louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05237752: A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of LG00034053 in Patients With Knee OA
Official title: A Phase Ib/II, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of a Single Dose of LG00034053 Administered by Intra-articular Injection in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis, Knee
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2022-02-14
Enrollment: 74
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multi-center, randomized, placebo-controlled, double-blind clinical study, consisting of Part 1 (Phase 1b) in a sequential, dose-escalating design and Part 2 (Phase 2) in a parallel design.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with primary osteoarthritis of the knee according to the ACR clinical criteria, with Kellgren-Lawrence grade 2 to 3 in the corresponding knee as determined in the X-ray test
* Patients with pain in the index knee requiring NSAIDs or analgesics which sustained for at least 6 months
* Patients with a score of ≥ 4 and ≤ 9 in response to question 1 (walking pain) on the WOMAC pain subscale (11-point NRS)
* Patients with the subtotal score of ≥ 20 and ≤ 45 on the WOMAC pain subscale (11- point NRS)
* Patients with BMI at or below 40 kg/m2

Exclusion Criteria:

* Patients with chronic pain requiring continuous treatment
* Patients with rheumatoid arthritis or other inflammatory arthritis
* Patients with skin disorders at the administration site
* Patients with clinically significant renal or cardiovascular disease or those with suspected SARS-CoV-2 infection
* Patients in a medical condition which may affect the efficacy and/or safety assessment
* Patients with Kellgren-Lawrence grade 4 in the contralateral knee
* Patients with tense effusion
* Patients having administered an opioid analgesic/ other analgesic/health functional foods, single dose of IA injection within a certain period prior to drug administration
* Patients having undergone knee replacement

Primary outcomes:
measure: Changes in WOMAC (Western Ontario and McMaster Universities Arthritis Index) (11-point NRS) pain score from baseline to time point
timeFrame: week 12
Secondary outcomes:
measure: Change in WOMAC score from baseline to time point
timeFrame: week 1 ~ week 24
measure: Weekly mean of the average daily pain intensity score (11-point NRS) from baseline to time point
timeFrame: week 1 ~ week 24
Other outcomes:
Locations:
city: Camberwell
country: Australia
facility: Emeritus Research
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital
Study officials:
References:
Clinical trial NCT00733252: Optical Coherence Tomography of the Airway for Lung Cancer or Lung Disease
Official title: Optical Coherence Tomography of Human Airways
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Cancer
Malignant Mesothelioma
Metastatic Cancer
Nonmalignant Neoplasm
Precancerous Condition
Keywords: non-small cell lung cancer
small cell lung cancer
benign respiratory tract neoplasm
lung papilloma
recurrent respiratory papillomatosis
squamous lung dysplasia
malignant mesothelioma
pulmonary carcinoid tumor
lung metastases
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-08-13
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: RATIONALE: Diagnostic procedures, such as optical coherence tomography, may help find and diagnose lung cancer or precancerous cells.

PURPOSE: This phase I trial is studying how well optical coherence tomography of the airway works in detecting abnormal cells in patients undergoing surgery for lung cancer or lung disease.

Detailed description: OBJECTIVES:

* Correlate optical coherence tomography images of the airway with airway histology.
* Develop an imaging technique to detect premalignant airway epithelial changes (carcinoma in situ, dysplasia) to study the transformation process as well as intervene and prevent the development of lung cancer.

OUTLINE: Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery. All imaged areas are marked. The marked areas are then excised and fixed in formalin for histopathologic analysis.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Undergoing pneumonectomy or lobectomy for malignant or benign lung processes

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Correlation of optical coherence tomography images of the airway with airway histology
timeFrame: This study will involve discarded tissue from 10 subjects with pathology specimens over one year.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Rana Hejal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01899352: Procedures, Complications and Follow-up of Tracheostomy in Intensive Care Units.
Official title: Procedures, Complications and Follow-up of Tracheostomy in Intensive Care Units - a Prospective Study by Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Neurological Disease
Heart Failure
Airway Management
Lead sponsor: University of Genova
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Tracheostomy is worldwide used for critically ill patients. The aim of our study is to assess the mortality, quality of life, laryngeal function, procedures, early and late complications of tracheostomy performed for critically ill patients admitted in intensive care units.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* indications for tracheostomy

Exclusion Criteria:

* Infection/inflammation of neck tissue
* Previous neck surgery causing abnormal anatomy of the site
* Recent surgery of cervical spine

Primary outcomes:
measure: Mortality at ICU discharge
timeFrame: within 2 days after discharge
Secondary outcomes:
measure: Quality of Life
timeFrame: within 2 days after discharge, at 3, 6 and 12 months after tracheostomy
measure: Laryngeal organ function
timeFrame: within 2 days after discharge, at 3, 6 and 12 months after tracheostomy
measure: Late complications
timeFrame: from day 2 until the discharge
measure: Procedural findings of percutaneous tracheostomy
timeFrame: at the beginning and at the end of tracheostomy procedures
measure: Early complication
timeFrame: in the first 24 hours from the end of the procedure
Other outcomes:
Locations:
city: Assisi
country: Italy
facility: Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care
city: Assisi
country: Italy
facility: Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care
city: Catania
country: Italy
facility: Policlinico Vittoio Emanuele
city: Chieti
country: Italy
facility: Policlinico SS Annunziata
city: Genoa
country: Italy
facility: Intensive care unit - San Martino-IST
city: Genoa
country: Italy
facility: IRCCS Azienda Ospedaliera San Martino IST
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
city: Naples
country: Italy
facility: University of Naples "Federico II"
city: Rimini
country: Italy
facility: Ospedale Morgagni-Pierantoni
city: Rome
country: Italy
facility: Università Cattolica del Sacro Cuore
city: Turin
country: Italy
facility: Università di Torino
Study officials:
References:
Clinical trial NCT06944652: Stretching to Improve Jumping Performance
Official title: Flexibility Training (Stretching) to Improve Jumping Performance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vertical Jump Performance
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study involves comparison of an 8-week plantar flexor stretching program to a shoulder stretching program for improving vertical jump performance in adolescent athletes.

Detailed description: Increasing flexibility may improve vertical jump performance. For example, being able to go deeper into a squat before jumping may allow for greater force development through the range of movement and this may transfer to greater vertical jump height. The study compares plantar flexor stretching to shoulder stretching for improving vertical jump performance in adolescent athletes. Athletes are being stratified by sex and maturity status (before or after estimated age at peak height velocity) and randomized to one of two groups: Plantar flexor stretching (2 sets of 6 stretches, 5 times per week) or the same volume of shoulder stretching. Before and after training, participants are being assessed for vertical jump and landing performance.

Eligibility criteria: Inclusion Criteria:

* Currently involved in a sport training program

Exclusion Criteria:

* Current or past injuries that might affect jumping performance or stretching the plantar flexors or shoulder joint

Primary outcomes:
measure: Counter movement jump height
timeFrame: Change over 8 weeks
Secondary outcomes:
measure: Take-off velocity
timeFrame: Change over 8 weeks
measure: Ground reaction force on take off
timeFrame: Change over 8 weeks
measure: Ground reaction force on landing
timeFrame: Change over 8 weeks
measure: Ground reaction force when landing from a standard height
timeFrame: Change over 8 weeks
measure: Functional dorsiflexor range of movement
timeFrame: Change over 8 weeks
measure: Active dorsiflexor range of movement
timeFrame: Change over 8 weeks
measure: Passive dorsiflexor range of movement
timeFrame: Change over 8 weeks
measure: Shoulder flexibility
timeFrame: Change over 8 weeks
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: College of Kinesiology University of Saskatchewan
state: Saskatchewan
Study officials:
References:
Clinical trial NCT02013752: The Effect of the Modified Perineal Protection Device During Delivery
Official title: Randomized Controlled Trial (RCT) of Primiparous Women Using the Modified Perineal Protection Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Perineal Tears.
Keywords: Delivery tears
Birth injuries
Perineal protection device
Lead sponsor: Helsingborgs Hospital
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether a modified perineum protection device can reduce tearing during delivery.

Detailed description: RCT investigation using a modified device during delivery of the baby's head (an earlier model has proved successful) and assess whether the use can decrease delivery tears as measured in length.

Eligibility criteria: Inclusion Criteria:

* Vaginal delivery at term (week 36 - 41)

Exclusion Criteria:

* Age below 18
* Breech delivery
* Not understanding written and oral information

Primary outcomes:
measure: Length of delivery tear measured in cm with ruler
timeFrame: at delivery - Participants will be followed for the duration of the first 24 hours
Secondary outcomes:
measure: Adverse effects of the device on mother and child
timeFrame: at delivery-Participants will be followed for the duration of the first 24 hours
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Dept Obstetrics and Gynecology, Helsingborg Hospital
state: Skåne
Study officials:
affiliation: Campus Helsingborg, Clinical Science Faculty of Medicine, Lund University, Helsingborg, Sweden
name: Knut Haadem, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04872452: Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders
Official title: Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Small Fiber Neuropathy
Gastrointestinal Dysmotility
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is being done to evaluate cutaneous nerve biopsies from patients with refractory gastrointestinal motility disorders. The purpose of the study is to evaluate skin biopsies for signs of small fiber neuropathy in GI dysmotility patients, which may provide a better understanding of the underlying pathology of their condition. Specifically, identifying any small fiber neuropathy that may exist in the peripheral nervous system may help us to better understand the mechanism of presumed enteric neuropathy that may be involved in causing GI dysmotility.

Detailed description: 1. Gather basic, clinical information and perform small 3-6mm skin biopsies.
2. Identify characteristics of epidermal nerve fibers in patients with symptoms of gastrointestinal dysmotility
3. To isolate skin-derived precursor cells from skin biopsies and test their ability to generate neurons in vitro and in immune-deficient mouse models.

Eligibility criteria: Inclusion Criteria:

* Individual with a gastrointestinal motility disorder that has failed both clinical and surgical options for symptomatic management

Exclusion Criteria:

* Child 17 years of age or younger
* Individuals incapable of informed consent
* Patient with diseased skin or on drugs which affect skin biology.

Primary outcomes:
measure: Presence of small fiber neuropathy in skin biopsy samples
timeFrame: Only one biopsy but analysis may take one year.
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Pankaj J Pasricha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01327352: Evaluation of the Influence of Food Regimen on Oshadi D Absorption
Official title: A Single Center, Non-randomized, Placebo Controlled Study for the Evaluation of the Influence of Food Regimen on Oshadi D Absorption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lupus Erythematosus, Systemic
Keywords: lupus
Lead sponsor: Oshadi Drug Administration
Sponsor class: INDUSTRY
First posted: 2011-04-01
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The study will be a non-randomized, open label, single dose, placebo control, single center, and single arm study in healthy subjects. The study will include one administration of placebo and four single administrations of Oshadi D in two different dose levels, administered in two feeding regimen for the evaluation of the influence of food on Oshadi D absorption.


Eligibility criteria: Inclusion Criteria:

* Healthy Male/female 21 years old and up.
* Subject must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements.
* Subject must be sterile or infertile or use an approved method of contraception from the time that the first dose of study medication is taken until three months following study completion or discontinuation.

Exclusion Criteria:

* Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results.
* Subject with positive HIV serology or positive HBsAg at screening.
* History or evidence of any active liver disease.
* Female subject who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
* Inability to give written informed consent
* History of alcohol or drug abuse within 6 months of screening.
* Subject who have a positive urine drug screen for substances of abuse (benzodiazepine, THC, opiates, amphetamines, cocaine) at the screening.
* Mental disorders.
* Subject with poor venous access
* Significant swallowing disorders
* Digestive disorders;
* Small bowel surgery;
* Mall absorption disorders.

Primary outcomes:
measure: DNase activity level (Kunitz/mL) for 2 dose levels, and different food regimen
timeFrame: 24 hours
Secondary outcomes:
measure: Maximum plasma DNase concentration (ng/mL) in different food regimen and dose levels
timeFrame: 24 hours
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Assaf Harofe Medical Center,
Study officials:
affiliation: Assaf Harofe Medical Center, Israel
name: Keren Duanis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oshadi Drug Administration
name: Hanna Levy, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00549952: Observational Study of Anti-Cancer Therapy Induced Oral Mucositis in Korean Cancer Patients
Official title: Observational Study of Anti-Cancer Therapy Induced Oral Mucositis in Korean Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Mucositis
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2007-10-26
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: to survey oral mucositis after chemotherapy and Concurrent chemoradiotherapy in Korean cancer patients


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with one cancer among head and neck cancer, esophageal cancer, breast cancer, colorectal cancer, gastric cancer, and non-small cell lung cancer, who are being treated or going to be treated as one between A and B A. Chemotherapy only B. Concurrent chemoradiotherapy

Exclusion Criteria:

* Patients who are pregnant or breast feeding, absent from effective(medically proven) contraceptive method for females of childbearing potential
* Patients with performance status of ECOG score is more than 3

Primary outcomes:
measure: incidence and severity of oral mucositis
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University hospital
Study officials:
affiliation: Seoul National University Hospital
name: Do-Youn Oh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02063152: 102 Annual Pap Smear Screening Database Maintenance Project
Official title: 102 Annual Pap Smear Screening Database Maintenance Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Human Papillomavirus
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 300000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women attended screening and found abnormal results, and women who were diagnosed as cervical cancer were the main study population. Women who did not attend screening for at least 6 years were also included.

Brief summary: This study aimed to evaluate the subsequent cancer risks, including gynecological cancers and malignancies at other sites, after the detection of screening positives and the diagnosis for primary cervical cancer.


Eligibility criteria: Inclusion Criteria:

* Citizens in Taiwan
* Women who attended screening, or who were diagnosed as cervical cancer
* Women who did not attend screening for at least 6 years

Exclusion Criteria:

* Women died before the follow-up initiation
* Women who had received hysterectomy before the follow-up initiation

Primary outcomes:
measure: Time to the cancer diagnosis or the recurrence, the death, or the last date of follow-up, whichever came first
timeFrame: up to 25 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taiwan Cervical Cancer Prevention Monitoring Center
Study officials:
affiliation: Department of Obstetrics and Gynecology, College of Medicine, National Taiwan University
name: Chi-An Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tai YJ, Chen YY, Hsu HC, Chiang CJ, You SL, Chen CA, Cheng WF; Taiwan Cervical Cancer Control Task Force. Risks of cervical intraepithelial neoplasia grade 3 or invasive cancers in ASCUS women with different management: a population-based cohort study. J Gynecol Oncol. 2018 Jul;29(4):e55. doi: 10.3802/jgo.2018.29.e55. Epub 2018 Mar 20.
Clinical trial NCT01752452: Effect of Ulnar Styloid Fracture on the Outcome of Distal Radial Fractures Treated With External Fixation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fracture of Distal End of Radius
Fracture of Ulnar Styloid
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 106
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: unstable distal radial fracture patients: (1) the initial dorsal angulation \>20°, (2) with dorsal or volar comminution of the metaphysis, (3) shortening of radius \>5 mm, and (4) with an associated ulnar fracture.

Brief summary: Untreated ulnar styloid fracture may affect the outcomes of distal radial fracture patient treated with external fixation.


Eligibility criteria: Inclusion Criteria:

* unstable distal radial fracture
* fixed with external fixator

Exclusion Criteria:

* multiple fracture
* open fracture
* nerve injury
* vascular injury

Primary outcomes:
measure: wrist motion range
timeFrame: 3 months, 6 months, and 1 year
measure: ulnar sided pain
timeFrame: 3 months, 6 months, and 1 year
Secondary outcomes:
measure: radiographic analysis
timeFrame: 6 weeks, 3 months, and 1 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Yi-xin Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: