louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05418959: Genetic Risk Stratification of Pediatric Skin Lesions
Official title: Genetic Risk Stratification of Pediatric Skin Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Skin Lesion
Nevus
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-invasive adhesive biopsies of suspicious skin lesions.
Primary purpose: DIAGNOSTIC

Brief summary: A study to understand the clinical utility of noninvasive adhesive skin biopsies in pediatric patients by exploring whether DermTech Pigmented Lesion Assay (PLA) genetic risk analysis of suspicious lesions in children correlates with histopathological diagnosis.

Detailed description: Patients (20 years of age or younger) with one or more atypical skin lesions requiring surgical biopsy within the next 6 months will be enrolled in the study. Prior to surgical biopsy, a DermTech PLA noninvasive adhesive will be performed on the lesion. The results of DermTech PLA genetic analysis will be compared to the results of histopathological diagnosis from surgical biopsy. Incidents of adverse events will also be collected.

Eligibility criteria: Inclusion Criteria:

* 20 years of age or younger.
* Subjects or parents willing and able to give informed consent, and assent as appropriate
* Patients will have one or more atypical skin lesions with management plan of monitoring, surgical biopsy, and/or excision of atypical nevi within the next 6 months

Exclusion Criteria:

* Lesions on palms, soles, mucosal membranes, or area where hair cannot be trimmed
* Bleeding or ulcerated lesions
* Previously biopsied, scarred, or known melanoma lesions
* Presence of active psoriasis/eczema/other skin condition in area to be biopsied

Primary outcomes:
measure: Presence or absence of PRAME genetic marker.
timeFrame: 1 day
measure: Presence or absence of LINC genetic marker.
timeFrame: 1 da7
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Elena B Hawryluk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jansen, B., Dobak, J. (2019) The Pigmented Lesion Assay Breakthrough: Enhanced Early Melanoma Detection with a Non-Invasive Gene Expression Test. DermTech, Inc. retrieved 4/11/20 from: https://dermtech.com/wp-content/uploads/PLA-TA.pdf
citation: Brouha B, Ferris LK, Skelsey MK, Peck G, Moy R, Yao Z, Jansen B. Real-World Utility of a Non-Invasive Gene Expression Test to Rule Out Primary Cutaneous Melanoma: A Large US Registry Study. J Drugs Dermatol. 2020 Mar 1;19(3):257-262. No abstract available.
Clinical trial NCT01788059: The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital
Official title: The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonunion Fracture
Keywords: nonunion
mesenchymal stem cell
long bone
Lead sponsor: Emdadi Kamyab Hospital
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Because the rate of non union of long bone in lower extremities specially in tibia in this two last decade due to malnutrition and smoking and other risk factors was increased, so many patient in our country suffer from non union on the other hand it seems that the use of the mesenchymal stem cells can irritate the union rate. Therefore the investigators decide to inject the mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure to non union site in patient that are resistant to other treatment. Then the investigators will follow the patient with monthly radiography and evaluate the callus volume and clinical union and any side effect of this treatment.clinical union consider to relief pain in non union site and be stable in examination.


Eligibility criteria: Inclusion Criteria:

* Every patient with non union in the site of long bone fracture
* Age more than 18 and under 60 years old
* Fracture having no radiological callus after 6 months and absence of any hypertrophic bone reaction.
* No infection in site of surgery
* Be able and willing to participate in the study
* Written informed consent

Exclusion Criteria:

* Evidence of malignancy
* Pregnancy or breastfeeding
* Patient positive by serology or PCR for HIV, hepatitis B or C infection the patient with Accompanied fracture such as hip fracture that could not weight bearing

Primary outcomes:
measure: clinical and radiological union at 1 month to 6 months
timeFrame: 6 months
Secondary outcomes:
measure: •Safety of Mesenchymal Stem Cells injection in nonunion fractures. Follow-up for revealing any significant immediate or late adverse effects.
timeFrame: 12 months
measure: Incidence of adverse events in patients (e.g infection , malignancy , ...) Adverse events will be continuously monitored
timeFrame: 12 months
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Emdai Kamyab Hospital
state: Khorasan
Study officials:
affiliation: Emdadi Kamyab Hospital
name: mohammad taghi peivandi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05044559: Continuous Positive Air Way Pressure in Cardiac Rehabilitation After CABG
Official title: Effect of Continuous Positive Airway Pressure in Phase 1 Cardiac Rehabilitation After Post CABG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-cardiac Surgery
Keywords: Continuous Positive Airway Pressure
Coronary Artery Bypass Graft Surgery
Inpatients Rehabilitations
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 38
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different studies reported that CPAP is effective to prevent respiratory complication in post CABG patient and have greater impact on walking time, ventilatory function and breathing pattern.

Detailed description: The walking time (6 minute walk test), effect on arterial blood gasses and long term effects of CPAP on cardiac activity, the previous studies focus only on the acute effects of CPAP along with specific exercises but did not tell about the long term effects. based on these finding this study is design to assess the effectiveness of CPAP in Post-op CABG patients regarding there early mobilization, walking time, ABGs and Ejection Fraction as there prognostic parameters in both phase-1 cardiac rehabilitation within hospital as well as in long-term prognosis, is of great interest.

Eligibility criteria: Inclusion Criteria:

* age between 35 to 60 years.
* With a clinical diagnosis of coronary artery disease, underwent elective CABG (Acute)

Exclusion Criteria:

* Low ejection friction (15%)
* Patient those who have any arrhythmias
* Unstable angina
* Patient having pace maker and implantable cardioverter defibrillator
* COPD and asthmatic patient
* Patient having BMI more then 40

Primary outcomes:
measure: Arterial Blood Gasses
timeFrame: 3 days
Secondary outcomes:
measure: 6 minute walk test
timeFrame: 3 days
measure: Ejection Fraction
timeFrame: 4 week
measure: Short Form 12 Questionnaire
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Northwest General Hospital and research center
state: KPK
Study officials:
affiliation: Riphah International University
name: Sumaiyah Obaid, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02503059: Etanercept Survival in Elderly Population
Official title: Etanercept Survival in Elderly Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over 60 who received etanercept for the treatment of moderate / severe psoriasis

Brief summary: Evaluate the 3-year survival of etanercept in patients over 60 years with psoriasis in moderate / severe plaque and the reasons that led to the abandonment. Besides factors that might have had a positive or negative influence on adherence to treatment and analysis of efficacy (PASI 75) and safety will be identified.

All variables were collected through retrospective review of medical records of patients dermatology unit are made.


Eligibility criteria: Inclusion Criteria:

* Patients with moderate / severe psoriasis (with / without psoriatic arthritis,PAs) defined by: PASI(Psoriasis Area and Severity Index)\> 10 and / or BSA(Body Surface Area)\> 10% and / or DLQI(Dermatology Life Quality Index)\> 10
* PASI\> 10 and / or BSA(Body Surface Area)\> 10% and / or DLQI(Dermatology Life Quality Index)\> 10
* Over 60 years of age at the start of treatment
* Receiving etanercept at any time
* Available history in the Dermatology

Exclusion Criteria:

* Patients with insufficient clinical data in the medical record

Primary outcomes:
measure: primary ineffectiveness in patients with etanercept treatment
timeFrame: 24 weeks
measure: Secondary ineffectiveness in patients with etanercept treatment
timeFrame: 24 weeks (duration of treatment with etanercept)
measure: Ineffectiveness of treatment in localized lesions in patients with etanercept treatment
timeFrame: 24 weeks(duration of treatment with etanercept)
measure: primary ineffectiveness in patients with etanercept treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: Number of participants with adverse events during treatment with etanercept
timeFrame: 24 weeks
measure: Number of participants with disease remission
timeFrame: 24 weeks
measure: number of participants with Poor adherence to treatment with etanercept
timeFrame: 24 weeks
measure: number of participants with Conditions requiring hospitalization and / or surgery
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Córdoba
country: Spain
facility: H.U. Reina Sofía
city: Jaén
country: Spain
facility: Hospital de Andújar
city: Madrid
country: Spain
facility: Hospital la Paz
city: Málaga
country: Spain
facility: H.U. Virgen de la Victoria
Study officials:
affiliation: H.U. Virgen de la Victoria
name: Enrique Herrera Ceballos, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02434159: Role of Cardiac Computed Tomography in Optimising Response to Cardiac Resynchronisation Therapy
Official title: Role of Cardiac Computed Tomography and Cardiac Magnetic Resonance in Optimising Response to Cardiac Resynchronisation Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
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 if detailed scanning of the heart before biventricular device insertion will improve outcomes for heart failure patients.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18, \<90
2. Patients with moderate or severe heart failure ( NYHA functional class II-IV) due to ischaemic or non-ischaemic cardiomyopathy.
3. QRS duration \>120ms on 12 lead ECG
4. LVEF \< 35%
5. LVEDD \>55 mm
6. Patients on optimum medical treatment for heart failure. The doses of these medications have been stable for 3 months.

Exclusion Criteria:

1. Patients with a cardiac or cerebral ischemic event within the previous three months prior to recruitment
2. Patients who had had an atrial arrhythmia within one month prior to recruitment
3. Patients with a systolic blood pressure of more than 170 or less than 80 mm Hg
4. Patients with a heart rate of more than 140 beats per minute
5. Patients with severe renal failure (eGFR \< 30)
6. Patients with a history of allergy to iodine based contrast agents
7. Predicted life expectancy \< 1 year
8. Pregnancy

Primary outcomes:
measure: 6 minute walk test
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
References:
Clinical trial NCT02536859: Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus
Official title: A Randomised, Single-centre, Double-blind, Two-period Cross-over, Multiple Dose Trial Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2015-09-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec and insulin glargine 300 U/mL at steady-state conditions in subjects with type 1 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
* Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
* Body mass index 18.5-29.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the in-patient period

Primary outcomes:
measure: Area under the glucose infusion rate curve
timeFrame: During one dosing interval (0-24h) at steady-state. At day 6, 9 and 12
Secondary outcomes:
measure: Area under the glucose infusion rate curve
timeFrame: During one dosing interval at steady state.At day 6, 9 and 12
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Heise T, Norskov M, Nosek L, Kaplan K, Famulla S, Haahr HL. Insulin degludec: Lower day-to-day and within-day variability in pharmacodynamic response compared with insulin glargine 300 U/mL in type 1 diabetes. Diabetes Obes Metab. 2017 Jul;19(7):1032-1039. doi: 10.1111/dom.12938. Epub 2017 Apr 23.
citation: Heise T, Kaplan K, Haahr HL. Day-to-Day and Within-Day Variability in Glucose-Lowering Effect Between Insulin Degludec and Insulin Glargine (100 U/mL and 300 U/mL): A Comparison Across Studies. J Diabetes Sci Technol. 2018 Mar;12(2):356-363. doi: 10.1177/1932296817731422. Epub 2017 Sep 26.
Clinical trial NCT00325000: Interpersonal Psychotherapy for Severely Depressed Inpatients
Official title: An Intensive Treatment Program of Interpersonal Psychotherapy Plus Pharmacotherapy for Severely Depressed Inpatients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Major Depression
Lead sponsor: German Research Foundation
Sponsor class: OTHER
First posted: 2006-05-11
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: TREATMENT

Brief summary: We examined the hypotheses that severely depressed inpatients treated for 5 weeks with IPT-S plus pharmacotherapy have 1) a higher reduction in depressive symptoms and 2) higher response- and remission rates compared to pharmacotherapy plus CM. For the follow-up period (12 months) we hypothesized a better symptomatic and psychosocial longterm outcome and lower rates of relapse for patients initially treated with combination therapy.

Detailed description: A randomized controlled trial was conducted in 124 hospitalized patients with a DSM IV diagnosis of Major Depressive Disorder comparing 5 weeks of Interpersonal Psychotherapy modified for depressed inpatients (IPT-S) plus pharmacotherapy versus medication plus intensive Clinical Management (CM). The study included a prospective, naturalistic follow-up 3- and 12 months after acute treatment in 97 of 105 treatment completers. The 17-item version of the Hamilton Rating Scale for Depression (HAMD) served as the primary outcome measure.

Eligibility criteria: Inclusion Criteria:

Major Depression (single episode, recurrent or bipolar II) according to the Structured Clinical Interview for DSM IV (SCID)and a score of ≥ 16 on the 17-item version of the Hamilton Rating Scale for Depression (HAMD)

Exclusion Criteria:

(1) concurrent diagnosis of bipolar I disorder, primary substance abuse or dependency, mental disorder due to organic factors, and borderline or antisocial personality disorder, (2) psychotic symptoms, (3) severe cognitive impairment, (4) contraindications to the study medication, and (5) being actively suicidal

Primary outcomes:
measure: The 17-item version of the Hamilton Rating Scale for Depression (HAMD) served as the primary outcome measure
Secondary outcomes:
measure: Beck Depression Inventory
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Clinic Freiburg , Dept. of Psychiatry and Psychotherapy
Study officials:
affiliation: University Clinic Freiburg, Dept. of Psychiatry and Psychotherapy
name: Mathias Berger, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05354700: A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer
Official title: An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + Chemotherapy in Patients With Extensive Small Cell Lung Cancer (ES-SCLC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small-cell Lung Cancer
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 20
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 is conducted in patients with advanced metastatic small cell lung cancer (SCLC). This study includes a single arm: the patients will receive HLX07 combination therapy with HLX10 and chemotherapy (carboplatin+etoposide) as first-line treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system)
* No prior systemic therapy for ES-SCLC
* Major organs are functioning well
* Participant must keep contraception

Exclusion Criteria:

* Histologically or cytologically confirmed mixed SCLC
* Known history of severe allergy to any monoclonal antibody
* Known hypersensitivity to carboplatin or etoposide
* Pregnant or breastfeeding females
* Patients with a known history of psychotropic drug abuse or drug addiction
* Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment

Primary outcomes:
measure: ORR
timeFrame: up to 2 years
measure: PFS
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
Study officials:
References:
Clinical trial NCT03797300: Pulse Oximeter and Respiratory Rate Test
Official title: Accuracy of Pulse Oximeters With Profound Hypoxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Hypercapnia
Hypocapnia
Lead sponsor: Spry Health
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2019-01-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Assessment of Spry Health's Loop oximetry accuracy in profound hypoxia Assessment of Spry Health's Respiratory rate accuracy in normal conditions and profound hypoxia


Eligibility criteria: Inclusion Criteria:

* Healthy adult willing to participate

Exclusion Criteria:

* Wrist size outside the indicated use
* Low perfusion
* Smoking

Primary outcomes:
measure: Accuracy of SpO2 measurement
timeFrame: duration of subject monitoring, usually up to one hour
measure: Accuracy of Respiratory Rate measurement
timeFrame: duration of subject monitoring, usually up to one hour
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Hypoxia Lab
state: California
Study officials:
References: