louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05739851: Phamacokinetics and Safety Profiles of DA-1229_01 2.5/500mg in Healthy Subjects at Fasting State
Official title: An Open Label, Randomized, Single Dose, Cross-over ,Two-group Study to Evaluate the Pharmacokinetics and Safety of DA-1229_01 2.5/500mg in Healthy Subjects at Fasting State
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-22
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01(2.5/500 mg) at fasting state.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers
* BMI between 18 and 30 kg/m2
* Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria:

* Allergy or Drug hypersensitivity
* Clinically significant Medical History

Primary outcomes:
measure: AUCt
timeFrame: pre-dose~96 hours post-dose
measure: Cmax
timeFrame: pre-dose~96 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Metro Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT01405651: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects
Official title: A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Keywords: ONO-6950
Healthy adult subjects
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2011-07-29
Enrollment: 24
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 primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending multiple doses in healthy adult male and female subjects. The secondary objectives are to characterize the PK and pharmacodynamic (PD) profiles of ONO-6950 by measuring plasma concentrations of ONO-6950 and pulmonary function.


Eligibility criteria: Inclusion Criteria:

* Healthy non-smoking male or female subjects (18-55 inclusive)
* Body mass index (BMI)of 10-35 kg/m2 (inclusive)
* For females; postmenopausal, non-lactating, and non-pregnant

Exclusion Criteria:

* History or presence of clinical significant disease

Primary outcomes:
measure: Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests ECGs, laboratory tests and physical examinations
timeFrame: At protocol-specified timepoints before and after study drug administration up to 21 days
Secondary outcomes:
measure: Characterization of PK ( Cmax, Tmax, AUC, ty2, etc.) and PD profiles of ONO-6950 using plasma concentration of ONO-6950 in blood and pulmonary function tests
timeFrame: At protocol-specified timepoints before and after study drug administration up to 21 days
Other outcomes:
Locations:
city: Miramar
country: United States
facility: Miramar Clinical Site
state: Florida
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharma USA, Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03415451: Explore the Efficiency of Fiberscope-guided Nasogastric Tube Insertion
Official title: Explore the Efficiency of Fiberscope-guided Nasogastric Tube Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasogastric Tube Esophagitis
Keywords: cancer patients, Nutritional status
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: For Head and neck cancer and uncooperative patients, blind nasogastric tube (NGT) insertion may sometimes be very difficult because of the anatomical obstructions in the pharynx and uncoordinated swallowing motion. To solve the problem, flexible endoscope has been used widely to assist the NGT insertion via direct visual assistance, working channels/guide wires, or suture fixation. Unfortunately, these tools are not easily assessed in the outpatient department. Here, we try to use a simpler method for the flexible endoscope to guide the NGT insertion.

Detailed description: NGT and fiberscope was combined to facilitate NG tube insertion

Eligibility criteria: Inclusion criteria: dysphagia patients who need nasogastric tube feeding Exclusion criteria: Patients who ever had human immunodeficiency virus infection and were not suitable for fiberscope exam without protection sheath

Primary outcomes:
measure: The success rates of fiberscope-guided NG tube insertion
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital, Yun-Lin Branch
name: CHI-MAW LIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02938351: Collaborative Care Intervention for Chronic Kidney Disease
Official title: Collaborative Care Intervention for Kidney Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant
Depression
Pain
Keywords: Collaborative care intervention
kidney transplant
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patient and caregiver will receive an IPAD with Vidyo software to complete the treatment sessions
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aims of the present study will be to pilot test the efficacy of a collaborative care intervention in patients awaiting kidney transplant to reduce symptoms of depression, pain, fatigue and improve quality of life.

Detailed description: Symptom management is critical to maintain quality of life in those with life limiting conditions. Stepped collaborative care interventions have been widely employed in the primary care setting for the treatment of depression and more recently have been utilized to treat other symptoms (e.g., pain) in a variety of settings. A recent meta-analyses concluded that collaborative care interventions were superior to usual care and are more cost-effective than face to face and pharmacological treatment for depression. Collaborative care interventions have begun to be extended to other settings but have not been tested in patients who are being treated with dialysis. The aims of the present study were to pilot test the efficacy of a collaborative care intervention in patients awaiting kidney transplant to reduce symptoms of depression, pain, fatigue and improve quality of life.

Eligibility criteria: Inclusion Criteria:

Age 18 or older Currently receiving dialysis at UPMC dialysis facility for chronic kidney disease Fluent in English

Exclusion Criteria:

Under the age of 18 years or over 90 years Not fluent in English

Primary outcomes:
measure: Depression Level
timeFrame: change from baseline at 3 month and 6 month
measure: Perceived Stress level
timeFrame: change from baseline at 3 month and 6 month
measure: degree of Pain
timeFrame: change from baseline at 3 month and 6 month
Secondary outcomes:
measure: Dyadic functioning
timeFrame: change from baseline at 3 month and 6 month
measure: level of physical activity (mild, moderate or high)
timeFrame: change from baseline at 3 month and 6 month
measure: sleep quality
timeFrame: change from baseline at 3 month and 6 month
measure: quality of life
timeFrame: change from baseline at 3 month and 6 month
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Physicians
name: Jennifer Steel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02068651: A Community-based Advance Care Planning Programme for Patients With Advanced Disease
Official title: A Community-based Advance Care Planning Programme to Improve End-of-life Care in Patients With Advanced Disease: A Mixed-method Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: End-of-life care
Treatment decision making
Advance care planning
Lead sponsor: Food and Health Bureau, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2014-02-21
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Advance care planning has been recommended as an integral part of care for patients with life-limiting disease, but relevant development in Hong Kong is still in its infancy. This proposed study attempts to address this service gap by promoting advance care planning to patients with advanced disease. It is hypothesized that the proportion of patients whose end-of-life care preferences were known in the experimental group will be significantly higher than that in the control group.

Detailed description: This study aims to evaluate the impacts of a community-based advance care planning programme on end-of-life care of patients with advanced disease. A mixed-method approach, including a randomized controlled trial and qualitative interviews, will be used. Participants in the experimental group will received a structured advance care planning programme delivered by a trained facilitator. It includes an educational component, reflection and a family meeting.

Eligibility criteria: Inclusion Criteria:

* aged 18 or above
* meet one of the three triggers for supportive /palliative care as suggested in the Gold Standards Framework
* living at home
* being communicable

Exclusion Criteria:

* mentally incompetent
* cannot nominate a family carer
* have already signed an advance directive
* have been referred to palliative care service

Primary outcomes:
measure: End-of-life care preferences
timeFrame: 6 months
Secondary outcomes:
measure: Level of certainty about future care
timeFrame: 6 months
measure: Health care utilization
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Haven of Hope Hospital
Study officials:
affiliation: The Nethersole School of Nursing, The Chinese University of Hong Kong
name: Helen Chan, RN PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Nethersole School of Nursing, The Chinese University of Hong Kong
name: Diana Lee, RN PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Nethersole School of Nursing, The Chinese University of Hong Kong
name: Carmen Chan, RN PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Nethersole School of Nursing, The Chinese University of Hong Kong
name: Iris Lee, RN PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Nethersole School of Nursing, The Chinese University of Hong Kong
name: Doris Leung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03180151: The Effect of Corticotomy in En-mass Retraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accelerate Tooth Movement
Keywords: corticotomy
enmass retraction
mini implant
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * To compare patients who will undergo orthodontics treatment involving upper premolar extraction for space of time whether with or without corticotomy by Piezotome.
* Assess the safety of both methods of retraction in regard to the quality of the surrounding periodontium and roots of anterior teeth.
* Monitor postoperative pain.


Eligibility criteria: Inclusion Criteria:

* On the basis of the diagnosis of the malocclusion, individuals who have Class I and Class II malocclusions and requiring extraction of premolars and retraction of anterior teeth will be selected (maxillary/mandibular or both).
* Good oral hygiene, healthy gingiva and no evidence of bone loss as seen in radiograph.
* Healthy systemic conditions.
* No previous orthodontic treatment.
* Patient needs to be in permanent dentition (hence, we need to define their age range).

Exclusion Criteria:

* Patient with systemic disease.
* Patient having any signs of active periodontal disease.
* Patients on long-term corticosteroid therapy.
* Persons taking medications that slows down bone metabolism.
* Craniofacial anomalies.

Primary outcomes:
measure: rate of tooth movement per time
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hatrom AA, Howait MS, Zawawi KH, Al-Turki GA, Alansari RA, Almehayawi NF, Alammari SH, Mohammed RA, Hassan AH. Pulp volume changes after piezocision-assisted tooth movement: a randomized clinical trial. BMC Oral Health. 2021 Jan 13;21(1):28. doi: 10.1186/s12903-020-01382-2.
Clinical trial NCT02293551: A Study of Lispro Formulations in Healthy Participants
Official title: Safety, Tolerability, and Pharmacokinetics of Multiple Novel Insulin Lispro Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-11-18
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purposes of this study are to determine:

* Part A

  * How quickly your body absorbs, breaks down and gets rid of the different formulations of insulin lispro compared to insulin lispro alone formulation.
  * The safety of insulin lispro in different formulations and any side effects that might be associated with it.
* Part B:

  * How much insulin lispro from different dose ranges is found in the bloodstream using a test insulin lispro formulation (selected from Part A).
  * The safety of insulin lispro in different formulations and any side effects that might be associated with it.

Participants may only enroll in one part. The study is expected to last up to 10 weeks for each part.


Eligibility criteria: Inclusion Criteria:

- Overtly healthy males or females (nonchildbearing potential and with absent cyclical hormonal changes), as determined by medical history and physical examination

Exclusion Criteria:

- Have a fasting plasma glucose less than or equal to (≤) 4.0 millimole per liter (mmol/L) at screening

Primary outcomes:
measure: Part A and B: Pharmacokinetics: Area Under The Concentration Curve (AUC) of LY275585
timeFrame: Predose through day 1 in each period
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04333251: Study Testing Convalescent Plasma vs Best Supportive Care
Official title: Evaluating Convalescent Plasma to Decrease Coronavirus Associated Complications. A Phase I Study Comparing the Efficacy and Safety of High-titer Anti-Sars-CoV-2 Plasma vs Best Supportive Care in Hospitalized Patients With Interstitial Pneumonia Due to COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pneumonia, Interstitial
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 115
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: Currently there are no proven treatment option for COVID-19. Human convalescent plasma is an option for COVID-19 treatment and could be available from people who have recovered and can donate plasma.

Detailed description: Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1 shows that convalescent plasma contains neutralizing antibodies to the relevant virus. In the case of SARS-CoV-2, the anticipated mechanism of action by which passive antibody therapy would mediate protection is viral neutralization. The only antibody type that is currently available for immediate use is that found in human convalescent plasma. As more individuals contract COVID-19 and recover, the number of potential donors will continue to increase. The investigators seek to treat participants who are sick enough to warrant hospitalization prior to the onset of overwhelming disease.

Eligibility criteria: Inclusion Criteria Donor:

* 18 years or older
* must have been hospitalized w/COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing but are now PCR negative by 2 nasopharyngeal testing
* females of child-bearing potential must have a negative serum pregnancy test
* subject and/or LAR willing to provide informed consent
* patient agrees to storage of specimens for future testing

Inclusion Criteria Recipient:

* 18 years or older
* must have been hospitalized w/COVID-19 respiratory symptoms within 3 to 7 days from the beginning of illness
* subject and/or LAR willing to provide informed consent
* patient agrees to storage of specimens for future testing

Exclusion Criteria:

* 18 years or older
* receipt of pooled immunoglobulin in past 30 days
* contraindication to transfusion or history of prior reactions to transfusion blood products
* females who are identified as donors must not be pregnant

Primary outcomes:
measure: reduction in oxygen and ventilation support
timeFrame: through study completion, an average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04624451: Evaluation of Intravenous Dalbavancin for Peritonitis
Official title: Evaluation of Intravenous Dalbavancin for Treatment of Peritonitis in Peritoneal Dialysis Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Peritonitis
Peritonitis Bacterial
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients currently receiving peritoneal dialysis that are found to have bacterial peritonitis

Brief summary: This study evaluates the use of Dalbavancin 1500 mg IV x 1 dose for treating patients with gram positive peritonitis in patients requiring peritoneal dialysis.


Eligibility criteria: Inclusion Criteria:

Patients \> 18 years of age actively receiving peritoneal dialysis diagnosed with a gram + peritonitis determined to be a good candidate for dalbavancin treatment by the attending nephrology attending.

Exclusion Criteria:

Patients with contraindications to dalbavancin therapy

Primary outcomes:
measure: Clinical cure
timeFrame: 14 days
measure: Clinical cure
timeFrame: 28 days
Secondary outcomes:
measure: Treatment emergent adverse events
timeFrame: 14 days
measure: Treatment emergent adverse events
timeFrame: 28 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: California
Study officials:
References:
citation: Van Matre ET, Teitelbaum I, Kiser TH. Intravenous and Intraperitoneal Pharmacokinetics of Dalbavancin in Peritoneal Dialysis Patients. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02089-19. doi: 10.1128/AAC.02089-19. Print 2020 Apr 21.
Clinical trial NCT00409851: One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With Hypertension
Official title: A 52 Week, Open Label Extension to the Randomized, Double-blind, Multicenter, Multifactorial, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: HYPERTENSION, VALSARTAN, AMLODIPINE,SAFETY
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-11
Enrollment: 1293
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: A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2201.


Eligibility criteria: Inclusion Criteria:

* SUCCESSFUL COMPLETION OF VAA489A2201 CORE TRIAL
* VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg

Exclusion Criteria:

* PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2201 CORE
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough.
Secondary outcomes:
measure: Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough
measure: Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough
measure: Sitting and standing pulse
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Sites in Germany
country: Germany
Study officials:
affiliation: Sponsor GmbH
name: Novartis pharmaceuticals
role: STUDY_CHAIR
References: