louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01524302: Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia
Official title: Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia (CABP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumonia, Bacterial
Community-acquired
Keywords: pneumonia
ceftaroline
community-aquired
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2012-02-01
Enrollment: 12
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: This study will further analyze the use of ceftaroline for CABP and compare its potential to eradicate bacterial pathogens to standard fluoroquinolone therapy. The enhanced spectrum of ceftaroline compared to levofloxacin may be further highlighted from this investigation.


Eligibility criteria: Inclusion Criteria:

* non-pregnant adults (≥ 18 years old) with suspected CABP admitted to the hospital for parenteral antibiotic therapy.
* All patients will have a creatinine clearance (CrCl) \>50 ml/min.

Exclusion Criteria:

* pregnant or nursing patients,
* allergy to penicillin/cephalosporin antibiotics,
* allergy to fluoroquinolones,
* renal or hepatic failure, or have received an antimicrobial in past 96h.
* Patients who require antibiotics other than the study drugs will also be excluded.

Primary outcomes:
measure: Serum Cidal Activity as Tested Against Staphylococcus Aureus Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
timeFrame: 2 hour (levofloxacin) and 12 hour (ceftaroline) after receiving the drug
Secondary outcomes:
measure: Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic Volume of Distribution Parameter in Community-Acquired Bacterial Pneumonia Patients
timeFrame: 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion
measure: Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Community-Acquired Bacterial Pneumonia Patients
timeFrame: 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion
measure: Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic (PK) Half Life Parameter in Community-Acquired Bacterial Pneumonia Patients
timeFrame: 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion
measure: Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Community-Acquired Bacterial Pneumonia Patients.
timeFrame: 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion
Other outcomes:
Locations:
city: Lansing
country: United States
facility: Sparrow Hospital
state: Michigan
Study officials:
affiliation: Michigan State University
name: Gary E Stein, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01155102: Bioequivalency Study of Anastrozole 1 mg Under Fasted Conditions
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Anastrozole 1 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-07-01
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Anastrozole Tablet under fasted conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to anastrozole or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 31 days
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications
state: Missouri
Study officials:
affiliation: Bio-Kinetic Clinical Applications
name: Dennis Morrison, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00527202: Efficacy Study of Botox to Treat Neuropathic Pain
Official title: Randomized Placebo-controlled Study of the Efficacy of Botulinum Toxin Type A (Botox) in Spontaneous Pain and Allodynia Related to Traumatic Nerve Injury or Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postherpetic Neuralgia
Nerve Trauma
Lead sponsor: Hospital Ambroise Paré Paris
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 29
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: Objectives : to investigate the analgesic effects and safety of intradermal botulinum toxin A injection in the treatment of focal painful neuropathies (eg, postherpetic neuralgia, nerve trauma)

Detailed description: The study will be randomized, performed in parallel group and double blind versus saline and will include 30 patients. Botulinum toxin injection will be injected intradermally in the painful area (one single injection) following a method adapted from that used in hyperhidrosis. The patients will be followed for 6 months after the injection. Primary outcome will be self-reported pain from the patients diaries. Secondary outcomes will be neuropathic symptoms, quality of life, allodynia to brush and pressure, detection and pain thresholds, proportion of responders, pain relief and clinical global impression. Clinical assessment will take place before injection then at 1 month, 3 months and 6 months.

Eligibility criteria: Inclusion Criteria:

* daily pain for at least 6 months of at least moderate intensity clearly attributed to the nerve lesion
* limited area of pain
* mechanical allodynia in the painful area

Exclusion Criteria:

* contraindication to BTXA formulation
* coagulation disorders
* another painful condition
* current major depression
* history of drug or alcohol abuse
* compensation claim or litigation
* facial neuropathic pain

Primary outcomes:
measure: Self-reported pain (numerical scales) on patients diaries
timeFrame: prospective
Secondary outcomes:
measure: mean pain (VAS) at each visit Quality of life Proportion of responders % pain relief Clinical global impression Assessment of blindedness
timeFrame: prospective
Other outcomes:
Locations:
city: Boulogne-billancourt
country: France
facility: Hôpital Ambroise Paré, AP-HP
Study officials:
affiliation: INSERM U 792
name: Didier BOUHASSIRA, MD, PHD
role: STUDY_DIRECTOR
affiliation: hôpital de Limoges (FRANCE)
name: Danièle RANOUX, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02880202: Impact of Massage Therapy on the Quality of Life of Hospice Patients
Official title: Impact of Massage Therapy on the Quality of Life of Hospice Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Depression
Quality of Life
Keywords: Massage Therapy
Hospice
Integrative Medicine
Palliative Care
Caregivers
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 53
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot study to evaluate the impact of massage therapy in hospice patients.

Detailed description: As an integrative therapy, there is growing evidence that massage therapy can be an effective therapeutic tool for relief of pain and non-pain symptoms in hospice and palliative care patients. Massage therapy can provide comfort, relaxation, and improve quality of life for patients. The primary aim of the study is to gather data on the effects of complementary massage therapy on patient's symptoms and quality of life. The study goal is to improve patient symptoms of pain, anxiety, depression, and quality of life through the use of massage therapy provided to hospice patients. Questionnaires would be utilized before and after each massage intervention and would quantify symptom and quality of life levels.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Clinically determined by hospice staff to be appropriate for massage therapy (ESAS-r scores of 5 or greater on pain, depression, anxiety, or best well-being)
3. Place of residence within 30 minutes of downtown Rochester
4. Patient or caregiver must be able to participate in brief interviews and complete questionnaires (verbally or physically)

Exclusion Criteria:

1. Patients ineligible for massage therapy due to complexity of medical care including complex wound and multiple drains

Primary outcomes:
measure: Change in Edmonton Symptom Assessment System - Revised
timeFrame: Baseline to 3 weeks
Secondary outcomes:
measure: Change in Edmonton Symptom Assessment System - Revised (Other symptoms)
timeFrame: Baseline to 3 weeks
measure: Change in Linear Analogue Self Assessment (LASA)
timeFrame: Baseline to 3 weeks
measure: Change in Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
timeFrame: Baseline to 3 weeks
measure: Change in Pearlin role overload measure (ROM)
timeFrame: Baseline to 3 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Professor of Psychiatry
name: Maria I Lapid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06704802: Observational Cohort Study Evaluating the Effectiveness of an Education Program (NGAYDAUTIEN) in Combination With Gliclazide MR in the Management of Uncontrolled Type 2 Diabetic Patients.
Official title: Observational Cohort Study Evaluating the Effectiveness of an Education Program (NGAYDAUTIEN) in Combination With Gliclazide MR in the Management of Uncontrolled Type 2 Diabetic Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: observational
HbA1c
type 2 diabetes
Diamicron® MR 60
T2D
patient educational program
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2024-11-26
Enrollment: 678
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female who have a diagnosis of uncontrolled T2D and who initiate a new OAD monotherapy or on top of metformin

Brief summary: The primary objective is to assess the change of HbA1c level from baseline after a 6-month follow up among uncontrolled patients with T2D who will be initiated to Diamicron® MR 60 (originator product) plus an educational program (NGAYDAUTIEN) as monotherapy or in add on to metformin in comparison to an initiation of an Oral Antidiabetic Drug (OAD) (except Diamicron®) as monotherapy or in add on to metformin.


Eligibility criteria: Inclusion Criteria:

1. Aged at least 18 years (without upper limit of age)
2. HbA1c value is required at the baseline visit
3. Patients with diagnosis of uncontrolled T2D
4. Initiation of a new OAD as monotherapy or on top of metformin
5. Patient follow-up within the scope of the current medical practice and in the same health center during the 6-month period.

Exclusion Criteria:

1. Diagnosis of diabetes other than T2D
2. HbA1c value not available at baseline
3. Patients who previously attended to the NDT educational program for T2D management
4. Required at baseline an insulin therapy according to national guideline
5. Used any other OAD (except metformin)
6. Used a single pill combination in addition to the medicine of interest
7. Have a severe disease (i.e. cirrhosis, end stage renal disease...)
8. Are unlikely to cooperate in the study or to follow the educational program

Primary outcomes:
measure: change of HbA1c level (measured in %) from baseline after a 6-month follow-up among the 2 arms
timeFrame: from baseline to 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Servier Affaires Médicales
Study officials:
References:
Clinical trial NCT02524002: Enhanced vs. Routine Clear Liquid Intake in Labor
Official title: Clear Liquids vs Enhanced Clear Liquids; Effect on Labor Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abnormal Labor
Failed Induction of Labor
Ketosis
Keywords: Abnormal Labor
Prolonged Induction
Ketosis
Diet
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2015-08-14
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of the study is to see if the addition of a carbohydrate- and protein-enhanced gel during labor speeds labor and reduces the rate of cesarean delivery.

Detailed description: Patients will be randomized to placebo or experimental arm of study. In the placebo arm, patients will receive standard clear liquid diet, which includes ginger ale, variety of fruit juices, and plain soup broth. The experimental arm will receive the standard clear liquid diet, and in addition will receive Accel Gel every 3 hours while in labor.

Eligibility criteria: Inclusion criteria:

* Nulliparity (first baby)
* Admission with the intent to deliver vaginally
* Gestational age \>36 weeks
* Age ≥ 18

Exclusion criteria:

* Planned cesarean delivery
* Renal Disease
* Preeclampsia
* Diabetes (Pre-gestational or Gestational)
* Allergy to any component of sports drink
* NPO diet by physician

Primary outcomes:
measure: Time from admission to delivery
timeFrame: Participants will be followed during labor until delivery, an expected range of 1-48 hours
Secondary outcomes:
measure: Duration of second stage of labor
timeFrame: Participants will be followed during labor until delivery, an expected range of 1-48 hours
measure: delivery in <24 hours
timeFrame: Participants will be followed during labor until delivery, an expected range of 1-48 hours
measure: cesarean delivery
timeFrame: Participants will be followed during labor until delivery, an expected range of 1-48 hours
measure: rate of composite adverse GI outcome (vomiting or diarrhea)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: patient satisfaction with diet
timeFrame: Participants will be followed during labor until delivery, an expected range of 1-48 hours
measure: Urine Ketones
timeFrame: Participants will be followed during labor until full dilation, an expected range of 1-48 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple University Hospital
name: Laura Goetzl, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02382302: Research to Evaluate Efficiency in U-health Solution Service for the Chronic Wound Management
Official title: A Smart Phone-based Tele-consultation System in the Management of Chronic Pressure Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: U-health
chronic wound management
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: KT Corporation
First posted: 2015-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This trial is a prospective research to evaluate efficiency in U-health solution service based on Mobile for the chronic wound management.

Detailed description: This trial conducted to assess the efficiency of teleconsultation using the smart-phone-based store-and-forward system in promoting the wound healing process as well as cost-effectiveness in patients with pressure ulcer.

Eligibility criteria: Inclusion Criteria:

* Subjects who have pressure ulcer
* Subjects who voluntarily decided the participation of the study and signed the informed consent

Exclusion Criteria:

* Subjects who have Osteomyelitis
* Subjects who have suppuration
* Subjects who participated in other clinical trial within 30 days from screening date

Primary outcomes:
measure: Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
timeFrame: 4weeks post-treatment
Secondary outcomes:
measure: Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
timeFrame: 1week post-treatment
measure: Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
timeFrame: 2weeks post-treatment
measure: Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)
timeFrame: 3weeks post-treatment
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: ChanYeong Heo, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00384202: A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients
Official title: A Multicenter, Open, Single Sequence Crossover Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Stable Liver Transplant Patients Converted From a Prograf® Based Immunosuppressive Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transplantation
Keywords: Tacrolimus
Liver Transplantation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-10-05
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable liver transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.

Detailed description: Multicenter, open, single sequence crossover study. Subject Enrolment: Prograf® administered twice daily is replaced by Prograf as study medication, administered twice daily.

Six weeks Prograf-Treatment Phase to confirm compliance to regimen stability requirements (see Inclusion and Exclusion Criteria), and collection of data under Prograf treatment.

Conversion from Prograf (twice daily, morning \& evening dosing) total daily dose to MR4 once daily (only morning dosing) on a 1:1 (mg:mg) basis on Day 1.

Twelve weeks MR4-Treatment Phase with study assessments for safety and efficacy.

Eligibility criteria: Inclusion Criteria:

* Liver transplant at least 12 months prior to enrollment.
* Prograf® dose remained unchanged for a minimum of 12 weeks prior to enrollment and tacrolimus whole blood trough level measurements were in the range of 5-15 ng/mL.

Exclusion Criteria:

* Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.

Primary outcomes:
measure: Creatinine clearance
timeFrame: 12 weeks
Secondary outcomes:
measure: Blood pressure, HbA1c, Acute rejection episodes
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lyon
country: France
city: Strasbourg
country: France
city: Villejuif
country: France
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Dublin
country: Ireland
city: Warszawa
country: Poland
city: Barakaldo
country: Spain
city: Barcelona
country: Spain
city: Santiago de Compostela
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Birmingham
country: United Kingdom
Study officials:
affiliation: Astellas Pharma GmbH
name: Use Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT00532402: Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas
Official title: Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas - Compared With Propofol Concentration in Plasma (Before and) After Lung Passage and Neurophysiological Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Anesthesia
Keywords: Monitoring
Breathing Gas
Propofol
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2007-09-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients having general anesthesia for cardiac and non-cardiac operation

Brief summary: This study should compare the propofol concentration in breathing gas and in plasma (before and) after lung passage. Propofol concentrations in breathing gas are continuously measured by a sensor. For comparison a discontinuous method is used. Neurophysiologic parameters for determination of depth of anesthesia are compared to the continuous measured propofol concentration in breathing gas.

Study hypothesis: continuous measured propofol concentration in breathing gas correlates to propofol concentration in plasma and depth of anaesthesia.


Eligibility criteria: Inclusion Criteria:

* Patient destined for general anesthesia

Exclusion Criteria:

* Heart insufficiency NYHA IV
* Allergy to propofol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: Dept. of Anesthesiology , UK-SH, Campus Luebeck
state: Schleswig-Holstein
city: Luebeck
country: Germany
facility: Dept. of Anesthesiology, UK-SH, Campus Luebeck
state: Schleswig-Holstein
Study officials:
affiliation: Dept of Anesthesiology, UK-SH, Campus Luebeck
name: Hartmut Gehring, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Grossherr M, Hengstenberg A, Meier T, Dibbelt L, Gerlach K, Gehring H. Discontinuous monitoring of propofol concentrations in expired alveolar gas and in arterial and venous plasma during artificial ventilation. Anesthesiology. 2006 Apr;104(4):786-90. doi: 10.1097/00000542-200604000-00024.