louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04146675: Evaluation of a T-shirt "Balance" Containing Ceramic Fibers
Official title: Pilot Study for the Evaluation of a T-shirt "Balance" Containing Ceramic Fibers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatrics
Keywords: Gerontology
elderly,
falls
balance and walking disorders.
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Falls are frequent and often serious events in the elderly. The consequences of falls are often severe: traumatic (fractures, hematomas, ..) and psychological. Falls are among the top ten causes of death in this population and, for people older than 70, falls are the leading cause of accidental death.

The Damart company has developed a fabric containing ceramic fibers. Clothes containing such fibers have been found to improve balance.

This study aims to measure the effect of a t-shirt with a ceramic membrane ("ceramic" t-shirt) on the balance and walking compared to the effect of a "placebo" t-shirt (same weight, appearance and texture).

The hypothesis is that wearing the ceramic tee-shirt significantly improves balance and walking, suggesting that it can also reduce falls - the main consequence of the balance and walking disorder.


Eligibility criteria: Inclusion Criteria:

* Presenting disturbances of balance (determined by a Tinetti test score strictly greater than 12)
* Hold the balance while standing with his feet and arms along the body and walk for 3 meters without major imbalance that may cause a fall
* Consent to participate in the study (a signed written consent form)
* Covered by a social security system

Exclusion Criteria:

* A motor deficit of the lower limbs focused and characterized by neurological or orthopedic cause (for example hemiplegia after a cerebrovascular accident, limb amputation).
* Inability to receive the protocol information
* Inability to participate in the entire study
* Absence of a social security coverage
* Refusal to sign the Informed Consent form

Primary outcomes:
measure: Variation of the Tinetti score between the two group
timeFrame: Baseline
Secondary outcomes:
measure: variation of the posturography technique
timeFrame: Baseline
measure: variation of motion analysis (the optoelectronic system (VICON®)
timeFrame: Baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital gériatrique les Bateliers
Study officials:
affiliation: University Hospital, Lille
name: François Puisieux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03997175: Effect of Modified Playground Environment on Health, Particularly Immune System
Official title: ImmunoGarden - Effect of Modified Playground Environment on Health, Particularly Immune System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Disorders
Immune System Diseases
Keywords: biodiversity intervention
sand box
guidance
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Tampere University
First posted: 2019-06-25
Enrollment: 25
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One arm received biodiversity sand and the other arm normal sand.
Primary purpose: BASIC_SCIENCE

Brief summary: Children were exposed to biodiverse material or non-diverse material in sand pits. The two arms were compared. Immune response and bacterial markers were followed.

Detailed description: Children of age 3-5 were randomly divided into two groups (arms). One received guidance and biodiverse material for 20 minutes each day for two weeks. The other received the a similar material and guidance but the microbial community in the material was poor in diversity. Bacterial community changes and immune system markers were analyzed and compared between the two arms. Potential changes in Interleukin 10 was the primary outcome.

Eligibility criteria: Inclusion Criteria:

* healthy
* born in Finland
* spends daily (5 d a week) several hours in one of the daycares in which the trial was performed

Exclusion Criteria:

* medication affecting immune system function
* medication affecting microbiota
* cancer
* immune deficiency
* living on a farm
* not born in Finland

Primary outcomes:
measure: Change in Interleukin 10 level in blood
timeFrame: two weeks
Secondary outcomes:
measure: changes in microbiota
timeFrame: two weeks
measure: changes in interleukin 17 levels
timeFrame: two weeks
measure: changes in tgf-beta levels
timeFrame: two weeks
measure: ratio il-10 / il-17
timeFrame: two weeks
measure: long-term changes in microbiota
timeFrame: four weeks
Other outcomes:
Locations:
city: Lahti
country: Finland
facility: Helsinki University
state: Häme
Study officials:
affiliation: University of Helsinki
name: Aki Sinkkonen, ph d
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00189475: Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds
Official title: A Pilot Study to Evaluate the Potential of Montelukast to Prevent the Development of Nasal Symptomatology During Natural Viral Upper Respiratory Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Upper Respiratory Infection
Keywords: Cold
Upper Respiratory Infection
Lead sponsor: West Penn Allegheny Health System
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2005-09-19
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years.

Detailed description: This is a randomized double-blinded placebo controlled trial to assess the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years. All subjects complete daily assessments of cold symptoms, nasal clearance rates and secretion rates during each day of the study. Phlebotomy is performed once for the determination of cytokine genotyping and allergy skin testing is performed once for the assessment of atopy.

Eligibility criteria: Inclusion Criteria:

* Adults 18 to 50 years of age.
* Male or female, who are not pregnant or lactating.
* Common cold symptoms for less than 24 hours.
* At least 2 of the following 9 symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratch throat, sneezing and malaise.

Exclusion Criteria:

* Investigational medication in past 30 days.
* Known hypersensitivity to any ingredients in study medication.
* History of asthma or other chronic diseases.
* Females of childbearing potential who are not using a medically acceptable form of birth control.
* Patients with nasal ulcers within the past 1 month, nasal surgery within the past 6 months, nasal trauma within the past 2 months or presence of nasal polyps or nasal deformities causing significant nasal obstruction.
* Females with a positive urinary HCG test.
* Patients with a positive rapid antigen test for streptococcal infection.
* Common cold symptoms for more than 24 hours.
* Patients who are users of illicit drugs.
* Patients who are on rifampin or phenobarbital.

Primary outcomes:
measure: Nasal Secretion Weights
timeFrame: 6 days after naturally acquiring an upper respiratory infection
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: West Penn Allegheny Health System
name: Deborah Gentile, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01406275: Special Drug Use Investigation for CLAVAMOX® (Amoxicillin/Clavulanate) Pediatrics Dry Syrup (Every Indication Excluded Otitis Media)
Official title: Special Drug Use Investigation for CLAVAMOX® (Amoxicillin/Clavulanate) Pediatrics Dry Syrup (Every Indication Excluded Otitis Media)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otitis Maedia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-08-01
Enrollment: 363
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese pediatric patients who have superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis, pyelonephritis other than otitis media, and treated with amoxicillin and clavulanate

Brief summary: This post-marketing surveillance study of CLAVAMOX® was designed to collect and assess the information on proper use, such as safety and efficacy, under actual use conditions, targeting pediatric Japanese patients with diseases (superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis, pyelonephritis) other than otitis media.

("CLAVAMOX" is a trademark of the GlaxoSmithKline group of companies.)


Eligibility criteria: Inclusion Criteria:

* Pediatric subjects with diseases of superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis and pyelonephritis

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: The number of incidence of adverse events in Japanese pediatric patients, with diseases other than otitis media, treated with amoxicillin and clavulanate based on prescribing information
timeFrame: 2 months
measure: Clinical symptoms after treatment with amoxicillin and clavulanate
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01055275: Cook Iliac Branch Graft Post-market Registry
Official title: Cook Iliac Branch Graft Post-market Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Iliac Aneurysm
Aortic Aneurysm
Keywords: iliac aneurysm
aortic aneurysm
endovascular grafts
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2010-01-25
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with a Cook Iliac Branch Graft.

Brief summary: The Cook Iliac Branch Graft Post-market Registry will obtain case reports of physician experience with a CE-marked Cook Iliac Branch Graft to further confirm device safety and performance.


Eligibility criteria: Inclusion Criteria:

* CE-Marked Cook Iliac Branch Graft (e.g., Zenith® Branch Endovascular Graft-Iliac Bifurcation, Zenith® Helical Branch Endovascular Graft)
* Registry data are de-identified with respect to patient.

Exclusion Criteria:

* Patient for whom this device would not normally be considered standard of care.

Primary outcomes:
measure: Internal iliac artery patency
timeFrame: 1 year
measure: Aneurysm Exclusion
timeFrame: 1 year
Secondary outcomes:
measure: Death
timeFrame: 1 year
measure: Conversion
timeFrame: 1 year
measure: Rupture
timeFrame: 1 year
measure: Success Measures
timeFrame: 1 year
measure: Major Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Hospital Clinic, Barcelona, Spain
name: Vincent Riambau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04097275: Induced Pluripotent Stem Cells for the Development of Novel Drug Therapies for Inborn Errors of Metabolism (iPSC-IEM)
Official title: Induced Pluripotent Stem Cells for the Development of Novel Drug Therapies for Inborn Errors of Metabolism, an International, Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inborn Errors of Metabolism
Lead sponsor: CENTOGENE GmbH Rostock
Sponsor class: INDUSTRY
First posted: 2019-09-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with an Inborn Error of Metabolism

Brief summary: Human induced pluripotent stem cells (iPSCs), are reprogrammed from somatic cells that can self-renew indefinitely and produce different types of cells. They provide human model cell lines for orphan drug development. It is the goal of this study to define new cellular disease models for Inborn Erors of Metabolism, as enabling tools for both drug discovery and development.


Eligibility criteria: Inclusion Criteria:

* Informed consent is obtained from the participant or from the parent/ legal guardian
* The participant is aged between 2 months and 50 years
* The diagnosis of an Inborn Error of Metabolism (IEM) is genetically confirmed by Centogene
* The participant is a first-degree or a second-degree relative of an individual with Inborn Error of Metabolism (IEM) genetically confirmed by Centogene

Exclusion Criteria:

* Inability to provide informed consent
* The participant is younger than 2 months or older than 50 years
* The diagnosis of an Inborn Error of Metabolism (IEM) is not genetically confirmed by Centogene and
* The participant is not a first-degree or a seconddegree relative of an individual with Inborn Error of Metabolism (IEM) genetically confirmed by Centogene
* Previously enrolled in the study

Primary outcomes:
measure: Generation of patient-specific induced pluripotent stem cells and then differentiate them into neural cells.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Children Hospital and Institute of Child Health
Study officials:
affiliation: Centogene GmbH
name: Peter Bauer, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT00853775: Family Research Study: Metabolism of Fats and Proteins in Specific Ethnic Groups
Official title: Regulation of Lipoprotein(a) Metabolism in Humans With Reference to Ethnicity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Heart Disease
Keywords: heart disease
cardiovascular disease
lipoproteins
lipoprotein(a)
Lp(a)
apolipoprotein(a)
apo(a)
fats
proteins
metabolism
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-03-02
Enrollment: 325
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are recruiting 100 African American and 100 Caucasian families. The families that will be recruited will have two natural parents and two natural offspring.

Brief summary: The purpose of this study is to determine whether lipoprotein(a), also called Lp(a), is a risk factor for cardiovascular (heart) disease. Lipoproteins are tiny particles that circulate in the blood. They contain cholesterol, fat, and protein in varying amounts depending on the body's need. Higher levels of lipoproteins in the blood can cause an increased risk of heart disease.

The investigators believe that by studying the Lp(a) lipoprotein in Caucasians and African Americans, the investigators can assess for genetic variation factors related to cardiovascular (heart) disease. The investigators will be looking at 100 African-American families and 100 Caucasian families to confirm whether a higher Lp(a) level is an indicator of a higher risk for heart disease.

Detailed description: During the study visit the research staff will ask about the medical history, perform a brief physical exam, and draw approximately 4 teaspoons of blood of each family member.

Eligibility criteria: Inclusion Criteria:

* Of Caucasian or African descent
* Families must have 2 natural/biological parents and 2 natural/biological offspring
* 6 years old or older

Exclusion Criteria:

* Races other than African American or Caucasian
* Families without 2 natural/biological parents and 2 natural/biological offspring
* younger that 6 years old

Primary outcomes:
measure: Genetic variation of Lp(a) levels in each group
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Mather
country: United States
facility: UC Davis CTSC Clinical Research Center (CCRC) at Veterans Affair Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Lars Berglund, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04684875: Quality of Life Impact of Chronic Rhinitis Treatment With Aerin Medical Device
Official title: A Prospective, Multi-center, Non-Randomized Study to Evaluate the Quality of Life Impact and Symptoms After Treatment Using Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Rhinitis
Keywords: Chronic rhinitis
Posterior nasal nerve
Quality of life
Lead sponsor: Aerin Medical
Sponsor class: INDUSTRY
First posted: 2020-12-28
Enrollment: 45
Sex: ALL
Minimum age (years): 22
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who completed the 52-week follow-up visit of Aerin Study TP668 and consent to provide long-term quality of life and symptom information.

Brief summary: Evaluation of long-term (2-year) quality of life and symptoms after chronic rhinitis treatment with the Aerin InSeca/RhinAer Stylus

Detailed description: This is a prospective, non-randomized, multicenter follow-up study to collect long-term data on a cohort of patients who participated in the Aerin Medical TP668 study, "Clinical Evaluation of Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis". The study will be conducted in a maximum of 5 centers that participated and enrolled patients in the TP668 study.

Eligibility criteria: Inclusion Criteria:

* Received treatment for chronic rhinitis in Aerin Study TP668

Exclusion Criteria:

* Unwilling to participate in this long-term study

Primary outcomes:
measure: Change from Baseline rTNSS
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Colorado ENT and Allergy
state: Colorado
city: New Albany
country: United States
facility: Advanced ENT and Allergy
state: Indiana
city: Winston-Salem
country: United States
facility: Piedmont ENT Associates
state: North Carolina
city: Fort Worth
country: United States
facility: Fort Worth ENT
state: Texas
city: McKinney
country: United States
facility: ENT and Allergy Associates of Texas
state: Texas
Study officials:
affiliation: Aerin Medical, Inc.
name: Scott Wolf, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05797675: Osseodensification Plus Platelet Rich Fibrin With Simultaneous Implant Installation in Closed Sinus Lift
Official title: Osseodensification Plus Platelet Rich Fibrin With Simultaneous Implant Installation in Closed Sinus Lift : A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Sinus
Lead sponsor: Arab American University (Palestine)
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 12 patients with indirect sinus lift will be selected with RBH\&gt;5mm , surgical procedure

=osseodensification + Prf+ implant .

1. versah drilling system (osseodensefication technique )will be used , moreover Prf will be prepared by Blood collected in PRF tubes from patients then centrifuge (1300rpm ,14min ) .
2. primary stability will be measured using Resonance Frequency Analysis by Osstellimmediately and after 6 Mn .
3. CBCT will be taken before surgery , perioapical x-ray immediately after surgery and CBCT at 6m follow up to be apple to see the differences regarding bone quality and volume.


Eligibility criteria: Inclusion Criteria:

- medically fit non pregnant no sinus pathology

Exclusion Criteria:

* young patients under 18
* sinus pathology

Primary outcomes:
measure: secondary stability of implant
timeFrame: 6 months
measure: bone density
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nablus
country: Palestinian Territory, occupied
facility: Hadeel Albahar
Study officials:
affiliation: Arab American University
name: hadeel albahar, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00706875: A Global Assessment of Medical, Emotional and Reproductive Concerns in Gestational Trophoblastic Disease Survivors
Official title: A Global Assessment of Medical, Emotional and Reproductive Concerns in Gestational Trophoblastic Disease Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Cancer
Cervix Uteri Nos
Gestational Trophoblastic Disease
Keywords: GTD survivors
questionnaires
GTD
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-06-30
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: GTD survivors treated at Memorial Sloan-Kettering Cancer Center (MSKCC).

Brief summary: The purpose of this study is to collect information on the effects of treatment for gestational trophoblastic disease (GTD). We plan to use the findings from this study to better understand GTD survivors' health and quality of life.

We would like to know more about the health, quality of life and pregnancies of women treated for GTD. This information will be used to try and improve the treatments for women who have this disease.


Eligibility criteria: Inclusion Criteria:

* Pathology confirmed GTD by MSKCC
* Sufficient proficiency in the English language to respond to quality of life surveys
* Age ≥ 18 years
* Benign or malignant disease
* Treated with surgery and/or chemotherapy or observation

Exclusion Criteria:

* None

Primary outcomes:
measure: The primary outcomes include reproductive concerns (as measured by the Reproductive Concern Scale, RCS) and sexual functioning (as measured by the Female Sexual Function Index, FSFI).
timeFrame: conclusion of the study
Secondary outcomes:
measure: To describe the prevalence of premature menopause and increased bone loss through the Menopausal Symptom Check List and medical follow-up information.
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Elizabeth Jewell, MD
role: PRINCIPAL_INVESTIGATOR
References: