louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06899425: Effect of Kinesio Tape on Neck Pain in Lactating Women
Official title: Effect of Kinesio Tape on Neck Pain in Lactating Women. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neck Pain Musculoskeletal
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate the effect of kinesio tape on neck pain in lactating women.

Detailed description: Neck pain is widely prevalent and can be exacerbated by poor posture and prolonged or repetitive positions-both of which are common in lactating mothers. Research shows that a significant percentage of breastfeeding women experience musculoskeletal pain, often linked to specific postures such as the cross-cradle hold. Prolonged forward head posture (FHP) and muscle imbalances in the neck-shoulder region further contribute to mechanical neck pain by placing excessive strain on muscles, joints, and connective tissues.

Kinesio taping (KT) is a non-pharmacological technique aimed at alleviating pain and improving functional movement. By lifting the skin slightly, KT is proposed to enhance local blood and lymphatic flow, reduce nociceptive signals, and stimulate proprioceptive feedback. Multiple studies suggest KT can help correct posture, relieve muscle fatigue, and improve range of motion, thus offering a promising intervention for mechanical neck pain. These benefits are potentially valuable for lactating mothers, who are especially prone to postural stresses and neck discomfort due to the physical demands of breastfeeding.

Eligibility criteria: Inclusion Criteria:

* All women are complaining from neck pain.
* Their ages will be ranged from 20 to 30 years old.
* Their body mass index will not exceed 30 kg/m².
* They are medically stable and consented to participate in the study.

Exclusion Criteria:

* Cervical spondylosis.
* Cervical disc prolapse.
* History of fracture of cervical spine.

Primary outcomes:
measure: Pain intensity
timeFrame: 12 weeks
measure: Pain pressure threshold
timeFrame: 12 weeks
Secondary outcomes:
measure: Neck flexion range of motion
timeFrame: 12 weeks
measure: Neck extension range of motion
timeFrame: 12 weeks
measure: Neck lateral flexion range of motion
timeFrame: 12 weeks
measure: Neck rotation range of motion
timeFrame: 12 weeks
measure: Northwick park neck pain questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Zahra University Hospital
Study officials:
affiliation: Al-Azhar University
name: Abd El Hamid Atta Allah, PHD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Mohamed Awad, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00863525: A Study to Assess the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822)
Official title: A Double-Blind, Randomized, 2-Period Crossover, Placebo Controlled Study to Asses the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Single Oral Dose of MK0822
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and tolerability of single doses of odanacatib (MK0822) when administered with a light breakfast.


Eligibility criteria: Inclusion Criteria:

* Subject is male and between the ages of 18 and 45
* Subject is within 25% of ideal body weight and weighs between 55 and 95 kg
* Subject is in generally good health
* Subject is a nonsmoker

Exclusion Criteria:

* Subject has multiple or severe allergies to food or medications
* Subject has a history of metabolic bone disease, kidney/bladder stones, or treatment with bisphosphonates
* Subject has any infections, including HIV
* Subject has donated blood or taken another investigational drug in the last month
* Subject consumes excessive amounts of caffeine or alcohol
* Subject has a history of any illness that may confound the results of the study or pose additional risk in administering the study drug

Primary outcomes:
measure: Safety and tolerability of MK0822 based on clinical and laboratory adverse experiences
timeFrame: Throughout the study
measure: Effect of a low-fat meal on pharmacokinetics of MK0822
timeFrame: Through 240 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Stoch SA, Zajic S, Stone JA, Miller DL, van Bortel L, Lasseter KC, Pramanik B, Cilissen C, Liu Q, Liu L, Scott BB, Panebianco D, Ding Y, Gottesdiener K, Wagner JA. Odanacatib, a selective cathepsin K inhibitor to treat osteoporosis: safety, tolerability, pharmacokinetics and pharmacodynamics--results from single oral dose studies in healthy volunteers. Br J Clin Pharmacol. 2013 May;75(5):1240-54. doi: 10.1111/j.1365-2125.2012.04471.x.
Clinical trial NCT03238625: Painless Local Anaesthesia With Bicarbonate Admixture
Official title: Painless Local Anaesthesia With Bicarbonate Admixture: A Phase II, Monocentric, Double-blind, Randomized, Placebo-controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Local Infiltration
Anesthesia
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study examines whether the injection of local anesthesia mixed with sodium bicarbonate in the ratio of 3:1 creates a less burning sensation and is as effective regarding the anesthetic effect as in the ratio of 9:1.

Detailed description: Therefore the investigators compare two groups with 24 healthy individuals in each group in a cross-over study. One group receives four injections (two in each forearm) and one group receives only two injections (one in each forearm)

The four injections of group 1 are:

* IMP1: Lidocaine and sodium bicarbonate ratio 3:1
* IMP 2: Lidocaine and sodium bicarbonate ratio 9:1
* IMP 3: Lidocaine
* IMP 4: Sodium cloride 0.9% (=placebo)

The two injections of group 2 are IMP1 and IMP2.

After each injection the individual has to rate their pain sensation on a NRS scale and afterwards the anesthetic effect gets tested by a standardized laser application.

Eligibility criteria: Inclusion Criteria:

* healthy male or female individuals between 18 and 75 years
* able to understand and speak German
* able to follow the instructions

Exclusion criteria:

* oversensitivity to lidocaine or other local anesthetics of amide type or sulfites
* prone to bleeding, intake of aspirine or anticoagulation
* pregnancy
* skin on forearms with lesions (i.e. sunburn, wounds, eczema or other skin diseases)

  * previous participation at the same study

Primary outcomes:
measure: Rating of injection pain between IMP1 and IMP2
timeFrame: 1 minute
Secondary outcomes:
measure: rating of injection pain of IMP3 and IMP4
timeFrame: 1 minute
measure: rating of clinical relevance of the difference between pain sensation of the injections
timeFrame: 5 minutes
measure: assessment of local anesthesia of each injection with a standardized laser
timeFrame: 90 minutes
measure: duration of anesthetic effect of each injection
timeFrame: maximum 90 minutes
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University hospital, Department of Dermatology
state: Zurich
Study officials:
References:
Clinical trial NCT01388725: Comparison the Value of Several Biomarkers of Sepsis
Official title: Comparison of the Value of Serum sTREM-1, sCD163, PCT, CRP Concentrations, WBC Count and SOFA Score During Sepsis and Their Clinical Informative Value in Predicting Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Inflammatory Response Syndrome
Sepsis
Keywords: sTREM-1
sCD163
PCT
CRP
WBC count
SOFA score
SIRS
sepsis
severity
prognosis
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2011-07-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Between September 2009 and July 2011, inpatients were included who were in the intensive care units (ICU) of the Department of Respiratory Disease, the Emergency Department, and the Department of Surgery of the Chinese People's Liberation Army General Hospital.

Brief summary: The purpose of this study is to describe the value of serum sTREM (soluble triggering receptor expressed on myeloid cells)-1, sCD163, procalcitonin (PCT), C-reactive protein (CRP) concentrations, white blood cell (WBC) count and SOFA score during sepsis and their clinical informative value in predicting outcome.

Detailed description: The investigators enrolled 130 subjects admitted to an ICU: 30 cases with systemic inflammatory response syndrome (SIRS), 36 cases with sepsis, 35 cases with and 29 with septic shock. Results for sTREM (soluble triggering receptor expressed on myeloid cells)-1, sCD163, procalcitonin (PCT), C-reactive protein (CRP) concentrations, white blood cell (WBC) count and SOFA score were recorded on days 1, 3, 5, 7, 10, and 14.

Eligibility criteria: Inclusion Criteria:

* Male and female aged 18 years old and over;
* Clinically suspected infection;
* Fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °C or lower than 36 °C (b)respiratory rate above 20/min, or PCO2 below 32 mmHg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands.

Exclusion Criteria:

* Those who fulfilled one below:
* neutropenia (≤ 500 neutrophils/mm3)
* HIV infection, and
* patients or their relatives refused

Primary outcomes:
measure: Patients Outcome
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Department Of Respiratory Diseases, Chinese PLA General Hospital
name: Xie Lixin, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04607525: Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy
Official title: Efficacy of Dexmedetomidine Infusion Without Loading Dose on Hemodynamic Variables and Recovery Time During Craniotomy: A Randomized Double Blinded Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodynamic Instability
Supratentorial Neoplasms
Keywords: Postoperative analgesia
Craniotomy
Dexmedetomidine
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There is no clear consensus among neuroanesthesiologists regarding which anesthetic regimen is optimal for craniotomy. Propofol and short-acting opioids (such as remifentanil, fentanyl, or sufentanil) are commonly used. However, use of opioids is associated with increased risk of respiratory depression and postoperative nausea and vomiting. Dexmedetomidine is a highly selective α2-adrenoreceptor agonist that has been considered as a useful and safe adjunct to anesthesia for various surgical procedures

Detailed description: The investigators designed this randomized, double-blind study to evaluate the effectiveness of administration of Dexmedetomidine infusion at a dose of 0.5 µg/kg/h without loading dose during elective supratentorial craniotomy under GA. The investigators will compare intraoperative hemodynamics in both groups, intraoperative analgesic consumption, intraoperative blood loss, postoperative sedation scores, intraoperative need for rescue hypotensive agents, and finally the satisfaction of surgeons.

To our knowledge, the present study is the first to evaluate the effect of Dexmedetomidine infusion without loading dose in elective supratentorial craniotomy

Eligibility criteria: Inclusion Criteria:

* American society of anesthesiologists- Physical status (ASA-PS) I and II patients,
* aged 18 to 65 years
* 70-80 kg
* both sexes
* undergoing elective supratentorial craniotomy for tumor resection

Exclusion Criteria:

* Patients under 18 years of age
* pregnancy,
* emergency surgery
* patients with a Glasgow Coma Score (GCS) less than 15.
* Those who had respiratory or cardiac dysfunction, renal insufficiency, liver impairment, or bleeding disorders

Primary outcomes:
measure: Mean areterial blood pressure
timeFrame: 4 to 8 hours
measure: Heart rate
timeFrame: 4 to 8 hours
measure: Number of Participants needed rescue agents
timeFrame: 4 to 8 hours
Secondary outcomes:
measure: Recovery time in minutes
timeFrame: At the end of operation
measure: Postoperative sedation level
timeFrame: 1st 2 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
References:
Clinical trial NCT02111525: Fluid Status of Outpatients With Dyspnea
Official title: Fluid Status of Outpatients With Dyspnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspnea,
Acute Heart Failure Syndrome
Pulmonary Congestion
Lead sponsor: Intersection Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-11
Enrollment: 156
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who present with shortness of breath to an emergency department or urgent care facility are possible candidates for the study and shall be screened for suitability based on the inclusion and exclusion criteria.

Brief summary: The purpose of this study is to determine the distribution of lung fluid status as reported by the IMED-4 system in patients presenting to the emergency department or urgent care facility with shortness of breath.


Eligibility criteria: INCLUSION CRITERIA

* Shortness of breath as the most prominent presenting symptom
* Age greater ≥ 45
* Willingness, ability, and commitment to participate in the study

EXCLUSION CRITERIA

* Patients with any active implantable medical device
* Patients who are pregnant or lactating
* Patients who have tattoos and or non-intact skin directly under the electrode position
* Patients who have had past allergic reactions to medical grade adhesives
* Patients that are dialysis dependent
* Patients who have had a lung lobectomy
* Patients in whom the shortness of breath presentation is due to obvious non HF cause such as acute chest trauma
* Patients who have received nitrates (sub-lingual, topical or IV), diuretics or vasopressors ≥ 1 hour prior to IMED-4 Recording
* Patients who decline to have their backs photographed with the IMED-4 device in position
* Patients who are receiving invasive or non-invasive positive airway pressure (PAP) ventilation prior to or following presentation to the ED (Self presentation or admission via EMS).
* Severe co-morbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, incarceration, shortened life expectancy, etc.)

Primary outcomes:
measure: Lung Fluid Status
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University Hospital
state: Michigan
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
References:
Clinical trial NCT00740025: Once Daily vs Twice Daily Administration of Gonadotropins in Assisted Reproductive Technologies (ART)
Official title: A Prospective Randomized Study of QD vs BID Dosing in ART
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: QD dose
BID dosing
peak estradiol
oocytes
implantation rate
pregnancy rate
Lead sponsor: Virginia Center for Reproductive Medicine
Sponsor class: OTHER
First posted: 2008-08-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between 21-40 yo

Brief summary: This is a prospective randomized study evaluating dosing frequency of gonadotropin administration in ART cycles.

Detailed description: Using once daily or bid dosing of gonadotropins in ART has been arbitrary with no studies showing whether splitting the medication dose improves ART parameters. This study was undertaken to provide an answer to this important question.

Eligibility criteria: Inclusion Criteria:

* women \< 40 undergoing ART

Exclusion Criteria:

* women \> 40
* endometriomas
* severe cervical stenosis
* testicular sperm

Primary outcomes:
measure: Ongoing pregnancy
timeFrame: 1 year
Secondary outcomes:
measure: peak estradiol, number of follicles, number of oocytes, implantation rate, multiple pregnancy rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Reston
country: United States
facility: Virginia Center for Reproductive Medicine
state: Virginia
Study officials:
affiliation: Virginia Center for Reproductive Medicine
name: Fady I Sharara, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06384625: Developing and Evaluating an Indoor Air Pollution Intervention Among Cardiovascular Patients: the AIRWISE Study
Official title: Developing and Evaluating an Indoor Air Pollution Intervention Among Cardiovascular Patients: the AIRWISE Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Heart Disease
Cardiovascular Diseases
Environmental Exposure
Lead sponsor: University of Montana
Sponsor class: OTHER
Collaborators: name: Providence Heart Institute
First posted: 2024-04-25
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This pilot study (n=20) is a prospective evaluation of the implementation of an indoor air pollution intervention among adults 55 years of age or older. The intervention, called Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE), is focused on improving indoor air quality through air filtration, education, and behavioral recommendations. All participants will receive the AIRWISE intervention with the objective of evaluating acceptance and use of the individual intervention components. This implementation study will inform the submission of a larger NIH proposal for a randomized trial. The central study hypothesis is that an intervention program with educational strategies and visual behavioral cues will increase knowledge and awareness of air pollution exposures among the participants and lead to improved intervention compliance.


Eligibility criteria: Inclusion Criteria:

* Adult of at least 55 years of age
* One primary residence (5+ days per week)
* Own a computer or electronic device (tablet or phone with web browser), and reliable internet connection or cell phone service (required to submit study surveys)
* Access to a working email address (required to submit study surveys)
* Electricity in the home (required to power the study equipment)

Exclusion Criteria:

* Current smoking of any kind (tobacco, cannabis, vape pens, cigars, etc.) or living in a household with someone who currently smokes
* Current use of stand-alone home high efficiency purified air (HEPA) filtration or PAC unit in the home
* Intention to move in the next 6 months
* Another person in the household is enrolled in this study (one person per household can enroll)
* Having any health condition that prevents the participants from having blood pressure measured using an upper-arm cuff: lymphedema, paresis or paralysis, arterial or venous lines/catheters, dialysis shunt, recent surgical wounds, or mastectomy

Primary outcomes:
measure: Evaluate the implementation of an indoor air pollution intervention.
timeFrame: 6 months
Secondary outcomes:
measure: Fine particulate matter (PM2.5)
timeFrame: 6 months
measure: Life's Essential 8
timeFrame: 6 months
Other outcomes:
Locations:
city: Missoula
country: United States
facility: University of Montana
state: Montana
Study officials:
References:
Clinical trial NCT05018325: Assessing Effect of Withdrawal Time on Adenoma Detection Rate for Screening Colonoscopy
Official title: Assessing Effect of Withdrawal Time on Adenoma Detection Rate for Screening Colonoscopy: A Randomized Tandem Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colon Cancer
Rectal Cancer
Colorectal Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The investigators' null hypothesis is that a withdrawal time of 9 to 10 minutes is non-inferior to a withdrawal time of 12 minutes or greater. Thus, the goal of this tandem design trial is to compare the additional diagnostic yield (# of missed lesions) for withdrawal times exceeding 10 minutes for screening/surveillance colonoscopies. Although withdrawal times longer than the standard 6-minute recommendation have been shown to be beneficial, there is limited prospective evidence investigating the benefit or lack thereof for withdrawal times greater than 9-10 minutes.


Eligibility criteria: Inclusion Criteria:

* Must be between the ages of 18 and 75 years
* Must be a patient undergoing screening or surveillance colonoscopy
* Must be able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Inability to provide informed consent.
* Personal history of colorectal cancer (CRC)
* Personal history of colon surgery or colon resection
* Personal history of Inflammatory bowel disease
* Personal history of familial polyposis
* Current pregnancy
* Active GI bleeding
* Colonoscopy exams where the cecum cannot be reached (randomization will occur after cecum is reached).

Primary outcomes:
measure: Miss rate of polyps
timeFrame: Time of colonoscopy (day 1)
Secondary outcomes:
measure: Miss rate of advanced adenomas
timeFrame: Time of colonoscopy (day 1)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Vladimir Kushnir, M.D.
role: PRINCIPAL_INVESTIGATOR
References: