louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03748693: Inflammation and Cellular Immunity in Vaginal Tissue in Patients With Pelvic Organ Prolapse
Official title: Inflammation and Cellular Immunity in Vaginal Tissue in Patients With Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Organ Prolapse
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-11-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women attending our OB/GYN department because of POP and other gynecological disorders

Brief summary: The aim of this study is to investigate the inflammatory and maturation processes of immature myeloid cells (IMC) in the vaginal tissue in women with advanced pelvic organ prolapse (POP) (stage III-IV) and in normal non-POP controls.

We hypothesize that the processes contributing to POP may be related to immune response and changes in myeloid cell populations and the cytokine environment.


Eligibility criteria: Inclusion Criteria:

* Women with POP undergoing colporrhaphy
* Women undergoing hysterectomy

Exclusion Criteria:

* Autoimmune and connective tissue disorders
* Cancer in genital tract

Primary outcomes:
measure: Immune response in POP
timeFrame: Two weeks
measure: Cytokine environment in POP
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00204893: Evaluation of the Ocular Safety of Calcium Formate in Normal, Healthy Female Subjects
Official title: Evaluation of the Ocular Safety of Calcium Formate in Normal, Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Nephro-Tech 1, LLC
First posted: 2005-09-20
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a Phase I, single center, open-label study of the dietary supplement calcium formate in normal, healthy female subjects. The purpose of the study is to determine whether daily use of calcium formate is safe and whether it accumulates in the eye.

Detailed description: This is a Phase I, single center, open-label study of the dietary supplement calcium formate in normal, healthy female subjects. The purpose of the study is to determine whether daily use of calcium formate is safe and whether it accumulates in the eye.

Eligibility criteria: Inclusion Criteria:

* Healthy females

Exclusion Criteria:

* no ocular diseases

Primary outcomes:
measure: Vision Testing (refraction) over baseline
timeFrame: Up to 15 days
measure: Change in Serum Formate Levels over baseline
timeFrame: Up to 15 days
Secondary outcomes:
measure: Change in Visual Acuity over baseline
timeFrame: Up to 15 days
measure: Change in 100 Hue Vision Testing results over baseline
timeFrame: Up to 15 days
measure: Change in ERG/VEP over baseline
timeFrame: Up to 15 days
measure: Change in Visual Fields over baseline
timeFrame: Up to 15 days
measure: Fundus Photography
timeFrame: Up to 15 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael M Altaweel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Altaweel MM, Hanzlik RP, Ver Hoeve JN, Eells J, Zhang B. Ocular and systemic safety evaluation of calcium formate as a dietary supplement. J Ocul Pharmacol Ther. 2009 Jun;25(3):223-30. doi: 10.1089/jop.2008.0128.
Clinical trial NCT02351193: a Predictive Scheme for Poor Responders in IVF Cycles
Official title: A Predictive Scheme to Assess the Outcome of IVF/ICSI Cycles in Poor Responders. an Observational Study in Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 928
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Poor responder females

Brief summary: While practicing the different assisted reproductive techniques, the investigators are faced daily by the problem of poor responder females, and the debate about predicting its results based on the outcome of the different ORTs used. Due to the cost of AMH as an indicator for ovarian response, the need to re-assess its role was essential in our community, which led us to conduct this prospective multi-center IVF study.


Eligibility criteria: Inclusion Criteria:

* normal body mass index (BMI)
* AMH from 0.5-1.1 ng/ml.
* previous history of ≤3 oocytes retrieved using conventional long stimulation protocol

Exclusion Criteria:

* Females suffering from other causes of infertility as tubal, uterine factors or known cases of endometriosis
* severe cases of male factor as azospermia
* females who were unable or not willing to participate in the study were excluded from the study.

Primary outcomes:
measure: Number of MII oocytes
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el aini hospital
Study officials:
affiliation: Cairo University
name: Dina MR Dakhly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01568593: Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
Official title: Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2012-04-02
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent
* Male or female aged from ≥ 18 years old.
* Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection.

Exclusion Criteria:

* Best far corrected visual acuity \< 1/10
* Severe blepharitis
* Severe Dry Eye
* Eyelid malposition
* Known hypersensitivity to one of the components of the study medications or test products.
* Pregnant or breast-feeding woman.
* Woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms).
* Inability of patient to understand the study procedures and thus inability to give informed consent.
* Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).
* Already included once in this study.
* Patient under guardianship.

Primary outcomes:
measure: Global Ocular Staining (With Oxford Scale - Ranges :0-15)
timeFrame: Baseline and 35 days
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
Study officials:
References:
Clinical trial NCT04734093: Sonographic Signs of Gouty Arthritis in a Cohort of Egyptian Patients: a Cross Sectional Multicenter Study
Official title: Sonographic Signs of Gouty Arthritis in a Cohort of Egyptian Patients: a Cross Sectional Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sonographic Signs of Gouty Arthritis in Diagnosed and Suspected Patients
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be collected from several university clinics all over Egypt. All are aged 40 or more with a history of definite gouty arthritis or at high risk and they have active arthritis of at least one joint.

Brief summary: The study is a cross sectional observational multicenter study. It is established in collaboration with the Egyptian college of rheumatology study group (ECRsg). It is conditioned that all the study participants had either mono- or oligo-arthritis with effusion of the knee or the first metatarsophalangeal (MTP) joint in patients with a known history of gout or at high risk. Patients with any known chronic arthritis, comprising rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus, scleroderma, neuropathic arthritis, seronegative spondyloarthropathy, will be excluded from the study. None of the participants had a history of intra-articular injection or aspiration in the scanned joints for 3 months prior to the inclusion in the study. The sonographers will be blinded for clinical data and the EULAR scanning protocol for the knee and 1st MTP will be considered \[2\]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. All the sonographers in the study had an experience between 5 and 10 years in the field of musculoskeletal ultrasound.


Eligibility criteria: Inclusion Criteria:

* mono- or oligo-arthritis with effusion of the knee or the first metatarsophalangeal
* patients with a known history of gout or at high risk

Exclusion Criteria:

* Patients with any known chronic arthritis, comprising rheumatoid arthritis, Sjoegren's syndrome, systemic lupus erythematosus, scleroderma, neuropathic arthritis, seronegative spondyloarthropathy
* History of intra-articular injection in the last 3 months.

Primary outcomes:
measure: Sonographic signs of gouty arthritis in the knee or 1st MTP joint
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Ahmed Elsaman
state: سوهاج
Study officials:
References:
Clinical trial NCT03583593: Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
Official title: Evaluation of Nutritional Supplement DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Foot Ulcer
Diabetic Foot
Diabetes Mellitus, Type 2
Keywords: Diabetes
Insulin
Diabetic Foot
Nutritional supplement
Diamel
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2018-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Diabetic foot syndrome is one of the most frequent complications in type 2 diabetic patients. The present work is carried out with the objective of evaluating the use of DIamel combined with insulin in diabetic foot ulcers. Method. Phase II clinical trial. A study group was created that receives the active product and another control group that receives a placebo. Double-blind study with a monthly follow-up for the first 6 months and then quarterly until the end of 1 year. Complementary tests are performed every 6 months to evaluate metabolic, lipid and renal function control.


Eligibility criteria: Inclusion Criteria:

* Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (% B) and insulin sensitivity (% S), as percentages of a normal reference population

Exclusion Criteria:

* Manifestation of hypersensitivity to any component of the product
* Uncooperative patients
* Severe infection
* Debilitating diseases
* Steroid treatment
* Pregnancy

Primary outcomes:
measure: Time of healing
timeFrame: 1 year
Secondary outcomes:
measure: Glycemic control
timeFrame: 1 year
measure: Lipidic control
timeFrame: 1 year
measure: Body mass control
timeFrame: 1 year
measure: Renal function control
timeFrame: 1 year
measure: Insulin control
timeFrame: 1 year
Other outcomes:
Locations:
city: Vedado
country: Cuba
facility: National Institute of Endocrinology
state: Havana
Study officials:
References:
Clinical trial NCT02897193: Central Incisors Narrow Implants in Alternative to Bone Augmentation With 4.2 mm Implants .
Official title: 3.2 mm Diameter Implants and Soft Tissue Grafts in Alternative to Horizontal Bone Augmentation for Placing 4.2 mm Diameter Implants at Central Incisors. A Multicenter Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Upper Central Incisor Edentulism
Lead sponsor: Alpha - Bio Tec Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-13
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Horizontal bone augmentation procedures are commonly used to increase bone width to allow the placement of dental implants or to improve aesthetics in deficient areas. Smaller diameter implants could be used instead in order to avoid bone augmentation procedures.

The comparison between these two solutions will be evaluated in the trial.


Eligibility criteria: Inclusion Criteria:

* Upper central incisor edentulism
* bone width between 3.5-4.5 mm
* requirement of only one implant supported crown
* patient is willing to sign an informed consent

Exclusion Criteria:

* General contraindications to implant surgery.
* Immunosuppressed or immunocompromised patients
* Patients irradiated in the head and neck area.
* Patients with poor oral hygiene and motivation.
* Uncontrolled diabetes.
* Pregnancy or lactation.
* Addiction to alcohol or drugs.
* Untreated periodontal disease.
* Treated or under treatment with intravenous amino-biphosphonates.
* Poor oral hygiene and motivation.
* Psychiatric problems and/or unrealistic expectations.
* Acute infection (abscess) or suppuration in the area intended for implant placement.
* Patients referred only for implant placement if cannot be followed at the treatment centre.
* Patient unable to attend the follow-up controls for 3 years after implant loading.
* Patient included in other studies, if this protocol cannot be properly followed.
* Immediate post-extractive sites (to be eligible at least 3 months must have passed since extraction).

Primary outcomes:
measure: bone loss
timeFrame: 2 years
Secondary outcomes:
measure: Cumulative implant survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Antofagasta
country: Chile
facility: University of Antofagasta
city: Santiago
country: Chile
facility: Andrés Bello National University
Study officials:
References:
Clinical trial NCT03263871: PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)
Official title: Pilot Study of PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Environmental Enteric Dysfunction
Keywords: nutrition
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Virginia Commonwealth University
First posted: 2017-08-28
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness of PTM202 in treating environmental enteric dysfunction.


Eligibility criteria: Inclusion Criteria:

* Aged 6 - 9 months old
* -1\> Weight-for-age Z score \> -3
* Parental consent to participate and receive daily supplementation with either PTM202 and/or micro-nutrient sprinkles, participate in specimen collection

Exclusion Criteria:

* Presence of known kidney, liver, heart, developmental, or neurologic disease
* Allergy to milk and/or egg (assessed by history)
* Milk intolerance (assessed by history)
* Abnormal liver or kidney function tests
* Family is planning to move from the study area or children is enrolled to the other clinical trial within 3 months of follow up
* Child being exclusively breast fed at the time of enrollment

Primary outcomes:
measure: EED biomarker composite score
timeFrame: 4 months
Secondary outcomes:
measure: Weight gain
timeFrame: 4 months
measure: Height gain
timeFrame: 4 months
measure: Number of diarrheal episodes
timeFrame: 4 months
measure: Glucose hydrogen breath test
timeFrame: 4 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh
Study officials:
References:
Clinical trial NCT01043471: The Effects of Gum Chewing on Energy Intake and Expenditure
Official title: The Effects of Gum Chewing on Energy Intake and Expenditure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: The Obesity Society
First posted: 2010-01-06
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if chewing gum increases energy expenditure and decreases food intake.


Eligibility criteria: Inclusion Criteria:

* BMI 27-37, between the ages of 18 and 38

Exclusion Criteria:

* History of chronic disease (e.g. liver, kidney, or heart disease, or diabetes)
* Medications that affect energy expenditure, appetite, or body composition (e.g. antidepressants, beta blockers, antipsychotic, or weight loss medications)
* A history of irregular menstrual cycles in women (indication of onset of menopause or other metabolic disturbances such as polycystic ovary syndrome)
* A history of phenylketonuria (PKU)
* Symptoms of depression
* A history of eating disorders
* Concurrent participation in a weight loss program
* Cigarette smoking or other tobacco use
* Jaw problems such as temporomandibular joint disorder (TMJ)
* Allergies to any of the common components in gum (sweeteners, mint flavors, etc)
* Heavy gum chewing prior to study ( \> 3 times per week)
* Pregnancy or lactation.

Primary outcomes:
measure: Change in body composition
timeFrame: Baseline and end of study (6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: Board of Regents of the University of Wisconsin System
name: Leah D Whigham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01654471: Validation of the Korean Version of the Walking Impairment Questionnaire in Patients With Peripheral Arterial Disease
Official title: Validation of the Korean Version of the Walking Impairment Questionnaire in Patients With Peripheral Arterial Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Occlusive Disease
Keywords: Walking Impairment Questionnaire
Peripheral arterial occlusive disease
Korean version
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Korea, Inc.
First posted: 2012-07-31
Enrollment: 47
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with peripheral arterial disease

Brief summary: The aim of the study is to validate the Korean version of Walking Impairment Questionnaire in patients with peripheral arterial occlusive disease.

Detailed description: First, the original version of WIQ will be translated into Korean, then it will be translated into English, again. The translated version will be sent to the original author to compare with the original version. After correcting, the Korean version will be completed.

The patients with peripheral arterial disease will fill in the Korean version of WIQ before starting treatments. Baseline results of arterial function test, toe-brachial index and treadmill test will be recorded. Three months later, the patients will complete the questionnaire again. Arterial function test, toe-brachial index and treadmill test also will be taken again after treatment and the correlation of WIQ and other exams will be evaluated.

Eligibility criteria: Inclusion Criteria:

* 19\~ 80 years
* claudication
* Ankle brachial index \< 0.9 or TBI \< 0.7 (in patients with DM and ABI higher than 1.3)
* patients who can complete the treadmill test (slope 12%, 2.4km/hr)

Exclusion Criteria:

* critical limb ischemia
* Ankle pressure \< 40mmHg
* claudication due to other causes (i.e. spinal stenosis, arthritis, etc)
* patients with high risk of coronary artery syndrome during treadmill test

Primary outcomes:
measure: Reproducibility of Korean version Walking Impairment Questionnaire
timeFrame: One month
measure: Correlation of WIQ score improvement and change in ABI and treadmill test results
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01248871: "Volatile Anesthetic Protection Of Renal Transplants: VAPOR-1-trail
Official title: "Volatile Anesthetic Protection Of Renal Transplants: VAPOR-1-trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Donation/Transplantation
Keywords: renal
transplantation
Volatile
anesthetic
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the renal protective properties of two currently used anaesthetic techniques - a sevoflurane-remifentanil/sufentanil combination with a propofol-remifentanil/sufentanil combination for anaesthesia in patients undergoing living donor kidney donation/transplantation.


Eligibility criteria: Inclusion Criteria:

* All patients: Age \> 18 years

Exclusion Criteria:

* patient refusal
* BMI\< 17, \>35
* neurological disorder
* recent use of psycho-active medication, including alcohol.
* Donor-recipient couples from the ABO-incompatible program
* Altruistic donor

Primary outcomes:
measure: To compare the renal protective properties of two currently used anaesthetic techniques
timeFrame: participants will be followed for the duration of hospital stay
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: M.M.R.F Struys, Prof.dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: R,J. Ploeg, Prof.dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nieuwenhuijs-Moeke GJ, Nieuwenhuijs VB, Seelen MAJ, Berger SP, van den Heuvel MC, Burgerhof JGM, Ottens PJ, Ploeg RJ, Leuvenink HGD, Struys MMRF. Propofol-based anaesthesia versus sevoflurane-based anaesthesia for living donor kidney transplantation: results of the VAPOR-1 randomized controlled trial. Br J Anaesth. 2017 May 1;118(5):720-732. doi: 10.1093/bja/aex057.