louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00541229: Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)
Official title: A Phase 1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover Clinical Trial of Sitagliptin 100 mg and Sitagliptin 200 mg in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 103
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Patient has Type 2 Diabetes
* Patient is between the ages of 30-65 years
* Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin \[A1C\] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%).

Exclusion Criteria:

* Patient has Type 1 Diabetes
* Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months
* Patient has taken insulin within the past 3 months

Primary outcomes:
measure: 24-hour Weighted Mean Glucose (WMG)
timeFrame: Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Alba M, Sheng D, Guan Y, Williams-Herman D, Larson P, Sachs JR, Thornberry N, Herman G, Kaufman KD, Goldstein BJ. Sitagliptin 100 mg daily effect on DPP-4 inhibition and compound-specific glycemic improvement. Curr Med Res Opin. 2009 Oct;25(10):2507-14. doi: 10.1185/03007990903209514.
Clinical trial NCT03819829: Blood Sampling of Healthy Volunteers for Immunological Research
Official title: Blood Sampling of Healthy Volunteers for Immunological Research
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 36
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This protocol will be used to collect crucial components of the immune system from healthy volunteers for the characterization of immune cells in fresh blood. A pipeline has been set up for comprehensive immune phenotyping of both lymphoid and myeloid cells within 24 hours after blood withdrawal.

Detailed description: In order to properly compare the immunobiology of healthy volunteers to (advanced) cancer patients, the investigators use age-matched controls with no history of cancer and no potentially interfering medication.

Healthy volunteers will be asked to donate 5 tubes of blood

Eligibility criteria: Inclusion Criteria:

* Age above 35 years
* Written informed consent
* No history of cancer
* No use of systemic immunosuppressive medication (eg. corticosteroids). Local use of corticosteroids (eg. topical or inhalation) is allowed.

Exclusion Criteria:

* Fever 14 days before blood withdrawal
* Donated blood for the same program within the last 2 years
* Pregnancy

Primary outcomes:
measure: The number of immune cells, both lymphoid and myeloid, present in the blood of healthy individuals, assessed by flow cytometry, as well as cytokine expression and transcriptome profiles of these cells
timeFrame: assessed up to 12 months
Secondary outcomes:
measure: Immunophenotyping of both myeloid and lymphoid cells in healthy individuals
timeFrame: assessed up to 12 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: NKI-AVL
Study officials:
affiliation: NKI-AvL
name: M Kok, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03961529: Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis
Official title: A Multicenter, Open-label, Uncontrolled, Long-term Trialto Demonstrate the Safety and Efficacy of 1% OPA-15406 Ointment in Adult Patients With Atopic Dermatitis and of 0.3% and 1% OPA-15406 Ointments in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-23
Enrollment: 366
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.


Eligibility criteria: Inclusion Criteria:

* Age: At least 2 years (at time of obtaining informed consent)
* Diagnosis of AD based on the Japanese Dermatological Association's criteria
* Atopic dermatitis affecting ≥5% of body surface area (BSA, excluding scalp) at the screening and baseline examinations

Exclusion Criteria:

- Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination

Primary outcomes:
measure: Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Treatment period (52 weeks)
Secondary outcomes:
measure: Responder Rate of Investigator's Global Assessment (IGA)
timeFrame: Week 52
measure: Responder Rate of Eczema Area and Severity Index 75 (EASI 75)
timeFrame: Week 52
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Shirao clinic of pediatrics and pediatric allergy
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Osamu Sato
role: STUDY_DIRECTOR
References:
citation: Saeki H, Imamura T, Yokota D, Tsubouchi H. Difamilast Ointment in Japanese Adult and Pediatric Patients with Atopic Dermatitis: A Phase III, Long-Term, Open-Label Study. Dermatol Ther (Heidelb). 2022 Jul;12(7):1589-1601. doi: 10.1007/s13555-022-00751-9. Epub 2022 Jun 18.
Clinical trial NCT02617329: Extracorporeal Therapy on Shoulder and Neck Pain
Official title: Effects of Extracorporeal Shock Wave Therapy on Shoulder and Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Disorders
Keywords: Extracorporeal shock wave therapy (ESWT), Neck Pain
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this research was to investigate the clinical effects on the ESWT treatment of shoulder and neck pain.

Detailed description: Extracorporeal shock wave therapy (ESWT) has been used to treat various musculoskeletal disorders. The beneficial effects of the ESWT included pain alleviation and improvement in local blood circulation. However, few study exploring the effects of the ESWT for subjects with shoulder and neck pain.

Eligibility criteria: Inclusion Criteria:

* Non-specific shoulder and neck pain
* Ages between 20yr to 45yr
* Shoulder and neck syndrome of upper trapezius and levator scapulae more than 3 months
* No using medicine such as anodyne and muscle relaxants.

Exclusion Criteria:

-

Primary outcomes:
measure: The change of visual analogue scale (VAS)
timeFrame: Baseline, week 3
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
affiliation: Department of Sports Medicine, College of Medicine, Kaohsiung Medical University
name: Lan Y Guo, Ph.D
role: STUDY_CHAIR
References:
citation: Cote P, Cassidy JD, Carroll L. The Saskatchewan Health and Back Pain Survey. The prevalence of neck pain and related disability in Saskatchewan adults. Spine (Phila Pa 1976) 23 (15): 1689-1698, 1998 Cagnie B, Danneels L, Van Tiggelen D, De Loose V, Cambier D Individual and work related risk factors for neck pain among office workers: a cross sectional study. Eur Spine J 16(5): 679-686, 2007 Lee HY, Yeh WY, Chen CW, Wang JD. psychosocial risk factors of upper extremity musculoskeletal pain in industries of Taiwan: a nationwide study. J Occup Health, 47(4): 311-318, 2005. Sjölander P, Michaelson P, Jaric S Djupsjöbacka M. Sensorimotor disturbances in chronic neck pain--range of motion, peak velocity, smoothness of movement, and repositioning acuity. Man Ther 13(2): 122-131, 2008.
Clinical trial NCT01257529: An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following A Low, Medium, And High-Fat Evening Meal As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers
Official title: An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Evaluate The Effects Of A Low, Medium And High Fat Evening Meal On The Pharmacokinetics Of Pregabalin Controlled Release Formulation As Compared To The Immediate Release Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pregabalin
pharmacokinetics
bioavailability
bioequivalence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-09
Enrollment: 28
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 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet following either a low, medium, or high-fat evening meal as compared to a single dose of the pregabalin immediate release capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet following a low, medium, or high fat evening meal as compared to a single dose of the pregabalin immediate release capsule.

Detailed description: Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule

Eligibility criteria: Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Primary outcomes:
measure: Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments
timeFrame: 3 days
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Chew ML, Plotka A, Alvey CW, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):617-26. doi: 10.1007/s40261-014-0211-4.
Clinical trial NCT02255929: Gamma Knife Radiosurgery for Treatment of Essential Tremor
Official title: Gamma Knife Thalamotomy for Treatment of Essential Tremor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Essential Tremor
Keywords: Benign Essential Tremor
Tremor
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine effects (good and bad) of gamma knife radiosurgery for essential tremor. The gamma knife places a small lesion in the brain to suppress tremors.

Detailed description: This research is being done because although multiple studies evaluating gamma knife for essential tremor show good results, few studies evaluating patients prospectively have been done. Prior studies have looked at patient outcomes following treatment - also known as retrospective studies. In this study, data collection will initiate before treatment, to obtain consistent baseline evaluations from all study participants undergoing the gamma knife treatment and at specific intervals following treatment.

Eligibility criteria: Inclusion Criteria:

* Men and women age 18 years or older
* Diagnosis of essential tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon
* Tremor following prior first line therapy with either propranolol or primidone
* Must be able to undergo MRI of brain and CT of head for treatment planning
* Postural or intention tremor severity score of greater than or equal to 2 in one hand/arm as measured by the CRST rating scale

Exclusion Criteria:

* Prior ipsilateral stereotactic radiosurgical ablation of the thalamus, ipsilateral deep brain stimulation, radiofrequency ablation of a ipsilateral thalamic target, or ultrasound ablation of an ipsilateral thalamic target
* Prior whole brain radiation therapy
* Pregnancy

Primary outcomes:
measure: Change in Effectiveness based on Clinical Rating Scale for Tumor (CRST-Part B) questionnaires.
timeFrame: Baseline, 6, 12, 24, and 36 Months Post Treatment
Secondary outcomes:
measure: Safety Based on the Number of Incidences and Severity of Adverse Events Related with Gamma Knife Thalamotomy
timeFrame: Baseline, 6, 12, 24, and 36 Months Post Treatment
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Swedish Medical Center Radiosurgery Center
state: Washington
Study officials:
affiliation: Swedish Medical Center Radiosurgery Center
name: Christopher Loiselle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03701529: Effect of Anesthetic Agents on Optic Nerve Sheath Diameter
Official title: Effect of Anesthetic Agents (Propofol, Sevoflurane) on Optic Nerve Sheath Diameter(ONSD) in Patients Undergoing Robot-assisted Laparoscopic Gynecology Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterus Myoma
Uterine Cancer
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2018-10-10
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study is to evaluate the effect of anesthetic agents ( propofol , sevoflurane) on intracranial pressure of female patients undergoing laparoscopic-robotic surgery.

Detailed description: Anesthetic agents (propofol and sevoflurane)have different effect on intracranial pressure. Sevoflurane when used over 0.5 minimum alveolar concentration, dilates intracranial vasculature and increases intracranial pressure. On the other hand, propofol decreases intracranial blood pressure and intracranial pressure is maintained or decreases.

Optic nerve sheath diameter is a feasible diagnostic tool in evaluating intracranial pressure. Female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy are evaluated.

Eligibility criteria: Inclusion Criteria:

* female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy

Exclusion Criteria:

* history of brain hemorrhage or brain infarction
* liver disease or end stage renal disease
* glaucoma or any signs of increased intraocular pressure
* combined wtih other types of operation
* patient refusal
* weight less than 40 kg or over 100 kg

Primary outcomes:
measure: difference of optic nerve sheath diameter
timeFrame: During the operation.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangnam Sungshim Hospital
Study officials:
affiliation: Kangnam Sungshim Hospital
name: Choi Eun-Mi, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT04363229: Psychological Impact of COVID19 Among Doctors in Assiut University Hospitals
Official title: Psychological Impact of COVID19 Among Doctors in Assiut University Hospitals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Occupational Stress
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 250
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Doctors currently working in Assiut University Hospitals in all titles: resident doctors, assistant lecturer, lecturer, assistant professor and professor

Brief summary: study aimed to investigate the psychological impact of corona virus among doctor in Assiut University Hospitals, mainly stress and burn out will be assessed

Detailed description: Prolonged exposure to stressful working environments resulting in a state of physical and emotional depletion and burnout. Nowadays, while facing corona virus, health care workers are on the front line and directly assist in diagnosis, caring and treatment of patients with COVID, thus keeping them at higher risk developing psychological distress and other mental health symptoms.

According to previous studies, during the outbreaks of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), frontline medical staff had reported high levels of stress that resulted in posttraumatic stress disorder (PTSD)

A lot of factors contribute to increase mental effect among healthcare workers as increasing the suspected cases and workload , depletion of personal protective equipment's , drug shortage and feeling inadequately supported .

In Toronto study(2008), four major risk factors for stress among medical staff during the SARS outbreak were identified; including the perception of the medical of their risk of infection, the impact of SARS on their work, feelings of depression, and working in high-risk medical units. moreover, there are other factors as social stigmatization and contact with infected patients, also has previously been shown to be associated with increased levels of stress and anxiety in medical staff .

Eligibility criteria: Inclusion Criteria:

* all doctors currently working in assiut University hospitals

Exclusion Criteria:

* no exclusion critiria

Primary outcomes:
measure: The MBI-HSS (MP) addresses three scales:Emotional Exhaustion ,Depersonalization and Personal Accomplishment
timeFrame: baseline
Secondary outcomes:
measure: GHQ-12 questionnaire for measuring of current mental health
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00818129: Study to Investigate Safety, Tolerability and PK Following Single and Multiple Ascending Doses of AZD7295 in Japanese
Official title: A Phase I, Randomized, Double-Blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7295 Following Single and Multiple Ascending Oral Dose Administration in Healthy Male Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Phase I
Japan
Japanese
oral solution
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-01-07
Enrollment: 62
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
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 investigate the safety and tolerability of single and multiple oral doses of AZD7295 in healthy male Japanese subjects. This will be done by comparing the effect of AZD7295 to placebo. The study will aslo investigate the absorption, distribution and disappearance of AZD7295 in the body.


Eligibility criteria: Inclusion Criteria:

* Provision of signed, written and dated informed consent
* Healthy male Japanese volunteers aged 20-55 years
* BMI between 18 and 27 kg/m2
* Have negative screens for HIV, hepatitis B and C viruses and syphilis

Exclusion Criteria:

* Use of prescribed medication within 2 weeks prior to the dose of study medication
* Participation in another study that included drug treatment within 16 weeks before the start of the present study.
* History or presence of gastrointestinal, hepatic or renal disease or a condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
* History of severe food or drug allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged relevant by the investigator.

Primary outcomes:
measure: AE, safety laboratory test (haematology, clinical chemistry, urinalysis), 12-lead ECG, BP, pulse rate, body temperature
timeFrame: During the study
Secondary outcomes:
measure: Pharmacokinetics (Cmax, tmax, AUC, AUC0-t, CL/F, Vss/F, t1/2 , Cmin, Rac, etc)
timeFrame: Frequent sampling until 72 hours after single administration in Single Dose Part and until 72 hours after last administration (6 days administration) in Multiple Dose Part
Other outcomes:
Locations:
city: Fukuoka-City
country: Japan
facility: Research Site
state: Fukuoka
Study officials:
affiliation: Kyushu Clinical Pharmacolgy Reasearch Clinic
name: Masatoshi Tsukamoto, MD
role: PRINCIPAL_INVESTIGATOR
References: