louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06573593: Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study
Official title: Efficacy and Safety of JAK Inhibitors in Patients With Alopecia Areata: a Single-center, Real-world Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alopecia Areata
Janus Kinase Inhibitors
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with alopecia areata treated with JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib for more than 3 months in Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine

Brief summary: The introduction of Janus Kinase inhibitors (JAKi) seems to revolutionize the field of alopecia areata (AA) therapeutics. However, the ideal JAKi is not yet settled and the real-world data are still missing. To provide evidence about effectiveness and safety of different JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib in real-world settings and describe baseline disease characteristics and patients profiles that are considered good candidates for JAKi in the daily practice. Furthermore, we intended to investigate the efficacy and safety of JAK Inhibitors in patients With AA, as well as to provide clinical evidence for the clinicians and patients when they formulate individualized treatment plans.


Eligibility criteria: Inclusion Criteria:

* Patients with alopecia areata between 2 to 18 years old
* Patients diagnosed with alopecia areata according to AA guideline
* AA Patients treated with JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib for more than 3 months

Exclusion Criteria:

* Patients had previously received hair implants
* Other alopecia
* Other diseases may induce alopecia including psoriasis, lichen planus, et al.
* Unable to estimate SALT score at baseline or at follow-up
* Patients are participating in other clinical trials

Primary outcomes:
measure: Mean SALT
timeFrame: at week 24
measure: SALT50
timeFrame: at week 24
measure: SALT75
timeFrame: at week 24
Secondary outcomes:
measure: Mean SALT
timeFrame: at week 12, 36, 48, 56
measure: SALT50
timeFrame: at week 12, 36, 48, 56
measure: SALT75
timeFrame: at week 12, 36, 48, 56
measure: Safety profile
timeFrame: at week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Xianjie Wu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03033693: Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor
Official title: Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Brain Tumor, Supratentorial,Outcome
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Shanxi Provincial People's Hospital
name: Guiyang Jinyang Hospital
name: Beijing Sanbo Brain Hospital
name: The Second Hospital of Hebei Medical University
name: The Affiliated Hospital of Inner Mongolia Medical University
name: Chinese PLA General Hospital
name: Anhui Provincial Hospital
name: Guangdong 999 Brain Hospital
name: Zhejiang University
First posted: 2017-01-27
Enrollment: 1461
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Recent studies have shown that deep anesthesia is associated with poor outcome. There is still lack of randomized controlled trials with large sample size on the effect of depth of anesthesia on the postoperative outcomes in patients undergoing brain tumor resection. The investigators are performing a randomized and parallel group trial. The aim of the study is to determine whether there is a causal relationship between the depth of anesthesia and postoperative clinical outcome in patients undergoing supratentorial tumor surgery.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled to receive elective supratentorial tumor resection under general anesthesia from 2017 to 2019 will be recruited in the trial. Inclusion criteria include ages between 18 and 80 years old, American Society of Anesthesiologists (ASA) physical status Ⅲ-Ⅳ, surgery duration expected to be equal or more than three hours, postoperative hospital stay expected to be equal or more than five nights, and monitoring BIS throughout anesthesia.

Exclusion Criteria:

* Patients who undergo emergency or awake craniotomy surgery, or unable to present the written consent will be excluded from the trial. The patients whose incision site conflicts with the placement of BIS electrode on the frontal and temporal lobe will also be excluded from the study.

Primary outcomes:
measure: Disability-free survival rate
timeFrame: Postoperative 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tian Tan Hospital
Study officials:
affiliation: Department of Anesthesiology, Beijing Tian Tan Hospital
name: Ruquan Han, M.D., Ph.D
role: STUDY_CHAIR
References:
citation: Cui Q, Peng Y, Liu X, Jia B, Dong J, Han R. Effect of anesthesia depth on postoperative clinical outcome in patients with supratentorial tumor (DEPTH): study protocol for a randomized controlled trial. BMJ Open. 2017 Sep 11;7(9):e016521. doi: 10.1136/bmjopen-2017-016521.
Clinical trial NCT06417593: Phenotypic and Genotypic Characteristics of Pseudomonas Aeruginosa Isolates in Sohag University Hospitals
Official title: Phenotypic and Genotypic Characteristics of Pseudomonas Aeruginosa Isolates in Sohag University Hospitals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pseudomonas Aeruginosa Infection
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients with different types of health care associated infections as urinary tract infections, infected burn, ventilator associated pneumonia, blood stream infections and surgical site infections will be obtained under complete aseptic precautions.

Brief summary: Isolation and identification of Pseudomonas aeruginosa using basic microbiological methods, such as Gram staining, cultivation on cetrimide agar and biochemical reactions from Samples from patients with different types of health care associated infections as urinary tract infections, infected burn, ventilator associated pneumonia, blood stream infections and surgical site infections that will be obtained under complete aseptic precautions.


Eligibility criteria: Inclusion Criteria:

* Samples from patients with different types of health care associated infections as urinary tract infections, infected burn, ventilator associated pneumonia, blood stream infections and surgical site infections will be obtained under complete aseptic precautions.

Exclusion Criteria:

* Any infection before 48 hours of patient admission at Hospital

Primary outcomes:
measure: Isolation and identification of pseudomonas aeruginosa causing different nosocomial infections.
timeFrame: 6 months
measure: Identification of antibiotic susceptibility pattern of isolated strains of pseudomonas
timeFrame: 6 months
measure: Detection of biofilm forming isolates
timeFrame: 6 months
measure: Detection of virulence and antibiotic resistance genes of pseudomonas aeruginosa.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of medicine Sohag university hospital
Study officials:
References:
Clinical trial NCT01329393: Benefits Management for People With Psychiatric Disabilities
Official title: Benefits Management for People With Psychiatric Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dual Diagnosis
Schizophrenia
Bipolar Disorder
Keywords: Disability
Social Security
Representative Payee
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: VA Connecticut Healthcare System
First posted: 2011-04-05
Enrollment: 99
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: This stage 1 clinical trial will determine pilot efficacy, develop a therapy manual, and collect qualitative data concerning a brief money management intervention for people disabled by psychiatric illnesses.


Eligibility criteria: Inclusion Criteria:

* Has received treatment for a psychiatric disorder within 60 days of enrollment
* Receives SSI or SSDI payments totaling at least $600 per month
* Has an identified outpatient clinician
* Either i) Homeless within the past 3 months. Homeless is defined as having spent at least seven days in a shelter, outdoors (e.g. in a park, in a car), in a public or abandoned building (e.g. train station), or temporarily (less than a continuous month) housed by family or friends OR ii) Hospitalized within the past 3 months

Justification for Inclusion Criteria: Homelessness and hospitalization are common reasons for payee assignment (Conrad, Matters et al. 1998). In a prior study, we found that a high proportion of hospitalized inpatients meet criteria for needing a payee (Rosen, Rosenheck et al. 2002a). There is no point enrolling clinically stable outpatients in this study because they are unlikely to need payees.

Exclusion Criteria:

* Already has a conservator or representative payee
* An application to assign a payee or conservator has been initiated
* Unable to speak and understand English

Primary outcomes:
measure: Change in the Summed score on the Heinrich-Carpenter Quality of Life Measure
timeFrame: Change from Week 0 to Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Institute of Living
state: Connecticut
Study officials:
affiliation: Yale University
name: Marc I. Rosen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05654493: Use of Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) for Glaucoma Patients
Official title: Use of Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) for Glaucoma Patients: Clinical Outcomes. Prospective Observational Cohort Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Glaucoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 65
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: The purpose of this study is to evaluate the clinical outcomes of the Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) after 1 day, 1 week,1 month, 3 months, 6 months and one year of follow-up, with the intent to evaluate the efficacy of using MP-TSCPC to treat glaucoma patients.

Detailed description: Patients will be submitted to MP-TSCPC throughout the year of 2020, according to parameters determined by the Principal Investigator and executed by the Principal Investigator, after signing the Consent Form and agreeing on having their data used for research purpose. Postsurgical follow up visits will be scheduled for 1 month, 3 months, 6 months and 12 months. Patients IOP, number of medications, visual acuity, visual field, iris color, retinal nerve fiber layer thickness on OCT and any complications (iritis, corneal edema, hyphema, vitreous hemorrhage, vision loss, cataract progression or hypotony maculopathy) will be measured by trained ophthalmic assistants supervised by the Principal Investigator and documented at each visit. Authorized Mayo Clinic personnel will perform chart reviews; using administrative data as designated by Dr. Dorairaj. The data will be statistically analyzed to illustrate the results and determine if the objectives and primary and secondary endpoints were achieved

Eligibility criteria: Inclusion Criteria:

* Diagnose of glaucoma
* Indication to be submitted to the procedure

Exclusion Criteria:

* Significant thinning of the sclera
* Current eye infection or inflammation
* Intraocular surgery performed less than 2 months prior to the enrollment in the study

Primary outcomes:
measure: Change In IOP
timeFrame: Baseline, 12 months post procedure
Secondary outcomes:
measure: Number of anti-glaucoma medications
timeFrame: 12 months
measure: Change in visual acuity
timeFrame: Baseline, 12 months post procedure
measure: Change in cup-disc ratio
timeFrame: Baseline, 12 months post procedure
measure: Change in visual field
timeFrame: Baseline, 12 months post procedure
measure: Change in iris color
timeFrame: Baseline, 12 months post procedure
measure: Complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Syril Dorairaj, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06556693: Janus II Feasibility
Official title: Janus II: A Feasibility Study to Evaluate Response to Remede Dual Channel System Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep Apnea
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2024-08-16
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to evaluate the feasibility of the remedē® Dual Channel System at implant and overnight sleep studies and to assess chronic safety.


Eligibility criteria: Inclusion Criteria:

* Severe sleep disordered breathing
* Expected to tolerate study procedures
* No heart failure or medically stable heart failure

Exclusion Criteria:

* Currently implanted with a neurostimulator to treat sleep disordered breathing without sponsor approval
* History of severe COPD or pulmonary arterial hypertension
* Current or previous history of nerve injury or palsy
* Prior cervical surgeries or radiation treatment to head region
* Known need for an MRI
* History of psychosis or severe bipolar disorder
* Active Infection or sepsis within 30 days of enrollment
* Currently on kidney dialysis or significantly reduced kidney function
* Hemoglobin less than 8g/dl
* Pacemaker dependance
* New defibrillator or any implantable device or device generator changeout within 30 days prior to study implant or anticipated within the first 12 months
* Other conditions or anticipated surgical procedure expected to affect ability to complete study procedures
* Allergy to contrast dye unless can be prophylactically treated
* Known pregnancy or planning to become pregnant

Primary outcomes:
measure: Safety through 12 months
timeFrame: 12 Months post implant
measure: Successful Implantation
timeFrame: implant procedure
measure: Improvement in sleep disordered breathing
timeFrame: 12 months post implant
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ZOLL Respicardia
name: Robin Germany, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06490393: The Impact of Supervision by a Health Care Professional on Quality of Life Questionnaire
Official title: The Impact of Supervision by a Health Care Professional on Quality of Life (QoL) Questionnaire Scoring and Completion:, Randomized, Cross-over Study in Cancer Patients Receiving Systemic Antineoplastic Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Health-related Quality of Life
Lead sponsor: St. Claraspital AG
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is planned to enroll at least 200 patients into this study. Patient recruitment will be conducted during 2 years (2024-2026)

Brief summary: Effect of supervision on scoring and completion on Quality of Life Questionnaire

Detailed description: This protocol will study the impact of supervision on completion and scoring of sensitives domains of QoL Questionnaires and QoL Questionnaires in general in a multi-center, randomized, cross-over design in cancer patients receiving systemic antineoplastic therapy

Eligibility criteria: Inclusion Criteria:

* Patient is ≥18 years of age and legally competent
* Signed informed consent available
* Systemic oncologic treatment (e.g. chemotherapy, immunotherapy, endocrine therapy)
* Current systemic therapy started at least 4 weeks before randomization and is scheduled to continue for at least another 4 weeks after randomization in the same dose and interval
* Patient is ready and able to complete quality of life questionnaires in German (on paper

Exclusion Criteria:

* One or more of the inclusion criteria not met.

Primary outcomes:
measure: EORTC QLQ-C30
timeFrame: 2024-2026
measure: EORTC QLQ-SH22
timeFrame: 2024-2026
measure: Questionnaire called "Financial consequences" routinely used by the Social department of St. ClaraSpital
timeFrame: 2024-2026
Secondary outcomes:
measure: Incidence of reported sexual problems
timeFrame: 2024-2026
measure: Patient preference
timeFrame: 2024-2026
measure: Time
timeFrame: 2024-2026
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: St Clara Research Ltd
state: Basel-Stadt
Study officials:
affiliation: St. Claraspital Klinische Forschung
name: Diana de Jong-Bakker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02409693: Retrospective Analysis of Perioperative Anesthetic Care and Analgesia Management of Patient Undergoing Bilateral Myringotomy With Tube Insertion
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Otitis Media With Effusion (OME)
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone anesthesia for surgical ear tube placement at Nationwide Children's Hospital from January 1, 2015 through February 28, 2015.

Brief summary: This is a retrospective chart review. The purpose of this study is to retrospectively examine the use of perioperative analgesics on the incidence of postoperative pain and emergence delirium in patients undergoing bilateral myringotomy with tube insertion (BTI), as well as events associated with treatment including postoperative vomiting and time to discharge.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent myringotomy with tube insertion from January 1, 2015 through February 28, 2015 at NCH.

Exclusion Criteria:

* None

Primary outcomes:
measure: Post-operative pain scores
timeFrame: 1 hr post-op
Secondary outcomes:
measure: Presence of emergence delirium
timeFrame: 1 hr post-op
measure: Post-operative nausea & vomiting
timeFrame: 1 hr post-op
Other outcomes:
Locations:
Study officials:
affiliation: Nationwide Children's Hospital
name: Richard Cartabuke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01835093: An Open Study of Tipepidine Hibenzate in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: Tipepidine for ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Chiba University
Sponsor class: OTHER
First posted: 2013-04-18
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Accumulating evidence suggests a role of G protein-coupled inwardly-rectifying potassium (GIRK) channel in the pathology of excitement of nerve, and the medicine with the action (like the Tipepidine Hibenzate) is expected as a new curative medicine of Attention Deficit / Hyperactivity Disorder (AD/HD).

The purpose of this research is to confirm the effect by carrying out the additional dosage of the Tipepidine Hibenzate to the AD/HD patients.

If suggestion is obtained by this research about the effect on AD/HD of Tipepidine Hibenzate, it can contribute to development of the medical treatment of AD/HD.


Eligibility criteria: \[Inclusion Criteria\]

1. Attention-Deficit/Hyperactivity Disorder (AD/HD) for DSM-IV TR criteria.
2. Patients are treated with Atomoxetine, Methylphenidate, atypical antipsychotic drugs (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone) or not treated.
3. Patients are stable for 4-weeks for medication.

\[Exclusion Criteria\]

1. Patients with a previous hypersensitivity to Tipepidine Hibenzate.
2. Patients treated with typical antipsychotics and selective norepinephrine reuptake inhibitor (NRI) except atomoxetine and stimulants except methylphenidate.
3. Pregnant or breast-feeding women

Primary outcomes:
measure: ADHD Rating Scale-IV (ADHD-RS) Japanese Version
timeFrame: Changes from baseline in ADHD-RS at 4-weeks
Secondary outcomes:
measure: Cognition using DN-CAS (Das-Naglieri Cognitive Assessment System) Japanese Version
timeFrame: Change from baseline in the scores of battery at 4-weeks
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Department of Psychiatry, Chiba University School of Medicine
state: Chuo-ku
Study officials:
affiliation: Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine
name: Masaomi Iyo, MD,PhD
role: STUDY_CHAIR
References:
citation: Sasaki T, Hashimoto K, Tachibana M, Kurata T, Okawada K, Ishikawa M, Kimura H, Komatsu H, Ishikawa M, Hasegawa T, Shiina A, Hashimoto T, Kanahara N, Shiraishi T, Iyo M. Tipepidine in children with attention deficit/hyperactivity disorder: a 4-week, open-label, preliminary study. Neuropsychiatr Dis Treat. 2014 Jan 24;10:147-51. doi: 10.2147/NDT.S58480. eCollection 2014.