cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1500

This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety, tolerability, pharmacokinetic (PK), immunogenicity, and pharmacodynamic (PD) effects of REGN1500 in patients with a metabolic disorder.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed informed consent
* Otherwise healthy men and women ages 18 to 65 years, inclusive
* Body mass index of 18.0 kg/m2to 38.0 kg/m2, inclusive
* Normal standard 12-lead ECG
* Willing to refrain from the consumption of alcohol for 24 hours prior to each study visit
* Willing to consistently maintain his/her usual diet for the duration of the study
* Willing to refrain from strenuous exercise for the duration of the trial
* Willing and able to comply with clinic visits and study-related procedures
* For sexually active men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant) during the full duration of the study.

Exclusion Criteria:

* Any clinically significant abnormalities observed during the screening visit
* History of drug or alcohol abuse within 1 year of screening
* Receipt of another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit.
* Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that may adversely affect the subjects participation in this study
* Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen (HBsAg), and/or positive hepatitis C antibody (HCV) at the screening visit
* Hospitalization for any reason within 60 days of screening
* History or presence of malignancy within 5 years prior to the screening visit (other than successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, and/or localized carcinoma in situ of the cervix
* Any medical or psychiatric condition which, in the opinion of the investigator, would place the subject at risk, interfere with participation in the study or interfere with the interpretation of the study results
* Any subject who is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved in the conduct of the protocol, or family member of staff involved in the conduct of the protocol
* Pregnant or breast-feeding women

Note: The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial and not all inclusion/ exclusion criteria are listed.
Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function

The purpose of the study is to determine whether vestibular and postural compensation following schwannoma surgery is improved by ablating vestibular function prior to surgery, even if vestibular function is absent according to modern assessment techniques

Patients subjected to vestibular schwannoma surgery most often suffer from vertigo after surgery, even if no vestibular function can be found in pre-surgical assessment. According to retrospective data about 33% of patients scheduled for surgery do not have any measurable vestibular function. Even the occurrence of spontaneous nystagmus has been recorded in patients with no or very little function prior to surgery (Parietti-Winkler et al. 2008 JNNP). This indicates that despite new methods of measuring vestibular function, remaining vestibular function can be present and patients might benefit from pre-treatment of gentamicin (Tjernström et al. 2009 JNNP)

Eligibility Criteria:
Inclusion Criteria:

* Vestibular schwannoma advised to surgical treatment
* No measurable remaining vestibular function

Exclusion Criteria:

* impaired decision making
* neurofibromatosis
* signs for central dysfunction
* remaining vestibular function
* Patients are advised not to participate in the gentamicin arm if
* hearing is better than 30 deciBel (dB) in pure tone average (500, 1000, 2000, 3-4000 Hz) and speech discrimination better than 70%
* the neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin associated hearing loss
Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer

Phase I: will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.

Phase II: will assess the efficacy and safety of the 10mg daily dose of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female or male patients ≥ 18 years old with WHO performance status ≤ 1
* HER-2 over-expressing metastatic breast cancer cells confirmed by histology
* Progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy (phase l)
* Patient resistance to trastuzumab and taxanes (Phase ll)
* Measurable disease according to RECIST (Phase ll)
* Patients neurologically stable with adequate bone marrow, liver and renal function

Exclusion Criteria:

* Patients receiving endocrine therapy for breast cancer ≤ 2 weeks prior to study treatment start
* Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these ≤ 4 weeks prior to study treatment start or patients who have received lapatinib ≤ 2 weeks prior to study treatment start
* Patients who have previously received mTOR inhibitors

Other protocol-defined inclusion/exclusion criteria may apply
mHealth for ART Adherence by HIV+ African Americans

The objective of this grant is to create and test a mobile app to support ART adherence among HIV+ African American adults.

The Phase II project will enhance the existing (Phase 1) mobile intervention by offering: 1) a two-way communication capability through which participants can: i) indicate "pill taken" in response to pill reminders, and ii) receive a positive visual icon as behavioral-economics based reinforcement for "pill taken" responses; 2) pharmacist counseling and medication support; and, 3) the addition of educational and motivational text messages. Overall aims are to: 1) expand mhealth intervention to incorporate new Phase II features; 2) evaluate effectiveness in an RCT of HIV+ African Americans; and 3) prepare marketing and commercialization plans. Our long-term goal is to increase ART medication adherence, thus decreasing health disparities, among HIV+, African-Americans.

Eligibility Criteria:
Inclusion Criteria:

(a) self-identify as African American, (b) age 30 or older, (c) HIV positive (d) currently on ART (e) report having problems with, and interest in improving their ART adherence (f) own a smartphone (g) report English as their primary language

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Exclusion Criteria:

(a) not self-identified as African American, (b) under age 30 (c) HIV negative (d) not currently on ART (e) do not report having problems with, or interest in, improving their ART adherence (f) do not own a smartphone (g) do not report English as a primary language and (h) participating in another research study or clinical trial (i) receiving care at non-participating site and, (j) dementia diagnosis.

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The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta

It is claimed that SBO may be responsible for bladder dysfunction in patients without known neurological disease. Subsequently, it was reported that the frequency of SBO in NE cases was higher than normal children. However, in controlled trials, SBO frequency was not different in NE patients compared to the normal population. Conversely, the incidence of dysfunctional bladder in the presence of SBO in NE patients was found to be higher and the response to treatment was worse than in non-SBO patients.

The present study aimed to determine whether the frequency of SBO in patients with NE was higher than in healthy subjects, the effect of SBO on the severity of LUTS and whether treatment response of primary NE patients changed in the presence of SBO.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 6 to 15 years
* at least one night-time wetting weekly

Exclusion Criteria:

* neurological disease,
* diabetes mellitus or insipidus,
* spinal surgery history, spina bifida skin findings,
* chronic renal insufficiency
* and secondary enuresis
Study of ORIC-101 in Healthy Adult Subjects

ORIC-GR-17001 is an open-label, single center, non-randomized, single ascending dose study in healthy male subjects and healthy female subjects of non-child bearing potential. In this study, ORIC-101 will be administered as single-ascending oral doses. The primary objective is to characterize the safety and tolerability of oral ORIC-101.

This is an open-label, single center, non-randomized, single ascending dose study in healthy male subjects and healthy female subjects of non-child bearing potential.

Subjects will receive a single administration of ORIC-101 oral suspension on a single occasion and will be followed in the clinic for at least 96 hours post-dose. Total subject participation will be approximately 5 weeks from screening until discharge from the study.

The primary objective of the study is to characterize the safety and tolerability of oral ORIC-101 administered as a single dose in adult healthy subjects. The secondary objective of the study is to evaluate the pharmacokinetics of ORIC-101 and its metabolites M1 and M2. The exploratory objective of the study is to assess the pharmacodynamics of ORIC-101 by measurement of serum and urine levels of cortisol and other biological markers in healthy subjects

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males or healthy females of non-child bearing potential
2. Age 18 to 55 years, inclusive
3. Weighs more than 50 kilograms (kg), and less than 120 kg, with a body mass index of 18.0 to 32.0 kg/meters squared

Exclusion Criteria:

1. Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 5 half-lives or within 45 days prior to first dose. However, in no event, shall the time between last receipt of IMP and first dose be less than 30 days
2. History of any drug or alcohol abuse in the past 2 years
3. Current smokers and those who have smoked within the last 12 months
4. Females of childbearing potential (female subjects must have a negative pregnancy test). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone \[FSH\] concentration ≥40 international units per litre (IU/L))
5. Women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma
6. Current disease requiring treatment with systemic corticosteroids.
7. Serious adverse reaction or serious hypersensitivity to mifepristone, or any other drug, or the formulation excipients
A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older

The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to adhere to the prohibitions and restrictions specified in this protocol
* In the investigator's clinical judgment, the participant must be in stable health at the time of vaccination. Participants will be included on the basis of medical history and vital signs performed between informed consent from (ICF) signature and vaccination
* Before randomization, a participant must be not intending to conceive by any methods, postmenopausal or surgically sterile
* From the time of vaccination through 3 months after vaccination, agrees not to donate blood
* Must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study
* Participant must be able to work with smartphones/tablets/computers

Exclusion Criteria:

* History of malignancy within 5 years before screening not in the following categories: a) participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; b) participants with a history of malignancy within 5 years before screening, with minimal risk of recurrence per investigator's judgement, can be enrolled
* Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
* History of severe allergic reactions (example, anaphylaxis) to any component of the Quadrivalent high-dose influenza vaccine, including egg protein, or following a previous dose of any influenza vaccine
* Has abnormal function of the immune system resulting from either clinical condition, chronic or recurrent use of systemic corticosteroids within 2 months prior to study vaccination, or immunomodulating agents within 6 months prior to study vaccination
* Per medical history, participant has chronic active hepatitis B or hepatitis C infection
* History of acute polyneuropathy (example, Guillain-Barre syndrome) or chronic idiopathic demyelinating polyneuropathy
* Has a serious chronic disorder, example, chronic obstructive pulmonary disease or congestive heart failure, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition, including conditions placing the participant at high risk for severe influenza, for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
* Received vaccination with seasonal influenza vaccine for the current influenza season in the Northern Hemisphere
Evaluation of an Early Support Programme in Orthophony

Prospective, interventionnal with minimal risks and constraints, multicentric, non-randomized, open study, to measure the impact of an early support programme in speech and language therapy for vulnerable children (PAPEV-ortho), in children born very prematurely or very hypotrophically, on the incidence of language and communication deficits at the corrected age of 2 years.

Prospective, interventionnal with minimal risks and constraints, multicentric, non-randomized, open study, to measure the impact of an early support programme in speech and language therapy for vulnerable children (PAPEV-ortho), in children born very prematurely or very hypotrophically, on the incidence of language and communication deficits at the corrected age of 2 years.

Parents of eligible children are informed of the study either during the hospitalization of the neonatal newborn by a hospital physician, or during a consultation performed during the first 6 months by a pilot physician from the RPSOF-ASNR network, hospital or private practitioner. Parents who agree that the data collected about their child may be used in the study sign a written declaration of free and informed consent.

The Early Support Programme in orthophony (PAPEV-ortho) is systematically proposed to families with possible access to a language therapist in the network.

Early support in speech therapy lasts between 6 months and 24 months of corrected age. It includes 10 to 20 sessions depending on the child's needs. These sessions are conducted by a speech-language pathologist from the RPSOF-ASNR network, trained in the issues specific to the very premature child and the network's tools. The support focuses on:

* the development of parental sensitivity and receptivity
* the development of parental reactivity
* optimization of communication sequences in routine acts and play
* the development of the child's intentionality in play and routine acts
* support for verbal and non-verbal oral communication The participation of the child and his or her parents in the study ends at the end of the consultations and evaluations carried out at 24 months of corrected age.

Children within the group that followed the PAPEV-ortho program will be compared to children who did not benefit from this program.

Eligibility Criteria:
Inclusion Criteria:

* Premature birth \< 32 weeks of amenorrhea
* or premature birth with intrauterine growth restriction (IUGR) \< P3
* corrected age ≤ 6 months at the time of inclusion
* affiliation to a social security system + mutual insurance

Exclusion Criteria:

* genetic pathology
* ongoing developmental care: psychomotricity or speech therapy
* neuromuscular pathology affecting oral and facial motor skills
* severe oral disorders: feeding by gastric tube or gastrostomy
* severe sensory, auditory or visual impairment
* neither of the 2 French-speaking parents
Connective Tissue Graft and Leucocyte - Platelet Rich Fibrin in Alveolar Ridge Preservation

The purpose of our randomized controlled clinical trial is to evaluate radiographic bone dimensional changes and soft tissue healing and thickness after teeth extraction and the implementation of alveolar ridge preservation (RAP) procedures that will involve the application of L-PRF inside the socket in association with a connective tissue graft (CTG) used as a barrier with the periosteal inhibition technique (PI). The present experimental treatment (test group) will be compared with an active comparator (control group) which will involve the insertion of L-PRF alone inside the socket.


Eligibility Criteria:
* Age \> 18 years old;
* General good health (ASA I-II);
* Adequate oral hygiene (Full Mouth Plaque Score ≤ 20%, Full Mouth Bleeding Score ≤ 20%);
* Presence of one or more hopeless teeth requiring extraction.
Assessing Dementia Risk in the Community: The Dementia Population Risk Tool

The purpose of this study is to develop and validate the Dementia Population Risk Tool (DemPoRT) algorithm to predict dementia incidence in the population setting.

The burden of disease from dementia is a growing global concern as incidence increases exponentially with age and average life expectancy has been increasing around the world. Planning for an aging population requires reliable projections of future dementia prevalence and resource requirements, however, existing population projections are simple and have poor predictive accuracy. The Dementia Population Risk Tool (DemPoRT) will predict incidence of dementia in the population setting using multivariable modeling techniques.

The derivation cohort will consist of elderly Ontario respondents of Canadian Community Health Survey (CCHS) (2001, 2003, 2005, 2007; approximately 19 000 males and 25 000 females). Pre-specified predictors include sociodemographic, general health, behavioral, functional and health condition variables. Incident dementia will be identified through individual linkage of survey respondents to population-level administrative health care databases. Using time of first dementia capture as the primary outcome and death as a competing risk, sex-specific proportional hazards regression models will be estimated. The 2008/2009 CCHS survey be used for validation (approximately 4 600 males and 6 300 females). Overall calibration and discrimination will be assessed as well as calibration within predefined subgroups of importance to clinicians and policy makers.

Eligibility Criteria:
Inclusion Criteria:

* Respondents to the Canadian Community Health Surveys

Exclusion Criteria:

* Less than 55 years of age at survey administration
* Prior history of dementia
* Not eligible for Ontario's universal health insurance program
Adipose Derived Regenerative Cells In the Treatment of Diabetic Foot Ulcers

A Prospective, Double-blind, Multi-center, Randomized, Parallel-group safety and efficacy study of adipose-derived regenerative cells (ADRCs) in the treatment of patients with diabetic foot ulcers (DFU).

Subjects will have at least one diabetic foot ulcer between 1 cm2 and 16 cm2 area that remains open despite at least 30 days of DFU care and will need debridement as a part of their care.

Subjects will be randomly assigned to one of two groups (ADRC Group will receive standard care plus ADRC, and Control Group will receive standard care plus matched placebo).

ADRCs will be harvested from a small volume liposuction performed on the same day as, but prior to, the debridement procedure. Fat harvest will occur through small volume (approximately 100-200 mL) liposuction prior to the surgical debridement procedure on the same day as the planned autograft procedure.

The lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs for application to an autograft site. Cells will be delivered via direct injection (minimal wound penetration with a 22 gauge needle, total volume 5 mL) into the DFU (injected around the circumference and applied to the base of the ulcer).

Eligibility Criteria:
Inclusion Criteria:

* T1D or T2D
* Diabetic Foot Ulcer, from 1 to 12 months in duration
* Wagner Grade 1 or Superficial 2
* Adequate perfusion
* Able to undergo liposuction

Exclusion Criteria:

* Diabetic Foot Ulcer penetrates to capsule, tendon, or bone
* Active infection
* Non-diabetic neuropathy
* Significant cardiovascular event within 6 months before screening
Extension Study of GI198745 to Treat Benign Prostatic Hyperplasia

The primary objective is to assess the safety of GI198745 0.05mg, 0.5mg, 2.5mg once daily for 52 weeks.

Upon completion of 24 weeks of GI198745 0.05 mg, 0.5 mg, 2.5 mg, or placebo therapy in study ARI20005, subjects are enrolled into an extension phase and are continued on the same therapy once daily for up to further 28 weeks, followed by up to 16 weeks of post-dosing assessments.

Eligibility Criteria:
Inclusion Criteria:

* Has been receiving the investigational product for at least 20 weeks in the preceding dose finding study and the investigator or subinvestigator has confirmed the tolerability and has judged as appropriate to participate continuously in further 28 weeks treatment.

Exclusion Criteria:

* Is withdrawn from the dose finding study.
* Has less than 75% compliance with the investigational product in the dose finding study at given the informed consent for the long-term extension study.
* Has a prostate cancer at giving informed consent for participating in the long-term extension study; or is suspected to have a prostate cancer in palpation, ultrasound imaging, biopsy, etc. at giving informed consent for participating in the long-term extension study.
* Has the post void residual volume \> 250 ml at starting the long-term extension study. (as measured by suprapubic ultrasound).
* Has chronic bacterial prostatitis or chronic urinary tract infections during the dose finding study
* Has acute urinary retention in the dose finding study.
* Has a history or current evidence of drug or alcohol abuse during the dose finding study
* Has been treated with any investigational product including post-marketing clinical trials during the dose finding study.
* Has myocardial infarction, coronary arterial bypass surgery, unstable angina, arrhythmia, congestive heart failure, cerebrovascular accident during the dose finding study.
* Has any concurrent disease or complication that, in the opinion of the investigator/sub-investigator, is difficult to evaluate efficacy of GI198745 in this study and that might poses additional risk to the patient.
* Is actively trying to procreate in the study period.
* Is unsuitable for this study, in the opinion of the investigator/sub-investigator.