louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00856258: Multiple Dose Study in Healthy Volunteers to Assess Safety, Pharmacokinetics and Pharmacodynamics of PF 03882845
Official title: A Phase 1, Double Blind (Sponsor Open), Randomized, Placebo Controlled, Parallel Group, Oral Multiple Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF 03882845 In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Multiple dose in healthy volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To demonstrate the safety, pharmacokinetics and pharmacodynamics of drug candidate.

Detailed description: The study was terminated on June 19, 2009. Decision to terminate was based on Cohort 1 related safety concerns. An alternative clinical design was envisaged to better assess the benefit to risk.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant disease, allergy or clinical findings at screening.
* A positive urine drug screen, history of significant regular alcohol consumption within 6 months of screening or use of tobacco or nicotine containing products within the three months preceding study date or a positive urine cotinine at screening or Day -3.
* Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
* Pregnant or nursing females; females of childbearing potential.

Primary outcomes:
measure: Single Dose PK: Cmax, Tmax, and AUCtau; Multiple Dose PK (Assumed Steady State): Cmax(ss), Tmax(ss), AUC(tau,ss), half life, Cmin(ss), Cave(ss), Ae%, CL/F, V/F, CL renal; accumulation ratios AUC(tau,ss)/AUC(tau,sd) and Cmax(ss)/Cmax(sd).
timeFrame: 13 days
measure: Safety and tolerability as determined by adverse event reporting, clinical laboratory results, vital signs (supine blood pressure and heart rate), physical examinations, and electrocardiograms (ECGs).
timeFrame: 13 days
Secondary outcomes:
measure: Area under the effect curve (AUEC) for serum aldosterone and plasma renin activity (PRA) on Days 0, 1 and 10.
timeFrame: 14 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04835558: Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome
Official title: Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome; Evaluation by Incremental Load Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity Hypoventilation Syndrome (OHS)
Keywords: Respiratory Muscle Endurance
Sleep
Fatigue
Quality of Life
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 24
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects who had polysomnography performed in the sleep laboratory and were diagnosed with OHS were screened.

Age and sex-matched obese subjects (30 \< body mass index \< 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score \< 3) included in the study as the control group.

Brief summary: Obesity hypoventilation syndrome (OHS) is defined as a combination of obesity \[body mass index (BMI) ≥30 kg/m2\], chronic daytime hypercapnia (PaCO2 \>45 mm Hg), and sleep-apnea in the absence of other known causes of hypercapnia. Respiratory system compliance decreases and resistance increases in OHS. This causes increase in work of breathing and oxygen cost of breathing, which may result in respiratory muscle fatigue. Increase in respiratory workload and increase in resistance to respiration is expected to decrease in respiratory muscle endurance (RME) in subjects with OHS.

Detailed description: In the literature, studies evaluating RME in subjects with OHS are limited. No study has been found to evaluate RME using the incremental load test in subjects with OHS. Accordingly, it was aimed to evaluate and compare respiratory muscle endurance in subjects with OHS and a control group, and to determine factors associated with respiratory muscle endurance.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with OHS
* Obese subjects (30 \< body mass index \< 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score \< 3)

Exclusion Criteria:

* Severe respiratory disease
* Subjects with orthopeadic and/or neurologic disorders that could limit exercise tests

Primary outcomes:
measure: Incremental load test
timeFrame: 1 day
Secondary outcomes:
measure: Mouth pressure measurements
timeFrame: 1 day
measure: 6 minute walk test
timeFrame: 1 day
measure: Epworth Sleepiness Scale
timeFrame: 1 day
measure: Pittsburg Sleep Quality Index
timeFrame: 1 day
measure: Fatigue Severity Scale
timeFrame: 1 day
measure: EQ-5D Health-Related Quality of Life Questionnaire
timeFrame: 1 day
measure: Obesity and Weight Loss Quality of Life Instrument
timeFrame: 1 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
References:
Clinical trial NCT06480058: Predictors of Bariatric Surgery Weight Loss
Official title: Determinants of Eating Disorder Risk in Pre-intervention Bariatric Surgery Candidates.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Mild
Obesity, Morbid
Diabete Mellitus
Diabetes Mellitus, Type 2
Eating Disorders
Keywords: Obesity
Metabolic disease
Eating disorder
Mental health
Lead sponsor: Kuwait University
Sponsor class: OTHER
Collaborators: name: Dasman Diabetes Institute
name: Jaber Al Ahmad Al Sabah Hospital
First posted: 2024-06-28
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A cohort of patients attending a bariatric clinic

Brief summary: The aim of the observational cross-sectional study is to determine the prevalence and correlates of disordered eating among candidates for bariatric surgery in the BariPredict cohort.

The study aims to answer the following question on whether the prevalence of disordered eating is higher in individuals that are candidates of bariatric surgery compared to the general population with obesity.

Detailed description: Participants referred to Jaber Al Ahmad Al Sabah Hospital, Hawalli, Kuwait, for bariatric surgery were consecutively screened for the study.

A cross-sectional analysis was performed on a subgroup of this cohort with complete baseline data. The analysis investigates the influence of psychological factors associated with obesity before bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* Obesity BMI \> 30 kg/m2
* 18 years and older

Exclusion Criteria:

* BMI \< 30 kg/m2

Primary outcomes:
measure: Eating Disorder Screening
timeFrame: 1 Day
Secondary outcomes:
measure: Anxiety
timeFrame: 1 Day
measure: Depression
timeFrame: 1 Day
measure: Obesity
timeFrame: 1 Day
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Dana AlTarrah
Study officials:
References:
Clinical trial NCT05043558: The Protective Effect of Prostaglandin on Coronary Microcirculation and Ventricular Remodeling After Reperfusion Therapy in Acute ST-segment Elevation Myocardial Infarction
Official title: The Protective Effect of Prostaglandin on Coronary Microcirculation and Ventricular Remodeling After Reperfusion Therapy in Acute ST-segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: STEMI
Keywords: Beprostaglandin sodium
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the protective effect of prostaglandin sodium on coronary microcirculation function and ventricular remodeling after reperfusion treatment of acute ST-segment elevation myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* 1) Meet the diagnostic criteria for acute ST-segment elevation myocardial infarction: ①The onset of ischemic chest pain lasts for more than 30 minutes and cannot be relieved by taking nitroglycerin; ②The ECG has two or more ST-segment elevations in adjacent leads , Limb leads ≥ 1mm, pectoral leads ≥ 2mm; or newly-appearing left bundle branch block; ③The increase in serum markers of myocardial necrosis is at least twice the normal value; (2) Coronary angiography confirmed acute myocardial infarction; (3) Direct PCI treatment within 12 hours of onset; (4) Complete clinical and radiographic data.

Exclusion Criteria:

* (1) Those who do not cooperate in the inspection, have poor compliance, and cannot guarantee the completion of the test; (2) Persons with consciousness impairment, obvious intellectual impairment and mental abnormality; (3) With metal foreign bodies, such as metal prostheses, intraocular metal foreign bodies, intracranial aneurysm clamps, etc.; (4) Those who suffer from closure phobia; (5) Those who have had a history of myocardial infarction, PCI treatment, or coronary artery bypass graft; (6) Factors affecting the changes in the ST segment of the electrocardiogram: complete left bundle branch block, pre-excitation syndrome, pacemaker electrocardiogram

Primary outcomes:
measure: ultrasound and CMR to assess the characteristics of myocardial infarction
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People' S Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT05611658: Inter-observer Variation in Gross Tumor Delineation of Esophageal Cancer on MR, CT and PET CT
Official title: Inter-observer Variation in Gross Tumor Delineation of Esophageal Cancer on MR, CT and PET CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Lead sponsor: Institute of Oncology Ljubljana
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for esophageal cancer with preoperative or curative chemoradiotherapy.

Brief summary: The aim of the study is to investigate inter-observer variation in gross tumor volume (GTV) delineation of oesophageal cancer on different imaging modalities - CT, PET CT and MR.Twenty-three consecutive patients with esophageal cancer treated with preoperative or curative chemoradiotherapy were selected. All patients had CT, PET CT and MR imaging in treatment position prior to radiotherapy.Five experienced observers from our institution will independently delineate GTV on CT alone, MR alone, PET CT alone, on co-registered CT and MR and co-registered PET CT and MR. Inter-observer agreement, expressed in generalized conformity index (CIgen) and mean volumes of GTV will be calculated per patient and imaging modality.


Eligibility criteria: Inclusion Criteria:

* locally advanced esophageal cancer eligible for treatment with preoperative or curative chemoradiotherapy

Exclusion Criteria:

* contraindications for MR

Primary outcomes:
measure: Change of interobserver variability in target volume delineation on CT, PET CT and MR.
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Institute of Oncology
Study officials:
References:
Clinical trial NCT06650358: Clinical Outcomes of Patients with LAL+ in At Least One Eye
Official title: CLINICAL OUTCOMES of BILATERAL PSEUDOPHAKIC PATIENTS with a LIGHT ADJUSTABLE LENS+ (LAL)+ IMPLANTED in AT LEAST ONE EYE
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: IOL, Cataract
Keywords: LAL+
Light Adjustable Lens+
Mix and match IOLs
Lead sponsor: Bucci Laser Vision Institute
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PI's current patients

Brief summary: The objective of this study is to collect data on bilateral pseudophakic patients implanted with the RxSight Light Adjustable Lens+ (LAL+) in at least one eye

Detailed description: A retrospective-prospective, single-center study will be conducted. Patient charts will be retrospectively reviewed to collect data from the patient's comprehensive preoperative exam. Subjects will attend one stud visit post final LDD light treatment.

Eligibility criteria: Inclusion Criteria:

* Adults with bilateral pseudophakia who have been implanted with the LAL+ in at least one eye and who have completed LDD light treatments
* Sign a written Informed Consent Form

Exclusion Criteria:

* Visually significant eye disease

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 3-18 months after phacoemulsification
Secondary outcomes:
Other outcomes:
Locations:
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03345758: Long Term Outcome of Extracorporeal Membrane Oxygenation Patients in China
Official title: Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China;
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Long-term Outcome
Extracorporeal Membrane Oxygenation
Keywords: respiratory failure, circulatory failure
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated with extracorporeal membrane oxygenation during March,1,2017 to March,1,2019

Brief summary: Outcomes and Long-term Quality-of-life of Patients requiring Extracorporeal Membrane Oxygenation are not known in china. A prospective study survey will be performed to assess the long-term outcome of these patients.

Detailed description: Patients admitted to ICUs and treated with extracorporeal membrane oxygenation from March 1,2015 to March 1,2019 were screened . Pre-Ecmo clinical parameters(diagnose,APACHE-II, SOFA,indications,expected mortality) and related treatment conditions(duration of ICU stay, duration of ECMO,duration of mechanical ventilation,ventilation conditions,prone ventilation,ECMO complications )will be used to assess the severity and curative effect of these patients.Short Form-36 Health Status Questionnaire,EuroQol-5 Dimensions and St. George's Respiratory Questionnaire(SGRQ) will deliver in these survivors ,which are used to assess the physical and mental health ,as well as the social adaptation. Finally a comprehensive assessment will be obtained to describe the outcomes and long-term quality-of-life of patients treated With ECMO.

Eligibility criteria: Inclusion Criteria:

* require extracorporeal membrane oxygenation

Exclusion Criteria:

* irreversible disease

Primary outcomes:
measure: survival rate
timeFrame: August,1,2017-March,1,2020
Secondary outcomes:
measure: Quality of live
timeFrame: August,1,2017-March,1,2020
measure: Cognitive function
timeFrame: August,1,2017-March,1,2020
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Zhong-Da Hospital
state: Jiangsu
Study officials:
affiliation: professor
name: Haibo Qiu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05416996: A Study of Telemedicine Shared Medical Appointments (SMAs) Versus Individual Telemedicine Visits for People With Prostate Cancer
Official title: Feasibility Study of Randomizing Patients to Telemedicine Shared Medical Appointments Versus Telemedicine Single Visits for Men With Prostate Cancer on Active Surveillance
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Keywords: Telemedicine
Shared Medical Appointments
Individual Telemedicine Visits
22-184
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 88
Sex: MALE
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 will be recruited through two routes: 1) by physician invitation during routine Active Surveillance (AS) office visits or 2) by the physician's assistant or research team calling.

Brief summary: The purpose of this study is to see if a telemedicine group doctor's appointment is a practical (feasible) and acceptable method for following people with prostate cancer being managed with active surveillance when compared with the usual approach of individual telemedicine visits, which involve the participant visiting a doctor on their own. The researchers will compare the telemedicine group and individual visits by measuring on participant satisfaction and quality of life in each type of visit. Telemedicine is the use of secure video technology on a desktop computer, laptop, smartphone, or tablet to provide and receive healthcare from a distance.


Eligibility criteria: Inclusion Criteria:

* A scheduled appointment for a subsequent Active Surveillance (AS) follow-up visit for management of localized prostate cancer
* Biopsy Gleason score 3+3=6 (Grade Group 1) or biopsy Gleason score 3+4=7 (Grade Group 2)
* Clinical T stage ≤T2B
* Access to a device with Zoom
* Ability to speak and understand English

Exclusion Criteria:

* Plan to undergo a prostate biopsy at this follow-up visit

Primary outcomes:
measure: accrual number
timeFrame: 1 year
measure: patient satisfaction
timeFrame: 1 week
Secondary outcomes:
measure: adherence to active surveillance
timeFrame: 6 months
Other outcomes:
measure: Functional status
timeFrame: 1 year
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Behfar Ehdaie, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03834896: Madrid - Tolerance and Acceptability Study
Official title: Madrid - Tolerance and Acceptability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Lead sponsor: Aymes International Limited
Sponsor class: INDUSTRY
First posted: 2019-02-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Tolerance and Acceptability of a gum based thickener.

Detailed description: To evaluate the tolerance and acceptability of AYMES MADRID, in patients that may require modified consistency fluids. Measuring GI tolerance, compliance, convenience and preference.

To obtain data to support an ACBS submissions for AYMES MADRID (to allow for prescription in the community at NHS expense).

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years) who are able to communicate clearly.
* Patients with dysphagia requiring Stage 1, 2 or 3 thickened fluids as determined by -Speech and Language Therapist.
* Patients expected to require provision of Stage 1, 2 or 3 thickened fluids for at least 2 further weeks.
* Informed consent obtained from patient or for those without capacity following consultation with carers.

Exclusion Criteria:

* Patients with maize / corn allergy requiring a maize free diet
* Patients with inherited metabolic conditions.
* Patients requiring enteral tube feeding or parenteral nutrition.
* Patients with medical or dietary contraindication to any feed ingredients
* Patients with delayed oral phase of swallowing.
* Patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis)
* Patients with dysphagia not requiring stage 1, 2 or 3 thickened fluids.
* Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
* Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study (to prevent over burdening of participants and ensure a period of normalisation between study involvement)

Primary outcomes:
measure: GI side effects when using AYMES MADRID
timeFrame: 9 Days
Secondary outcomes:
measure: Compliance with prescription of AYMES MADRID
timeFrame: 9
measure: Bowel habits of subjects when using AYMES MADRID - frequency
timeFrame: 9 days
measure: Bowel habits of subjects when using AYMES MADRID - stool consistency
timeFrame: 9 days
Other outcomes:
Locations:
city: Haywards Heath
country: United Kingdom
facility: AYMES International Ltd.
Study officials:
References: