louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00404469: Effects of Peritendinous Corticosteroid Injections, Eccentric Training and Heavy Slow Resistance Training in Patellar Tendinopathy
Official title: Effects of Peritendinous Corticosteroid Injections, Eccentric Training and Heavy Slow Resistance Training in Patellar Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellar Tendinopathy / Jumpers Knee
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2006-11-28
Enrollment: 39
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: We will investigate the effect of peritendinous corticosteroid injections, eccentric training and heavy resistance training in male patellar tendinopathy patients. The purpose is to compare the clinical effect of these three treatments in a randomised controlled trial. Also we wish to investigate the treatment mechanisms responsible for the effectiveness of the three treatments.

Detailed description: 3 interventions groups as described above (n=13 in each group) 12 weeks intervention period. Clinical assessments before and after intervention: VAS, VISA, Tendon thickness, Doppler us activity.

Before and after intervention tendon biopsies will be taken and analyzed for crosslinks and fibril diameter. Also tendon mechanical properties will be measured. Tendon and muscle structural properties will be measured with MRI.

Treatment satisfaction will be stated after intervention period.

Eligibility criteria: Inclusion Criteria:

* Clinical patellar tendinopathy pain.
* Tendon swelling
* Hypoechoic
* Doppler activity in tendon

Exclusion Criteria:

* Previous knee surgery
* diabetes
* arthritis
* previous steroid injections

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sports Medicine Copenhagen. Dept 8 1st floor. Bispebjerg Hospital
Study officials:
affiliation: Institute of Sports Medicine, Copenhagen
name: Mads Kongsgaard, PhD., MSc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06990269: Phase 2 Study of ADX-038 in Participants With Geographic Atrophy
Official title: A Phase 2, Randomized, Masked, Placebo-Controlled Study of Subcutaneously Administered ADX-038 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Geographic Atrophy Secondary to Age-related Macular Degeneration
Lead sponsor: ADARx Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-25
Enrollment: 240
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Masked, Placebo-Controlled
Primary purpose: TREATMENT

Brief summary: Phase 2 study is designed to assess the efficacy of ADX-038 compared with placebo in participants with GA secondary to AMD. Safety, pharmacokinetics (PK), and pharmacodynamics (PD) will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of GA of the macula secondary to AMD
* GA lesions between 2.5 and 12.5 mm2 at screening
* Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol
* Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol

Exclusion Criteria:

* Has GA secondary to causes other than AMD
* Has active ocular disease that compromises or confounds visual function
* History of surgery for retinal detachment
* Has ocular condition other than GA secondary to AMD
* Use of intravitreal complement inhibitors in study eye
* Hereditary or acquired complement deficiency
* Active viral, bacterial or fungal infection
* Liver injury as evidenced by abnormal liver function tests
* Donating blood
* History of choroidal neovascularization in the study eye

Primary outcomes:
measure: Evaluate the effect of ADX-038 on the preservation of the EZ layer
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ADARx Pharmaceuticals, Inc.
name: Daniel Chao, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01054469: Transversus Abdominus Plane Block
Official title: Ultrasound Guided Transversus Abdominus Plane Block for Patients Undergoing Laparoscopic Hand-assisted Nephrectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephrectomy
Keywords: nephrectomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-01-22
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Transversus Abdominus Plane (TAP) block may reduce need for postoperative pain medications in patients undergoing laparoscopic hand assisted nephrectomy. Our hypothesis is that the TAP block will result in a significant reduction in pain scores and morphine requirements in the active group.


Eligibility criteria: Inclusion Criteria:

* Patients who are ≥ 18 and ≤ 80 years of age.
* Patients scheduled to undergo hand assisted laparoscopic removal of a single kidney for either tumor or living donor transplantation.

Exclusion Criteria:

* Patients scheduled to undergo an open procedure for nephrectomy
* Patients who are converted from hand assisted laparoscopic surgery to open surgery due to intraoperative complications.
* Bilateral nephrectomy
* Pregnant or lactating patients
* Patients unable or unwilling to provide informed consent
* Patients unable to comprehend the use of a visual analog scale
* Patients desiring preemptive antiemetics
* Opioid tolerance
* Allergy to amide local anesthetics or any of the study drugs (morphine).
* Contraindication to regional nerve block (bleeding disorder, infection at site of block)
* Patients with history of dementia

Primary outcomes:
measure: Determine if TAP block is a viable alternative to PCA narcotics for the control of pain after hand-assisted, laparoscopic nephrectomy.
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: TAP block with ropivacaine will lead to equivalent or better results with regard to the following outcomes:pain scores, nausea, vomiting, sedation, request for PCA, discontinuation of Foley catheter, discharge from the hospital
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Stephen Aniskevich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05607069: Multifactorial Evaluation of COVID-19 Respiratory Reliquates
Official title: Multifactorial Evaluation of COVID-19 Respiratory Reliquates
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19 Respiratory Infection
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll patients scheduled for lung resection surgery that had a documented previous SARS-Cov2 infection.

Brief summary: The present study aims to evaluate how commonly diagnostic tools employed in the preoperative evaluation of respiratory function in thoracic surgery can identify pathological alteration due to a previous SARS-CoV-2 infection. In particular, the investigators will gather information concerning imaging (lung ct and lung ultrasound), arterial blood gas analysis, and pulmonary function tests.


Eligibility criteria: Inclusion Criteria:

* previous SARS-Cov2 infection
* awaiting lung resection surgery

Exclusion Criteria:

* less than 18 years of age
* unable to consent to enroll
* refuse to enroll

Primary outcomes:
measure: sensibility of preoperative evaluation in identifying pathological sequelae due to SARS-Cov2 infection
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza di Torino
Study officials:
References:
Clinical trial NCT02617069: Botulinum Toxin Injection Into Epicardial Fat Pads to Prevent Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Official title: Botulinum Toxin Injection Into Epicardial Fat Pads to Prevent Atrial Fibrillation in Patients Undergoing Cardiac Surgery: Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
botulinum toxin
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2015-11-30
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective randomized double-blind study was to compare the efficacy of botulinum toxin injection in epicardial fat pads for preventing recurrences (in early postoperative period) of atrial tachyarrhythmia in patients undergoing cardiac surgery.


Eligibility criteria: Key inclusion Criteria:

* Indication for cardiac surgery (e.g. coronary artery bypass grafting, valve repair/replacement) according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for cardiac surgery

Key exclusion Criteria:

* Planned maze procedure or pulmonary vein isolation

Primary outcomes:
measure: Recurrence of >30 s of any atrial tachyarrhythmia, including atrial fibrillation (AF) and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug.
timeFrame: 1 month
Secondary outcomes:
measure: Recurrence of >30 s of any atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug.
timeFrame: 12 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Study officials:
References:
Clinical trial NCT05733169: Pre-calculation for Frequency Lowering With Hearing Devices
Official title: Pre-calculation for Frequency Lowering With Hearing Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frequency Lowering
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2023-02-17
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Perceptual evaluation of the parametrization and pre-calculation of frequency lowering requires the participation of subjects with hearing loss.


Eligibility criteria: Inclusion Criteria:

* Experienced hearing aid user (minimum use duration 1 year)
* Adult (minimum age: 18 years),
* Experience with frequency lowering,
* Hearing thresholds with N5-N7, S1, S2, S3 hearing loss
* Symmetrical hearing loss (difference between ears \<= 10 dB for 1kHz-6kHz) ,
* Sensorineural hearing loss,
* Air Conduction - bone conduction gap \<= 10 dB,
* Written and spoken German,
* Ability to understand instruction,
* Ability to describe listening experiences,
* Ability to attend to the appointments,
* Ability to fill in a questionnaire conscientiously
* Healthy outer ear (without previous surgical procedures)
* Hearing loss within the fitting ranges of the investigational product,
* Informed consent as documented by signature.

Exclusion Criteria:

* Clinical contraindications deformity of the ear (closed ear canal
* or absence of pinna),
* Not willing to wear the hearing aid,
* Fluctuating hearing that could influence the results,
* Contraindications to the MD in this study, e.g. known hypersen-sitivity or allergy to the investigational product,
* Limited mobility and not in the position to attend all appoint-ments,
* Limited ability to describe listening impressions/experiences and the use of the hearing aid,
* Inability to produce a reliable hearing test result,
* Massively limited dexterity,
* Known psychological problems,
* Known central hearing disorders.

Primary outcomes:
measure: Measurement of sound quality and audibility of high-frequency sounds for hearing-impaired subjects with the new parametrization compared to the current implementation of the parametrization.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
state: Kanton Zürich
Study officials:
References:
Clinical trial NCT00283569: Genetic Epidemiology of Adult Onset Glioma
Official title: Genetic Epidemiology of Adult-Onset Glioma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult-Onset Glioma
Keywords: Glioma
Lead sponsor: Kentuckiana Cancer Institute
Sponsor class: OTHER
Collaborators: name: DR. Kathleen Egan
First posted: 2006-01-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Glioma and a Control

Brief summary: To establish a clinic based case control study for examination of potential risk factors for primary adult brain tumors.

Detailed description: Genetic epidemiology of adult glioma to establish potential risk factors for primary adult brain tumors.

Eligibility criteria: Inclusion Criteria:

* primary glioma of any stage
* diagnosed within 4 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kentuckiana Cancer Institute
state: Kentucky
Study officials:
affiliation: Director
name: Renato V. LaRocca, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06662669: YL-13027 and/or HY-0102 Combined With AG Regimen Chemotherapy for Metastatic Pancreatic Cancer
Official title: A Randomized, Open, Parallel-controlled, Multi-center , Phase Ib/Ⅱ Clinical Trial of YL-13027 and/or HY-0102 Combined With AG（Nab-paclitaxel and Gemcitabine) Regimen Chemotherapy for Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Metastatic Pancreatic Cancer
Lead sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In Phase 1b study, six subjects will be enrolled in Arm A (YL-13027 + AG regimen) and Arm B (HY-0102 + AG regimen). The first 12 subjects will be evaluated for safety after one cycle. After safety assessment, subjects will start to enroll in Arm C (YL-13027 + HY-0102 + AG regimen). Each group is planned to include 12-20 subjects. According to the safety and efficacy results of 3 arms of subjects in phase Ib, 1-2 groups were selected for expansion, and a randomized controlled study will be conducted with the standard treatment AG （Arm 4）regimen chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Subject aged between 18 and 75 years.
* Subject has histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
* Subject has at least one evaluable metastatic lesion according to RECIST 1.1 criteria;
* Subject has an ECOG score of 0-1 and is expected to survive more than 3 months;
* Subjects have a good level of organ function.

Exclusion Criteria:

* Subject suitable for potentially curative surgery.
* The subject confirmed by tissue or cytology as other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, etc.
* The subject has previously received gemcitabine and nab-paclitaxel combination therapy within 6 months of progression or intolerance.

Primary outcomes:
measure: Objective response rate
timeFrame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
measure: Progression-free survival
timeFrame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
Secondary outcomes:
measure: Disease control rate
timeFrame: From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.
measure: Adverse events
timeFrame: From time of first dose to 30 days after the last dose.
measure: Plasma concentration of YL-13027 and HY-0102
timeFrame: From one hour before the first dose to the last dose up to 24months.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01775969: Effect of Modality on Discharge Instruction in Patients Receiving Outpatient Antibiotic Prescriptions From the Emergency Department
Official title: Effect of Modality on Discharge Instruction in Patients Receiving Outpatient Antibiotic Prescriptions From the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Modality of Discharge Instructions
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2013-01-25
Enrollment: 2874
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Outpatient antibiotics are frequently prescribed from the emergency department, and limited health literacy may impact compliance with recommended treatments. The investigators are looking to determine if patient preference for multimodality discharge instructions for outpatient antibiotic therapy varies by health literacy level, and if modality effected patient-reported antibiotic compliance and 72-hour antibiotic pick-up.

Detailed description: This is a prospective randomized trial that includes consenting patients discharged with outpatient antibiotics. Health literacy is assessed using a validated health literacy assessment, the Newest Vital Sign (NVS). Patients are randomized to a discharge instruction modality: 1) standard of care, typed and verbal medication and case-specific instructions; 2) standard of care plus text messaged instructions sent to the patient's cell phone; or 3) standard of care plus voicemailed instructions sent to the patient's cell phone. Antibiotic pick-up is verified with the patient's pharmacy at 72 hours. Patients are called at 30 days to determine antibiotic compliance.

Eligibility criteria: Inclusion Criteria:

* Emergency department patient being prescribed an outpatient antibiotic or the parent of a patient under the age of 18 being prescribed on outpatient antibiotic

Exclusion Criteria:

* Doesn't have a cell phone that can receive text messages and voicemail messages
* Unable to provide informed consent
* Prisoners

Primary outcomes:
measure: 72-hour antibiotic pickup
timeFrame: 72 hours
measure: Antibiotic compliance
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: James R Miner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02093169: D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound
Official title: Interventional, Open-label, Positron Emission Tomography (PET) Study Investigating D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Men
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2014-03-20
Enrollment: 12
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the relationship between the combined Lu AF35700 and Lu AF36152 plasma concentration and D2 dopamine receptor occupancy up to 172 hours after oral dosing of Lu AF35700


Eligibility criteria: Inclusion Criteria:

* Healthy young men \>=25 and \<=45 years of age with a Body Mass Index (BMI) \>=18.5 kg/m2 and \<=30 kg/m2.

Other protocol-defined Inclusion and Exclusion criteria may apply.

Primary outcomes:
measure: Relationship between plasma concentrations and pharmacodynamic (PD) measures specified as binding potential at each scanning time point
timeFrame: Up to 172 hours after dosing
measure: Relationship between plasma concentrations and PD measures specified as plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152 at each scanning time point
timeFrame: Up to 172 hours after dosing
measure: Relationship between plasma concentrations and PD measures specified as occupancy in relation to plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152, respectively
timeFrame: Up to 172 hours after dosing
Secondary outcomes:
measure: Adverse events
timeFrame: Up to Week 12
measure: Columbia Suicide Severity Rating Scale (C-SSRS) (Part B only)
timeFrame: Up to Week 12
measure: Area under the curve (AUC), maximum observed concentration (Cmax), oral clearance (CL/F), and apparent elimination half-life (t½)
timeFrame: Up to 168 hours after dosing
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GB801
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: