louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02512822: Usefulness of Non-invasive Radiofrequency Therapy for Facial Contouring
Official title: Usefulness of Non-invasive Radiofrequency Therapy for Facial Contouring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subcutaneous Fat
Keywords: radiofrequency
submental fat
fat reduction
body contouring
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
Collaborators: name: Cutera Inc.
First posted: 2015-07-31
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of novel noninvasive RF technology for reduction of submental fat.

Detailed description: Recently, Novel radiofrequency (RF) technology was introduced as a promising tool for non-invasive body and face contouring, which can heats subcutaneous fat up to 45℃ continuously without surface damage and induces adipocytes apoptosis.

Subjects with an excessive subcutaneous fat on the submental area received twice treatments at 1-month intervals. Clinical outcomes including the thickness of the submental fat (measured by ultrasound) and the submental circumference (measured by a tape measure), and clinical photographs were obtained at baseline, and 1-month and 6-month after last treatment.

Eligibility criteria: Inclusion Criteria:

* clinically appreciable localized excess of subcutaneous fat on the submental area
* no history of systemic underlying disease

Exclusion Criteria:

* any infectious or inflammatory skin diseases
* keloids
* psychiatric patients
* systemic underlying disease
* who had taken aesthetic procedure on the face, before 6-month

  * more than 5% weight change were dropped out.

Primary outcomes:
measure: Change from Baseline in thickness of the submental fat at 6 months
timeFrame: 6 months
measure: Change from Baseline in submental circumference at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: participants' assessment for improvement at 6 months
timeFrame: 6 months
measure: participants' assessment for satisfaction at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Won-Serk Kim, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: Franco W, Kothare A, Ronan SJ, Grekin RC, McCalmont TH. Hyperthermic injury to adipocyte cells by selective heating of subcutaneous fat with a novel radiofrequency device: feasibility studies. Lasers Surg Med. 2010 Jul;42(5):361-70. doi: 10.1002/lsm.20925.
citation: Franco W, Kothare A, Goldberg DJ. Controlled volumetric heating of subcutaneous adipose tissue using a novel radiofrequency technology. Lasers Surg Med. 2009 Dec;41(10):745-50. doi: 10.1002/lsm.20876.
Clinical trial NCT03096522: Randomized Trial on the Effect of Topical Phenytoin on Healing After Fistulotomy
Official title: A Randomized Controlled Trial on the Effect of Topical Phenytoin 2% on Wound Healing After Fistulotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anal Fistula
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 38
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with anal fistula who will undergo anal fistulotomy will be randomized into one of two groups; the first group will receive topical phenytoin therapy postoperatively and the second group will not receive such topical treatment.

Detailed description: Patients with anal fistula who will undergo anal fistulotomy will be randomized into one of two groups; the first group will receive topical phenytoin therapy postoperatively and the second group will not receive such topical treatment.

Healing of the wound after fistulotomy will be observed every week and the duration till complete healing will be recorded. The two groups will be compared regarding the mean duration till complete healing and postoperative complications.

Eligibility criteria: Inclusion Criteria:

* Patients of both genders aging between 18-65 years with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers)

Exclusion Criteria:

* Patients with high trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary, or recurrent anal fistulas.
* Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, and inflammatory bowel diseases.
* Patients under chronic corticosteriod or immunosuppressive therapy.

Primary outcomes:
measure: Healing
timeFrame: 4-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University, Faculty of medicine
name: Sameh H Emile, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00846222: Adjunctive Mild Hypothermia Therapy to Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated With Shock: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Myocardial Infarction Complicated With Cardiogenic Shock
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-02-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is evaluate the safety and feasibility of mild therapeutic hypothermia (TH) during and 12 hours after primary percutaneous coronary intervention for acute myocardial infarction complicated with shock


Eligibility criteria: Inclusion Criteria:

* Recent myocardial infarction: 24 hours of start pain
* Pump failure cardiogenic shock (defined as persistent hypotension, systolic BP \< 90 mmHg, despite fluids and catecholamines infusion, with tissue hypoperfusion signs
* Candidate for immediate percutaneous reperfusion
* Maximal care support: mechanical ventilation, intraaortic balloon contrapulsation

Exclusion Criteria:

* Cardiogenic shock related to mechanical complication: free wall rupture, acute mitral regurgitation, acute VSD, tamponade
* Pregnant women
* Absence of maximal support care

Primary outcomes:
measure: Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction.
timeFrame: 30 days
Secondary outcomes:
measure: Infarct size calculated by area under thr curve creatinine kinase according consecutive samples Reversal stunning by blinded observer echocardiographic assessment
timeFrame: 30 days
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh MC
Study officials:
References:
citation: Dixon SR, Whitbourn RJ, Dae MW, Grube E, Sherman W, Schaer GL, Jenkins JS, Baim DS, Gibbons RJ, Kuntz RE, Popma JJ, Nguyen TT, O'Neill WW. Induction of mild systemic hypothermia with endovascular cooling during primary percutaneous coronary intervention for acute myocardial infarction. J Am Coll Cardiol. 2002 Dec 4;40(11):1928-34. doi: 10.1016/s0735-1097(02)02567-6.
citation: Hale SL, Dave RH, Kloner RA. Regional hypothermia reduces myocardial necrosis even when instituted after the onset of ischemia. Basic Res Cardiol. 1997 Oct;92(5):351-7. doi: 10.1007/BF00788947.
Clinical trial NCT00774722: A Randomised Controlled Trial of the Use of Topical Metronidazole (10%) to Reduce Pain After Haemorrhoidectomy
Official title: Phase 2 Study Evaluation of Topical 10% Metronidazole Ointment for the Reduction of Pain After Haemorrhoidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Haemorrhoidectomy
Lead sponsor: S.L.A. Pharma AG
Sponsor class: INDUSTRY
First posted: 2008-10-17
Enrollment: 59
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 determine whether metronidazole 10% ointment , applied topically three times a day in and around the anus, on the reduction of pain following haemorrhoidectomy.


Eligibility criteria: Inclusion Criteria:

* Have Grade 3 or 4 haemorrhoids (external disease with or without significant internal component)
* Be scheduled for diathermy haemorroidectomy with ≥2 quadrant involvement
* Be medically fit for surgery
* Subjects must be aged 18 years or over and of the legal age of consent.
* If female, the subject must not be lactating and must be (a) post-menopausal, (b) surgically sterilised, or (c) have a negative pregnancy test result prior to entry into the study and will use adequate contraception for the duration of the study.
* Must have provided written informed consent to participate.

Exclusion Criteria:

* They have had surgery to the anus or rectum in the past 8 weeks
* Suffer from a chronic pain syndrome which requires regular narcotic analgesia
* Have anal fissures
* Have diagnosed Crohn's disease
* Allergic to metronidazole
* Are taking any prohibited medication.
* Deemed mentally incompetent
* Considered by their physician unlikely to be able to comply with the protocol.
* Taken part in an experimental drug study in the preceding three months.

Primary outcomes:
measure: The primary objective is to evaluate the efficacy of 10% metronidazole ointment in reducing post-operative pain associated with haemorrhoidectomy as compared to placebo.
timeFrame: 14 days
Secondary outcomes:
measure: evaluate and compare the expected pain following haemorrhoidectomy in the treatment and placebo groups. overall patient satisfaction with the operation. the number of analgesics required post-operatively the time taken to return to work and/or
timeFrame: 56 days
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital, Eastern Road,
city: Harrow
country: United Kingdom
facility: St Marks Hospital
city: London
country: United Kingdom
facility: North Middlesex University Hospital
city: London
country: United Kingdom
facility: St Thomas' Hospital, Lambeth Palace Road
city: Stockport
country: United Kingdom
facility: Stepping Hill Hospital
Study officials:
affiliation: SLA Pharma
name: Christopher J Jordan, BSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01622322: Nitrous Oxide On Acute Postoperative Pain and Opioid Consumption and Chronic Pain After Inguinal Hernia Repair Surgery
Official title: Effect Nitrous Oxide On Acute Postoperative Pain and Opioid Consumption and Chronic Pain After Inguinal Hernia Repair Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Inguinal Hernia Repair
Post Operative Pain
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare postoperative pain, opioid consumption and chronic pain in patients undergoing to hernia repair surgery after receiving nitrous oxide or oxygen during the general anesthesia.

Detailed description: The study is prospective and double blind. In the clinic, patients undergoing inguinal hernia surgery that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups. In the first group of patients will receive Nitrous Oxide and In the second group of patients will receive oxygen during the general anesthesia.

Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old at time of the first procedure
* American Society of Anesthesiologists physical status I or II
* Inguinal hernia repair surgery undergoing the general anesthesia

Exclusion Criteria:

* Neuropathic disease
* Chronic opioid users
* Contraindication for Nitrous Oxide receive
* Consent will not be obtained patient
* Psychiatric disorders
* Current or recent drug abuse (within past 6 months).

Primary outcomes:
measure: Nitrous oxide and chronic pain
timeFrame: 30 days post operative
measure: Nitrous oxide and opioid consumption
timeFrame: 4 hours after surgery
Secondary outcomes:
measure: smoking and post operative pain
timeFrame: 4 hours after surgery
measure: smoking and chronic pain
timeFrame: 30 days post operative
Other outcomes:
Locations:
city: Etlik
country: Turkey
facility: Gulhane Military Medical Academy Hospital
state: Ankara
Study officials:
affiliation: The Cleveland Clinic
name: Alparslan Turan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02051322: Comparison of Lung Administration With Three Different Nebulizer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison between three modalities of nebulization.


Eligibility criteria: Inclusion Criteria:

* Healthy Subjects

Exclusion Criteria:

* Pulmonary disease
* Cardiac disease

Primary outcomes:
measure: Lung deposition by urinary measure
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT00822822: Evaluation of Patient Functionality and Utility of Web-Based Personal Health History and Risk Assess
Official title: Evaluation of Patient Functionality and Utility of Web-Based Personal Health History and Risk Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Cancer Screening Patients
Patient Volunteers
Keywords: Questionnaire
Electronic Health History
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2009-01-14
Enrollment: 17
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People receiving services at Moffitt Cancer Center or Lifetime Cancer Screening Center

Brief summary: The purpose of this research study is to find out what Moffitt and Lifetime patients think of the electronic medical records process.

Detailed description: Patient will complete a questionnaire about their knowledge of computers and how long they think it will take them to finish the patient health history using a computer.

Patient will complete the electronic record carefully and tell us if they had any difficulties, questions or comments about the format.

Patient will answer a questionnaire about how well they liked or did not like using the electronic system to give their health history.

Participation in this study will take approximately 30 minutes to 1 hour.

Eligibility criteria: Inclusion Criteria:

* The breakdown of patients recruited by stratified dimensional sampling. Overall, we will attempt to equally recruit patients from the unique strata for each domain evaluation in this study. Patients health status will be determined by the ECOG Performance status . We assume that all patients being seen at the Lifetime Cancer Screening and Prevention center will be of good to fair health, while patients seen at the Cancer hospital will range from good- to- fair to poor health status. Gender is also used as a sampling factor because there are modules within this web-based health history forms that are specific for each gender.

Exclusion Criteria:

* Respondents who refuse to participate or who become too ill at any point in the assessment, will be excluded. Non-English speaking patients will be excluded. Names and other identifying information will not be collected and all data will be reported in aggregate form. Due to the nature of our stratified samples strategy, some patients will be excluded if they meet the criteria for a recruitment stata, but that stata is full.

Primary outcomes:
measure: Create a system for collecting patient health histories that may be beneficial to patients and people receiving services at Moffitt Cancer Center or Lifetime Cancer Screening Center
timeFrame: 1 hour per participant
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Erin Siegel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00855322: Study Examining the Effect of Exercise in People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication
Official title: Randomized Controlled Trial Examining The Effect Of Exercise In People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Keywords: Arthritis, Rheumatoid
Exercise
Biological Therapy
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2009-03-04
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 determine whether exercise is beneficial for people with rheumatoid arthritis(RA) taking antiTNFalpha medication

Detailed description: Substantial progress has been made in the medical management of RA over the past decade but at present no drug therapy leads to long-term remission for all patients with RA. People may still continue to experience physical, psychological and functional consequences which could benefit from rehabilitation.little research exists on the effects of exercise for people with RA taking anti-TNFalpha therapy medication.

It is proposed to conduct a randomized controlled trial to examine the effects of group exercise therapy in a gym setting or in a hydrotherapy pool compared to a control group.

Eligibility criteria: Inclusion Criteria:

* Patients with RA receiving anti-TNFalpha therapy medication for more than three months
* Consenting male and female patients aged 18 - 70 years
* Patients will have a documented diagnosis of RA as classified by the American College of Rheumatology (ACR) criteria
* ACR functional class I, II, III

Exclusion Criteria:

* Patients who have attended physiotherapy in the past three months
* Patients to whom exercise therapy or hydrotherapy are contraindicated
* Patients who have undergone joint surgery in the past six months

Primary outcomes:
measure: Stanford Health Assessment Questionnaire
timeFrame: Baseline, 8 weeks and 24 weeks
Secondary outcomes:
measure: 50 foot Walk Test
timeFrame: Baseline, 8 weeks and 24 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Our Lady's Hospice
Study officials:
affiliation: University College Dublin
name: Oliver FitzGerald, MB, BcH, BAO
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Dublin
name: Tara Cusack, PhD, MMedSc,
role: STUDY_DIRECTOR
References:
citation: Reid A, Brady A, Blake C, Mongey AB, Veale DJ, FitzGerald O, Cusack T. Randomised controlled trial examining the effect of exercise in people with rheumatoid arthritis taking anti-TNFalpha therapy medication. BMC Musculoskelet Disord. 2011 Jan 13;12:11. doi: 10.1186/1471-2474-12-11.
Clinical trial NCT04124822: Effectiveness if Premedication With Single Dose Piroxicam and Prednisolone After a Single Visit Root Canal Treatment .
Official title: Effectiveness of Single Dose Pre Medication of Piroxicam and Prednisolone on Post Endodontic Pain After a One Visit Root Canal Treatment. Randomized Trial .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Post-operative Endodontic Pain
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: subjects are randomly placed into one of the three groups: Placebo, Piroxicam (20 mg), Prednisolone (20 mg). The drugs will be given thirty minutes before procedure starts,followed by one visit root canal procedure. Postoperative pain will be evaluated up to 96 hours interval using a visual analog scale.
Primary purpose: TREATMENT

Brief summary: Two drugs (Piroxicam and Prednisolone)are being compared for post operative endodontic pain after a single visit root canal treatment for 74 hours.

Detailed description: To evaluate effectiveness of single dose premedication with piroxicam(20mg) and prednisolone(20mg) on post endodontic pain after a single visit root canal treatment .

patient will be recalled every day for 4 days to know the pain scale using visual analogue scale .

Eligibility criteria: Inclusion Criteria:

1. Patient ages from 20-40 years(28).
2. Single rooted tooth with symptomatic irreversible pulpitis.
3. With no analgesic or anti-inflammatory drug taken within a week period before procedure.

Exclusion Criteria:

1. Patients presenting with any systemic disease
2. Patients already taking premedication for endodontic pain.
3. Pregnant or lactating patients.
4. Multirooted teeth.
5. Teeth with Pulpal necrosis.
6. Previously treated or initiated root canal treatment.
7. Patient presenting with allergy due to drug

Primary outcomes:
measure: post operative pain
timeFrame: 76 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: DUHS
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Anum Tanwir, BDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tanwir A, Ahmed S, Akhtar H, Wahid U, Shakoor Abbasi M, Ahmed N. Effectiveness of Single Dose Premedication of Piroxicam and Prednisolone on Post Endodontic Pain in One Visit Root Canal Treatment: A Randomized Clinical Trial. Eur Endod J. 2022 Oct;7(3):187-192. doi: 10.14744/eej.2022.24119.