cyrilzakka/clinical-trials huggingface dataset:
Diaphragm's Manual Therapy in Patients With Chronic Neck Pain

The aim of this study is to evaluate the effect of diaphragm's manual therapy in addition to cervical spine manual therapy in terms of pain, cervical spine range of motion, trigger points pain pressure threshold, disability and quality of life in patient with chronic aspecific neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Neck pain since at least 3 months
* Age \> 18 years and \< 65 years
* Male or Female

Exclusion Criteria:

* Pregnancy
* Contraindications for manual therapy or inability to complete the treatment
* Patients who received a physiotherapy or osteopathic treatment during the last 3 months
* Medical diagnosis of rheumatologic disease
* Medical diagnosis of respiratory disease (COPD, asthma)
* Spine surgery
* Medical diagnosis of past or present cancer
* Thoracic or abdominal surgery in the last 3 years
* Whiplash injuries
* Previous cervical fracture
* Cervical anatomical changes
* Thrombotic events
* Body temperature greater than 37 degrees in the previous 48 hours
* Obesity (BMI greater than 30)
Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

This is a phase I/II multi-center open-label proof of concept study, consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant (KRASm) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the combination of dacomitinib and PD-0325901 versus standard of care therapy in patients with advanced KRASm NSCLC. It is hypothesized that with this combination strategy the progression free survival of patients with KRASm NSCLC will be doubled.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological proof of advanced non-small cell lung cancer
* Written documentation of KRAS (exon 2, 3 or 4) mutation
* At least 18 years of age or older
* Able and willing to give written informed consent
* WHO performance status of 0 or 1

Exclusion Criteria:

* Symptomatic or untreated leptomeningeal disease
* Symptomatic brain metastasis
* Impairment of gastrointestinal function
* Uncontrolled infectious disease
* Left ventricular ejection fraction \< 50%
* Retinal degenerative disease or with history of uveitis, retinal vein occlusion or retinal detachment

Other protocol-defined inclusion/exclusion criteria may apply
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to 10% hypersensitivity response was considered acceptable.


Eligibility Criteria:
Inclusion Criteria:

* Avoid disallowed meds throughout study

Exclusion Criteria:

* Known hypersensitivity to hyaluronidase and/or bee sting
* Atopic individuals assessed by med history
* Topical/systemic corticosteroids within 30 days
* Concurrent use of antihistamines or anti-inflammatory during study
* Active or chronic disease likely to affect immune function
* History of alcohol/drug abuse within 6 months
A Study to Evaluate the Safety of QCZ484 in Healthy and Mild Hypertensive Subjects

This is a randomized, double-blind, placebo-controlled study including Part A single ascending dose (SAD) in healthy subjects and Part B single dose in subjects with mild hypertension.

Phase 1, multicenter, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of QCZ484. In Part A, single ascending doses of QCZ484 are tested in healthy subjects, while in Part B, single doses of QCZ484 are tested in subjects with mild hypertension. One dose of QCZ484 is administered subcutaneously.

This study was started by Argo Biopharma, and global sponsorship was transferred to Novartis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females aged 18 to 60 years, inclusive, at the time of informed consent. (Part A only).
* Males or females aged 18 to 72 years, inclusive, at the time of informed consent (Part B only).
* Body mass index (BMI) \>= 18 and \<= 32 kg/m2 and body weight \>50 kg (Part A only).
* Body mass index (BMI) \>=18 and \<=35 kg/m2 and body weight \>50 kg (Part B only).
* Triplicate 12-lead electrocardiogram (ECG) after \>5 minutes resting without clinically significant findings at screening and Day -1.
* Mean sitting systolic blood pressure (SBP) of \>=130 and \<160 mm Hg (Part B only).

Exclusion Criteria:

* History of hypotension or orthostatic hypotension.
* History of syncope within 1 year.
* SBP \<90 mmHg or DBP \<60 mm Hg at screening (Part A only).
* Clinical laboratory findings outside of range are deemed clinically significant by the investigator at screening.
* Any liver function panel analyte value \> 1.2 ×upper limits of normal (ULN) at screening.
Compare Effects of the Mirror Therapy and Robotic Mirror Therapy in Electroencephalography of Healthy Adults and Stroke Patients.

Mirror therapy has recently attracted increasing attention; however, most patients have the difficulties to perform mirror therapy due to limited imaginary ability. A mirror robotic hand system was developed, which consisted with a wearable exoskeletal hand, sensor glove, and a control box. The patient's unaffected hand wears the sensor glove, the affected hand wears the wearable exoskeleton hand, and the unaffected hand does the certain transitive and intransitive tasks as the mirror group, and then makes the affected hand do the same movements driven by the exoskeleton robotic hand. The investigators hypothesize that combining both approaches might facilitate the sensorimotor cortex that controls movement and might augment somatosensory input and further treatment efficacy. This study is aimed at investigating the effects of Mirror therapy and robotic mirror therapy on motor cortical activations in healthy adults and stroke patients using electroencephalography. All participants will perform the conditions of resting, moving right hand with or without robotic hand as the baseline data, then they will do mirror therapy using the right hand as active hand, or wearing robotic hand doing mirror therapy in random sequence. Electroencephalography (EEG) assessment will be done to assess the neurophysiologic effects of the different interventions. The investigators will use a questionnaire to assess the subjective opinion about the different interventions.

combined with execution (video AOE). The investigators will use the pair-t test to assess the within subjects differences in EEG and the questionnaire results.

This study will be done during 2020/02/01 - 2021/03/31.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults: right handed, with normal upper extremity and cognition functions
* stroke patients:one side upper limb spasticity

Exclusion Criteria:

* 1. wrist weakness or deformity 2. skin problem 3. musculoskeletal injury of upper extremities
Investigation of the Learning Effect in the Measurement of Circulation in Calf Muscle Using MSOT

The goal of this observational study is to investigate the learning effect in the measurement of micro-circulation in healthy participants using MSOT. The main question it aims to answer are:

If there if a learning effect in MSOT measurement. How long does it takes for the trainees to reach the professional level. Is there a difference between different learning methods? Participants will have to lie on the examination bed while investigator making measurements 7 times in a row on one single location.

Learning effect of MSOT measurements have been observed by previous studies. Therefore, in this study, we aim to quantify the learning effect with circulation-related parameters (Hb, HbO2, SO2) and the similarity between repeated images (structural similarity index measure, SSIM). The measurement would be repeated by 5 different investigators, two of them are professionals, defined as experience over 200 times of MSOT measurement, while the other three are trainees, who haven't performed any MSOT measurements before and each has received one different teaching method, one receiving personal teaching from a professional, one receiving video instruction and one receiving instructions written in paper form.

Eligibility Criteria:
Inclusion Criteria:

-all those who with the age between 18 and 40 year-old

Exclusion Criteria:

* diabetes mellitus
* hypertension
* cardiovascular diseases
* chronic kidney diseases
* amputation in either lower extremities
* tatoos in either lower extremities
Effects of Myo-inositol in Women With Polycystic Ovary Syndrome

The study will be carried out at the hospital of the medical school of sao paulo (HC-FMUSP) and the goal is to compare the effects of the administration of myo-inositol in relation to the effects of metformin in women with Polycystic Ovary Syndrome and insulin resistance or glucose intolerance. Menstrual cycle, hyperandrogenism, chronic inflammatory process, carbohydrate metabolism, hepatic steatosis will be evaluated. In total, 60 women in the reproductive period, with a variable age between 18 and 36 years old will be recruited and randomized in two groups: intervention- myo-inositol for 6 months, control group will use metformin also for 6 months.

The study will involve 60 women in the reproductive period, with a variable between 19 and 36 years old and diagnosed with polycystic ovary syndrome (PCOS), according to Rotterdam- European Society of Human Reproduction and Embryology (ESHRE) / American Society for Reproductive Medicine (ASRM) criteria defined in 2003 and revised in 2018, and insulin resistance (presence acanthosis nigricans) or glucose intolerance (fasting glycemia, glycated hemoglobin or 75g glycemic overload and blood glucose assessment after 2 hours). It is a comparative and non-inferiority study of myo-inositol in relation to metformin. They will be divided into two groups of 30 patients: Group I (control) - they will receive metformin 850 mg, orally, twice a day; Group II (experiment) - they will receive myo-inositol 2g + folic acid 200mcg, orally, twice a day.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 19 to 36 with diagnosis of PCOS and insulin resistance or glucose intolerance.

Exclusion Criteria:

* Previous use of any hormonal treatment in the past three months;
* Other causes of anovulation;
* Gynecological or other associated conditions (endometriosis, adenomyosis or diabetes mellitus);
* FSH (Follicle Stimulating Hormone) \> 15 Ul / L (2nd to 5th day of the cycle);
* Beta-hcG (human chorionic gonadotropin) positive (pregnancy).
Clinical Trial on Alpha Lipoic Acid in Diabetic Macular Edema

To evaluate the effect of alpha lipoic acid (ALA) on the occurrence of diabetic macular edema.

Randomised, double-blind, placebo controlled multicentre study. Patients were randomised to the treatment group with 600 mg ALA per day or the placebo group. At each examination we took stereo fundus photographs, HbA1c levels, and performed an ophthalmological examination. Primary endpoint of the study was the occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes type II, mild non proliferative diabetic retinopathy,
* Microalbuminuria \> 30 mg/L

Exclusion Criteria:

Ophthalmic exclusion criteria

* severe non-proliferative or proliferative diabetic retinopathy
* Macular edema
* Eye diseases interfering with the examinations of the fundus such as preretinal haemorrhage, cataract, vitreous haemorrhage
* Amblyopia
* Best corrected visual acuity (VA) over 0.5
* Glaucoma
* Patients with cataract surgery within a period of three months
* Other relevant retinal diseases
* Non-authorized interventional therapy of diabetic retinopathy (e.g. laser, kryo-coagulation, vitrectomy)
* General exclusion criteria
* Chronic administration of alpha lipoic acid or of more than five successive days during the last twelve months
* Known intolerance/hypersensitivity to alpha lipoic acid
* Type I diabetes mellitus
* Poor metabolic control with HbA1c \>10.5 %/dl
* Late sequelae of diabetes with organic manifestation (e.g. dialysis in cases of renal insufficiency, history of kidney transplantation, creatinine \> 1.6 mg/dl)
* Poorly controlled arterial hypertension (systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 95 mmHg)
* Severe disturbances in lipid metabolism (triglycerides \> 500 mg/dl or total cholesterol \> 320 mg/dl)
* Unpermitted concomitant medication defined as any medicine with a potential interaction with alpha lipoic acid or with the effect of alpha lipoic acid were excluded as concomitant medication. These included aldose reductase inhibitors, substances promoting blood flow, anticoagulants apart from acetylsalicylic acid 500 mg/day and short-term treatment of diseases with the normal dose of acetylsalicylic acid, chronically and systemically administered corticosteroids, hormonal contraceptives
* Malignancies or life threatening diseases
* Drug or alcohol abuse
* Blood donation or blood loss greater than 500 ml) within the last 3 months
* Pregnancy or breast feeding
* Participation in a clinical trial within the last 30 days
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Hereditary Ataxia

The Hereditary Ataxias are a group of genetic disorders characterized by slowly progressive incoordination of gait and often associated with poor coordination of hands, speech, and eye movements. Current treatments for Hereditary Ataxias are mainly pharmacological, rehabilitative, or psychological treatments，while no effective treatment available. Stem Cell therapy is a novel and promising therapeutic strategy for Hereditary Ataxias treatment. In this study, the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells transplantation will be evaluated in patients with Hereditary Ataxias.

This Study is designed to evaluate the the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells transplantation in patients with Hereditary Ataxias.

Eligibility Criteria:
Inclusion Criteria:

* Aged 16-65 years.
* Harding Diagnosis of SCAs, gene type confirmed.
* Candidates who did not receive any stem cell therapy in past 6months.
* sign the consent form and follow the clinic trail procedure.

Exclusion Criteria:

* Cardiac insufficiency; Renal insufficiency; hepatic insufficiency; Total bilirubin higher than 1.5 times of upper limit of normal value; AST /ALT higher than 2.5 times of upper limit of normal value；
* Routine Blood Test: WBC count \<3.0×109/ L; PLT count \<5×109/L ; or Hemoglobin \<100g/L；
* Combined Pneumonia or other Severe systemic bacteria infection；
* Severe drug allergic history or anaphylaxis to 2 or more food or medicine；
* Other brain organic disease (eg. Brain cancer)；
* HIV+, Tumor Markers + ；
* Severe psychotic patients, cognitive dysfunction， or can not understand or sign the Consent Form；
* Other severe systemic or organic disease；
* Uncontrolled hypertension，blood pressure≥180mmHg/110 mmHg after treatment；
* Pregnancy；
* Enrollment in other trials in the last 3 months；
* Other criteria the investigator consider improper for inclusion.
MRI Investigations in Attention Deficit Hyperactivity Disorder (ADHD) and High Potential (HP) Children for a Better Therapeutic Approach

Impulsivity and/or hyperactivity in children has become one of the main clinical symptom for consultation, among the most frequent, in general or pediatric medicine. Among the different clinical forms of instability, ADHD appears to be an especially disabling condition for the development of the child, both in psychomotor, cognitive, emotional and relational aspects. Further, a significant link between ADHD children and some children with High Potential (HP) is observed. HP children show overall ahead cognitive developments compared to children with the same age. In these children, as well as in children with ADHD, an attention vulnerability, psychomotor deficits are noted, as well as emotional and relational deficits that significantly contrasted with some of their cognitive skills. Regarding the HP, the hypothesis is that children with significantly heterogeneous results (Complex) to the Wechsler IV scales are affected by this shift, and hence, by the difficulty of a differential diagnosis with ADHD, unlike those whose intelligence quotient (IQ) results that are more homogeneous (Laminar).

The goal of this work was to study a population of 80 children aged from 8 to 12 years (20 subjects per group) to evaluate the functional and structural brain development by:

* Functional magnetic resonance imaging (fMRI) acquisitions with cognitive stimulations, involving attention, working memory and semantic processing, and emotional stimulations,
* fMRI acquisitions at rest (without activation),
* diffusion tensor magnetic resonance imaging (DTI) acquisitions,
* 3D anatomic acquisitions. Identification of developmental differences in certain cortical brain areas (eg, prefrontal vs parietal), white matter fiber bundles or functional networks preferentially used by one or other of these groups, will help to better understand this disease, and to improve the differential diagnosis in order to implement a more appropriate and personalized management of the patients via new therapeutic strategies.


Eligibility Criteria:
Inclusion Criteria:

* Right-hand 4 groups :
* Laminar HP : IQ \> 130 and difference between Verbal Comprehension Index (VCI) and Perceptual Reasoning Index (PRI) \< 9
* Complex HP : IQ \> 130 and difference between VCI and PRI \>15
* ADHD : 90 \< IQ \<110
* Controls : 90 \< IQ \<110

Exclusion Criteria:

* Subjects with any psychiatric disorders except ADHD,
* Subjects with known learning deficits (dyslexia, dysphasia...), attention deficits except for ADHD group
* Subjects with claustrophobia or magnetic devices
* Children with out both parental agreements
Stroke's Gait Pattern Modifications of Induced by Repeated BTI

Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved kinematic gait parameters(GP) but surprisingly none of them assessed the effects of repetitive multifocal BTI on patient's gait pattern and their duration.

The aim was to evaluate the impact of repetitive multifocal BTI-sessions on GP of chronic stroke patients. To that end, gait of patients has been compared using 3D-gait analysis after at least 2 consecutive BTI sessions.

All the patients will be tretaed with BTI . these injections will be performed under electrical stimulation control (\~5mA). The dose, the number of site of injection per muscle is at the discretion of the physician according to patients' needs and physicians' routine clinical practice. The dilution the most commonly used will depend on the type of BoNT-A (BOTOX®, XEOMIN® or DYSPORT®) and was 100 U for 2.5ml (BOTOX® and XEOMIN®) or 500 U for 2.5 ml (Dysport®).

Eligibility Criteria:
Inclusion Criteria:

-\>18 years

* a single hemispheric cerebral vascular lesion more than 6 months previously
* able to walk 10 meters without any assistance
* having benefited of at least 2 consecutive BTI sessions, second 3D gait analysis performed at least 3 months after the last BTI.

Exclusion Criteria:

* patient's refusal to participate to the study
* Inability to read the selected text
* Inability to cooperate
* No affiliation to social security
Effects of Aerobic Exercises on Dual-task Performance and Motor Skills in Children With Mild Cognitive Impairment

Cognition refers to the mental processes involved in gaining knowledge and understanding, encompassing aspects such as thinking, knowing, remembering, judging, and problem-solving. These processes include attention, memory, executive functions, perception, language, and visuospatial skills. In children, cognitive development is critical for academic success, social interactions, and daily living activities. In the context of mild cognitive impairment (MCI) in children, cognitive processes may be less efficient or slower than in typically developing peers.This can affect their ability to perform tasks that require simultaneous cognitive and motor functions, known as dual tasks. Aerobic exercises are known to provide numerous cognitive and physical benefits, but their specific impact on children with MCI has not been thoroughly investigated. The aim of study is to analyze the effects of aerobic exercises on dual-task performance and motor skills in children with mild cognitive impairment.The current study will be randomized control trial; data will be collected from Government special education center Johar Town. The study will include patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will be both genders, having age between7 to 12, children with IQ ranging from 50-70, who are cooperative. Children with Hearing or vision impairment, any neurological/musculoskeletal disorder or already involved in an intervention program will also be excluded from the study. Experimental group will perform a structured aerobic exercise program and control group will do its daily routine activities. The intervention group will receive 3 sessions per week for 12weeks. Each session lasted 45 min on average. Outcomes to be analyzed will be dual-task performance and motor skills. Tools used for data collection will be Timed Up and Go, Single Leg Stance, Tandem Stance, and 30-second Sit-to-Stand tests and TGMD-2. Data will be analyzed through SPSS version 26.00.


Eligibility Criteria:
Inclusion Criteria:

* IQ from 50 to 70
* Who can easily understand instructions
* Both genders are included

Exclusion Criteria:

* Hearing or vision impairment
* Any neurological/musculoskeletal disorder
* Already involved in an intervention program
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)

Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Cytochalasin D serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Cytochalasin D during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes.


Eligibility Criteria:
Inclusion Criteria:

* ICSI indicated participants

Exclusion Criteria:

-