louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05087407: Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula
Official title: Cutting Seton Versus Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Complex Anal Fistula
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare the efficacy of the decompression and drainage seton (DADS) and cutting seton (CS) in the treatment of high complex anal fistula.


Eligibility criteria: Inclusion Criteria:

* high trans-sphincteric cryptoglandular anal fistulas (involving \>30% of the EAS muscles evaluated through magnetic resonance imaging (MRI) scan, endoanal ultrasonography)
* suprasphincteric fistulas were enrolled

Exclusion Criteria:

* Low anal fistula; -Non-glandular anal fistulas, such as tuberculous anal fistula and Crohn's anal fistula; -
* Patients with symptoms of fecal incontinence;
* A previous history of anal fistula surgical treatment;
* Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.

Primary outcomes:
measure: Rate of healing
timeFrame: 6 months post-operation.
measure: Recurrence rate
timeFrame: within 12 months after the procedure
measure: The healing time of the anal wound (days)
timeFrame: 6 months post-operation.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan friendship Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04703907: Auricular Stimulation for Relief of Stress and Anxiety
Official title: Auricular Stimulation (AS) vs. "Waiting List" for Relief of Stress and Anxiety in Health Care Workers During COVID-19 Pandemic - a Prospective Controlled Investigation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress and Anxiety
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Prospective investigation during 15 weeks of treatment for each participant with "waiting list" control group (no intervention). Waiting group will receive the intervention (auricular stimulation) after 15 weeks of investigation.
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate whether auricular stimulation (percutaneous sensory stimulation of cranial nerves) as compared vs. no intervention (waiting list) reduces stress and anxiety in health care providers, working at the time of COVID-19 pandemic at the University Medicine of Greifswald.


Eligibility criteria: Inclusion Criteria:

1. Medical care workers at the University Medicine of Greifswald
2. Experiencing stress and anxiety in connection with COVID-19 pandemic
3. Participants without previous anxiolytic medication
4. Ability to understand and fill in the structured questionnaire (Appendix D \& E)
5. Written informed consent

Exclusion Criteria:

1. Recidivist alcoholics
2. Local auricular skin infection
3. Pregnant or lactating women
4. Participants with prosthetic or damaged cardiac valves and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of AHA)
5. Participants who are unable to understand the consent form
6. History of psychiatric disease

Primary outcomes:
measure: Anxiety
timeFrame: 15 weeks of investigation
Secondary outcomes:
measure: Trait anxiety
timeFrame: Before and after 15 weeks of intervention application
measure: Sleep quality
timeFrame: 15 weeks of investigation
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine of Greifswald
Study officials:
References:
Clinical trial NCT03652207: Effects of Palatinose™ on Weight Management and Body Composition
Official title: The Effects of Palatinose™ on Weight Management and Body Composition in Overweight and Obese Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Diet Modification
Body Weight
Lead sponsor: Beneo-Institute
Sponsor class: INDUSTRY
First posted: 2018-08-29
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to assess body weight and body composition changes in overweight and obese persons consuming an energy-reduced diet containing foods with either sucrose or isomaltulose (Palatinose(TM)) over a period of 3 months.


Eligibility criteria: Inclusion Criteria:

* Subject is healthy at the time of pre-examination
* Subject has a BMI of 25 - 35 kg/m² and motivated to lose weight
* Subject is aged 18 - 60 years at the time of pre-examination

Exclusion Criteria:

* Person suffers from an acute or chronic disease
* Person has known dietary restrictions or allergies to Foods
* Intake of medications which interfere with body composition, appetite, satiety or food intake

Primary outcomes:
measure: Body Weight Change
timeFrame: 12 weeks
Secondary outcomes:
measure: Body fat percentage
timeFrame: 12 weeks
measure: postprandial respiratory quotient (RQ)
timeFrame: 120 minutes postprandial
measure: BMI
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Brookes University
Study officials:
References:
citation: Maresch CC, Petry SF, Theis S, Bosy-Westphal A, Linn T. Low Glycemic Index Prototype Isomaltulose-Update of Clinical Trials. Nutrients. 2017 Apr 13;9(4):381. doi: 10.3390/nu9040381.
Clinical trial NCT01819207: Evaluation of the Coagulation Profile by Thromboelastography in Bariatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Patients Undergoing Bariatric Surgery
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2013-03-27
Enrollment: 93
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: thromboelastography can identify alteration in the coagulation profile in bariatric patients who undergo sleeve gastrectomy or gastric bypass


Eligibility criteria: Inclusion Criteria:

* patients undergoing bariatric surgery

Exclusion Criteria:

* none

Primary outcomes:
measure: coagulation profile by thromboelastography
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Naharia
country: Israel
facility: Naharia Medical Center
Study officials:
References:
citation: Munro TG. Glass is detectable on plain radiographs. CMAJ. 1989 Feb 15;140(4):365. No abstract available.
Clinical trial NCT01067807: Proellex Pharmacokinetics Bridging Study
Official title: Proellex Pharmacokinetics Bridging Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-12
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations

Detailed description: Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations (24 and 50 mg dose). Blood was collected pre-dose, at specified intervals and 24 hours post dose. Each dose was separated by at least one week interval from the previous dose.

Eligibility criteria: Inclusion Criteria:

* Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the clinical Investigator
* Subject was willing to remain in the clinic for the screening visit; and for the treatment visits (day -1, day of treatment and day 1; approximately 36 hrs per treatment visit)

Exclusion Criteria:

* Post-menopausal women,
* Subject with documented endometriosis
* Subject with known uterine fibroids or vaginal polyps

Primary outcomes:
measure: Proellex peak plasma concentration (Cmax)
timeFrame: 24 hours
measure: Proellex time to peak plasma concentration (tmax).
timeFrame: 24 hours
Secondary outcomes:
measure: The area under the plasma concentration over time curve from zero to the last measurable Proellex plasma concentration (AUC0-24) was calculated.
timeFrame: 24 hours
measure: The area under the plasma concentration over time curve from zero to infinity (AUC 0-infinity).
timeFrame: 24 hours
measure: Terminal elimination half-life (t1/2).
timeFrame: 24 hours
measure: Vital signs evaluated at screening, treatment days 0 and 1. Clinical laboratory values obtained at screening, treatment days 0 and 1. Adverse events assessed at treatment visits and followed until resolution.
timeFrame: 24 hours
Other outcomes:
Locations:
city: San Antonio,
country: United States
facility: Healthcare Discoveries, Inc
state: Texas
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre van As, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02951507: Evaluation of Patient Satisfaction and Biting Force of New Design of Extracoronal Attachment (O T Cap Unilateral Attachment) Versus Conventional Partial Denture for Treatment of Unilateral Mandibular Distal Extension Area
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Acceptance of Health Care
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Comparison of new design of extra coronal castable precision attachment (OT unilateral attachment) and conventional partial denture in patient satisfaction and biting force.


Eligibility criteria: Inclusion Criteria:

* patients with unilateral mandibular distal extension area
* Normal crown/root ratio of last premolar
* co-operative patients

Exclusion Criteria:

* completely edentulous patient
* few remaining teeth
* patients exposed to radiotherapy and chemotherapy
* patients with maxillary or mandibular defect

Primary outcomes:
measure: Patient satisfaction
timeFrame: 12 months
Secondary outcomes:
measure: Biting force
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04306107: Prone Position in Non-Invasive Ventilation and High-Flow Oxygen Therapy
Official title: Prone Position in Non-Invasive Ventilation and High-Flow Oxygen Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Evaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory Failure
Keywords: Noninvasive ventilation
High-flow nasal oxygen therapy
Prone position
Lead sponsor: Hospital General Universitario Morales Meseguer
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this trial is to study the effect of prone position during NIV and HFNC on acute hypoxemic respiratory patients.

Detailed description: Inclusion Criteria:

Adult patients with:

• ARDS/pneumonia/acute hypoxemic respiratory failure with PaO2/FiO2 between 150 and 300 (on 5 cmH2O PEEP level)

Exclusion Criteria

* General NIV or HFNC contraindications
* Immediate need for IOT
* Prone position intolerance
* Patients refusal to participate

Interventions:

* Prone position for 2-4 hours twice a day, for 3 days (first 3 days since admission to ICU)
* Nurse surveilance: at least every 15 minutes

Outcomes:

* Need for IOT
* Effects on the measurements specified above (particularly PaO2/FiO2)

Eligibility criteria: Inclusion Criteria:

* Adult patients with:

  * ARDS/pneumonia/acute hypoxemic respiratory failure with PaO2/FiO2 between 150 and 300 (on 5 cmH2O PEEP level)

Exclusion Criteria:

* General NIV or HFNC contraindications
* Immediate need for IOT
* Prone position intolerance
* Patients refusal to participate

Primary outcomes:
measure: Oro-tracheal entubation
timeFrame: 1 month
Secondary outcomes:
measure: PaO2/FiO2
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06734507: Laparoscopic Cholecystectomy Using Airseal in Children
Official title: Laparoscopy Using the Airseal System Versus Standard Insufflation in Cholecystectomy in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gall Stones (&amp; [Calculus - Gall Bladder])
Cholecystitis
Pancreatitis Due to Gallstones
Child, Only
Keywords: Laparoscopy
Cholecystectomy
Airseal
Valveless Trocar
Standard Insufflation
Retrospective Study
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 23
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients adressed to the University Hospital

Brief summary: The goal of this observational study is to compare the use of Airseal versus a standard insufflation, in children who underwent laparoscopic cholecystectomy, between January 2021 and December 2022.

The main questions it aims to answer are:

* amount of analgesics consumed postoperatively
* mean digital pain scale

Data are directly extracted from patients medical files.

The investigators will compare the Airseal group (A group) to the Standard insufflation group (S group) to see if the A group consumes significatively less analgesics and are less painful than the S group.

Detailed description: Choosing to enter the A or the S group depends on the surgeon's choice.

Only the surgeon, the anesthetic and the nurses in the operating room know which type of insufflation has been chosen.

Eligibility criteria: Inclusion Criteria:

* Patients aged under 18 years old
* Who underwent laparoscopic cholecystectomy
* From January 2021 to December 2022

Exclusion Criteria:

* Patients older than 18 years old

Primary outcomes:
measure: Amount of analgesics consumed
timeFrame: From the end of surgery to the discharge home, up to 20 days
measure: Mean Digital Pain Scale
timeFrame: From the end of surgery to the discharge home, , up to 20 days
Secondary outcomes:
measure: Operating time
timeFrame: Perioperatively
measure: Anesthetic time
timeFrame: Perioperatively
measure: Length of stay
timeFrame: From the day of hospitalization to the day of discharge home, up to 20 days
measure: Histological results
timeFrame: Between 2 weeks and 4 weeks after surgery
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
Study officials:
References:
citation: Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16.
citation: de'Angelis N, Petrucciani N, Giannandrea G, Brunetti F. The protocol of low-impact laparoscopic cholecystectomy: the combination of mini-laparoscopy and low-pressure pneumoperitoneum. Updates Surg. 2018 Dec;70(4):553-556. doi: 10.1007/s13304-018-0591-8. Epub 2018 Aug 29.
Clinical trial NCT00315107: Estrogen Treatment in Acromegalic Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acromegaly
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2006-04-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Oral estrogens may be an effective adjuvant treatment for control of acromegaly in patients with resistance to somatostatin analogs.

Detailed description: This will be a canadian multicenter study with a randomized, double-blind, placebo-controlled design, to assess the efficacy and safety of adjuvant alesse in female acromegalic patients with suboptimal response to sandostatin LAR treatment.

Eligibility criteria: Inclusion Criteria:

* Women 18 years and older treated with somatostatin analogs
* Active acromegaly

Exclusion Criteria:

* Cardiovascular or cerebrovascular disease
* Thrombophlebitis or thromboembolism
* Breast cancer
* Non-controlled arterial hypertension
* Smoking
* Pregnancy or lactation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHUM - Notre-Dame Hospital
state: Quebec
Study officials:
affiliation: CHUM- Endocrinology
name: Omar Serri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kestler E, Ambrosio G, Hemming K, Hughes JP, Matute J, Moreno M, Madriz S, Walker D. An integrated approach to improve maternal and perinatal outcomes in rural Guatemala: A stepped-wedge cluster randomized trial. Int J Gynaecol Obstet. 2020 Oct;151(1):109-116. doi: 10.1002/ijgo.13262. Epub 2020 Jul 27.
Clinical trial NCT04404907: Deliberate Ultraviolet Light Exposure to Get a Tan by Young Adult Sexual Minority Males
Official title: Analysis of Tanning Attitudes and Behaviors by Young Adult Sexual Minority Males in the Greater Chicago Area
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sun Sensitivity
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 537
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: RADAR is a longitudinal study with cohorts from the greater Chicago region recruited between 2008 and 2015. Participants respond to online surveys every 6 months.

Brief summary: The purpose of this study is to: a) identify enablers and barriers to deliberate ultraviolet light exposure by young sexual minority men (SMM), and b) quantify the extent of their deliberate ultraviolet light exposure.

Detailed description: Aim 1: To develop survey items to assess tanning attitudes and behaviors Nine survey items used by the PI in previous deliberate tanning research were adapted with the expert consensus of members of Northwestern's Institute for Sexual and Gender Minority Health and Wellbeing. Discussions with the PI, research personnel and members of the institute developed the hypothesis that in addition to the previously reported appearance motivations young SMM may be engaging in tanning (indoors or outdoors) as a social activity. A tenth survey item was developed to assess deliberate tanning as a social activity.

Aim 2: Analyze the tanning attitudes and behavior data acquired in an online survey of young adult sexual minority males, who regularly participate in the RADAR study.

RADAR is a longitudinal study with cohorts from the greater Chicago region recruited between 2008 and 2015. The 10 survey items about tanning attitudes and behaviors were added to the online survey that examines SMMs' behavior in the prior 6 months. This is a secondary analysis of registry data acquired by the RADAR study.

Eligibility criteria: Inclusion Criteria:

* Young adult SMM (age 18-39)
* Able to read English
* Have internet access
* Willing to complete the online survey

Exclusion Criteria:

* None

Primary outcomes:
measure: Outdoor Tanning Motives
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: June K Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robinson JK, Wahood S, Stapleton JL. Motives for intentional sunlight exposure among young adult sexual minority men: appearance, relaxation and socialization in a cohort study. Br J Dermatol. 2021 Mar;184(3):563-564. doi: 10.1111/bjd.19609. Epub 2020 Nov 18. No abstract available.
Clinical trial NCT05750407: Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting
Official title: Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Inactivity, Physical
Obesity
Keywords: home visiting
obesity
pregnancy
postpartum
cardiovascular health
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
Collaborators: name: The Miriam Hospital
name: Bradley Hospital
First posted: 2023-03-01
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to examine the feasibility and acceptability of brief lifestyle intervention modules designed to promote healthy eating, activity, and weight control for pregnant and postpartum clients receiving care as part of evidence-based home visiting.

Detailed description: The purpose of this pilot study is to examine the feasibility and acceptability of brief lifestyle intervention modules designed to promote healthy eating, activity, and weight control behaviors for pregnant and postpartum clients receiving care as part of evidence-based home visiting. A 6 week, pre-post test of evidence-based home visiting (usual care) plus three lifestyle intervention modules (eating, activity, tracking) will be conducted at two sites (California and Rhode Island). Three, 10 minute intervention modules will target healthy eating, activity, and self-monitoring of weight and diet. Pregnant and postpartum clients (N =20) in home visiting programs will be recruited over 2 months and evaluated at baseline and after 6 weeks. Home visitors will participate in one training session and deliver the intervention content during three visits over 6 weeks. Quantitative data from will inform feasibility of lifestyle intervention within evidence-based home visiting. Findings will inform the cardiovascular health intervention and study protocol for a full scale trial.

Eligibility criteria: Inclusion Criteria:

* self-reported current participation in a home visiting program
* self-reported currently pregnant or postpartum less than or equal to 6 weeks
* English or Spanish speaking

Exclusion Criteria (based on self report):

* Age less than 18 years
* Lower than 5th grade reading level

Primary outcomes:
measure: Perceived acceptability of treatment score
timeFrame: 6 week
Secondary outcomes:
measure: Change in life's essential 8 total score
timeFrame: 6 weeks
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: Cal Poly
state: California
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
Study officials:
References: