cyrilzakka/clinical-trials huggingface dataset:
Pain Education Added to Conventional Physiotherapy Program for Patients With Neck Pain

Purpose: The aim of this study is to examine the effects of pain training applied with conventional physiotherapy on pain, range of motion, disability, kinesiophobia and quality of life in patients with neck pain.

Methods: The research is planned to be completed within 18 months at Istanbul Hospital.

It is planned to include 40 individualsbetween the ages of 18-65 with neck pain persisting for 3 months or more.Individuals will be randomly divided into 2 groups.

Conventional physiotherapy program will be applied to the first group. Conventional physiotherapy will be applied to the second group and neuroscience education will be given.Pain intensity will evaluate before and after exercise with 'Visual Analog Scale' (VAS), and algometer,range of motion will evaluate with C-ROM, kinesiofobia will questioned with Tampa Kinesiofobia Score, Quality of life will evaluate with Nottingham Health Profile, whereas the level of neck disability will evaluate before and after exercise with 'Neck Pain and Disability Score' (NPDS). The obtained results will analyze using appropriate statistical methods.

The treatment program will be applied 3 days a week for 8 weeks.Each 2 groups; will be evaluated twice, at the beginning of the treatment and at the end of the 8th week.

Conventional physiotherapy program consists of neck isometric exercises, neck isotonic exercises, stabilization exercises, stretching exercises and posture exercises and physiotherapy agents.

Neuroscience education; The trainings will be conducted in the form of face-to-face interviews and 45-50 minute one-to-one sessions.

Posters, pictures, graphics and stories, as well as booklets and videos from Explain Pain, Pain in motion and retrainpain websites will be used in appropriate sessions.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18-65
* neck pain that persists for 3 months or more

Exclusion Criteria:

* Patients undergoing cervical surgery
* Patients with neck pain secondary to neurological or vascular disease or neoplasia
* Patients with radiculopathy with neurological deficits
* Patients with a history of inflammatory or infective arthritis of the cervical spine
* Patients who received a physical therapy program in the last 6 months
* Patients with pain in the scapula, shoulder, upper extremity or lumbar region that may interfere with neck stabilization exercises
Bioequivalence of Two Mixtard® 30 Formulations in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to to test for bioequivalence between two formulations of Mixtard® 30 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
* Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2, inclusive
* Non-smoker, defined as no nicotine consumption for at least one year
* Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)

Exclusion Criteria:

* Previous participation in this trial or other clinical trials within the last 3 months
* Body weight above 87.5 kg
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3
* History of alcohol or drug abuse
Mindfulness-Based Self-Compassion and Vagal Nerve Stimulation on Heart Rate Variability, Psychological Resilience, and Sleep Quality

This study was conducted to determine the effects of a mindfulness-based self-compassion intervention and vagal nerve stimulation on heart rate variability, psychological resilience, and sleep quality in earthquake victims.

Design: "The study was designed as a randomized experimental research, where pre- and post-intervention measurements were administered to Intervention I and Intervention II groups."

Hypotheses

H1: The post-intervention sleep quality scores of earthquake victims in the intervention group, who received Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation, will be higher than their scores before the intervention.

H2: The Psychological Resilience Scale scores of earthquake victims in the intervention group, who received Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation, will be higher post-intervention compared to pre-intervention.

H3: The post-intervention heart rate variability of earthquake victims in the Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation intervention group will be higher than their pre-intervention levels.

H4: The earthquake victims in the Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation intervention group will exhibit higher post-intervention sleep quality scores compared to those in the Vagal Nerve Stimulation-only group.

H5: Earthquake victims in the intervention group receiving Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation will demonstrate higher Psychological Resilience Scale scores post-intervention compared to those in the group receiving only Vagal Nerve Stimulation.

H6: Earthquake victims in the intervention group receiving Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation will show higher post-intervention heart rate variability compared to those in the group receiving only Vagal Nerve Stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 18 and 35,
* who have been exposed to an earthquake and have relocated to Istanbul,
* who are accessing psychological first aid information channels.

Exclusion Criteria:

* Individuals with a psychiatric diagnosis
Multicentric, Transversal, Descriptive, Epidemiological Study on the Management of Asthma in Asthmatic Middle East Adult Population

Descriptive study on the management of asthma in asthmatic Middle East adult population : Algeria,Egypt, Irak,Iran, Jordan, Koweit, Lebanon, Qatar,Saudi,Tunisia, UAE

Multicentric, transversal, descriptive, epidemiological study, conducted in a random sample of general practitioner and medical specialist (Pulmonologist and/or allergologist) in the public and the private sector.

Eligibility Criteria:
Inclusion Criteria:

Men and women, 18 years of age and older. Asthmatic since at least one year before inclusion. Patient's informed consent obtained.

Exclusion Criteria:

* Patient concurrently participating to another study. Patient with concomitant pulmonary disease. Patient with psychiatric disorders. Patient consulting for an asthma attack
OCT Angiography in Vitreo and Chorioretinal Pathologies

In many diseases of the vitreo and chorioretinal complex, perfusion changes have a diagnostic, prognostic or causative role. The visualisation of perfusion was limited to invasive techniques, which were only to depict vasculature in one plane. Optical coherence tomography is able to visualise and quantify eye perfusion layer-specific and non-invasive.


Eligibility Criteria:
Inclusion Criteria:

* Patient with vitreo and chorioretinal pathology, aged-adapted controls

Exclusion Criteria:

* Minors, concomitant ocular pathologies, pregnancy, contra-indication for tropicamide
Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function

The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is absorbed by the body and how long it takes to be eliminated from the body in healthy subjects and subjects with mild, moderate, and severe hepatic (liver) impairment compared with subjects with healthy normal liver function.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years inclusive at the time of consent.
* Willingness to comply with any applicable contraceptive requirements of the protocol and is:
* Male, or
* Non pregnant, non lactating female
* Females must be at least 90 days post partum or nulliparous.

Subjects who do not have hepatic impairment (healthy subjects)

* Normal renal function.

Subjects with hepatic impairment

* Subjects must provide a letter of evaluation from a hepatologist or copy of supporting documents confirming the subject's hepatic impairment (a liver biopsy is preferable but not mandatory).
* Hepatic impairment should be primary and must not be a complication of an underlying primary systemic disease (eg, patients with metastatic cancer and cancer cachexia)
* Documented chronic stable liver impairment

Exclusion Criteria

Subjects who do not have hepatic impairment (healthy subjects)

* A positive HIV antibody screen, Hepatitis B surface antigen, or Hepatitis C virus antibody screen.

Subjects with hepatic impairment

* Presence of a hepatocellular carcinoma, or an acute hepatic disease caused by an infection or drug toxicity.
* Presence of surgically created or transjugular intrahepatic portal systemic shunts.
* A positive HIV antibody screen.
* Renal insufficiency.

All subjects

* Subject has a history of thyroid disorder.
* History of nephrotic syndrome.
* History of alcohol or other substance abuse within the last year.
* A positive screen for alcohol or drugs of abuse.
* Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day. (1 alcohol unit = 1 beer \[12 oz/355 mL\] = 1 wine \[5 oz/150 mL\] = 1 liquor \[1.5 oz/40 mL\] = 0.75 oz/20 mL alcohol.)
* Caffeine consumption: For healthy subjects: Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches or have a history of caffeine withdrawal headaches. (One caffeine unit is contained in the following items: one 6 oz/180 mL cup of coffee, two 12 oz/355 mL (ie, 24 oz/710 mL cola) cans of cola, one 12 oz/355 mL cup of tea, three 1 oz/28 g chocolate bars (ie, 3 oz/85 g chocolate). Decaffeinated coffee, tea, or cola are not considered to contain caffeine.)
* Donation of blood or blood products within 60 days.
* Substantial changes in eating habits within 30 days.
Assesment of Retinal Nerve Fiber Layer in First Episode Depressive Patients Using Selective Serotonin Reuptake Inhibitor

The aim of this study is to assess the changes in retinal nerve fiber layer due to SSRI treatment in first-attack major depressive patients.

Selective serotonin reuptake inhibitors (SSRIs) are among the most used and safe antidepressant drugs in the world. In previous studies, SSRIs have been found to cause an increase in brain gray matter volume in patients with major depression (MD). Optical coherence tomography (OCT) is a non-invasive medical imaging method that displays biological tissue layers by taking high-resolution tomographic sections. Changes in the thickness of the retinal nerve fiber layer (RNFL), a layer of the ganglion cell complex in the retinal layer of the eye and composed of ganglion cell axons, occur due to axonal damage in the retinal nerve tissue. Since RNFL is similar to brain gray matter tissue, recently neurological and psychiatric studies have been conducted to provide data on the neurodegeneration that occurs in the brain by OCT. However, in a recent cross-sectional study, contrary to what was expected, thinning of the retinal nerve fiber layer was detected in psychiatric patients using SSRI drugs compared to the healthy group, and this was attributed to a probable maculopathy caused by SSRIs in the eye. In this study, it is aimed to assess the probable cortical volume changes of the patients by measuring the changes in retinal nerve layers due to SSRI treatment in first-attack MD patients.

Eligibility Criteria:
Inclusion Criteria:

* First attack depressive patients between 18 and 65 years
* Diagnosed with the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5 / Clinical Version (SCID-5 / CV)
* Started to be treated with selective serotonin reuptake inhibitors
* Having a Standardized Mini Mental Test (SMMT) score of 24 or more and
* Healthy subjects with no psychiatric history, having a SCL-90-R (GSI) score of less than 1.0

Exclusion Criteria:

* Depressive subjects with any neurological (cerebrovascular disease, head trauma, intracranial mass, dementia, epilepsy, multiple sclerosis, etc.) or general medical (such as diabetes, hypertension, myocardial infarction, etc.) diagnosis, with an ocular surgery or a history of ocular trauma, retinal pathology (detachment, etc.), other eye pathologies such as optic nerve neuropathy and refractive error, previous history of antidepressant drug use, alcohol-substance abuse or addiction,
* Healthy individuals with a history of psychiatric diagnosis or a SCL-90-R (GSI) score of 1.0 or above
Measuring Electrical Properties of Breast Tissues

The goal of this observational study is to use a low-powered microwave imaging system to provide insight into the correlation of electrical properties of breast tissue at microwave frequencies and breast density obtained from mammograms in healthy women between the ages of 18 and 74. The main questions it aims to answer : • Is there a correlation between the electrical properties of breast tissue and breast density obtained from mammograms? Both breasts of each participant will be scanned by the microwave imaging system six times in total.

A new approach to imaging that uses low-power microwaves to scan the breast has been developed. Since the imaging system uses low power, there is no risk of tissue heating. The imaging system places the sensors in contact with the breast and does not require compression. The research team at the University of Calgary has previously developed microwave imaging systems that have been tested on volunteers and patients. This included repeated scanning of a group of volunteers to evaluate the consistency of the approach. The information collected from experiences scanning volunteers and patients have been reviewed and translated into a next-generation imaging system design. Aspects of this system have been further improved by Wave View Imaging, which is a company formed by members of the University's research team.

The proposed study involves collecting electrical property measurements of breast tissues and comparing these measurements to clinical information. The investigators also aim to compare regions of interest in the microwave scans with regions of interest in the mammograms. This includes regions dominated by fibroglandular tissues, as well as regions of interest that correspond to anomalies identified in the mammograms

The plan is to scan both breasts of up to 200 volunteers. Each volunteer will participate in a single scanning session. Breast tissue composition (VOLPARA score) will be compared with the microwave properties and registration of mammograms with microwave images will be performed for a more detailed comparison.

Eligibility Criteria:
Inclusion Criteria:

* Must have had a previous mammogram in the last 2 years

Exclusion Criteria:

* Participants currently undergoing chemotherapy and/or radiation treatment.
* Participants with breast implants.
* Participants who are breast or breastfeeding.
* Participants with active breast infections.
* Participants with nipple piercings (unless they can be removed prior to scanning).
* Participants with an implanted electronic device.
* Participants with physical limitations that prevent them from placing their breasts in the scanner.
A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)

To determine the safety, tolerability, dose-limiting toxicity (DLT), pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when administered orally to patients with advanced solid tumours. To further evaluate the safety and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily ovarian cancer patients


Eligibility Criteria:
Inclusion Criteria:

* Confirmed malignant advanced solid tumour refractory to standard therapy or for which no suitable effective standard therapy exists.

Exclusion Criteria:

* Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).
Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions

Attempts to quit cigarette smoking are often accompanied by negative mood and problems in attention and memory. These effects, in turn, may contribute to smoking relapse. This exploratory/developmental project examines the effects of a novel medication, GTS-21, on individuals interested in smoking cessation. It is hypothesized that GTS-21 will reduce negative affect, improve cognition and/or reduce smoking relapse in healthy adult men and women who are chronic cigarette smokers.

The project is a clinical trial assessing the effects of GTS-21 (an α7 nicotinic receptor partial agonist) on smoking, mood, neurocognition, and neurophysiology, in a small sample of chronic smokers who are currently healthy and interested in smoking cessation. Using a double-blind, placebo controlled, parallel group design, 54 (27 women) community smokers who have demonstrated a readiness to quit will participate over a 7 week active trial. Subjects will be randomly assigned to active drug or placebo groups. Across the study period, participants will undergo repeated neurobehavioral testing, laboratory assessments of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood state and side-effects.

Eligibility Criteria:
Inclusion Criteria:

* Minimum of 12 years of education
* Must report typical daily smoking of \> 10 cigarettes/day over the previous year
* Must report a history of at least 3 years of regular smoking
* Must provide carbon monoxide measures of at least 6.5 ppm
* Must report a willingness to quit smoking

Exclusion Criteria:

* Participants engaged in behavioral and/or nicotine replacement therapies, or assisted quit efforts, within previous 6 months.
* Must not meet criteria for other substance dependence or major psychiatric disorders.
* Must be absent chronic medical conditions that might jeopardize health and safety, confound data interpretation or that contraindicate the administration of compounds acting at nAChR sites. This list includes disorders with direct effects on neurologic function (e.g., seizure disorders, transient ischemic events, chronic or active hepatic disease), metabolic disorders (e.g., uncontrolled Type 2 diabetes), or cardiovascular disease (e.g., hypertension, mitral valve compromise, tachycardia, or irregular heart rates).
* Must not smoke only cigars, pipes or hookahs or use nicotine products but not cigarettes
* Must not report current use of nicotine replacement therapies (i.e., occasions of \> 4 h/week during a typical week, even if not used as a cessation aid)
* Must not have used bupropion within the previous year
* Must not report any past use (regardless of year) of varenicline
* Women may not be breastfeeding, pregnant or intending to become pregnant during the study period
Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

This will be a randomized controlled trial of asymptomatic (Cryptococcal Antigen test)CrAg positive persons in Uganda.

Patients will be randomized to receive preemptive treatment with 1 dose of liposomal amphotericin (10mg/kg) in addition to standard of care fluconazole therapy.

How the enhanced antifungal therapy prevents progression to meningitis in the first 24-weeks and overall survival in those who receive the intervention compared with participants receiving fluconazole per World Health Organisation (WHO) and national standard of care therapy will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection
* Age \> or equal to15 years
* Ability and willingness to give informed consent.
* Plasma/Serum cryptococcal antigen (CRAG)+ with a titer 1:160 or greater

Exclusion Criteria:

* Cannot or unlikely to attend regular clinic visits
* History of cryptococcal infection
* Symptomatic meningitis (confirmed by CSF CRAG+)
* \>14 days of fluconazole therapy
* Pregnancy (confirmed by urinary or serum pregnancy test)
* Current breastfeeding
* Known allergy to amphotericin
Efficacy of Digital Otoscope and Otoendoscope for Diagnosis of Middle Ear Pathology

For diagnosis of external and middle ear diseases, an otoscope is a key instrument to use. A microscope has been used as a reference standard to confirm pathology. An endoscope has been also widely used. Both microscope and endoscope provide an excellent image quality, can record and capture the images, and the images can be visualized with an export system.

A digital otoscope is widely available and more affordable. A comparative study of the efficacy of the endoscope and the digital endoscope will be performed.

A comparative study for the diagnosis of middle ear disease usingTeslong digital otoscope, model MS450D39, and the otoendoscope will be performed. The participants will be recruited at the ENT clinic, University Hospital. A handheld otoscope will be used to identify the patients who have the pathology of the middle ear.

The images will be captured with both endoscopes and will be reviewed by staff, residents training in ENT, and residents training in ENT and family medicine.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with middle ear disease after examination by conventional otoscope at ENT clinic, Chiang Mai University Hospital
* Had otoscopic examination with both digital otoscope and otoendoscope in the same visit in one ear or both ears

Exclusion Criteria:

* Having abnormal external ear canals such as external auditory canal stenosis, otitis external, otomycosis, or pus/ debris in the ear canal that obscures the view of the eardrum
* Changing the pathology of the ear canal or middle ear in the same visit
* Trauma after otoscopic examination
* can not record or focus the entire view of the eardrum by both otoscopes
Whole-body Vibration Training in Older People

This is a randomized, multicentre, and parallel clinical trial with blinded to evaluator.

The principal hypothesis is that whole-body vibration training plus exercise improves the body balance and prevents falls more than only exercise training in institutionalized older people. The number needed of patients is 160 (80 per group).


Eligibility Criteria:
Inclusion Criteria:

* Institutionalized older people who were 65 years and older
* The patient consent to participate in the study

Exclusion Criteria:

* Residents who present an acute disease that not resolved during 10 days.
* Residents with a pacemaker (or serious cardiac alterations)
* Residents with epilepsy
* Residents with a high risk of thromboembolism
* Residents with a history of a hip or knee joint replacement
* Residents who not were musculoskeletal disorders and cognitive or physical dysfunction that interfering with test and training procedures.
* Residents that not accept to participate in the study.