louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03496038: Transcrestal Lateral Sinus Floor Elevation in Implant Therapy
Official title: Trans-crestal Sinus Floor Elevation in Implant Therapy: A Randomized Controlled Clinical Trail With Parallel Group Design: L-PRF Compared With DBBM
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous; Alveolar Process, Atrophy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Dentsply International
First posted: 2018-04-12
Enrollment: 40
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: This is a non-inferiority study to evaluate whether L-PRF achieves similar or perhaps better results in bone gain, compared with "the golden standard" DBBM, after trans-crestal sinus floor elevation.

Detailed description: This is a randomized controlled clinical trial with parallel group design. A total of 40 patients, needing transcrestal sinus lift (T), will be enrolled.

Under local anesthesia, the required T and implant placement will be performed and ISQ values will be recorded. Afterwards a CBCT will be taken for control. Randomization will be performed by computer generated random codes, using random permuted blocks with a block size of 4 to avoid uneven splits and minimization for the key prognostic factors RBH. Allocation will be concealed to the surgeons at completion of the common part of treatment, by opening an opaque envelope. At the same time an oral implant(s) will be inserted in the augmented area.

After 6 months a CBCT will be taken for control of the bone healing and the measurements of the newly formed bone. The abutment will be placed on top of the osseo-integrated implant(s) under local anesthesia. ISQ values will be recorded. Follow-up will be till 1 year.

Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Need for T and oral implant placement.
* RBH \>3mm

Exclusion Criteria:

* Unlikely to be able to comply with the study procedures, as judged by the investigator
* Untreated periodontal disease
* Unfavorable plaque control
* Known or suspected current malignancy
* History of chemotherapy within 5y prior to study
* History of radiation on the head and neck region
* History of other metabolic bone diseases
* Need for systemic corticosteroids
* Current or previous use of intravenous/oral bisphosphonates
* Present alcohol and/or drug abuse
* Involvement in the planning and conduct of the study
* Psychiatric disorders which do not allow a normal treatment outcome

Primary outcomes:
measure: Volumetric bone regeneration en volumetric change
timeFrame: 6 and 12 months
measure: Linear bone regeneration en lineair change
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Implant stability based on resonance frequency
timeFrame: 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT02042638: The Effects of Gonadotropin Replacement Therapy in Patients With Hypogonadism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Hypogonadotropic Hypogonadism
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 16
Sex: MALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Idiopathic Hypogonadotropic Hypogonadism

Brief summary: Effects of hCG replacement therapy on metabolic syndrome parameters in hypogonadotrophic hypogonadism.


Eligibility criteria: Inclusion Criteria: Serum testosterone concentration \< 300ng/dL Absence of a pituitary or hypothalamic mass lesions, Presence of gonadotropin response to GnRH, -

Exclusion Criteria: Previous androgen treatment, diabetes mellitus, arterial hypertension other hormone deficiencies

-

Primary outcomes:
measure: HDL after hCG treatment
timeFrame: 2011-2013
measure: LDL levels after hCG treatment
timeFrame: 2011-2013
measure: total cholesterole levels after hCG treatment
timeFrame: 2011-2013
Secondary outcomes:
measure: Body fat ratio after hCG treatment
timeFrame: 2011-2013
measure: hsCRP levels after hCG treatment
timeFrame: 2011-2013
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine Dep. of Endocrinology and Metabolism
Study officials:
affiliation: Erciyes University School of Medicine Depatment of Endocrinology and Metabolism Kayseri TURKEY
name: Fahri Bayram, Proffesor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00831038: A Pilot Study of Pulmonary Function in Dysphagic Infants
Official title: A Pilot Study of Pulmonary Function in Dysphagic Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Lung Disease
Keywords: pulmonary function tests
infants
chronic lung disease
dysphagia
chronic aspiration
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2009-01-28
Enrollment: 26
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Infants less than 2 years old who have been newly diagnosed with problems swallowing will have pulmonary function tests performed to try to detect the presence of chronic lung disease. Six months later after the infants have received appropriate therapy for their swallowing problems, pulmonary function tests will be performed again to see if there has been any change in their chronic lung disease.

Detailed description: Twenty-five infants between the ages of 1 month and 24 months who have just been diagnosed with dysphagia via a modified barium feeding study will be recruited into the study. The infants will be sedated with chloral hydrate and have pulmonary functions measured (pre- and post-bronchodilator spirometry and lung volume) using the infant pulmonary laboratory. Treatment for the infants' dysphagia/chronic aspiration will be treated as determined by the primary care physicians. Six months later the infants will again be sedated and have pulmonary functions measured. Results of the two sets of tests will be compared statistically.

Eligibility criteria: Inclusion Criteria:

* infants between ages 1-24 months who have been newly diagnosed with dysphagia

Exclusion Criteria:

* cystic fibrosis
* obstructive sleep apnea
* seizures
* allergy or adverse reaction to chloral hydrate
* heart disease
* liver disease
* kidney disease
* pneumonia
* pleural effusion
* neuromuscular disease
* major congenital anomalies
* tracheoesophageal fistula
* vascular ring
* bronchopulmonary dysplasia
* pharyngeal anomalies
* Arnold-Chiari malformation

Primary outcomes:
measure: infant pulmonary function test results
timeFrame: On admission to study and 6 months later
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: LeBonheur Children's Medical Center
state: Tennessee
Study officials:
affiliation: Methodist/LeBonheur Healthcare/University of Tennessee College of Medicine
name: James D Tutor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00996138: Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects
Official title: A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Influenza
Keywords: Influenza A
H1N1 subtype
Adult
Vaccine
Adjuvant
Swine-Origin Influenza A H1N1 Virus
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-10-16
Enrollment: 200
Sex: ALL
Minimum age (years): 29
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults based on EMEA/CHMP criteria, and safety \& tolerability.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese adults aged 20 to 60 years

Exclusion Criteria:

* History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients
* Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start
* Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week
* History of progressive or severe neurological disorders

Primary outcomes:
measure: Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6
timeFrame: 6 weeks
Secondary outcomes:
measure: AEs, vital signs, laboratory tests
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kagoshima pref.
country: Japan
facility: Osaka pref.
Study officials:
References:
citation: Fukase H, Furuie H, Yasuda Y, Komatsu R, Matsushita K, Minami T, Suehiro Y, Yotsuyanagi H, Kusadokoro H, Sawata H, Nakura N, Lattanzi M. Assessment of the immunogenicity and safety of varying doses of an MF59(R)-adjuvanted cell culture-derived A/H1N1 pandemic influenza vaccine in Japanese paediatric, adult and elderly subjects. Vaccine. 2012 Jul 13;30(33):5030-7. doi: 10.1016/j.vaccine.2012.03.053. Epub 2012 Apr 1.
Clinical trial NCT00203138: Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease
Official title: A Multicenter, Open-Label, Phase III Study for the Safety, Tolerability and Clinical Effect of Rasagiline Mesylate in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 306
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients who completed the study TVP-1012/232 are eligible to enter the extension study to continue their rasagiline therapy for their Parkinson's disease (PD). During this study the patient's safety, tolerability of rasagiline, and effectiveness of this therapy will be monitored.


Eligibility criteria: Inclusion Criteria:

• Patients who completed evaluations of week 52 of the TVP 1012/232 protocol, where continued rasagiline therapy is warranted, in the opinion of the principal investigator

Exclusion Criteria:

• Patients having suffered adverse effects that were probably drug-related in the TVP-1012/232 study

Primary outcomes:
measure: Tolerability - Number of patients completing study on their original treatment assignment (dose reduction and dropout)
timeFrame: 2.5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Teva Neuroscience, Inc.
name: Phyllis Salzman, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06855238: Clinical Validation of an Artificial Intelligence Tool to Predict Inversion Time
Official title: Clinical Validation of an Artificial Intelligence Tool to Predict Inversion Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Introduction: Inversion-recovery (IR) magnetic resonance (MR) sequences are commonly used to perform late-gadolinium enhancement (LGE) imaging during cardiac magnetic resonance (CMR) scans. Inversion Time (TI), i.e. the time between the 180° inverting pulse and the 90°-pulse, must be manually input to obtain optimal myocardium nulling. Determinants of this value are patient's, sequence, and contrast characteristics, and the time after contrast injection. The identification of the correct TI is pivotal to quality images. The determination of TI is mostly based on experience, and it can be challenging in some diseases and for less experienced operators.

Aim of this study is to test in a clinical setting an Artificial Intelligence (AI) tool, which we developed to automatically predict TI in CMR post-contrast IR LGE sequences, named "THAITI".

THAITI performance will be evaluated in terms of 1) quality of images obtained using the AI-predicted TI with a 4-point Likert scale; 2) quality of images obtained using the AI-predicted TI in terms of Contrast-Enhancement ratio, i.e. the signal intensity of enhanced/remote myocardium in CMR-LGE images; 3) numbers of images that need to be reacquired; 4) average time duration of CMR-LGE imaging.


Eligibility criteria: Inclusion Criteria:

* Patients in whom CMR-LGE is performed for a clinical reason
* Mixed cardiac conditions (including cardiomyopathies, ischemic heart disease, normal scans, focal and diffuse myocardial pathological processes)
* Both sexes
* Any age
* Availability of serum creatinine, measured within one month prior to CMR
* Provision of the written informed consent

Exclusion Criteria:

* Non-contrast CMR
* First-pass perfusion stress-CMR
* Absolute contraindication to CMR
* Inadequate overall image quality

Primary outcomes:
measure: Images quality proportion
timeFrame: At examination
Secondary outcomes:
measure: contrast-enhancement ratio
timeFrame: At examination
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano IRCCS
Study officials:
References:
Clinical trial NCT00139438: Improving Management of Patients at High Risk for Osteoporotic Fractures (0000-038)
Official title: Improving Management of Patients at High Risk for Osteoporotic Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 4266
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess the impact of disease management interventions on percent receiving a bone densitometry test and percent appropriately prescribed a medication for osteoporosis.


Eligibility criteria: Inclusion Criteria:

* Members of the Horizon Blue Cross Blue Shield of New Jersey who are at risk for osteoporosis based on age (women age 65 or older, men and women age 45 or older who have a history of fragility fracture or have a history of taking oral glucocorticoids over 3 months).

Exclusion Criteria:

* Individuals who are not members of Horizon Blue Cross Blue Shield of New Jersey and who otherwise do not meet the inclusion criteria.

Primary outcomes:
measure: A composite measure of bone mineral density (BMD) testing and/or osteoporosis medications prescriptions.
Secondary outcomes:
measure: BMD testing, osteoporosis medication prescriptions, fracture
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Woman's Hospital
name: Daniel H. Solomon, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01397838: Safety Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women
Official title: Phase 1 Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Osteopenia
Keywords: Osteopenia
Lead sponsor: OsteoBuild Ltd.
Sponsor class: INDUSTRY
First posted: 2011-07-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Recent studies have shown that inhibition of Aquaporine-9 channels may ameliorate the bone degradation process. Pro-bone is an AQ - 9 channels inhibitor. This study is design to evaluate the safety of Pro-bone.


Eligibility criteria: Inclusion Criteria:

* BMD as measured by DEXA at screening, should range between (-1)to (-2.5) SD from normal values.
* At least 12 months of spontaneous amenorrhea or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
* Study participants not taking estrogen alone or estrogen/progestin containing drug products.
* Study participants not taking any anti-osteoporosis treatment for at list one year.
* The following washout periods should be before baseline assessments are made for subjects previously on estrogen alone or estrogen/progestin containing products:

  1. 8 weeks or longer for any prior use of estrogen and/or progestin products.
  2. 6 months or longer for prior progestin injectable drug therapy.
  3. Women between 45 and 65 years (inclusive) of age.
  4. BMI 22-30 (inclusive)
  5. Non-smoking (by declaration) for a period of at least 6 months.
  6. Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
* Subjects who provide written informed consent.

Exclusion Criteria:

* Women have documentation of a positive screening mammogram (obtained at screening or within 9 months of study enrolment) or abnormal clinical breast examination prior to enrolment in clinical studies.
* Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications.
* Any clinically significant abnormality, upon physical examination or in clinical laboratory test, at screening visit.
* Known history of drug or alcohol abuse according to participant declaration at screening visit.
* Any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
* Subjects who are non-cooperative or unwilling to sign consent form.

Primary outcomes:
measure: Adverse events recorded throughout the study
timeFrame: 4 weeks
measure: Blood and urinalysis values assessed at pre-dose and according to study design.
timeFrame: 4 weeks
Secondary outcomes:
measure: Vital signs
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Rabin Medical Center
name: Boris Kaplan, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04564638: Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous Corticosteroids
Official title: Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous Corticosteroids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Keywords: corticosteroids, cyclosporine, colectomy, clinical outcome
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 217
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: IBD patients treated in hospital ward with first intravenous corticosteroid

Brief summary: All episodes of patients with acute UC admitted to Tampere University Hospital and treated with intravenous corticosteroids between January 2007 and January 2016 were identified from patient records and reviewed. The risks for colectomy and for continuous use of corticosteroids were evaluated. Predictive factors were analysed.

Detailed description: Data collected included epidemiological (gender, age at index flare, smoking status), clinical (UC duration, extent of the disease, prior Cs usage, disease severity, laboratory results at index flare) and treatment data (occurrence of new flares, need for further Cs therapy; CyA, thiopurines, biologics or colectomy during follow-up). The diagnosis of UC was made on basis of clinical history, symptoms, endoscopic and histological features. Disease extent was categorized by the Montreal classification and the severity of the flare was assessed by Mayo scoring system based on clinical and endoscopic characteristics. ASUC was characterized by more than six bloody stools/day along with any of the following: tachycardia, elevated temperature, anemia and/or ESR \>30 mm/h (Truelove and Witt´s criteria)5. Alleviation of UC was defined as clinical response to intravenous corticosteroids with no need for colectomy or rescue therapy at the same hospitalization as the index flare. Relapse was defined as requiring further corticosteroid treatment, rehospitalization, rescue-therapy, or colectomy later in follow-up.

Eligibility criteria: Inclusion Criteria:

* Acute severe ulcerative colitis treated first time with iv corticosteroids
* Follow-up for at least six months after hospitalization or until colectomy.

Exlusion:

-Under 16 year of age

Primary outcomes:
measure: Colectomy
timeFrame: Long-term follow-up. Years 2007-2016. Mean follow-up of 7.5 years.
measure: Responce to Corticosteroid
timeFrame: Admission on index flare
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06908538: Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Official title: Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain (VANISH)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Amputation
Amputation of Lower Limb
Amputation of Upper Limb
Amputation, Limb Loss
Amputation, Traumatic/Surgery
Cryo Analgesia
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-03
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have or will have an amputation procedure.

Brief summary: The goal of this Registry is to see how the device is used when freezing nerves during an amputation procedure.


Eligibility criteria: Inclusion Criteria:

* Patients who have or will have an amputation procedure;
* Patients who are willing and capable of providing informed consent;
* Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

* Women of childbearing potential who are, or plan to become, pregnant during the time of the study;
* Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol.

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: