louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05422846: Investigation of the Effects of Different Exercise on Wound Healing in Patients wıth Diabetic Foot Wounds
Official title: Investigation of the Effect of Different Exercise Training on Wound Healing ın Patients With Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Wound
Keywords: diabetes mellitus, exercise, ulcer
Lead sponsor: Harran University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 51
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups to be applied two different exercises progressing together with the control group
Primary purpose: TREATMENT

Brief summary: Exercise studies with patients with diabetic foot ulcers are very few. In this disease group, since it is considered dangerous to put a load on the foot, a barrier has been placed between the patients and the exercise. With the study investigators plan to do, investigators will try to exercise in these patients in a controlled manner. Among the patients divided into 3 groups, the 1st group will apply the control group, the 2nd group will perform aerobic exercise, and the 3rd group will apply the exercises investigators have determined as the protocol group. 12 weeks, 2 sessions a week will be exercised with the help of a physiotherapist. Patients will be evaluated at baseline, at the end of week 4, at the end of week 8, and at the end.


Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with Type II diabetes and having a foot ulcer
* Being in the 1st or 2nd category according to the Wagner classification
* Not to have a serious musculoskeletal, cardiac, neurological, etc. systemic disease that may interfere with the research.
* Not having any communication problems
* Having the same wound care procedure
* Not taking any other treatment that may have an effect on the wound.

Exclusion Criteria:

* Individuals with a diagnosed psychiatric illness,
* Individuals who have received any physiotherapy treatment in the last 3 months,
* Individuals with acute infection,
* Individuals with toe pressure \< 40 mmHg
* Individuals with Charcot Foot and/or osteomyelitis
* Individuals with venous ulcer disease
* Individuals who are morbidly obese (BMI \>40) according to body mass index
* Individuals with incurable proliperative retinopathy

Primary outcomes:
measure: ulcer area (mm²)
timeFrame: initial assessment- 4th week- 8th week- 12th week
measure: ulcer depth (mm)
timeFrame: initial assessment - 12th week
Secondary outcomes:
measure: quality of life score
timeFrame: initial assessment - 12th week
measure: sleep quality score
timeFrame: initial assessment - 12th week
Other outcomes:
measure: kinesiophobia score
timeFrame: initial assessment - 12th week
Locations:
city: Şanlıurfa
country: Turkey
facility: Harran Unıversıty
Study officials:
References:
Clinical trial NCT01465646: Bioavailability Investigations of Thyronajod Mite Tablets of Dosage Strengths 50 μg Levothyrox-ine/75 μg Iodine, and 100 μg Levothyroxine/75 μg Iodine vs. a Levothyroxine Drinking-Solution: A Randomised Cross Over Study in Healthy Male Individuals. Currently: 100 μg/ 75 μg Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: levothyroxine
bioavailability
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Sanofi-Synthelabo
First posted: 2011-11-06
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to measure the area under the curve (AUC0-48h; extent of systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered as a reference solution without iodine.


Eligibility criteria: Inclusion Criteria:

* Euthyroid men
* Age: 18 - 50
* Normal values for fT4 und TSH
* Good state of health

Exclusion Criteria:

* Thyroid function disorders in terms of subclinical or overt hyper- or hypothyroidism
* History of thyroid function disorders
* Focal or diffuse autonomies of the thyroid gland
* Thyroid nodules \>1 ml according to sonographic examination
* Any acute or chronic illness
* Dermatitis herpetiformis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Clinical Research Unit, University of Heidelberg
Study officials:
References:
Clinical trial NCT00906646: Preparation of Patients for Cardiac Surgery
Official title: Preparation of Patients for Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Bypass Graft Surgery
Cardiac Valve Surgery
Keywords: cardiac
surgery
metabolic
supplements
antioxidant
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: Griffith University
First posted: 2009-05-21
Enrollment: 117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a prospective randomised trial of metabolic therapy including antioxidants and cellular energisers to determine whether this therapy could improve the results of cardiac surgery. The hypothesis was that the metabolic therapy could improve clinical recovery.

Detailed description: Objective Perioperative therapy with antioxidants and metabolic substrates has the potential to reduce oxidative stress and improve recovery from cardiac surgery, particularly in elderly and high risk cases. The aim of the study was to assess the effect of perioperative metabolic therapy at a biochemical and clinical level in cardiac surgical patients.

Methods Patients (n = 117, mean age 65 ± 1.0 years, 74% male) undergoing elective coronary artery bypass graft (CABG) and/or valve surgery were randomized to receive for a minimum of 2 weeks before and one month after surgery, either metabolic therapy (coenzyme Q10, magnesium orotate, lipoic acid, omega-3 fatty acids and selenium) or placebo. Biochemical and clinical outcomes were assessed.

Eligibility criteria: Inclusion Criteria:

* patients undergoing elective coronary artery bypass graft (CABG) and/or valve surgery

Exclusion Criteria:

* urgent or emergency surgery
* NYHA class IV heart failure
* taken antioxidant supplements in the previous month

Primary outcomes:
measure: Troponin release
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 1 month
measure: Rate of atrial fibrillation
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: Franklin L Rosenfeldt, MBBS, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02825446: Angioplasty of the Tibial Arteries Augmented Radio Frequency Denervation of the Popliteal Artery
Official title: A Pilot Prospective Study of Two Methods of Revascularization of Tibial Arteries: Angioplasty Tibial Arteries, and Angioplasty Tibial Artery, Augmented by Radio Frequency Denervation Popliteal Artery in Patients With Steno-occlusive Lesion of the Tibial Arteries
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Сhronic Ischemia of the Lower Extremities
Atherosclerosis of the Tibial Arteries
Lesion no More Than Two Tibial Arteries
Steno-occlusive Lesion of the Tibial Arteries
Keywords: radio frequency denervation
tibial arteries
atherosclerosis of the peripheral arteries
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2016-07-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Angioplasty augmented radiofrequency denervation popliteal artery, in our opinion, will remove the spasm with macro and microcirculatory blood flow, which increases revascularization patency of tibial arteries.


Eligibility criteria: Inclusion Criteria:

* Chronic lower limb ischemia 3-6 degree by Rutherford;
* Stenosis or occlusion of no more than 2 tibial arteries;
* Stenosis of the tibial arteries more than 70 %;
* Duration stenosis or occlusion no more than 70 mm;

Exclusion Criteria:

* Diabetes mellitus type 2
* Occlusion or stenosis of all tibial arteries
* Expressed calcification of tibial arteries angioplasty tolerant
* Hemodynamically significant stenosis of the popliteal artery;
* Chronic heart failure of III-IV functional class by NYHA classification;
* Decompensated chronic "pulmonary" heart;
* Severe hepatic or renal failure (bilirubin\> 35 mmol / l, glomerular filtration rate \<60 mL / min);
* Polyvalent drug allergy;
* Cancer in the terminal stage with a life expectancy less than 6 months;
* Patient refusal to participate or continue to participate in the study;

Primary outcomes:
measure: the absence of thrombosis or stenosis of the popliteal artery
timeFrame: 12 mounth after intervention
Secondary outcomes:
measure: Primary patency after intervention
timeFrame: 12-mounth after intervention
measure: Secondary patency after intervention
timeFrame: 12-mounth after intervention
measure: Number of participants with limb salvage
timeFrame: 12 mounth after intervention
measure: Laser Doppler Flowmetry
timeFrame: 12 mounth after intervention
measure: Transcutaneous oxygen tension
timeFrame: 12 mounth after intervention
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: NRICP
Study officials:
affiliation: Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
name: Andrey Karpenko
role: STUDY_DIRECTOR
References:
Clinical trial NCT05716646: In the Real World Study, the Efficacy and Adverse Reactions of Ticagrelor on Ischemic Cerebrovascular Disease
Official title: Real-world Study on the Efficacy and Safety of Ticagrelor in the Treatment of Ischemic Cerebrovascular Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cerebral Infarction
Stroke
Nervous System Diseases
Ischemic Cerebrovascular Disease
Keywords: Vascular Diseases
Ticagrelor
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ischemic cerebrovascular disease must sign written informed consent before collecting blood samples

Brief summary: This is a forward-looking, open, one-arm, and real clinical trial world. The researchers plan to recruit at least 50 qualified patients. The main purpose of this study is to establish a population pharmacokinetic model of ticagrelor , explore the correlation between its blood concentration and the events of ischemia and the adverse effects of hemorrhage, and evaluate the effectiveness and safety of ticagrelor in the treatment of ischemic cerebrovascular disease.

Detailed description: Ischemic stroke and transient ischemic attack are the most common types of ischemic cerebrovascular disease. Patients will suffer from physiological function damage, even mental symptoms, social function and other obstacles, seriously affecting the quality of life, and bringing heavy burden to families and society.

Ticagelor is a new P2Y12 receptor antagonist. Compared with clopidogrel, ticagelor has stronger and more lasting platelet inhibition, and can reduce the recurrence of ischemic events in patients with acute coronary syndrome .

Therefore, at least 50 patients with ischemic cerebrovascular disease using ticagelor will be included. Before and after treatment, the laboratory examination data, NIHSS, mRS, combined medication and adverse events, and ischemic events of the patients will be collected. The population pharmacokinetics model of Ticagelor was established to evaluate its effectiveness and safety.

Eligibility criteria: Inclusion Criteria:

1. Female or male aged ≥ 18 years.
2. Clinically diagnosed as ischemic cerebrovascular disease.
3. Take ticagelor for antiplatelet therapy.
4. Provision of informed consent.

Exclusion Criteria:

1. Head CT or MRI suggests the presence of intracranial hemorrhagic disease.
2. People with tumors and other serious systemic diseases.
3. Allergy to ticagelor.

Primary outcomes:
measure: Correlation between blood drug concentration and adverse events
timeFrame: 6 months
Secondary outcomes:
measure: The incidence of adverse events caused by treatment
timeFrame: 6 months
measure: NIHSS
timeFrame: 6 months
measure: mRS
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Qianfoshan Hospital
name: Huang Xin
role: STUDY_DIRECTOR
References:
Clinical trial NCT01208246: Impact of Pelvic Floor Musculature on Peripartum Outcomes
Official title: Impact of Pelvic Floor Musculature on Peripartum Outcomes: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2010-09-23
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prenatal visits

Brief summary: The purpose of this study is to understand the effect of the pregnancy on the muscles in the pelvis. The purpose of this study is to evaluate the pelvic muscle changes related to pregnancy; to assess if the ability to squeeze and relax these muscles has any effect on delivery mode and if there are any injuries to the pelvic muscles.

Detailed description: Healthy women who are pregnant with their first child will be included in the study. Information about their general health will be gathered. These women will be screened for pelvic disorders at the start and end of study. Three-dimensional ultrasound will be performed three times: 12-24 weeks, 34-39 weeks and 4-6 weeks after delivery. Fetal measurements will be included in the third trimester ultrasound for prediction of estimated birth weight. The relationship of the predicted fetal weight and the likelihood of having a successful vaginal delivery will be studied. Images will be analyzed for pelvic muscles function and injuries. Information regarding the length of labor, types of delivery and vaginal tears will be gathered. The information obtained will be analyzed to look for the strength of correlation of variables to the outcomes.

Eligibility criteria: Inclusion Criteria:

* Primiparous or should not have given birth to a fetus older than 12 weeks.
* Singleton pregnancy.
* Age more than or equal to 18 years.
* Basal mass index between 18 - 40 kg/m2.
* Must plan to deliver at Strong Memorial Hospital at the University of Rochester Medical Center.

Exclusion Criteria:

* Basal mass index more than 40 kg/m2.
* Presence of current or prior history of cervical incompetence.
* Presence of diabetes mellitus (type I or type II).
* Presence of connective-tissue disorders such as Systemic lupus erythematosus, Rheumatoid Arthritis, or Sjogren's disease.
* Presence of neuromuscular disorders such as myasthenia gravis and neuropathies.

Primary outcomes:
measure: Serial changes in pelvic floor anatomy and function
timeFrame: 12-24 weeks, 34-39 weeks gestation, and 4-6 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Tulin Ozcan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01348646: Adult Follow-up of Preventive Study With Brief Smoking Intervention for Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking
Adolescence
Brief intervention
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Medical Research Fund of the Tampere University Hospital, Finland
First posted: 2011-05-05
Enrollment: 2582
Sex: ALL
Minimum age (years): 12
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to see whether a brief intervention given in adolescence has an effect on smoking in adulthood. The investigators also wanted to clarify the significance of some known psychosocial risk factors of smoking in adulthood.


Eligibility criteria: Inclusion Criteria:

* Born on 1979.
* Living in Vaasa, Pietarsaari, Kokkola or Seinäjoki at school age.

Exclusion Criteria:

* Other year of birth.

Primary outcomes:
measure: being a smoker
timeFrame: 29 years
Secondary outcomes:
measure: state of dental health
timeFrame: 29 years
measure: daily smoking
timeFrame: 15 years
measure: amount of cigarettes smoked
timeFrame: 29 years
measure: smoking mother
timeFrame: 15 years
measure: smoking father
timeFrame: 15 years
measure: smoking sister
timeFrame: 15 years
measure: smoking brother
timeFrame: 15 years
measure: smoking best friend
timeFrame: 15 years
measure: smoking best friend
timeFrame: 29 years
measure: willingness to experiment with smoking
timeFrame: 15 years
measure: self-perceived health
timeFrame: 29 years
measure: asthma diagnosis
timeFrame: 29 years
measure: recurrent airway tract infections
timeFrame: 29 years
measure: self esteem
timeFrame: 15 years
measure: smoking time
timeFrame: 29 years
measure: received 1-4 brief interventions at school age (Yes/No)
timeFrame: 12-15 years
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Department of General Practice, Medical School, University of Tampere, Finland
state: Pirkanmaa
Study officials:
References:
citation: Saari AJ, Kentala J, Mattila KJ. The smoking habit of a close friend or family member--how deep is the impact? A cross-sectional study. BMJ Open. 2014 Feb 18;4(2):e003218. doi: 10.1136/bmjopen-2013-003218.
citation: Saari AJ, Kentala J, Mattila KJ. Long-term effectiveness of adolescent brief tobacco intervention: a follow-up study. BMC Res Notes. 2012 Feb 16;5:101. doi: 10.1186/1756-0500-5-101.
Clinical trial NCT01128946: Enamel Remineralization Potential of Dentifrices in Situ
Official title: Comparison of Enamel Remineralization Potential of Dentifrices Incorporating Different Fluoride Salts Using an in Situ Caries Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Caries
Keywords: Enamel remineralization
Fluoride
caries
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-05-24
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.


Eligibility criteria: Inclusion Criteria:

* Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical or oral health.
* No current active caries or periodontal disease that may compromise the study or health of the subject.
* All restorations in a good state of repair
* Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accomodate two enamel specimens required dimensions 12 x 7 mm.
* Willing to have their denture modified to accomodate enamel test specimens
* Willing and capable of wearing removable mandibular partial dentures 24 hours per day during the treatment periods.
* Salivary flow rate in the range of normal values (unstimulated whole saliva flow rate greater than or equal to 0.2 mL/ minute; gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute.

Exclusion Criteria:

* Individuals currently taking antibiotics, or who have taken antibiotics within 30 days prior to the first treatment visit.
* Current active caries or periodontal disease that may compromise the study or health of the subject.

Primary outcomes:
measure: Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF)
timeFrame: Baseline to 14 days
Secondary outcomes:
measure: %SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)
timeFrame: Baseline to 14 days
measure: Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)
timeFrame: Baseline to 14 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Dentistry
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00941746: Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain
Official title: A Randomised, Double-blind, Placebo-controlled, Single Ascending Dose, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PG110 (Anti-NGF Monoclonal Antibody) in Patients With Pain Attributed to Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis, Knee
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-07-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of PG110, a monoclonal antibody that inhibits the effects of the naturally occurring substance, nerve growth factor (NGF).


Eligibility criteria: Inclusion Criteria:

* Moderate to severe pain attributed to knee osteoarthritis

Exclusion Criteria:

* Significant comorbidity
* Significant pain states other than osteoarthritis
* Concomitant medications that might affect assessments

Primary outcomes:
measure: The number and severity of adverse events
timeFrame: Three months
Secondary outcomes:
measure: Terminal elimination half-life
timeFrame: Three months
measure: Dose proportionality of the area under the serum concentration-time curve
timeFrame: Three months
measure: Pain in the index knee
timeFrame: Three months
measure: Western Ontario and McMaster Universities questionnaire
timeFrame: Three months
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Site Ref # / Investigator 51568
Study officials:
affiliation: Abbott
name: Jerry Hall, MD
role: STUDY_DIRECTOR
References: