louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00357604: Atazanavir and Ritonavir (ATV/RTV) and an Oral Contraceptive in Healthy Females
Official title: The Effect of the Co-administration of Atazanavir (ATV) and Ritonavir (RTV) on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV
Protease Inhibitor
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-07-27
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to administer a combined oral contraceptive (ethinyl estradiol and norgestimate) with the HIV treatment of atazanavir and ritonavir to healthy females in order to assess if the concentrations of the oral contraceptive change. The safety of this treatment regimen will also be studied.


Eligibility criteria: Inclusion Criteria:

* Women of childbearing potential with intact ovarian function who have been on a stable regimen of oral contraceptives for at least 2 months prior to beginning the study
* Documented acceptable Pap smear within 1 year prior to dosing
* Body mass index (BMI) 18-32 kg/m2

Exclusion Criteria:

* Males
* Subjects with an abnormal menstrual cycle during the 2 months prior to the start of the study or during the lead-in period (breakthrough bleeding/spotting)
* History of conditions where the use of oral contraceptives are contraindicated
* Known or suspected carcinoma or suspected estrogen dependent neoplasia
* History of migraine with focal aura
* History of uncontrolled hypertension
* Positive screening test for HIV-1, -2, HIV viral ribonucleic acid (RNA), hepatitis B surface antigen, or hepatitis C antibody

Primary outcomes:
measure: To determine the effect of co-administration of atazanavir 300 mg and ritonavir 100 mg on the pharmacokinetics of ethinyl estradiol
Secondary outcomes:
measure: To determine the effect of the co-administration of atazanavir 300 mg and ritonavir 100 mg on the pharmacokinetics (PK) of 17-deacetyl norgestimate
measure: To assess the safety of atazanavir 300 mg and ritonavir 100 mg co-administered with the oral contraceptive Ortho Tri-Cyclen LO
measure: To characterize the PK of atazanavir and ritonavir during co-administration with Ortho Tri-Cyclen LO
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Covance Cpu, Inc
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01786304: Effect of Sacral Nerve Stimulation on Enteric Nervous System
Official title: Effect of Sacral Nerve Stimulation on Enteric Nervous System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fecal Incontinence
Keywords: Fecal incontinence, sacral nerve stimulation
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Nantes University Hospital
First posted: 2013-02-07
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with fecal incontience refractory to standard medical treatment

Brief summary: Sacral nerve stimulation (SNS) is a new therapeutic option to treat fecal incontinence, although its mecanims of action remains poorly understood. The investigators hypothtized that SNS could act on enteric nervous system (ENS). To verify this hypothesis, the investigators will collect biopsy samples from patients implanted for SNS, and assess whether SNS induces changes in ENS.

Detailed description: Sacral nerve stimulation (SNS) is a new therapeutic option to treat fecal incontinence. Its efficacy yields 80% approximately, but its mecanims of action remains poorly understood. In particular, SNS does not restore anal squeezing contraction nor it increase anal tone. Recently, using a porcine model, it was shown that SNS changed colonic permeability, suggesting that SNS may activate the enteric nervous system (ENS).

The investigators hypothtized therefore that SNS could act on enteric nervous system (ENS).

To verify this hypothesis, the investigators will collect biopsy samples from patients before and after implantation for SNS. The investigators will assess whether SNS induces changes in ENS, and if this is correlated to SNS efficacy.

Eligibility criteria: Inclusion Criteria:

* Fecal incotinence
* refractory to medial treatment
* Eligible to a treatment with sacral nerve stimulation

Exclusion Criteria:

* age \< 18 yo
* age \< 75 yo
* anal defect \> 120°
* bilateral interruption of the bulbo-cavernous reflex
* patient not able to speack and understand the French Language
* patient not affilated to the French healthcare system
* pregnancy

Primary outcomes:
measure: Number of neurons producing vasoactive intestinal peptide (VIP)
timeFrame: 6 months
Secondary outcomes:
measure: Number of cholinergic neurons
timeFrame: 6 months
Other outcomes:
measure: Fecal incontinence score
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
state: Normandy
city: Nantes
country: France
facility: Nantes University Hospital
state: Pays de Loire
Study officials:
affiliation: Rouen University Hospital, France
name: Guillaume Gourcerol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00173004: Angiotensinogen Gene and Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Genetic studies of hypertension, focusing on renin-angiotensin system genes and other interacting genes


Eligibility criteria: Inclusion Criteria:

* Patients with hypertension

Exclusion Criteria:

* Patients with hypertension and reluctant for the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chia-Ti Tsai
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05876104: Harassment of Pain Clinic Staff by Patients
Official title: Harassment of Pain Clinic Staff by Chronic Pain Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Violence
Keywords: Harassment by patients
Lead sponsor: Salem Anaesthesia Pain Clinic
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 1102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult chronic pain patients who are undergoing treatment in a specialist pain clinic

Brief summary: Chronic pain is associated with psychological disorders, and many patients have behavioral problems. Some patients harass pain services staff. Most healthcare staff do not report harassment by patients.

Quantitative and qualitative analysis of prospective electronic and clinic diary data. Evaluation of incidents of clinic staff harassment; caused by patients and patients' family. Analysis of causative factors, incident outcome and lessons learned.

Detailed description: Chronic pain is associated with psychological and mental health disorders. Many patients have personality and behavioral disorders. Some patients harass their pain care providers. Most healthcare staff do not report harassment by patients.

This is a quantitative and qualitative analysis of prospective electronic and clinic diary data. It is an evaluation of incidents of pain clinic staff harassment; caused by patients and patients' family. This is an analysis of incident causative factors, incident outcome and lessons learned. The qualitative information of each incident is presented in a sensitive and careful format.

Eligibility criteria: Inclusion Criteria:

* adult chronic pain patients

Exclusion Criteria:

* pediatric chronic pain patients

Primary outcomes:
measure: Percentage of patients who harassed clinic staff
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Salem Anaesthesia Pain Clinic
state: British Columbia
Study officials:
affiliation: Salem Anaesthesia Pain Clinic
name: Olu Bamgbade, MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: David K, Anuj D, Nabil S. Violence toward chronic pain care providers: A national survey. Pain Med. 2015 Oct;16(10):1882-96. doi: 10.1111/pme.12794. Epub 2015 Jun 2.
citation: Bamgbade OA, Tai-Osagbemi J, Bamgbade DO, Murphy-Akpieyi O, Fadire A, Soni NK, Mumporeze L. Clonidine is better than zopiclone for insomnia treatment in chronic pain patients. J Clin Sleep Med. 2022 Jun 1;18(6):1565-1571. doi: 10.5664/jcsm.9930.
citation: Bamgbade OA, Onongaya V, Anomneze-Collins A, Omoniyi DA, Simmonds-Brooks P, Richards RN. Delayed surgical diagnosis and treatment of severe sickle cell arthropathy: The need to raise clinicians' awareness. J Taibah Univ Med Sci. 2021 May 31;16(5):683-688. doi: 10.1016/j.jtumed.2021.04.007. eCollection 2021 Oct.
Clinical trial NCT05798104: Collaborative Nurse-pharmacist Counseling for Self-administered Biologics
Official title: Improving Patient Knowledge and Confidence in Specialty Biologic Self-administration Through Collaborative Nurse-pharmacist Counseling
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Medication Adherence
Medication Nonadherence
Adverse Drug Event
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2023-04-04
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: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn if nurse-pharmacist counseling can improve patient knowledge and confidence and prevent side effects in patients who start a biologic medication in-office and later continue the medication at home. The main question it aims to answer are:

• Does nurse-pharmacist counseling improve patient-reported knowledge and confidence in biologic self-treatment when moving from in-office to at-home administration?

Participants will attend a brief counseling session in office and respond to a pre-counseling and post-counseling survey to look at medication knowledge and confidence. Participants will be contacted at three months after the survey to ask if they had any side effects related to their biologic medicine. Data will be collected from the participant's medical record at the study institution for up to six months after the study counseling session.


Eligibility criteria: Inclusion Criteria:

* Referred to University of Kentucky Specialty and Infusion Services for clinic-administration of a biologic medication
* Biologic medication is omalizumab, risankizumab-rzaa or ustekinumab
* Medication administration will be transitioned to self-administration

Exclusion Criteria:

* Less than 18 years of age
* have previously received the qualifying biologic at another institution
* non-English speaking subjects
* Subject will not be performing self-administration at home
* Does not transition to medication self-administration

Primary outcomes:
measure: Change in patient-perceived medication knowledge and confidence.
timeFrame: Immediately before and after counseling session during 1 day study visit
Secondary outcomes:
measure: Medication adverse events/self-administration errors
timeFrame: 90 days following study visit
measure: Medication adherence/persistence
timeFrame: 180 days following study visit
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Tonia Carr, BSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00850304: Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide
Official title: Feasibility Study of Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide on Ambulatory Schedule
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, Myeloid, Acute
Keywords: AML
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-02-24
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Our purpose in this study is to explore the feasibility of treatment of non promyelocytic Acute myeloid leukaemia on elderly patients. We select ten patients with age further than 60 with comorbidity and treat by low dose cytosar subcutaneous plus arsenic trioxide for ten days in month. We will assess overall response rate and overall survival in end of one year.

Detailed description: Acute myeloid leukemia is a disease in which characterised by blast further than 20% in bone marrow plus incomplete differentiation. Many of this patients are elderly with age further than 60 years(CALGB,ECOG,EORTC) or 55 years (SWOG). Mortality rate fallowing standard therapy of this patients is high that can reach to 50%. One of methods to apply a remission with least mortality and morbidity and also significant lower cost effects compare to historical and conventional standard regimen is low dose cytosar and arsenic trioxide combination that has been reported complete remission to 34%.

We select ten patients with age further than 60 with comorbidity and treat by low dose cytosar subcutaneous plus arsenic trioxide for ten days in month. We will assess overall response rate and overall survival in end of one year.

Eligibility criteria: Inclusion Criteria:

* Elderly patients with non promyelocytic AML
* Performance status (ECOG) 3 or 4

Exclusion Criteria:

* Age \<60 years
* Elevation of AST OR ALT more than ten times above normal
* Serum bilirubin above 5
* Cr level \> 2

Primary outcomes:
measure: Response Rate
timeFrame: 1, 2, 6 month and one year after intervention
Secondary outcomes:
measure: Overall Survival
timeFrame: One year after intervention
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hematology-Oncology and SCT Research Center
Study officials:
affiliation: Hematology-Oncology and SCT Research Center
name: Kamran Alimoghaddam, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04188704: Comparative Study of the Inclination Angle and Complications of Eccentric Grafts Position in ACL Reconstruction and Normal ACL: Retrospective Cohort
Official title: Comparative Study of the Inclination Angle and Complications of Eccentric Grafts Position in ACL Reconstruction and Normal ACL: Retrospective Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Keywords: ACL
screw fixation
graft inclination
reconstruction
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
Collaborators: name: Thammasat University
First posted: 2019-12-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The anatomic ACL reconstruction aims at functional restoration of the ACL to its native dimensions, collagen orientation and insertion sites. Even if the anatomic foot prints are correctly chosen for the tibial and femoral tunnels does the position of interference screw in the tibial tunnel alter the ACL orientation? The study hypothesized that the position of interference screw in the tibial tunnel would alter the graft orientation in anatomic ACL reconstruction. The purpose of this study was to compare graft orientation and inclination angle with posterolateral and anteromedial interference screw position in tibial tunnel in aperture fixation techniques.


Eligibility criteria: Inclusion Criteria:

* magnetic resonance imaging (MRI) of patients with ACL reconstruction was compared to MRI in which ACL was intact.
* patients with isolated ACL injury who underwent ACL reconstruction surgery using quadripled hamstrings graft and operated by a single senior surgeon
* Both pre-operative and post-operative MRI should be available for assessment
* No history of trauma in the post-operative or rehabilitation period

Exclusion Criteria:

* Concomitant bony or other ligament injury to the same knee
* history of previous surgery to the same knee
* Revision ACL reconstruction surgery
* surgery done at other center or by other doctors at our institute
* Pre-operative and/or post-operative MRI not available

Primary outcomes:
measure: Inclination angle
timeFrame: 6 months
Secondary outcomes:
measure: post-operative complications
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02731404: Intra-ocular Pressure and Ventilation
Official title: The Effects of High Frequency Jet Ventilation on Intra-ocular Pressure During Laparoscopic Operations (Lap. Cholecystectomy) With Positive Pressure Pneumoperitoneum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumoperitoneum
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2016-04-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Background: Positive pressure pneumoperitoneum (PP) may involve adverse pathophysiological changes, including increased intra-thoracic and ocular pressure, when combined with standard ventilation. High frequency jet ventilation (HFJV) was reported to reduce the adverse cardiovascular effects during laparoscopic cholecystectomy.

Aim: To study the effects of HFJV on intra-ocular pressure changes (reflecting intra-cranial pressure) during laparoscopic surgery under PP.

Detailed description: Patients and methods: The investigators studied 2 groups of patients electively scheduled for laparoscopic cholecystectomy. The study group included 10 patients that were ventilated by high frequency jet ventilation (HFJV). In the control group (16 patients) the investigators used the standard intermittent positive pressure ventilation (IPPV). Both groups were matched according to clinical and hemodynamic parameters. Intra-ocular pressure was measured by a senior ophthalmologist that was blinded to the ventilation technique. Laparoscopic surgery was done as usual, and the intra-peritoneal pressure was automatically set on 14 mmHg. Statistical significance was considered whenever P value was less than 0.05.

The investigators anticipate that the use of HFJV during laparoscopic operations under PP may prevent increased intra-ocular pressure that accompanies increased intra-abdominal pressure under conventional ventilation (IPPV).

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* Ophthalmologic and severe Cardiopulmonary diseases

Primary outcomes:
measure: Intra-ocular pressure
timeFrame: During procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Western Galilee Hospital, Bar Ilan Faculty of Medicine
name: Amitai Bickel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01047904: Anesthetizing the Tympanic Membrane in Healthy Volunteers
Official title: Performance and Reliability of the Acclarent Iontophoresis System for Anesthetizing the Tympanic Membrane in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluate Performance and Reliability of Iontophoresis System
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2010-01-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate the performance and reliability of minor design changes to the Acclarent Iontophoresis System components for anesthetizing the tympanic membrane in healthy volunteers. Data collected from this study will enable the development of future applications and technology.


Eligibility criteria: Inclusion Criteria:

1. \>=18 years of age
2. Both male and female subjects are eligible.

Exclusion Criteria:

1. Pregnant or lactating females
2. Subjects with a history of sensitivity or reaction to lidocaine, epinephrine or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution.
3. Markedly atrophic TM
4. Perforated TM
5. Sclerotic TM
6. Otitis externa
7. Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
8. Damaged or denuded skin in the auditory canal
9. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
10. Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure.

Primary outcomes:
measure: Procedural Success
timeFrame: X days
Secondary outcomes:
measure: Incidence of adverse effects associated with the System and the Iontophoresis procedure
timeFrame: X days
measure: Tolerability of the iontophoresis system
timeFrame: X days
Other outcomes:
Locations:
city: East Palo Alto
country: United States
state: California
Study officials:
References: