louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04881656: Evaluating the Impact of Telehealth-Based ASD Assessments and Supports on Child and Caregiver Outcomes
Official title: Evaluating the Impact of Telehealth-Based Autism Spectrum Disorder Assessments and Supports on Child and Caregiver Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: autism
telehealth
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2021-05-11
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall goal of this study is to evaluate telehealth and internet-based approaches to meet accessibility challenges for families with concerns about ASD in their infants. In this study, we will gather exploratory data related to the potential of two telehealth tools: 1) The Telehealth Evaluation of Development for Infants (TEDI); and 2) "Help is in Your Hands" (HIIYH), a set of video materials and information on interactive strategies parents can use to support their child's communication development. We will recruit families participating in an ongoing study using the TEDI (R21 HD100372, PI: Talbott) to evaluate infants' behavioral development. As families exit the parent TEDI study and enter the current study, we will ask parents to complete online questionnaires, and randomize them to either receive immediate access to additional online materials (HIIYH) for parents or no additional materials. After 12 weeks, parents will complete online questionnaires and all families will then be given access to the online materials. When children reach 30 months, we will collect additional questionnaires, complete a live telehealth behavioral session with toddlers and their caregivers, and conduct an exit interview with parents to gather feedback about their experience.


Eligibility criteria: Inclusion Criteria:

Previous enrollment in the parent R21 project (R21 HD100372, PI: Talbott).

Exclusion Criteria:

No previous enrollment in the parent R21 project (R21 HD100372, PI: Talbott).

Primary outcomes:
measure: Parent Stress Index 4th Edition, Short Form
timeFrame: Change from baseline at 12 weeks
measure: Parent Sense of Competence
timeFrame: Change from baseline at 12 weeks
measure: Telehealth Usability Questionnaire
timeFrame: Change from baseline at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Health
state: California
Study officials:
affiliation: University of California Davis, MIND Institute
name: Meagan Talbott, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02571556: OPEN-LABEL, MULTI-CENTER, PHASE 1b/2a CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND EFFICACY OF IONTOPHORETIC DEXAMETHASONE PHOSPHATE OPHTHALMIC SOLUTION IN PATIENTS HAVING UNDERGONE CATARACT SURGERY WITH IMPLANTATION OF A POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
Official title: OPEN-LABEL, MULTI-CENTER, PHASE 1b/2a CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND EFFICACY OF IONTOPHORETIC DEXAMETHASONE PHOSPHATE OPHTHALMIC SOLUTION IN PATIENTS HAVING UNDERGONE CATARACT SURGERY WITH IMPLANTATION OF A POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Patients Having Undergone Unilateral Cataract Extraction and Implantation of a Monofocal
Lead sponsor: Eyegate Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution, EGP-437®, using the EyeGate® II Drug Delivery System (EGDS) in patients having undergone cataract surgery with implantation of a posterior chamber intraocular lens (IOL)

Detailed description: This will be a Phase 1b/2a, open-label, multi-site study, in which a total of up to 20 eyes of up to 20 patients will be enrolled. Patients having undergone unilateral cataract surgery with implantation of a posterior chamber monofocal intraocular lens (IOL) who are interested in participating in the study will be provided an informed consent form prior to screening. Screening/Baseline procedures which include best corrected visual acuity (BCVA), slit lamp examination, conjunctival injection, and intraocular pressure (IOP) by tonometry will be used to determine eligibility just prior to cataract surgery on Day 0. Eligible subjects will undergo iontophoresis treatment immediately post-cataract surgery on Day 0 and Day 7, and will return to the clinic for examination on Days 1, 14, and 28.

Eligibility criteria: Inclusion Criteria:

1. Have undergone unilateral cataract extraction and implantation of a monofocal IOL at the time of enrollment
2. Age 18 to 85 years
3. Receive, understand, and sign a copy of the written informed consent form
4. Be able to return for all study visits and willing to comply with all study-related instructions

Exclusion Criteria:

-

Primary outcomes:
measure: The proportion of subjects with an anterior chamber cell count of zero on Day 14
timeFrame: Day 14
Secondary outcomes:
measure: The proportion of subjects with a pain score of zero on Day 7
timeFrame: Day 7
Other outcomes:
Locations:
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
Study officials:
References:
Clinical trial NCT00733109: Management of Cervical Intraepithelial Neoplasia Grade 2
Official title: Management of Cervical Intraepithelial Neoplasia Grade 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Intraepithelial Neoplasia
Keywords: CIN2
management
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2008-08-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare two management options for CIN 2. This randomized clinical trial performed between 2003 and 2006. A series of 90 Brazilian women diagnosed as CIN2 were randomized into two groups: 1) 45 whose lesion was excised and,2) 45 women subjected to follow-up at 3-month intervals for 12 months.

Detailed description: Pap smear and colposcopy were performed at every follow-up visit and all lesions were completely visible at colposcopy.

The researchers purpose was to make some comments about the over treatment and the misclassification of CIN 2.

Eligibility criteria: Inclusion Criteria:

* Histological CIN2 diagnosis

Exclusion Criteria:

* Previous CIN treatment

Primary outcomes:
measure: 43 women in the follow-up group, 44.1% experienced spontaneous regression, 20.9% had partial regression, 23.2% progressed to CIN3, and 11.6% showed persistence. 44 women whose lesion was excised, the regression rate was 90.9%
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Leonor Mendes de Barros Maternity Hospital
Study officials:
affiliation: Universidade Cidade de Sao Paulo
name: Sylvia F Brenna, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Cidade de Sao Paulo
name: Ana C Guedes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turku
name: Kari J Sirjanen, MD, PhD
role: STUDY_CHAIR
affiliation: University of Campinas, Brazil
name: Luis C Zeferino, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00418756: Effects of Rifampin on the Pharmacokinetics of Nilotinib in Healthy Subjects
Official title: A Phase I Open-label, Two Period, Single Center Study to Assess the Effect of 600 mg Daily Oral Dose of Rifampin (CYP3A4 Inducer) on the Pharmacokinetics of a Single 400 mg Oral Dose of Nilotinib in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: nilotinib
Rifampin
PK
healthy subjects
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of 600 mg daily oral dose of rifampin (CYP3A4 inducer) on the pharmacokinetics of a single 400 mg oral dose of nilotinib in healthy subjects


Eligibility criteria: Inclusion Criteria:

1. Healthy adult male (18 - 55 yrs) and sterile or post menopausal female subjects:
2. Body weight must be ≥50 kg and \<100 kg, with a body mass index (BMI) \>18 but \<33.

Exclusion Criteria:

1. Female who is pregnant, test positive for a serum pregnancy test or currently breast feeding.
2. Contraindication to receiving nilotinib or rifampin.
3. Smokers or use of tobacco products or products containing nicotine in the last 30 days
4. A past medical history of clinically significant Electrocardiogram abnormalities, or a history/family history of long QT-interval syndrome.

Other protocol-defined inclusion/exclusion may apply.

Primary outcomes:
measure: To evaluate the effects of 600 mg rifampin on the pharmacokinetics (PK) of a single 400mg (2 x 200mg capsules) oral dose of AMN107
timeFrame: at pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose after AMN107 administration on Days 1 and 16.
Secondary outcomes:
measure: To assess the safety and tolerability of a single 400mg (2x200mg capsules) oral dose of AMN107 given alone and concomitantly with 600mg rifampin
measure: To determine the ratio of 6ß - hydroxylcortisol to cortisol in urine as an in-vivomarker of CYP3A4 induction with rifampin treatment4.
timeFrame: on Days -1, 11, 15 and 19
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT05522556: Pre-approval Single-patient Expanded Access for Ritlecitinib (PF-06651600)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Alopecia Areata
Keywords: Alopecia Areata (AA)
Alopecia
Patchy AA
Alopecia Universalis (AU)
Alopecia Totalis (AT)
Ophiasis
Eyelash Loss
Eyebrow Loss
Hair Loss
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-08-31
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Provide pre-approval single patient Expanded Access (compassionate use) of Ritlecitinib for patients.

Detailed description: In Expanded Access, treating physicians are the Sponsors. Expanded Access requests from treating physicians may be submitted to www.pfizercares.com. Availability will depend on location and country.

Eligibility criteria: Must have ≥ 50% hair loss on scalp due to Alopecia Areata (AA) and be intolerant or have inadequate response to all commonly used AA therapies accessible in the country. Additional eligibility criteria may be required.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00618709: Dose-Escalation Safety and Pharmacokinetic Study of ATX-101
Official title: Phase 1, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of ATX-101 (Sodium Deoxycholate for Injection) Following Subcutaneous Injections in the Submental Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: Kythera Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-02-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this research is to evaluate the safety and pharmacokinetic profile of single doses of ATX-101

Detailed description: This is a single center, open-label, dose-escalation study in which subjects will receive 4 different dosage concentrations (3 dosing paradigms) of ATX-101 in a single dosing session.

Eligibility criteria: Inclusion Criteria:

* Healthy males or nonpregnant females
* Age 18 to 65
* Sufficient submental fat for injections
* Signed informed consent

Exclusion Criteria:

* Prior interventions in the chin or neck area
* History or presence of drug or alcohol abuse
* Treatment with an investigational agent within 30 days before the dose

Primary outcomes:
measure: Safety assessed by: Laboratory tests
timeFrame: 12 weeks
measure: Safety assessed by: medical evaluations
timeFrame: 24 weeks
measure: Safety assessed by: ECG results
timeFrame: 24 weeks
Secondary outcomes:
measure: Pharmacokinetic profile
timeFrame: 24 hours, before and after dosing
Other outcomes:
measure: Pain assessed by visual analog scale
timeFrame: 24 weeks
Locations:
city: Tempe
country: United States
facility: MDS Pharma Services
state: Arizona
Study officials:
affiliation: MDS Pharma Services
name: Dennis Swearingin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sponsor GmbH
name: Frederick Beddingfield, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06980909: The Food Effect on Pharmacokinetics Study of QLC1101 in Healthy Subjects
Official title: A Single-dose, Randomized, Open-label, Three-period, Crossover Pharmacokinetic Study of QLC1101 in Healthy Subjects in the Fasting and Fed State
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Effect of Food
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This randomized, open-label, three-period, three-treatment crossover Phase I clinical trial is designed to evaluate the pharmacokinetic profile of QLC1101 capsules administered as a single oral dose under fasting conditions, following a high-fat meal, and following a low-fat meal in healthy adult subjects. The study will further characterize the food effect on QLC1101 pharmacokinetics.

A total of 18 eligible subjects will be enrolled and randomized into three treatment sequences (A, B, C) using a balanced crossover design, with 6 subjects per sequence. The study comprises three treatment periods separated by appropriate washout intervals. In each period, subjects will receive a single dose of QLC1101 under one of three distinct dietary conditions according to their assigned sequence. Following completion of the first treatment period and a washout phase, subjects will crossover to the next dietary condition in the subsequent period, with this process repeating through all three study periods.


Eligibility criteria: Inclusion Criteria:

* Male subjects weigh ≥50 kg, female subjects weigh ≥45 kg.
* BMI is within the range of 18.0\~28.0 kg/m2 (including the boundary value).

Exclusion Criteria:

* Those who have a history of allergies to drugs, food, pollen, or other clear allergies, or those who are allergic to the experimental drugs and their ingredients;
* Patients with dysphagia or any disease that affects drug absorption, distribution, metabolism and excretion, especially those with a history of gastrointestinal diseases (such as gastric ulcer, gastric bleeding, long-term diarrhea, etc.)

Primary outcomes:
measure: Cmax
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose
measure: AUC
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose
measure: Tmax
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose
measure: t1/2
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose
measure: CL/F
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose
measure: VZ/F
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 144 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05053009: Effect of Ibuprofen Sustained Release on Intraoperative and Postoperative Pain in Mandibular Molars
Official title: The Effect of Ibuprofen Sustained Release Oral Premedication on Intraoperative and Postoperative Pain After Single-visit Root Canal Treatment of Mandibular Molars With Symptomatic Irreversible Pulpitis and Apical Periodontitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief summary: The study is conducted to evaluate the effect of Ibuprofen sustained release premedication on the success of buccal infiltration anaesthesia, intaroperative pain and post operative pain in mandibular molars with symptomatic irreversible pulpitis and apical periodontitis


Eligibility criteria: Inclusion Criteria:

1. Systemically healthy patients (ASA I or II).
2. Patients with Mandibular molar teeth diagnosed with:

   * Pre-operative sharp pain marked on VAS scale by reading not less than 6.
   * Vital exaggerated response of pulp tissue to cold pulp tester (ethyl chloride spray) and electric pulp tester.
   * Normal periapical radiographic appearance or slight widening in lamina dura.
   * Positive response and pain provoked by percussion.

Exclusion Criteria:

1. Allergy to Ibuprofen
2. Medically compromised patients having significant systemic disorders. (ASA III or IV).
3. History of intolerance to NSAIDS.
4. Patients with two or more adjacent teeth requiring endodontic treatment.
5. Pregnant or nursing females.
6. Teeth that have:

   * Periodontal affection (with pocket depth greater than 5mm, associated with swelling or fistulous tract, or greater than grade I mobility)
   * No possible restorability.

Primary outcomes:
measure: Efficacy of buccal infiltration anaesthesia measured using Visual analogue scale
timeFrame: During root canal treatment procedures
Secondary outcomes:
measure: Intensity of intraoperative pain
timeFrame: During root canal treatment procedures
measure: Postoperative pain
timeFrame: up to 48 hours after endodontic treatment
measure: Number of needed analgesic tablets in case of intolerable pain
timeFrame: up to 48 hours after endodontic treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05778409: To Study the Effects of Cordyceps Cicadae on Vision Care
Official title: To Study the Effects of Cordyceps Cicadae on Vision Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Myopia
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Cordyceps cicadae is a traditional Asian herbal medicine with a variety of bioactive substances and curative effects similar to Cordyceps Cicadae, and it has been reported that anti-dry eye and eye protection ingredients can be extracted. With the advancement of civilization, the number of patients with high myopia is increasing year by year and suffers from complications of dry eye or other eye diseases. In this study, the subjects were provided with cicadae extract or placebo in a double-blind manner, tracked the degree of visual fatigue by regular questionnaires, and measured for visual acuity, axial length and diopter. The purpose of this study is to investigate the effect of cicadae extract on visual acuity and visual fatigue, and to evaluate its potential as a health food ingredient.

Detailed description: 1. Visual acuity measurement: Snellen's Chart was used to measure visual acuity.
2. Refractive examination: Measure binocular refraction with Open Field computer refractor (Shin-Nippon Nvision K5001 Wide View).
3. Measuring the axial length of the eye: Use the multifunctional optical eyeball length measuring instrument (Lenstar) to measure the distance from the instrument to the optical paths such as the cornea, lens, and retina, and then convert to the axial length of the eye.
4. Corneal radian measurement: Use a keratometer (Bausch \& Lomb Keratometer) to measure the corneal radian and curvature, and estimate the degree of corneal astigmatism.
5. Visual fatigue questionnaire survey: A visual fatigue scale questionnaire was designed using Ocular Surface Disease Index (OSDI) and Computer Vision Syndrome (CVS).

Eligibility criteria: Inclusion Criteria:

1. Adults aged 20 or over
2. Willing to participate in this study and sign the subject's consent form
3. Myopia less than 700 degrees

Exclusion Criteria:

1. Have consumed related eye care products in past 3 months
2. Those who have eye infection in the past 3 months
3. People who have been diagnosed with any eye diseases in past 3 months
4. Those who are allergic to cicadae

Primary outcomes:
measure: Eye fatigue questionnaire
timeFrame: one month
measure: Best vision test
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Asia university
Study officials:
affiliation: Asia University
name: Hui-Wen Lin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: