louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00704717: Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301)
Official title: Evaluation of Satisfaction in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 185
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hepatitis C under treatment with PegIntron Pen plus Rebetol therapy at approximately 70 sites in Romania.

Brief summary: The objective of this study is to evaluate patient satisfaction in hepatitis C patients receiving PegIntron pen plus Rebetol. The rationale is that the effectiveness of treatment is correlated with adherence to the prescribed regimen which, in turn, is affected by the ease of use and accuracy of treatment administration. Since the PegIntron pen is a novel device, the results of this study will be used to improve the training of patients and healthcare providers in PegIntron pen use.


Eligibility criteria: Inclusion Criteria:

* Patients with hepatitis C under treatment with PegIntron Pen and Rebetol in Romania.

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey.
timeFrame: The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01111617: Applications of Realtime Functional Magnetic Resonance Imaging (fMRI )
Official title: Applications of Realtime fMRI Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-04-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this research program is to determine the potential effectiveness of real-time fMRI training in improving mental control over pain.

Detailed description: A research study that looks at pain and how you experience pain. This research project aims to use virtual reality-based real-time functional Magnetic Resonance Imaging (rtfMRI) to assess brain activation during the experience of pain and while subjects attempt to mentally control their pain response.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Chronic Pain patient or healthy control
* Ability to perform the experimental task

Exclusion Criteria:

* MRI contraindication (metal implants, claustrophobia, pregnant or planning to become pregnant)
* History of psychiatric disorder (at the discretion of the investigator as to whether it interferes with the experimental task)
* History of Blistering

Primary outcomes:
measure: Pain reduction as measured by visual analog scale (VAS) pain report
timeFrame: Within the 2 hour feedback session
Secondary outcomes:
measure: Control of brain activity as measured by fMRI analysis
timeFrame: Within the 2 hour feedback session
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Sean Mackey
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05024617: Stage-Specific Recovery Changes in the International Classification of Functioning Components Following Conservative Rehabilitation of Trigger Finger
Official title: Stage-Specific Recovery Changes in the International Classification of Functioning Components Following Conservative Rehabilitation of Trigger Finger
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trigger Finger
Keywords: trigger finger
ICF
rehabilitation
splinting
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 34
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diagnosed with Stage 1, Stage 2 and Stage 3 trigger finger based on the Froimson Classification

Brief summary: The aim of this study was to determine the effectiveness of conservative rehabilitation on the multi-dimensional health components based on WHO ICF model in Stage 1, Stage 2 and Stage 3 trigger finger and to determine the functional recovery patterns of each dimension during a three-month rehabilitation period. Thirty-four patients were participated in the study.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Stage 1, Stage 2 and Stage 3 trigger finger based on the Froimson Classification

Exclusion Criteria:

* Paediatric trigger finger, trigger thumb, concomitant de'Quervain tenosynovitis, carpal tunnel syndrome, or Dupuytren's contracture, neurological or rheumatological diseases, chronic pain syndromes, pregnancy and patients with treatment history of related finger/fingers.

Primary outcomes:
measure: Pain (VAS)
timeFrame: one month
measure: Number of triggering (ten active fist test / 30 second active fist test)
timeFrame: one month
measure: Grip strength (hand dynomometer and pinchmeter)
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Physical Therapy and Rehabilitation
Study officials:
affiliation: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
name: Seda Namaldi, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06067217: Comparative Study of Tranexamic Acid, Estrogen for Treatment AUB in DMPA Users
Official title: Comparative Study of Tranexamic Acid, Estrogen for Treatment Abnormal Uterine Bleeding in Depot-medroxyprogesterone Acetate Users. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abnormal Uterine Bleeding
Tranexamic Acid
Estrogen
Depot Medroxyprogesterone Acetate
Keywords: AUB
DMPA
Tranexamic acid
Estrogen
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2023-10-04
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Abnormal uterine bleeding is the most common problems to discontinue Depo-medroxyprogesterone acetate (DMPA) in Thailand. This clinical trial use to provide drug to stop abnormal uterine bleeding from DMPA

Detailed description: Abnormal uterine bleeding is the most common problems to discontinue Depo-medroxyprogesterone acetate (DMPA) in Thailand. After discontinue DMPA, patients have not used any method. Unwanted pregnancy are rising. The reason of abnormal uterine bleeding from DMPA aren't clearly understand. In present, no standard treatment to treat abnormal utrerine bleeding in DMPA users.This clinical trial use to provide drug to stop abnormal uterine bleeding from DMPA with minimal dose and minimal side effect

Eligibility criteria: Inclusion Criteria:

* Abnormal uterine bleeding more than 7 days after first DMPA injection
* Provide inform consent with patient
* Can understand thai language

Exclusion Criteria:

* Have contraindication to use Tranexamic acid and estrogen such as hypertension, Stroke, MI, DM, Renal disease, Liver disease, CA breast etc.
* Have pathology in uterus from pelvic examination, pap smear and ultrasound
* Current pelvic infection
* Postpartum less than 6 months
* History deep vein thrombosis
* Breastfeeding

Primary outcomes:
measure: Day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen
timeFrame: 1 week after intervention
Secondary outcomes:
measure: Side effect after receiving Tranexamic acid
timeFrame: 1 week after intervention
measure: Side effect after receiving estrogen
timeFrame: 1 week after intervention
measure: Frequency of bleeding after DMPA injection
timeFrame: after DMPA injection
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Krittiporn Mahachiraphat
state: Ratchathewi
city: Phaya Thai
country: Thailand
facility: Krittiporn Mahachiraphat, M.D.
state: Ratchathewi
Study officials:
References:
Clinical trial NCT02917317: South China Prospective Cohort Study of Chronic Disease
Official title: South China Prospective Cohort Study of Chronic Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Disease
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 110000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: aged 35-74 years local residents or lived in local for 5 years more,no gender perfomance

Brief summary: To investigate the risk factors and prediction biomarkers of chronic disease in adults aged 35-74 years.

Detailed description: To investigate the risk factors and prediction biomarkers of chronic disease within adults aged 35-74 years in South China. Following up the incidence of major chronic disease including stroke, coronary heart disease, cancer, chronic obstructive pulmonary disease, diabetes and hypertension.

Eligibility criteria: Inclusion Criteria:

aged 35-74 years local residents or lived in local for 5 years more

Exclusion Criteria:

Malignancy Cognitive impairment that can not cooperate with investigation

Primary outcomes:
measure: Incidence of chronic disease
timeFrame: 4 years or more
Secondary outcomes:
measure: Outcome of chronic disease
timeFrame: 4 years or more
measure: Death
timeFrame: 4 years or more
measure: Incidence of other disease
timeFrame: 4 years or more
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)
state: Guangdong
Study officials:
affiliation: School of Public Health,Nutrition and Food Hygiene,Sun Yat-sen University
name: Fan J Hua, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03120117: Importance of Patient Positioning at Cough Test When Considering Success Following Sling Procedures
Official title: Importance of Patient Positioning at Cough Test When Considering Success Following Sling Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Midurethral Slings
Lead sponsor: Michigan Institution of Women's Health PC
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 87
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective study to assess the feasibility and success of performing an intra-operative standing cough test and the correlation with the long term success of the sling surgery.

Detailed description: The goal is to seek correlation or disparity between the supine versus the sitting cough test, supine (lying down) versus standing cough test and sitting versus the standing cough test performed at a constant bladder volume; empty in the office and full in the operating room. Secondary objective is to test if the intra-operative standing cough test at fullness correlates with long term success of the sling surgery.

Eligibility criteria: Inclusion Criteria:

* Patients who present with stress-dominant urinary incontinence
* Patients who have undergone a stress test documentation both in the supine and standing/sitting position.
* Patients who have completed child bearing.
* Patients between 21 and 89 years of age.

Exclusion Criteria:

* Patients who do not agree to participate and do not sign the informed consent.
* Patients undergoing concomitant surgery
* Patients undergoing surgery under anesthesia.

Primary outcomes:
measure: Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative cough test.
timeFrame: Within first two years following sling procedure
measure: Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative MESA questionnaire.
timeFrame: Within first two years following sling procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Dearborn
country: United States
facility: Advanced Urogynecology of Michigan, P.C.
state: Michigan
Study officials:
affiliation: Michigan Institute of Women's Health
name: Salil Khandwala, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04395534: Non-microradical Resection Margin as a Predictor for Recurrence After Complete Mesocolic Excision
Official title: Non-microradical Resection Margin as a Predictor for Recurrence After Complete Mesocolic Excision: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 276
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: Patients undergoing elective curative intended complete mesocolic excision for primary colon adenocarcinoma at Nordsjællands Hospital in Hillerød, Denmark

Brief summary: The study aim to investigate the value of the current definition of microradical resection margin in colon cancer. Is the distance from tumor tissue to resection margin and the site of any clinically prognostic importance if complete mesocolic excision has been performed.


Eligibility criteria: Inclusion Criteria:

* Undergoing elective curative intended complete mesocolic excision for primary colon adenocarcinoma at Nordsjællands Hospital in Hillerød, Denmark
* International Union Against Cancer (Union Internationale Contre le Cancer - UICC) stage III - pT1-4, pN1-2 cM0 (gastroepiploic and infrapyloric lymph node metastases are not considered as distant metastases)
* Resident in Denmark at the time of surgery.

Exclusion Criteria:

* Patients who did not undergo macroradical resections
* Synchronous colorectal cancer
* Venous invasion at central venous ligation.

Primary outcomes:
measure: Recurrence
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gundestrup AK, Olsen ASF, Ingeholm P, Bols B, Kleif J, Bertelsen CA. Nonmicroradical Resection Margin as a Predictor of Recurrence in Patients With Stage III Colon Cancer Undergoing Complete Mesocolic Excision: A Prospective Cohort Study. Dis Colon Rectum. 2022 May 1;65(5):683-691. doi: 10.1097/DCR.0000000000001996.
Clinical trial NCT01027234: This Study Will Assess the Safety and Tolerability of AZD8418 After Single Increasing Oral Doses
Official title: A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Single-ascending Dose, First Time Into Man Study to Assess the Safety, Tolerability, and Pharmacokinetics (Part A) and an Open-label Assessment of the Effect of Food on the Pharmacokinetics (Part B) of Orally Administered AZD8418
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-12-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to assess the safety and tolerability of AZD8418 after single increasing oral doses.

Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves the body and how your body acts on the study drug) of AZD8418. Part B of the study will assess the effect of food on the safety and pharmacokinetics of AZD8418.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers
* Healthy female volunteers of non-childbearing potential

Exclusion Criteria:

* History of any clinically significant medical, neurologic, or psychiatric disease (including repeated episodes of major depression) or a disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD8418

Primary outcomes:
measure: To assess the safety and tolerability of AZD8418 following the oral administration of single ascending doses and to estimate the maximum tolerated dose in healthy volunteers.
timeFrame: Safety assessments will be obtained daily throughout the study
Secondary outcomes:
measure: To characterise the pharmacokinetics of AZD8418 and its metabolites in plasma and urine, and provisionally assess the dose proportionality of the pharmacokinetics following administration of single ascending doses of AZD8418.
timeFrame: samples will be obtained pre and post dose
measure: To assess the effect of food on the safety and pharmacokinetic profile of AZD8418 and its metabolites.
timeFrame: samples will be obtained pre and post dose
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: Quintiles, Inc.
name: Philip T. Leese, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004334: Study of Depression, Peptides, and Steroids in Cushing's Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cushing's Syndrome
Keywords: Cushing's syndrome
endocrine disorders
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of Michigan
First posted: 1999-10-19
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Study the relationship between dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis and disorders of mood, vegetative function, and cognition in patients with Cushing's disease.

II. Identify subgroups of patients with Cushing's disease who differ in the presence and severity of the depressive syndrome, and uncover HPA axis dysregulation differences among them using corticotropin-releasing hormone, metyrapone, and dexamethasone challenge testing.

Detailed description: PROTOCOL OUTLINE: All patients receive a psychiatric evaluation at baseline, as well as assessments of plasma adrenocorticotropin, beta lipotropin, beta endorphin, and cortisol, and urinary cortisol. Peptide and steroid assays are performed, alone and in response to corticotropin-releasing hormone, metyrapone, and dexamethasone. Patients are given sleep electroencephalograms at baseline and 1 year following treatment.

A weight maintenance diet is prescribed for all patients.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

* Patients aged 20 to 60 with spontaneous active Cushing's syndrome
* At least 2 weeks since medication with psychoactive effects or influence on cortisol metabolism by hepatic hydroxylating enzyme induction
* Antihypertensives allowed for severe hypertension
* No barbiturates
* No phenytoin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
Study officials:
affiliation: University of Michigan
name: Monica N. Starkman
role: STUDY_CHAIR
References:
Clinical trial NCT00529334: A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast
Official title: A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast for Women With Stage 0, 1, or IIA (<=3cm) Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Partial breast irradiation
Radiosurgery
CyberKnife
Radiotherapy
PBI
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2007-09-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the CyberKnife in anticipation of a larger multi-institutional Phase II study. It will evaluate quality of life (QOL) issues as they relate to treatment related side effects, cosmetic result, and patient convenience.

Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed within 7 weeks of lumpectomy and sentinel/axillary node sampling over a period of five to ten days using the CyberKnife (CK). Subjects will receive CK before chemotherapy, if applicable.


Eligibility criteria: Inclusion Criteria:

* DCIS or infiltrating ductal carcinoma of the breast \<= 3cm
* margins clear by at least 2 mm
* age \>=45 years

Exclusion Criteria:

* invasive lobular carcinoma
* multicentric disease
* nodal metastases
* breast implants
* pregnancy
* connective tissue disease

Primary outcomes:
measure: 1. To evaluate the feasibility of CyberKnife body radiosurgery as the sole radiation therapy for this patient population 2. To evaluate the complication rate of CyberKnife body radiosurgery as the sole radiation therapy for this patient population
timeFrame: 1 year
Secondary outcomes:
measure: 1. To evaluate the local control rate of CyberKnife body radiosurgery as the sole radiation therapy for this patient population. 2. To evaluate Quality of Life after CyberKnife body radiosurgery PBI.
timeFrame: 1 - 5 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgtown University Medical Center
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Jefferson EC Moulds, MD
role: PRINCIPAL_INVESTIGATOR
References: