louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01081483: A Study of Single Doses of ABT-072 in Japanese Healthy Male Adults
Official title: A Blinded, Randomized, Placebo-controlled Phase 1 Study in Healthy Male Adults to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single Doses of ABT-072
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: Healthy Volunteers
HCV Infections
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Abbott Japan Co.,Ltd
First posted: 2010-03-05
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of blinded, single ascending oral doses of ABT 072 under non-fasting conditions in healthy adult Japanese male subjects.


Eligibility criteria: Inclusion Criteria:

* Overall healthy adult Japanese males

Exclusion Criteria:

* Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
* Positive screen for drugs of abuse, alcohol, or cotinine.
* Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
* Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.

Primary outcomes:
measure: Safety and tolerability assessment
timeFrame: Day 1 to Day 4 and Day 15.
measure: Pharmacokinetic profile evaluation
timeFrame: Day 1 to Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Kagoshima
country: Japan
state: Prefecture
Study officials:
affiliation: Abbott Japan Co.,Ltd
name: Kazuko Kobayashi
role: STUDY_DIRECTOR
References:
Clinical trial NCT03967483: Study on Indomethacin-responsive Headaches
Official title: Non Interventional Study on Indomethacin-responsive Headaches
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Headache, Migraine
Lead sponsor: French Society for the Study of Migraine Headache
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient sufffuring from headaches or migraine and who is receiving Indometacine

Brief summary: Description of modalities concerning the patient care of headaches sensible to indometacine.

Detailed description: Description of clinical profile, treatment of crisis and background treatment

Eligibility criteria: Inclusion Criteria:

* patient with a diagnosis of migraine with or without aura, or trigemino-autosomic headaches or other primary headaches
* patient who are taking indometacine
* patient with written consent form

Exclusion Criteria:

* patient under 18 years
* pregnant woman or breastfeeding patient
* patient who refuses to participate

Primary outcomes:
measure: Description of headaches sensible to indometacine
timeFrame: 24 monthes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00860483: Correlation of Laparoscopic Experience and Functional Brain Activation: A PET Scan Study
Official title: GAC 0201 Correlation of Laparoscopic Experience and Functional Brain Activation: A Pet Scan Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Function
Keywords: Comparison of experienced and novice laparoscopic surgeons
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2009-03-12
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the research is to determine how practicing laparoscopic motor tasks affects the functional anatomy of the brain, and to investigate whether there is a correlation between surgical experience and functional brain activition. Additionaly, the investigators plan to use eye-tracking technology to see if the use of this technology can distinguish surgeons of various skill levels. The investigators hope that this study leads to new and effective methods of training surgical residents. All of the data will be collected at The Feinstein Institute for Medical Research, and may be used in future studies, which may or may not be related to urological diseases.


Eligibility criteria: Inclusion Criteria:

1. Urology resident or fellow at Long-Island Jewish Hospital
2. Urology attending surgeon with previous laparoscopic experience
3. Medical Student Research Fellow with no previous laparoscopic experience
4. Right hand dominant subjects
5. No known neorologic defect reported by the subject -

Exclusion Criteria:

1. Left-hand dominant subjects
2. Self-reported neurologic defect reported by the subject -

Primary outcomes:
measure: Laparoscopic experience
timeFrame: 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
Study officials:
affiliation: Northwell Health
name: Louis R. Kavoussi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05600283: Patient Self-sampling of HPV to Screen for Cervical Cancer
Official title: Validation and Feasibility of Patient Self-sampling of HPV for Cervical Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus
Keywords: Cervical Cancer Screening
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 223
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Researchers will compare the laboratory results of self-collected vaginal swab samples to usual healthcare provider-collected cervical swab samples to determine the laboratory HPV testing accuracy of the self-collection swab.


Eligibility criteria: Inclusion Criteria:

* Appointment at Mayo Clinic Rochester in Gynecology Colposcopy Clinic or ICS (integrated community specialty) Colposcopy Clinic (will always include a speculum exam).
* Appointment at Mayo Clinic Rochester in Gynecology Clinic for indication that will already include a speculum exam (e.g., cervical cancer screening or IUD insertion).

Exclusion Criteria:

* Excluded if self-reported as currently menstruating, pregnant, or within 3 months following pregnancy.
* Excluded if no cervix (history of total hysterectomy).
* Excluded if moderate to heavy vaginal bleeding on the day of the visit.
* Excluded if reason for visit in Gynecology Clinic is abnormal vaginal discharge.
* Exclude patients who are on Gynecology Colposcopy Clinic for LEEP (loop electrosurgical excision procedure).
* Exclude if any use of over-the-counter or prescription vaginal cream for vaginal infection or prescription vaginal estrogen cream for at least two days before using the Evalyn Brush.

(Vaginal contraceptives, condoms and water-based lubricants can be used as normal.)

Primary outcomes:
measure: Concordance of patient-collected and clinician-collected samples to detect HPV infection
timeFrame: Anticipate 6-8 months to collect number of samples needed
Secondary outcomes:
measure: Patient-reported acceptability and feasibility of using the Evalyn brush
timeFrame: Patient will complete survey after using the Evalyn brush (same day)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kathy MacLaughlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02205983: The Effects of Hydromorphone on Responses to Verbal Tasks
Official title: The Effects of Hydromorphone on Responses to Verbal Tasks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: enrolling
adult
volunteers
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-08-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, the investigators will examine the effects of hydromorphone, as compared to placebo, upon physiological, subjective, and hormonal responses to a stressful speech task and a non-stressful control task in healthy adults. There is strong evidence in support of the role of endogenous opioids and opiates in mediating social behavior in humans and other animals, and particularly, in social distress. The investigators have recently shown that buprenorphine, a partial mu-opioid agonist, reduces cortisol responses to stress. Here, the investigators propose to further explore the role of the opioid system in mediating stress responses in humans through the use of hydromorphone, a full mu opioid agonist, in addition to acetaminophen. The investigators hypothesize that like acetaminophen, hydromorphone will reduce both physiological and subjective measures of stress.

Detailed description: Participants be randomly assigned to receive 1000 mg acetaminophen, 2mg hydromorphone, 4mg hydromorphone, or placebo at each of two sessions; one during which they well participate in a stressful speaking task, and one during which they'll participate in a nonstressful control task. Physiological and subjective measures will be taken throughout each session.

Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers

Exclusion Criteria:

1. any current medical condition requiring medication or abnormal electrocardiogram
2. current or past medical condition considered to be a contraindication for the study conditions
3. any current Axis I psychiatric disorder (APA, 1994) including Substance Use Disorder, or Anxiety Disorder or Major Depression in the past year, any history of psychosis
4. less than high school education
5. lack of fluency in English
6. night shift work
7. Pregnancy, lactation or plans to become pregnant.
8. Use of hormonal contraception.
9. Daily cigarette smokers i.e., \>7 cigarettes per week

Primary outcomes:
measure: Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire
timeFrame: End of study (time 0 and approximately 4 weeks later), week 4 reported.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
Study officials:
affiliation: University of Chicago
name: Harriet de Wit, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Jerome Jaffe, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01643083: Rifaximin for Functional Dyspepsia
Official title: Use of Rifaximin in Patients With Functional Dyspepsia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Functional Dyspepsia
Keywords: Post-prandial distress syndrome
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 95
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: Functional dyspepsia is a very common medical condition, which occurs in up to 30% of people in the community. However, results of current pharmacological treatment on functional dyspepsia are unsatisfactory. Rifaximin is a minimally absorbed antibiotic that has been used in treatment of non-constipated irritable bowel syndrome (IBS). In particular, bloating and abdominal pain was improved by rifaximin treatment in this group of IBS patients. Whilst there is considerable overlap in symptoms of functional dyspepsia and IBS, the investigators test whether rifaximin is also effective in curing post-prandial distress symptoms related to dyspepsia.

Detailed description: The aim of this study is to test the effects of rifaximin, a minimally absorbed antibiotics, on symptoms of patients with functional dyspepsia.

Eligibility criteria: Inclusion Criteria:

* Non-ulcer dyspeptic patients who fulfill post-prandial distress syndrome according to the Rome III Criteria
* Active dyspeptic symptom
* Normal upper endoscopy
* Urea Breath Test -ve or Rapid urease test -ve
* Not typical gastroesophageal reflux or biliary colic symptoms, but presence of infrequent acid reflux is allowed

Exclusion Criteria:

* No active dyspeptic symptom
* Allergic to rifaximin
* Recent antibiotics use in the past 8 wk
* Recent PPI or H2RA in past 4 wk
* On anti-coagulants, anti-convulsant or oral contraceptives
* On NSAIDs, aspirin or Clopidogrel
* Pregnancy or breast feeding
* Previous gastric surgery

Primary outcomes:
measure: Adequate relief of dyspeptic symptoms at end of treatment
timeFrame: end of treatment (week 2)
Secondary outcomes:
measure: Individual dyspeptic symptom scores
timeFrame: week 2, 4 and 8
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Wai Keung Leung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tan VP, Liu KS, Lam FY, Hung IF, Yuen MF, Leung WK. Randomised clinical trial: rifaximin versus placebo for the treatment of functional dyspepsia. Aliment Pharmacol Ther. 2017 Mar;45(6):767-776. doi: 10.1111/apt.13945. Epub 2017 Jan 23.
Clinical trial NCT05236283: Epidemiology of Bacteremia at Two Tertiary ICUs in Switzerland
Official title: Duration of Antimicrobial Treatment for Bloodstream Infections in Swiss Critically Ill Patients - Retrospective Double Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient is critically ill at the time the blood culture was collected and was treated at the ICU/IMC at the time of blood culture collection or has been admitted to ICU/IMC in the 48 hours after blood culture collection.

Brief summary: The objectives of the retrospective cohort study is to describe the actual current practice of antibiotic treatment duration for bloodstream infections in critically ill patients at two tertiary hospitals (ICU Inselspital Bern and ICU CHUV Lausanne), to examine patient, pathogen and infectious syndrome factors associated with selection of shortened treatment duration, and to describe the expected time course of clinical resolution among bacteremic patients.


Eligibility criteria: Inclusion Criteria:

Patient has a positive blood culture with a pathogenic organism Patient is critically ill at the time the blood culture was collected as defined by the following:

1. was treated at the ICU/IMC at the time of blood culture collection;
2. or has been admitted to ICU/IMC in the 48 hours after blood culture collection

Exclusion Criteria:

1. Patient has a single positive blood culture with a common contaminant organism:

   * coagulase negative staphylococci;
   * Bacillus spp.;
   * Corynebacterium spp.;
   * Propionibacterium spp.;
   * Aerococcus spp.;
   * Micrococcus spp.
2. Explicit documentation that the patient does not want to participate in any study

Primary outcomes:
measure: Antibiotic Treatment Duration
timeFrame: Hospital discharge, expected to be on average ca. 15-20 days
Secondary outcomes:
measure: Days of ICU stay
timeFrame: ICU discharge, expected to be on average ca. 5-15 days
measure: Days of hospital stay
timeFrame: Hospital discharge, expected to be on average ca. 15-25 days
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Departement of Intensive Care Medicine
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Josef Prazak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00011583: Robot Assisted Upper Limb Neuro-Rehabilitation
Official title: Robot Assisted Upper Limb Neuro-Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Stroke
Keywords: Cerebrovascular
Hemiplegia
Robotics
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Our long term objectives are to understand the mechanisms of motor impairment following neurologic injury and to develop interventions to improve motor recovery. A series of complementary, overlapping clinical trials and development activities will validate and optimize the use of robot-assisted upper limb therapy for neuro rehabilitation.

We have developed a robotic system that assists or resists elbow and shoulder movements in three dimensional space. In addition to unilateral exercise modes, a novel bimanual mode enables hemiparetic subjects to practice mirror image upper limb exercises.

Detailed description: Randomized controlled clinical trial of the Mirror Image Movement Enabler (MIME) robotic device for shoulder and elbow neurorehabilitation in subacute stroke patients. MIME incorporates a PUMA 560 robot that applies forces to the paretic limb during unilateral and bilateral movements in three dimensions. Robot-assisted treatment (bilateral, unilateral, and combined bilateral and unilateral) was compared with conventional therapy.

Eligibility criteria: Inclusion Criteria:

Stroke patients

Exclusion Criteria:

Unable to follow instructions; medically unstable.

Primary outcomes:
measure: Fugl-Meyer score
timeFrame: end of training, 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Temple
country: United States
facility: Central Texas Veterans Health Care System
state: Texas
Study officials:
affiliation: Central Texas Veterans Health Care System
name: Charles Burgar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00432783: A Comparison of Adherence Rates to Ritonavir and Its Accompanying Protease Inhibitor
Official title: A Comparison of Adherence Rates to Ritonavir (Soft-gel Capsules) and Its Accompanying Protease Inhibitor (PI) in Patients Receiving Ritonavir Boosted PI Regimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV, antiretroviral therapy, adherence, ritonavir
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2007-02-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the Montefiore Medical Center Infectious Diseases Clinic who meet eligibility criteria described below.

Brief summary: Pharmacologic boosting of protease inhibitors with ritonavir has become standard practice in antiretroviral therapy. Patients are instructed to take ritonavir at the same time as its accompanying protease inhibitor. However, ritonavir is unpopular with many patients because of its large size and because of the recommended need for refrigeration. This study will test the hypothesis that adherence to ritonavir is inferior to adherence to its accompanying protease inhibitor in patients receiving such therapy.

Detailed description: The study staff will employ MEMS caps to prospectively measure adherence to ritonavir and its accompanying protease inhibitor over 24 weeks of follow-up. Paired sample t-tests will be employed to compare adherence to the two agents, and secondary analyses will be conducted to evaluate the chronologic concordance of ritonavir and accompanying protease inhibitor dosing.

Eligibility criteria: Inclusion Criteria:

* HIV infection, age\>18 years, receiving therapy with ritonavir-boosted atazanavir or fosamprenavir, willingness to use MEMS caps, willingness to provide informed consent

Exclusion Criteria:

* Treatment with any medication that is contraindicated in combination with ritonavir or its accompanying protease inhibitor

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Jonathan Shuter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shuter J, Sarlo JA, Rode RA, Zingman BS. Occurrence of selective ritonavir nonadherence and dose-staggering in recipients of boosted HIV-1 protease inhibitor therapy. HIV Clin Trials. 2009 May-Jun;10(3):135-42. doi: 10.1310/hct1003-135.