louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01277341: Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-01-14
Enrollment: 601
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Male or female at least 12 years of age with a history of mountain cedar allergy

Exclusion Criteria:

* No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments

Primary outcomes:
measure: Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS
timeFrame: Baseline, 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: ISTA Pharmaceuticals, Inc.
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Tim McNamara, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04180241: Development of Endoscopic Treatment for Achalasia
Official title: Development of Endoscopic Treatment for Achalasia, POEM (Per Oral Esophageal Myotomy): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Achalasia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: POEM with division all the esophageal muscle layers compared to deviding only the inner circular muscle layer of the esophagus.
Primary purpose: TREATMENT

Brief summary: Per Oral Endoscopic Myotomy (POEM); comparison of two surgical techniques division all the esophageal muscle layers versus division the inner circular muscle layer of the esophagus only.

Detailed description: Prior to surgery, all patients undergo upper endoscopy , x-ray "time barium" manometry, 24 hours pH registration. Moreover Quality of Life instrument (RAND-36), GSRS (Gastrointestinal Symptom Rating Scale) and a dysphagia score (Eckardt score) are completed by all patients.

Follow-up with surveys 3, 6, 12, and 36 months (GSRS, RAND-36 and Eckardt score).

At 3,12 and 36 months an x-ray "time barium" is performed and after 12 months a gastroscopy and at 24 hours esophageal pH monitoring are performed.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed achalasia
* the patient should understand the nature and the purpose of the study and give informed consent

Exclusion Criteria:

* previous surgical treatment of achalasia
* inability to understand the contents of or follow the protocol
* other pathology as an explanation for the obstruction of the esophageal transition

Primary outcomes:
measure: The proportion of patients who develop gastroesophageal reflux disease (GERD)
timeFrame: 1 year
Secondary outcomes:
measure: Esophageal emptying function
timeFrame: 1 year
measure: Eckardt score
timeFrame: 1 year
measure: RAND-36
timeFrame: 1 year
measure: Dysmotility
timeFrame: 1 year
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Ersta Hospital
state: Region Stockholm
city: Stockholm
country: Sweden
facility: Karolinska Institutet
state: Stockholm County Council
Study officials:
affiliation: Karolinska Institutet
name: Anders Thorell, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03772041: Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
Official title: A Multicenter, Double-blind, Randomized, Active-controlled, Parallel-group, Non-inferiority Trial to Evaluate the Efficacy and Safety of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Congestive Heart Failure
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-12-11
Enrollment: 294
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To confirm the non-inferiority of OPC-61815 16-mg injection to tolvaptan 15-mg tablet using as the primary endpoint the change in body weight following 5-day intravenous administration of OPC-61815 16-mg injection or 5-day oral administration of tolvaptan 15-mg tablet to CHF patients with volume overload despite having received diuretics other than vasopressin antagonists


Eligibility criteria: Inclusion Criteria:

* Patients who are currently on treatment with any of the following diuretics

  1. Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher
  2. Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose
  3. Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose
* Patients with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
* Patients who are currently hospitalized or who are able to be hospitalized during the trial

Exclusion Criteria:

* Patients with acute heart failure
* Patients who are on a ventricular assist device
* Patients who are unable to sense thirst or who have difficulty with fluid intake

Primary outcomes:
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Day 6
Secondary outcomes:
measure: Improvement Rate for Lower Limb Edema and Pulmonary Congestion
timeFrame: Baseline, Day 6
measure: Change From Baseline in Jugular Venous Distension and Hepatomegaly
timeFrame: Baseline, Day 6
measure: Percentage of Subjects Who Achieve Resolution of Pulmonary Rales and Third Cardiac Sound
timeFrame: Baseline, Day 6
measure: Improvement Rate for New York Heart Association (NYHA) Classification
timeFrame: Baseline, Day 6
Other outcomes:
Locations:
city: Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Osamu Sato
role: STUDY_DIRECTOR
References:
Clinical trial NCT05677841: Effects of Spinal Stabilization Exercises Focusing on the Pelvic Floor in Women With Overactive Bladder
Official title: Investigation of the Effects of Spinal Stabilization Exercises Focusing on the Pelvic Floor in Women With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the effects of spinal stabilization exercises focusing on the pelvic floor on urinary symptoms, spinal stability, pelvic floor muscle functions, quality of life and perception of recovery in women with overactive bladder.

Detailed description: Overactive bladder (OAB) is defined by the International Continence Society and the International Society of Urogynecology as urinary urgency with or without urinary incontinence, usually accompanied by frequency and nocturia. Among the treatment options of OAB; first-line treatments include lifestyle recommendations, exercise approaches, and bladder training. Lifestyle recommendations; healthy lifestyle includes behavioral changes. Spinal stabilization exercise also aims to improve the neuromuscular control, strength and endurance of the muscles that are important in maintaining trunk stability. In recent years, it has been stated that trunk stability is impaired in women with OAB. However, no study was found on spinal stabilization exercises in patients with OAB.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65
* Women with a diagnosis of overactive bladder
* Women who volunteered to participate in the study

Exclusion Criteria:

* Women with only stress urinary incontinence
* Presence of advanced pelvic organ prolapse
* Having a mental problem that will prevent cooperation in assessment and/or practices
* Women with the presence of a malignant condition
* Concomitant neurological disease and/or neurogenic bladder
* Presence of infection
* Pregnancy

Primary outcomes:
measure: Overactive bladder symptoms
timeFrame: change from baseline at 8 weeks
Secondary outcomes:
measure: Bladder function
timeFrame: change from baseline at 8 weeks
measure: Urgency severity
timeFrame: change from baseline at 8 weeks
measure: Spinal stability
timeFrame: change from baseline at 8 weeks
measure: Pelvic floor muscle function
timeFrame: change from baseline at 8 weeks
measure: Life Quality
timeFrame: change from baseline at 8 weeks
measure: Perception of Recovery
timeFrame: after treatment (8th week)
measure: Compliance with recommendation
timeFrame: after treatment (8th week)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
state: Esenboğa Külliyesi
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06327841: Plaque Reduction Sesame Oil
Official title: The Plaque Reducing Efficacy of Oil Pulling With Sesame Oil. A Randomized-controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Gingivitis
Oral Microbial Colonization
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trials to learn about potential additives in reducing dental plaque. The main questions it aims to answer is:

• is there a difference in the plaque reducing effect of oil pulling with sesame oil compared to rinsing with distilled water? Participants will rinse with 15 ml of their allocated liquid for 15 min every morning for 8 weeks.

Researchers will compare sesame oil against distilled water to see if there is a difference in the plaque reducing effect.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* contractual capability
* the presence of ≥ 10 teeth,
* community periodontal index of treatment needs (CPITN) grade 1 or 2

Exclusion Criteria:

* missing consent
* community periodontal index of treatment needs (CPITN) grade 0, 3 or 4
* pregnancy or breastfeeding
* systemic diseases or conditions that are associated with an increased risk of infection or necessitate concomitant antibiotic therapy with dental treatment
* mental and behavioral disorders that impede (verbal) communication
* allergy against sesame(oil)
* intake of antibiotics 6 months prior to or during study duration
* intake of medication potentially influencing gingival inflammation or bleeding (e.g. anticoagulants, cortisone)
* infectious diseases (e.g. HIV, hepatitis B or C)
* fixed orthodontic appliances
* ongoing oil pulling or mouth rinsing
* adult guardianship
* insufficient nasal breathing

Primary outcomes:
measure: Rustogi Modified Navy Plaque Index (RMNPI)
timeFrame: first follow up after 4 weeks, full study duration 8 weeks
Secondary outcomes:
measure: Gingival Index (GI)
timeFrame: first follow up after 4 weeks, full study duration 8 weeks
measure: microbial analysis
timeFrame: first follow up after 4 weeks, full study duration 8 weeks
measure: Oral Health Impact Profile (OHIP)
timeFrame: first follow up after 4 weeks, full study duration 8 weeks
measure: Interview halitosis, xerostomia
timeFrame: first follow up after 4 weeks, full study duration 8 weeks
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University
state: Tyrol
Study officials:
affiliation: Medical University Innsbruck
name: Ines Kapferer-Seebacher
role: STUDY_CHAIR
affiliation: Medical University Innsbruck
name: Markus Nagl
role: STUDY_CHAIR
References:
Clinical trial NCT02933541: Central Arterial Pressure Changes With Use of Regional Anesthesia in Obstetric Patients
Official title: Central Arterial Pressure Changes With Use of Regional Anesthesia in Obstetric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Blood Pressures
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 12
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who are admitted to our obstetrics ward and are planning on receiving regional anesthesia will be approached.

Brief summary: Plan to monitor central arterial pressure in women who are undergoing spinal anesthesia for cesarean delivery or epidural anesthesia for vaginal delivery.

Detailed description: Subjects will be screened as they are admitted to the maternity care floor (5th floor St. Mary's Hospital). Subjects will be approached if they are desiring regional anesthesia.

The subject will have an additional blood pressure cuff placed on the arm that anesthesia is not using for their blood pressure cuff. Central arterial pressure will be measured from the cuff:

* Prior to regional anesthesia placement
* Every 15 minutes for 1 hour
* Every 30 minutes for 2 hours Routine sphygmomanometer measurements will also completed at the above times. These are all study procedures.

Anesthesia will use their usual protocol for blood pressure monitoring and management during placement of, and after the procedure. No changes in patient management will be made based upon the central arterial pressure as the guidelines were developed with routine brachial pressure.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Planned regional anesthesia

Exclusion Criteria:

* Multiple pregnancy
* Emergent cesarean delivery
* Irregular heart rhythms or arrhythmias
* Peripheral arterial disease, leg artery disease
* Reynaud's phenomena
* Intense cold/hypothermia
* If there is a wound at location of where central arterial cuff would be placed or tonometer for carotid assessment
* Severe tachycardia (\>120)
* Greater than 1st degree heart block
* Congestive heart failure or heart disease
* Inability to adequately monitor BP
* Use of magnesium sulfate

Primary outcomes:
measure: Amount of change in central arterial pressure in obesity.
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Mary's Health Center
state: Missouri
Study officials:
References:
Clinical trial NCT04735341: Prospective Post-market Data Collection for Ion Endoluminal System to Understand CT to Body Divergence
Official title: Prospective Post-market Data Collection for Ion Endoluminal System to Understand CT to Body Divergence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Pulmonary Nodule, Solitary
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2021-02-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who will undergo an Ion Endoluminal Procedure with a pulmonary nodule, 18 years or older

Brief summary: The goal of this study is to collect post-market data for the Ion Endoluminal System to understand CT to body divergence.


Eligibility criteria: Inclusion Criteria:

* Age of 18 years or older

  * Undergoing a lung biopsy procedure with Ion System
  * Have peripheral pulmonary lesion (5th bronchial generation or higher)
  * Willingness to participate as demonstrated by signing the informed consent

Exclusion Criteria:

* Unable to provide informed consent

  * Presence of bilateral nodules intended to be biopsied during procedure
  * The presence of medical conditions contraindicating general anesthesia or bronchoscopic biopsy
  * Vulnerable population (e.g., prisoners, mentally disabled)

Primary outcomes:
measure: Ion Catheter Shape
timeFrame: Intra-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Pinehurst
country: United States
facility: FirstHealth of the Carolinas Moore Regional Hospital
state: North Carolina
Study officials:
References:
Clinical trial NCT04033341: A Study of LY3214996 in Healthy Participants
Official title: Disposition of [14C]-LY3214996 Following Oral Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-07-26
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will involve a single dose of 14C radiolabelled LY3214996. This means that a radioactive substance, C14, will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to six weeks.


Eligibility criteria: Inclusion Criteria:

* Overtly health males
* Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria:

* Females
* Male participants sexually active with a pregnant partner
* Are currently enrolled in a clinical study or have participated, within the last 30 days, in a clinical study
* Have participated in a radiolabeled drug study within the previous 4 months
* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
* Have a history of Gilbert's syndrome
* Have history or presence of psychiatric disorders
* Show evidence of human immunodeficiency virus (HIV) infection
* Show evidence of hepatitis C
* Show evidence of hepatitis B

Primary outcomes:
measure: Urinary Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
timeFrame: Baseline through Day 8 after administration of study drug
measure: Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
timeFrame: Baseline through Day 8 after administration of study drug
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3214996
timeFrame: Predose through Day 8 after administration of study drug
measure: PK: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3214996
timeFrame: Predose through Day 8 after administration of study drug
measure: Total Number of Metabolites of LY3214996
timeFrame: Baseline through 48 hours after administration of study drug
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Inc
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06335641: Head COOLing in IscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety StuDy
Official title: Head COOLing in IscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety StuDy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke, Acute
Keywords: Hypothermia
Large vessel occlusion
Neuroprotection
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an investigator-initiated, prospective, open-label, single-arm, non-randomized study to assess the safety and feasibility of external active conductive head cooling during endovascular thrombectomy procedures.


Eligibility criteria: Inclusion Criteria:

- All patients with anterior circulation acute ischemic stroke planned to undergo endovascular thrombectomy will be screened for recruitment.

Exclusion Criteria:

* Admission core body temperature \<35°C.
* Known contraindications to hypothermia, including hemodynamically unstable patients, new/symptomatic arrhythmia, hematological dyscrasias that affect thrombosis (cryoglobulinemia, sickle cell disease, serum cold agglutinins), or vasospastic disorders such as Raynaud's or thrombo-angiitis obliterans.
* Skin lesions not allowing secure application of the cooling cap.
* Unable to participate in follow-up at 3 months (e.g., resides outside of Alberta).

Primary outcomes:
measure: Adherence to the intervention
timeFrame: From time of application in the emergency department until the end of the endovascular thrombectomy procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Auckland
country: New Zealand
facility: Te Whatu Ora Te Toka Tumai Auckland
Study officials:
References: