louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01419015: PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
Official title: A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: SAPIEN XT Valve (20mm)
Cardiovascular Disease
Valvular Heart Disease
Aortic Stenosis
Heart Valve Therapy
Transcatheter
Transfemoral
Efficacy endpoints
Indexed Aortic Valve Area
NYHA
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2011-08-17
Enrollment: 17
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the 20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, and crimper accessories. The trial includes a premarket pivotal cohort to evaluate the system performance as well as a post market clinical follow-up phase involving long term follow-up of all patients to evaluate the safety of investigational devices up to 5 years.

Detailed description: Purpose: To evaluate the safety and efficacy of THV-9300 (20mm) for patients who have severe symptomatic aortic stenosis attributed to calcification and degeneration of a valve leaflet and for whom undergoing a surgery safely would be difficult.

Enrollment: 15 patients (No.of patients needed: 12)

Follow-up: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 months and annually for 5 years.

Clinical sites:

1)Osaka University Hospital, 2)Kurashiki Central Hospital, 3)Sakakibara Heart Institute, 4) Kokura Memorial Hospital

Eligibility criteria: Inclusion Criteria:

* Patients who were judged difficult to safely undergo AVR
* Severe senile degenerative aortic valve stenosis
* NYHA Functional Class II or greater
* Signed Informed Consent

Exclusion Criteria:

* Aortic valve is congenital unicuspid or bicuspid
* Annulus size between \< 16 mm or \> 19 mm
* LVEF \< 20 %

Primary outcomes:
measure: NYHA Improvement and AVA >= 0.65 cm2
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Fuchu
country: Japan
facility: Sakakibara Heart Institute
state: Toyko
Study officials:
affiliation: Sakakibara Heart Institute
name: Morimasa Takayama, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06990815: Immediate Effects of Kinesio Taping in Primary Dysmenorrhea
Official title: The Immediate Effect of Kinesio Taping on Pain, Menstrual Symptoms, Fear of Movement, and Sleep Quality in Primary Dysmenorrhea: A Randomized Sham-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Kinesio Taping
Pain
Menstrual Symptoms
Fear of Movement
Sleep Quality
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary dysmenorrhea is characterized by recurrent, cramping lower abdominal pain during menstruation and affects approximately 50% to 90% of women. The etiology of primary dysmenorrhea involves the increased release of prostaglandins and other inflammatory mediators, which cause uterine contractions and reduced blood flow. In addition to pharmacological approaches, non-pharmacological methods also play an important role in the treatment of dysmenorrhea.

Kinesio taping helps relieve pain by reducing pressure on the muscle and supports treatment through various application techniques. It improves local circulation, reduces muscle tension, and alleviates symptoms of primary dysmenorrhea.

The aim of this study is to investigate the effects of kinesio taping on pain, menstrual symptoms, fear of movement, and sleep quality in women with primary dysmenorrhea, and to compare the outcomes with those of a sham taping group.

The hypothesis is that kinesio taping will be more effective than sham taping in improving these parameters in women with primary dysmenorrhea.


Eligibility criteria: Inclusion Criteria:

* Being a nulliparous woman aged between 18 and 24 years
* Having a diagnosis of primary dysmenorrhea confirmed by a physician,
* Being literate
* Cooperating in completing the assessment scales
* Scoring one or above on the Weissman Scale
* Agreeing to participate in the study
* Having regular menstruation in the last 6 months
* Being willing and voluntary to participate in the research.

Exclusion Criteria:

* Having a diagnosis of secondary dysmenorrhea
* Using contraceptive pills
* Having a history of childbirth or pregnancy
* Having irregular menstrual cycles (menstrual cycle length less than 21 days or longer than 35 days)
* Having any pelvic pathology or history of pelvic surgery
* Having gastrointestinal, urogynecological, autoimmune, psychiatric, neurological diseases, or other chronic pain syndromes.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 2 weeks
measure: Menstrual Symptom Questionnaire
timeFrame: 2 weeks
measure: Menstrual Attitude and Behavior Scale
timeFrame: 2 weeks
measure: Tampa Scale of Kinesiophobia
timeFrame: 2 weeks
measure: Richard Campbell Sleep Questionnaire
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Okan University
Study officials:
References:
Clinical trial NCT00545415: The Effect of Fruit and Fruit Juice on Plasma Total Antioxidant Capacity
Official title: The Effect of Fruit and Fruit Juice on Plasma Total Antioxidant Capacity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: fruit
antioxidant
Healthy subjects
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2007-10-17
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of the study is to compare the effect of consumption of a fruit beverage on plasma antioxidant capacity with that of the consumption of fruit.


Eligibility criteria: Inclusion Criteria:

* Healthy males
* body mass index between 20-25

Exclusion Criteria:

* use of any medication
* smoking
* consumption of 3 or more glasses of alcohol per day
* involved in top sport

Primary outcomes:
measure: The total plasma antioxidant capacity after intake of three different kinds of fruit(beverage)
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University of Maastricht
Study officials:
affiliation: Maastricht University
name: Aalt Bast, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05121415: Investigation of Genetic Disease Marker Associated With Spontaneous Haemorrhagic Stroke Complicating Severe Pre-eclampsia in Pregnancy
Official title: Preventive and Personalized Medicine (2021-2023)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhagic Stroke
Eclampsia
Keywords: SNP
Lead sponsor: Asfendiyarov Kazakh National Medical University
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with hemorrhagic stroke complicating severe eclampsia in pregnancy who visited Scientific Center for Obstetrics, Gynecology and Perinatology. Kazakhstan, Almaty

Brief summary: To search for a genetic marker of hemorrhagic stroke complicating severe eclampsia, a single nucleotide polymorphism (SNP) analysis of DNA obtained from the peripheral blood of patients with hemorrhagic stroke and normal control will be performed.

Detailed description: Detailed Description:

Unrelated Korean subjects who have Spontaneous hemorrhagic stroke complicating severe eclampsia in pregnancy were recruited in the current study. Genotyping for various SNP associated due to the linkage disequilibrium patterns is to be performed. Genotypes would be statistically compared between patients with hemorrhagic stroke and normal control subjects free of hemorrhagic stroke

Eligibility criteria: Inclusion Criteria:

-patients with hemorrhagic stroke complicating severe eclampsia in pregnancy

Exclusion Criteria:

patients without hemorrhagic stroke complicating severe eclampsia in pregnancy

Primary outcomes:
measure: genotyping for the SNP associated with hemorrhagic stroke complicating severe eclampsia in pregnancy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Hospital
Study officials:
affiliation: JSC "Scientific center of obstetrics, gynecology and perinatology"
name: Aygul Terlikbayeva, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05925985: Propel Drug-Eluting Sinus Stent Family Open Cohort
Official title: Propel Drug-Eluting Sinus Stent Family Open Cohort
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Rhinosinusitis (Diagnosis)
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 200
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: European CRS population implanted with Propel implants

Brief summary: The purpose of this study is to confirm the long-term clinical safety and performance, acceptability of identified risks, and to detect emerging risks based on factual evidence for the PROPEL family of products when used according to labeling (in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery). Additionally, this study intends to collect data on use of corticosteroid-eluting implants in the European CRS population. Data collected will be used to ensure continued consistency between clinical data, the information materials supplied by the manufacturer, and the risk management documentation.


Eligibility criteria: Inclusion Criteria:

* Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
* Patient has or is intended to receive or be treated with an eligible Medtronic product
* Patient is consented within the enrollment window of the therapy received, as applicable

Exclusion Criteria:

* Patient who is, or is expected to be, inaccessible for follow-up
* Participation is excluded by local law
* Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results

Primary outcomes:
measure: Long-term safety and efficacy of corticosteroid-eluting implants in patients with CRS undergoing Functional Endoscopic Sinus Surgery (FESS)
timeFrame: 6 months
Secondary outcomes:
measure: Endoscopic evaluation
timeFrame: 12 months
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg Klinik für Hals, Nasen und Ohrenheilkunde
city: Hagen
country: Germany
facility: Katholisches Krankenhaus Hagen
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe GmbH
city: Köln
country: Germany
facility: Saint Elisabeth Krankenhaus Köln-Hohenlind
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck
city: München
country: Germany
facility: HNO Praxis & Rhinologie Zentrum München
city: Münster
country: Germany
facility: Universitätsklinikum Münster Klinik für Hals, Nasen und Ohrenheilkunde
city: Wiesbaden
country: Germany
facility: Helios Dr Horst Schmidt Kliniken
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital
Study officials:
References:
Clinical trial NCT03813485: Electromyographic´s Differences Between Dry Needling in Tonic or Phasic Skeletal Muscle Fibers.
Official title: Electromyographic´s Differences Between Dry Needling in Latent Myofascial Trigger Point in Tonic or Phasic Skeletal Muscle Fibers of Trapezius
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Disorder
Trigger Point Pain, Myofascial
Keywords: surface electromyographic
dry needling
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the surface electromyography (EGM) changes between dry needling in the upper trapezius, is a prevalence tonic fiber or lower trapezius is a prevalence phasic fiber.

Detailed description: Several studies already found a disturbed surface electromyography activity in myalgic muscle tissue and in the vicinity of myofascial trigger points, however studies about the effect of dry needling in this fibers type on these disturbances in EMG activity are scarce.

The surface electromyography of upper trapezius is related with a tonic muscle dysfunction, for example muscle contracture; and the lower fiber of trapezius is related with atrophy muscle.

Dry needling is an effective method for the treatment of myofascial trigger points for immediate reduction of pain. There are some studies about latent myofascial trigger point and motor activity, but we don't know any research about the effect of dry needling in the differences fibers.

Eligibility criteria: Inclusion Criteria:

* Presence latent myofascial trigger point in the upper/lower trapezius asymptomatic subjects

Exclusion Criteria:

* neck or shoulder pain at the moment or 6 month ago. whiplash injury previous spine or shoulder surgery pregnancy diagnosis of radiculopathy or myelopathy

Primary outcomes:
measure: Changes in surface electromyographic before and after the intervention.
timeFrame: Baseline and 10 minutes after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Francisco de Vitoria
state: Pozuelo De Alarcón
Study officials:
References:
Clinical trial NCT04781985: Prostatic Resection Cavity Stone Post Transurethral Resection of the Prostate (TURP). A Rare Case Scenario
Official title: Kafrelsheikh University Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Hyperplasia
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 1
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: surgical treatment for bladder stone
Primary purpose: TREATMENT

Brief summary: Prostatic resection cavity stone post transurethral resection of the prostate (TURP). A rare case scenario

Detailed description: Transurethral resection of the prostate (TURP) is the gold standard surgical therapy for lower urinary tract symptoms (LUTS) owing to senile prostatic enlargement. Following TURP, LUTS may persist in a percentage of patients. Persistent LUTS necessitates proper evaluation and management (1).

In a rare case report, delayed occurrence of storage and obstructive voiding symptoms after TURP can be caused by dystrophic calcification of the prostatic resection cavity and might be misinterpreted as post-TURP infection. The mechanism of dystrophic calcification entails minimizing tissue trauma by cautious removal of calcifications rather than performing extensive Re-TURP (2).

In our case, a rare presentation of storage LUTS as result of prostatic cavity stone extending into the bladder with same continuum, elicite the core issue of post TURP storage LUTS.

Eligibility criteria: Inclusion Criteria:

* patient with prostatic fossa stone post TURP

Exclusion Criteria:

* none

Primary outcomes:
measure: cystscopic evaluation of the prostate
timeFrame: one month
measure: extraction of the bladder stone
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Diaa-Eldin Taha
state: Dakahlia
Study officials:
References:
Clinical trial NCT05296785: Evaluate Clinical and Radiological Outcomes After Limb Reconstruction Using Monorail Fixator Over Intramedullary Nailing in Tibial Open Fractures With Bone Loss
Official title: Management of Open Tibial Fractures With Bone Loss Using Monorail Fixator Over Intramedullary Nail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Open Fracture Tibia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Road traffic accidents (RTA) is the most common cause of open fractures of long bones, increase in RTA leading to increase of complex non-unions incidence. the Participants are usually undergoing multiple surgeries for healing or to eradicate infection, which in turn leading to loss of bone and soft tissues and require skin grafting, muscle pedicle graft or bone grafting. Sometimes the Participants end up with deformity, limb length discrepancy, joints stiffness, disuse osteoporosis and muscle atrophy after management


Eligibility criteria: Inclusion Criteria:

* Age from 18-60 years old.
* Open Grade II, Open Grade III (a \& b) diaphyseal fractures of Tibia (judged after primary and/or secondary to debridement).
* Bone defect \< 10 cm.
* Patients with Injury severity score (ISS) \< 17.

Exclusion Criteria:

* Massive bone defect \> 10 cm.
* Patients with ISS \> 17, polytrauma patient.
* Age \< 18 years old or \> 60 years old.
* Associated vascular injury ischemic limb.

Primary outcomes:
measure: ASAMI Scoring System
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06094985: Prognostic Markers for a Better Follow-up in Head and Neck Cancer.
Official title: Prognostic Markers for a Better Follow-up in Head and Neck Cancer.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients diagnosed with a primary head and neck cancer Nov 2023 to May 2024 at Karolinska will be asked to participate.

Brief summary: To identify tumor specific DNA mutations and aberrations and to follow these in blood over time to predict treatment response/survival and secondly to correlate presence of these markers in blood to pathological parameters (LVI, Pn, WPOI and margins), radiological findings and to tumor stage.


Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with head and neck cancer
* Treatment includes surgery
* Consent to participate

Exclusion Criteria:

* No consent
* Age below 18 years
* No surgery
* No tumor material to sample

Primary outcomes:
measure: Recurrence
timeFrame: 2 years
measure: Survival
timeFrame: 2 years
measure: Treatment response
timeFrame: 6 months
Secondary outcomes:
measure: Pathological parameters
timeFrame: 6 months
measure: Radiological parameters
timeFrame: 9 months
measure: Stage
timeFrame: 2 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska universitetssjukhuset
Study officials:
affiliation: Karolinska institutet and Karolinska Universitetssjukhuset
name: Anders Näsman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00035685: Exposure of Children With Asthma to Household Environmental Tobacco Smoke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2002-05-06
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: To examine whether or not primary school-aged children with asthma from low-income households have lower household environmental tobacco smoke (ETS) exposure than matched control children.

Detailed description: BACKGROUND:

Children with asthma are particularly vulnerable to environmental tobacco smoke (ETS). However, despite this special vulnerability to ETS, children with asthma are at least as likely to live in smoking households, as are healthy children. Controversy exists, however, about whether or not the smoking members of households with children with asthma use specific strategies to reduce the harmful effects of their smoking on their children more than the smoking members of households of healthy children.

DESIGN NARRATIVE:

The case-control study examines whether or not primary school-aged children with asthma from low-income households have lower household ETS exposure than matched control children. Household ETS exposure will be measured by both objective monitoring, specifically passive nicotine dosimeters and child cotinine assays (the primary hypothesis), and maternal-report (the secondary hypothesis). Ninety children with physician diagnosed asthma and smoking mothers will be matched by age, gender, race/ethnicity, and other relevant variables to 90 healthy children. All children will be recruited from Metro Denver clinics providing services to low-income, underserved populations. The sample will contain equal numbers of African Americans, Hispanics, and Whites. Recruitment will target low-income populations due to their increased prevalence of, and associated morbidity from both asthma and tobacco smoking. Specific household smoking behaviors, as reported by mothers, will be examined for association with household nicotine and child cotinine levels. Finally, a set of carefully chosen measures will be examined in tertiary, exploratory analyses to help understand, clarify, and contextualize the observed results.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Jewish Medical & Research Center
name: Frederick Walboldt
References: