louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01828710: Myo-inositol on Human Semen Parameters
Official title: Effect of Treatment With Myo-inositol on Human Semen Parameters in Patients Undergoing IVF Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthenozoospermia
Oligospermia
Keywords: Myo-inositol
oligoasthenoteratospermia
semen parameters
IVF
Lead sponsor: AGUNCO Obstetrics and Gynecology Centre
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 62
Sex: MALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Many clinical evidences suggest that Myo-inositol plays a crucial role in human reproduction. Also, it was shown that Myo-inositol concentration in the seminiferous tubules was higher than in serum, and interestingly it was increasing through the epididymis and the deferent duct mining that sperm cell before ejaculation are stored in a "medium" highly enriched in myo-inositol.

Starting from this evidences, the investigators hypothesized that myo-inositol may be a possible factor able to improve the semen parameters of samples used in in vitro fertilization cycles.

Detailed description: Samples of seminal fluid were obtained from two groups of patients undergoing to an IVF cycle: healthy normospermic subjects and subjects with oligoasthenoteratospermia (OAT, \< 15 mil/ml).

Semen volume, spermatozoa number and motility were evaluated during the initial semen analysis and after density gradient separation method. These parameters were evaluated before and after the administration of 4000mg/die of myo-inositol associated to 400 µg of folic acid (Inofolic lolipharma Rome) for three months.

A third group of healthy normospermic subject were traded with 400 µg of folic acid for three months and was consider a control group.

Eligibility criteria: Inclusion Criteria:

Undergoing to IVF cycle OAT

Exclusion Criteria:

No undergoing to IVF cycle

Primary outcomes:
measure: sperm concentration
timeFrame: after 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Centre of Physiopathology of Reproduction
state: CT
Study officials:
affiliation: University of Catania - Department of Surgery - Section of Obstetrics and Gynecology - Centre of Physiopathology of Reproduction
name: Marco Palumbo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: A.G.Un.Co. Obstetrics and gynaecology center
name: Gianfranco Carlomagno, Ph.D.
role: STUDY_DIRECTOR
References:
citation: de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, Fleischer K, de Bruin JP, Showell MG. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2022 May 4;5(5):CD007411. doi: 10.1002/14651858.CD007411.pub5.
Clinical trial NCT02802410: Cross Sectional Study to Evaluate Effects of Kinesiotaping on Muscle Activity During Climbing Stairs and Sport Activity
Official title: Cross Sectional Study to Evaluate the Effects of Kinesio IQ-Tape, Kinesiotaping and no Taping on Muscle Activation and Reflex Activity During Climbing Stairs, Drop Jump and Running With 10, 12 and 15km/h
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: Bern University of Applied Sciences
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effects of IQ-Tape, Kinesiotaping and no Taping on muscle activity during daily activity and sport activity.


Eligibility criteria: Inclusion Criteria:

* healthy
* able to perform daily activities and sport performance

Exclusion Criteria:

* lower body and pelvic injuries
* fractures of the spine oder lower limb
* cardiac or neurological diseases

Primary outcomes:
measure: Muscle activity of the quadriceps muscles during drop-jump, running and climbing stairs.
timeFrame: up to one week
Secondary outcomes:
measure: Muscle activity of the hamstrings muscles during drop-jump, running and climbing stairs
timeFrame: up to one week
measure: Muscle activity of the soleus muscles during drop-jump, running and climbing stairs
timeFrame: up to me week
measure: Muscle activity of the tibialis muscles during drop-jump, running and climbing stairs
timeFrame: up to one week
measure: Muscle activity of the gastrocnemius muscles during drop-jump, running and climbing stairs
timeFrame: up to one week
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bern University of Applied Sciences, Department Health
Study officials:
References:
Clinical trial NCT00571610: Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device
Official title: A Single-Center, Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Implantable Device Used to Reduce Mitral Valve Regurgitation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Failure
Mitral Regurgitation
Keywords: Heart Failure
Mitral Regurgitation
Lead sponsor: Viacor
Sponsor class: INDUSTRY
First posted: 2007-12-12
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.


Eligibility criteria: Inclusion Criteria:

* Functional MR 2+ - 4+ with left ventricular enlargement
* Symptomatic heart failure
* 20% - 50% LVEF

Exclusion Criteria:

* mitral regurgitation of organic origins
* recent cardiac interventions
* severe comorbidities

Primary outcomes:
measure: percent of patients who remain free from device-related major adverse events (death, myocardial infarction, tamponade, emergent cardiac surgery
timeFrame: 30 days
Secondary outcomes:
measure: percent of implanted patients who maintain a sustained 1 grade reduction in MR and reduction of mitral annulus anterior posterior dimension
timeFrame: 30 days
measure: percent of implanted patients who exhibit improvement of clinical symptoms as one of the following: decrease in NYHA class, improvement of Minnesota QOL survey, increase exercise capacity 6 minute walk or improvement in VO2 max
timeFrame: 30 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Luc Bilodeau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dubreuil O, Basmadjian A, Ducharme A, Thibault B, Crepeau J, Lam JY, Bilodeau L. Percutaneous mitral valve annuloplasty for ischemic mitral regurgitation: first in man experience with a temporary implant. Catheter Cardiovasc Interv. 2007 Jun 1;69(7):1053-61. doi: 10.1002/ccd.21186.
Clinical trial NCT06311110: Impaired Toilet Training, LUTS and Bowel Dysfunction in Children With DCD
Official title: Impaired Toilet Training, Lower Urinary Tract Symptoms and Bowel Dysfunction in Children With Developmental Coordination Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Developmental Coordination Disorder
Lower Urinary Tract Symptoms
Bowel Dysfunction
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 84
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with developmental coordination disorder and grade- and gender matched typically developing children.

Brief summary: This cross-sectional case-control study aimed to determine whether there is a significant difference in the prevalence of impaired toilet training, LUTS, and functional bowel problems among children diagnosed with DCD and typically developing children (TDC).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with DCD by a multidisciplinary team (DCD case group)
* Children with a typical development, grade and gender matched with the DCD case group (TDC control group).

Exclusion Criteria:

* A DCD-Q score indicative for DCD (TDC control group)
* Presence of other developmental disorders, such as ASS, ADHD or intellectual disability (TDC control group)

Primary outcomes:
measure: Impaired toilet training
timeFrame: through study completion, 25 minutes
measure: Daytime incontinence
timeFrame: through study completion, 25 minutes
measure: Enuresis
timeFrame: through study completion, 25 minutes
measure: Fecal incontinence
timeFrame: through study completion, 25 minutes
Secondary outcomes:
measure: Toilet training difficulties
timeFrame: through study completion, 25 minutes
measure: General bladder and bowel dysfunction
timeFrame: through study completion, 25 minutes
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital/Ghent University
state: East Flanders
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Ellen Vandamme, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Bieke Samijn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00914810: Effect of Supplemental Vitamin D on Skeletal Muscle Function in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Effect of Supplemental Vitamin D on Skeletal Muscle Function in COPD Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease
Vitamin D
Cholecalciferol
Skeletal muscle
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2009-06-05
Enrollment: 39
Sex: ALL
Minimum age (years): 40
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 determine whether or not vitamin D supplementation can improve physical performance in persons with severe chronic obstructive pulmonary disease (COPD).


Eligibility criteria: Inclusion Criteria:

* COPD
* Forced expiratory volume in one second (FEV1) \< or = 50% of predicted
* Smoking history of at least 10 pack-years
* Able to ambulate independently or with the use of an ambulatory assist device (such as a cane or walker)

Exclusion Criteria:

* Currently taking \> 500 I.U. per day of vitamin D supplements
* Primary diagnosis of asthma
* Uncompensated heart failure
* Heart attack in the previous 6 months
* Kidney disease (glomerular filtration rate \< 45 mL/min/1.73m2)

Primary outcomes:
measure: Change in Short Physical Performance Battery (SPPB) Score
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change in Blood Level of Vitamin D (25-hydroxyvitamin D)
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Ken M. Kunisaki, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01053312: PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
Official title: A Principal, Open-Label, Single Center Study to Validate the Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Subjects Previously Biopsied
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Normal Pressure Hydrocephalus
Keywords: Amyloid
NPH Normal pressure hydrocephalus
PET Positron Emission Tomography
SUVR Standard uptake value ratios
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: i3 Statprobe
First posted: 2010-01-21
Enrollment: 7
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will determine the level of association between the quantitative estimates of brain uptake of \[18F\]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples previously obtained during shunt placement in patients who have normal pressure hydrocephalus (NPH).


Eligibility criteria: Inclusion Criteria:

* The subject is 50 years old or older.
* The subject has had a frontal lobe cortical biopsy adequate for the detection and quantitation of amyloid.
* Informed consent has been signed and dated by the subject/and/or subjects' legally acceptable representative, if applicable, in accordance with local regulations.

Exclusion Criteria:

* The subject has a contraindication for MRI or PET.
* The subject has a known or suspected hypersensitivity/allergy to \[18F\]flutemetamol.
* The subject has participated in any clinical study using an investigational agent within 30 days of dosing.

Primary outcomes:
measure: Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained.
timeFrame: Post-contrast administration
measure: Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen.
timeFrame: Post-contrast administration
Secondary outcomes:
measure: Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects
timeFrame: Post-contrast Administration
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Kim A Mansfield, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT03750812: The Effect of Age, Physical Fitness and a Single Bout of Aerobic Exercise on Motor and Cognitive Functions
Official title: The Effect of Age, Physical Fitness and a Single Bout of Aerobic Exercise on Motor and Cognitive Functions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Age-related Cognitive Decline
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-11-23
Enrollment: 120
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed study is intended to examine the connection between two types of inhibition - cognitive and motor and the connection between motor inhibitory functions and a single bout of physical exercise in the context of age and physical fitness.


Eligibility criteria: Inclusion Criteria:

* Non-smokers
* Do not take psychiatric drugs on a regular basis
* Geriatric Depression Scale score less than 3
* Mini-Mental State Examination score higher than 27
* Healthy and able to exercise at medium intensity

Exclusion Criteria:

* All others

Primary outcomes:
measure: Improvement in cognitive functions after exercise
timeFrame: One and a half hours
measure: Improvement in motor functions after exercise
timeFrame: One and a half hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hille Yaffe Medical Center
Study officials:
affiliation: Wingate Academic Institute
name: Yael Netz, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02584712: Effect of Exercise Training in Autonomic Modulation in Breast Cancer Patients
Official title: Effect of Exercise Training in Autonomic Modulation in Breast Cancer Patients Treated With Doxorubicin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Autonomic Nervous System Diseases
Lead sponsor: Federal University of Maranhao
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 18
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of exercise training in the autonomic nervous system activity in breast cancer patients, who underwent doxorubicin medication.


Eligibility criteria: Inclusion Criteria:

* Breast cancer patients at stages 1, 2 and 3;
* Sedentary;
* Currently at treatment;
* 4-6 months after surgery

Exclusion Criteria:

* Musculoskeletal injuries or disorders;
* Mental illnesses
* Stage 4 (Metastasis)
* Enrolled in other exercise program

Primary outcomes:
measure: Reduction in Low Frequency Heart rate variability component (LF)
timeFrame: 4 weeks
measure: Increase in High Frequency heart rate variability component (HF)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Maranhao
name: Cristiano T Mostarda, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00814112: Glycosaminoglycans During Septic Shock - a Temporal Study
Official title: GAGS - Glykosaminoglykaner Vid Sepsis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Septic Shock
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2008-12-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Septic Shock

Brief summary: We have previously shown that the plasma level of glycosaminoglycans (GAG) in septic shock patients are elevated compared to controls. The purpose of this study is to investigate the temporal dynamic of the blood level of GAG in ten septic shock patients. In addition, to assess the kinetics of GAG during septic shock we examine the liver function by galactose elimination capacity as well as excreted urinary GAG.


Eligibility criteria: Inclusion Criteria:

* 2 out of 4 SIRS criteria, where the circulatory criteria must be fulfilled
* Clinical sepsis is suspected
* Informed consent from relative
* Study subject must be over 18 years old

Exclusion Criteria:

* Pregnancy
* \>24h post sepsis diagnosis
* Ongoing oral or intravenous cortisone treatment for more than one month.
* Malignancy with metastasis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Intensive Care Unit, Lund University Hospital
Study officials:
affiliation: Intensive Care Unit, Lund University Hospital, Sweden
name: Mikael Bodelsson, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03340012: Clinical and Radiographic Evaluation of Guided Tissue Regeneration With Radiation-sterilized Allogenic Bone Grafts or Xenogenic Grafts for the Treatment of Intrabony Defects in Aggressive Periodontitis
Official title: Clinical and Radiographic Evaluation of Guided Tissue Regeneration With Radiation-sterilized Allogenic Bone Grafts or Xenogenic Grafts for the Treatment of Intrabony Defects in Aggressive Periodontitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis, Aggressive
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The treatment of intrabony defects in patients with aggressive periodontitis remains a challenging procedure and novel therapeutic strategies are sought. The purpose of this study is to compare the clinical and radiographic outcomes of using guided tissue regeneration (GTR) with radiation-sterilized allogenic bone grafts (material prepared in the Central Tissue Bank in Warsaw, Poland) versus guided tissue regeneration with xenogenic grafts (Bio-Oss®, Geistlich Biomaterials, Princeton, New Jersey, United States) in the treatment of localized intrabony defects in patients with aggressive periodontitis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of aggressive periodontitis in line with American Academy of Periodontology classification (Lang et al. 1999)
* Familial aggregation (history of periodontitis in parents or siblings)
* Presence of at least two teeth with probing pocket depth (PPD) ≥ 6mm and clinical attachment level (CAL) ≥ 5 mm associated with an intrabony defect of at least 3 mm as detected in diagnostic periapical radiographs
* No furcation involvement of the teeth presenting the intraosseous defects
* The width of keratinized tissue on the facial aspect of the selected teeth ≥ 2 mm

Exclusion Criteria:

* Full-mouth plaque index ≥ 20% (Ainamo \& Bay 1975)
* Full-mouth sulcus bleeding index ≥ 15% (Mühlemann \& Son 1971)
* Smoking more than 10 cigarettes/day
* Systemic diseases with compromised healing potential of infectious diseases
* Drugs affecting periodontal health / healing
* Pregnant and lactating females
* Previous periodontal surgery in the area

Primary outcomes:
measure: Change in Clinical attachment level (CAL)
timeFrame: Baseline and 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
state: Mazowsze
Study officials:
References:
Clinical trial NCT01546012: Assessment of Patient's Satisfaction Regarding the Handiness of Two Hyaluronic Acid Eye Drops Vials
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Assess the Patient Feeling About the Handiness of Two Different Vials Used to Deliver Both, Unpreserved Hyaluronic Eye Drops
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
Collaborators: name: Axial Biotech, Inc
First posted: 2012-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Assess the patient feeling about the handiness of two different vials used to deliver both, unpreserved hyaluronic eye drops.


Eligibility criteria: Inclusion Criteria:

* Man or woman aged 18 and older
* Patient with dry eye for at least 3 months
* Having given his written informed consent

Exclusion Criteria:

* Intolerance to studied products
* Patient's inability to understand the study procedures and give informed consent.
* Patient unwilling to follow the study procedures and visits defined by the protocol.
* Pregnant or lactating women.
* Patient under guardian ship

Primary outcomes:
measure: Overall preference of the patient
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Augenklinik
Study officials:
affiliation: Augenklinik, Wittenbergplatz, Kleiststrasse 23-26, 10787 Berlin
name: Carl Erb
role: PRINCIPAL_INVESTIGATOR
References: