louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00902369: A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: AK106-001616
Lead sponsor: Asahi Kasei Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 130
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: This will be a Phase II, multi-centre study consisting of 2 parts. Part 1: Clinical Pharmacology Study (drug-drug interaction between AK106-001616 and methotrexate) Part 2: Proof of Concept Study


Eligibility criteria: Inclusion Criteria:

* Diagnosis of RA (class I to III)
* Stable dose of methotrexate (at least 12 weeks)

Exclusion Criteria:

* Pregnant or breastfeeding
* Abnormal screening laboratory test values considered to be clinically significant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hlucin
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Uherske Hradiste
country: Czech Republic
city: Frankfurt
country: Germany
state: Hessen
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Budapest
country: Hungary
city: Érd
country: Hungary
city: Vilnius
country: Lithuania
city: Bucharest
country: Romania
city: Cambridge
country: United Kingdom
state: Cambridgeshire
city: Sheffield
country: United Kingdom
state: South Yorkshire
Study officials:
References:
citation: Kozaki T, Tagashira M, Yamanishi K, Ellis B, Kayanoki T, Ooishi R, Sugiyama K, Matsuda S, Tsuruta K, Kohira T, Tsurui K. Evaluation of drug-drug interaction between the novel cPLA2 inhibitor AK106-001616 and methotrexate in rheumatoid arthritis patients. Xenobiotica. 2015;45(7):615-24. doi: 10.3109/00498254.2014.1000430. Epub 2015 Jan 12.
Clinical trial NCT01545869: Efficacy and Safety of Fractional Carbon Dioxide Laser for Treatment of Facial Freckles.
Official title: Efficacy and Safety of Fractional Carbon Dioxide Laser for Treatment of Facial Freckles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Freckles
Keywords: carbon dioxide laser
fractional resurfacing
freckles
melanosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Freckles are clusters of melanin in the superficial epidermis. They affect mostly face and sun exposed areas, and appear as flat brown or red macules that fade in winter, usually in a fair complexion patient, but may be present in other skin types.

The gold standard in the industry for non-surgical facial rejuvenation, removal of wrinkles, pigmentation, and general sun damage has been the carbon dioxide (CO2) laser since the mid 1990s. The traditional CO2 laser was very effective, however it fell out of favor because it required general anesthesia. It also had a prolonged recovery time. Over the last several years, advances in technology known as fractional resurfacing has made the CO2 laser popular again: Fractional CO2 laser treatment is one of the newest laser rejuvenation technology. It proved successful in treatment of melasma, one of the pigmented dermatoses. To the best of our knowledge, based on a thorough search of literature, no clinical studies assessing fractional CO2 laser in treatment of freckles could be retrieved.


Eligibility criteria: Inclusion Criteria:

* -Patients affected with facial freckles.
* Age: 10 years or more

Exclusion Criteria:

* Patients younger than 10 years old.
* Patients aged 10-21 years who can not provide a written consent of parents or legal guardian.
* Patients with known tendency to keloid or hypertrophic scar formation.
* Patients receiving treatment with systemic retinoids or having stopped their course since less than six months duration.

Primary outcomes:
measure: treatment success
timeFrame: One month
Secondary outcomes:
measure: Treatment safety
timeFrame: three months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dermatology department - faculty of medicine- Cairo University
Study officials:
affiliation: Cairo University
name: Bakr M Elzawahry, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Vanessa G Hafez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Aya Fahim, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06993168: To Evaluate Effect of Food of DA-5222 in Healthy Adult Subjects
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of DA-5222 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-28
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: DA-5222
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the effect of food on pharmacokinetics of DA-5222 in healthy adult subjects


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* BMI between 18 and 30 kg/m2
* Body weight: Male≥50kg, Female≥45kg
* Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study

Exclusion Criteria:

* Subjects with clinically significant medical history
* Subjects with history of drug abuse or addicted
* Subjects with allergy or drug hypersensitivity

Primary outcomes:
measure: AUCt
timeFrame: pre-dose~72 hours post-dose
measure: Cmax
timeFrame: pre-dose~72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Bumin Hospital
state: South Korea
Study officials:
References:
Clinical trial NCT00880568: Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4)(COMPLETED)
Official title: A Phase I Dose Escalation Study of MK1496 in Patients With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Malignant
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-04-14
Enrollment: 27
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: This study determines recommended clinical dose, to evaluate the safety, tolerability and pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors who have failed standard therapy or for whom no standard therapy exists, in two dosing schedules in Japan.


Eligibility criteria: Inclusion Criteria

* Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
* Participant must have Performance Status 0 or 1.
* Participant must have adequate organ function.

Exclusion Criteria

* Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
* Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
* Participant has known hypersensitivity to the components of study drug or its analogs.
* Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.

Primary outcomes:
measure: Number of Participants With Dose-limiting Toxicities (DLTs)
timeFrame: Cycle 1 (up to 21 or 28 days, depending on treatment arm)
measure: Number of Participants With Any Clinical or Laboratory Adverse Event
timeFrame: First dose up to 30 days after last dose (up to 2 years)
Secondary outcomes:
measure: Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle)
timeFrame: Cycle 1, Day 1 (Hour 0 through Hour 24)
measure: Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle)
timeFrame: Cycle 1, Day 1 (Hour 0 through Hour 24)
measure: Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle)
timeFrame: Cycle 1, Day 3 (Hour 0 through Hour 24)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03497468: Effects of Task-oriented Training on Functional Mobility and Fatigue in Patients With Multiple Sclerosis
Official title: Effects of Task-oriented Training on Functional Mobility and Fatigue in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: task-oriented training
exercise training
mobility
balance
fatigue
quality of life
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 34
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: Multiple Sclerosis (MS) is inflammatory, demyelinating and autoimmune disease of the central nervous system. It is usually seen with relapses and genetic and environmental factors play a role in the etiology. Neurological symptoms seen in MS restrict the patient's daily activity and social role participation. Mobility problems and fatigue are the most important reasons of role limitations and decreased quality of life. The importance of exercise training in disease management has been emphasized in recent years. However, few studies have investigated the effects of task-oriented trainings on symptoms of the disease. The aim of this sudy is to investigate the effects of task-oriented training additional to combined exercise training on functional capacity, mobility, balance, fatigue and quality of life in patients with MS.


Eligibility criteria: Inclusion Criteria:

* Multiple Sclerosis diagnosis
* Expanded Disability Status Scale \> 5,5
* No cognitive problems
* No relapses in the last 3 months
* No other neurological or chronic disease

Exclusion Criteria:

* Relapse during the intervention
* Exercise intolerance

Primary outcomes:
measure: Functional capacity
timeFrame: 6 weeks
Secondary outcomes:
measure: dynamic gait skills
timeFrame: 6 weeks
measure: limitation of gait
timeFrame: 6 weeks
measure: dynamic balance and fall risk
timeFrame: 6 weeks
measure: sitatic balance
timeFrame: 6 weeks
measure: dynamic balance
timeFrame: 6 weeks
measure: severity of fatigue
timeFrame: 6 weeks
measure: impact of fatigue
timeFrame: 6 weeks
measure: Quality of life
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05096468: Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.
Official title: Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Esketamine
Pregabalin
Acute Postoperative Pain
Neurosurgical Procedures
Perioperative Complication
Spinal Cord Neoplasms
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 90
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: Postsurgical pain is now known to be one of the most common and difficult-to-treat complications of surgery. severe postoperative pain can significantly impair patients' quality of life, social functioning and contribute to excessive health care expenditures. It is worth noting that acute postoperative pain may play a vital role in central sensitization and up-regulation of pain receptors, even factors implicated in the development of CPSP. According to previous studies, the incidence of postoperative pain among patients undergoing spinal surgery was nearly 80%. At the same time, perioperative pain management of patients undergoing spinal surgery has not been clearly. For the past few years, pregabalin and esketamine are becoming important roles in perioperative pain management, lots of studies have shown that these two analgesics might relieve postoperative pain. The aim of this study was to evaluate the acute analgesic effects of esketamine and pregabalin in combination after spinal cord neoplasms resection, so as to find a better way to help the patients undergoing spinal surgery keep away from the acute perioperative pain.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing elective spinal cord neoplasms resection;
* Ages between 18 and 65 years old;
* American Society of Anaesthesiology (ASA) status I-III;
* Signed informed consent.

Exclusion Criteria:

* Previous adverse reaction to ketamine, s-ketamine or pregabalin;
* Patients with a diagnosed history of severe chronic pain;
* Patients with long-term analgesic treatment(gabapentin/opioids/ketamine);
* Patients with aphasia or inability to cooperate with the pain assessments;
* Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
* Patients with a diagnosed history of psychiatric disorder;
* Patients treated with gabapentin/pregabalin in the last three months;
* Drug abuse;
* Body mass index (BMI) \> 35 kg/m2 ;
* Pregnancy or lactation.

Primary outcomes:
measure: the proportion of patients with acute moderate-to-severe postsurgical pain during 48h after operation
timeFrame: 48 hours after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
affiliation: Beijing Tiantan Hospital
name: Ruquan Han, M.D., Ph D.
role: STUDY_CHAIR
References:
Clinical trial NCT06878768: Translational Research GRICS-CineCardiac
Official title: Imagerie Cardiaque Ciné Par Résonance Magnétique En Respiration Libre
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feasibility of GRICS CardioCine on Patients with Ischemic or Dilated Cardiopathy
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2025-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This project is a pilot study which aims at showing the feasibility of free breathing cardiac MRI using GRICS (Generalized Reconstruction by Inversion of Coupled System)software in a clinical environment.

The GRICS technique has been developed by the IADI (Diagnostic, Adaptive and Interventional Imaging)lab, Nancy, France. It enables free breathing MRI thanks to a reconstruction algorithm which provides artefact-free images based on raw MR data and physiological data from external sensors (respiratory belts, ECG.

In this study, we want to acquire free breathing cardiac cine images during a standard cardiac MR exam and compare those data with the breath-hold ones.


Eligibility criteria: Inclusion Criteria:

* candidate to cardiac MR exam because of ischemic or dilated cardiopathy
* legally an adult
* having heath insurance
* having signed the consent form

Exclusion Criteria:

* dyspnea
* atrial fibrillation
* pain while lying on the back for a long time
* inability to follow a procedure
* contraindication to MRI
* contraindication to gadolinium chelate injection

Primary outcomes:
measure: Qualitative image reading by the radiologist
timeFrame: 1 Month
measure: Quantitative image analysis by the radiologist
timeFrame: 1 Month
Secondary outcomes:
measure: Right ventricular end-diastolic volume
timeFrame: Day 1
measure: Left ventricular end-diastolic volume
timeFrame: Day 1
measure: Right ventricular end-systolic volume
timeFrame: Day 1
measure: Left ventricular end-systolic volume
timeFrame: Day 1
measure: Right ventricular systolic ejection volume
timeFrame: Day 1
measure: Left ventricular systolic ejection volume
timeFrame: Day 1
measure: Right ventricular ejection fractions
timeFrame: Day 1
measure: Left ventricular ejection fractions
timeFrame: Day 1
measure: Left ventricular mass in diastole
timeFrame: Day 1
measure: Aortic flow
timeFrame: Day 1
measure: Analysis of the segmental kinetics of the left ventricle
timeFrame: Day 1
Other outcomes:
Locations:
city: Vandoeuvre-lès-Nancy
country: France
facility: CHU Brabois
Study officials:
References:
Clinical trial NCT06558968: Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children
Official title: Evaluation of Polyetheretherketone and Monolithic Zirconia as Esthetic Functional Space Maintainers in Children (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Dentistry
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Compare two band and loop space maintainers made from two tooth colored materials; Polyetherethherketone (PEEK) and monolithic Zirconia (BruxZir) as regards to:

* Clinical performance of space maintainers in terms of frequency of debonding or fracture of the appliance and health of adjacent gingiva during a one-year follow up.
* Wear of the opposing teeth.

Detailed description: After extraction of the mandibular first primary molars in both mandibular quadrants, impressions will be taken with intraoral scanner. Then, it will be sent to the CAD/CAM laboratory to construct functional band and loop space maintainers using PEEK and monolithic zirconia 'BruxZir' blocks with proper shades.

After the fabrication of the space maintainers of both sides, they will be cemented with resin luting cement containing MDP monomer. Photographs will be taken after cementation for the space maintainers and the patient will be informed and educated about the oral hygiene measures. The parents will also be inquired to call if any discomfort, debonding or fracture of the appliances happens.

Eligibility criteria: Inclusion Criteria:

* Clinical inclusion criteria:

  * Children requiring bilateral extraction of mandibular first primary molars or those with previously extracted molars no more than 6 months prior to intervention (11) .
  * Existence of teeth on the mesial and distal side of edentulous area.
  * Angle's Class I molar relationship and/or flush terminal/mesial step primary molar occlusion

Radiographic inclusion criteria:

* No periapical and/ or furcural pathological condition related to abutment teeth.
* Presence of tooth germ of the succeeding tooth (mandibular first premolars).
* Presence of more than 1 mm of bone overlying the successor tooth germ

Exclusion Criteria:

* Carious abutment teeth requiring pulp therapy.

  * Carious abutment primary teeth requiring a full coverage restoration.
  * Patients with history of bruxism or/and clenching.
  * Patients with medical, intellectual or physical disabilities.
  * Patients with abnormalities as posterior cross-bite, open bite, and deep bite

Primary outcomes:
measure: Clinical performance
timeFrame: 1 year
measure: Gingival health
timeFrame: 1 year
Secondary outcomes:
measure: Wear of the opposing tooth
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ainshams U
name: Nagwa Khattab, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06561568: Additional Effects of Kinesio Taping on Knee Joint Proprioception and Spatiotemporal Gait Parameters in Patient With Chrondromalacia Patellae
Official title: Additional Effects of Kinesio Taping on Knee Joint Proprioception and Spatiotemporal Gait Parameters in Patient With Chrondromalacia Patellae
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chondromalacia
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 46
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial having two groups. KInesio taping along with conventional physical therapy will be applied in one group and the second will receive conventional physical therapy only. Both groups will be recruited concurrently.
Primary purpose: TREATMENT

Brief summary: Chondromalacia patellae (CMP), also known as runner's knee, is characterized by anterior knee pain (AKP) and typically occurs in youngsters. Causes of chondromalacia patellae include micro trauma wear and tear, post traumatic injuries and muscular imbalance. In Chondromalacia patella pain is behind or around the patella caused by stress in the patellofemoral joint that usually provoked by climbing stairs, squatting, and sitting with flexed knees for longer time periods. Patients of CMP presents with patellar mal-tracking, muscular weakness, proprioceptive deficit. Exercise training has been proven beneficial for CMP patients but additive effect of kinesio taping along with exercise have not been seen yet in these patients. The study will help people with chondromalacia patellae to improve their quality of life. The findings will contribute to future research in chondromalacia patellae management.


Eligibility criteria: Inclusion Criteria:

* Both genders
* Age: Under 60yrs
* Pain while stair climbing, kneeling, squatting, changing position from sitting to standing and running

Exclusive criteria:

* Instability of tibiofemoral joint
* Subluxation of patellofemoral joint
* Patellar instability
* Previous surgery of lower limb
* Positive findings on examination of knee ligaments, menisci and bursa.

Exclusion Criteria:

-

Primary outcomes:
measure: Proprioception
timeFrame: 4 weeks
measure: Pain intensity
timeFrame: 4 weeks
measure: Functional status
timeFrame: 4 weeks
measure: Gait Speed
timeFrame: 4 Weeks
measure: Gait cadence
timeFrame: 4 Weeks
measure: Gait cycle time
timeFrame: 4 weeks
measure: Stride length
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physical Therapy
Study officials:
References: