louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05523141: Study to Evaluate Safety, Tolerability, Pharmacokinetics and the Food Effect on PK of ASC10 Tablets in Healthy Subjects
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of ASC10 Tablets and an Open-label, Crossover Design to Evaluate the Food Effect on PK of ASC10 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: SARS CoV 2 Infection
Keywords: ASC10
RdRp
Healthy
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2022-08-31
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase I, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of ASC10 tablets and an open-label, crossover design to evaluate the food effect on PK of ASC10 in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Male or female volunteers between the ages 18 and 45, inclusive
* Those who do not have plans for pregnancy within six months and are willing to take effective contraceptive measures from the first dose of the study drug to 3 months after the last dose.
* If male, agree to use adequate contraception throughout the study and for at least 3 months after the last dose of study drug.
* Body mass index (BMI) was between 19 and 26 kg/m\^2. Weight ≥50 kg for males and ≥45 kg for females.

Exclusion Criteria:

* Females who are pregnant, planning to become pregnant, or breastfeeding.
* Has any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders.
* Has a history of cancer (other than basal cell or squamous cell cancer of the skin), rheumatologic disease or blood dyscrasias.
* Has a history of blood dizziness or difficulty in blood collection.
* Has donated blood within 30 days, plasma within 2 weeks, or platelets within 6 weeks before the first dose of study drug.

Primary outcomes:
measure: Part1: Number of participants with Treatment Emergent Adverse Events (TEAEs) in multiple ascending dose (MAD)
timeFrame: From screening through study completion, up to 12 days
measure: Part1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs in MAD
timeFrame: From screening through study completion, up to 12 days
measure: Part1: Number of Participants With Laboratory Abnormalities in MAD
timeFrame: From screening through study completion, up to 12 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Yunqing Qiu, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00613041: 3-D Reconstruction of CT Scan Images in the Evaluation of Non-Specific Pulmonary Nodules
Official title: Pilot Study: 3-D Reconstruction of CT Scan Images in the Evaluation of Non-Specific Pulmonary Nodules
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Undiagnosed Pulmonary Nodules
Lung Nodules
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-02-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who meet eligibility criteria will be recruited from the services that comprise the Thoracic Disease Management Team (DMT), specifically the Divisions of Pulmonary Medicine and Thoracic Surgery.

Brief summary: In recent years, more and more people are having lung CT scans performed to screen for various cancers. Many of them have small abnormalities detected, called "nodules", which - for a variety of reasons - doctors are unable to biopsy. As a result, many patients have their CT scans repeated on a regular basis to see if their nodules grow. This process can last several years.

Many patients experience significant anxiety during this process, when they are aware of a spot in the lung, but are not told any specific cause.

Researchers at Memorial Sloan-Kettering have developed a new way to look at lung nodules in three dimensions. The purpose of this project is to see if any change in the nodules can be detected sooner by this method than by traditional CT scans.


Eligibility criteria: Inclusion Criteria:

* Referral to the pulmonary or thoracic surgery service for undiagnosed pulmonary nodules.
* History of smoking exceeding 10 pack-years (pack year defined as number of packs of cigarettes per day multiplied by the number of years smoked).
* Age \>18
* Nodule size 5 to 15 mm in diameter.

Exclusion Criteria:

* Clinical indication for immediate biopsy via bronchoscopy, fine needle aspiration, or video-assisted thoracoscopic Surgery (VATS)
* Active lung cancer or metastasis to the lung.
* Contraindication to needle biopsy.
* Pneumonectomy
* Need for supplemental oxygen.
* Radiation pneumonitis
* Interstitial lung disease.

Primary outcomes:
measure: To collect preliminary data regarding the comparative sensitivity and specificity of conventional CT scan and three-dimensional CT for detecting the growth of nonspecific pulmonary nodules.
timeFrame: conclusion of the study
Secondary outcomes:
measure: To determine three-dimensional characteristics of pulmonary nodules which may discriminate between benign and malignant diseases.
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Marc Feinstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01740141: Plexus Brachialis Block. Better to do by Start Than by End of Surgery?
Official title: Plexus Brachialis Block. Better to do by Start Than by End of Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to find out if the timing of brachial plexus block, before or after surgery, has an impact of the extent of acute postoperative surgical pain or the incidence and severity of long-lasting (chronic) pain after surgery.

This is a prospective, randomized, double blind study in patients with radial fractures undergoing surgery with volar plate. The patients will be followed up for 6 months after surgery.


Eligibility criteria: Inclusion Criteria:

* Radial fracture
* ASA 1 and 2
* Able to communicate in norwegian
* Suitable for surgery in general anaesthesia and brachial plexus block

Exclusion Criteria:

* Pregnancy
* Chronic pain
* BMI over 35

Primary outcomes:
measure: Pain
timeFrame: postoperative to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten
Study officials:
affiliation: MD Ullevaal sykehus
name: Anne Holmberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02534441: Epidemiology and Co-Reactivity of Novel Surfactant Allergens
Official title: Epidemiology and Co-Reactivity of Novel Surfactant Allergens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Contact Dermatitis
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2015-08-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The primary objectives of this study are to identify positivity rates to three novel surfactants (ingredients used in soaps, detergents, and other cleansers that serve to lower the surface tension of the skin and remove debris) and co-reactivity with other surfactants in patients with known surfactant sensitivity on skin patch testing. The investigators hypothesize that subjects who previously tested positive to known allergenic surfactants (cocamidopropyl betaine, stearamidopropyl dimethylamine, dimethylaminopropylamine, coconut diethanolamide, oleamidopropyl dimethylamine, and decyl glucoside) may demonstrate co-reactivity to the three novel surfactant sensitizers (sodium lauroyl sarcosinate, isostearmidopropyl morpholine lactate, and disodium lauroamphodiacetate) on skin patch testing.


Eligibility criteria: Inclusion Criteria:

1. Documentation of a previous contact allergy to one or more surfactant(s) on our screening series including:

   * cocamidopropyl betaine
   * stearamidopropyl dimethylamine
   * dimethylaminopropylamine
   * coconut diethanolamide
   * oleamidopropyl dimethylamine, and
   * decyl glucoside
2. Age 18 years or greater.

Exclusion Criteria:

1. Pregnant or lactating women
2. Use of systemic therapy (corticosteroid, immunosuppressive agents, cytostatics, pentoxifylline, leukotriene antagonists or other medication known or suspected to have an effect of ACD) within two weeks prior to participation
3. Use of intramuscular steroids in the last month.
4. Phototherapy (PUVA or UVB) within two weeks prior to participation.
5. Direct sunlight or tanning booth use to the back within the two weeks prior to participation.

Primary outcomes:
measure: Number of participants with positive skin patch test reaction, scored using the North American Contact Dermatitis Group (NACDG) criteria, to three novel surfactant antigens.
timeFrame: Five days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02195141: Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer
Official title: Randomized Phase II Tiral of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: Preoperative Chemoradiotherapy
Locally Advanced Rectal Cancer
boost
IMRT
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2014-07-21
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pathological complete response, (pCR) correlates with a favorable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological complete remission rate.


Eligibility criteria: Inclusion Criteria:

* histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge
* the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound

Exclusion Criteria:

* metastatic disease
* Eastern Cooperative Oncology Group (ECOG) performance status \> 3
* patients not deemed fit for radiotherapy, capecitabine or surgery
* pregnant or lactating patients
* women with child bearing potential who lack effective contraception
* patients below 18 years old

Primary outcomes:
measure: • Pathological complete remission rate (pCR)
timeFrame: after pathological examination of surgical speciments (6-8 weeks after chemoradiation)
Secondary outcomes:
measure: Number of participants with adverse events (according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
timeFrame: during preoperative treatment and after surgery for 5 years
Other outcomes:
measure: • Disease-free survival
timeFrame: 3 year afte concurrent chemoradiation
Locations:
city: Beijing
country: China
facility: Cancer Hospital, CAMS
Study officials:
affiliation: Dept of Radiation oncology, Cancer hospital, CAMS
name: Jing Jin, proffessor
role: STUDY_CHAIR
References:
Clinical trial NCT01747941: Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects
Official title: A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Crossover Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study is designed to test safety tolerability and PK of single oral ascending doses of PF-06305591,


Eligibility criteria: Inclusion Criteria:

* healthy young subjects
* aged 18-55

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Pregnant or nursing females; females of childbearing potential.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 72 hr
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 72 hr
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02416141: Fast-release Orodispersible Tramadol as Analgesia in Termination of Pregnancy by Vacuum Aspiration.
Official title: Fast-release Orodispersible Tramadol as Analgesia in Termination of Pregnancy by Vacuum Aspiration.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fertility
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: If a termination of pregnancy procedure is performed by vacuum aspiration our patients receive a paracervical block. Nevertheless these patients are not free of pain. We randomised our patients: one group will receive additional orodispersible tramadol, the other group will receive a placebo.

Detailed description: Patients were administered either 50 mg of fast-release orodispersible tramadol (Meda Pharma, Brussels, Belgium) or placebo 30 min before the procedure. Both, patient and gynecologist were blinded.

Patients underwent the following procedure: a sterile bivalve speculum was introduced into the vagina, then cervix and vagina were washed with an antiseptic solution. The cervix was grasped with a tenaculum and straigthened. A paracervical block was achieved using a 27-gauge spinal needle. Lidocaine was injected and distributed equally around the cervicovaginal junction at 1, 5, 7 and 11 o'clock. The suction curettage was accomplished through the following steps: the cervix was dilated, in function of the gestation, to Hagar number 5 to 11 (Aesculap, Ag and Co. KG, Tuttlingen, Germany); The uterine depth was measured using a hysterometry; suction curettage was performed by using plastic canula (Luneau Sas, France) and a classic suction pump (AMEDA Egnell SA, Switserland). The patients were observed for 2 hours after the curettage procedure.

Patients were asked to rate the pain during different steps of the procedure.

Eligibility criteria: Inclusion Criteria:

* - Patients above 18 ans.
* Non desired pregnancy.
* Non evolutive pregnancy.
* Pregnancy \< or = 14 weeks of amenorrhea.

Exclusion Criteria:

* - Interruption of pregnancy due to medical reasons
* Patient already included in this study
* Intolerance for Tradonal Odis 50mg

Primary outcomes:
measure: Will fast-release orodispersible tramadol reduce the pain (VAS) significantly in a vacuum aspiration procedure in this placebo-controlled trial.
timeFrame: 6 to 8 month to include all patients
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UniversitairZB
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Michael De Brucker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06502041: MARPE Effect With/Without MOP in Non-growing Patients
Official title: A Randomized Clinical Trial Comparing MARPE Effect With/Without MOP in Management of Skeletal Transverse Deficiency in Non-growing Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Transverse Deficiency
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the effect of MARPE (mini-implant assisted rapid palatal expansion) versus MARPE+ MOP (Micro-osteo-perforation) on nasal airway and maxillary transverse deficiency in non-growing patients.

Detailed description: All participants with skeletal transverse deficiency with unilateral or bilateral cross-bite aging 20-25 years were treated by expansion of maxillary arch as a first phase of treatment with one expander screw which was anchored to mini-implants placed in the palatal region (Mini-implant assissted rapid palatal expansion; MARPE). The patient's bone support in the anterior area of the palate was examined on CBCT. Micro-osteoperforation (MOP) was done along of medial palatine raphe in the intervention group. Control-group is the same of the intervention group but without micro-osteo-perforations.

Eligibility criteria: Inclusion Criteria:

1. The age ranges from 20-25 years.
2. Post pubertal adolescent
3. Skeletal transverse deficiency with unilateral or bilateral cross-bite
4. Extraction is not indicated in the lower arch.
5. Upper permanent dentition is erupted up to the second molars.
6. Average facial vertical growth pattern.
7. Space deficiency in the upper arch is less than 8 mm

Exclusion Criteria:

1. Diseases and medications those are likely to affect bone biology.
2. Evidence of root resorption.
3. Poor oral hygiene.
4. Previous orthodontic treatment.
5. Evidence of bone loss.
6. Active periodontal disease.
7. Craniofacial congenital anomalies, such as cleft lip and palate.

7. Pregnant females. 8. Presence of oral habits.

Primary outcomes:
measure: Number of days till diastema appearance
timeFrame: about 1 month
measure: Amount of skeletal expansion
timeFrame: about 1 month
measure: Pain experience during activation of expander by visual analogue scale ( VAS)
timeFrame: about 1 months
measure: Skeletal, Dental & Nasal readings
timeFrame: measured before treatment and after 6 month of treatment
measure: Stability of correction of transverse deficiency
timeFrame: about 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Adakhlia
Study officials:
References:
Clinical trial NCT00502541: Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema
Official title: A Multicenter, Randomized, Masked, Controlled Study to Evaluate Retisert, and Intravitreal Fluocinolone Acetonide Implant, in the Treatment of Patients With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetic Macular Edema
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2007-07-17
Enrollment: 196
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 was a multi-center, randomized, masked, parallel-group, controlled study in patients with diabetic macular edema, comparing RetisertTM (0.59 mg) with control therapy (standard of care (SOC) - repeat macular grid laser or observation). The objective was to evaluate the safety and efficacy of the intravitreal fluocinolone acetonide implant in the treatment of patients with diabetic macular edema.


Eligibility criteria: Inclusion Criteria:

* Males and nonpregnant females at least 18 years of age, with DME in the study eye
* Edema must involve fixation and be at least 1 disc area in size
* Visual acuity of ≥20 and ≤68 letters by ETDRS in the study eye
* The study eye must have received at least one macular laser treatment \> 12 weeks prior to entry into the study
* Ability and willingness to comply with treatment and follow-up
* Ability to understand and sign the Informed Consent form

Exclusion Criteria:

* Pregnant, lactating females
* Allergy to fluocinolone acetonide or any component of the delivery system
* Any disease or condition that would preclude study treatment or follow up
* Presence at screening of IOP greater or equal to 22 mm HG while on antiglaucoma medication(s).
* History of uncontrolled IOP within the last 12 months

Primary outcomes:
measure: A change from baseline in visual acuity using ETDRS charts • Humphrey Visual Field Mean Defect (24-2) • Masked reading of the size of the area of retinal thickening on color photographs and OCT, where available, and of severity of fluorescein leakage
timeFrame: at 26 weeks and yearly through completion of the study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Laura Trusso
role: STUDY_DIRECTOR
References:
citation: Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.