louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01784757: Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
Official title: A Bioavailability Study of ODM-201 Formulations With a Safety and Tolerability Extension Component in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
Collaborators: name: Endo Pharmaceuticals
First posted: 2013-02-06
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the bioavailability study will be able to receive further treatment with the current capsule formulation of ODM-201 until progression of their disease with the safety and tolerability of ODM-201 being assessed throughout.


Eligibility criteria: Inclusion Criteria:

* Written informed consent (IC) obtained.
* Histologically confirmed adenocarcinoma of prostate
* Progressive metastatic disease
* Ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone (LHRH) analogue or antagonist or bilateral orchiectomy
* Adequate bone marrow, hepatic and renal function
* Able to swallow the ODM-201 whole as a capsule or tablet.

Exclusion Criteria:

* Previous chemotherapy for prostate cancer.
* Known metastases in the brain.
* History of other malignancy within the previous 5 years, except a basal cell carcinoma of skin.
* Known gastrointestinal condition that can significantly affect the absorption of the study treatment.

Primary outcomes:
measure: Area under the curve (AUC) of ODM-201
timeFrame: 0-48 hrs
measure: Cmax of ODM-201
timeFrame: 0-48 hrs
Secondary outcomes:
measure: tmax of ODM-201
timeFrame: 0-48 hrs
measure: Terminal elimination rate constant of ODM-201
timeFrame: 0-48 hrs
measure: Terminal elimination half-life of ODM-201
timeFrame: 0-48 hrs
Other outcomes:
Locations:
city: Riga
country: Latvia
facility: P. Stradina Clinical University Hospital
Study officials:
affiliation: Institut Gustave Roussy, University of Paris
name: Karim Fizazi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shore ND, Tammela TL, Massard C, Bono P, Aspegren J, Mustonen M, Fizazi K. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naive and CYP17 Inhibitor-naive Patients: Follow-up from the ARADES and ARAFOR Trials. Eur Urol Focus. 2018 Jul;4(4):547-553. doi: 10.1016/j.euf.2017.01.015. Epub 2017 Feb 14.
Clinical trial NCT00792857: Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
Official title: Single-Dose, Two-Period, Open Label, Dose Determination, Randomized, Cross-Over Study of CTAP201 Injection and Doxercalciferol (Hectorol) Injection in Subjects With Stage 5 CKD and SHPT on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Kidney Disease
Secondary Hyperparathyroidism
Chronic Renal Insufficiency
Chronic Renal Failure
Keywords: Parathyroid Diseases
Renal Insufficiency
Kidney Failure, Chronic
Hyperparathyroidism, Secondary
Vitamin D
Hyperparathyroidism
Renal Insufficiency, Chronic
Kidney Diseases
Kidney Failure
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths. This study will also investigate the levels of CTAP201 in the body over time and determine the safety of CTAP201.


Eligibility criteria: Inclusion Criteria:

* Body mass index between 18 and 40
* On maintenance hemodialysis three times per week
* Visit 1: Serum iPTH value greater than or equal to 200 pg/mL and lower than or equal to 1000 pg/mL
* Visit 1: Serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
* Visit 1: Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL
* Serum 25-hydroxyvitamin D level greater than or equal to 15 ng/mL
* Visit 2: Serum iPTH value greater than 300 pg/mL
* Visit 2: Serum Ca x P product less than 56 \[mg/dl\]2
* Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and length of study

Exclusion Criteria:

* Taking cytochrome P450 3A inhibitors and/or inducers
* Abnormal liver functions

Primary outcomes:
measure: Blood levels of CTAP201 and doxercalciferol
timeFrame: Day 1 and Day 15 of each dose level
measure: Safety of a single dose of CTAP201 Injection
timeFrame: Throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Pivotal Reseach Centers
state: Arizona
city: Springfield
country: United States
facility: Western New England Renal and Transplant Associates
state: Massachusetts
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Allentown
country: United States
facility: Northeast Clinical Research
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: Southwest Houston Research Ltd.
state: Texas
Study officials:
affiliation: OPKO Renal
name: Joel Melnick, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03456557: The Use of Perfusion CT Derived Parameters as Early Acute Pancreatitis Severity Biomarker Compared to Clinico Biological Score
Official title: The Use of Perfusion CT Derived Parameters as Early Acute Pancreatitis Severity Biomarker Compared to Clinico Biological Score
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pancreatitis
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators to establish whether early microvascular permeability parameter evaluated by perfusion-CT could be good biomarkers for severity in acute pancreatitis.

Therefore the investigators want to compare 48 hours-clinico-biological systemic inflammatory response syndrome score to initial microvascular permeability parameters ( ktrans - capillary membrane permeability factor- and pancreatic blood flow ) calculated by OLEA software using inclusion perfusion CT.


Eligibility criteria: Inclusion Criteria:

* Patient with acute pancreatitis (based on the Atlanta definition).

Exclusion Criteria:

* Patient under 18 yearras old
* Contraindication of injection of iodinated contrast medium
* Pregnancy

Primary outcomes:
measure: Relation between CT perfusion calculated k-trans and clinicobiological SIRS score in early phase of acute pancreatitis.
timeFrame: admission day
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Chu de Poitiers
Study officials:
References:
Clinical trial NCT04599257: Fat Reduction and Muscle Toning of Thighs
Official title: Simultaneous Application of High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Changes in Subcutaneous Fat Tissue and Muscle Toning of Thighs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Burn
Keywords: muscle strengthening
muscle tone
fat reduction
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 93
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the clinical efficacy and safety of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for changes in subcutaneous fat tissue and muscle toning of thighs.


Eligibility criteria: Inclusion Criteria:

* Age \> 21 years
* Voluntarily signed an informed consent form
* BMI ≤ 35 kg/m2
* Women of child-bearing potential are required to use birth control measures during the whole duration of the study
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
* Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation

Exclusion Criteria:

* Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
* Metal implants
* Drug pumps
* Malignant tumor
* Pulmonary insufficiency
* Injured or otherwise impaired muscles
* Cardiovascular diseases
* Disturbance of temperature or pain perception
* Hemorrhagic conditions
* Septic conditions and empyema
* Acute inflammations
* Systemic or local infection such as osteomyelitis and tuberculosis
* Contagious skin disease
* Elevated body temperature
* Pregnancy, postpartum period, nursing, and menstruation
* Intrauterine device (IUD)
* Swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area
* Basedow's disease

Primary outcomes:
measure: Evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging
timeFrame: 7 months
Secondary outcomes:
measure: Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire
timeFrame: 7 months
measure: Assess safety profile by recording of adverse events
timeFrame: 7 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Brian M. Kinney M.D., Inc
state: California
city: Solana Beach
country: United States
facility: Art of Skin MD
state: California
city: New York
country: United States
facility: Yael Halaas, M.D., F.A.C.S.
state: New York
city: Langhorne
country: United States
facility: Center For SmartLipo & Plastic Surgery
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03628157: GBR With Ptfe With Bovine Bone With and Without Autogenous
Official title: Ridge Augmentation in Atrophic Anterior Maxillary Ridges With a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral With and Without Particulated Autogenous Bone Chips
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Atrophied Anterior Maxillary Ridges
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Ridge Augmentation in Atrophic Anterior Maxillary Ridges with a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral in intervention group and Anorganic Bovine Bone-Derived Mineralwith Particulated Autogenous Bone Chips in control group.

CBCT will be done before surgery, immediate after surgery and 6 month to compare the bone gain in mm.

Bone sample will be collected during exposure after 6 month of surgery by trephine bur to assess the bone quality through histo-morphometric analysis in order to determine the size, shape and orientation of the bony trabeculae, the size and porosity of the bony cortex in addition to the new bone/ bone substitute ratio

* 1ry outcome: Amount of bone gain will be measured using linear measurements from CBCT immediate after surgery and after 6 month.
* 2ry outcome: a bone sample will be collected and analyzed under histo-morphometric analysis.


Eligibility criteria: Inclusion Criteria:

* • Patients with atrophied anterior maxillary ridge area.

  * Age: 18 years and older.
  * Both sexes.
  * No intraoral soft and hard tissue pathology.
  * No systemic condition that contraindicate bone augmentation

Exclusion Criteria:

* • Heavy smokers more than 20 cigarettes per day.(32)

  * Patients with systemic disease that may affect normal healing.
  * Psychiatric problems.
  * Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia.
  * Pregnant or nursing women.
  * Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis.
  * Patient with previous history of radiotherapy.

Primary outcomes:
measure: Amount of bone gain (height and width in mm)
timeFrame: 6 months
Secondary outcomes:
measure: a bone sample will be collected and analyzed under histo-morphometric analysis. (no of bone cells in cubic mm)
timeFrame: 6 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Oral and Dental Medicine
Study officials:
References:
Clinical trial NCT01269957: Halitosis and Mouth Breathing in Children
Official title: Halitosis and Mouth Breathing in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mouth Breathing
Halitosis
Keywords: halitosis
pediatric dentistry
mouth breathing
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 55
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children registered at the clinic of the specialization course in pediatric dentistry of the ABCD/SP in 2008 were included in the study.

The children were divided into two groups based on breathing pattern (nasal and mouth) for the evaluation of halitosis. Breathing pattern was determined by a clinical evaluation and specific tests (mirror test and water-in-mouth test) and confirmed by the evaluation of an otolaryngologist.

Brief summary: Objective: determine whether there is a correlation between halitosis and mouth breathing in children. Study design: Fifty-five children between three and 14 years of age were divided into two groups (nasal and mouth breathing) for the assessment of halitosis. Descriptive analysis was carried out regarding the degree of halitosis in each group. The chi-square test was used for the comparison between groups, with 5% level of significance.


Eligibility criteria: Inclusion Criteria:

All children registered at the clinic of the specialization course in pediatric dentistry of the ABCD/SP in 2008 were included in the study.

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Nove de Julho University
Study officials:
affiliation: Nove de Julho University
name: Lara Motta
role: PRINCIPAL_INVESTIGATOR
References:
citation: Motta LJ, Bachiega JC, Guedes CC, Laranja LT, Bussadori SK. Association between halitosis and mouth breathing in children. Clinics (Sao Paulo). 2011;66(6):939-42. doi: 10.1590/s1807-59322011000600003.
Clinical trial NCT05268757: Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation
Official title: Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Deerland Probiotics and Enzymes
First posted: 2022-03-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded randomized clinical trial with a test and placebo group
Primary purpose: PREVENTION

Brief summary: The present study is a double-blinded randomized clinical trial with a duration of 28 days.

Detailed description: The present study is a double-blinded randomized clinical trial with a duration of 28 days.

80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline.

The intervention is oral hygiene discontinuation, which will be applied at baseline and continue through day 14, followed by 14 days with regular oral care.

Clinical measurements and sampling will be performed at baseline, day 14 and day 28

Primary endpoint: Changes in microbial composition.

Secondary endpoints: Changes in clinical and immunological parameters

Eligibility criteria: Inclusion Criteria:

- age \> 18 yrs.

Exclusion Criteria:

* Presence of oral diseases i.e. gingivitis, periodontitis and dental caries
* Current smokers
* Any systemic diseases and current use of any medication with known effect on oral health
* Use of systemic antibiotics within the latest three months
* Age \< 18 yrs., and age \> 30 yrs.

Primary outcomes:
measure: Changes in microbial composition in dental
timeFrame: Baseline vs. Day 14 and Day 28
Secondary outcomes:
measure: Changes in clinical parameters
timeFrame: Baseline vs. Day 14 and Day 28
Other outcomes:
measure: Changes in salivary levels of inflammatory cytokines
timeFrame: Baseline vs. Day 14 and Day 28
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen, Department of Odontology
Study officials:
References:
Clinical trial NCT04955457: BDNF Promoter Methylation: Effects on Cognition, Stress and Anxiety and Depression Symptom in Healthy Women.
Official title: BDNF Promoter Methylation: Effects on Cognition, Stress and Anxiety and Depression Symptom in Healthy Women.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BDNF
Memory Impairment
Stress
Well-being
Methylation
Keywords: BDNF methylation
Memory
women
Stress
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Federal University of São Paulo
First posted: 2021-07-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female participants will be recruited from public schools linked to the "Diretoria Regional de Educação de Santo Amaro - DRESA" - a southern section of the São Paulo City Hall public education secretaryship.

Brief summary: The purpose of this study is to explore the association between BDNF methylation and neurocognitive performance, perceived stress, and well-being in healthy women.


Eligibility criteria: Inclusion Criteria: (1)Brazilian female aged between 23 and 65 years and (2) currently working in the classroom

Exclusion Criteria:

1. diagnosis of depression
2. diagnosis of anxiety disorder
3. diagnosis of squizofrenia
4. report of an infectious condition in the last 15 days before collecting a blood sample;

Primary outcomes:
measure: Explore BDNF methylation level in healthy women active teachers
timeFrame: baseline
measure: Explore episodic memory in healthy women active teachers
timeFrame: Baseline
measure: Explore working memory in healthy women active teachers
timeFrame: Baseline
measure: Explore attention in healthy women active teachers
timeFrame: Baseline
measure: Explore selective attention in healthy women active teachers
timeFrame: Baseline
measure: Explore perceived stress in healthy women active teachers
timeFrame: Baseline
measure: Explore resilience in healthy women active teachers
timeFrame: Baseline
measure: Explore psychological well-being in healthy women active teachers
timeFrame: Baseline
measure: Explore positive and negative affect in healthy women active teachers
timeFrame: Baseline
measure: Explore anxiety and depression symptoms in healthy women active teachers
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
state: WI
Study officials:
affiliation: Federal University of São Paulo
name: Daniela Rodrigues de Oliveira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01428557: BREATHE Registry - I Brazilian Registry of Heart Failure
Official title: BREATHE Registry - I Brazilian Registry of Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
Epidemiology
Evidence-Based Practice
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Brazilian Society of Cardiology
First posted: 2011-09-05
Enrollment: 3013
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: Public and Private Hospitals

Brief summary: The purpose of this study is to evaluate the demographic, clinical, prognostics characteristics of 1,200 patients admitted with clinical diagnosis of decompensate heart failure in a group of 60 hospitals representative in different regions.

Detailed description: Background: Several local registries seek to show an isolated clinical characteristics of patients hospitalized with heart failure (HF) in hospitals and communities in Brazil. Overall, the analysis of these data suggests that there are important differences in etiology, the factors of decompensation, treatment and prognosis of HF patients in different regions.

Objectives: To evaluate the demographic, clinical, prognostics characteristics of 1,200 patients admitted with clinical diagnosis of decompensate heart failure in a group of 60 hospitals representative in different regions. Other specific objectives include describing the in-hospital mortality after admission, to describe the content and the reason for re-admission, to assess adherence to evidence-based guidelines (recommended by guidelines), to measure indicators of quality of care and establish a national registry data to allow for comparison with international records of patients admitted with ADHF.

Methods: Observational cross (record) with longitudinal follow-up where patients admitted to public and private hospitals primarily defined in IC will be studied.

Eligibility criteria: Inclusion Criteria:

* \> 18 years old,
* Boston Criteria \> 7,
* patients hospitalized \> 24 hours.

Exclusion Criteria:

* myocardial revascularization during last month,
* heart failure due to sepsis,
* acute coronary syndrome with ventricular dysfunction as reason for current hospitalization

Primary outcomes:
measure: Total mortality
timeFrame: follow up at 3, 6 and 12 months
Secondary outcomes:
measure: Proportion of patients receiving interventions with proven benefit shown by different indicators of quality of care.
timeFrame: follow up at 3, 6 and 12 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital do Coracao
state: SP
Study officials:
References: