louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06824259: The Value of Dual-parametric Magnetic Resonance Combined with Regional Saturation Biopsy in Patients with Suspected Prostate Cancer
Official title: The Value of Dual-parametric Magnetic Resonance Combined with Regional Saturation Biopsy in Diagnostic Decision-making in Patients with Suspected Prostate Cancer--a Single-center Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to investigate the value of dual-parameter magnetic resonance imaging(bpMRI) combined with regional saturation biopsy in the diagnosis of prostate cancer by means of a prospective randomized controlled study.

The main questions it aims to answer are:

Can bpMRI guide the timing of prostate puncture and avoid unnecessary prostate biopsy? Effectiveness of focal saturation biopsy versus systemic biopsy + targeted biopsy.


Eligibility criteria: Inclusion Criteria:

1. Be 18 years of age or older.
2. Compliance with clinical guidelines for indications for prostate puncture:

   * suspicious prostate nodule detected on rectal palpation;
   * suspicious lesion detected by transrectal ultrasound or magnetic resonance;
   * tPSA \> 10 ng/mL;
   * tPSA 4-10 ng/mL with f/t \< 0.16 or PSAD \> 0.15.
3. Complete sequence of bpMRI of the prostate at our institution;

Exclusion Criteria:

1. tPSA \>50ng/mL;
2. Presence of contraindications to prostate puncture and inability to tolerate prostate puncture;
3. reatment with radiotherapy, chemotherapy and surgery before prostate puncture;
4. History of prostate cancer;
5. Prostate multiparametric magnetic resonance images of poor quality or some sequences are missing.

Primary outcomes:
measure: The clinically significant prostate cancer (csPCa) detection rate
timeFrame: One month after the biopsy procedure.
Secondary outcomes:
measure: The Gleason score (GS) of the biopsy sample
timeFrame: One month after the biopsy procedure.
measure: The PCa detection rate
timeFrame: One month after the biopsy procedure.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05680259: Assessment of the Effects of Maela Connected Follow-up on Well-being and Pain After Lumbar Spine Surgery
Official title: Assessment of the Effects of Maela Connected Follow-up on Well-being and Pain After Lumbar Spine Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lumbar Spine Surgery
Quality of Life
Pain
Keywords: mobile app follow-up
lumbar spine surgery
Quality of Life
Pain
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Digital technologies could reduce the length of hospital stay and improve post-operative recuperation after discharge by offering a remote follow-up. No study has investigated the effects of connected follow-up on lumbar spine inpatients.

The purpose of this project is to assess the effects of connected follow-up on pain and quality of life after lumbar spine surgery.


Eligibility criteria: Inclusion Criteria:

* First ever lumbar spine surgery in the context of a degenerative spinal pathology
* Age between 18 and 60 yo
* Providing free and informed consent to participate
* Having a smartphone able to process MAELA application

Primary outcomes:
measure: Variation of number of well-being patients in both groups
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT00257959: Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ventricular Tachycardia
Lead sponsor: Connolly, Stuart, M.D.
Sponsor class: INDIV
Collaborators: name: Abbott Medical Devices
First posted: 2005-11-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is an open parallel design randomized trial of amiodarone plus a beta blocker vs a beta blocker alone vs sotalol for the prevention of ICD shocks in patients receiving an ICD for spontaneous or inducible ventricular tachycardia or fibrillation


Eligibility criteria: Inclusion Criteria: spontaneous or inducible ventricular tachycardia or fibrillation -

Exclusion Criteria:

-

Primary outcomes:
measure: ICD shock for any cause
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Stuart Connolly
role: PRINCIPAL_INVESTIGATOR
References:
citation: Connolly SJ, Dorian P, Roberts RS, Gent M, Bailin S, Fain ES, Thorpe K, Champagne J, Talajic M, Coutu B, Gronefeld GC, Hohnloser SH; Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators. Comparison of beta-blockers, amiodarone plus beta-blockers, or sotalol for prevention of shocks from implantable cardioverter defibrillators: the OPTIC Study: a randomized trial. JAMA. 2006 Jan 11;295(2):165-71. doi: 10.1001/jama.295.2.165.
citation: Hohnloser SH, Dorian P, Roberts R, Gent M, Israel CW, Fain E, Champagne J, Connolly SJ. Effect of amiodarone and sotalol on ventricular defibrillation threshold: the optimal pharmacological therapy in cardioverter defibrillator patients (OPTIC) trial. Circulation. 2006 Jul 11;114(2):104-9. doi: 10.1161/CIRCULATIONAHA.106.618421. Epub 2006 Jul 3.
Clinical trial NCT06500559: Alveolar Bone Dehiscence and Fenestration Following Accelerated Maxillary Canine Retraction
Official title: Comparison of Alveolar Bone Dehiscence and Fenestration Following Maxillary Canine Retraction Using Two Methods of Tooth Movement Acceleration. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fenestration
Dehiscence
Keywords: accelerated orthodontics
Dehiscence
fenestration
CBCT
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Alveolar bone loss and fenestration are the most prevalent bone defects that often result in root exposure, gingival recession, and potential treatment relapse or failure. These issues present complications in orthodontic therapy. Hence, reducing the length of orthodontic therapy and minimizing the occurrence of these serious complications are highly important for orthodontic patients, particularly adults. platelet-rich plasma (PRP) injection and decortication are two promising methods for accelerated tooth movements. Thus, The aim of this study is to evaluate alveolar bone dehiscence and fenestrations after canine retraction, using alveolar decortication and PRP injection as two methods for accelerating tooth movements.


Eligibility criteria: Inclusion Criteria:

1. Age of the patients ranged from 16: 22 years old.
2. Malocclusion that requires extraction of the maxillary first premolar and canine retraction (e.g. class I bimaxillary dentoalveolar protrusion and class II div 1 malocclusion).
3. Maximum anchorage needed for the maxillary arch as a part of the orthodontic treatment plan.
4. Good oral hygiene and periodontal condition.

Exclusion Criteria:

1. Medically compromised patients.
2. Severe crowding in the maxillary arch.
3. Chronic intake of NSAIDs or any medication that interfere with OTM.
4. Previous orthodontic treatment.

Primary outcomes:
measure: Alveolar bone dehiscence
timeFrame: 4 months
measure: Alveolar bone fenestration
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
References:
Clinical trial NCT02711059: Insulin Resistance in Primary Hyperparathyroidism
Official title: Insulin Resistance in Primary Hyperparathyroidism, a Non-classical Manifestation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hyperparathyroidism
Diabetes
Hypercalcemia
Keywords: hyperparathyroidism
insulin resistance
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aims of this study is to analyse if insulin resistance in primary hyperparathyroidism (pHPT) is normalised after parathyroid adenomectomy and if glucose tolerance test may be useful as a diagnostic tool by predicting potential improvement of insulin sensitivity after biochemical cure of pHPT.

Detailed description: To be conducted at the Karolinska University Hospital, Stockholm. Patients with fb-glucos \>6.1 and HbA1c without medical treatment will be included after informed consent and randomised to parathyroidectomy (PTX) within three months or not. The groups will be examined 4 ±4 weeks before and 12±2 weeks after PTX, similar for the control group. The number of participants will be estimated by power calculations based on a pilot study including 20 patients.

The test protocol includes glucose load with control of glucose and insulin, (0, 30, 60 and 120 min) together with measurement of markers of oxidative stress and inflammation.

Eligibility criteria: Inclusion Criteria:

* primary hyperparathyroidism and fb-glukos\>6,1 and/or HbA1c \> 39 mmol/mol

Exclusion Criteria:

* Treatment with insulin, sulfonylurea or metformin

Primary outcomes:
measure: glucose tolerance test with estimation of insulin resistance
timeFrame: 3 months
measure: quality of life - self estimation protocol
timeFrame: 3 months
Secondary outcomes:
measure: psychological wellbeing
timeFrame: 3 months
measure: anxiety, depression
timeFrame: 6 months
measure: cognition
timeFrame: 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Universitetssjukhuset
name: Inga-Lena Nilsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Norenstedt S, Pernow Y, Brismar K, Saaf M, Ekip A, Granath F, Zedenius J, Nilsson IL. Primary hyperparathyroidism and metabolic risk factors, impact of parathyroidectomy and vitamin D supplementation, and results of a randomized double-blind study. Eur J Endocrinol. 2013 Oct 21;169(6):795-804. doi: 10.1530/EJE-13-0547. Print 2013 Dec.
Clinical trial NCT01112059: Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients
Official title: A Randomized Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult CF Patients Hospitalized for Pulmonary Exacerbations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2010-04-28
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the role of a well-known and well-tolerated antibiotic, doxycycline, in the treatment of cystic fibrosis patients who are hospitalized. This antibiotic does not effectively treat the bacteria in airways of cystic fibrosis patients, but may reduce the activity of inflammatory molecules in the disease.

Detailed description: One molecule that is inhibited by doxycycline is matrix metalloprotease-9, which is emerging as an important mediator of lung inflammation and damage in cystic fibrosis. We hypothesize that the addition of treatment with doxycycline in CF inpatients will reduce MMP-9 activity and inflammatory markers in the sputum of cystic fibrosis patients compared to CF patients not treated with doxycycline.

Eligibility criteria: Inclusion Criteria:

* Cystic Fibrosis
* Hospitalization for Pulmonary exacerbation

Exclusion Criteria:

* Significant GI illness
* Participation in another Investigational Protocol
* Allergies to Doxycycline
* Sputum Culture only positive for Staphylococcus aureus,
* Pregnant or Nursing
* Unwilling to use effective birth control
* Elevated LFT's greater than 3x the upper limit of normal
* Creatinine greater than 1.5x the upper limit of normal
* Lung transplantation
* Substance abuse within 30 days of screening

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 1 month from enrollment
measure: Matrix Metalloprotease-9 (MMP-9) Protein Levels in Sputum
timeFrame: 8 days past baseline
Secondary outcomes:
measure: Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment
timeFrame: 8 days
measure: Mean Change in Pulmonary Function Over Treatment Duration
timeFrame: Baseline to end of inpatient clinical exacerbation (average 14 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Amit Gaggar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu X, Abdalla T, Bratcher PE, Jackson PL, Sabbatini G, Wells JM, Lou XY, Quinn R, Blalock JE, Clancy JP, Gaggar A. Doxycycline improves clinical outcomes during cystic fibrosis exacerbations. Eur Respir J. 2017 Apr 5;49(4):1601102. doi: 10.1183/13993003.01102-2016. Print 2017 Apr.
Clinical trial NCT05675059: Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients
Official title: Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Pancreatic Cancer Action Network
First posted: 2023-01-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are receiving chemotherapy.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer
* Receiving chemotherapy under the guidance of Moffitt
* Able to speak and read English
* Able to provide informed consent

Exclusion Criteria:

* Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse).
* Undergoing concurrent treatment for a second primary GI cancer
* ECOG status of 2 or greater
* Use of parenteral or enteral nutrition
* Presence of malignant ascites

Primary outcomes:
measure: Feasibility of the STRONG Program
timeFrame: at 12 weeks
measure: Acceptability of the STRONG Program
timeFrame: at 16 weeks
measure: Participant adherence to the STRONG Program
timeFrame: Up to 90 days
measure: Malnutrition: Significant Weight Loss
timeFrame: at 16 weeks
measure: Malnutrition: Low BMI
timeFrame: at 16 weeks
measure: Malnutrition: Low Skeletal Muscle Mass
timeFrame: at 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Amir Alishahi Tabriz, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Pamela Hodul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00189059: Effects of Amitriptyline for the Treatment of Pain on Driving Performance and Cognition.
Official title: Effects of Pain and the Treatment of Pain With Amitriptyline on Driving Performance, Attentional Capacity and Psychomotor Performance in Chronic Neuropathic Pain Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Neuropathic Pain
Keywords: neuropathic pain
erp
driving
attention
amitriptyline
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Utrecht University
First posted: 2005-09-16
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The acute and subchronic effects of amitriptyline were compared to placebo in a double-blind crossover randomized study on driving ability and driving-related skills in chronic neuropathic pain patients.It was hypothesized that nocturnally administered 25 mg amitriptyline might affect driving performance negatively after acute, but not after subchronic treatment.

Detailed description: The present study was designed to determine the effects of nocturnally administered 25 mg amitriptyline, compared to placebo, after single (Day 1, acute effects) and repeated (Day 15, subchronic effects) administration on driving performance in neuropathic pain patients. In addition to the on-the-road driving test, laboratory tests measuring driving-related skills were administered. Moreover, effects of amitriptlyine on an attentional capacity task were tested using Event-Related Potentials (ERPs). It was hypothesized that nocturnally administered 25 mg amitriptyline might affect driving performance negatively after acute, but not after subchronic treatment.

Eligibility criteria: Inclusion Criteria:

* age, amitriptyline responder, adequately treated with amitriptyline in studied dose before study participation, pain intensity score (VAS) of at least 4 cm on a 10 cm scale, driving licence, driving experience, speak fluently Dutch, normal vision, right-handed

Exclusion Criteria:

* psychological or physical disorder other than pain(-related), other psychotropic medication use, excessive drinking or smoking, alcohol- or drug dependence, illigal drug use

Primary outcomes:
measure: driving parameters
Secondary outcomes:
measure: laboratory task parameters
measure: ERPs
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University of Utrecht
Study officials:
affiliation: University of Utrecht, department of Psychopharmacology
name: Edmund Volkerts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01577459: A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response
Official title: A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2012-04-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult volunteers.

Detailed description: Eligible subjects will be randomized to 1 of 2 possible treatment sequences (N=9 per sequence) on Study Day 1. Subjects will receive oral 200 mg TR 701 FA or Placebo for TR 701 FA once daily for 5 days during each treatment period, with a 2 day washout between periods (72 hours between doses). On Study Day 5 of each treatment period, subjects will also receive oral 60 mg PSE.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects between 18 and 45 years of age, inclusive
* Healthy males and females with no clinically significant abnormalities identified by a detailed medical history
* Body mass index ≥ 19.0 kg/m2 and ≤ 31.0 kg/m2

Exclusion Criteria:

* Systolic blood pressure \> 130 mmHg or \< 90 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
* Diastolic blood pressure \> 90 mmHg or \< 60 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
* Heart rate \> 90 bpm or \< 50 bpm measured after 10 minutes supine at the Screening Visit and Study Day
* Known allergy or hypersensitivity to PSE

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 13 days
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Trius Investigator Site 001
state: Kansas
Study officials:
affiliation: Trius Therapeutics
name: Philippe G Prokocimer, MD
role: STUDY_CHAIR
References:
citation: Flanagan S, Minassian SL, Prokocimer P. Pharmacokinetics of Tedizolid and Pseudoephedrine Administered Alone or in Combination in Healthy Volunteers. J Clin Med. 2018 Jun 14;7(6):150. doi: 10.3390/jcm7060150.
citation: Flanagan S, Bartizal K, Minassian SL, Fang E, Prokocimer P. In vitro, in vivo, and clinical studies of tedizolid to assess the potential for peripheral or central monoamine oxidase interactions. Antimicrob Agents Chemother. 2013 Jul;57(7):3060-6. doi: 10.1128/AAC.00431-13. Epub 2013 Apr 22.