louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02415205: Pain and Stress Assessment and ROP Screening
Official title: Pain and Stress Assessment and ROP Screening Examination in Premature Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Stress
Keywords: Pain and stress assessment in premature infants
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 42
Sex: ALL
Minimum age (years): 24
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature infants undergoing SOC ROP eye exams

Brief summary: The study will measure the effects of eye exams on markers of stress in the urine. In addition, measurements will be taken to show the effects of stress on brain activity, O2 sats, and blood flow.


Eligibility criteria: Inclusion Criteria:

* Premature infants between 24 -32 weeks of gestational age

Exclusion Criteria:

* Infants scheduled for laser eye surgery on the day of the examination
* Infants with intraventricular hemorrhage ≥ grade 3 (Papile classification) diagnosed by head ultrasound
* Infants receiving the following medications: morphine, fentanyl, methadone, midazolam, lorazepam, muscle relaxants, phenobarbital, phenytoin, levetiracetam
* Renal injury defined with plasma creatinine \> 1.5 mg/dL
* Severe cyanotic congenital heart disease
* Unstable respiratory distress (hypoxemia PaO2 \< 50 mm Hg or SpO2 \< 90%)

Primary outcomes:
measure: Urine Stress Marker
timeFrame: 24 hours
Secondary outcomes:
measure: aEEG
timeFrame: 24 hours
measure: NIRS
timeFrame: 24 hours
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Children's Hospital
state: California
Study officials:
affiliation: Loma Linda University
name: Andrew Hopper, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02827305: Centella Asiatica (Gotukola) Mouthwash as an Adjunct to Mechanical Plaque Control
Official title: Clinical Evaluation of the Centella Asiatica (Gotukola) Mouthwash as an Adjunct to Mechanical Plaque Control: A RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gingival Diseases
Keywords: antiplaque
antigingivitis
Lead sponsor: Sri Hasanamba Dental College and Hospital
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 36
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the adjunctive use of Centella Asiatica (gotukola) to scaling in the reduction of plaque and gingival inflammation. Patients were divided into three groups of which group 1 received scaling and gotukola mouthwash, group 2 received scaling only and group 3 received gotukola mouthwash only.

Detailed description: Mechanical plaque control by tooth brushing is considered to be the ideal way of preventing plaque associated gingivitis. However due to various factors individuals fail to perform an adequate quality of self performed plaque control. Centella Asiatica (gotukola) possess wide range of biological activities like anti-inflammatory, anti-psoriatic, anti-ulcer, hepato-protective, anticonvulsant, immunostimulant, cardioprotective, antidiabetic, antiviral, antibacterial, antifungal, etc. So, it could be used as adjunctive to mechanical periodontal therapy.

Eligibility criteria: Inclusion Criteria:

* Minimum of 22 natural teeth
* Participants with Chronic generalized gingivitis
* Participants with plaque index score ≥1

Exclusion Criteria:

* Participants with fixed or removable appliances
* Participants with more than full coverage restorations
* Medically compromised participants
* Participants on long term medications
* Smokers
* Participants who had used any type of antibacterial mouthwash in 4weeks of commencement.
* Patients with history of recent periodontal therapy

Primary outcomes:
measure: The efficacy of gotukola as an adjunct to scaling was assessed by using plaque index and gingival indes
timeFrame: 2-8-2015 to 16-8-2015
Secondary outcomes:
Other outcomes:
Locations:
city: Hassan
country: India
facility: Talat Mohammadi
state: Karnataka
Study officials:
affiliation: Sri Hasanamba Dental College and Hospital
name: Talat Mohammadi, PG student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sastravaha G, Yotnuengnit P, Booncong P, Sangtherapitikul P. Adjunctive periodontal treatment with Centella asiatica and Punica granatum extracts. A preliminary study. J Int Acad Periodontol. 2003 Oct;5(4):106-15.
citation: Sastravaha G, Gassmann G, Sangtherapitikul P, Grimm WD. Adjunctive periodontal treatment with Centella asiatica and Punica granatum extracts in supportive periodontal therapy. J Int Acad Periodontol. 2005 Jul;7(3):70-9.
Clinical trial NCT04969705: Intrathecal Dexmedetomidine Versus Transversus Abdominus Plane Block (TAP) for Postoperative Analgesia After Cesarean Section.
Official title: Intrathecal Dexmedetomidine Versus Transversus Abdominus Plane Block (TAP) for Postoperative Analgesia After Cesarean Section.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management in Adult Females in Child Bearing Period Aging From 20 to 45 Years Who Are Scheduled for Elective Cesarean Section
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spinal anesthesia is the most commonly used technique for lower abdominal surgeries as it is very economical and easy to administer. However, postoperative pain control is a major problem because spinal anesthesia using only local anesthetics is associated with relatively short duration of action, and thus early analgesic intervention is needed in the postoperative period The transversus abdominus plane (TAP) block is a regional analgesic technique which blocks T6-L1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries


Eligibility criteria: Inclusion Criteria:

1. ASA physical status classes I and II
2. Scheduled for elective cesarean section
3. Aged between 20-45 years .

Exclusion Criteria:

1. patient refusal.
2. patient with significant cardiovascular disease , hepatic dysfunction , renal failure , chronic pulmonary disease .
3. neuromuscular disorder.
4. infection.
5. bleeding disorder.
6. Obesity ( BMI \> 30 kg/m2 ) .
7. History of allergy or sensitivity to any of the study drugs in previous surgeries .

Primary outcomes:
measure: Analgesic efficacy of both routes
timeFrame: 24 hours
Secondary outcomes:
measure: 1. Hemodynamic effect on the patient
timeFrame: 1 hour
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Betran AP, Merialdi M, Lauer JA, Bing-Shun W, Thomas J, Van Look P, Wagner M. Rates of caesarean section: analysis of global, regional and national estimates. Paediatr Perinat Epidemiol. 2007 Mar;21(2):98-113. doi: 10.1111/j.1365-3016.2007.00786.x.
citation: Madadi P, Ross CJ, Hayden MR, Carleton BC, Gaedigk A, Leeder JS, Koren G. Pharmacogenetics of neonatal opioid toxicity following maternal use of codeine during breastfeeding: a case-control study. Clin Pharmacol Ther. 2009 Jan;85(1):31-5. doi: 10.1038/clpt.2008.157. Epub 2008 Aug 20.
citation: Elia N, Culebras X, Mazza C, Schiffer E, Tramer MR. Clonidine as an adjuvant to intrathecal local anesthetics for surgery: systematic review of randomized trials. Reg Anesth Pain Med. 2008 Mar-Apr;33(2):159-67. doi: 10.1016/j.rapm.2007.10.008.
Clinical trial NCT01470105: Improving a Bayesian Model's Survival Estimates in Patients Needing Surgery for Bone Metastases
Official title: Improving a Bayesian Model's Survival Estimates in Patients Needing Surgery for Bone Metastases
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bone Metastases
Keywords: questionnaire
11-121
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Montefiore Medical Center
First posted: 2011-11-11
Enrollment: 230
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: Potential subjects will be recruited by the Orthopaedic Service of the Department of Surgery.

Brief summary: The goal of this study is to improve how we estimate survival of people with cancer that has spread to their bone. There have been previous attempts to estimate survival of people with cancer that spread to the bone, but they have not been accurate. This study will try to improve the way we estimate survival in people with cancer that has spread to their bone by looking to see if a physician assessment and a patient assessment of the health status can be blended to give a better estimate of survival than patients or doctors alone.


Eligibility criteria: Inclusion Criteria:

* ≥ to 18 years of age
* Diagnosed with a metastatic malignancy
* histologically proven in oligometastatic disease or by clinical suspicion in widely metastatic disease
* by conventional radiographs, cross sectional imaging and/or scintigraphy
* Scheduled for an orthopaedic operative intervention for skeletal metastases at MSKCC or Montefiore Medical Center including, not limited to the following:
* Resection
* Intramedullary Fixation
* Prophylactic fixation
* Curettage and cementation
* Internal fixation
* Arthroplasty
* Spine stabilization

Exclusion Criteria:

* None

Primary outcomes:
measure: serum inflammatory cytokines
timeFrame: 3 years
Secondary outcomes:
measure: chemokine analysis
timeFrame: 3 years
measure: patient-reported SF-36 data
timeFrame: 3 years
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: John Healey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03797105: Frequency Needed for School-based Obesity Intervention
Official title: Frequency of Intervention Needed to Improve Weight Outcomes of Mexican-American Adolescents With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Child
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
First posted: 2019-01-08
Enrollment: 243
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial compared changes in Mexican-American, adolescent standardized body mass index (zBMI) from a school-based obesity intervention given zero, one, three, or five days a week.

Detailed description: Efficacious school-based interventions have been intensive making it difficult for interventions to be scaled. The more components there are to an intervention, typically the better the results. Instead of decreasing intensity via the removal of intervention components, this randomized controlled trial aimed to compare changes in Mexican-American adolescent standardized body mass index (zBMI) based on the number of days per week they received a multi-component intervention. Mexican-American middle school students (n=203) with overweight or obesity were recruited from an independent school district in Houston. Students were randomized to receive an obesity intervention with established efficacy zero (control), one, three, or five days/week. In each condition, 80% of intervention time was allocated to physical activity and 20% to nutrition. Directly measured height and weight were used to calculate zBMI.

Eligibility criteria: Inclusion Criteria:

1. BMI-for-age (Body Mass Index) percentile ≥ 85
2. Male or female between ages 10 - 17 years
3. Self-identified as Mexican-American

Exclusion Criteria:

1. Student who is pregnant, planning to become pregnant, or becomes pregnant
2. School report of cognitive impairment significantly below average age and/or grade level
3. Use of any weight-loss medication (prescription or nonprescription) for at least 6 months prior to screening
4. Type 1 or 2 diabetes medical diagnosis

Primary outcomes:
measure: Change in Standardized Body Mass Index (zBMI)
timeFrame: baseline, 6, and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: YES Prep Brays Oaks
state: Texas
Study officials:
affiliation: University of Houston
name: Craig A Johnston, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00573105: Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)
Official title: Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: C. R. Bard
First posted: 2007-12-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. General

   - antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery
2. Laparoscopic surgery

   * at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)
   * with or without anchoring transparietal sutures or double crown technique


Eligibility criteria: Inclusion Criteria:

* written informed consent from the patient or his/her legal representative
* ventral hernia requiring elective surgical repair

Exclusion Criteria:

* no written informed consent
* 'hostile' abdomen; open abdomen treatment
* contraindication to pneumoperitoneum
* emergency surgery (incarcerated hernia)
* parastomal hernia

Primary outcomes:
measure: recurrence rate
timeFrame: after 1 year
Secondary outcomes:
measure: morbidity rate
timeFrame: perioperative
measure: quality of life
timeFrame: after 1 year
measure: postoperative pain
timeFrame: within 1 week
measure: long term complication rate
timeFrame: after 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Frederik Berrevoet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06830005: Validating Osteoporosis Detection in Rho AI Software
Official title: Validating Osteoporosis Detection in Rho AI Software
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteopenia or Osteoporosis
Keywords: orthopedic surgery
screening
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 800
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To assess the effectiveness of 16bit's Rho AI (artificial intelligence) software at identifying known cases of osteoporosis. 800 de-identified images from January 2007 to January 2024 will be accessed to test the software prospectively.

Detailed description: Osteoporosis is underrecognized and undertreated in the orthopedic surgery patient population. Osteoporosis is diagnosed by dual-energy x-ray absorptiometry which is costly and imparts radiation. Preoperative radiographs are universally obtained in orthopedic surgery patients, however up to this point radiographs have not been able to diagnose osteoporosis. This software program is a new technology that is able to leverage radiographs to opportunistically screen for osteoporosis.

The study team will identify applicable patient records from medical record review, and Radius will de-identify the x-ray images. The de-identified images will be run through the Rho AI program to identify osteoporosis or osteopenia, and a report will be generated to summarize the program's findings.

Eligibility criteria: Inclusion Criteria:

* images from people who have undergone total joint arthroplasty
* images from people who have undergone spine fusion

Exclusion Criteria:

-

Primary outcomes:
measure: AI Predicted Osteoporosis Score
timeFrame: through study completion (data collected up to 1 month)
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: James Bernatz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06076005: Lung Cancer ID (Identity) Study
Official title: Demographic, Clinical, Histological and Molecular Characteristics of Advanced LUNG CANCER at the tIme of Diagnosis in a Large Italian Cohort: an Observational Cohort Study: Lung Cancer ID Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer Stage IV
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive, treatment-naïve, patients with clinical and radiological suspicion of advanced lung cancer referred for the initial diagnosis/staging/molecular profiling.

Brief summary: The distribution of demographic, clinical, radiological, pathological and molecular characteristics of lung cancer at the time of diagnosis, as well as preferential association between elements of those domains, have not been specifically studied in Italy. The aim of the present project is to assess, in a systematic fashion, the demographic, clinical, radiological, pathological and molecular characteristics of advanced lung cancer at the time of diagnosis in a large Italian cohort of consecutive patients referred to two tertiary referral centers.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Suspicion of lung cancer based on imaging (CT and/or PET/CT)
* Indication to a biopsy for diagnosis, staging and/or molecular profiling

Exclusion Criteria:

* Inability or unwillingness to provide a written informed consent
* ECOG performance status (\>3) which makes a tissue diagnosis unfeasible
* ASA 4 status
* TNM Stage I-III

Primary outcomes:
measure: Distribution of histologic subtypes
timeFrame: 24 months
Secondary outcomes:
measure: Distribution of histologic subtypes according to clinical and radiological characteristics
timeFrame: 24 months
measure: Molecular profiling
timeFrame: 24 months
measure: Time to diagnosis
timeFrame: 24 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Interventional Pulmonology Division - Fondazione Policlinico Universitario A. Gemelli IRCCS
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Roma
country: Italy
facility: Medical Oncology Division - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References:
Clinical trial NCT02672605: Measurement of Individual Level of Abortion Stigma Study
Official title: Measurement of Individual-Level Abortion Stigma Resulting From Pennsylvania State-Mandated Abortion Consent Language: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion Stigma
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is a randomized controlled trial designed to measure abortion stigma related to the Pennsylvania Abortion Control Act. Women seeking abortion will be randomized to receive the validated Individual Level Abortion Stigma Scale either before or after consent via the Pennsylvania Abortion Control Act language. The primary outcome will be the stigma scores in the two groups.


Eligibility criteria: Inclusion Criteria:

1. Women ≥18 years old
2. Seeking induced abortion for any indication
3. Gestation ≤ 24 weeks
4. Plan for procedural or state consent at current visit
5. Willing and able to consent in English

Exclusion Criteria:

1. Have previously been consented in the current pregnancy using the Pennsylvania Abortion Control Act consent language
2. Have previously had an abortion

Primary outcomes:
measure: Individual level stigma scores
timeFrame: Stigma store is collected during one 30-minute study visit, either directly prior or directly following the patient being consented using the PA Abortion Control Act language
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Family Planning and Pregnancy Loss Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Sarita Sonalkar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04840498: UAB AIM Virtual Magic Camp
Official title: UAB Arts in Medicine's Evaluation of a Virtual Magic Camp
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 18
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be with other individuals who do not have ASD.

Brief summary: The magic camp for children with disabilities at UAB has been conducted yearly since 2018. This year, because of the Covid-19, the magic camp will be conducted online. The virtual magic camp will start in the beginning of June . It will run for 4 weeks. After one cohort, there will be another cohort starts in the beginning of July . Each cohort will have about 30 children with disabilities. Two occupational therapy graduate students will teach each child via Zoom to learn magic hand trick 3 times a week, one hour each. No studies evaluate the psychological benefits of learning magic tricks via online in children with disabilities. Therefore, this study is to evaluate the psychological being of the children participants after completing a virtual magic camp.


Eligibility criteria: Inclusion Criteria:

* Have some form of ASD

Primary outcomes:
measure: Self Esteem
timeFrame: 2 weeks
measure: Strengths & Difficulties
timeFrame: 2 weeks
measure: Social Anxiety
timeFrame: 2 weeks
measure: Social Skills
timeFrame: 2 weeks
measure: Social Responses
timeFrame: 2 weeks
measure: Parental Stress
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Alys Sthepens Center
state: Alabama
Study officials:
References: