louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00803153: PASCAL: Safety and Complications, Experience After 1301 Consecutive Cases
Official title: Pattern Scan Laser Photocoagulation: Safety and Complications, Experience After 1301 Consecutive Cases.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Bruch Rupture
Choroidal Detachment
Keywords: Panretinal photocoagulation
Bruch rupture
Choroidal detachment
complication rates
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients which has been treated with the pattern scan laser system between november 2007 to july 2008.

Brief summary: To report the safety and incidence of adverse effects, during and after a successful photocoagulation for different pathologies using a Pattern Scan Laser (PASCAL) system and its modified settings


Eligibility criteria: Inclusion Criteria:

* Patients treated with PASCAL system

Exclusion Criteria:

* Uncompleted file.
* Loss of follow-up.

Primary outcomes:
measure: Complication rates
timeFrame: during treatment and follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Asociación para Evitar la Ceguera en México
state: DF
Study officials:
References:
Clinical trial NCT04053153: Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity
Official title: Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sleep Apnea
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Asate LLC, DE
First posted: 2019-08-12
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of Asate Silent Sleep Training on obstructive sleep apnea (OSA) severity in patients with mild to moderate OSA. The Asate Silent Sleep Training is a muscle strengthening program that uses exercise equipment (a musical instrument that is based on the didgeridoo). The equipment is connected to an application, which provides instruction on how to perform the strengthening exercises, measures the sound produced by the musical instrument, which enables the app to provide feedback on whether the individual should blow less or more and also tracks adherence to the strengthening program.


Eligibility criteria: Inclusion Criteria:

* Age 21 to 50
* Diagnosed by a physician with mild to moderate OSA, based upon interpretation of data recorded on a take home sleep study
* Body mass index \< 30 kg/m2
* Mild to moderate OSA, AHI of 5-30

Exclusion Criteria:

1. Apnea hypopnea index on overnight sleep study \> 30 per hour
2. Currently practices didgeridoo
3. Consumes more than 2 alcoholic beverages per day
4. History of chronic lung disease (e.g., COPD, asthma)
5. Oral maxillofacial issue or craniofacial musculoskeletal conditions
6. Any treatment for OSA (current or past)
7. Mobile device use frequency \< once per week
8. Homelessness
9. No reliable transportation to assessment sessions
10. Planned social/family/employment obligations that would limit participant from engaging in Asate Silent Sleep training during the intervention period
11. Significant upper extremity weakness/paralysis or pain limiting ability to hold the Medical Didgeridoo
12. Uncorrected low vision or blindness
13. Deafness
14. No Internet connection/Chrome browser/mobile devices with iOS and Android
15. No USB port in computer
16. Pregnancy

Primary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: 8-12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02890953: Efficacy and Safety of Pneumostem® for IVH in Premature Infants (Phase 2a)
Official title: Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of IVH in Premature Infants (Phase 2a)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cell Transplantation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 22
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of a single intraventricular administration of Pneumostem® for treatment of Intraventricular hemorrhage (IVH) in high-risk premature infants by comparing Pneumostem-treated group with a control group.


Eligibility criteria: Inclusion Criteria:

* IVH grade 3-4
* age : within postnatal day 28
* gestational age: 23-\<34 weeks

Exclusion Criteria:

* Patient with severe congenital abnormalities
* Patient with antenatal brain hemorrhage
* Patient with asphyxia or Hypoxic ischemic encepalophathy
* Patient with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc)
* Patient with a concurrent severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc)
* Patient withCRP \> 30 mg/dL; Severe sepsis or shock
* Patient with a history of participating in other clinical studies
* Patient who is considered inappropriate to participate in the study by the investigator

Primary outcomes:
measure: Shunt or death
timeFrame: 40 weeks of corrected age
Secondary outcomes:
measure: Death
timeFrame: at 2years
measure: Developmental delay in gross motor function, 2y
timeFrame: at 2years
measure: Developmental delay Bayley -3
timeFrame: at 2years
measure: Developmental delay in KDST, 2y
timeFrame: at 2 years
measure: Language delay
timeFrame: at 2 years, at 5 years
measure: Developmental delay in KDST, 5y
timeFrame: at 5 years
measure: Developmental delay in gross motor function
timeFrame: at 2years
measure: Developmental delay in gross motor function, 5y
timeFrame: at 5years
measure: epilepsy
timeFrame: at 2 years, at 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: So Yoon Ahn, MD. Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00961753: Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates
Official title: Safety and Efficacy of an Optimized Ibuprofen Dosing Regimen Versus Standard Dosing for Pharmacologic Closure of Patent Ductus Arteriosus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Patent Ductus Arteriosus
Keywords: PDA
Ibuprofen
Preterm
Neonate
Lead sponsor: OSF Healthcare System
Sponsor class: OTHER
First posted: 2009-08-19
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 29
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies.

Detailed description: Failure to close the PDA in premature neonates in a timely fashion can lead to pulmonary over-circulation and systemic under-circulation. The PDA often fails to close using currently approved Ibuprofen dosing regimens, and surgical closure becomes necessary. Ibuprofen clearance in premature neonates is significantly correlated with postnatal age, increasing rapidly over time. Hirt et al. published and optimized dosing scheme for preterm neonates based on pharmacokinetic and pharmacodynamic data. We aim to use this dosing regimen in the clinical setting to determine if increased rates of pharmacologic PDA closure can be achieved.

Eligibility criteria: Inclusion Criteria:

* All neonates (0-29 days old) less than or equal to 33 post-menstrual age at time of PDA diagnosis requiring nasal CPAP or mechanical ventilation
* Echo confirmed PDA with a transductal diameter of 1.5 mm or greater and demonstrating a left-to-right shunt
* Signed informed consent

Exclusion Criteria:

* Presence of: ductal-dependent congenital heart disease, pulmonary hypertension,
* Active bleeding (including Grade 3 or 4 IVH)
* Platelet count \< 100,000
* Coagulopathy
* Suspected NEC
* Suspected perforation
* Creatinine \> 1.5
* Hyperbilirubinemia requiring exchange transfusion
* Hypotension requiring pressor support
* Life-threatening congenital malformation

Primary outcomes:
measure: PDA Closure
timeFrame: 1-42 days of age
Secondary outcomes:
measure: renal function
timeFrame: 1-30 days of age
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Children's Hospital of Illinois at OSF Saint Francis Medical Center
state: Illinois
Study officials:
affiliation: OSF Healthcare System
name: James R Hocker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05514353: A Phase 1 Study to Assess Single and Multiple Ascending Doses of PBI-100 Topical Cream
Official title: A Phase 1, Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetic Characteristics of Single and Multiple Ascending Doses of PBI-100 Topical Cream in Healthy Adult Subjects and Subjects With Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Psoriasis
Lead sponsor: Pyramid Biosciences
Sponsor class: INDUSTRY
First posted: 2022-08-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, randomized, double-blind, vehicle-controlled, SAD / MAD study evaluating three dose levels of PBI-100 topical cream in healthy adult volunteers and/or subjects with psoriasis.

Detailed description: This is a Phase 1, randomized, double-blind, vehicle-controlled, SAD / MAD study. Three dose levels of PBI-100 topical cream will be evaluated in healthy adult volunteers and/or subjects with psoriasis. Dose escalations will follow a satisfactory review by the Safety Review Committee of all available safety, tolerability, and PK data from the current dose level.

Eligibility criteria: Key Inclusion Criteria:

* Is male or female, between 18 and 65 years of age
* Has a body mass index (BMI) between 18.0 and 32.0 kg/m2
* Is in good general health, as determined by the Investigator, without clinically significant medical history, with the exception of psoriasis for those subjects enrolled in the psoriasis groups

Key Exclusion Criteria:

* Has any visible skin disease (other than psoriasis for subjects in Groups 4 and 7) at the application site which, in the opinion of the Investigator, would interfere with the evaluation of the test site reaction

Primary outcomes:
measure: Number of Adverse Events (AEs) in Healthy Adult Subjects
timeFrame: From dosing until discharge, up to Day 28
measure: Number of Adverse Events (AEs) in Adult Subjects with Psoriasis
timeFrame: From dosing until discharge, up to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Fair Lawn
country: United States
facility: TKL Research Inc.
state: New Jersey
Study officials:
affiliation: Pyramid Biosciences
name: Chief Medical Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT01956253: Single Subject Neratinib in Bladder Cancer (NRR)
Official title: Single Subject Neratinib in Bladder Cancer
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Bladder Cancer
Keywords: Bladder Cancer
Neratinib
13-2526
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-10-08
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study will be a single subject study to evaluate the efficacy of the HER2 kinase inhibitor, neratinib, in a patient with metastatic bladder cancer harboring a HER2-GRB7 gene fusion.


Eligibility criteria: Inclusion Criteria:

\* none

Exclusion Criteria:

\* none

We have received FDA approval for a single subject Investigational New Drug (IND) Application to treat a specific patient with the HER2 kinase inhibitor neratinib. Therefore there is no inclusion / exclusion criteria.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: North Carolina Cancer Hospital (UNC)
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: William Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01306253: A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2009/2010 Influenza Virus Strains for the Northern Hemisphere
Official title: Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2009/2010-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: 2011-03-01
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to assess whether the Northern Hemisphere 2009/2010 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, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (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: Numbers of Subjects Reporting Solicited Local Adverse Events
timeFrame: Days 1 to 4 inclusive, and Day 22
measure: Numbers of Subjects Reporting 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 NCT03465553: Palliative Short Course Radiotherapy for Advanced Thoracic Cancer
Official title: Palliative Short Course Accelerated Radiation Therapy for Advanced Thoracic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Keywords: palliative care
thoracic cancer
radiotherapy
pain
quality of life
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation therapy in patients with symptomatic advanced thoracic cancer.

Detailed description: The study wants to define the maximum tolerated dose (MTD) of a conformal short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of advanced thoracic cancer.

Eligibility criteria: Inclusion Criteria:

* histologically proven advanced thoracic cancer
* excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status
* age \> 18 years
* Eastern Cooperative Oncology Group (ECOG) \<3

Exclusion Criteria:

- prior radiotherapy to the same region

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: 1 year
Secondary outcomes:
measure: Acute toxicity
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
measure: Pain relief
timeFrame: 1 year
measure: Late toxicity
timeFrame: 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Radiation Oncology Center, Dept. of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital
Study officials:
affiliation: Radiation Oncology Center, Dept. of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy
name: Alessio G. Morganti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farina E, Macchia G, Buwenge M, Siepe G, Zamagni A, Cammelli S, Cilla S, Wondemagegnhu T, Woldemariam AA, Uddin AFMK, Sumon MA, Cellini F, Deodato F, Morganti AG. Radiotherapy in palliation of thoracic tumors: a phase I-II study (SHARON project). Clin Exp Metastasis. 2018 Dec;35(8):739-746. doi: 10.1007/s10585-018-9942-6. Epub 2018 Oct 8.
Clinical trial NCT00002353: A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects
Official title: A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Vaccines, Synthetic
AIDS Vaccines
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate an HIV lipopeptide immunotherapeutic, P3C541b, at two dose levels administered subcutaneously in HIV-seropositive patients.

Detailed description: Patients are randomized to receive P3C541b or placebo within each of two study groups. Enrollment in the first group will be independent of HLA type, whereas all but two of the patients enrolled in group 2 must have one or more HLA types A33, B8, B27, or Bw62. Treatment in group 2 will not begin until those in group 1 have reached day 14 without serious toxicity.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV positivity.
* CD4 count \>= 500 cells/mm3.
* No evidence of AIDS, persistent diarrhea, fever, oral hairy leukoplakia, herpes varicella-zoster (multidermatomal), oral candidiasis, opportunistic infections, severe cytomegalovirus infection, or disseminated or chronic herpes simplex.
* Successful establishment of EBV transformed B lymphoblastoid cell line.

NOTE:

* Most patients in group 2 must possess one or more HLA types A33, B8, B27, or Bw62.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active syphilis.
* Positive circulating hepatitis B virus antigen.
* Active clinically significant medical problems.
* Evidence of psychiatric, medical, or substance abuse problems that would affect ability to participate on study.
* Occupational or other responsibilities that would prevent completion of study.

Concurrent Medication:

Excluded:

* Other HIV immunotherapeutic.
* Zidovudine or analog.
* Investigational therapies for HIV.

Patients with the following prior conditions are excluded:

* History of cancer unless surgically excised with reasonable assurance of cure.
* History of anaphylaxis or other serious adverse reactions to vaccines.
* History of serious allergic reaction to any substance that required hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasms, or hypotension).
* History of autoimmune disease or use of immunosuppressive medications.
* History of suicide attempts or past psychosis.

Prior Medication:

Excluded within the past 6 months:

* HIV immunotherapeutic.
* Zidovudine or analog.
* Investigational therapies for HIV. Illicit drug use within past 30 days.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Hosp
state: Massachusetts
Study officials:
References: