louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01028950: YM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness
Official title: A Multi-center, Open Label Study With YM150, a Direct Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: YM150
Bleeding
VTE
FXa inhibitor
Deep Vein Thrombosis
Venous thromboembolism
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the safety and efficacy of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients with acute medical illness.


Eligibility criteria: Inclusion Criteria:

* Patient is hospitalized within 2 days before the study and has more than 1 basic VTE risks
* Complete bed rest is required in the fist day of hospitalization and at least 4 days hospitalization
* Written informed consent obtained

Exclusion Criteria:

* Subject has history of deep vein thrombosis and/or pulmonary embolism
* Subject has a hemorrhagic disorder and/or coagulation disorder
* Subject has had clinically important bleeding occurred within 90 days prior to obtaining informed consent
* Subject has an acute bacterial endocarditis
* Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke
* Subject is receiving anticoagulants/antiplatelet agents
* Subject has a body weight less than 40 kg
* Major trauma, major surgery, eye, spinal cord and/or brain surgery within 90 days prior to obtaining informed consent, or the subject scheduled for these surgeries during the study periods

Primary outcomes:
measure: Composite assessment of VTE events and all cause death
timeFrame: Until day 28
Secondary outcomes:
measure: Incidence of bleeding events
timeFrame: Until day 28
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT00311350: Study Evaluating the Safety of MOA-728 Administered Orally to Healthy Subjects
Official title: Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of MOA-728 Administered Orally to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postoperative Complications
Constipation
Keywords: Safety
Health
Pharmacokinetics
ileus
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2006-04-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED

Brief summary: This is the first multiple-dose experience in humans with MOA-728 in an oral formulation. This study will provide an assessment of the safety, tolerability, and pharmacokinetics (PK) of MOA-728 following administration of ascending multiple oral doses to healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women

Primary outcomes:
measure: Safety
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Jeff Cohn
role: STUDY_DIRECTOR
References:
Clinical trial NCT01649050: Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis
Official title: A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Assess the Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Muscle Spasticity Due to Multiple Sclerosis
Keywords: Spasticity
Multiple Sclerosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-07-25
Enrollment: 0
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: To evaluate efficacy and safety of BGG492 versus placebo on moderate to severe spasticity due to multiple sclerosis


Eligibility criteria: Key Inclusion Criteria:

* Diagnosis of multiple sclerosis (MS) of any type.
* MS diagnosis at least 6 months prior to screening.
* Stable MS with no relapse within 3 months prior to screening.
* Treated or untreated spasticity due to MS for at least 3 months prior to screening, not wholly relieved with antispasticity medications.

Key exclusion criteria:

* Patients with symptoms of spasticity not due to MS.
* Patients taking three or more different anti-spasticity medications.
* Acute MS exacerbation requiring treatment within 3 months of the Screening Visit.
* Initiation of, or the discontinuation of interferon beta or any other disease modifying therapy for MS within 3 months of the Screening Visit.
* Use of baclofen pump at any time.
* Wheelchair or bed-bound patients.

Primary outcomes:
measure: Change in spasticity NRS score from baseline to 5 weeks
timeFrame: 5 weeks
measure: PGIC score at 5 weeks
timeFrame: 5 weeks
Secondary outcomes:
measure: Change from baseline to 5 weeks in Ashworth spasticity score
timeFrame: 5 weeks
measure: Safety and tolerability
timeFrame: average of 70 days, maximum from day -19 to day 52, i.e. from first baseline up to study completion visit
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02314650: TEAS to Reduce Propofol Consumption During General Anesthesia
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Propofol Consumption During General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 162
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: The study is aimed at whether transcutaneous electrical acupoint stimulation (TEAS) during general anesthesia could reduce the need for propofol in patients undergoing minor surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing minor surgeries including laparoscopic surgery and breast surgery under general anesthesia
* Patients with written informed consent

Exclusion Criteria:

* Patients with difficulty to communicate,including psychiatric disorder and Alzheimer's disease
* Patients with drug abuse
* Patients with disease of central nervous system
* Patients with renal or hepatic dysfunction

Primary outcomes:
measure: propofol consumption
timeFrame: from induction to the end of surgery,at an average of 1 hour
Secondary outcomes:
measure: time to awake
timeFrame: from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes
measure: time to extubation
timeFrame: from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes
measure: effect site concentration of propofol at awake
timeFrame: from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes
measure: highest sedation score during stay at postanesthesia care unit
timeFrame: from end of surgery to discharge from post anesthesia care unit, at an average of 1 hour
measure: nausea and vomiting during stay at postanesthesia care unit
timeFrame: 30min after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Zhihong LU, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fassoulaki A, Paraskeva A, Patris K, Pourgiezi T, Kostopanagiotou G. Pressure applied on the extra 1 acupuncture point reduces bispectral index values and stress in volunteers. Anesth Analg. 2003 Mar;96(3):885-890. doi: 10.1213/01.ANE.0000048713.41657.D3.
citation: Nayak S, Wenstone R, Jones A, Nolan J, Strong A, Carson J. Surface electrostimulation of acupuncture points for sedation of critically ill patients in the intensive care unit--a pilot study. Acupunct Med. 2008 Mar;26(1):1-7. doi: 10.1136/aim.26.1.1.
Clinical trial NCT03729050: Rehabilitation Coordinators in Specialist Psychiatry
Official title: Rehabilitation Coordinators in Specialist Psychiatry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Disorder
Rehabilitation
Keywords: Mental Disorder
Rehabilitation
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: REKO-A is a randomized controlled intervention study that addressed women and men on sick leave in Uppsala County. Participants which are on sick leave due to mental illness.


Eligibility criteria: Inclusion Criteria:

* Be on sick leave
* Have moderate to severe affective and / or moderate / severe anxiety disorder, such as: Bipolar disorder, depression, posttraumatic stress disorder, generalized anxiety disorder, neuropsychiatric disability
* Enrolled at the Academic hospital in Uppsala

Exclusion Criteria:

* High suicidal risk
* Extensive somatic disorders (somatic multichannel)
* Patients outside Uppsala County
* Taking part in an ongoing vocational rehabilitation

Primary outcomes:
measure: Return to work (RTW)/entry into work or studies
timeFrame: 1 year
measure: Magnitude of sick leave
timeFrame: 1 year
measure: Length of sick leave
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala university
Study officials:
References:
citation: Andersen A, Berglund E, Anderzen I. Rehabilitation coordinator intervention versus control in psychiatric specialist care for return to work and reduced sick leave: study protocol of a randomised controlled trial. BMC Public Health. 2020 Feb 19;20(1):250. doi: 10.1186/s12889-020-8238-3.
Clinical trial NCT05676450: Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas
Official title: Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 517
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To test the feasibility of collecting cell-free DNA (cfDNA) samples from DLBCL patients before and after treatment. cfDNA is DNA traveling in your blood outside of a cell and is easily collected from blood samples drawn using the vein puncture method.

Detailed description: Primary Objective:

• To determine the feasibility and clinical utility of ctDNA in identifying actionable alterations and minimal residual disease for lymphoma patients across community centers in Texas.

Secondary Objectives:

* To provide useful prognostic information before treatment, assess molecular response at interim time points and residual disease at the end of therapy, and identify tumor-specific mutations
* Levels of cfDNA and its association with both EFS and OS in patients receiving therapy

Eligibility criteria: Inclusion Criteria:

1. Male/female patients who are at least 18 years of age on the day of informed consent signing.
2. Patients must have a histologically documented diffuse large B-cell lymphoma requiring therapy.
3. Provision of written informed consent for the study.
4. Pregnant women not included
5. Cognitively impaired adults are not included.

Exclusion Criteria:

None

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: through study completion; an average 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Christopher Flowers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03016650: Opioid-sparing Effect of Intravenous Ibuprofen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Analgesia
Percutaneous Nephrolithotomy
Keywords: Acetaminophen
Ibuprofen
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 80
Sex: ALL
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: The investigators aimed to evaluate tramadol-sparing effect of intravenous (IV) ibuprofen in patients undergoing percutaneous nephrolithotomy (PCNL).

Detailed description: Eighty patients who will undergoing PCNL are randomized to intravenous paracetamol (n=40) and intravenous ibuprofen (n=40) groups. Patients will receive 100 mL of physiologic saline with 1 g IV paracetamol or 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL in the paracetamol and ibuprofen groups, respectively. Patients in both groups will receive intravenous tramadol with patient controlled analgesia device (PCA).

The visual analog scale (VAS) will used to evaluate pain intensity scores in the postoperative period.

Total tramadol consumption, mean VAS score in the 1, 8 and 24 hours, demographic variables, operative variables, and side effects will record.

Eligibility criteria: Inclusion Criteria:

* Study include 80 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-70 years who scheduled for percutaneous nephrolithotomy operation.

Exclusion Criteria:

* chronic pain,
* psychiatric disease,
* renal dysfunction,
* allergy to nonsteroidal anti-inflammatory drugs,
* history of drug addiction,
* pregnancy,
* inability to use a patient controlled analgesia (PCA) device.

Primary outcomes:
measure: Morphine Consumption
timeFrame: postoperatively 24 hours
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: postoperatively 30 minute, 2, 4, 6,12 and 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: İnonu University Faculty of Medicine
name: Muharrem Ucar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maghsoudi R, Tabatabai M, Radfar MH, Movasagi G, Etemadian M, Shati M, Amjadi M. Opioid-sparing effect of intravenous paracetamol after percutaneous nephrolithotomy: a double-blind randomized controlled trial. J Endourol. 2014 Jan;28(1):23-7. doi: 10.1089/end.2013.0267. Epub 2013 Oct 17.
Clinical trial NCT05750550: Acute Effect of Instrument-Assisted Soft Tissue Mobilization on Hamstring Flexibility Via Fascial Chain
Official title: Acute Effect of Instrument-Assisted Soft Tissue Mobilization on Hamstring Flexibility Via Fascial Chain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Instrument assisted soft tissue mobilization (IASTM) is one of the methods used to achieve fascial release. In this study, it will be examined whether there will be an increase in hamstring flexibility by releasing the superficial posterior fascial chain as a result of the IASTM technique to be applied over the triceps surae muscle and plantar fascia. Sociodemographic information of individuals who meet the inclusion criteria and volunteer to participate in the study will be obtained, and straight leg lift test and popliteal angle measurement will be performed with the digital inclinometer (Baseline Digital Inclinometer) to be provided within the scope of the project to measure hamstring flexibility. Then, IASTM will be applied to the triceps surae muscle and plantar fascia for 15 minutes. Measurements will be repeated after the application.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals with a straight leg lift test less than 80° and a popliteal angle greater than 15° will be included in the study.

Exclusion Criteria:

* Individuals with a history of lower extremity fractures, lumbar disc herniation, acute pain, a history of lesion in the hamstring muscles at least 1 month before the study, knee or hip prosthesis, and those using drugs that may affect the measurements (e.g., muscle relaxants) will not be included in the study.

Primary outcomes:
measure: Straight Leg Raise Test
timeFrame: Baseline
measure: Straight Leg Raise Test
timeFrame: 1 hour
measure: Popliteal angle test
timeFrame: Baseline
measure: Popliteal angle test
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Faculty of Health Sciences, Tokat Gaziosmanpaşa University
Study officials:
References:
Clinical trial NCT00137150: Comparison of Outcome and Complications Encountered in Flapless Surgery and Immediate Loading Versus the Classical Surgical Approach and Loading After 6-8 Weeks in the Posterior Maxilla
Official title: Comparison of Outcome and Complications Encountered in Flapless Surgery and Immediate Loading Versus the Classical Surgical Approach and Loading After 6-8 Weeks in the Posterior Maxilla
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Institut Straumann AG
First posted: 2005-08-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a comparison of outcome and complications encountered in flapless surgery and immediate loading versus the classical surgical approach and loading after 6-8 weeks in the posterior maxilla.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older

Exclusion Criteria:

* Smoking
* Medical risk patients

Primary outcomes:
measure: Implant survival at 6-12 months
Secondary outcomes:
measure: Prosthetic complications
measure: Patient opinion
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Hugo De Bruyn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05617950: Salicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts
Official title: Salicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Warts
Lead sponsor: The 306 Hospital of People's Liberation Army
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 174
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate whether salicylic acid was superior to cryotherapy for plantar warts

Detailed description: Patients with plantar warts were randomized equally to receive salicylic acid or cryotherapy. Cryotherapy is delivered by a technician up to a maximum of four treatments 3 weeks apart. Thirty percent of salicylic acid is applied once daily by the patient (or parent) for a maximum of 12 weeks. The primary outcomes were the cure rates at 12 weeks; secondary outcomes included time to clearance of warts, patient satisfaction with the treatment and treatment-related adverse effects.

Eligibility criteria: Inclusion Criteria:

* Patients with HPV1-induced plantar warts.
* Total number of warts is ≤5.
* Aged 12 years or older.

Exclusion Criteria:

* Patients are currently participating in another trial for the treatment of plantar warts.
* Patients had received two or more consecutive sessions of cryotherapy, with an interval of no more than 4 weeks (The history of salicylic acid treatment was not considered as criteria for exclusion because high concentration salicylic acid is not commercially available in Chinese mainland).
* Patients have taken immunosuppressant drugs (such as oral corticosteroids) during the past three months.
* Patients have impaired healing eg due to diabetes, vitamin A deficiency, hyperthyroidism and hypothyroidism.
* Patients have autoimmune diseases (such as systemic lupus erythematosus, dermatomyositis, scleroderma or other diseases).
* Patients are pregnant or ready for pregnancies or breast-feeding.
* Patients have cold intolerance (such as cold urticaria, cryoglobulinaemia, cold agglutinin syndrome or Raynaud's syndrome).
* Patients have local pain intolerance.
* Patients have local hypoesthesia.
* Patients are unable to tolerate salicylic acid or cryotherapy.

Primary outcomes:
measure: cure rate at 12 weeks
timeFrame: 12 weeks since the initial treatment
Secondary outcomes:
measure: time to clearance of warts
timeFrame: 12 weeks since the initial treatment
measure: patient satisfaction with the treatment
timeFrame: 12 weeks since the initial treatment
measure: treatment-related adverse events
timeFrame: 12 weeks since the initial treatment
Other outcomes:
Locations:
Study officials:
affiliation: The 306 Hospital of People's Liberation Army
name: Shichao Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: