louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05324410: A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy Participants
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of VX-840 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: APOL1-mediated Kidney Disease
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2022-04-12
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and PK of single and multiple ascending doses of VX-840 in healthy participants.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Female participants must be of non-childbearing potential
* Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m\^2)
* A total body weight greater than (\>) 50 kg

Key Exclusion Criteria:

* History of febrile illness or other acute illness within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Parts A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 25
Secondary outcomes:
measure: Parts A and B: Plasma Concentration of VX-840 Over Time
timeFrame: From Day 1 up to Day 14
measure: Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity [AUC(0 - inf)]
timeFrame: From Day 1 up to Day 14
measure: Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration [AUC(0-tlast)]
timeFrame: From Day 1 up to Day 14
measure: Part B: Amount of VX-840 Excreted in the Urine During the Dosing Interval (Ae)
timeFrame: From Day 1 up to Day 14
measure: Part B: Associated Renal Clearance (CLr) of VX-840
timeFrame: From Day 1 up to Day 14
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON Lenexa
state: Kansas
Study officials:
References:
Clinical trial NCT06009510: Exploring Engagement Dynamics Among Individuals Impacted by Bladder Cancer
Official title: Participation Trends in Bladder Cancer Clinical Trials - Exploring Engagement Dynamics Among Individuals Impacted by Bladder Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bladder Cancer
Keywords: bladder cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bladder cancer patients who are actively considering enrolling in an observational clinical trial, but have not yet completed enrollment and randomization.

Brief summary: The study seeks to delve into the firsthand experiences of patients diagnosed with bladder cancer who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.

By joining this clinical trial, individuals have the unique opportunity to contribute to the betterment of future bladder cancer patients and play an active role in advancing medical research.


Eligibility criteria: Inclusion Criteria:

* Patient has self-identified as planning to enroll in a clinical trial
* Patient has been diagnosed with bladder cancer
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Inability to perform regular electronic reporting
* Patient is pregnant

Primary outcomes:
measure: Number of patients who decide to participate in a bladder cancer clinical research
timeFrame: 3 months
measure: Rate of patients who remain in bladder cancer clinical research to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Ng K, Stenzl A, Sharma A, Vasdev N. Urinary biomarkers in bladder cancer: A review of the current landscape and future directions. Urol Oncol. 2021 Jan;39(1):41-51. doi: 10.1016/j.urolonc.2020.08.016. Epub 2020 Sep 9.
citation: Gaya JM, Territo A, Woldu S, Schwartzmann I, Verri P, Gonzalez-Perez L, Cozar JM, Minana B, Medina RA, de la Rosa-Kehrmann F, Lozano-Palacio F, Ribal MJ, Hernandez C, Castineiras JJ, Requena MJ, Moreno J, Caraballido JA, Baena V, Breda A, Palou Redorta J. Incidental diagnosis of bladder cancer in a national observational study in spain. Actas Urol Esp (Engl Ed). 2023 Jun;47(5):296-302. doi: 10.1016/j.acuroe.2022.09.005. Epub 2022 Oct 1. English, Spanish.
citation: Malhotra B, Hiteshi P, Khalkho P, Malik R, Bhadada SK, Bhansali A, Shafiq N, Malhotra S, Kumar N, Rajput R, Rastogi A. Bladder cancer with pioglitazone: A case-control study. Diabetes Metab Syndr. 2022 Nov;16(11):102637. doi: 10.1016/j.dsx.2022.102637. Epub 2022 Oct 8.
Clinical trial NCT00220610: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN the Treatment of DEPRESSION
Official title: Right Parietal Inhibition With rTMS in the Treatment of Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Depression
Lead sponsor: St. Lucas Andreas Ziekenhuis Hospital
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects received rTMS daily on 10 consecutive weekdays (five sessions per week), during 20 minutes per session.During the rTMS session, the coil was centered flat over the right parietal cortex.

We follow the patient during 12 weeks after the 2 weeks of tms (follow-up period) to measure the depression with different rating scales.

We hypothesized that rTMS has a positive effect in the treatment of depression


Eligibility criteria: Inclusion Criteria:

* In and outpatients aged between 16 and 65 who met DSM-IV criteria for major depressive episode, and who had a score of 25 or higher on the 10-item Montgomery Asberg Depression Rating Scale (MADRS) were included

Exclusion Criteria:

* A history of epilepsy and any other medical disorder that should preclude the administration of rTMS. Only SSRI's, Mirtazapine and Promethazine as psychotropic medication was accepted if the dosage of antidepressive medication had not been changed for 6 weeks, and if the dosage of Promethazine had not been changed for 2 weeks prior to inclusion. Antidepressive medication had to remain stable during the 14 weeks of the study.

Furthermore: schizophrenic disorder, a piece if metal in the brain, pacemaker and left-handed patients.

Primary outcomes:
measure: To determine the depression (and so the effect of the treatment)we use the 10-item Montgomery Asberg Depression Rating Scale (MADRS)and we measure before tms (T=0), at week 1 (T=1), at week 2 (T=2), at week 4 (T=3), at week 8 (T=4), at week 14 (T=5)
measure: Besides the MADRS we use the BDI (Beck depression Inventory, the Hamillton deppression and anxiety scale)
Secondary outcomes:
measure: -Changes in anxiety
measure: -.Autonomic changes
measure: -.changes in the emotioneal attention, in the emotional memory en in de emotional recognition.
measure: -.Biochemical changes
measure: -.Changes in the EEG
measure: >> measured before tms and after (at T=0 and T=2)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: st. Lucas Andreas Ziekenhuis/ Hospital
Study officials:
affiliation: st Lucas Andreas Ziekenhuis
name: G.F Koerselman, prof. dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02582710: Impact of an Optimized Formulation of Omega 3 on the Composition of Atheromatous Plaques in Patients Requiring Carotid Endarterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Carotid Endarterectomy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 96
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Determining whether treatment with an optimized formulation of omega 3 for 6 weeks causes a 40% decrease in the average concentration of total microparticles (MPs) in the atheromatous plaque.


Eligibility criteria: Inclusion Criteria:

* Men or women between 30 and 85 years
* Affiliated to a social security scheme
* Informed consent signed
* Patients to get an endarterectomy carotid stenosis\> 70% asymptomatic is
* Women of childbearing potential (negative pregnancy test), effective contraception for the duration of the study

Exclusion Criteria:

* Inability to give informed information about the study (subject in emergencies, difficulty of understanding ...)
* Patient treated by OMACOR®
* Patients on oral anticoagulant (AVK, apixaban, dabigatran, rivaroxaban)
* Daily consumption of fish oil (medical food with fish oil (omega 3))
* Carotid Restenosis
* Pregnancy (positive pregnancy test) and lactation
* Hypersensitivity to fish
* Allergy to fish
* Subject under judicial protection
* Subjects under guardianship or curatorship

Primary outcomes:
measure: Number of participants with treatment-related postive event assessed by the reduction of the concentration of procoagulant microparticles in the atherosclortic plaque
timeFrame: an average of 1 to 6 months after the carotid endarterectomy
Secondary outcomes:
measure: Number of participants with treatment-related modification of the content of the plaque assessed by protein biomarkers of the plaque instability and thrombogenicity, and by the identification of the cell origin of the procoagulant microparticles
timeFrame: an average of 1 to 6 months after the carotid endarterectomy
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
Study officials:
References:
Clinical trial NCT01303510: A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2008/2009 Influenza Virus Strains for the Northern Hemisphere
Official title: Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2008/2009-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
Virus
Vaccination
Immunisation
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2011-02-24
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to assess whether the Northern Hemisphere 2008/2009 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines


Eligibility criteria: Inclusion criteria:

* Healthy female and male adults
* Aged ≥18 to ≤60 years or \>60 years on Day 1
* Written informed consent

Exclusion criteria:

* Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
* Acute febrile illness (≥38.0 °C)
* Prior vaccination with an influenza vaccine in the past 330 days
* Known hypersensitivity to any vaccine component
* Previous history of a serious adverse reaction to influenza vaccine
* History of egg protein allergy or severe atopy
* Known blood coagulation disorder
* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of study vaccine; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed
* Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)
* Investigational medicinal product received in the past 3 months (90 days)
* Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
* Pregnancy or lactation
* Participation in another clinical trial
* Employee at the investigational site, or relative or spouse of the investigator
* Suspected non-compliance

Primary outcomes:
measure: Seroconversion
timeFrame: Day 22 ± 2 days
measure: Seroprotection
timeFrame: Day 22 ± 2 days
measure: Fold Increase in Geometric Mean Titer (GMT)
timeFrame: Day 22/Day 1
Secondary outcomes:
measure: Safety: Incidence of Solicited Local Adverse Events
timeFrame: Days 1 to 4 inclusive, and Day 22
measure: Incidence of Solicited Systemic Adverse Events
timeFrame: Days 1 to 4 inclusive, and Day 22
Other outcomes:
Locations:
city: Allschwil
country: Switzerland
facility: Covance Clinical Research Unit AG
Study officials:
affiliation: Covance Clinical Research Unit AG
name: Michael Seiberling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01631110: Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains
Official title: Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2012/2013-Season Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Virus
Vaccination
Inflexal V
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.


Eligibility criteria: Inclusion Criteria:

* Healthy female and male adults aged ≥18 on Day 1
* Written informed consent
* Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years

Exclusion Criteria:

* Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
* Acute febrile illness (≥38.0 °C)
* Prior vaccination with an influenza vaccine in the past 330 days
* Known hypersensitivity to any vaccine component
* Previous history of a serious adverse reaction to influenza vaccine
* History of egg protein allergy or severe atopy
* Known blood coagulation disorder
* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
* Known immunodeficiency (incl. leukemia, HIV seropositivity), cancer
* Investigational medicinal product received in the past 3 months (90 days)
* Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
* Pregnancy or lactation
* Participation in another clinical trial
* Employee at the investigational site, or relative of the investigator
* Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol

Primary outcomes:
measure: Seroprotection
timeFrame: Day 22 +/- 2 days
measure: Seroconversion
timeFrame: Day 22 +/- 2 days
measure: Geometric Mean Titer
timeFrame: Day 22 +/- 2 days
Secondary outcomes:
measure: Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability
timeFrame: Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)
Other outcomes:
Locations:
city: Allschwil
country: Switzerland
facility: Covance Clinical Research Unit AG
Study officials:
affiliation: Covance Clinical Research Unit AG
name: Michael Seiberling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06608810: The Application of Pectoral Nerve II(PECS II)block in Breast Fibroadenoma Resection Surgery
Official title: Comparison of Efficacy in Pectoral Nerve Block Type II, Thoracic Paravertebral Block, and General Anesthesia Alone for Excision of Breast Fibroma: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Lead sponsor: Inner Mongolia Baogang Hospital
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Patients were randomly assigned to the GA group, PECS II group, or TPVB group using a computer-generated random number table. Group assignments were kept in a sealed envelope, which was opened only after induction of general anesthesia on the day of surgery. This study was a double-blind trial, ensuring that neither the patients nor the investigators were aware of the analgesic method used. The same anesthesiologist was responsible for PECS II block or TPVB, while different anesthesiologists were responsible for anesthesia implementation and postoperative follow-up.

Detailed description: Written informed consent was obtained from all participants.90 female patients aged 18 to 65 with ASA I-II status were selected at Baogang Hospital, Inner Mongolia, who had been diagnosed with breast fibroadenomas. Exclusion criteria included pre-existing infection at the site of block, coagulation disorders, morbid obesity (body mass index \&amp;gt; 40 kg/m²), allergy to local anesthetics, impaired lung function, significant cardiac disease, renal dysfunction, pre-existing neurological disorders, and psychiatric conditions.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of breast fibromas

Exclusion Criteria:

* heart attack mental disorder

Primary outcomes:
measure: Changes in visual analog scale scores
timeFrame: From enrollment to the end of treatment at 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Baotou
country: China
facility: Inner Mongolia Baogang Hospital
state: Inner Mongolia
Study officials:
References:
Clinical trial NCT05731310: Clinical Study of Angong Niuhuang Pill and Acupuncture on PSCI Angong Niuhuang Pill Combined With Supervised Pulse Music Electroacupuncture on Cognitive Impairment After Ischemic Stroke
Official title: Efficacy Evaluation and Evaluation of Peripheral Neuroprotective Mechanism of Amgong Niuhuang Pill Combined With Supervised Pulse Music Electroacupuncture on Cognitive Impairment After Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Post-stroke Cognitive Impairment
Keywords: Post-stroke cognitive impairment;acupuncture
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 65
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post stroke cognitive impairment (PSCI) refers to the attainment of cognitive impairment after the clinical event of stroke A range of syndromes that impede diagnostic criteria. Epidemiologically, PSCI is one of the common complications in stroke patients

Detailed description: (1) Clinical scale data of cognitive function, daily living ability of PSCI patients integrated with the research of this project using uterine Niu Huang pill combined with examined pulse music electroacupuncture

For analysis, the efficacy of PSCI patients was observed; (2) In depth studies on auditory event-related potentials of PSCI treated by uterine Niu Huang pill combined with examined pulse music electroacupuncture

The changes of serum related nerve growth factor and the relationship between each other in order to enrich / fill our province's research results in this field; (3) In key academic journals

1 high level scientific research paper published.

Eligibility criteria: Inclusion Criteria:

(1) All were the first stroke, confirmed by head computed tomography (CT) or magnetic resonance imaging (MRI), with vital signs

stable; (2) Those who are conscious and can cooperate with relevant treatment; (3) Montreal Cognitive Assessment Scale (MoCA) score ≤ 24 points; （4）

The course of disease is more than 1 month, and the patient is 40-70 years old.

Exclusion Criteria:

(1) People with cognitive impairment before onset; (2) There are contraindications of Angong Niuhuang Pill or electroacupuncture treatment;

(3) Complicated with dysfunction of heart, liver, kidney and other important organs; (4) Previous history of cerebral hemorrhage, epilepsy, brain injury, etc; (5) Before onset

Have a history of alcohol and drug dependence; (6) The condition worsens, and new hemorrhagic or infarcted foci appear.

-

Primary outcomes:
measure: Simple intelligence state examination scale
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine
name: le zhang
role: STUDY_CHAIR
References: