louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05370716: Drug-Drug Interaction Study of "CG-651" in Healthy Volunteer
Official title: A Randomized, Open-label, Multiple-dose, Parallel Study to Compare the Pharmacokinetics and to Evaluate Drug-Drug Interaction of "CG-651" in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: CrystalGenomics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-11
Enrollment: 47
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Group A: Pregabalin + Polmacoxib
* Group B: Polmacoxib
* Group C: Pregabalin
Primary purpose: TREATMENT

Brief summary: This is randomized , open-label, multiple-dose, parallel study to compare the pharmacokinetics and to evaluate Drug-Drug Interaction of "CG-651" in healthy volunteers.

Detailed description: Total of 39 health volunteers will be randomized to receive either of Group A,B or C. (13 subjects each)

\[Group A\] Pregabalin+ Polmacoxib. \[Group B\] Polmacoxib \[Group C\] Pregabalin

Eligibility criteria: Key Inclusion Criteria:

* Adequate Biochemistry, Urinalysis, Serology and so on.
* Subject who understand the objective, method of the study and the characteristics of investigational drug and expected adverse events and provide written informed consent prior to study participation.
* Negative pregnancy test (hCG) and agree to contraception during the trial.

Key Exclusion Criteria:

* History of hypersensitivity to investigational products.
* History of hypersensitivity or allergic reaction to sulfonamide.
* Patients with a history of asthma, acute rhinitis, non specific polyps, angioedema, urticaria or allergic reactions to aspirin or other nonsteroidal anti-inflammatory analgesics(including COX-2 inhibitors)
* Any other reason or situations that the investigator decides the patient is not eligible to participate the clinical trial.

Primary outcomes:
measure: Cmax of polmacoxib and pregabalin
timeFrame: upto 4 weeks
measure: AUC of polmacoxib and pregabalin
timeFrame: upto 4 weeks
measure: The Number of Participants Who Experienced Adverse events (AEs)
timeFrame: upto 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT04636216: Open Trial of a Program to Support Parents of Children With Attention-deficit/Hyperactivity Disorder (ADHD)
Official title: Open Trial of a Program to Support Parents of Children With Attention-deficit/Hyperactivity Disorder in Online Group Meetings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 14
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open, single-group trial
Primary purpose: TREATMENT

Brief summary: Behavioral parent training is an evidence-based treatment for ADHD. The intervention can be implemented individually, or in groups. Currently, group-based parent training programs require considerable coordination, including ascertainment of a large physical space, the coordination of all families traveling to the same location at the same time, and the require for the provision of childcare. Innovations in online connectivity and ease of implementation of online support applications (e.g., Zoom) may reduce these barriers. However, it is necessary to investigate the feasibility and promise of the online approach to ensure it supports parents effectively.

Detailed description: This study will utilize a pre-post, open trial design as the primary aim is to investigate feasibility. Approximately sixty parents will complete prepost ratings of parenting behaviors and measures of child functioning. They will also complete post treatment measures of satisfaction and open-ended questions about feasibility and suggestions for future iterations of the approach. Process measures will include data collection related to attendance and engagement in the activities. Risks include breach of confidentiality and a lack of effectiveness of the intervention for the child's presenting problems. Benefits include the parent receiving an effective intervention.

Eligibility criteria: Inclusion Criteria:

* ADHD diagnosis
* Intelligence Quotient (IQ) greater than or equal to 70
* At least 1 parent/guardian who can attend zoom sessions
* Access to reliable internet connection for zoom meetings

Exclusion Criteria:

* Evidence of psychosis, suicidal behaviors, or autism level 2/3

Primary outcomes:
measure: Observations of parenting behaviors during parent-child interaction
timeFrame: 8 weeks
measure: Impairment Rating Scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amherst
country: United States
facility: Center for Children and Families
state: New York
Study officials:
affiliation: Florida International University
name: Gregory A Fabiano, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00239616: Pharmacokinetic of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin
Official title: Open-label Multicenter, Pharmacokinetic Study of a Single Dose of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Keywords: Anemia
Pharmacokinetics
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, multicenter pharmacokinetic study of Hemodialysis (HD) or Peritoneal Dialysis (PD) patients receiving erythropoietin. Patients were administered 100mg of iron sucrose undiluted by slow IV push over 5 minutes. Patients underwent serial blood draws and were subsequently followed for 7 days for safety endpoints.

Detailed description: This is an open-label, multicenter pharmacokinetic study of HD of adolescent PD patients receiving erythropoietin. Patients between the ages of 12 and 18 were administered 100mg of iron sucrose, undiluted by slow IV push over 5 minutes, and underwent serial blood draws. The patients were subsequently followed for 7 days for safety endpoints.

Eligibility criteria: Inclusion Criteria:

* Age between 12 and 18 years
* History of Chronic Renal Failure requiring HD or PD
* Hgb \</= 13 g/dL
* Ferritin \< 800 ng/ml
* Transferrin Saturation (TSAT) \< 50%
* Receiving epoetin

Exclusion Criteria:

* Known Sensitivity to Iron Sucrose
* Severe Concomitant disease of the liver or cardiovascular system
* Serious bacterial Infection
* Pregnancy / Lactation
* Active Hepatitis
* Patients with Causes of iron deficiency other that Chronic Renal Failure
* Blood Transfusion
* Body Weight \< 25 kilograms
* Currently being treated for Asthma
* Received investigational drug within last 30 days

Primary outcomes:
measure: Maximum Measured Plasma Concentration (Cmax)
timeFrame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
measure: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC 0-t)
timeFrame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
measure: Area Under the Curve From Time Zero Extrapolated to Infinity (AUC 0-∞)
timeFrame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
measure: Terminal Elimination Half-life (T1/2)
timeFrame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
Secondary outcomes:
measure: Total Body Clearance (CL)
timeFrame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
measure: Volume of Distribution (Vd)
timeFrame: 0, 5, 15, 30, 60, 90, 120, 240, 360, 480, and 720 minutes
Other outcomes:
Locations:
Study officials:
affiliation: American Regent, Inc.
name: Mark A Falone, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01863316: The Comparison of the Clinical Efficacy Between I-gel and LMA-Supreme, the Two Most Recently Developed Supraglottic Airway Devices, in Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elective Surgery of Short Duration (Less Than 2 hr) Undergoing General Anesthesia Using Supraglottic Airway
Keywords: LMA Supreme, i-gel, supraglottic airway
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-05-27
Enrollment: 100
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Although the safety and efficacy of the I gel in children has been shown in several large observational studies, There is no study about comparison of the clinical efficacy between I-gel and LMA-Supreme , in particular sizes 1 and 1½. The pediatric i-gel and LMA Supreme are new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel and LMA Supreme in adults have been promising, showing an easy insertion, high airway leak pressures, and low complication rates with few postoperative complaints. The aim of this study is to compare clinical performance of the pediatric i-gel and LMA Supreme in infants.


Eligibility criteria: Inclusion Criteria:

1. Infants (0-1 year of age) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway

Exclusion Criteria:

1. Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period

Primary outcomes:
measure: airway leak pressure
timeFrame: within 5 min of insertion of each device
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00407316: Quality of Life and Visual Function in Uveitis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Uveitis
Posterior Uveitis
Panuveitis
Uveitis
Keywords: Uveitis
Quality of life
Visual function
Lead sponsor: The New York Eye & Ear Infirmary
Sponsor class: OTHER
First posted: 2006-12-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study was to measure the quality of visual function and quality of daily living in patients with anterior, posterior, and panuveitis.

Detailed description: The National Eye Institute Visual Functioning Questionnaire, version August 2000 (NEI VFQ-25) and the Medical Outcomes Study (MOS) 36 Item Short Form Health Survey Instrument (SF-36) (RAND 36-Item Health Survey 1.0 Questionnaire) will be administered by a trained interviewer. Socio-demographic and clinical data will be collected for additional QOL parameter.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent
* Subjects of either gender
* Age greater than or equal to 18 years of age
* Diagnosed with Uveitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
Study officials:
affiliation: New York Eye and Ear Infirmary
name: C. Michael Samson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06439316: Physical Function and Mental Health in Cancer Survivors
Official title: Joint Association Between Sedentary Behavior and Depressive Symptoms With Mortality Outcomes Among Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Sedentary Behavior
Depressive Symptoms
Survivorship
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 2932
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer survivors were selected from the National Health and Nutrition Examination Survey (NHANES) program between 2007 and 2018.

Brief summary: The goal of this observational study is to evaluate the joint prognostic effects of physical function and mental health on survival of cancer survivors.

Detailed description: Cancer survivors were selected from the National Health and Nutrition Examination Survey (NHANES) between 2007 and 2018. Total sedentary time was assessed by self-reported daily hours of sitting and depressive symptoms were assessed by Patient Health Questionnaire 9 (PHQ-9). Kaplan-Meier (KM) curves and the Cox regression analyses were used to evaluate the separate and joint prognostic effects of sedentary behavior and depressive symptoms with mortality outcomes of cancer survivors.

Eligibility criteria: Inclusion Criteria:

* Adults with aged above 18 year old

Exclusion Criteria:

* Without a history of cancers
* Without records of sedentary behavior or depressive symptoms test
* Incomplete follow-up information

Primary outcomes:
measure: All-cause mortality of cancer survivors
timeFrame: Jan 1, 2007 to 31 Dec, 2019
measure: Cancer mortality of cancer survivors
timeFrame: Jan 1, 2007 to 31 Dec, 2019
measure: Non-cancer mortality of cancer survivors
timeFrame: Jan 1, 2007 to 31 Dec, 2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03779516: Effect of Nebulized Lidocaine on Postoperative Sore Throat
Official title: Effect of Preoperative Nebulized Lidocaine on Postoperative Sore Throat After Endotracheal Intubation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sore Throat
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-12-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the hypothesis that use of preoperative nebulized lidocaine is reduced the incidence of postoperative sore throat after endotracheal intubation.

Detailed description: Adult patients undergoing video-assisted thoracic surgery (VATS) requiring double lumen tube (DLT) endotracheal intubation for one-lung ventilation (OLV) were enrolled in the study. Patients were randomized by means of computer-generated order randomization into two groups: Group C (those who received a saline solution as placebo delivered by nebulization) and Group L (those who received lidocaine delivered by nebulization).

At 1, 6 and 24 h after tracheal extubation, an observer blinded to treatments evaluated the patients in terms of sore throat and hoarseness. In addition, Patients' satisfaction, intraoperative and postoperative opioid and analgesics consumption and complaints such as dysphagia, nausea and vomiting were recorded. Hemodynamic variables such as blood pressure and heart rate were also recorded.

Eligibility criteria: Inclusion Criteria:

* patients undergoing video-assisted thoracic surgery requiring double lumen tube endotracheal intubation for one-lung ventilation
* American Society of Anesthesiologists class 1,2 and 3
* Ability to consent

Exclusion Criteria:

* patients \<18 years old
* body mass index (BMI) \<20 or \>35 kg/m2
* Mallampati grade 3 or 4
* mouth opening \< 3 cm
* preexisting hoarseness or sore throat
* coagulopathy
* patient with upper respiratory tract infection

Primary outcomes:
measure: Changes in the incidence of postoperative sore throat
timeFrame: 24 hours
Secondary outcomes:
measure: whether the hoarseness was present or not
timeFrame: 24 hours
measure: Intraoperative opioid consumption
timeFrame: 60 minutes
measure: Postoperative analgesic consumption
timeFrame: 24 hours
measure: Changes in mean arterial pressure
timeFrame: 60 minutes
measure: Changes in heart rate
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
Study officials:
affiliation: Antalya Training and Research Hospital
name: Ali Sait Kavakli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
name: Hilal Yavuzel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karabuk University Training and Research Hospital
name: Ulku Arslan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01771016: Emergency Contraception - User's Profile
Official title: Emergency Contraception - Observational Study of User's Profile
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postcoital Contraception
Keywords: Emergency contraception
Emergency hormonal contraception
Community pharmacies
Pharmaceutical care
Time to access
Written assessments
Switzerland
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 729
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pharmacies in Basle, Berne or Zurich, three major towns in the German speaking part of Switzerland, were purposively recruited if they had extended opening hours (emergency pharmacies) or if they were located downtown and open during traditional business hours (walk-in pharmacies).

The pharmacists were asked if a pharmacy student could come to their place and photocopy the completed official one-page EHC written assessment forms.

Brief summary: Retrospective analysis of requests of emergency hormonal contraception using pharmacy protocols registered in 2003 and 2006.

Detailed description: In 2002, Levonorgestrel was introduced in Switzerland for emergency hormonal contraception (EC) without prescription ('pharmacist only'). In 2003, a first analysis of requests of EC showed that the dispensing of EC through pharmacies could successfully be implemented (Lemke et al 2004).

This study was repeated three years later with the aim to explore whether the user's profile has changed after introduction of a low threshold access to EC.

Eligibility criteria: Inclusion Criteria:

* women seaking emergency hormonal contraception

Exclusion Criteria:

-

Primary outcomes:
measure: Sexual and protective behaviour
timeFrame: 2 years
Secondary outcomes:
measure: elapsed hours since unprotected intercourse
timeFrame: 1 month
Other outcomes:
measure: pharmacy status and care activity
timeFrame: 1 month
Locations:
Study officials:
affiliation: Dept Pharmaceutical Sciences, University Basel
name: Kurt E Hersberger, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06168916: AIMN Multicenter Study: 18 F-FDG PET-CT With or Without Contrast Medium in the Staging and Radiation of Lung Cancer?
Official title: AIMN Multicenter Study: 18 F-FDG PET-CT With or Without Contrast Medium in the Staging and Radiation of Lung Cancer?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 14
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: Adult patients with non-small cell lung cancer undergoing PET and contrast-enhanced CT during staging or restaging.

Brief summary: Accurate staging of patients with non-small cell cancer (NSCLC) is of fundamental importance both for the correct choice of treatment plan and for prognosis. Numerous studies have demonstrated the added value of co-registration of functional PET images and anatomical CT images using hybrid PET-CT tomographs and the consequent benefits on the choice of treatment in patients with NSCLC. Currently in most PET centers CT is performed with a "low dose" technique and is used exclusively as a transmissive source for attenuation correction and anatomical localization. The availability of new generation hybrid tomographs allows for "diagnostic" CT examinations (contrast CT) to be performed with a standard dose of radiation and with the use of intravenous and/or oral iodinated contrast medium (contrast medium). Little data is currently available on the added value of a PET-CT scan performed in a single session compared to PET-CT performed independently and, generally, subsequently to CT scan.

The objective of the study is to evaluate the ability to correctly define the accuracy in localizing and characterizing lung "lesions" in patients with confirmed NSCLC, in the staging or restaging phase, through the use of: PET-CT "low-dose" and PET contrast CT.

The effects of the two procedures on the patient's quality of life and on the costs incurred by the patient and the healthcare service will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* patients with histologically proven NSCLC, undergoing staging or restaging;
* plasma creatinine normal;

Exclusion Criteria:

* patients with lung microcytoma;
* pregnant women

Primary outcomes:
measure: Use of PET and CT with contrast in a single session
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05647616: Strengthening of the Peroneus Longus Muscle in Patients With Dorsiflexed First Ray
Official title: Strengthening of the Peroneus Longus Muscle in Patients With Dorsiflexed First Ray
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: First Ray Dorsiflexion
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: BACKGROUND: The first metatarsal and medial cuneiform form an important functional unit in the foot called "first ray". The first ray normal function requires that it load part of the body weight in the last period of the stance phase of gait. A dorsiflexed first ray may exist due to abnormal function of the peroneus longus muscle.

OBJECTIVE: To evaluate the improvement in first ray function in tha push-off phase of gait after a 4-week strengthening programme for the peroneus longus.

SUBJECTS: Patients with flexible dorsiflexed first ray. INTERVENTIONS: Patients will be randomly assigned to either group A, which will receive instructions for a strengthening programme of the peroneus longus muscle, or group B, which will receive no treatment.

MAIN MEASURES: The primary outcomes will be mean and maximum plantar pressure under the first metatarsal head.


Eligibility criteria: Inclusion Criteria:

* Flexible dorsiflexed first ray.

Exclusion Criteria:

* Traumatisms on the feet in the last 12 months.
* Previous foot surgery.
* Hallux abducto-valgus.
* Being in treatment with foot orthoses.
* Systemic musculoskeletal disease.

Primary outcomes:
measure: Maximum plantar pressure under the first metatarsal head
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Department of Podiatry
Study officials:
affiliation: University of Seville
name: Pedro V Munuera-Martínez, Ph.D
role: STUDY_DIRECTOR
References: