louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06580821: Efficacy of the Modified Free Gingival Graft Technique
Official title: Evaluation of the Efficacy of the Modified Free Gingival Graft Technique
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Modified Free Gingival Graft , Connective Tissue Graft
Keywords: Gingival Recession
Surgical Flaps
Connective Tissue
Lead sponsor: Universidad de Especialidades Espiritu Santo
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial will performed in 30 patient with RT1 gingival recessions at mandibular incisors
Primary purpose: TREATMENT

Brief summary: Gingival recessions can be defined as the exposure of the root surface after an apical migration of the gingival margin in relation to the cemento-enamel junction. Gingival recessions affect both younger and older populations. Various surveys revealed that 88% of people ≥65 years of age and 50% of people between 18 and 64 years of age have ≥1 site with gingival recession. Gingival recessions can occur due to anatomical, pathological factors or trauma and will result in a loss of attachment.


Eligibility criteria: Inclusion Criteria:

* Patients with at least two or less localized recession in mandibular incisors
* Cairo type 1 recession
* Patients who have good plaque control of less than 20%
* Patients between 18-64 years old

Exclusion Criteria:

* Systemically compromised patients
* Smoker patients
* Pregnant women, breastfeeding or use of oral contraceptives
* Patients who are taking medication that may affect healing and coagulation
* Previous periodontal surgeries in the RG area
* Patients with periodontal disease
* Patients who have undergone chemotherapy and radiotherapy

Primary outcomes:
measure: To evaluate the long-term efficacy of the modified free gingival graft technique on root coverage.
timeFrame: From enrollment to the end of treatment at 12 months, evaluating at 7 days, 14 days, at the first month and after that every 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Samborondón
country: Ecuador
facility: Universidadees
state: Guayas
Study officials:
References:
citation: Carcuac O, Trullenque-Eriksson A, Derks J. Modified free gingival graft technique for treatment of gingival recession defects at mandibular incisors: A randomized clinical trial. J Periodontol. 2023 Jun;94(6):722-730. doi: 10.1002/JPER.22-0581. Epub 2023 Jan 30.
Clinical trial NCT01682421: Topical Steroid Treatment After Posterior Lamellar Corneal Transplantation
Official title: Investigation of Treatment With Topical Corticosteroid After Posterior Lamellar Corneal Transplantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Endothelial Dystrophy
Secondary Bullous Keratopathy
Posterior Lamellar Keratoplasty
Descemet's Stripping Endothelial Keratoplasty
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 0
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: After corneal transplantation, topical corticosteroids are used to reduce the risk of rejection.

However, the optimal postoperative treatment regimen is unknown. In most cases, a topical steroid is administered for at least 6 months after surgery, but it remains to be determined whether potent steroids offer better protection than weak steroids. Also, the length of the treatment is debated.

Since the use of steroids is not without potential serious ocular side effects, it is of considerable importance to investigate these problems.

The study aims to examine the frequency of rejection episodes after posterior lamellar keratoplasty; specifically comparing a short course of potent steroids versus a long course of weak steroids.


Eligibility criteria: Inclusion Criteria:

* Patients treated for primary or secondary corneal endothelial failure at the department of ophthalmology, Aarhus University Hospital

Exclusion Criteria:

* Not fulfilling the above

Primary outcomes:
measure: Freedom from rejection
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Ophthalmology, Aarhus Universtity Hospital
Study officials:
References:
Clinical trial NCT01900821: National Mammography Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Screening and Diagnosis
Lead sponsor: American College of Radiology
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 8000000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women (primarily, but not exclusively), having mammograms at facilities participating in the registry

Brief summary: The National Mammography Database (NMD) leverages data that radiology practices are already collecting under federal mandate by providing them with comparative information for national and regional benchmarking. Participants receive semi-annual feedback reports that include important benchmark data such as cancer detection rates, positive predictive value rates and recall rates. Participation in the NMD is free to Breast Imaging Center of Excellence (BICOE) facilities.


Eligibility criteria: Inclusion Criteria:

* All

Exclusion Criteria:

* None

Primary outcomes:
measure: Cancer Detection Rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Reston
country: United States
facility: ACR
state: Virginia
Study officials:
References:
Clinical trial NCT02736721: Expanded Access Study With Peginterferon Alfa-2a (Pegasys) in Participants With Chronic Myelogenous Leukemia (CML)
Official title: Multicenter Open Label Expanded Access-Program of Pegylated Interferon Alfa-2a (Pegasys) in Patients With Chronic Myelogenous Leukemia (CML)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myelogenous Leukemia, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-04-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy, safety and tolerability of long-term use of peginterferon alfa-2a in participants with CML who have previously participated in peginterferon alfa-2a study ML16544 (NCT number not available), NO16006 (NCT number not available) or ML17228 (NCT number not available) and treating physician has decided to continue treatment with peginterferon alfa-2a within the frame of another clinical study.


Eligibility criteria: Inclusion Criteria:

* Participants with CML
* Previous participation in studies: ML16544, NO16006 or ML17228; for which the treating physician recommends a continuation of the study drug according to defined minimal criteria

Exclusion Criteria:

* Major protocol violator in the participated study prior to participation in this study

Primary outcomes:
measure: Number of Participants With Complete Hematologic Response
timeFrame: Up to approximately 7 years
measure: Time to Loss of Previous Hematologic Response
timeFrame: Up to approximately 7 years
measure: Number of Participants With Major Cytogenetic Response (CyR)
timeFrame: Up to approximately 7 years
measure: Time to Loss of Previous CyR
timeFrame: Up to approximately 7 years
measure: Number of Participants With Molecular Response (MR)
timeFrame: Up to approximately 7 years
measure: Time to Loss of Previous MR
timeFrame: Up to approximately 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
city: Mainz
country: Germany
city: Mannheim
country: Germany
city: Marburg
country: Germany
city: Tübingen
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT06689202: Assessment of Oral Health Knowledge, Attitude and Behavior of Adult Patients in Egypt
Official title: Assessment of Oral Health Knowledge, Attitude and Behavior of Adult Patients Attending a Dental School Hospital in Egypt: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Health Knowledge, Attitude and Practice Among Patients
Lead sponsor: NewGiza University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients attending the diagnostic center in Newgiza University

Brief summary: Oral health is a significant contributor to public health and is classified by the World Health Organization (WHO) as a major global health concern. Notably, one in two adults suffer from dental decay ,with oral diseases ranking among the most prevalent non-communicable disease (NCDs) . Thus, public health programs focus on modifying lifestyle factors for prevention rather than treatment. In developed countries , public health programs have successfully improved oral health through dietary and lifestyle modifications, as well as fluoride use .

Furthermore, oral health professionals have a crucial in role in influencing the behaviors of their patients and preventing oral diseases .Therefore, enhancing oral health knowledge is essential for positive health behaviors and hence better oral health outcomes .


Eligibility criteria: Inclusion criteria:

* Adult patients attending the diagnostic center in Newgiza University
* 18 years or older Exclusion criteria
* Patients who refuse to consent to participate in the survey

Primary outcomes:
measure: Oral Health Knowledge, Attitude & Behavior
timeFrame: November 2024-January 2025
Secondary outcomes:
measure: DMFT Scores
timeFrame: November 2024-January 2025
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Newgiza University
state: Newgiza
Study officials:
References:
Clinical trial NCT00539721: A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1)(COMPLETED)
Official title: A Randomized, Double-Blind, Double-Dummy, Dose-Ranging, Active- and Placebo-Controlled Study of Single-Dose Oral Rolapitant Monotherapy for the Prevention of Postoperative Nausea and Vomiting (PONV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Nausea and Vomiting
Keywords: Nausea
Vomiting
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-04
Enrollment: 619
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a multicenter, randomized, controlled study in women who are having elective open abdominal surgery with general anesthesia and who are expected to need patient-controlled analgesia (PCA) after surgery. The primary objective is to assess the effect of rolapitant in the prevention of postoperative nausea and vomiting as measured by the prevention of vomiting in the first 24 hours after surgery. Participation in the study may last up to 3 months. The total duration of the study will be approximately 36 weeks.


Eligibility criteria: Inclusion Criteria:

* Women aged 18 years or older of any race with an American Society of Anesthesiologists (ASA) physical status of I to III who are scheduled to undergo elective open abdominal surgery under general anesthesia.
* Women whose postoperative hospitalization is expected to last at least 24 hours
* Women expected to require postoperative intravenous opioid PCA.
* Women whose surgery is expected to require at least 1 hour, but not more than 4 hours, of general anesthesia using the regimen defined in this protocol.
* Women of childbearing potential who have a negative pregnancy test or women who have been surgically sterilized or are postmenopausal.

Exclusion Criteria:

* Women with clinically significant or unstable cardiac, respiratory, hepatic, renal, or other major organ system disease.
* Women with a known hypersensitivity to ondansetron (or any other 5-HT3 antagonist), to any agent that is part of the anesthesia regimen, or to other medications to be administered under this protocol.
* Women who are scheduled to undergo certain types of surgery.
* Women who are breastfeeding.
* Women who have retching/vomiting or moderate or severe nausea in the 24 hours prior to surgery or suffer from chronic nausea and/or vomiting.
* Women with a body mass index (BMI) \>40.
* Women who have participated in a clinical trial of an investigational drug within 30 days prior to drug administration.

Primary outcomes:
measure: No emetic episodes regardless of rescue medication use.
timeFrame: First 24 hours after surgery.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02565121: Olfaction Disorders in Patients Included in The Trauma Brain Injury (TBI) Database at Trondheim University Hospital
Official title: Olfaction Disorders in Patients Included in The Trauma Brain Injury (TBI) Database at Trondheim University Hospital: Prevalence and Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Olfaction Disorders
Keywords: Olfactory perception
Adrenal cortex hormones
Steroids
Education
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2015-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to see whether patients with chronic smell impairment after brain injury benefit from a treatment that consists of corticosteroids, and then olfactory training in 3 months.


Eligibility criteria: Inclusion Criteria:

* Registered in the TBI Database
* 18-65 years of age per 01.10. 2012
* Olfaction score by Sniffin Sticks Threshold-Discrimination-Identification (TDI) \< 30 confirming dysosmia

Exclusion Criteria:

* Unable to express senses.
* Unable to follow treatment and protocol
* pregnancy
* diabetes
* tendency to infections
* hypertonia
* dyspepsia
* interfering medication (hormonal treatment, NSAIDS, antidiabetics, barbiturates, fenitoin, carbamazepin, rifampicin, cyclophosphamides)

Primary outcomes:
measure: number of patients who have improved olfaction perception (by at least 5 points on the Threshold-Discrimination-Identification (TDI) score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: ENT department St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Nils Kvermo
role: STUDY_DIRECTOR
References:
citation: Bratt M, Skandsen T, Hummel T, Moen KG, Vik A, Nordgard S, Helvik AS. Frequency and prognostic factors of olfactory dysfunction after traumatic brain injury. Brain Inj. 2018;32(8):1021-1027. doi: 10.1080/02699052.2018.1469043. Epub 2018 May 9.
citation: Bratt M, Moen KG, Nordgard S, Helvik AS, Skandsen T. Treatment of posttraumatic olfactory dysfunction with corticosteroids and olfactory training. Acta Otolaryngol. 2020 Sep;140(9):761-767. doi: 10.1080/00016489.2020.1767301. Epub 2020 Jun 3.
Clinical trial NCT02095821: Fibrinogen as a Surrogate for Global Haemostasis in Plasma Exchange
Official title: Observational Study of Fibrinogen as a Surrogate for Global Haemostasis in Plasma Exchange Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Clotting Disorder Due to Plasma Exchange Therapy
Humoral Rejection After Kidney Transplantation
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 2
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: Tertiary hospital patients after kidney transplantation, humoral rejection

Brief summary: Plasma exchange is a frequently used therapy in many antibody-mediated disorders, such as humoral rejection after kidney transplantation. Treatment frequency is adjusted to daily measured fibrinogen blood levels to prevent bleeding complications. However, data about the correlation of fibrinogen blood levels and function of the coagulation system during plasma exchange therapy is scarce. In the present study we examine blood fibrinogen levels and coagulation factors as well as thrombin clotting time in patients under plasma exchange therapy.


Eligibility criteria: Inclusion Criteria:

* plasma exchange therapy due to humoral rejection after kidney transplantation

Exclusion Criteria:

* hereditary coagulopathy
* chronic liver disease (Child C)
* therapeutic anticoagulation
* malnutrition (BMI\<17.5)

Primary outcomes:
measure: Thrombin clotting time
timeFrame: Baseline, daily measurement until hospital discharge (avarage hospital stay: 10 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Medical School Hannover
name: Sascha David, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05885321: Exploring the Correlation Between Post Traumatic Stress Disorder, Perceived Stress and Scar Pruritus in Burn Patients
Official title: Exploring the Correlation Between Post Traumatic Stress Disorder, Perceived Stress and Scar Pruritus in Burn Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Scar Pruritus
Post Traumatic Stress Disorder
Perceived Stress
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 45
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: * Patients with hypertrophic scars 3 months after the burn event occurred
* Adult patients over 18 years old
* Patients without serious mental disorders, and are able to express themselves in Chinese with clear consciousness.
* The patient has no open wound on the wrist and is able to wear the smart watch continuously for one month

Brief summary: Pruritus, post traumatic stress disorder and perceived stress are common issues in burn patients. The correlation between the three is unclear so far.

This study will collect data among adult patients with hypertrophic scars 21 days after the burn event has occurred. Using a Chinese version of the 5D itch scale,Chinese version of the posttraumatic diagnostic scale and Perceived Stress Scale to investigate self-reported postburn pruritus,post traumatic stress disorder and perceived stress. The patients will be wearing the smart watch for one month to collect data on their stress levels. This data will be used to analyze the correlation between posttraumatic stress syndrome, perceived stress and scar pruritus. There will be two rounds of data collection. The first will be when the smart watch is issued to patients, and the second will be at the end of the one month period.


Eligibility criteria: Inclusion Criteria:

* Patients with hypertrophic scars 21 days after the burn event occurred
* Adult patients over 18 years old
* Patients without serious mental disorders, and are able to express themselves in Chinese with clear consciousness.
* The patient has no open wound on the wrist and is able to wear the smart watch continuously for one month

Exclusion Criteria:

* Patients with first-degree burns
* Non-traumatic electrical burns

Primary outcomes:
measure: the Chinese version of the 5D itch scale
timeFrame: up to one months
measure: Chinese version of Perceived Stress Scale
timeFrame: up to one months
measure: Chinese version of the post traumatic diagnostic scale for DSM-5
timeFrame: up to one months
measure: garmin_Vivosmart 3
timeFrame: up to one months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT04802421: Effect Alveolar Recruitment Manoeuver on Stroke Volume a Randomized Study
Official title: Hemodynamic Effect of Alveolar Recruitment Manoeuver Through Stepwise Increase and Decrease in Irway Pressure or Sustained 30 Secondes 30 cmH2O Continuous Positive Airway Pressure. A Randomized Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Recruitment Manoeuver
Anesthesia
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised parallel groups. randomisation between 2 groups equilibated by randomised blocks of 4, 6 or 8
Primary purpose: OTHER

Brief summary: Objective: to compare the effect of alveolar recruitment manouver through stepwise increase and decrease in airway pressure or sustained 30 secondes 30 cmH2O continuous positive airway pressure on cardiac stroke volume estimated by oesophageal doppler in preload independent anesthetized patients scheduled for surgery.

Detailed description: Following anesthesia and preload optimisation guided by cardiac stroke volume, patients will be randomised to one alveolr recruitment manoeuver :

* stepwise increase and decrease in positive airway pressure
* sustained 30 secondes 30 cmH2O continuous positive airway pressure The primary objective is the change in cardiac stroke volume.

Eligibility criteria: Inclusion Criteria:

* adult patients scheduled for major surgery requiring hemodynamic monitoring
* written signed informed consent

Exclusion Criteria:

* pregnancy
* non sinusal heart rate
* known cardiac right ventricular failure or arterial pulmonary hypertension
* pneumothorax
* known pulmonary emphysema

Primary outcomes:
measure: cardiac stroke volume
timeFrame: 1 min
Secondary outcomes:
measure: arterial pressure
timeFrame: 1 min
measure: recovery at 3 min
timeFrame: 3 min
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
Study officials:
References:
Clinical trial NCT05670821: PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms
Official title: Post-marketing Surveillance of Spesolimab I.V. Infusion in Improvement of Generalized Pustular Psoriasis (GPP) With Acute Symptoms in Japan
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Generalized Pustular Psoriasis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-01-04
Enrollment: 52
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: Patients with generalized pustular psoriasis (GPP).

Brief summary: Non-interventional cohort study in patients with newly initiated Spesolimab to evaluate the incidence of adverse drug reactions and to understand generalized pustular psoriasis (GPP) disease activities in the real world setting.


Eligibility criteria: Inclusion Criteria:

* GPP patients with acute symptoms who are administered Spesolimab Intravenous (I.V.) Infusion in Japan
* Patients who have never been treated with Spesolimab I.V. Infusion before enrolment

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of adverse drug reactions (ADRs)
timeFrame: Up to 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Nippon Boehringer Ingelheim Co., Ltd.
Study officials:
References: