louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02346435: The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry
Official title: The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Neoplasm
Keywords: small renal mass
active surveillance
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
First posted: 2015-01-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients (18-100) presenting with a clinically localized, solid renal mass (cT1a, \<=4cm).

Brief summary: Retrospective studies indicate that active surveillance for clinically localized, small renal masses (cT1a, \<=4cm) is safe. It is our hypothesis that active surveillance is safe and efficacious when compared prospectively to patients undergoing immediate intervention for their small renal mass.

Detailed description: All patients are offered active surveillance or immediate intervention, as applicable, prior to being offered consent for the DISSRM Registry. All patients are enrolled and followed prospectively. Surveillance patients are followed per protocol with serial imaging, blood work and quality of life questionnaires. Intervention patients are followed at the discretion of the attending surgeon with serial QOL appointments/questionnaires.

Eligibility criteria: Inclusion Criteria:

* Must have a solid, enhancing renal mass ≤4cm at its greatest dimension found on incidental scanning in the last 6 months.
* Age ≥ 18 and able to read, understand and sign informed consent.
* Must be willing to adhere to the treatment algorithm and time constraints therein.

Exclusion Criteria:

* Cannot have suspicion of metastases to the kidney if any other malignancy diagnosed within two years of study entry.

Primary outcomes:
measure: Disease-specific survival
timeFrame: 5 years
Secondary outcomes:
measure: Objective Safety and Tolerability of Percutaneous Renal Biopsy
timeFrame: 5 years
measure: Quality-of-life outcomes for patients undergoing AS versus definitive therapy.
timeFrame: 5 years
measure: To determine objective selection criteria for active surveillance.
timeFrame: 5 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mohamad E Allaf, MD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Nirmish Singla
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06442735: Clinical Application of Intrapartum Ultrasound
Official title: Vaginal Delivery Facilitated by Intrapartum Ultrasound During Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abnormal Labor
Complication of Delivery
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 455
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Intrapartum ultrasound monitoring is to be compared with conventional labor monitoring to clarify the accuracy of this technology, and then provide a basis for later related research.

Detailed description: Intrapartum ultrasound monitoring is to be compared with conventional labor monitoring to clarify the accuracy of this technology, and then provide a basis for later related research. All pregnant women intending to have a vaginal delivery were enrolled in the study. After admission, women were randomly assigned to either intrapartum ultrasound (IPUS) or vaginal examination (VE). In IPUS group, the patient was evaluated by ultrasound, including fetal orientation, pelvic and cervical conditions. IPUS and VE were performed every 2 to 4 hours during the first stage of labor and at least hourly during the second stage. The progress of labor, the occurrence of complications and the prediction of the success rate of vaginal delivery were observed. Finally, the investigators compared whether there were any differences in labor and vaginal delivery complications between the two groups.

Eligibility criteria: Inclusion Criteria:

* All pregnant women in the delivery room for vaginal trial labor

Exclusion Criteria:

* Those who reject ultrasound

Primary outcomes:
measure: Duration of the first stage of labor
timeFrame: Day 1
measure: Duration of the second stage of labor
timeFrame: Day 1
measure: Number of Participants with fever
timeFrame: Day 3
measure: Number of Participants with the soft birth canal laceration I, II,III, IV
timeFrame: Day 1
measure: Number of Participants with postpartum hemorrhage
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT00317135: Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.
Official title: Assess Reactogenicity and Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Compared to Tritanrix™-HepB/Hiberix™ (Control) in Healthy Infants (2,4,6 Months Age), After a Hepatitis B Birth Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Hepatitis B
Whole Cell Pertussis
Haemophilus Influenzae Type b
Tetanus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-04-24
Enrollment: 500
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the reactogenicity \& safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.

Detailed description: Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth:

- One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups) - GSK Biologicals' Tritanrix™-HepB/Hiberix™

Eligibility criteria: Inclusion criteria at study entry:

* Healthy infants aged less than or equal to 3 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.

Exclusion criteria at study entry:

* Any confirmed immunodeficient condition, based on medical history \& physical examination.
* A family history of congenital or hereditary immunodeficiency.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Acute disease at the time of enrolment.

Primary outcomes:
measure: Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1
timeFrame: Days 0-3 post dose 1
measure: Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2
timeFrame: Days 0-3 post dose 2
measure: Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3
timeFrame: Days 0-3 post dose 3
Secondary outcomes:
measure: Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose
timeFrame: Days 0-3 after each dose
measure: Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose
timeFrame: Day 0-30 after each dose
measure: Occurrence of serious adverse events during the entire study period
timeFrame: Day 0 up to Month 5
Other outcomes:
Locations:
city: Muntinlupa
country: Philippines
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03745235: A Study Comparing the Influence of a Mindfulness-based Stress Reduction Program vs. Routine Management on Psychological Variables and Biological Markers Related to Immuno-inflammation Associated With Psychological Stress in Caregivers of Patients With Severe Psychiatric Disorders
Official title: A Randomized Controlled Study Comparing the Influence of a Mindfulness-based Stress Reduction Program vs. Routine Management on Psychological Variables and Biological Markers Related to Immuno-inflammation Associated With Psychological Stress in Caregivers of Patients With Severe Psychiatric Disorders.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychiatry
Caregivers
Mindfulness
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this project is to study the influence of mindfulness meditation on psychological health (stress level, affects, emotions) and physical health parameters (rate of inflammatory markers in the blood, activity of white blood cells involved in immuno-inflammation) in caregivers of people with psychiatric disorders. This study will provide the objective scientific data required for the development of mindfulness meditation programs for psychiatric caregivers.

80 participants will be randomly assigned to one of the following two groups:

* 40 participants in the "Mindfulness" group who will attend mindfulness meditation sessions in addition to their standard follow-up
* 40 participants in the "Control" group who will have a standard follow-up The duration of participation is 12 months and includes 3 visits and 8 mindfulness-based meditation sessions for the "Mindfulness" group.


Eligibility criteria: Inclusion Criteria:

* patient who has given oral consent
* adult patient
* a caregiver of a person with a severe psychiatric disorder (schizophrenia, recurrent depression, bipolar disorder, obsessive-compulsive disorder)

Exclusion Criteria:

* protected adult
* patient not affiliated to the national health insurance system
* pregnant, parturient or breastfeeding woman
* person suffering from a severe psychiatric disorder indicating a state of decompensated stress (with risk of associated biological inflammatory disturbances)
* person suffering from an inflammatory disease (autoimmune, infectious, neoplastic, cardio-vascular pathologies

Primary outcomes:
measure: measurement of inflammation by analysis of US-CRP blood levels
timeFrame: Change from Baseline US-CRP blood levels at 3 and 12 months
measure: measurement of inflammation by analysis of IL-6 blood levels
timeFrame: Change from Baseline IL-6 blood levels at 3 and 12 months
measure: measurement of lymphocyte activity Th1 Th2 Th17 Treg
timeFrame: Change from Baseline lymphocytes activity Th1 Th2 Th17 Treg at 3 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT04340635: Multi-center Ocular Biological Parameters Study
Official title: Analysis of Eye Bioparametric Data of Chinese Population Based on Big Data
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Keywords: Corneal astigmatism
axial length (AL), anterior chamber depth (ACD)
partial coherence interferometry
Lead sponsor: Aier School of Ophthalmology, Central South University
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 20000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Select elderly cataract patients from different regions of China (at least one representative city in each of east, south, west, north, and central China) who were treated in Aier Eye Hospital.

Brief summary: This study is a multi-center study, which collects data from multiple regions to obtain the general biological characteristics of the Chinese population. The formula for calculating the artificial lens power based on foreign populations is effectively modified based on the Chinese population.

Detailed description: ①Relevant domestic studies on the biological characteristics of the eye are mainly limited to a certain city and region. Most of the studies that represent the biological characteristics of the general population in China and the differences in biological parameters at home and abroad are in the research process, or Semi-finished products.

②The investigators found in clinical observation that the eyeball biological data of the Chinese population may not be consistent with the foreign population.

③ This study is the first study of human eye biological parameters based on different regions of large-scale populations in China, which is of great significance for understanding the human eye structure in different regions of China.

Eligibility criteria: Inclusion Criteria:

* patients aged over 50 years

Exclusion Criteria:

* history of refractive surgery,
* corneal diseases
* ocular inflammation
* trauma

Primary outcomes:
measure: axial length (AL)
timeFrame: 1 hour
measure: anterior chamber depth (ACD)
timeFrame: 1 hour
measure: keratometric power (K)
timeFrame: 1 hour
measure: corneal astigmatism (CA)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Aier Eye Hospital
state: Shanghai
Study officials:
References:
citation: Qian Z, Xie X, Yang J, Ye H, Wang Z, Chen J, Liu H, Liang J, Jiang L, Zheng C, Chen X. Detection of shallow anterior chamber depth from two-dimensional anterior segment photographs using deep learning. BMC Ophthalmol. 2021 Sep 22;21(1):341. doi: 10.1186/s12886-021-02104-0.
Clinical trial NCT02646358: Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer
Official title: A Phase 1, Open-Label, Non-Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Vepoloxamer in Subjects With Varying Degrees of Renal Impairment and Healthy Matched Control Subjects With Normal Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics of Vepoloxamer
Healthy Volunteers
Renal Impaired
Lead sponsor: Mast Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is an open-label study designed to evaluate the effect of renal disease on the pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with normal renal function.


Eligibility criteria: Key Inclusion Criteria:

* Subject must weigh ≤ 125 kg and have a body mass index between 20 and 40 kg/m2
* Subject must be willing to be confined in the clinical research unit for the duration of the study, up to 5 days
* If female, subject must not be pregnant or lactating, have a negative pregnancy test, and agrees to sexual abstinence, or use of an appropriate birth control method from screening through 30 days after study drug administration
* If male, subject agrees to sexual abstinence, is surgically sterile, or is using an appropriate birth control method from screening through 30 days after study drug administration
* Considered by the Investigator to be healthy or clinically stable with respect to underlying renal impairment based on medical evaluation including vital signs, ECG and laboratory test results
* Non-smoker, or smokes fewer than 10 cigarettes/day

Key Exclusion Criteria

* Uncontrolled medical condition (treated or untreated) considered to be clinically significant by the Investigator
* Experienced an illness considered by the Investigator to be clinically significant within 2 weeks of study drug administration
* Treatment with another investigational drug or device study within 30 days or 5 half-lives (whichever is longer) prior to screening
* Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1
* Donated or lost a significant volume of blood or plasma within 90 days prior to study drug administration

Primary outcomes:
measure: Pharmacokinetics variable - Area under the plasma concentration curve
timeFrame: Time zero through 96 hours
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03
timeFrame: Time zero through Day 14
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: DaVita Clinical Research
state: Colorado
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
Study officials:
affiliation: Mast Therapeutics, Inc.
name: Edwin L Parsley, DO
role: STUDY_DIRECTOR
References:
Clinical trial NCT00848458: Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma
Official title: Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma - An Open Randomized, Controlled, Prospective, Single Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Melasma
Keywords: Azelaic Acid
Iontophoresis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-02-20
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this prospective, randomized, controlled, single-blinded investigation is to study the efficacy, tolerability and safety of azelaic acid iontophoresis (AAI) versus topical treatment with azelaic acid cream in female patients with melasma.

Detailed description: Patients will be randomized and allocated in concealed manner to one of the two treatment arms: AAI or topical azelaic acid cream.

Azelaic acid iontophoresis treatment schedule:

Patients randomized to the AAI group will receive iontophoresis with 15% azelaic acid twice weekly over a period of 12 weeks.

Azelaic acid topical treatment schedule:

Patients randomized to the topical treatment group will receive topical treatment with 20% azelaic acid cream twice daily over a period of 12 weeks.

Besides emollients no additional specific treatments will be allowed during the study.

The use of broad spectrum (UVA+UVB) sunscreen is recommended over the entire study period (9 month).

Follow-up period:

After completion of the active study period (3 month in both treatment groups), maintenance and efficacy of both treatment schedules will be followed up quarterly over 6 month

Eligibility criteria: Inclusion Criteria:

* Woman
* MASI - Score over 6
* Age: over 18 years
* Skin Type: III, IV, V

Exclusion Criteria:

* Skin Type: I, II, VI
* Pregnant or lactating women
* Local therapy of intent-to-treat area within the last 6 month
* Patient with a pacemaker or metal implant
* Epileptic
* Mental incompetence to understand the protocol
* Known allergic reactions to one of used substances
* Serious encroachment on physical condition

Primary outcomes:
measure: Change in colorimetric measurement of skin colour and MASI-Score after 12 weeks of treatment
timeFrame: 3 month
Secondary outcomes:
measure: Physician Global Assessment, Patient Global Assessment, Overall Response Assessment
timeFrame: 3 month
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna / Depatment of Dermatology
Study officials:
affiliation: MUV
name: JB Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MUV
name: Oliver Schanab, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01429558: Electrophysiological Recording for Patients Receiving Deep Brain Stimulation Electrode for Treatment-resistant Obsessive-compulsive Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obsessive-compulsive Disorder
Keywords: treatment resistant obsessive-compulsive disorder
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2011-09-07
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects in this study are suffering from treatment-resistant OCD

Brief summary: The purpose of this project is to study live recordings from neuronal population of the human nucleus accumbens during the implantation of deep brain stimulation (DBS) electrodes for the treatment-resistant obsessive compulsive disorder (OCD). The central aim of this project is to determine if intra-operative electrophysiological data can confirm that the electrode is located in the nucleus accumbens. This confirmation could allow the placement of the DBS electrodes with a higher degree of precision. An additional aim of this project will be to study the activity of the neuronal population of the nucleus accumbens while a subject is presented with a task involving an unexpected reward.

The investigators central hypothesis is that unexpected reward will be associated with increase firing and synchrony in the neuronal population. This will translate into recordable increase activity in the investigators region of interest and therefore confirm the proper placement of the electrode.

This study enrolled 2 subjects, with 1 subject completing the protocol showing the feasibility of the experiment. There were electrophysiological variations with the task presented but no conclusion could be drawn given the small sample size.


Eligibility criteria: Inclusion Criteria:

* Treatment-resistant OCD
* Failure of psychotherapy
* Failure of pharmacotherapy
* Meets inclusion criteria for DBS implant in OCD

Exclusion Criteria:

* Significant substance use disorder
* Significant personality disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
References: