louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01895465: Improvement in Urine Collection Methods in Children
Official title: Improvement in Urine Collection Methods in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Tract Infection
Unspecified Fever
Keywords: urine collection, contamination
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The population of children presenting to the Emergency Department (ED) for treatment increases day by day, creating a further burden on the limited nursing staff and where many children and their parents are forced to wait many hours until their medical investigation ends. Part of the many hours waited are for various tests the patient has to undergo, where the urine test is one of the main ones.

Urinary tract infections in children are a common cause of death due to acute and chronic complications alike. Our study aims to test a urine collection method to see whether it reduces parents' and/or nursing staff's involvement and thereby reducing the urine sample's percentage of contamination.

Detailed description: The study intends to explore whether on obtaining a pediatric urine sample by using a diaper in an innovative way can shorten the waiting time parents have to endure until an urine sample is perceived, and accordingly, the percentage of contamination in the samples obtained. The innovativeness introduced is that by using an ordinary everyday diaper, which is found in all marketing outlets, and by making a slit in the diaper where the pediatric urine collecting bag can be pulled out and thus allowing parents/care takers to see straight away whether urine has been given and thus cut back on opening and reopening of the diaper.

Eligibility criteria: Inclusion Criteria:

1. Children incapable of giving urine voluntarily in the Emergency Department
2. Children requiring an urine test
3. Children whose parents have agreed to take part in the research and have signed a consent form

Exclusion Criteria:

1. Children who have an immediate medical condition which requires catheterization
2. Parents who have declined taking part in the research
3. Children who give urine voluntarily
4. Children who do not need an urine test for their continued treatment

Primary outcomes:
measure: Recording of time elapsed between physician's request for an urine test to be taken until obtained
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of contamination in urine cultures obtained
timeFrame: 12 months
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
References:
Clinical trial NCT05353465: The Cervical Trident Study
Official title: Cervicale Facet Joint Denervation With a Trident Electrode, a Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Facet Joint Pain
Lead sponsor: Ospedale Regionale di Lugano
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients that are treated with radiofrequency (RF) ablation of the facet joints in patients selected by symptom improvement with dual medial branch blocks.

Brief summary: This observational retrospective study evaluates the efficacy of RF with the three-tined expandable electrode needle compared to before treatment in the treatment of chronic cervical facet joint pain.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Patients with neck pain
* Patient who had two diagnostic medial branch blocks with significant (\>50%) improvement on both injections.

Exclusion Criteria:

- No patient related outcome measures available in hospital's patient charts

Primary outcomes:
measure: Pain measurement by numeric rating score
timeFrame: 2 months after injection in comparison to baseline
Secondary outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: 2 months after injection
measure: Use of analgesics
timeFrame: 2 months after injection
measure: Sleep
timeFrame: 2 months after injection
measure: Walking ability
timeFrame: 2 months after injection
measure: Patient satisfaction
timeFrame: 2 months after injection
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Pain Management Center, Neurocenter of Southern Switzerland
Study officials:
affiliation: Neurocenter of Southern Switzerland, EOC, Lugano
name: Eva Koetsier, MD PhD LLM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01466465: Vitamin D and Grass Pollen Specific Immunotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinoconjunctivitis
Keywords: Vitamin D
SIT
Grass pollen
allergic rhinoconjunctivitis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Allergen-specific immunotherapy is the only causal therapy of Immunoglobulin E-induced allergies like allergic rhinoconjunctivitis. Despite progress during the last decades it is limited by a long treatment time and high non-responder frequency. Based on experimental and epidemiological evidences we hypothesize that vitamin D can act as an effective immunomodulatory adjuvant to overcome these limitations.


Eligibility criteria: Inclusion Criteria:

* written informed consent
* relative Vitamin D deficiency
* clinical relevant grass pollen allergy
* positive intradermal test with grass pollen
* forced expiratory volume at one second (FEV1) \> 70%

Exclusion Criteria:

* current specific immunotherapy
* instable allergic asthma
* pregnancy and lactation
* treatment with immunomodulators or immunosuppressive drugs
* sarcoidosis, chronic diseases, malignancy

Primary outcomes:
measure: wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin, Allergy-Centre-Charité, CCM
Study officials:
affiliation: Charite University, Berlin, Germany
name: Worm Margitta, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05366465: Quality of Life and Participation of the Adult with Spinal Muscular Atrophy in France
Official title: Specificities of Quality of Life and Influence of Participation on the Quality of Life of the Adult with Spinal Muscular Atrophy in France: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Muscular Atrophy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with spinal muscular atrophy in France. And adult NMD patients from the study of Dany et al "Construction of a Quality of Life Questionnaire for slowly progressive neuromuscular disease" (2015)

Brief summary: Spinal muscular atrophy is a hereditary motorneuron disease caused by a mutation of the SMN1 gene, which is at the origin of a progressive limb and axial motor deficiency. It concerns 1200 individuals in France, including 700 adults in 2018. The main objective of this study is to assess the quality of life of SMA patients in France.

The secondary objectives are, in one hand, to compare the quality of life of SMA patients to a population of neuromuscular diseases patients. And on the other hand to evaluate the determinants of participation and the impact of participation on quality of life in adult SMA patients.


Eligibility criteria: Inclusion Criteria:

* Patient with SMA type 1, 2, 3 or 4
* ≥ 18 years old
* giving informed consent to participate to the study
* patients from the study of Dany et al "Construction of a Quality of Life Questionnaire for slowly progressive neuromuscular disease" (2015)

Exclusion Criteria:

* patients who do not complete ≥ 80% of the questionnaire)-

Primary outcomes:
measure: Quality of life
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service L'Escale - Médecine Physique et de Réadaptation Pédiatrique Groupement Hospitalier Est des Hospices Civils de Lyon
city: Bron
country: France
facility: VUILLEROT Carole
Study officials:
References:
Clinical trial NCT06679465: Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response
Official title: Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Asthma Bronchiale
Keywords: asthma
Tiotropium
Early asthmatic response
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluate single dose (2 x 2.5mcg/puff; total dose 5mcg) effect of tiotropium administered 30 minutes prior to allergen challenge on allergen-induced EAR assessed as the maximal % fall in FEV1 after allergen inhalation compared to that of single dose (two puffs) matched placebo administered 30 minutes prior to allergen challenge.


Eligibility criteria: Inclusion Criteria:

* age (years) at least 18 years
* no confounding health issue (i.e. no health conditions, other than asthma, that would put the participant at risk or affect data integrity as determined by the principal investigator)
* baseline FEV1 ≥ 65% of predicted normal at Visit 1
* evidence of atopy to an allergen suitable for inhalation challenge following skin prick testing such as house dust mite, grass, cat or horse
* fall in FEV1 of ≥ 20% at a dose of methacholine ≤ 600mcg (methacholine PD20) at Visit 1
* positive response to allergen inhalation challenge (fall in FEV1 of ≥ 15% after inhalation of allergen at a dilution 1:32 or more dillute.
* absence of respiratory infection for at least 4 weeks prior to Visit 1
* absence of significant worsening of asthma that requires health care intervention or prolonged change in medication due to allergen exposure (or other trigger) for at least 4 weeks prior to Visit 1
* women of child-bearing potential shall not be pregnant or lactating
* non-smoker (cigarettes, vaping); ex-smoker with \<10 pack year history allowed; cannabis use will be evaluated on a case-by-case basis
* if on as needed budesonide/formoterol therapy, no reported use within 3 weeks prior to allergen challenge

Exclusion Criteria:

* Smoker \>10 pack year history

Primary outcomes:
measure: Early asthmatic response
timeFrame: 2 hours post-allergen challenge
Secondary outcomes:
measure: Inflammatory response
timeFrame: Five hours post-allergen challenge
measure: FEV1
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
References:
Clinical trial NCT05170165: A Pilot Study to Increase Utilization of GDMT in Patients With HFrEF
Official title: A Pilot Study to Increase Utilization of Guideline Directed Medical Therapy in Patients With HFrEF
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2021-12-27
Enrollment: 50
Sex: ALL
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: Patients \>18 years with HFrEF who have suboptimal HF medical regimen

Brief summary: The purpose of this study is to test a clinical decision support (CDS) tool that provides clinicians (cardiologists and nurse practitioners) medication recommendations regarding guideline directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF).

Detailed description: The purpose of our study is to test whether home blood pressure monitoring (HBPM) with clinical-decision support (CDS) will optimize the use of GDMT in patients with HFrEF. HBPM allows cardiologists and NPs to monitor patients outside the clinical setting so that GDMT can be safely initiated and up-titrated. The CDS employs HBPM and electronic medical record (EMR) data to implement the ACC/AHA HF guidelines and provides cardiologists and NPs with GDMT recommendations.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of HFrEF (left ejection fraction \< 40%, assessed by transthoracic echo, cardiac MRI, cardiac SPECT) within the past year.
* New York Heart Association (NYHA) class II-III at most recent screening assessment.
* GDMT composite score of less than or equal to 50% at baseline

Exclusion Criteria:

* Previous contraindication to beta blockers, ACE inhibitors, and/or ARB.
* Baseline creatinine \> 2 mg/dl or potassium level at baseline \> 5 mEq/L or eGFR \<30 mL/min/1.73 m2.
* Baseline systolic blood pressure \< 100 mmHg.
* Concomitant use of ACE, ARB, and/or ARNI
* Polycystic kidney disease
* History of angioedema
* History of or currently on a transplant list
* Left ventricular assist device
* Uncontrolled asthma
* Severe COPD
* Cirrhosis
* Currently receiving hospice or comfort care
* Patient not proficient with written and spoken English
* Patient has diminished decision making capability
* History of non-compliance

Primary outcomes:
measure: Proportion of patients at or above 50% target dose of GDMT in HFrEF patients
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of accepted medication recommendations
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Raj Khandwalla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04158765: The Impact of Lifestyle on Sperm Telomere Length and Telomerase Activity in Men Undergoing IVF Treatments
Official title: Investigating the Impact of Lifestyle on Telomere Length and Telomerase Activity on Sperm Cells Originating From Infertile Men Undergoing IVF Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Male Infertility
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-11-12
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile men attending a university-affiliated IVF Unit at Hillel Yaffe Medical Center

Brief summary: This aim of this study is to determine the impact of lifestyle on telomere length and telomerase enzyme activity on sperm cells of men undergoing IVF treatments.

Detailed description: Following approval of the study by the Hospital Ethical Committee (Helsinki), semen samples and blood will be collected from infertile individuals referred to our IVF unit at Hillel Yaffe Medical Center. Informed written consent will be obtained from each participant. Standard semen analysis will be carried out according to World Health Organization protocol. An aliquot of semen sample will be used for assessment of sperm motility, concentration, and morphology by using computer-aided sperm analysis (CASA) and the remaining sample will be used for assessment of sperm telomere lengths and telomerase activity. Genomic DNA will be extracted from the remaining washed sperm and peripheral blood. Sperm telomere length will be determined by real-time polymerase chain reaction (qRT-PCR) and telomerase activity will be determined by TRAP assay (Telomeric Repeat Amplification Protocol).

Eligibility criteria: Inclusion Criteria:

* Infertile couple

Exclusion Criteria:

* Chronic disease
* Azoospermia

Primary outcomes:
measure: Telomere length
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hille Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Ofer Limonad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06216665: Effect of Pulsatile Hormone Administration on Insulin Action
Official title: Effect of Pulsatile Hormone Administration on Insulin Action
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insulin Sensitivity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants receive insulin delivered continuously or every five minutes during the hyperinsulinemic euglycemic clamp test
Primary purpose: OTHER

Brief summary: In humans, insulin is secreted in pulses from the pancreatic beta-cells, and these oscillations help to maintain fasting plasma glucose levels within a narrow normal range. Given the fluctuations in insulin concentrations, oscillations enhance precision of control. The hyperinsulinemic euglycemic clamp test (clamp) involves a continuous infusion of insulin and is the gold standard for measuring insulin sensitivity. In this study, insulin sensitivity measured using the standard clamp will be compared with a clamp in which the same total amount of insulin as the standard clamp is infused every five minutes instead of continuously.

Detailed description: Participants with obesity and insulin resistance completing a randomized, controlled, two-arm parallel trial (Motivate) will be enrolled in this cross-sectional study. Twelve participants from the Motivate study will return within two weeks to complete two clamp tests within a week of each other. At these clamps, the insulin will be infused continuously at a dose of 40mU/m2/min during the first clamp test and the same total amount of insulin will be infused every five minutes at the second clamp. The day following the clamps, participants will return to the clinic in a fasted state and blood will be drawn for measurement of glucose and insulin.

Eligibility criteria: Inclusion Criteria:

* Completion of the Motivate Study (NCT05649176)

Exclusion Criteria:

* Non-completion of the end-of-study hyperinsulinemic euglycemic clamp test of the Motivate study

Primary outcomes:
measure: Insulin sensitivity
timeFrame: One day
Secondary outcomes:
measure: Insulin resistance
timeFrame: 24 hours
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Candida Rebello, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rebello CJ, Morales TS, Chuon K, Dong S, Lam VT, Purner D, Lewis S, Lakey J, Beyl RA, Greenway FL. Physiologic hormone administration improves HbA1C in Native Americans with type 2 diabetes: A retrospective study and review of insulin secretion and action. Obes Rev. 2023 Dec;24(12):e13625. doi: 10.1111/obr.13625. Epub 2023 Aug 14.
Clinical trial NCT01270165: Lamivudine Plus Adefovir Versus Telbivudine Plus Adefovir in Lamivudine Resistant Chronic Hepatitis B
Official title: Antiviral Efficacy of Continuing Lamivudine Plus Adefovir or Switching to Telbivudine Plus Adefovir in HBeAg-positive Lamivudine-refractory Chronic Hepatitis B Patients Who Have Suboptimal Response to Lamivudine Plus Adefovir for at Least 12 Months
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Hepatitis B
Keywords: lamivudine
telbivudine
adefovir
lamivudine resistance
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-01-05
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: No study has reported on the comparative effect of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir in HBeAg-positive lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir. The goal of this study is to compare the efficacy of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir directly in patients with lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir for at least 12 months.


Eligibility criteria: Inclusion Criteria:

* HBeAg positive
* lamivudine and adefovir at least 12 months over 6 months lamivudine treatment for YMDD positive patients
* HBV DNA over 300 copies/ml

Exclusion Criteria:

* decompensated cirrhosis
* renal failure
* prior interferon usage
* evidence of HCC or prior organ transplantation

Primary outcomes:
measure: Virologic response
timeFrame: 1 year
Secondary outcomes:
measure: Safety, virologic breakthrough and biochemical response
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
affiliation: Department of Internal Medicine, Yonsei University College of Medicine
name: Sang Hoon Ahn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park H, Park JY, Kim SU, Kim DY, Han KH, Chon CY, Ahn SH. Efficacy of switching to telbivudine plus adefovir in suboptimal responders to lamivudine plus adefovir. World J Gastroenterol. 2013;19(43):7671-9. doi: 10.3748/wjg.v19.i43.7671.
Clinical trial NCT00061074: Tobacco Cessation in Postmenopausal Women (Part II) - 2
Official title: The Effects of ERT on Appetitive Behavior and Withdrawal in Short-term Smoking Cessation in Postmenopausal Females on Transdermal Nicotine Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tobacco Use Disorder
Keywords: Smoking
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2003-05-22
Enrollment: 1
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of ERT on appetitive behavior and withdrawal in short-term smoking cessation in postmenopausal females on transdermal nicotine replacement


Eligibility criteria: Inclusion Criteria:

(Same as Part I)

Exclusion Criteria:

Same as Part I, with the addition of those who have had a past reaction to transdermal nicotine patch or have active skin diseases will be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Sharon Allen, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: