cyrilzakka/clinical-trials huggingface dataset:
RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment

The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of rimegepant as preventive migraine treatment in a cohort of episodic or chronic migraine patients.

Rimegepant belongs to the gepants family, small molecules calcitonin gene- related peptide (CGRP) receptor antagonists. It is a new generation gepant, currently available as an orally disintegrating tablet at a single dose of 75 mg.

It has a double indication both for acute treatment for migraine with and without aura and preventive treatment of migraine. A previous randomized, placebo-controlled phase 2/3 trial demonstrated its effectiveness and tolerability in the preventive setting for patients with episodic and chronic migraine. Previous studies also demonstrated a good tolerability profile. The most commonly reported adverse events were nausea, nasopharyngitis, upper respiratory tract infections and urinary tract infections.

In this prospective multicentric study the investigators aim to evaluate rimegepant effectiveness and tolerability as preventive migraine treatment in a real-world setting. Subjects who meet the inclusion criteria will be enrolled and will participate in the study. Baseline demographic and clinical data will be collected at the baseline visit. The observation period will last for two years during which patients will take rimegepant 75 mg orally disintegrating tablet every other day for a time period related to eventual approval of reimbursability criteria.

Data will be collected at baseline and every three months for two years. Subjects will be asked to keep a headache diary to collect monthly headache and migraine days, migraine severity, associated symptoms and drug consumption. Questionnaires will be collected every three months.

Data collection will focus on: i) demographic data, ii) migraine history, iii) pain intensity, iv) presence and evolution of migraine associated symptoms and aura, v) migraine associated disability, vi) tolerability and eventual treatment- emergent adverse events, vii) treatment persistence, viii) questionnaires related to disability, allodynia, quality of life, interictal burden and effectiveness of the ongoing acute and preventive treatments. The online database REDCap will be used for data collection.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III);
* At least 4 monthly migraine days;
* Good compliance to study procedures;
* Availability of headache diary at least of the preceding months before enrollment.

Exclusion Criteria:

* Subjects with contraindications for use of gepants;
* Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments;
* medical comorbidities that could interfere with study results;
* Pregnancy and breastfeeding.
* Changes in preventive treatments in the month before the first administration of rimegepant
Semaglutide and Intestinal Iron Absorption

Semaglutide belongs to a group of long-acting glucagon-like peptide 1 receptor agonists (GLP-1). Disorders in iron absorption have been linked to numerous medication, dietary, and nutrient interactions thus far. The study aimed to determine whether there is an effect of concomitant parenteral administration of semaglutide and oral iron preparations on iron absorption in patients with type 2 diabetes (T2DM).

Type 2 diabetes mellitus (T2DM) affects over 537 million people worldwide, making it a major chronic and progressive health problem among adults. Novel approaches to managing T2DM have been developed as a result of medical advancements. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are appealing options for the treatment of T2DM, since they efficiently reduce body weight and haemoglobin A1C with a minimal risk of hypoglycaemia.

Semaglutide, a long-acting GLP-1 RA, has a very high structural homology with endogenous GLP-1, high binding affinity to albumin, and resistance to degradation by the intestinal enzyme dipeptidyl peptidase-4. Because of these characteristics and his extended half-life, it can be used once weekly. Similar to all other GLP-1 RAs, semaglutide decreases gastrointestinal motility and slows stomach emptying. Delay in stomach emptying and intestinal motility can interfere with vitamin, mineral, and drug absorption. Iron is one of the essential micronutrients in the human body. On average, 10 - 20 mg of iron is consumed daily through food, but only 1 - 2 mg of iron is absorbed in the duodenum and the first section of the small intestine. It has been shown that drugs which decrease gastrointestinal motility can interfere with iron absorption. However, the relationship between parenteral semaglutide administration and intestine iron absorption has not been the subject of any prior studies. Thus, this study aimed to determine whether there is an effect of parenteral administration of semaglutide on iron absorption in patients with T2DM.

Eligibility Criteria:
Inclusion Criteria:

* T2DM patients
* ages between 45 and 65
* with poorly managed T2DM (HbA1c ≥ 7%)
* who are candidates for treatment intensification and beginning of parenterally administered semaglutide

Exclusion Criteria:

* hypersensitivity to GLP-1 RAs,
* adequately controlled with current glucose-lowering medications,
* already treated with GLP-1 RA,
* type 1 diabetes mellitus or any other form of diabetes,
* hemochromatosis,
* iron deficiency anaemia,
* sideropaenia,
* severe chronic illnesses,
* malignant neoplasms of any site,
* chronic infectious diseases,
* chronic rheumatic inflammatory diseases,
* malabsorption syndrome,
* inflammatory bowel disease,
* history of gastrointestinal tract reduction surgery,
* medications that interfere with absorption,
* perimenopausal women
Homeless Youth Study - Stepping Stone Project

Homelessness is associated with a multitude of negative consequences including an increased risk for mental health problems. Once homeless, these individuals face significant barriers to mental health care and are therefore less likely to receive the treatment they need. Mobile technology may offer a novel platform for increasing access to mental health care in this population. Thus, the primary goals of this pilot study are to (1) establish the feasibility and acceptability of delivering a brief cognitive-behavioral intervention to homeless youth via smartphone technology, (2) examine the extent to which brief cognitive-behavioral interventions delivered via mobile technology improve mental health and trauma-related psychological symptoms in homeless youth, and (3) establish smartphone usage patterns among homeless youth to inform future interventions.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Homeless as defined by lacking "a fixed, regular, and adequate nighttime residence," (Department of Education) including youth who temporarily share the housing of others due to financial hardship
* Currently sleeping in a Chicago-based shelter (at least 50% of nights in the past week)
* Willingness and ability to comply with requirements of the study protocol

Exclusion Criteria:

* Involvement in risky behaviors that could interfere with the ability to fully engage in the study, as determined by the Principal Investigator
* Current involvement in legal proceedings
* Mental retardation or significant cognitive impairment
* Significant suicidal ideation indicated by a BDI-II item 9 score ≥ 2 or enacted suicidal behaviors within 6 months prior to eligibility
* Any concurrent psychotherapy of any duration
* Inability to understand study procedures and participate in the informed consent process
Snacks and Satiety

This study is designed to compare two types of snacks (almonds or a cereal-based snack), eaten between meals, on measures of appetite, including appetitive hormones, self-reported feelings of hunger and fullness, and food intake at a buffet meal or in the home environment. The investigators hypothesize that the acute responses of appetitive hormones to a meal challenge protocol will differ between almond and cereal-based snacks based on multivariate models of satiety that will be predictive of ad libitum food intake at a dinner meal as part of the meal challenge protocol. Further, the investigators will estimate if, under free-living conditions, self-selected and self-reported food intake will show appropriate energy compensation for the added calories of the snacks, and determine if one type of snack is superior to the other in this regard.

This study will use a randomized, parallel design that includes an almond snack intervention and a cereal-based snack intervention group. The almond intervention will be roasted, unsalted almonds at a level of 56 grams per day for 4 weeks. The cereal-based intervention will be isocaloric snacks provided in the form of a mixture of dry cereal, pretzels, and bread sticks for 4 weeks. A satiety test protocol will be done at the beginning and the end of the intervention period. Each test day will include measures of satiety responses to two standard meals, two snacks (either almonds or cereal-based snacks), and a dinner buffet. The protocol to evaluate satiety signals include tonic measures that may signal homeostasis to the brain and evaluation of episodic signals that may drive food intake In addition, other modulators of satiety will be tested including evaluation of preferences for palatable foods, self-reports of cravings and satiety using questionnaires, and perceived hunger, fullness, desire to eat.

Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal
* Body Mass Index 25 - 39.9 kg/m2

Exclusion Criteria:

* Women who are post-menopausal or peri-menopausal
* BMI \< 25 or \> 40 kg/m2
* Allergies to tree nuts
* Using any hormonal contraception including oral contraceptive, contraceptive patch, contraceptive ring, contraceptive injection (e.g. Depo-Provera), or contraceptive implant (e.g. Nexplanon/Implanon)
* Menstrual cycle lengths \< 25 days or \> 45 days, or have amenorrhea, eumenorrhea, or polymenorrhea.
* Pregnant or nursing within the last 6 months, or plan to become pregnant during the trial
* Medical diagnoses of chronic diseases including cardiovascular or pulmonary diseases, renal disease, cancer, type 1 or type 2 diabetes mellitus, thyroid disease requiring medication, inflammatory bowel disease, irritable bowel disease, or those with recent major surgeries
* current medical diagnosis of polycystic ovarian syndrome (PCOS).
Germline Alterations of Tumor Susceptibility Genes in New York Cancer Patients

The basic premise of this research proposal is to determine whether there is any significant association between germline polymorphisms and cancers of colon, bladder, breast, testicular, prostate, ovaries, kidney, lung, lymphoid organs, and head and neck. This is an exploratory study designed to generate hypotheses for further research.

To establish significant correlations between genetic polymorphisms and cancer, a largescale, systematic comparison of genetic alterations utilizing a case-control methodology is proposed. To date, such studies have been limited due to the large number of samples necessary for obtaining statistical significance, and the lack of rapid and accurate methods to screen for genetic polymorphisms. We propose to utilize an anonymized design to obtain DNA from residual material from routine diagnostic blood tests, to link these samples to a limited set of clinical variables, and to test for the frequency of candidate low-penetrance cancer susceptibility alleles. These data will be combined with similar data from a control group of age- and ethnically-matched volunteers for a related cohort study to be conducted separately. Polymorphisms to be screened for include those involving the genes PTEN, APC, TGF βR-I, BLM, CHK2, a p85 phosphoprotein, ATM, ER, PR, MCP-1, MPIF, CCR2/5, CCR3, and SULT1A1. Cancers to be included are breast, bladder, kidney,colon, testicular, lung, prostate, ovarian, lymphoid neoplasms, and head and neck carcinomas. Genes with SNPs known to be relevant for either the development or treatment of lymphoid malignancies will also be targeted. Specifically, candidate genes will be selected from 1) cytokine signaling, 2) DNA repair, and 3) apoptosis regulatory pathways.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a histologic diagnosis of cancer of the colon, breast, bladder, kidney, testicles, lungs, prostate, head and neck, or lymphoid organs, who have donated a diagnostic blood sample as either an inpatient or outpatient at MSKCC.
* All patients who have two or more histologic diagnoses of the same primary tumor type involving the above sites.
* Patients of Ashkenazi Jewish ancestry with a histologic diagnosis of cancer of any type.
* Samples ascertained as part of protocol 98-024A(1) are also eligible for ascertainment in this study.

Exclusion Criteria:

* MSKCC patients without a histologic diagnosis of cancer of the breast, bladder, kidney, colon, testicles, lungs, prostate, or lymphoid malignancy (including all types of lymphoma) will not be eligible for the AMDeC sponsored component of the study.
Optimized Referral of Knee Patients at the Clinic of Sports Injuries

The aim of the study is to evaluate an algorithm to screen patients with a possibility of meniscal injury referred to a sports injury outpatient clinic by using patient-reported symptoms. It will be investigated whether the algorithm is able to identify which patients are deemed relevant to undergo assessment by a physician (i.e. in case the patient need to undergo surgery) and which patients are relevant to undergo assessment by a physiotherapist. This will be evaluated by estimating the sensitivity of the new algorithm compared to actual relevancy based on the traditional clinical assessment of the patients.

According to current practice, patients referred to the Clinic of Sports Injuries will be assessed by either a physician or a physiotherapist. Current practice will continue unchanged during this study.

Before the scheduled assessment, patients will be asked to fulfill a questionnaire including KOOS, a further description of symptoms, previous treatment by physiotherapist and expected upcoming treatment (i.e. surgery or referral to physiotherapist).

An algorithm based on the self-reported information will be used to categorize whether the patient are considered relevant to be referred to assessment by a physician or to assessment by a physiotherapist.

After clinical assessment of the patient, the physician or physiotherapist does a registration of diagnosis, choice of treatment and complexity. Based on choice of treatment and complexity, the patient will be categorized as either relevant to be referred to assessment by a physician or to assessment by a physiotherapist. This categorization is by definition considered correct.

The ability of the algorithm will be evaluated by comparing it's categorization to the correct result. Sensitivity will be estimated.

Eligibility Criteria:
Inclusion Criteria:

* Patients above the age of 35 referred to the Clinic of Sports Injuries with knee symptoms

Exclusion Criteria:

* Cognitive or language problems that precludes the filling of the questionnaires
* Previous surgery in the knee
* Symptoms only located in the anterior part of the knee
Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine

To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study.

Eligibility Criteria:
Inclusion criteria

* Subjects must have been enrolled in the Rota-028 study.
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Subjects should have received two doses of hepatitis B vaccine: at birth and at approximately one month of age.

Exclusion criteria

* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Primary ACL Reconstruction in Patient Over 40 Years: Allograft Versus Autograft

The aim of this study is to investigate the differences in graft failure between patients that underwent ACL reconstruction using allograft tendons and patients that underwent ACL reconstruction using autograft tendons in patients older than 40 y.o. and after at least 2 years of follow-up. The hypothesis of the study is that there will be a difference in graft failure and patient reported functional outcomes between allograft and autograft ACL reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male and female patients of fertile age can be recruited
* Patients aged 40 years old and above, and 2 years minimum of follow-up
* Patients that underwent primary ACL reconstruction with allograft an autograft tendons

Exclusion Criteria:

* Multiligamentous lesion
* Meniscal tear leading to subtotal or total meniscectomy or meniscal graft
* Indication for major cartilage restoration or resurfacing
* Ipsilateral knee fractures
* History of ligament injury
* Concomitant extracapsular procedures
* Ipsilateral or contralateral knee surgeries
Effects of Whole Body Vibration in Elderly Patients Requiring Rehabilitation: A Pilot Study

The aim of this study is to accumulate data about the influence of whole body vibration on the functional recovery of adult patients with various neuromuscular and musculoskeletal deficits requiring physical medicine and rehabilitation treatments.

We know that whole body vibration can cause remarkable increase in power in athletes, however, to what extent elderly and disabled individuals could benefit from it is currently unknown. Our primary goal is to investigate if treatment with whole body vibration in elderly persons and patients with various neuromuscular and musculoskeletal deficits would result in more rapid return of their function and presumably at a higher level than comparable group of patients undergoing standard physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* A history of one of the following conditions: CVA, Parkinson's disease, incomplete spinal cord injury, frail elderly, urinary incontinence, COPD, fibromyalgia
* Patients with neuromusculoskeletal problems affecting strength, balance, and coordination
* Must have all appendages (arms and legs) intact, not an amputee

Exclusion Criteria:

* Pregnancy
* Unable o participate in continuing outpatient therapy services at a location where the whole body vibration equipment is available
* Untreated deep venous thrombosis
* Other condition that will lead to poor treatment adherence
* History of join replacement of lower limbs, shoulders, or devices in the spine
Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload

The primary purpose of this study is to evaluate the effect of deferasirox on renal hemodynamics by determining glomerular filtration rate (GFR), renal plasma flow (RPF) and filtration fraction (FF).


Eligibility Criteria:
Inclusion criteria:

* Male or female patients ≥ 18 years of age without prior history of deferasirox treatment
* β-thalassemia patients receiving regular transfusions every 2-5 weeks
* Transfusion history of ≥ 20 units of packed red blood cells

Exclusion criteria:

* Abnormal renal function at baseline
* ALT greater than 5 x ULN at screening
* Patients with underlying cardiac disease requiring continuous iron chelation therapy

Other protocol-defined inclusion/exclusion criteria may apply.
Feasibility and Efficacy of Assisstive Tactile and Auditory Communicating Devices

This pilot study will integrate multi-sensor fusion techniques (software) to effectively combine information obtained from the newly embedded infrared, ultrasound, and stereo-camera-based sensor systems (hardware) that are implemented into the VIS4ION platform.

The core of this technology is based on 4 components: (1) a wearable vest with several distinct range and image sensors embedded. These sensors extract pertinent information about obstacles and the environment, which are conveyed to (2) a haptic interface (belt) that communicates this spatial information to the end-user in real-time via an intuitive, ergonomic and personalized vibrotactile re-display along the torso. (3) A smartphone serves as a connectivity gateway and coordinates the core components through WiFi, bluetooth, and/or 4G LTE, (4) a headset that contains both binaural, open-ear, bone conduction speakers (leaving the ear canal patent for ambient sounds) and a microphone for oral communication-based voice recognition during use of a virtual personal assistant (VPA).

Blindfolded-sighted, and blind subjects in a real-world, combined obstacle avoidance / navigation task will serve as an independent measure of overall improvements in the system as well as a roadmap for future avenues to enhance performance.

Further, a prospective, randomized crossover, controlled, non-blinded phase will be conducted in Thailand as part of this study to compare and evaluate effectiveness of the wearable vest for increasing navigation and quality of life.

Investigators will try to develop algorithms that will recognize multiple objects and persons in real-time (enhanced scene interpretation for multi-object identification). And based on that, human-centered simulation trials and experiments for feasibility and efficacy of the platform's tactile and auditory 'communication' outputs will be conducted. Finally auditory and tactile 'prompts' (system output) based on the end user's immediate needs based on initial testing results, will be integrated into the platform.

Additional activities will occur at the Thailand site. In the second phase, an improved system will be tested in an extended-use experiment, detecting for health-related changes in our participants (increased mobility and QoL). The study team will further test the generalizability of the new mapping technology in a more challenging environment, testing system performance using metrics, comparing results between current and previous systems.

Eligibility Criteria:
Inclusion Criteria:

* People with visual impairments of all different levels and etiologies.

Exclusion Criteria:

* Significant cognitive dysfunction (score \<24 on Folsteins' Mini Mental Status Examination)
* Previous neurological illness, complicated medical condition;
* Significant mobility restrictions; people using walkers and wheelchairs
* Pregnancy