louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02092831: A Study of the Effect of Formulation and Tablet Hardness on the Bioavailability of Pictilisib in Healthy Volunteers
Official title: A PHASE 1, OPEN-LABEL STUDY TO EVALUATE THE EFFECT OF FORMULATION AND TABLET HARDNESS ON THE RELATIVE BIOAVAILABILITY OF PICTILISIB (GDC-0941) IN HEALTHY SUBJECTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This Phase 1, open-label, randomized, 4-period crossover study is designed to determine the relative bioavailability of GDC-0941 administered as a single dose of the market image formulation at 3 different hardnesses (hardness 1, 2, and 3) and as a single dose of the Phase 2 formulation to healthy male and female volunteers. Participants will be randomly assigned to 4 possible treatment sequences, each comprising 4 periods (1 per formulation), and GDC-0941 will be administered based on the assigned sequence. The study is expected to last 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Male and female participants between 18 and 55 years of age, inclusive,
* Body mass index (BMI) between 18.5 to 32 kg/m2, inclusive,
* Healthy, as determined by no clinically significant findings from medical history, ECG, and vital signs, and who are able to swallow and tolerate a tethered Heidelberg pH Capsule and have gastric pH measurements taken

Exclusion Criteria:

* Any medical condition or history of such condition that may, in the opinion of the investigator, contraindicate participation in this study

Primary outcomes:
measure: Area under the concentration-time curve (AUC) of plasma GDC-0941
timeFrame: 25 Days
measure: Maximum plasma concentration (Cmax) of GDC-0941
timeFrame: 25 Days
measure: Relative bioavailability (Frel) according to the model independent approach
timeFrame: 25 days
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 25 days
measure: Electrocardiogram (ECG)
timeFrame: 25 days
Other outcomes:
Locations:
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00544531: The Cytogenetic Constitution of Embryos Resulting From Immature Oocytes (M1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: MI oocytes, FISH,chromosomal aberrations
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-10-16
Enrollment: 23907
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: To examine the chromosomal number content in the blastomeres of embryos achieved from fertilization of immature oocytes at MI stage recruited following COH for IVF.

comparison of the genetic number content of embryos and their quality in terms of cleavage rate and morphological score reached after fertilization of immature oocytes at MI stage whether arrested at the MI stage or extruded the polar body, after in vitro maturation for a variable length of time.

Detailed description: Patients undergoing routine IVF, following informed consent, donated some of their unusable, immature- MI stage oocytes for our research. Following in vitro maturation for up to 2, 4, 8 and 24 hours after harvest, all immature oocytes in these 4 study groups underwent intracytoplasmic donor sperm injection (ICSI), whether they extruded their polar body (MI-PB or rescued MI) or not (arrested MI). Oocyte fertilization rate after 24 hours and embryonic development in terms of cleavage rate and morphology were assessed, for another 48 hours. Then the whole embryo was prepared for molecular cytogenetic evaluation using FISH (Fluorescence in situ hybridization) analysis of chromosomes x, y and 18.

Eligibility criteria: Inclusion Criteria:

* Patients with presence of immature oocytes after ART stimulation

Exclusion Criteria:

* Patients with less than total 7 oocytes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Infertility unit,Assaf-Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Raphael Ron-el, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02237131: Continuous Versus Cyclic Oral Contraceptives for Endometriosis
Official title: Continuous Versus Cyclic Use of Oral Contraceptives Following Surgery for Symptomatic Endometriosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dysmenorrhea
Pelvic Pain
Dyspareunia
Endometrioma
Keywords: Endometriosis
Oral contraceptives
Laparoscopy
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2014-09-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To evaluate the efficacy of oral contraceptives in a continuous fashion versus the usual cyclic fashion in the recurrence of endometriosis related symptoms and endometriomas following fertility-sparing surgery.

Detailed description: Oral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for 21 days followed by 7 days pill free (cyclic fashion) or one tablet a day in a continuous fashion.

Eligibility criteria: Inclusion Criteria:

Women of reproductive age with Symptomatic endometriosis following fertility sparing surgery

Exclusion Criteria:

Contraindications of use of oral contraceptives

Primary outcomes:
measure: Pelvic pain
timeFrame: 6 months
Secondary outcomes:
measure: recurrence rate for endometrioma
timeFrame: 6 months
Other outcomes:
measure: dysmenorrhea
timeFrame: 6 months
Locations:
city: Athens
country: Greece
facility: Aretaieion Hospital
Study officials:
affiliation: University of Athens, 2nd Department of Obstetrics and Gynecology
name: Nikos Vlahos, AssProfessor
role: STUDY_CHAIR
affiliation: University of Athens, 2nd Department of Obstetrics and Gynecology
name: Olga Triantafyllidou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05429931: Reliability and Validity of Urdu Version of Ronald Morris Disability Questionnaire in Patients With Low Back Pain
Official title: Urdu Version of The Ronald Morris Disability Questionnaire in Patients With Low Back Pain : Assessing Its Psychometric Properties and Cultural Adaptation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: Ronald Morris Disability Questionnaire
Urdu Version
Reliability
Validity
Low Back Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pakistani population with Chronic Low back pain.

Brief summary: Purpose of this Research is to convert Ronald Morris Disability Questionnaire into Urdu language and check the accuracy and logic in Pakistani low back pain population. Also check its correlation with Oswestry Disability Index and Visual Analogue Scale.

Detailed description: The Ronald Morris Disability Questionnaire will be translated into Urdu and culturally adapted for people with low back pain. Ronald Morris Disability Questionnaire will be given to 80 people who will be chosen by using a convenient sampling method. Method of sampling based on pre-determined inclusion and exclusion criteria. To examine intra-observer reliability of the final Ronald Morris Disability Questionnaire, two observers will fill out Oswestry Disability Index and Visual Analogue Scale questionnaires on the same day to test inter-observer evaluation. After 30 minutes of the initial treatment, the second application will be applied. The first observer will do the third assessment after seven days. Statistical Package of Social Sciences Version 24 will be used to enter and analyse data. The alpha value of Cronbach's alpha will be examined.

Eligibility criteria: Inclusion Criteria:

* Average Age of patient 48 years.
* Patient with chronic low back pain have at least 3 month duration .
* Patient with mechanical Low Back Pain

Exclusion Criteria:

* Patient with non - mechanical Low Back Pain
* Patient have neurological deficits .

Primary outcomes:
measure: Roland-Morris Disability Questionnaire
timeFrame: 1st day
measure: Oswestry Disability Index
timeFrame: 1st day
measure: Visual Analogue Scale
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT02944331: 3-4 Year Outcomes Following Endovenous Steam Ablation for Venous Insufficiency
Official title: 3-4 Year Outcomes Following Endovenous Steam Ablation of the Saphenous Veins for the Treatment of Venous Insufficiency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Varicose Veins
Keywords: Steam ablation
Endothermal ablation
Varicose vein treatment
Venous insufficiency
Saphenous vein reflux
Recurrent varicosity
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 200
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: Patients who received steam ablation for treatment of saphenous vein reflux (clinical classes C2-C4) 3-4 years prior to study enrollment

Brief summary: The aim of this study is to evaluate the long-term effects of endovenous steam ablation (EVSA). Postoperative data at 3-4 year follow-up will be collected from patients treated with EVSA.

Detailed description: Endovenous steam ablation (EVSA) of saphenous veins (saphenous vein reflux) is one of the endothermal methods in the modern treatment of venous insufficiency. Good results and long-term follow-up have been published for endovenous laser ablation (EVLA) and radiofrequency ablation (RFA), while long-term effects of EVSA are less documented. Therefore, the aim of this study is to evaluate the effect of EVSA in 200 consecutive patients treated with EVSA and conduct prospective evaluations at 3-4 year follow-up. Standardized and validated measures will be compared to preoperative measures to evaluate change in patient-reported and clinical outcomes over time.

Eligibility criteria: Inclusion Criteria:

* Received steam ablation for treatment of saphenous vein reflux (clinical classes C2-C4) at Lovisenberg Diakonale Hospital 3-4 years (i.e, 36-48 months) prior to study enrollment.
* Ability to speak, understand, read, and write Norwegian in order to complete follow-up exams and questionnaires.

Exclusion Criteria:

* \<18 years of age

Primary outcomes:
measure: Vein obliteration or abolition of reflux
timeFrame: 3-4 years after treatment
Secondary outcomes:
measure: Recurrent varicosities
timeFrame: 3-4 years after treatment
measure: Recanalization
timeFrame: 3-4 years after treatment
measure: Venous Clinical Severity Score
timeFrame: 3-4 years after treatment
measure: Aberdeen Varicose Vein Questionnaire
timeFrame: 3-4 years after treatment
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lovisenberg Diakonale Hospital
Study officials:
References:
Clinical trial NCT06342531: More Effective Violence Risk Management - eDASA+APP FI
Official title: More Effective Violence Risk Management for Psychiatric Wards - eDASA+APP FI
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Violence
Keywords: violence risk assessment
DASA
Dynamic Appraisal of Situational Aggression
mental health nursing
EPIC
electronic health records
violence risk management
inpatient psychiatric care
coercive measures
clinical decision support system
CDSS
co-design
nurse-patient collaboration
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
First posted: 2024-04-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A pre-post design (quasi-experimental), a cluster design
Primary purpose: SCREENING

Brief summary: The main goal of this study is to evaluate if the Finnish version of eDASA+APP (electronic Dynamic Appraisal of Situational Aggression + Aggression Prevention Protocol), a clinical decision support system (CDSS), has an impact on reducing workplace violence, use of coercive measures and increasing nurses' job satisfaction in adult psychiatric inpatient care.

Detailed description: The study includes three phases: 1) exploring attitudes of nurses and nurse managers towards validated tools, violence risk assessment and management, 2) a pre-implementation including a co-design process of the eDASA+APP to ensure optimal integration and adaptation to local context and integration into the local EPIC based EHR system together with relevant stakeholders (health care staff and expert-by-experience), and 3) a quasi-experimental implementation study to evaluate the impact of the intervention (eDASA+APP FI).

Eligibility criteria: Inclusion Criteria:

* adult psychiatric wards

Exclusion Criteria:

* psychiatric wards specialized only for the care of people with intellectual disabilities, wards providing care for both adults and underaged patients (eating disorder units)

Primary outcomes:
measure: Workplace violence
timeFrame: Pre-post (3 months)
Secondary outcomes:
measure: Coercive measures
timeFrame: Pre-post (3 months)
measure: Job satisfaction
timeFrame: Pre-post (3 months)
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUS University Hospital
Study officials:
affiliation: Department of Nursing Science, University of Turku, Finland
name: Tella Lantta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Griffith JJ, Meyer D, Maguire T, Ogloff JRP, Daffern M. A Clinical Decision Support System to Prevent Aggression and Reduce Restrictive Practices in a Forensic Mental Health Service. Psychiatr Serv. 2021 Aug 1;72(8):885-890. doi: 10.1176/appi.ps.202000315. Epub 2021 May 17.
Clinical trial NCT05432531: Efficiency of Use of Baracetinib in Treatment of Lupus Nephritis
Official title: Efficiency of Baracetinib to Induce Remission of Active Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lupus Nephritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with systemic lupus erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with systemic lupus erythematosus and had a diagnosis of systemic lupus erythematosus, and had active renal disease as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug.

Detailed description: Patients with systemic lupus erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with systemic lupus erythematosus and had a diagnosis of systemic lupus erythematosus, and had active renal disease as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug.

The baricitinib 4 mg dose suggestive to significantly improved the signs and symptoms of active systemic lupus erythematosus in patients who were not adequately controlled despite standard of care therapy, with a safety profile consistent with previous studies of baricitinib. This study provides the idea for future trials of JAK1/2 inhibition with baricitinib as a new potential oral therapy for

Eligibility criteria: Inclusion Criteria:

* lupus nephritis

Exclusion Criteria:

* cardiac disease Thrombosis

Primary outcomes:
measure: Album in urine
timeFrame: 6 months
Secondary outcomes:
measure: complement 3
timeFrame: 3 and 6 months
measure: anti double strand DNA
timeFrame: 3 and 6 months
measure: lupus activity index-2K
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Manal Hassanien
state: Assuit
Study officials:
affiliation: Associate professor
name: Manal M Hassanien, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02030431: Dynaloc for Treatment of Femoral Neck Fractures
Official title: Dynaloc vs. Multiple Cancellous Screws for Treatment of Femoral Neck Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Femoral Neck Fracture
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, randomized study comparing the effectiveness of a new system, Dynaloc compared with three cancellous screws, for osteosynthesis of femoral neck fractures


Eligibility criteria: Inclusion Criteria:

* Adult men or women (see age specifications below) with subcapital femoral neck fractures (stable or unstable) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
* Patients between 50 and 69 years of age with any Garden type femoral neck fracture
* Patients older than 70 years of age with femoral neck fractures Garden type I and II
* Patients older than 70 years of age with a femoral neck fracture Garden types III and IV and contraindication to hemiarthroplasty.
* Operative treatment within 4 days (i.e., 72 hours) of presenting to the emergency room.
* Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
* Anticipated medical optimalization of the patient for operative fixation of the hip.
* Provision of informed consent by patient or proxy.
* Low energy fracture (defined as a fall from standing height).
* No other major trauma.

Exclusion Criteria:

* Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
* Retained hardware around the affected hip.
* Abnormal opposite hip making end-point evaluation impossible
* Infection around the hip (i.e., soft tissue or bone).
* Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy).
* Moderate or severe cognitively impaired patients (i.e., Six Item Screener with three or more errors).
* Patients with Parkinson's disease (or dementia or other neurological deficit) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
* Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.

Primary outcomes:
measure: Shortening of the femoral neck
timeFrame: 1 year
Secondary outcomes:
measure: Reoperation
timeFrame: 1 year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT01263431: Comparison Between Excisional Hemorrhoidectomy and Haemorrhoidal Dearterialisation With Anopexy
Official title: Prospective Randomized Trial on Surgical Treatment of Grade 3 Hemorrhoids: Hemorrhoidectomy Versus Doppler-guided Transanal Haemorrhoidal Dearterialisation and Anopexy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Third Degree Hemorrhoids
Keywords: Hemorrhoidectomy, haemorrhoidal dearterialisation, anopexy
Lead sponsor: Scientific Institute San Raffaele
Sponsor class: OTHER
First posted: 2010-12-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study is to compare short term results of 2 surgical treatment for grade 3 hemorrhoidal disease, namely: pain and postoperative morbidity,complications and effectiveness within 30 days, re-starting daily and working activity, patients' satisfaction

Detailed description: Excisional haemorrhoidectomy is burdened by severe postoperative pain. For this reason less painful treatments have been developed, such as Doppler-guided haemorrhoidal artery ligation and stapled anopexy. Both techniques seem to be safe, causing little postoperative pain. A combination of the two techniques could possibly treat both bleeding and prolapse with minimal discomfort

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-80, candidate to surgery for 3rd degree hemorrhoids

Exclusion Criteria:

* Previous anal surgery or pelvic radiotherapy
* Fecal incontinence or obstructed defecation
* IBD, IBS

Primary outcomes:
measure: postoperative pain
timeFrame: 1 week
Secondary outcomes:
measure: postoperative morbidity
timeFrame: 30 days
measure: resumption of working activity
timeFrame: 30 days
measure: patient's satisfaction
timeFrame: 30 days
measure: Relapse
timeFrame: 24 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: San Raffaele Scientific Institute
Study officials:
affiliation: San Raffaele Scientific Institute
name: Paola De Nardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Nardi P, Capretti G, Corsaro A, Staudacher C. A prospective, randomized trial comparing the short- and long-term results of doppler-guided transanal hemorrhoid dearterialization with mucopexy versus excision hemorrhoidectomy for grade III hemorrhoids. Dis Colon Rectum. 2014 Mar;57(3):348-53. doi: 10.1097/DCR.0000000000000085.