cyrilzakka/clinical-trials huggingface dataset:
A Randomised Controlled Clinical Trial of Memory Specificity Training (MEST) for Depression

Depression involves the tendency to recall overgeneral personal memories, a phenomenon which has been linked to numerous adverse psychological outcomes. The purpose of this study is to investigate whether a group-based Memory Specificity Training (MEST) programme improves outcomes in depression, and how this compares to an education and support control group. The primary aim is to examine whether MEST, which involves repeated practice retrieving specific autobiographical memories reduces depressive symptoms immediately post-treatment, and whether this is maintained 3 months after treatment. The secondary objective of this trial is to examine the role of hypothesised cognitive processes (ie., rumination, executive control, cognitive avoidance) which may underlie improvements in depression and memory.


Eligibility Criteria:
Inclusion Criteria:

* Principal diagnosis of Major Depressive Disorder
* History of more than one previous depressive episode
* Current diagnosis of a Major Depressive Episode
* Depressive symptoms rated in the mild-severe range (\> 13 on the BDI-II)
* Memory specificity \< .70 (as assessed on the AMT)

Exclusion Criteria:

* Head trauma
* Organic brain damage
* Secondary diagnosis of another affective disorder
* Psychosis
* Current drug or alcohol abuse or dependence
* A diagnosed Axis II disorder
Impact of Yoga on Blood Pressure, Quality of Life and Stress in Patients With Hypertension

The purpose of this study is to determine the effects of a short yoga program practiced daily at home on blood pressure, quality of Life and stress. The subjects of the study are primary health care patients diagnosed with hypertension, with or without current medication.

Hypertension is one of the most common diseases in the world, affecting approximately 26% of the adult population. Persistent hypertension increases the risk of developing coronary heart disease, stroke and other cardiovascular diseases, such as heart failure. Hypertension is a common diagnosis in primary health care and the societal costs of examination and treatment of hypertension and its consequences are considerable.

The YHIP-study (The Impact of Yoga on Blood Pressure and Quality of Life in Patients With Hypertension), that investigated yoga as additional treatment for hypertension on primary care patients, showed that a short yoga program practiced daily at home had a blood pressure lowering effect as well as a positive effect on self-rated quality of life compared to control.

Other previous studies have demonstrated positive effects of yoga on blood pressure, quality of life, subjective well-being and stress. However, these studies are relatively few and we need to further investigate the possibility of using yoga as a treatment in primary health care.

If the yoga intervention shows to be effective, yoga exercises may be useful as a supplementary BP therapy in addition to medical treatment when prescribed by primary care physicians. It is to be hoped that patients will also experience a higher quality of life and less stress if they perform yoga on a regular basis.

Eligibility Criteria:
Inclusion Criteria:

* 30-80 years old
* Diagnosed with hypertension since at least one year
* Blood pressure 130-160 mm Hg systolic and/or 85-100 diastolic at the last blood pressure control by doctor or nurse.
* Blood pressure within inclusion- and exclusion-limits at baseline control

Exclusion Criteria:

* Blood pressure outside the range of 120-180 systolic and 80-110 diastolic at the last blood pressure control or at baseline control.
* Medical adjustments regarding hypertension within 4 weeks prior to begin of study.
* Expected inability to understand instructions about yoga exercises (e.g dementia and mental retardation) or physical or psychical inability to carry out yoga exercises (e.g severe physical or psychical handicap).
* Need for interpreter. Linguistic/language difficulties
Safety and Efficacy of a Drink Containing Lupine Protein Hydrolysates on the Immune, Oxidative and Metabolic Status

The purpose of this study is to determine the health effects of the 4 weeks daily intake of a drink manufactured from lupine protein hydrolysates in healthy volunteers. For that, blood markers of inflammation, oxidative stress, carbohydrate, lipid, protein and liver metabolism, together with general hematology and blood coagulation will be assessed at baseline time (day 0) and after drink ingestion (day +14 and +28).

The main objective of the present study is to verify the hypothesis that the intake of the drink based on lupine peptides is safe and has beneficial effects on the immune and oxidative status.

The secondary objectives are:

* Assess the effect of the drink on biological parameters of the carbohydrate, lipid, renal and hepatic metabolism as well as hematology analysis.
* Assess whether the new product is well tolerated.
* Evaluate the effect of the drink on the general health of the volunteers through the Short Form-36 health survey.
* Determine the degree of drink acceptability through the acceptability Likert test.

Eligibility Criteria:
Inclusion Criteria:

* Subject between 18 and 50 years old
* Body mass index between 19 and 26 kg/m2
* No severe disease
* Biochemical markers within the normal range
* No previous history of drug abuse
* Negative serology for hepatitis C virus (HCV), hepatitis B virus (HBV) and HIV
* Females must have a negative pregnancy test
* The volunteer should signed the informed consent approved by the Ethics Committees of Clinical Trials

Exclusion Criteria:

* Pre-existing disease
* Treatment with anti-inflammatory, antipyretic or antibiotic drugs
* Smoker
* Harmful alcohol consumption according to World Health Organization standards
* Pregnant females
* Hypersensitivity to lupine, corn or xanthan gum.
* Allergies to plant derivatives and celiac.
* Participation in another clinical trial.
* Blood donation in the previous three months.
* Any other circumstance that according to the research team may lead to increased risk for voluntary
Maximal and Self-selected Walkingspeed After Knee Arthroplasty - a Prospective Cohort Study

The purpose of this prospective study is to explore whether maximal and self-selected walking speed in individuals with knee arthroplasty is a useful and applicable clinical measure that can provide new insights into physical function after prosthetic surgery. We will examine the progression of walking speed and other measures of physical function, and investigate if walking speed can predict postoperative function. Individuals over 55 years, scheduled for knee arthroplasty will be invited to participate. Standardized functional tests such as walking speed, sit to stand and one legged stance along with patient reported outcomes will be assessed preoperatively, three months and 12 months after surgery. The study may provide useful knowledge that can be aplied clinically in the assessment and follow-up of this patient group.


Eligibility Criteria:
Inclusion Criteria: age 55 +, living in or near the city of Oslo (up to appox 2 hours commute), sceduled for primary knee arthroplasty, able to walk independently with or without walking aids, understand and speak Norwegian sufficently to take instructions and respond to questionnaires

Exclusion Criteria:

Other reasons than osteoarthritis for knee arthroplasty, revision due to infection or failure, arthroplasty in the same or other limb during the 12 months time period, severe neurological or ohter types of disease that affects walking (e.g MS; parkinsonism, hemiplegiea)
Galantamine Effects on Cognitive Function in Abstinent Cocaine Users

To evaluate galantamine's effects on cognitive performance in abstinent cocaine users. Galantamine, a medication approved for treatment of Alzheimer's disease, is an acetylcholine esterase inhibitor. Galantamine also directly potentiates nicotine receptors. Both of these effects may result in improved cognitive performance in a group of subjects known to have impaired performance in various cognitive tasks.

Galantamine, compared to placebo, will improve cognitive performance in abstinent cocaine users. The cognitive performance will be measured with the Stroop test and 3 Cambridge Neuropsychological Test Automated Battery (CANTAB) tests: Paired Associate Learning (PAL), Delayed Pattern Recognition Memory (PRM),and Rapid Visual Information Processing (RVIP). Performance on these tests has been shown to be impaired in abstinent cocaine users, compared to healthy controls.

Galantamine, compared to placebo, will not be associated with any significant changes in mood. Monitoring of mood will be achieved with 3 mood scales: 1) Center for Epidemiologic Studies Depression (CES-D) scale, Positive and Negative Affect Schedule (PANAS) and the Profile of Mood States (POMS).

Currently this study is completed, Patients are no longer being enrolled. There were 28 completers. This study has been published.

Eligibility Criteria:
Inclusion Criteria:

* Male and females, between the ages 21 and 50
* Fulfill criteria for past cocaine dependence
* No cocaine use for the past 30 days
* No other current dependence or abuse of other drugs or alcohol
* No current medical problems and normal ECG
* Not pregnant,nor breast feeding,
* Using acceptable birth control methods.

Exclusion Criteria:

* Current major psychiatric illness including mood, psychotic or anxiety disorders
* History of major medical illnesses; including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment and cardiac rhythm disturbances
* Use of other medications including,drugs that slow heart rate
* Known allergy to galantamine
Clinical Trial Using Pupillometry to Measure Nociception in Healthy Volunteers.

Pupillometry has been used in healthy volunteers to investigate the usefulness of the pupil light reflex as an indicator of pain intensity on pressure as a nociceptive stimulus. In this sense, it is necessary to check if the pupillometry is sensitive to different types or sources of pain. One of these devices is the Algiscan® portable pupillometer (IdMed, Marseille, France), which we propose to use in the present study. This pupillometer has previously been used in healthy volunteers, and in patients admitted to the intensive care unit, subjected to mechanical ventilation and sedation / analgesia.

This study in healthy volunteers aims to evaluate whether the PDR can be a reliable and discriminatory measure of the intensity of nociception, applying various types of nociceptive stimuli. If so, this study could lead to the use of pupillometry as an objective measure of nociception in settings where patients cannot communicate, such as intensive care areas or perioperative settings.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects of both sexes (balanced)
2. Caucasian race
3. Ages between 25 and 65 years old (balanced, 50% from 25-45 and 50% from 45-65)
4. Body weight within the normal range (Quetelet index: 19-30)
5. Clinical history, physical examination and vital signs within normality
6. Free acceptance to participate, with written informed consent

Exclusion Criteria:

1. Previous history of alcoholism or drug dependence (year prior to the screening visit or daily alcohol consumption\> 40 gr / day for men or\> 24 gr / day for women)
2. Significant consumption of stimulating drinks (\> 5 coffees, teas, chocolate or cola drinks / day).
3. Taking any medication in the 15 days prior to the study and / or medicinal plants that may have an effect on the pupil (beta-blockers, droperidol, metoclopramide, clonidine ...). Oral contraceptives and paracetamol will be allowed.
4. Pregnancy (β-hCG test).
5. Menstruation and / or dysmenorrhea on the day of the study
6. Family or personal history or clinical evidence of psychiatric, neurological or ophthalmological problems: anxiety, depression, Parkinson's, glaucoma, dry eyes, retinal diseases, eye surgery and pupil abnormalities, presenting migraine pathology and diabetes
7. Pupillary diameter ≥ 5mm
8. Smokers or ex-smokers \<6 months.
9. Have participated in a clinical trial in the 3 months prior to the start of this study.
Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers

The aim of the study is to compare the implementation and effectiveness of group and self-help based cognitive behavioral treatment for insomnia (CBT-I) delivered by occupational health services (OHS) in a randomized and controlled design (RCT) among different types of shift workers.

Because of irregular sleep-wake pattern shift work is a challenge in the screening and treatment of chronic insomnia. Earlier results has showed that CBT-I delivered by trained nurses of OHS may be effective treatment also among workers with irregular work hours. The aim of the present study is to compare the implementation and effectiveness of OHS delivered group and self-help based CBT-I in a RCT design among different types of shift work.

Participants (n=90-120) are shift workers with insomnia disorder that has lasted at least three months. The participants are randomized to a) group-based CBT-I (6 group sessions); or b) mainly computerized self-help CBT-I (an individual session before and after the intervention) delivered by a trained OHS nurse or psychologist; or c) control group given a sleep hygiene intervention (1 individual session). Outcomes are assessed using a sleep diary, questionnaires, actigraphy and cognitive performance tests. To study the effect of CBT-I program at molecular level, blood samples of participants will be collected at baseline and at the end of the program for genetic analyses. The measurements are conducted at five time points for a period of two years.

The investigators expect to find that both group and self-help based CBT-I among different types of shift workers are effective low-intensity treatments of chronic insomnia compared to control intervention.

Through the training of OHS or general medical practitioners and by computerised self-help interventions the investigators may have better chance to make CBT-I more accessible to a larger number of insomniacs also with different types of working hours. Additionally, it may be possible to decrease chronic insomnia and unfavourably consequences of insomnia to the health and performance capacity in shift workers.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Insomnia (F51.0)
* Difficulty initiating and/or maintaining sleep for ≥ 30 minutes and/or the use of sleep promoting medicine on three or more nights per week for at least 3 months
* Motivation to treat insomnia with non-pharmacological methods
* Full-time shift work (at least 10 % of shifts are morning, evening and/or night shifts)
* Fluent Finnish (due to interventions)

Exclusion Criteria:

* Non-assessed or untreated somatic or mental illness which may explain insomnia
* Planned changes in the work (for example retirement)
Evaluation Of Valaciclovir In Patients With Chickenpox

This study will assess the safety and efficacy, and the pharmacokinetics of aciclovir and valaciclovir in children with chickenpox following oral administration of valaciclovir, for the purpose of seeking approval of valaciclovir HCl for the treatment of chickenpox.


Eligibility Criteria:
Inclusion criteria:

* Subjects aged 1 year to less than 12 years with a clinical diagnosis of chickenpox within 48 hours of the onset of the rash.

Exclusion criteria:

* History of hypersensitivity reactions.
* Impaired hepatic or renal function.
* Gastrointestinal dysfunction.
* Serious underlying disease.
* Weigh over 40kg.
* Vaccinated for chickenpox.
The Interaction Between Metformin and Physical Training

Physical activity is a first line treatment for patients with type 2 diabetes (T2D), however, the vast majority of patients with T2D do not achieve satisfying glycemic control with physical activity alone, which is why pharmacological treatment with metformin is most often initiated.

It is known that metformin and exercise both activates 5' adenosine monophosphate-activated protein kinase (AMPK) in skeletal muscle and liver, and the activation of AMPK results in many different metabolic effects, including improvements in glycemic control. Because of this similarity in mechanism of action, an interaction between metformin and exercise is plausible, but knowledge in the area is sparse. Thus, the aim of this study is to assess the effects of training with and without concomitant metformin treatment, in order to investigate whether an interaction between the two occur.

Subjects with impaired glucose tolerance will all undergo 12 weeks of training but will be randomized (1:1) to concomitant metformin/placebo treatment in a double-blinded way. Experimental days will be performed before randomisation (before initiation of metformin/placebo treatment), before initiation of the training period and after the training period.


Eligibility Criteria:
Inclusion Criteria:

* Glucose-lowering-medication naïve T2D and/or subjects with impaired glucose tolerance defined as: 2-h plasma glucose (PG) in the 75-g OGTT (7.8-11.0 mmol/L) and/or HbA1c (39-47 mmol/mol)
* Caucasian
* BMI \> 25 but \< 40 kg/m2
* Low to moderate physically active (≤90 min of structured physical activity/week)

Exclusion Criteria:

* Pregnancy
* Smoking
* Glucose-lowering treatment
* Treatment with steroids and other immunomodulating drugs
* Contraindication to increased levels of physical activity
* Liver disease (ALAT elevated more than 3 times above upper normal limit, or reduce levels of the liver function markers albumin and KF II+VII+X)
* Renal insufficiency (eGFR\<60 ml/min)
* Prior history of lactic acidosis
* HbA1c \>55 mmol/mol and/or 2-hPG in the 75-g OGTT \> 15 mmol/L
Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers

Given the challenges to delivering tobacco cessation treatment in oncology care and the unique challenges faced by individuals attempting to quit tobacco after a cancer diagnosis, scalable cessation programs that are tailored to the experiences of cancer survivors that also integrate caregiver/family support are needed. To address this need, this study will use an intervention that consists of two primary strategies: 1) a tailored cessation program for cancer survivors and family members/caregivers who use tobacco and 2) healthcare provider training.

Healthcare providers will receive training on the AAC model (Ask patients about tobacco use, Advise patients to quit, Connect patients to cessation resources), including materials focused on tobacco cessation in cancer care from the CDC, as well as a brief evidence-based communication skills training based on the C-LEAR (Counsel, Listen, Empathize, Answer, Recommend) approach.


Eligibility Criteria:
Inclusion Criteria:

Cancer Survivors including Current Cancer Patients

* Current self-reported user of any tobacco/nicotine product at time of baseline screening assessment (e.g., cigarettes, e-cigarettes, cigars, dip/chew) in the past month.
* Any history of cancer diagnosis. Subjects currently receiving cancer-related treatments are eligible for enrollment.
* Receiving care from the participating UF Health clinics (Medical Oncology, Urology, and Radiation Oncology).
* Capable of completing study requirements
* Informed consent obtained from the subject and documentation of subject agreement to comply with all study-related processes
* Adults aged ≥18 years

Informal Caregivers/Family Members of Cancer Survivors

* Current self-reported user of any tobacco/nicotine product at time of baseline screening assessment (e.g., cigarettes, e-cigarettes, cigars, dip/chew) in the past month.
* A family member, informal caregiver, or friend of an enrolled cancer survivor receiving care from the participating UF Health clinics as described above
* Capable of completing study requirements
* Informed consent obtained from the subject and documentation of subject agreement to comply with all study-related processes
* Adults aged ≥18 years

Exclusion Criteria:

Cancer Survivors including Current Cancer Patients

* Patients unable to complete the sessions because of language, travel or technology barriers
* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Informal Caregivers/Family Members of Cancer Survivors

* Participants unable to complete the sessions because of language, travel or technology barriers
* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Project SOLVE: Trial of a Brief Digital Problem-solving Intervention

The goal of this trial is to examine the effectiveness of a universal, self-guided, digital single-session intervention focusing on problem-solving skills in improving adolescent mental health and well-being, relative to an active control intervention focusing on study skills, within the context of school settings during the coronavirus disease pandemic.

More than 20% of adolescents will experience at least one mental health disorder or problem before adulthood that warrants treatment, yet 80% of these adolescents will never receive care. This need-to-access gap appears to be heightened during the current coronavirus disease pandemic and its resulting disruptions to healthcare and education systems. Both within and beyond the context of the pandemic, preventive mental health interventions are positioned to help adolescents build and strengthen coping strategies that can preclude the emergence of mental health difficulties that require more resource-intensive levels of clinical care. Preventive mental health interventions delivered via digital platforms and within school-based settings might be especially scalable.

The current school-based trial is designed to test one such strategy that harnesses technology to boost the scalability of adolescent mental health interventions: a brief (one 30 minute session) digital program designed to empower adolescents (10-14 years old) to solve, rather than be overwhelmed by, everyday problems (Project SOLVE). Single-session interventions designed to help adolescents cultivate adaptive mindsets have reduced anxiety and depression among adolescents with and without elevated symptoms of these disorders. Building on this strong foundation, Project SOLVE targets these mental health challenges with problem solving skills-one of the most versatile, commonly used, and potent therapeutic techniques for adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent is in grades 6-8 (inclusive) at partnering schools
* Adolescent is between the ages of 10-14 years (inclusive) at the time of study enrollment
* Adolescent and at least one guardian consent to adolescent participation in study
* Adolescent reads English well enough to effectively complete the digital programs
* Adolescent has access to a digital device

Exclusion Criteria:

* Adolescent is non-English speaking, as the programs are only available in English
* Adolescent does not have access to a digital device
* Adolescent has an intellectual disability that precludes comprehension of the program content
Incidence of Postoperative Residual Neuromuscular Blockade in the Era of Sugammadex

This study is a prospective observational study. A total 52 patients will be included in this study. We will observe the incidence of postoperative residual neuromuscular blockade in patients receiving sugammadex.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective surgery under general anesthesia.
* American Society of Anesthesiologists grade 1, 2, or 3.
* Aged \>18 years

Exclusion Criteria:

* Refusal to participate in the study
* Body Mass Index \< 18.5 kg/m2 or \> 35 kg/m2
* History of neuromuscular disease.
* History of allergy to neuromuscular blockade
* Scheduled to transfer to the intensive care unit