louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04892966: TXI for the Recognition of Adenomas in Colonoscopy
Official title: Texture and Color Enhancement Imaging (TXI) Versus Standard White-light (WLI) Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Polyp
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 747
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This two parallel arms, randomized, multicenter trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of adenoma detection. Secondary aims will be advanced adenoma detection rate, serrated polyp/adenoma detection rate, as well as procedure variables such as withdrawal time.


Eligibility criteria: Inclusion criteria:

- All \>40 years-old patients undergoing a colonoscopy for primary screening, Faecal Immunochemical Test (FIT) +, post-polypectomy surveillance

Exclusion criteria:

* patients with personal history of colorectal cancer (CRC), or Inflammatory Bowel Disease (IBD).
* Patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.
* patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \<2 in any colonic segment).
* patients with previous colonic resection.
* patients on antithrombotic therapy, precluding polyp resection.
* patients who were not able or refused to give informed written consent.

Primary outcomes:
measure: Adenoma Detection Rate (ADR)
timeFrame: 1 year
Secondary outcomes:
measure: Advanced ADR
timeFrame: 1 year
measure: polyps, adenomas, advanced adenomas and Sessile Serrated Polyps (SSP) per subject
timeFrame: 1 year
measure: proximal and flat adenomas detection rate
timeFrame: 1 year
measure: Withdrawal time
timeFrame: 1 year
Other outcomes:
Locations:
city: Ariccia
country: Italy
facility: Ospedale Dei Castelli
state: Rome
Study officials:
References:
Clinical trial NCT05776966: Women's Opioid Treatment Follow-up Study
Official title: Increasing Women's Engagement in Medication Treatment for Opioid Use Disorder Through Digital Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-03-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to examine the feasibility of a gender-specific digital intervention for women with opioid use disorder. In this study, women with opioid use disorder will be randomized to receive treatment-as-usual plus a gender-specific digital intervention or treatment-as-usual only. Feasibility, satisfaction, and engagement with the intervention are the primary outcomes and will be measured post-intervention and at two-week, 6-week, and 12-week follow-up visits.

Detailed description: This study has two aims: (1) to demonstrate the feasibility of delivering a gender-specific digital intervention (GSDI) to women with opioid use disorder; (2) to collect preliminary estimates on the effect of the GSDI on engagement in medication treatment for opioid use disorder (MOUD). The investigators will conduct a pilot randomized controlled trial to achieve these aims. Women (N=40) who have recently initiated MOUD (within 30 days) will be enrolled and randomized to receive either the GSDI+TAU (gender-specific digital intervention + treatment as usual) or TAU-only. Feasibility, satisfaction, and engagement with the GSDI are the primary outcomes and will be measured post-intervention and at two-week, 6-week, and 12-week follow-ups. MOUD engagement will be assessed at two time-points: (1) 6-weeks and (2) 12-weeks post-enrollment to collect preliminary estimates on the effect of the GSDI on MOUD engagement.

Eligibility criteria: Inclusion Criteria:

* age 18 years of age or older
* current opioid use disorder diagnosis
* have a smartphone
* initiated medication treatment for opioid use disorder in the past 30 days,
* able to provide informed consent

Exclusion Criteria:

* an acute psychiatric or medical condition, or cognitive impairment, that would impair the ability to complete study procedures
* admitted to their current treatment episode on an involuntary status

Primary outcomes:
measure: Client Satisfaction Questionnaire
timeFrame: Immediately after the web-based portion of the intervention, Week 12
measure: System Usability Scale
timeFrame: 12 weeks
measure: Engagement metrics
timeFrame: Week 1 - Week 12
measure: Qualitative Exit Interview
timeFrame: Week 12
Secondary outcomes:
measure: Timeline Followback
timeFrame: Week 2, Week 6, Week 12
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT04525066: Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma
Official title: Injection Thyroplasty During Transoral Laser Microsurgery for Early Glottic Cancer: Single-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Neoplasms
Head and Neck Squamous Cell Carcinoma
Voice Disorders
Laryngeal Cancer
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Authority
First posted: 2020-08-25
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: Transoral Laser Microsurgery (TLM) is widely used in for treating T1/T2 glottic cancers. Hyaluronic acid (HA) is a safe and commonly-used injectable in vocal cord augmentation. We report on the results of our single-blinded, randomized-controlled trial (RCT) investigating the impact of intra-operative HA injection on voice outcomes in early glottic cancer.

Methods: Patients with T1/T2 glottic cancers were randomized to the treatment group (n=14) receiving HA injection to the unaffected cord during TLM; or the control group, receiving no injection (n=16). All patients had a Voice Handicap Index-10 (VHI-10) questionnaire and a Maximum Phonation Time (MPT) measurement preoperatively and at 3, 12 and 24 months post-operatively. Mean change in VHI-10 and MPT, between pre-operative and post-operative time points, and between the time points, were compared. Survival estimates were also calculated.


Eligibility criteria: Inclusion Criteria:

* Males and females
* 18 years of age or older with a biopsy-proven T1a, T1b or T2 glottic SCC
* Lesion amenable to CO2 TLM resection.

Exclusion Criteria:

* Previous radiotherapy to the head and neck.
* Palpable, or radiographic, pathological lymphadenopathy.
* Allergy, or sensitivity, to HA or components of the injectable.
* Neurological disorder affecting phonation, such as multiple sclerosis or stroke.

Primary outcomes:
measure: Voice Outcome
timeFrame: Change at 3 months post-operatively compared to baseline.
measure: Voice Outcome
timeFrame: Changes at 12 months post-operatively compared to baseline.
measure: Voice Outcome
timeFrame: Changes at 24 months post-operatively compared to baseline.
measure: Voice Outcome
timeFrame: Changes at 3 months post-operatively compared to baseline.
measure: Voice Outcome
timeFrame: Changes at 12 months post-operatively compared to baseline.
measure: Voice Outcome
timeFrame: Changes at 24 months post-operatively compared to baseline.
Secondary outcomes:
measure: Overall survival
timeFrame: 24 months post-augmentation
measure: Disease free survival
timeFrame: 24 months post-augmentation
measure: Recurrence-free survival
timeFrame: 24 months post-augmentation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02841566: Comparative Study of the Link Between the Practice of Gambling and Money and Materialism Among Problem Gamblers and Non-problem Gamblers
Official title: GAMbling and MAterialism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gambling
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All new patients be seen by a doctor for a behavioral addiction in the addictology and psychiatric department

Brief summary: The purpose of this study is to to explore the link between materialism and addiction to gambling and money


Eligibility criteria: Inclusion Criteria: ( specific to problem gamblers)

* subject having at least four diagnostic criteria in "Trouble linked to gambling and money" DSM-5 (APA 2013)
* subject who had written consent for participation in the EVALADD cohort
* Subject who has started treatment for a problem with the practice of gambling and money in the addictology and psychiatric department

( specific to non-problem gamblers)

* Subject playing games of chance and money at least once a year
* Subject playing games of chance and money less than once per week OR less than € 500 per year
* Subject having a score of 0-2 at ICJE questionnaire

Exclusion Criteria:

* Subject having difficulty reading or writing of the French language
* Subject having Parkinson's Disease
* Subject under guardianship

Primary outcomes:
measure: Materialism level among problem gamblers compared to non-problem gamblers
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02270866: Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-stroke Aphasia
Keywords: aphasia
stroke
Lead sponsor: Scion NeuroStim
Sponsor class: INDUSTRY
First posted: 2014-10-21
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a single site, open label study with a single arm designed to assess the feasibility of use of caloric vestibular stimulation (CVS) in patients with post-stroke aphasia. CVS is delivered via a portable, non-invasive device. Both language and movement assessments are made.


Eligibility criteria: Inclusion Criteria:

* \>6 months post-stroke (ischemic or hemorrhagic)
* receptive or expressive aphasia
* little or no improvement in language ability in the preceding 3 months

Exclusion Criteria:

* persons under the age of 18 or over the age of 75
* patients with pure receptive aphasia
* co-morbid CNS disease
* primary motor/oral apraxia
* pregnant or nursing women
* have a history of unstable mood disorder or unstable anxiety disorder or psychosis
* use of a hearing aid
* have a cochlear implant
* have a diagnosed vestibular dysfunction
* abuse alcohol or other drugs
* have had eye surgery within the previous three months or ear surgery within the previous six months
* have active ear infections or a perforated tympanic membrane
* have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
* Though not excluded, patients taking anti-histamines or anti-nausea drugs will be encouraged not to take such medications within four hours prior to a CVS treatment. The Investigator should review other medications taken by the patient with properties that mimic anti-nausea or anti-dizziness drugs as these may reduce responsiveness of the vestibular system to caloric stimulation.

Primary outcomes:
measure: Measure and quantify any improvements in verbal fluency at the end of a 3-month Tx period
timeFrame: after completing 84 days of device use
Secondary outcomes:
measure: Mood & QoL
timeFrame: after completing 84 days of device use
measure: Gait and posture
timeFrame: after completing 84 days of device use
measure: Heart rate variability (HRV)
timeFrame: after completing 84 days of device use
measure: Durability of gains
timeFrame: 3 months after the completion of therapy
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT01934166: Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment and in Healthy Subjects
Official title: An Interventional, Single-site, Open-label, Four-group, Single-dose Study Investigating the Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment (Mild, Moderate, or Severe) and in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2013-09-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To investigate if renal impairment will have an impact on the pharmacokinetics of nalmefene


Eligibility criteria: Inclusion Criteria:

* Healthy young subjects and subjects with renal impairment with a Glomerular Filtration Rate (GFR) of 50-80 ml/min/1.73m2, 30-\<50 ml/min/1.73m2, \<30 ml/min/1.73m2 will be included in the study.
* The subjects must have a BMI between 19 and 32 kg/m2.

Exclusion Criteria:

* The subject has a history of renal transplant or is undergoing dialyse treatment.
* The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to infinity (AUC0-inf)
timeFrame: Up to 120 hours post-dose
measure: For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to time t (t being the time for last quantifiable concentration) (AUC0-t)
timeFrame: Up to 120 hours post-dose
measure: For nalmefene and the metabolite nalmefene 3-O-glucuronide: maximum observed concentration (Cmax)
timeFrame: Up to 120 hours post-dose
measure: For nalmefene and the metabolite nalmefene 3-O-glucuronide: nominal time corresponding to the occurrence of Cmax (tmax)
timeFrame: Up to 120 hours post-dose
measure: For nalmefene and the metabolite nalmefene 3-O-glucuronide: apparent elimination half life in plasma (t½)
timeFrame: Up to 120 hours post-dose
measure: For nalmefene and the metabolite nalmefene 3-O-glucuronide: renal Clearance (CLR)
timeFrame: Up to 120 hours post-dose
measure: For nalmefene: oral clearance for nalmefene defined as dose/AUC0-inf (CL/F)
timeFrame: Up to 120 hours post-dose
measure: For nalmefene: apparent volume of distribution for nalmefene (Vz /F)
timeFrame: Up to 120 hours post-dose
measure: For the metabolite nalmefene 3-O-glucuronide: metabolic ratio (MR) defined as AUC0-inf,metabolite/AUC0-inf,parent
timeFrame: Up to 120 hours post-dose
Secondary outcomes:
measure: Safety and tolerability
timeFrame: Up to 10 days
Other outcomes:
Locations:
city: Munich
country: Germany
facility: DE801
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT01157026: A Pilot Clinical Trial With Tocotrienol on Breast Cancer
Official title: Effectiveness of Tocotrienol-rich Fraction Combined With Tamoxifen in the Management of Women With Early Breast Cancer: A Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Tocotrienol-rich fraction with tamoxifen
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
First posted: 2010-07-05
Enrollment: 240
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tocotrienol Rich Fraction (TRF) in combination with Tamoxifen will improve breast cancer specific survival and recurrence free survival, in women with early breast cancer and estrogen receptor positive tumors.

Detailed description: We conducted a, double-blinded, placebo controlled trial of TRF plus tamoxifen versus placebo plus tamoxifen in women with primary breast cancer for five years. Both the TRF and placebo drugs were prepared and supplied by Hovid Sdn Bhd, Malaysia. Hovid Sdn. Bhd. absolutely did not have any influence in the trial designing, patient recruitment, data collection, analysis and reporting. The placebo drug which contained soy oil without tocotrienols had similar appearance and taste as the TRF drug. A total of 240 women breast cancer patients were assigned to two groups by minimization method that balanced treatment groups. The intervention group was given TRF plus tamoxifen, (n = 120) while control group was given placebo plus tamoxifen, (n = 120). The primary end point was breast cancer specific survival, defined as the time from minimization to death due to breast cancer. The secondary end points included disease free survival, biochemical parameters, liver function and plasma levels of vitamin E.

Eligibility criteria: Inclusion criteria:

1. women with estrogen receptor positive tumors.
2. 40-60 years of age at the start of the tamoxifen therapy.
3. histologically confirmed primary breast cancer.
4. a tumor that was positive for estrogen receptors, progesterone receptors, or both.
5. an Eastern Cooperative Oncology Group performance status of 0,1, or 2 (scored on a scale of 0 to 5, with lower scores indicating better function).

Exclusion criteria:

1. concurrent use of investigational drugs and estrogen receptor status negative or unknown.

Primary outcomes:
measure: breast cancer specific survival
timeFrame: Five Years
Secondary outcomes:
measure: disease free survival
timeFrame: Five years
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Malaysian Palm Oil Board
state: Selangor
Study officials:
affiliation: Malaysia Palm Oil Board
name: Kalanithi Nesaretnam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nesaretnam K, Selvaduray KR, Abdul Razak G, Veerasenan SD, Gomez PA. Effectiveness of tocotrienol-rich fraction combined with tamoxifen in the management of women with early breast cancer: a pilot clinical trial. Breast Cancer Res. 2010;12(5):R81. doi: 10.1186/bcr2726. Epub 2010 Oct 8.
Clinical trial NCT06276166: Trajectory of Frailty and Cognitive Dysfunction in Older Adults
Official title: Study of the Joint Trajectory of Frailty and Cognitive Dysfunction Among Community-dwelling Older Adults
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Frailty
Cognitive Dysfunction
Community-dwelling Older Adults
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 934
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults without clear diagnosis of any type of dementia, neurological diseases, and mental disorders that affecting cognitive function.

Brief summary: To explore the heterogeneity of the development trend of frailty and cognitive function of older adults.

Detailed description: According to the inclusion and exclusion criteria, the older adults will be selected from community health service centers in four districts of Beijing. Frailty and cognitive function of the older adults will be assessed for a 24-month longitudinal multi-time (baseline, 6, 12 and 24 months). The heterogeneity of the development trend of frailty and cognitive function will be explored, and the subgroups of joint development trajectory of frailty and cognitive impairment will be classified, so as to identify high-risk populations that need to be managed.

Eligibility criteria: Inclusion Criteria:

* Age ≥60 years.
* Older adults with clear consciousness, ability of simple written and verbal communication.
* They volunteered to participate in this study, and signed an informed consent.

Exclusion Criteria:

* A clear diagnosis of any type of dementia.
* There are neurological diseases that clearly lead to cognitive dysfunction, such as severe cerebrovascular disease, brain trauma, intracranial tumors, etc.
* They have been clearly diagnosed with mental disorders affecting cognitive function, including schizophrenia, depression, bipolar disorder, etc.

Primary outcomes:
measure: Frailty
timeFrame: Baseline, 6 month, 12 month, and 24 month
measure: Cognitive function
timeFrame: Baseline, 6 month, 12 month, and 24 month
Secondary outcomes:
Other outcomes:
measure: Health status and life style
timeFrame: Baseline, 6 month, 12 month, and 24 month
measure: Activities of daily life (ADLs)
timeFrame: Baseline, 6 month, 12 month, and 24 month
measure: Anxiety
timeFrame: Baseline, 6 month, 12 month, and 24 month
measure: Apathy
timeFrame: Baseline, 6 month, 12 month, and 24 month
measure: Perceived social support
timeFrame: Baseline, 6 month, 12 month, and 24 month
measure: Social network
timeFrame: Baseline, 6 month, 12 month, and 24 month
Locations:
Study officials:
affiliation: Chinese Academy of Medical Sciences & Peking Union Medical College
name: Zheng Li
role: STUDY_CHAIR
References:
Clinical trial NCT00247026: The Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes
Official title: A Pilot Study to Determine the Clinical Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Myelodysplastic Syndrome
Keywords: myelodysplasia
curcumin
coenzyme Q10
cytopenia
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-11-01
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the clinical effects of coenzyme Q10 and Curcumin in improving the cytopenias of patients with myelodysplastic syndromes. we propose to explore the efficacy of the natural compounds curcumin and CoQ10 in MDS because these two agents possess many of the effects that are desirable in MDS.


Eligibility criteria: Inclusion Criteria:

* MDS patients with RA, RARS or RAEB will be eligible for treatment with CoQ10 as long as their IPSS score ≤ 1.5.

Exclusion Criteria:

* Pregnant women and nursing women will be excluded.
* History of clinically significant liver or kidney disease.
* ECOG\>2
* IPSS score \>1.5
* Poorly controlled diabetes mellitus, hypertension, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol.

Primary outcomes:
measure: major hematologic improvement in any lineage
Secondary outcomes:
measure: Time to disease progression
measure: Overall and progression-free survival
measure: Cytogenetic response
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: moshe e gatt, dr
role: PRINCIPAL_INVESTIGATOR
References: