louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02697175: Video Colposcopy in Women With Dysplasia
Official title: Does Live Video Colposcopy Reduces Anxiety in Women With Cervical Dysplasia? A Randomised Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Dysplasia
Keywords: live video-colposcopy
cervical dysplasia
anxiety
randomized controlled trial
colposcopy
Lead sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 275
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess the effect of live video-colposcopy on women´s anxiety.


Eligibility criteria: Inclusion Criteria:

* women referred for colposcopy due to cervical abnormalities
* We included women if they attended colposcopy for the first time

Exclusion Criteria:

* pregnant women
* presence of a language barrier
* known anxiety disorder or depression
* history of conization or other treatments
* known oncological disorder
* inadequate colposcopy

Primary outcomes:
measure: Anxiety score after colposcopy
timeFrame: 10 minutes
Secondary outcomes:
measure: Change in anxiety scores
timeFrame: 10 minutes
measure: Pain during examination
timeFrame: 10 minutes
measure: Pain after examination
timeFrame: 10 minutes
measure: general unpleasantness during examination
timeFrame: 10 minutes
measure: Anxiety during examination
timeFrame: 10 minutes
measure: Satisfaction concerning the medical consultation
timeFrame: 10 minutes
measure: Overall Satisfaction
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Zydolab - Institute of Cytology and Immune Cytochemistry
state: NRW
city: Herne
country: Germany
facility: Department of Obstetrics and Gynecology of the Ruhr University Bochum
state: NRW
Study officials:
affiliation: Zydolab - Institute of Cytology and Immune Cytochemistry
name: Ziad Hilal, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hilal Z, Alici F, Tempfer CB, Seebacher V, Rezniczek GA. Video Colposcopy for Reducing Patient Anxiety During Colposcopy: A Randomized Controlled Trial. Obstet Gynecol. 2017 Aug;130(2):411-419. doi: 10.1097/AOG.0000000000002127.
Clinical trial NCT00401375: Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)
Official title: A Phase 3, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Operative Ileus (POI)
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2006-11-20
Enrollment: 524
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: To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.


Eligibility criteria: Inclusion Criteria:

* Male and female participants at least 18 years of age.
* All participants must meet American Society of Anesthesiologists (ASA) physical status I, II, or III.
* Participants must sign an informed consent form (ICF).
* Participants must be scheduled for a segmental colectomy via open laparotomy with general anesthesia.
* Females of childbearing potential must have a negative serum pregnancy test at the screening visit.
* Negative for history of chronic active hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection.

Exclusion Criteria:

* Participants who received any investigational new drug in the 30 days prior to screening visit.
* Females who are pregnant or lactating.

Primary outcomes:
measure: Time to First Bowel Movement
timeFrame: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
Secondary outcomes:
measure: Time to Discharge Eligibility
timeFrame: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
measure: Time to Discharge Order Written From the End of Surgery
timeFrame: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
measure: Number of Participants With Clinically Meaningful Events (CMEs) for Nausea or Retching/Vomiting at 0 or 24 Hours as Evaluated by the Opioid-Related Symptom Distress Scale (SDS)
timeFrame: 0 and 24 hours
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals
state: New York
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Lindsey Mathew
role: STUDY_DIRECTOR
References:
citation: Yu CS, Chun HK, Stambler N, Carpenito J, Schulman S, Tzanis E, Randazzo B. Safety and efficacy of methylnaltrexone in shortening the duration of postoperative ileus following segmental colectomy: results of two randomized, placebo-controlled phase 3 trials. Dis Colon Rectum. 2011 May;54(5):570-8. doi: 10.1007/DCR.0b013e3182092bde.
Clinical trial NCT05788575: Study of the Incidence of Surgical Site Infections Developed by Patients Hospitalized in the Wards of a Large Teaching Hospital in Rome, Italy
Official title: Study of the Incidence of Surgical Site Infections (SSI) in a Large Teaching Hospital in Rome, Italy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Site Infection
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 5424
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hospitalized patients undergoing surgery

Brief summary: The surgical departments of the hospital were included in the study on a rotational basis over a period of 5 months. All patients undergoing surgery during this period were enrolled in the study.

The data collection in each department lasted 6 months (8 in the case of the use of prostheses) of which:

* 5 months of continuous survey of hospitalized patients
* 30 days of post-operative surveillance for all operations, 90 days for operations involving the use of prosthetic material Surveillance ends when a surgical site infection occurs, even if the event is prior to 30 or 90 days.

For each surgery, information was recorded such as the type of surgery, duration, ASA score, prophylaxis.


Eligibility criteria: Inclusion Criteria:

* patient undergoing surgery

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence of surgical site infection
timeFrame: 30 days or 90 days (prosthesis)
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario "A. Gemelli" IRCCS
state: RM
Study officials:
References:
Clinical trial NCT03915275: Clinical Impact of 16S rDNA PCR
Official title: Clinical Impact of 16S rDNA PCR, a Monocentric Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bacterial Infections
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tients that had a 16S rDNA PCR positive result in Strasbourg University Hospital laboratory from 2014 to 2018

Brief summary: The main objective of this study is to evaluate the impact of a positive 16S rDNA PCR in various sites on patient's management.

The secondary objectives of the protocol are:

* to evaluate bacterial identification performance
* to evaluate the effect of previous antibiotic therapy
* to analyze the management of discordant results between 16S PCR and culture identification


Eligibility criteria: Inclusion Criteria:

* Patients that had a 16S rDNA PCR positive result in Strasbourg University Hospital laboratory from 2014 to 2018
* Patients consent for this analysis of their past medical history
* Legal guardians consent for the analysis of their children's medical history

Exclusion Criteria:

* Patients who express opposition for this study
* Incomplete clinical record

Primary outcomes:
measure: Study of the modification of the care of the patients by the use of the 16S PCR
timeFrame: The period from Junuary 1st, 2014 to Dcember 31, 2018 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Maladies Infectieuses et Tropicales
Study officials:
References:
Clinical trial NCT00179075: Repository: Evaluation of Immunoregulatory Cells in Hematopoietic Stem Cell Transplant
Official title: Repository for Study: Evaluation of Immunoregulatory Cells in Hematopoietic Stem Cell Transplant (HSCT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic Stem Cell Transplantation
Graft vs Host Disease
Keywords: T-Lymphocyte Subsets
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18-70 years old undergoing either autologous transplant or allogeneic transplant for various hematologic conditions

Brief summary: This is a repository to store blood and stem cell samples for future research.

Detailed description: Our Hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the complications of GVHD by determining the qualitative and quantitative changes in T regulatory cells throughout the transplant process. Our understanding of this can lead to new treatment strategies and improved clinical therapeutic implications.

Eligibility criteria: Inclusion Criteria:

* Patients 18-70 years old undergoing either autologous transplant or allogeneic transplant for various hematologic conditions

Exclusion Criteria:

* Patients \< 18 or \> 70 years old undergoing either autologous transplant or allogeneic transplant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Adetola A Kassim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00155675: Pseudodrynaria Coronana (Wall) Ching
Official title: Clinical Effect of Traditional Chinese Medicine - "Gusuibu"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Sheng Chang Pharmaceutical
First posted: 2005-09-12
Enrollment: 120
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Study to evaluate the clinical effect of "Gusuibu" lasts for 3 years. It aims to evaluate its effect on bone density of postmenopausal osteoporosis. Besides, its effects on the liver, kidney and the hematological influence will be evaluated, too.

Detailed description: Research of the this traditional chinese medicine clinucal, Gusuibu, curative effect is plan three years time. The entire studyaims to evaluated the effect of the traditional chinese medicine on postmenpausal osteoporosis as well as the possible side effects on the experimental animal and the human body. All subjects were postmenopausal woman with established osteoporosis.

Eligibility criteria: Inclusion Criteria:

* postmenopausal osteoporosis

Exclusion Criteria:

* Insulin dependent diabetes

Primary outcomes:
measure: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Medical Center
state: 7, Chung-Shan S. Road
Study officials:
affiliation: National Taiwan University Medical Center
name: Liu Hwa-Chang, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT01488175: Clinical and Stereoradiological Comparison of the Results After Primary Cemented Total Knee Arthroplasty Inserted With or Without the Use of a Tourniquet
Official title: Clinical and Stereoradiological Comparison of the Results After Primary TKA Inserted With or Without the Use of a Tourniquet
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Osteoarthritis of the Knee
Keywords: TKA
RSA
Tourniquet
Arthroplasty
Knee
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
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 investigate if the use of a tourniquet during insertion of a cemented primary total knee arthroplasty will influence clinical and radiological (measured with RSA X-ray technique) outcome.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis og osteoarthritis of the knee
* patients must be 18 years or older
* patients must understand and speak danish
* must be able to give signed consent

Exclusion Criteria:

* severe medical illness
* documented osteoporosis
* rheumatoid arthritis
* prior surgery in the knee
* neuropathy

Primary outcomes:
measure: migration of the prosthesis in millimeters assessed vith RSA.
timeFrame: 2 years
Secondary outcomes:
measure: postoperative pain.
timeFrame: 2 years
measure: Patient satisfaction (VAS-scale)
timeFrame: 2 years
measure: Knee range of motion (degrees)
timeFrame: 2 years
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.
Study officials:
affiliation: Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.
name: Anders Troelsen, M.D, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT00134875: Assessing Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers
Official title: Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Opioid-Related Disorders
Keywords: opioid dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2005-08-25
Enrollment: 9
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: Buprenorphine, a treatment for opioid dependence, can be mixed with another drug, naloxone, to limit abuse potential. Parenteral administration (intravenous or intramuscular injection) of buprenorphine/naloxone causes withdrawal symptoms in opioid dependent individuals. However, naloxone does not cause withdrawal symptoms in non-dependent opioid abusers. This study will investigate whether naloxone decreases the opioid agonist effect from injected buprenorphine, hence decreasing the abuse potential of buprenorphine/naloxone, in non-dependent opioid abusers.

Detailed description: Naloxone has been combined with buprenorphine to decrease the parenteral abuse potential of buprenorphine in opioid dependent individuals through the mechanism of naloxone-precipitated withdrawal. While naloxone will not precipitate withdrawal in individuals who are not physically dependent on opioids, it is possible naloxone might attenuate buprenorphine's agonist effects, especially if administered parenterally. The purpose of this study is to assess the effect of sublingual (SL) and intramuscular (IM) buprenorphine and buprenorphine/naloxone in non-dependent opioid abusers.

Participants will stay on a research ward and will undergo challenge sessions twice per week. The following conditions will be tested: placebo; IM hydromorphone (2 and 4 mg; an opioid agonist positive control condition); SL buprenorphine (4, 8, and 16 mg); IM buprenorphine (4, 8, and 16 mg); SL buprenorphine/naloxone(4/1, 8/2, and 16/4 mg); and IM buprenorphine/naloxone (4/1, 8/2, and 16/4 mg). During challenge sessions, physiological status will be recorded continuously and tasks assessing psychomotor, subjective, and objective status will be performed repeatedly.

Eligibility criteria: Inclusion Criteria:

* Non-dependent opioid abuser
* Actively abusing opioids by injection

Exclusion Criteria:

* Opioid dependence
* Signs or symptoms of opioid withdrawal, once admitted to residential unit

Primary outcomes:
measure: Opioid agonist effects
timeFrame: 3.5 hours
measure: Physiologic measures
timeFrame: 3.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University (BPRU) Bayview Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eric C. Strain, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06378775: Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery
Official title: Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery: a Pilot Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Multivessel Coronary Artery Disease
Keywords: CABG
Hybrid Coronary Revascularization
Robotically-assisted minimally-invasive direct coronary artery bypass
RA-MIDCAB
Lead sponsor: Cardiology Research UBC
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study objective is to compare standard CABG to a hybrid revascularization strategy (RA-MIDCAB + PCI) in patients who have multi-vessel CAD and an indication for surgery, but who have a slightly higher risk of post-operative complications.


Eligibility criteria: Inclusion Criteria:

1. Multi-vessel CAD with an indication for revascularization,
2. Presence of at least 1 risk factor for increased risk of post-operative death or major complication,

   * Any patient Age \> 80, OR
   * Any patient with eGFR (Glomerular Filtration Rate) \< 50, OR
   * Any patient with LVEF \< 40%, OR
   * Any patient deemed to be "frail" by consulting surgeon. OR
   * Patients \> 75 years of age with at least one of the following:

     * Ejection fraction \< 50%
     * History of prior CVA (Cerebral Vascular Accident)
3. Coronary artery anatomy appropriate for a robotically-assisted MIDCAB or regular CABG, vessels other than the left anterior descending with lesions amenable to either CABG or PCI.

Exclusion criteria

1. Significant left main coronary artery disease,
2. Ejection fraction \< 30%,
3. Patients with GFR \< 30,
4. Patients unable to take dual anti-platelet agents due to high bleeding risk,
5. Patients requiring emergent surgery, including patients with hemodynamic instability,
6. Patients with anatomy not suitable for a robotically-assisted approach (by CT chest).

Primary outcomes:
measure: Post-operative Length of Stay
timeFrame: From end of surgery (Skin time) to hospital discharge time, assessed up to 30 days
Secondary outcomes:
measure: Conversion to sternotomy / CABG
timeFrame: From beginning of surgery time to end of surgery time (skin to skin)
Other outcomes:
measure: Intubation duration
timeFrame: From end of surgery time to extubation time
measure: ICU length of stay
timeFrame: From end of surgery time to ICU discharge time, assessed up to 10 days
Locations:
Study officials:
References:
Clinical trial NCT00392275: Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs
Official title: Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Cataract
Aqueous absorption
Funtioning Filtering Blebs
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2006-10-25
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on previous results with eyes without filtering blebs, the aqueous concentrations of ofloxacin and levofloxacin will exceed the concentration of ciprofloxacin after either topical or topical plus oral administration.

Detailed description: The purpose of this study is to assay human aqueous for concentrations of ofloxacin, ciprofloxacin and levofloxacin after topical or combined topical and oral administration in eyes with filtering blebs.

Eligibility criteria: Inclusion Criteria:

* All patients with functioning filtering blebs will be evaluated prospectively for inclusion

Exclusion Criteria:

* Any subject who is already scheduled to have cataract surgery performed will qualify for participation with the exception of the following exclusion criteria:

  * Ongoing ocular inflammatory disease
  * Bleb leakage - determined by Seidel test
  * Suspected infection
  * Known contraindications to use of any of these study medications.
  * Pregnancy

Primary outcomes:
measure: Aqueous levels of antibiotics
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Richard L Rodeboush VA Medical Center
state: Indiana
city: Indianapolis
country: United States
facility: Wishard Memorial Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Louis B Cantor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cantor LB, Donnenfeld E, Katz LJ, Gee WL, Finley CD, Lakhani VK, Hoop J, Flarty K. Penetration of ofloxacin and ciprofloxacin into the aqueous humor of eyes with functioning filtering blebs: a randomized trial. Arch Ophthalmol. 2001 Sep;119(9):1254-7. doi: 10.1001/archopht.119.9.1254.
citation: Cantor LB, WuDunn D, Yung CW, Valluri S, Catoira YP, Hoop JS, Morgan LS. Ocular penetration of levofloxacin, ofloxacin and ciprofloxacin in eyes with functioning filtering blebs: investigator masked, randomised clinical trial. Br J Ophthalmol. 2008 Mar;92(3):345-7. doi: 10.1136/bjo.2007.121541. Epub 2008 Jan 22.