 days) exposure to close personal contact who has tested positive for COVID19.
* Uncontrolled hypertension (systolic blood pressure \>190 mm Hg or diastolic blood pressure \>100 mm Hg)
* A recent history of alcohol or drug abuse
* Inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion
* Other exclusions include those with contraindications to MRI; unstable angina; inability to exercise on a treadmill or stationary cycle; significant ventricular arrhythmias (\>20 PVCs/min due to gating difficulty); atrial fibrillation with uncontrolled ventricular response; acute myocardial infarction within 28 days; claustrophobia; pregnancy; those unable to provide informed consent (able to read and write English); or moving within 12 mos. of enrollment.
PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Opioid-Naive Population

The objective of this research is to assess the effects of electronic health record (EHR)-based decision support tools on primary care provider (PCP) decision-making around pain treatment and opioid prescribing. The decision support tools are informed by principles of "behavioral economics," whereby clinicians are "nudged," though never forced, towards guideline-concordant care.

To test the effects of these decision support tools for improving the quality of care for pain treatment, the investigators will implement a pragmatic clinic-randomized trial across the primary care clinics of Fairview Medical Group and University of Minnesota Physicians.

The study has two parallel components. The decision support tools to be tested will differ somewhat depending on whether a given patient is opioid-naïve, or whether a given patient is a current opioid-user. Four sets of analyses will be conducted separately: one for the opioid-naïve group using EHR data, one for the current opioid-user group using EHR data, one at the PCP-level using web survey data, and one at the PCP-level using MN Prescription Drug Monitoring Program (PDMP) data.

Eligibility Criteria:
Inclusion Criteria:

- All primary care providers from all of the Fairview and University of Minnesota Physicians study clinics

Exclusion Criteria:

- Primary care providers who work less than 20% full time equivalent (FTE)
Nasogastric Tube vs. Orogastric Feeding Tube in Preterm Infants: Which is Best?

The purpose of this study is to find out which method (nasogastric vs. orogastric) of feeding tube for premature infants results in earlier only oral feeding.

Preterm infants, even as young as 23 weeks gestational age, can be fed enterally at the first week of life. Coordination of sucking and swallowing, and coordination of both and breathing is necessary for efficient and safe oral feeding, and is not well established before the 35th week gestational age. That is why tube feeding is essential for preterm infants younger than that age.

There is no consensus regarding the best way for the feeding tube, i.e. oral vs. nasal, and whether placing the tube should be continuous or intermittently. Nasogastric tube has been associated with vagal responses. Both tubes may cause gastric perforation.

Development and function of oral feeding has been described. It is known that non-nutritive sucking and early introduction of oral feeding accelerate the transition from tube feeding to oral feeding. It is suggested that the preterm infant may experience a maturational lag in vagal function related to ingestive needs, which may contribute to continued feeding difficulties and may be a measurable marker of subtle neurodevelopmental problems. Both oral and nasal feeding tube may interfere with establishment of efficient oral feeding. The purpose of this study is to see whether there is a difference between oral and nasal tube feeding, regarding the institution of oral feeding.

Eligibility Criteria:
Inclusion Criteria:

* All preterm infants, born during one year, who required tube feeding, and later discharged from neonatal intensive care unit.

Exclusion Criteria:

* Infants who died during hospitalization
* Infants with severe neurologic deficit (e.g. after Sarnat II-III asphyxia, or as a part of a syndrome
* Infants with gastrostomy
* Infants who were transferred to another hospital for any reason (e.g. heart surgery)