cyrilzakka/clinical-trials huggingface dataset:
FUSION Regimen: Combined Pro re Nata and Fixed Regimen Ranibizumab in Exudative Age-related Macular Degeneration

The purpose of this study is to investigate the safety and efficacy of a combined fixed-interval and a pro re nata (PRN) regimens of ranibizumab (FUSION regimen) for the treatment of exudative age-related macular degeneration (AMD) in patients with good visual acuity (VA) at baseline. To establish whether similar efficacy to monthly regimens can be achieved with fewer injections, even in patients with good VA.

This is a prospective, open-label, consecutive interventional case series in treatment-naïve patients with exudative AMD. A loading phase of 2-3 injections is followed by a fixed-interval regimen of injections combined with a pro re nata regimen for 12 months. Endpoints include VA, presence of fluid at spectral domain optical coherent tomography (SD-OCT), adverse events and number of injections administered.

Eligibility Criteria:
Inclusion Criteria:

* subfoveal or juxtafoveal CNV owing to AMD, defined by fluorescein angiography (FA)
* presence on SD-OCT of subretinal or intraretinal fluid associated or not with macular edema
* Best corrected visual acuity (BCVA) in the study eye between 20/20 and 20/125, inclusive
* total area of the lesion (including blood, neovascularization and scar/atrophy) of ≤8 disc areas, of which at least 50% must be active choroidal neovascularization (CNV) (defined as the neovascular component of the lesion as defined by FA
* all angiographic subtypes \[predominantly classic, minimally classic and occult\] were eligible)
* clear ocular media and adequate pupillary dilatation to allow collection of fundus photographs and FA of a sufficient quality to be analyzed
* intraocular pressure of 21 mmHg or less
* and no previous treatment for AMD

Exclusion Criteria:

* presence of scarring or atrophy \>75% of the total lesion size (patients with subfoveal scar or atrophy were excluded)
* subretinal haemorrhage \>75% of the total lesion size; presence of serous retinal pigment epithelial detachments \>5 disc areas
* presence of intraocular inflammation (≥ trace cell or flare), epiretinal membrane, macular hole or vitreous haemorrhage
* history of idiopathic or autoimmune-associated uveitis in either eye
* significant media opacities, including cataract, which might interfere with VA, assessment of toxicity or fundus photography in the study eye
* presence of other causes of CNV, including pathological myopia (spherical equivalent of -3 diopters or more, or axial length of 25 mm or more, or fundus findings suggestive of pathologic myopia), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis
* any retinal treatment (aside from antioxidants), including (but not limited to) intravitreal injections, photodynamic therapy with verteporfin, laser photocoagulation or surgery
* history of rhegmatogenous retinal detachment, pars plana vitrectomy or corneal transplant
* and previous radiation in the region of the study eye.
Biomarkers for Monitoring Dementia Progression

The variable course of Alzheimer's disease (AD) and the paucity of adequate cures urges to implement new strategies for its early detection and clinical intervention. Studying the etiopathogenesis and pathophysiological mechanisms of AD is a necessary prerequisite for the development of new biomarkers and innovative therapies. Contrarily to anatomical structures, cortical connectivity networks are already deteriorated in early AD and could be a reliable marker of early cognitive decline. Our aim is to characterize the neurophysiological parameters in mild AD, in patients with mild cognitive impairment and in matched healthy subjects to identify discriminating criteria. Concurrently, the study of AD onset and progression in a mouse model, will allow evaluating the causal effect of inflammation on disease progression and to develop a new class of biomimetic anti-inflammatory nanoparticles formulated to have the intrinsic ability to induce brain's activated microglia to an M2 phenotype.


Eligibility Criteria:
Inclusion Criteria:

* mild AD and patients with mild cognitive impairment (MCI).

Exclusion Criteria:

* major psychosis, genetic, metabolic and other neurological disorders, acute or chronic non-compensated medical illness
* any medical or drug-related condition affecting cognitive or mood status
* history or current alcohol/illicit drug abuse.
Non-invasive Assessment of RECTUM (POUCH) by US (RECT-US) in a Cohort of IBD Patients

At enrollment, after informed consent form will be discussed and signed, subjects will undergo complete disease assessment.

In this study, 150 adult subjects with IBD will be enrolled at the Gastroenterology Department of the San Raffaele Hospital (50 patients with Crohn's disease, 50 with Ulcerative colitis not undergoing proctocolectomy, and 50 with Ulcerative colitis undergoing proctocolectomy with ileal pouch-anal anastomosis).

All the patients will perform routine investigations with Ileocolonoscopy (IC), according to the current standard of care indications and ECCO guidelines, and they will be assessed by both Intestinal Ultrasound (IUS) and Trans-perineal ultrasound (TPUS). Blood and stool samples will be obtained for fecal calprotectin (FC) and C-reactive protein (CRP) measurements, respectively, as normal clinical practice.

All the procedures of this study are performed routinely in clinical practice. All the procedures are performed in a single day-visit for the patient.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of IBD for at least 3 months, in particular 50 with Crohn\&amp;;s disease (CD), 50 with ulcerative colitis (UC) not undergoing proctocolectomy, 50 with ulcerative colitis (UC) undergoing proctocolectomy with ileal pouch-anal anastomosis
* Performing ileocolonoscopy, according to current standards of care and ECCO guidelines, will be assessed by both IUS and TPUS. Procedures performed routinely in clinical practice
* Ability to understand and comply with the study procedure and sign an informed consent form

Exclusion Criteria:

* Pregnancy;
* Concomitant intestinal infection (e.g. Clostridium difficile);
* Cirrhosis or intra-abdominal ascites.
* Subjects not able to comply with any study procedure;
* Subjects not able to understand and give informed consent form;
* Subjects with any contraindication to any study procedure.
RAPP-children, Rhinitis & Asthma in Patient Perspective: Development and Validation of a Questionnaire for Quality of Life Evaluation in Children With Asthma and Allergic Rhinitis

This observational study aims at developing and validating a simple questionnaire to be routinely applied in the clinical practice, for the evaluation of the quality of life in children with concomitant asthma and allergic rhinitis. The study consists of two phases:

Phase 1: Development of the RAPP-children questionnaire starting from the validated RHINASTHMA-children questionnaire.

Phase 2: Administration and validation of the RAPP-children questionnaire. 150 children with concomitant asthma and allergic rhinitis will be followed-up for one month. Both at baseline and after one month, the RAPP children and several other standardized questionnaires will be administered.


Eligibility Criteria:
Inclusion Criteria:

* Age between 6 and 11 years
* Concomitant asthma and allergic rhinitis
* Males and Females

Exclusion Criteria:

* Immunological and metabolic systemic disease
* Major malformations of the upper airways
* Active smoker
Menstrual Cycle Phase and Oral Contraceptive Pill (OCP) Use on Muscle Protein Synthesis

Skeletal muscle size and function is regulated by various factors, including hormones. While we understand the role of male sex hormones (testosterone), we aren't sure how female sex hormones (estrogen and progesterone) influence muscle mass and strength. Female physiology is unique in that hormones fluctuate throughout the menstrual cycle. In the first phase (follicular phase) following menstruation, estrogen levels are high while progesterone levels are low. In the second phase (luteal phase), progesterone levels are high. Females are often excluded from studies because researchers are concerned that the menstrual cycle might affect the results. The purpose of this study is to investigate the response to resistance exercise in each phase of the menstrual cycle.


Eligibility Criteria:
Inclusion Criteria:

* Healthy females, between the ages of 18 and 30 y with a regular menstrual cycle
* Body Mass Index between 18.5 and 30.0 kg/m2
* Able and willing to provide informed consent

Exclusion Criteria:

* A history of neuromuscular disorders or muscle/bone wasting diseases
* Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin-dependent or insulin-independent diabetes, or the presence of any other metabolic disease - all of which will be determined via a medical history screening questionnaire
* The use of any medications known to affect protein metabolism (glucocorticoids, non-steroidal anti-inflammatory medication, or prescription strength acne medication, etc.)
* A (family) history of thrombosis
* The use of anticoagulant medications
* Consumption of tobacco-containing products
* Excessive alcohol consumption (\>21 units/wk)
* History of bleeding diathesis, platelet or coagulation disorders
* Currently pregnant
* Irregular menstrual cycle as defined in the study protocol
Mulligan Stretch With Traction Versus Post Isometric Relaxtion on Hamstring Flexibility

The design of my study will be Randomized Control Trial (RCT) study. And the sampling technique will be non-probability convenience sampling. A sample of 32 (16 in each group) has been selected using 10% level of significance and 80% power of test.

Three groups will be made each containing 16 participants with inclusion criteria met. Group A will be given control group treatment with Muscle Energy Technique applied over the period of 4 weeks. Group B will be given control group treatment with Mulligan Stretch with Traction Technique applied over the period of 4 weeks.

Total 3 recordings of Hip Flexion ROMs shall be taken with manual goniometry as follows initial/first day, 3rd week, final week/last treatment. A sum of 8 treatments shall be given to the intervention group over the period of 4 weeks, 2 treatments per week.

INTRODUCTION:

Mobility in human gait depends on flexibility of hamstring muscles. Hamstring muscles function is hip extension and knee flexion. In most of the population, tightness or shortening of hamstring muscles occur which limits hip flexion. To measure hamstring muscles flexibility simple passive SLR is performed and range is recorded by manual goniometer. To increase SLR, several techniques are used: MET's and TSLR. Effectiveness of these techniques depend on muscle flexibility.

OBJECTIVE:

The purpose of this study is to compare the effectiveness of mulligan stretch with traction technique and muscle energy technique to increase the SLR in athletes with hamstring tightness.

METHOD:

The data will be collected from Athletes in sports clubs, gyms, and sports fields of Lahore. The study will be completed in a period of six months after the approval of synopsis. The design of my study will be Randomized Control Trial (RCT) study. And the sampling technique will be non-probability convenience sampling. A sample of 32 (16 in each group) has been selected using 10% level of significance and 80% power of test.

Three groups will be made each containing 16 participants with inclusion criteria met. Group A will be given control group treatment with Muscle Energy Technique applied over the period of 4 weeks. Group B will be given control group treatment with Mulligan Stretch with Traction Technique applied over the period of 4 weeks.

Total 3 recordings of Hip Flexion ROMs shall be taken with manual goniometry as follows initial/first day, 3rd week, final week/last treatment. A sum of 8 treatments shall be given to the intervention group over the period of 4 weeks, 2 treatments per week.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* Negative Spring test
* Asymptomatic
* SLR \< 80⸰

Exclusion Criteria:

* Positive LBP
* Lumbar Straightening
* SI Joint Dysfunction
* History of hamstring injury
* Current musculoskeletal pain in hip region
* Any other comorbidity limiting joint ROM
STOMP Early Years: A Pilot RCT of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity

This internal pilot study will determine whether a highly promising primary care based intervention that combines group based parenting skills training and public health nurse home visits with a focus on healthy nutrition, activity and sleep, will lead to improved weight status in 1 to 5 year old children with severe obesity.

Children with severe obesity will be identified through the obesity management clinical program at The Hospital for Sick Children called STOMP (SickKids Team Obesity Management Program). The STOMP Early Years Program is a unique and intensive, paediatric obesity management program designed for 1 to 5 year-olds with severe obesity and their families. Families who participate in this study will be randomly assigned (having an equal chance of being in either group) to one of the two study groups that will run for 6 months:

Group A: Ten weeks of group parenting education sessions with 2-4 public health nurse home visits and four one-on-one check-ins with an interdisciplinary team at STOMP.

Group B: Wait listed to receive parenting education sessions; receive one-on-one checks with an interdisciplinary team at STOMP.

In addition to the measures collected as part of STOMP, families will complete the following questionnaires before the start of the trial, and after 6 months:

Parenting Scale, Parenting Stress Index, Depression, Anxiety, and Stress Scale (DASS-21), Cost Questionnaire, and Children's Behaviour Questionnaire (CBQ).


Eligibility Criteria:
Inclusion Criteria:

* Children with obesity and severe obesity (BMI ≥97th percentile) and at least one parent (primary caregiver), and families who are fluent in English (written and oral) will be eligible to participate.

Exclusion Criteria:

* Children with diagnosed Prader-Willi syndrome; severe developmental delay; and families who reside beyond the Toronto Public Health catchment area for home visiting.
Call to Door Timing in Out-of-hospital Cardiac Arrest

The investigators aimed to investigate the effect of delayed hospitalization on the basis of the call time on the clinical outcomes of patients with OHCA patients using a nationwide OHCA registry.

According to "2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care", immediate call for the local emergency response number takes a key role in the OHCA as the CPR in community does not provide quality of in-hospital CPR. The strong recommendation of speedy transportation, however, does not provide time limitation, and evident data supporting benefit within certain minutes to transfer is lack through our best of search. Therefore, The investigators aimed to investigate the effect of delayed hospitalization on the basis of the call time on the clinical outcomes of patients with OHCA patients using a nationwide OHCA registry.

Eligibility Criteria:
Inclusion Criteria:

* Out-of-hospital cardiac arrest event

Exclusion Criteria:

* Arrest of non-cardiac origin
* Age \< 18 years
* No any CPR
* Missing data on call time
Pilot Study for Speculum Free Cervical Cancer Screening

The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.

This project is to assess if the introducer, "calla", can be used in place of a speculum during a routine Pap smear. For the patient arm, the introducer will be used in conjunction with standard of care procedures. The healthy volunteer arm will include taking the introducer home for a week to determine if each person can find their cervix without the help of a physician. As well as completing surveys on ease of use and demographics related to their medial history.

Eligibility Criteria:
Inclusion Criteria:

Healthy female

* Aged 21-65 years
* Have had a pelvic exam
* Have conversational proficiency in English
* Highest level of education attained

Exclusion Criteria:

- Pregnant women
Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) in Routine Clinical Practice in the Russian Federation

ANIMA-R is an observational, prospective, non-interventional, multicenter study to assess real-world effectiveness of secukinumab in the treatment of Hidradenitis Suppurativa (HS).

The index date will be the date of secukinumab initiation. During the study, data will be collected from patients receiving routine secukinumab treatment, which is representative of the actual patient population.

The attending physician will decide whether to prescribe secukinumab based on the approved instructions for medical use in a routine clinical setting, regardless of the patient's participation in a non-interventional study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who provide written informed consent form (ICF) to participate in the study.
2. Male and female.
3. ≥ 18 years old.
4. Diagnosis of moderate or severe HS (Hurley stage and IHS4).
5. Patient who initiated treatment with secukinumab no longer than 4 weeks prior to written ICF.
6. Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of study participation.

Exclusion Criteria:

1. Any medical or psychological condition that may prevent the study participation, based on practitioners' decision-making.
2. Participation in an ongoing clinical trial.
3. Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
4. Clinically significant infection exacerbation, including active tuberculosis.
5. Patients with active inflammatory bowel disease (IBD).
6. Age \<18 years.
7. Pregnancy and breastfeeding.
8. Patients who received any vaccine within 4 weeks prior to secukinumab initiation.
Erythromycin in Parkinson's Disease

Gastroparesis (slow stomach emptying) is a common feature of Parkinson's Disease. Levodopa (Sinemet), a common medication for Parkinson's Disease, can make gastroparesis worse. Gastroparesis effects how the levodopa is absorbed and used by the body. This study will explore the possibility of using Erythromycin, a drug commonly used (off label) for gastroparesis, along with levodopa to determine if there is improved levodopa absorption and motor function.

Participants will be required to make four visits for evaluation. Visit 1 is a screening visit, participants will receive the study drug or a placebo during visits 2 and 3, and visit 4 is a follow up visit. Participants will provide blood and urine samples during the visits. Participants will also be required to complete questionnaires and a series of motor tests.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a definitive diagnosis of Parkinson's Disease (per United Kingdom brain bank criteria), Hoehn and Yahr stage 1-3,
* must exhibit unequivocal levodopa responsiveness
* must be able to distinguish between the "off" versus "on" state
* Subjects must be on a stable dose of levodopa for at least 28 days prior to enrollment and should be anticipated to maintain a stable dose throughout both study periods
* Subjects may be on concomitant therapy with Monoamine oxidase B inhibitors, entacapone, and amantadine, though the doses of these medications must have remained stable for at least 28 days prior to enrollment and must be expected to remain stable throughout both study periods.

Exclusion Criteria:

* History of deep brain stimulation for Parkinson Disease
* History of ablative (tissue removal) surgery for Parkinson Disease
* Presence of dementia (MMSE\<25)
* Presence of active psychosis
* History of any chronic gastrointestinal diseases
* History of any prior gastrointestinal surgeries except for appendectomy, cholecystectomy, and hysterectomy
* Any gastrointestinal surgeries in the past 3 months
* Severe dysphagia (difficulty swallowing) to pills or food
* History of physiological or mechanical gastrointestinal obstruction
* History of strictures or fistulae (abnormal or narrow connections) along the gastrointestinal tract
* History of gastric bezoars (undigested mass)
* Allergy to wheat, soy, milk, or nuts
* Presence of portable electromechanical devices such as pacemaker, defibrillator, or infusion pump
* Female subjects who are pregnant or lactating
* Symptomatic orthostatic hypotension (low blood pressure)
* Diabetes
* Presence of symptomatic anemia
* Abnormal liver or kidney function
* Cardiac arrhythmia (past or present) or abnormal QT interval on entrance EKG
* Known hypersensitivity to any of the study drugs
* Subjects receiving certain medications during specified time frames
Mirror Illusion Training and Cross-education

Cross-education describes the transfer of motor performance to the opposite limb following unilateral training and is primarily explained by adaptations within the brain. The mirror training hypothesis suggests that illusionary mirror visual feedback may augment the cross-education of strength to the untrained, contralateral limb. The purpose of this project is to examine how the use of illusionary mirror visual feedback shapes the neuromuscular adaptations that occur for both limbs during unilateral (single-limb) strength training. Our hypothesis is that mirror training will augment the level of cross-education for the untrained arm.

Recent empirical evidence shows a heightened level of strength transfer with the use of illusionary mirror visual feedback, but this was shown for the small muscles of the wrist during isokinetic training. It is unknown if larger, multi-joint muscles respond favorably to mirror training in practical settings. A randomized controlled study design will allocate approximately 20 participants into two groups. One group will perform unilateral strength training with illusionary mirror visual feedback (Mirror) and the other will perform the same unilateral strength training but without a mirror (No-Mirror). The intervention will involve four weeks of unilateral strength training performed twice weekly at high intensities (\>80%1RM).

Eligibility Criteria:
Inclusion Criteria:

* right-hand dominance
* no previous strength training of upper body last 3 months
* no injuries or recent surgeries of the upper limbs
* willingness to adhere to the strength training requirements of the study

Exclusion Criteria:

* current use of hormone replacement therapy
* pregnancy/breastfeeding