louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05730426: Comparison Between Deep Dry Needling and Muscle Energy Technique on Chronic Non-specific Neck Pain Patients.
Official title: Deep Dry Needling Versus Muscle Energy Technique on Chronic Non-specific Neck Pain; a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare between applying deep dry needling and muscle energy technique in chronic non-specific neck pain patients. Researchers will compare between deep dry needling group, muscle energy technique group and control group to see if there are change in pain, range of motion or function.


Eligibility criteria: Inclusion Criteria:

1. Age 18 and 40 years.
2. Current neck pain.
3. Presence of at least one or two trigger points .
4. Patients are diagnosed and referred from orthopedist complaining from chronic neck pain for at least 12 weeks.
5. No clinical treatment for neck pain within the past month.
6. lacked a history of neck and shoulder myopathy, neuropathy, myelopathy and neck, torso and shoulder surgery.
7. Patients with body mass index less than 30 kg/m2.

Exclusion Criteria:

1. Patients outside the target range.
2. Neck pain associated with vertigo.
3. Osteoporosis.
4. Diagnosed psychological disorders.
5. Fibromyalgia syndrome.
6. Vertebral fractures.
7. Spinal stenosis.
8. Tumors.
9. Previous neck surgery.
10. Red flags (night pain, severe muscle spasm, loss of involuntary weight, symptom mismatch).
11. Physiotherapeutic treatment continued in the last 3 months. Any contraindications for deep dry needling such as anticoagulants, infections and bleeding.

Primary outcomes:
measure: Change in pain intensity from baseline to 4 weeks after.
timeFrame: at baseline and after 4 weeks from the baseline.
measure: Change in function from baseline to 4 weeks after.
timeFrame: at baseline and after 4 weeks from the baseline.
measure: Change in cervical range of motion (ROM) in sagittal, coronal and transverse planes from baseline to 4 weeks after.
timeFrame: at baseline and after 4 weeks from the baseline.
measure: Change in pain threshold from baseline to 4 weeks after.
timeFrame: at baseline and after 4 weeks from the baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Delta University for science and technology.
Study officials:
affiliation: Delta University for Science and Technology
name: Haneen M. Ghalwash
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06623526: Clinical Trial to Evaluate the PK Interactions of YHR2402 Monotherapy and YHR2402 and YHR2403 Co-Administration in Healthy Volunteers
Official title: An Open-label, Randomized, Fasting, Single-Crossover Study to Compare the Pharmacokinetic Interactions and Safety of YHR2402 Monotherapy and YHR2402 and YHR2403 Co-Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: pharmacokinetic interactions
Drug-Drug Interaction
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2024-10-02
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: two-way crossover
Primary purpose: TREATMENT

Brief summary: An open-label, randomized, single-dose, crossover study to evaluate the pharmacokinetic interactions and safety after co-administration of YHR2402 and YHR2403 compared to the administration of YHR2402 independently in healthy subjects

Detailed description: 26 healthy subjects will be randomized to one of the 2 groups in the same ratio.

"YHR2402" and "YHR2402"+"YHR2403" will be administered to Subjects in group 1 by crossover design on day 1, 15

"YHR2402"+"YHR2403" and "YHR2402" will be administered to Subjects in group 2 by crossover design on day 1, 15.

Eligibility criteria: Inclusion Criteria:

* Those who are 19 years old and under 55 years old at the screening visit
* Those whose weight is over 50kg(male), over 45kg(female) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
* Those who express their voluntary consent to participate in the trial by signing a written consent
* Those who are judged eligible to participate in the trial by the principal investigator(or delegated investigators) after screening test

Exclusion Criteria:

* Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration
* Others who are judged ineligible to participate in the trial by the principal investigator

Primary outcomes:
measure: Area under the plasma drug concentration-time curve [AUCt]
timeFrame: 0-96 hours
measure: Maximum plasma concentration [Cmax]
timeFrame: 0-96 hours
Secondary outcomes:
measure: Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
timeFrame: 0-96 hours
measure: Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]
timeFrame: 0-96 hours
measure: Time of Maximum observed plasma concentration [Tmax]
timeFrame: 0-96 hours
measure: Apparent Terminal Elimination Half-life [t1/2]
timeFrame: 0-96 hours
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
Study officials:
affiliation: Jeonbuk National University Hospital
name: Mingul Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01368926: A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects
Official title: A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics, Safety and Tolerability of RO4917523 Conducted in 2 Phases: a Single-Dose, Cross-Over Administration to Healthy Japanese Subjects and a Multiple-Dose Administration to Healthy Japanese and Caucasian Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-06-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This double-blind, randomized, placebo-controlled, 2-Part study will evaluate the pharmacokinetics and safety of RO4917523 in healthy Japanese and Caucasian volunteers. In Part 1, healthy Japanese volunteers will be randomized to receive 2 oral doses of either RO4917523 or placebo, with a washout period of 21 days between dosing. In Part 2, healthy Japanese and Caucasian volunteers will be randomized in cohorts to receive either RO4917523 or placebo orally daily for 14 days.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese (Part 1 + 2) or Caucasian (Part 2) adults, 18- 50 years of age
* Japanese subjects must have Japanese parents and grandparents who were born in Japan
* Caucasian subjects must have 4 Caucasian grandparents
* Body mass index (BMI) 18.5 to 26 kg/m2, and a body weight of at least 45 kg
* Non-smoker for at least 90 days prior to dosing Day 1

Exclusion Criteria:

* Participation in a clinical trial with an investigational drug within 90 days prior to dosing Day 1. (Volunteers having participated in Part 1 will not be allowed to participate in Part 2 and vice versa)
* History or evidence of any clinically significant disease or disorder
* Pregnant or lactating women
* Positive for hepatitis B, hepatitis C or HIV
* Positive drug screen test, positive cotinine test and/or positive alcohol test
* Any confirmed significant allergic reactions to any drug, or multiple allergies in the judgement of the investigator

Primary outcomes:
measure: Part 1: Pharmacokinetics: Area under the concentration - time curve (AUC) (single/multiple oral dose in healthy Japanese subjects)
timeFrame: approximately 12 weeks
measure: Part 2: Comparison of pharmacokinetics (area under the concentration - time curve [AUC]) between healthy Caucasian and Japanese subjects after 14 days of daily oral dosing
timeFrame: approximately 9 weeks
measure: Safety: Incidence of adverse events in Japanese an Caucasian subjects
timeFrame: approximately 21 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
state: New York
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01679626: Airway Manoeuvers - Implications for Airway Management?
Official title: The Effect of Cricoid Pressure and Backward Upward Rightward Pressure on Airway Dimensions - Implications for Airway Management?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Management
Keywords: cricoid pressure (CP)
backward upward rightward pressure (BURP)
AP-rima distances
Glottic area
Extralaryngeal manoeuvres
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: 200 consecutive adult patients scheduled for elective surgery requiring endotracheal intubation.

Brief summary: In anesthesia, intubation is a technique used to secure an airway. This technique is not always straightforward. Sometimes it is difficult to place an endotracheal tube. There are two manners of giving pressure to the patients neck, to improve view and facilitate intubation.

The investigators hypothesize that by giving this pressure the effective work area is likely to be smaller. The investigators would like to quantify this effect by measuring the effective work area, using a specially designed computer program.

Detailed description: Cricoid pressure (CP) and the backward-upward-rightward pressure (BURP) manoeuver, are extralaryngeal manoeuvers which are widely applied during endotracheal intubation, respectively offering potential protection against passive gastric regurgitation and improved laryngeal view in emergency airway management.

Their validity in achieving an improvement of the laryngeal view has been questioned.

The objective of this study is to measure the change in mean anterior-posterior rima glottidis (APRIMA) distance and mean area under the vocal cords after backward upward rightward pressure (BURP) and cricoid pressure (CP).

The investigators will measure the APRIMA distances and areas under the vocal cords, using a specially created module in the program DeVIDE. The measurements assessed during BURP and CP will be expressed relative to the measurements when no external pressure is applied.

Eligibility criteria: Inclusion Criteria:

- 200 consecutive adult patients scheduled for elective surgery requiring endotracheal intubation

Exclusion Criteria:

* BMI \> 35 kg.m-2);
* chronic obstructive pulmonary disease;
* history of difficult intubation;
* mouth opening \< 3 cm;
* inadequate neck mobility;
* history of oropharyngeal pathology.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
Study officials:
References:
Clinical trial NCT02265926: Respiratory Consequences of N95-type Mask Usage in Pregnant Healthcare Workers - A Controlled Clinical Study
Official title: Respiratory Consequences of N95-type Mask Usage in Pregnant Healthcare Workers - A Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoventilation
Keywords: filtering facepiece respirators
N95 masks
pandemic response
pregnant healthcare workers
Lead sponsor: National University Health System, Singapore
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 20
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study aims to find out if usage of N95 type respirators affects respiratory parameters in pregnant women so as to provide guidance on N95 respirator usage in pregnant healthcare workers.

Detailed description: The first phase of the study aims to determine the average workload of a nurse. In the second phase of the study, this workload is then translated to walking on a treadmill while pregnant subjects wore special masks open to air, then occluded with N95 mask materials.

Eligibility criteria: Inclusion Criteria:

* Subjects had spontaneously conceived singleton pregnancies and were between 21 to 40 years old. Their hemoglobin levels were ≥11g/dL

Exclusion Criteria:

* Any cardiorespiratory illness, influenza-like illness in the week prior to the trial, or any pregnancy-related complications such as gestational diabetes, hypertension, intrauterine growth restriction, placenta previa, ruptured membranes, or threatened preterm labor. Any neuromuscular conditions that would preclude them from using the treadmill.

Haemoglobinopathies.

Primary outcomes:
measure: Minute Ventilation
timeFrame: 15 minutes
Secondary outcomes:
measure: Oxygen and carbon dioxide exchanged
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: NUHS
Study officials:
affiliation: NUHS
name: Eu-Leong Yong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00959426: A Multiple Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers
Official title: A Phase 1 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Multiple Escalating Oral Doses Of PF-04620110 In Otherwise Healthy Overweight And Obese Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Overweight
Healthy
Keywords: - Mutliple Ascending Dose Study in Overweight Subjects - Body Weight - Signs and Symptoms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2009-08-14
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics, of multiple oral doses of PF-04620110.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years
* Body Mass Index (BMI) of 26.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.

Primary outcomes:
measure: To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, andc linical safety laboratory measurements.
timeFrame: Baseline to 2 weeks
measure: To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects.
timeFrame: Baseline to 2 weeks
measure: To characterize the effect of PF-04620110 on postprandial lipid metabolism measures.
timeFrame: Baseline to 2 weeks
Secondary outcomes:
measure: To examine additional pharmacodynamic markers in response to multiple oral doses of PF-04620110.
timeFrame: Day -1 and Day 14
measure: Secondary Pharmacodynamic Endpoints in response to a liquid meal test
timeFrame: Day -1 and Day 14
measure: Triglyceride excursions
timeFrame: Day -1, Day 1, and Day 14
measure: Glucose, insulin, and C-peptide excursions
timeFrame: Day -1 and Day 14
measure: Gut hormone excursions- including active GLP-1, total amide GLP-1, ghrelin, GIP, and PYY
timeFrame: Day -1 and Day 14
measure: Additional Secondary Pharmacodynamic Endpoint: Fasting adiponectin
timeFrame: Day -1 and Day 14
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00815126: Nasal Provocation Test With Lysine-Acetylsalicylate (ASA) in Patients With Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Hypersensitivity
Official title: Association Between Nasal Provocation Test With Lysine-Acetylsalicylate(ASA) and Clinical Diagnosis in Patients With Aspirin/Nonsteroidal Anti-Inflammatory Drugs(NSAIDs) and/or Acetaminophen Immediate Sensitivity Reactions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aspirin Hypersensitivity
NSAIDs Hypersensitivity
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2008-12-29
Enrollment: 34
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to compare the efficacy of nasal provocation test with Lysine-Acetylsalicylate in patients with history of NSAIDs hypersensitivity between mucocutaneous symptoms and respiratory symptoms and laboratory outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients with history of ASA/NSAIDs hypersensitivity with mucocutaneous symptoms and/or respiratory symptoms

Exclusion Criteria:

* Patients who cannot discontinue drugs before the test as follow

  * Nasal corticosteroids/Oral corticosteroids/Leukotriene modifiers for 1 week
  * Short-acting antihistamines for 3 days
  * Nasal a-mimetics/Oral a-mimetics/Local cromones for 24 hours
* Contraindicated for nasal provocation test: pregnant, exacerbation of allergic rhinitis/asthma, having upper respiratory tract infection within 2 weeks prior to the test, having nose surgery within 8 weeks prior to the test, having severe systemic disease(s)
* Having factors interfere nasal provocation test with Lysine-ASA such as massive nasal polyp, nasal septal perforation, total nasal obstruction at least 1 nostril

Primary outcomes:
measure: Symptom scores and/or acoustic rhinometry result upon Lysine-ASA nasal provocation test in patients with history of mucocutaneous or respiratory symptoms from NSAIDs
timeFrame: 5 months
Secondary outcomes:
measure: Correlation between clinical manifestations and laboratory results (basophil activation test, etc.)
timeFrame: 5 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Jettanong Klaewsongkram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06064526: An Observational, Retrospective Multicentre Medical Record Review to Describe the Post-authorisation Early Clinical Experience of Dupilumab in the Treatment of Adult Severe Asthma
Official title: Real-world Experience of Dupilumab for the Treatment of Severe Asthma in the United Kingdom: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-10-03
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult participants with severe asthma treated with dupilumab in routine clinical practice from medical records of nine participating centres meeting the study eligibility criteria.

Brief summary: The purpose of this retrospective medical record review is to describe the real-world clinical effectiveness of dupilumab with patients in the United Kingdom with severe asthma.

Detailed description: Participants initiating treatment with dupilumab in the UK between 5th July 2019 and 12th August 2021 will be included in the study record review, permitting participation in research and if medical records are available for review. No intervention will be administered in this clinical trial. Data will be collected from hospital medical records and other hospital databases.

Eligibility criteria: Inclusion Criteria:

• Adult participants (aged ≥18 years at index) with severe asthma, initiated with dupilumab treatment (≥1 dose) between 07/05/2019 (EU licence) and 08/12/2021 • Participants with ≥1 routine asthma clinic visit recorded within 6 months prior to or on the date of dupilumab initiation and ≥1 routine asthma clinic visit recorded between 9 and 16 months post-dupilumab initiation

Exclusion Criteria:

• Participants known to have opted out of participation in research • Participants whose medical records are not available for review The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Primary outcomes:
measure: Oral corticosteroid (OCS) dose
timeFrame: Up to 25 months
measure: Annual asthma exacerbation rate
timeFrame: Up to 25 months
measure: Forced expiratory volume in one second (FEV1)
timeFrame: Up to 25 months
measure: Peak expiratory flow rate (PEF)
timeFrame: Up to 25 months
measure: Asthma Control Questionnaire (ACQ) score
timeFrame: Up to 25 months
measure: Asthma Quality of Life Questionnaire (AQLQ) score
timeFrame: Up to 25 months
Secondary outcomes:
measure: Body mass index (BMI [kg/m2])
timeFrame: At baseline
measure: Inhaled corticosteroid dose
timeFrame: At baseline
measure: Dupilumab treatment duration
timeFrame: Up to 25 months
Other outcomes:
Locations:
city: Chilly-Mazarin
country: France
facility: Sanofi-Aventis, France
Study officials:
affiliation: Sanofi
name: Clinical Sciences &amp; Operations
role: STUDY_DIRECTOR
References: