louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04169386: A Study of PCSK9 Inhibitor AK102 in Healthy Subjects
Official title: A First-in-Human,Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation,Phase 1 Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of AK102 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolaemia
Lead sponsor: Akeso
Sponsor class: INDUSTRY
Collaborators: name: AD Pharmaceuticals Co., Ltd.
First posted: 2019-11-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a first-in-human,randomized, double-blind, placebo-controlled, single dose escalation, phase 1 study to evaluate the safety, tolerability, PK/PD and immunogenicity of AK102 administered subcutaneously in healthy subjects. Subjects will be randomized into 4 planned single dose escalation cohorts or placebo cohort.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent.
* No clinically significant abnormalities judged by the principal investigator based on the medical history, physical examination, electrocardiogram and routine laboratory evaluations.
* Low-density lipoprotein cholesterol (LDL-C) level of 70-190 mg/dL (inclusive).
* Body mass index (BMI) ≥18 and ≤ 28 kg/m\^2 , body weight \>= 50 kg for male or \>= 45 kg for female.

Exclusion Criteria:

* Triglyceride concentration \>400 mg/dL (4.5 mmol/L).
* History of hypersensitivity reactions to any substance of the investigation drug or other monoclonal antibodies.
* Drug or alcohol abuse within 6 months prior to dosing.
* Blood pressure \>140 mmHg (systolic) or \> 90 mmHg (diastolic)

Primary outcomes:
measure: Incidence of treatment emergent AE
timeFrame: From single dose of AK102 through 12 weeks
Secondary outcomes:
measure: Pharmacokinetic characteristics of AK102
timeFrame: over 12 weeks
measure: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
timeFrame: At different time points from baseline through 12 weeks
measure: Percent Change From Baseline in PCSK9
timeFrame: At different time points from baseline through 12 weeks
measure: Number of subjects who develop detectable anti-drug antibodies (ADAs)
timeFrame: At different time points from baseline through 12 weeks
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Rui Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00603486: SuperSTAT Noninvasive Blood Pressure Monitor Evaluation
Official title: SuperSTAT Noninvasive Blood Pressure Monitor Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Invasive Blood Pressure
Keywords: Non-invasive Blood Pressure (NIBP)
GE Dinamap
SuperSTAT
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 20
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates in the NICU and newborn areas and/or infants.

Brief summary: The accuracy and/or performance of the GE DINAMAP noninvasive blood pressure (NIBP) monitors may be improved with modifications in software and/or hardware monitoring techniques and/or accessories. When changes are being made to the GE Monitor, testing can be done to evaluate performance of the investigational devices during and/or after product development.


Eligibility criteria: Inclusion criteria

* Signed informed consent
* Ability to single or dual monitor NIBP, ECG, and/or SpO2, whether or not already being monitored for any or all of these parameters.

Exclusion Criteria

* Any subject deemed too unstable, at the clinician's discretion, to participate in the study
* Any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery.
* Any subject who cannot tolerate, in the opinion of the clinician, multiple blood pressure measurements
* Known disease state or medical condition that A) compromises circulation to the extremity (ies), B) compromises musculo-skeletal integrity, or C) otherwise contraindicates use of a NIBP cuff and/or SpO2 sensor on an extremity or ECG patches on skin
* Excessive movement or excitability causing false values or no determinations (SP10 accuracy study only)

Primary outcomes:
measure: Evaluation of one of the GE DINAMAP NIBP Monitor algorithms, SuperSTAT NIBP, in neonatal and/or infant subjects.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: GE Healthcare
state: Florida
Study officials:
affiliation: University of South Florida
name: Laura Haubner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00505986: Genomic Endometrial Expression in Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity and Embryo Implantation
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2007-07-25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Determine if different genomic endometrial expression exists during embryo implantation in obese women in comparison with non obese women.


Eligibility criteria: Inclusion Criteria:

* group A: non obese oocyte donors (BMI: 18 - 29 kg. /m2)with proven fertility
* group B: obese oocyte donors: (BMI: \>29 kg./m2)with proven fertility
* group C: obese (BMI: \>29 kg./m2) infertile patients,

Exclusion Criteria:

* recurrent miscarriage

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Instituto Valenciano de Infertilidad Spain
Study officials:
affiliation: Instituto Valenciano de Infertilidad
name: Jose Bellver, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01023386: A Clinical Pharmacological Study of YM155 After Intravenous Infusion in Patients With Advanced Cancer
Official title: A Clinical Pharmacological Study to Assess the Distribution, Metabolism, and Elimination of YM155 After i.v. Infusion in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: YM155
Mass-balance
Phase I
Pharmacokinetics
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the pharmacokinetics of YM155, identifies the metabolic profile of YM155 and evaluates the safety and tolerability of YM155 after a 3-hour infusion in patients with advanced cancer


Eligibility criteria: Inclusion Criteria:

* Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors or non-Hodgkin's lymphomas for which YM155 has the potential, based on preclinical and/or clinical data, to show efficacy, namely:

  * castrate resistant prostate cancer
  * non-small cell lung cancer
  * metastatic melanoma
  * muscle invasive bladder cancer
  * follicular lymphoma
  * diffuse large B-cell lymphoma
* Life expectancy ≥ 3 months; and Performance status (PS) ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale at baseline

Exclusion Criteria:

* Radiotherapy, major surgery, hormonal therapy, and chemotherapy within 4 weeks prior to the first dose of study medication and 6 weeks in the case of mitomycin-C or nitrosourea
* Previous therapy with YM155
* Patients with renal, hepatic or colorectal cancers
* Inadequate bone marrow, renal and/or hepatic function
* History of being treated for other malignancy within 5 years except for treated basal or squamous cell carcinoma of the skin
* Participation in any clinical study within 4 weeks prior to start of the first dose of study medication
* Known brain or leptomeningeal metastases
* Active uncontrolled systemic infection at baseline

Primary outcomes:
measure: To evaluate the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of YM155 after a 3-hour infusion
timeFrame: Day -1 up to and including Day of discharge (Day 11)
Secondary outcomes:
measure: To identify the metabolic profile of YM155
timeFrame: Day -1 up to and including Day of discharge (Day 11)
measure: To evaluate the safety and tolerability of YM155 through vital signs, laboratory analysis, adverse events, physical exams, ECOG performance status and echo-cardiography
timeFrame: Screening (Day -21 to -2), Day -1 up to and including Day of discharge (Day 11) and end of study visit (7-14 weeks after discharge)
Other outcomes:
Locations:
city: Budapest
country: Hungary
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT02090686: Pulsatile Cupping in Low Back Pain
Official title: Efficacy of Pulsatile Cupping in Patients With Chronic Low Back Pain - a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: HeVaTech GmbH
First posted: 2014-03-18
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether pulsatile cupping with a cupping device is effective in the treatment of patients with chronic low back pain compared to no cupping or to minimal cupping.


Eligibility criteria: Inclusion Criteria:

* Male and female, 18-65 years
* Chronic low back pain (disease duration \> 3 months)
* Pain intensity on visual analogue scale at inclusion \> 40 mm (0-100 mm scale)
* Only pharmacological treatment with NSAID or no treatment in the last 4 weeks
* Undersigned informed consent form

Exclusion Criteria:

* Use of anticoagulants (Phenprocoumon, Heparin)
* Coagulopathy
* Cupping in the last 6 weeks
* Other CAM therapies in the last 12 weeks (e.g. acupuncture)
* Physical therapy in the last 12 weeks (e.g. massage, osteopathy)
* participation in another study in the last 3 months
* Paracetamol allergy or intolerance
* Pathological neurological symptoms such as muscular paralysis or paraesthesia due to spinal disc herniation or other causes
* Known renal and / or hepatic diseases
* Intake of central nervous system-acting analgesics in the last 6 weeks
* Applying for early retirement due to low back pain
* Severe disease that does not allow participation
* No undersigned informed consent form

Primary outcomes:
measure: Intensity of pain on visual analogues scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Intensity of pain on visual analogue scale
timeFrame: 12 weeks
measure: Back function - FFbH-R-Questionnaire
timeFrame: 4 weeks, 12 weeks
measure: Quality of Life - SF 36
timeFrame: 4 weeks, 12 weeks
measure: Assessment of perceived effect on Likert Scale
timeFrame: 4 weeks, 12 weeks
measure: Intake of paracetamol
timeFrame: 4 weeks
measure: Adverse events
timeFrame: week 1- 12
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Benno Brinkhaus, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teut M, Ullmann A, Ortiz M, Rotter G, Binting S, Cree M, Lotz F, Roll S, Brinkhaus B. Pulsatile dry cupping in chronic low back pain - a randomized three-armed controlled clinical trial. BMC Complement Altern Med. 2018 Apr 2;18(1):115. doi: 10.1186/s12906-018-2187-8.
Clinical trial NCT04322786: The Use of Angiotensin Converting Enzyme Inhibitors and Incident Respiratory Infections, Are They Harmful or Protective?
Official title: The Use of Angiotensin Converting Enzyme Inhibitors and Incident Respiratory Infections, Are They Harmful or Protective? An Analysis Using UK Based Electronic Health Records of 5.6 Million Individuals.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19, Coronavirus, Angiotensin Converting Enzyme Inhibitors, Influenza, Electronic Health Records, Epidemiology, Comorbidity, Incidence, United Kingdom
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 1302508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The nested case-control study include cases who had an ACEI prescription during study follow-up. We randomly select one control per case from the study cohort of individuals without any documented ACEI use. Controls are matched to incident AF patients according to sex, age (10-year age strata).

Brief summary: The study use UK based linked electronic health records from the Clinical Research Datalink (CALIBER) of 5.6 million individuals to conduct a matched case-control study to investigate the incidence of influenza in individuals prescribed ACEI compared to those not prescribed ACEI.


Eligibility criteria: Inclusion Criteria:

* We identify individuals aged 18 years or older and registered in the current primary care practice for at least one year.

Exclusion Criteria:

* We exclude individuals with a prior history of influenza and viral pneumonia before study entry.

Primary outcomes:
measure: Incidence of influenza
timeFrame: Jan 1st 1998 - May 31st 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05715086: UPURS Trial for Patient-centered Management of Symptomatic Obstructing Stones
Official title: Upfront vs Postponed Ureteroscopy (UPURS) Trial for Patient-centered Management of Symptomatic Obstructing Stones
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ureteral Stone
Keywords: Symptomatic ureteral stones
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: State University of New York - Upstate Medical University
First posted: 2023-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, non-blinded, randomized controlled trial with two study arms.
Primary purpose: TREATMENT

Brief summary: A prospective, non-blinded, randomized controlled trial studying the management of symptomatic ureteral stones. This study will compare upfront ureteroscopy vs observation and delayed intervention for patients presenting to the emergency department with a symptomatic ureteral stone.

Detailed description: Management of symptomatic ureteral stones is variable across the United States due to a lack of clear, patient-centered guidelines. For patients who do not meet criteria for emergent stenting, the decision to recommend upfront definitive treatment (ureteroscopy, ESWL) or medical expulsion therapy is influenced by factors such as practice setting, insurance status, and day of the week. This has resulted in health disparities and delays in care that disproportionately affect vulnerable patient populations.

For patients presenting to the emergency department with a symptomatic ureteral stone investigators will randomize into Group A: Upfront Ureteroscopy or Group B: Delayed intervention and observation. Both arms are considered standard of care for patients presenting with the above diagnosis.

Eligibility criteria: Inclusion Criteria:

* Presenting to the Emergency Department (ED)
* Adult (\> 18 yo)
* ≥5mm ureteral stone diagnosed on CT scan
* Presence of symptoms (pain, nausea, vomiting, hematuria)

Exclusion Criteria:

* Strict indication for stent
* Stone burden not amenable to Ureteroscopy (URS)
* Dirty urine analysis (UA) or positive urine culture (UCx)
* Transplant kidney
* Presence of conduit
* Comorbidities not optimized for surgery
* Strong preference for surgery or observation

Primary outcomes:
measure: Pain Score
timeFrame: 3 months
measure: Anxiety Score
timeFrame: 3 months
Secondary outcomes:
measure: Hospital visit length
timeFrame: 3 months
Other outcomes:
measure: Days of work lost
timeFrame: 3 months
measure: Hospital visits
timeFrame: 3 months
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas Chi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03901586: Satisfaction and Long-term Anatomic Efficacy Study on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008
Official title: Satisfaction and Long-term Anatomic Efficacy Study on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genital Prolapse
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Satisfaction and Long-term Anatomic Efficacy will be assessed on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008.

Detailed description: Satisfaction and Long-term Anatomic Efficacy will be assessed on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008.

Eligibility criteria: Inclusion Criteria:

* Patient who underwent a Richter intervention between 01/01/2008 and 31/12/2017 in the Gynecology Department of Foch Hospital

Exclusion Criteria:

* None

Primary outcomes:
measure: Long-term satisfaction of the Richter procedure
timeFrame: 4 months
Secondary outcomes:
measure: Long term anatomic impact of the procedure
timeFrame: 7 months
measure: Post-operative complications
timeFrame: 7 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Angeline Favre-Inhofer
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Foch
name: Jean-Marc Ayoubi
role: STUDY_DIRECTOR
References:
Clinical trial NCT01345422: Wii Balance Board in Dizziness
Official title: A Pilot Study to Assess the Usefulness of the Wii Balance Board for Dizziness
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dizziness
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2011-05-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients with dizziness presently undergo physical therapy rehabilitation. Our study will study whether Wii Balance Board made by Nintendo Inc. will be helpful in patients with dizziness. They will undergo dizziness evaluation to quantify their dizziness.


Eligibility criteria: Inclusion Criteria:

* Abnormal posturography exam

Exclusion Criteria:

* Pregnant Women and children

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Southern California Permanente Medical Group
name: David Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03598322: The Volume Effect of Hydrodissection for Carpal Tunnel Syndrome
Official title: The Volume Effect of Hydrodissection for Injection Therapies in Patients With Carpal Tunnel Syndrome - Evaluation Model by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators investigated the volume effect of hydrodissection for Injection therapies in patients with Carpal Tunnel Syndrome. The investigators evaluated participants by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis

Detailed description: The investigators investigated the volume effect of hydrodissection for Injection therapies in patients with Carpal Tunnel Syndrome. The investigators evaluated participants by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis

Eligibility criteria: Inclusion Criteria:

* Age 20-80
* Electrophysiological diagnosis of carpal tunnel syndrome
* At least one of the following two:

  1. Tenderness or numbness over median nerve innervated dermatome over 2 months
  2. Phalen test or Tinel sign or flick sign positive

Exclusion Criteria:

* History of wrist surgery
* Wrist trauma in recent two years
* Received wrist injection in recent three months
* History of brachial plexopathy, cervical radiculopathy or thoracic outlet syndrome
* History of DM, thyroid disorder or autoimmune disease
* Unable to cooperate with interview, examination or injection

Primary outcomes:
measure: Change of Visual analog scale (VAS)
timeFrame: 1 week, 4 weeks, 12 weeks, 24 weeks
Secondary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ)
timeFrame: 1 week, 4 weeks, 12 weeks, 24 weeks
measure: QuickDASH
timeFrame: 1 week, 4 weeks, 12 weeks, 24 weeks
measure: MSK US finding
timeFrame: 1 week, 4 weeks, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chueh Hung Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin MT, Liao CL, Hsiao MY, Hsueh HW, Chao CC, Wu CH. Volume Matters in Ultrasound-Guided Perineural Dextrose Injection for Carpal Tunnel Syndrome: A Randomized, Double-Blinded, Three-Arm Trial. Front Pharmacol. 2020 Dec 17;11:625830. doi: 10.3389/fphar.2020.625830. eCollection 2020.