louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01829529: Antibiotic Prophylaxis - Amoxicillin
Official title: Susceptibility Changes Among Oral Microorganisms Following Single Dose Antibiotic Prophylaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Antibiotic prophylaxis
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The hypothesis of the present study is that quantitative and qualitative oral microflora alterations and changes in antibiotic susceptibility among oral commensal microflora will occur following a single dose administration of amoxicillin.

Detailed description: A total of 33 healthy volunteers, 16 males and 17 females, will be included. Written informed consent will be obtained from all participants.

Subjects will be excluded if they have taken antibiotics within the previous three months, are pregnant, breast-feeding or allergic against penicillin.

The participants will be given a single dose of 2 g amoxicillin. Saliva samples will be collected before administration of antibiotics (day 1) and on day 2, 5, 10, 17 and 24. Un-stimulated saliva will be accumulated in a plastic container. Concentration of amoxicillin in saliva will be measured on day 1, 2 and 5. Samples will be used for the determination of antibiotic concentration. Analyses of the sensitivities to amoxicillin and some other clinically relevant antibiotic compounds will also be performed.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Healthy
* Age 18-45
* Understands the study procedure and speaks Swedish and/or English

Exclusion Criteria:

* Treatment with antibiotics within the previous three months
* Pregnant
* Breast-feeding
* Allergic against penicillin
* Concomitantly participate in another medical product study
* Treatment with any kind of medication, health food preparations or probiotics

Primary outcomes:
measure: Quantitative and qualitative changes in the oral microflora will be determined as well as changes is susceptibility to amoxicillin among these commensals.
timeFrame: Day 1, 2, 5, 10, 17 and 24
Secondary outcomes:
measure: Concentration of amoxicillin in saliva after one dose administration of amoxicillin
timeFrame: Day 1, 2, 5
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital. Department of Dental Medicine
state: Huddinge
Study officials:
affiliation: Department of Dental Medicine, Karolinska Institute
name: Margareta Hultin, Dentist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00780429: Pharmacokinetics and Pharmacodynamics of MPA in Stable Renal Transplant Patients
Official title: Evaluation of Pharmacokinetic and Pharmacodynamic Parameters in Renal Transplant Patients Receiving Mycophenolic Acid and Stable for at Least 3 Months
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Transplantation
Keywords: kidney
transplant
Mycophenolic acid
Inosine monophosphate dehydrogenase
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2008-10-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female renal transplant patients

Brief summary: Study of the pharmacokinetic and pharmacodynamic variability of mycophenolate mofetil in renal transplant patients already on long-term MMF treatment (at least 6 months post-transplant; at least 3 months in therapy).

Study hypothesis: to investigate whether long-term MMF therapy alters IMPDH biological activity and if there are any correlations with the risk of AR.


Eligibility criteria: Inclusion Criteria:

* Renal transplant recipients
* Age range: 18-70
* Patients taking MMF
* Able to understand and sign an informed consent

Exclusion Criteria:

* Active myelodepression
* Systemic infections or other that may affect MMF absorption
* Pregnancy/breastfeeding
* (History of) cancer
* Drug abuse, psychiatric conditions
* Already enrolled in other clinical trials or participation ended less than one month earlier
* Known sensitivity to polysorbate 80 or MMF

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Fondazione Policlinico San Matteo
Study officials:
References:
Clinical trial NCT00269529: Intraarticular Analgesia After Total Knee Arthroplasty, a Randomised Study
Official title: Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Femoral Block and Extensive Intraoperative Infiltration With Local Anesthetic Supplemented With Intraarticular Bolus the Following Day.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Keywords: postoperative pain
knee arthroplasty
analgesia
infiltration
femoral nerve block
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
name: Aarhus University Hospital
First posted: 2005-12-23
Enrollment: 80
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to compare two different kinds of pain treatment after total knee replacement (operation with artificial knee joint): 1) a large local injection in and around the knee, supplemented with injection the day after, or 2) the department's conventional pain treatment consisting of continuous nerve block in the groin.

Detailed description: Postoperative pain after total knee arthroplasty is moderate to severe and can be difficult to treat. The current use of femoral nerve block by ropivacain pump for 48 hours provides considerable analgesia, but patients often experience slight motor block, inhibiting rehabilitation, and pain in the posterior part of the knee, innervated by the sciatic nerve. This study compares femoral nerve block to a new technique, where ropivacaine, ketorolac and adrenalin is used to infiltrate the tissue in and around the knee joint during surgery, and is injected by an intraarticular catheter at 10 pm on the day of surgery and again at 10 am the day after. Data of pain scores, analgesia consumption, adverse effects and mobilisation is collected for the first four postoperative days.

Eligibility criteria: Inclusion Criteria:

* patients planned for primary total knee arthroplasty due to primary arthrosis

Exclusion Criteria:

* Patients unable to provide informed consent
* patients with contraindications for spinal anesthesia
* patients with known hypersensitivity towards the used drugs
* patients with severe chronic neurogenic pain or sensitivity disorders in the leg to be operated
* patients who have undergone major bone surgery in the knee to be operated

Primary outcomes:
measure: pain, by numeric rating scale
measure: pain, by consumption of analgesics
measure: side effects
measure: return of function
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Hospital, Tage Hansens Gade
Study officials:
affiliation: Department of Anesthesiology, Aarhus University Hospital, Aarhus, Denmark
name: Else Tønnesen, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopedic Center, Aarhus University Hospital, Aarhus, Denmark
name: Kjeld Søballe, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01487629: Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema
Official title: Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetic Retinopathy
Macular Edema
Keywords: Diabetic Retinopathy
Macular Edema
Bevacizumab
Ranibizumab
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-12-07
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 compare the morphological and visual acuity outcomes associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for treatment of diabetic macular edema.


Eligibility criteria: Inclusion Criteria:

* Center-involving Diabetic macular edema unresponsive to LASER therapy performed at least 3 moths prior to inclusion;
* Best corrected visual acuity equal or worse than 20/40 and better than 20/800;
* Central subfield macular thickness greater than 300 µm

Exclusion Criteria:

* Aphakia
* High-risk proliferative diabetic retinopathy
* Previous treatment for DME in the past three months

Primary outcomes:
measure: Central subfield macular thickness (CSFT) change
timeFrame: Monthly from baseline to Week 48
Secondary outcomes:
measure: Best-corrected visual acuity change
timeFrame: Monthly from baseline to week 48
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Rodrigo Jorge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital das Clinicas - Faculdade de Medicina de Ribeirão Preto
name: Felipe Almeida, MD
role: STUDY_DIRECTOR
References:
citation: Nepomuceno AB, Takaki E, Paes de Almeida FP, Peroni R, Cardillo JA, Siqueira RC, Scott IU, Messias A, Jorge R. A prospective randomized trial of intravitreal bevacizumab versus ranibizumab for the management of diabetic macular edema. Am J Ophthalmol. 2013 Sep;156(3):502-510.e2. doi: 10.1016/j.ajo.2013.04.026. Epub 2013 Jun 21.
Clinical trial NCT01661829: An RCT for the Effect of Biofeedback Therapy the Prevention of AR Syndrome in Rectal Cancer Patients
Official title: A Randomised Controlled Trial for the Effect of Biofeedback Therapy for the Preveintion of Anterior Resection Syndrome in Rectal Cancer Patients Who Have Undergone Low Anterior Resection With Total Mesorectal Excision Following Neoadjuvant Chemoradiation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Rectal cancer patients who underwent sphincter saving surgery with total mesorectal excision and diverting stoma after neoadjuvant chemoradiation therapy.

Brief summary: In patients who underwent sphincter preserving surgery with toal mesorectal excision and diverting stoma after neoadjuvant chemoradiation therapy for rectal cancer, the inestigators would evaluate the effect of a biofeedback therpy before stoma closure on their anorectal function after stoma closure.


Eligibility criteria: Inclusion Criteria:

* rectal cancer patients
* neoadjuvant chemoradiation therapy (+)
* sphincter saving surgery with total mesorectal excision (+)
* temporary loop stoma (+)
* adult who is 17 years or older
* patinet who aggree with our study
* if woman is childbearing age, her pregnancy test shoud be indentified 'negative'

Exclusion Criteria:

* patients who have been enrolled to other clinical studies related to this study
* patients who underwent diverting stoma before neoadjuvant chemoradiation
* temporary end -ostomy (+)
* uncontrolled metabolic or systemic disease
* patients who do not understand the purpose of this study because of dementia or pshycologic problem
* MRSA or Clostridium difficille (+)
* Pregnant or during breast feeding
* serious complication after sphincter saving surgery

Primary outcomes:
measure: Incidence of anterior resection syndrome after stoma closure
timeFrame: 1 year after stoma closure
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Division of Colorectal Disease, Department of Surgery, St. Vincent's Hospital, The Catholic University of Korea
Study officials:
References:
citation: Cho HM, Kim H, Yoo R, Kim G, Kye BH. Effect of Biofeedback Therapy during Temporary Stoma Period in Rectal Cancer Patients: A Prospective Randomized Trial. J Clin Med. 2021 Nov 4;10(21):5172. doi: 10.3390/jcm10215172.
citation: Kye BH, Kim HJ, Kim G, Yoo RN, Cho HM. The Effect of Biofeedback Therapy on Anorectal Function After the Reversal of Temporary Stoma When Administered During the Temporary Stoma Period in Rectal Cancer Patients With Sphincter-Saving Surgery: The Interim Report of a Prospective Randomized Controlled Trial. Medicine (Baltimore). 2016 May;95(18):e3611. doi: 10.1097/MD.0000000000003611.
Clinical trial NCT02720029: Detection of Silent Aspiration Events Utilizing pH/Impedance Probes in Hospitalized Patients
Official title: Detection of Silent Aspiration Events Utilizing pH/Impedance Probes in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acid Aspiration Syndrome
Keywords: aspiration
reflux
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-03-25
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: DIAGNOSTIC

Brief summary: Monitoring and quantification of reflux events in high risk critically ill inpatients and lower risk general medical/surgical inpatients, with comparison to relevant clinical variables.

Detailed description: The investigators will conduct a pilot prospective cohort study of the incidence of reflux of gastric contents into the esophagus and the correlation with clinically evident aspiration events. The investigators will demonstrate that an esophageal multichannel pH/impedance probe can be used safely and effectively in an inpatient population to monitor reflux of acidic and non-acidic contents into the esophagus. The investigators will determine the frequency and severity of reflux events in a 24 hour period in two hospitalized patient populations: general medicine patients on the wards and critically ill patients in the intensive care unit. The investigators will then examine the relationship between the documented reflux events and clinically apparent aspiration events. The incidence of these silent reflux events in hospitalized patients is currently unclear.

Eligibility criteria: Inclusion Criteria:

1. Age greater than 18 years
2. Admitted to medical-surgical floor or medical intensive care unit

Exclusion Criteria:

1. Patients with contraindication to nasogastric tube placement (facial trauma, active epistaxis, abnormal nasopharyngeal or facial anatomy, esophageal stricture or injury, esophageal varices)
2. Patients requiring non-invasive positive pressure ventilation
3. Patients with uncontrolled vomiting
4. Patients with planned or anticipated airway or esophageal procedure within the 24-hour monitoring period
5. Patients not expected to survive for 24 hours or those receiving hospice/palliative care

Primary outcomes:
measure: Number of reflux events
timeFrame: 24 hours
Secondary outcomes:
measure: Clinically apparent aspiration events
timeFrame: Duration of hospitalization, on average 14 days
measure: Combined aspiration event endpoint
timeFrame: Duration of hospitalization, on average 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University
name: Joshua P Fessel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01157429: D-cycloserine Adjunctive Treatment for Posttraumatic Stress Disorder (PTSD) in Adolescents
Official title: D-cycloserine Adjunctive Treatment for PTSD in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Posttraumatic Stress Disorder
PTSD
Keywords: Cognitive Behavior Therapy
Children
Adolescents
Pharmacotherapy
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2010-07-07
Enrollment: 24
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to show whether D-cycloserine in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of posttraumatic stress disorder (PTSD) in 13-18 year-old children.

Detailed description: While most individuals with PTSD treated with cognitive behavioral therapy (CBT) show improvement, they still have some enduring symptoms and functional impairment. Accordingly, there is a need for treatment advances. D-cycloserine (DCS), an antibiotic that has been used for over 50 years, has also been found to have positive effects on cognition and anxiety. DCS was found to enhance learning and memory, and also facilitates extinction of fear reactions. However, DCS only produces an extinction effect when paired with behavioral training, not when simply given alone. Thus, the medication only needs to be given for seven doses in this research and youth do not need to take the medication long term. The research also includes a three-month follow-up.

Eligibility criteria: Inclusion Criteria:

* Certain number of PTSD symptoms plus functional impairment
* Must be able to swallow pills

Exclusion Criteria:

* Serious kidney or liver disease
* Epilepsy
* Bipolar disorder
* Psychosis

Primary outcomes:
measure: Child PTSD Symptom Scale (CPSS)
timeFrame: After 12 therapy sessions, up to 28 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center, 1440 Canal St.
state: Louisiana
Study officials:
affiliation: Tulane University School of Medicine
name: Michael S Scheeringa, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scheeringa MS, Lilly ME, Staiger AB, Heller ML, Jones EG, Weems CF. Do Children and Adolescents Have Different Types of Trauma Narratives and Does It Matter? Reliability and Face Validation for a Narrative Taxonomy. J Trauma Stress. 2017 Jun;30(3):323-327. doi: 10.1002/jts.22190. Epub 2017 Jun 1.
citation: Scheeringa MS, Weems CF. Randomized placebo-controlled D-cycloserine with cognitive behavior therapy for pediatric posttraumatic stress. J Child Adolesc Psychopharmacol. 2014 Mar;24(2):69-77. doi: 10.1089/cap.2013.0106. Epub 2014 Feb 7.
Clinical trial NCT02016729: A Phase 1b Study Evaluating AMG 232 Alone and in Combination With Trametinib in Acute Myeloid Leukemia
Official title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 232 Alone and in Combination With Trametinib in Adult Subjects With Relapsed/Refractory Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignancy
Cancer
Oncology
Oncology Patients
Acute Myeloid Leukemia
Keywords: AML
Lead sponsor: Kartos Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-20
Enrollment: 36
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: Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute myeloid leukemia.


Eligibility criteria: Inclusion Criteria:

* Men or women \> 18 years old
* Pathologically-documented, definitively-diagnosed AML that is relapsed or refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy
* Ability to take oral medications and willing to record daily adherance to investigational product
* Adequate hematological, renal, hepatic, and coagulation laboratory assessments

Exclusion Criteria:

* Active infection requiring intravenous (IV) antibiotics
* Prior participation in an investigational study (procedure or device) within 21 days of study day 1
* Major surgery within 28 days of study day 1
* Anti-tumor therapy within 14 days of study day 1

Primary outcomes:
measure: To evaluate the safety and tolerability of AMG 232
timeFrame: 36 months
measure: Characterize the pharmacokinetics of AMG 232 alone and in combination with trametinib when administered orally.
timeFrame: 36 months
measure: Determine the maximum tolerated dose of AMG 232 alone and in combination with trametinib, if possible.
timeFrame: 36 months
Secondary outcomes:
measure: Treatment Response
timeFrame: 36 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Seattle
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Erba HP, Becker PS, Shami PJ, Grunwald MR, Flesher DL, Zhu M, Rasmussen E, Henary HA, Anderson AA, Wang ES. Phase 1b study of the MDM2 inhibitor AMG 232 with or without trametinib in relapsed/refractory acute myeloid leukemia. Blood Adv. 2019 Jul 9;3(13):1939-1949. doi: 10.1182/bloodadvances.2019030916.