cyrilzakka/clinical-trials huggingface dataset:
Effects of Nordic Walking in Parkinson Disease Patients

The aim of this study was to evaluate and compare the effects of a Nordic and free walking training program on clinical, functional and biomechanical parameters of gait, in people with PD.

Outcomes: Motor symptoms: Staging and severity of PD, balance, walking functional mobility, self-selected walking velocity, and rehabilitation index. Non-Motor symptoms: Cognitive function, depressive symptoms, and quality of life (QL). Outcomes Biomechanics: Kinematic parameters (spatiotemporal and dynamic stability of walking) and neuromuscular parameters (amplitude of the electromyography signal, initial and final activation threshold, activation time and co-contraction index, of the following muscles: Vastus Lateralis (VL), Biceps Femoris (BF), Tibialis Anterior (TA), Gastrocnemius Medialis (GM).

Introduction: Changes in clinical, functional and biomechanical parameters of gait are remarkable features in Parkinson's disease (PD). Such changes are disabling for the performance of daily living activities (DLAs) as they represent a high risk of falls and impair quality of life (QL) in this population. Although exercise is recommended as an effective model of therapeutic intervention, to minimize the symptoms of this disease, little is known about the effects of Nordic walking on motor and non-motor symptoms in patients with PD. Purpose: The aim of this study was to evaluate and compare the effects of a Nordic and free walking training program on clinical, functional and biomechanical parameters of gait, in people with PD. Experimental Design: Randomized controlled clinical trial (RCT). Study Site: Physical Education School of the Federal University of Rio Grande do Sul and the Clinical Hospital of Porto Alegre, in Porto Alegre, Rio Grande do Sul, Brazil. Methods: The sample comprised 33 participants, aged above 50 years, of both sexes, with a clinical diagnosis of idiopathic PD, with the staging of 1-4 in the Hoehn and Yahr scale (H\&Y). The participants received two types of intervention: Nordic walking training program (NW, n = 16) and free walking training program (FW, n = 17), during six weeks. Aiming to evaluate the effects of the training program, the participants underwent the tests in the following period: pre-training + pre-familiarization (T1); post-familiarization + pre-training (T2); post-training (T3).

Eligibility Criteria:
Inclusion Criteria: volunteers aged over 50 years, of both sexes, with a clinical diagnosis of idiopathic PD and staging between 1 and 4 in Hoehn and Yahr Scale (H\&Y).

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Exclusion Criteria:

* Show chronic pain or presence of a migraine or nausea in daily life;
* History of labyrinthitis;
* Deep Brain Stimulation (DBS);
* The frequency of training below of 75%.
French Validation of the Memorial Anxiety Scale for Patients With Prostate Cancer.

A specific scale allowing the measure of anxiety of patients with protate cancer has been designed and validated but the French version needs to be validated. This study aims at validating the French translation of this scale.

The psychological difficulties encountered by patients with prostate cancer are widely known. There are, however, problems in the identification of certain disorders that require appropriate psychological management. In order to diagnose patients with anxiety more finely, a prostate cancer-specific anxiety measurement scale (MAX-PC) was developed and validated. This scale includes three sub-dimensions: anxiety related to prostate cancer, anxiety related to the PSA assessment and fear of recurrence. This scale generally has good psychometric properties which are found in different populations and in different countries. The dimensions of the MAX-PC correlate with other anxiety measurement scales such as Beck or HADS, but do not show redundancy: it captures a specific anxiety related to the experience of patients with prostate cancer.

To date, this sclae is not validated in French, and its use in the frame of clinical trials or in routine practice require a first validation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with prostate cancer diagnosed within 12 months

Exclusion Criteria:

N/A
IVB for Post-vitrectomy Hemorrhage in Diabetic Eyes

Recurrent vitreous hemorrhage following pars plana vitrectomy (PPV) for proliferative diabetic retinopathy remains a significant complication with reported incidence ranging from 11 to 75%. Early and late recurrences are associated with various factors, including residual blood, fibrovascular tissue, and neovascularization. Despite attempts to reduce this complication with therapies like anti-fibrinolytic agents, gas tamponade, and peripheral cryotherapy, the outcomes remain unsatisfactory.

Recurrent vitreous hemorrhage following pars plana vitrectomy (PPV) for proliferative diabetic retinopathy remains a significant challenge with high incidence and negative impact on visual outcomes. Despite various treatments, intravitreal bevacizumab (IVB) has shown potential in reducing post-operative vitreous hemorrhage (PO-VH). This study aims to determine the efficacy and safety of intraoperative IVB in preventing PO-VH in patients undergoing vitrectomy for diabetic vitreous hemorrhage. This prospective, randomized controlled trial compared patients receiving intraoperative IVB to a control group. The primary outcome was PO-VH incidence at one month, with secondary outcomes including visual acuity change, time to VH clearance, and safety. Outcome assessors were masked to the study treatment. Data on demographics, medical history, visual acuity, VH grading, intraoperative findings, and postoperative complications will be collected. Statistical analysis compared PO-VH incidence and other outcomes between groups. This study will provide valuable evidence on the efficacy and safety of intraoperative IVB in preventing PO-VH, contributing to improved clinical practice and patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with spontaneous, non-clearing vitreous hemorrhage for at least one month as the initial vitrectomy indication for diabetic retinopathy.

Exclusion Criteria:

* Patients with tractional retinal detachment (ART)
* Patients with severe fibrovascular traction,
* Patients with intravitreal gas or silicone oil tamponade at the end of surgery
* Patients with other eye diseases besides diabetic vitreous hemorrhage
* Patients with history of intravitreal bevacizumab injection in the last 3 months before surgery
* Patients with other health condition includes uncontrolled hypertension, a history of coagulopathy
* Patients with inability to attend follow-up examinations for at least 1 month
* Patients taking anti-aggregation and anti-platelet medications with abnormal bleeding time (BT) and clotting time (CT)
XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)

This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human (FIH) study to evaluate the safety, tolerability, food effect (FE), pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered XW014 in healthy participants and patients with T2DM. This study will consist of 4 parts: a Single Ascending Dose (SAD) part in healthy subjects (Part A), and Multiple Ascending Dose (MAD) parts in healthy subjects with elevated BMI (Part B and Part B-EXT) and patients with T2DM \[Optional\] (Part C).

Part A - SAD, including FE cohort: Healthy participants with BMI in the range of ≥18.5 kg/m2 to ≤35.0 kg/m2 will be randomized to receive a single oral dose of either XW014 or placebo in each of the planned SAD cohorts.

Part B and Part B-EXT - MAD in healthy participants with elevated BMI: Healthy subjects with BMI in the range of ≥30 kg/m2 to ≤40.0 kg/m2 will be randomized to receive oral doses of XW014 or placebo in each of the planned MAD cohorts.

Part C - MAD in patients with T2DM: Patients with T2DM for at least 6 months, having hemoglobin A1c (HbA1c) in the range of 6.5% to 8.5% will be randomized to receive oral doses of XW014 or placebo in each of the planned MAD cohorts.

Eligibility Criteria:
Inclusion Criteria:

1. Ability and willingness to participate in the study, give written informed consent, and comply with the study restrictions and all protocol procedures
2. Sex: male or female
3. Weight: \>50 kg, inclusive, at screening
4. Age:

   1. For Part A 18 to 70 years, inclusive, at screening
   2. For Part B, Part B-EXT, and C 18 to 55 years, inclusive, at screening
5. Body Mass Index

   1. For Part A: ≥18.5 kg/m2 and ≤35.0 kg/m2, inclusive, at screening
   2. For Part B and Part B-EXT: ≥30.0 kg/m2 and ≤40.0 kg/m2, inclusive, at screening
   3. For Part C: ≥25.0 kg/m2 and ≤40.0 kg/m2, inclusive, at screening
6. Patients with T2DM for at least 6 months, having HbA1c of 6.5% to 8.5% (Part C)

Key Exclusion Criteria:

1. History or clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurologic, renal, pancreatic, immunologic, dermatologic, endocrine, genitourinary, or hematologic system
2. Uncontrolled hypertension
3. History of type 1 diabetes mellitus
4. History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis
5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 or subjects with suspected medullary thyroid carcinoma
6. Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of the investigational product
Effect of Strategy for Blood Pressure Control on Cerebral Oxygen Balance During Aortic Coarctation Repair: A Randomized Study

In a prospective and randomized study protocol, three different blood pressure regulating agents (nitroprusside, nitroglycerine, sevoflurane) will be compared concerning their effect on the cerebral oxygen balance between both hemispheres during aortic coarctation repair. Cerebral and somatic saturation will be monitored non-invasively and continuously via optical sensors applied to the right and left forehead and the somatic regions. Arterial blood pressure, central venous pressure, heart rate and systemic saturation will be recorded continuously. Intermittently, arterial and venous blood gas analysis will be performed at 6 definite time intervals. The study ends at the end of the operation.


Eligibility Criteria:
Inclusion Criteria:

* All neonates and infants
* Aged 0-18 year
* With aortic coarctation requiring surgical correction without the additional use of cardiopulmonary bypass will be included.

Exclusion Criteria:

* All patients with an associated cardiac effect are excluded.
Sleep Timing and Insulin Resistance in Adolescents With Obesity

This study examines the relationship between sleep timing and insulin resistance in adolescents with obesity. The investigators also aim to develop a physiologically-based mathematical model of adolescent sleep/wake and circadian interactions.


Eligibility Criteria:
Inclusion Criteria:

* High school students between the ages of 15-19
* BMI \> 90th percentile
* Tanner stage 2 or greater

Exclusion Criteria:

* Any medications that affect insulin resistance or sleep (e.g., metformin, hormonal contraception, stimulants, atypical antipsychotics)
* Regular use of melatonin or sleep aids
* A prior diagnosis of obstructive sleep apnea, diabetes (HbA1c \> 6.5), liver disease other than non-alcoholic fatty liver disease, pregnancy or breastfeeding
* IQ \< 70 or severe mental illness that may impact sleep (e.g., schizophrenia, psychotic episodes)
* Not enrolled in a traditional high school academic program (e.g., home school students)
* Night shift employment
* Travel across more than 2 time zones in the month prior to the study
Effect of Pimecrolimus Cream on Cathelicidin Levels in Subjects With Eczema

The purpose of this study is to determine the effect of topical pimecrolimus on the immune system by assessing the levels of antimicrobial peptides in the skin of patients with eczema. It is hypothesized that pimecrolimus applied topically will repair the body's immune system in patients with eczema by increasing antimicrobial peptides.

Patients with atopic dermatitis (AD) have higher rates of skin infections from viruses and bacteria. They also have an impaired innate immune system. Antimicrobial peptides are a component of the innate immune system which are decreased in atopics. In vitro, pimecrolimus has demonstrated its ability to increase antimicrobial peptides. This study will examine the ability of pimecrolimus to increase antimicrobial peptides in vivo in AD patients. Thus, the study will yield a better understanding of the role of pimecrolimus in regulating the immune system in atopics.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years
2. Target lesion IGA ≥2
3. Target IGA=0 (for non-lesional site)
4. Male or female of any race and ethnicity
5. Chronic AD for more than one year duration
6. Subject of child-bearing potential must be willing to practice effective birth control during the study
7. Subject agrees to comply with study requirements and attend all required visits.

Exclusion Criteria:

1. Patients ≥ 18 years of age with only AD of the face
2. Women of childbearing potential not using the contraception method(s) specified in this study (abstinence, IUD, diaphragm, oral contraceptives)
3. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
4. Hypersensitivity to pimecrolimus cream or any excipient of the cream
5. Subject has a skin disorder in addition to dermatitis in the areas to be treated
6. Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
7. Pregnant or nursing females
8. Immunocompromised patient (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome), or with a history of active or malignant disease (excluding non-melanoma skin cancer)
9. History of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
10. Patients known to be non-compliant with a medication regimen
11. Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits participation in the study (e.g., severe concurrent allergic disease, condition associated with malignancy, and condition associated with immunosuppression)
12. Active viral or fungal skin infections at the target areas
13. Previous participation in this study
14. Ongoing participation in another investigational trial
15. Use of any oral or topical antibiotic during the study and up to one week prior to entering the study
16. Use of any local therapy for AD less than one week prior to screening
17. Use of any systemic immunosuppressive therapy for AD less than four weeks prior to screening.
Evaluation of the Added Value of an Internet-based Educational Program for Patients With Atrial Fibrillation.

This study is prospective, open and randomized concerning the value of an Internet-based educational program for patients with atrial fibrillation compared to "care as usual".

In the present guidelines for treatment of atrial fibrillation education and information are underlined as important parts of the care. The investigators developed an Internet-based educational program in close collaboration with patients, specialists in the field, both physicians and nurses, and a phycologist, specialized in cognitive behavioral therapy.

The aim of the study is to evaluate this program in comparison to "care as usual" with reduction in symptom burden as primary endpoint, secondary endpoints being improvement in health-related quality of life and reduction in health-care costs.

Eligibility Criteria:
Inclusion Criteria:

Patients evaluated for electrical or pharmaceutical cardioversion or evaluated for treatment with antiarrhythmic drugs for paroxysmal or persistent atrial fibrillation.

Exclusion Criteria:

Age below 18, planned for cardiac surgery or catheter ablation, acute coronary syndrome during three months prior to randomisation. Insufficient knowledge of the Swedish language or other reasons making it impossible for the patient to independently fill out the questionnaires.
Neurodevelopmental Disorder Diagnosis During Adulthood

The prevalence of neurodevelopmental disorders (specific learning disorders: dyslexia, dysorthographia, dysgraphia and dyscalculia; communication disorders; developmental coordination disorders; attention deficit disorder with or without hyperactivity (ADHD); intellectual disability (ID) and autism spectrum disorders) in the general population is very high, representing over 15% of the paediatric population. Among this population, between 40% and 90% remain symptomatic into adulthood. In addition to the part of the population diagnosed in childhood and lost to the transition to adulthood, a significant part of this population remains unidentified and therefore untreated (up to 60%). It is in adulthood that the diagnosis of neurodevelopmental disorders must be identified as being at the origin of at least some of the cognitive dysfunctions observed: failure at school, difficulties in socio-professional integration... Thus, the lifelong care diagnostic pathway needs to be developed both from an organizational point of view and in terms of the scientific knowledge required to best organize a personalized health pathway for this population. The current challenge for this population is to offer a structured care pathway, from diagnosis to care and medico-social integration.

This project will provide comprehensive, homogeneous data for cohorts of patients requiring diagnostic advice and lifelong management of their disorders. Thesecomprehensive data will contribute to scientific publications on patient cohorts. At present, very few centers have complete, homogeneous data on late-diagnosis adults, so our project will have a scientific and academic impact in its own right.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 or over
* Men or women under 55 years of age
* Patients with a neurodevelopmental disorder according to the latest DSM5 criteria diagnosed after age 18
* Patient with sufficient visual and auditory skills, oral and written language in French accessible to clinical and neuropsychological evaluation.

Exclusion Criteria:

* Patients with intellectual disabilities
* Patients with serious addictive and/or psychiatric comorbidities
Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion

The overall goal of this clinical study is to characterize the fusion rate of geneX® ds bone graft substitute in comparison to autograft, which is considered the gold standard for posterolateral fusion. Assessments are made using AP and Lateral x-rays, F/E x-rays, and CT scans geneX® ds has been cleared by the FDA for use in these procedures; however this study will allow more detailed characterization of geneX® ds performance in the long-term (1 year). By using the patient as their own control, direct comparison to autograft can be performed while minimizing other variables.


Eligibility Criteria:
Inclusion Criteria:

* Men or women 18-75 years of age
* Have ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol
* Have a spinal condition of the lumbar spine (L1-S1) requiring instrumented posterolateral fusion at one or two levels

Exclusion Criteria:

* Patients undergoing instrumented fusion for trauma, tumor, psuedoarthrosis, or same- - level recurrent stenosis
* Patients where placing graft material on both sides (posterolateral gutters) is not possible, for example in the case of a complete facetectomy
* Patients requiring instrumented fusion in the cervical or thoracic spine
* Extraspinal cause of back pain such as trauma, infection, instrumentation failure, or neoplasm
* Severe degenerative bone disease
* Hypercalcemia
* Active local or systemic infection
* Morbid obesity defined as BMI \> 40
* Patients who are pregnant / able to become pregnant and not following a reliable contraceptive method
* Uncooperative patients who can't or won't follow post-operative instructions including individuals who abuse drugs or alcohol
* Anatomy or other factors that prohibit safe surgical access to the surgical site
* Allergy or sensitivity to any component of the treatment procedure
* Inadequate tissue coverage over the operative site
* Inadequate bone stock or bone quality
* Fever or leukocytosis
* Uncorrectable coagulopathy or hemorrhagic diathesis
* Uncontrolled diabetes
* Severe vascular disease or cardiopulmonary conditions that present prohibitive anesthesia risk
* Neuromuscular disease or disorder
* Mental illness
* Has an active workman's compensation lawsuit
Different Endurance Training Protocols in Cardiac Rehabilitation

It is the aim of the study to compare the effects of 6 weeks of either high-intensity interval training (HIT; carried out at correctly assessed 85-95% of maximal heart rate), pyramid, or continuous endurance training, on changes of physical exercise capacity in cardiac patients.

The three exercise arms (isocaloric) are composed as follows:

Endurance training (n=15): 31min at 65-75% HRmax; HIT (n=15): 4x4min intervals at 85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min; Pyramids (n=15): One Pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block at 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min.

All protocols are initiated by 5min of warm-up and end with 5min of cool-down, both at 60-70% HRpeak.

Primary Outcome: Individual maximum power output in watt (Pmax). Secondary Outcome: Change of power output in watt at lactate thresholds at 2 and 4 mmol/l.


Eligibility Criteria:
Inclusion Criteria:

At least one of the following diagnoses within the previous 3 months:

* acute coronary syndrome (STEMI)
* acute coronary syndrome (NSTEMI)
* aortocoronary bypass surgery
* PCI
* stable coronary heart disease

Exclusion Criteria:

* Unstable angina pectoris
* Heart failure (NYHA IV)
* Acute endomyocarditis or other acute infections
* Pulmonary artery embolism or phlebothrombosis within the previous 6 months
* Hemodynamically unstable arrhythmia
* Hypertrophic cardiomyopathy
* participation in another study within the previous 6 months
* Medical conditions which prevent patients from complying with the exercise program
Detection of Hemodynamic Changes in TBI Population With Functional Near Infrared Spectroscopy

The goal of this project is to develop a test to assess frontal lobe function using a rapid, inexpensive, objective, and standardized method, without the need for expertise in cognitive test administration. Such methods would be particularly helpful in traumatic brain injury (TBI), where objective measures are needed, and would greatly expand the capacity to make such assessments in clinical practice and research.


Eligibility Criteria:
Inclusion Criteria:

* Able to read, write, speak and understand English
* history of having sustained a TBI prior to enrollment. Evidence will be any one of the following 3 criteria:

  1. GCS 3 - 12
  2. Post-traumatic amnesia \> 24 hours
  3. TBI-related abnormality on neuroimaging (either CT or MRI). (Some missing information about the initial injury (i.e. documentation of initial GCS) is not necessarily exclusionary if the bulk of the available history is indicative that the patient suffered a TBI and meets the inclusion criteria)

Exclusion Criteria:

* Multiple sclerosis, pre- or co-existing
* Stroke (other than stroke at the time of TBI)
* Pre-existing developmental disorder
* Pre-existing epilepsy
* Pre-existing major depressive disorder
* Pre-existing schizophrenia