louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04852003: A Trial of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal
Official title: A Phase Ⅲ, Randomized, Double-blind, Placebo- and Active-controlled Study of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-21
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR0410 injection compared with placebo and morphine
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after endoscopic surgery of the lower abdominal.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring elective general anesthesia endoscopic surgery of the lower abdominal
3. Male or female
4. Meet the body mass index standard
5. Conform to the ASA Physical Status Classification

Exclusion Criteria

1. Subjects with a history of difficult airway
2. Subjects with a history of mental illness
3. Subjects with a history of cognitive impairment epilepsy
4. Subjects with a history of myocardial infarction or unstable angina pectoris
5. Subjects with atrioventricular block or cardiac insufficiency
6. Subjects with a history of ischemic stroke or transient ischemic attack
7. Subjects with poor blood pressure control after medication
8. Subject with a history of substance abuse and drug abuse
9. Abnormal values in liver function
10. Subjects with an oxygen saturation below 90% on room air
11. Allergic to drugs that may be used during the study
12. Pregnant or nursing women
13. No birth control during the specified period of time
14. Participated in clinical trials of other drugs (received experimental drugs)
15. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Primary outcomes:
measure: The area under the curve of pain intensity over 24 hours
timeFrame: 24-hours
Secondary outcomes:
measure: Total consumption of remedial analgesics from 0h to 24h
timeFrame: 24-hours
measure: Participant ' satisfaction score for analgesia treatment
timeFrame: 24-hours
measure: Investigator satisfaction score for analgesia treatment
timeFrame: 24-hours
measure: Frequency and severity of adverse events
timeFrame: Day 4（or early termination on Day 3）
measure: Safety as assessed by vital signs
timeFrame: Day 4（or early termination on Day 3）
measure: Safety as assessed by laboratory evaluations
timeFrame: Day 4（or early termination on Day 3）
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT02124603: Microbiological Evaluation of the Ocular Flora Before Cataract Surgery
Official title: Evaluation of Ocular Flora in Patients Undergoing Cataract Surgery. An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorders of the Eye Following Cataract Surgery
Keywords: cataract
prophylaxis
susceptibility
Lead sponsor: SIFI SpA
Sponsor class: INDUSTRY
First posted: 2014-04-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing routine cataract surgery

Brief summary: The purpose of the present study is to elucidate the spectrum of ocular flora and their antimicrobial susceptibility profiles in patients undergoing routine cataract surgery.

Detailed description: A conjunctival and palpebral swab will executed at least 14 days before routine cataract surgery. Isolates will be identified using standard microbiological protocols. In vitro susceptibility will be determined using a breakpoint minimal inhibitory concentrations. In case of positivity, the swab will be repeated the day of surgery. Topical antibiotic may be used in case of positivity at the discretion of the surgeon. Descriptive statistics will be calculated.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for cataract surgery
* Age \> 18 years
* Any gender and race
* Willing to sign informed consent

Exclusion Criteria:

* Any antibiotics within 3 months
* Any ocular infection within 3 months

Primary outcomes:
measure: Positive Culture in Subjects Scheduled for Cataract Surgery
timeFrame: At least 14 days before surgery
Secondary outcomes:
measure: Antibiotic Susceptibility
timeFrame: At least 14 days before surgery
measure: Eradication Rate
timeFrame: Day of surgery
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Casa di Cura Di Stefano
Study officials:
affiliation: Casa Di Cura Di Stefano Catania (Italy)
name: Marcello Santocono, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04616703: Natural History of NFAI: 10 Year Follow-up Results
Official title: Natural History of Benign Nonfunctioning Adrenal Tumors: 10 Year Follow-up Results
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adrenal Incidentaloma
Keywords: adrenal incidentaloma
BMI
NFAI
MACE
long term follow up
natural history
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana, Faculty of Medicine
name: University Rehabilitation Institute, Republic of Slovenia
First posted: 2020-11-05
Enrollment: 65
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: Adult patients with diagnosisi of NFAI, hospitalized between 2005-2012 at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia.

Brief summary: The data on long term natural history of benign nonfunctioning adrenal tumors (NFATs) are lacking. The aim is to identify clinical characteristics associated with tumor growth and progression to mild autonomous cortisol excess over time.

Detailed description: After being informed about the study, all patients with NFAT given written informed consent will underwent a control visit approximatly 10 years after initial visit at the outpateint clinic at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia. The included patients will be divided in three groups regarding the BMI as follows: BMI \< 25 kg/m2, 25-30 kg/m2 and \> 30 kg/m2. The investigators will assess clinical, and laboratory parameters and CT findings at the follow up visit and compere them to baseline characteristics.

Eligibility criteria: Inclusion Criteria:

- Patients hospitalized because of NFAI between 2005-2012 at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia.

Exclusion Criteria:

* age below 18 years
* relatives reported that patient died in the time since hospitalization
* patient did not want a follow up
* patient did not attend follow up appointment
* patient underwent adrenalectomy
* misdiagnosis / missing main information in hospitalization record

Primary outcomes:
measure: Natural History of NFAT - horomnal activity
timeFrame: 10 years
measure: Natural History of NFAT - growth
timeFrame: 10 years
measure: Natural History of NFAT - BMI
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
Study officials:
affiliation: University Medical Center Ljubljana, Slovenia
name: Mojca Jensterle, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01339403: Kaiser Permanente HIV Cohort Study
Official title: Hiv Infection, Antiretroviral Therapy Use And Other Predictors Of Selected Clinical Events In Kaiser Permanente
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
AIDS
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Kaiser Permanente
name: Pfizer
First posted: 2011-04-20
Enrollment: 282368
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: HIV infected patients in the HIV Registry of Kasier Permanente Northern and Southern California and a matched cohort of non-HIV infected patients in Kaiser Permanente

Brief summary: Human Immunodeficiency Virus (HIV) infected patients in the Kaiser Permanente HIV registry wil be followed in the usual clinical care to estimate the rates of specified clinical events. The rates will be stratified by relevant characteristics like age, CD4 counts, HIV Viral Load (VL), HIV medication history. The rates in the HIV infected cohort wil be compared with the rates of these events in patients in the Kaiser Permanente database who are not infected with HIV.

Detailed description: All HIV infected patients in the database will be included without any sampling. A random sample of non-HIV infected patients will be included as comparator.

Eligibility criteria: Inclusion Criteria:

HIV infection.

Exclusion Criteria:

None

Primary outcomes:
measure: Incidence Rate of Malignancies
timeFrame: Up to Week 835
measure: Incidence Rate of Myocardial Infarction and Ischemia
timeFrame: Up to Week 835
measure: Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
timeFrame: Up to Week 835
measure: Incidence Rate of Liver Failure
timeFrame: Up to Week 835
measure: Incidence Rate of Liver Related Death
timeFrame: Up to Week 835
measure: Incidence Rate of Rhabdomyolysis
timeFrame: Up to Week 835
measure: Incidence Rate of All-Cause Mortality
timeFrame: Up to Week 835
measure: Incidence Rate of Viral Encephalitis
timeFrame: Up to Week 730
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05349903: Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis
Official title: Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Obesity
Diabetes Mellitus, Type 2
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Société des Produits Nestlé (SPN)
First posted: 2022-04-27
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Our laboratory is investigating the physiological outcomes and health benefits of the consumption of high-quality carbohydrates. One important aspect of the high-quality carbohydrate characteristics is a slow and sustained digestion and glucose release to the blood. In the proposed study, the investigators will evaluate the consumption of different types of slowly digestible carbohydrates (SDCs) and their beneficial effects including moderation of the glycemic response profile (postprandial glycemic response, PPGR) and stimulation of the gut-brain axis, which controls appetite and food intake. This stimulation will be evaluated in terms of second-meal food intake and the circulatory level of appetite-suppressing gut hormones (such as glucagon-like peptide-1).


Eligibility criteria: Inclusion Criteria:

* BMI 18.5 - 25 kg/m2
* Stable weight for the past 3 months (i.e. +/- 2..5 kg)

Exclusion Criteria:

* Pregnant or nursing women
* Diabetic
* Individuals with history of gastrointestinal disease

Primary outcomes:
measure: Postprandial glycemic response
timeFrame: Acute study: [4 hours of measurement after consumption of test food]
measure: Postprandial glycemic response
timeFrame: Acute study: [4 hours of measurement after consumption of test food]
measure: Postprandial glycemic response
timeFrame: Acute study: [4 hours of measurement after consumption of test food]
measure: Postprandial plasma gut hormone response
timeFrame: Acute study: [4 hours of measurement after consumption of test food]
measure: Postprandial plasma gut hormone response
timeFrame: Acute study: [4 hours of measurement after consumption of test food]
measure: Postprandial plasma gut hormone response
timeFrame: Acute study: [4 hours of measurement after consumption of test food]
Secondary outcomes:
measure: Gastric emptying rate
timeFrame: Acute study: 4 hours of measurement after consumption of test food]
measure: Appetite ratings (Visual Analog Scale, VAS)
timeFrame: Acute study: [4 hours of measurement after consumption of test food]
measure: Food Intake of the next meal
timeFrame: Acute study: After the consumption a second meal [4 hours later after consuming the first meal]
measure: Breath hydrogen (fermentability)
timeFrame: Acute study: [4 hours of measurement after consumption of test food]
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Bruce R Hamaker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00575003: Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
Official title: Double-Blind, Placebo-Controlled Study to Investigate an Immunomodulatory Therapy (CYT003-QbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Perennial Allergy to House Dust Mite and/or Cat
Lead sponsor: Cytos Biotechnology AG
Sponsor class: INDUSTRY
First posted: 2007-12-17
Enrollment: 64
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: TREATMENT

Brief summary: The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or cat allergy compared to placebo in adult patients.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite and/or cat allergens

Exclusion Criteria:

* Clinical relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments.
* Use of any concomitant medication that could affect the patient's study treatment response or assessment results.
* Any clinically relevant concomitant disease as judged by the investigator.
* Pregnancy or female planning to become pregnant during the study.

Primary outcomes:
measure: Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life
timeFrame: on 4 occations over 1 year
Secondary outcomes:
measure: Safety and tolerability of the vaccine by collection of adverse events
timeFrame: at each visit
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Clinic, Out-Patients Department
city: Tartu
country: Estonia
facility: Tartu University Clinic, Lungs Clinic
city: Riga
country: Latvia
facility: The centre of the investigation in treatment of allergic disease
city: Riga
country: Latvia
facility: SNC Uniclinica
city: Kaunas
country: Lithuania
facility: Kaunas County Hospital, Department of Pulmonology and Allergology
city: Kaunas
country: Lithuania
facility: Kaunas Medical University Hospital, Department of Pulmonology and Immunology
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital, Centre of Pulmonology and Allergology
Study officials:
affiliation: Vilnius University Hospital
name: Audra Blaziene
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01514903: Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Erectile Dysfunction
Keywords: anti erectile dysfunction agent
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 54
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single dose open-label comparative pharmacokinetic study to assess the pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra (tablet) in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* age between 20 and 45
* weight : over 55kg and 18.5 \< BMI, 25.0
* have to give their consent to participating clinical trial by oneself

Exclusion Criteria:

* has a medical history of hypersensitivity to drug including PDE5 inhibitor and QTc \> 430ms or uncontrolled arrhythmia

Primary outcomes:
measure: AUC and Cmax of sildenafil
timeFrame: Pre-dose (0h), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hr post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sinchon Severance Hospital
Study officials:
References:
Clinical trial NCT01565603: Sleep and Cerebral Responses to High Altitude
Official title: Intolerance Mechanisms and Exercise Performance Limitation During a High Altitude Stay: Investigation of Sleep and Cerebral Responses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Mountain Sickness
High Altitude Pulmonary Edema
High Altitude Cerebral Edema
Keywords: Hypoxia
Exercise
Sleep
Brain
Neuromuscular function
Heart
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy young subjects

Brief summary: Mechanisms underlying high-altitude intolerance as well as exercise performance limitation in hypoxia still remain to be fully understood. Recent data suggest that sleep disturbances on one hand and cerebral perturbations on teh other hand may be key mechanisms. The investigators evaluated 12 healthy subjects at sea level and at 4400 m of altitude for 7 days in order to better describe sleep and cerebral responses. The investigators hypothesized that sleep and cerebral disturbances play a critical role for the developement of acute mountain sickness and for exercise performance limitation during acute high-altitude exposure.


Eligibility criteria: Inclusion Criteria:

* 18 to 50 yrs old
* Male

Exclusion Criteria:

* Respiratory, cardiac, metabolic or neuromuscular diseases
* History of severe acute mountain sickness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02476903: Viscosupplementation in the Hip Following Hip Arthroscopy
Official title: Viscosupplementation in the Hip Following Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
Collaborators: name: Sean McMillan, DO
First posted: 2015-06-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Hip arthroscopy is a rapidly evolving procedure that has seen an exponential increase in the number of cases performed yearly. With hip arthroscopy still in its infancy in relation to knee and shoulder arthroscopy, there are still many questions yet to be answered. Axioms that were once thought to be true regarding indications and treatment for hip arthroscopy are continually being revised. As with the knee and shoulder before it, the hip is now graduating into treatment avenues that were otherwise thought to only be possible through an open surgical procedure.

Viscosupplementation in patients post arthroscopy with known articular cartilage injury has been shown to be efficacious. The pathophysiology of hyaline degradation during the arthritic process within the knee has been studied, and with this understanding has grown the widespread usage of viscosupplementation. While questions still exist regarding the effectiveness of viscosupplementation in non-weightbearing joints, it appears the benefits seen in the weight bearing joints, such as the knee, are apparent


Eligibility criteria: Inclusion Criteria:

Preoperative inclusion criteria will be made via x-ray and MRI evaluation. These criteria shall include: 2 mm or greater joint space preservation of the hip on radiographs, absence of acetabular subcortical bone cysts, Tonnis Score less than 2 on radiographs, and patient age greater than 18.4 Intra-operative evaluation of the cartilage will be performed by the surgeon on both the acetabular and femoral head sides. Patients shall be included if the osteochondral defect meets Outerbridge Classification criteria of stage II or greater. Furthermore the lesion shall be greater than 1cm in size (and thus not amenable to other procedures such as microfracture). Subjects must be willing to sign the IRB-approved informed consent and be older than 18 years old.

Exclusion Criteria:

All patients 55 years of age and older. All patients with previous hip surgery on a concomitant side. Patients who present a history of radiculopathy or regional pain syndrome. Patients with a worker's compensation claim or pending litigation claim. Patients with Outerbridge Grade IV changes on either acetabular or femoral articular cartilage.

Primary outcomes:
measure: Pain Using Visual Analog Scale
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: