louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02157090: Clinical Assessment of the Effectiveness and Safety of Herpes Patch SOS in the Treatment of Herpes Simplex Labialis in Comparison to a Competitor's Product.
Official title: Clinical Assessment of the Effectiveness and Safety of Herpes Patch SOS (Hansaplast®) Based on Hydrocolloids Without Active Substances in the Treatment of Herpes Simplex Labialis in Comparison to a Competitor's Product (Herpes Vesicle Patch of COMPEED®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herpes Simplex Labialis
Keywords: HSL of lips
perioral skin
duration of HSL symptoms not more than three days
not acyclovir or other cold sore therapies
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Beiersdorf AG
First posted: 2014-06-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Recent clinical studies showed, that a hydrocolloid patch is effective, well tolerated and comparable with aciclovir cream 5 % for the treatment of HSL lesions, while affording additional benefits of wound protection, discretion and relief of social embarrassment. The aim of the actual study was the clinical assessment of the effectiveness and safety of Hansaplast® SOS Herpes Patch (HPHP) in comparison to Compeed® Herpes Vesicle Patch (CHP) in treating HSL. Both products are CE-certificated and are available at the market for medical devices.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* with a history of recurrent HSL of the lips and/or perioral skin
* lesions typically manifesting as classical lesions
* duration of HSL symptoms not more than three days
* haven´t used acyclovir or other cold sore therapies

Exclusion Criteria:

* pregnancy
* lactating women
* women of child-bearing age without medically secured contraceptions
* topical or systemic therapy with analgesic
* anti-inflammatory or antiviral agents within the last 2 weeks
* topical therapy within the treatment area
* systemic therapy with cytostatics or immunosuppressants

Primary outcomes:
measure: The primary endpoint of this study was the Subjects Global Assessment of Therapy (SGAT) at final visit.
Secondary outcomes:
measure: Number of patients with healed HSL lesions on day 5 and day 10 (assessed by clinician)
measure: Blinded clinician global assessment (IGAT) at the end of therapy.
measure: Development of lesion size.
measure: The number of study subjects with vesicles at onset of the study and at visit 2 and the final visit 3.
measure: Clinician-assessed lesion stage at onset of the study and at visit 2 and the final visit 3.
measure: Clinician-assessed time to complete healing from begin of the study.
measure: Time to complete healing of HSL after beginning of signs and symptoms.
measure: Assessment of the local compatibility by patient and by investigator.
measure: The severity and duration of subject-assessed individual signs and symptoms.
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus at the Technische Universität Dresden
state: Saxony
Study officials:
References:
Clinical trial NCT05741190: Correlation of Angle Kappa , Corneal High Order Aberrations and Total Eye Aberrations in Various Refractive Errors
Official title: Correlation of Angle Kappa , Corneal High Order Aberrations and Total Eye Aberrations in Various Refractive Errors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aberration, Corneal Wavefront
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with no ocular disease other than errors of refraction over 18 years old

Brief summary: Identification of the correlation between angle kappa , corneal high order aberrations and total eye aberrations in myopic hyperopic and astigmatic patients

Detailed description: The patient will be thoroughly examined clinically on slit lamp detailed history will be obtained visual acuity will be measured and patient refraction will be taken then imaging on Sirius topographer will be used to obtain angle Kappa and high order aberrations of the cornea and I-design pentacam imaging will be used to get the total aberrations of the eye

Eligibility criteria: Inclusion Criteria:

1. Patients with errors of refraction above the age of 18
2. No history of trauma.
3. No other ocular disease .

Exclusion Criteria:

1. patient under age of 18
2. patients with systemic disease.
3. patient with corneal diseases
4. Patient who did any sort of occular surgery
5. patient refusal

Primary outcomes:
measure: correlation between angle Kappa and high order aberrations of the cornea and total aberrations of the eye in various refractive errors
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gharieb Ibrahim HM, Gharieb HM, Othman IS. Angle kappa Measurement and Its Correlation with Other Ocular Parameters in Normal Population by a New Imaging Modality. Optom Vis Sci. 2022 Jul 1;99(7):580-588. doi: 10.1097/OPX.0000000000001910. Epub 2022 Jun 3.
Clinical trial NCT02405390: Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy Versus Direct Laryngoscopy
Official title: Comparison of Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy (Storz C-Mac®) Versus Direct Laryngoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult
Cervical Spine Injury
Keywords: Storz C-Mac®
Pediatric Airway
Cervical Spine Injury
Trauma Airway Management
Lead sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Sponsor class: OTHER
Collaborators: name: Florida International University
First posted: 2015-04-01
Enrollment: 92
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate if intubation with video laryngoscopy (VL) will result in less head motion and therefore less cervical motion when compared with direct laryngoscopy (DL).

The aim of the study is to determine the amount of head motion (extension, flexion and rotation) when using Storz C-Mac® video laryngoscopes and direct laryngoscopes. Secondarily, the study will also measure the number of attempts to properly intubate and the time required for intubation with either technique.

Detailed description: Investigator initiated single site prospective and randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* patients being orally intubated in the Operating Room as per standard anesthesia procedures

Exclusion Criteria:

* previous history of cervical spine injury or surgery
* craniofacial abnormalities
* airway congenital abnormalities
* airway prior to surgery

Primary outcomes:
measure: Head Motion - Extension or Flexion
timeFrame: During the process of intubation (less than one minute)
Secondary outcomes:
measure: Time for Intubation
timeFrame: During the process of intubation (less than one minute)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
Study officials:
affiliation: Miami Children's Hospital Pediatric Emergency Medicine Fellow
name: Jose Vargas Loayza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Miami Children's Hospital Pediatric Emergency Medicine Attending
name: Vincenzo Maniaci, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02894190: Development and Validation of the BVQ
Official title: Development and Validation of the Beliefs About Ventilation Questionnaire (BVQ)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Respiratory Disease
Keywords: Non Invasive Ventilation (NIV)
Adherence
Beliefs
Development
Validation
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
First posted: 2016-09-09
Enrollment: 250
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: People with obstructive or restrictive respiratory diseases

Brief summary: The main aim of this study is the development of the Beliefs about Ventilation Questionnaire (BVQ).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Indication to Non Invasive Ventilation (NIV), in three slots: \<4; \>4 e \<12; \<12 hours
* Outpatients or Inpatients
* Obstructive or restrictive reparatory disorder
* Voluntary agreement to be involved in the Study

Exclusion Criteria:

* Psychiatric Disorder
* Glasgow Coma Scale (CGS) \<14
* Pure Obstructive Sleep Apnea Syndrome (OSAS)
* Tracheostomy with Invasive Ventilation (TIV) o Invasive Ventilation (IV)

Primary outcomes:
measure: Change from baseline in adherence NIV in COPD patients at 3, 6 and 12 months as measured by the Beliefs of Ventilation Questionnaire (BVQ)
timeFrame: Baseline + After 3, 6 and 12 months following the recruitment
Secondary outcomes:
measure: Feasibility and acceptability of the questionnaire (duration / missing data)
timeFrame: Baseline + After 3, 6 and 12 months following the recruitment
measure: Reliability over time of the questionnaire
timeFrame: Baseline + After 3, 6 and 12 months following the recruitment
measure: External construct validity (The World Health Organization Quality of Life (WHOQOL); hours of Non Invasive Ventilation (NIV) prescribed, effective and referred by patients)
timeFrame: Baseline + After 3, 6 and 12 months following the recruitment
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi
Study officials:
References:
citation: Lopez-Campos JL, Jara-Palomares L, Munoz X, Bustamante V, Barreiro E. Lights and shadows of non-invasive mechanical ventilation for chronic obstructive pulmonary disease (COPD) exacerbations. Ann Thorac Med. 2015 Apr-Jun;10(2):87-93. doi: 10.4103/1817-1737.151440.
citation: Ozyilmaz E, Ugurlu AO, Nava S. Timing of noninvasive ventilation failure: causes, risk factors, and potential remedies. BMC Pulm Med. 2014 Feb 13;14:19. doi: 10.1186/1471-2466-14-19.
citation: van Boven JF, Chavannes NH, van der Molen T, Rutten-van Molken MP, Postma MJ, Vegter S. Clinical and economic impact of non-adherence in COPD: a systematic review. Respir Med. 2014 Jan;108(1):103-13. doi: 10.1016/j.rmed.2013.08.044. Epub 2013 Sep 11.
Clinical trial NCT02657590: Documentation of Cardiac Arrhythmias After Open Heart Surgery
Official title: Documentation of Cardiac Arrhythmias After Open Heart Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrhythmias
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 200
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: All patients aged 18 and over who underwent open-heart surgery.

Brief summary: This study aims at recording cardiac arrhythmias in patients after open heart surgery. The arrhythmias will be monitored during the entire first postoperative period, till six weeks after surgery.

Detailed description: Approximately 30-50% of patients after cardiac surgery develop cardiac arrhythmias, most often atrial, and most frequently atrial fibrillation (AF).

Various risk factors, inter alia, the type of surgery itself are risk factors. The major additional risk factors for postoperative atrial fibrillation are: age, valvular involvement, length of cardiopulmonary bypass and cross-clamp times.

Postoperative atrial fibrillation is associated with increased length of stay, higher morbidity and mortality including stroke.

Documentation of postopertive atrial fibrillation is well gathered during the postopertive length of stay, but scarce information exists regarding the development and occurence of atrial arrhythmias after the patient's discharge.

Additionally, the various management protocols which exists with regard to postoperative atrial fibrillation, rely on continuous treatment of the patients with amiodarone or various other anti-arrhythmic agents for the initial postoperative period, and the initial first month after discharge.

So far there is not an unambiguous recommendation regarding the duration of treatment required with amiodarone after releasing the patient.

The aim of this study is to document and record cardiac arrhythmias in patients after open-heart surgery within the time window since the release from hospital and up to six weeks after surgery.

Results of the study will allow us to fully characterize postoperative arrhythmias and their risk factors.

Eligibility criteria: Inclusion Criteria:

1. 18 years or older.
2. Patients after open-heart surgery (any type of surgery).

Exclusion Criteria:

1. Patients with internal pacemaker.
2. patients with known basic arrhythmia (pre-surgery) or patients who are discharged with some arrhythmias.
3. Patients with low response which it is expected that there will not be able to use the monitoring device

Primary outcomes:
measure: Arrhythmia
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Hospital
name: ziv Becerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00955890: Dexrazoxane as a Protective Agent in Anthracycline Treated Breast Cancer
Official title: Randomized Phase II Trial Of Interventional Therapy Investigate Cardiac Protection of Dexrazoxane In Women With Breast Cancer Having Experienced Grade 1 Cardiotoxicity During Prior Anthracycline-based Chemotherapy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: cardioprotection
anthracycline chemotherapy
breast cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-08-10
Enrollment: 12
Sex: FEMALE
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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. CTnT/cTnI/ANP/BNP were proved to be used as a biomarker of drug related cardiotoxicity. There are excellent correlations between the total cumulative dose of doxorubicin, the severity of the resulting cardiomyopathy, and the level of serum troponin-T.

Detailed description: Patients with breast cancer receiving anthracycline chemotherapy randomized to 3 groups:chemotherapy plus low dose dexrazoxane,chemotherapy plus middle dose dexrazoxane, chemotherapy only.Every patient receive at least 2 cycles anthracycline chemotherapy.

Eligibility criteria: Inclusion Criteria:

DISEASE CHARACTERISTICS:

* Histologically confirmed primary infiltrating adenocarcinoma of the breast

  * Confirmed by core needle biopsy or incisional biopsy or surgery
  * Experienced grade 1 cardiac toxicity during prior anthracycline-based chemotherapy
  * At least 2 cycles same anthracycline based chemotherapy are needed

Exclusion Criteria:

* Accumulated dose of EPI ≥1000mg/m2,ADM≥550mg/m2
* With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension); Prior or Concurrent radiation to heart
* Pregnant or nursing
* Other currently active malignancy except nonmelanoma skin cancer
* Uncontrolled or severe bleeding,diarrhea,intestinal obstruction
* Grade 2 or more Cardiac Toxicity (CTC AE3.0)

Primary outcomes:
measure: Occurence of cardiac toxicity in patients with breast cancer receiving anthracycline chemotherapy
timeFrame: 1 year
Secondary outcomes:
measure: Relationship between serum level of cTnT/cTnI/ANP/BNP and cardiac toxicity
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: member of Fudan University
name: xichun Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00818090: Paclitaxel and Cisplatin for Thymic Neoplasm
Official title: A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Thymoma
Thymic Carcinoma
Keywords: thymic epithelial tumor
paclitaxel
cisplatin
thymic carcinoma
invasive thymoma
Lead sponsor: Korean Cancer Study Group
Sponsor class: OTHER
First posted: 2009-01-07
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma


Eligibility criteria: Inclusion Criteria:

* histologically or cytologically confirmed invasive thymoma or thymic carcinoma
* unresectable tumor: by either local invasion, distant metastasis, or recurred (assessed by investigator)
* no previous systemic treatment for invasive thymoma or thymic carcinoma
* at least one measurable lesion by RECIST criteria
* 18 years old or older
* ECOG performance status 0, 1, 2
* adequate lab. findings neutrophil ≥ 1.5 x 10\^9/L platelet ≥ 75 x 10\^9/L hemoglobin ≥ 9.0 g/dL bilirubin ≤ 1.5 x upper normal limit AST, ALT ≤ 2.5 x upper normal limit Alkaline phosphatase ≤ 2.5 x upper normal limit (if liver metastasis, ≤ 5 x upper normal limit) serum creatinine ≤ 1.0 x upper normal limit if serum creatinine \> 1.0 x upper normal limit, creatinine clearance ≥ 60 mL/min
* patient who agree to written, informed consent

Exclusion Criteria:

* other malignancy (exception: non-melanoma skin cancer, cervical carcinoma in situ, cancer without evidence more than 5 years since curative resection)
* active bacterial infection
* history of clinical trial with investigational drug within 30 days
* radiotherapy to thoracic or mediastinal area (other area radiotherapy is permitted)
* pregnant, or lactating women
* patient with organ transplantation
* peripheral neuropathy, grade 2 or greater
* severe, medical condition unstable cardiac disease despite of adequate management myocardial infarction within 6 months active ulcer disease refractory to medication chronic obstructive lung disease requiring admission treatment within 1 year
* uncontrolled seizure, cerebral nervous system disorder, psychiatric problem which decrease treatment compliance

Primary outcomes:
measure: Response rate
timeFrame: 6 weeks, 12 weeks, 18 weeks
Secondary outcomes:
measure: toxicity
timeFrame: start of medication to 4 weeks since the last medication
measure: progression-free survival
timeFrame: till progression
measure: duration of response
timeFrame: till progression
measure: overall survival
timeFrame: till death, last follow-up
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University
name: Dae Seog Heo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05310903: Prevalence of Hospital Malnutrition in Afghanistan
Official title: A Multi-Centre Survey on Hospital Malnutrition in Afghanistan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malnutrition
Keywords: Malnutrition
Nutrition Disorders
Lead sponsor: Kateb University
Sponsor class: OTHER
Collaborators: name: Afghanistan Medical Council
First posted: 2022-04-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients admitted or discharged from hospitals in Afghanistan during the defined study period will be eligible.

Brief summary: This study aims to determine the prevalence of malnutrition among adult patients in hospitals across Afghanistan.

Detailed description: Malnutrition is associated with negative patient outcomes and increased healthcare costs. The purpose of this cross-sectional study is to determine the prevalence of malnutrition at admission or discharge in adult patients in hospitals across Afghanistan. The secondary outcome is to assess risk factors for malnutrition.

Eligibility criteria: Inclusion Criteria:

* All admitted or discharged patients age 18-65
* Males and females
* Conscious
* Informed consent provided

Exclusion Criteria:

* Patients undergoing surgery on the data collection day
* Outpatients
* Pregnant females
* Pediatric patients Patients with psychiatric or eating disorders Patients on dialysis

Primary outcomes:
measure: Prevalence of Malnutrition
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical Research Center, Kateb University
name: Jaffer Shah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02378103: A Single-center Trial of Patients With Aortic Dissection in the Chinese XinJiang Province
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Dissection
Keywords: Aortic Dissection
Chinese XinJiang Province
Lead sponsor: First Affiliated Hospital of Xinjiang Medical University
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Between March, 2015 and March, 2016, we aim to collect 100 patients with AD as the case group. As the control group, 100 patients without AD were obtained from the hospitalized patients in the same period.

Brief summary: To evaluate epidemiological features of risk factors for aortic dissection (AD) in Chinese XinJiang Province patients.

Detailed description: The epidemiological features of risk factors for aortic dissection (AD) in China were obtained from developed population in east of China, however, such information was not available for the remote population. Moreover, people in the western region have significant difference with developed population in lifestyle, diet, ethnic and so on. Therefore, the aim of our study was to evaluate epidemiological features of risk factors for AD in Chinese remote patients. We anticipated that this analysis would provide helpful information preventing and controlling AD in Chinese XinJiang Province.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of aortic dissection
2. ≥18 years old
3. good compliance with the instructions and cooperate with follow-up voluntarily signed the informed consent form

Exclusion Criteria:

1. pregnant or lactating female
2. bad compliance with the instructions and follow-up
3. estimated remaining life is less than 12 months
4. Aortic aneurysm、Acute Myocardial infarction、Acute Cerebral accident

Primary outcomes:
measure: Participants with related events for aortic dissection in Chinese XinJiang population
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: