louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02332356: Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
Official title: Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Crohn Disease
Keywords: Crohn Disease
Inflammatory Bowel Diseases
Disease Attributes
Lead sponsor: Tokyo Medical and Dental University
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized, controlled study aims to evaluate the impact of therapeutic intervention (step up) for the patients who are clinical remission with Magnetic Resonance Enterocolonography (MREC) active. In addition, to evaluate the impact of therapeutic step down for the patients who archived clinical and MREC remission. The primary endpoint is the rate of clinical remission at 104 weeks.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Crohn's and proven history of disease with clinical remission (CDAI\<150)
* Signed written consent form to enroll the study (Need agreement from deputy for patients under 20years old)

Exclusion Criteria:

* Contraindication for infliximab, adalimumab, or azathioprine
* Lactating woman
* Presence of malignancy
* Within 3 month from intestinal surgery
* Presence of an end stoma
* Planned surgery

Primary outcomes:
measure: The rate of clinical remission at 104 weeks.
timeFrame: 104 weeks
Secondary outcomes:
measure: The rate of hospitalization and operation
timeFrame: 104 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Gastroenterology and Hepatology, Tokyo Medical and Dental UNIV
Study officials:
affiliation: Tokyo Medical and Dental University Hospital
name: Toshimitsu Fujii
role: PRINCIPAL_INVESTIGATOR
References:
citation: Takenaka K, Ohtsuka K, Kitazume Y, Nagahori M, Fujii T, Saito E, Naganuma M, Araki A, Watanabe M. Comparison of magnetic resonance and balloon enteroscopic examination of the small intestine in patients with Crohn's disease. Gastroenterology. 2014 Aug;147(2):334-342.e3. doi: 10.1053/j.gastro.2014.04.008. Epub 2014 Apr 13.
citation: Hyun SB, Kitazume Y, Nagahori M, Toriihara A, Fujii T, Tsuchiya K, Suzuki S, Okada E, Araki A, Naganuma M, Watanabe M. Magnetic resonance enterocolonography is useful for simultaneous evaluation of small and large intestinal lesions in Crohn's disease. Inflamm Bowel Dis. 2011 May;17(5):1063-72. doi: 10.1002/ibd.21510. Epub 2010 Oct 25.
Clinical trial NCT06704256: SCM Muscle as a Marker for Frailty in Patients Undergoing ENT Surgery
Official title: SCM Muscle as a Marker for Frailty in Patients Undergoing ENT Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-oncologic patients presenting for head and neck surgery with available neck CT scans

Brief summary: This study focuses on evaluating the relationship between physical frailty and measurements of the muscles of the neck in patients undergoing non-cancer Head and Neck surgery.


Eligibility criteria: Inclusion Criteria:

• Non-oncologic patients presenting for head and neck surgery with available neck CT scans.

Exclusion Criteria:

* Patients undergoing cancer surgery
* Patients under18 years of age
* Patients without pre-surgical CT-scans of the head and neck

Primary outcomes:
measure: Skeletal muscle size
timeFrame: End of study at 6 months
measure: Skeletal muscle density
timeFrame: End of study at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Gabriela Hernandez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01274156: Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction
Official title: The Effect of Low Intensity Shock Wave Therapy on Erectile Dysfunction in Patients Responding to PDE5i's
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
Low Intensity Shock Wave
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Medispec
First posted: 2011-01-11
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner.

Detailed description: This study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction.

Eligibility criteria: Inclusion Criteria:

* ED of more than 6 months
* Rigidity score ≥ 3 under PDE5i therapy
* SHIM ≤21 under PDE5i therapy
* Non- hormonal, neurological or psychological pathology
* Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

* Prior prostatectomy surgery
* Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Anti-androgens, oral or injectable androgens
* Radiotherapy in pelvic region

Primary outcomes:
measure: International Index of Erectile function- Erectile Function Domain
timeFrame: At screening and 17 weeks later at last visit
Secondary outcomes:
measure: Rigidity scale
timeFrame: At screening and 17 weeks later at last visit
measure: Flow Mediated Dilatation Technique
timeFrame: At screening and 17 weeks later at last visit
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
References:
Clinical trial NCT04123756: Predicting Outcome Following Standardized Exercise Therapy in Knee Osteoarthritis Patients
Official title: Smerteprofiler Som Redskab Til at prædiktere Effekten af 6-8 Ugers GLA:D®-forløb Hos Patienter Med Smertefuld Slidgigt i knæene
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Knee Osteoarthritis
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 130 patients with knee osteoarthritis scheduled for standardized exercise therapy

Brief summary: Pain sensitization has been associated with pain severity in people with knee osteoarthritis (KOA) and a neuropathic pain component has been identified in up to 30% of KOA patients. Mechanistic pain profiling aims to identify the underlying mechanisms in the peripheral and central nervous systems, which are associated to the clinical pain.

In addition, the mechanisms underlying the pain relieving effect of standardized exercise therapy are largely unknown, but it is hypothesized that they are linked to the patient's ability to activate the descending pain inhibitory pathways (conditioned pain modulation, CPM) in the central nervous system. Mechanistic pain profiling including CPM have been used prognostic to identify responders to treatment, but these measures as a prognostic tool for standardized exercise therapy has not been investigated.

The primary aim of this study is to investigate if mechanistic pain profiling alone or in combination with clinical pain measures before standardized exercise therapy can predict the patients' pain reduction following the exercise therapy program


Eligibility criteria: Inclusion Criteria:

* The American College of Rheumatology for clinical knee osteoarthritis (excluding radiological OA assessment)

Exclusion Criteria:

* Known factors to influence pain and pain sensitization

Primary outcomes:
measure: pain reduction
timeFrame: 1-2 weeks after last exercise session
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: FysioDanmark Aarhus
Study officials:
References:
Clinical trial NCT00667056: Study of the Safety and Efficacy of Tacrolimus Ointment in Treating Chronic Allergic Contact Dermatitis
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Trial to Assess the Safety and Efficacy of 0.1% Tacrolimus Ointment in the Treatment of Chronic Allergic Contact Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermatitis
Keywords: Chronic Allergic Contact Dermatitis
Protopic
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-04-25
Enrollment: 98
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study of subjects with a known nickel allergy comparing Tacrolimus to placebo, both associated with nickel patches to determine the safety and efficacy of treating Chronic Allergic Contact Dermatitis with Tacrolimus Ointment


Eligibility criteria: Inclusion Criteria:

* Subject has a history of allergy to nickel

Exclusion Criteria:

* Subject is pregnant or lactating
* Subject fails to react to the nickel disks (grade 0), reacts with a questionable (grade 1) or extreme (grade 4) reaction or the subject's reactions on the left and right arms are not of the same grade of intensity
* Subject has a known hypersensitivity to any component of the test medications
* Subject has any other significant dermatological condition that affects \>10% of the body surface area or general medical condition that could interfere with the study evaluation
* Subject has any significant medical condition that could compromise immune responsiveness

Primary outcomes:
measure: Success using the Physician's Global Assessment (PGA)
timeFrame: 8 Weeks
Secondary outcomes:
measure: Investigator and subject ACD Sign and Symptoms
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Washington
country: United States
state: District of Columbia
city: Kansas City
country: United States
state: Kansas
city: Shawnee
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Minneapolis
country: United States
state: Minnesota
city: New York
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Hershey
country: United States
state: Pennsylvania
city: Lynchburg
country: United States
state: Virginia
Study officials:
affiliation: Astellas Pharma US, Inc.
name: use central contact
role: STUDY_DIRECTOR
References:
citation: Belsito D, Wilson DC, Warshaw E, Fowler J, Ehrlich A, Anderson B, Strober BE, Willetts J, Rutledge ES. A prospective randomized clinical trial of 0.1% tacrolimus ointment in a model of chronic allergic contact dermatitis. J Am Acad Dermatol. 2006 Jul;55(1):40-6. doi: 10.1016/j.jaad.2006.03.025. Epub 2006 May 26.
Clinical trial NCT01293656: Study of Participants With Crohn's Disease and Ulcerative Colitis in Eastern Europe, Middle East, and North Africa (P08166)
Official title: Cross-sectional Study of Inflammatory Bowel Disease Severity and Treatment Patterns in Eastern Europe, Middle East, and North Africa. (P08166)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-02-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with CD or UC who visit the study sites in Eastern Europe, Middle East, and North Africa during the study period will be asked to participate.

Brief summary: This study is being done to assess the clinical course and treatment options for Crohn's Disease (CD) and ulcerative colitis (UC) in the populations of Eastern Europe, Middle East, and North Africa.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Crohn's disease or ulcerative colitis.

Primary outcomes:
measure: The number of participants with Crohn's Disease (CD) or ulcerative colitis (UC) who visit the participating sites.
timeFrame: 1 Year
measure: The number of participants with different degrees of CD and UC severity.
timeFrame: 1 Year
measure: Use rates of classes of drug therapy.
timeFrame: 1 Year
measure: Number and types of surgical interventions.
timeFrame: 1 Year
measure: Outcomes of surgical intervention.
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03528356: Impact of Dietary Counseling on Efficacy of Tooth Bleaching
Official title: The Impact of Dietary Counseling on the Efficacy of Tooth Bleaching: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Discoloration
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 40
Sex: ALL
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: The aim of this study will be to evaluate if subjects submitted to a white diet counseling during home dental bleaching will present better results than subjects that maintained their usual diets. Forty patients will be divided into two groups and randomly allocated to each group: usual diet (control) or white diet, avoiding dye-containing food and beverages. patients will be assessed through a food frequency questionnaire and color measurement using a spectrophotometer at baseline and six months after bleaching.


Eligibility criteria: Inclusion Criteria:

* Adults, aged 18 or higher;
* Central incisors with shade A2 or darker

Exclusion Criteria:

* Undergone previous dental bleaching procedures;
* Under orthodontic treatment;
* Pregnant or lactating women.

Primary outcomes:
measure: Tooth color
timeFrame: 6 months
Secondary outcomes:
measure: Food frequency questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Federal Univeristy of Pelotas
state: RS
Study officials:
References:
Clinical trial NCT05300256: Peripheral Heating and Glucose Tolerance
Official title: Peripheral Heating and Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glucose Tolerance
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Effect of peripheral heating on glucose tolerance


Eligibility criteria: Inclusion Criteria:

* 18-80 years

Exclusion Criteria:

* Open wounds on feet or legs
* Peripheral neuropathy

Primary outcomes:
measure: Glucose concentrations
timeFrame: 1 hour
Secondary outcomes:
measure: Insulin concentrations
timeFrame: 1 hour
measure: Blood flow
timeFrame: 1 hour
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
References:
Clinical trial NCT04226456: Intratympanic Administration of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity
Official title: Clinical Trial: Intratympanic Injection of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ototoxic Hearing Loss
Ototoxic Hearing Loss, Bilateral
Ototoxicity
Tinnitus
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 19
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: The purpose of this study is to assess the efficacity of N-acetylcystein against Cisplatin-induced ototoxicity.

Detailed description: This is a monocentric, randomized, controlled, open label phase IV superiority trial.

After signing the informed consent form and upon the confirmation of the patient eligibility, patients will be randomized 1:1 to the experimental arm (NAC + Cisplatin) or the standard arm (Cisplatin).

The primary objective of this trial is to evaluate the protecting effect of Lysomucil® 10% against Cisplatin-induced ototoxicity. In this case, we will evaluate its effect through the transtympanic administration in both ears.

Eligibility criteria: Inclusion Criteria:

* ≥ 18-year-old
* Patients suffering from a neoplastic disease for which treatment protocol includes Cisplatin.

Exclusion Criteria:

* Women of childbearing potential pregnant or with intention to become pregnant within the trial duration
* Women who are breastfeeding
* Pathological findings on otoscopy that do not allow safe intratympanic drug delivery.
* Conductive hearing loss \> 20dBHL
* Meniere disease
* Medical history of sudden hearing loss
* Sensoryneural Hearing loss (SNHL) with mean ≥ 40dbHL Pure Tonal Audiometry (PTA)

Primary outcomes:
measure: Apparition of ototoxicity
timeFrame: 6 month after last injection
Secondary outcomes:
measure: Evaluate the apparition of ototoxicity defined by the inclusion of high frequency audiometry (Tune Grading System)
timeFrame: 6 month after last injection
measure: Hearing quality of life: Evaluation of the Impact of Hearing Loss in Adults ERSA
timeFrame: 6 month after last injection
measure: Hearing quality of life: Tinnitus Handicap Index (THI)
timeFrame: 6 month after last injection
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Saint-Pierre
Study officials:
affiliation: Centre Hospitalier Universitaire Saint Pierre
name: Gaëtan Cavelier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05625256: Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure
Official title: Clinical Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure Against Invasive Arterial Blood Pressure
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Blood Pressure
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 0
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: Consenting adults scheduled for elective major surgery that requires an arterial catheter will be recruited into the study. There will be no restriction on race or ethnicity.

Brief summary: To compare continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in supine position.

Detailed description: Analysis of number and magnitude of BP changes Adjust endpoint calculation definitions and methods based on this lead in results Estimate sample size for main study Demonstration of capability to quantify and annotate interference in the arterial line signal and detect and changes in patient orientation Parallel recording of SentiCor-300 PPG sensor

Main study:

Validate SentiCor-300 noninvasive blood pressure against direct arterial pressure measurements.

Up to 200 (10 run-in, the balance- study) Run in phase will be performed with Senticor-100, data will be used for sample size estimation of balance study.

Eligibility criteria: Inclusion Criteria:

* Clinical indication for arterial catheter insertion;
* Age ≥18 years;
* American Society of Anesthesiologists (ASA) physical status class ≤3;
* Enrollment will be adjusted as necessary so the final population includes at least 40% men and 40% women;
* Planned length of surgery \>60 minutes;
* Anticipated supine positioning;
* Anticipated initial recovery in the post-anesthesia care unit.

Exclusion criteria:

* Severe peripheral vascular disease;
* Surgery that involves manipulation of large arteries
* Bypass surgery
* Positive Allen's test
* Inability to insert a catheter into an upper extremity artery;
* Patients with an arterial-venous shunt for hemodialysis;
* Inability to measure NIBP on the arm with the arterial catheter;
* Atria l fibrillation;
* Body Mass Index (BMI) \>35kg/m2;
* Esophageal or nasopharyngeal pathology, coarctation of the aorta;
* Emergency surgery.
* Surgery which involves manipulation of major arteries

Primary outcomes:
measure: Accuracy
timeFrame: During hospital admission
Secondary outcomes:
measure: Change
timeFrame: During hospital admission
measure: Calibration Duration
timeFrame: During hospital admission
measure: Gender and Fitzpatrick index
timeFrame: During hospital admission
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Alparslan Turan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00938509: Ibuprofen Suppositories Administration in Infants and Children
Official title: Ibuprofen Suppositories Administration for Fever Treatment in Infants and Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fever
Keywords: IBUPROFEN
CHILDREN
FEVER
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2009-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate the efficacy of Ibuprofen administered as suppositories in the treatment of fever in infants and children. Ibuprofen as suppositories is not yet registered in Israel, although widely used in Europe.

Detailed description: The drug will be used in 100 consecutive infants and children admitted with fever at the pediatric ER of the Soroka Medical Center. The information on the drug efficacy will be collected in appropriate parental questionnaires.

Eligibility criteria: Inclusion Criteria:

* Infants and children with rectal temperature \> 38.5 C

Exclusion Criteria:

* Infants \< 6 months of age

Primary outcomes:
measure: Fever decrease
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: pediatric emergency room, SOROKA MEDICAL CENTER
Study officials:
References: