louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04119102: Duobrii in Combination With Biologics
Official title: Open Label Study Evaluating DUOBRII in Psoriasis Patients Being Treated With Biologic Agents.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Psoriasis Treatment Center of Central New Jersey
Sponsor class: OTHER
Collaborators: name: Ortho Dermatologics
First posted: 2019-10-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label
Primary purpose: TREATMENT

Brief summary: 12 weeks DUOBRII to patients with 2%-10% BSA who are receiving biologic therapy for at least 24 weeks

Detailed description: A single center, pilot study of 25 subjects to assess 12 weeks DUOBRII to patients with 2%-10% body surface area who are receiving biologic therapy for at least 24 weeks

Eligibility criteria: Inclusion Criteria:

1. Male or female adult ≥ 18 years of age;
2. Diagnosis of chronic plaque-type
3. Psoriasis affecting 2%-10% BSA
4. Patient is being treated with biologic therapy for a minimum of 24 weeks
5. Able and willing to give written informed consent prior to performance of any study-related procedures

Exclusion Criteria:

1. Psoriasis affecting ˂2% or \>10% BSA
2. Patient not receiving a biologic agent, or receiving biologic agent \<24weeks
3. Received treatment with any topical antipsoriatic drug product within 14 days prior to the Baseline visit.
4. Has previously used DUOBRII

Primary outcomes:
measure: Body surface area improvement
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
Study officials:
References:
Clinical trial NCT00399802: A Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD)(0822-016)(COMPLETED)
Official title: A Phase II Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Women With Breast Cancer and Established Bone Metastases (MBD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Metastatic Bone Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-11-15
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 4-week study to examine the effects of a new experimental medication on women with breast cancer and established bone metastases. This study will enroll approximately 45 women. The primary hypotheses are: (1) odanacatib will result in a substantial suppression of urinary N-telopeptide of type I collagen (u-NTx) similar to that achieved with an intravenous (IV) infusion of zoledronic acid (ZA) over 4 weeks of treatment; and (2) odanacatib (MK-0822) will be safe and well tolerated during 4 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Patient has histologically or cytologically-confirmed breast cancer
* Patient has documented skeletal metastases

Exclusion Criteria:

* Patient is undergoing current oral bisphosphonate therapy, or has a history of oral bisphosphonate use within 6 months of entry into study

Primary outcomes:
measure: Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4
timeFrame: Baseline and Week 4
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to 6 weeks
measure: Number of Participants Who Discontinued Treatment Due to an AE
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Jensen AB, Wynne C, Ramirez G, He W, Song Y, Berd Y, Wang H, Mehta A, Lombardi A. The cathepsin K inhibitor odanacatib suppresses bone resorption in women with breast cancer and established bone metastases: results of a 4-week, double-blind, randomized, controlled trial. Clin Breast Cancer. 2010 Dec 1;10(6):452-8. doi: 10.3816/CBC.2010.n.059.
Clinical trial NCT06079502: Electrical Muscle Stimulation Versus Resistive Training On Physical Measures, And Fatigue In Hemodialysis Patients
Official title: Electrical Muscle Stimulation Versus Resistive Training On Physical Measures, And Fatigue In Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemodialysis
Fatigue
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare effect of intradialytic NMES versus resistive training on physical measures and fatigue in HDP.

Detailed description: In this study we will compare between the effect of intradialytic neuromuscular electrical stimulation and resistive training on physical measures, dialysis efficiency and fatigue in HDP. This is first study that will compare between NMES and resistive training in HDP, investigating their effect on physical performance; dialysis efficiency and level of fatigue as previous studies show effect of each intervention alone.

Eligibility criteria: Inclusion Criteria:

* Patients of both sexes, with CKF on HD for more than 3 years.
* Age between 40 to 55 years old.
* BMI is between 25 and 29.9 kg/m2.

Exclusion Criteria:

Patients who have one of the following contraindications to the interventions or affect the results

* Cognitive impairment that prevented them from performing the evaluations and who were unable to understand and sign the written informed consent.
* Stroke
* Smokers
* Anemic patients
* Osteoarticular or disabling musculoskeletal disorders
* Uncontrolled hypertension (systolic blood pressure\>230 mm Hg and diastolic blood pressure\>120 mm Hg)
* Patients with coronary artery disease or heart failure.
* Diabetic patients
* Infectious diseases and chest diseases
* Active smokers' patients with peripheral vascular disease in the lower limbs such as deep vein thrombosis or thromboangiitis

Primary outcomes:
measure: Assessing the change in maximal strength of quadriceps and calf muscles
timeFrame: at baseline and after 16 weeks of intervention
measure: Assessing the change in predicted peak vo2 max
timeFrame: at baseline and after 16 weeks of intervention
Secondary outcomes:
measure: Assessing the change in physical and psychological fatigue
timeFrame: at baseline and after 16 weeks of intervention
measure: Assessing the change in Dialysis efficiency
timeFrame: at baseline and after 16 weeks of intervention
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Outpatient clinic faculty of physical therapy cairo university
Study officials:
affiliation: Cairo University
name: Asmaa Yacoub
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03760302: Analgesia in ÖAMTC Helicopter Emergency Service in Austria
Official title: Analgesia in ÖAMTC Helicopter Emergency Service in Austria: A Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Field Physician Care
Analgesics
Hypnotics
Emergencies
Safety
Accident
Trauma, Multiple
Pain, Acute
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 35000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients screened with the described inclusion criteria - eligible to be included in analysis.

Brief summary: A sufficient analgesia in injured or sick people is the main goal of physicians treating a patient. In emergency medicine potent analgesia like ketamine or opioids are routinely used. It is unknown if there are any severe side effects or if the use is safe while in use in a Helicopter Emergency Service equipped with emergency physicians.


Eligibility criteria: Inclusion Criteria:

* Analgesia or use of hypnotics in ÖAMTC Air Ambulance Service in Austria 2000-2016

Exclusion Criteria:

* No analgesia, or analgesia use not in connection to ÖAMTC Air Ambulance Service. Analgesia given not in the period of examination (2000-2016)

Primary outcomes:
measure: Successful analgesia
timeFrame: 2000-2016
measure: Analgesic, drug type
timeFrame: 2000-2016
measure: Analgesic, frequency
timeFrame: 2000-2016
measure: Analgesic, amount of analgesics
timeFrame: 2000-2016
Secondary outcomes:
measure: Side effects
timeFrame: 2000-2016
measure: Frequency of side effects
timeFrame: 2000-2016
measure: Severity of side effect
timeFrame: 2000-2016
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: General and Surgical Critical Care Medicine, Medical University of Innsbruck
Study officials:
affiliation: General and Surgical Critical Care Medicine, Medical University of Innsbruck
name: Mathias Ströhle, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03066102: Muscle Fatigue and Scapular Sensorimotor System
Official title: Muscle Fatigue and Scapular Sensorimotor System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle; Fatigue
Keywords: sensorimotor system
scapular joint position sense
fatigue
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aims of this study are to investigate the effects of scapular muscle fatigue on scapular joint position sense and neuromuscular performance (scapular muscle strength, the kinematics data and muscle activity of shoulder during scaption (arm elevation in the scapular plane)). The investigators hypothesize that scapular muscle fatigue would increase scapular reposition error and affect neuromuscular performance of the scapular during scaption.


Eligibility criteria: Inclusion Criteria:

* no shoulder, cervical, and thoracic spine pain within six months
* negative for subacromial impingement test
* normal range of motion of glenohumeral joint

Exclusion Criteria:

* history of dislocation, fracture, or surgery of shoulder joint
* history of central nervous system disorder, rheumatoid arthritis, shoulder osteoarthritis, or cervical radiculopathy

Primary outcomes:
measure: Change From Baseline in Scapular Proprioception
timeFrame: through fatigue intervention completion, an average of 20 minutes in female subjects and 40 minutes in male subjects
measure: Change From Baseline in Muscle Activation During Scapular Proprioception
timeFrame: through fatigue intervention completion, an average of 20 minutes in female subjects and 40 minutes in male subjects
Secondary outcomes:
measure: Change From Baseline in Scapular Muscle Strength
timeFrame: through fatigue intervention completion, an average of 20 minutes in female subjects and 40 minutes in male subjects
measure: Change From Baseline in Shoulder Kinematics Data During Shoulder Elevation in the Scapular Plane
timeFrame: through fatigue intervention completion, an average of 20 minutes in female subjects and 40 minutes in male subjects
measure: Change From Baseline in Scapular Muscle Activity During Shoulder Elevation in the Scapular Plane
timeFrame: through fatigue intervention completion, an average of 20 minutes in female subjects and 40 minutes in male subjects
measure: Change From Baseline in Scapular Muscle Recruitment Timing During Arm Elevation in Scapular Plane
timeFrame: through fatigue intervention completion, an average of 20 minutes in female subjects and 40 minutes in male subjects
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang Ming University
Study officials:
References:
Clinical trial NCT00740402: Motor Learning of a Planning Task in Stroke Patients: the Maze Paradigm Measured Through Time and Error as Variables
Official title: Motor Learning of a Planning Task in Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Faculdades Metropolitanas Unidas
Sponsor class: OTHER
First posted: 2008-08-25
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients after stroke

Brief summary: The purpose of this study is to investigate the process of acquiring a motor skill subject in post-stroke, comparing them with healthy subjects.

Detailed description: 20 post-stroke patients were comprised to the experimental group (EG) and 20 health subjects were included to the control group (CG. Inclusion criteria: chronic stroke, single stroke event, lesion in anterior circulation, right handed subjects, MEEM over 23 points. The task consisted in a maze paradigm, made by pencil and paper, with the non affected side for EG and left upper extremity for CG. The instruction was given to the subjects to complete the task as fast as possible. The study consisted in three phases: acquisition (AQ)with 30 trials, transfer (TR, short retention (R1)and long term retention (R2 both with 5 trials.

Eligibility criteria: Inclusion Criteria:

* Age between 40 and 65
* Injury in territory of movement earlier, as shown by examination of image and finding medical neurologist
* Time of injury over 6 months
* Single vascular event
* Right handed, by applying the Inventory of Dominance Side of Edinburgh Mini mental with scores over 23 points

Exclusion Criteria:

* Aphasia of understanding
* Instability clinic
* Other neurological diseases associated (Parkinson's disease, dementias, Alzheimer)

Primary outcomes:
measure: TIME
timeFrame: 3 times in a week (acquisition, transfer an retention phase)
Secondary outcomes:
measure: error
timeFrame: 3 times in a week (acquisition, transfer an retention phase)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University Center of Metropolitan United
Study officials:
affiliation: University of Sao Paulo
name: Camila Torriani, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT00970021: Agaricus Blazei Murill in Patients With Multiple Myeloma
Official title: Use of the Medicinal Mushroom Agaricus Blazei Murill in Addition to High Dose Chemotherapy in Patients With Multiple Myeloma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2009-09-02
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Extract from the mushroom Agaricus blazei Murill har been shown to have strong immunomodulating properties both in cell cultures, animal models and in humans. Furthermore antitumor properties have been shown in animal models, among them in mice with multiple myeloma. The investigators now want to investigate the effect of Agaricus as supplementary treatment in addition to chemotherapy in patients with multiple myeloma.

Detailed description: Patients who are scheduled to undergo high dose chemotherapy for multiple myeloma will receive in addition in a double blinded manner 60 ml of agaricus extract or placebo once daily from the start of stem cell mobilizing therapy until one week after the end of aplasia after high dose melphalan.

Primary endpoints will be cytokine levels of degree of activation of tumor supressor genes before and after start of the investigational product.

Secondary endpoints will be treatment response and quality of life.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo high dose chemotherapy with autologous stem cell support for multiple myeloma

Exclusion Criteria:

* None

Primary outcomes:
measure: Cytokine levels in serum
timeFrame: 7 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: 4 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of hematology, Oslo University Hospital, Ullevaal
Study officials:
affiliation: Department of Hematology, Oslo University Hospital, Ulleval
name: Jon-Magnus Tangen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tangen JM, Tierens A, Caers J, Binsfeld M, Olstad OK, Troseid AM, Wang J, Tjonnfjord GE, Hetland G. Immunomodulatory effects of the Agaricus blazei Murrill-based mushroom extract AndoSan in patients with multiple myeloma undergoing high dose chemotherapy and autologous stem cell transplantation: a randomized, double blinded clinical study. Biomed Res Int. 2015;2015:718539. doi: 10.1155/2015/718539. Epub 2015 Jan 18.
Clinical trial NCT01712321: Study of Vilazodone to Treat Social Anxiety Disorder
Official title: Vilazodone in the Treatment of Social Anxiety Disorder: A Double Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: Social Anxiety Disorder
Social Anxiety
Social Phobia
SAD
Lead sponsor: The Medical Research Network
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2012-10-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Vilazodone is effective in the treatment of symptoms of Social Anxiety Disorder among adults.

Detailed description: The proposed study is a 12 week double-blind, placebo-controlled trial in which daily doses of vilazodone 20 to 40 mg/day or matching placebo will be administered on a 1:1 ratio. The study will include 30 outpatients age 18-75 with SAD, generalized subtype who return for at least one post randomization visit where efficacy evaluations are conducted.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Social Anxiety Disorder, generalized subtype
* LSAS total score of 70 at visits 1 and 2

Exclusion Criteria:

* Lifetime history of Bipolar disorder or Schizophrenia
* Current suicidal risk
* Current unstable medical condition

Primary outcomes:
measure: Change in Liebowitz Social Anxiety Scale (LSAS) - total score
timeFrame: Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks
Secondary outcomes:
measure: Responder rate, as defined by Clinical Global Impression of Improvement score of 1 or 2
timeFrame: Study Endpoint: minimum 6 weeks - maximum 12 weeks
measure: Change in the Clinical Global Impression of Severity of Illness score
timeFrame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
measure: Change on the LSAS anxiety and avoidance subscales
timeFrame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
measure: Change in Hamilton Depression scale total
timeFrame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
measure: Change in Hamilton Anxiety scale total
timeFrame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
measure: Subject-assessed responder rate
timeFrame: Study Endpoint: minimum 6 weeks - maximum 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
Study officials:
affiliation: The Medical Research Network, LLC
name: Michael R. Liebowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Careri JM, Draine AE, Hanover R, Liebowitz MR. A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Vilazodone in Generalized Social Anxiety Disorder. Prim Care Companion CNS Disord. 2015 Nov 26;17(6):10.4088/PCC.15m01831. doi: 10.4088/PCC.15m01831. eCollection 2015.
Clinical trial NCT06367621: Retrospective Study of iStatis Syphilis Ab Test (POC)
Official title: Retrospective Evaluation of Diagnostic Specificity and Sensitivity for iStatis Syphilis Ab Test at the Point-Of-Care Sites
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syphilis
Syphilis Infection
Keywords: diagnostic kit
diagnostic devices
lateral flow device test
syphilis rapid test
syphilis point of care tests
iStatis Syphilis Antibody Test
Lead sponsor: bioLytical Laboratories
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 1500
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective cross-sectional study on left-over samples stored at -80°C from previous trials conducted by Epicentre Heath Research.

Brief summary: The purpose of this retrospective clinical trial is to establish the clinical performance of the iStatis Syphilis AbTest. The data will be used to demonstrate the product is safe and effective for its intended use. The data obtained will be used in the application for CE certification under In Vitro Diagnostic Medical Device Regulation (IVDR) and World Health Organization (WHO) prequalification.

Detailed description: The objectives of this study are to establish the diagnostic sensitivity and diagnostic specificity of the iStatis Syphilis Ab Test. Left-over samples stored at -80ᵒC from the previous trials conducted by Epicentre will be used for this study. The samples are tested in a routine testing environment. Serum samples were tested for evidence of syphilis infection using a non-treponemal Rapid Plasma Reagin (RPR) assay. All reactive samples were further tested quantitatively.

Eligibility criteria: Inclusion Criteria:

1. Anti-Tp negative samples:

   -Stored at ≤ -80°C.
2. Anti-Tp negative samples - pregnant women:

   * Samples from pregnant women, 1st and multipara
   * Samples found negative or false reactive for anti-Tp assay with the reference method.
   * Stored at ≤ -80°C.
3. Anti-Tp positive samples:

   * Samples screened with Abbott Architect Syphilis Tp and confirmed positive with BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA).
   * Stored at ≤ -80°C.
4. Anti-Tp positive samples - pregnant women:

   * Samples from pregnant women
   * Samples screened with Abbott Architect Syphilis Tp and confirmed positive with BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA).
   * Stored at ≤ -80°C.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Sensitivity and specificity of the iStatis Syphilis Ab Test
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hillcrest
country: South Africa
facility: Epicentre Health Research
state: KwaZulu Natal
Study officials:
References: