cyrilzakka/clinical-trials huggingface dataset:
A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)

This is a randomized, observer-blinded, placebo-controlled study to evaluate safety, tolerability, immunogenicity, and pharmacokinetics of repeat dosing of intravenous (IV) UTTR1147A. The study will consist of a repeat dose escalation in HVs, in participants with UC, and in participants with CD across multiple sites.


Eligibility Criteria:
Inclusion Criteria:

General inclusion criteria:

* No history of malignancy
* Documentation of age-appropriate cancer screening based on local/country-specific guidelines
* For women of childbearing potential: agreement to remain abstinent or use contraceptive methods
* For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm

For HVs Only:

* Age 18 - 50
* Body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m2), inclusive
* In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs, and clinical laboratory evaluations should be within the reference range for the test laboratory unless deemed not clinically significant by the investigator and Sponsor

For Participants with UC or CD:

* Age 18 - 80
* Eligible to receive biologic therapy
* Disease duration of \>/= 12 weeks
* Diagnosis of moderate to severe UC or CD

Exclusion Criteria:

General exclusion criteria:

* History of inflammatory skin disorders
* History of any cancer
* History of anaphylaxis, hypersensitivity, or drug allergies
* History of alcoholism or drug addiction
* Positive tests indicating infection for hepatitis C, hepatitis B, or HIV
* Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days or 5 half-lives of investigational product, whichever is greater, prior to study drug administration
* Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 90 days or 5 half-lives, whichever is greater, prior to study drug administration
* History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
* Family history of sudden unexplained death or long QT syndrome
* Any acute or chronic condition that would limit the subject's ability to complete and/or participate in this clinical study
* Pregnant or lactating, or intending to become pregnant for duration of study

For HVs Only:

* Known family history of gastrointestinal (GI) and/or colon cancer
* Prior exposure to UTTR1147A

For Participants with UC or CD:

* Significant uncontrolled co-morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or GI disorders
* History of primary sclerosing cholangitis
* Active anti-TNF induced psoriasiform or eczematous lesions
* Moderate to severe anemia
* Presence of an ileostomy or colostomy
* Total proctocolectomy
* Positive screening for latent mycobacterial tuberculosis infection
* Impaired renal function
* Impared hepatic function
Kinematic, Kinetic, and Metabolic Comparison of Bilateral Transfemoral Ambulation With Passive Versus Powered Prosthetic Devices

The purpose of this descriptive and exploratory pilot study is to investigate: (1) sagittal plane hip kinematics and kinetics and (2) metabolic consumption/cost, for bilateral transfemoral walking with passive prostheses versus powered prostheses. The pilot study will collect data from three subjects with bilateral transfemoral amputations. Differences in kinetics, kinematics, and oxygen consumption/cost when comparing passive and powered components may indicate benefits for clinical application of powered devices for persons with lower limb amputation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* All causes of limb amputation: congenital, trauma, vascular, limb salvage, infection.
* All transfemoral residual limb lengths: joint disarticulation, long, medium, short, very short.
* Subjects currently walk with entirely passive type prostheses daily.
* Subjects walk without assistive devices OR with single point cane.
* High-activity level walkers

Exclusion Criteria:

* Ages \< 18 or \> 45 years
* Medical comorbidities or existing conditions that may impede the subjects ability to complete the protocol excluding the amputations.
* Current medications or pharmaceutical interventions that may impede the subjects ability to complete the protocol.
* Any powered prosthetic component or prosthesis, including but not exclusive to: Ossur Proprio Foot, BiOM or BiOM T2 System Foot, Ossur Power Knee, Ossur Symbionic Leg.
* Subjects requiring a walker, crutches, quad cane, or other assistive devices excluding a single point cane.
* Low-activity level walkers
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects

This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of CC-90006 following administration of single subcutaneous doses in healthy subjects.

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic profile of single-ascending doses of CC-90006 in healthy subjects.

This will be a placebo-controlled, single-ascending dose study of CC-90006. Approximately 40 subjects will be enrolled. Five dose levels are planned. Each dose level will enroll 8 subjects who will be assigned randomly to receive active CC-90006 (6 subjects) and placebo (2 subjects).

Eligible subjects will check into the clinic site on the day before dosing (Day -1) and receive the assigned dose by subcutaneous injection the following day (Day 1). Subjects will be discharged from the site on Day 4 and return for visits on Days 8 (week 1), 15 (week 2), 22 (week 3), 29 (week 4), 36 (week 5), 43 (week 6), 57 (week 8), and 71 (week 10). Subjects will also be followed up via a phone call on Day 105 (week 15). Safety assessments will be performed and blood samples will be collected for determination of levels of CC-90006 in the blood.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, and a body mass index (BMI) of ≥ 18 and ≤ 33 kg/m2 with body weight ≥ 50 and ≤ 90 kg at screening.
* Females must have been surgically sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingo-oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle-stimulating hormone \[FSH\] level of \> 40 IU/L at screening).

Exclusion Criteria:

* Exposure/treatment to an investigational (new chemical entity) or marketed drug or biologic within 30 days preceding the first dose administration, or five half-lives of that investigational drug or biologic, if known (whichever is longer).
* Donation blood or serum within 8 weeks before the first dose administration to a blood bank or blood donation center.
* History of alcohol or drug abuse (as defined by the current version of the DSM) within 2 years before the first dose administration, or positive alcohol or drug screen.
* Vaccination within 30 days prior to the first dose administration or has plans to receive a vaccination during the course of the study (including the follow phone call on Day 105).
Exposure Therapy for Auditory Sensitivity in Autism

Auditory hyper-reactivity affects up to 66% of children with autism spectrum disorder (ASD) and has been linked to greater stress and anxiety for children and their families. Exposure and Response Prevention (E/RP) is highly effective for reducing obsessive/compulsive behaviors in children with both OCD and ASD. This study is the first to assess the feasibility and efficacy of E/RP for auditory sensory hyper-reactivity in ASD.

Sensory processing difficulties have been well documented in children with Autism Spectrum Disorder (ASD). In fact, "hyper- or hypo-reactivity to sensory input" has recently been added to the diagnostic criteria of this disorder. Hyper-reactivity features are particularly disruptive to children's abilities to engage in everyday activities and pose a significant problem for patients and their families. In children with high functioning pervasive developmental disorder, hyper-sensitivity is associated with symptoms of anxiety and depression. For sensory processing difficulties, children with ASD are primarily referred to Occupational Therapy (OT) services for treatment. These patients are also often seen by mental health professionals to address related disorders such as anxiety, ADHD and behavior problems. Currently, there are no evidence based approaches for specifically addressing auditory hyper-reactivity in ASD. Exposure and response prevention (E/RP), derived from systematic desensitization, is highly effective at reducing avoidance behaviors associated with phobias and obsessive and compulsive disorder (OCD). In mental healthcare settings, ER/P has been shown to be effective for reducing compulsive behaviors in children with OCD and concurrent ASD. E/RP has also been piloted for treating restricted, repetitive behaviors in ASD and demonstrates good feasibility. E/RP may also be useful for reducing aversive responses to auditory stimuli in children with ASD. Occupational Therapists (OT) are the primary service for providing treatment for sensory processing and arousal level modulation difficulties in children with ASD. Thus, OTs are potentially well suited to provide an E/RP aimed at reducing sensory hyper-reactivity in ASD. This study will investigate the feasibility and efficacy of utilizing an E/RP approach for treating auditory hyper-reactivity in ASD.

Eligibility Criteria:
Inclusion Criteria of children:

* autism spectrum disorders (ASD) diagnosis with symptoms of auditory hyper-sensitivity/reactivity.
* verbal communication skills for utilizing the Subjective Units of Distress (SUD) scale (no cut-off for IQ).

Exclusion Criteria of children

* behavioral diagnosis of Oppositional Defiant Disorder or Conduct Disorder
* history of child abuse that is related to sound sensitivity
Use of Virtual Reality to Reduce Morphine Consumption in Adolescents Undergoing Scoliosis Surgery

The objective is to evaluate the effect of the association of virtual reality sessions with usual management on the cumulative consumption of morphine equivalent post-operatively in adolescents aged 13 to 18 years who have undergone scoliosis surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient between 13 and 18 years old, i.e. the age to use a virtual reality helmet according to the manufacturer's recommendations.
* Patient with an indication for idiopathic scoliosis surgery.
* Free, informed and signed consent by patients (or parents/parental guardians) and the investigator (no later than the day of inclusion and prior to any review required by the research)

Exclusion Criteria:

* Patient undergoing surgery for neurological scoliosis.
* Impossibility to use the VR helmet (blindness, eye infection, helmet wound, epilepsy, psychiatric or cognitive disorder incompatible with VR).
* History of adverse effects while wearing an VR helmet (nausea, vomiting, headache, visual disturbances)
* Patient with a contraindication to the use of morphinics
* Patient whose both parents benefit from a legal protection measure (guardianship, curatorship, safeguard of justice)
Adherence to Dolutegravir and Outcome

The main assumption is that the dolutegravir can get virologic suppression to suboptimal adherence levels (between 80 and 95%, and after treatment interruptions) where other molecules are not capable, due to their pharmacokinetic/pharmacodynamic (pardonnance).

While the investigators goal is not to compare molecules (study with one arm) in terms of forgiveness, the results of this cohort in terms of forgiveness could be compared to other cohorts available.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1
* Age over 18 years
* Information letter signed
* ART (antiretroviral therapy) with at least 3 active molecules
* Patients starting treatment with dolutegravir (naïve to antiretroviral treatment, switch, virologic failure)

Exclusion Criteria:

* pregnant woman
* HIV-2
* Patient does not have responsibility for the observance of treatment (disorder of judgment, guardianship, institutionalization)
* Patient receiving aid incompatible with compliance with the use of electronic pillbox
Sleep Disturbances on Postural Control in the Elderly Population

The sleep disorders are common among older adults and comprises of wide spectrum of the sleep related issues like poor sleep quality, sleep deprivation and excessive day time sleepiness.

Earlier studies were carried to determine the effect of sleep deprivation on the postural control parameters. The effect of poor sleep quality and excessive daytime sleepiness on the postural control were not widely studied. Aim : To determine the effect of the sleep quality and excessive daytime sleepiness on the postural stability during quiet standing and whether this influence vary based on the availability of the visual feedback.

Eligibility Criteria:
Inclusion Criteria:

* Be able to stand unsupported with eyes opened and eyes closed for 30 seconds.

Exclusion Criteria:

* Elderly with uncorrected visual impairment, Underwent bilateral hip replacement.
* Participants using drugs which affect control.
* Participants with previous history of conditions which affect postural control.
Precision Medicine in the Prostate Cancer Care Pathway

This study aims to evaluate the use of a prostate cancer specific predisposition genetic panel test in men with / at high risk of prostate cancer. The genetic test will analyse men's DNA samples for the presence of mutations in rare genes as well as common genetic variation to provide men with information about their risk of prostate cancer. This study will evaluate the clinical impact of the test on risk assessment and clinical management in terms of screening and treatment.


Eligibility Criteria:
Inclusion Criteria:

Affected cohort:

1. Affected with PrCa \< 70 years or
2. Affected with metastatic castration resistant PrCa (mCRPC) at any age or
3. Affected with PrCa and a family history defined as

   1. two or more cases in family with one case \< 70
   2. three or more cases any age (FDR or SDR)

Unaffected cohort:

Aged \>30 and with a family history defined as:

1. FDR diagnosed \< 70
2. 2 or more cases in First or Second Degree Relatives (FDR/SDR) with one case diagnosed \< 70 years
3. 3 or more cases at any age (on same side of family)

Exclusion Criteria:

* • WHO performance status 4
Brief Child Safety Interventions in Emergency Departments (Safety in Seconds)

Safety in seconds is a randomized controlled trial of a computer tailored Injury Prevention program which was conducted in the waiting area of a level 1 pediatric trauma center. A computer kiosk was used to randomly assign participants to study groups, collect baseline data and generate tailored reports based on responses to assessment items. An intervention group received a personalized and stage-tailored safety report and a control group received a personalized, but otherwise generic report on other child health topics. Telephone follow-up interviews were conducted 2-4 weeks and again 4-6 months after enrollment. Home visits were completed for a subset (n=100) of parents who completed the 4-6 month follow-up interview. The study aimed to increase knowledge, self reported and observed safety behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Eligible parents or guardians had to be English-speaking;
* have a child between 4-66 months of age seeking treatment for an injury or medical complaint, or have an age-appropriate sibling of a child being seen for these reasons;
* live in Baltimore City;
* and live with the child at least some of the time.

Exclusion Criteria:

-parents which did not meet inclusion criteria
AMG 386 (Trebananib) in Ovarian Cancer (TRINOVA-2)

To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS)

The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo plus PLD in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer
* Radiographically documented disease progression either on or following the last dose of the prior regimen for epithelial ovarian, primary peritoneal, or fallopian tube cancer
* Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
* Female 18 years of age or older at the time the written informed consent is obtained
* Adequate organ and hematological function

Exclusion Criteria:

* Subjects who have received more than 3 previous regimens of anti cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
* Subjects treated with prior pegylated liposomal doxorubicin (PLD) or any anthracycline-based or mitoxantrone-based chemotherapy
* Subjects with primary platinum-refractory disease
* Subjects with platinum-free interval (PFI) \> 12 months from their last platinum based therapy
* History of central nervous system metastasis
* Major surgery within 28 days prior to randomization or still recovering from prior surgery
A Biological Sample Collection Protocol of Women With and Without Breast Cancer

The purpose of this trial is to collect plasma, serum, whole blood and tissue samples from women with breast cancer and plasma, serum, whole blood from healthy women, which will be made available to researchers for biomarker analysis.

OUTLINE: This is a multi-center study.

The treatment plan for each breast cancer subject will be determined at the discretion of the treating physician and subject. This protocol does not prescribe any particular standard of care treatment.

There will be no treatment for the healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

FOR WOMEN WITH BREAST CANCER

* Histologically or cytologically confirmed invasive malignancy or ductal carcinoma in situ of the breast.
* Preparing to begin a new regimen for breast cancer (adjuvant, locally recurrent, any line metastatic).
* Female.
* Age \> 18 years at the time of consent.
* Written informed consent and HIPAA authorization for release of personal health information.

FOR HEALTHY VOLUNTEERS

* No known history of invasive malignancy or ductal carcinoma in situ. Volunteers must not have prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), colonic polyp with focus of adenocarcinoma) can also be enrolled as healthy volunteers.
* Female
* Age \> 18 years at the time of consent.
* Written informed consent and HIPAA authorization for release of personal health information.

Exclusion Criteria:

* Females must not be pregnant.
Scale Development Study

The aim of this study was to develop a scale to measure humanistic care competencies for nursing students.

Studies in the literature show that humanistic care perception should develop as a student. At this point, it is of great importance to know the competency level of nursing students regarding humanistic care. Although the evaluation of competency and professional development is an important point in nursing education, the difficulty of defining the concept of competency reveals the need for measurement tools. A valid and reliable scale is needed to be used in measuring the humanistic care competencies of nursing students. Reliable measurement of humanistic care competency in nursing students will guide the education curriculum. This study is an original study in its field as it is the development of a scale measuring competency regarding humanistic care.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate.
* Being a 2nd, 3rd or 4th grade student in the nursing department.

Exclusion Criteria:

* Being a first year student.
* Being absent and on academic leave during the period in which the study was conducted.
Clinical Study to Compare the Efficacy of Erbium-Yag Laser or CO2RE Intimate Laser With Sham (COER)

This trial compares the efficacy of two different laser treatments for vaginal atrophy symptoms between them and with sham treatment. Patients will be randomized to one of the two lasers or sham treatment.

Patients over 45 years of age with one or more AVV symptoms who wish to participate in the study will be included, 2 laser sessions spaced one of another 4-6 weeks, and final tracking visit 4-6 weeks of the last laser session.

Each patient shall be randomly assigned an arm of tto, with laser CO2, or laser Erbium, or sham group

Eligibility Criteria:
Inclusion Criteria:

* Women older than 45 years with at least one year of amenorrhea and at least one symptom of vulvovaginal atrophy of moderate and / or severe intensity.

Exclusion Criteria:

* Hormone treatment in the last three months for vulvovaginal atrophy
* Treatment with vaginal moisturizers in the last week for vulvovaginal atrophy
* Laser treatment in the last 12 months.
* Acute and recurrent infections of the urinary tract in the last 3 months.
* Acute genital infections
* Vaginal prolapse
* Alterations in the area to be treated, such as lacerations, abrasions or ulcers (time of resolution at medical discretion)
* Chronic decompensated noncommunicable diseases
* Women who are pregnant or have given birth in the last 3 months