louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03321500: Measuring Quality of Life of Versacryl Relined Dentures
Official title: Comparative Study of Silicone-based Soft Liner Versus Versacryl Liner for Mandibular Complete Denture Cases(Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Denture Liners
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 28
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Resilient liners were introduced in the1950s and have been used since then as a gold standard material to increase the tolerance, retention and comfort of complete dentures. Due to drawbacks of conventional resilient liners, their longevity is questionable and they require replacement which is time consuming and costly for the dentist and patient respectively. Versacryl is a biocompatible intraoral thermo-elastic material. So versatile, it can be used to improve esthetics, retention and comfort for the patient. It softens with heat and when it is inserted to patient's mouth, it cools to body temperature providing desired rigidity. This process can be repeated many times to ensuring the comfort for the patient. Versacryl has a reported predictable long term performance, durable bonding to acrylic denture bases, high fatigue endurance, excellent wear characteristics and solvent resistance with almost no free monomer in the processed material .

The investigators' trial is done in order to improve the longevity and oral health related quality of life of soft liners in comparison to silicone-based soft liners.


Eligibility criteria: Inclusion Criteria:

1. Completely edentulous patients wearing complete dentures.
2. Flat mandibular residual ridge.
3. Mandibular denture indicated for relining.
4. Patients with minimum of 2 years and maximum of 5 years complete denture usage.
5. Angle's class I maxillary-mandibular relationship

Exclusion Criteria:

1. Drug or alcohol abuse.
2. Inflammatory changes in the oral cavity.
3. Candidiasis.
4. Any intra-oral soft tissue hyperplasia.
5. Physical reasons that could affect follow-up.
6. Psychiatric problems.
7. Heavy smokers.
8. Dentures indicated for remake.

Primary outcomes:
measure: oral health related quality of life
timeFrame: 4 months
Secondary outcomes:
measure: tissue keratinization
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
References:
citation: Krunic N, Kostic M, Petrovic M, Igic M. Oral health-related quality of life of edentulous patients after complete dentures relining. Vojnosanit Pregl. 2015 Apr;72(4):307-11. doi: 10.2298/vsp1504307k.
Clinical trial NCT00907400: Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Naprosyn E
Official title: Phase I, Open-label, Randomized, 2-way Crossover Study to Assess Relative Bioavailability of Single Oral Dose of Naproxen as PN400 Compared to Naproxen as Naprosyn E Under Fasting and Fed Conditions in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
Healthy Volunteer
Healthy Volunteer Study
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-05-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body's uptake of naproxen given as PN400 is comparable to that of currently marketed naproxen tablets.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects 18-55 yrs. of age (inclusive) at Screening Visit
* Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg
* Clinically normal physical exams and laboratory measurements

Exclusion Criteria:

* Subject has received another investigational drug within 4 weeks preceding this study or planning to participate in another study at any time during the period of this study
* Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial
* Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
* Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit

Primary outcomes:
measure: Pharmacokinetics
timeFrame: pre-dose and multiple times post-dose
Secondary outcomes:
measure: Safety
timeFrame: Throughout study
Other outcomes:
Locations:
city: Lulea
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Mark Sostek, MD
role: STUDY_DIRECTOR
affiliation: Quintiles Hermelinen
name: Aslak, Rautio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Quintiles AB
name: Elisabeth Eden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00196300: Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Eldery
Official title: Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Eldery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: Assessment, Risk
Autonomic nervous system
Aged
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 500
Sex: ALL
Minimum age (years): 76
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The objective of this study was to determine the prognostic utility of established risk predictors following acute ST elevation myocardial infarction in patients over 75 years of age.


