cyrilzakka/clinical-trials huggingface dataset:
Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)

To make adalimumab available to subjects suffering from moderately to severely active Crohn's Disease (CD) and to expand the safety information on adalimumab. The study also assessed changes in Patient Reported Outcome Measures from baseline.

This was a Phase 3, multicenter, open-label, Early Access Study with an induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4 in subjects with moderately to severely active Crohn's Disease (CD) who were eligible to receive biologic therapy or who had failed to respond to, lost response to, or were intolerant to infliximab. Failure of prior therapy was determined by the Investigator. Subjects were to have an 8-week wash-out period prior to Baseline from the last dose of infliximab.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 years of age and older
* Females: Not of childbearing potential OR Practicing approved birth control throughout the study and for 150 days after study completion
* Diagnosis of moderate to severe CD for greater than 16 weeks prior to screening; Crohn's Disease Activity Index score \> 220 OR Harvey Bradshaw Index equal to or higher than 7, and who are refractory to optimal conventional therapies such as, 5-aminosalicylic acid (5-ASA), glucocorticoids, and immunosuppressive therapies (azathioprine, 6-MP and MTX)
* Subjects who failed prior infliximab therapy (as determined by the primary investigator), including those who never clinically responded ("primary non-responders")

Exclusion Criteria:

* History of cancer other than some skin and cervical cancers
* History of opportunistic infections, central nervous system (CNS) demyelinating disease, chronic viral hepatitis, or untreated tuberculosis
* Subjects with other, poorly controlled medical conditions
* Subjects with any prior exposure to Tysabri® (natalizumab)
* Subjects who have received any investigational agent in the past 30 days or 5 half-lives prior to screening (whichever is longer)
* Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
Changes in Unstable Ankles After Balance Training

This study is evaluating reflex board training to see if it will help people who frequently roll their ankles. We are investigating several tests that evaluate the ability of the neuromuscular system to control ankle movement. This study is in 2 parts:Part 1 looks at changes after 1 day of reflex training; Part 2 looks at changes after 6 weeks of reflex training. It is thought that the reflex training will improve measures of static and dynamic balance as well as spinal reflex measures.

Research has utilized multiple measures in an effort to detect chronic ankle instability (CAI). Recently, investigations have focused on assessment of sensorimotor function in those who suffer from CAI. These measures have included traditional and functional postural control variables, as well as measures of joint position sense, neuromuscular control and recruitment, and nerve conduction velocity. This study seeks to modulate sensorimotor measures through both short- and long-term reflex training. This information may help to better assess sensorimotor deficits associated with CAI, to focus future research, evaluate rehabilitation protocols and to improve our understanding of this chronic disability.

Eligibility Criteria:
Inclusion Criteria:

* chronically unstable ankles with a history of at least 2 ankle sprains in the past year, M/F 18-30, healthy

Exclusion Criteria:

* ankle sprain within past 6 months, any chronic lower extremity injury or condition, neurological condition, balance-inner ear or vestibular condition, any other condition that would interfere with testing
MyPad - Intelligent Bladder Pre-void Alerting System

Development a 'dry alarm' that can help children and adolescents become dry at night.

Enuresis / Bedwetting is a common problem causing much emotional distress. Most children are dry by the age of 5 years, but a significant number of older children still wet their bed. This can be very distressing for child and family. There is also an associated cost due to extra laundry and impact of lost sleep.

Programmes to help children become dry at night often include the use of a moisture alarm. The alarms sound when the child begins to wet the bed, waking them up to go to the toilet instead. Most alarms work by detecting wetness, sounding the alarm when the child starts to pass urine. As such, they still need to change pyjamas and bed sheets.

The investigators aim to develop a 'dry alarm' that can help children and adolescents become dry at night. The alarm will sound when the bladder is full, before the child passes urine. This would avoid wet beds. The investigators have engineered parts for this alarm, but need to work on making it ready for use. This device will enable children to have dry nights whilst learning bladder control.

This study has several phases. The alarm will consist of a small box worn over the abdomen. The aim is to test this overnight, and adjust it for comfort and ease. The device uses a mini ultrasound machine, which measures how much urine is in the bladder. There will be a series of tests to calibrate the device compared to a clinical ultrasound device. Then children with enuresis/ bed wetting will wear it overnight. It will be linked to an alarm which will sound once the bladder is full.

This particular study will determine the feasibility of the product, to confirm the design and specifications, including a comfort trial, calibration and comparison with clinical scans, and operating process prior to a future clinical trial.

The total number of participants is 25 - however this will be split over the different phases of the trial.

Comfort Trial - 5 Calibration trial 3 month testing phase - 10

Eligibility Criteria:
Inclusion Criteria:

* Age 7 years to 12 years
* Bedwetting twice a week or more
* Good understanding of English language
* For the initial comfort trials and the calibration trial healthy volunteers may be invited to take part.

Exclusion Criteria:

* there is a medical cause for bedwetting
* they have significant learning difficulties
* they are obese (above 98th centile for Body Mass Index)
* they have severe hearing impairment
A Study of Evacetrapib in Japanese and Non-Japanese Participants

The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels in the blood when both drugs are taken at the same time. The study will also assess how well the body handles evacetrapib and pravastatin when given at the same time.

This study has two periods in fixed order. Each participant will enroll in both periods. This study will last approximately 25 days, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy participants, as determined by medical history and physical examination
* Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)
* Japanese participants must be first generation Japanese
The Use of EEG in Alzheimer's Disease, With and Without Scopolamine - A Pilot Study

The objective of this study is to compare the electroencephalography (EEG) responses of three distinct groups of individuals to scopolamine: 1) a group of Alzheimer Dementia (AD) patients, 2) a group of individuals suffering from Mild Cognitive Impairment (MCI) and 3) a group of controls. The main purpose of this comparison is to discover ways to use these responses to distinguish between the group of AD patients and controls in order to develop a diagnostic tool for AD. The purpose of including the MCI group is to investigate whether this diagnostic tool can predict which member of the MCI group will develop AD later in life.


Eligibility Criteria:
Inclusion Criteria:

Healthy subjects:

* Between 60-80 years of age.
* Volunteers will have to be in good general health as determined by standard physical examination.
* Normal Electrocardiograph (ECG)

MCI subjects:

* Diagnosed with MCI at the Memory Clinic at the Landspitali University Hospital using F 06,7 according to International Classification of Diseases (ICD) - 10.
* Between 60-80 years of age.
* Subjects need to score between 2 and 3 on the Global Deterioration Scale (GDS).
* Normal ECG

Alzheimer's patients:

* Diagnosed with AD according to ICD - 10 in Follow up at the Memory Clinic at the Landspitali University Hospital.
* Between 60-80 years of age.
* Subjects need to score between 3-5 on the GDS.
* Normal ECG
* Treated with Reminyl® for the Alzheimer disease.

Exclusion Criteria:

* Smoking or any other use of tobacco.
* Taking neuroleptics or benzodiazepines (allowed to take oxazepam ad vesp).
* Neurological-, cardiovascular-, gastrointestinal- or genitourinary disorders of medical importance.
* Glaucoma or history of possibly raised intraocular pressure.
* Impaired liver- or kidney function.
* Hypersensitivity to Scopolamine or any component in the formulation.
* Any indication of drug, alcohol or medicine abuse.
* Participation in another investigational study at the same time.
Diagnostic Yield of Deep Learning Based Denoising MRI in Cushing's Disease

Negative MRI findings may occur in up to 40% of cases of ACTH producing microadenomas. The aim of the study is to evaluate if detection of ACTH producing microadenomas can be increased using deep learning based denoising MRI.

Detecting ACTH producing microadenoma in MRI is important in establishing the diagnosis of Cushing disease and may enable patients to avoid additional diagnostic tests such as inferior petrosal sinus sampling. However, detecting ACTH producing microadenoma in MRI remains as a diagnostic challenge due its small size with its median diameter of 5-mm. Many attempts have been made in order to improve the sensitivity of detecting ACTH producing microadenoma. It is generally accepted as standard clinical practice to perform dynamic contrast enhanced T1 weighted image to delineate delayed enhancing microadenonoma in comparison to the background enhancement of the normal gland. Despite these attempts, negative MRI findings may occur in up to 40% of cases of ACTH producing microadenomas and there is a need to improve its detection rate. Theoretically, performing thin slice thickness scans should help detecting the lesion but this is unavoidably accompanied with increased level of noise. Deep learning based denoising algorithm can be applied to reduce the noise level and potentially increase the detection rate of ACTH producing microadenomas. The aim of the study is to evaluate if detection of ACTH producing microadenomas can be increased using deep learning based denoising MRI.

Eligibility Criteria:
Inclusion Criteria:

* Patients suspected of Cushing disease undergoing MRI
* Signed informed consent

Exclusion Criteria:

* Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction
* Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
* Poor MRI image quality due to artifacts
Effects of Chemotherapy on Perceived Daily Performance and Executive Functions of Adults With Cancer

The purpose of this study is to examine changes in perceived daily performance and executive functioning following chemotherapy in individuals with non-central nervous system cancers.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with a primary non-central nervous system malignancy (lung, breast, colon, ulcer, urinary tract, canine tumors).
* Stages I-III.
* Pre-commencement of adjuvant (post-surgery) or neoadjuvant (prior to surgery) chemotherapy.
* Understand and read Hebrew.
* Have at least 12 years of education.

Exclusion Criteria:

* Diagnosed with central nervous system malignancies.
* Had a previous malignancy.
* Have or had metastatic disease.
* Have a history of a neurological condition or severe depression.
The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes

The importance of Aldosterone for endothelial function and Insulin resistance observed within patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed diabetic \< 5 Yrs.
* BMI \< 32 kg/m2
* Non-smoking
* Blood pressure \< 140/90 mmHg (treatment with maximum of two antihypertensive drugs)

Exclusion Criteria:

* Insulin treatment
* Hypertension (\>140/90 mmHg)
* Sequelae to diabetes
* Smoking
* Known chronic diseases
* Pregnancy or birth within 3 month
* Alcohol misuse
Auricular Stimulation vs. Expressive Writing for Exam Anxiety

Title of the study: Auricular acupuncture (AA) vs. expressive writing for pre-exam anxiety - a randomised crossover study

Study period: 04 / 2014 - 07 / 2014

Principal Investigator: Prof. Dr. T. Usichenko Department of Anaesthesiology and Intensive Care Medicine University Medicine of Greifswald

Aim of the study: To investigate the anxiolytic effect of AA vs. expressive writing and vs. no intervention in students, passing the oral exams in anatomy at the University of Greifswald

Design: Prospective randomised crossover trial

Interventions: 1. AA using indwelling fixed needles, retained 24 h in situ 2. Expressive writing

Number of volunteers: N = 40

Healthy medical students at the University of Greifswald Participants of the anatomy exams in spring/summer 2014 Without previous anxiolytic, sedative and analgesic medication No pregnancy or lactating Informed consent

Outcome measures: Anxiety level Heart rate, blood pressure Salivary α-amylase


Eligibility Criteria:
Inclusion Criteria:

1. Medical students at the University of Greifswald
2. Going to take part in oral exams of human anatomy
3. Participants without previous anxiolytic medication
4. Ability to express the thoughts and emotions ("expressive writing")
5. Written informed consent

Exclusion Criteria:

1. Recidivist alcoholics
2. Local auricular skin infection
3. Pregnant or lactating women
4. Participants with prosthetic or damaged cardiac valves, intracardiac and intravascular shunts, hypertrophic cardiomyopathy and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of AHA)
5. Participants who are unable to understand the consent form
6. History of psychiatric disease
Effect of Spinal Cord Stimulation (SCS) on Insulin Secretion in Humans

This trial investigates the effect of BurstDR and tonic spinal cord stimulation (SCS) on glucose metabolism and heart rate variability in patients with neuropathic pain.

This study investigates the effect of spinal cord stimulation (BurstDR stimulation versus tonic stimulation versus no stimulation) on glucose metabolism, insulin secretion and heart rate variability in patients with neuropathic pain. To assess insulin secretion, hyperglycaemic clamps are performed in 10 patients. Three different stimulation conditions (BurstDR, tonic and no stimulation) are tested in 10 hyperglycaemic clamps each. A total of 30 clamps are carried out.

Eligibility Criteria:
Inclusion Criteria:

* implanted BurstDR spinal cord stimulating system
* body mass index 18-25 kg/m2

Exclusion Criteria:

* neurological and psychatric diseases
* decompensated diabetes mellitus
* hemoglobin \< 13 g/dl
* thrombocytopenia
Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care

This study evaluates the addition of a group based stabilization and skill-training intervention to individual out-patient treatment for long lasting post-traumatic reactions. Half of the participants will receive the combined treatment while the other half will receive individual treatment as usual.

Many patients in mental health care have previously experienced life-stressors and traumatic events that are related to the problems they seek treatment for. Although the diagnostic labels vary, the clinical picture often demonstrates long lasting complex psychological and somatic post-traumatic symptoms such as avoidance, bodily activation, difficulties in regulating emotions and in relationships with others, impaired quality of life and reduced level of function. Patients often receive long-term individual therapy in general mental health care, occasionally without clinically significant improvement. Still, they continue treatment due to high symptom pressure and low level of functioning. The study targets a novel intervention which tests the effect of adding a group based stabilization and skill training intervention to conventional individual treatment among 160 patients already receiving treatment in a community mental health hospital. Change in variables covering mental health issues, functional impairment, well-being, use of hospital services and drug prescriptions will be examined, as well as markers of inflammation found in sera before and after intervention. The purpose is to develop better and more effective treatment options for a large number of patients who receive mental health care in community mental health hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Receiving treatment in ordinary out-patient clinics
* Having been exposed to or witnessing to traumatic event(s) defined as "one or several extremely threatening or horrific events or series of events or situations being of such a character which is likely to overwhelming distress in almost anyone in a similar situation", measured by Stressful Life Events Screening Questionnaire
* Presenting with posttraumatic reactions such as hyperarousal, avoidance, intrusions, emotional dysregulation or interpersonal difficulties.
* Symptom duration for a minimum of six months.
* Understand and speak Norwegian to an extent that is required to participate in a stabilization- and skill-training group.

Exclusion Criteria:

* Active psychotic symptoms.
* Substance or drug addiction or abuse.
* High suicidal risk considered by the individual therapist.
* Having participated in the course previously.
Modified Constraint Induced Movement Therapy Versus Virtual Reality Training in Children With Cerebral Palsy

Children with hemiplegic cerebral palsy (CP) are characterized by motor impairments mainly lateralized to one side of the body, with greater upper limb than lower limb involvement; these impairments may further limit the daily activities and school participation of children with hemiplegic CP. For the improvement of activity limitations in hemipelagic cerebral palsy children will take 20 hemiplegic cerebral palsy children with the age of 5-16 year all participants will be randomly assign and use modified Constraint induced movement therapy and virtual reality techniques.

mCIMT and Hot pack will be given to group I and unaffected hand will immobilized by a volar resting splint extending from finger tips to the proximal forearm. Use splint every day for at least 5 waking hours individualized, 18-hour program of mCIMT every other day, 3 times per week during a 4-week period. Each modified CIMT session continued for 1.5 hours will give to group I on the other hand VR and Hot pack will give to group II and 18-hour VR program, every other day, 3 times per week for 4 weeks will give Each VR session continued for 1.5 hours. Then evaluate both groups on follow up.

All the data will be collected from Rising Sun Institute by using ABILHAND-KIDS questionnaire and Children's hand-use experience questionnaire. The reliability and validity of tools and mentioned.

The duration of study will be 6-months. Data will be analyzed with the help of SPSS 27


Eligibility Criteria:
Inclusion Criteria:

* Age range between 5 to 16 years of age.
* Medical diagnosis of spastic hemiparetic CP.
* At least 20◦wrist and 10◦ active finger extension from full flexion.
* More movement deficits in 1 upper extremity (less than 2.5 on the Amount of Use scale (AOU) on the Pediatric Motor Activity Log (PMAL)).
* Muscle tone less than 3 on the Modified Ashworth Scale.
* Normal or corrected-to-normal vision and hearing.
* Classified level I, II, or III of the Manual Ability Classification System ( MACS) for Children with CP

Exclusion Criteria:

* Health problems not associated with CP.
* Seizure hemispatial neglect.
* Orthopaedic surgery on the involved upper extremity.
* Botulinum toxin therapy for the affected upper extremity within the past 6 months or within the study period.
* Balance problems
Intensive Care Unit (ICU) Diaries as a Therapeutic Intervention for Post Traumatic Stress Disorder (PTSD) Following Critical Illness

The incidence of PTSD post ICU varies from unit to unit, however a significant number of patients have been shown to develop this disorder. Many patients do not recall their stay in ICU properly and yet can clearly recall nightmares, hallucinations or paranoid delusions, which may be very frightening for the patient to recall at a later stage. As yet, no interventional studies have had an impact on the development of PTSD in this population of patients. However, a recent observational multi-centre study suggested that those patients receiving a diary of their time in ICU had lower levels of symptoms of PTSD than those who did not. These results need to be verified in the form of a randomized study.


Eligibility Criteria:
Inclusion Criteria:

* Patients staying on the ICU for at least 72 hours (with greater than 24 hours of artificial ventilation)

Exclusion Criteria:

* ICU stay \< 72 hours
* Too confused for informed consent
* Pre-existing psychotic illness
Study of the Safety and Efficacy of an Investigational Drug in Adult Patients With Multiple Myeloma

The primary goal of the study is to determine the best dose of an investigational drug to give to patients with multiple myeloma and to evaluate the investigational drug's effectiveness as a treatment for multiple myeloma.


Eligibility Criteria:
Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.

Inclusion Criteria:

* Eligible patients must be at least 18 years of age with a diagnosis of multiple myeloma including elevated M-blood/urine protein or a tumor that can be evaluated by the doctor during the investigational drug's treatment.
* The patient's multiple myeloma must have gotten worse during/after previous chemotherapy was given.
* Any side-effects from prior chemotherapy must have subsided
* Blood and urine tests must show adequate bone marrow, liver, and kidney function.

Exclusion Criteria:

Any of the following will exclude patients from study participation:

* indolent or smoldering myeloma or localized plasmacytoma
* hyperviscosity syndrome
* irradiation to 25% or more of bone marrow
* prior high dose chemotherapy with bone marrow or stem cell support
* current participation in other clinical trials
* pregnant or breast-feeding women
* known HIV-positive or AIDS-related illness
* patients planning to have radiation therapy or surgery that would interrupt study therapy in the next 6 months.
Senescent Immunity in Elders and Vaccine Responses (SILVER)

To study the effects of age on the immune system's response to flu vaccine and to study the connection between the immune system and physical and cognitive changes associated with aging.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 years and over
* Independent Living (including Assisted Living)

Exclusion Criteria:

* Unable to understand the consent or the study.
* Allergic to any vaccine components, excluding eggs.
* History of Guillain-Barre.
* Residing in a long -term care facility such as a nursing home.