louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03661749: Urinary Protein to Creatinine Ratio in Term Pregnant Women
Official title: Urinary Protein to Creatinine Ratio in Term Pregnant Women: What is the Effect of a Clean Catch Urine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Complications
Lead sponsor: St. Luke's Hospital, Pennsylvania
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 240
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: PR/CR urine collected by clean catch or non -clean catch technique will be compared in term pregnancy
Primary purpose: OTHER

Brief summary: This study will determine the incidence of elevated U Pr/Cr in normal term pregnant women. In addition we will determine if a "clean catch" urine has an effect on the U Pr/Cr.

Detailed description: Clean catch urine should be used due to possible vaginal secretion contamination with falsely elevated U Pr/Cr ratio. However, no supporting reference was found in the article and no control group with random urine collection for comparison to clean catch specimen U Pr/Cr was included in their study. The original studies that validated spot Pr/Cr urine as a predictor of 24 -hour total urine protein used random non-clean catch random urines . They had an r value of .93-.99 in estimating total protein excreted in 24 hours. At our institution we use Siemens-base test to determine U Pr/Cr. In the product insert the company states that no special patient preparation is necessary.

Thus, this study will determine the incidence of elevated U Pr/Cr in normal term pregnant women. In addition we will determine if a "clean catch" urine has an effect on the U Pr/Cr.

Eligibility criteria: Inclusion Criteria:

* women of 37 weeks gestation or greater

Exclusion Criteria:

* Urinary tract infections
* Hypertension
* Pre-eclampsia
* Renal dysfunction

Primary outcomes:
measure: elevated PR/CR ratio using clean catch technique
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Report the incident of PR/CR ratio greater than 0.3
timeFrame: through study completion, average of 1 year
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: St Luke's University Hospital
state: Pennsylvania
Study officials:
affiliation: St Luke's University Hospital
name: James N Anasti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05918549: Movement Analysis in Musculoskeletal Oncology: a Pilot Study
Official title: Movement Analysis in Musculoskeletal Oncology: a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Motion Analysis in Musculoskeletal Oncology
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Azienda Policlinico Umberto I
name: Università degli studi di Roma Foro Italico
First posted: 2023-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary and secondary cancers of the musculoskeletal system with estimated survival greater than one year who are candidates for bone resection surgery or wide excision of soft tissue lesion and/or radio and chemotherapy treatments

Brief summary: Noninterventional, prospective, multicenter pilot study of patients with primary and secondary musculoskeletal tumors designed to investigate functional outcomes after therapy using both subjective and quantitative motion detection techniques


Eligibility criteria: Inclusion Criteria:

* Age \> 6 years
* Diagnosis of primary and secondary tumors of the musculoskeletal system
* Patients who will need to undergo surgery for bone resection or wide excision of soft tissue lesion, and/or radiation or drug treatments
* Availability of follow-up data (for at least 6 months)
* Written informed consent

Exclusion Criteria:

- Inability to perform pre-post treatment assessment

Primary outcomes:
measure: Quality of life
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References:
Clinical trial NCT01992549: Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
Official title: Extension Study for Patients Who Completed GENA-05 (NuProtect)- to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Hemophilia A
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 48
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to collect long-term data on the inhibitor development rate of Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.


Eligibility criteria: Inclusion Criteria:

1. Patients who completed GENA-05 in accordance with the study protocol

Exclusion Criteria:

1. Severe liver or kidney disease
2. Concomitant treatment with any systemic immunosuppressive drug;
3. Other FVIII concentrate than Human-cl rhFVIII was received between completion visit of GENA-05 and start of GENA-15 (except emergency cases).

Primary outcomes:
measure: Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors
timeFrame: Maximum two years
Secondary outcomes:
measure: Frequency of Spontaneous Break-through Bleeds
timeFrame: Maximum 2 years
measure: Efficacy of Human-cl rhFVIII for the Treatment of Bleeds
timeFrame: Maximum 2 years
measure: Efficacy of Human-cl rhFVIII for Surgical Prophylaxis
timeFrame: Maximum 2 years
measure: The Occurrence of Any Adverse Event (AE)
timeFrame: Maximum 2 years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
city: Marseille
country: France
facility: Hopital de la Timone
city: Paris
country: France
facility: Hôpital Kremlin Bicètre
city: Tbilisi
country: Georgia
facility: Institute of Hematology and Transfusiology
city: Pune
country: India
facility: Sahyadri Speciality Hospital
city: Vellore
country: India
facility: Christian Medical College
city: Chişinău
country: Moldova, Republic of
facility: IMSP Mother and Child Institute
city: Warsaw
country: Poland
facility: University Medical School
city: Kiev
country: Ukraine
facility: The National Children Specialized Hospital "OHMATDET"
city: Lviv
country: Ukraine
facility: Danylo Halytsky Lviv National Medical University
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children
Study officials:
affiliation: Octapharma
name: Sigurd Knaub, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02105649: Calf Muscle Strength and Standing Efficiency in Children With Spastic Diplegia
Official title: CALF MUSCLE STRENGTH AND STANDING EFFICIENCY IN CHILDREN WITH SPASTIC DIPLEGIA: A RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
standing
strengthening
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It will be hypothesized that strengthening the calf muscles will improve standing efficiency in children with spastic diplegia.


Eligibility criteria: Inclusion Criteria:

* Children age will be ranging between 2 and 4 years.
* They are classified at level III by GMFCS-ER, i.e. they can stand with minimal support.
* Full mobile lower limbs joints.
* Children with mild and moderate spasticity ( i.e. grade 1 and 2, according to Modified Ashworth Scale).

Exclusion Criteria:

* Children with severe spasticity ( i.e. grade 4, according to Modified Ashworth Scale).
* Fixed deformities.
* Uncontrolled seizures.

Primary outcomes:
measure: Gross Motor Function Measure
timeFrame: 2 months
Secondary outcomes:
measure: Ultrasonography
timeFrame: 2 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza
Study officials:
References:
citation: Wiley ME, Damiano DL. Lower-extremity strength profiles in spastic cerebral palsy. Dev Med Child Neurol. 1998 Feb;40(2):100-7. doi: 10.1111/j.1469-8749.1998.tb15369.x.
Clinical trial NCT06178549: Emergency Room HPV Self-Sampling Study (ACT NOW)
Official title: Feasibility and Effectiveness of HPV Self-Sampling for Cervical Cancer Screening Among Women Seeking Health Care At a Safety Net Hospital Emergency Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer Screening
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The goal of this study is to develop and evaluate an evidence-based public health intervention using HPV self-sampling approach in an opportunistic setting to increase cervical cancer screening among screening non-attendees, particularly those uninsured or underinsured, who use emergency services to access medical care. The proposed pilot study will examine the feasibility and efficacy of HPV self-sampling among women at a safety net hospital emergency room. Participant recruitment and self-sample will take place in the waiting rooms in the ER. All women sitting in the waiting room will serve as the source population for the study and will be approached and invited to participate in the study.


Eligibility criteria: Inclusion Criteria:

* Eligible participants are women ages 25 years to 65 years, with a cervix, presenting in the waiting areas at the Ben Taub General Hospital Emergency Department

Exclusion Criteria:

* Women under 25 years or older than 65 years of age,
* self-reported current pregnancy,
* self-reported history of cervical cancer,
* past hysterectomy,
* had Pap Smear within past 3 years or HPV/Pap co-test within past 5 years.

Primary outcomes:
measure: HPV self-sampling completion
timeFrame: 1 day
Secondary outcomes:
measure: HPV self-sampling acceptability
timeFrame: 1 day
measure: Attendance for cervical cancer screening among HR-HPV positive women
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
Clinical trial NCT06593236: Association of Digital Aid Use With Infant Sleep and Maternal Mental Health
Official title: Association of Digital Aid Use With Infant Sleep and Maternal Mental Health
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infant Development
Maternal Behavior
Keywords: Infant Sleep
Maternal Mental Health
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Huckleberry Labs, Inc.
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-09-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will receive healthcare in the UMass Memorial Health System and must be a part of the Medicaid Accountable Care Organizations (ACO). Participants will be a birthing parent of a child aged 0-12 months.

Brief summary: The goal of this study is to better understand the use of the Huckleberry app, a pediatric sleep guidance app and the impacts on infant sleep and maternal mental health.

Detailed description: This study aims to understand the impact of the Huckleberry app, a scalable low-cost solution to problematic child sleep patterns, on pediatric sleep and maternal mental health, especially in the Medicaid population.

A secondary aim for this study is to determine if Medicaid Accountable Care Organizations (ACO) goals are improved according to stakeholder interviews.

Eligibility criteria: Inclusion Criteria:

* Is at least 18 years old
* Has a child between the age of 0-12 months
* Receives healthcare through UMass Memorial Health
* Is a part of the Medicaid Accountable Care Organizations (ACO) population

Exclusion Criteria:

* Lacks capacity to consent
* Does not understand English
* Does not have internet access on their smartphone or at home
* If the infant is in Department of Children and Families (DCF) custody or is admitted into the Neonatal Intensive Care Unit (NICU)

Primary outcomes:
measure: Infant sleep quality
timeFrame: Baseline and 3 months
measure: Maternal mental health
timeFrame: Baseline and 3 months
measure: Maternal bonding assessment
timeFrame: Baseline and 3 months
measure: Infant and parent sleep practices
timeFrame: Baseline and 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: Assistant Professor
name: Nish Fahey, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02086149: Exercise for Depressed Smokers
Official title: Aerobic Exercise for Smokers With Depressive Symptomatology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking
Smoking Cessation
Keywords: Quit smoking
Exercise
Tobacco
Smoking
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-03-13
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for helping individuals with elevated depressive symptoms to quit smoking. The investigators expect that this project will contribute much needed knowledge about the role that aerobic exercise can play in smoking cessation. The long-term goal of this program of research is to disseminate an effective, aerobic exercise (AE) intervention for smoking cessation that can be readily adopted by smokers with elevated depressive symptoms, including those with current major depressive disorder (MDD).


Eligibility criteria: Inclusion Criteria:

1. are between 18 and 65 years of age
2. are current smokers (i.e., smoking at least 10 cigarettes per day)
3. have currently elevated depressive symptoms (CES-D ≥ 6)
4. are sedentary, i.e., have not participated regularly in aerobic exercise (for at least 90 minutes per week during the past three months)

Exclusion Criteria:

1. DSM-IV diagnosis of current mania
2. DSM-IV diagnosis of bipolar rapid cycling
3. lifetime history of psychotic disorder or DSM-IV diagnosis of current psychotic symptoms
4. DSM-IV diagnosis of current substance abuse or dependence in the past 6 months
5. DSM-IV diagnosis of anorexia or bulimia nervosa
6. current suicidality or homicidality
7. marked organic impairment
8. current use of antidepressant medication for less than 3 months or change in antidepressant medication or dosage in the past 3 months,
9. physical disabilities or medical problems that would prevent or hinder participation in a program of moderate intensity exercise (i.e., physician denied medical clearance)
10. current pregnancy or intent to become pregnant during the next 12 weeks
11. contraindications for use of the nicotine patch (e.g., pregnancy, recent myocardial infarction, arrhythmia, angina, untreated hypertension, untreated diabetes, and previous adverse reaction to the patch)
12. current illness or medications that may alter proposed inflammatory markers (e.g., acute infection, immune disorders, aspirin)
13. current use of any pharmacotherapy or other treatment for smoking cessation.

Primary outcomes:
measure: Smoking Cessation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Ana M. Abrantes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00168649: Vitamin A and Response to Endotoxin
Official title: The Effect of Vitamin A on the Response to Endotoxin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: TNF-alfa
Endotoxin Levels
Keywords: Vitamin A
Endotoxin
TNF-alfa
Lead sponsor: Bandim Health Project
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
name: Institute for Human Nutrition, Royal Veterinary School, Copenhagen, Denmark
First posted: 2005-09-15
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Vitamin A given as treatment and pre-treatment has reduced the severity of symptoms after infusion with endotoxin in several animal models. We intend to examine the effect of vitamin A as pre-treatment on the response to endotoxin in humans. We furthermore wish to examine the long-term effects of vitamin A on the response to endotoxin. We hypothesise that vitamin A decreases endotoxin levels and TNF-alfa responses.

Detailed description: Vitamin A given as treatment and pre-treatment has reduced the severity of symptoms after infusion with endotoxin in several animal models. We intend to examine the effect of vitamin A as pre-treatment on the response to endotoxin in humans. As studies in children in low-income countries have indicated that vitamin A has long-term effects on the immune system, we furthermore wish to examine the long-term effects of vitamin A on the response to endotoxin. This will be done in an established model using infusion with endotoxin to male human volunteers. We hypothesise that vitamin A decreases endotoxin levels and TNF-alfa responses. Furthermore, we hypothesise that it reduces oxidative stress and injury.

Eligibility criteria: Inclusion Criteria: Healthy, male, between 18 and 35 years of age, non-smoker, no medicine, no infections in preceding 14 days

Exclusion Criteria:

Primary outcomes:
measure: Endotoxin levels
measure: TNF-alfa levels
Secondary outcomes:
measure: Measures of oxidative injury and stress
measure: Retinol and beta-caroten levels
measure: Haematological values
measure: Clinical markers
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Department M7641
Study officials:
affiliation: Rigshospitalet, Denmark
name: Bente K Pedersen, MD, DMSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT05758649: Cardiovascular and Psychological Consequences of COVID-19
Official title: Cardiovascular and Psychological Consequences of COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-COVID Conditions
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who will refer to the disease clinics 2-3 months after discharge from the COVID-19 areas of ICS Maugeri.

Brief summary: The study will assess cardiac and psychological profile at 2-3 months after recovery from COVID-19 infection.

Detailed description: A significant proportion of patients hospitalized for COVID-19 showed laboratory signs of myocardial damage, detected by elevated troponin levels, and these were associated with more severe clinical course and higher mortality. Moreover, it is unknown how the health emergency and the associated conditions may have influenced and still influence the psychological experience of the affected people.

Thus, in order to promote continuity of care, post-COVID-19 disease clinics have therefore been activated dedicated to a specific follow-up program for monitoring long-term alterations and for the early identification of patients requiring rehabilitation.

The program includes a first follow-up visit (2-3 months after recovery) including cardiac (2D-echocardiography, six-minute walking test, autonomic function evaluation) and psychological (Patient Health Questionnaire-9 (PHQ-9) Generalized Anxiety Disorder-7 (GAD) National Stressful Events Survey PTSD Short Scale (NSESSS)) evaluation.

A second follow-up visit will be performed at 12 months in the form of structured interview,

Eligibility criteria: Inclusion Criteria:

* Recent discharge (≤ 3 months) from a COVID+ ward for SARS-CoV-2 disease

Exclusion Criteria:

* Serious clinical conditions (severe chronic inflammatory diseases, neoplasms, neurological pathologies).
* Non-Italian education, illiteracy, or return to illiteracy.
* Severe visual-perceptual deficits.
* Low motivation/interest or refusal to undergo the assessment.

Primary outcomes:
measure: prevalence of patients with cardiovascular or psychological sequelae
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: ICS Maugeri
Study officials:
References:
citation: Vigore M, Steccanella A, Maffoni M, Torlaschi V, Gorini A, La Rovere MT, Maestri R, Bussotti M, Masnaghetti S, Fanfulla F, Pierobon A. Patients' Clinical and Psychological Status in Different COVID-19 Waves in Italy: A Quanti-Qualitative Study. Healthcare (Basel). 2023 Sep 6;11(18):2477. doi: 10.3390/healthcare11182477.