louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05917691: Impact of Functional Status on 30-day Resource Utilization and Organ System Complications Following Bariatric Surgery
Official title: Impact of Functional Status on 30-day Resource Utilization and Organ System Complications Following Index Bariatric Surgery: a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dependence
Perioperative/Postoperative Complications
Frailty
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 65627
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective bariatric surgical patients, ACS-NSQIP 2015-2019

Brief summary: The goal of this observational study is to assess the effect of functional status on bariatric surgical thirty-day outcomes. The main questions it aims to answer are:

* Is functional status associated with higher incidence of 30-day unplanned resource utilization?
* Is functional status associated with higher incidences of secondary adverse events?

Participants will be sampled from the 2015-2019 American College of Surgeons National Surgical Quality Improvement Program


Eligibility criteria: Inclusion Criteria:

* Current Procedural Terminology (CPT) codes: 43644, 43645, 43770, 43775, 43842, 43843, 43845, 43846, 43847
* Elective, non-emergent cases
* "General surgery" surgical specialty
* "General anesthesia" anesthetic technique

Exclusion Criteria:

* Documented concurrent or other procedures
* Patients admitted to the hospital for greater than one day preceding surgery
* Acute kidney injury (preoperative)
* End-stage renal disease (preoperative)
* Metastatic disease (preoperative)
* Wound infection (preoperative)
* Sepsis (preoperative)

Primary outcomes:
measure: Unplanned resource utilization (composite)
timeFrame: 30 days
Secondary outcomes:
measure: Composite organ system complications
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01001091: AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Keywords: Conjunctivitis
conjunctival inflammation
ocular allergies
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: Ophthalmic Research Associates, Inc.
First posted: 2009-10-23
Enrollment: 312
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: The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Presence of signs and symptoms of ocular inflammation in both eyes.
* Have a positive CAC response at Visit 1.
* Able to avoid the use of disallowed medications as well as contact lens wear for the specified period prior to Visit 1, and for the duration of the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Have known history or presence of persistent dry eye syndrome.
* Presence of any ophthalmic abnormality that may affect the study outcomes.
* Have a history of moderate to severe allergic asthma reaction to mountain cedar or the perennial allergens used in the study.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores
timeFrame: Day 14
Secondary outcomes:
measure: Mean daily diary ocular redness scores
timeFrame: 2 week period between Day 0 and Day 14
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Michela Palmer
role: STUDY_DIRECTOR
References:
Clinical trial NCT00861991: Enhancing Empathy in Medical Communication Through Perspective-Taking
Official title: Enhancing Empathy in Medical Communication Through Perspective-Taking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Keywords: medical communication
empathy
medical education
standardized patients
enhancing "patient" satisfaction
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2009-03-16
Enrollment: 608
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Background: Empathy is critical to clinician-patient communication and patient outcomes. Perspective-taking, an intervention demonstrated in other contexts to induce empathy, has never been studied in a medical context. As a first step in evaluating its potential clinical value, the studies described below assess perspective taking in a series of clinical skills examinations. These examinations are simulated clinical encounters: students encounter and are evaluated by standardized patients (SPs)--actors trained to take on patient roles. Though not real clinical encounters, clinical skills examinations have been demonstrated to test clinical competency well enough to be incorporated into the licensure examination of the National Board of Medical Examiners.

Objective: To assess if perspective-taking improves the satisfaction of standardized patients in three clinical skills examinations.

Hypothesis: Students receiving a perspective taking intervention will receive better standardized patient satisfaction scores than control students.

Design and Setting: Three randomized, controlled studies. Studies 1 and 3: Junior medical students(N = 503), 6-station clinical skills examination. Study 2: physician assistant students (N = 105), 3-station clinical skills examination.

Intervention: The intervention students received a perspective-taking instruction prior to their examination asking them to put themselves in their "patients" shoes and to imagine what they were thinking and feeling. The control students received standard pre-examination instructions. Simulated patients were blind to study condition. Main Outcome Measure: Simulated patient satisfaction scores.

Detailed description: These studies assess the interaction of students and simulated patients (actors)--no real patients were involved.

Eligibility criteria: Inclusion Criteria:

* All third year medical and first and second year physician assistant students, George Washington University School of Medicine and Health Sciences

Exclusion Criteria:

* None

Primary outcomes:
measure: standardized patient satisfaction
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University School of Medicine
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Benjamin C Blatt, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06730191: Soft Tissue Graft Over Immediately Placed Dental Implant in Maxillary Molar Socket
Official title: Free Buccal Pad Graft Versus Free Palatal Gingival Tissue Graft for Primary Soft Tissue Closure Over Immediately Placed Dental Implant in Maxillary Molar Socket
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Diseases
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare between free tissue graft of buccal pad of fat BFP and free palatal gingival tissue graft for primary soft tissue closure over immediately placed dental implant

Detailed description: Buccal pad of fat BFP and free palatal gingival tissue graft over immediately placed dental implant

Eligibility criteria: Inclusion Criteria:

* class one molar extraction socket

Exclusion Criteria:

* pregnant females psychiatric problems

Primary outcomes:
measure: Soft tissue healing
timeFrame: 1,2,3,4,weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mansoura University
name: mansoura university
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rajan SA, Ramabhadran BK, Emmatty R, Paul TP, Jose P, Ameyaroy DK, Variath PT, Joseph M. Comparative Evaluation of Different Soft Tissue Coverage Techniques at Immediate Implant Sites: A Cohort Study. J Contemp Dent Pract. 2021 Nov 1;22(11):1268-1274.
citation: Bleyan S, Gaspar J, Huwais S, Schwimer C, Mazor Z, Mendes JJ, Neiva R. Molar Septum Expansion with Osseodensification for Immediate Implant Placement, Retrospective Multicenter Study with Up-to-5-Year Follow-Up, Introducing a New Molar Socket Classification. J Funct Biomater. 2021 Nov 25;12(4):66. doi: 10.3390/jfb12040066.
Clinical trial NCT05962229: Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine
Official title: Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Nicotine Dependence
Nicotine Vaping
Keywords: Nicotine Pharmacokinetics
Nicotine Pharmacodynamics
Vaping
E-cigarettes
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-07-27
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within-subject, single-blinded crossover study. Participants will be randomized to the order of the 3 conditions using a Latin Square design.
Primary purpose: BASIC_SCIENCE

Brief summary: In a crossover study, experienced electronic cigarette users will vape 3 different forms of nicotine: natural (derived from tobacco), synthetic, or a 50:50 mixture of both natural and synthetic. The investigators will compare nicotine metabolism, cardiovascular effects, patterns of self-administration, and participants' feelings of craving/withdrawal and enjoyment.


Eligibility criteria: Inclusion Criteria:

* Healthy on the basis of medical history and limited physical examination.
* Current regular user of E-Cigarettes (≥ 15 days in the past 30 days)

Exclusion Criteria:

* • Medications

  * Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs).
  * Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers).
  * Concurrent use of nicotine-containing medications (Example: nicotine patch, lozenge, gum).
  * Any stimulant medications (example: Adderall) generally given for ADHD treatment.

    • Pregnancy
  * Pregnancy (self-reported and urine pregnancy test)
  * Breastfeeding (determined by self-report)
  * Women of childbearing potential must be using an acceptable method of contraception

    * Inability to read and write in English
    * A known propylene glycol/vegetable glycerin allergy
    * Uncomfortable with getting blood drawn

Primary outcomes:
measure: Mean Nicotine Exposure Over Time
timeFrame: Up to 7 hours
Secondary outcomes:
measure: Mean Amount of Nicotine Consumed Over Time
timeFrame: 120 minutes
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital (ZSFG)
state: California
Study officials:
affiliation: University of California, San Francisco
name: Neal Benowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01330329: Comparison of Weight Loss Programs for Individuals With Severe Obesity
Official title: Comparison of a Traditional Behavioral Weight Loss Program Versus a Technology - Based Weight Loss Program in Severely Obese Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: Obesity
Weight loss
Exercise
Intervention studies
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2011-04-06
Enrollment: 29
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of a technology-based system (the Body Media FIT system) for enhancing weight loss in severely obese individuals (BMI: ≥ 40 kg/m2). The investigators will compare two 6-month interventions: 1) a standard behavioral weight loss program (SBT) and 2) a standard behavioral weight loss program plus the use of the Body Media FIT system (SBT+FIT). The Body Media® FIT system is a novel weight loss tool consisting of an armband that measures energy expenditure, a digital display watch that provides "real time" physical activity and energy expenditure feedback, and access to a system website which allows individuals to track their food intake and set exercise and dietary goals. We will examine differences in physical activity, weight loss, and program adherence between groups.


Eligibility criteria: Inclusion Criteria:

* Age 21-55
* Body mass index (BMI) ≥40kg/m2 (or no more than 440 lbs)

Exclusion Criteria:

* Recent weight loss (≥ 10 pounds within the past 6 months)
* Currently pregnant, pregnant within the last 6 months, or planning on becoming pregnant in the next 6 months.
* Presence of any condition that would limit exercise participation (assessed by the Physical Activity Readiness Questionnaire (PAR-Q)).
* A history of myocardial infarction or other heart-related surgeries.
* Currently enrolled in a commercial weight loss program.
* A recent (\< 1 year) diagnosis or hospitalization for a psychological condition or history of psychosis (e.g. - Schizophrenia, Bipolar, Eating Disorder)
* Diagnosed with cancer within the past year or currently undergoing cancer treatment.
* Currently taking weight loss medications.
* Currently do not have daily access to a computer or Internet.
* Individuals with diabetes

Primary outcomes:
measure: Change in body weight
timeFrame: 6-months
Secondary outcomes:
measure: Change in physical activity
timeFrame: 6-months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Rena Wing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Unick JL, O'Leary KC, Dorfman L, Thomas JG, Strohacker K, Wing RR. Consistency in compensatory eating responses following acute exercise in inactive, overweight and obese women. Br J Nutr. 2015 Apr 14;113(7):1170-7. doi: 10.1017/S000711451500046X. Epub 2015 Mar 17.
Clinical trial NCT02714829: Clinical Study of Injectable Ceramics Bone Graft Substitute Containing rhBMP-2
Official title: Clinical Study to Evaluate Efficacy and Safety of "Inject BMP(Beta-TCP Containing rhBMP-2)" for Socket Preservation After Extraction of a Single-rooted Tooth: A Randomized, Outcomes Assessor-Blinded, Multi-center, Prospective Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Preservation
Bone Graft
Keywords: Injectable Ceramics Bone Graft Substitute Containing rhBMP-2
Lead sponsor: BioAlpha Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-22
Enrollment: 88
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, outcomes assessor-blinded, randomized study to evaluate the efficacy and safety of "Inject BMP(Injectable Ceramics Bone Graft Substitute Containing rhBMP-2)" for socket preservation after extraction of a single-rooted tooth, compared to ExcelOS-inject(Injectable Ceramics Bone Graft Substitute).

Detailed description: Inject BMP is Injectable Ceramics Bone Graft Substitute(ExcelOS-inject) containing rhBMP-2. Recombinant human Bone morphogenetic protein 2 (rhBMP-2) stimulates the production of bone.

Eligibility criteria: Inclusion Criteria:

* Persons without periodontal disease

Exclusion Criteria:

* Women who are pregnant or plan to be pregnant within study period

Primary outcomes:
measure: compared the changed height and standard height by computed tomography.
timeFrame: at 12 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Dental Hospital
name: Soon Jung Hwang, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Jong-Rak Hong, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University
name: Hee-Kyun Oh, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han JJ, Chang AR, Ahn J, Jung S, Hong J, Oh HK, Hwang SJ. Efficacy and safety of rhBMP/beta-TCP in alveolar ridge preservation: a multicenter, randomized, open-label, comparative, investigator-blinded clinical trial. Maxillofac Plast Reconstr Surg. 2021 Dec 20;43(1):42. doi: 10.1186/s40902-021-00328-0.
Clinical trial NCT04541329: Predicting Inflammatory Skin Disease Response to IL-23 Blockade
Official title: Predicting Inflammatory Skin Disease Response to IL-23 Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis Vulgaris
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Sun Pharmaceutical Industries Limited
First posted: 2020-09-09
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study examines the effect of IL-23 blockade with Tildrakizumab on the immune cells of psoriatic skin lesions.

Detailed description: This is a one-arm, open-label study to examine the effect of Tildrakizumab. Tildrakizumab is a FDA-approved medication for the treatment of cutaneous psoriasis. This study will examine how Tildrakizumab affects immune cells within psoriatic skin lesions. Fifteen subjects with moderate to severe psoriasis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with and to predict Tildrakizumab treatment response.

Eligibility criteria: Inclusion Criteria:

* Male or female ≥18 years of age at clinic visit.
* Documentation of moderate-severe psoriasis or atypical psoriasis.
* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
* Tuberculosis, active serious infection, active systemic malignancy,
* Received a systemic medication for psoriasis within 3 months of study screening

Primary outcomes:
measure: Psoriasis Area and Severity Index (PASI) Score
timeFrame: baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Raymond Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05095129: The Role of Genetic Factors in the Development of Idiopathic Scoliosis in the Kazakh Population
Official title: Preventive and Personalized Medicine (2021-2023)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Scoliosis
Keywords: SNP
Lead sponsor: Asfendiyarov Kazakh National Medical University
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 400
Sex: ALL
Minimum age (years): 4
Maximum age (years): 40
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Persons of Kazakh nationality

Brief summary: The purpose of this study is to identify genetic determinants of susceptibility to idiopathic scoliosis . It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of idiopathic scoliosis


Eligibility criteria: Inclusion Criteria:

1. Persons with a doctor-confirmed diagnosis of idiopathic scoliosis;
2. Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs;
3. Hereditary history of scoliosis;
4. Persons who are able and willing to provide written informed consent;

Exclusion Criteria:

1. Patients diagnosed with idiopathic scoliosis under 4 and over 40 years of age;
2. Representatives of the Kazakh ethnic group less than 3 generations;
3. No family history of bilateral idiopathic scoliosis;
4. Patients with an acute period of the inflammatory process (laboratory and clinical signs);
5. Persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent;
6. Pregnant or lactating women;
7. Tuberculosis of any localization in the active phase and in history;
8. Severe and decompensated diseases of the liver and kidneys, cardiovascular system;
9. Severe and decompensated course of endocrine diseases;
10. Autoimmune diseases;
11. Systemic diseases;
12. Oncological diseases;

Primary outcomes:
measure: Genotyping for the SNP associated with liver cirrhosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Scientific center of traumatology and orthopedics named after academician Batpenova ND
Study officials:
affiliation: Scientific center of traumatology and orthopedics named after academician Batpenova ND
name: Oljas Bekarïsov, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03202329: Evaluation of Post-operative, Nurse-based Heart Failure Care in Non-cardiac Surgery
Official title: Evaluation of Post-operative, Nurse-based Heart Failure Care Compared to Standard Treatment in Patients With Heart Failure Undergoing Non-cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure，Congestive
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with heart failure NYHA \>= II receiving non-emergent non-cardiac in-patient surgery will be randomized to receive either standard post-operative care (surgeon has to ask actively for specialist cardiological support) or a nurse-based heart failure management (nurses provide week-day support every day after surgery, if needed together with a heart failure doctor)


Eligibility criteria: Inclusion Criteria:

patients with heart failure NYHA \>= II (HFrEF and HFpEF) or LVEF \<= 40% non-cardiac surgery planned later than 24 hours age \> 18 years written informed consent

Exclusion Criteria:

patients on intensive care life-expectancy \< 3 months

Primary outcomes:
measure: composite endpoint of in-hospital heart failure-related complications (readmission on ICU, re-initiation of inotropic support, pleural effusion, pulmonary edema, pneumonia requiring antibiotic treatment, non-invasive or invasive ventilation)
timeFrame: 30 days
Secondary outcomes:
measure: days in hospital
timeFrame: 90 days
measure: acute kidney injury
timeFrame: 90 days
measure: Qulity of Life by SF-12
timeFrame: 90 days
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Goethe University Hospital
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Klinikum Goethe University
Study officials:
References: