louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06041074: Adenoid Vegetations in Adult Patients
Official title: The Clinical Characteristics of Adenoid Vegetations in Adult Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenoid Vegetation
Lead sponsor: Varazdin General Hospital
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 161
Sex: ALL
Minimum age (years): 1
Maximum age (years): 105
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult group: All patients aged 14 and more treated for adenoid vegetations in Varazdin General Hospital from 1 January 2013 to 31 December 2019

Children group: All patients aged 13 and less treated for adenoid vegetations in Varazdin General Hospital from 1 January 2019 to 31 December 2019

Brief summary: In this observational cross-sectional study " the clinical characteristics of adenoid vegetations in adulthood will be investigated.

Detailed description: Adenoid vegetations typically appear in childhood and are well described in this population. However, in adulthood, adenoid vegetations appear rarely and their characteristics have not been described.

The clinical characteristics of adenoid vegetations in adulthood will be investigated, and compared with clinical characteristics of adenoid vegetations in childhood.

Eligibility criteria: Inclusion Criteria:

* patient with adenoid vegetations

Exclusion Criteria:

* other concomitant otorhinolaryngological diagnoses
* hypertrophy of the tonsils
* oropharyngeal carcinomas
* chronic sinuitis
* allergic rhinitis

Primary outcomes:
measure: Symptoms
timeFrame: 2 months
Secondary outcomes:
measure: Duration of symptoms
timeFrame: 2 months
measure: OTS (otoscopic)
timeFrame: 2 months
measure: RNS (rhinoscopic)
timeFrame: 2 months
measure: OFS (oropharyngoscopic)
timeFrame: 2 months
measure: PRNS (post-rhynoscopic)
timeFrame: 2 months
measure: Referring physician
timeFrame: 2 months
measure: PHD ( pathohistological findings)
timeFrame: 2 months
measure: Surgery
timeFrame: 2 months
measure: Outcome
timeFrame: 2 months
measure: Recurrence
timeFrame: 2 months
Other outcomes:
Locations:
city: Varazdin
country: Croatia
facility: Varazdin General Hospital
Study officials:
affiliation: Varazdin General Hospital, Varazdin, Croatia
name: Drazen Shejbal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00146874: CRT RENEWAL Registry
Official title: Cardiac Resynchronization Therapy Registry Evaluating Patient Response With RENEWAL Family Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 1000
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: Standard CRT population

Brief summary: This registry will provide detailed patient demographics and characteristics at the time of enrollment and will also provide data regarding predictors of clinical outcomes such as heart failure decompensation, heart failure hospitalization, NYHA class, and quality of life.

Detailed description: The CRT RENEWAL Registry aims to characterize patient demographics and clinical attributes at enrollment and overall event rates as defined by heart failure decompensation, heart failure hospitalization, death, and ventricular arrhythmic events. The registry will also assess clinical outcomes including quality of life (QOL), physical activity habits, and events rates, along with device diagnostics such as Activity Log Index and heart rate

Eligibility criteria: Inclusion Criteria:

* Patients who meet current indications for the CONTAK RENEWAL® family of CRT-P or CRT-D devices
* Patients who receive either transvenous Guidant manufactured ventricular leads or non-Guidant epicardial leads
* Patients who have had an ejection fraction measured within six months of enrollment
* Patients who sign and date a Patient Informed Consent form at the enrollment visit
* Patients who remain in the clinical care of the enrolling physician in approved centers

Exclusion Criteria:

* Patients who are expected to receive a heart transplant during the duration of the registry
* Patients who currently have or who are likely to receive a tricuspid valve prosthesis
* Patients who are currently enrolled in another observational registry or investigational study that would directly impact the treatment or outcome of the CRT RENEWAL Registry. Each instance will be brought to the attention of Guidant's Clinical Application Research Studies (CARS) Department to determine eligibility
* Patients who are younger than 18 years of age
* Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the registry
* Patients who are pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tri-City Cardiology Consultants
name: Andrew Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00831974: Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis
Official title: Phase IIa, Open-label, Randomized Study of Oral AB1010 in Patients With Systemic Indolent Mastocytosis With Handicap and Not Bearing Activating Point Mutations in the Phosphotransferase Domain of c-Kit Such as the Main Mutation Asp-816-Val (D816V)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mastocytosis
Keywords: mastocytosis
indolent
handicap
wild-type
systemic
not D816V mutated
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2009-01-29
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 12 weeks study aimed at assessing the safety and efficacy of 2 doses of AB1010 in patients suffering from indolent systemic mastocytosis with handicap.

Detailed description: Efficacy will be assessed based on:

Pruritus score Number of flush per day Pollakyuria (on a daily basis) Number of stools per day QLQ-C30 score Hamilton Rating Scale for depression

Eligibility criteria: Inclusion Criteria:

1. Patients with documented Indolent systemic mastocytosis with handicap (ISMwh) having at least 2 infiltrated\* organs (skin and /or bone-marrow and/or internal organ).
2. Bone-marrow, or skin or internal biopsy-documented mastocytosis and evaluable disease.
3. The absence of an activating point mutation in the phosphotransferase domain of c-Kit such as D816V c-Kit mutation in at least one of the two infiltrated organs: bone marrow and/or skin and/or other tissue.
4. Handicap defined as at least one of the following handicaps:

   * a number of flush per day ≥ 1 ,
   * a pruritus score ≥ 9 ,
   * a number of stools per day ≥ 4 ,
   * a Pollakyuria (on a per day basis) ≥ 8 ,
   * a QLQ-C30 score ≥ 83 ,
   * a Hamilton rating scale for depression ≥ 12

Exclusion Criteria:

1. Performance status \> 2 (ECOG).
2. Inadequate organ function, except if the abnormalities are due to involvement by mast cells

Primary outcomes:
measure: Response on: Pruritus score, Number of flush per day, Pollakyuria (on a daily basis), Number of stools per day, QLQ-C30 score, Hamilton Rating Scale for depression
timeFrame: 12 weeks
Secondary outcomes:
measure: AFIRMM score, reduction of organ infiltration,level of tryptase, reduction on bio markers (TNFα, eosinophils, histamine levels), pharmacokinetic profile of AB1010
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital Necker, Paris, France
name: Olivier Lortholary, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paul C, Sans B, Suarez F, Casassus P, Barete S, Lanternier F, Grandpeix-Guyodo C, Dubreuil P, Palmerini F, Mansfield CD, Gineste P, Moussy A, Hermine O, Lortholary O. Masitinib for the treatment of systemic and cutaneous mastocytosis with handicap: a phase 2a study. Am J Hematol. 2010 Dec;85(12):921-5. doi: 10.1002/ajh.21894.
Clinical trial NCT02306174: Cognitive Rehabilitation and Exposure-based Class for Compulsive Hoarding
Official title: Cognitive Rehabilitation and Exposure-based Class for Compulsive Hoarding
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hoarding Disorder
Keywords: Hoarding
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this protocol is to investigate the effectiveness of a manualized, 20-week group cognitive rehabilitation (CR) and exposure therapy (ET) course for compulsive hoarding. The overarching aim is to understand whether this course will decrease the core symptoms of hoarding and associated features.


Eligibility criteria: Inclusion Criteria:

* Include:

  * Individuals who exhibit subclinical and clinical levels of hoarding disorder, as determined by the SCID interview conducted at the screening assessment, will be eligible to participate in the study. Individuals may also display clinically relevant symptoms of hoarding as indicated by scores on the Hoarding Rating Scale Interview (HRS-I) and/or on the Saving Inventory-Revised (SIR).
  * Comorbid mood and anxiety disorders are permitted.
  * English-speaking
  * Pregnant women

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Individuals who are over the age of 85
* Individuals with cognitive or physical impairments that would interfere with their participation (e.g., Dementia, uncorrected hearing)
* Participants who have current or past psychotic symptoms or current or past alcohol/substance abuse/dependence may also be excluded.
* Participants may also be excluded if they are currently in other forms of psychotherapy.
* Participants may be excluded if they have had a change in psychotropic medications within three months of the baseline assessment/first class.
* Participants may be excluded if hoarding is not their primary diagnosis.
* Prisoners

Primary outcomes:
measure: Hoarding Rating Scale Interview
timeFrame: 22 weeks
measure: Clinician's Global Impression Improvement and Severity ratings
timeFrame: 22 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Kiara Timpano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05644574: Surgical Management of Post-Traumatic Kyphosis
Official title: Posterior Surgical Management of Post-Traumatic Kyphosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Post-Traumatic Kyphosis
Keywords: Post-Traumatic Kyphosis
Posterior only surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with age range from 18-65 years old with PTK underwent posterior only corrective surgery and have been followed for at least 2 years with complete documentation.

Brief summary: The goal of this observational study is to examine the safety and efficacy of posterior sugary only in addressing post traumatic kyphosis. The main question\[s\]it aims to answer are:

Is it a safe procedure? Is it a sufficient approach to address deformity? Participants will be managed by posterior only surgery to address their deformity and will be assessed for the radiological and functional outcomes.


Eligibility criteria: Inclusion Criteria:

- All patients with age range from 18-65 years old with PTK underwent corrective surgery and have been followed for at least 2 years with complete documentation.

Exclusion Criteria:

* Traumatic cervical spine deformities
* Pathologic fracture spine
* Congenital or developmental cases
* Degenerative cases

Primary outcomes:
measure: change in degree of kyphosis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05424874: Clinical Validation of NAVOY® Acute Kidney Injury in Swedish ICU Patients
Official title: Clinical Validation of NAVOY® Acute Kidney Injury in Swedish ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: AlgoDx
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult ICU patient population

Brief summary: The study aims to evaluate the performance of the prediction algorithm NAVOY® AKI in a Swedish adult ICU patient population versus fulfilment of KDIGO diagnostic criteria.


Eligibility criteria: Inclusion Criteria:

* The study will only include the subjects from the SEP-SE-02 study population. (NCT04570618)

Exclusion Criteria:

* None

Primary outcomes:
measure: Prediction performance of NAVOY® AKI
timeFrame: Data from ICU stay between December 2020 to October 2021.
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Intensiv- och perioperativ vård
Study officials:
affiliation: Skånes Universitetssjukhus
name: Fredrik Sjövall, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00139074: Seroquel in Acute Mania: Study to Investigate if Valproate Add-On Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients
Official title: Phase IV Study to Investigate if Valproate Add-on Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: Bipolar I Disorder (DSM-IV 296.01, DSM-IV 296.4, DSM-IV 296.61)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose is to investigate whether the addition of sodium valproate will be superior to treatment with quetiapine (Seroquel) given as monotherapy for an additional 14 days in non-responding patients after a 14 day initial treatment period with quetiapine.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from a manic or mixed episode.

Exclusion Criteria:

* Patients who have not provided personal informed consent,
* Known intolerance, hypersensitivity or lack of antimanic response to sodium valproate or quetiapine fumarate,
* Involuntary admittance/detainment.

Primary outcomes:
measure: The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate)
timeFrame: after 2 weeks treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Research Site
city: Frederikssund
country: Denmark
facility: Research Site
city: Haderslev
country: Denmark
facility: Research Site
city: Hellerup
country: Denmark
facility: Research Site
city: Kobenhavn
country: Denmark
facility: Research Site
city: Kolding
country: Denmark
facility: Research Site
city: Svendborg
country: Denmark
facility: Researcg Site
Study officials:
affiliation: AstraZeneca
name: Dr. Rasmus Wenzer Licht
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: AstraZeneca Seroquel Medical Science Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06826274: Cervical TsDCS on Stroke Patients
Official title: Clinical and Neurophysiological Evaluation of the Effects of Cervical TsDCS on Stroke Patients with Distal Upper Limb Strength Deficit
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Functional Recovery
Motor Rehabilitation
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The present project aims to evaluate the facilitatory modulation of motor responses of the limb upper limb by tsDCS in patients with arm/hand hyposthenia after cerebral ischemia to verify the possible therapeutic benefits that this type of stimulation can induce in terms of of strength, dexterity and effectiveness in acts of daily living.


Eligibility criteria: Group Stroke:

Inclusion criteria:

1. age over 18 years;
2. first ischemic/hemorrhagic stroke (within 30 days of onset);
3. mild-to-moderate stroke (NIHSS scale score\<16).
4. residual function of the upper limb, assessed by the following scales: - MRC of the distal muscles of the upper limb: score between 2 and 4; - NHISS (items 5A and 5B): score between 1 and 3;
5. ability to give informed consent and understand instructions.

Exclusion criteria:

1. severe spasticity (Ashworth Scale score \> 2);
2. severe aphasia;
3. severe neglect;
4. history of disabling neurological disease;
5. history of epilepsy;
6. significant comorbidities;
7. contraindications to tsDCS.

Healthy Group:

Inclusion criteria:

1. age over 18 years;
2. equalized in age with the patient group.

Exclusion criteria:

1. history of stroke progress;
2. history of severe neurological disease.

Primary outcomes:
measure: improvement of paretic hand performance
timeFrame: through study completion, an average of 1 year
measure: improvement of paretic hand performance
timeFrame: through study completion, an average of 1 year
measure: improvement of paretic hand performance
timeFrame: through study completion, an average of 1 year
measure: improvement of paretic hand performance
timeFrame: through study completion, an average of 1 year
measure: improvement of paretic hand performance
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS San Raffaele Roma
Study officials:
References:
Clinical trial NCT04683874: Transfer Accuracy of 3D-printed Indirect Bonding Trays
Official title: Transfer Accuracy of 3D-printed Trays for Indirect Bonding of Orthodontic Brackets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Bonding
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 23
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study evaluates the transfer accuracy of 3D-printed trays for indirect bonding of orthodontic brackets in vivo. Accurate placement of orthodontic brackets at the beginning of treatment improves treatment efficiency and shortens treatment time. Indirect bonding is a method of placing orthodontic brackets on a plaster or digital model of the dentition, followed by the transfer of these brackets to the patients' teeth using a transfer tray. Various indirect bonding methods have been developed with the aim of improved bracket positioning and reduced chair time. The success of these methods ultimately depends on how reliably the precise positioning of the brackets on the model can be transferred to the patient's teeth.


Eligibility criteria: Inclusion Criteria:

* Adults and children (ages 12 years and older) who are in the permanent dentition.

Exclusion Criteria:

* Less than 12 years of age, primary or mixed dentition, or bonded orthodontic appliances present, prosthetic restorations on the facial surfaces of teeth, craniofacial anomalies, and dental anomalies such as malformation, microdontia, or severe attrition

Primary outcomes:
measure: Transfer accuracy
timeFrame: At time of bonding, i.e. day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT02701374: Efficacy and Safety of TRK-700 in Patient With Post-Herpetic Neuralgia
Official title: TRK-700 An Early Phase II Study in Patients With Post-Herpetic Neuralgia -Double Blind Comparison With Placebo-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-Herpetic Neuralgia
Keywords: TRK-700
Post-Herpetic Neuralgia
Lead sponsor: Toray Industries, Inc
Sponsor class: INDUSTRY
First posted: 2016-03-08
Enrollment: 184
Sex: ALL
Minimum age (years): 20
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In Post-Herpetic Neuralgia(PHN) patients:

* To conduct an explorative investigation of the efficacy and safety of repeated oral doses of TRK-700 via a randomized double blind comparative study
* To measure the plasma concentration of TRK-700 and its metabolites


Eligibility criteria: Inclusion Criteria:

* Patients with pain persisting for at least 3 months after the onset of herpes zoster
* Patients whose average pain score on the Numerical Rating Scale (NRS) over the past 24 hours at preliminary enrollment is at least 4

Exclusion Criteria:

* Patients with another skin disease that may affect the evaluation of the pain at the site of PHN
* Patients with pain other than PHN that may affect the evaluation of pain
* Patients with pain that is suspected to be mainly psychogenic
* Patients who have received neurolytic or neurosurgical therapy for PHN

Primary outcomes:
measure: Change in average Numerical Rating Scale (NRS)
timeFrame: baseline to week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Tokyo
Study officials:
References: