cyrilzakka/clinical-trials huggingface dataset:
Vibrotactile Feedback in Exoskeletons

This study aims to investigate the impact of providing discrete vibrotactile feedback related to weight shift and step initiation on exoskeleton use in individuals with motor-complete SCI.

Rationale: People with motor-complete spinal cord injury (SCI) lack motor function below the lesion level and are, thus, wheelchair-dependent. In recent years, wearable exoskeletons have emerged as potential mobility devices for this population. Although exoskeletons generate the basic motions for ambulation, postural stability must be maintained by the user. People with motor-complete SCI miss essential somatosensory perception, which affects their ability to maintain postural stability. Hence, walking in an exoskeleton is demanding, and crutches are necessary.

When sensory information of a specific system is lost, the lack of sensory information can be substituted by providing feedback to another sensory system. As sensory feedback has been shown to improve postural control in people missing essential sensory information, such sensory substitution may also be effectively incorporated in people with complete SCI using an exoskeleton.

Objective: The study aims to investigate the effect of vibrotactile feedback on exoskeleton use in people with motor-complete SCI.

Study design: The proposed study is an experimental study. The study protocol includes six sessions of 90 minutes spread over three weeks. Sessions one to five are dedicated to training to assess the effect of vibrotactile feedback on exoskeleton motor learning. Session six is dedicated to evaluation to assess the effect of vibrotactile feedback on exoskeleton motor control.

Eligibility Criteria:
Inclusion Criteria:

* SCI classification American Spinal Injury Association Impairment Scale (AIS) A or B
* Minimally six months post-injury
* Prior experience with the ReWalk Exoskeleton, able to walk independently

Exclusion Criteria:

* Pre-existing somatosensory problems before the SCI
* Visual or auditory issues that are not resolved with glasses or a hearing device
* Insufficient mastery of the Dutch language
* Contraindications related to the ABLE Exoskeleton
Nefazodone in the Treatment of Cocaine Dependence and Depression - 4

The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity.

The objective of this study is to determine the safety and efficacy of nefazodone (Serzone ) in depressed cocaine dependent subjects. This is a hypothesis-testing study which will explore whether cocaine usage will be reduced in the nefazodone treatment group compared to a placebo control group.

Eligibility Criteria:
Inclusion Criteria:

DSM-IV diagnosis of cocaine dependence, Depression score of 12 or above and history of depression. Males and non-pregnant, non-nursing females 21-55 years of age.

Exclusion Criteria:

Axis I diagnosis other than substance use disorder, major depression, anxiety of dysthymic disorder. Physiological dependence on alcohol. Significant medical or neurological history. Abnormal UA, CBC or Chem 23 (LFT's may be up to 3 times normal). Enrollment in an opiate-substitution treatment program within 45 days of enrollment in the present study.
Online Tai Chi Intervention to Promote Smoking Cessation Among Cancer Survivors

This clinical trial evaluates an online Tai Chi intervention to promote smoking cessation among cancer survivors. Tai chi is a practice that involves a series of slow gentle movements and physical postures, a meditative state of mind, and controlled breathing. It is a gentle form of exercise that can be done while sitting or standing and does not involve any medications or medical procedures. Tai chi originated as an ancient martial art in China. Over the years, it has become more focused on health promotion and rehabilitation. The use of Tai Chi may be beneficial for cancer patients who want to quit smoking.

Aim 1: The primary objective of this study is to pilot an online Tai Chi intervention promoting smoking cessation among cancer survivors1.

Aim 2: Examine whether an online Tai Chi intervention reduces cigarette dependence among cancer survivors who are aged 21 and are interested in quitting smoking.

Aim 3: Test whether an online Tai Chi intervention increases quit attempts and cessation abstinence among cancer survivors who are aged 21 or older and are interested in quitting smoking.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants participate in an 8-week supervised online WaQi/Tai Chi program. Participants receive standard cessation treatment which includes receiving a document highlighting smoking cessation resources.

ARM II: Participants receive standard cessation treatment which includes receiving a document highlighting smoking cessation resources. Participants also receive an 8-week online Tai Chi self-administered teaching module subscription at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Cancer survivor (i.e., have had a cancer diagnosis)
* Age 21 years and older
* English speaking/reading
* Report smoking tobacco in the past 30 days
* Report at least moderate interest in quitting smoking (\>= 3 on a Likert type scale with 5 being very extremely interested)
* Can participate in Zoom calls for orientation and intervention
* Have access to a smartphone or tablet
* Willing to download a free application (app)
* Can commit to the 8-weeks intervention (WaQi program)
* Are not currently or have not regularly practiced Tai Chi in the last 6 months
* Willing to blow into a device (for carbon monoxide measurements)

Exclusion Criteria:

* Non-cancer survivors
* Patients under 21 years old
* Non-English speaking/reading
* Non-smokers in the past 30 days
* Report lower than moderate interest in quitting smoking (\< 3 on a Likert type scale with 5 being very extremely interested)
* Cannot to participate Zoom calls for orientation and intervention
* No access to a smartphone or tablet
* Not willing to download a free app
* Cannot commit to the intervention
* Has practiced Tai Chi regularly in the last 6 months
* Not willing to blow into a device
* Eligible, but sampling quotas full
Maximizing Outcomes in Treating Acute Migraine

AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan, which is being developed for the acute treatment of migraine with or without aura in adults. AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This study is designed to evaluate the efficacy and safety of AXS-07 compared to meloxicam, rizatriptan, and placebo for the treatment of a migraine attack.

This is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled trial. Subjects who successfully complete screening and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07, meloxicam, rizatriptan, or placebo upon the occurrence of a qualifying migraine.


Eligibility Criteria:
Key Inclusion Criteria:

* Has an established diagnosis of migraine with or without aura.
* Has experienced an inadequate response to prior acute treatments.

Key Exclusion Criteria:

* Has previously received any investigational drug or device or investigational therapy within 30 days before Screening.
* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder

The purpose of this study is to evaluate the long-term safety and tolerability of cariprazine in the treatment of pediatric participants with schizophrenia, bipolar I disorder, or autism spectrum disorder (ASD) and to establish the benefit-risk profile of long-term treatment in this population.


Eligibility Criteria:
Inclusion Criteria:

* Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia or bipolar I disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL) at the Screening Visit 1 (for de novo subjects, or as previously confirmed in parent study for subjects who completed Study 3112-301-001 or M21-465).
* De novo participants must have normal physical examination findings, clinical laboratory test results, and electrocardiogram (ECG) results at Screening Visit 1. Abnormal results must not be clinically significant as determined by the investigator. Participants enrolling after completion of Study M21-465 or 3112-301-001 have had monitoring of laboratory tests, physical examinations, and ECGs at the completion visit of the parent studies.
* Participant must have a caregiver (parent or legally authorized representative) who is willing and able to be responsible for safety monitoring of the participant, provide information about the participant's condition, oversee administration of study intervention, and accompany the participant to all study visits.

Exclusion Criteria:

* Participants with DSM-5-TR diagnosis of major depressive disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition. Participants with ASD that is associated with Rett disorder, fragile-X syndrome, or childhood disintegrative disorder.
* Prior DSM-5-TR diagnosis of intellectual disability (IQ \< 70) for schizophrenia and bipolar I disorder participants. Prior DSM-5-TR diagnosis of profound intellectual disability (IQ \< 25) for ASD participants.
* Participant has a condition or is in a situation, which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.
tDCS Effects on GABA Concentration and Brain Functional Connectivity in Older Adults Of Working Age

The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a decrease of GABA concentration and alterations of functional brain connectivity in older people, compared to sham tDCS.


Eligibility Criteria:
Inclusion Criteria:

* unobtrusive neuropsychological screening
* age: older adults of working age: 50-65 years

Exclusion Criteria:

* Mild cognitive impairment (MCI) or other neurological diseases.
* History of severe alcoholism or use of drugs.
* Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems.
* Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women).
A MEDITATION PROGRAM IN HIGH-BURDEN INFORMAL CAREGIVERS

The aim of the present study was to investigate in high burden caregivers the effects of a face-to-face meditation program during four weeks (16 hours) on physiological parameters, psychological state and vagal nerve activity comparing with a control group.

A non-randomized repeated-measures controlled clinical trial was conducted with convenience allocation of participants into intervention (n = 18) or control group (n = 17). Due to ethical reasons, it was not possible to randomize the patients.

The investigators invited from different associations in Granada city and its province through word and mouth or by telephone to 45 volunteer informal caregivers. 40 of them enrolled in this study but only 37 finalized the program, 24.3% male and 75.7% female with a mean (SD) age of 44.03 (7.30) years. The people that have previous experience in mind body practices or cardiovascular diseases were excluded. All the caregivers received information about the study and informed consent was obtained from all participants. This study was approved by the CEI-GR (C-9) ethics committee and followed the principles of the Declaration of Helsinki. Convenience sampling was used to assign caregivers to the control or experimental groups.

Eligibility Criteria:
Inclusion Criteria:

* People who care for a dependent family member or close relative and live with him/her in the same home for at least two years with a caregiver burden of more than 55 points in Zarit Burden Scale.

Exclusion Criteria:

* People that have previous experience in mind body practices or cardiovascular diseases.
Effect of Neuromuscular Electrical Stimulation Applied to the Lumbar Multifidus Muscle on Sit to Stand Kinematics in Individuals With Low Back Pain

The goal of this randomized controlled trial, is to investigate the effect of functional NMES and conventional NMES applied to the lumbar multifidus muscle on body kinematic and kinetic values during the sit-to-stand in individuals with non-specific low back pain. Our study will include 24 participants between the ages of 18-65. Which physiotherapy intervention will be applied to the participants will be determined by the block randomization method, using a table of random numbers. After randomization; NMES to the participants' lumbar multifidus muscle during physiotherapy intervention will be applied in two groups; In the first group, NMES will be applied with the conventional technique during prone position and in the second group, NMES will be applied with the functional technique during the sit-to-stand activity. Evaluations will be made twice for each participant- before and after the intervention. During the evaluation, data regarding the change in body kinetics and kinematics of individuals during the sit-to-stand activity will be recorded with a Vicon camera system. For secondary outcome measures, a visual analog scale will be used to evaluate pain, the Roland Morris Disability Questionnaire and the Oswestry Disability Index will be used to evaluate functional status, and the Tampa Kinesiophobia Scale will be used to evaluate fear-avoidance behavior.


Eligibility Criteria:
Inclusion Criteria:

* History of chronic low back pain (12 weeks\<)
* Pain in the lumbar and/or hip area (VAS\>3)
* Volunteering to participate in the study

Exclusion Criteria:

* History of neurological, metabolic, cardiovascular disease
* Having had spinal surgery, specific lumbar pathology, scoliosis, pregnancy, history of systemic or degenerative disease
* Musculoskeletal system pathology in the last year
* Body mass index being over 30 kg/m2
* Continuing any exercise program
The Impact of Sleep Disorders on Motor Vehicle Accidents

Patients who have sleep disorders may be involved in accidents more frequently than those without. In addition patients who have sleep disorders may have more serious accidents and have increased length of stay.We aim to recruit drivers admitted as a result of a motor vehicle accidents and to ascertain the prevalence of sleep disorders in this group.


Eligibility Criteria:
Inclusion Criteria:Drivers admitted as result of motor vehicle accidents -

Exclusion Criteria:Drivers aged \< 18 years

-
Effect of Thrower's Ten Exercises on Flick Movement Kinematics in Underwater Hockey

Underwater hockey is a team game which is played at the bottom of the swimming pool with palettes, a mask, a snorkel, earmuffs, a stick, and a puck. The aim of the game is for one of the teams to try to score goals to the goalpost of the other by using a flicking movement. The players can drag the puck, being a kind of ball, or pass it to a teammate to reach the opponent's goalpost. The puck is passed by way of pushing or flicking.

The Thrower's Ten exercises are used for such sports branches, which involve the upper extremity and particularly the overhead activity and throwing, in order to ensure coordination, proprioception, balance and symmetry in the double upper extremity. The Thrower's Ten exercises are comprised of special exercises selected for the improvement of the flexibility, strength and endurance of the major muscles that are frequently used for throwing and overhead activity such as deltoid muscles, supraspinatus muscles, latissimus dorsi, biceps, triceps and wrist extensors. The Thrower's Ten exercises are an exercise program that focuses on the scapular muscles, particularly on posterior rotator cuff muscles in order to ensure the balance of the anterior and the posterior shoulder muscles.

The aim of this study is to evaluate the effects of The Thrower's Ten exercise program on the flicking movements in underwater hockey players.

Underwater hockey is a team game which is played at the bottom of the swimming pool with palettes, a mask, a snorkel, earmuffs, a stick, and a puck. The aim of the game is for one of the teams to try to score goals to the goalpost of the other by using a flicking movement. The players can drag the puck, being a kind of ball, or pass it to a teammate to reach the opponent's goalpost. The puck is passed by way of pushing or flicking.

The Thrower's Ten exercises are used for such sports branches, which involve the upper extremity and particularly the overhead activity and throwing, in order to ensure coordination, proprioception, balance and symmetry in the double upper extremity. The Thrower's Ten exercises are comprised of special exercises selected for the improvement of the flexibility, strength and endurance of the major muscles that are frequently used for throwing and overhead activity such as deltoid muscles, supraspinatus muscles, latissimus dorsi, biceps, triceps and wrist extensors. The Thrower's Ten exercises are an exercise program that focuses on the scapular muscles, particularly on posterior rotator cuff muscles in order to ensure the balance of the anterior and the posterior shoulder muscles.

The aim of this study is to evaluate the effects of The Thrower's Ten exercise program on the flicking movements in underwater hockey players.

Eligibility Criteria:
Inclusion Criteria:

* 1st league healthy underwater hockey players

Exclusion Criteria:

* Previous shoulder injury
Aerobic Exercise in Patients Receiving Chemotherapy for Cancer

RATIONALE: Aerobic exercise may help prevent side effects caused by chemotherapy and help improve heart health.

PURPOSE: This randomized clinical trial is studying the side effects of aerobic exercise and to see how well it works in patients receiving chemotherapy for cancer.

OBJECTIVES:

* To determine if patients with cancer can exercise safely and routinely, under supervision, while receiving anthracycline chemotherapy.
* To determine the magnitude of the change in the peak ventilatory oxygen uptake (VO2) before and after completion of anthracycline chemotherapy with concurrent exercise versus without exercise in patients with cancer.

OUTLINE: Patients are randomized to 1 of 2 intervention arms.

* Arm I (exercise): Patients undergo supervised aerobic exercise (walk or bicycle) 3 days a week concurrently with standard anthracycline-based chemotherapy for approximately 18-24 weeks.
* Arm II (non-exercise): Patients receive standard anthracycline-based chemotherapy for approximately 18-24 weeks.

Patients undergo peak ventilatory oxygen uptake (VO_2) by exercise bike test with gas exchange analysis at baseline and at 2 weeks after completion of anthracycline-based chemotherapy.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients with cancer scheduled to receive 4-6 courses of an anthracycline-based chemotherapy

PATIENT CHARACTERISTICS:

* Able to pedal a stationary bicycle
* No severe hypertension (systolic blood pressure \> 220 mm Hg or diastolic blood pressure \>120 mm Hg)
* No atrial fibrillation with an uncontrolled ventricular response
* No ventricular arrhythmias
* No unstable angina
* No acute myocardial infarction within the past 28 days of enrollment
* No severe valvular heart disease
* No severe (exercise-limiting) peripheral vascular disease
* No severe pulmonary disease

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Study of Difluprednate in the Treatment of Uveitis

The purpose of this study is to determine the safety and efficacy of difluprednate compared with prednisolone acetate in the treatment of endogenous anterior uveitis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of endogenous anterior uveitis in at least 1 eye

Exclusion Criteria:

* Presence of intermediate uveitis, posterior uveitis or panuveitis
* Corneal abrasion
* Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease
* Allergy to similar drugs, such as other corticosteroids
WEakness and Atrophy: isoKinetic With Surface Electromyography Assessment in ACL Surgery

An assessment of the effect of surgical anterior cruciate ligament (ACL) on thigh muscles is critical to the improvement of knee rehabilitation and preservation. However, if a large number of studies had rated surgical technics, giving high results level for ACL reconstruction (ACLR), muscle recovery is still conditioning functional success. Furthermore there is no consensus about criteria in return to sport.

The aim of this exploratory study is to quantify the mechanisms of neuromuscular adaptation of muscle thigh after ACL surgery.

The aim of this study is to assess the qualitative and quantitative variations of the strength, work and fatigue of the thigh muscles after ACL surgery. The reference is the preoperative assessment (V1), the variation is measured on V2 (measurements at 3 months) and V3 (measures at 9 months). Each patient is his own control. In addition, a control group of healthy subjects is used to determine level of significance of each parameter.

Eligibility Criteria:
Inclusion criteria:

ACLR group :

* men or woman
* 18 to 45 years old
* No injuries sequels on contralateral limb
* No contraindication to magnetic resonance imaging

Control group :

* men or woman
* 18 to 45 years old
* No limb injuries sequels
* No contraindication to magnetic resonance imaging

Exclusion criteria:

* age less than 18 years
* limb injuries sequels
* contraindication to magnetic resonance imaging