louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06008899: Efficacy of Ultrasound-assisted Caudal Epidural Pulsed Radiofrequency for Anal Pain in Cancer Patients,
Official title: Efficacy of Ultrasound-assisted Caudal Epidural Pulsed Radiofrequency for Anal and Perineal Pain in Cancer Patients, a Prospective Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perineal Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Our primary goal will be to investigate the analgesic efficacy of ultrasound (US)-assisted caudal epidural PRF (pulsed radiofrequency)( stimulation in patients with perineal or anal pain cancer patients using (visual analog scale (VAS) scores from 0 to 10 at the baseline (pretreatment), two, four, and eight weeks; secondary outcomes will be the effects on opioid use and total opioid use in the 24 h, quality of life, patient satisfaction and opioid and intervention related side effects.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology physical status of I or III (ASA), of both sex
* cancer-related anal or perineal pain

Exclusion Criteria:

* coagulopathies
* allergies to the contrast dye
* patients with moderate or significant cardiac/respiratory disease or hepatic

Primary outcomes:
measure: visual analog scale (VAS) score 4 weeks post-intervention
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: South Egypt Cancer instIitute
Study officials:
References:
Clinical trial NCT01141699: A Study of Compliant Behaviors and Associated Factors of Women Breast Screening
Official title: A Study of Compliant Behaviors and Associated Factors of Women Breast Screening in the Shuang Ho Region of Taipei City.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Behaviors
Keywords: women health behaviors
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
Collaborators: name: Taipei Medical University Shuang Ho Hospital
First posted: 2010-06-10
Enrollment: 191
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The women live in the Shuang Ho Region of Taipei City

Brief summary: There were a breast cancer screening activity in Taipei Medical University-Shuang Ho Hospital. We did an intervention with woman who joined the activity.The most important part in the intervention was to know health behavior about the breast cancer prevention.By doing the study, the investigators will know how to promote the health activity in our community.

Detailed description: When the investigators get these women's health behavior imagination, the investigators can know how much breast cancer screening activity do these people have. The most important part for us is to understand how to promote health behavior to women who live around Shuang area.

Eligibility criteria: Inclusion Criteria:

1. women
2. can read words

Exclusion Criteria:

NA

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cancer Center of Taipei Medical University Shuang Ho Hospital
name: Shing-Fang Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04646499: Feasibility of Gamma Transcranial Alternating Current Stimulation to Reduce Beta-amyloid Load and Improve Memory
Official title: Feasibility of Gamma Transcranial Alternating Current Stimulation to Reduce Beta-amyloid Load and Improve Memory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-11-30
Enrollment: 14
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project assessed the feasibility of transcranial alternating current stimulation in the gamma band to lower beta-amyloid load and improve memory performance.

Detailed description: Thirteen individuals with aMCI received eight 60-minute sessions of 40-Hz (gamma) transcranial alternating current stimulation (tACS) in a single-arm design. Outcome measures were assessed pre- and post-intervention.

Eligibility criteria: Inclusion Criteria:

* English speaking
* Grade 12 or more education
* Normal or corrected to normal vision and hearing
* Ability to complete cognitive tasks
* Ability to cooperate and comply with all study procedures
* Ability to tolerate tACS
* Self-reported memory complaint
* Diagnosed with mild cognitive impairment
* Amyloid positive

Exclusion Criteria:

* Neurological or psychiatric disorders other than mild cognitive impairment
* Receiving investigational medications or have participated in a trial with investigational medications within last 30 days
* Family history of epilepsy
* Implanted electronic devices (e.g., pacemaker)
* Prior head trauma
* Pregnant
* IQ \< 80
* Taking cholinesterase inhibitory, memantine, or psychotropic medication
* Taking anti-depressants or anti-anxiety medication
* Color blind
* Substance abuse
* Glaucoma
* Macular degeneration
* Amblyopia (lazy eye)
* Strabismus (crossed eyes)

Primary outcomes:
measure: Side Effects
timeFrame: Average of all post-tACS sessions, up to 1 month
measure: Drop Out
timeFrame: post-tACS, up to 1 month
Secondary outcomes:
measure: Beta Amyloid Load Change
timeFrame: pre-tACS (baseline) and post-tACS (1 month)
measure: Memory: Recall Change
timeFrame: pre-tACS (baseline), post-tACS (after one month of treatment)
measure: Memory: Paired Associates Change
timeFrame: pre-tACS (baseline), post-tACS (after one month of treatment)
measure: Memory: Fluency Change
timeFrame: pre-tACS (baseline), post-tACS (after one month of treatment)
measure: Change in Tau
timeFrame: pre-tACS (baseline), post-tACS (after one month of treatment)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Theodore Zanto, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02125799: Accelerated rTMS for Treatment-Resistant Major Depression
Official title: A Pilot Trial on the Effectiveness and Tolerability of Accelerated High Frequency Repetitive Transcranial Magnetic Stimulation for Treating Resistant Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Douglas Mental Health University Institute
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 20
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: TREATMENT

Brief summary: High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has shown safety and efficacy for treatment-resistant depression, but requires daily treatment for 4-6 weeks. Accelerated HF-TMS (aHF-rTMS), in which all treatments are delivered in less time, would have significant advantages in terms of access, patient acceptance and costs. In the present open label trial the investigators intend to assess the effectiveness and acceptability of a novel aHF-rTMS protocol (i.e., 2 daily sessions over 2 consecutive weeks; 6,000 pulses per day). For this, depressed outpatients will receive the aHF-rTMS protocol and will be assessed at baseline and at weeks 3 and 9 with several clinician- and patient- reported measures as well as with computerized neurocognitive tests.


Eligibility criteria: Inclusion Criteria:

* Presence of a current major depressive disorder (according to the DSM-IV-TR) that has not improved after ≥ 2 adequate antidepressant trial(s) in the current episode;
* Baseline score ≥ 13 on the QIDS-C
* Stable medication regimen (\>= 4 weeks) prior to study enrolment

Exclusion Criteria:

* Psychotic features in the current episode
* Lifetime history of psychotic disorders and/or bipolar I or II disorders
* Substance or alcohol abuse/dependence in the past 6 months
* Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
* Uncontrolled medical disease (e.g., cardiovascular, renal)
* Pregnancy and/or lactation
* Presence of a specific contraindication for rTMS (e.g., personal history of epilepsy, metallic head implant)
* Hearing loss

Primary outcomes:
measure: Quick Inventory of Depressive Symptomatology - Clinician Version
timeFrame: Week 3
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Douglas Mental Health University Institute
state: Quebec
Study officials:
affiliation: McGill University - Dept of Psychiatry
name: Marcelo Berlim, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004799: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pertussis
Keywords: bacterial infection
immunologic disorders and infectious disorders
pertussis
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: National Bacteriological Laboratory
First posted: 2000-02-25
Enrollment: 10000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: OBJECTIVES: I. Compare the safety and efficacy of acellular 2-component vs. acellular multicomponent vs. whole-cell pertussis vaccine vs. placebo in infants living in Sweden.

II. Compare the relative protection of each vaccine against atypical or subclinical pertussis infection.

III. Analyze possible laboratory correlates to vaccine protection.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.

The first group of infants receives a vaccine composed of inactivated pertussis toxin (iPT) and filamentous hemagglutin (FHA).

The second group receives a vaccine containing iPT, FHA, pertactin, agglutinogen 2, and agglutinogen 3.

The third group receives a whole-cell pertussis vaccine. The fourth group receives a diphtheria-tetanus vaccine as the control. All vaccines are given as an intramuscular injection, at 2-3, 4, and 6 months of age.

Close surveillance of infants and families continues for 2-3 years.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Population Characteristics--

* Infants aged 2 months at planned date of first vaccination
* No prior pertussis confirmed by culture
* The following do not exclude: Down syndrome Prematurity Healthy babies vaccinated according to chronological age Recent pertussis exposure Seizures in parent or sibling Sudden infant death in sibling Close relative with history of anaphylaxis or allergy Close relative with history of strong reaction to vaccination

--Patient Characteristics--

* Age: Under 3 months
* Renal: No renal failure
* Other: No prior gammaglobulin No requirement for immunosuppressives, e.g., HIV infection No manifest immunosuppression No serious chronic illness associated with failure to thrive No cardiac disease No progressive neurologic disease No uncontrolled epilepsy or infantile spasms No parental language or communication barrier

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Bacteriological Laboratory
name: Patrick Olin
role: STUDY_CHAIR
References:
Clinical trial NCT03532399: Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation
Official title: Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Drug Effect
Keywords: Bivalirudin
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 30
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric (age less than 18 years and more than 3kg) patients who present to Boston Children's Hospital (BCH) for cardiac catheterization, a cardiac surgical procedure utilizing CPB, or the institution of extracorporeal support and who require the administration of bivalirudin as part of their treatment plan will be included.

Brief summary: This study will measure plasma concentrations of bivalirudin in pediatric patients undergoing cardiac catheterization, cardiac surgical procedures utilizing cardiopulmonary bypass (CPB), or extracorporeal support with ECMO, ventricular support devices (VAD) or lung-assist devices (LAD). The aim is to understand the pharmacokinetics of bivalirudin in these settings.


Eligibility criteria: Inclusion Criteria:

* pediatric patient (age less than 18 years)
* weight \> 3kg
* scheduled to undergo 1) cardiac catheterization, 2)cardiac surgical procedure utilizing CPB, and/or 3) the institution of extracorporeal support
* must already require the administration of bivalirudin as part of their treatment plan

Exclusion Criteria:

* Age equal to or greater than 18 years,
* weight less than 3kg
* end-stage renal failure requiring renal replacement therapy.

Primary outcomes:
measure: Plasma Bivalirudin Concentration
timeFrame: Throughout the duration of treatment with bivalirudin and for one hour after the infusion is stopped. To be specific: 1. In CPB and cath lab cases arm: average 6 hours. 2. In ECLS arm: average 10 days.
Secondary outcomes:
measure: thrombotic complications
timeFrame: Data will be assessed continuously in the procedural groups throughout the duration of the infusion and then continued weekly throughout the length of the hospital stay up to one year from enrollment.
measure: bleeding in excess of expectations for a given procedure or ECLS modality
timeFrame: Data will be assessed continuously in the procedural groups throughout the duration of the infusion and then continued weekly throughout the length of the hospital stay up to one year from enrollment.
measure: mortality
timeFrame: Data will be assessed continuously in the procedural groups throughout the duration of the infusion and then continued weekly throughout the length of the hospital stay or until death up to one year from enrollment.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT03479099: Liquid Biopsy in Lung Cancer
Official title: Clinical Utility of Combined CTC and ctDNA Assay in the Diagnosis of Primary Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer (Diagnosis)
Circulating Tumor Cell
Keywords: Lung cancer
Circulating Tumor Cell
Cell-Free Tumor DNA
Liquid Biopsy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects who are referred for the evaluation and management of primary lung cancer in the tertiary care center

Brief summary: The purpose of this study is to assess clinical utility of combined circulating tumor cell (CTC) and circulating tumor DNA (ctDNA) in the diagnosis of primary lung cancer.

Detailed description: The peripheral blood and tumor tissue samples are collected from the participants.CTC and ctDNA are analyzed from the blood samples.

Eligibility criteria: Inclusion Criteria:

* Patients with histology-proven lung cancer or a clinical suspicion of lung cancer
* Age \>=18, \< 80 years
* No previous history of cancer treatment within 5 years
* Patients who agree to participate

Exclusion Criteria:

* Patients who have been diagnosed with malignancy within 5 years
* Patients with previous history of lung cancer
* Patients who have uncontrolled coagulopathy

Primary outcomes:
measure: Diagnostic sensitivity of combined CTC and ctDNA
timeFrame: 1 year
Secondary outcomes:
measure: Diagnostic accuracy of combined CTC and ctDNA
timeFrame: 1 year
measure: Diagnostic specificity of CTC and ctDNA
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Moon SM, Kim JH, Kim SK, Kim S, Kwon HJ, Bae JS, Lee S, Lee HS, Choi MY, Jeon BH, Jeong BH, Lee K, Kim HK, Kim J, Um SW. Clinical Utility of Combined Circulating Tumor Cell and Circulating Tumor DNA Assays for Diagnosis of Primary Lung Cancer. Anticancer Res. 2020 Jun;40(6):3435-3444. doi: 10.21873/anticanres.14329.
Clinical trial NCT02862899: Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy
Official title: Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraperitoneal Chemotherapy
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The investigator will study the possibility of in situ heating of the liquid containing the chemotherapy, so as to avoid the need for an external pumping system with its complexity, and its associated risks and costs.

The use of a heating cable (prototype hereinafter called Thermowire, made by the company EFS, which is in charge of its development) was patented and tested in pigs in two studies that included 15 animals altogether (in 7 of which the heating cable was used). The aim of the first study was the purely safety aspects, while the efficacy to obtain hyperthermia, the quality and the homogeneity of the hyperthermia and its effect on the tissue penetration of the chemotherapy were evaluated in a second study. The results obtained justify transfer to use in humans in the context of a clinical trial so as to obtain CE certification.


Eligibility criteria: Inclusion Criteria:

* Patients with national health insurance cover
* With scheduled hyperthermic intraperitoneal chemotherapy (HIPEC) because of known peritoneal disease (primary or secondary)
* Who have provided written consent

Exclusion Criteria:

* Persons under guardianship
* Persons under 18 years old
* Pregnant or breast-feeding women
* Allergy to latex
* Abandon of HIPEC following surgical exploration

Primary outcomes:
measure: SAE due to use of Thermowire
timeFrame: Through study completion up to 22 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT03428399: Depression and Body Image Distress Following Mastectomy With Reconstruction
Official title: Risk and Protective Factors for Depression and Body Image Distress Following Mastectomy With Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
BRCA1 Mutation
BRCA2 Mutation
Keywords: breast reconstruction
mastectomy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 51
Sex: FEMALE
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: Women who are scheduled for mastectomy with immediate breast reconstruction at Massachusetts General Hospital as part of their routine medical care. The treatment plan for eligible participants may not include chemotherapy or radiation at the time of enrollment.

Brief summary: Mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress. Reconstructive breast surgery aims to improve patients' psychosocial adjustment to mastectomy, yet for some women substantial distress persists after reconstruction. However, very little is known about risk or protective factors for persistent depression or body image distress following mastectomy with reconstruction. The present study aims to address this critical gap. In women undergoing mastectomy with breast reconstruction, the investigators will assess risk and protective factors for post-surgery depression severity and body image distress.


Eligibility criteria: Inclusion Criteria:

1. Female adults (age 18+) who are scheduled for mastectomy with immediate breast reconstruction at the Massachusetts General Hospital (MGH) Plastic and Reconstructive Surgery Program
2. English language proficiency
3. Ability to provide informed consent.

Exclusion Criteria:

1. Current psychotic disorder, manic episode, serious neurological disorder, intellectual disability, or developmental disorder
2. Current active suicidal ideation
3. Current treatment plan includes radiation and/or ongoing chemotherapy
4. Does not have access to Internet at home, required to complete study questionnaires

Primary outcomes:
measure: Body Image Scale (BIS)
timeFrame: 2-3 months post-surgery (i.e., Time 2)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 2-3 months post-surgery (i.e., Time 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Hilary Weingarden, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weingarden H, Laky ZE, Ladis I, Austen WG Jr, Wilhelm S. Body Image After Mastectomy Scale: A New Measure of Body Image Behaviors and Beliefs in Women Following Mastectomy. J Womens Health (Larchmt). 2022 Jan;31(1):47-54. doi: 10.1089/jwh.2021.0131. Epub 2021 Aug 26.