louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01950208: The Munich Knee Questionnaire - Development and Validation
Official title: The Munich Knee Questionnaire (MKQ) - Development and Validation of a New Patient-reported Outcome Measurement Tool in Knee Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Injury
Keywords: Assessment
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2013-09-25
Enrollment: 105
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 with knee pain

Brief summary: the purpose of this study is to develop and validate a new PRO measurement tool for the knee joint, the so-called Munich Knee Questionnaire (MKQ), allowing for a qualitative self-assessment of the Knee Injury and Osteoarthritis Outcome Score (KOOS), the International Knee Documentation Committee (IKDC), the Lysholm Knee Score, the Western Ontario Meniscal Evaluation Tool (WOMET) and the Tegner Score.

Detailed description: A systematic review of the literature was performed to identify valid and commonly used instruments regarding follow-up examinations in the field of knee surgery. PubMed.gov was searched for knee-specific terms (knee, surgery, joint, lower extremity) combined with psychometric (follow-up, validity, reliability, responsiveness) and instrument-specific terms (self-reported, patient-based, measurement tool, outcome measure, questionnaire). Hence, the KOOS, IKDC, Lysholm, WOMET and Tegner Score were identified as frequent used and valid measurement tools in the evaluation of knee joint function. After analysing each single question of these questionnaires for coincidences regarding measurement of specific knee function, the identified items were condensed to one single question for each specific item. Typical functional abilities (flexion/extension) were depicted as photographs. Thus, one single questionnaire with a total of 33 questions divided in five subscales (Symptoms, Pain, Work and Activities of daily life, Sports and Recreational activities, Physical function and knee related Quality of Life), was created.

Eligibility criteria: Inclusion Criteria:

* all patients presenting with knee pain

Exclusion Criteria:

* no exclusion

Primary outcomes:
measure: Munich Knee Questionnaire (MKQ)
timeFrame: up to 6 weeks starting from onset of symptoms
Secondary outcomes:
measure: The self-assessment of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: up to 6 weeks starting from onset of symptoms
Other outcomes:
measure: The International Knee Documentation Committee (IKDC)
timeFrame: up to 6 weeks starting from onset of symptoms
Locations:
city: Munich
country: Germany
facility: Klinik und Poliklinik für Unfallchirurgie
state: Bavaria
Study officials:
affiliation: Technical University of Munich
name: Chlodwig Kirchhoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04485338: Chest Radiography in COVID-19 Patients
Official title: Radiographic Assessment of Lung Edema in Invasively Ventilated COVID-19 Patients (RALE-COVID) - Protocol for an International Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Chest radiography
RALEscore
Radiographic Assessment of Lung Edema
ICU
invasively ventilated
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: University of Bari Aldo Moro
name: Mahidol University
name: Universitair Ziekenhuis Brussel
name: Chonburi hospital
First posted: 2020-07-24
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe COVID-19 patients under invasive ventilation who received as part of standard care and routine imaging.

Brief summary: To assess the prognostic performance of the RALE score with respect to duration of ventilation, and to describe changes in the RALE score over time.


Eligibility criteria: Inclusion Criteria:

* Admitted to an ICU participating in this study between December 1, 2019 and May 31, 2020
* Having had received invasive ventilation
* Having had received at least one chest radiograph under invasive ventilation
* Confirmed novel coronavirus diseases (COVID-19)

Exclusion Criteria:

- Age \< 18 years

Primary outcomes:
measure: The prognostic capacity of the Radiographic Assessment of Lung Edema (RALE) score of the first CXR under invasive ventilation in patients with severe COVID-19.
timeFrame: 90 days
Secondary outcomes:
measure: The prognostic capacity of changes in the RALE score of consecutive CXRs under invasive ventilation in patients with severe COVID-19
timeFrame: 90 days
measure: Number of ventilator-free day and alive at day 28 (VFD)
timeFrame: 28 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC location AMC
Study officials:
affiliation: Amsterdam University Medical Centers, location 'AMC'
name: Marcus J. Schultz, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02423538: First-in-Human Single Ascending Dose of SHR0302
Official title: A Phase I, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-04-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral doses of SHR0302 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of SHR0302 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects, age 18-45 years (inclusive);
* The weight of the subject should be more than 50 kg, body mass index (BMI = weight/height squared (kg/m2)) within the range of 19 to 24.

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in the study
* History of heart failure or renal insufficiency
* Smoking; Drug or alcohol abuse

Primary outcomes:
measure: Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability.
timeFrame: up to 72 hrs postdose
measure: The maximum plasma concentration (Cmax) of SHR0302
timeFrame: At protocol-specified times up to 72 hrs postdose
measure: The area under the plasma concentration-time curve (AUC) of SHR0302
timeFrame: At protocol-specified times up to 72 hrs postdose
measure: t1/2 of SHR0302
timeFrame: At protocol-specified times up to 72 hrs postdose
measure: Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers
timeFrame: At protocol-specified times up to 24 hrs postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Fourth Military Medical University
state: Shanxi
Study officials:
References:
Clinical trial NCT03286738: Pattern of Use of Bevacizumab or Cetuximab + FOLFIRI Regimen as First-line Treatment in Metastatic Colorectal Cancer
Official title: Pattern of Use of Bevacizumab or Cetuximab in Patients With Metastatic Colorectal Cancer When Added to FOLFIRI Regimen as First-line Treatment; Multicenter, Registry Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 1800
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hemato oncology clinic

Brief summary: * Registry
* Multicenter, prospective observational study
* Observe adverse events and efficacy in recruited patients for 3 years under real world settings.


Eligibility criteria: Inclusion Criteria:

1. Adult patients at least 19 years of age with metastatic colorectal cancer who are planned to receive Bevacizumab or Cetuximab in combination with FOLFIRI regimen as first-line treatment
2. Patients who will receive irinotecan, a component of FOLFIRI regimen, using Camtop Injection®

Exclusion Criteria:

1) Patients with conditions in which any study drug is contraindicated per the respective approved label.

Primary outcomes:
measure: percentage of use FOLFIRI regimen and target agents
timeFrame: through study completion, 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Severance Hospital, YUHS
name: Joong Bae Ahn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03255538: Deep Friction Massage: Symptomatic
Official title: Deep Friction Massage Effects on Pain and Function in Patellar Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendinopathy
Keywords: patellar tendon
Lead sponsor: Cooperativa de Ensino Superior, Politécnico e Universitário
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Despite DFM being a widely-used technique and the empirical grounding regarding the importance of the pressure applied, there is no study characterizing the pressure applied during DFM, remaining it a discretion of the physiotherapist. Additionally, it is not known how the amount of pressure applied may influence pain mechanisms or function in the symptomatic patellar tendon. Having this, our objective is to characterize the pressure applied during deep friction massage and evaluate the immediate effects of different pressures applied during deep friction massage in the time until analgesia as well as in function, in patellar tendinopathy.


Eligibility criteria: Inclusion Criteria:

* The participants should have a symptomatic patellar tendon

Exclusion Criteria:

* History of other previous injuries of the lower limbs;
* Intake of medication that could interfere with pain mechanisms;
* Presence of any factors or conditions that could interfere with the awareness and sensibility to pain.

Primary outcomes:
measure: Time until analgesia
timeFrame: 10 minutes
measure: Numeric Pain Rating Scale
timeFrame: 20 minutes
measure: Maximal isometric strength of quadriceps
timeFrame: 20 minutes
measure: Knee flexion range of movement
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Gandra
country: Portugal
facility: Cooperativa Ensino Superior Politécnico e Universitário
state: Paredes
Study officials:
affiliation: Cooperativa Ensino Superior Politécnico e Universitário
name: Maria A Paço, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01289938: Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
Official title: Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Drug Metabolism, Poor, CYP2D6-RELATED
Keywords: pharmacokinetic
pharmacogenetic
Metoclopramide
Diphenhydramine
CYP2D6 polymorphisms
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2011-02-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Pharmacokinetic of Metoclopramide (MCP) in correlation to polymorphisms of CYP2D6 and Dopamine-D2-Receptor. Pharmacokinetic of Diphenhydramine (DPH) in correlation to polymorphisms of CYP2D6


Eligibility criteria: Inclusion Criteria:

* BMI 20 - 27kg/m2
* Caucasians
* Healthy volunteers

Exclusion Criteria:

* Pregnancy/lactation period
* Drug allergy
* Acute and chronic diseases
* Taking medication
* Abuse of drugs, alcohol etc.
* Smoker

Primary outcomes:
measure: Area under curve of metoclopramide (MCP)
timeFrame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
measure: Area under curve of diphenhydramine(DPH)
timeFrame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Secondary outcomes:
measure: Cmax of metoclopramide
timeFrame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
measure: Tmax of metoclopramide
timeFrame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
measure: Cmax of diphenhydramine
timeFrame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
measure: Tmax of diphenhydramine
timeFrame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Abteilung Klinische Pharmakologie, UKT Tübingen
state: BW
Study officials:
affiliation: UKT
name: Matthias Schwab, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kirchheiner J, Seeringer A. Clinical implications of pharmacogenetics of cytochrome P450 drug metabolizing enzymes. Biochim Biophys Acta. 2007 Mar;1770(3):489-94. doi: 10.1016/j.bbagen.2006.09.019. Epub 2006 Oct 4.
citation: Schroth W, Antoniadou L, Fritz P, Schwab M, Muerdter T, Zanger UM, Simon W, Eichelbaum M, Brauch H. Breast cancer treatment outcome with adjuvant tamoxifen relative to patient CYP2D6 and CYP2C19 genotypes. J Clin Oncol. 2007 Nov 20;25(33):5187-93. doi: 10.1200/JCO.2007.12.2705.
Clinical trial NCT05223738: Resident Memory T Cells in Vitiligo
Official title: Tissue Resident Memory T Cells in Early & Late Cases of Generalized Non-segmental Vitiligo
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitiligo
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Generalized Non-segmental Vitiligo

Brief summary: This study aims to detect the presence and diversity of Tissue resident memory T cell populations in early and late cases of generalized non-segmental Vitiligo.

Detailed description: * Written informed consent obtained from every participant.
* Detailed history taking including onset, course, duration of the disease, aggravating factors and received medications
* VASI score assessed in every patient.
* Patients photographed, divided into two groups early \& late cases and 3 mm punch biopsies will be taken from perilesional and non lesional skin.
* Biopsies processed and stained for CD8 \& CD69 in cases of early group, \& late group and controls by immunofluorescence.

Eligibility criteria: Inclusion Criteria:

* - Patients with Generalized non-segmental Vitiligo ( lesions in more than one anatomical site ).
* Both genders.
* Early group: onset less than or equal 6 months.
* Late group: onset more than 6 months

Exclusion Criteria:

* Localized or Segmental Vitiligo.
* Age \< 14 years.
* Pregnant females
* Patient who received treatment of any type within the last 3 months for the late group.
* Patients with other skin diseases or immunosuppression

Primary outcomes:
measure: CD8+ immunofluorescence
timeFrame: 6months-1 year
measure: CD69+ immunofluorescence
timeFrame: 6months-1 year
measure: Double CD8+ and CD69+ immunofluorescence
timeFrame: 6months-1 year
measure: VASI
timeFrame: 6months-1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainy University hospital
Study officials:
affiliation: Kasr El Ainy University Hospital, Faculty of medicine, Cairo University
name: Hilal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04278638: IORT in Local Advanced Laryngocarcinoma
Official title: Study of Safety and Feasibility With or Without Intraoperative Radiation in Local Advanced Laryngocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laryngeal Neoplasms
Lead sponsor: Tianjin First Central Hospital
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 120
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 incidence of laryngeal cancer accounts for about 1 \~ 5% of the total body tumors. For the surgical treatment of laryngeal cancer, the development trend of laryngocarcinoma treatment is to improve the local control rate, preserve the laryngeal function of patients as far as possible, and improve the life quality of patients. The efficacy, safety and feasibility of intraoperative radiotherapy (IORT) in head and neck cancer has been demonstrated in multiple institutional (3-5) studies to optimize local control. It is still unclear whether IORT can improve the local control and have efficacy, safety and feasibility in clinic. The purpose of this study was to observe the efficacy, safety and feasibility of IORT in local advanced laryngocarcinoma .


Eligibility criteria: Inclusion Criteria:

1. adults over the age of 18;
2. radiographic or pathological diagnosis of local advanced laryngocarcinoma (according to NCCN guidelines);
3. the expected survival time ≥ 3 months;
4. sign informed consent for treatment and research with self-knowledge.

Exclusion Criteria:

1. there is distant metastasis;
2. pregnant women;
3. patients with CT/MRI contraindications;
4. the patient fails to receive treatment and/or follow-up as scheduled;
5. bad fluid and organ function decompensation;
6. multiple primary cancers;
7. patients participating in other trials.

Primary outcomes:
measure: 2-year local recurrence rate
timeFrame: 2 year
Secondary outcomes:
measure: 2-year disease free survival
timeFrame: 2 years
measure: 2-year overall survival
timeFrame: 2 years
measure: tissue necrosis
timeFrame: 2 years
measure: fibrosis
timeFrame: 2 years
measure: time of wound healing
timeFrame: up to 1 month
Other outcomes:
measure: pharyngeal fistula
timeFrame: 3 months
Locations:
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
Study officials:
References:
citation: Yang Y, Li L, Zheng Y, Liu Q, Wei X, Gong X, Wang W, Lin P. A prospective, single-arm, phase II clinical trial of intraoperative radiotherapy using a low-energy X-ray source for local advanced Laryngocarcinoma (ILAL): a study protocol. BMC Cancer. 2020 Aug 6;20(1):734. doi: 10.1186/s12885-020-07233-1.
Clinical trial NCT02794038: Accuracy & Usability Study for Soberlink Cellular Device
Official title: Accuracy & Usability Study for Soberlink Cellular Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Lead sponsor: Soberlink Healthcare LLC
Sponsor class: INDUSTRY
First posted: 2016-06-08
Enrollment: 43
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study scope is to validate the accuracy and usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro.

Detailed description: The purpose of this accuracy and usability study is to validate the performance of Soberlink Cellular Device in the hands of the intended (lay) users - untrained study participants who have consumed alcohol and use the Soberlink Cellular Device to measure their blood alcohol content (BAC) in comparison to a predicate device.

The purpose of this document is to define how the human factors environment impacts the actual user interface design as well as how usability engineering evaluates user interface via usability objectives and usability tests. This accuracy and usability study will be performed on Soberlink Cellular Device in order to comply with FDA's Draft Guidance for Industry and Food and Drug Administration Staff, titled: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, IEC 60601-1-6 (collateral standard for usability engineering of medical electrical equipment), and IEC 62366 (application of usability engineering to medical devices).

Eligibility criteria: Inclusion Criteria:

* Subject willing to sign an informed consent
* Male or female subject between the ages of 21-99 years old
* Untrained subject in the use of an Alcohol Breathalyzer
* Subject willing to consume two alcoholic drinks
* Subjects willing to use two Alcohol Breathalyzers
* Subject willing to complete a Questionnaire

Exclusion Criteria:

* Subject with previous Alcohol Breathalyzer experience
* Subject currently in substance use rehabilitation or post rehabilitation, or unauthorized to consume alcohol for any other reason
* Subject with lung disease, or is physically unable to provide a deep lung exhalation for 4 seconds
* Subject unwilling to drink two alcoholic drinks
* Subject unwilling to complete a questionnaire
* Subject that is non-English speaking
* Subject that is a child, adolescent, or cognitively impaired.
* Subject that is a pregnant and/or breastfeeding woman

Primary outcomes:
measure: Validate the accuracy of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by linear regression.
timeFrame: Day 1
Secondary outcomes:
measure: Validate the usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by Questionnaire.
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Private Practice
name: Shannon Hanrahan, PhD
role: PRINCIPAL_INVESTIGATOR
References: