louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04566172: Preoperative Optimization to Improve Functional Status
Official title: Preoperative Optimization to Improve Functional Status
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pulmonary Atelectasis
Pneumonia, Ventilator-Associated
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the same intervention.
Primary purpose: PREVENTION

Brief summary: This is a pilot study to obtain preliminary information on the usability and efficacy of a pre-habilitation program. The investigators will recruit up to 100 patients.

The two specific aims of this study are to conduct an initial pilot study with the following goals:

1. To obtain information on feasibility and utilization of the program
2. To determine whether participation in the program improves a patient's Maximal Inspiratory Pressure

Detailed description: Participants will engage in a pre-habilitation program prior to surgery at home, that includes using an inspiratory muscle training (IMT) device that will strengthen the muscles of breathing. Participants will keep a log of training. The Maximum Inspiratory Pressure will be measured at baseline and prior to surgery.

Eligibility criteria: Inclusion Criteria:

* Undergoing thoracic or upper abdominal surgery with an estimated date of surgery between 2-10 weeks after enrollment
* Age\>65 y/o

Exclusion Criteria:

* Impaired cognition that would limit participation in the program
* History of spontaneous pneumothorax
* Any other physician judgement

Primary outcomes:
measure: Overall Inspiratory muscle training compliance as assessed by daily logs
timeFrame: Up to 10 Weeks
Secondary outcomes:
measure: Number of attempted inspiratory muscle training as assessed by percent days the program was attempted
timeFrame: Up to 10 Weeks
measure: Number of completed inspiratory muscle training as assessed by percent days with full compliance
timeFrame: Up to 10 Weeks
measure: Change in maximum inspiratory pressure
timeFrame: Baseline and on the day of surgery, up to 10 weeks from enrollment
measure: Interest in Using Program for Future Surgeries as assessed by a likert scale
timeFrame: Day of Surgery, up to 10 weeks from enrollment
measure: Overall Satisfaction with the Program as assessed by a likert scale
timeFrame: Day of Surgery, up to 10 weeks from enrollment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins Univesity School of Medicine
name: Charles Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03844672: Impact of E-cigarette Characteristics on Reinforcement and Tobacco Use Patterns
Official title: Impact of E-cigarette Characteristics on Reinforcement and Tobacco Use Patterns Among
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Tobacco Use
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-02-18
Enrollment: 93
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this project is to understand how different e-cigarettes influence their likeability and use among current smokers who try using e-cigarettes. Participants will receive an e-cigarette to sample over a three week period. During this time period they will complete daily electronic diaries and weekly lab visits. The results from this information will help understand how different types of e-cigarettes are likely to influence cigarette and e-cigarette use.


Eligibility criteria: Inclusion criteria include

* adults who have been smoking daily
* interested in using e-cigarettes
* who have a smartphone that can receive text messages and access to the internet or has an e-mail account that they check daily

Exclusion criteria include

* minimal prior e-cigarette use
* use of tobacco products other than cigarettes
* current use of cessation medications
* pregnant, trying to become pregnant, or breastfeeding,
* recent history of cardiovascular distress in the last three months (e.g., arrhythmia, heart attack, stroke, uncontrolled hypertension),
* household member currently enrolled in the study.

Primary outcomes:
measure: Mean Cigarettes Per Day
timeFrame: Week 3
Secondary outcomes:
measure: Average Number of E-cigarette Puffing Episodes
timeFrame: Week 3
measure: Number of Choices to Smoke Cigarette in Lab Setting
timeFrame: Week 3
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Tracy Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05149872: The Breath-2 Trial
Official title: Recovery of Carotid Body Function After Full Recovery Neuromuscular Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Chemosensitivity
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a randomized, cross over, experimental trial in which carotid body function will be evaluated in 35 healthy subjects during partial muscle relaxation and after recovery from muscle relaxation


Eligibility criteria: Inclusion Criteria:

\* age \> 18 years

Exclusion Criteria:

* BMI index \> 30 kg/m2
* Known or suspected neuromuscular disorders impairing neuromuscular function;
* Allergies to muscle relaxants, anesthetics or narcotics;
* A (family) history of malignant hyperthermia or any other muscle disease;
* Any neurological or psychiatric illness (including a history of anxiety).
* ASA class 3 or higher
* Gastro-oesophageal regurgitation

Primary outcomes:
measure: Carotid body function after full recovery of neuromuscular block
timeFrame: 40 minutes after full recovery of neuromuscular block
Secondary outcomes:
measure: Carotid body function at symptomatic neuromuscular block
timeFrame: 5 minutes after stable partial neuromuscular block
measure: Carotid body function at full recovery of NMB symptoms
timeFrame: 0 minutes after full recovery of neuromuscular block symptoms
measure: Carotid body function after full recovery of neuromuscular block
timeFrame: 20 minutes after full recovery of neuromuscular block symptoms
measure: Carotid body function after full recovery of neuromuscular block
timeFrame: 40 minutes after full recovery of neuromuscular block symptoms
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden Medical University
state: Zuid Holland
Study officials:
References:
Clinical trial NCT01970072: A Phase Ⅰa Study of Remimazolam Tosylate in Healthy Volunteers
Official title: A Placebo- and Midazolam-Controlled, Phase Ia, Single Ascending-Dose Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Remimazolam Tosylate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Remimazolam Tosylate
Phase Ⅰ study
Health
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-10-25
Enrollment: 79
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: The purpose of this study is to evaluate and compare the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate with midazolam in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy males or females
* Weight range 50 to 100 kg inclusive
* Body mass index (BMI) 18 to 26 kg/m2

Exclusion Criteria:

* Has a known sensitivity to benzodiazepines, flumazenil, or anesthetic agents, or a medical condition such that these agents are contraindicated
* With evidence of uncontrolled renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction, in the opinion of the investigator or medical monitor
* Has known or suspected history of alcoholism or drug abuse or misuse within 6 months of Screening or evidence of tolerance or physical dependence before dosing with study drug
* With a history of laboratory results that show the presence of hepatitis B surface antigen (HBs Ag), hepatitis C antibody (HCV Ab), or human immunodeficiency virus (HIV)
* Pregnant,lactating
* Mallampati score ≥3

Primary outcomes:
measure: To study the Pharmacokinetics of Remimazolam Tosylate by assessment of drug concentration through blood sample analysis
timeFrame: Pre-dose to 8 hours post-dosee
measure: Bispectral index (BIS) and Modified Observer's Assessment of Alertness/Sedation(MOAA/S) score assessments
timeFrame: Pre-dose to 2 hours post-dose
measure: Adverse event；Vital sign；Physical examination；Laboratory examination；ECG；The nervous system function test
timeFrame: Pre-dose to 24 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peiking Union Medical College Hospital
name: Bei Hu, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen X, Sang N, Song K, Zhong W, Wang H, Jiang J, Huang Y, Hu P. Psychomotor Recovery Following Remimazolam-induced Sedation and the Effectiveness of Flumazenil as an Antidote. Clin Ther. 2020 Apr;42(4):614-624. doi: 10.1016/j.clinthera.2020.02.006. Epub 2020 Mar 13.
citation: Zhou Y, Hu P, Huang Y, Nuoer S, Song K, Wang H, Wen J, Jiang J, Chen X. Population Pharmacokinetic/Pharmacodynamic Model-Guided Dosing Optimization of a Novel Sedative HR7056 in Chinese Healthy Subjects. Front Pharmacol. 2018 Nov 19;9:1316. doi: 10.3389/fphar.2018.01316. eCollection 2018.
Clinical trial NCT03606772: Gynecological Presentations Following Supracervical Hysterectomy
Official title: Gynecological Presentations and Pelvic Symptoms Following Supracervical Hysterectomy for Benign Pathologies: A Survey Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecological Survey
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 130
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: • Patients: 1280 patients with hysterectomy recruited at Tanta University Hospital, gynecology clinics in central hospitals in Gharbia governorate

Brief summary: Supracervical hysterectomy is widely common and had many complications either immediate or delayed. In these patients bleeding, infection, chronic pelvic pain are common. In these patients cervical biopsy will be done and histopathological examinations will be done to evaluate the pathology in these patients.

Detailed description: * Study design and settings: Cross sectional descriptive studies
* Patients: 130 patients with hysterectomy recruited at Tanta University Hospital, gynecology clinics in central hospitals in Gharbia governorate will be recruited according inclusion and exclusion criteria. Inclusion criteria include all symptomatizing patients following supracervical hysterectomy, of any age, of any complaints. The
* Methods: All patients' demographic data, history, indication of hysterectomy, duration since operation, postoperative complications and their main complaint.

Eligibility criteria: Inclusion Criteria:

* Hysterectomy for benign pathologies

Exclusion Criteria:

* Hysterectomy for malignancy

Primary outcomes:
measure: number of participant with gynecological symptoms following hysterectomy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ayman Shehata Dawood
state: Algharbia
Study officials:
affiliation: Lecturer at Tanta University
name: Ayman Dawood
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07024472: NIBP Cuff Comparison Study
Official title: NIBP Cuff Material Comparison Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Pressure
Blood Pressure Measurement
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: The purpose of the study is to compare NIBP cuff materials and their effect on the measurement results.

Detailed description: Non-invasive blood pressure measurement is based on the estimation of blood pressure by using cuffs. Because the accuracy in blood pressure measurement is essential to monitor patients, the reliability of non-invasive sphygmomanometers is required by internationally recognized standards. New NIBP standard ISO 81060-2 AMD2 highlights the impact of cuff materials and construction on NIBP clinical accuracy. This study is designed to gather evidence that different cuffs provide equally comparable NIBP measurement results

Eligibility criteria: Inclusion Criteria:

1. Age \>= 18 years to 65 years
2. Are able and willing to comply with the study procedures.
3. Are able and willing to provide written informed consent to participate.
4. A cuff of same size is applicable to both arms (difference between the limbs should be less than 2cm)
5. Blood pressure needs to be measurable from both arms.

Exclusion Criteria:

1. Are pregnant.
2. Are breastfeeding.
3. Have participated in the study. No subject may participate more than once.
4. Have an AV fistula.
5. Have acute infection.
6. Have subject reported arrythmias.
7. PI or designee decision due to subject health conditions

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: From admission to discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Metropolia University of Applied Sciencies
city: Helsinki
country: Finland
facility: Metropolia University of Applied Sciencies
city: Helsinki
country: Finland
facility: Metropolia University of Applied Sciencies
Study officials:
References:
Clinical trial NCT02145572: Metabolomic Profiling in Adolescents With Obesity and Diabetes
Official title: Metabolomic Profiling in Adolescents With Obesity and Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolomics
Obesity
Diabetes
Diabetic Nephropathies
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2014-05-23
Enrollment: 90
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from clinical practices affiliated with Rady Children's Hospital.

Brief summary: The purpose of this study is to identify unique metabolite signatures associated with the development of Type 2 diabetes and diabetic kidney disease in children.

We have a sub-study, with the purpose to validate the presence of a genetic marker (DENND1A) in the urine of adolescent females with polycystic ovarian syndrome.


Eligibility criteria: Inclusion Criteria:

* Age of 13-19 years
* Gender: male and female
* Ethnic background: any
* Obesity will be defined as BMI \>95th percentile for age/gender
* Diagnosis of diabetes will be defined by current American Diabetes Association criteria
* Diabetes duration \< 2.5 years
* Absence of pancreatic autoimmunity (GAD65 and ICA512 and Insulin autoantibody)
* Adult caregiver willing to actively support study participation
* Signed parental informed consent form and adolescent assent form
* For PCOS substudy, the diagnosis of PCOS will be defined according to the 1990 US National Institute of Health (NIH) criteria (oligomenorrhea, clinical or biochemical signs of hyperandrogenism, and exclusion of other known disorders)

Exclusion Criteria:

* Creatinine clearance \<60 mL/min (calculated from estimated GFR)
* Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the investigator, would prevent participation.
* For PCOS substudy, use of medications that effect androgen levels in the blood (i.e. oral contraceptive pills, or metformin) for the last 3 months prior to enrollment

Primary outcomes:
measure: Differences in metabolite concentrations measured by mass spectrometry, comparing blood and urine samples from obese adolescents with type 2 diabetes, obese adolescents without diabetes, and age-matched healthy non-obese controls.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
measure: Validation of presence of DENND1A isoform in the urine of adolescent females with polycystic ovarian syndrome
timeFrame: 2 years
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
Study officials:
affiliation: University of California, San Diego
name: Jane J Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02582372: Subarachnoidal Anesthesia: Dexmedetomidine vs Fentanyl Plus Hyperbaric Bupivacaine for Lower Abdomen Surgery
Official title: Subarachnoidal Anesthesia: Dexmedetomidine vs Fentanyl Plus Hyperbaric Bupivacaine for Lower Abdomen Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dexmedetomidine in Subarachnoidal Anesthesia
Lead sponsor: Hospital Central Dr. Luis Ortega
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 50
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: TREATMENT

Brief summary: Dexmedetomidine, highly selective agonist for alpha-2 receptors, enhances the sensory and motor block with prolonged postoperative analgesia without hemodynamic compromise.

OBJECTIVE: To evaluate effects of dexmedetomidine vs fentanyl with hyperbaric bupivacaine spinal anesthesia for lower abdominal surgeries.

METHODS: double-blind, randomized, American Society Anesthesiologist classification (ASA) : I - II, 18-65 years. F group (23 patients) received 25 mcg fentanyl, Group D (27 patients), 10 mcg dexmedetomidine with 12.5 mg hyperbaric bupivacaine . 0,02mgrs morphine / kg intravenously if EVA≥4was administered in postoperative period. Hemodynamic variables and O2 saturation intraoperatively was recorded, EVA every 4 hours, side effects, sensory block, motor, sedation and peripheral neurological manifestations of toxicity.


Eligibility criteria: Inclusion Criteria:

* ASA I and II
* lower abdominal surgery

Exclusion Criteria:

* Consumption antagonists adrenergic or channel blockers Ca ++
* Patients with arrhythmias or heart block
* Allergic to any drugs under study
* Obese
* Physical or mental incapacity to understand and use the pain scale
* Contraindication for anesthesia conductive
* Realization difficulty or complication during anesthesia and / or surgery

Primary outcomes:
measure: Changes of baseline blood pressure
timeFrame: during anesthesia and 1 hour of postoperatory
measure: Changes of baseline cardiac rate
timeFrame: during anesthesia and 1 hour of postoperatory
measure: Changes of baseline oxygen saturation
timeFrame: during anesthesia and 1 hour of postoperatory
measure: Postoperatory pain visual analogue scale
timeFrame: during first 24 hours of postoperatory
measure: Changes of motor block using Bromage scale
timeFrame: during anesthesia and 1 hour of postoperatory
Secondary outcomes:
measure: Numbers of patients with hypotension using non invasive blood presure monitor
timeFrame: during anesthesia and first 24 hours of postoperatory
measure: Numbers of patients with excessive sedation using Ramsay scale
timeFrame: during anesthesia and first 24 hours of postoperatory
measure: Numbers of patients with nauseas
timeFrame: during anesthesia and first 24 hours of postoperatory
Other outcomes:
measure: Numbers of patients with signs of peripheral neurological toxicity using questionnaire
timeFrame: during first seven days of postoperatory time
Locations:
Study officials:
References:
Clinical trial NCT00372372: The Efficacy of Risedronate in Prevention of Bone Loss in Patients Receiving High Dose Corticosteroid Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Keywords: corticosteroids, bone mineral, risedronate, bisphosphonate
Lead sponsor: Tuen Mun Hospital
Sponsor class: OTHER_GOV
First posted: 2006-09-06
Enrollment: 120
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: The efficacy of risedronate in prevention of bone loss in patients receiving high dose corticosteroid treatment

Detailed description: We compare the effect of risedronate with placebo in bone mineral density changes in patients receiving high dose corticosteroids for their underlying diseases

Eligibility criteria: Inclusion Criteria:

1. Patients with various medical conditions who require high dose glucocorticoid treatment: (1) pulse methylprednisolone; (2) oral prednisolone (\>=0.8mg/kg/day) or equivalent for at least 6 weeks.
2. Age\>=18 years and \<75 years.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Uncorrected hypocalcemia.
3. History of esophageal stricture.
4. Previous intolerance or hypersenstivity to biphosphonates.

Primary outcomes:
measure: bone mineral density
Secondary outcomes:
measure: Adverse events, new vertebral fractures
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Tuen Mun Hospital
Study officials:
affiliation: Tuen Mun Hospital Hong Kong
name: CC Mok, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References: