louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03644368: Children's Deep Neck Infections at the Montpellier Hospital
Official title: Retrospective Evaluation of the Management of Children's Deep Neck Infections at the Montpellier Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Neck Infections
Keywords: cervical phlegmon
tonsillar abscesses
retropharyngeal or parapharyngeal abscesses
medical and chirurgical treatment
Bacteria in deep neck infections
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 83
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children hospitalized for acute pharyngeal infection

Brief summary: To descride the clinical presentation, diagnosis, management and complications of children with a deep neck infection. A retrospective chart review was conducted at the Montpellier hospital in France. All children aged less than 18 years who had been admitted with a diagnosis of cervical phlegmon, tonsillar abscesses, retropharyngeal or parapharyngeal abscesses between January 2015 and December 2017 were included. The investigators collected the demographic, biological, radiological data and treatment received of the patients to the admision. The results of the bacteriological samples were collected. The investigators compared our results to those of the 10-year cohort. The investigators wish to compare the duration of hospitalization and the duration of the fever enter the group treated by alone antibiotic and the group treated by antibiotic and surgical drainage


Eligibility criteria: Inclusion criteria:

* under 18 years old
* hospitalized for acute pharyngeal infection ( cervical phlegmon, tonsillar abscesses, retropharyngeal or parapharyngeal abscesses)

Exclusion criteria:

* neck infection in the context of immune deficiency
* malignancy or post-traumatic disease
* others deep neck infections: angina, otitis, sinusitis, ethmoiditis, mastoiditis.

Primary outcomes:
measure: Clinical description of acute peripharyngeal suppuration
timeFrame: 1 day
Secondary outcomes:
measure: Description of therapeutic management
timeFrame: 1 day
measure: Description of bacteria in deep neck infections
timeFrame: 1 day
Other outcomes:
measure: duration of hospitalization
timeFrame: 1 day
measure: duration of the fever
timeFrame: 1 day
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Eric JEZIORSKI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01698268: Study of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair Surgery
Official title: The Efficacy of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydrocele
Inguinal Hernia
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study measures the difference in pain after hernia \&/or hydrocele repair based on site of local anesthesia injection.

Detailed description: This single-center, prospective, single blind, randomized study will enroll up to 50 subjects who are scheduled for elective hydrocelectomy and/or hernia repair. At Beaumont Health System, post-operative pain management in children is managed either via oral/parenteral opiates and opiate adjuncts, surgeon-administered field blocks (instillation of local anesthetics in the general area of incision), or via regional techniques (spinal, epidural, or peripheral nerve blocks). We have designed this study to determine if there is improved qualitative and quantitative post-operative pain control in patients receiving TAP block versus intraoperative peri-incisional, surgeon administered field block. Once informed consent has been given, each patient will be randomized (like flip of the coin) to either Transverse Abdominis Plane Block (TAP Block)or surgeon administered anesthesia.

Eligibility criteria: Inclusion Criteria:

* Children 2-8 years of age
* Elective inguinal hernia repair, inguinal hernia repair with peritoneoscopy and/or hydrocelectomy to be performed in the Center for Children's Surgery, Beaumont Hospital, Royal Oak
* American Society of Anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness, or mild systemic disease that is well controlled, eg. mild asthma)

Exclusion Criteria:

* History of allergy to study medications
* Enrollment in concurrent research study
* Pregnant patients\*
* Students/trainees/staff\*
* Mentally disabled/cognitively impaired\*

Primary outcomes:
measure: FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)
timeFrame: Admission into PACU
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Health System
state: Michigan
Study officials:
affiliation: Beaumont Health
name: Kaveh Aslani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03526068: Proof-of-concept Study on Disinfection and Healing Acceleration Capabilities of 222nm Wave Length Narrow Band Ultraviolet Lighting Device
Official title: The First in the World Human Proof-of-concept Study on Disinfection and Healing Acceleration Capabilities of 222nm Wave Length Narrow Band Ultraviolet Lighting Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultraviolet Rays
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: USHIO. INC
First posted: 2018-05-16
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The threat of MRSA and multi-drug resistant pathogens have been growing in recent years. A new means of countering the infectious threat is required and one such modality is the use of UV light for disinfection. The aim of the study is to proof the efficacy of the 222nm UV light in disinfection on patients with sacral sores. This is a first in human proof-of-concept study

Detailed description: Recent outbreaks of Ebola and MERS, and in the trend of growing threat of MRSA and multi-drug resistant pathogens, it is clear that a new means of countering the infectious threat is needed - even the US, EU, and Korean hospitals with the latest facilities has failed to stop the spread of these pathogens inside their wards.

This novel "Harmless UV Light," operating within the "Safe Zone Wave Length," will be a disruptive technology to counter the growing threats of infectious diseases, such as multi-drug-resistant bacteria and also viruses such as Ebola, MERS and new type Influenza. It will be a disruptive device in that it aims to be applied to fast, effective and labor-free disinfection of living environments, such as hospital wards, airports, and other public spaces to stop the spread of pathogens. This research is the first human clinical trial using this device that will spearhead the development of this technology, providing the key starting clinical data which would be the lead to development for a wider range of indications and markets. Successful proof of concept will lead to the next stage collaboration of larger scale clinical trials, and trials targeting wider range of indications and markets, at NUHS.

Eligibility criteria: Inclusion Criteria:

1. patients with pressure sore estimate at 2 cm X 2 cm or bigger
2. Patients with grade 2 or 3 sacral sores

Exclusion Criteria:

1. Patient who has pressure sore exposing bone
2. Patient who are beyond the age limits
3. Patient who is septic
4. Patient with obviously infected wound / pus in the wound
5. Patient who is pregnant.

Primary outcomes:
measure: Bacterial colony forming unit counts
timeFrame: Up to 2 weeks for completion of 4 sessions of UV therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
Clinical trial NCT06009068: Reliability and Validity of the Surgimap Software for Measuring Quadriceps Angle in Healthy Subjects
Official title: Reliability and Validity of the Surgimap Software for Measuring Quadriceps Angle in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reliability and Validity
Keywords: Surgimap
Q-angle
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be conducted in the out-patient clinic Faculty of physical therapy, Cairo University. The expected duration to recruit patients and collect data is 3 months .

Brief summary: The purpose of this study is to investigate the intra- and inter-rater reliability and concurrent validity of surgimap software for measuring the Q angle Surgimap (Nemaris Inc, New York, NY, USA) is a dedicated spine measurement and surgical planning software which is used in both the research works and the clinical rehabilitation. Q angle is considered to be an index of the vector for action of the patellar tendon and extensors mechanism which is highly affects the patellofemoral joint dysfunction and foot mechanics.

Detailed description: specialised software for assessing the sagittal plane has arisen. Digital measuring software of many types has been proved to be faster, more accurate, more precise, and less variable than manual procedures. Angle measurement software is available in different formats and applications. Surgimap is another programme used for measuring angles. The current software has proven to be a godsend and is currently being used in the medical industry to measure joint angles especially the spine alignment. The programme is also used for scientific reasons, such as digital photo analysis. A recent study discovered that Surgimap software is a viable approach for evaluating spinal postural angles in teenagers from varied standing position perspectives using digital pictures.

As there a lack of knowledge about the reliability and validity of the surgimap software to measure the Q- angle. Therefore, The study will investigate the inter-rater, intra-rater reliability and concurrent validity of the surgimap software for measuring the Q-angle.

Eligibility criteria: Inclusion Criteria:

* Both male \& female
* Aged 18:25
* BMI 18.5: 25
* Normal foot posture as assessed by foot posture index.

Exclusion Criteria:

* Subjects who have operations in the knee joint
* Subjects who have traumatic knee injury
* High arched or low arched foot.

Primary outcomes:
measure: The inter-rater, intra-rater reliability and concurrent validity of the surgimap software for measuring the Q-angle.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy, Cairo University
Study officials:
affiliation: lecturer of physical therapy, Cairo University
name: Aida Nassif, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092768: A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-076)(COMPLETED)
Official title: A 26-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind, 2-Part Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Patients With Osteoarthritis (Study 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Arcoxia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and effectiveness of an investigational drug and an approved drug in the treatment of osteoarthritis of the knee and hip.

Detailed description: The duration of treatment is 26 weeks.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of the knee or hip which requires treatment with a medication to obtain pain relief

Exclusion Criteria:

* Any known allergy to the study drugs

Primary outcomes:
measure: Osteoarthritis of the knee & hip as assessed by WOMAC VA 3.0 pain and physical function subscales, Patient/Investigator assessments of disease and response to therapy over 12 weeks of treatment.
Secondary outcomes:
measure: Maintenance of clinical efficacy as assessed by WOMAC subscales and Patient assessments over a 26-wks of treatment. Safety / tolerability over a 12-wk and 6-mo treatment period.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Bingham CO 3rd, Sebba AI, Rubin BR, Ruoff GE, Kremer J, Bird S, Smugar SS, Fitzgerald BJ, O'Brien K, Tershakovec AM. Efficacy and safety of etoricoxib 30 mg and celecoxib 200 mg in the treatment of osteoarthritis in two identically designed, randomized, placebo-controlled, non-inferiority studies. Rheumatology (Oxford). 2007 Mar;46(3):496-507. doi: 10.1093/rheumatology/kel296. Epub 2006 Aug 27.
citation: Bingham CO 3rd, Bird SR, Smugar SS, Xu X, Tershakovec AM. Responder analysis and correlation of outcome measures: pooled results from two identical studies comparing etoricoxib, celecoxib, and placebo in osteoarthritis. Osteoarthritis Cartilage. 2008 Nov;16(11):1289-93. doi: 10.1016/j.joca.2008.04.009. Epub 2008 Jun 2.
citation: Bingham CO 3rd, Smugar SS, Wang H, Tershakovec AM. Early response to COX-2 inhibitors as a predictor of overall response in osteoarthritis: pooled results from two identical trials comparing etoricoxib, celecoxib and placebo. Rheumatology (Oxford). 2009 Sep;48(9):1122-7. doi: 10.1093/rheumatology/kep184. Epub 2009 Jul 9.
Clinical trial NCT02378168: 6-month Follow up After Sevoflurane Postconditioning
Official title: Late Postconditioning After Cardiac Surgery - Bridge From Surrogate Markers to Clinical Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Surgical Procedures
Keywords: postconditioning
six month follow up
cardiac event
non-cardiac event
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had successfully completed the late postconditioning trial (NCT00924222) were included in this retrospective follow-up analysis.

Brief summary: Retrospective analysis of a 6-month follow up within a randomised controlled study in cardiac surgery with pharmacological postconditioning (sedation on intensive care unit with sevoflurane)

Detailed description: Introduction: In a recent randomized controlled (RCT; NCT00924222) trial the investigators demonstrated in 102 patients that late post-conditioning with sevoflurane performed in the intensive care unit (ICU) reduced myocardial injury. These patients presented with lower troponin T values on the first post-operative day compared with patients undergoing propofol sedation. In order to assess possible clinical relevant long-term implications in patients enrolled in this study, the current retrospective analysis is performed focusing on cardiac and non-cardiac events during the first six months after surgery.

Methods: All patients who had successfully completed the late post-conditioning trial were included in this follow-up. Primary and secondary endpoints were the proportion of patients experiencing cardiac and non-cardiac events, respectively. Additionally, therapeutic interventions such as initiation or change of drug therapy, interventional treatment or surgery were assessed.

Eligibility criteria: All patients who had successfully completed the late post-conditioning trial were included in this retrospective follow-up analysis. Written and informed consent of all patients included in the first study had to be available.

Primary outcomes:
measure: the proportion of patients with cardiac events
timeFrame: 6 months after cardiac surgery
Secondary outcomes:
measure: proportion of patients experiencing non-cardiac events
timeFrame: 6 months after cardiac surgery
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University Hospital Zurich, Anesthesiology
name: Beatrice Beck Schimmer, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03437668: Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia
Official title: Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Withania Somnifera
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
name: University of Maryland
First posted: 2018-02-19
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether a standardized extract of Withania somnifera will reduce psychopathology scores (PANSS total score) in persons with schizophrenia. A secondary aim is to determine whether WSE reduces measures of positive and negative symptoms (PANSS subscales) and stress scores on the Perceived Stress Scale (PSS).


Eligibility criteria: Inclusion Criteria:

* Diagnostic and Statistical Manual (DSM) 5 diagnosis of schizophrenia or schizoaffective disorder
* Ability to provide informed written consent
* PANSS total score ≥ 70 or a CGI Severity Scored ≥ 4; and at least 2 positive symptom subscale items (i.e., delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility and unusual thought content) scoring ≥ 4, or one of these items scoring ≥ 5, on a scale ranging from 1 = absent to 7 = extreme.
* Evidence of a positive symptom exacerbation during the year prior to study entry.
* For women of child bearing age, a negative serum pregnancy test at screening

Exclusion Criteria:

* Testing positive for illicit substances (positivity to marijuana or opioids will be assessed on a case by case basis due to the long elimination half life in the urine of marijuana and the use of opioids for various pain disorders, caffeine and nicotine are excepted)
* Receiving pharmacological treatment for addictions (naltrexone, suboxone, acamprosate, others) will be reviewed on a case by case basis
* Seriously unstable medical illnesses
* Pregnant or breast feeding women
* Known allergy or history of serious adverse event with WSE
* Subjects who may require imminent hospitalization (examples: suicidal or aggressive behavior)
* Currently receiving antibiotics, anti-viral, or anti-parasitic medications
* Currently receiving immunosuppressive medications (e.g. oral scheduled corticosteroids, chemotherapy or transplantation or HIV/AIDS associated drugs).

Primary outcomes:
measure: Positive and Negative Symptom Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: PANSS Negative Factor Score Also Know as Marder Factors
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Catonsville
country: United States
facility: Maryland Psychiatric Research Center
state: Maryland
Study officials:
affiliation: Semel Inst at UCLA
name: Stephen Marder, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05476068: Dry Eye Under China's Dynamic COVID-zero Strategy
Official title: Dry Eye Symptoms of University Students Under China's Dynamic COVID-zero Strategy: A Comparison Between the Epidemic and Non-epidemic Areas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Symptoms
Keywords: dry eye symptoms
anxiety
depression
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 1807
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects of the study are students from Nanchang University and Henan University.

Brief summary: To compare the prevalence of dry eye symptoms and to investigate the association of the risk factors with the dry eye symptomatology among university students in the epidemic and non-epidemic areas of China under the COVID-zero strategy.

Detailed description: As the COVID-19 outbreak at the end of 2019 spread around the world, the World Health Organization declared it a public health emergency of international concern on 30th January, and a global pandemic on 1st March. In addition to the threat of coronavirus itself, anti-epidemic measures such as wearing masks, maintaining social distance, prohibiting group gathering, blockade, isolation, curfew, closure, working at home, online learning, etc., have also greatly changed people's daily life dynamics. Unlike the previous regional blockade (city-wide) suspension of school and work, China has shifted to dynamic prevention and control in April 2020, and the basic life and activities in the epidemic area are not restricted. This study aims to compare the prevalence of dry eye symptoms and to investigate the association of the risk factors with dry eye symptoms among college students in the epidemic and non-epidemic areas of China under the dynamic COVID-zero strategy.

Eligibility criteria: Inclusion criteria:

* College students with age ≥18 years
* No other medication history in recent 2 weeks;
* Have high compliance and are willing to fill in the questionnaire on time

Exclusion criteria:

* routinely using artificial tears and Other eye drops;
* taking any medication that could interfere with the results of the study;
* with any history of eye surgery

Primary outcomes:
measure: A score of ocular surface disease index (OSDI)questionnaire
timeFrame: DAY 0
measure: A score of GAD-7 questionnaire
timeFrame: DAY 0
measure: A score of PHQ-9 questionnaire
timeFrame: DAY 0
Secondary outcomes:
measure: A score of UCLA Loneliness Scale questionnaire
timeFrame: DAY 0
measure: Students' increased use of mobile phones
timeFrame: DAY 0
measure: Frequency of student sports
timeFrame: DAY 0
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
References: