louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03855397: Pain and Safety of Microneedles in Oral Cavity
Official title: Pain and Safety of Microneedle Application in the Oral Cavity of Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Cavity Disease
Keywords: Microneedles
Buccal mucosa
Transbuccal administration
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Texas Tech University
First posted: 2019-02-26
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30 male volunteers was performed to access pain and safety of microneedle topical application in different regions of the oral cavity.

Detailed description: A randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30 male volunteers was performed by applying a microneedle patch in the following regions of the oral cavity: lip (inner lower), buccal (cheek: 1 cm behind the month angle), tongue (dorsal surface), hard palate (anterior region), and attached gingiva (between central and lateral upper incisors). A 30 gauge hypodermic needle and an identical patch but without microneedles sticking out, were used as positive and negative controls, respectively. The application force was standardized to 10N by an applicator composed of a 5 mL syringe and a spring. Insertions were performed with a gap of 30 seconds. Pain and discomfort associated to the procedure was evaluated with a Visual Analogue Scale (VAS), by a blinded-dentist. The safety associated to microneedle application was verified immediately after the application (0h) and after the next day (24h). The different application sites were inspected visually for bleeding, ulceration, bruising, redness or swelling.

Eligibility criteria: Inclusion Criteria:

- Healthy male

Exclusion Criteria:

- Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders, smokers or alcoholic.

Primary outcomes:
measure: Pain sensitivity assessment by Visual Analogue Scale after microneedle application in the oral cavity
timeFrame: 30 seconds
measure: Number of participants with treatment-related adverse events as assessed by visual inspection of ecchymosis, ulceration, redness, swelling or bleeding after microneedles use in the oral cavity
timeFrame: 24 hours
Secondary outcomes:
measure: Confirmation of mucosal perforationin the oral cavity after application of the devices
timeFrame: Right after microneedle application
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Michelle Franz Montan Braga Leite
state: São Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Michelle Leite, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Tech University
name: Harvinder S Gill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03549897: Bronchoprovocation Study to Evaluate the Pharmacodynamics of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base
Official title: A Randomized, Single-Dose, Double-Blind, Double-Dummy, Four-Period, Four-Sequence, Four-Treatment, Placebo and Active Controlled, Comparative, Multiple-Center, Crossover-Design, Bronchoprovocation Study to Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Amneal Ireland Limited) to PROAIR® HFA (Albuterol Sulfate) Inhalation Aerosol, eq 90 mcg Base (Teva Respiratory, LLC) in Patients With Stable, Mild Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Amneal Ireland Limited
Sponsor class: INDUSTRY
First posted: 2018-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This randomized, single-dose, double-blind, double-dummy, four-period, four-sequence, four-treatment, placebo and active controlled, comparative, multiple-center, crossover-design bronchoprovocation study has been designed to evaluate the pharmacodynamic equivalence of albuterol sulfate HFA inhalation aerosol, eq 90 mcg base (Amneal Ireland Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in patients with stable mild asthma.


Eligibility criteria: Inclusion Criteria:

* Male and non-pregnant female subjects (18-65 years of age).
* Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
* FEV1 ≥ 80% of predicted.
* Airway responsiveness to methacholine demonstrated by a pre-albuterol-dose (baseline) PC20 ≤ 8 mg/mL.
* Nonsmokers for at least six months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).
* Written informed consent

Exclusion Criteria:

* Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study.
* History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season.
* History of cystic fibrosis, bronchiectasis or other respiratory diseases.
* History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, including ECG with evidence of ischemic heart disease.
* Treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months.
* Known intolerance or hypersensitivity to any component of the albuterol MDI.

Primary outcomes:
measure: Primary Pharmacodynamic Endpoint Post-dose PC20
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brookhaven
country: United States
facility: Amneal Pharmaceuticals LLC
state: New York
Study officials:
affiliation: Amneal Pharmaceuticals, LLC
name: Irshad Haque
role: STUDY_DIRECTOR
References:
Clinical trial NCT04429997: Incidence of Patellar Crepitus in Removal and Non-removal of Fibrosynovial Tissue at Superior Pole of Patella
Official title: Prospective Randomized Controlled Trial: Comparison of Incidence of Patellar Crepitus Between Removal and Non-removal of Fibrosynovial Tissue at the Border of the Superior Pole of the Patellar
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Removal of Fibrosynovial Tissue
Non-removal of Fibrosynovial Tissue
Patellar Non-resurfacing
Lead sponsor: Navamindradhiraj University
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 138
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the incidence of patellar crepitus complication and the clinical outcome between remove and not remove fibrosynovial tissue at the border of the superior pole of the patellar in posterior stabilized total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty

Exclusion Criteria:

* Valgus deformity
* History of inflammatory arthroplathy
* Previous fracture or open surgery on the same knee
* History of patellar instability

Primary outcomes:
measure: Incidence of patellar crepitus complication
timeFrame: Change from baseline patellar crepitus complication 3 months, 6 months, and 12 months after surgery
Secondary outcomes:
measure: Knee Society and Knee Society function score
timeFrame: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery
measure: New patellar score
timeFrame: Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery
measure: Oxford knee score
timeFrame: Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery
measure: Change of post-operative anterior knee pain
timeFrame: Change from baseline Visual Analog Scale for anterior knee pain at 3 months, 6 months, and 12 months after surgery
Other outcomes:
Locations:
city: Dusit
country: Thailand
facility: Navamindradhiraj University
state: Bangkok,
Study officials:
affiliation: Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
name: Satit Thiengwittayaporn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01732497: A Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry System
Official title: A Prospective Study of Axillary Hair Loss in Patients Treated With the miraDry System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Underarm Hair
Keywords: Underarm Hair
Underarm Hair Reduction
Axillary Hair
Axillary Hair Reduction
Underarm Odor
Axillary Odor
Lead sponsor: Miramar Labs
Sponsor class: INDUSTRY
First posted: 2012-11-22
Enrollment: 56
Sex: ALL
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 study is to evaluate hair reduction in the underarms in patients treated with the miraDry System.

Detailed description: This study is designed to quantify the amount of hair reduction in patients treated with the miraDry System in the axilla. Hair counts will be assessed before and after treatments including at follow up visits.

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Visible underarm hair (prefer light colored hair; blonde, red, gray)

Exclusion Criteria:

* Secondary Axillary Hyperhidrosis
* Prior surgery and/or Botox Injections in axillae
* Pacemaker or requires supplemental oxygen
* Pregnant

Primary outcomes:
measure: Patients with successful hair reduction
timeFrame: 3 months
Secondary outcomes:
measure: Patients with successful hair reduction
timeFrame: 12 months
Other outcomes:
measure: Patient satisfaction with hair reduction
timeFrame: All follow-up visits through 12 months
Locations:
city: Edina
country: United States
facility: Zel Skin and Laser Specialists
state: Minnesota
city: New York
country: United States
facility: Laser & Skin Surgery Center of NY
state: New York
city: Bethlehem
country: United States
facility: Lehigh Valley Dermatology
state: Pennsylvania
Study officials:
affiliation: Miramar Labs, Inc
name: Kathy Quiroz, BS, RN
role: STUDY_DIRECTOR
References:
Clinical trial NCT04205097: Deep vs Moderate Neuromuscular Blocks on Remifentanil for Laparoscopic Gastrectomy
Official title: Deep Versus Moderate Neuromuscular Blocks on Remifentanil Requirements in Patients Undergoing Surgical Pleth Index-guided Analgesia for Laparoscopic Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose is to compare the remifentanil requirements in deep vs moderate neuromuscular blocks during the surgical pleth index -guided anesthesia in patients undergoing laparoscopic gastrectomy.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of gastric cancer Scheduled laparoscopic gastrectomy

Exclusion Criteria:

* Patients refusal to consent Hyperbilirubinemia Chronic pain Opioid abuse Incurrent infective status Peripheral vascular disease

Primary outcomes:
measure: total dose of remifentanil
timeFrame: from pneumoperitoneum to removal of laparoscope
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
state: Gyeonggido
Study officials:
References:
Clinical trial NCT04328597: Portuguese Inguinal Hernia Cohort (PINE) Study
Official title: Portuguese Inguinal Hernia Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inguinal Hernia
Chronic Pain
Lead sponsor: Portuguese Surgical Research Collaborative
Sponsor class: NETWORK
Collaborators: name: University of Lisbon
First posted: 2020-03-31
Enrollment: 500
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: Portuguese patients undergoing inguinal hernia repair in one of the hospitals participating in the study

Brief summary: Prospective national cohort study of patients submitted to elective inguinal hernia repair. The primary outcome is the prevalence of chronic postoperative inguinal pain, according to the EuraHS QoL questionnaire at 3 months postoperatively. The study will be delivered in all Portuguese regions through a collaborative research network. Four 2-week inclusion periods will be open for recruitment. A site-specific questionnaire will capture procedure volume and logistical facilities for hernia surgery.


Eligibility criteria: Inclusion Criteria:

* Elective inguinal hernia repair in a portuguese hospital
* Willing and able to consent and comply with the follow up protocol

Exclusion Criteria:

* Urgent/emergent inguinal hernia repair

Primary outcomes:
measure: Chronic postoperative pain
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Proportion of patients receiving antibiotic prophylaxis before inguinal hernia repair
timeFrame: Intraoperatively
measure: Proportion of patients operated as day case surgery
timeFrame: 30 days after surgery
measure: Postoperative morbidity
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Hospital prof. Dr. Fernando Fonseca
Study officials:
affiliation: Portuguese Surgical Research Collaborative
name: Antonio Soares
role: STUDY_CHAIR
References:
Clinical trial NCT06637397: Probiotics for Alleviating Functional Constipation in Adults
Official title: Assessing the Safety and Effectiveness of Weizmania Coagulant BC99 in Relieving Functional Constipation in Adults Based on Randomized, Double-Blind, Placebo-Controlled Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Constipation
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 100
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: To investigate the clinical effects of probiotics in relieving chronic constipation in adults, and evaluate the improvement of symptoms in patients with constipation as well as their impacts on gastrointestinal function, immunity, and gut microbiota.


Eligibility criteria: Inclusion Criteria:

1. Chinese adults who meet the diagnostic criteria of Rome III, aged between 18 and 70;
2. Patients with chronic constipation (disease duration exceeding 6 months, with fewer than 3 bowel movements per week and/or Bristol stool form scale types 1 and 2);
3. Able to complete the study according to the requirements of the experimental protocol;
4. Patients who have signed the informed consent form;
5. Research participants (including male participants) who do not have fertility plans from 14 days before screening to 6 months after the end of the trial and are willing to take effective contraceptive measures voluntarily.

Exclusion Criteria:

1. Individuals who have taken items with similar functions to the tested product within a short period of time, which may affect the judgment of the results;
2. Patients who have changed their diet during the study period;
3. Patients with severe allergies and immune deficiencies;
4. Female patients who are pregnant, breastfeeding, or have plans to become pregnant;
5. Patients with severe diseases in vital organs such as cardiovascular, lung, liver, and kidney, as well as severe metabolic diseases such as diabetes, thyroid disease, malignant tumors, and severe immune system diseases;
6. Individuals who have used antibiotics within the past two weeks;
7. Individuals with severe psychological or mental illnesses;
8. Participants who have not consumed the tested samples as required or failed to follow up on time, resulting in an inability to determine the effectiveness;
9. Other research participants deemed unsuitable for participation by the researchers.

Primary outcomes:
measure: Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Luoyang
country: China
facility: The School of Food and Bioengineering, Henan University of Science and Technolog
state: He Nan
city: Luoyang
country: China
facility: Henan University of Science and Technology
state: Henan
Study officials:
References:
Clinical trial NCT01560897: Investigating Project of the Functional C13 Test "Pilot Study"
Official title: Investigating Project of the Functional C13 Test
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Disorder of the Urea Cycle
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this pilot study is to evaluate the validity and reproducibility of a functional test "Test C13" ureogenesis to measure in vivo, using the methodology Laboratory of Metabolic Diseases of "Cliniques Universitaires Saint-Luc"


Eligibility criteria: Inclusion Criteria:

* healthy or with a disorder of the urea cycle

Exclusion Criteria:

Primary outcomes:
measure: Subject with a disorder of the urea cycle
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Saint Luc
Study officials:
References:
Clinical trial NCT05389397: De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas
Official title: De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyp of Colon
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 604
Sex: ALL
Minimum age (years): 54
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare the effectiveness of three standard of care outreach approaches (i.e., mailed letter, secure message, and telephone call) on patient adoption of the new 10-year colonoscopy surveillance interval recommendation for a random sample of health plan members who have a now-outdated 5-year surveillance interval due to a finding of 1-2 small adenomas at their prior colonoscopy. The primary study endpoint is the proportion of patients in each outreach arm who adopt the new 10-year colonoscopy surveillance interval.


Eligibility criteria: Inclusion Criteria:

* Kaiser Permanente Northern California (KPNC) membership\>12 months
* Primary medical center is either KP San Rafael, KP San Francisco, KP San Leandro, or KP Walnut Creek
* 54-70 years of age at time of 5-year surveillance colonoscopy interval
* A baseline colonoscopy with a finding of 1-2 small tubular adenomas and are due for their 5-year surveillance procedure in 2022
* Average risk for CRC
* A valid mailing address, kp.org account (i.e., KPNC's secure messaging portal), and telephone number at time of study enrollment.

Exclusion Criteria:

* More than 12 months of membership prior to index colonoscopy, and indications that would make an individual above average risk for CRC, such as: adenoma with advanced histology on colonoscopy, adenoma \>10 mm on colonoscopy, family history of CRC, prior history of colonoscopy, prior history of adenomas or colon polyp diagnoses, history of IBD, history of hereditary polyposis syndrome, 3 or more adenomas, adenoma 10 mm in size or greater, adenoma with advanced histology, and any sessile serrated polyp or traditional serrated adenoma

Primary outcomes:
measure: Percentage of patients who respond with a 10-year surveillance interval change
timeFrame: 2 months following outreach intervention
Secondary outcomes:
measure: Percentage of patients requesting a physician appointment
timeFrame: 2 months following outreach intervention
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco Medical Center
state: California
Study officials:
affiliation: Kaiser Permanente
name: Jeffrey K Lee, MD
role: STUDY_CHAIR
References: