louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03871179: Cognoa ASD Diagnostic Device - Data Collection Study
Official title: Cognoa ASD Diagnostic Device - Data Collection Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Cognoa, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to collect data to ascertain the PPV and NPV of the current version of the Cognoa diagnostic device. A secondary objective is to collect data, in the form of additional questions, in order to train new algorithms related to children's developmental and behavioral conditions.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 months of age and \< 72 months of age
* Functional English capability in the home environment
* Documented parental and/or clinician concern for developmental delay
* Participants must have a smartphone capable of downloading the Cognoa App (Cognoa supports iOS 10.0 and up, Android 6.0 and up)

Exclusion Criteria:

* Children with suspected auditory or visual hallucinations or with prior diagnosis of childhood onset schizophrenia.
* Children with known sensory impairment such as deafness or blindness
* Children with known physical impairment affecting their ability to use their hands
* Children with major dysmorphic features or prenatal exposure to teratogens (such as fetal alcohol syndrome)
* Children with history or diagnosis of genetic conditions (such as Rett's syndrome or fragile X)
* Children with microcephaly
* Children with history or prior diagnosis of epilepsy or seizures
* Children with history of or suspected neglect
* Children with history of brain defect, injury or insult requiring interventions such as surgery or chronic medication
* Children whose age on the date of enrollment is outside the target age range
* Children who have been previously enrolled in any Cognoa clinical study or survey
* Children whose medical records had been included in any internal Cognoa training or validation sets

Primary outcomes:
measure: Positive and negative predictive value of ASD Dx in relation to clinician diagnostic evaluation
timeFrame: approximately one month
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
Study officials:
affiliation: Children's Hospital of Orange County
name: Tom Megerian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02818179: Monitoring HDR Brachytherapy for Cervical Cancer by Optic and Thermal Imaging
Official title: Monitoring HDR Brachytherapy for Cervical Cancer by Optic and Thermal Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: MALIGNANCY
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-06-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This research aims to investigate the correlation between tumor temperature difference and biological factors, such as size, metabolism, treatment response, and tumor aggressiveness.

In addition, normal tissue response to radiation therapy in treated organ will be evaluated.


Eligibility criteria: Inclusion Criteria:

* signed informed consent
* biopsy proven cervical cancer which will undergo definitive radiation

Exclusion Criteria:

* not eligible to sign informed consent

Primary outcomes:
measure: The change in Infra-Red radiation emitted at wavelengths 0.8-1nm
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Evaluating of efficacy of the radiation
timeFrame: 3 months after the treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00492479: An Evaluation of Kinerase Pro+Therapy Regimen Vs. Kinerase Vs. Control for the Treatment of Skin Aging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Skin Aging
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2007-06-27
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare the efficacy of the Kinerase Pro+Therapy regimen versus a single Kinerase product vs. control for the treatment of the signs of skin aging.


Eligibility criteria: Inclusion Criteria:

* Female patients 35-55 years of age with at least moderate signs of facial aging
* Written informed consent
* Likely to complete all study visits and follow study protocol

Exclusion Criteria:

* Any dermatological or medical condition which would make patient participation unsafe or interfere with study outcomes or measurements
* Known hypersensitivity to any study product or their components
* Recent (within 4 weeks of baseline) surgical treatment to face (including IPL and other laser procedures)
* Prior use of anti-aging treatments for 30 days prior to study entry (physician dispensed or prescribed treatments)
* Planned facial procedures during the study (microdermabrasion, facials, etc)

  o Botox and fillers cannot be used during the trial or for 3 months prior to study entry
* Recent (within 60 days) or concurrent participation in another clinical trial
* Concomitant topical or systemic therapy that my interfere with study measurements or outcomes
* Use of any other topical photoaging/antiaging therapies during the study, other than the prescribed study regimens
* Patients who are habitual tanners (outdoors or with tanning beds) who plan on tanning during the study
* Wearing of cosmetics during study visits

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: Steve Yoelin MD practice
state: California
Study officials:
affiliation: Private Practice
name: Steven Yoelin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01666379: Pain Management After Forefoot Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Hallux valgus
Forefoot
transdermal fentanyl
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2012-08-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the efficacy of transdermal fentanyl to placebo both administered together with peroral nonsteroidal antiinflammatory drug (NSAID) and paracetamol in treatment of postoperative pain after hallux valgus or hallux rigidus surgery.


Eligibility criteria: Inclusion Criteria:

* unilateral hallux valgus or hallux rigidus surgery
* 18-75 yrs old
* ASA I-III

Exclusion Criteria:

* previous history of intolerance to the study drug
* history of alcoholism
* drug abuse
* psychological or other emotional problems that are likely to invalidate informed consent
* sleep apnoea
* BMI ≥ 35 kg/m2

Primary outcomes:
measure: Consumption of rescue opioid
timeFrame: on the 1st postoperative day
Secondary outcomes:
measure: Pain on a numerical scale
timeFrame: on the 1st postoperative day
Other outcomes:
Locations:
city: Turku
country: Finland
facility: The Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Management of Turku University Hospital
Study officials:
References:
Clinical trial NCT05884879: Listening Effort in Tinnitus Patients
Official title: Assessment of Listening Effort in Tinnitus Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Listening Effort
Tinnitus
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: TINNITUS GROUP:

Tinnitus patients visiting the Audiological Centre of Maastricht UMC+, Adelante Zorggroep Hoensbroek and Blerick, Libra Eindhoven, Kentalis Eindhoven, Den Bosch and Nijmegen.

CONTROL GROUP:

General population visiting the Maastricht UMC+.

Brief summary: About 5-15% of the general population experience a chronic ringing, buzzing, hissing or roaring sound in one or two ears, without any external source. This so-called tinnitus can be present in people with normal hearing, but often coexists with hearing loss. Most people suffering from tinnitus can cope with it, however a minority experiences emotional distress or cognitive dysfunction as a result of the tinnitus, called tinnitus disorder. People suffering from tinnitus disorder regularly complain about an increased experienced effort when listening to speech or other sounds in daily life situations. As this has never been proven scientifically, the investigators aim to evaluate the effect of the tinnitus percept and tinnitus disorder on experienced listening effort by comparing listening effort between a population with tinnitus disorder and a population without tinnitus.


Eligibility criteria: Inclusion Criteria:

* Young adults, i.e. 18-69 year old;
* Pure tone average \<35 dB HL (0.5, 1, 2, 4 kHz);
* Proficient and native speaker of Dutch language;
* TINNITUS GROUP: Severe unilateral or bilateral tinnitus disorder (TQ \> 46).
* CONTROL GROUP: No tinnitus.

Exclusion Criteria:

* Significant asymmetric hearing loss: \|PTAright - PTAleft\| \> 15 dB (PTA = pure tone average of 500, 1000, 2000 and 4000 Hz);
* Significant loss of vision (text on screen at 70 cm should be readable);
* Frequent user of any of the following devices: Hearing Aid, Bone Conduction Device, Cochlear Implant, Tinnitus Masker;
* Additional mental or physical disabilities that may prevent active participation and testing as per protocol.

Primary outcomes:
measure: Listening effort
timeFrame: 1 day
Secondary outcomes:
measure: Listening effort predictability of tinnitus related questionnaire: TQ
timeFrame: 1 day
measure: Listening effort predictability of tinnitus related questionnaire: TFI
timeFrame: 1 day
measure: Listening effort predictability of tinnitus related questionnaire: HADS
timeFrame: 1 day
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: Limburg
Study officials:
affiliation: Maastricht UMC+
name: Erwin LJ George, MPE PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01484379: Surgical Approach for Primary Hyperparathyroidism in the Elderly
Official title: Surgical Approach for Primary Hyperparathyroidism in the Elderly - a Prospective Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Multigland Disease in Primary Hyperparathyroidism
Keywords: Primary Hyperparathyroidism
multigland disease
neck exploration
elderly
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-12-02
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Following a personal observation and a retrospective analysis of the data, the investigators hypothesise that there is increased frequency of multiple gland disease in primary hyperparathyroidism in the elderly.

This study will include patients over the age of 65, diagnosed with primary hyperaprathyroidism, referred for surgery and suspected to have a single adenoma according to preoperative imaging. Surgery will begin with a focal parathyroid exploration as suspected followed by an exploration of the other gland at the same time. Data will be analysed to determine the frequency of multigland disease in this population.


Eligibility criteria: Inclusion Criteria:

* patient with primary hyperparathyroidism.
* patients with an indication for surgery.
* Suspected adenoma on preop images.
* minimum age of 65.

Exclusion Criteria:

* patients younger than 65.
* cases where imaging didn't locate any adenoma.
* patients who did not consent to participate in the study.

Primary outcomes:
measure: Frequency of multigland disease in hyperparathyroidism in the elderly.
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam health care campus Haifa Israel
name: Michal Mekel, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kebebew E, Duh QY, Clark OH. Parathyroidectomy for primary hyperparathyroidism in octogenarians and nonagenarians: a plea for early surgical referral. Arch Surg. 2003 Aug;138(8):867-71. doi: 10.1001/archsurg.138.8.867.
citation: Shin SH, Holmes H, Bao R, Jimenez C, Kee SS, Potylchansky E, Lee JE, Evans DB, Perrier ND. Outpatient minimally invasive parathyroidectomy is safe for elderly patients. J Am Coll Surg. 2009 Jun;208(6):1071-6. doi: 10.1016/j.jamcollsurg.2009.01.048. Epub 2009 Apr 17.
citation: Uden P, Chan A, Duh QY, Siperstein A, Clark OH. Primary hyperparathyroidism in younger and older patients: symptoms and outcome of surgery. World J Surg. 1992 Jul-Aug;16(4):791-7; discussion 798. doi: 10.1007/BF02067389.
Clinical trial NCT06360679: Clinical Feasibility Study of the BariTon™ System in Obese or Overweight Patients.
Official title: Clinical Feasibility Study of the BariTon™ System in Obese or Overweight (BMI > 27) Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: BariaTek Medical
Sponsor class: INDUSTRY
First posted: 2024-04-11
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety and efficacy evaluation of the BariTon™, BariaTek Medical gastric restriction and biliodigestive diversion device.


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects aged between 25 and 60 years inclusive
2. A BMI between 30.0 and 40.0 kg/m2 inclusive with a history of obesity for at least 2 years and a history of failure of supervised weight loss program
3. Stable weight, i.e. \< 5% change in body weight for minimum of 3 months prior to enrolment
4. Willing and able to provide written informed consent
5. Willing and able to comply with the study procedures and follow-up schedule

Primary outcomes:
measure: Safety of the BariTon™
timeFrame: 3 months
measure: Safety of the BariTon™
timeFrame: 3 months
Secondary outcomes:
measure: Safety of the BariTon™
timeFrame: 1 year
measure: Safety of the BariTon™
timeFrame: 1 year
measure: Efficacy of the BariTon™
timeFrame: 1 year
measure: Efficacy of the BariTon™
timeFrame: 1 year
measure: Efficacy of the BariTon™
timeFrame: 1 year
measure: Efficacy of the BariTon™
timeFrame: 1 year
measure: Efficacy of the BariTon™
timeFrame: 1 year
measure: Efficacy of the BariTon™
timeFrame: 1 year
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: BMI Clinic Double Bay
state: New South Wales
city: Sydney
country: Australia
facility: BMI Clinic Liverpool
state: New South Wales
Study officials:
affiliation: The BMI Clinic
name: Adrian Sartoretto, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04187079: Immunopathologic Profiles and Blood Biomarkers in Patients With IPF
Official title: Immunopathologic Profiles of the Lung Micro- Environment Using Cryobiopsies and Identification of Blood Biomarkers in Patients With IPF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2019-12-05
Enrollment: 100
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 suspected of having an ILD who are having cryobiopsies performed to get a histological specimen for the diagnoses.

Brief summary: Examination of expression of PD-L1, PD-L2, Beta- catenin, B-cell follicles and Tenascin- C in patients with IPF compared with other interstitial lung diseases. Examination of anti HSP 70, p-ANCA, c-ANCA, CD4+/CD28- and CD8+/CD28- cells in patients with IPF compared with other interstitial lung diseases.

Compare the above mentioned findings with changes in pulmonary function tests, 6 minute walking test, exacerbation and mortality over a 2 year follow-up period.

Detailed description: Examination of expression of PD-L1, PD-L2, Beta- catenin, B-cell follicles and Tenascin- C in cryobiopsies from the lungs inpatients with IPF compared with other interstitial lung diseases. Examination of anti HSP 70, p-ANCA, c-ANCA, CD4+/CD28- and CD8+/CD28- cells in blood samples in patients with IPF compared with other interstitial lung diseases.

Compare the above mentioned findings with changes in pulmonary function tests, 6 minute walking test, exacerbation and mortality over a 2 year follow-up period.

Eligibility criteria: Inclusion Criteria:

* Patients suspected of having an ILD who are having cryobiopsies performed

Exclusion Criteria:

* BMI \> 35
* DLCO \< 35%
* FVC \< 45%
* Pulmonary hypertension
* Cardiac or other severe comorbidity that will increase the risk of complications

Primary outcomes:
measure: PD-L1
timeFrame: At diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Respiratory Diseases and Allergy
Study officials:
affiliation: Department of Respiratory Diaseses, Aarhus University Hospital
name: Venerino Poletti, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06762379: Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC Through Liquid Biopsy Integration
Official title: Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Prostate Cancer (mPC)
Keywords: HRR liquid biopsy
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2025-01-07
Enrollment: 125
Sex: MALE
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: Patients with metastatic prostate cancer

Brief summary: Implementation of a new algorithm for HRR gene mutation testing in patients with mPC through liquid biopsy integration

Detailed description: Analysis of the current clinical landscape of mPC Italy to identify gaps and opportunities for improvement.

Patient identification and enrollment Blood sample collection and plasma purification ctDNA extraction and NGS analysis of homologous recombination repair (HRR) genes. Clinical Real-World Data (RWD) and molecular analysis data collection Testing algorithm development based on collected data Finalization and sharing of a best practice model for diagnostic procedures in mPC patients

Eligibility criteria: Inclusion Criteria:

* Patients with metastatic prostate cancer whose tumor tissue is unavailable or inadequate for molecular testing. • Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.

Exclusion Criteria:

* Unable to provide written informed consent

Primary outcomes:
measure: Validation of an assay for homologous recombination repair (HRR) gene mutation testing using liquid biopsy
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of oncology
Study officials:
References:
Clinical trial NCT02295579: Will Lactobacillus Increase Cure Rate After Treatment of Bacterial Vaginosis and Chronic Vulvovaginal Candida
Official title: Vaginal Colonization After Treatment With Lactobacillus in Women With BV or Candida Will That Increase the Cure Rate After Treatment With Clindamycin for BV and Flucnazole for Candida
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Vaginosis
Lead sponsor: Skaraborg Hospital
Sponsor class: OTHER_GOV
First posted: 2014-11-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women with vaginal discharge with either bacterial vaginosis or candida infection

Brief summary: From the earlier studies the investigators have treated women with bacterial vaginosis and cronic vulvovaginal candida. The investigators have then treated them with laktobacilli 10 days for 2 month. The investigators will continue to follow them and investigate if treatment with lactobacilli every week for 6 month will increase cure rate.

Detailed description: Clinical diagnosis of bacterial vaginosis using air dried smears combined with Hay/Ison classification. Test of cure every month or every menstrual cycle using self taken smears. The cure will be if the woman are in group 1 according to Hay/Ison classification. This will also allow us to use molecular diagnosis of BV to test cure and compare this with hay/Ison.

Test of cure for candida patiens are no visibel candida on wet smear and free of symtoms of candida.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of bacterial vaginosis according to Hay/Ison or with candida diagnosed with wet smear.

Exclusion Criteria:

* Women with chlamydia infection, Pregnancy, Herpes

Primary outcomes:
measure: cure rate
timeFrame: 6 month
Secondary outcomes:
measure: colonization of lactobacilli
timeFrame: 6 month
Other outcomes:
Locations:
city: Skövde
country: Sweden
facility: Department of Ob/Gyn, Skaraborgshospital Skövde
city: Skövde
country: Sweden
facility: Kvinnokliniken
Study officials:
affiliation: Department of Ob/Gyn Skaraborgs hospital
name: Per-Göran Larsson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Larsson PG, Brandsborg E, Forsum U, Pendharkar S, Andersen KK, Nasic S, Hammarstrom L, Marcotte H. Extended antimicrobial treatment of bacterial vaginosis combined with human lactobacilli to find the best treatment and minimize the risk of relapses. BMC Infect Dis. 2011 Aug 19;11:223. doi: 10.1186/1471-2334-11-223.
citation: Pendharkar S, Brandsborg E, Hammarstrom L, Marcotte H, Larsson PG. Vaginal colonisation by probiotic lactobacilli and clinical outcome in women conventionally treated for bacterial vaginosis and yeast infection. BMC Infect Dis. 2015 Jul 3;15:255. doi: 10.1186/s12879-015-0971-3.