louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00190723: A Study of LY317615 in Patients With Brain Tumors
Official title: A Phase II Trial of LY317615 in Patients With Recurrent High-Grade Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Glioma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 120
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: 1. The safety of LY317615 and any side effects that might be associated with the drug.
2. Whether LY317615, can help patients with brain tumors.


Eligibility criteria: Inclusion Criteria:

* You must be at least 18 years old
* You must have been diagnosed with a recurrent brain tumor by MRI or CT scan
* You must be able to swallow the LY317615 tablets

Exclusion Criteria:

* You are a woman who is pregnant or breastfeeding
* In view of your doctor, you have significant heart, liver, kidney, or psychiatric disease

Primary outcomes:
measure: To establish data regarding the anti-tumor activity of LY317615 in patients with recurrent high-grade gliomas.
Secondary outcomes:
measure: To obtain preliminary information regarding the spectrum of toxicities of LY317615 administered to patients with recurrent high-grade gliomas
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Maryland
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01607723: "NAVA-PAV" Study: a Cross-over Comparative Study of 2 Advanced Modes
Official title: Comparison of Two New Ventilatory Modes: NAVA vs PAV+: a Randomized Controlled Cross-over Study: the "NAVA-PAV" Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Critical Illness
Mechanical Ventilation
Intensive Care
Ventilation Weaning
Keywords: Sleep pattern
Mechanical ventilation
weaning
Intensive Care
NAVA (Neurally Adjusted Ventilatory Assist)
PAV+ (Proportional Assist Ventilation Plus)
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Neurally adjusted ventilatory assist (NAVA) and Proportional Assist Ventilatory Plus (PAV +) are new modes of mechanical ventilation that delivers ventilatory assist in proportion to the electrical activity of the diaphragm for NAVA and to patients efforts for PAV +. The goal of this trial is to compare oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern between NAVA and PAV+.

Detailed description: Twenty patients will be enrolled. They will be ventilated with PAV+ and NAVA for one day, each in a randomized crossover order. The oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern will be compared.

Eligibility criteria: Inclusion Criteria:

* Estimated remaining duration of mechanical ventilation for more than two days
* patient alert and calm
* Surrogate decision maker's consent

Exclusion Criteria:

* Clinical contraindication for the use of NAVA: contraindications for an EAdi catheter placement (e.g., esophageal varices, upper gastrointestinal bleeding, gastroesophageal surgery)
* Clinical instability for any reason
* Contraindications for continuing intensive care treatment
* Patient under tutelage
* Age \< 18 years
* Pregnancy
* No French health insurance

Primary outcomes:
measure: Oxygenation in NAVA and in PAV+
timeFrame: after one day of ventilation in NAVA and in PAV+
Secondary outcomes:
measure: Ventilatory comfort
timeFrame: Every 6 hours in the two ventilatory modes
measure: Patient-ventilator asynchronies
timeFrame: During the 24h of mechanical ventilation in NAVA and in PAV+
measure: Ventilatory parameters
timeFrame: During the 24h of mechanical ventilation in NAVA and in PAV+
measure: Sleep pattern
timeFrame: During 24h of mechanical ventilation in NAVA and in PAV+
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Department of Anesthesiology & Critical Care, St Eloi University Hospital
Study officials:
References:
Clinical trial NCT02025023: Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study
Official title: Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chalazion
Keywords: Size
Pain
Resolution
Complications
Swelling
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Local injection of 5-fluorouracil into a chalazion (stye) is as effective as local injection of triamcinolone (steroid) and incision and curettage for treatment of chalazia.

Detailed description: This is a prospective randomized interventional study comparing four current standard-of-care treatments for chalazia: incision and curettage, local injection of triamcinolone, local injection of 5-FU, and local injection of combination triamcinolone/5-FU.

Eligibility criteria: Inclusion Criteria:

* Single or multiple chalazia in a single eyelid

Exclusion Criteria:

* Chalazia present for less than one month and no previous injection or incision and curettage

Primary outcomes:
measure: Size of chalazion
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Eye Institute at Harborview
state: Washington
Study officials:
affiliation: University of Washington Eye Institute
name: Matthew M Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06745050: Hybrid Type-1 Effectiveness-Implementation Trial of Motivation Matters!
Official title: Hybrid Type-1 Effectiveness-Implementation Trial of Motivation Matters! A Theory-Based mHealth Intervention to Support Early Antiretroviral Adherence in HIV+ African Women Who Engage in Sex Work
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Antiretroviral Therapy (ART) Adherence
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Partners for Health and Development in Africa (PHDA)
First posted: 2024-12-20
Enrollment: 350
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 goal of this clinical trial is to learn if an interactive mHealth intervention will be effective in helping HIV-positive women in high-burden settings who are initiating antiretroviral therapy (ART) take their ART regularly as prescribed, effectively reducing their viral load. The main question it aims to answer is:

- Compared to standard of care, will Motivation Matters! (MM!) be significantly more effective at achieving undetectable viral load in women with HIV by month six.

Researchers will compare the undetectable HIV viral load in women who receive individualized text messages (intervention group) in addition to standard care to those who receive standard care alone (control group).

Participants in the intervention group will receive three messages per week in month one, then two messages per week for the six-month intervention period. Participants will be asked to send a brief, standardized reply to each message, indicating that they are doing well or that they have a question or problem. Regardless of study arm, women will receive ART and counseling consistent with Kenyan guidelines.


Eligibility criteria: Inclusion Criteria:

* Age \>18
* Transactional sex in past 12 months
* HIV-positive
* Not currently on ART
* Enrolled in one of the Sex Workers Outreach Program clinics
* Has access to mobile phone
* Willing to receive study text messages
* Able to read or have someone else read

Exclusion Criteria:

* Plans to move away in next 6 months
* Undetectable viral load at baseline
* Pregnant

Primary outcomes:
measure: Participants with undetectable viral load at 6 months
timeFrame: From enrollment to end of study at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Partner for Health and Development in Africa
Study officials:
affiliation: University of Washington
name: Raymond S McClelland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01825850: Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects
Official title: A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Irbesartan in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2013-04-08
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of the study is to investigate the drug interaction between Gemigliptin and Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered concomitantly and each alone in healthy male subjects.


Eligibility criteria: * Inclusion Criteria

  * Age between 20 to 45, healthy male subjects (at screening)
  * BMI between 18 - 27 kg/m2 (at screening)
  * Blood pressure SBP 90-140 mmHg, DBP 60-95 mmHg
  * FPG 70-125mg/dL glucose level (at screening)
  * Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the
* Exclusion Criteria

  * Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
  * Subject who had GI tract disease that influencable to drug absorption or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
  * Subject who had drug hypersensitivity reaction.(gemigliptin, irbesartan, aspirin, antibiotics)
  * Subject who already admitted in other investigator product in 80 days
  * Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently

Primary outcomes:
measure: Cmax,ss
timeFrame: up to 72h post-dose
measure: AUCτ,ss
timeFrame: up to 72h post-dose
Secondary outcomes:
measure: Cmin,ss
timeFrame: up to 72h post-dose
measure: Tmax,ss
timeFrame: up to 72h post-dose
measure: Cmax,ss
timeFrame: up to 72h post-dose
measure: AUCτ,ss
timeFrame: up to 72h post-dose
measure: metabolic ratio
timeFrame: up to 72h post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
citation: Choi HY, Lim HS, Kim YH, Jeon HS, Kim MJ, Lee SH, Jung JH, Lee YK, Kim HJ, Bae KS. Evaluation of the pharmacokinetics of the DPP-4 inhibitor gemigliptin when coadministered with rosuvastatin or irbesartan to healthy subjects. Curr Med Res Opin. 2015 Feb;31(2):229-41. doi: 10.1185/03007995.2014.980886. Epub 2014 Nov 6.
Clinical trial NCT03731650: Non-grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Using Different Implant Lengths
Official title: Non-grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Using Different Implant Lengths
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillary Sinus Lift
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: twenty recruited patients indicated for sinus augmentation and simultaneous implant placement will be divided into two groups (10 in each of the groups).to evaluate \& compare bone formation \& implant stability after shneiderian membrane elevation and augmentation with graft less tenting technique with different implant lengths.

group one will receive 8mm implant lenght while group two will receive 10mm implants.


Eligibility criteria: Inclusion Criteria:

* patient with atrophic maxilla \& pneumatized maxillary sinus with residual bone height at least 4mm of residual ridge
* both sexes

Exclusion Criteria:

* patients with systematic diseases that may affect normal healing
* sinus pathology
* heavy smokers more than 20 cigarettes per day

Primary outcomes:
measure: height of gained bone
timeFrame: 6 months post operative
Secondary outcomes:
measure: implant stability
timeFrame: will be measured intra operative after implant insertion and will be measured once more 6 months post operative after the first operation at the time of implant exposure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05819450: Sonography-Guided Volumetric Rejuvenation on Dorsal Hands
Official title: Sonography-Guided Volumetric Rejuvenation on Dorsal Hands: A Split-Hand Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ultrasound
Injection Site
Keywords: Cosmetic
Volumetric rejuvenation
Filler
Dorsal hand
Ultrasound
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 200
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: The goal of this randomized controlled study is to guide volumetric rejuvenation on dorsal hands with the maximal aesthetic appearance. The main questions it aims to answer are:

* Which fatty layer(s) is/are the most suitable for filler injection?
* Is it feasible to make precise filler injections with sonography guidance? Participants will receive sonography-guided injection on the one hand and another with blinded injection.

Detailed description: In our previous study, volumetric fat loss was noted in the 3 fatty laminae of dorsal hands during aging; the dorsal intermediate lamina (DIL) showed the greatest progressive fat loss after the age of 30. Volumetric rejuvenation of the 3 laminae may result in the most aesthetic appearance, especially in women. It is necessary to develop precise rejuvenation therapies according to the aging process of the dorsum of the hands that will yield the most aesthetic appearance.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of aging changes on the dorsal hands
* Aged ≥18 years

Exclusion Criteria:

* History of severe hand dermatitis
* History of rheumatic arthritis
* History of major hand trauma
* History of limb edema
* History of recent significant weight changes
* History of previous filler injection to the dorsal hands
* History of intravenous catheter insertion and hemodialysis via the forearms or hands

Primary outcomes:
measure: Aesthetic improvement
timeFrame: Day 0, 30, 180 follow up
Secondary outcomes:
measure: Thickness of the fatty laer
timeFrame: Day 0, 30, 180 follow up
Other outcomes:
Locations:
city: Marbella
country: Spain
facility: Ocean Clinic Marbella
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yi-Teng Hung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05019950: Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers
Official title: A Randomized, Placebo-Controlled, Double-Blind, Single-Center Study to Evaluate Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Normal Healthy Volunteers
Lead sponsor: NImmune Biopharma
Sponsor class: INDUSTRY
First posted: 2021-08-25
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The primary objective of this study is to assess the safety and tolerability of single and 7-day repeat oral doses NIM-1324 in healthy adult volunteers.


Eligibility criteria: Key Inclusion Criteria:

1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects;
2. Adult males and females, 18 to 64 years of age (inclusive) at screening;
3. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Key Exclusion Criteria:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant;
2. Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications;
3. COVID-19: Testing positive for COVID-19, a current symptomatic infection within 20 days, or an asymptomatic infection within 6 weeks.

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 1 to 14 days
Secondary outcomes:
measure: PK
timeFrame: 24 hours
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Clinical Site
state: Queensland
Study officials:
References:
Clinical trial NCT00005650: Genetic Study of Patients With Primary Ciliary Dyskinesia
Official title: Genetic Study of Patients With Primary Ciliary Dyskinesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Ciliary Dyskinesia
Keywords: cardiovascular and respiratory diseases
genetic diseases and dysmorphic syndromes
primary ciliary dyskinesia
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of North Carolina
First posted: 2000-05-03
Enrollment: 180
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY

Brief summary: OBJECTIVES:

I. Characterize the clinical presentation of patients with primary ciliary dyskinesia.

II. Identify the genetic mutations associated with this disease.

Detailed description: PROTOCOL OUTLINE:

Participants undergo a scrape biopsy acquisition of nasal cells for ciliary studies, a chest radiograph, sinus radiographs, lung function tests, sputum cultures, nitric oxide measurement, and an ear, nose and throat evaluation to screen for primary ciliary dyskinesia (PCD). Blood collection and/or a buccal scrape is also performed for genetic studies.

Genetic studies include molecular linkage analyses, genetic mapping, and gene mutation identification based on large deletions. Microsatellite markers are used to identify polymorphism.

Genetic counseling is provided to all participants.

Eligibility criteria: * Histologically or cytologically confirmed primary ciliary dyskinesia (PCD)
* Family members of patients with PCD

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Peadar G. Noone
role: STUDY_CHAIR
References:
Clinical trial NCT05692050: Expanded Access to Epcoritamab
Official title: Expanded Access to Epcoritamab
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Lymphoma
Keywords: Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Genmab
First posted: 2023-01-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to epcoritamab prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria: Inclusion Criteria:

- The participant must not be eligible for an epcoritamab clinical trial.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: