louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01735786: EndoClot for Preventing Rebleeding After Endoscopic Mucosal Resection (EMR)
Official title: EndoClotTM Absorbable Polysaccharide Hemostat for Preventing Rbleeding After Endoscopic Mucosal Resection (EMR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopic Hemostasis
Colonic Polyps
Keywords: Endoscopic Hemostasis
EndoClot Absorbable Polysaccharide Hemostat
Colonic Polyps
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive cases of colorectal mucosal and submucosal lesions with intented EMR treatment

Brief summary: Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Postoperative rebleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic application remains unknown. This study has been designed to observe the effect of rebleeding prevention after EMR.


Eligibility criteria: Inclusion Criteria:

* consecutive cases of colorectal polyps and submucosal lesions with anticipated complete removal endoscopically by EMR.

Exclusion Criteria:

* severe cardiovascular diseases, liver and kidney dysfunction;
* platelet and coagulation dysfunction (PLT \< 50\*109/L, INR \> 2);
* cases that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 1 month before the procedure;
* cases unavailable for follow-up.

Primary outcomes:
measure: Rebleeding rate after EMR procedure
timeFrame: up to 1 week
Secondary outcomes:
measure: Mucosal healing after EMR
timeFrame: up to 1 month
measure: gastrointestinal tract obstruction
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shanxi
Study officials:
affiliation: Xijing Hospital of Digestive Diseases, Xi'an, Shaanxi, China 710032
name: Zhiguo Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04542486: Clinical Efficacy of Soft Tissue Trimmer in Cases of Gingival Hyperplasia.
Official title: Clinical Efficacy of Soft Tissue Trimmer on Postoperative Pain and Wound Healing When Compared to the Conventional Surgical Excision of Gingival Hyperplasia: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Wound Heal
Gingival Hyperplasia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative pain and wound healing are compared after using conventional scalpel technique in comparison with the intervention which is using Soft tissue Trimmer for cases of gingival hyperplasia.

Detailed description: In the control group:

1. Following the local anaesthetic administration, A reverse bevel gingivectomy will be performed with a #15c scalpel.
2. The borderline of gingiva will be determined via the use of a pointer dental tweezers, and excessive gingival tissue will then be removed with Gracey curettes
3. No periodontal packs to be applied to ensure accurate evaluations of follow-up pain and wound healing

In the intervention group:

1. Following the local anaesthetics administration for the Soft tissue trimmer(STT) gingivectomies, Soft tissue trimmer will be used with 400-rpm rotary systems and with no serum irrigation, per the manufacturer's recommendation.
2. Gingivoplasties will be performed with the same Soft tissue trimmer to easily provide a knife-edge appearance.
3. No periodontal packs will be applied to ensure accurate evaluations of follow-up pain and wound healing.

Eligibility criteria: Inclusion Criteria:

* Anterior region (minimum of four teeth at each surgical site)
* Age range (18-45) years old
* Plaque-induced inflammatory gingival enlargement
* Altered passive eruption
* No clinical attachment loss
* Systemically healthy individuals

Exclusion Criteria:

* Gingival enlargement due to any systemic predisposing factors
* Pregnancy and/or lactation
* Allergy
* Conditions requiring antibiotic prophylaxis and anti-inflammatory medications.
* Acute or untreated periodontitis
* Systemic disease that could influence the outcome of the treatment (i.e. Diabetes)

Primary outcomes:
measure: Pain VAS
timeFrame: 7 days
Secondary outcomes:
measure: Epithelization
timeFrame: 14 days.
measure: Tissue colour
timeFrame: 6 weeks.
measure: Bleeding
timeFrame: From 3-5 days
measure: Surgical time
timeFrame: During surgical procedure itself.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine-CU
Study officials:
References:
Clinical trial NCT03139786: Follow-up of a Cohort of Patients With Aortic Valve Bicuspidia
Official title: Prospective Follow-up of a Cohort of Patients With Aortic Valve Bicuspidia: Multicentre Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve, Bicuspid
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 232
Sex: ALL
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: Patients with aortic bicuspidia examined in the echocardiography laboratory at one of the participating centers will be systematically eligible to participate in the study

Brief summary: The aortic valve bicuspidia (BVA) is a congenital condition corresponding to the presence of 2 sigmoids instead of 3. This is the most common cardiac congenital anomaly affecting 0.5 to 2% of the population The general rule. BVA may be associated with structural damage to the ascending aorta, which exposes BVA patients to a risk of developing ascending aortic aneurysm and acute aortic accidents. Recent data from the literature have revealed that the natural history of BVA is marked by a possible development towards significant valvulopathy and / or an ascending aortic aneurysm often requiring surgical treatment. However, the natural history of bicuspid disease remains poorly understood and the prognostic factors for progression to severe valvulopathy and / or aneurysmal dilatation of the ascending aorta remain to be determined.


Eligibility criteria: Inclusion Criteria:

* All patients examined in the echocardiography laboratory whose objective examination was a bicuspid valve of the aortic valve
* Bicuspidia may be formerly known

Exclusion Criteria:

* Refusal to participate
* Patients who had already undergone bicuspid surgery or ascending aorta before being examined at the echocardiography laboratory

Primary outcomes:
measure: Analysis of 10 year mortality in cardiac surgery in a patient with bicuspid
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT03836586: Study of Pain Catastrophizing
Official title: Contribution of Pain Catastrophizing to Race Group Differences in Pain and Pain-Related Brain Responses in Older Adults With Knee Osteoarthritis (OA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: catastrophizing
cognitive-behavior therapy
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2019-02-11
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study proposes to experimentally manipulate pain catastrophizing in order to investigate the neural mechanisms by which pain catastrophizing influences the experience of pain among non-Hispanic Blacks (NHBs) and non- Hispanic Whites (NHWs) with knee osteoarthritis (OA). Therefore, participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group.


Eligibility criteria: Inclusion Criteria:

* symptomatic knee OA

Exclusion Criteria:

* Younger than 45 years of age or older than 85 years of age
* Prosthetic knee replacement or other clinically significant surgery to the arthritic knee
* uncontrolled hypertension (\>150/95)
* Heart disease including heart failure
* Peripheral neuropathy in which pain testing was contraindicated
* Systemic rheumatic disorders including rheumatoid arthritis, systemic lupus erythematosus, gout, and fibromyalgia
* Neurological diseases such as Parkinson's, multiple sclerosis, stroke with loss of sensory or motor function, or uncontrolled seizures
* Significantly greater pain in body sites other than in the knee
* Daily opioid use
* Hospitalization within the preceding year for psychiatric illness
* Currently pregnant or nursing/breastfeeding

Primary outcomes:
measure: Pain Catastrophizing Scale (PCS) at Day 2
timeFrame: Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Ellen Terry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02263586: Influence of Triathlon on the Electrolyte Balance
Official title: Acid-base and Electrolyte Balance Among Triathletes in the Ironman European Championship
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyponatremia
Keywords: Ironman
Triathlon
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 1089
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants of a long-distance triathlon

Brief summary: Aim of the study is examining the incidence of the occurrence of hyponatremia during a Triathlon

Detailed description: Studies in similar endurance sports (e.g. marathon) could already indicate a high incidence for the appearance of hyponatremia during competitions. The loss of sodium through sweating and the excessive fluid intake during the competitions is a primary risk factor for the development of hyponatremia.

Based on the known occurrence of hyponatremia in marathon runners, participants of the Ironman European Championship between the years 2005 and 2014 were screened for the occurrence of hyponatremia after finishing the race for safety reasons. Subjects were approached at random in the athlete's garden and invited to participate. All participants were 18 years or older.

Eligibility criteria: Inclusion Criteria:

* finisher of a long-distance triathlon
* \> 18 years
* \< 60 years

Exclusion Criteria:

* not finished a long-distance triathlon
* \< 18 years
* \> 60 years

Primary outcomes:
measure: Electrolyte balance Blood sodium
timeFrame: within 20 minutes after finishing the race
Secondary outcomes:
measure: Acid balance
timeFrame: within 20 minutes after finishing the race
Other outcomes:
Locations:
city: Köln
country: Germany
facility: Uniklinik Köln
state: NRW
Study officials:
affiliation: University Hospital Cologne
name: Stefan Braunecker, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Almond CS, Shin AY, Fortescue EB, Mannix RC, Wypij D, Binstadt BA, Duncan CN, Olson DP, Salerno AE, Newburger JW, Greenes DS. Hyponatremia among runners in the Boston Marathon. N Engl J Med. 2005 Apr 14;352(15):1550-6. doi: 10.1056/NEJMoa043901.
Clinical trial NCT00004286: Phase III Multicenter Double Blind Controlled Trial of Human Immune Globulin Therapy in Previously Untreated Patients With Chronic Inflammatory Demyelinating Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Keywords: demyelinating neuropathy
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Vermont
First posted: 1999-10-19
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Compare and evaluate the response to treatment with intravenous human immune globulin (IVIG) or placebo in previously untreated patients with chronic inflammatory demyelinating polyneuropathy.

Detailed description: PROTOCOL OUTLINE: This is a double blind, randomized, controlled study. Patients receive either intravenous human immune globulin (IVIG) or placebo infused at a rate of 40 mL/hr, increasing every 30 min to a maximum of 100 mL/hr daily over 6 to 8 hours for 2 days. On day 2, infusions of IVIG or placebo are delivered at the highest dose tolerated on day 1.

On day 21, patients receive another IVIG or placebo infusion. Following day 42, patients may choose to continue infusions of IVIG every 21 days for 2 doses.

Patients not receiving additional treatment are released from study. Patients are evaluated on days 10, 21, and 43.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Chronic inflammatory demyelinating polyneuropathy (CIDP) characterized by:

Progressive or relapsing disease or chronic stable course with elevated cerebrospinal fluid protein with normal cell counts Acquired demyelination on electrophysiologic studies Segmental demyelination on nerve histology

--Patient Characteristics--

* Not pregnant No significant medical disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Vermont
name: Rup Tandan
role: STUDY_CHAIR
References:
Clinical trial NCT01946386: A Vasoconstriction Study With LEO 90100
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2013-09-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacodynamic activity of LEO 90100 with Dermovate® cream, Dovobet® ointment, betamethasone dipropionate in LEO90100 vehicle, Synalar® ointment and LEO 90100 vehicle using a human skin blanching test.


Eligibility criteria: Inclusion Criteria:

* Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out.
* Healthy male or female volunteers, 18 to 50 years old, both inclusive

Exclusion Criteria:

* Female subjects who are pregnant or who are breast feeding.
* Abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type V and VI on the Fitzpatrick scale)

Primary outcomes:
measure: Visual assessment of skin blanching (visual score (VS))
timeFrame: 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
Secondary outcomes:
measure: Change from baseline in colorimetric parameter a* (the red/green balance) at each time point
timeFrame: 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
measure: Change from baseline in colorimetric parameter L* (luminance) at each time point (ΔL*)
timeFrame: 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
Other outcomes:
Locations:
city: Nice
country: France
facility: CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References:
citation: Queille-Roussel C, Bang B, Clonier F, Lacour JP. Phase I evaluation of the vasoconstrictor potential of an innovative fixed combination calcipotriene plus betamethasone dipropionate aerosol foam versus other corticosteroid psoriasis treatments. J Am Acad Dermatol. 2015:72 Suppl 1;AB243 (P915).
Clinical trial NCT05499286: A Mindfulness-Based Intervention to Improve CPAP
Official title: A Mindfulness-Based Intervention to Improve CPAP Adherence in Adolescents With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea (Moderate to Severe)
Obstructive Sleep Apnea
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 102
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main purpose of this study is to assess the effectiveness of a mindfulness-based intervention in improving CPAP use compared to online peer support


Eligibility criteria: Inclusion Criteria:

* Adolescent age (13-18 years)
* Confirmed diagnosis of moderate or severe OSA
* Adolescent should have the capacity to consent themselves

Exclusion Criteria:

* Known developmental delay such that they are not able to participate in the study;
* Neuromuscular disorders
* Central sleep apnea
* Known diagnosis of severe psychiatric illnesses (e.g. suicidal ideation)
* Limited knowledge and proficiency in English to complete the study as judged by the clinical team

Primary outcomes:
measure: The effectiveness of MBI for CPAP adherence.
timeFrame: Week 4-12
Secondary outcomes:
measure: The effects of increased adherence on mental, physical, and psychosocial statuses.
timeFrame: Week 4-12
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Indra Narang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00430586: Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Determine the Optimal Dose of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glabellar Frown Lines
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2007-02-02
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: NT 201 is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, NT 201 causes local weakening to full paralysis depending on the administered dose. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study will determine the optimal dose of NT 201 in the treatment of glabellar frown lines.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe glabellar frown lines

Exclusion Criteria:

* Previous insertion of permanent material in the glabellar area
* Neuromuscular function disease

Primary outcomes:
measure: Percentage of responders at maximum frown at Day 30 as assessed by the investigator according to Facial Wrinkle Scale (FWS)
timeFrame: Baseline (Day 0) to Day 30
measure: Percentage of responders at maximum frown at Day 30 as assessed by patient's assessment according to 4-point scale
timeFrame: Baseline (Day 0) to Day 30
Secondary outcomes:
measure: Percentage of responders at maximum frown at Day 90 as assessed by the investigator according to FWS
timeFrame: Baseline (Day 0) to Day 90
measure: Percentage of responders at maximum frown at Day 90 as assessed by patient's assessment
timeFrame: Baseline (Day 0) to Day 90
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Merz Pharmaceuticals GmbH
Study officials:
affiliation: Merz Pharmaceuticals GmbH
name: Merz Pharmaceuticals
role: STUDY_CHAIR
References:
Clinical trial NCT05193786: Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure
Official title: Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Noninvasive Ventilation
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 380
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Low versus high PEEP
Primary purpose: TREATMENT

Brief summary: Current study aimed to explore the effect of high PEEP during noninvasive ventilation among hypoxemic patients with acute respiratory failure.

Detailed description: This was a 1:1 randomized control trial to explore the effect of high versus low PEEP in noninvasive ventilation hypoxemic patients with acute respiratory failure. Several ICUs in China performed this study. In the high PEEP group, the PEEP maintained at 10-15 cmH2O, the inspiratory pressure maintained at 15-20 cmH2O. In the low PEEP group, the PEEP maintained at 5 cmH2O, the inspiratory pressure maintained at 10-20 cmH2O. The primary outcome was incidence of noninvasive ventilation failrue.

Eligibility criteria: Inclusion Criteria

* age between 16 and 85 years
* use of dedicated noninvasive ventilator
* PaCO2 ≤50 mmHg
* PaO2/FiO2 ≤300mmHg
* expectation of noninvasive ventilation \>12 hours
* consciousness (Kelly score ≤3 or GCS≥13)

Exclusion Criteria

* use of noninvasive ventilation before randomization \> 24 hours
* use of noninvasive ventilation due to heart failure, asthma, acute excerbation of COPD
* presence of contraindication of noninvasive ventilation such as malformation, rencent pulmonary or esophageal surgery et al.
* end stage disease (expectation of life \< 6 months)
* pneumothorax
* noninvasive ventilation intolerance
* refusal of paticipation
* pregant woman
* requirement of emergency intubation

Primary outcomes:
measure: Rate of noninvasive ventilation failure
timeFrame: From randomization to 28 days of study
Secondary outcomes:
measure: 28-day mortality
timeFrame: From randomization to 28 days of study
measure: Duration of noninvasive ventilation
timeFrame: From beginning to 28 days of study
measure: Duration of invasive mechanical ventilation
timeFrame: From randomization to 28 days of study
measure: Length of stay in ICU
timeFrame: From beginning to 28 days of study
measure: Length of stay in hospital
timeFrame: From beginning to 28 days of study
measure: The changes of PaO2/FiO2
timeFrame: From randomization to 28 days of study
measure: Side effect
timeFrame: From randomization to 28 days of study
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Jun Duan, Dr.
role: PRINCIPAL_INVESTIGATOR
References: