louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06862076: Impact of Lung Function Prehabilitation to Postoperative Pulmonary Complications
Official title: The Impact of Lung Function Prehabilitation to Postoperative Pulmonary Complications on Patient Undergoing Upper Abdominal Surgery Treated in Intensive Care Unit: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pulmonary Complications (PPCs)
Keywords: Prehabilitation
Postoperative pulmonary complications
Upper abdominal surgery
Intensive care unit
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the effect of lung function prehabilitation to postoperative pulmonary complications on patient undergoing upper abdominal surgery treated in intensive care unit.


Eligibility criteria: Inclusion Criteria:

* adults 18 years or older
* scheduled for the upper abdominal surgery under general anesthesia with intraoperative mechanical ventilation
* possess adequate cognitive function to comprehend and follow instructions
* possess sufficient physical capacity to perform structured prehabilitation exercises
* express willingness to participate in the intervention program before surgery

Exclusion Criteria:

* pregnancy
* pre-existing severe pulmonary diseases such as chronic obstructive pulmonary disease (COPD)
* planned laparoscopic procedures
* history of significant neuromuscular impairment (e.g: stroke)
* declined to participate

Primary outcomes:
measure: Postoperative pulmonary complications
timeFrame: Postoperative day 1 and 3
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSUPN dr. Cipto Mangunkusumo
state: Jakarta
Study officials:
References:
Clinical trial NCT00844376: Bioavailability Study for New Atorvastatin Formulation
Official title: An Open Label, Single Dose, Randomized 2-Way Crossover Study To Estimate The Relative Bioavailability Of Atorvastatin Commercial Tablet, And An Extemporaneous Preparation (EP) Suspension Formulation, In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Keywords: Cardiovascular Diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-02-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to estimate the relative bioavailability of the commercial tablet with one prototype extemporaneous preparation suspension formulation, to assist with internal decision making on formulation development.

Detailed description: Estimation of Relative Bioavailability

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects
* Body Mass Index (BMI) of approximately 18 to 30 kg/m2

Exclusion Criteria:

* Any condition possibly affecting drug absorption
* A positive urine drug screening

Primary outcomes:
measure: Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48)
timeFrame: 5 days
measure: Area Under the Curve From Predose (Time Zero) to Extrapolated Infinite Time (AUC Infinity)
timeFrame: 5 days
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 5 days
Secondary outcomes:
measure: Area Under the Curve From Predose (Time Zero) to Last Quantifiable Concentration (AUClast)
timeFrame: 5 days
measure: Terminal Phase Rate Constant (Kel)
timeFrame: 5 days
measure: Time to Reach Maximum Plasma Concentration (Tmax)
timeFrame: 5 days
measure: Plasma Elimination Half-life (t1/2)
timeFrame: 5 days
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 NCT01639404: Umbilical Cord Blood Therapy for Children With Cerebral Palsy
Official title: Allogeneic Umbilical Cord Blood Therapy for Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Umbilical Cord Blood
Rehabilitation
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 17
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of umbilical cord blood therapy for children with cerebral palsy.

Detailed description: Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.

Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in brain.

On the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.

Eligibility criteria: Inclusion Criteria:

* Cerebral Palsy with abnormal muscle tone
* Gross Motor Function Classification System (GMFCS): I, II, III, IV, V
* Willing to comply with all study procedure

Exclusion Criteria:

* Medical illnesses including pneumonia or renal function at enrollment
* Presence of known genetic disease
* Presence of drug hypersensitivity which is related to this study remedy
* Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
* Decision by the principal investigator when there are unexpected events that may affect the outcomes

Primary outcomes:
measure: Changes in Motor Performance
timeFrame: Baseline - 1 month - 3 months
measure: Changes in Standardized Gross Motor Function
timeFrame: Baseline - 1 month - 3 months
Secondary outcomes:
measure: Changes in Cognitive Neurodevelopmental Outcome
timeFrame: Baseline - 1 month - 3 months
measure: Changes in Motor Neurodevelopmental Outcome
timeFrame: Baseline - 1 month - 3 months
measure: Changes in Functional Independence in Daily Activities
timeFrame: Baseline - 1 month - 3 months
measure: Changes in Visual Perception Test
timeFrame: Baseline - 1 month - 3 months
measure: Changes in Muscle Strength
timeFrame: Baseline - 1 month - 3 months
measure: Changes in Functional Performance in Daily Activities
timeFrame: Baseline - 1 month - 3 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
Study officials:
affiliation: CHA University
name: MinYoung Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00919204: Axitinib Pharmacokinetics in Chinese Healthy Volunteers
Official title: An Open Label Phase 1 Study To Evaluate The Pharmacokinetics Of AG-013736 In Healthy Chinese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: AG-013736, axitinib, pharmacokinetics, healthy, Chinese
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: As part of the global clinical development program for AG-013736, studies are ongoing (and planned) in cancer patients in China. An assessment of AG-013736 pharmacokinetics in Chinese subjects, as required by the Chinese Health Authorities, is therefore warranted.

In the current study the single dose pharmacokinetics of AG-013736 will be characterized at 3 doses (5 mg, 7 mg and 10 mg).


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female (of nonchildbearing potential) Chinese (individuals currently residing in mainland China who were born in China and have both parents of Chinese descent) subjects between the ages of 18 and 45 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.)
* Body Mass Index (BMI) of 19 to 24 kg/m2; and a total body weight \>50 kg (110 lbs). A BMI lower limit of 18.5 kg/m2 may be rounded up to 19.0 kg/m2; a BMI upper limit of 24.5 kg/m2 may be rounded down to 24.0 kg/m2 and will be acceptable for inclusion.

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.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Drug dependency, a positive urine drug screen, or alcohol dependency.
* History of regular alcohol consumption exceeding 28 or more units per week. (One unit=285 mL of beer or 25 mL of spirits or 125 mL of wine).
* Use of tobacco- or nicotine-containing products (or a positive urine cotinine test).
* Treatment with an investigational drug within 3 months (or as determined by local regulations) or 5 half-lives preceding the first dose of study medication.

Primary outcomes:
measure: Plasma Pharmacokinetics of AG-013736 in Chinese Healthy Volunteers
timeFrame: 3 months
Secondary outcomes:
measure: Safety of AG-013736 in Chinese Healthy Volunteers
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijng
country: China
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05885204: RARC vs LRC in A Multicenter Cohort Study
Official title: Robot-Assisted Versus Conventional Laparoscopic Radical Cystectomy in A Multicenter Cohort Study: A Propensity Score Matching Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Keywords: Bladder cancer
Radical cystectomy
Robot-assisted laparoscopy
Conventional laparoscopy
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 3815
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent robot-assisted radical cystectomy or laparoscopic radical cystectomy for bladder cancer from 2012 to 2021 in 10 large tertiary hospitals

Brief summary: A multicenter, retrospective research was conducted. Patients who underwent robot-assisted radical cystectomy and laparoscopic radical cystectomy in 10 large medical centers in China were enrolled, comparing the oncologic outcomes of the patients.


Eligibility criteria: Inclusion Criteria:

* \>18 years old; Clinical stage Ta-T4a/N0-3/M0

Exclusion Criteria:

* Severe cardiovascular disease; History of previous major abdominopelvic surgery; Patients with distant metastases; Medical history of malignancy in other organs.

Primary outcomes:
measure: Overall Survival
timeFrame: Five years
measure: Recurrence-free Survival
timeFrame: Five years
measure: Cancer-specific Survival
timeFrame: Five years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05479604: Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure
Official title: Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Facial Pain
Keywords: Facial Pressure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 27
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 purpose of this study is to investigate if the SinuSonic device decreases facial pain and pressure compared to the placebo device.


Eligibility criteria: Inclusion Criteria:

* Participant must be \> 18 years of age inclusive, at the time of signing the informed consent.
* Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Facial pain or pressure for \> 3 months of symptom duration.
* Pain/pressure VAS (Visual Analogue Scale) Score of \> 5.

Exclusion Criteria:

* Upper respiratory illness within the last 2 weeks.
* History of severe epistaxis.
* Known pregnancy.
* Allergic sensitivity to silicone or any other component of device.
* Sinonasal surgery in the last 3 months.
* Topical decongestant use in the last week.
* Nasal polyposis, purulence/edema, or other signs of sinusitis on exam.
* Sinusitis on imaging.
* Nasal crusting or ulceration on exam.
* Inability to read or understand English.

Primary outcomes:
measure: Change in facial pain
timeFrame: Baseline, 8 weeks
measure: Change in Brief Pain Inventory Short Form
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Subjects reporting pain with device use
timeFrame: 8 weeks
measure: Subjects reporting epistaxis
timeFrame: 8 weeks
measure: Change in nasal obstruction symptoms
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Amar Miglani, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04197804: Impulse Control in Gilles de la Tourette Syndrome
Official title: Do Mirror Neurons Play a Role in Tourette Syndrome Physiopathology? A Pilot Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tourette Syndrome
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The calculated sample size is 20 subjects per arm considering:

1. error of I type with two queues = 0.05;
2. Type II error β = 0.20, which corresponds to a test power (1-β = 0.80) of 80%;
3. a clinically significant difference of 4%;

Brief summary: The study intends to evaluate the role of Mirror Neurons in the determination of gestures, words, and repetitive vocalizations in subjects affected by Tourette's syndrome and to verify if these subjects are faster to assemble sounds, in phonology and morphology, than the non-pathological population.


Eligibility criteria: Inclusion Criteria:

TOURETTE GROUP

* Consecutive patients belonging to the Tourette Center
* Caucasian
* Italian mother-tongue
* Age between 6 and 10 years completed
* Male and female 4: 1 (16 males and 4 females)
* Diagnosis of Tourette's syndrome for at least 1 year
* Presence of a value of YGTSS\> 50%

NOT GROUP TOURETTE

* Caucasian
* Italian mother-tongue
* Age between 6 and 10 years completed
* Male and female 4: 1 (16 males and 4 females)

Exclusion Criteria:

TOURETTE GROUP

* Diagnosis of DSA
* Presence of significant psychiatric disorders, with the exception of those belonging to the Tourette Syndrome itself (eg ADHD, OCD).

NOT GROUP TOURETTE

* Diagnosis of DSA
* Presence of significant psychiatric disorders

Primary outcomes:
measure: Tourette syndrome and the imitation of gestures
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCCS Istituto Ortopedico Galeazzi
name: Mauro Porta
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05055804: The ELG Analysis of Glucose a Correlational to Blood Glucose Assay
Official title: The ELG Analysis of Glucose a Correlational to Blood Glucose Assa
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Keywords: ELG
Diabetes
Lead sponsor: XP Technology, LLC
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical trials with a single arm
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is an investigational study of the ELG medical device to monitor glucose blood level in diabetes mellitus Type 1 and 2 without blood samples in comparison to blood testing methods."Investigational" means the ELG medical device is subjected by the FDA (Food and Drug Administration) for premarket testing requirements. The purpose of this study is to collect data comparison values between ELG testing device to current blood testing methods.


Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with type 1 or 2 diabetes
* Be 25 - 65 years of age
* Male or female
* Various ethnicities are desired
* Must be available for 2 visits within a 2-4 week period and willing to spend up to 1-2 hours/visit
* Must have daytime availability for visits
* Able to have 1 venous blood draw \& up to 4 fingersticks for complete blood testing at each visit
* Must be willing and able to fast (for at least 6 hours) prior to first visit

Exclusion Criteria:

* Taking drugs of abuse (illegal and/or prescription)
* Have been in another research study in the last 30 days
* Have had a blood transfusion or severe blood loss in the last 14 days
* Have Sickle Cell Anemia

Primary outcomes:
measure: Standard OTC Glucose, A1C & Laboratory Results in Comparison to ELG Device During Fasting Event
timeFrame: Visit will last for up to 1-2 hours. This outcome will measure overnight fasting results.
measure: Standard OTC Glucose, A1C & Laboratory Results in Comparison to ELG Device During Non-Fasting Event
timeFrame: This visit will be measured within a 4 week time frame, following the 1st visit. This visit will last for up to 1-2 hours. This outcome will measure non-fasting results.
Secondary outcomes:
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Rouse Family Medical Clinic
state: Arkansas
Study officials:
name: Dr. Joe P Rouse, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: XP Technology, LLC
name: Dr. Peter P Xaysanasy, DPM
role: STUDY_DIRECTOR
References:
Clinical trial NCT03693404: Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery
Official title: Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pertrochanteric Fracture
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 190
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: This is a phase I, randomized, single-blind, placebo-controlled, single-center study of the effects of surgical site injection on pain and narcotic utilization in participants who undergo surgery for lower extremity fractures. 200 participants with lower extremity fractures who are admitted for operative fixation will be included in the study. Participants will be randomized to receive either a pain cocktail injection around the fracture site and surrounding tissues or control (no injection). An analysis of pain scores, rehabilitation progress, length of stay, narcotic utilization, and satisfaction scores will be performed.


Eligibility criteria: Inclusion Criteria:

* Lower extremity fracture including femoral neck, intertrochanteric, sub-trochanteric, and femoral shaft fracture

Exclusion Criteria:

* Pregnant women
* Treatment with Arthroplasty
* Patients who receive a peripheral nerve block
* Patients who receive intra-op or post-op ketamine
* Patients with concomitant TBI or MR
* Polytrauma patients
* Pathologic Fractures
* Patients who live greater than 10 miles from NYU or who will not be followed by an NYU provider
* Patients with a contraindication to any of the medications on the study list due to other medical problems such as renal or liver disease or due to allergy/intolerance
* Patients with prior extremity weakness resulting from stroke or other neurological condition
* Prior or current history of narcotic use
* Patients with advanced dementia
* NYUMC Students, Residents, Faculty

Primary outcomes:
measure: Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used
timeFrame: Post-Operative Day 0
measure: Ambulation Distance
timeFrame: Post-operative Day 3
measure: Score on Visual Analogue Scale (VAS) for Pain
timeFrame: Hour 24
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Philipp Leucht, MD
role: PRINCIPAL_INVESTIGATOR
References: