cyrilzakka/clinical-trials huggingface dataset:
Mirror Therapy in Pos Stroke Individuals

To evaluate the benefits of Mirror Therapy (MT) and motivation in patients with different levels of post-stroke motor impairment with two different therapy protocols. This is a randomized uncontrolled blinded study, with 27 individuals in the chronic phase of stroke. Participants were randomized into two intervention groups: MT group with motor patterns of movement (MP, n=13) and MT group with specific functional activities (SA, n=14). Motor impairment assessments (Fugl-Meyer Assessment - FMA), motivation (Intrinsic Motivation Inventory) and functionality (Functional Independence Measure - FIM) were performed before and after treatment, and 3 months after the end of sessions (follow-up). In each intervention group,there were patients classified with mild, moderate or severe motor impairment, according to FMA. All participants performed 15 MT sessions, 3 times a week for 50 minutes each session.

Objective: To evaluate the benefits of Mirror Therapy (MT) and motivation in patients with different levels of post-stroke motor impairment with two different therapy protocols. Methods: This is a randomized uncontrolled blinded study, with 27 individuals in the chronic phase of stroke. Participants were randomized into two intervention groups: MT group with motor patterns of movement (MP, n=13) and MT group with specific functional activities (SA, n=14). Motor impairment assessments (Fugl-Meyer Assessment - FMA), motivation (IntrinsicMotivationInventory) and functionality (Functional Independence Measure - FIM) were performed before and after treatment, and 3 months after the end of sessions (follow-up). In each intervention group,there were patients classified with mild, moderate or severe motor impairment, according to FMA. All participants performed 15 MT sessions, 3 times a week for 50 minutes each session.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were age over 18 years, clinical diagnosis of chronic and unilateral stroke (greater than six months after injury), hemiparesis sequel in the upper limb, absence of severe cognitive impairment with scores for the Mini Mental State Examination (MMSE) greater than or equal to 24 points for the educated and 14 for uneducated 17 and good sitting balance, qualified with scores between 20 and 40 on the Berg Balance Scale (BBS)

Exclusion Criteria:

* Those with other neurological diseases and associated physical or mental disabilities, stroke trauma, pain and joint contractures in the upper limb that prevented movement and the ones who missed therapy more than 3 times in a row were excluded
Study of Natural Killer Cells in Bone Marrow and Blood Samples From Patients With and Without Hematologic Cancer

RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors find better ways to treat the cancer.

PURPOSE: This research study is looking at natural killer cells in bone marrow and blood samples from patients with hematologic cancer and from patients who do not have cancer.

OBJECTIVES:

* To collect normal and malignant cells in bone marrow and peripheral blood samples from patients with acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or multiple myeloma and from patients with no malignancy to use as target cells in cytotoxicity assays.
* To collect information about HLA type and immunophenotype of malignant cells as determined by clinical flow cytometry.

OUTLINE: Bone marrow aspirates and/or peripheral blood samples are collected and used as target cells in standard cytotoxicity assays, with notch-induced natural killer (N-NK) cells as the effector cells, to determine whether N-NK cells are capable of killing malignant cells and/or non-malignant cells. Receptor-blocking antibodies may be added to determine which NK cell receptors are responsible for malignant cell recognition and killing.

Information about HLA type and immunophenotype of the malignant cells is collected from the patient's medical record.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets one of the following criteria:

  * No evidence of malignancy
  * Diagnosis of one of the following:

    * Acute myeloid leukemia
    * Acute lymphoblastic leukemia
    * Chronic myelogenous leukemia
    * Multiple myeloma

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Debio 1143 in Combination With Carboplatin and Paclitaxel in Patient With Advanced Solid Malignancies

This is a two-part trial in patients with squamous non-small cell lung cancer (NSCLC), platinum (Pt)-refractory ovarian cancer, and basal-like/claudin low triple negative breast cancer (TNBC).

The primary objective of Part A is to determine the maximum tolerated dose (MTD) of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.

The primary objective of Part B is to consolidate the safety profile of the recommended dose of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.


Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception
* Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff;
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); or
  3. the analysis of results
Self-Management Training With Online Intervention Process for Young Adults With Chronic Conditions

The study was conducted from 15th April 2021 to 15th August 2021. It employed a pretest-posttest design with control and training groups. In this study, a pretest-posttest design including control and training groups was used. Pre-assessments were taken from young adults who reported that they wanted to participate in the study via social media accounts and e-mail and who met the study criteria, and two groups were formed by the simple randomization method. The study group received 8 weeks of self-management training. The control group was informed about self-management for 1 week. Final evaluations were conducted for both groups after eight weeks.

Pre-assessments were taken from young adults who reported that they wanted to participate in the study via social media accounts and e-mail and who met the study criteria, and two groups were formed by simple randomization method. The study group received 8 weeks of self-management training. The control group was informed about self-management for 1 week. Final evaluations were conducted for both groups after eight weeks.

Eligibility Criteria:
Inclusion Criteria:

* having no communication barriers
* having a chronic disease such as asthma, diabetes, heart disease, or hypertension

Exclusion Criteria:

* being under 35 years old
* undergoing concurrent psychological treatment/therapy
* having Covid-19
* requiring treatment for other diseases during the training process
A 24-Week Efficacy, Safety and Tolerability of Rivastigmine Patch Study in Patients With Probable Alzheimer's Disease

The purpose of this study is to assess the efficacy, safety, and tolerability of Exelon® patch in patients with probable AD (MMSE 10-20), in order to support a planned regulatory submission and registration of Exelon transdermal patch in China. The study is designed to confirm the non-inferiority of the efficacy of Exelon patch (target 10 cm² patch size) versus Exelon capsules (target 6.0 mg bid dose) on cognition, using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).


Eligibility Criteria:
Inclusion criteria:

* have a diagnosis of dementia of the Alzheimer's type according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria;
* have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria.
* have a brain scan (magnetic resonance imaging (MRI) or computed tomography (CT)) consistent with the diagnosis of AD. The brain scan must have been performed within one year prior to randomization;
* have an MMSE score of ≥ 10 and ≤ 20;
* have sufficient education to have been able to read, write, and communicate effectively during the premorbid state;
* be residing with someone in the community throughout the study or, if living alone, in contact with the primary caregiver everyday;

Exclusion criteria:

* have an advanced, severe, progressive, or unstable infectious, metabolic, immune, endocrinologic, hepatic, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological condition that may interfere with efficacy and safety assessments or put the patient at special risk;
* have a history or current diagnosis of any medical or neurological condition other than AD that is identified as contributing cause of the patient's dementia;
* have a current diagnosis of probable or possible vascular dementia according to the National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences criteria (NINDS-AIREN);
* have a score of \> 4 on the Modified Hachinski Ischemic Scale (MHIS);
* have a current DSM-IV diagnosis of major depression, unless, in the opinion of the investigator, is in remission for at least 12 weeks;

Other protocol-defined inclusion/exclusion criteria may apply
Anlotinib for Hepatocellular Carcinoma

The purpose of this study is to observe and explore the effect of single or combined treatment of arotinib on the survival and prognosis of patients with advanced liver cancer in the real world, and to summarize the treatment experience of a wide range of people.


Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥ 18 years old, male or female;
2. Patients with advanced liver cancer were diagnosed;
3. Patients assessed by doctors to benefit from single or combined treatment of arotinib;
4. Patients volunteered to join the project.

Exclusion Criteria:

None
Kalifilcon A Toric Compared to Commercially Available Lenses

Approximately thirty contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study.

Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study in the opinion of the Investigator.
2. Considered by the Investigator to not be a suitable candidate for participation
Effect of a Vegan Mediterranean Diet on Cardiometabolic Biomarkers, Functional Capacity, and Quality of Life in Patients with Fibromyalgia

This study aims to evaluate the effect of a vegan Mediterranean diet compared to a traditional Mediterranean diet on inflammatory biomarkers, functional capacity, and quality of life in patients with fibromyalgia.

The study involves two visits to the Exercise Physiology Research Laboratory at UFV. During the first visit, participants will complete functional capacity tests, respond to questionnaires (Fibromyalgia Impact Questionnaire, Short Form-36, MDF-Fibro-17, and Tampa Scale for Kinesiophobia), and provide a blood sample from the antecubital vein collected by an auxiliary nurse from the Eurofins MEGALABS laboratory. The biochemical markers to be analyzed include: white blood cell count (neutrophils, lymphocytes, monocytes, and platelets), lipid profile, fasting blood glucose levels and acute-phase proteins (C-reactive protein). Additionally, body composition will be assessed using a Tanita TBF300, and waist circumference will be measured. Functional capacity tests will include a handgrip strength test, a 30-second chair-to-stand test, and a timed up-and-go test. Participants will undergo a six-week dietary intervention and will return for a second visit at the end of the intervention period. They will be randomly assigned to follow either a vegan Mediterranean diet or a traditional Mediterranean diet, both of which will be guided and supervised by registered dietitians. These diets will be designed to meet individual energy needs and key nutrient requirements, following the standards set by the National Academy of Medicine and the Academy of Nutrition and Dietetics. Both diets will be isocaloric and maintain an identical macronutrient distribution. After the intervention, participants will repeat the same functional tests, questionnaires, and capillary blood measurements.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 18 and 50 years.
* Participants with a Fibromyalgia diagnosis according to the American College of Rheumatology (ACR) criteria.
* Functional independence.
* Non-smokers.
* Low alcohol consumption (\<1 serving/day).
* Pharmacological treatment stabilized for at least 4 weeks prior to the start of the study.

Exclusion Criteria:

* Pregnant, lactating, or menopausal women.
* Physical condition that prevents the performance of functional capacity tests.
* Change in pharmacological therapy during the intervention period.
* Concomitant inflammatory conditions.
Evaluation of the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (the RAINIER Study)

The objective of this study is to evaluate the safety and effectiveness of OC-02 nasal spray compared to placebo on signs and symptoms of dry eye disease (DED).

This was a Phase 2, multicenter, randomized, double-masked, placebo-controlled study designed to evaluate the safety and efficacy of OC-02 Nasal Spray in adult subjects with dry eye disease. Approximately 45 subjects, at least 22 years of age, with a history of dry eye disease and meeting all other study eligibility criteria were planned to be randomized to receive an application of OC-02 or placebo twice daily (BID) for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 60 days prior to Visit 1

Exclusion Criteria:

* Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery (e.g. laser epithelial keratomileusis, laser-assisted in-situ keratomileusis, photorefractive keratectomy or corneal implant) within twelve months of Visit 1
* Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with dry eye disease are allowed.
* Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
* Have a known hypersensitivity to any of the procedural agents or study drug components
* Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)

To study the effects of two combination therapies for patients with obstructive sleep apnea (OSA) who have been both intolerant to Positive Airway Pressure (PAP) therapy and sub-therapeutic to oral appliance therapy.

Hypothesis

1. There is a difference between Continuous Positive Airway Pressure (CPAP) vs CPAP/Oral Appliance (OA) connect vs CPAP/OA disconnected in terms of:

1. Apnea Hypopnea Index (AHI) reduction
2. Amount of side effects
3. Amount of Leaks
4. Hours of use (compliance)
5. CPAP pressure

2. There is a difference between connected and disconnected for the following symptoms:

1. Epworth sleepiness Scale (ESS)
2. Functional Outcomes of Sleep Questionnaire (FOSQ)
3. Side effects Study Design - randomized prospective parallel


Eligibility Criteria:
Inclusion Criteria: Baseline diagnosis AHI \> or = 5 plus ESS . or = 10.

* PAP Intolerance
* Partial Response to oral appliance therapy: AHI \> 5
* Age: \> 18 Exclusion Criteria: History of daily use of alcohol, narcotics or Central Nervous System (CNS) depressants.
* Diagnosis of Central Sleep Apnea
* Pregnancy
* Edentulous
* Prisoners
HaemoDYNAMICs in Primary and Secondary Hypertension

The primary aim of the present study was to examine the haemodynamic changes in primary hypertension and secondary hypertension (renal diseases, endocrine diseases, obesity-associated hypertension) with a non-invasive haemodynamic measurement protocol utilizing radial pulse wave analysis and whole-body impedance cardiography in both supine position and during head-up tilt. For comparison, haemodynamics of subjects with chronic fatigue syndrome will also be recorded.

Elevated blood pressure (BP) and related cardiovascular complications are the leading causes of morbidity and mortality in the modern world. In routine clinical practice, the haemodynamic status is commonly assessed by measuring heart rate and blood pressure at rest, which provides only limited information about functional haemodynamic status. In addition, the haemodynamic changes resulting in similar elevations of BP may differ substantially between patients and disorders.

Therefore, we investigated the haemodynamic changes in primary and secondary hypertension and in the control subjects with non-invasive radial pulse wave analysis and whole-body impedance cardiography. The method includes the determination of volume status using bioimpedance spectroscopy, determination of peripheral and central BP, cardiac function, vascular resistance, arterial compliance and indices of pulse wave reflection. Besides the measurements performed in the supine position, passive orthostatic challenge is included in the protocol to assess the upright functional haemodynamic status.

The repeatability and reproducibility of the protocol was first examined with a double-blind, randomized protocol in 35 subjects (methodological study group), and after that the administration of research drugs has been open-label. The effects of single doses of two largely endothelium-dependent agents, inhaled salbutamol and intravenous L-arginine, and one endothelium-independent agent, sublingual nitroglycerin, were investigated. However, challenges with the acute dosing of all medical compounds was terminated at the end of December 2016. Thereafter, the measurement protocol has included supine and upright recordings on the tilt-table, followed by supine measurements during paced breathing (15 breaths per minute for 5 minutes, 6 breaths per minute for 5 minutes) that modulate the autonomic nervous tone.

The study population has consisted of subgroups described below. The study protocol of each subgroup has been approved by the ethics committee of the Pirkanmaa Hospital District (Ethics committee ID's above), and the administration of research drugs has also been approved by the Finnish Agency for Medicines (EudraCT-numbers above).

Eligibility Criteria:
Inclusion Criteria:

* Independent, community-dwelling adults
* Hypertensive subjects (primary or secondary hypertension)
* Normotensive control subjects
* Subjects with aortic stenosis (subgroup "aortic stenosis")
* Participants of Ironman Triathlon competition

Exclusion Criteria:

* Pregnancy
* Systolic blood pressure \<90 mmHg
* Allergies to test compounds
Mechanics of Knee Bracing

The overall objective of this project is to determine whether the provision of a pneumatic knee brace in patients with medial knee osteoarthritis (OA) improves knee mechanics. Secondary objectives will be to assess if the brace relieves knee pain and improves function. We will test the hypothesis that compared to the control treatment (see below for the definition) the use of a pneumatic knee brace is effective in medial knee OA.

This study is closed to enrollment and in the data analysis phase

Eligibility Criteria:
Inclusion Criteria:

* knee pain, aching or stiffness on most of the past 30 days
* x-ray verified predominant medial tibiofemoral osteoarthritis (TFOA)
* overall pain that is due to the medial TFOA (versus being referred from the back, hips, or other pre-existing conditions)
* ambulatory persons

Exclusion Criteria:

* use of a crutch, walker, or wheelchair or cane more than 50% of the time
* history of Deep Vein Thrombosis
* Pain emanating more from back or hip than from knee
* Low pain score on WOMAC
* predominant patellofemoral disease or knee pathology other than medial compartment OA likely to be causing their knee pain.
* Planning to move from area within 1 month of study screening.
* Unable to fit the brace properly
* BMI greater than 35
* corticosteriod injections in the past month
* Bilateral total knee replacements or plan for TKR
* Other types of arthritis including Rheumatoid Arthritis, Systemic Lupus Erythematosus, gout, psoriatic arthritis, pseudogout.
* woman who are pregnant (due to x-rays taken to determine eligibility)