louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00750425: Phase 1 Study of the Effect of Ketoconazole on the PK of Multiple Doses of Cediranib in Patients With Solid Tumours
Official title: A Phase I, Open Label, Non-Randomised Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTINÔ), in Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: advanced cancer,
metastatic
ketoconazole
pharmacokinetics
Phase I
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase I, open study to assess the effect of ketoconazole, a marketed drug, on the way the body handles the experimental drug cediranib, in patients with advanced cancer.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Histological or cytological confirmation of advanced solid tumour (with the exception of prostate cancer), which is refractory to standard therapies or for which no standard therapy exists.
* Estimated life expectancy of at least 8 weeks
* WHO performance status (PS) 0-2.

Exclusion Criteria:

* Unstable brain/meningeal metastases
* Biochemistry/haematology results outside of required ranges
* History of significant GI impairment
* Inadequate bone marrow reserve

Primary outcomes:
measure: To assess the steady-state PK parameters of cediranib in the presence and absence of ketoconazole.
timeFrame: PK assessments to be taken until Day 42. Days 7 and 10 PK parameters used to assess the primary variables.
Secondary outcomes:
measure: Safety and tolerability of cediranib in the presence of ketoconazole by assessment of Adverse events (AEs) Laboratory findings,Vital signs, physical examination and Electrocardiogram.
timeFrame: Until study drug is discountinued
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Research Site
city: Toronto
country: Canada
facility: Research Site
city: Vancouver
country: Canada
facility: Research Site
city: Herlev
country: Denmark
facility: Research Site
city: Kobenhavn
country: Denmark
facility: Research Site
Study officials:
affiliation: AstraZeneca Aderley Park
name: Jane Roberston
role: STUDY_DIRECTOR
affiliation: The Finsen Center, Copenhagen, Denmark
name: Dr U Lassen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04499625: Lateral Window Versus Intralift™ Sinus Floor Elevation
Official title: Intraoperative and Postoperative Outcomes of Sinus Floor Elevation Using Lateral Window Technique Versus Hydrodynamic Transalveolar Approach: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Outcomes
Postoperative Outcomes
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several approaches have been used in order to regenerate bone in the upper jaw in case of insufficient alveolar bone height for implant placement. However, new emerging techniques need to be assessed and compared to conventional methods in order to define their potential indications.

The purpose of the present randomized controlled clinical trial was to compare the clinical outcomes of two sinus floor elevation techniques: conventional lateral window technique versus a novel transalveolar approach using hydrodynamic ultrasonic device.


Eligibility criteria: Inclusion Criteria:

* edentulism in the posterior maxilla (unitary or plural)
* need of a sinus floor augmentation procedure before implant placement

Exclusion Criteria:

* any uncontrolled systemic disease
* ongoing chemo- or radiotherapy
* history of maxillary sinus diseases or acute sinus-related issues

Primary outcomes:
measure: Sinus membrane perforation
timeFrame: During the surgery (from beginning to end)
measure: Surgical procedure duration
timeFrame: From beginning of surgery until the end of surgery
measure: Edema
timeFrame: From the end of surgery up to 1 week postoperatively
measure: Hematoma
timeFrame: From the end of surgery up to 1 week postoperatively
measure: Postsurgical bleeding
timeFrame: From the end of surgery up to 1 week postoperatively
measure: Nasal discharge
timeFrame: From the end of surgery up to 1 week postoperatively
measure: NSAID consumption
timeFrame: From the end of surgery up to 1 week postoperatively
measure: Patient related outcome measures (PROMs)
timeFrame: From right before the surgery up to 1 week postoperatively
Secondary outcomes:
measure: Radiographic outcomes
timeFrame: From the baseline (surgery procedure) up to 1 year post-surgery
measure: Implant survival rates
timeFrame: From the baseline (surgery procedure) up to 1 year post-surgery
Other outcomes:
Locations:
Study officials:
References:
citation: Bacevic M, Compeyron Y, Lecloux G, Rompen E, Lambert F. Intraoperative and postoperative outcomes of sinus floor elevation using the lateral window technique versus the hydrodynamic transalveolar approach: a preliminary randomized controlled trial. Clin Oral Investig. 2021 Sep;25(9):5391-5401. doi: 10.1007/s00784-021-03847-2. Epub 2021 Mar 10.
Clinical trial NCT03353025: Study on Therapy of Non-invasive Prolactinoma
Official title: Prospective Randomized Clinical Study on Transsphenoidal or Dopamine Drugs Therapy Treat Non-invasive Prolactinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prolactinoma
Keywords: non-invasive prolactinoma
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 394
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: the study aim to investigate the endocrine remission rate of non-invasive prolactinoma between transsphenoidal surgery treatment and Dopamine agonist treatment.

Detailed description: Non-invasive prolactinomas were treated by transsphenoidal surgery or Dopamine agonist until now. However，this two type therapies were controversial. The study aim to investigate the endocrine remission rate of non-invasive prolactinoma between transsphenoidal surgery treatment and Dopamine agonist treatment.

Eligibility criteria: Inclusion Criteria:

non-invasive prolactionma

Exclusion Criteria:

invasive prolactioma

Primary outcomes:
measure: Endocrine remission rate
timeFrame: five-year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen 5010 program
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Haijun Wang, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT03538925: Building Sentences With Preschoolers Who Use AAC
Official title: Word by Word: Building Sentences With Preschoolers Who Use AAC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Down Syndrome
Speech and Language Disorder
Speech Disorders in Children
Speech Intelligibility
Speech Sound Disorder
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: University of New Mexico
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2018-05-29
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The focus of this investigation is to compare the effectiveness of the AAC Generative Language Intervention approach to an AAC Standard of Care condition on preschool sentence productions. All children will use existing AAC iPad applications.

Detailed description: The central hypothesis is that preschoolers receiving AAC Generative Language Intervention will create longer, more grammatically complete sentences compared with the Standard of Care condition. Specific Aim 1 compares these interventions for preschoolers with severe speech impairments and typical receptive language, and Specific Aim 2 does the same for children with Down syndrome. Specific Aim 3 tests for possible moderation of the intervention effect by age, dynamic assessment scores, sentence type, receptive language abilities, prior AAC use, sex, mental age, and disability. Aims 1 and 2 will be accomplished using randomized controlled trials.

Eligibility criteria: Inclusion Criteria:

* Clinical Identification of Significant Speech Impairment
* Must Speak English as a Primary Language
* Must Be Able to Express At Least 25 Words (using any communication mode)
* Must Be Able to Accurately Select Picture Symbols on iPad Communication App with at Least 50% Accuracy
* Vision and Hearing within Functional Limits or Corrected to be within Functional Limits for Study Activities

Exclusion Criteria:

* Clinical Diagnosis of Autism or Social Communication Disorder
* Primary Language Spoken is a Language Other than English

Primary outcomes:
measure: Aided AAC Utterance Length
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: FAAST Center at the University of Central Florida
state: Florida
city: Albuquerque
country: United States
facility: University of New Mexico Department of Speech and Hearing Sciences
state: New Mexico
Study officials:
References:
Clinical trial NCT00153725: Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Cerebrovascular Disorders
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate whether intravenous infusion of pantoprazole (Pantoloc) is effective in preventing recurrent bleeding in patients who present with acute ulcer bleeding and continue to use aspirin

Detailed description: Aspirin is an effective treatment for acute stroke and heart attack. However, aspirin also induces ulcer and provokes acute ulcer bleeding. Thus, aspirin is often withheld in acute ulcer bleeding but this precipitate recurrent stroke or heart attack. We previously showed that intravenous infusion of a potent acid suppressant substantially reduced the incidence of recurrent ulcer bleeding in patients who withheld aspirin. The aim of this study is to investigate whether intravenous infusion of an acid suppressant (Pantoprazole) is effective in preventing recurrent ulcer bleeding with continuous use of aspirin.

Eligibility criteria: Inclusion Criteria:

* Patients received daily anti-platelet therapy for vascular prophylaxis before admission and will continue need to do so
* Patinets with bleeding peptic ulcers;ulcer actively bleeding or with SRH (Forrest I, IIa and IIb ulcers)
* Endoscopic haemostasis achieved

Exclusion Criteria:

* Presence of ulcer complication precluding endoscopic treatment such as gastric outlet obstruction or ulcer perforation mandating surgical intervention.
* Concomitant use of anticoagulant, NSAIDs or steroid
* Pending to undergo cardiac interventions that need double anti-platelet agent
* Pregnancy
* Terminal illness, or cancer

Primary outcomes:
measure: Primary Outcome:
measure: Recurrent upper gastrointestinal bleeding within 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Endoscopy Center, North District Hospital
city: Hong Kong
country: China
facility: Endoscopy Center, Prince of Wales Hospital
city: Hong Kong
country: China
facility: Endoscopy Center, United Christian Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Joseph J Sung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sung JJ, Lau JY, Ching JY, Wu JC, Lee YT, Chiu PW, Leung VK, Wong VW, Chan FK. Continuation of low-dose aspirin therapy in peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2010 Jan 5;152(1):1-9. doi: 10.7326/0003-4819-152-1-201001050-00179. Epub 2009 Nov 30.
Clinical trial NCT05076825: Neurodynamic Sliding Verses Static Stretching
Official title: Comparison Of Neurodynamic Sliding Verses Static Stretching On Clinical Outcomes In People With Hamstring Tightness: A Randomized Control Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Individuals With Hamstring Tightness
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Hamstring muscle are more likely to shorten among all biarticular muscles of human body. One of the many factors of hamstring tightness is increased tension in the neural structure. Apart from routine stretching techniques, mobilization of nervous system proves to be more effective. There are lot of stretching techniques available but they are more effective after multiple sessions. This study aims to cater the problem of hamstring tightness by neural sliding and static stretching in minimum sessions and compare which technique is more effective in resolving the issue.

Detailed description: Randomized Controlled Trials was used to collect data. Total patients were selected in two group with each 31 subjects. Purposive sampling technique was used. Experimental group will receive routine physical therapy along with TENS, Hot pack and Neurodynamic Stretching. (For 30 seconds, 3 times per session for 3 alternative days a week \& duration of 4 weeks). Outcome measure will be the hamstring tightness value angle in degrees, which will be obtained with the help of goniometer after performing active knee extension test and active straight leg raise test

Eligibility criteria: Inclusion Criteria:

* People with age ranging between 25 and 35 years.
* Hamstring tightness of twenty degrees
* Incapability to reach seventy degree hip flexion in SLR.

Exclusion Criteria:

* Neurological or orthopedic diseases
* Chronic or acute low back pain, Hamstring injury.
* During last three month, involved in any lower extremity exercise programs.

Primary outcomes:
measure: Change from Baseline in Hamstring flexibility assessed with Active Knee Extension Test
timeFrame: Baseline, 2nd Week, 4th week
measure: Change from Baseline in Hamstring flexibility assessed with Straight Leg raise
timeFrame: Baseline, 2nd Week, 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Jhang
country: Pakistan
facility: Iqbal Memorial Hospital
state: Punjab
Study officials:
affiliation: University of Lahore
name: Mohsin Majeed
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lahore
name: Fahad Tanveer
role: STUDY_CHAIR
References:
Clinical trial NCT00325325: Pharmacokinetic Study on the Combination of Everolimus-Tacrolimus
Official title: A Pilot Study to Investigate Pharmacokinetic Characteristics of Everolimus in Patients Treated With Tacrolimus-Based Immunosuppression in De Novo Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Kidney Diseases
Keywords: Kidney Transplantation
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Novartis
name: Astellas Pharma Inc
First posted: 2006-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 address the pharmacokinetic (PK) profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. For comparison purposes, pharmacokinetic profiles will be performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation.

Detailed description: To address the pharmacokinetic profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. For comparison purposes, pharmacokinetic profiles will be performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation. Patients will receive triple therapy steroids, tacrolimus and everolimus. Tacrolimus will be administered at a dose of 0.15 mg/kg/day to achieve 10-15 ng/ml 14 days, and 5-10 thereafter. During the first 6 weeks (the PK study period) everolimus will be assigned to fixed dose of 0.75 or 1.5 mg bid. After day 42, everolimus will be adjusted for 3-8 ng/ml and tacrolimus minimized to optimize graft function. Efficacy and safety parameters at 6 months post-transplantation will be secondary endpoints.

Eligibility criteria: Inclusion Criteria:

* Kidney transplant recipients aged 18-65 years old with a presumed immediately functioning graft

Exclusion Criteria:

* Non-functioning kidneys

Primary outcomes:
measure: 12-hour PK profiles of everolimus and tacrolimus on day 14 post-transplantation with everolimus 1.5 mg versus 3 mg per day
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
Study officials:
affiliation: Hospital Universitario Ramon y Cajal
name: Julio Pascual, MD
role: STUDY_CHAIR
affiliation: Hospital de Cruces, Bilbao
name: Gorka G Erauzquin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital 12 de Octubre, Madrid
name: José M Morales, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Dr Peset, Valencia
name: Luis Pallardó, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Germans, Trias i Puyol, Badalona
name: Ricardo Lauzurica, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Reina Sofía, Córdoba
name: Domingo del Castillo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Bellvitge, Barcelona
name: Josep M Grinyó, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00226525: Effect of Metal Skin Sensitivity on Restenosis After Stent Implantation
Official title: Rate of Metal Skin Allergy in Cohorts of Patients With and Without Coronary Stent Restenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Stent Restenosis
Keywords: Restenosis, skin metal allergy
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This trial is intended to find wether there is a connection between allergy to metals and reooclusion of stents in the coronary arteries


Eligibility criteria: Inclusion Criteria:

Patients with 2 cardiac catheterization in one years time and in the first one stent implantation

Exclusion Criteria:

None

Primary outcomes:
measure: The rate of skin delayed type hypersensitivity to metals among patients with restenosis and without restenosis
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Cardiology Department Hadassah Medical Center Jerusalem Israel
name: Ronen Durst, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07024225: Colorectal Cancers :A Retrospective Study
Official title: Clinico-epidemiological and Endoscopic Characteristics of Patients With Colorectal Cancers : A Retrospective Study in Sohag, Egypt
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Keywords: Clinical
Endoscopic
Pathological features
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study will be carried on patients more than 18 diagnosed as colon or rectal cancer supported by histopathological result

Brief summary: Clinico-epidemiological and endoscopic characteristics of patients with colorectal cancers:A Retrospective study in Sohag

The aim :

1. determine the prevalence and clinicopathological pattern of patients with colorectal cancers
2. interpretative association between risk factors and severity of patient condition to define possible predictors
3. assess potential association between serum markers, imaging, endoscopic features and underlying condition.

Detailed description: Methods :

1. all data will be obtained from patients as personal history (name, age, sex, occupation,residence , marital status, personal habits), history of illness at diagnosis, presence of diabetes or hypertension and other co-morbidity
2. general examination as general appearance,vital signs ,head and neck ,chest ,upper and lower limbs, Abdomen and pelvis ,and local examination as per rectal examination.
3. laboratory test as complete blood count and tumor markers ,imaging as abdominal ultrasound, CT,MRI, endoscopic findings and pathological features.

Eligibility criteria: Inclusion Criteria:

* patients aged 18 years old and above
* patients with confirmed diagnosis of colon or rectal cancer ,supported by histopathological result

Exclusion Criteria:

* patients with missed pathological or endoscopic data
* patients diagnosed with other malignancies rather than colorectal cancers

Primary outcomes:
measure: Number and proportion of patients diagnosed with colon or rectal cancers within study period in sohag, Egypt
timeFrame: Retrospective review from 2015 to 2025
measure: Correlation between baseline serum carcinoembryonic antigen (CEA) levels and tumor stage (TNM classification)
timeFrame: As recorded at diagnosis
measure: Association between personal risk factors (e.g, age, sex, lifestyle habits, comorbidities) and tumor stage at diagnosis
timeFrame: based on initial diagnosis records from 2015 to 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag faculty of medicine
state: Sohag Government
Study officials:
affiliation: Sohag faculty of medicine, internal medicine department
name: Ahmed O Ahmed, Lecturer
role: STUDY_DIRECTOR
References: