louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01537172: A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of ONO-4053 in Healthy Volunteers
Official title: A Phase 1, Single Centre, Three-part, Randomised, Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Single and Multiple Ascending Doses of Oral ONO-4053 and the Effects of Food in Healthy Males and Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Keywords: ONO-4053 healthy subjects
3 part adaptive design
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2012-02-23
Enrollment: 80
Sex: ALL
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: The primary objective of this study is to evaluate the safety and tolerability of ONO-4053 across ascending single and multiple doses in healthy adult male and female subjects.

The secondary objective of the study is to characterize the pharmacokinetic profile of ONO-4053 in healthy adult male and female subjects.

Detailed description: Ono Pharma UK Ltd is the European subsidiary of Ono Pharmaceutical Co. Ltd. As the European Legal Representative of Ono Pharmaceutical Co. Ltd, Ono Pharma UK Ltd is carrying out this study.

This is a clinical study of ONO-4053 in healthy volunteers. This study consists of three parts. Part A will investigate the safety, tolerability and pharmacokinetics when single ascending doses of ONO-4053 are administered in a double-blind manner. Part B will investigate the pharmacokinetics of ONO-4053 in the fed and fasted state in an open-label manner. Part C will investigate the safety, tolerability and pharmacokinetics when multiple ascending doses of ONO-4053 are administered in a double-blind manner. Doses for Part B and C will be determined after data from Part A are available.

Eligibility criteria: Inclusion Criteria:

* Healthy caucasian subjects aged 18-45 years inclusive.
* Subjects with a body mass index of 19-30 kg/m2 inclusive and who weigh at least 50 kg and no more than 100 kg at screening.

Exclusion Criteria:

* Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder.
* Current smokers or those that have smoked or used nicotine products within 6 months of the Screening visit.

Primary outcomes:
measure: Safety and tolerability of ONO-4053 across ascending single and multiple doses using adverse events, vital signs, 12-lead ECG, continuous ECG monitoring and clinical lab tests.
timeFrame: Day 17
Secondary outcomes:
measure: Plasma and urine concentrations of ONO-4053 and derived pharmacokinetic parameters
timeFrame: Day 17
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research Ltd
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Clinical Department
role: STUDY_DIRECTOR
References:
Clinical trial NCT04827472: Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics After Intravenous DWJ1521 Administration in Healthy Adult Volunteers
Official title: A Randomized, Double Blind, Placebo-controlled, Single Dose, Dose-escalation Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics After Intravenous DWJ1521 Administration in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The safety/tolerability and pharmacokinetic properties of DWJ1521 are evaluated after single intravenous administration of DWJ1521 in healthy adults.

The safety/tolerability and pharmacokinetic properties of DWJ1521 single intravenous administration and DWP14012 single oral administration in healthy adults are compared.


Eligibility criteria: Inclusion Criteria:

1. Healthy adults aged 19 to 50 years old at the time of screening test
2. Those who weigh 55.0 kg or more and 90.0 kg or less at the time of the screening test and have a body mass index (BMI) of 18.0 or more and 28.0 or less ☞ BMI(kg/m2) = weight(kg) / {height(m)}2

Exclusion Criteria:

1. Clinically significant, liver, kidney, nervous system, immune system, respiratory system, endocrine system, etc., or blood or tumor disease, cardiovascular disease, mental disease (mood disorder, obsessive-compulsive disorder, etc.) or have a history of character
2. Those with a history of gastrointestinal diseases (gastrointestinal ulcers, gastritis, gastric cramps, gastroesophageal reflux disease, Crohn's disease, etc.) that may affect the safety and pharmacokinetics evaluation of investigational drugs, and those with a history of gastrointestinal surgery (However, simple appendic surgery and hernia surgery are excluded)
3. Those who were tested positive for Helicobacter pylori
4. serologic test results (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test) positive
5. Those whose blood AST and ALT exceeds 1.5 times the upper limit of the normal range in screening tests including additional tests.

Primary outcomes:
measure: 24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%)
timeFrame: [Time Frame: [Time Frame: 0 - 72 hours after dosing]]
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06405672: The Effect of Endotracheal Tube With Stylet in Morbidly Obese Patients
Official title: Comparison of Using an Endotracheal Tube With Stylet Versus an Endotracheal Tube Alone in Morbidly Obese Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intubation; Difficult or Failed
Obesity, Morbid
Keywords: different intubation techniques
endotracheal tube
obesity
stylet
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators aimed to compare the effects of using enotracheal tube with stylet versus endotracheal tube alone in morbidly obese patients undergoing sleeve gastrectomy.

Detailed description: Different intubation techniques have been used in morbidly obese patients undergoing general anesthesia. No study comparing the use of endotracheal tube with or without stylet was found in literature. Thus, the investigators aimed to compare the effects of using enotracheal tube with stylet versus endotracheal tube alone in morbidly obese patients undergoing sleeve gastrectomy.

Eligibility criteria: Inclusion Criteria:

Body mass index over 30 ASA physical status I-III Undergoing laparoscopic sleeve gastrectomy -

Exclusion Criteria:

Body mass index under 30 ASA physical status IV Unable to cooperate Refused to give writtten informed consent-

Primary outcomes:
measure: Intubation time
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Intubation success
timeFrame: through study completion, an average of 6 months
measure: complications
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Antalya TRH
name: Kerem İnanoğlu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaszynski T, Pietrzyk M, Szewczyk T, Gaszynska E. A comparison of performance of endotracheal intubation using the Levitan FPS optical stylet or Lary-Flex videolaryngoscope in morbidly obese patients. ScientificWorldJournal. 2014;2014:207591. doi: 10.1155/2014/207591. Epub 2014 May 20.
citation: Nicholson A, Smith AF, Lewis SR, Cook TM. Tracheal intubation with a flexible intubation scope versus other intubation techniques for obese patients requiring general anaesthesia. Cochrane Database Syst Rev. 2014 Jan 17;2014(1):CD010320. doi: 10.1002/14651858.CD010320.pub2.
Clinical trial NCT04932772: Abdominal Muscles Recovery Response to Kinesiotaping in Women With Postnatal Diastasis
Official title: Abdominal Muscles Recovery Response to Kinesiotaping in Women With Postnatal Diastasis Recti: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diastasis Recti
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 24
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate abdominal muscle recovery in response to KT by using objective method for assessment as digital caliper, and waist circumference. KT technique will include rectus abdominis, internal and external oblique muscles among females after normal vaginal delivery.


Eligibility criteria: Inclusion Criteria:

1. Age will range from 25-35 years.
2. All women give birth by normal vaginal delivery.
3. Diastasis recti more than 2.5 cm at any point along linea alba.
4. Body mass index (BMI) less than 30 kg/m2.
5. After the end of Puerperium period i.e. after eight weeks postnatal.

Exclusion Criteria:

1. Women with skin over sensitivity to tape.
2. Women with abdominal skin diseases.
3. Abdominal hernia.
4. Previous cesarean section.
5. Multiple pregnancies more than 3 times.
6. Other abdominal or back operation.
7. Pregnancy related complications such as polyhydramnios, fetal macrostomia, diabetes, and hypertension.
8. Spinal disorders.
9. Lower limbs deformities.

Primary outcomes:
measure: Change from Abdominal Caliper at 8 weeks
timeFrame: Baseline and after 8 Weeks
Secondary outcomes:
measure: Change from Waist circumference at 8 weeks
timeFrame: Baseline and after 8 Weeks of training
measure: Change from Abdominal strength and endurance test one minute sit-up test at 8 weeks
timeFrame: Baseline and after 8 Weeks of training
measure: Change from The Oswestry Low Back Pain Disability Questionnaire at 8 weeks
timeFrame: Baseline and after 8 Weeks of training
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: October 6 University Hospital
state: Giza
Study officials:
affiliation: Cairo University
name: Dalia M Kamel, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01060072: Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
Official title: A Randomized, Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate, 0.5% Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammation
Pain
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-02-02
Enrollment: 407
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 study is being conducted to compare the safety and efficacy of loteprednol etabonate to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects who are at least 18 years of age.
* Subjects who are candidates for routine, uncomplicated cataract surgery.

Exclusion Criteria:

* Subjects who have known hypersensitivity or contraindication to the study drug or components.
* Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up.
* Subjects with elevated intraocular pressure (\>/=21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
* Subjects who are monocular or have pinholed Snellen visual acuity (VA) 20/200 or worse in the non-study eye.

Primary outcomes:
measure: Resolution of Anterior Chamber Cells.
timeFrame: Visit 5 (Postoperative day 8)
measure: Grade 0 Pain
timeFrame: Visit 5 (Postoperative day 8)
Secondary outcomes:
measure: Resolution of Anterior Chamber Cells
timeFrame: Visit 4-7 (postoperative day 3-18)
measure: Grade 0 Pain
timeFrame: Visits 4-7 (Postoperative days 3-18)
measure: Resolution of Anterior Chamber Flare
timeFrame: Visit 4-7 (postoperative day 3-18)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Laura Trusso
role: STUDY_DIRECTOR
References:
citation: Rajpal RK, Fong R, Comstock TL. Loteprednol etabonate ophthalmic gel 0.5% following cataract surgery: integrated analysis of two clinical studies. Adv Ther. 2013 Oct;30(10):907-23. doi: 10.1007/s12325-013-0059-7. Epub 2013 Oct 18.
Clinical trial NCT00209872: Optimal Multimodal Analgesia in Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Planned Abdominal Hysterectomy
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 60
Sex: FEMALE
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 test the current standard of care (SOC) treatment for abdominal hysterectomy with a group receiving SOC minus epidural analgesia plus additional perioperative analgesics in terms of postoperative abilities, postoperative nausea and vomiting (PONV), pain and discharge time from the PACU (post-anaesthesia care unit).

Detailed description: Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups, for patients admitted for planned abdominal hysterectomy with or without BSO:

* A: standard of care (SOC) receiving paracetamol, celecoxib, epidural analgesia, dexamethasone, ondansetron and droperidol, and general anaesthesia with propofol, remifentanil and cisatracurium
* B: SOC with sham epidural analgesia, preoperative gabapentin, intraoperative lidocaine, s-ketamine and sufentanil

Eligibility criteria: Inclusion Criteria:

* Planned abdominal hysterectomy with or without BSO
* Age above 18 years
* Written informed consent
* American Society of Anesthesiologists (ASA) class I-III

Exclusion Criteria:

* Planned vaginal or laparoscopic hysterectomy
* Hysterectomy as part of other surgery
* Allergy to part of the treatment regimen
* Previous reactions to opioids (nausea, cognition)
* Previous inability to place correct epidural catheter
* Severe state anxiety according to the OCAP or STAI
* ASA class IV
* Dependency on alcohol, opioids or central stimulants
* Chronic pain condition
* Hemorrhagic diathesis
* Participation in another study

Primary outcomes:
measure: Postoperative abilities over time
measure: Discharge time from PACU according to fixed criteria
measure: Consumption of analgesics and antiemetics in the PACU
Secondary outcomes:
measure: Degree of nursing requirements at the PACU
measure: General tolerability of the regimes
measure: Threshold for sensory perception and pain using the Pain Matcher device, pre- and postoperatively
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. of Anaesthesia, Hvidovre Hospital
state: Hvidovre
Study officials:
affiliation: Dept. of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark
name: Kenneth Jensen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark
name: Claus Lund, Dr. Med. Sci.
role: STUDY_CHAIR
References:
Clinical trial NCT01916772: Natural History of Cherubism Observational Study
Official title: Natural Hisotry of Cherubism Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cherubism
Keywords: cherubism
bone tumors
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will see patients with cherubism

Brief summary: To observe the natural history of cherubism.

Detailed description: The investigators will take a history and examine patients with cherubism to determine the natural history of the disease. The investigators also may take skin or blood samples (IRB approved 7256) from patients to learn more about this disorder.

Eligibility criteria: Inclusion Criteria:

patients with cherubism

Exclusion Criteria:

patients without cherubism

Primary outcomes:
measure: Disease progression
timeFrame: 10 years
Secondary outcomes:
measure: patient growth
timeFrame: 10 years
measure: bone abnormalities
timeFrame: 10 years
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Steven Lietman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lietman SA, Kalinchinko N, Deng X, Kohanski R, Levine MA. Identification of a novel mutation of SH3BP2 in cherubism and demonstration that SH3BP2 mutations lead to increased NFAT activation. Hum Mutat. 2006 Jul;27(7):717-8. doi: 10.1002/humu.9433.
citation: Fan C, Gaivin RJ, Marth TA, Willard B, Levine MA, Lietman SA. Cloning and characterization of the human SH3BP2 promoter. Biochem Biophys Res Commun. 2012 Aug 17;425(1):25-32. doi: 10.1016/j.bbrc.2012.07.043. Epub 2012 Jul 17.
citation: Reichenberger EJ, Levine MA, Olsen BR, Papadaki ME, Lietman SA. The role of SH3BP2 in the pathophysiology of cherubism. Orphanet J Rare Dis. 2012 May 24;7 Suppl 1(Suppl 1):S5. doi: 10.1186/1750-1172-7-S1-S5. Epub 2012 May 24.
Clinical trial NCT01426672: Monovision for the Treatment of Diplopia
Official title: Monovision for Treatment of Diplopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Strabismic Deviation
Keywords: Strabismic deviation less than 12 prism diopeters
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2011-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PURPOSE:

The purpose of this study is to quantitatively assess the efficacy of monovision correction in the treatment of acquired small angle binocular diplopia in adult patients.

METHOD:

Twenty patients with symptomatic diplopia were enrolled in a prospective treatment trial. All had stable deviations of 10 prism diopters or less for over three months. Each received monovision spectacles and/ or contact lenses with distance correction in the dominant eye. Half received a +3.00 diopter (D) add and the others received +2.50 D. The validated and standardized Diplopia Questionnaire and Amblyopia and Strabismus Questionnaire (ASQE) were used to quantify the efficacy of monovision correction for diplopia by measuring the functional impact on vision-specific quality of life.


Eligibility criteria: Inclusion Criteria:

* Strabismic Deviation less than 12 Prism Diopters

Exclusion Criteria:

* Inability to sign informed consent

Primary outcomes:
measure: Patients satisfaction with monovision was measured by standardized diplopia questionnaire and results reported in statistical terms on multiple measures tested on the questionnaire.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Edward Margolin, MD
state: Ontario
Study officials:
References:
Clinical trial NCT02501772: The Evaluation of Effect of Sanyinjiao (SP6) Acupressure on Early Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Nephropathy
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For diabetic patient with persisted albuminuria under the intensive control on blood pressure and blood glucose, the non-invasive method of acupressure at Sanyinjiao (SP6) is easy to use and significantly effect on albuminuria reduction in patients of diabetic nephropathy.


Eligibility criteria: Inclusion Criteria:

1. age between 20 and 80 years old;
2. HbA1c was lower than 9% according to the NGSP(National Glycohaemoglobin Standardisation Programme);
3. estimated glomerular filtration rate (eGFR) was more than 60 mL/min/1.73 m2.

Exclusion Criteria:

1. Hyperglycemic crisis, including HHS(hyperglycemic hyperosmolar syndrome) and DKA(diabetic ketoacidosis );
2. Persist diabetes poorly control, Hemoglobin A1c \[HbA1c\] \>9%;
3. Endocrine disorders: such as abnormal function of thyroid, pituitary, and sex glands;
4. heart diseases:such as arrhythmia, myocardial infarction, heart failure, or installed pacemaker;
5. immune and allergic diseases: such as systemic lupus erythematosus and asthma;
6. liver or kidney dysfunction: GOT or GPT(glutamate-pyruvate transaminase ) \> 80 IU/L, eGFR\<60 (mL/min);
7. pregnant or lactating women;
8. less than 6months postpartum;
9. acute illness, fever, Lower urinary tract infection, NSAID(nonsteroidal antiinflammatory drug) administration;
10. physical dysfunction because of stroke.

Primary outcomes:
measure: urinary spot albumin creatine excretion ratio (UACR) change
timeFrame: 8 week duratoin
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memerial Hospital
Study officials:
References: