louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02958826: Impact of Sensory Stimuli on Patient Preferences During Outpatient Surgery
Official title: Determining the Impact of External Sensory Stimuli on Patient Preferences During Outpatient Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Satisfaction
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult (\> 18 years old) patients presenting for Mohs surgery and reconstruction for the treatment of nonmelanoma skin cancer on the head and neck.

Brief summary: The purpose of this study is to determine the effect surgical lights, surgical smoke, and surgical sounds have on patient satisfaction with their outpatient Mohs surgical procedure.

Detailed description: The purpose of this study is to determine the impact of external sensory stimuli on patient preferences during outpatient Mohs surgery. Study participants will be asked to complete a questionnaire after their procedure sharing their experience with surgical lights, surgical smoke, and surgical noise. All responses are anonymous.

Eligibility criteria: Inclusion Criteria:

* All adult (\> 18 years old) patients presenting for Mohs surgery and reconstruction for the treatment of nonmelanoma skin cancer on the head and neck

Exclusion Criteria:

* Subjects not meeting inclusion criteria.

Primary outcomes:
measure: Effect of Surgical Lights on Patient Preference
timeFrame: Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.
measure: Effects of Surgical Smoke on Patient Preference
timeFrame: Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.
measure: Effect of Surgical Sounds on Patient Preference
timeFrame: Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Nicholas Golda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01651026: Multicenter Cohort Prospective Study on Multidisciplinary Treatment of Rectal Cancer
Official title: Multicentered Observational Prospective Cohort Study on Multidisciplinary Treatment of Rectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Colorectal Cancer
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients at participating Institutes with confirmed diagnosis of colorectal cancer.

Brief summary: The purpose of this study is to describe the diagnostic and treatment procedures employed for patients with rectal cancer in each participating center. Outcomes to treatment, costs of treatment will be described. Exploratory analyses will be done to identify factor that influence patient prognosis, as well as factors that predict patient response to treatment.


Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis rectal carcinoma
* Signed informed consent

Exclusion Criteria:

* Refusal or incapability of providing informed consent

Primary outcomes:
measure: list of diagnostic procedures used in clinical practice, according to participating Institute
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
measure: all treatments received for colorectal cancer (surgery, radiation therapy, chemotherapy, supportive care, etc) per patient
timeFrame: 5 years
measure: rectal cancer surgical interventions/approaches per participating center
timeFrame: 5 years
measure: disease outcomes per patient per treatment received
timeFrame: 5 years
measure: estimated costs per treatment pattern per center
timeFrame: 5 years
measure: factors that influence patient prognosis
timeFrame: 5 years
measure: predictive factors for response to treatment
timeFrame: 5 years
Locations:
city: Napoli
country: Italy
facility: A.O.R.N. V. Monaldi
city: Napoli
country: Italy
facility: A.O.U. Federico II
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico
Study officials:
affiliation: National Cancer Institute, Naples
name: G. Romano, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: C. Sassaroli, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: M. C. Piccirillo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Francesco Perrone, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04914026: MicroRNA as Markers in Testicular Cancer
Official title: MicroRNA-371 as Markers for Disease Activity and as a Tool to Monitor the Effect of Chemotherapy and Early Detection of Recurrence in Patients With Testicular Germ Cell Tumours
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Testicular Germ Cell Cancer
Seminoma
Non-Seminoma Testicular Cancer
Stage I Testicular Cancer
Stage II Testicular Cancer
Stage III Testicular Cancer
Stage IV Testicular Cancer
Relapse Testicular Cancer
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Sahlgrenska University Hospital
name: Helse Fonna
name: University Hospital of North Norway
name: Oslo University Hospital
First posted: 2021-06-04
Enrollment: 350
Sex: MALE
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: PROBABILITY_SAMPLE
Study population: Men with suspected and confirmed testicular germ cell cancer, aged 18-70 years. Seminomas and non-seminomas, stage I-IV.

Brief summary: The main objective of this study is establish the performance of miR371 in management of testicular cancer

Detailed description: The main objective of the study is to asses the sensitivity and specificity of microRNA-371a-5p (miR371) in detection of viable testicular germ tumour cells. To assess the utility of miR371 at orchiectomy, during treatment and surveillance and in early detection of recurrence.

Eligibility criteria: Inclusion Criteria:

* Patients with suspected testicular cancer, referred to orchiectomy.
* Patients diagnosed with testicular germ cell cancer.
* Age 18-70 years of age.
* Must be able receive information and to consent.

Exclusion Criteria:

* Other prior or concomitant malignancy (other than testicular cancer).
* Other diseases or conditions that hinder the ability to receive information and to participate in follow-up procedures.

Primary outcomes:
measure: miR371 as a biomarker in testicular germ cell cancer at orchiectomy
timeFrame: 5 years
measure: miR371 as a biomarker in testicular germ cell cancer at RPLND
timeFrame: 5 years
measure: miR371 as a biomarker in testicular germ cell cancer during chemotherapy treatment
timeFrame: 5 years
measure: miR371 as a biomarker in testicular germ cell cancer and detection of recurrence
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Haugesund
country: Norway
facility: Haugesund Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Mette Pernille Myklebust, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04888026: Impact on Pain Sensitivity of Clinical Interaction
Official title: Impact on Pain Sensitivity of Clinical Interaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Measurement
Keywords: Low back pain
Lead sponsor: Spine Centre of Southern Denmark
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2021-05-17
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Pain can currently be quantified using quantitative sensory tests (QSTs). However, we lack knowledge concerning how relational and contextual factors impact these quantitative tests. We will examine how a standard QST battery is affected by "removing" the social and human interaction from the test session compared to usual QST testing where the participant is guided through the assessment by a research assistant.

Our objectives are:

1. How is the QST affected when guided by a research assistant compared to guided by a computer
2. Does the level of the assessor's empathy affect the QST outcome
3. How do psychological factors affect the QST testing
4. are these outcomes affected by the patient profile (low back pain patients vs healthy controls)


Eligibility criteria: Inclusion Criteria:

* Primary complaint of low back pain
* No pain for healthy controls
* No serious psychological or somatic disorders potentially interfering with the QST

Exclusion Criteria:

* Incomplete QST data

Primary outcomes:
measure: The Conditioned pain modulation effect [changes in kPa]
timeFrame: Baseline
Secondary outcomes:
measure: Pressure pain threshold
timeFrame: Baseline
Other outcomes:
Locations:
city: Middelfart
country: Denmark
facility: Spine Centre of Southern Denmark
city: Middelfart
country: Denmark
facility: The Spine Center of Southern Denmark
city: Odense
country: Denmark
facility: Department of Physocolgy
Study officials:
affiliation: Director of research
name: Søren Neill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03096626: Association Between Depression and Iron Metabolism in Hemodialysis Patients
Official title: Association Between Depression and Iron Metabolism in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodialysis
Keywords: Depression
Lead sponsor: University of Hyogo
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 152
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study subjects were the patients undergoing HD.

Brief summary: This study assesses the association of depression symptoms and iron metabolism in patients undergoing hemodialysis.

Detailed description: The Beck Depression Inventory (BDI), second version, was used to quantify the levels of depression. Mean age, duration of HD, hemoglobin levels, serum ferritin levels, serum iron levels, TSAT, TIBC, serum albumin levels, CRP and energy consumption (kcal/week) were included in the model as multivariate variables. Backward stepwise logistic regression (ROC) analysis was performed.

Eligibility criteria: Inclusion Criteria:

* Patients with stable undergoing hemodialysis

Exclusion Criteria:

* Patients those who refused to join present study, and those who could not complete the questionnaires by themselves, and the patients with chronic hepatitis B or C were excluded.

Primary outcomes:
measure: Measurement of depression status
timeFrame: day 1
Secondary outcomes:
measure: The values of serum ferritin
timeFrame: day 1
Other outcomes:
Locations:
Study officials:
affiliation: Graduate School of Applied Informatics, University of Hyogo
name: Yuko Mizuno-Matsumoto, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04101526: Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance
Official title: Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.


Eligibility criteria: Inclusion Criteria:

* Located in the Southern Puerto Rico area
* Able to speak and read Spanish
* Have no documented or observable disabilities that would interfere with study participation
* Has completed primary treatment for breast cancer (e.g., surgery, chemotherapy, radiation)
* Has clinically significant sleep disturbance (i.e., \>/= 8 on the Insomnia Severity Index)
* Is at low risk of other sleep disorders that are not amenable to treatment with cognitive-behavioral therapy
* Has access to the Internet and a digital device (e.g., smartphone) capable of using videoconference software

Exclusion Criteria:

* Not able to read and speak Spanish

Primary outcomes:
measure: Recruitment Rate - Acceptability of New Intervention for Cancer-Related Sleep Disturbances
timeFrame: Baseline
measure: Self Report Outcome - Acceptability of New Intervention for Cancer-Related Sleep Disturbances
timeFrame: Approximately 6 weeks after first intervention session
measure: Number of Participants Attending Educational Component - Feasibility of New Intervention for Cancer-Related Sleep Disturbances
timeFrame: approximately 6 weeks after first intervention session
Secondary outcomes:
measure: Efficacy of New Intervention Using PSQI Scoring
timeFrame: Baseline and approximately 6 weeks after first intervention session
measure: Efficacy of New Intervention Using ISI Scoring
timeFrame: Baseline and approximately 6 weeks after first intervention session
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H Lee Moffitt Cancer and Research Institute
state: Florida
city: Ponce
country: Puerto Rico
facility: Ponce Health Services University
Study officials:
affiliation: H. Lee Moffitt Cancer and Research Institute
name: Brian D Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oswald LB, Morales-Cruz J, Eisel SL, Del Rio J, Hoogland AI, Ortiz-Rosado V, Soto-Lopez G, Rodriguez-Rivera E, Savard J, Castro E, Jim HSL, Gonzalez BD. Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. J Behav Med. 2022 Jun;45(3):503-508. doi: 10.1007/s10865-022-00313-6. Epub 2022 Apr 19.
Clinical trial NCT05158426: Application of the Propofol Precise Infusion Model
Official title: Application of the Propofol Precise Infusion Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Propofol Overdose of Undetermined Intent
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who will undergo gastrointestinal endoscopy with propofol

Brief summary: Propofol is one of the most commonly used anesthetics in the world. However, the dose-response of propofol was remarkable variety. Herein, this study aims to investigate the possible association of gene polymorphism and propofol susceptibility, and to research more precise infusion model of this drug.

Detailed description: Patients undergoing gastrointestinal endoscopy will be recruited. Anesthesia is induced with propofol via TCI at 1.5µg/ml, and increases 0.5µg/ml for every 3min until OAA/S score 0. During this period, OAA/S score will be evaluated every 1min until OAA/S score 0. At this moment, the blood concentration of propofol, the doses of propofol, the onset time and BIS are recorded, and blood sample for gene polymorphism detection were required.

Eligibility criteria: Inclusion Criteria:

1. patients who undergoing gastrointestinal endoscopy with anesthesia
2. age ≥18 years

Exclusion Criteria:

1. hepatic or kidney function injured;
2. received hypnotic sedative drug regularly;
3. Pregnancy, excessive drinking, or current smoker;
4. be allergic to propofol
5. patients who with difficulty communication

Primary outcomes:
measure: gene polymorphism of propofol susceptibility
timeFrame: from anesthesia induction to the end of the gastrointestinal endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Weimin Li
role: STUDY_DIRECTOR
affiliation: West China Hospital
name: lin Zhang
role: STUDY_DIRECTOR
References:
Clinical trial NCT04299126: Efficacy and Safety of High Absorption Pad in Split-thickness Skin Graft Donor Site Wound
Official title: Efficacy and Safety of High Absorption Pad for Blood and Pus With Natural Antimicrobial Agent in Split-thickness Skin Graft Donor Site Wound
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Disorder of Skin Donor Site
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High absorption pad for blood and pus with natural antimicrobial agent or gauze dressing impregnated with paraffin, containing 0.5% chlorhexidine acetate (Bactigras) will be randomly covered on half of split-thickness skin graft donor site wound. The another will be cover on another half of split-thickness skin graft donor site wound. Then, they will be covered with gauzes and bandage. Time to wound healing, amounts of covered dressing gauzes, signs of infection, pain score, erythema index, melanin index, trans epidermal water loss index, and adverse events will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Have split-thickness skin graft donor site wound on thigh
* Age 18-60 years
* Can read and write
* Can follow the study protocol
* Available on appointment date

Exclusion Criteria:

* Systemic infection
* Chronic skin diseases
* Immune deficiency
* Allergic to cellulose, chitosan, sericin, and chlorhexidine
* Psychotic disorders
* Pregnancy or breast feeding

Primary outcomes:
measure: wound healing time
timeFrame: not more than 28 days
measure: amounts of secondary gauze dressing
timeFrame: not more than 28 days
Secondary outcomes:
measure: pain score
timeFrame: 5 days after donor site wound was created
measure: signs of infection
timeFrame: not more than 28 days
measure: scar melanin index
timeFrame: 3 months
measure: scar erythema index
timeFrame: 3 months
measure: transepidermal water loss index
timeFrame: 3 months
measure: scar quality
timeFrame: 3 months
measure: adverse events
timeFrame: not more than 28 days
measure: aspartate aminotransferase in serum
timeFrame: not more than 28 days
measure: alanine aminotransferase in serum
timeFrame: not more than 28 days
measure: blood urea nitrogen
timeFrame: not more than 28 days
measure: serum creatinine
timeFrame: not more than 28 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Study officials:
References:
Clinical trial NCT05817526: BMAC Loaded Collagen Jumping the Gap Around Immediate Implants
Official title: Assessment of Collagen Loaded With Bone Marrow Aspirate Concentrate Versus Autograft on Marginal Bone Changes Around Immediate Implants in Esthetic Zone. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Implant Site Reaction
Dental Implantation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims to evaluate the effect of utilization of BMAC/ collagen on marginal bone changes around immediate implants in the esthetic zone of maxilla.

Methodology: Twenty dental implants will be installed in the esthetic zone and patients will be randomly divided into two groups:

study group: The jumping gap surrounding the immediate implants will be grafted with BMAC/collagen, whereas in the control group, autograft from the chin will be used to fill the defect. Cone beam CT (CBCT) will be requested Preoperative, immediate and 4 months Postoperative for assessment of marginal bone changes around implants.

.

Detailed description: The aim of present study is to evaluate the effect of utilization of bone marrow aspirate concentrate (BMAC) loaded on collagen on the marginal bone changes around immediate implants in the esthetic zone of maxilla.

Methodology: Twenty dental implants will be installed in patients suffering from non- restorable teeth in esthetic zone.

Patients will be randomly divided into two equal groups:

study group: The jumping gap surrounding the immediate implants will be grafted with bone marrow aspirate concentrate loaded on collagen, whereas in the control group, autogenous bone graft from the chin will be used to fill the peri-implant defect. CBCT will be requested Preoperative, immediate and 4 months Postoperative for assessment of marginal bone changes around dental implants.

.

Eligibility criteria: Inclusion Criteria:

* Patients with non- restorable teeth in esthetic zone
* Patients above 18 us
* Highly motivated patients.

Exclusion Criteria:

* patients with systemic diseases • immunocompromised patients . Patients with bleeding disorders

Primary outcomes:
measure: Marginal bone changes
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Walaa Kadry
Study officials:
affiliation: Lecturer at Faculty of Dentistry, Cairo University
name: Eman Said
role: STUDY_DIRECTOR
References: