louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05031182: Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.
Official title: Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hysterectomy
Laparoscopy
vNOTES
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. The surgeon will randomize the patient using RedCap computer software. The patient will then be referred either to the vNOTES group or to the laparoscopy group. The surgery will be performed by surgeons called "expert" in one of the ways first. For this, it will be necessary to have performed at least 25 hysterectomies by laparoscopy or vNOTES. The surgery will take place using the usual techniques. Per and postoperative complications will be studied and noted up to six months postoperatively.


Eligibility criteria: Inclusion Criteria:

* Adult woman eligible for total hysterectomy for benign lesions with or without bilateral adnexectomy.
* Able to give informed consent to participate in research.
* Affiliation to a Social Security scheme.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Contraindication to the laparoscopic approach
* Contraindication to first vNOTES, in particular: virginity, history of rectal surgery, rectovaginal endometriosis, high active genital infection
* Indications for another concomitant surgical procedure (other than procedure on the appendix)
* Indication of hysterectomy for malignant lesion.
* Any concomitant pathology deemed incompatible with the study.
* COVID not cured or SARS-COv2 positivity dating less than 3 days before surgery.
* Adult patient protected, under guardianship or curatorship or legal safeguard
* Refusal of participation.

Primary outcomes:
measure: Complications per or post Operative
timeFrame: one month after surgery
Secondary outcomes:
measure: Measure of pain
timeFrame: Until one month
measure: Duration of operation
timeFrame: one day
measure: Assessment of quality of life
timeFrame: Six month
measure: Assessment of satisfaction
timeFrame: Six month
measure: Duration of work stoppage
timeFrame: one month
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
city: Issoire
country: France
facility: CH d'Issoire
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sandra CURINIER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01457482: Art Therapy as Treatment for Fear of Childbirth
Official title: Art Therapy as Treatment for Fear of Childbirth:a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fear of Childbirth
Keywords: Fear
Childbirth
Art therapy
Therapeutic conversations
W-DEQ
Lead sponsor: Helsingborgs Hospital
Sponsor class: OTHER
First posted: 2011-10-24
Enrollment: 124
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Earlier research has shown that pregnant women with a pronounced fear of childbirth have a significantly increased risk for birth complications and subsequent psychological trauma. In Sweden and also internationally, women in fear of childbirth are treated in many differing ways. Evidence for best care for these women is lacking. The Art Therapy method is a creative, psycho-therapeutic form of treatment which has been used for several decades within psychiatry. It has recently been seen that the Art Therapy method has positive effects during treatment for crisis reactions.

Recruitment has recently been initiated for a randomized controlled study of Art Therapy for the treatment of fear of childbirth.

The hypothesis for the study is as follows:

H1 = treatment with Art Therapy and therapeutic conversations will result in a decrease in fear of childbirth when compared to treatment by therapeutic conversations only.

The instrument which is to be used for measurement of childbirth fear is the Wijma Delivery Expectancy Questionnaire (W-DEQ). This is a well validated instrument which was developed in Sweden. A power calculation has shown a need for 62 x 2 participants; a total of 124 women.


Eligibility criteria: Inclusion Criteria:

* Pregnant women
* Pronounced fear of childbirth

Exclusion Criteria:

* Women with a current psychiatric diagnosis
* Women who do not understand Swedish
* Women with a current substance misuse

Primary outcomes:
measure: Scores for the Wijma Delivery Expectancy Questionnaire (W-DEQ)
timeFrame: Change in W-DEQ scores measured at entry to the study (approximately gestational weeks 20 to 31) and again at gestational week 36.
Secondary outcomes:
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
state: Skane
Study officials:
affiliation: Lund University, Lund, Sweden
name: Linda J Kvist, PhD
role: STUDY_CHAIR
References:
citation: O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.
Clinical trial NCT01058382: Progesterone Support of FET
Official title: Progesterone Support for Frozen Embryo Transfer: Intramuscular Versus Vaginal Suppository - A Prospective, Randomized, Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frozen Embryo Pregnancy Rate
Keywords: FET
Progesterone Support
Frozen Embryo Transfer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-01-28
Enrollment: 57
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women having a frozen embryo transfer.

Brief summary: There have been two very common forms of progesterone administration that have been used during ovulation induction, in vitro fertilization (IVF) and embryo transfers. There are currently no randomized clinical trials to demonstrate which method of progesterone administration is more effective for frozen embryo transfer. We raise the question: Is there a difference between the two accepted methods of progesterone administration, intramuscular and vaginal suppositories, for frozen embryo transfer? Studies for fresh embryo transfer after in vitro fertilization, have demonstrated that there is not a difference between the two methods of progesterone administration. We will evaluate the question for frozen embryo transfer.


Eligibility criteria: Inclusion Criteria:

* Females \< 50 years of age
* Having frozen embryo transfer at Mayo Clinic
* Embryos have been created prior to age 42
* Willing to be randomized to either method of progesterone administration

Exclusion Criteria:

* Diagnosis of severe medical illness
* Uterine lesions affecting the cavity or endometrium
* Uterine anomaly
* Presence of hydrosalpinx
* Extreme difficulty with embryo transfer

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: 3 years
Secondary outcomes:
measure: Implantation rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Charles Coddington, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05787782: Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts
Official title: Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fever
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2023-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This is a prospective, non-randomized data collection study to evaluate the performance of the Masimo INVSENSOR00063 in obtaining temperature measurements.

Detailed description: Individual sites are only representative of a subset of the overall population, per ISO 80601-2-56:2017(Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement), and therefore clinical bias and limits of agreement should not be evaluated for the subsets. Publication of results should include repeatability from individual sites and the combined clinical bias and limits of agreement (NCT05787782, NCT05674344 and NCT05779397).

Eligibility criteria: Inclusion Criteria:

* Participant age ≥ 1 year
* Afebrile or febrile at time of enrollment: For febrile subjects, ≥ 99.5 F/ 37.5 C for sublingual temperature reference; ≥ 100.4 F/ 38 C for temporal artery temperature reference.
* English-or Spanish-speaking patient or parent/Legal Guardian

Exclusion Criteria:

* Participants deemed not suitable for the study at the discretion of the investigator

Primary outcomes:
measure: Accuracy of Temperature Measurements Using Masimo INVSENSOR00063
timeFrame: About 15-30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Ascada Research
state: California
Study officials:
References:
Clinical trial NCT05014282: Automated Video-Assisted Smoking Treatment for People Living With HIV
Official title: Randomized Trial of Automated Video-Assisted Smoking Treatment for People Living With HIV (Project RESOURCE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-08-20
Enrollment: 638
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate if Automated Treatment performs better, in terms of facilitating long-term smoking abstinence, than the more resource-intensive Standard Treatment.


Eligibility criteria: Inclusion Criteria:

* smoked \>/=100 cigarettes in lifetime
* English or Spanish speaking
* Currently smoke \> 5 cigarettes/day
* Willing to make a quit attempt within 1 week of enrollment
* HIV positive
* Process a smartphone compatible with the project app
* Have a valid email address

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Current use of smoking cessation medications
* Enrolled in a smoking cessation study
* Household member enrolled in the study
* Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone

Primary outcomes:
measure: Self Reported 7 Day Abstinence Smoking Status
timeFrame: 12 Month Follow-Up
Secondary outcomes:
measure: Smoking Status by Saliva Cotinine Kit
timeFrame: 12 Month Follow-Up
measure: Self Reported 24 Hours Smoking Abstinence
timeFrame: 12 Month Follow-Up
measure: 30 Day Smoking Abstinence
timeFrame: 12 Month Follow-Up
measure: Continuous Smoking Abstinence
timeFrame: 12 Month Follow-Up
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Damon J Vidrine, Dr.PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vidrine DJ, Bui TC, Businelle MS, Shih YT, Sutton SK, Shahani L, Hoover DS, Bowles K, Vidrine JI. Evaluating the Efficacy of Automated Smoking Treatment for People With HIV: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 17;10(11):e33183. doi: 10.2196/33183.
Clinical trial NCT00408382: Lipitor Phase 4 Clinical Trial in Hypercholesteremia Patients With Yellow Coronary Plaque
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesteremia
Coronary Artery Disease
Keywords: Lipitor
atorvastatin
Hypercholesteremia
yellow coronary plaque
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of intensive lipid-lowering therapy with Lipitor on the changes of characteristics of yellow coronary plaque in subjects with hypercholesteremia accompanying coronary artery disease


Eligibility criteria: Inclusion Criteria:

* Patients with hypercholesteremia
* The indication of coronary angiography, coronary angioscopy and intravascular ultrasound are expected

Exclusion Criteria:

* Patients who has current administration of Lipitor or history of discontinued administration of Lipitor
* Acute cardiac infarction

Primary outcomes:
measure: Changes in plaque characteristics as observed by coronary angioscopy
measure: (the amount of yellow plaque and grade shall be determined by the coronary angioscopic findings evaluation committee)
measure: Changes in the volume and the echogenicity as observed by intravascular ultrasound
Secondary outcomes:
measure: Rate of change in serum lipid level
measure: Changes in the surface character and size of plaque as observed by coronary angioscopy (determined by the angioscopic findings evaluation committee)
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Hirayama A, Saito S, Ueda Y, Takayama T, Honye J, Komatsu S, Yamaguchi O, Li Y, Yajima J, Nanto S, Takazawa K, Kodama K. Qualitative and quantitative changes in coronary plaque associated with atorvastatin therapy. Circ J. 2009 Apr;73(4):718-25. doi: 10.1253/circj.cj-08-0755. Epub 2009 Feb 18.
Clinical trial NCT04383782: Examining Outcome Expectancies and Behavioral Reinforcers Among Young Adult Smokers
Official title: Examining Outcome Expectancies and Behavioral Reinforcers Among Young Adult Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking cessation
motivation
outcome expectancies
behavioral reinforcers
Lead sponsor: American University
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic cigarette smoking habits often begin in adolescence or early adulthood. 98% of cigarette smokers try their first cigarette before the age of 26. Thus, young adult smokers represent an important target for early smoking cessation intervention. This study tests two interventions designed to increase motivation to quit and decrease smoking behavior. These interventions include: an expectancy challenge approach, which aims to increase negative beliefs about the consequences of smoking; and a behavioral economics approach, which encourages participants to substitute non-smoking behaviors that may still provide reinforcement similar to reinforcement derived from smoking a cigarette.


Eligibility criteria: Inclusion Criteria:

* 18-35 years old
* English fluency
* Living in the United States
* Smoked at least 1 cigarette per week during the past month
* Willing to be contacted for 1-month follow up assessment

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Quit attempt
timeFrame: 4-week follow up
measure: Motivation to quit
timeFrame: 4-week follow up
Secondary outcomes:
measure: Smoking rate
timeFrame: 4-week follow up
measure: Outcome expectancies
timeFrame: 4-week follow up
measure: Behavioral reinforcers
timeFrame: 4-week follow up
Other outcomes:
Locations:
city: Washington
country: United States
facility: American University
state: District of Columbia
Study officials:
References:
Clinical trial NCT04600882: Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder
Official title: Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder (ASD)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Autism Spectrum Disorder
Keywords: autism spectrum disorder
endophenotyping
observational
Lead sponsor: Stalicla SA
Sponsor class: INDUSTRY
First posted: 2020-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nationwide Children's Hospital Primary Care Clinic

Brief summary: This single-center, observational study is being conducted to identify a well-characterized subgroup within the ASD patient population, based on clinical symptoms and biosample analysis.


Eligibility criteria: Inclusion Criteria:

* Previously diagnosed with ASD (based on DSM-5 criteria and supported by either ADI-R or ADOS-2 scores)
* At least two well documented head circumference values recorded within the first 2 years of life
* Participants must have a parent or reliable caregiver who agrees to provide information about the participant as required by the protocol and should be fluent in English

Exclusion Criteria:

* Genetically identified ASD (syndromic form of autism, e.g. fragile X)
* Episode of fever (i.e. ≥100.5 °F) or clinically significant illness without fever (as judged by the Investigator), within 10 days before the study visit

Primary outcomes:
measure: Prevalence of non-behavioral phenotypical traits in sub-populations with Autism Spectrum Disorder (ASD)
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT04691882: Effect of Abdominal Wall Activity on the Responses to Meal Ingestion
Official title: Factors That Determine the Responses to Meal Ingestion: Effect of Abdominal Wall Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: meal ingestion
postprandial responses
hedonic sensations
homeostatic sensations
abdominal wall activity
abdominal distension
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Meal ingestion induces sensations that are influenced by a series of conditioning factors. Aim: to determine the effect of abdominal wall activity on the responses to a standard probe meal. Study in healthy subjects comparing postprandial digestive sensations (abdominal bloating and digestive well-being) during consecutive maneuvers of diaphragmatic contraction (i.e. descent) versus diaphragmatic relaxation (i.e. ascent) in a cross-over randomized design. Primary outcome: effect of somatic maneuvers on abdominal bloating sensation; secondary aim: effect on digestive well-being.

Participants (16 women) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 4 h after breakfast. Studies will be conducted in a quiet, isolated room. Participants will be taught to produce diaphragmatic contraction and visible abdominal distention. A probe meal up to maximal satiation will be administered to induce abdominal fullness/bloating sensation; immediately after ingestion, bloating sensation (from 0 to 10) and digestive well-being (from -5 to +5) will be scored during 8 alternating episodes (30 s each) in random sequence of diaphragmatic contraction (abdominal distension) versus diaphragmatic relaxation.


Eligibility criteria: Inclusion Criteria:

* non-obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders

Primary outcomes:
measure: Changes in abdominal fullness/bloating sensation induced by the probe meal
timeFrame: 10 min
Secondary outcomes:
measure: Changes in digestive well-being sensation induced by the probe meal
timeFrame: 10 min
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
References:
citation: Livovsky DM, Pribic T, Azpiroz F. Food, Eating, and the Gastrointestinal Tract. Nutrients. 2020 Apr 2;12(4):986. doi: 10.3390/nu12040986.
citation: Livovsky DM, Barber C, Barba E, Accarino A, Azpiroz F. Abdominothoracic Postural Tone Influences the Sensations Induced by Meal Ingestion. Nutrients. 2021 Feb 18;13(2):658. doi: 10.3390/nu13020658.