louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00724373: Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol (Study P05269)(COMPLETED)
Official title: Retrospective Data Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with genotype 1 HCV infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months at sites in the UK.

Brief summary: The study is designed as a retrospective data review of medical records from participants selected from specialist secondary and tertiary care centers across the United Kingdom (UK), specializing in Hepatitis C treatment. The study is non-interventional and is designed to identify subgroups of Hepatitis C Virus (HCV) genotype 1 participants in the 'real world', including the relation between subgroup characteristics and treatment responsiveness.

Detailed description: Physicians will record information (from the time of first exposure to pegylated interferon alfa-2b and ribavirin) from the medical notes of participants who fit the inclusion criteria. To prevent selection bias, data are to be taken from the latest consecutive, unique participants seen by the physician over the previous 48 months. This provides a method of random sampling from a physician practice.

Eligibility criteria: Inclusion Criteria:

* Participants with genotype 1 HCV infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months will be included. They will be divided into:
* Completer participants: Patients with a diagnosis of HCV genotype 1 who have completed a course of interferon alfa-2b and ribavirin, with no prior treatment for HCV (ie, previously treatment naïve). Completer participants must have at least 24 weeks of follow up data available post completion of treatment to ensure ability to assess SVR rates.
* Early terminators: Participants who have terminated treatment early due to adverse events or other reasons (ie, exposure is incomplete).

Exclusion Criteria:

* Participants currently undergoing therapy and therefore have not terminated treatment, ie, exposure is still ongoing.
* Co-infected HCV participants (eg, human immunodeficiency virus \[HIV\] or hepatitis B virus \[HBV\]).
* Participants who received their first HCV treatment in relation to a clinical trial.

Primary outcomes:
measure: Participants With Treatment Success
timeFrame: Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04434573: Consensus in Surgical Community for Asymptomatic Abdominal Wall and Incisional Hernias
Official title: Asymptomatic Abdominal Wall and Incisional Hernias: Is Therapeutic Decision Consensual An International Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Study of Practices of Surgeons on Surgical Management of Asymptomatic Hernias
Comparison With International Recommendations
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: French-speaking surgeons

Brief summary: Hernia pathology is one of the leading causes of surgery worldwide. For asymptomatic patients, surgery remains questionable. Although there are new European recommendations, the practice of digestive surgeons regarding the management of asymptomatic hernias is unknown. The objective of this study was to evaluate the practices of a large population of digestive surgeons with asymptomatic hernia.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* No

Primary outcomes:
measure: number and type of clinical cases for which a consensus, defined by an arbitrary value of 75% of surgeons with the same therapeutic attitude
timeFrame: The outcome measure is evaluated after 6 months during which the survey is online (from october 2016 to march 2017), time during which surgeons had access to answer it
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Ile De France
Study officials:
References:
Clinical trial NCT04971473: Comparison of the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal
Official title: An Open, Single-arm, Self-controlled, Multi-center Phase 3 Study to Compare the Efficacy and Safety of rhTSH as An Adjunctive Diagnostic Tool in Differentiated Thyroid Cancer Patients Who Had Been Thyroidectomized Vs. Patients Who After Thyroid Hormone Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Differentiated Thyroid Cancer
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2021-07-21
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is A non-blinded trial. Oral radioiodine was given 24 hours after the second injection of rhTSH, and scanning was done 48 hours after the radioiodine administration. Each patient was scanned first following rhTSH and then scanned after thyroid hormone withdrawal.


Eligibility criteria: Inclusion Criteria:

* Subjects voluntarily sign the informed consent form (ICF).
* Age 18-75 years old, either male or female.
* Patients with diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant,.
* Patients with a total or near-total thyroidectomy within 6 weeks prior to administered.
* Low iodine diet for 4 weeks prior to randomized.

Exclusion Criteria:

* Pregnant or breast feeding women.
* Patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission)
* Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator.
* Subjects who have participated in another clinical trial of a new drug or medical instrument within 1 months before screening.

Primary outcomes:
measure: the rate of concordant scans
timeFrame: 48 hours after the radioiodine administration
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yansong Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04437173: Pain Procedures and Anxiolysis Via Distraction With Virtual Reality
Official title: Immersive Audiovisual Distraction With Virtual Reality (VR) to Reduce Anxiety and Sedation Requirements During Pain Procedures in the Interventional Pain Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Anxiety
Pain
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 99
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: The purpose of this study is to evaluate the efficacy of VR distraction on reducing anxiety patients undergoing interventional pain procedures compared to placebo/active placebo or a non VR option.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years old, who are referred to University of California Davis Pain Medicine Clinic and require an interventional pain procedure
* English speaking
* Having the ability to understand oral and written instructions
* Willing to fill out psychometric surveys.

Exclusion Criteria:

* Pregnant women
* Prisoners
* Patients who have high risk of motion sickness, seizure disorder, or visual/hearing impairment

Primary outcomes:
measure: Anxiety Score
timeFrame: Immediately before procedure and immediately after procedure.
Secondary outcomes:
measure: Pain Score
timeFrame: Immediately before procedure, during procedure, and immediately after procedure
measure: Sedation Requirements
timeFrame: During course of procedure
measure: Global Impression of Change
timeFrame: Immediately after procedure
measure: Patient Experience Satisfaction
timeFrame: Immediately after procedure
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Interventional Pain Clinic
state: California
Study officials:
affiliation: University of California, Davis
name: Naileshni Singh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: John Sun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Michael Jung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05791773: Robotic Total Knee Arthroplasty Anesthesia Management
Official title: Robotic Total Knee Arthroplasty Anesthesia Management: Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Joint Diseases
Anesthesia
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with American Society of Anesthesiologists (ASA) physical status I-III and elective unilateral TKAs between the ages of 40 and 85 will be analyzed.

Brief summary: Robotic arthroplasty is increasing in acceptance on a global scale as a result of advancements in orthopedic surgery technology.

The investigators aimed to share our anesthesia management experience as well as compare robotic unilateral total knee arthroplasty with conventional surgical technique in this retrospective study.

Detailed description: This study was approved by the ethics committee of a tertiary academic hospital.

The following criteria were used to assess inclusion: ASA physical status I-III patients aged 40-85 years, elective unilateral total knee arthroplasty (TKAs) performed by a single senior orthopedic surgeon and orthopedic team under combined spinal epidural anesthesia (CSEA) between January 2021 and January 2023. Exclusion criteria included urgent surgery, bilateral surgery, previous surgery, missing data, and being lost to follow-up during the perioperative period. Data was collected from the hospital's electronic database records, patient files, and anesthesia charts.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-III
* Between 40-85 years
* Elective unilateral TKAs which were performed by a single senior orthopedic surgeon
* Between January 2021 and January 2023 under CSEA.

Exclusion Criteria:

* Urgent surgery
* Bilateral surgery
* Previous surgery
* Missing data and lost to follow-up in the perioperative period

Primary outcomes:
measure: Time
timeFrame: Only in surgery time, an average of 3 hours
Secondary outcomes:
measure: Complications
timeFrame: After the end of surgery, in the first 1-month follow-up
measure: Hospital discharge time
timeFrame: Time from discharge from PACU to discharge from hospital, an average of 96 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03124173: Cognitive Control of Language
Official title: Cognitive Control of Language and Frontal Cortex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: fMRI
cingulate cortex
adaptation
frontal cortex
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The cognitive control of speech is central to human social communication. Two frontal brain regions seem to have a critical role: 1) Broca's area (BA) and 2) the mid-cingulate cortex (MCC). Current rehabilitation strategy is clearly based on therapies promoting language performance. However, there is few evidence that rehabilitation strategies based on nonlinguistic aspects of brain function may enhance recovery. Such strategies may benefit from knowledge about the primary -nonlinguistic- function of the BA-MCC network. The aim of LANGUAGE is to identify this primary function. One hypothesis is that, in non-speaking primates, this network is involved in cognitive control of voluntary vocal/orofacial production. Specifically, whereas BA may be responsible for the high-level selection of orofacial and vocal responses during learning, the face motor representation within the MCC may be responsible for performance monitoring, a process inherently required in learning. LANGUAGE aims to test this hypothesis by determining in human the anatomo-functional organization of the BA-MCC network thanks to functional magnetic resonance imaging (fMRI).


Eligibility criteria: Inclusion Criteria:

* being able to provide a written consent form
* having a social insurance
* have a normal vision (with or without corrections)
* Right-handed

Exclusion Criteria:

* Subjects with MRI contraindications (e.g. pacemaker, claustrophobia, metal in the body, etc...).
* Subjects must be willing to be advise in case of discovery of brain abnormality.
* History of known neurological or psychiatric illness
* Pregnant or nursing women
* Persons under guardianship, curators or any other administrative or judicial measure of deprivation of rights

Primary outcomes:
measure: Behavioral data: performance in the task
timeFrame: 3 years
measure: fMRI data
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Creteil
country: France
facility: Hôpital Henri Mondor
Study officials:
affiliation: Henri Mondor University Hospital
name: Philippe Domenech, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hillis AE. Magnetic resonance perfusion imaging in the study of language. Brain Lang. 2007 Aug;102(2):165-75. doi: 10.1016/j.bandl.2006.04.016. Epub 2006 Jun 6.
Clinical trial NCT01763073: Beliefs and Practice Intentions of Future Ob/Gyn Residents Regarding Reproductive Healthcare
Official title: Beliefs and Practice Intentions of Future Ob/Gyn Residents Regarding Reproductive Healthcare
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus: Pre-residency Intention to Provide Abortion
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2013-01-08
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fourth-year students in accredited US medical schools who have applied to, but not yet been matched with, residency programs in obstetrics and gynecology.

Brief summary: The objective of this study is to ascertain factors shaping medical students' pre-residency intention to provide abortion through an in-depth qualitative investigation into the context and experiences that shape intention to provide.


Eligibility criteria: Inclusion Criteria:

* current 4th-year medical student
* US accredited medical school
* has applied to, but not yet been accepted into, obstetrics and gynecology residency programs

Exclusion Criteria:

* age less than 18 years
* former student reapplying to residency (e.g., not current 4th-year student)
* has not yet applied to residency
* has already been accepted to residency

Primary outcomes:
measure: Factors affecting pre-residency intention to provide abortion
timeFrame: Up to 15 months. Each participant will be interviewed once, between January and March 2013 or between September 2013 through March 2014.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01035073: Functional Change and Efficacy of Duloxetine in Patients With Co-Morbid Depression & Soft Tissue Discomfort Syndrome
Official title: Functional Change and Efficacy of Duloxetine in Patients With Major Depression and Co-Morbid Soft Tissue Discomfort Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Soft Tissue Discomfort Syndrome
Pain
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2009-12-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the time course of duloxetine efficacy on the symptoms of Major Depressive Disorder (MDD)and on the symptoms of Soft Tissue Discomfort Syndrome(STDS) via use of 24-hour Actigraph™ measures.

We hypothesize that there will be a reduction in both MDD and STDS symptoms in MDD patients with co-morbid STDS symptoms. We further hypothesize that there will be a rapid improvement in functional outcome ratings and 24-hour activity in MDD patients with co-morbid STDS symptoms which may occur even before the antidepressant effect is observed.


Eligibility criteria: Inclusion Criteria:

* \> 17 years old
* All races and ethnicity
* DSM IV-TR Axis I diagnosis of MDD
* Co-morbid STDS
* Baseline 17-item Hamilton Depression Rating \> 13

Exclusion Criteria:

* Primary Axis I disorder other than MDD
* History of mania or psychosis
* Actively suicidal
* Required hospitalization
* A alcohol or substance abuse or dependence within the preceding 3 months
* Pregnant or nursing
* Unstable medical condition (other than STDS)
* Narrow-angle glaucoma
* Sensitivity to duloxetine, concurrent antidepressant, tranquilizer, or mood stabilizer use
* Hepatic or renal insufficiency

Primary outcomes:
measure: 24-hour Activity Level
timeFrame: Baseline and Week One of Treatment
Secondary outcomes:
measure: Functional Symptom Questionnaire
timeFrame: Baseline; Week 6 and Week 8 of Treatment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Depression Research Unit, University of Pennsylvania School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jay D Amsterdam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01440673: Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: Postoperative Nausea and Vomiting
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
name: University of California, San Francisco
First posted: 2011-09-26
Enrollment: 150
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: * Gynecological surgery is associated with a high incidence of postoperative nausea and vomiting.
* NK1 receptor antagonists such as aprepitant appear to be highly effective for treating acute and delayed emesis, and yet understanding of the efficacy of different doses of aprepitant is limited.
* We performed a prospective, randomized, double-blinded placebo-controlled study of 123 female adults scheduled for laparoscopic hysterectomy who received 80 mg aprepitant, 125 mg aprepitant, or a placebo.

Detailed description: 123 female patients (ages 21-60) undergoing laparoscopic hysterectomy

1. 80mg aprepitant
2. 125mg aprepitant
3. placebo

Incidences of nausea, vomiting/retching, and use of rescue antiemetics were recorded at 0, 1, 2, 24, and 48 h after surgery.

Eligibility criteria: Inclusion Criteria:

* female laparoscopic hysterectomy isoflurane anesthesia postoperative opioid use

Exclusion Criteria:

* liver disease neurologic disease active pulmonary disease cardiac arrhythmia allergies to any perioperative medications

Primary outcomes:
measure: The numbers (and percentages) of patients who experienced complete response
timeFrame: 48 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Inchon
country: Korea, Republic of
facility: Gil Medical Center Gachon University
Study officials:
affiliation: Gil Medical Center Gachon University
name: WOL SEON JUNG, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: