louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05009017: Multi-Centre, Observational Study on Safety of Bevacizumab Biosimilars in Clinical Practice Among Chinese Patients
Official title: The Safety Study of Bevacizumab Biosimilars in the Real World
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biosimilar
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients in 3 study hospitals diagnosed with non-small cell lung cancer or colorectal cancer using originator or biosimilar of bevacizumab

Brief summary: Monoclonal antibody drugs are expensive, and the listing of biosimilar drugs can help increase the availability and lower prices of biologic drugs, and can better meet the public's demand for biotherapeutic products. The first bevacizumab biosimilar in China was launched in December 2019. Although monoclonal antibody biosimilar drugs are similar to the original drug in terms of quality, safety and effectiveness, their production process may be different from the original drug, and their clinical application cannot be completely equivalent to the original drug. Especially after the market is applied to a wider patient population, the safety and effectiveness are more worthy of attention. This study started from the perspective of pharmacy. Three hospitals in China participated in the real-world safety assessment of bevacizumab biosimilars. An observational cohort study design was adopted to include all cases of lung cancer and colorectal cancer using bevacizumab biosimilars and original drugs during the study period, and the propensity score matching was used to reduce the influence of confounding factors and conduct safety assessment.


Eligibility criteria: Inclusion Criteria:

* ①Inpatients diagnosed with non-small cell lung cancer or colorectal cancer; ②Bevacizumab biosimilars or original drugs were used for treatment during the study period.

Exclusion Criteria:

* ①Age\<18 years old; ②Person who has used bevacizumab within six months.

Primary outcomes:
measure: Adverse drug reactions
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Zhengzhou
country: China
facility: Wenzhou Zhang
state: Henan
Study officials:
References:
Clinical trial NCT03321617: Glutamate Reducing Interventions in Schizophrenia
Official title: Glutamate Reducing Interventions in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clinical High Risk for Psychosis
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-10-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, randomized, phase 1b, multiple dose trial
Primary purpose: TREATMENT

Brief summary: Participants will be administered several doses of pomaglumetad (POMA) (low and high doses) over 14 days to individuals at clinical high risk for developing psychosis and use magnetic resonance imaging (MRI) brain imaging to determine whether these doses of POMA are affecting glutamate levels.

Detailed description: A double-blind, randomized, phase 1b, multiple dose trial of 14 days of treatment with POMA (80 mg, 160 mg, 240 mg, 320 mg) in clinical high risk patients to determine which dose, if any, reduces glutamate and metabolism using MRI techniques. The GO NO-GO decision will be whether or not any dose tested in the R61 phase of the trial decreases left hippocampal CA1 region cerebral blood volume (CBV).

Eligibility criteria: Inclusion Criteria:

* Capacity to provide informed consent
* Currently using a reliable form of birth control

Exclusion Criteria:

* Metal implants in body or a history of metal working
* Lifetime diagnosis of asthmatic symptoms within the past 3 years or known sensitivity to contrast agents
* Lifetime diagnosis of renal failure/disease
* Acute neurological, neuroendocrine, or medical disorder including renal insufficiency (CrCl\<40 mL/min/1.73m2)
* Lifetime diagnosis of hypertension or diabetes or seizure disorder
* IQ\<70
* Acute risk for suicide and/or violence
* Pregnant lactating
* Current abuse of substances (alcohol, cocaine, stimulants, cannabis, opiates, sedative hypnotics)
* Current use or anticipated need for antipsychotics or mood stabilizers (all antipsychotics, also depakote, lithium, lamotrogine, pregabalin or any med with a mechanism of action like gabapentin), probenecid, selective serotonin reuptake inhibitors, tricyclic antidepressants, and monoamine oxidase inhibitors
* More than one previous gadolinium scan

Primary outcomes:
measure: Percent Change in Left Hippocampal CA1 Region Cerebral Blood Volume (CBV) From Baseline to Day 14
timeFrame: Baseline to 14 days of POMA/placebo
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia University
name: Scott Small, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01762917: Influence of Bag Volume Variation on the Reproducibility of Inert Gas Rebreathing
Official title: Influence of Bag Volume Variation in Inert Gas Rebreathing Pulmonary Blood Flow Measurements on the Reproducibility in Patients With Pulmonary Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Bronchial Asthma
Restrictive Pulmonary Disease
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2013-01-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: inpatients and outpatients, internal medicine, university hospital

Brief summary: Non-invasive inert gas rebreathing (IGR) based on the Fick Principle showed promising results in the determination of pulmonary blood flow (PBF). The volume of the rebreathing bag (Vbag) is proposed by the system, however, elderly patients or those suffering from high grade pulmonary diseases might be unable to entirely rebreathe this volume and therefore fail to completely mix the test gases. The aim of our study is to evaluate the effect of adapting Vbag on the reproducibility of IGR measurements in patients with obstruction (group A), restriction (group B) and pulmonary healthy controls (group C).


Eligibility criteria: Inclusion Criteria:

* ability to perform rebreathing maneuver

Exclusion Criteria:

Primary outcomes:
measure: pulmonary blood flow
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Hospital Mannheim
Study officials:
References:
Clinical trial NCT01132417: In Vitro Activity of Tigecycline Among Key Bacterial Pathogens Exhibiting Multidrug Resistance
Official title: In Vitro Activity of Tigecycline Among Key Bacterial Pathogens Exhibiting Multidrug Resistance
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Infections, Bacterial
Keywords: Tigecycline, MDR
Patient infected with multidrug resistance bacteria
Lead sponsor: King Faisal University
Sponsor class: OTHER
First posted: 2010-05-28
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Definition: For observational studies only, a description of the population from which the groups or cohorts will be selected (e.g., primary care clinic, community sample, residents of a certain town).

Brief summary: Observational: studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

Detailed description: Study Phase Definition: Phase of investigation, as defined by the US FDA for trials involving investigational new drugs. Select only one.

N/A: for trials without phases Observational Study Design Case-control: group of individuals with specific characteristics (e.g., conditions or exposures) compared to group(s) with different Time Perspective Cross-sectional: observations or measurements made at a single point in time, usually at subject enrollment Biospecimen Retention - select one Samples Without DNA - samples retained, with no potential for DNA extraction from any retained samples (e.g., fixed tissue, plasma) Biospecimen Description

Sputum, whole blood, urine, tissue Enrollment

Single group study Number of Groups/Cohorts Definition: Number of study groups/cohorts. Enter 1 for a single-group study. Many observational studies have one group/cohort; case control studies typically have two.

One study group, anticipated samples in the rang of 400-500 samples 8. Arms, Groups and Interventions N/L Group/Cohort Label

Eligibility criteria: Inclusion Criteria:

* All patients with infection with MDRs infections will be included

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: King Faisal Univrsity, Departmentof Microbiology and Immunology,, dammam branh
state: Eastern
Study officials:
affiliation: Assist. Professor and Consultant Microbiologist
name: Asim E Ltayeb Diab, MD, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00911417: A Study to Collect Intravascular Ultrasound Images Before and After Treatment With the Jetstream System
Official title: The Jetstream G2 System Post-Market Peripheral Vascular IVUS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Peripheral Vascular Disease
Keywords: peripheral arterial disease
peripheral vascular disease
Lead sponsor: Pathway Medical Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Jetstream System is a commercially available rotating, aspirating, expandable catheter designed to remove atherosclerotic plaque and blood clots in the lower limbs. The purpose of this study is to use intravascular ultrasound (IVUS) during the interventional procedure to measure the amount of plaque and blood clots removed by the Jetstream System.


Eligibility criteria: Inclusion Criteria:

* The patient is ≥ 18 years of age.
* The documented peripheral vascular disease is/are located in a superficial femoral, popliteal or tibial peroneal trunk arteries in the lower limb.
* The patient is an acceptable candidate for percutaneous intervention using the Jetstream G2 System in accordance with its labeled indications and instructions for use.
* The patient has been informed about the nature of the study and has provided informed consent.

Exclusion Criteria:

* Patient has no distal runoff.
* Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
* Patient is pregnant or nursing a child.
* Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Jetstream G2 System.
* Patient has clinically significant abnormal ECG or blood test results or any other factor that would put the patient at increased risk if participating in the study.

Primary outcomes:
measure: Plaque Morphology
timeFrame: up to 12 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Phoenix
country: United States
facility: St. Luke's Hospital
state: Arizona
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Detroit
country: United States
facility: St. John Hospital & Medical Ctr.
state: Michigan
city: New York City
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
affiliation: St. John's Hospital and Medical Center
name: Tom Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04492917: The Effect of CV4 and Sacral Technique on the Alpha Bands Power
Official title: The Effect of CV4 and Sacral Technique on the Alpha Bands Power: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Osteopathic Manipulation
Keywords: EEG
Alpha Rhythm
CV4
Lead sponsor: Istituto Superiore di Osteopatia di Milano
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Compression of the fourth ventricle (CV4), is the most studied cranial technique, commonly used by Osteopathy in Cranial Field practitioners. Evidence attributed to CV4 some effects on nervous system functions, however, the supporting evidence for CV4 clinical benefits is promising but still poor. The osteopathic tradition considers the sacrum linked to the cranium through anatomical and functional connections. To our knowledge, no studies explored the potential effect of a sacral technique on brain activity as an indicator of a neurophysiological connection between the occiput and sacrum. This study aims to explore this effect by measuring the alpha-band activity during the application of a sacral technique (ST) compared to the CV4 application.

Detailed description: Forty healthy volunteers will receive a combination of CV4 technique, CV4 sham, sacral technique (ST) and sacral sham technique (sST).

Each session, split by a 4-hour washout, will start with 10 min of no treatment (resting state), followed by two randomized interventions. Alpha EEG will be continuously recorded during each intervention and 10 min after, for a total of approximately 50-60 min per session.

Eligibility criteria: Inclusion Criteria:

* Age
* Subjects had to sleep for at least 6 hours the night before the experiment

Exclusion Criteria:

* Use of Psychoactive or Psychotropic Substances
* Cerebrovascular diseases
* Recent headaches
* Use of nicotine in the 24 hours prior to the quantitative EEG registration
* Use of alcohol in the previous 12 hours.

Primary outcomes:
measure: Alpha EEG
timeFrame: 50 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Centro di Medicina Osteopatica
Study officials:
affiliation: Istituto Superiore di Osteopatia
name: Pisa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04606017: Effect of Vitamin D Supplementation on Infliximab Response in Patients With Crohn's Disease
Official title: Influence of Vitamin D3 Supplementation on Infliximab Efficacy in Chinese Patients With Crohn's Disease: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Vitamin D Deficiency
Vitamin D Supplement
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese

Brief summary: Background: It remains uncertain whether vitD3 supplementation is beneficial for remission of Crohn's disease (CD). The influence of vitD3 supplementation on Infliximab (IFX) efficacy was retrospectively analyzed in Chinese CD patients. Methods: Patients with moderate-to-severe CD, who were bio-naïve and prescribed with IFX treatment for at least 54 weeks were recorded. VitD3 supplementation was defined as patients additionally took oral vitD3 (125 IU/d) within 3 days after the first infusion and persisted in the whole follow-up period. Disease activity was assessed using Harvey-Bradshaw Index (HBI). Serum cytokine profiles were quantitatively analyzed in a subset of all patients at baseline and 54-week after intervention.


Eligibility criteria: Inclusion Criteria:

* moderate-to-severe CD
* Treated with Infliximab
* bio-naïve at the time of diagnosis

Exclusion Criteria:

* had recent supplementation of vitD3
* had prior or concomitant use of other biologic agent, glucocorticoid and/or immunomodulators at the time of enrollment
* pregnant
* had cognitive/developmental disorders that affected their ability to complete the study procedures
* had medical illness or therapies potentially affecting bone, nutrition or growth status

Primary outcomes:
measure: Serum 25 (OH) D level
timeFrame: 54 weeks
measure: disease activity
timeFrame: 54 weeks
Secondary outcomes:
measure: the metabolism of calcium and phosphorus
timeFrame: 54 weeks
measure: the expression profiles of Th-cell-related cytokines
timeFrame: 54 weeks
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: SAHWenzhouMU
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Xia sheng long long, Master
role: STUDY_DIRECTOR
References:
citation: Xia SL, Min QJ, Shao XX, Lin DP, Ma GL, Wu H, Cao SG, Jiang Y. Influence of Vitamin D3 Supplementation on Infliximab Effectiveness in Chinese Patients With Crohn's Disease: A Retrospective Cohort Study. Front Nutr. 2021 Oct 22;8:739285. doi: 10.3389/fnut.2021.739285. eCollection 2021.
Clinical trial NCT03889717: Comparison of Two Different Doses of Vitamin D in Preterm Infants
Official title: A Randomized Controlled Trial Comparing Two Regimens of Vitamin D Supplementation in Preterm Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteopenia of Prematurity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: after randomization ,two different groups of premature neonates are enrolled in the study baseline calcium,phosphorus and alp and vitamin D withdrawn at the 1st 48 hrs, then neonates started to administer vitamin D drops after they reached 100 cc per kg per day until they complete 40th week gestational age .follow up labs will be done at this age to determine which dose is better in vitamin d deficiency prevention
Primary purpose: TREATMENT

Brief summary: randomized clinical trial comparing two different doses of vitamin d supplementation in preterm infants

Detailed description: after randomization each group of preterm neonates (28-32) weeks consisting of 40 neonates

within 48 hrs of birth baseline ca.phosphorus, alkaline phosphatase and vitamin D level were withdrawn from each neonate

then babies started to take oral vitamin d in different doses (400 IU /day in the 1st group and 1000 iu per day in the 2nd group) after they reach 100 cc per kg per day enteral feeding

after they complete 40th week gestational age the investigators repeat the labs again ( serum ca, phosphorus,alp and vitamin D and compare the rate of rise in vitamin D and calcium

Eligibility criteria: Inclusion Criteria:

* Preterm infants delivered at a gestational age ≤ 32 weeks
* Birth weight ≤1500 kg

Exclusion Criteria:

* Neonates with major congenital anomalies,
* maternal condition or medications likely to influence vitamin D or calcium metabolism
* neonates not receiving 100 ml/ kg / day of enteral feeds by 14 days of life

Primary outcomes:
measure: Compare the level of serum 25 hydroxy vitamin D between the two groups of newborns. 2- Detect vitamin D deficiency among both groups.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr alainy
Study officials:
References:
Clinical trial NCT04830917: Conservative Treatment of Mallet Finger Injury
Official title: Prospective Randomized Clinical Trial Comparing Kinesiotape and Oval 8 to Quick Cast for Conservative Treatment of Mallet Finger Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conservatively Treated Mallet Finger Injury
Lead sponsor: Orthopaedic Specialty Group PC, Fairfield
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 70
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: Comparing outcomes of individuals treated with Kinesiotape and oval 8 versus quick cast for a conservatively managed mallet finger injury. Outcomes include DIP joint extension lag, patient satisfaction and function via the MHQ.


Eligibility criteria: Inclusion Criteria:

* determined by a physician to require conservative treatment for a mallet finger injury, at least 18 years of age

Exclusion Criteria:

* previous injury to the involved digit impacting ROM

Primary outcomes:
measure: Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit
timeFrame: 12 weeks from injury
Secondary outcomes:
measure: Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit
timeFrame: 6 months post injury
measure: Brief Michigan Hand Outcome Questionnaire
timeFrame: 12 weeks from injury
measure: Brief Michigan Hand Outcome Questionnaire
timeFrame: 6 months post injury
measure: Satisfaction on a visual analog scale (0-10)
timeFrame: 12 weeks from injury
measure: Satisfaction on a visual analog scale (0-10)
timeFrame: 6 months post injury
measure: Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit
timeFrame: 12 week post injury
measure: Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit
timeFrame: 6 months post injury
measure: Pain according to a numeric pain rating scale (0-10/10)
timeFrame: 12 weeks after injury
measure: Pain according to a numeric pain rating scale (0-10/10)
timeFrame: 6 months post injury
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Orthopaedic Specialty Group PC
state: Connecticut
Study officials:
References: