cyrilzakka/clinical-trials huggingface dataset:
The Impact of Group Singing on Patients With Stroke and Their Personal Caregivers

The study will focus on the impact of communal singing on patients with stroke and their personal caregivers. Forty post-stroke patients will be randomly assigned to two groups: the first group of 20 stroke survivors and their caregivers (up to 40 total participants) will receive 6 months (approximately 24 sessions) of music therapy. The second control groups of 20 stroke survivors and their caregivers will receive standard post-stroke care

The study will focus on the impact of communal singing on patients with stroke and their personal caregivers. Forty post-stroke patients will be randomly assigned to two groups: the first group of 20 stroke survivors and their caregivers (up to 40 total participants) will receive 6 months (approximately 24 sessions) of music therapy. The second control groups of 20 stroke survivors and their caregivers will receive standard post-stroke care.

All enrolled participants will be assessed on their mood, past music experience and music genre preference (music therapy assessment). They will complete the abridged Beck (BDI-2-fastscreen) questionnaire, the stoke and aphasia quality of life scale; a Likert which measures distress; the Western Aphasia Battery (WAB); the NIH Stroke Scale (SS); the Figely compassion scale; and the driving scene test (Stern and White); and the Rankin. In additional we will take saliva samples from all participants to measure hormone levels.

Participants can attend zoom or live.

Eligibility Criteria:
Inclusion Criteria:

* Stroke victim, regardless of level of stroke

Exclusion Criteria:

* None
Pain Associated With Interproximal Enamel Reduction in Orthodontics: a RCT

Prospective randomised crossover trial to assess if there is a difference in the level of pain experienced by orthodontic patients undergoing interpromixal enamel reduction at the lower incisor region using either a motor driven reduction device or a hand held device

Consenting participants will be randomly allocated to one of the two groups ( motor driven device or hand driven device). A pain questionnaire in the form of a Visual Analogue Scale will be used before the treatment to determine a baseline level of pain and after the chosen treatment to determine the effect or the intervention on pain experience.

After a washout period of 6 weeks the participants will crossover to have the opposite intervention carried out. A VAS will be filled in before and after the intervention again to determine a baseline pain score and pain score associated with the intervention.

The data will be gathered and entered electronically into a statistical package whereby appropriate statistics will be carried out to determine if there is a significant difference in pain experienced between the two methods of enamel reduction.

A secondary aim willl be to determine if there is any correlation with pain experienced and age or gender.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Requiring IER in the lower anterior teeth as part of treatment plan
* mild crowding in the lower incisor region
* centreline discrepancy
* discrepancy between the arches mild and thus requiring IPR to correct incisor position
* requiring IER for arch coordination No medications Willing to participate

Exclusion Criteria:

* Under 18 years of age Not requiring IER
* moderate or severe crowding necessitating extraction for relief of crowding
* patients with removable appliances as their only mode of treatment Patient taking medication Not willing to participate
The Effect of Probiotics on Symptoms and Intestinal Flora in Patients With Irritable Bowel Syndrome

To demonstrate benefit of a probiotic product in adults with irritable bowel syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* Age ≥18 and ≤70 years at Visit 1
* IBS according to the Rome III criteria
* A score on abdominal pain NRS ≥3 and ≤6 at least two days a week measured the weeks before Visit 2 (baseline)
* IBS-SSS ≥75 and ≤300 at Visit 2 (baseline)
* Ability and willingness to understand and comply with the study procedures

Exclusion Criteria:

* Known intolerance or allergy to milk products (protein or lactose) or gluten
* History of alcohol or substance abuse six months prior to screening
* Known Hepatitis B or C or Human Immunodeficiency Virus (HIV) 1 or 2
* Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study
* Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the Investigator
* Other gastrointestinal disease(s) that explains the patient's symptoms, as judged by the Investigator
* Other severe disease(s) such as malignancy, severe coronary disease, kidney disease or neurological disease, as judged by the Investigator
* Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, loss of weight or fever, as judged by the Investigator
* Severe psychiatric disease as judged by the Investigator
* Lack of suitability for participation in the study for any reason as judged by the Investigator
* Use of other probiotic products from Visit 1 and throughout the study.
* Consumption of antibiotic drugs 1 month prior to screening and throughout the study.
* Consumption of drugs on a regular basis which could interfere with symptom evaluation as judged by the Investigator.
Evaluation of Mechanical Stapler for Aortic Anastomoses

Demonstrate the safety and performance of the Aortic Stapler when used to attach a synthetic graft to an aorta in AAA and Leriche Syndrome patients


Eligibility Criteria:
Inclusion Criteria:

* Patient age is between 21 to 85 years old.
* Patient is diagnosed with Abdominal Aortic Aneurysm (AAA) or -aorto-Iliac/Femoral Occlusive Arterial Disease (Leriche' syndrome) by CT-Angio examination and/or angiography examination in patients with Leriche' syndrome.
* Patient with an aneurysm at the neck of the proximal or distal site that is between 5 to 10 mm and with a diameter of 16-22 mm.
* Patient is scheduled for AAA repair

Exclusion Criteria:

* Pregnant women
* Active malignancy
* Ruptured aneurysm
* Thoraco-AAA
* Patient with at least one of the following unstable risk factors:
* Renal disease (Cr \>2)
* Ischemic heart disease (unstable Angina)
* Obstructive Pulmonary Disease (contraindicated for open aortic surgery by respiratory function exam)
* Severe CHF (EF \< 25%)
* Patient with known allergy to metals or to the contrast media
* Participation in current or recent (within 60 days prior to surgery) clinical trial
Correlation Between Pupil Size and Ocular Signs of Pseudoexfoliation Syndrome

To study possible correlation between the size of the pupil in both room light and after dilation between both eyes in bilateral pseudoexfoliation with Intraocular pressure, lens clarity and stability, Optic disc , Visual changes and glaucoma changes by optical coherence tomography

For each patient. Full preoperative ophthalmological assessment will be done using slit lamp , size of the pupil in regular room light (usually around 2000 Lux) and post dilation with tropicamide 1%. baseline IOP measurement using Goldmann applanation tonometer, UCDVA (Uncorrected Distance Visual Acuity)and CDVA (Corrected Distance visual acuity), lens opacification or clarity, stability or subluxation. corneal endothelial cell count. Fundus examination using 90 D or 78D lenses, Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC)

Eligibility Criteria:
Inclusion Criteria:

All patients with pseudoexfoliation syndrome

Exclusion Criteria:

previous ocular surgery or ocular trauma affecting pupil. Any systemic or neurologic disease affecting pupil
Dietary Intake of Salmon and Bone Health

The aims of this study were to investigate how intake of tailor-made salmon affected bone biomarkers, nutritional status, as well as body composition and bone mineral density. The 122 healthy postmenopausal women included in this 12 weeks intervention study were randomized into four groups: three salmon groups (with three different vitamin D3/vitamin K1 combinations) and one tablet group (vitamin D and Calcium).

Suboptimal vitamin D status is common among humans, and might have a negative impact on bone health. Fatty fish, including Atlantic salmon, is an important dietary vitamin D source. However, due to a considerable change in fish feed composition, the contribution of vitamin D from salmon fillet has been reduced. The aims were to investigate how intake of tailor-made salmon affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density (BMD). The 122 healthy postmenopausal women (median 55 years) included in this 12 weeks intervention study were randomized into four groups: three salmon groups (150 grams/two times/week) and one tablet group (800IU vitamin D and 1000 mg Calcium/day). The salmon groups also received calcium supplements (1000 mg/d). The salmon had three different vitamin D3/vitamin K1 combinations: high D3 + high K1, low D3 + high K1, or high D3 + low K1.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Caucasian ethnicity
* Age range 50-65 years
* Having postmenopausal age of at least one year

Exclusion Criteria:

* Osteoporotic fractures
* Medical treatment for osteoporosis
* Warfarin treatment
* Creatinine above or below normal range
* Hypervitaminosis D
* Malabsorption syndrome
* Inflammatory bowel disease
* Inflammatory rheumatic diseases
* Women who had planned to go away on holiday during the intervention could not participate
Microassay and Allergy Skin Prick Test Correlation Study

The purpose of this study is to evaluate the potential correlation of the results of allergen-specific skin prick tests (SPT) to that of allergen-specific microarray determination (microassay test). Subjects who meet enrollment criteria, after signing an IRB approved consent form, will perform a minor finger prick blood draw and blot to be mailed off for microassay analysis. Specific statistical analysis will be done to assess all potential correlations between SPT and microassay. This study design should enable assessment of the level of correlation between SPT results and microassay results for specified allergens within a cohort of subjects with allergic rhinitis.

Prospective subjects for study entry will initially be screened by the results of their allergy skin test that were acquired within the past two years. In order to be a prospective subject positive SPT results of five of the following ten allergens will be required: Dust Mite, Ragweed, Cat Dander, Johnson Grass, Bermuda Grass, Timothy Grass, Oak, Cladosporium, Dog Dander, and Cockroach. After signing an IRB approved consent form, these patients will undergo a finger prick blood draw and blot. This study will be conducted in compliance with the protocol, GCP and applicable regulatory requirements.

Subjects 18 years of age or over who have never initiated a course of allergy immunotherapy or have not completed more than three months of SCIT immunotherapy will be enrolled.

Sub-investigator(s) will screen patient charts from a database of patients previously tested using the UAS protocol. Patients that qualify based on inclusion criteria will be contacted by phone and asked if they would be willing to participate in this study.

Subject arrives to the clinic and all inclusion and exclusion criteria are verified by their primary physician and the sub-investigator. Sub-investigator insures that the IRB verified consent form is signed and that the patient has no questions. Subject or sub-investigator will perform the finger prick and blot using the instructions listed on the Allergenex sample collection packet. The sample will be mailed to Spiriplex to be analyzed using their microarray device. The microassay results will be sent to the primary investigation site for correlation analysis with the previously logged SPT results. These results will be blinded to the statisticians and researchers that will be determining potential correlation between SPT and microassay results.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age or over who have never initiated a course of allergy immunotherapy or have not completed more than three months of subcutaneous immunotherapy will be enrolled.

Exclusion Criteria:

* Subjects with bleeding disorders or a history of vasovagal reactions to blood draws will not be enrolled in this study.
Feasibility of an Artificial Intelligence Phone Call After Cataract Surgery

To analyze the evidence for clinical safety, usability, acceptability, satisfaction, appropriateness, and cost-effectiveness of Dora for recognizing patients who require additional in-person evaluation post cataract surgery. To assess Dora's sensitivity and specificity in cataract surgery management To determine what can be learnt to enhance AI technology in the field of ophthalmology especially when working with culturally diverse patients such as Punjabi and Chinese speaking patients.

Background:

Cataract is defined as the degradation of the optical quality of the crystalline lens that affects vision and is the current leading cause of blindness worldwide. AI is set to revolutionize post-cataract surgery management by enhancing automation, increasing effectiveness, decreasing burdens placed on patients and the health care system. Ultimately, using AI-enabled automation could enhance patient management during and post cataract surgery.Cataract post-operative contact will be delivered by Dora agent, a natural language AI assistant.

Aim and objective:

Dora is a clinically safe, usable, appropriate, satisfactory and cost-effective AI technology for recognizing patients who require additional evaluation post cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are undergoing uncomplicated cataract surgery at a high volume surgical centre.

Exclusion Criteria:

* clinically significant complications during surgery that require more than the standard postop treatment or follow-up
Human Skin Aging: Clinical Parameters and Gene Expression Profiling

Skin aging is a complex process involving genetic and environmental factors. The investigators hope to learn more about how human genes and their function can contribute to skin aging and human health.

This study includes answering a survey on prior sun exposures, donating two small pieces of skin (4mm each), one blood draw, complexion analysis, photographs, and non-invasive tests such as skin surface lipid analysis. Your blood and tissue will be sent for DNA analysis and gene expression profiling.

Eligibility Criteria:
Inclusion Criteria:

* healthy female, age 18 or older,
* Fitzpatrick type 1 or 2 skin,
* able to read and understand written consent form,
* body mass index normal or overweight range,
* willing to take blood tests and donate skin samples

Exclusion Criteria:

* pregnant or lactating,
* history of cosmetic surgery affecting the face,
* use of prescription anti-aging medications for 2 weeks prior to study,
* use of dietary supplements for 2 weeks prior to study, use of tanning beds or excessive light exposure (\>2 hours) in the past 2 weeks,
* medical conditions which at the discretion of the investigator will have significant impact on ability to judge subjects' skin characteristics and age, sunless tanner use in past 2 weeks
Pix2pix Networks for Scheimpflug Corneal Tomography Image Generation

Computer-aided medical image analysis has advantages, but requires large amounts of training data, which are scarce and costly to obtain, are subject to privacy concerns, and are often highly imbalanced, with over-representation of common conditions and poor representation of rare conditions. Consequently, some methods have been proposed to generate artificial medical images using generative adversarial networks (GANs). Computer aided diagnosis of keratoconus is an emerging research field that may benefit greatly from medical image synthesis, which can affordably provide an arbitrary number of sufficiently diverse synthetic images that mimic real Pentacam images. A new conditional GAN, the pix2pix cGAN, has not been used in this context to date. Here, investigators will assess the efficacy of a cGAN implementing pix2pix image translation for image synthesis of color-coded Pentacam 4-map refractive displays of clinical and subclinical keratoconus as well as normal corneas.


Eligibility Criteria:
Inclusion Criteria:

* Keratoconus group:

  * Presence of a central protrusion of the cornea with Fleischer ring, Vogt striae, or both by slitlamp examination.
  * irregular cornea determined by distorted keratometry mires and distortion of retinoscopic red reflex or both in addition to the following topographic findings as summarized by Pińero and colleagues :
  * focal steepening located in a zone of protrusion surrounded by concentrically decreasing power zones
  * focal areas with dioptric (D) values \>47.0D
  * inferior- superior(I-S) asymmetry measured to be \> 1.4 D
  * Angling of the hemimeridians in an asymmetric or broken bowtie pattern with skewing of the steepest radial axis(SRAX) .

Suspicious group:

• Defined as subtle corneal tomographic changes as the aforementioned keratoconus abnormalities in the absence of slit- lamp or visual acuity changes typical of keratoconus (forme fruste keratoconus).

Normal group:

* Refractive surgery candidates
* Refractive error of less than 8.0 D sphere
* Less than 3.0 D of astigmatism
* without clinical, topographic or tomographic signs of keratoconus or suspect keratoconus.

Exclusion Criteria:

* • Systemic disease

  * Other corneal disease such as pellucid marginal degeneration
  * History of trauma
  * Corneal surgery such as corneal cross- linking for progressive keratoconus.
Epidemiology and Control of Mansonella Perstans Infection in Uganda

Mansonella perstans (M. perstans) infection is widespread in Uganda. Knowledge about the epidemiology of this infection, and of the morbidity it induces is poor, and no effective treatment is available. The study aims at providing data on diagnostic, epidemiological, morbidity and treatment aspects of M. perstans infections in Uganda.

Overall objective: to investigate diagnostic, epidemiological and treatment aspects of M. perstans in Uganda with relevance to control

Specific objectives:

1. To establish the pattern of diurnal periodicity of M. perstans microfilaraemia in humans
2. To establish the patterns of M. perstans microfilaraemia and possible clinical manifestations related to this infection in two communities with medium to high endemicity
3. To determine the efficacy of ivermectin alone and the combination of ivermectin and albendazole on M. perstans microfilaraemia.

Eligibility Criteria:
Inclusion Criteria:

* Individuals \>= 5 years with or without M. perstans infection

Exclusion Criteria:

* Individuals \< 5 years
* Pregnant women
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* HCV RNA ≥ 10\^4 IU/mL at screening
* HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at screening by the central laboratory
* Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
* Classification as treatment naive or treatment experienced
* Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Exclusion Criteria:

* Current or prior history of clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
* Screening ECG with clinically significant abnormalities
* Laboratory results outside of acceptable ranges at Screening
* Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old

The purpose of this study is to evaluate immunogenicity and safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.


Eligibility Criteria:
Inclusion Criteria:

* Health infants and children aged from 3 months to 5 years old.
* Subject or legal representative who consent and has signed written informed consent.
* Subject and parent/guardian who is able to comply with all study procedures.
* Subject who did't receive blood products within 30 days ,immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
* Subject who haven't immuned with diarrhea vaccination,3-11 months health infants who haven't immuned with Haemophilus b Conjugate vaccination,or had a history of Hib vaccination before the age of 1 but no history of vaccination after 1 year of age,and the interval between the day of the enrollment and the previous dose is more than one month.
* Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

* Febrile illness (temperature ≥ 38°C) in the 3 days or in the acute phase of the disease / active period.
* Subject who have symptoms such as diarrhea, abdominal pain, and pus and bloody stools in the past 3 days.
* Subject who are allergic to tetanus toxoid.
* Allergic history after vaccination.
* Immunodeficiency diseases patients (such as perianal abscess suggests that there may be immunodeficiency in infants and young children) who administered with immunosuppressive agents (≥14 days).
* Subject who are suffering from serious chronic diseases, cardiovascular disease,liver or kidney disease.
* Subject with congenital malformations, drug allergies, convulsions, epilepsy, history of craniocerebral trauma, encephalopathy and psychosis, or family history.
* Subject who diagnosis of thrombocytopenia or other history of coagulopathy may cause intramuscular contraindication.
* Children with abnormal labor（pregnancy week\<37w,\>42w）,birth weight (\<2500g,\>4000g), asphyxia rescue history(Only applicable to 3-5 months old group).
* Subject who plan to participate in or is in any other drug clinical trial.
* Any condition that, in the judgment of investigator, may affect trial assessment.