louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00180388: VENEK: Healing in Different Vein Harvesting Methods During Aortocoronary Coronary Artery Bypass Graft Surgery (CABG)
Official title: Comparison of Clinical and Economical Parameters of Healing in Different Vein Harvesting Methods During Aortocoronary CABG
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: cardiovascular system
veins
saphenous vein
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Herzzentrum Dresden
First posted: 2005-09-16
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The VENEK trial is a randomized, prospective trial to compare economic parameters, quality of life and wound healing after endoscopic vein harvesting versus open vein harvesting.

Detailed description: The VENEK trial is a randomized, prospective trial to compare economic parameters, quality of life and wound healing after endoscopic vein harvesting versus open vein harvesting.

Eligibility criteria: Inclusion Criteria:

* Age over 60 years
* Admission at Herzzentrum Dresden - Herzchirurgie for bypass-operation (OP) with planned veinectomy
* Eligibility for different modes of planned intervention according to study protocol
* Signed patient informed consent

Exclusion Criteria:

* Varicose crural veins
* Emergency patients
* Combined operational procedures
* Preoperative complete immobilization

Primary outcomes:
measure: Evaluation of the economic differences between methods of treatment
timeFrame: up to 2 months
Secondary outcomes:
measure: Evaluation of the outcome in quality of life (questions according to the protocol) and rate of disorders in wound healing
timeFrame: up to 2 months
Other outcomes:
Locations:
city: Bad Gottleuba
country: Germany
facility: Klinik Bad Gottleuba
city: Dresden
country: Germany
facility: TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie
Study officials:
affiliation: TU Dresden, Medizinische Fakultät Carl Gustav Carus, Klinik für Kardiochirurgie, D - 01062 Dresden, Germany
name: Matschke Knaut, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03468088: Handgrip Strengthening Exercise in Treatment of the Patients With Primary Sub-Acromial Impingement Syndrome
Official title: The Relative Effect of Handgrip Strengthening Exercise in Treatment of the Patients With Primary Sub-Acromial Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Impingement Syndrome, Shoulder
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the relative effect of handgrip strengthening exercise in improving function, pain, strength, and active range of motion (AROM) of the shoulder among patients with primary sub-acromial impingement syndrome (SAIS).

Detailed description: The current study is a Single-Blind Randomized Clinical Trial to investigate the effectiveness of handgrip strengthening exercise in the treatment of patients with primary subacromial impingement syndrome. The randomization process will be based on concealed envelop picked up by participants.The patient will be conveniently recruited from the ministry of health hospitals in Jeddah.The patient who will meet the inclusion criteria; they will sign the consent form. The baseline data will be collected. The assessment will be carried out at the baseline, 4 weeks and 8 weeks; end of the treatment program; by the same blinded examiner for each patient and consist of the following instrument: Disabilities of Arm, Shoulder \& Hand (DASH questionnaire), Visual analog scale (VAS), Hand-held dynamometer (HHD), and smartphone clinometer.

Eligibility criteria: Inclusion Criteria:

* Willing to comply with all study procedures and be available for the duration of the study
* Aged 18 to 45
* Diagnosed by their referring physician with subacromial impingement syndrome and has a positive impingement \& rotator cuff test
* Pain intensity between 3 to 8 in VAS

Exclusion Criteria:

* History of shoulder fracture or dislocation, osteophytes, and labral tear.
* History of cardiac, neurological or musculoskeletal disease that precludes the ability to perform the exercise in the upper extremity.
* Treatment with another intervention.
* Hand or forearm dysfunction
* Rheumatoid disease
* Diabetic
* History of shoulder, cervical, and thoracic surgery
* Pregnancy
* Malignancy
* Symptoms for more than 1 year
* Bilateral SAIS

Primary outcomes:
measure: Function
timeFrame: Change from baseline functional score at 8 weeks
Secondary outcomes:
measure: Strength
timeFrame: Change from baseline muscle strength at 8 weeks
measure: Range of motion
timeFrame: Change from baseline range of motion at 8 weeks
measure: Pain
timeFrame: Change from baseline pain intensity at 8 weeks
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Ministry of Health Hospital
Study officials:
affiliation: King Saud University
name: Amal AlAnazi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04349488: Transcranial Direct Current Stimulation Acute Stroke Walking
Official title: Transcranial Direct Current Stimulation Improves Walking and Balance in Acute Stroke Patients - a Randomized, Double-blind, Sham-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Stroke
Keywords: Acute Stroke
tDCS
Anodal
Balance
Walking
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group receives anodal tDCS, one placebo
Primary purpose: TREATMENT

Brief summary: 16 acute stroke patients will be split into 2 groups. One group will receive the real treatment (anodal tDCS) and one group sham.

Subjects will receive, in addition to conventional rehabilitation, 2mA for 20 mins of their attributed tDCS, 5 times a week.

Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks.

The evaluations are the Four Square Step Test, the Berg Balance Scale, the Postural Assessment Scale For Stroke, the Trunk Impairment Scale, the Time Up \& Go and the 10 meter walking test.


Eligibility criteria: Inclusion Criteria:

* First Ever Stroke
* Motor or sensory deficit
* Understands and follows orders
* Signed inform consent

Exclusion Criteria:

• One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)

Primary outcomes:
measure: Changes Four Square Step Test
timeFrame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
measure: Changes Berg Balance Scale
timeFrame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
measure: Changes Postural Assessment Scale For Stroke
timeFrame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
measure: Changes Trunk Impairment Scale
timeFrame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
measure: Changes Time Up & Go
timeFrame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
measure: Changes 10 meter walking test
timeFrame: Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Liege Univeristy Hospital
Study officials:
References:
citation: Bornheim S, Croisier JL, Maquet P, Kaux JF. Proposal of a New Transcranial Direct Current Stimulation Safety Screening Tool. Am J Phys Med Rehabil. 2019 Jul;98(7):e77-e78. doi: 10.1097/PHM.0000000000001096. No abstract available.
Clinical trial NCT01371188: Effects of Exposure to Biomass-burning Air Pollution on Lung Function, Heart Rate Variability and Inflammatory Markers in Sugarcane Workers
Official title: Effects of Exposure to Outdoor Air Pollution From Biomass Burning on Lung Function, Heart Rate Variability and Systemic Inflammatory Blood Markers in Sugarcane Workers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Function
Heart Rate Variability
Oxidative Stress
Systemic Inflammatory Response
Lead sponsor: InCor Heart Institute
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2011-06-10
Enrollment: 222
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population from the city of Mendonça, São Paulo-Brazil, divided into the following groups: sugarcane workers (those who work in sugarcane plantations) and controls (healthy volunteers from the same city)

Brief summary: Introduction: Non-mechanized sugar cane harvesting preceded by burning, an important and prevalent professional activity of agribusiness segment of the Brazilian economy, exposes workers and people of neighboring towns to high concentrations of pollutants and, therefore, potentially several risks to health hazards.

Objectives: Assessing cardiopulmonary impacts and inflammatory markers in sugarcane workers and volunteers from a nearby town in non-harvest and harvest periods.


Eligibility criteria: Inclusion Criteria:

* The criteria for inclusion in the study were: age between 20 and 40 years, male gender and being non-smokers (or former-smokers for at least a year and a smoking history of less than 20 pack-years).

Exclusion Criteria:

* Exclusion criteria were history of cardiovascular or respiratory disease, the use of bronchodilator, non-steroidal anti-inflammatory drugs, anticoagulants or antiplatelet drugs and statins.

Primary outcomes:
measure: Lung function
timeFrame: six months
measure: Heart rate variability
timeFrame: six months
measure: Oxidative stress
timeFrame: six months
Secondary outcomes:
measure: Environmental evaluation
timeFrame: one year
Other outcomes:
Locations:
city: Mendonça
country: Brazil
facility: City of Mendonça (urban area and sugarcane plantations)
state: Sao Paulo
Study officials:
References:
citation: Paula Santos U, Zanetta DM, Terra-Filho M, Burdmann EA. Burnt sugarcane harvesting is associated with acute renal dysfunction. Kidney Int. 2015 Apr;87(4):792-9. doi: 10.1038/ki.2014.306. Epub 2014 Sep 17.
Clinical trial NCT03572088: Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs
Official title: Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Terlipressin
Blood Loss
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims to look at the effect of terlipressin infusion on blood loss and blood transfusion needs during Whipple procedure


Eligibility criteria: Inclusion Criteria:

* All patients older than 18 years of age,
* ASA classification class I and II,
* Patients assigned for Whipple procedure.

Exclusion Criteria:

* Preoperative renal failure,
* Severe liver dysfunction (Child-Turcotte-Pugh grade C),
* Hyponatremia (Na+ \<132mmol/l),
* Severe valvular heart disease,
* Heart failure,
* Symptomatic coronary heart disease,
* Bradycardic arrhythmia (heart rate \< 60/min),
* Peripheral artery occlusive disease (clinical stadium II-IV),
* Uncontrolled arterial hypertension (Blood pressure \>160/100mmHg despite intensive treatment),
* Pregnancy.

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: intaoperative periods
Secondary outcomes:
measure: Patients needing blood transfusion
timeFrame: intaoperative periods
measure: Red blood cell units transfused
timeFrame: intaoperative periods
measure: portal pressure changes
timeFrame: intaoperative periods
measure: ICU stay
timeFrame: postoperative periods
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Assiut University hospital Egypt, Egypt
role: STUDY_DIRECTOR
References:
Clinical trial NCT05848388: Molar Incisor Malformation in Egypt
Official title: Prevelance of Molar Incisor Malformation in Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paediatric Dentistry
Keywords: molar-incisor malformation, developmental malformation
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 5630
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: panoramic radiographic images from a private dental radiology center in Fayoum Egypt

Brief summary: The aim of the current study is to assess the prevalence of molar incisor malformation in Fayoum-Egypt.

Detailed description: Localized developmental radicular dysplasia is a rare finding. This radicular formation arrest may be due to traumas, infections, radiation therapy, chemotherapy, or idiopathic.

Molar Incisor Malformation is a condition characterized by arrested or altered radicular development of first permanent molars. Roots may be thin, short, or totally missing. In some patients, there are constrictions located in the cervical part of the crown of the permanent incisors. There are also cases where the roots of the second primary molars are affected.

MIM could also have been mistaken for a consequence of severe root resorption, or dentine dysplasia prior to its initial description.

This unique deformity, regardless of its nomenclature, presents previously undescribed clinical features and it is quite difficult to get a successful conservative treatment result.

The aim of the current study is to assess the prevalence of this rare condition in Fayoum-Egypt.

Eligibility criteria: Inclusion Criteria:

* Panoramic radiographs for older than nine-year-old patients, having completely developed first permanent molars

Exclusion Criteria:

* Panoramic radiographs with missing first permanent molars or pathological lesions which may cause root resorption

Primary outcomes:
measure: molar incisor malformation
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Alpha Dent
Study officials:
affiliation: Fayoum University
name: maha M azab
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05631288: Association of Herpesvirus and Periodontitis
Official title: Association of Herpesvirus and Periodontitis: A Clinical and Laboratorial Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Keywords: periodontitis
herpes virus
Lead sponsor: Malo Clinic
Sponsor class: OTHER
Collaborators: name: Egas Moniz - Cooperativa de Ensino Superior, CRL
First posted: 2022-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients (\> 18 years of age) with natural teeth present attending clinical appointments at the Egas Moniz university dental clinic.

Brief summary: A significant influence of the Herpes viruses family in the progression of periodontal disease has been suggested. The aim of this study was to investigate the potential association of four Herpes viruses (HSV-1, HSV-2, CMV and EBV) with periodontal disease using a qualitative test for evaluating the presence or absence of viral DNA in crevicular fluid samples of both healthy periodontal patients and periodontal compromised patients.

Adult patients with healthy periodontium or periodontally compromised attending the Egas Moniz university dental clinic (Almada, Portugal) are eligible to participate The study involves a periodontal diagnosis and collection of unstimulated crevicular fluid from saliva samples.

There will be no direct benefits for patients, but indirect benefit of advancing science in the study of potential involvment of Herpes viruses in periodontitis. No risks of participating are antecipated as the study material and data will be anonymized.

The study runs from the the Cooperativa de Ensino Egas Moniz and is expected to run for 3 months.


Eligibility criteria: Inclusion Criteria:

* Patients (\> 18 years of age) with natural teeth attending clinical appointments at the Egas Moniz university dental clinic;
* Cases (periodontally compromised) included at the Department of Periodontology of the same clinic;
* Controls (periodontally healthy) included at the remaining departments of the same clinic.

Exclusion Criteria:

* Occurrence of a viral infection during the six months prior to the clinical study;
* Exposure to antiviral medication in the six months prior to the survey;
* Clinical history of immunosuppression, either exogenous or endogenous;
* Chemotherapy in the previous six months.

Primary outcomes:
measure: The presence of virus DNA (HSV1, HSV2, EBV and CMV)
timeFrame: 1 day
Secondary outcomes:
measure: Smoking
timeFrame: one year
measure: Alcohol consumption
timeFrame: one year
measure: Oral hygiene habits
timeFrame: one year
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Malo Clinic
Study officials:
affiliation: Maló Clinic
name: Miguel A de Araújo Nobre, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01627288: Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)
Official title: Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of the Cervix
Cervical Neoplasms
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2012-06-25
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).


Eligibility criteria: Inclusion Criteria:

* Biopsy confirmed malignancy of the gynecologic tract
* Involved pelvic or para-aortic lymph nodes
* Treatment plan to include delivery of concurrent chemoradiotherapy.
* Good performance status
* Negative pregnancy test in women of child-bearing potential
* Signed study-specific informed consent
* Lab results within study specific limits

Exclusion Criteria:

* Prior radiation to the abdomen or pelvis
* A history of Scleroderma or Inflammatory bowel disease
* Contraindication to chemotherapy or radiation

Primary outcomes:
measure: Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).
timeFrame: During RT to 6 weeks post RT
Secondary outcomes:
measure: Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)
timeFrame: 3 years following treatment
measure: Time to Distant Recurrence (TTDR)
timeFrame: 3 years after treatment
measure: Disease Free Survival (DFS)
timeFrame: 3 years after treatment
measure: Overall Survival (OS)
timeFrame: 3 years after treatment
measure: Number of Participants With Acute Dose Limiting Toxicities (DLT)
timeFrame: 6 weeks following treatment
measure: Number of Participants With Late Dose Limiting Toxicities (DLT)
timeFrame: 3 years following treatment
Other outcomes:
Locations:
city: Durham
country: United States
facility: Radiation Oncology, DUMC
state: North Carolina
Study officials:
affiliation: Duke Cancer Center/Radiation Oncology
name: Junzo Chino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02824588: Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain
Official title: Executive Control, Processing Speed and Memory Function in Long- Term Peripheral Neuropathic Pain and Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Working Memory Deficits
Neuropathic Pain
Fibromyalgia
Keywords: Pain
Working memory
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this project is to investigate and improve executive control function in two distinct pain conditions, namely neuropathic pain and fibromyalgia (FM). It is hypothesized that there is a significant difference in the executive control function of patients with neuropathic pain and FM pain. It is also hypothesized that all participants with poor executive control functioning will report significant improvements in pain intensity, functioning and cognitive complaints following cognitive training. The study tests and influence the working memory concepts of inhibition, updating and flexibility through an experimental, cross-over treatment design.

To perform the experiment, we will recruit 160 participants (80 with neuropathic pain and 80 with FM) from the Departments of pain management and research at St Olav's University Hospital and Oslo University Hospital (OUS). The proposed design will be able to determine whether or not executive control, processing speed and memory function differs in two distinct populations of pain patients. Moreover, whether impairments are amended by computerized training.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of fibromyalgia or neuropathic pain
* Confirmed objective cognitive impairments on the CANTAB battery compared to IQ control

Exclusion Criteria:

* Mania, suicidal ideation and/or active psychosis
* No objective cognitive impairments
* Personality disorders
* Pregnancy

Primary outcomes:
measure: Objective neuropsychological tests
timeFrame: 36 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: 36 weeks
measure: Stress regulation
timeFrame: 36 weeks
measure: Symptoms of depression
timeFrame: 36 weeks
measure: Sleep duration, quality and awakening
timeFrame: 36 weeks
measure: Quality of life
timeFrame: 36 weeks
measure: Medication use
timeFrame: 36 weeks
measure: Self-reported memory and concentration impairments
timeFrame: 36 weeks
measure: Self-reported cognitive intrusion
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References: