louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00336427: MRSA Colonization in Peripartum Women and Their Offspring
Official title: A Prospective Study of MRSA Colonization in Peripartum Women and Their Offspring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Bacterial Colonization
Keywords: MRSA
Colonization
Pregnancy
Neonates
Lead sponsor: Orlando Regional Medical Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2006-06-13
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: We hypothesize that pregnant women are at baseline risk for carrying community-acquired MRSA, but also have frequent contact with healthcare workers which may put them at risk for hospital-acquired MRSA carriage. Our study aimed to identify the colonization rate of women in active labor and whether transmission to infants may occur.

Detailed description: Mothers are at risk for carrying MRSA. What this risk is is not known. We have seen a dramatic increase in neonatal intensive care unit MRSA infections. Could mothers transmit MRSA to their newborns if they are asymptomatic carriers? Mothers come into close contact with health care providers, often have other children in daycare (known risk factor) and may have other exposures to MRSA. Our study was designed to sample 300 mother-infant pairs to determine whether MRSA carriage is present in asymptomatic women. The study consisted of obtaining informed consent, then performing a sterile swab of mothers' nares and vaginal area, then babies' nares and umbilicus once the baby was born.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy expected to deliver next 24 hours

Exclusion Criteria:

* Cesarean sections

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ORMC
name: Margret G Reusch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01701427: Pain After Deep Electrical Stimulation in the Groin in Pain Free Subjects
Official title: Hyperalgesia After Deep Electrical Stimulation in Pain Free Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Persistent Postherniotomy Pain
Keywords: Hyperalgesia
Persistent pain
deep pain
electrical stimulation
groin hernia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-10-05
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy young men.

Brief summary: Sensory disturbances in persistent postherniotomy pain, include hyperalgesia from deeper structures as well as the skin. Whether this is one combined pain syndrome, where for instance deep pain leads to cutaneous hyperalgesia, or two isolated synchronous pain conditions, is unknown. By Giving pain free subjects an intense non-harmful electrical stimulation in deeper tissues in the groin and recording the skin sensory function, this hypothesis will be tested


Eligibility criteria: Inclusion Criteria:

* male, age \>18 yr, pain-free, caucasian

Exclusion Criteria:

* previous groin surgery, groin hernia, sensory disturbaces, use of painmedication, drug or alcohol abuse.

Primary outcomes:
measure: Change in skin pain detection threshold before and during deep electrical pain stimulation.
timeFrame: 14 days
Secondary outcomes:
measure: Test-retest of primary outcome
timeFrame: 14 days
Other outcomes:
measure: deep electrical and pain detection thresholds
timeFrame: 14 days
measure: warmth and mechanical detection and pain detection thresholds
timeFrame: 14 days
Locations:
city: Copenhagen
country: Denmark
facility: Section for Surgical Pathophysiology, Rigshospitalet
Study officials:
References:
citation: Aasvang EK, Werner MU, Kehlet H. Referred pain and cutaneous responses from deep tissue electrical pain stimulation in the groin. Br J Anaesth. 2015 Aug;115(2):294-301. doi: 10.1093/bja/aev170. Epub 2015 Jun 12.
Clinical trial NCT00925327: Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Progressive Keratoconus
Lead sponsor: Peschke Meditrade, GmbH
Sponsor class: INDUSTRY
First posted: 2009-06-22
Enrollment: 7
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a compassionate treatment protocol for the use of the UV-X system for corneal collagen cross-linking (CXL) in eyes with progressive keratoconus in patients who have conditions that limit their capacity to comply with the cross-linking treatment procedures required by ongoing clinical trials.

Detailed description: This is a non-randomized study. All eyes that qualify for the study will receive the cross-linking (CXL) procedure. Corneal collagen cross-linking is performed as a single treatment. Depending on the patient's condition, the CXL procedure may be performed under sedation or anesthesia. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.

Eligibility criteria: Inclusion Criteria:

* Age 6 to 18 years
* Having a diagnosis of progressive keratoconus
* Signed written informed consent
* Having a condition that limits the patient's capacity to comply with the cross-linking treatment procedures and/or the diagnostic tests and measurements required by the ongoing clinical studies
* Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

* Corneal pachymetry at the screening exam that is \<400 microns at the thinnest point
* Previous ocular condition in the eye(s) to be treated that may predispose the eye for future complications, for example (herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
* A history of delayed epithelial healing in the eye(s) to be treated
* Pregnancy or lactation during the course of the study
* A known sensitivity to study medications

Primary outcomes:
measure: Change in keratometry
timeFrame: 3 Months
Secondary outcomes:
measure: Change in manifest refraction spherical equivalent
timeFrame: 3 Month
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
Study officials:
References:
Clinical trial NCT06571227: Establishing the Clinical Significance Values of the Lysholm Knee Score
Official title: Establishing the Clinical Significance Values of the Lysholm Knee Score in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Injuries
Keywords: Lsholm knee score
Anterior cruciate ligament injury
Minimal important change
Substantial clinical benefit
Clinical significance
Patient reported outcome
Lead sponsor: Kırklareli University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2024-08-26
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted with people undergoing anterior cruciate ligament reconstruction at Gazi University Hospital.

Brief summary: The goal of this observational study is to learn about patients who will undergo anterior cruciate ligament reconstruction. The main questions it aims to answer are:

* What is the minimal clinically important difference value of the Lysholm Knee Score?
* What is the substantial clinical benefit value of the Lysholm Knee Score?
* What are the risk factors that prevent patients who have undergone anterior cruciate ligament reconstruction from reaching the minimal clinically important difference value?
* What are the risk factors that prevent patients who have undergone anterior cruciate ligament reconstruction from reaching the substantial clinical benefit value?


Eligibility criteria: Inclusion Criteria:

* to be over 18 years old
* to undergo surgery for a ruptured anterior cruciate ligament

Exclusion Criteria:

* to have metabolic or autoimmune diseases
* to undergo revision anterior cruciate ligament surgery or anterior cruciate ligament repair
* to have cognitive issues that will hinder the completion of the study forms
* to lack sufficient proficiency in Turkish

Primary outcomes:
measure: Functional level
timeFrame: before the surgery and after 3 months from the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi Üniversitesi Hastanesi
Study officials:
affiliation: Kırklareli University
name: Ozan Gür, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02003027: Botulinum Toxin Injection to Prevent VT Storm
Official title: Endomyocardial Botulinum Toxin Injection Can Decrease the Number of Episodes of VT Storm: Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: VT Storm
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2013-12-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this prospective non-randomized study was to assess the efficacy and safety of endomyocardial botulinum toxin injection in left ventricle for preventing episodes of VT Storm.


Eligibility criteria: Inclusion Criteria:

* 3 or more episodes of ventricular tachycardia within 24 hours

Exclusion Criteria:

* Failure to provide informed consent.
* Non-cardiac illness with a life expectancy of less than 3 year
* Non-cardiac illness imposing substantial operative mortality
* Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device

Primary outcomes:
measure: number of episodes of VT Storm
timeFrame: 1 year
Secondary outcomes:
measure: serious adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
References:
Clinical trial NCT06203327: Atrophic Gastritis Predicts the Risk of Gastric Cancer
Official title: Atrophic Gastritis Predicts the Risk of Gastric Cancer: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrophic Gastritis
Keywords: Atrophic Gastritis
Gastric Cancer
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 2042
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic gastritis diagnosed by routine endoscopic screening

Brief summary: Despite declining incidence rates, gastric cancer (GC) ranks the fourth leading cause of cancer-related mortality and the fifth most common cancer worldwide, with the highest incidence reported in Eastern Asia. The 5-year overall survival rate of early GC exceeds 90%, which was well above advanced GC. Most intestinal-type GCs follow the Correa cascade-inflammation,atrophy, intestinal metaplasia (IM), dysplasia and subsequent carcinoma. The presence of gastric mucosal atrophy and intestinal metaplasia are important risk factors for GC. The purpose of this study was to investigate the incidence of GC attributed to atrophic gastritis in a region with high incidence of GC.


Eligibility criteria: Inclusion Criteria:

* Ability and willingness to participate in the study and to sign and give informed consent
* Biopsies were collected based on the recommendation of updated Sydney system

Exclusion Criteria:

* under 18 or over 80 years old
* history of gastrectomy
* severe systemic diseases or malignancy

Primary outcomes:
measure: early gastric neoplasm
timeFrame: After the baseline endoscopy, participants were scheduled for surveillance endoscopies at years 3-5 for subjects with operative link on gastritis assessment (OLGA) 0-Ⅰ, at years 2-3 for subjects with OLGA II and 1 year for subjects with OLGA III-IV.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
References:
Clinical trial NCT00743873: Platelet-rich Plasma (PRP) Treatment for Medial Retinaculum Tear Post Medial Patellar Dislocation
Official title: PRP Treatment for Medial Retinaculum Tear - Randomized-Double-Blind-Placebo Control Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Patella-Dislocation
Keywords: medial retinaculum tear s/p patella dislocation
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2008-08-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To check the influence of injected platelet-rich plasma (PRP) on the healing of medial retinaculum and the redaction in recurrent dislocation of the patella.

Detailed description: Autologous platelet-rich matrices may aid in the healing of ligaments \& tendons by promoting and accelerating tissue healing because of the release of growth factors including transforming growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from platelet alpha-granules.

Eligibility criteria: Inclusion Criteria:

* age 18-40 years old
* first time patella dislocation

Exclusion Criteria:

* pregnancy
* mental or physical disabilities

Primary outcomes:
measure: redaction in healing time and recurrence
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir medical center
Study officials:
affiliation: Meir Medical Center
name: Omer Mei Dan, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06007573: Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia
Official title: Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-stroke Dementia
Keywords: randomized controlled trial
post-stroke dementia
Acupuncture
nimodipine
Lead sponsor: The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Department of acupuncture and massage, Nanling Hospital of traditional Chinese Medicine, Nanling County, Wuhu City, Anhui Province
First posted: 2023-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To observe the clinical efficacy of TCM acupuncture combined with western medicine nimodipine for prevention of post-stroke dementia by comparing with clinical conventional treatment methods.


Eligibility criteria: Inclusion Criteria:

1. Definite ischemic stroke or hemorrhagic stroke confirmed by head CT / MRI examination
2. Memory or cognitive and executive dysfunction. Cognitive dysfunction will be determined after the mini mental state evaluation (MMSE) score
3. Age limited to 40-85 years, irrespective of gender
4. Stable condition, clear consciousness, no aphasia, oral medication available
5. No major comorbidity, no major depression
6. Consent and signed patient informed consent

Exclusion Criteria:

1. Had serious medical conditions, such as heart, liver, kidney, or endocrine disease
2. Aphasia or hearing impairment
3. Participants in other clinical trials
4. Patients currently on medication to improve cognitive function

Primary outcomes:
measure: Response Rate
timeFrame: 24 weeks
Secondary outcomes:
measure: Hasegawa Dementia Scale
timeFrame: 24 weeks
measure: Montreal Cognitive Assessment
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui University of Chinese Medicine
state: Anhui
Study officials:
References:
Clinical trial NCT03657173: Ultrasound Image Quality of the Brachial Plexus at the Interscalene Space Before and After Shoulder Arthroscopy
Official title: Ultrasound Image Quality of the Brachial Plexus at the Interscalene Space Before and After Shoulder Arthroscopy: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 30
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: Adult patients (\>18 years of age) undergoing shoulder procedures involving arthroscopy who have consented to interscalene blockade for postoperative analgesia.

Brief summary: Ultrasound guided interscalene nerve blockade with local anesthesia is a standard regional anesthetic technique for providing postoperative analgesia during shoulder arthroscopy and wide variety of shoulder procedures. There is a paucity of data regarding the effects of shoulder arthroscopy on ultrasound image quality, including the effects of muscle mobilization and the use of large volume irrigation and subsequent tissue absorption, though increased neck circumference and airway edema are known complications of arthroscopic shoulder procedures.

The objective of the study is to determine if there is a difference in ultrasound image quality of the interscalene block anatomy, by Likert scale, pre- versus post-operatively in a cohort of patients undergoing shoulder arthroscopy who routinely receive blockade of the brachial plexus for postoperative analgesia. Further, if there are differences in imaging quality, correlations with surgical and patient factors will be studied.


Eligibility criteria: Inclusion Criteria:

* Subject is undergoing shoulder procedures involving arthroscopy
* Subject has consented to interscalene blockade for postoperative analgesia

Exclusion Criteria:

* Patient refusal
* Contraindications to interscalene blockade, including significant pulmonary insufficiency, hemi-diaphragmatic paralysis, brachial plexus or degenerative neuropathy
* Allergy to proposed local anesthetic medication\\
* Severe cervical spine disease.
* BMI \>40 kg/m2
* Neck Circumference \> 50cm
* Failed preoperative interscalene blockade
* Patients known to be currently pregnant or actively breastfeeding
* Patients where English is a language barrier

Primary outcomes:
measure: Change in Likert Scale
timeFrame: 2-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
citation: Panchamia JK, Jagannathan R, Pulos BP, Amundson AW, Sanchez-Sotelo J, Martin DP, Smith HM. The effects of shoulder arthroscopy on ultrasound image quality of the interscalene brachial plexus: a pre-procedure vs post-procedure comparative study. BMC Anesthesiol. 2021 Jul 9;21(1):187. doi: 10.1186/s12871-021-01409-3.
Clinical trial NCT02303873: Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta
Official title: Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta: an Age Stratified Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteogenesis Imperfecta
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2014-12-01
Enrollment: 99
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Alendronate should be considered as an alternative therapy of osteogenesis imperfecta (OI) because it significantly increased areal bone mineral density (BMD) and its Z score, decreased fracture incidence, inhibited bone resorption biomarkers. Alendronate exerted beneficial roles in different age brackets, especially in young patients with OI.


Eligibility criteria: Inclusion Criteria:

1. children or adolescents aged 0-18 years,
2. had either a history of at least once minor-impact fracture or age and sex adjusted areal BMD Z score of -1.0 or less at lumbar spine or total hip;
3. with or without blue sclera, impaired hearing, joint hypermobility or dentinogenesis imperfecta;
4. with or without slim long bone; with or without cranial epactal bones, signs of multiple fractures, bony deformity in skeletal X-ray films.

Exclusion Criteria:

1. previous history of rickets, hyperparathyroidism, other metabolic or inherited bone diseases; malignant disease; coeliac disease; hyperthyroidism;
2. therapy history of BPs within recent two years; severe renal failure (creatinine clearance \<40 ml/min), chronic liver disease; severe diseases of gastrointestinal tract;
3. unable to keep upright for at least 30 minutes daily .

Primary outcomes:
measure: changes from baseline of areal BMD at lumbar spine and total hip
timeFrame: baseline and 12,24,36 months
measure: annual clinical fracture incidence
timeFrame: baseline and 12,24,36 months
Secondary outcomes:
measure: changes of bone turnover biomarkers
timeFrame: baseline and 6,12,24,36 months
measure: changes of height
timeFrame: baseline and 12,24,36 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00093873: Study Evaluating AMG 706 in Subjects With Advanced Solid Tumors
Official title: A Phase 1, First in Human, Open-Label, Dose Finding Study Evaluating the Safety and Pharmacokinetics of AMG 706 in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Keywords: Cancer
antiangiogenesis
Solid Tumors
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-10-08
Enrollment: 71
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 will determine the safety and pharmacokinetics of AMG 706 in subjects with advanced solid tumors.


Eligibility criteria: Inclusion Criteria: Exclusion Criteria:

Primary outcomes:
measure: Dose limiting toxicity
timeFrame: Cycle 1
Secondary outcomes:
measure: Dose selection
timeFrame: Study completion
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Rosen LS, Kurzrock R, Mulay M, Van Vugt A, Purdom M, Ng C, Silverman J, Koutsoukos A, Sun YN, Bass MB, Xu RY, Polverino A, Wiezorek JS, Chang DD, Benjamin R, Herbst RS. Safety, pharmacokinetics, and efficacy of AMG 706, an oral multikinase inhibitor, in patients with advanced solid tumors. J Clin Oncol. 2007 Jun 10;25(17):2369-76. doi: 10.1200/JCO.2006.07.8170.