louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04602949: Detection of COVID-19 Using Breath Analysis - Validation Study
Official title: Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Scentech Medical Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2020-10-26
Enrollment: 2558
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY

Detailed description: A diagnostic prospective single-site study, with no anticipated risks or constraints.

Primary objective- To validate the value of a set of breath VOC biomarkers that enable us to distinguish between Coronavirus (SARS-CoV-2) carriers and SARS-CoV-2-negative in comparison to the gold-standard testing methodology.

Eligibility criteria: Inclusion Criteria:

* Age 6 to 75 years at the time of consent
* Capable of understanding written and/or spoken language
* Able to provide informed consent
* Was not treated with Anti-viral drugs

Exclusion Criteria:

* Age under 6 years old
* Under guardianship or deprived of liberty
* Pregnant or lactating woman

Primary outcomes:
measure: Presence of Volatile Organic Compounds indicating carriers of COVID-19.
timeFrame: Through the study completion, up to 3 months.
Secondary outcomes:
measure: Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.).
timeFrame: Through the study completion, up to 3 months.
measure: sensitivity level of biomarkers' algorithm.
timeFrame: Through the study completion, up to 3 months.
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Shamir Medical Center
Study officials:
affiliation: Scentech Medical Technologies Ltd
name: Natalie Dror, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00903149: Long-term Effect of The Mother Infant Transaction Program (MITP)
Official title: Long-term Effect of The Mother Infant Transaction Program (MITP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Births
Keywords: Premature babies
Social interaction
Psychoeducative intervention
Mother Infant Transaction Program
Three years follow-up
Late preterm
Cognitive development
Social development
Emotional development
Motor development
Children born preterm and their parents
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Foundation for Health and Rehabilitation
First posted: 2009-05-18
Enrollment: 88
Sex: ALL
Minimum age (years): 35
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: The cohort is 42 preterm infants in the intervention group, 40 preterm and 40 full term in control groups.

Brief summary: The purpose of this study is to investigate if a cost and time effective intervention in a previous RCT for preterm infants and their parents can reduce the parents experience of concern and stress, and improve the childrens development in various aspects at three years of corrected age.

Hypothesis 1: The preterm born children of parents who were enrolled in the earlier RCT have a higher developmental level then preterm children of parents who received the usual treatment.

Hypothesis 2: Parents who who were enrolled in the earlier RCT will have a lower level of stress and concern then parents who received treatment as usual.

Detailed description: A previous RCT by Ravn (NCT00245843) investigated if the MITP could sensitize the mothers toward the babies signals and thereby increase the quality of joint attention. The study followed the children for 1 year.

This study is a follow-up to the above mentioned RCT. It investigates whether the effect of the RCT is present at three years corrected age.

The research questions are:

1. Can a psychoeducative program like the MITP influence the childrens' development in various aspects?
2. How did the MITP influence the parents experience of concern and stress three years later?
3. Were there any differences by the groups? a) Preterm intervention group b)Preterm control group c) Full term control group

The questionnaires to be used in this observational study are:

Ages and Stages

Eligibility criteria: Inclusion Criteria:

* All parents of children who participated in Ravn's RCT and who said yes to be asked for participation in an eventually later study will be asked.

Primary outcomes:
measure: Child development
timeFrame: 36 months
measure: Parenting stress
timeFrame: Child age 36 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03575949: Standard and Delayed FDG PET/CT After Chemoradiation Therapy in Assessing Patients With Metastatic Head and Neck Squamous Cell Cancer
Official title: Dual-Time Point (DTP) FDG PET CT for the Post-Treatment Assessment of Head and Neck Tumors Following Definitive Chemoradiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Head and Neck Squamous Cell Carcinoma
Metastatic Malignant Neoplasm in the Spine
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-07-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This trial studies how well standard and delayed fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) given after standard radiation and chemotherapy works in assessing patients with head and neck squamous cell cancer that has spread to other places in the body. Diagnostic procedures, such as PET/CT, use radioactive material, such as fludeoxyglucose F-18, to find and diagnose head and neck tumors and may help to find out how far the disease has spread.

Detailed description: PRIMARY OBJECTIVE:

I. To assess the optimal imaging time using FDG positron emission tomography (PET) with comparison between a standard of care 1-hour scan (early) and the research scan of 3-hours scan (delayed) post radiotracer administration that maximizes separation of activity between lesion and non-lesional parenchyma (measured as lesion/background \[L/B\] ratio) in patients with head and neck primary squamous cell carcinoma following chemoradiation treatment.

OUTLINE:

Patients receive fludeoxyglucose F-18 intravenously (IV) over 1 minute and undergo PET/CT at 70 and 180 minutes after injection at 12-14 weeks following standard chemoradiation (CRT) completion.

After completion of study, patients are followed up at 30 days and then periodically for up to 6 months.

Eligibility criteria: Inclusion Criteria:

* Adult with computed tomography (CT) or fludeoxyglucose F-18 (FDG) positron emission tomography (PET) findings of cervical nodal metastasis from a head and neck primary squamous cell carcinoma treated with definitive chemoradiation

Exclusion Criteria:

* Children
* No evidence of cervical nodal metastasis
* Active infection of the head and neck
* Known allergy to FDG, iodine or gadolinium-based contrast agents
* Blood glucose (\> 250 mg/dl)
* Pregnant women

Primary outcomes:
measure: Optimal imaging time
timeFrame: Up to 6 months
measure: Differences in L/B ratio
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jason M Johnson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00411749: V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)
Official title: V501 Phase II Immunogenicity Study in Females Aged 9 to 17 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HPV Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-12-15
Enrollment: 107
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females


Eligibility criteria: Inclusion Criteria:

* Virginal Female Subject Aged 9 To 17 Years

Exclusion Criteria:

* Male Subject

Primary outcomes:
measure: Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series
timeFrame: At one month after completed vaccination series (Month 7)
measure: Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series
timeFrame: At one month after completed vaccination series (Month 7)
measure: Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series
timeFrame: At one month after completed vaccination series (Month 7)
measure: Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series
timeFrame: At one month after completed vaccination series (Month 7)
Secondary outcomes:
measure: HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series
timeFrame: 24 month after completed vaccination series (Month 30)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Murata S, Shirakawa M, Sugawara Y, Shuto M, Sawata M, Tanaka Y. Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants. Papillomavirus Res. 2020 Dec;10:100205. doi: 10.1016/j.pvr.2020.100205. Epub 2020 Aug 19.
Clinical trial NCT03588949: Role of Nutritional Support in Idiopathic Male Infertility
Official title: Role of Nutritional Support in Idiopathic Male Infertility: a Randomized Dietary Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility, Male
Lead sponsor: NATURAmedicatrix Sàrl
Sponsor class: INDUSTRY
First posted: 2018-07-17
Enrollment: 100
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Approximately 100 males with idiopathic infertility and oligo- and/or astheno- and/or and/or teratozoospermia and fertile woman will take a Test dietary supplement (TDS), containing carnitine, vitamins and trace elements (active group) or carotene (control group) for 6 months (50 subjects in active and control groups). Before intake, and 2 and 4 months after the commencement of TDS, all males will have spermogram. After 6-month use of the TDS and during the 12th month of the study, couples will be screened for conception, pregnancy, and a newborn


Eligibility criteria: Inclusion Criteria:

1. Informed consent form signed;
2. Age: 21-50;
3. Idiopathic male infertility;
4. Idiopathic oligo- and/or astheno- and/or teratozoospermia;
5. Stated availability throughout the study period and a mobile phone

Exclusion Criteria:

1. Allergy to any component of the dietary supplement;
2. Known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of male infertility;
3. Known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of female infertility;
4. Inflammatory bowel disease;
5. Known moderate to severe disease of any systems;
6. Known or suspected sexually transmitted diseases;
7. Alcohol or drug addiction of any couple counterpart as suspected by investigator;
8. Difficulty to comprehend study requirements as judged by investigator;
9. Use of any investigational product within the previous 3 months before entering the study;
10. Use of any drugs that stimulate or suppress spermatogenesis within previous 3 months

Primary outcomes:
measure: Rate of normalization of spermogram
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lviv
country: Ukraine
facility: MedianaStatistics
Study officials:
affiliation: NATURAmedicatrix Sarl
name: Marco Pietteur
role: STUDY_DIRECTOR
References:
Clinical trial NCT01534949: Provide Initial Evidence of Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy to Support the Pivotal CT-P10 Therapeutic Equivalence Trial
Official title: A Phase 1, Multicenter, Open-Label, Single-Arm Study to Evaluate the Initial Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of CT-P10 Given in Combination With Dexamethasone, Cytosine Arabinoside, and Cisplatin (DHAP) in Patients With Diffuse Large B-Cell Lymphoma as Second-Line Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diffuse Large B-Cell Lymphoma
Keywords: DLBCL, Biosimilar
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2012-02-17
Enrollment: 1
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to provide initial evidence of safety, pharmacokinetics, pharmacodynamics, and efficacy to support the pivotal CT-P10 therapeutic equivalence trial.


Eligibility criteria: Inclusion Criteria:

1. Patient has histologically proven DLBCL, which may represent de novo DLBCL or DLBCL arising from transformed follicular lymphoma or chronic lymphocytic leukemia.
2. Patient has relapsed or refractory CD20-positive disease following previous first-line systemic chemotherapy. Patients who have failed to achieve complete remission with previous chemotherapy are defined as refractory, and those who relapsed after an initial complete remission are classified as having relapsed. A biopsy must be performed to confirm diagnosis of relapsed disease. Tumor tissue within 6 months of Day 1 of Cycle 1 of study treatment will be used for the central review.
3. Patient has at least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension, or 1.1 to 1.5 cm in the longest dimension, and greater than 1.0 cm in the shortest axis) that has not previously been irradiated or has grown since previous irradiation

Exclusion Criteria:

1. Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins.
2. Patient has had prior allogeneic or ASCT.
3. Patient has received any other anticancer therapy within 28 days before Day 1 of Cycle 1 of study treatment and more than 1 prior line of chemotherapy, with the exception of having received the last dose of rituximab within 6 months before Day 1 of Cycle 1 of study treatment if they have undergone prior treatment with rituximab.

Primary outcomes:
measure: safety
timeFrame: after 6 weeks of treatment begin
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Wonseog Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01063049: Gatorade/Miralax With or Without Bisacodyl Versus NuLytely for Colonoscopy Preparation
Official title: Gatorade/Miralax With or Without Bisacodyl vs NuLytely for Colonoscopy Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preparation for Colonoscopy
Lead sponsor: Gastroenterology Services, Ltd.
Sponsor class: OTHER
First posted: 2010-02-05
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare Nulytely (or Trilyte) with a Gatorade and Miralax combination for cleaning out the colon before colonoscopy. A laxative pill called Bisacodyl may also be used with the Gatorade and Miralax to see if it helps with the clean out process. We are trying to find out if either of these methods is more acceptable to the patient and does a better job cleaning out the colon for a colonoscopy.


Eligibility criteria: Inclusion Criteria:

1. Patients at least 18 years old planning to undergo an elective colonoscopy.

Exclusion Criteria:

1. Patients who are allergic or intolerant to any on the study drugs.
2. Pregnant patients.
3. Patients who required multiple day colon preparation in the past.
4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.

Primary outcomes:
measure: The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale
timeFrame: After Colonoscopy
Secondary outcomes:
measure: The Ottawa Scale for Colonoscopy Preparation Will be Reported and Compared Among the 3 Groups to Allow for Comparisons to Some of the Older Literature
timeFrame: After Colonoscopy
Other outcomes:
Locations:
city: Downers Grove
country: United States
facility: Gastroenterology Services
state: Illinois
Study officials:
affiliation: Gastroenterology Services, Ltd.
name: David P Gerard, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerard DP, Holden JL, Foster DB, Raiser MW. Randomized Trial of Gatorade/Polyethylene Glycol With or Without Bisacodyl and NuLYTELY for Colonoscopy Preparation. Clin Transl Gastroenterol. 2012 Jun 21;3(6):e16. doi: 10.1038/ctg.2012.11.
Clinical trial NCT02784249: A Comparison of Two Ab Interno Procedures in the Treatment of Glaucoma in Patients Undergoing Cataract Extraction
Official title: A Prospective, Randomized, Multi-Center, Open-Label Trial Comparing a Novel Goniotomy Procedure and an Ab Interno Trabecular Bypass Device in the Treatment of Mild to Moderate Glaucoma in Patients Undergoing Cataract Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Angle Glaucoma
Keywords: Glaucoma
glaucoma surgery
ab interno
Lead sponsor: New World Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-27
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and efficacy of goniotomy performed with a novel ophthalmic knife compared to trabecular bypass stent implantation in mild to moderate glaucoma subjects who are also undergoing cataract extraction with phacoemulsification (Phaco) and posterior chamber intraocular lens (PCIOL) implant.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of open angle glaucoma (including pseudoexfoliation and pigmentary glaucoma)
* Diagnosis of mild to moderate glaucoma as defined by ICD-9 staging definitions 365.71 Mild/365.72 Moderate (including visual field defects and/or characteristic optic nerve abnormalities consistent with mild to moderate glaucoma)
* Planned removal of a visually significant cataract as determined by the Investigator (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification cataract extraction

Exclusion Criteria:

* Any glaucoma diagnosis other than those noted in inclusion criteria

Primary outcomes:
measure: Percent reduction in mean IOP
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Crosse
country: United States
facility: Gundersen Health System
state: Wisconsin
Study officials:
affiliation: Pilot to Pivotal Consulting, Inc.
name: Luana Wilbur, BS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04488549: Delayed Colorectal Cancer Care During Coronavirus Disease (COVID-19) Pandemic (DECOR-19)
Official title: DElayed COloRectal Cancer Care During Coronavirus Disease (COVID-19) Pandemic (DECOR-19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colo-rectal Cancer
Colon Cancer
Rectal Cancer
Oncology
Surgery
Lead sponsor: Treviso Regional Hospital
Sponsor class: NETWORK
Collaborators: name: Gaetano Gallo
name: Gian Luca Di Tanna
First posted: 2020-07-28
Enrollment: 1051
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The survey link was sent to scientific societies of interest to coloproctologists and disseminated to their members. Participation was entirely voluntary with no compensation offered. Informed consent was obtained from all those agreeing to complete a survey. This study was exempt from review board approval at authors' institutions.

Brief summary: To understand and analyse the global impact of COVID-19 on outpatient services, inpatient care, elective surgery, and perioperative colorectal cancer care, a DElayed COloRectal cancer surgery (DECOR-19) survey was conducted in collaboration with numerous international colorectal societies with the objective of obtaining several learning points from the impact of the COVID-19 outbreak on our colorectal cancer patients which will assist us in the ongoing management of our colorectal cancer patients and to provide us safe oncological pathways for future outbreaks.


Eligibility criteria: Inclusion Criteria:

* Members of renowned scientific societies with an interest in coloproctology

Exclusion Criteria:

* None

Primary outcomes:
measure: Predictive power of respondents' and hospitals' demographics on delaying colorectal cancer care across 6 geographical regions
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: Treviso Regional Hospital
Study officials:
References:
Clinical trial NCT04227249: 3 Year Recurrence Free Survival in Ultra-low-risk Endometrial Cancer
Official title: Three-year Recurrence Free Survival in Patients With Ultra-low-risk Endometrial Cancer Who do Not Undergo Lymph Node dissEction
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Endometrial Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 153
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: endometrial cancer with ultra-low risk for lymph node metastasis

Brief summary: To verify the safety of omission of lymph node dissection in ultra-low-risk endometrial cancer (KGOG criteria), we examine the survival of women with ultra-low-risk endometrial cancer who do not undergo lymph node dissection


Eligibility criteria: Inclusion Criteria:

* endometrioid type
* anticipated surgery omitting lymph node dissection for endometrial cancer
* pelvis MRI, CA125 - satisfying KGOG criteria
* no distant metastasis
* age 19 or more

Exclusion Criteria:

* other cancer within 5 yr
* previous hysterectomy
* previous therapy for endometrial cancer

Primary outcomes:
measure: 3 year recurrence free survival
timeFrame: 3 year since surgery
Secondary outcomes:
measure: 5 year recurrence free survival
timeFrame: 5 year since surgery
measure: 5 year overall survival
timeFrame: 5 year since surgery
measure: surgery time
timeFrame: surgery visit
measure: change of Functional Assessment of Cancer Therapy - General (FACT G) score from baseline
timeFrame: baseline - 1week - 5week - 3month - 6month
measure: change of Gynecologic Cancer Lymphedema Questionnaire - Korean (GCLQ-K) score from baseline
timeFrame: baseline - 5week - 6month - 12month - 18month - 24month - 36month - 48month - 60month
measure: change of Female Sexual Function Index (FSFI) score from baseline
timeFrame: baseline - 6month - 12month - 24month - 36month - 48month - 60month
measure: length of stay
timeFrame: surgery visit
measure: transfusion
timeFrame: surgery visit
measure: hemoglobin decline
timeFrame: surgery visit
measure: surgery complication
timeFrame: surgery visit
Other outcomes:
Locations:
Study officials:
References: