cyrilzakka/clinical-trials huggingface dataset:
Balance Control During Gait

Gait and balance disorders are important public health problem necessitating studies to try to prevent falls. Many studies have dealt with spatiotemporal gait parameters or balance during quiet standing (posturography). Nevertheless, falls occurred predominantly during gait, and rarely during quiet standing. We have developed a tool to measure balance during gait : the braking of the center of mass (CM), a biomechanical parameter obtained from the vertical velocity of the CM recorded with a force plate.

In previous studies, we have shown that the braking of the CM was a physiological and a active mechanism, reflecting balance during gait. Unfortunately, the braking of the CM measured on a force plate provide an important intra-individual variability.

The 3D optoelectronic gait analysis system (VICON) also provide an estimation of the CM. The primary goal of this study is to compare intra-individual variability of the braking of the CM determined by a force plate or the 3D optoelectronic gait analysis system (VICON) in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Between 20 and 40 years old
* Effective contraception for women of childbearing age

Exclusion Criteria:

* Neurological, vestibular, rheumatologic, orthopaedic disorders, which could influence gait and balance.
* Known spinal deformity
* Severe visual impairment : visual acuity less than 6/10
* Inability to stand and walk without assistance 15 meters
* Subjects without social security
* Subjects involved in another biomedical trial during this study
* Pregnant or breastfeeding women
Rapid Evaluation of Baclofen for Treatment of Cocaine Abuse/Dependence - 6

The purpose of this study is to empirically test a series of medications to: 1) determine each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective dose range for each medication. In this study, baclofen is tested.

16-week participation plus a 2 week lead in period. Participants are assigned randomly to placebo or baclofen. Participant attend group meetings 3 x/week.

Eligibility Criteria:
Inclusion Criteria:

M/F ages 18-65. cocaine dependence according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy, history of seizures, pregnant and/or nursing women, dependence on ethanol (ETOH) or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
A Psychosocial Intervention for Bereaved Spousal Caregivers of Persons With Dementia

The purpose of this study is to evaluate the feasibility and acceptability of a writing intervention (Reclaiming Yourself), intended to facilitate bereavement for spousal caregivers whose partners died with dementia.

The current research is part 3 of a multi-phase project, whose purpose was to examine the experience of bereavement for spousal caregivers to persons with dementia. Based on spouses' shared experiences and the input of experts in the field (i.e. bereavement/dementia researchers, health care providers), an existing writing intervention called the Finding Balance tool was adapted from the context of cancer bereavement to that of dementia.

The purpose of this third phase is to test this adapted writing intervention (Reclaiming Yourself) with bereaved spouses of persons with dementia. Participants will be randomly assigned into one of two groups: treatment (who will receive the tool); and control (who will not be offered the tool until a later stage). The feasibility and acceptability of the intervention will be assessed, as well as the degree to which it facilitated participants' bereavement, ability to find balance, and psychological health.

Eligibility Criteria:
Inclusion Criteria:

* bereaved for three months or longer
* were a caregiver for their spouse with advanced dementia
* English speaking
* willing and able to share their bereavement experience

Exclusion Criteria:

* those with other than a spousal relationship to the person with dementia
* spousal caregivers of persons with another terminal disease
* those bereaved less than 3 months
* those unable to provide consent
Core Stability, Trunk Position Sense, Balance and Functional Mobility in Patients With Multiple Sclerosis

The aim of this study is to compare balance, functional mobility, core stability and trunk position sense in patients with Multiple Sclerosis (PwMS) and healthy controls and investigate the relationship between core stability and trunk position sense with balance and functional mobility in PwMS.

Balance and mobility disorders are seen in various degrees in patients with Multiple Sclerosis (PwMS). Balance and mobility impairments are observed in the beginning with the early period and are one of the most common causes of disability in PwMS.

Coordination between the peripheral sensory system, the central sensory-motor system and the musculoskeletal system which generates motor responses is required to provide balance. If one or more of these systems do not function properly, this results in deficiency in trunk stability and also causes balance and mobility disorders.

It has been shown that balance and mobility disorders are mostly associated with loss of strength, spasticity, coordination disorders and sensory loss. Especially, it is known that strength of core are related to balance and mobility. Although core muscle strength is a significant element of trunk stability, position sense is also responsible for trunk stability. When literature is examined, there is no study which examines the relationship between balance and mobility with core muscles' strength and trunk position sense in PwMS. For all these reasons, we think that balance and functional mobility may be related to core stability and trunk position sense in PwMS

Our study was carried out with the purpose of comparing balance, functional mobility, core stability and trunk position sense in PwMS and healthy controls and investigating the relationship between core stability and trunk position sense with balance and functional mobility in PwMS.

45 PwMS and 29 healthy volunteers with matching ages and genders were included the study. Balance was assessed by Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York). Timed Up and Go (TUG) tests were used to evaluate functional mobility. Core endurance and core strength, which are two specific components of core stability, were evaluated separately. Trunk flexor, trunk extensor, right and left side bridge and prone bridge tests were applied to assess the endurance of the core muscles. The power of core muscles was evaluated with sit-ups and modified push-ups tests. Trunk position sense was evaluated by the trunk reposition test with Dualer IQ digital inclinometer (J-TECH medical, Salt Lake City, UK, USA).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Multiple Sclerosis Disease
* Must be able to walk independently
* The level of disability should be between 0.5-4 according to EDSS

Exclusion Criteria:

* Having acute attack (three months prior to the study)
* Having vision and circulatory system problems,
* Orthopedic problems and pain in the spine, hip, knee or ankle
* Mini-Mental State Examination Test score of less than 25 points
Clinical Observation of Warm Needling Combined With and Electroacupuncture Therapy on Ovulatory Dysfunction

To observe the effect of warm needling combined with electroacupuncture on the ovulation promotion rate and pregnancy rate in luteinized unruptured follicle syndrome (LUFS).


Eligibility Criteria:
Inclusion Criteria:

* Infertility diagnosis criteria refer to the "Obstetrics and Gynecology" \[10\]: Infertility refers to the patient fails to conceive a pregnancy with normal sexual life and without contraception for 1 year. In primary infertility, pregnancy has never occurred. In secondary infertility, patients have previously conceived, but are unable to conceive again without contraception for 1 year.
* The standard for ovulation infertility is formulated according to the first series of Guiding Principles for Clinical Research of New Chinese Medicine: Basal body temperature was continuously recorded for single phase for more than 3 months; Vaginal detached cell smear examination showed no significant periodic changes; Cervical mucus crystallization examination showed no periodic changes, and ellipsoid; There was no typical secretory period change in endometrial examination on 6 days before menstruation; a series of B-ultrasound monitoring showed no ovulation signs; Blood and urinary progesterone levels were lower than those in the luteal phase. Patients who met two of the above 6 items could be diagnosed with anovulation

Exclusion Criteria:

* Those who have any serious adverse reactions during the treatment process and cannot continue the treatment
* Failing to follow the treatment plan and receiving other treatment
* Patients who quit the treatment process by themselves, or who have an incomplete course of treatment, will have a negative effect on the curative effect
The Effects of IMT on Physical Activity and Quality of Life in LTx Candidates

Inspiratory Muscle Training (IMT), which is used to strengthen the respiratory muscles, is one of the techniques used in PR. It is mostly used in patients with chronic obstructive pulmonary disease, and has been shown to be beneficial for functionality and also for relieving dyspnea perception. It is reported in the guidelines that IMT has additional benefit for endurance in COPD patients. However, there are no studies related to its use and effectiveness in lung transplantation. In this study, investigators hoped to increase these known benefits by adding IMT to the standard Pulmonary Rehabilitation.

There are two main objectives of this study:

* to examine the effect of inspiratory muscle training on physical activity status and quality of life in lung transplantation candidates,
* to compare physical activity and quality of life changes between the IMT+PR group and the PR group

The patients in the lung transplantation waiting list were included the study. These patients were with severe lung disease requiring transplantation, and that the intervention was undertaken before any lung transplantation. The patients were eligible for inclusion if participitants have: a diagnosis of terminally severe lung disease, being listed for lung transplantation, medically stable, had no orthopedic or cardiac problems that would prevent them from exercising and had no transfer problem to the PR centre.

Participants who meet the study inclusion criteria and complete the baseline assessments were randomly allocated into one of the two groups: namely Pulmonary Rehabilitation plus Inspiratory Muscle Training Group (IMT+PR) or Pulmonary Rehabilitation Group (PR) using a numbered series of 34 prefilled envelops specifying group assignment generated by a computer-based program.

All patients underwent supervised PR program on 2 days per week for 3 months. Apart from that, participitant were asked to perform the home exercise program which was scheduled as 3 days per week and fill out the exercise follow-up form. The study group was provided with IMT in addition to the standard program.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of terminally severe lung disease,
* being listed for lung transplantation,
* medically stable,
* had no orthopedic or cardiac problems that would prevent them from exercising
* had no transfer problem to the PR centre.

Exclusion Criteria:

* Malignancy in the last 2 years,
* Other advanced major organ / system dysfunction that can not be treated outside the lung,
* Untreated non-pulmonary infection,
* Disputed medical treatment discontinuity,
* Untreatable psychiatric illness or psychosocial condition that interferes with treatment compliance,
* No appropriate, reliable social support,
Physiologic Approach to Sodium Supplementation in Premature Infants

Postnatal growth failure occurs in up to 50% of very low birth weight (VLBW, \<1500 grams at birth) infants as assessed by discharge weight. This study will evaluate if a sodium supplementation algorithm guided by spot urine sodium measurements can improve postnatal growth.

Postnatal growth failure is a significant morbidity in very low birth weight (VLBW, \<1500 grams at birth) infants. Efforts to promote growth and optimize nutritional support have included earlier initiation of parenteral nutrition and increased caloric and protein administration. While these advances in nutritional practices have resulted in improved growth, up to 50% of VLBW infants continue to experience postnatal growth failure (defined as discharge weight \<10th percentile by Fenton growth charts) and over 25% experience severe postnatal growth failure (\<3rd percentile). Current nutritional recommendations for sodium provision to preterm infants is 3-5 mEq/kg/d and fails to take into account the degree of renal immaturity present in extremely preterm infants. The investigators hypothesize that the sodium supplementation algorithm will improve in-hospital somatic growth (weight, length, and head circumference) between 2 weeks of postnatal age and 36 weeks postmenstrual age over current sodium replacement practices. The algorithm will be evaluated in a prospective, pragmatic, randomized trial. Infants in the sodium supplementation algorithm group will have a spot urine sodium concentration determined every two weeks beginning on the 14th postnatal day and continuing until 36 weeks postmenstrual age with sodium supplementation provided according to the algorithm.

Eligibility Criteria:
Inclusion Criteria:

1. Infants with gestational age 25 0/7 - 29 6/7 at birth
2. Birth weight ≥ 500 grams
3. Admitted within the 1st week of life
4. \< 17 days of age at time of enrollment

Exclusion Criteria:

1. Infants admitted after the 1st week of life
2. Major congenital anomalies
3. Structural genitourinary abnormality
4. Renal dysfunction (serum creatinine \> 1.0 mg/dl or an increase of ≥ 0.3 mg/dl between the 2 most recent consecutive measurements) immediately prior to the initiation of study procedures.
5. Diuretic use less than 48 hours prior to initiation of study procedures
6. Infant with an ostomy (infants receiving an ostomy after study entry will be withdrawn)
7. Infant with a diagnosis or suspicion of diabetes insipidus
Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199

The purpose of this study is to investigate the pharmacodynamics of single doses of AZD3199 in asthmatic patients.


Eligibility Criteria:
Inclusion Criteria:

* Asthmatic patients with pre-bronchodilatory FEV1 above 60% of predicted normal and above 1.5 liters.
* Men and post-menopausal women above 18 years of age.
* Reversible airway obstruction in response to classical beta2-agonist (salbutamol)
* Non/ex-smokers

Exclusion Criteria:

* Any clinically significant disease or disorder other than asthma
* Any clinically relevant abnormal findings at screening examinations
* Treatment with systemic glucocorticosteroids within the past 30 days
* Inhaled corticosteroid use if dosing is not kept constant
Study of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria

Based upon the preclinical evidence in models of diabetic nephropathy under conditions approximating both type I and II diabetes, treatment with alagebrium appears to have favorable and advantageous effects on the biochemical, structural, pathological and functional hallmarks of diabetic nephropathy. The renoprotective effects of alagebrium in preclinical models favor the evaluation of this drug in patients with type I diabetes.

This study is a double-blind, randomized, placebo-controlled, parallel design trial enrolling 80 patients (2x40) with Type 1 diabetes and microalbuminuria. Patients will be randomized to either 200 mg Alagebrium twice daily or placebo for a period of 24 weeks after an 8 week run-in period. There will be a 8 week run-out period. All patients will receive ramipril during the entire study period. Efficacy measurements will be performed at baseline, at 12 weeks and at the end of the study. Measurements for albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers and 24 hour blood pressure measurements will also be determined. A total of 9 visits will be performed during the entire study.

Eligibility Criteria:
Inclusion Criteria:

* Insulin-dependent type 1 diabetes
* Age 18-65 years
* Diagnosis of established microalbuminuria
* Blood pressure \<140 mm Hg, diastolic blood pressure \<90 mm Hg
* HbA1c \<10%

Exclusion Criteria:

* Body mass index \>40 kg/m2
* Cardiovascular event within 6 months prior to screening
* History of acute myocardial infarction within 12 months prior to screening
* Serum creatinine \>1.5 mg/dL
* Receiving chronic nonsteroidal anti-inflammatory therapy
* Receiving antihypertensive therapy except for angiotensin converting enzyme inhibitors or angiotensin receptor blockers
* Any significant systemic illnesses,medical conditions or abnormal laboratory values
Feasibility Randomized Controlled Trial Using a 'Leapfrog' Design

This study is a small-scale randomized controlled trial (RCT) using a 'Leapfrog' design (Blackwell, Woud, Margraf, \& Schönbrodt, 2019) with the aim of investigating feasibility of this design in the context of an RCT of an internet-delivered intervention. The leapfrog design will be applied to a simple cognitive training intervention, imagery cognitive bias modification (imagery CBM), completed over a four-week training period. The trial will start with the three arms described in the initial registration, but these will be removed and new arms added over the course of the trial on the basis of sequential Bayesian analyses.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over
* Fluent German
* Willing and able to complete all study procedures (including having a suitable device/ internet access)
* Interested in monitoring their mood over the study time-period (one month)
* Score of ≥ 6 on the Quick Inventory of Depressive Symptomatology, including ≥ 1 on item 13 (General Interest), indicating at least mild levels of depression symptoms and anhedonia

Exclusion Criteria:

* No exclusion criteria set
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 2

The purpose of this research study is to examine the effect of various forms of exercise training on blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).

Study #2 is made up of five sessions done on five separate days and the entire study can be completed in as little as 14 weeks. All testing sessions will take place at the Exercise Physiology Research Laboratory. Volunteers will be asked to participate in one initial testing session (Visit 1) lasting \< 1 hour that will help make them more familiar with the study equipment and procedures, determine body measures (height, weight, body fat), determine the maximum strength of their forearm and calf, and require one blood draw. The following two testing sessions (Visits 2 and 3) with each session lasting between 2-3 hours that will involve multiple tests designed to determine the health of their blood vessels. For Visit #2 they will be randomly given either antioxidant pills or placebo pills to determine the effect of oxidants on blood vessel health. For Visit #3, they will be given whatever set of pills (antioxidant or placebo) that they did not receive during Visit #2. also include two additional testing days (Visits 5 and 6) that are identical to Visits #2 and #3, two visits to test endurance or strength prior to and after the exercise training (Visit 4 and 7), and ten weeks of exercise training (done 3-5 days per week). The exercise training will include one of three treadmill running programs that differ by exercise intensity and/or exercise frequency.

Eligibility Criteria:
Inclusion Criteria:

* apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease
* for PTSD group, a score of ≥ 33 on PCL-5 checklist
* for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist
* for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and \< 33 on the PCL-5 checklist

Exclusion Criteria:

* taking medications that could influence cardiovascular function
* current smokers who have recently quit smoking
* illicit drug use or excessive alcohol consumption
* pregnant women
* significant calorie restriction or vitamin/mineral deficiencies
* limited English proficiency
Cardiac Involvement in Patients with Duchenne/Becker Muscular Dystrophy

This study evaluates the function of the heart in young patients with muscular dystrophy type Duchenne or Becker. Participants have their hearts examined at regular intervals by ultrasound (echocardiography) and cardiac magnetic resonance imaging.

Muscular dystrophy leads to progressive loss of function in all muscles during childhood and adolescence, including the heart. The usual method to evaluate the heart is echocardiography, emphasizing few parameters. Cardiac magnetic resonance imaging is not as widely available as echocardiography, but early changes can be detected before they become visible on echocardiography. In this study, the investigators compare the methods of measuring heart function in order to find the best measurements for follow up and to see how fast the degenerative changes occur in the hearts of patients with muscular dystrophy.

Eligibility Criteria:
Inclusion Criteria:

* Boys aged 8 to 18 years with DMD/BMD confirmed genetically or by muscle biopsy
* Informed consent

Exclusion Criteria:

* Other clinically significant concomitant disease states (e.g., renal failure)
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant or his/her parents or legal caregivers,
* Inability to lie still for the duration of the imaging procedures (approximately 45 minutes each for echocardiography and CMR)
* MR-incompatible implanted or accidentally incorporated metal device or claustrophobia that prohibits use of magnetic resonance imaging