Eligibility criteria: Inclusion Criteria:

acute myocardial infarction; aged \>75 years

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Munich
country: Germany
facility: 1. Medizinische Klinik, Klinikum rechts der Isar
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Georg Schmidt, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Petra Barthel, MD
role: STUDY_DIRECTOR
affiliation: Deutsches Herzzentrum Muenchen
name: Axel Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt G, Malik M, Barthel P, Schneider R, Ulm K, Rolnitzky L, Camm AJ, Bigger JT Jr, Schomig A. Heart-rate turbulence after ventricular premature beats as a predictor of mortality after acute myocardial infarction. Lancet. 1999 Apr 24;353(9162):1390-6. doi: 10.1016/S0140-6736(98)08428-1.
citation: Barthel P, Schneider R, Bauer A, Ulm K, Schmitt C, Schomig A, Schmidt G. Risk stratification after acute myocardial infarction by heart rate turbulence. Circulation. 2003 Sep 9;108(10):1221-6. doi: 10.1161/01.CIR.0000088783.34082.89. Epub 2003 Aug 25.
citation: Makikallio TH, Barthel P, Schneider R, Bauer A, Tapanainen JM, Tulppo MP, Schmidt G, Huikuri HV. Prediction of sudden cardiac death after acute myocardial infarction: role of Holter monitoring in the modern treatment era. Eur Heart J. 2005 Apr;26(8):762-9. doi: 10.1093/eurheartj/ehi188. Epub 2005 Mar 18.
citation: Bauer A, Guzik P, Barthel P, Schneider R, Ulm K, Watanabe MA, Schmidt G. Reduced prognostic power of ventricular late potentials in post-infarction patients of the reperfusion era. Eur Heart J. 2005 Apr;26(8):755-61. doi: 10.1093/eurheartj/ehi101. Epub 2005 Jan 26.
Clinical trial NCT02737800: Effect of Prolonged GnRh Agonists on Results of Intracytoplasmic Sperm Injection (ICSI ) in Endometrioma Patients
Official title: Effect of Prolonged GnRh Agonist Therapy on the Outcome of In-Vitro Fertilization& Embryo Transfer in Endometrioma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrioma
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators compare ICSI results for endometrioma patients with or without cyst aspiration if more than 5cm \&with or without GnRh agonists for all endometrioma patients

Detailed description: Group 1 consists of 30 patients of endometrioma more than 5cm subdivided into:

Group 1A;Cyst aspiration followed by standard long protocol in 15 patients Group 1B;Cyst aspiration followed by GnRh suppression for 3 months then standard long protocol in 15 patients

Group 2 consists of 30 patients of endometrioma less than 5cm subdivided into :

Group 2A;no intervention to the cyst. Standard long protocol Group 2B;GnRh suppression for 3 months then standard long protocol

Eligibility criteria: Inclusion Criteria:

* endometrioma patients

Exclusion Criteria:

* Follicle stimulating hormone(FSH)10 or more
* hydrosalpinx
* GnRh suppression in the last 12 months

Primary outcomes:
measure: Number of patients with urine pregnancy test positive 2 weeks after embryo transfer
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Kasrelaini Hospital
Study officials:
affiliation: Kasr El Aini Hospital
name: suzy abdelaziz, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00872300: PHA-739358 for the Treatment of Multiple Myeloma
Official title: An Exploratory Phase II Study of PHA-739358 in Patients With Multiple Myeloma Harbouring the t(4;14) Translocation With or Without FGFR3 Expression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Nerviano Medical Sciences
Sponsor class: INDUSTRY
First posted: 2009-03-31
Enrollment: 7
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: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the antitumor activity of PHA-739358 as single agent IV infusion in adult patients with Multiple Myeloma who have a history of at least 2 previous lines of treatment for the disease.


Eligibility criteria: Inclusion Criteria:

* active multiple myeloma progressing after at least 2 prior lines of treatment
* measurable disease
* t(4;14) translocation
* life expectancy of at least 3 months

Exclusion Criteria:

* uncontrolled hypertension
* myocardial infarction, unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the past 6 months.
* pregnancy or breast feeding
* active infections, including HIV

Primary outcomes:
measure: Response Rate according to International Myeloma Working Group uniform response criteria for multiple myeloma.
timeFrame: At end of each cycle
Secondary outcomes:
measure: Overall safety profile
timeFrame: All cycles
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: MAYO Clinic
state: Arizona
city: Chicago
country: United States
facility: The Robert H Lurie Comprehensive Cancer Center, Northwestern University
state: Illinois
city: Lille
country: France
facility: Hôpital Huriez, Centre Hospitalier Régional Universitaire de Lille
city: Nantes
country: France
facility: University Hospital Hôtel-Dieu
Study officials:
References:
Clinical trial NCT07023900: Lead Extraction With Manual Traction
Official title: Transvenous Lead Removal Only With Manual Traction Without Extraction Tools
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pacemaker Lead Dysfunction
Manual Traction
Lead sponsor: Bursa Postgraduate Hospital
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent transvenous lead extraction manually in our hospital.

Brief summary: The number of implantable cardiac rhythm devices is increasing. As a result, the number of patients requiring lead extraction is increasing. In this study, authors aimed to present their experience with lead extraction using manual traction.

Detailed description: Objectives: The number of implantable cardiac rhythm devices is increasing. As a result, the number of patients requiring lead extraction is increasing. In this study, authors aimed to present our experience with lead extraction using manual traction.

Methods: Patients (n=130) who underwent lead extraction by manual traction without the use of lead extraction devices (extraction sheaths, locking stylets, etc.) manufactured for extraction at our hospital between 2016 and 2021 were reviewed. Patient characteristics, indications for extraction, procedural success, complications, and mortality were evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients, who underwent transvenous lead extraction manually
* Patients, who had lead and device types

Exclusion Criteria:

* Patients, who underwent transvenous lead extraction with extraction device
* Patients, who had not baseline characteristics
* Patients, who had not procedure detail

Primary outcomes:
measure: Extraction the pacemaker or ICD lead manually without complication.
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kusumoto FM, Schoenfeld MH, Wilkoff BL, Berul CI, Birgersdotter-Green UM, Carrillo R, Cha YM, Clancy J, Deharo JC, Ellenbogen KA, Exner D, Hussein AA, Kennergren C, Krahn A, Lee R, Love CJ, Madden RA, Mazzetti HA, Moore JC, Parsonnet J, Patton KK, Rozner MA, Selzman KA, Shoda M, Srivathsan K, Strathmore NF, Swerdlow CD, Tompkins C, Wazni O. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551. doi: 10.1016/j.hrthm.2017.09.001. Epub 2017 Sep 15. No abstract available.
citation: Bongiorni MG, Burri H, Deharo JC, Starck C, Kennergren C, Saghy L, Rao A, Tascini C, Lever N, Kutarski A, Fernandez Lozano I, Strathmore N, Costa R, Epstein L, Love C, Blomstrom-Lundqvist C; ESC Scientific Document Group. 2018 EHRA expert consensus statement on lead extraction: recommendations on definitions, endpoints, research trial design, and data collection requirements for clinical scientific studies and registries: endorsed by APHRS/HRS/LAHRS. Europace. 2018 Jul 1;20(7):1217. doi: 10.1093/europace/euy050. No abstract available.
Clinical trial NCT01420900: Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: Influence of Component Design
Official title: Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: A Prospective, Blinded, Randomized Clinical Trial of Influence of Component Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Arthrosis
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2011-08-22
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators want to examine if specific acetabular liner designs can be a contributing factor to audible squeaking associated with CoC bearings. The aim of the present study is to compare two different designed and well documented acetabular component systems with reference to squeaking and other noises from the hip.


Eligibility criteria: Inclusion Criteria:

* All patients scheduled for uncemented THA under the age of 65 years.

Exclusion Criteria:

* Patients with the following diagnoses of the hip: Recent femoral fracture, sequelae from older femoral fracture, acetabular fracture, and traumatic dislocation of the hip.
* Patients without ability to give informed consent and/or willingness to participate in the follow-up protocol.
* Severely impaired level of function due to other physical deficiencies than the hip.
* Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
* Earlier primary THA or revision THA in the contralateral hip.
* Pathology requiring another prosthesis concept than the below mentioned.
* Body mass index greater than 35.

Primary outcomes:
measure: All noises from THA
timeFrame: One year
Secondary outcomes:
measure: Life quality
timeFrame: One year
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Department of Orthopedic Surgery, Vejle Hospital
Study officials:
References:
Clinical trial NCT00136500: Clinical Research in ALS Study
Official title: Clinical Research in Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Keywords: genetics
biomarkers
pre-symptomatic
natural history
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: ALS Association
name: ALS Recovery Fund
First posted: 2005-08-29
Enrollment: 10000
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: The CRiALS research program aims to recruit three types of participants:

* Individuals affected with ALS or a related neurodegenerative disease
* Unaffected individuals from pedigrees in which the genetic cause of ALS is known
* Healthy controls

Brief summary: CRiALS is an umbrella protocol through which people are recruited to participate in a range of research studies being conducted by the ALS Research Collaboration (ARC).

Detailed description: Research goals include elucidation of the complex relationship between ALS and related neurodegenerative disorders, development of both wet and dry biomarkers of disease, and delineation of the full course of the natural history of disease from the early pre-symptomatic stages through established and even late-stage disease. These goals are accomplished through the recruitment and evaluation of patients with ALS and related diseases, family members (including people at genetic risk for ALS, but who are not yet affected), and healthy controls.

Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age.
2. Member of at least one of the following categories:

   1. Individuals affected with ALS or a related neurodegenerative disease (sporadic or familial)
   2. Unaffected individuals from fALS pedigrees, including pre-symptomatic individuals at genetic risk for ALS or individuals from pedigrees of ALS related diseases.
   3. Healthy controls
3. Able and willing to comply with relevant procedures.

Exclusion Criteria:

1. Subject has a condition or is in a situation which, in the PI's opinion, could confound the study finding or may interfere significantly with the individual's participation and compliance with the study protocol -- including but not limited to neurological, psychological and/or medical conditions (e.g., multiple sclerosis, neuropathy, myelopathy).

Primary outcomes:
measure: Recruitment
timeFrame: Annually
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Michael Benatar, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02727400: Mitochondrial Energy Production in ART (Assisted Reproductive Technology )
Official title: Impact on Mitochondrial Energy Production in Different Patient Populations in Women Undergoing IVF-ICSI (in Vitro Fertilization-intracytoplasmic Sperm Injection)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Infertility Due to Advanced Maternal Age
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Controls: Young women between 18-35 years old with good reproductive prognostic undergoing COS (controlled ovarian stimulation) for IVF-ICSI

Cases: Infertile Women \> 38 years old undergoing COS (controlled ovarian stimulation) for IVF-ICSI

Brief summary: Oocyte maturation requires a lot of energy, which is provided by the mitochondria via the synthesis of ATP. The majority of patients with advanced maternal age (AMA) have poor egg quality. One of the reasons depends on oxidative phosphorylation of Pyruvate to undergo maturation; on the contrary, the cells of the cumulus (CC) show great activity glycolytic so that these cells are able to provide ATP(adenosine triphosphate and energy substrates to the oocyte. The goal of this work is to analyze the mitochondrial function and energy production in oocyte donors compared with a group of women of advanced maternal age subject to a same ovarian stimulation Protocol


Eligibility criteria: Inclusion Criteria:

* Controls: Women between 18-35 years old who are oocyte donors and fulfill the requirements of the our program of oocyte donation according to the Spanish Law of Human Reproduction
* Cases: infertile women undergoing IVF due to advanced maternal age (\>38 years)

Exclusion criteria:

For controls: Women with antral follicle count \>20 or \<6 follicle per ovary or with pathologies which, in the opinion of the investigator, may interfere with the treatment of ovarian stimulation

* Severe hypersensitivity to drugs of similar structure
* In the case of associated pathologies which can be considered as exclusion criteria on the part of the researcher are endocrine disruption and multi-follicular ovaries with risk of OHSS (Ovarian hyperstimulation syndrome)
* Be positive in serology for syphilis, toxoplasmosis, rubella, gonorrhea, hepatitis B, hepatitis C and HIV and lack of personal history and family of hereditary diseases.

Cases

* Irregular cycles
* Previous Ovarian surgery
* Previous chemotherapy or radiotherapy

Primary outcomes:
measure: Adenosine Triphosphate (ATP) production (nmol)
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: IVI Madrid
Study officials:
affiliation: IVI Madrid
name: Juan A Garcia-Velasco, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: