cyrilzakka/clinical-trials huggingface dataset:
Phase 1b Safety, Tolerability, and PK Study to Assess GS-5737 in Subjects With CF

This study will determine the safety, tolerability, and pharmacokinetics of a single dose of GS-5737 administered with a 2.8% saline solution vehicle in adult subjects with CF.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, ≥ 18 years of age, at Screening
* Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria, with at least 1 of the following: Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR Abnormal nasal transepithelial potential difference (NPD) test OR Two well-characterized, disease-causing genetic mutations in the CF transmembrane conductance regulator (CFTR) gene AND 1 or more accompanying clinical features consistent with CF
* FEV1 ≥ 40% and ≤ 90% predicted
* BMI ≥ 19 and ≤ 30 kg/m2
* Clinically stable with no evidence of significant new or acute respiratory symptoms
* Chest radiograph without significant acute findings; or chest radiograph, CT, or MRI obtained and interpreted within 90 days prior to enrollment, without acute findings and no significant intercurrent illness; chronic, stable findings are allowed
* History of lifetime smoking \< 5 pack-years (ie, 1 pack per day x 1 year =

  1 pack-year) and non-smokers of at least 60 days duration prior to Screening
* Estimated creatinine clearance ≥ 80 mL/min at Screening
* Negative drug tests; including alcohol
* Hepatitis B, C, \& HIV Negative
* Surgically sterile or ≥ 12 months post-menopausal
* Non-pregnant females

Exclusion Criteria:

* Experienced symptoms of recent acute upper or lower respiratory tract infection or acute pulmonary exacerbation requiring treatment within 2 weeks prior to Screening
* Plasma potassium ≥ 5 mEq/L
* Changes in chronic azithromycin use, bronchodilator (BD), dornase alfa, HS, physiotherapy technique or regimen, antibiotics or corticosteroid medications within 28 days prior to Screening
* History of sputum or throat swab culture yielding Burkholderia species within 2 years of Screening
A Biologic Validation of Biomarkers of Progressive NEC & Sepsis

Necrotizing enterocolitis (NEC) is a severe, sometimes life-threatening inflammation of the intestine that occurs most often in premature babies. If it progresses, the wall of the intestine may perforate, spilling bacteria and stool into the abdomen. Parts or all of the intestine may die. Despite 30 years of clinical studies, the cause of NEC remains unknown.

In this study, we will be conducting an independent case-control validation study to verify the diagnostic and prognostic biomarker panels, develop validated biomarkers on boisensors in preparation for prospective validation studies, and conduct independent prospective validation of biosensor based biomarker panels on clinical samples.


Eligibility Criteria:
Inclusion Criteria - NEC/Sepsis Cohort GA \< 29 weeks Current age equal or \<12 weeks Suspicion of NEC or Sepsis

Exclusion - NEC/Sepsis Cohort Current or prior diagnosis of NEC Early onset infection (equal or \<72 hours of life) Previous diagnosis of sepsis within 7 days Previous abdominal surgery Significant congenital anomaly

Inclusion Criteria - SIP Cohort Infants born at \<29 weeks gestation Equal to or \<12 weeks of age at the time of eligibility assessment a decision to perform surgery (or drain) for suspected NEC or SIP

Exclusion - SIP Cohort Congenital infection (Equal to \<72 hours of life) Prior episode of NEC or SIP Prior laparotomy or drain for SIP or NEC
CAPABLE for Frail Dually Eligible Older Adults

The Johns Hopkins School of Nursing offers this research study which aims to learn more about whether services that help with medications, muscle strengthening, pain management and changes to houses can help improve older adults' ability to, walk, and take care of themselves while saving costs by reducing hospitalizations and nursing home admissions.

* 65yrs or older
* Be able to stand (with or without assistance)
* Have some difficulty with getting dressed, or preparing food, bathing
* Receive a low monthly income
* Have no plans to move in the next year
* NOT be receiving home nursing or other therapy right now

Eligibility Criteria:
Inclusion Criteria:

* 65 or older
* Cognitively intact (≥ 10 on Brief Interview of Mental Status)
* Difficulty with ≥ 2 IADLS or ≥ 1 ADL
* ≤ 199% of Federal Poverty level

Exclusion Criteria:

* Terminally ill

  --Active cancer treatment
* Hospitalized \> 3 times in last 3 years
* Receiving home nursing, Occupational Therapy or Physical Therapy
* Don't have phone or do plan to move in less than a year
The Effects of OC000459 on Nasal Mediators

This is the first proof of concept study for OC000459 and is undertaken to assess the effects of the compound on the development of inflammatory cytokines in a model (nasal allergen challenge model) that is validated and clinically safe and easy to conduct. OC000459 will be compared with placebo in the study.

The study will be a randomised, double blind, placebo controlled, crossover evaluation of the effect of OC000459 on cytokine secretion induced by nasal allergen challenge. Male subjects with a known history of allergic rhinitis and screening positive to allergen will be included. After dosing with OC000459 or placebo, nasal allergen challenge will be performed and measurements made in the nasal fluids. Nasal symptom scores will also be recorded. Safety parameters will be monitored throughout.


Eligibility Criteria:
Inclusion Criteria:

1. Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.

Exclusion Criteria:

1. Medical conditions likely to affect the outcome of the study.

2 History of immunotherapy in the past 3 years or currently on an immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.

3. Any infirmity, disability, or geographic location which, in the opinion of the principal investigator, would limit compliance with the protocol.
Study Evaluating MYO-029 in Adult Muscular Dystrophy

The purpose of this phase I/II, multicenter, safety trial is to study MYO-029 in adult patients with muscular dystrophy.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Confirmed clinical and molecular diagnosis of Becker Muscular Dystrophy (BMD), Facioscapulohumeral Muscular Dystrophy (FSHD), or Limb-Girdle Muscular Dystrophy (LGMD)
* Independently ambulatory

Exclusion Criteria:

* Patients with certain clinical conditions
* Patients using steroids or other medications with the potential to affect muscle function
* History of sensitivity to monoclonal antibodies or protein pharmaceuticals
* Pregnant or lactating women.
Retrospective Study of the Safety and Efficacy of PLLA for Skin Flaccidity in Labia Majora and/or Pubis Region

Phase IV, retrospective, single-center, clinical trial, chart review to evaluate the safety and efficacy of poly-L-l-lactic acid \[PLLA-SCA, Sculptra®\] in women who underwent at least one treatment for skin flaccidity of the labia majora and/or pubis region for safety evaluation and three treatment sessions for efficacy evaluation.

This is a phase IV, retrospective, single-center, clinical trial of medical record data collection to evaluate the safety and effectiveness in subjects who have undergone at least one application of poly-L-l-lactic acid (Sculptra®) for skin flaccidity treatment in the labia majora and/or pubis region. All medical charts of subjects treated for this condition at the clinic treated from Jan1st 2022 and on will be screened for inclusion. The reason for not including a subject will be documented.

During the study, the medical records of subjects who presented skin flaccidity of the labia majora and/or pubis region will be evaluated to anamnesis and physical examination and information will be obtained on demographic data, clinical history, previous treatment(s) in the study region, number of treatment sessions with Sculptra®, as well as data on product dilution, technique used, doses injected, and adverse events related to Sculptra® and/or the injection procedure. Clinical evaluations will also be performed through the information and photographic records obtained through the evaluation of the medical records of these subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects able to read, or follow reading, understand, and sign the Informed Consent Form and the Authorization Form for Imaging Usage approved by the REC/CONEP system;
2. Subjects aged 18 years or older;
3. Having received at least 1 (one) session of Sculptra® for labia majora and/or mons pubis skin flaccidity.
4. Available clinical information and treatment data in the medical records.
5. Having medical records that present suitable photographic records prior and after the Sculptra® injections that allow a skin condition assessment of labia majora and/or mons pubis.

Exclusion Criteria:

1. Having any clinical condition or laboratory disorder, recorded at the medical record, which may compromise trial participation according to the investigator assessment.
2. Having any procedure performed on the labia majora and/or mons pubis skin within12 months prior to the first administration of PLLA (Sculptra®).
3. Participation in another clinical trial in the 30 days previous the study start.
Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection

The primary objective of this study is to characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment in CHB-infected adolescents. This includes prospectively evaluating and comparing the bone mineral density (BMD) change between CHB-infected adolescents 12 to \< 18 years of age treated with tenofovir DF in European treatment centers who are assigned to one of two schedules for renal and bone laboratory monitoring and BMD measurement.


Eligibility Criteria:
Key Inclusion Criteria:

1. 12 to \<16 years of age
2. Documented chronic hepatitis B virus (HBV) infection
3. Weight ≥ 35 kg
4. Able to swallow oral tablets
5. Negative pregnancy test for females of childbearing potential
6. Adequate kidney (renal) function
7. Parent or legal guardian of potential study subjects able to provide written informed consent

Key Exclusion Criteria:

1. Previously received tenofovir DF
2. Sexually-active males or females of reproductive potential who are not willing to use an effective method of contraception during the study
3. Females who are pregnant or breastfeeding, or females who wish to become pregnant during the course of the study
4. Known hypersensitivity to tenofovir DF, the metabolites or formulation excipients
5. Any condition (including alcohol or substance abuse) or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with treatment requirements

Note: Other protocol defined Inclusion/Exclusion criteria may apply
An Assistive Powered Wheelchair: Stage 2 Trial

Preliminary evaluation of an obstacle alerting system to enhance the user's independent mobility by improving their confidence to drive and their safety in driving a powered wheelchair.

Many powered wheelchair users find that collision free driving presents a significant challenge to confident and safe driving. In some cases so much so that the user will not drive their chair in some environments.

Interviews with users in the EDUCAT project confirmed that users had problems driving safely and confidently in a confined space, passing through doorways or down narrow corridors and when reversing.

Therefore the goal of this stage of the project is to improve the quality of life of the powered chair user by developing an obstacle alerting system which will help improve their confidence and safety in driving.

This was to be achieved by asking expert users to provide feedback on the impact and usefulness of providing information about the presence and location of obstacles in the vicinity of their powered wheelchair.

There are two aspects to this.

1. User assessment of the usefulness of the obstacle alerting feedback. This will include user evaluation of the value of the different modes of feedback - audio, visual and haptic - and how best to adapt these to the range of driving environments and driving speeds. And what level of control the user requires to select and deselect these options.
2. Monitoring the user's driving patterns with and without obstacle alerting -using the Stage 1 recording device.

The analysis of this data, and feedback from the Users and carers will inform the development and design of the obstacle alerting system.

Because of the COVID-19 pandemic the trial could not be carried out with powered wheel-chair users participating as they represented a clinically vulnerable part of the population. The trial was, therefore, adapted and carried out with adult non-wheelchair users.

Eligibility Criteria:
Inclusion Criteria:

1. Adults who are not wheelchair users.
2. Willing and able to provide a valid consent.
3. Able to participate in interviews aided or unaided using preferred method of communication.
4. Willing to drive a powered chair.

Exclusion Criteria:

1. Lacks capacity to consent
Clinical and Genetic Findings in Patients With PRPF31-associated Retinitis Pigmentosa

Retrospective chart review study to elucidate the genotype and phenotype of patients with PRPF31-associated retinitis pigmentosa and asymptomatic carriers of the respective variant(s)


Eligibility Criteria:
Inclusion Criteria:

* genetically confirmed PRPF31-associated inherited retinal dystrophy or asymptomatic carrier of the respective variant(s)

Exclusion Criteria:

* none
Usefulness of C-reactive Protein Testing in Acute Cough

The aim of this study is to evaluate the usefulness in Russian general practice of C-reactive protein testing in patients with acute cough or lower respiratory tract infections.

In addition to studying the effect of C-reactive protein testing on the prescription of antibiotics, the purpose is to find out whether the frequency of referral to radiography could be reduced.

Eighteen general practitioners, from both urban and rural offices, were randomised into intervention and control groups. All registrations were made by general practitioners in their offices.

The case report form was similar to that used in the GRACE study (Genomics to combat Resistance against Antibiotics in Community-acquired lower respiratory tract infections in Europe (www.grace-lrti.org) describing symptoms, findings, and treatment in lower respiratory tract infections.

* The clinical examination included a chest examination and the axillary temperature.
* After the clinical examination, the general practitioners recorded their provisional diagnosis.
* Chest radiography was accessible for all patients.

The C-reactive protein test was performed in the intervention group at both the first and second consultations. The Afinion test system was used, which provides results within 5 minutes and before treatment was determined. This test is based on solid-phase sandwich immunometric analysis.

General practitioners could prescribe any treatment, including antibiotics and other drugs for the cough and additional medication if deemed necessary.

Eligibility Criteria:
Inclusion Criteria:

* patients with lower respiratory tract infections/acute cough (including acute bronchitis, pneumonia, and infectious exacerbations of chronic obstructive pulmonary disease or asthma),
* age 18 years or older,
* an illness of less than 28 days duration,
* first consultation for the illness episode,
* being seen in a physician's office,
* written consent to participate.

Exclusion Criteria:

* an inability to fill out study documentation,
* being previously included in the study,
* immunocompromised status (HIV patients, immunosuppressive treatment),
* ongoing treatment with oral corticosteroids
Endoscopic Hand Suturing in the Prevention of Gastrointestinal Bleeding After Gastric Endoscopic Submucosal Dissection.

Endoscopic hand-suturing (EHS) is a significant improvement in gastrointestinal advanced endoscopic procedures. Evidence supporting its effectiveness in clinical practice is limited due to its recent introduction and limited availability. This study aims to demonstrate the feasibility of EHS following advanced endoscopic submucosal dissection (ESD) in the stomach and investigate its potential to prevent gastrointestinal bleeding.

Endoscopic hand-suturing (EHS) is a significant improvement in gastrointestinal advanced endoscopic procedures. Evidence supporting its effectiveness in clinical practice is limited due to its recent introduction and limited availability. This study aims to demonstrate the feasibility of EHS following advanced endoscopic submucosal dissection (ESD) in the stomach and investigate its potential to prevent gastrointestinal bleeding. The retrospective single-center study included individuals who underwent endoscopic submucosal dissection in the stomach. The resection site was either left open, clipped, or sutured. The study evaluated the overall procedure time (OPT), bleeding rate (BR), perforation rate, and length of hospital stay (HS). The assessment was conducted to compare the outcomes of "non-sutured vs. sutured" "no closure vs. closure" and "clipped vs. sutured" along with the propensity score matching analysis for reducing a potential selection bias.

Eligibility Criteria:
Inclusion Criteria:

* underwent gastric ESD from June 2015 to June 2024
* Eastern Cooperative Oncology Group performance status score of 0 or 1

Exclusion Criteria:

* none
Autonomic Nervous System Function - Hypertension

The Life University Center for Chiropractic Research is conducting a research study to better understand the physiological differences, in terms of Autonomic nervous system function, between individuals with Hypertension and control individuals with out hypertension. Data will be gathered using Heart Rate Variability (HRV), and Galvanic Skin Response (GSR). A series of tests will be conducted to elicit Autonomic Nervous system responses. These tests include Cold Face Test (mammalian dive reflex), Cold Pressor test, Sit to stand, and the Valsalva maneuver.

The objective of the study is to ascertain the level of autonomic health in persons with hypertension versus a healthy population. Further, via the implemented protocol, the study will attempt to develop a sequence of autonomic nervous system tests to be used in future studies and clinical settings

Eligibility Criteria:
Participants will be included in the hypertension group if they present with the following:

* Hypertension, defined as:
* Self-reported or previously diagnosed with elevated resting state blood pressure (120-129 systolic and less than 80 mmHg diastolic) or stage 1 hypertension with a blood pressure of Systolic between 130- and 139-mm Hg with a diastolic of 80-89 mmHg.
* Or medically diagnosed and managed stage 2 hypertension with blood pressure of Systolic between 140- and 159-mm Hg or diastolic 90 and 99 mm
* between the ages of 18-65
* Able to wear a monitor on their right wrist.
* Able to wear a pulse oximeter on their left hand.

Participants will be included in the healthy group if they present with the following:

* between the ages of 18-65
* Able to wear a monitor on their right wrist.
* Able to wear a pulse oximeter on their left hand.
Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent/assent as per local requirements
* Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal
* Has the potential to benefit from the administration of ALKS 3831, in the opinion of the investigator
* Subject met the eligibility criteria of the antecedent study at the time of enrollment in the antecedent study and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307
* Additional criteria may apply

Exclusion Criteria:

* Has any finding that, in the view of the investigator or medical monitor, would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirements
* Has a positive drug screen for drugs of abuse at study entry
* Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
* Additional criteria may apply
Lung Ultrasound in Bronchiolitis

prospective assessment of lung ultrasound score in children with different severities of bronchiolitis


Eligibility Criteria:
Inclusion Criteria:

* children with bronchiolitis

Exclusion Criteria:

* children with bronchiolitis and comorbidities
Impact of Antenatal Corticosteroid Therapy on Postnatal Surfactant Use in Preterm Infants

No study has shown that two doses of corticosteroids are more effective than a single dose in lung maturation and prevention of hyaline membrane disease (HMD) The aim of this study is to assess the impact of the number of doses on the severity of HMD.

Respiratory distress syndrome (RDS), formerly known as hyaline membrane disease, is a common problem in preterm infants. This disorder is caused primarily by deficiency of pulmonary surfactant in an immature lung. RDS is a major cause of morbidity and mortality in preterm infants.

Surfactant therapy has been shown to significantly reduce neonatal and infant mortality. Corticosteroids are given antenatal, and then surfactant is given, along with corticosteroids, postnatal.

A single course of corticosteroids is recommended for pregnant women between 24 weeks and 34 weeks of gestation who are at risk of preterm delivery within 7 days, including those with ruptured membranes and multiple pregnancies.

Betamethasone is recommended as the steroid of choice, to be administered in two doses of 12 mg given intramuscularly 24 hours apart.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants ≤ 37 SA
* Hospitalized in the neonatal intensive care unit between January 2018 and December 2019
* Having received at least one dose of corticosteroids antenatal

Exclusion Criteria:

* Parental Opposition
* Congenital malformations that may cause neonatal respiratory distress.