louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00970190: Olfactory Dysfunction of Rhinosinusitis - Cyclic Adenosine Monophosphate (cAMP)/Calcium Signaling Study
Official title: Olfactory Dysfunction of Rhinosinusitis - cAMP/Calcium Signaling Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinusitis
Keywords: sinusitis
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2009-09-02
Enrollment: 99
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 presenting to the University of Washington Rhinology Clinic for evaluation of sinus problems

Brief summary: The study examines the biochemistry underlying human olfaction in both normal and diseased states.

The study aims are: 1. to determine the levels of cAMP in olfactory tissue from people with chronic rhinosinusitis and other nasal disorders. 2. to correlate preoperative olfactory function with cAMP levels from biopsied olfactory tissue. 3. to determine odorant and pheromone-mediated activation of cultured human olfactory sensory neurons using calcium imaging and 4. to determine odorant and pheromone-mediated activation of cultured human olfactory sensory neurons using "smell-chip" technology.

Detailed description: Subject will be recruited from those scheduled to have endoscopic sinus surgery and similar procedures. This study uses the tissue that would normally be discarded during the surgical process. The tissue is cultured and frozen for purposes of the following testing:

odor detection and signal transduction, cyclic adenosine monophosphate and odor detection, the role of cAMP in olfactory dysfunction, and pheromone detection.

Only tissue that would normally be discarded during the course of the surgery will be used. The study does not interfere with or change any clinical care.

Eligibility criteria: Inclusion Criteria:

* Subjects will be 18 years old and over and scheduled for one of the following:

  * endoscopic sinus surgery for chronic sinusitis
  * endoscopic transnasal approach to the pituitary for pituitary tumor removal
  * endoscopic inferior turbinectomy or septoplasty for nasal congestion
  * endoscopic repair of cerebrospinal fluid (CSF) leaks

Exclusion Criteria:

* Subjects are excluded if they are unable to give informed consent or unable to complete self-administered questionnaires due to English language barrier, cognitive impairment, or severe medical conditions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Greg E Davis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02495090: Hypospadias and Exome: Identification of New Genes for Familial Hypospadias
Official title: Hypospadias and Exome: Identification of New Genes for Familial Hypospadias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypospadias
Keywords: Hypospadias
exome sequencing
genital malformation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Hypospadias is the second most common malformation of the male genitalia and consists in a congenital hypoplasia of its ventral face. Hypospadias results from abnormal development of the penis that leaves the urethral meatus proximal to its normal glanular position. Meatus position may be located anywhere along the penile shaft, but more severe forms of hypospadias may have a urethral meatus located at the scrotum or perineum. Glandular and penile anterior represents approximately 70% of all the diagnosed cases.

The frequency of family reached depend on the severity of hypospadias. The number of children which have hypospadias mutation discovered by classical technique is low. Families are often the cause of the discovery of new genes involved in sexual differentiation because they allow comparison of genomes of related persons, and detect more easily mutations.

Detailed description: The aim of this protocol is to search for new genes involved in genital malformations such as hypospadias. Addressed to families with usual causes of these malformations excluded. The search for these mutations will be done by exome sequencing in families where several cases of hypospadias were identified.

Eligibility criteria: Inclusion Criteria:

* Hypospadiac patients with a familial history of hypospadias

Exclusion Criteria:

* Hypospadiac patients without a family history of hypospadias
* Hypospadiac patients with a family history of hypospadias where etiology is identified

Primary outcomes:
measure: number of new genetic variants
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier Cedex 5
country: France
facility: Hôpital Lapeyronie
Study officials:
affiliation: UH Montpellier
name: Nicolas Kalfa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02262702: Panadol Osteo Pharmaceuticals Benefit Scheme (PBS) Claims Cohort Study
Official title: Panadol Osteo PBS Claims Cohort Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Osteoarthritis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-10-13
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohort of Australian concessional patients with osteoarthritis

Brief summary: The aim of this observational study is to compare the use of an extended release paracetamol formulation with standard paracetamol in a cohort of Australian concessional patients with osteoarthritis (OA), to assess differences in prescribing patterns and patient compliance.

Detailed description: This retrospective analysis of physician prescribing data (long-term concessional cohort from the Medicare Australia PBS claims dataset for the time period 2008-2011 (4 years) will compare the use of extended release paracetamol (Panadol Osteo) with standard paracetamol 500mg in a cohort of Australian concessional patients with OA, to assess differences in prescribing patterns and patient compliance.

Eligibility criteria: Inclusion Criteria:

* Participants prescribed with a paracetamol product and categorized as a concessional patient
* Participants with new episodes of OA (no history of OA paracetamol in previous 12 months) or suffering from chronic OA (history of OA paracetamol in the previous 12 months)

Exclusion Criteria:

* Participants with Rheumatoid arthritis or other auto-immune inflammatory conditions
* Participants receiving the following anti-rheumatoid therapies:Immunimodulators such as methotrexate, leflunamide and TNF blockers
* Participants receiving treatment for cancer pain

Primary outcomes:
measure: Relative number of prescriptions of an extended release paracetamol formulation and a standard release paracetamol formulation.
timeFrame: January 2009 to December 2010
measure: Relative treatment compliance with an extended release paracetamol formulation and a standard release paracetamol formulation
timeFrame: January 2009 to December 2010
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02199002: Acid Pocket: Position and Aspiration
Official title: Acid Pocket: Different Position and Chemical Content Between Healthy Volunteers and GERD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GERD - PPI Responders
GERD - PPI Non-responders
Barrett Esophagus
Healthy Volunteers
Keywords: acid pocket
GERD
Barrett
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Gastroesophageal reflux disease (GERD) is a very common condition affecting up to 30% of adults. To date, therapy consists of powerful acid suppression with proton pump inhibitors (PPI). Nevertheless, only 60-70% of GERD patients report complete symptom relief with this therapy. As the mechanisms underlying symptom perception in PPI resistant patients are not fully understood, there is currently no adequate therapy available.

It is becoming increasingly clear that reflux, especially in the postprandial period, occurs from a reservoir of acid floating on top of the meal: the so-called "acid pocket". In this study, we aim to investigate further the acid pocket by determining its exact position and chemical contents between healthy volunteers, GERD patient who respond well and bad to PPI therapy and GERD patients with barrett's esophagus.

Detailed description: A costume made multi-pH-impedance manometry catheter will be placed in the esophagus and clipped to the Z-line. Patients then will be given a standardized meal and the position of the acid pocket will be measured. After two hours the pocket will be aspirated through a gastric catheter. Then, patients will be allowed to return home and the study will be continued for another 22 hours.

The special catheter will be removed at the end of the study. Collected acid pockets will be used to analyze content and perform permeability experiments.

Data of the 24-hour experiment will be used to evaluate the position of the acid pocket and number of reflux episodes.

Eligibility criteria: Inclusion Criteria:

* signed informed consent
* older than 18 years
* fit to criteria of 'study population' (HV, PPI responder, PPI non-responder, Barrett)

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: acid pocket position
timeFrame: participants will be followed for 24 hours
Secondary outcomes:
measure: number of reflux episodes
timeFrame: 24 hours
Other outcomes:
measure: acid pocket contents
timeFrame: 1 year
Locations:
city: Leuven
country: Belgium
facility: Catholic University Leuven
Study officials:
affiliation: Catholic University Leuven
name: Guy Boeckxstaens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00011102: Prevention of Weight Gain
Official title: Prevention of Weight Gain in Women Aged 25 Through 44
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Body Weight Changes
Keywords: weight gain
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2001-02-09
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test methods for preventing weight gain in normal-weight and overweight women aged 25 through 44. Participants will complete brief questionnaires about their health, eating and exercise habits, and use of weight control strategies. They will then be randomly assigned to 1 of 3 treatment conditions. All 3 treatments receive information on the importance of maintaining a healthy body weight, the components of a healthy diet, and ways to increase activity levels. The 3 treatment differ in how this information is delivered. At 12, 24 and 36 months after enrolling in the study, participants will attend assessment sessions. They will complete questionnaires and have body weight measured.


Eligibility criteria: Inclusion Criteria:

* Body mass index of 21 through 30

Exclusion Criteria:

* Presence of chronic disease that precludes regular physical activity or changes in dietary intake
* Currently receiving treatment for psychological disorder
* Currently pregnant or having given birth within last 12 months
* Use in last 3 months of weight loss medications or other drugs that affect body weight
* Participation in a weight loss program in last 12 months
* Planning to relocate outside the study area in the next 3 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00918502: Monitor Patients With Sleep Apnea
Official title: Adherent Respiratory Monitoring for Apnea Detection and Evaluation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea
Lead sponsor: Corventis, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: sleep study

Brief summary: The primary objective of the study is to gather data to correlate physiological signals measured by the AVIVO™ Mobile Patient Management System with the patient's respiratory status, including apnea and hypopnea events, during polysomnography

Detailed description: Patients with suspected sleep disordered breathing will be monitored during polysomnography and the collected information will be used to assess patient's respiratory status.

Eligibility criteria: Inclusion Criteria:

* Is female or male, 18 years of age or older
* Undergoing polysomnography for suspected sleep apnea
* Is willing to provide written informed consent and comply with study guidelines

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Corventis, Inc.
name: Imad Libbus, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05446402: Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne
Official title: Double Blinded, Split Face Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be using Product 1 regimen on left side of face for 12 weeks and Product 2 regimen on right side of face for 12 weeks.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare tolerability of two similar commercially available over the counter acne regimens (Geologie and Proactiv) in individuals with mild to moderate acne vulgaris over a 12-week daily treatment course.

Detailed description: Acne vulgaris is a common, chronic inflammatory skin disorder that originates in the pilosebaceous unit. Acne typically begins in adolescence and often continues into adulthood, with about 20% of cases resulting in scars or hyperpigmentation. It's estimated that acne affects about 85% of adolescents. Individuals who experience acne and acne scars tend to also experience a negative impact on their social and mental health, including depression, anxiety, and social withdrawal. Currently, topical solutions and lifestyle changes are the primary treatment for mild to moderate acne.

This study will evaluate and compare the efficacy of two over the counter products in treating individuals with mild to moderate acne: Geologie and ProActive. Both sets of products will be provided to Northwestern in identical, unlabeled bottles for the purpose of blinding.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* No known active skin infection.
* Presence of mild or moderate acne on face (clinical diagnosis or self-report)
* Willingness to give written consent and comply with study procedures.

Exclusion Criteria:

* Active skin infection.
* Inability to understand instructions or procedures involved.
* Known allergy to ingredient(s) in products being used for study.
* Pregnant women, prisoners, and vulnerable populations.
* Has a history of acute or chronic disease that may interfere with or increase the risk of study participation.
* Has any dermatological disorder that may interfere with the accurate evaluation of the subject's facial appearance, based on the opinion of the investigator.

Primary outcomes:
measure: Change in IGA Score between Geologie and ProActiv daily treatment
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Stephanie Rangel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04232202: Socket Preservation With Er:YAG and Nd:YAG Lasers
Official title: Post-extraction Treatment With Er:YAG and Nd:YAG Lasers - Socket Preservation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-extraction Bone Regeneration
Keywords: tooth extraction
alveolar bone
bone regeneration
laser
Lead sponsor: Krizaj d.o.o.
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to either laser or control group.
Primary purpose: TREATMENT

Brief summary: Alveolar bone regeneration after laser-assisted extraction will be compared with bone regeneration after standard extraction procedure.


Eligibility criteria: Inclusion Criteria:

* Patient requires at least one simple extraction
* Voluntary informed consent to participate in the study

Exclusion Criteria:

* Pregnancy
* Use of photosensitizing medication
* Refuse participation
* Require complicated extraction

Primary outcomes:
measure: Change in bone density from immediate post-extraction
timeFrame: 3 months
Secondary outcomes:
measure: Bone density
timeFrame: 3 months
measure: Bone thickness
timeFrame: 3 months
measure: Treatment pain
timeFrame: day 1
measure: Treatment pain
timeFrame: day 3
measure: Treatment pain
timeFrame: day 5
measure: Treatment pain
timeFrame: day 7
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Klinika Križaj
Study officials:
affiliation: Krizaj d.o.o.
name: Aleksandra Križaj Dumić, MDD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04298502: The Molecular Mechanism of CMV-driven NKG2C+NK Cell Expansion in Human
Official title: The Molecular Mechanism of CMV-driven NKG2C+NK Cell Expansion in Human
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Leukemia
CMV Viremia
Hematopoietic Stem Cell Transplantation
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation AND the healthy donors.

Brief summary: This is an observation study to investigate the molecular mechanism of NKG2C+NK cell expansion after HCMV infection

Detailed description: According to the changes of molecular and gene expression in NK cells at different time points after infection, we want to find out the mechanism by which HCMV promotes the expansion of NKG2C + NK cells.

Eligibility criteria: Inclusion Criteria:

1. AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation
2. No severe organ dysfunction or failure
3. Subjects must be capable of, and willing to provide written informed consent to participate in the study. Subjects unable to provide written informed consent by themselves may be consented through their legal representative.

Exclusion Criteria:

1. Participation in another industry-sponsored clinical study where treatment for CMV is already specified by the study protocol.
2. Patients received other adoptive immunotherapy such as donor lymphocyte infusion (DLI), Epstein-Barr virus (EBV)-specific T cells and so on.

Primary outcomes:
measure: CMV viremia
timeFrame: 2 moths post-transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Institute of Hematology
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Xiaojun Huang, M.D., PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01182402: Electronic Compliance Monitoring in Opioid Substitution Treatment
Official title: Electronic Compliance Monitoring in Opioid Substitution Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opiate Dependence
Keywords: opiate dependence
substitution treatment
unsupervised dosing
monitoring
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2010-08-16
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to improve unsupervised dosing of opioid substitution medications. The aim of the study is to examine whether electronic compliance monitoring provides some advantages to patients'treatment and what kind of patients especially benefit from monitoring. We would also like to know if electronic compliance monitoring can prevent the abuse/diversion of medications and how implementing this method to wider treatment facilities succeeds.


Eligibility criteria: Inclusion Criteria:

* opiate dependence F11.22 according to ICD-10
* Suboxone treatment
* the duration of substitution treatment before study at least one month
* stable medication dose

Exclusion Criteria:

* unstable situation in life according to treatment staff's opinions

Primary outcomes:
measure: The effectiveness of treatment (Treatment Outcomes Profile TOP)
timeFrame: Every two months.
Secondary outcomes:
measure: Patients´opinions about the treatment.
timeFrame: Once when the study phase ends (after four months).
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
References: