louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00670436: The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions
Official title: The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Chronic Total Occlusion
Native Coronary Artery
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: B. Braun Melsungen AG
First posted: 2008-05-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting PTCA-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.


Eligibility criteria: Inclusion Criteria:

* chronic total occlusion
* Thrombolysis in Myocardial Infarction (TIMI) flow 0 or 1
* occlusion in native coronary artery
* indication for percutaneous coronary intervention based on symptoms, prognosis or evidence of ischemia
* reference diameter 2.5 mm to 4.0 mm

Exclusion Criteria:

* saphenous vein graft
* bifurcation lesion with need to stent main and side branch
* left main occlusion
* de-novo stenosis (no occlusion)
* restenosis
* in-stent restenosis
* contraindication for dual antiplatelet therapy with acetylsalicylic acid and clopidogrel for 6 months
* coronary aneurysm at target lesion

Primary outcomes:
measure: Late loss
timeFrame: 6 months
Secondary outcomes:
measure: percent diameter stenosis
timeFrame: 6 months
measure: binary angiographic restenosis rate
timeFrame: 6 months
measure: late loss index
timeFrame: 6 months
measure: Target lumen revascularization
timeFrame: 30 days, 6, 12, 24 months
measure: target vessel revascularization
timeFrame: 30 days, 6, 12, 24 months
measure: major adverse cardiac events
timeFrame: 30 days, 6, 12, 24 months
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt
city: Ulm
country: Germany
facility: University of Ulm
Study officials:
affiliation: University of Ulm, Ulm, Germany
name: Jochen Wöhrle, MD; FESC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wohrle J, Werner GS. Paclitaxel-coated balloon with bare-metal stenting in patients with chronic total occlusions in native coronary arteries. Catheter Cardiovasc Interv. 2013 Apr;81(5):793-9. doi: 10.1002/ccd.24409. Epub 2012 Nov 8.
Clinical trial NCT06979336: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Official title: A Phase IIb, Multicenter, Double-blind, Placebo-controlled Induction Study With an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-18
Enrollment: 224
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 purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed.

Detailed description: This study consists of up to 5-week screening period, a 12-week induction phase, a 40-week active treatment extension, and a safety follow-up period following the last dose of study treatment. The induction phase will be placebo-controlled and after its completion, all participants will receive treatment with active study drug, regardless of the treatment response.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of ulcerative colitis (UC) established at least 3 months
* Moderately to severely active UC assessed by mMS
* Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC

Exclusion Criteria:

* Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
* Diagnosis of Crohn's disease or indeterminate colitis
* Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)
* Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and/or IL-23

Primary outcomes:
measure: Percentage of Participants With Clinical Remission at Week 12
timeFrame: At Week 12
Secondary outcomes:
measure: Percentage of Participants With Clinical Response at Week 12
timeFrame: At Week 12
measure: Percentage of Participants With Endoscopic Improvement at Week 12
timeFrame: At Week 12
measure: Percentage of Participants With Endoscopic Remission at Week 12
timeFrame: At Week 12
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to Weeks 65
measure: Serum Concentration of RO7837195
timeFrame: Up to Weeks 65
measure: Percentage of Participants With Anti-drug Antibodies to RO7837195
timeFrame: Up to Weeks 65
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00575536: Optical Stimulation in Peripheral Nerves for Select Rhizotomy Procedures
Official title: Optical Stimulation in Peripheral Nerves in Selective Rhizotomy Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spasticity
Keywords: spasticity
rhizotomy
surgery
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2007-12-18
Enrollment: 19
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children over the age of 3 and younger than 17 years who have failed appropriate medical therapy for spasticity and are recommended for Rhizotomy surgery

Brief summary: The purpose of this study is to determine the safe and effective levels of optical stimulation in peripheral nerves of humans otherwise undergoing nerve lesioning in surgery.

Detailed description: The purpose of this study is to determine the safe and effective levels of optical stimulation in peripheral nerves of humans otherwise undergoing nerve lesioning in surgery, namely children undergoing selective rhizotomy for treatment of medically refractory spasticity.

Eligibility criteria: Inclusion Criteria:

* Children over the age of 3 and younger than 17 years
* Children who have failed appropriate medical therapy and are recommended for selective rhizotomy to treat spasticity by the pediatric neurosurgeon
* Children who would normally undergo electrodiagnostic testing including EMG monitoring for physiologic testing during surgery
* Surgery must be performed at the Vanderbilt University Children's Hospital

Exclusion Criteria:

* Patients in which a segment of the nerve (up to 2cm) cannot likely be identified at the time of surgery as determined by the pediatric neurosurgeon
* Children not undergoing routine selective rhizotomy for medically refractory spasticity as determined by the pediatric neurosurgeon
* Children who are medically unstable to tolerate an additional 20 minutes of experimental testing during the surgery
* Women who are pregnant will be excluded from this study

Primary outcomes:
measure: A brief series of optical versus electrical stimulation of the nerve will be used to measure the efficacy of optical stimulation
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University, Dept. Neurosurgery
name: Peter E Konrad, MD, Ph.D.
role: STUDY_CHAIR
affiliation: Vanderbilt University, Dept. Neurosurgery
name: Chanqing Kao, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University, Dept. Neurosurgery
name: Michael Remple, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cayce JM, Wells JD, Malphrus JD, Kao C, Thomsen S, Tulipan NB, Konrad PE, Jansen ED, Mahadevan-Jansen A. Infrared neural stimulation of human spinal nerve roots in vivo. Neurophotonics. 2015 Jan;2(1):015007. doi: 10.1117/1.NPh.2.1.015007. Epub 2015 Feb 23.
Clinical trial NCT06809036: Mobilisation and Breathing Exercises After Abdominal Surgery at Sahlgrenska University Hospital
Official title: Mobilisation and Breathing Exercises After Abdominal Surgery at Sahlgrenska University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Surgery
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2025-02-05
Enrollment: 100
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: Patients at Sahlgrenska university hospital.

Brief summary: The aim of the study is to evaluate the effect of a new care strategy, including earlier and more intensive mobilization and individually adapted breathing exercises, regarding length of stay, recovery, complications and which factors predict interventions early in the postoperative course after various abdominal surgical procedures.


Eligibility criteria: Inclusion Criteria:

* undergoing elective or emergency open, or robot-assisted abdominal surgery
* has an expected anesthesia time of over 4 hours
* is extubated on the operating table
* planned overnight stay in the postoperative ward.

Exclusion Criteria:

* plastic, trauma, transplant or orthopedic surgery.

Primary outcomes:
measure: Time in postoperative care
timeFrame: At discharge from postoperative care up to two days after surgery.
Secondary outcomes:
measure: Time to first mobilisation
timeFrame: Up to the second postoperative day
measure: Time to start of breathing exercises
timeFrame: Up to the second postoperative day
Other outcomes:
measure: Number of mobilisations
timeFrame: Up to the second postoperative day
measure: Number of sessions of breathing exercises
timeFrame: Up to the second postoperative day
measure: Time at hospital
timeFrame: At discharge from the hospital up to four weeks after surgery
measure: Type of mobilisation
timeFrame: Up to the second postoperative day
measure: Type of breathing exercises
timeFrame: Up to the second postoperative day
measure: Analgesia
timeFrame: Up to the second postoperative day
measure: Complications
timeFrame: At discharge from the hospital up to four weeks after surgery.
measure: Dose of analgesia
timeFrame: Up to the second postoperative day
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References:
Clinical trial NCT06208436: The Survival Outcome of Adjuvant Chemotherapy for Stage I Pancreatic Cancer
Official title: The Survival Outcome of Adjuvant Chemotherapy for Stage I Pancreatic Cancer Stratified by Pathologic Risk Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Cancer
Chemotherapy
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stage I PDAC patients who underwent radical surgery.

Brief summary: This study aimed to evaluate the impact of adjuvant chemotherapy on survival in patients with Stage I pancreatic cancer stratified by pathologic risk factors.


Eligibility criteria: Inclusion Criteria: Patients who underwent surgical resection and were pathologically diagnosed as PDAC between 2010 and 2021.

-

Exclusion Criteria: Patients with pN1-N2, patients with pT3-T4, patients with distant metastasis, patients who received neoadjuvant therapy, patients with R1 resection, and patients who died due to perioperative mortality within 30 days.

-

Primary outcomes:
measure: Recurrence-free survival
timeFrame: January 2010 to February 2023
Secondary outcomes:
measure: Overall survival
timeFrame: January 2010 to February 2023
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Jihui
state: Tianjin
Study officials:
References:
Clinical trial NCT02846636: Mpact Cup Performance After Total Hip Arthroplasty
Official title: Prospective, Multicentric, Non-controlled, Non-randomized Clinical Survey to Evaluate Mpact Cup Performance After Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Total Hip Replacement
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2016-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients eligible for total hip arthroplasty who meet the inclusion criteria will be invited in the study

Brief summary: The main objective of this study is to evaluate the 10 year performances of Mpact cup in total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* patients requiring a total hip replacement who meets the standard indications for use for Medacta implants
* patients who accept to participate in the study
* patients who signed the consent form for the treatment of personal data

Exclusion Criteria:

* patients presenting conditions identified as contraindication for Medacta implants
* revision surgeries

Primary outcomes:
measure: implant survival trough Kaplan-Meier curve
timeFrame: 10 years
Secondary outcomes:
measure: hip function with Harris Hip Score
timeFrame: preop, 3/6 months, 1, 3, 5, 7, 10 years
measure: record of adverse events
timeFrame: intraop, 3/6 months, 1, 3, 5, 7, 10 years
measure: implant stability trough assessment of presence of radiolucencies
timeFrame: 3/6 months, 1, 3, 5, 7, 10 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Médico-Chirurgicale Paris V
Study officials:
References:
Clinical trial NCT02663336: Prevalence of Masked Hypertension in Nephrological Patients
Official title: Prevalence of Masked Hypertension in Nephrological Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Masked Hypertension
Keywords: masked hypertension, chronic kidney disease
Lead sponsor: Waid City Hospital, Zurich
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease of the nephrological outpatient clinic of Waidspital with normal office blood pressure in the context of diagnosed arterial hypertension with or without antihypertensive medication

Brief summary: The purpose of this study is to determine the percentage of patients with masked hypertension in a population with chronic kidney disease. The investigators goal is to register prospectively ambulatory blood pressure measurement results of patients of a nephrological outpatient clinic with normal office blood pressure to finally find the percentage of masked hypertension in this population.


Eligibility criteria: Inclusion Criteria:

* Age: 20-90 years
* Known arterial hypertension and antihypertensive medical treatment
* Office blood pressure \< 140 mmHg systolic and \<90 mmHg diastolic

Exclusion Criteria:

* Age \<20 or \>90 years

Primary outcomes:
measure: Number of participants with uncontrolled masked hypertension assessed by comparison of ambulatory blood pressure with office blood pressure
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Stadtspital Waid Zurich
Study officials:
affiliation: Stadtspital Waid Zurich Switzerland
name: Andreas Schleich
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00736736: Effects of Hip Abductor and External Rotator Strength Training in Patients With Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-08-18
Enrollment: 85
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The first purpose was to compare the difference between leg press exercise(LPE) and additional hip abductor and external rotator muscle strength training to leg press exercise(LPE+HAE) in muscle strength, hip kinematics during step down, pain severity and function for patients diagnosed with patellofemoral pain syndrome. The second one was to discover the relationship between the change in muscle strength performance and the difference of hip joint kinematics post treatment.


Eligibility criteria: Inclusion Criteria:

* Patellofemoral pain syndrome ( Bilateral or unilateral)
* Special tests: crepitus during compression test, patellar grind test (Clarke's sign), pain during compression test, palpation ( at least 2 )
* Below 50 years old
* Pain :after long sitting, up/down stair, squat, kneeling, running \& jumping ( at least 2 )
* Pain duration at least 1 month
* At least 1 item of PSS score more than 3 cm

Exclusion Criteria:

* Knee operation
* Central or peripheral neurological deficits
* Obvious knee joint or lower extremity malalignment
* People involved in competitive sports
* PSS sub-scale pain experienced last week more than 8cm
* Have been taking anti-inflammatory drugs , received anti-inflammatory injection or received other therapy for past 3 months

Primary outcomes:
measure: Muscle Strength by hand-held dynamometry, hip joint kinematics during step down by electromagnetic motion tracking system (FASTRAK, Polhemus ), pain severity by PFPS pain severity scale (PSS), functional performance by Anterior Knee Pain Scale(AKP).
timeFrame: Pre and Post 8 weeks of exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: The School and Graduate Institute of Physical Therapy of National Taiwan University
Study officials:
affiliation: The School and Graduate Institute of Physical Therapy of National Taiwan University
name: Mei-Hwa Jan
role: STUDY_CHAIR
References:
citation: Mascal CL, Landel R, Powers C. Management of patellofemoral pain targeting hip, pelvis, and trunk muscle function: 2 case reports. J Orthop Sports Phys Ther. 2003 Nov;33(11):647-60. doi: 10.2519/jospt.2003.33.11.647.
Clinical trial NCT02740036: Quality Control of CE-Certified Phonak Hearing Aids - 2016_06
Official title: Quality Control of CE-Certified Phonak Hearing Aids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2016-04-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of hearing participants to grant quality control prior to product launch. The aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems and to equivalent competitor devices.

Detailed description: Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection"). This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility criteria: Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* 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
* Central hearing disorders

Primary outcomes:
measure: Zero-defect performance in daily life
timeFrame: Four weeks
Secondary outcomes:
measure: Speech intelligibility in percent in a quiet listening situation
timeFrame: Four weeks
measure: Speech intelligility in noise as signal to noise ration in dB (dB SNR)
timeFrame: Four weeks
Other outcomes:
measure: Initial first fit acceptance (pre-calculation) in lab
timeFrame: One week
measure: Real ear frequency responses of the hearing aids (Real Ear Measurements)
timeFrame: One week
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
state: Zürich
Study officials:
References:
Clinical trial NCT06478836: Planter Pressure and Body Mass Index Affect Balance in Normal Children
Official title: Does Planter Pressure and Body Mass Index Affect Balance in Normal Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plantar Pressure
Keywords: association
foot pressure
body mass index
balance
normal children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred normal children aged from 8 to 12 years old will participate in this study.

Brief summary: is there relation between planter pressure, body mass index and balance in normal children?

Detailed description: is there relation between planter pressure, body mass index and balance in normal children?

Eligibility criteria: Inclusion Criteria:

* Normal children from both sex
* Age from 8 to 12 years

Exclusion Criteria:

* recent fractures or procedures
* open wounds on the lower limbs,
* any fixed deformities in the lower limbs

Primary outcomes:
measure: Foot pressure will be recorded by a pedograph
timeFrame: 3 months
measure: BMI will be calculated by weight/height^2 (CDC chart).
timeFrame: 3 months
measure: Balance will be assessed by Biodex
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Mostafa S Ali
state: Married
Study officials:
References: