louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02475616: A Single Ascending Dose Study of PCO371 in Healthy Volunteers
Official title: A Randomized, Double-blind, Single Ascending Oral Dose Study To Evaluate Safety, Tolerability And Pharmacokinetics Of PCO371 In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-06-19
Enrollment: 64
Sex: MALE
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: This is a single-center, placebo-controlled, randomized, double-blind, dose-escalation study to evaluate safety, tolerability, and PK of a single oral (PO) administration of PCO371 in healthy adult males.

Caucasian and Japanese subjects will be randomized to receive either PCO371 or placebo.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers aged 18 to 45 years.
* Caucasian(BMI 18-30 mg/kg2) or first generation japanese(BMI 18-25kg/m2)
* Able and willing to abide by the protocol

Exclusion Criteria:

* Evidence of any medical condition that could affect renal, hepatic, or cardiopulmonary functions.

Primary outcomes:
measure: Safety as assessed by adverse events
timeFrame: 15days or 22days
measure: Safety as assessed by temperature
timeFrame: 15days or 22days
measure: Safety as assessed by systolic blood pressure, diastolic blood pressure
timeFrame: 15days or 22days
measure: Safety as assessed by pulse rate
timeFrame: 15days or 22days
measure: Safety assessed by physical findings examinations, including weight
timeFrame: 15days or 22days
measure: Safety as assessed by Laboratory test values
timeFrame: 15days or 22days
measure: Safety as assessed by ECGs
timeFrame: 15days or 22days
measure: Plasma concentrations and PK parameters (AUC, Cmax, Tmax, total clearance, volume of distribution and T1/2) of PCO371 in healthy male volunteers
timeFrame: 15days or 22days
measure: Urine concentrations and PK parameters (cumulative excretion and renal clearance) of PCO371
timeFrame: 15days or 22days
Secondary outcomes:
measure: The Time profile of serum/plasma concentrations in albumin-corrected total calcium (Ca); 25-hydroxy vitamin D (vit D), 1,25-dihydroxy vit D, and 24,25-dihydroxy vit D; phosphate; magnesium; and cAMP of PCO371
timeFrame: 15days
measure: The Urinary excretion of Ca, phosphate, magnesium, protein, sodium, potassium, chloride, and cAMP of PCO371
timeFrame: 15days
measure: The Nephrogenous cAMP of PCO371
timeFrame: 15days
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Wcct Global
state: California
Study officials:
affiliation: Chugai Pharmaceutical
name: Ger Rikken
role: STUDY_DIRECTOR
References:
Clinical trial NCT05087316: Therapy of Oral Appliance for Adults Jordanians With Obstructive Sleep Apnea
Official title: Biometric Oral Appliance Therapy for the Treatment of Obstructive Sleep Apnea in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Obstructive Sleep Apnea
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Introduction: Obstructive Sleep Apnea (OSA) is the most common form of sleep disordered breathing. Patients who arrive at the dental office with a diagnosis of OSA are often treated with a mandibular advancement device (MAD). A biomimetic oral appliance therapy (BOAT), offers an alternative non-surgical method, which can putatively resolve OSA by combined maxilla-mandibular correction, and addressing craniofacial deficiencies.

The aim: To determine whether maxilla-mandibular correction changes induced by BOAT produce a more favorable upper airway, which might result in a reduction in the severity of OSA.

Protocol: Adults who underwent an overnight sleep study and were diagnosed by a sleep specialist physician will be potential subjects for the current study. The BQ and EES will be recorded pre- and post- BOAT treatment. Subjects with mild to moderate OSA will have 2 months follow up visits and a final overnight sleep study to measure apnea-hypopnea index (AHI). The subjects will be asked to wear the appliance for 10-12 hours/day and at night. Findings will be analyzed statistically using paired t-tests.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of mild to moderate OSA with good oral hygiene
* Intolerant to CPAP therapy
* Having enough number of maxillary and mandibular teeth to retain the removable device.

Exclusion Criteria:

* Patients who are unable to attend regular appointments and unable to consent.
* Patients with severe OSA who met the inclusion criteria

Primary outcomes:
measure: AHI
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: King abdullah University Hospital (KAUH)
state: Others
Study officials:
References:
Clinical trial NCT00866216: Comparative Bioavailability Study of 600mg Azithromycin Monohydrate Tablets Under Fasting Conditions
Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Geneva 600mg Azithromycin Monohydrate Tablets and Pfizer Inc. (Zithromax) 600mg Azithromycin Dihydrate Tablets in Healthy Adult Volunteers Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-03-20
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the bioequivalence of Azithromycin Monohydrate 600 mg Tablets.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results on screening

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C
* Treatment for drug or alcohol dependence
* Female subjects who are pregnant or lactating

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 32 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MDS Pharma
name: Alan S Marion
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04686916: Clinical Trial Studying the Efficacy and Safety of IP2018 in Depressed, Erectile Dysfunction (ED) Patients
Official title: A Randomised, Double-Blind, Placebo-Controlled, Crossover Trial Studying the Efficacy and Safety of IP2018 in Young, Depressed, Erectile Dysfunction (ED) Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Erectile Dysfunction
Lead sponsor: Initiator Pharma
Sponsor class: INDUSTRY
First posted: 2020-12-29
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a Phase IIa, randomised, double-blind, placebo-controlled, 3-period, crossover study to assess two single oral dose levels of IP2018. It is planned to enrol 24 patients. Patients will take part in three treatment periods, in which they will be randomised to receive either a single dose of IP2018 or a single dose of placebo in each treatment period.


Eligibility criteria: Inclusion Criteria:

- Male patients with a diagnosis of mild to moderate depression and ED as determined from the Hamilton depression scale score of 7 to 23 and International Index of Erectile Function (IIEF-5) score of 12 to 18, respectively, with a body mass index of 18 to 32 kg/m2 (inclusive), of any ethnic origin.

Exclusion Criteria:

- Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal (GI), haematological, endocrinological, metabolic, neurological, psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of Investigator, may place the patient at unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion of drugs, or with the completion of treatment according to this protocol.

Primary outcomes:
measure: Erectile Function
timeFrame: A 6 hours time interval after dosing
Secondary outcomes:
measure: Safety assessment
timeFrame: From randomisation to end of study participation
measure: Pharmacokinetics of IP2018
timeFrame: From start to end of assessments
measure: Pharmacokinetics of IP2018
timeFrame: From start to end of assessment
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: MAC
Study officials:
affiliation: MAC UK
name: Giuseppe Fiore Fiore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01066416: Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control
Official title: Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthma
Chronic Sinusitis
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2010-02-10
Enrollment: 1
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: It is unknown whether surgical treatment of chronic sinusitis improves asthma control in patients with poorly controlled asthma. This is a randomized trial of surgical plus medical sinus therapy versus medical therapy alone.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria: General

  1. 18 years of age or older
  2. Women need one of the following: negative pregnancy test or suitable birth control or post-menopausal status
  3. Informed consent and ability to comply with study procedures
  4. Patients must meet inclusion criteria for both asthma and sinus disease.

Inclusion criteria: Asthma

In order to qualify for the 6 week run-in, patients must have poorly controlled asthma as defined by the following criteria:

1. Diagnosis of asthma confirmed either by demonstrating a positive methacholine challenge test (defined as a decrease in FEV1 by at least 20%, following administration of 8mg or less of inhaled methacholine) or a positive bronchodilator response (defined as a change from base line of \>12% and at least 200ml in either FEV1 or FVC, following administration of a short-acting, inhaled bronchodilator).
2. Either:

   * Asthma Control Questionnaire score \> 1.5 or
   * Use of inhaled rescue ß-agonist \>/= 16 puffs per week (excluding use as a pre-medication for exercise; 1 nebulizer treatment = 2 puffs of inhaler) at any time during the past month or
   * \>1 hospitalization or unscheduled MD visit in the past 6 months for asthma symptoms or
   * \>1 course of oral steroid use in past 6 months or
   * \> 2 weeks of systemic steroids in last 6 months.

Exclusion Criteria:

1. Current smokers or those with at least a 10 pack-year smoking history
2. Presence of any concurrent diseases that, in the investigator's opinion, would interfere with participation in the study or that might put the participant at risk

Primary outcomes:
measure: Asthma Control Score
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Evanston Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT05815316: 18F-PSMA PET/MRI for the Diagnosis of Clinically Significant Prostate Cancer
Official title: Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This project aims to evaluate the role of fully hybrid PET/MRI with 18F-PSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa).

This prospective PET/MRI clinical evaluation will ideally reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa.

The demonstration that, compared to mpMRI alone, the use of PET/MRI with 18F-PSMA has a superior diagnostic accuracy in detecting men with csPCa will strongly support the inclusion of 18F-PSMA as pre-biopsy triage test, in addition to mpMRI in daily clinical practice.


Eligibility criteria: Inclusion Criteria:

1. Men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy
2. Feasibility to undergo all procedures listed in protocol
3. Ability to provide written informed consent

Exclusion Criteria:

1. Prior diagnosis of prostate cancer
2. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min)
3. Contraindication to prostate biopsy

Primary outcomes:
measure: To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of csPCa
timeFrame: Biopsy at day 90 (+/-90)
measure: To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone
timeFrame: Biopsy at day 90 (+/-90)
measure: To report the change in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET, and consequently the proportion of unnecessary biopsies potentially spared.
timeFrame: Biopsy at day 90 (+/-90)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00785616: A Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence
Official title: A Trial to Determine the Long-term Durability of Virologic Suppression in Kaletra Recipients With Imperfect Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection
Keywords: HIV
Adherence
MEMS
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2008-11-05
Enrollment: 55
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will enroll completers of a prior 24 week MEMS cap study of Kaletra adherence, conducted in 2005 - 2006, and repeat the MEMS monitoring for an additional 24 weeks in 2008/2009 on the current antiretroviral anchor drug. The goals of the study are to correlate long-term adherence with virologic outcome, and to explore the stability of MEMS cap adherence measurements over time.


Eligibility criteria: Inclusion Criteria:

* Participation in the prior Kaletra MEMS cap study

Exclusion Criteria:

* Not receiving antiretroviral therapy, refusal to provide informed consent

Primary outcomes:
measure: Proportion with virologic suppression
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References:
Clinical trial NCT05971316: Effectiveness of a Warm-Up With Foam Roller in Professional Basketball Players
Official title: Effectiveness of a Warm-Up With Foam Roller for 3 Months in Professional Basketball Players: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletics Injury
Sports Physical Therapy
Keywords: Foam Roller
Performance
Warm-Up
Basketball
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomiced Controlled Trial
Primary purpose: OTHER

Brief summary: The purpose of this study is to analyze the effectiveness of a foam roller warm-up on sports performance in professional basketball players.

Detailed description: Twenty-two professional basketball players, divided into two randomized groups, carried out a specific warm-up for three months with a foam roller. Three measurements were made, pre-intervention, post-intervention at 12 weeks and a four-week follow-up. In these measurements reference data were taken for jumping, ankle dorsiflexion and balance. During this protocol, they performed three series of sixty seconds of application with thirty seconds of rest between series, three days a week and applied to the calf muscles, hamstrings, quadriceps, gluteus and TFL.

Eligibility criteria: Inclusion Criteria:

* Masculine or feminine
* Minimum 18 years and maximum 30
* Professional players
* Practice 3 training sessions per week + competition on weekends

Exclusion Criteria:

* Musculoskeletal injury in the last 3 months
* Surgery in the lower extremity in the last year
* Present a diagnosed orthopedic or neurological pathology of the lower limb.

Primary outcomes:
measure: Know the effectiveness of a warm-up with a foam roller in proffesional basketball player during 18 weeks on jumping using the Counter Movement Jump, dorsiflexión using the Lung Test and the balance using the Y-Balance Test
timeFrame: Baseline and week 18
Secondary outcomes:
measure: Evaluate the improvement obtained in the experimental group after a warm-up protocol with foam roller for 14weeks 3 days per week on the Counter Movement Jump, Lung Test and Y-Balance test vs non-intervention group.
timeFrame: Baseline and week 14
measure: Maintenance of foam roller warm-up adaptations on the Counter Movement Jump, Lung Test and Y-Balance Test after intervention for a 1 month
timeFrame: Week 14 and week 18
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Católica San Antonio de Murcia
state: Murica
Study officials:
affiliation: Universidad Católica San Antonio de Murcia
name: Daniel Casado
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03713216: Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy
Official title: Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Cathay General Hospital
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effect and safety of NALDEBAIN versus Morphine as needed in patients after laparoscopic cholecystectomy.

Detailed description: This is an open-labeled, randomized clinical trial. Group A will receive one dose of NALDEBAIN before surgery. Group B will receive morphine as needed. Pain will be assessed for PACU, 4, 24, 48, 72 hours after surgery.

Eligibility criteria: Inclusion Criteria:

1. Male or female with 20 years old or older.
2. Scheduled to electively undergo laparoscopic cholecystectomy.
3. Ability and willingness to provide informed consent.

Exclusion Criteria:

1. Not willing to adhere to the study visit schedule and complete all study assessments.
2. History of hypersensitivity or allergy to opioid, or NSAIDs or sesame oil.
3. Any clinically significant condition that may interfere with study assessments or compliance.
4. Pregnant or breastfeeding.
5. Medical history may cause abnormal intracranial pressure.
6. History of dependency, addiction, and withdrawal for narcotic drugs.

Primary outcomes:
measure: Postoperative pain score
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Consumption of supplemental analgesics
timeFrame: From Day 0 to Day 3
Other outcomes:
measure: Incidence of adverse event
timeFrame: From Day 0 to Day 3
measure: Percentage of Patient satisfaction
timeFrame: Day 3
Locations:
city: Taipei
country: Taiwan
facility: Cathay General Hospital
Study officials:
affiliation: Cathay General Hospital
name: Sing-Ong Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee SO, Huang LP, Wong CS. Preoperative Administration of Extended-Release Dinalbuphine Sebacate Compares with Morphine for Post-Laparoscopic Cholecystectomy Pain Management: A Randomized Study. J Pain Res. 2020 Sep 9;13:2247-2253. doi: 10.2147/JPR.S263315. eCollection 2020.
Clinical trial NCT05343416: NaROA STUDY: National Register of Open Abdomen
Official title: NaROA STUDY: OBSERVATIONAL, PROSPECTIVE, MULTICENTRIC, NATIONAL OPEN ABDOMEN REGISTRY FOR THE ANALYSIS OF INDICATIONS AND PRONOTIC FACTORS OF MORBI-MORTALITY IN PATIENTS UNDERGOING EMERGENCY SURGERY BY GENERAL SURGERY.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Open Abdomen Technique
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients underwent to open abdomen procedure

Brief summary: National Register of Open Abdomen Open Abdomen Procedure (Observational and Prospective Study)

Detailed description: The open abdomen technique has widely been proven useful in the treatment of traumatic patients, but its indication in non-traumatic patients with catastrophic abdomen (peritonitis, ischaemia, pancreatitis) generates controversy. Its heterogeneous implementation is based on insufficient evidence and originated in health systems very different from ours. Its low prevalence imposes the need for a multicentre study.

AIMS : Establish a national, prospective, multi-centre national registry of non traumatic patients with open abdominal indication whether or not they undergo damage control surgery and open abdomen for:

1. Describe in real time the indications, surgical technique, materials, time, risk factors, definitive closure, reinterventions and complications according to the Clavien-Dindo classification and mortality.
2. Compare the results of the application or non-application of the open abdomen in non-traumatic patients between the different participating centers.
3. Set the limits of the open abdomen in non-traumatic patients indication.

Eligibility criteria: Inclusion Criteria:

* Indication to Open Abdomen in non-trauma patients
* Informed consent

Exclusion Criteria:

* Open Abdomen in trauma patients
* No indication to Open Abdomen
* Informed consent refusal

Primary outcomes:
measure: OPEN ABDOMEN: NON-TRAUMATIC ABDOMINAL EMERGENCIES
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari del Mar (PSMar)
Study officials:
References: