louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05506007: A Clinical Trial to Compare the Safety, Tolerability, and PK Properties of DA-5216 and DA-5216-R and to Evaluate the Food Effect on DA-5216.
Official title: A Randomized, Open-label, Single Dose, Cross-over Clinical Trial to Compare the Safety, Tolerability, and Pharmacokinetic Properties of DA-5216 and DA-5216-R and to Evaluate the Food Effect on DA-5216 in Healthy Adult Subjects.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-18
Enrollment: 88
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, open-label, single dose, 2-part, cross-over clinical trial to compare the safety, tolerability, and pharmacokinetic properties of DA-5216 and DA-5216-R and to evaluate the food effect on DA-5216 in healthy adult subjects


Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteer 19 years to 50 years
* Body weight in the range of 50.0kg and body mass index in the range of 18 to 27kg/m2
* Subject who are negative in pregnancy test or pregnant or Lactating women
* The subjects personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate
* The subjects who are judged appropriate to participate this clinical trial according to the physical examination, routine laboratory examination and questionnaire

Exclusion Criteria:

* Subject with serious active hepatobiliary, respiratory, digestive, hematologic, endocrine(diabetes mellitus, aldosteronism), immunologic, cardiovascular(hypertension, angina, heart failure, myocardial infarction, etc.), neurologic, urologic, otorhinolaryngologic, musculoskeletal, psychological disease or history of such disease
* Subject with gastrointestinal disease (Crohn's disease, peptic ulcer, acute or chronic pancreatitis, etc.) or history of such disease/surgery (excluding simple appendic surgery, hernia surgery, hemorrhoid surgery).
* Subject who have galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption
* Subject who have had one or more of the following findings

  * AST, ALT \> 1.5 times the upper limit
  * CPK \> 2.5 times the upper limit
  * eGFR \<60mL/min/1.73m2

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) PK parameter
timeFrame: 0~48hours
measure: Area under the plasma concentration versus time curve (AUClast) PK parameter
timeFrame: 0~48hours
Secondary outcomes:
Other outcomes:
Locations:
city: Soeul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: SNUH Clinical Pharmacololgy and Therapeutics
name: Seung Hwan Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03532607: The Effect of Music Meditation Therapy in Patients With Chronic Pain Receiving Botox
Official title: The Impact of Music Meditation Therapy on Pain, Mood, and Stress When Botulium Toxin (Botox) Injection is Utilized: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Chronic
Lead sponsor: Rowan University
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot study is to examine the impact of music meditation therapy session on patients with chronic pain who are receiving Botox injections at a pain management center.

Detailed description: This study is a randomized controlled trial (RCT) that employs a two-arm parallel-group design. Ninety-eight participants scheduled to receive a Botox injection will be randomly assigned to receive individual music meditation therapy intervention group or standard care control group before the participant's Botox injection. The study team will use an embedded mixed methods study that uses both quantitative and qualitative data. Qualitative data play a supporting role and are embedded within a larger RCT. The qualitative data will help the investigators better understand the patients' experience of the interventions.

Eligibility criteria: Inclusion Criteria:

* Adult patients of both genders ages 18-60 who have been referred for Botox injection for treatment of chronic pain at the Rowan SOM NeuroMusculoskeletal Institute. These patients will have a prior diagnosis made by their physicians necessitating treatment with Botox injections.
* Patients who have previously received a Botox injection or patients receiving Botox injections for the first time can participate.

Exclusion Criteria:

* Patients who cannot speak or understand English for informed consent and patient teaching
* Patients with hearing impairment.
* Pregnant women, children and/or minors, cognitively impaired patients or the elderly (above 60 years of age).

Primary outcomes:
measure: Pain Visual Analogue Scale (VAS)
timeFrame: 3 minutes
Secondary outcomes:
measure: Stress Visual Analogue Scale (VAS)
timeFrame: 3 minutes
measure: Mood Visual Analogue Scale (VAS)
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Stratford
country: United States
facility: Rowan University SOM NeuroMusculoskeletal Institute
state: New Jersey
Study officials:
affiliation: Rowan University School of Osteopathic Medicine
name: Richard Jermyn, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02623907: China Valve Registry Study-1
Official title: Registry Study of Aortic Valve Diseases in Chinese Elderly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Disease
Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Valve Diseases
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aging more than 60 years diagnosed with severe AS or AR by echocardiography will be collected from multiple institutions.

Brief summary: With the aging of Chinese population, degenerative valvular disease is becoming more and more frequent, which has brought a heavy burden to our society. Taking aortic stenosis (AS) as an example, the incidence of AS in population over the age of 65 are about 2%, and in population above the age of 85 can be amounted to 4-8%, in the Western country. Since the invention of transcatheter aortic valve replacement (TAVR),aortic valve disease (AVD),including AS and aortic regurgitation (AR), has attracted more and more attention. To date, there are few data about the prevalence of AVD in China. The characteristics and prognosis of AVD in China are still unknown. Therefore, the investigators design a prospective, observational cohort study to investigate characteristics, treatments and prognosis of AVD in Chinese elderly population. The results of the study will provide a basis for the future national health policy for prevention and treatment of AVD in the elderly.


Eligibility criteria: Inclusion Criteria:

* Severe AS or AR indicated by echocardiography ;
* 60 years old or older.

Exclusion Criteria:

* Having both Severe AR and Severe AS;
* Having underwent surgical or transcatheter treatment for AVD;
* Non-degenerative AVD.

Primary outcomes:
measure: Cardiovascular (CV) death or hospitalization for heart failure (HF)
timeFrame: 36 months
measure: Surgical or transcatheter aortic valve replacement
timeFrame: 36 months
Secondary outcomes:
measure: Number of all-cause mortality
timeFrame: from date of enrollment until the date of death for any-cause, up to 36 months
measure: Number of patients developing major cardiovascular and cerebral events (MACCE)
timeFrame: 36 moths
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01674907: An Observational Study of Avastin (Bevacizumab) in First Line in Patients With Metastatic Colorectal Cancer (AVANiS)
Official title: Non-interventional Study of Avastin in 1st Line Metastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-29
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic colorectal cancer without prior chemotherapy in the metastatic setting

Brief summary: This observational study will evaluate the use in clinical practice and the efficacy of Avastin (bevacizumab) in patients with metastatic colorectal cancer who have not received prior chemotherapy treatment in the metastatic setting. Patients for whom the treating physician has decided to initiate therapy with Avastin will be followed for 10 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically confirmed metastatic colorectal cancer without prior chemotherapy in the metastatic setting

Exclusion Criteria:

* Contraindications for Avastin according to the locally approved package insert (version 7 April 2006)

Primary outcomes:
measure: Dosage/schedule of 1st-line Avastin
timeFrame: approximately 3 years
measure: Duration of treatment
timeFrame: approximately 3 years
measure: Chemotherapy regimens used in clinical practice
timeFrame: approximately 3 years
measure: Clinical/demographic patient characteristics at baseline
timeFrame: approximately 3 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: approximately 3 years
measure: Relationship between termination of Avastin treatment and time point of progression
timeFrame: approximately 3 years
Other outcomes:
Locations:
city: Cape Town
country: South Africa
city: George
country: South Africa
city: Port Elizabeth
country: South Africa
city: Pretoria
country: South Africa
city: Vereeniging
country: South Africa
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03609307: Comparison of Treatment Response to Intravitreal Injection of Combined Propranolol and Bevacizumab Versus Bevacizumab Monotherapy in Patients With Wet Age Related Macular Degeneration :A Clinical Trial
Official title: Comparison of Treatment Response to Intravitreal Injection of Combined Propranolol and Bevacizumab Versus Bevacizumab Monotherapy in Patients With Wet Age Related Macular Degeneration :A Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Age Related Macular Degeneration
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to compare the effect of combined intravitreal Bevacizumab and Propranolol injection versus Bevacizumab monotherapy in patients with Age Related Macular Degeneration.

Methods:

In this study patients with Age Related Macular Degeneration who are naïve or had history of previous treatment are included. The eligible patients in randomized in two groups "Bevacizumab" and "Bavacizumab + propranolol" and in injected intravitreally for 3 times monthly. In "Bevacizumab+propranolol" group patients receive two injections at each session Bavacizumab and propranolol. In "Bevacizumab" group patients receive only Bevacizumab. The patients are followed for 6 months and central macular thickness and visual acuity is measured at baseline and monthly for 6 month. Baseline ancillary exams include Fluorescein Angiography and OCT-Angiography which is performed at the final exam as well. Patients needing any therapeutic intervention is addressed during the 6 month follow up period.


Eligibility criteria: Inclusion Criteria:

* Patients with Wet AMD and Vision less than 20/40

Exclusion Criteria:

* History of cardiac ,renal, respiratory diseases (due to beta blocker toxicity),
* Associated with other Macular abnormalities such as Diabetic Retinopathy, Macular traction
* History of ocular inflammation
* Subretinal fibrosis
* History of Cataract surgey less than 6 months
* History of Glaucoma Surgery ,Vitreoretinal surgery
* Media opacity

Primary outcomes:
measure: Macular Thickness
timeFrame: 1 month
Secondary outcomes:
measure: Visual acuity
timeFrame: 1 month
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT05038007: Pain After Lung Cancer Surgery - Comparing Traditional Versus Prolonged Release Nerve Blockades
Official title: Pain After Thoracoscopic Lung Surgery - the Effect of Intercostal Nerve Blockades With Standard Bupivacaine and Liposomal Bupivacaine - a Randomised Controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Postoperative Pain
Lung Cancer
Video Assisted Thoracoscopic Surgery
Blockades Neuromuscular
Anesthesia, Local
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 50
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: To investigate the effect of liposomal bupivacaine compared with bupivacaine hydrochloride for intercostal blockades for patients undergoing Video-assisted thoracoscopic surgery.

Detailed description: Video-assisted thoracoscopic surgery (VATS) is a minimally invasive routine procedure. It's less invasive than thoracotomy but postoperative pain is still a problem.

At Aalborg University Hospital, intercostal blockades with bupivacaine is used as standard pain treatment for patients undergoing VATS. Adding adjuvants to the blockades may prolong the effect.

The aim of this study is to examine if intercostal nerve blockades with liposomal bupivacaine improves postoperative pain management compared to intercostal nerve blockades with bupivacaine hydrochloride.

Eligibility criteria: Inclusion Criteria:

* Adults independent of sex with an age of ≥ 18 years
* Patients undergoing VATS as a part of either examination or treatment of lung cancer

Exclusion Criteria:

* Patients who are unable to understand oral and written information.
* Patients with known chronic pain in the thorax which have been persisting for at least six months before the day of surgery.
* Pregnant and nursing women.
* Patients with hypersensitivity / allergy / Intolerance to dexamethasone or bupivacaine.
* Patients receiving a planned preoperative epidural blockade during their stay.
* Patients converted to open surgery.

Primary outcomes:
measure: Duration of analgesic effect
timeFrame: 48 hours
Secondary outcomes:
measure: Total equipotent opioid dose
timeFrame: 48 hours
measure: Numerical Rating Scale
timeFrame: 48 hours
measure: Mobilisation
timeFrame: 48 hours
measure: Opioids at discharge
timeFrame: Not fixed. On average 4 days and a maximum of 3 months.
measure: Patient-reported satisfaction of postoperative pain management assessed by self-made questionnaire in Danish
timeFrame: Measured twice. Once 48 hours after surgery and once at non fixed time(on average 4 days and a maximum of 3 months)
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Region Of Northern Jutland
Study officials:
affiliation: Aalborg University Hospital, department of Anaesthesiology
name: Jannie Bisgaard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00372307: Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris
Official title: Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitiligo Vulgaris
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2006-09-06
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with vitiligo vulgaris are treated with Pimecrolimus twice a day during 6 months. After a baseline visit, patient returns for a control visit after 3 and 6 months of treatment. One reference lesion is clinically evaluated with pictures.


Eligibility criteria: Inclusion Criteria:

* Active or stable vitiligo vulgaris
* lesions at head or neck + maximum 10% lesions at the rest of the body

Exclusion Criteria:

* Topica during last 2 weeks
* Photo(chemo)therapy during last 4 weeks
* Segmentary vitiligo

Primary outcomes:
measure: Repigmentation percentage of the reference lesion after 6 months.
Secondary outcomes:
measure: Number of patients with repigmentation after 3 and 6 months.
measure: Repigmentation percentage of the reference lesion after 3 months.
measure: Adverse events (month 3 and 6).
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Jean-Marie Naeyaert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boone B, Ongenae K, Van Geel N, Vernijns S, De Keyser S, Naeyaert JM. Topical pimecrolimus in the treatment of vitiligo. Eur J Dermatol. 2007 Jan-Feb;17(1):55-61. doi: 10.1684/ejd.2007.0093. Epub 2007 Feb 27.
Clinical trial NCT01789307: Lactose, Sucrose & Corn Syrup Tolerance
Official title: Lactose: A Unique Carbohydrate Enabling Homeostatic Regulation of Blood Glucose & Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of Study: Oral Tolerance Test With Glucose, Lactose, Sucrose
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 16
Sex: MALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Lactose, one of the key nutrients in human milk may be critically important to infants for more reasons than being a source of energy. We are interested in understanding how lactose when compared to other sugars influences how nutrients, specifically macronutrients are handled after digestion and absorption. To date, there have been no studies looking at how fat and protein varies when lactose compared to other sugars is ingested. There may be metabolic advantages to considering lactose for nutrition support of premature infants rather than glucose or dextrose as is often used in intravenous feeds, or the corn syrup solids in lactose-free formulas. We hope the information from this study will provide new information on the unique aspects of lactose.

Hypothesis: The hypothesis is that providing carbohydrate as lactose:

1. minimizes the amount of carbohydrate that is converted into fat
2. enables a relatively constant metabolic state throughout feeding interval that avoids swings of high to low insulin, glucose, and fats.


Eligibility criteria: Inclusion Criteria:

* male
* at least 19 years of age
* body mass index (BMI) between 18.5 and 25
* fasting blood glucose level \< 6.1 mmol/L (110 mg/dL) measured by glucometer on the day of the study and
* comfortable speaking, reading and understanding English
* comfortable drinking at least one cup (250 ml) of milk
* non-smoking

Exclusion Criteria:

* not willing to provide blood samples, have
* impaired lactose or glucose tolerance,
* pre-diabetes, diabetes mellitus and any other endocrine disorder,
* coronary heart disease, liver function test abnormalities or any chronic disease
* routinely take medications, including aspirin, cyclooxygenase-2 inhibitors, statins and fish oil
* consuming more than 1 alcoholic drink per day

Primary outcomes:
measure: Postprandial changes in plasma insulin, glucagon, triglycerides and amino acids.
timeFrame: 6 hours
Secondary outcomes:
measure: Postprandial changes in plasma fatty acids.
timeFrame: 6 hours
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Child & Family Research Institute
state: British Columbia
Study officials:
affiliation: University of British Columbia, Child & Family Research Institute
name: Sheila M Innis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04528407: BS-FU01 Follow-Up Study of FluBHPVE6E7 Study Subjects
Official title: Follow-up Study for Patients Having Received FluBHPVE6E7 in Clinical Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Safety Issues
HPV Infection
Lead sponsor: BlueSky Immunotherapies GmbH
Sponsor class: INDUSTRY
First posted: 2020-08-27
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who enrolled in previous phase 1 or 2 clinical studies of FluBHPVE6E7

Brief summary: This is a follow-up study for patients treated with FluBHPVE6E7 in previous interventional studies.

Detailed description: BS-FU01 is a follow-up study for patients treated with FluBHPVE6E7 in previous phase 1 and 2 interventional studies. The aim of the follow-up study is to assess the safety and immunogenicity of FluBHPVE6E7, changes in the HPV infection status, cervical cytology, and biodistribution after treatment with FluBHPVE6E7 in previous studies.

Eligibility criteria: Inclusion Criteria:

* Patient who enrolled in previous phase 1 or 2 clinical studies of FluBHPVE6E7
* Negative pregnancy test at baseline
* Written informed consent

Exclusion Criteria:

* Pregnancy, breastfeeding

Primary outcomes:
measure: Number of participants with adverse events (type, frequency, severity).
timeFrame: 1 year
Secondary outcomes:
measure: Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration
timeFrame: 1 year
measure: Induction of HPV-specific T-cell response following FluBHPVE6E7 administration
timeFrame: 1 year
measure: Induction of HPV-specific CD4+ and CD8+ T-cells following FluBHPVE6E7 administration
timeFrame: 1 year
measure: Local HPV clearance
timeFrame: 1 year
measure: Cervical cytology
timeFrame: 1 year
measure: Biodistribution: Detection of FluBHPVE6E7 in blood samples
timeFrame: 1 year
measure: Biodistribution: Detection of FluBHPVE6E7 in nasal secretions
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University of Vienna
Study officials:
References: