louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00502736: A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Malignant Bone Disease.
Official title: An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Bone Pain in Patients With Breast Cancer and Skeletal Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain; Bone Neoplasms; Neoplasm Metastasis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the efficacy and safety of loading doses of intravenous Bondronat in patients with breast cancer and malignant bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is 3 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* female patients, \>=18 years of age;
* breast cancer;
* bone metastases;
* moderate to severe pain;
* adequate renal function.

Exclusion Criteria:

* bisphosphonate treatment within 3 weeks of study enrollment.

Primary outcomes:
measure: Pain and analgesic consumption
timeFrame: Days 1, 7 and 14
Secondary outcomes:
measure: AEs and laboratory parameters
timeFrame: Days 1, 4 and 7
measure: Serum creatinine
timeFrame: Days 1, 4 and 7
measure: Karnofsky index
timeFrame: Day 7
Other outcomes:
Locations:
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Shhiye, Ankara
country: Turkey
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00968136: Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infantile Spasms
Keywords: refractory infantile spasms
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-08-28
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: refractory infantile spasms

Brief summary: This is a randomized, controlled study to compare Short-term ketogenic diet with conventional long-term trial in refractory infantile spasms.


Eligibility criteria: Inclusion Criteria:

1. Patients, who have recalcitrant infantile spasms and undertake the ketogenic diet at Severance Hospital and Sanggye Paik Hospital from 2005 to 2008.
2. Clinical and electroencephalography findings are compatible with infantile spasms
3. Spasms are intractable to the initial combination of vigabatrin (150 mg/kg) and topiramate (10 mg/kg) and/or additional indicated anti-epileptic drugs including prednisolone (2 mg/kg for 2 weeks and an additional 2 weeks for tapering).
4. Study entry requires magnetic resonance imaging to confirm the absence of a progressive cerebral lesion.

Exclusion Criteria:

1. Patients who have a history of hyperlipidaemia and underlying metabolic diseases including acute intermittent porphyria, pyruvate carboxylase deficiency, and fatty acid oxidation defects.
2. Patients who have a history of nephrolithiasis.

Primary outcomes:
measure: Primary outcome measures include seizure relapse and frequency after successful completion of the ketogenic diet.
timeFrame: Finally, 35 patients could be followed up for more than 12 months after successful discontinuation of the diet and then primary outcome will be measured.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01876836: Clasic Laryngeal Mask Airway(C-LMA) and I-gel Releated Regurgitation and Complications
Official title: Comparation the Effect of C-LMA and I-gel in Regurgitation and Postoperative Complications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bladder Tumour
Prostate Hyperplasia
Keywords: i-gel
C-LMA
gastroeosephageal reflux
sore troat
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2013-06-13
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 1. i-gel
2. C-LMA

Compare the effect on gastroeosephageal reflux Postoperative complicatios.

Detailed description: 120 ASA I-II adult patients. Patients were randomised into two groups

1. i-gel
2. C-LMA Volume controlled ventilation, general anesthesia Asses Gastroeosephageal reflux, sore throat, coughing, dysphagia,dysphonia recorded.

Eligibility criteria: Inclusion Criteria:

* ASA I-II
* Adult
* Elective surgery
* Bladder tumour
* Prostat hyperplasi

Exclusion Criteria:

* Emergency surgery
* Hiatal hernia
* Gastroeosephageal reflux disease

Primary outcomes:
measure: Ph MEASUREMENT
timeFrame: 1 MİNUTE AFTER EXTUBATİON
Secondary outcomes:
measure: Bleu dye on the airway device
timeFrame: 5 min after placenent
Other outcomes:
measure: Blue dye on airway device
timeFrame: 1 min after extubation
Locations:
city: Ankara
country: Turkey
facility: DiskapiYBERH
state: Altındağ
city: Ankara
country: Turkey
facility: DiskapiYBERH
state: Altındağ
Study officials:
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: Reyhan Polat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06567236: E4D Compare Adapted to Preclinical Endodontics
Official title: E4D Compare Adapted to Evaluate Pulpal Access Cavity Preparation in the D2 Preclinical Endodontics Course: Educational Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-Assessment
Self-Perception
Keywords: Endodontics
Predental education
Educational technology
Teaching methods
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 59
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Based on pilot study's promising results, we decided to further investigate the impact of adapting Planmeca Romexis Compare software to evaluate pulpal access preparations on second-year dental students' technical performance, self-evaluation skills and opinions. No educational records, grades, coursework, or any other assignments that are completed as part of the regular class will be analyzed as part of this study.


Eligibility criteria: Inclusion Criteria:

* Second-year dental students enrolled in DDDS 719 Integrated Practice of Dentistry Lab II during 2022-2023 at Texas A\&M School of Dentistry
* Students who have completed fixed prosthodontics preclinical course
* Students attending the endodontics preclinical course.

Exclusion Criteria:

* First, third and fourth-year dental students at Texas A\&M School of Dentistry
* Second-year dental students NOT enrolled in DDDS 719 Integrated Practice of Dentistry Lab II during 2022-2023 at Texas A\&M School of Dentistry
* Students who are not interested in participating.

Primary outcomes:
measure: Self-assessment - traditional method vs traditional method plus 3D software method
timeFrame: baseline, 2 weeks, 4 weeks, 5 weeks and 7 weeks
measure: Grading - traditional method vs traditional method plus 3D software method
timeFrame: baseline, 2 weeks, 4 weeks, 5 weeks and 7 weeks
Secondary outcomes:
measure: Grading - traditional/visual grading vs 3D software grading
timeFrame: baseline, 2 weeks, 4 weeks, 5 weeks and 7 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas A&M School of Dentistry
state: Texas
Study officials:
References:
citation: Poly A, Burnett JE, Buie CA, Schweitzer JL. Three-dimensional software adapted to evaluate endodontic access cavity preparation. J Dent Educ. 2023 Dec;87 Suppl 3:1848-1851. doi: 10.1002/jdd.13216. Epub 2023 Apr 11. No abstract available.
Clinical trial NCT02272036: Short Message Service in Colonoscopy Preparation (PERICLES-II-SMS)
Official title: Improvement of Colonoscopy Preparation by New Media (SMS) (PERICLES-II-Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: Colonoscopy
Colonoscopy preparation
screening
New media
SMS
Short message service
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to analyze if integration of new media (SMS) could improve the quality of colonoscopy preparation.

Detailed description: The study approach is the implementation of new media into colonoscopy preparation. As most of our patients already use mobile phones the study should evaluate if time adjusted information about diet recommendation, laxative intake and behavioral recommedation improve the patient compliance and the quality of colonoscopy preparation. In total 14 SMS wil be sent to the study participants starting 4 days prior the colonoscopy appointment. No additional or different information is provided in comparison to regular colonoscopy preparation for out-patient colonoscopy.

Study participant are randomized when included into the study. Group 1 receives a SMS- supported colonoscopy preparation, group 2 receive no SMS and prepares regularly.

Primary endpoint is bowel cleanness measured by Boston Bowel preparation scale, secondary endpoints are patient satisfaction, adenoma detection rate and compliance.

Eligibility criteria: Inclusion Criteria:

* over 18 years old
* written informed consent
* mobile phone user
* appointment for outpatient colonoscopy

Exclusion Criteria:

* no outpatient colonoscopy
* no mobile phone

Primary outcomes:
measure: Bowel cleanness measured by Boston Bowel preparation Scale
timeFrame: 1 day
Secondary outcomes:
measure: Adenoma detection rate
timeFrame: 1 day
measure: Patient satisfaction and compliance
timeFrame: 1 day
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Dr. Aschenbeck
city: Dornstadt
country: Germany
facility: Gastroenterologische Praxis Prof. Leopold Ludwig
city: Landshut
country: Germany
facility: II. Medizinische Klinik Krankenhaus Landshut-Achdorf
city: Munich
country: Germany
facility: 2nd Medical Department, Klinikum rechts der Isar
Study officials:
affiliation: Physician
name: Benjamin M Walter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walter B, Klare P, Strehle K, Aschenbeck J, Ludwig L, Dikopoulos N, Mayr M, Neu B, Hann A, Mayer B, Meining A, von Delius S. Improving the quality and acceptance of colonoscopy preparation by reinforced patient education with short message service: results from a randomized, multicenter study (PERICLES-II). Gastrointest Endosc. 2019 Mar;89(3):506-513.e4. doi: 10.1016/j.gie.2018.08.014. Epub 2018 Aug 21.
Clinical trial NCT00285636: Long Term Follow-Up of Burn Injuries
Official title: Long Term Follow-Up of Burn Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burn
Keywords: Long Term Follow-Up
Lead sponsor: National Institute of General Medical Sciences (NIGMS)
Sponsor class: NIH
Collaborators: name: U.S. Department of Education
First posted: 2006-02-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: burn patients

Brief summary: The purpose of the study is to investigate the psychological effects of burn injuries as experienced by patients.

Detailed description: We are interested in determining how people adjust to burn injuries as a way of facilitating optimal recovery. This is done by conducting several questionnaires at the time of the discharge in the hospital, and later follow up with the patients up to two years.

Eligibility criteria: Inclusion Criteria:

* patients with more than a 30% total surface area burn
* English speaking

Exclusion Criteria:

* Patients with less than a 30% total surface area burn
* Non English speaking

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington; Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: David R. Patterson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03153436: The Effect of In-vitro Myoinositol Supplementation of Human Sperm on the Outcome of Cryopreservation
Official title: The Effect of In-vitro Myoinositol Supplementation of Human Sperm on the Outcome of Cryopreservation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myoinositol
Cryopreservation
Human
Sperm
Lead sponsor: Sohag University
Sponsor class: OTHER
Collaborators: name: Ajyal Hospital
First posted: 2017-05-15
Enrollment: 41
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to evaluate the effect of in-vitro myoinositol supplementation of human sperm on the outcome of cryopreservation.

Detailed description: Sperm cryopreservation is considered the most valuable and used way to preserve male reproductive function. Unfortunately, osmotic effects of freezing and thawing during the cryopreservation process negatively affect sperm morphology and motility .

Myoinositol is the most biologically important form of inositol in nature. In male reproductive system, myoinositol appears to regulate sperm motility, capacitation and acrosomal reaction.

The objective of this study is to evaluate the effect of in-vitro myoinositol supplementation of human sperm on the outcome of cryopreservation.

Eligibility criteria: Inclusion Criteria:

* Infertile men with normal or abnormal semen analysis

Exclusion Criteria:

* Azoospermic samples

Primary outcomes:
measure: Cryo-survival rate
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sohag University
name: Ramadan Saleh, M.D.
role: STUDY_DIRECTOR
References:
citation: Ackerman DR. The effect of cooling and freezing on the aerobic and anaerobic lactic acid production of human semen. Fertil Steril. 1968 Jan-Feb;19(1):123-8. doi: 10.1016/s0015-0282(16)36552-9. No abstract available.
citation: Anger JT, Gilbert BR, Goldstein M. Cryopreservation of sperm: indications, methods and results. J Urol. 2003 Oct;170(4 Pt 1):1079-84. doi: 10.1097/01.ju.0000084820.98430.b8.
citation: Araki Y, Yao T, Asayama Y, Matsuhisa A, Araki Y. Single human sperm cryopreservation method using hollow-core agarose capsules. Fertil Steril. 2015 Oct;104(4):1004-1009. doi: 10.1016/j.fertnstert.2015.06.043. Epub 2015 Jul 21.
citation: Bahat A, Eisenbach M. Human sperm thermotaxis is mediated by phospholipase C and inositol trisphosphate receptor Ca2+ channel. Biol Reprod. 2010 Mar;82(3):606-16. doi: 10.1095/biolreprod.109.080127. Epub 2009 Dec 2.
citation: Beemster P, Groenen P, Steegers-Theunissen R. Involvement of inositol in reproduction. Nutr Rev. 2002 Mar;60(3):80-7. doi: 10.1301/00296640260042748.
citation: Oberoi B, Kumar S, Talwar P. Study of human sperm motility post cryopreservation. Med J Armed Forces India. 2014 Oct;70(4):349-53. doi: 10.1016/j.mjafi.2014.09.006. Epub 2014 Oct 16.
Clinical trial NCT05914636: Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm
Official title: Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm: a Comparison of Ruptured and Unruptured Patient With Taxonomic and Metabolic Evaluation of Microbiota
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intracranial Sacciform Aneurysm
Keywords: Intracranial aneurysm
intestinal microbiota
risk factor
ruptured
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients with ruptured aneurysm and unruptured aneurysm

Brief summary: The physiopathology of intracranial aneurysm from initiation to ruptured is incompletely understood but included inflammation. The microbiota is known to interact with brain and can promote inflammation. The objective of this study is to describe microbiota with taxonomic and metabolomic analysis. A comparison between ruptured and unruptured intracranial aneurysm will be performed. The study hypothesis is that microbiota is different between ruptured and unruptured patient.


Eligibility criteria: Inclusion Criteria:

* one or more intracranial sacciform aneurysm ruptured or not in function of the inclusion group

Exclusion Criteria:

* Transient modification of microbiota: Antibiotherapy in the last 3 months, pre or probiotic in the last month, gastrostomy, ileostomy, bariatric surgery, digestive tract resection, gastro-duodenal ulcer surgery or during the last month, chronic inflammatory disease of the digestive tract (like Crohn), BMI for more than 30, Very restrictive diet (like vegan
* Specific pathologies increasing the incidence of aneurysm ( kidney autosomic dominant polycystosis, Type 1 neurofibromatosis, Rendu-Osler, MArfan
* Participation to a study with the objective of microbiota modification

Primary outcomes:
measure: Taxonomic faecal microbiota description
timeFrame: The faecal samples will be taken at 3 days+/-2 after the ruptured and during the arteriography for the unruptured group within 3 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital neurologique P. Wertheimer
name: Dumot Chloé, Dr PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02203136: Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging
Official title: Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: Bladder cancer
Muscle invasive bladder cancer
MIBC
Biopsy specimen molecular profiling
Bladder surgery
Magnetic resonance imaging
MRI
Trans urethral resection of bladder
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-07-29
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants scheduled for bladder cancer surgery and biopsy from the Department of Urology at MD Anderson Cancer Center in Houston, Texas.

Brief summary: The goal of this research study is to improve detection of cancer outside of the bladder through genetic testing and improved imaging.

Detailed description: If participant agrees to take part in the study, a piece of the tumor that is removed during the biopsy will be collected for research purposes. The tissue will be sent to the laboratory for genetic testing.

If they have had a computed tomography scan (CT scan) or magnetic resonance imaging scan (MRI) recently, information collected from the scan will be collected. If they have not had one recently, they will have an MRI with contrast as part of this study. They will receive a separate consent form for this MRI scan.

The results of the test will be given to their doctor, but the results will not be used to decide their treatment.

After they have surgery, information will be collected from their medical records, such as their diagnosis.

Length of Study:

* Their participation on this study will be over once their surgery is completed.
* This is an investigational study.

Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.

Eligibility criteria: Inclusion Criteria:

1. Patients with biopsy proven bladder cancer of any age will be eligible for enrollment.

Exclusion Criteria:

1. Contraindication to pelvic MRI (metallic implants/hardware, claustrophobia)
2. Participants who have previously received chemotherapy as part of multimodal therapy.

Primary outcomes:
measure: Detection Improvement of Cancer Outside of the Bladder
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Neema Navai, MD
role: PRINCIPAL_INVESTIGATOR
References: