louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02770079: Insulin Sensitivity and Secretion During Pregnancy and Post Partum in Women With Gestational Diabetes.
Official title: Botnia Clamp in Women Before, Immediately After Delivery and 6 Months Post Partum.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes, Gestational
Keywords: Insulin sensitivity
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women visiting the outpatient gestational diabetes clinic at Aarhus University Hospital will be approached.

Brief summary: Aim of the study:

To define insulin requirement during pregnancy and to identify the rapid changes in insulin sensitivity around parturition and the first 6 months post partum. Such knowledge would be clinically useful and markedly improve insulin treatment before and after parturition for women with type 1 diabetes and serve to identify the best possible timing of testing women with gestational diabetes mellitus (GDM) for the development of type 2 diabetes post partum.

Method:

Botnia clamp in women before, immediately after delivery and 6 months post partum. The investigators will compare 20 women with GDM in late pregnancy, day 15 post partum and 6 months post partum with 20 normal women investigated at the same time points. In addition the investigators will collect feces samples from the mother and baby in order to determine microbiota.

Perspectives:

Diabetes is a common condition with important implications for pregnancy outcome and long-term morbidity for mother and offspring. Accordingly, tailoring the best treatment is expected to have beneficial consequences both for the pregnant women and the future generation.


Eligibility criteria: Inclusion Criteria:

* Written consent before study start.
* Pregnant.
* GDM for the GDM group.
* No diabetes for the control group.

Exclusion Criteria:

* Women with multiple pregnancy.
* New pregnancy before all three examinations has been done.
* Severe, debilitating, concurrent diseases.
* Serious or intolerable adverse reactions associated with the studies.

Primary outcomes:
measure: Change in insulin sensitivity
timeFrame: Determined one time between gestational week 32 to 37, 14 days postpartum and 6 months postpartum.
Secondary outcomes:
measure: Changes in the microbiota
timeFrame: Determined one time between gestational week 32 to 37 (only the mother), 14 days postpartum and 6 months postpartum.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, NBG
Study officials:
affiliation: University of Aarhus
name: Per G Ovesen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skajaa GO, Fuglsang J, Knorr S, Moller N, Ovesen P, Kampmann U. Changes in insulin sensitivity and insulin secretion during pregnancy and post partum in women with gestational diabetes. BMJ Open Diabetes Res Care. 2020 Oct;8(2):e001728. doi: 10.1136/bmjdrc-2020-001728.
Clinical trial NCT06216379: Sensory Processing Associated With Motor Skills
Official title: Is Sensory Processing Associated With Gross and Fine Motor Skills at 1-Year-Old?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Sensory Processing Disorder
Motor Delay
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 61
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children born preterm and term at 12 months of age

Brief summary: In the study, sensory processing skills of 1-year-old preterm and term children will be evaluated. The relationship between sensory processing skills and gross and fine motor development will be investigated.


Eligibility criteria: Inclusion Criteria:

Premature group: Healthy children with a gestational age below 34 weeks Term group: Healthy children with gestational age between 37-41 weeks

Exclusion Criteria:

they had major congenital malformations, had genetic or chromosomal abnormalities, had known metabolic disorders, or had seizures.

Primary outcomes:
measure: Test of Sensory Functions in Infants TSFI
timeFrame: 15 minutes
Secondary outcomes:
measure: Peabody Developmental Motor Scales-2
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum Technical University
Study officials:
References:
Clinical trial NCT01197079: Perception, Awareness, and Acceptance of Human Papillomavirus Disease and Vaccine Among Parents of Boys Aged 9 to 18 Years
Official title: Perception, Awareness, and Acceptance of Human Papillomavirus Disease and Vaccine Among Parents of Boys Aged 9 to 18 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus (HPV)
Keywords: HPV
Vaccine
Vaccine utilization
Disease awareness
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 500
Sex: MALE
Minimum age (years): 9
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Young men who have sex with men (MSM) that obtain medical care from a Gay/Lesbian/Bisexual/Transgender community health clinic

Parents of boys aged 9 to 18 years who obtain their medical care from several public health clinics or who obtain their medical care from private pediatrician offices in Chicago

Brief summary: The objectives of this study are:

1. to determine the degree of understanding and perceived risks for human papillomavirus (HPV) disease, to examine and assess attitudes for personal use of HPV vaccine and identify potential barriers to HPV vaccine access and utilization in a population of young men who have sex with men (MSM) (under 26 years of age)and in parents of boys aged 9 to 18 years
2. to determine HPV vaccine acceptance and predictors of acceptance in a population of young MSM and in patients of boys ages 9 to 18 years
3. to develop strategies to overcome potential barriers to vaccination and improve vaccine access and utilization via development of targeted educational initiatives.


Eligibility criteria: Inclusion Criteria:

* MSM group - under age 26 years
* Parent group - parent of boy(s) ages 9 to 18 years

Exclusion Criteria:

* MSM group - previous receipt of HPV vaccine
* Parent group - previous receipt of HPV vaccine by male child

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Pediatric Private practice
state: Illinois
city: Chicago
country: United States
facility: Children's Memorial Hospital Uptown Clinic
state: Illinois
city: Chicago
country: United States
facility: Pediatric Private Practice
state: Illinois
city: Chicago
country: United States
facility: Erie Family Health Clinic
state: Illinois
city: Chicago
country: United States
facility: Howard Brown Health Center
state: Illinois
city: Evanston
country: United States
facility: Private pediatric practice
state: Illinois
city: Evanston
country: United States
facility: Pediatric Private practice
state: Illinois
Study officials:
References:
Clinical trial NCT04101279: Midurethral Synthetic Tape With Tension Control Mechanism Versus Midurethral Free Tape
Official title: Evaluation of the Effectiveness and Safety of the Midurethral Synthetic Tape With Tension Control Mechanism and Midurethral Tension Free Tape
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Stress Incontinence
Keywords: stress urinary incontinence
midurethral tension free tape
patient reported outcome
bladder outlet obstruction
complications
tension control mechanism
Lead sponsor: Moscow State University of Medicine and Dentistry
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 120
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled comparative study
Primary purpose: TREATMENT

Brief summary: This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of midurethral synthetic tape with tension control mechanism and conventional midurethral tension free tape as surgical treatment for female urinary stress incontinence.


Eligibility criteria: Inclusion Criteria:

Women suffering from stress urinary incontinence, mixed urinary incontinence with prevalence stress urinary incontinence

Exclusion Criteria:

* Pregnancy
* Women with neurogenic bladder dysfunction
* Recurrent stress urinary incontinence
* Woman with history of pelvic surgery
* Mixed urinary incontinence with prevalence urgency urinary incontinence
* Women who suffer from advanced POP (POP-Quantification system (POP-Q) stage more than 2)
* Women with acute urinary tract infection
* Women with bladder outlet obstruction
* Women who are not able to give informed consent or participate with this randomized research study for any other reason

Primary outcomes:
measure: Patient reported outcome measured as urogenital distress inventory (UDI-6) will be assessed before and after surgery at 12 weeks and 1 year.
timeFrame: 1 year
Secondary outcomes:
measure: Bladder outlet obstruction measured during urodynamics pressure flow study
timeFrame: 1 year
measure: Stress cough test measured before and after surgery.
timeFrame: 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow state university of medicine and dentistry named after A.I. Evdokimov
Study officials:
References:
Clinical trial NCT05403879: Modified Hook Wiring Technique for Greater Tuberosity Fractures, a Prospective Study
Official title: Modified Hook Wiring Technique for Greater Tuberosity Fractures, a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Greater Tuberosity Fractures
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: the purpose of this study is to assess functional and radiological outcome of open reduction and internal fixation of isolated displaced greater tuberosity fractures (more than 5mm displacement) in adults advocating modified hook wiring with a follow-up period of one year.

Detailed description: after being informed about the study and potential risks, all enrolled cases giving informed consent will undergo fixation of their fractured greater tuberosity, then physiotherapy. patients will be followed up till full union, clinical and radiological follow up for at least one year utilizing approved clinical scores and radiological criteria for healing. any complication will be recorded.

Eligibility criteria: Inclusion Criteria:

Patients presented and admitted at Mansoura Trauma, emergency hospital affiliated to Mansoura university, with acute isolated displaced GT fractures ( more than 5mm displacement), with/without glenohumeral dislocations, with age between 18years to 50 years.

Exclusion Criteria:

1. Skeletally immature patients (less than 18 years), age more than 50 years.
2. Open and pathological fractures
3. Associated proximal humeral fractures
4. History of previous GH dislocations
5. History of previous shoulder injuries or surgeries

Primary outcomes:
measure: functional outcome using American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment score
timeFrame: at least one year follow up
Secondary outcomes:
measure: healing time
timeFrame: anticipated 2-4 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
References:
Clinical trial NCT03837379: Goal2Quit + NRT Sampling
Official title: Development and Testing of a Depression-Specific Behavioral Activation Mobile App Paired With Nicotine Replacement Therapy Sampling for Smoking Cessation Treatment Via Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Smoking Cessation
Depression
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-02-12
Enrollment: 164
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: The goal of this work is to develop, systematically evaluate, and clinically test an integrated cessation intervention comprised of a depression-specific Behavioral Activation (BA) for cessation mobile app ("Goal2Quit") packaged with nicotine replacement therapy (NRT) sampling. This integrated intervention will address the need for an easily disseminable, evidence-based, depression-specific cessation intervention for delivery via primary care.


Eligibility criteria: Inclusion Criteria:

* Current elevated depressive symptoms defined as a score of \> 10 (at least mild depression) on the Patient Health Questionnaire-8 (PHQ-8)
* Current smoking, defined as smoking 10+ cigarettes/day, for 25+ days out of the last 30, for the last 6+ months
* Ownership of an Android or iOS smartphone
* Age 18+
* Possess a valid e-mail address that is checked daily to access follow-up assessments
* English fluency

Exclusion Criteria:

- Contraindications for NRT (pregnancy/intention to become pregnant/breastfeeding, recent cardiovascular trauma/uncontrolled hypertension) - Severe visual impairment, which may limit ability to utilize an app

Primary outcomes:
measure: 7 Day Point Prevalence Abstinence
timeFrame: From 7 days preceding the 12-week follow-up assessment through the 12-week follow-up assessment.
Secondary outcomes:
measure: Mean Score of Depressive Symptoms
timeFrame: Change in BDI from baseline to Week 12
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Jennifer Dahne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02624479: Pharmacokinetic Study to Investigate the Bioavailability and Tolerability of 3 Oral Formulations of Sodium Thiosulfate
Official title: Phase I Pharmacokinetic Pilot Study to Investigate the Bioavailability and Tolerability of Three Different Oral Formulations of Sodium Thiosulfate
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Chronic treatment and prophylaxis of vessel and soft tissue calcification as well as of renal calculi could be a future indication for sodium thiosulfate (STS). Using an oral formulation might increase the compliance and treatment success compared to parenteral administration.

Three gastro-resistant formulations of STS for oral administration were developed with different release characteristics: fast-release, medium-release and slow-release tablets. Aim of the enteric coating was to increase the oral bioavailability of STS. The bioavailability and tolerability of these formulations for oral administration in healthy volunteers will be compared in this clinical trial.


Eligibility criteria: Inclusion Criteria:

* Male or female healthy subjects ≥ 18 years
* Negative pregnancy test in female subjects of childbearing age
* Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study

Exclusion Criteria:

* Pregnant or lactating subjects.
* Renal impairment (creatinine clearance \<60ml/min)
* Concomitant medication
* Gastrointestinal diseases
* History of alcohol abuse, illicit drug use, significant mental illness, physical dependance to opioid, other drug abuse or addiction (last 12 months)

Primary outcomes:
measure: Relative bioavailability of STS after oral administration based on urinary excretion of TS and sulfate
timeFrame: 7 weeks
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: 7 weeks
measure: TS excretion in urine
timeFrame: 48 hours
measure: TS excretion in urine: amount
timeFrame: 48 hours
measure: TS excretion in urine: fraction of administered TS
timeFrame: 48 hours
measure: Sulfate excretion in urine: amount
timeFrame: 48 hours
measure: Sulfate excretion in urine: fraction of administered TS
timeFrame: 48 hours
Other outcomes:
Locations:
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Dominik Uehlinger, Prof Dr.med.
role: STUDY_CHAIR
References:
Clinical trial NCT03334279: Effect of Cannabis and Cigarette Smoking on Oral Mucosa
Official title: Detection of Field Cancerization in the Clinically Normal Oral Mucosa of Cannabis and Cigarette Smokers (Ex-vivo Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Field Cancerization for Cannabis Smokers
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: routine patients already coming for simultaneous dental or surgical procedures..

Brief summary: The aim of this study is to detect P53 expression in clinically normal oral mucosa of cigarette smokers, simultaneous cigarette and cannabis smokers and non-smokers as a surrogate marker for field cancerization.

Detailed description: Roles and Responsibilities:

1. Ali Abd El Wahed Abd El Fatah Kotb (A.K.) operator, data enterer, Assistant lecturer, Oral and Maxillofacial Pathology, Faculty of Oral and Dental Medicine, Cairo university, Egypt.
2. Professor Dr. Heba Dahmoush (H.D.) main supervisor, data monitoring,auditing professor, Oral and Maxillofacial Pathology, Faculty of Oral and Dental Medicine, Cairo university, Egypt.
3. Eman Desoky (E.D.) sample size calculation, statistician,Faculty of Oral and Dental Medicine, Cairo University, Egypt.
4. Evidence Based Dentistry Committee (CEBD)help in reporting study protocol following SPIRIT guidelines,Faculty of Oral and Dental Medicine, Cairo University, Egypt.
5. Research Ethics Comittee (CREC)protocol reviewer in order to protect the right, safety, dignity and well-being of the participants, Faculty of Oral and Dental Medicine, Cairo University, Egypt.

1- Intervention: A.K. will collect specimens from cigarette smokers and simultaneous cigarette and cannabis smokers. then the expression of p53 as a marker for field cancerization will be investigated in formaline fixed paraffine embedded specimens of mucosal biopsies obtained from the oral mucosa of both groups.

2-comparator: mucosal biopsies from non smokers will be investigated as a copmaratitive to smokers group.

Eligibility criteria: Inclusion Criteria:

* frequent smokers (at least 10 cigarettes a day) for a period not less than 5 years.
* Simultaneous smokers to be included in the study must be frequent cigarette smokers (at least 10 cigarettes a day) for a period not less than 5 years plus frequent cannabis smoker (at least 3 times per week) for a period not less than 5 years.

Exclusion Criteria:

* Exposure to other carcinogens.
* un-clear smoking history.
* medically compromised patients

Primary outcomes:
measure: P53 expression as a surrogate marker for field cancerization
timeFrame: not less than 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04385979: Curcumin and Nanocurcumin in Oral Aphthous Ulcer
Official title: Comparison of Curcumin and NanoCurcumin in Recurrent Aphthous Stomatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Aphthous Ulcer
Recurrent Aphthous Stomatitis
Keywords: Recurrent Aphthous Stomatitis
Curcumin
Nanocurcumin
management
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recurrent aphthous ulcer is a painful inflammatory lesion with a high prevalence. Since the etiology is not clear, several strategies have been proposed to reduce pain and severity of its symptoms. Today, curcumin is considered as an herbal medicine with anti-inflammatory properties. Treatment or control of various inflammatory diseases has been proposed, but its low solubility in water has reduced bioavailability, while the use of nanoparticle pharmaceutical techniques has been able to solve these problems. Therefore, the aim of the present study was to evaluate the clinical efficacy of a new topical curcumin gel with nano-technology and compare it with 2% curcumin gel in patients with recurrent aphthous ulcers.

This randomized clinical trial was performed on 48 patients assigned to two groups (nano-curcumin gel) and (curcumin gel). Before treatment, the size of the wound and VAS were measured. After intervention, the two variables were measured again on the fourth and seventh days , then the amount of improvement was quantitatively and qualitatively compared in the two groups and a significant level of less than 0.05 was considered.


Eligibility criteria: Inclusion Criteria:

* Patients with minor and recurrent aphthous ulcer lesions within 48 hours and Aphthous like Lesions

Exclusion Criteria:

* Wounds are in inaccessible areas (such as posterior palate). If a person suffers from systemic disease (through questioning the patient) Patients with turmeric allergy and any type of gel used in this study. Pregnant or lactating women .. accompany with other mucosal lesions. Do not take any other medicine while taking intervention Major or herpeti form of aphthous ulcer

Primary outcomes:
measure: Wound size
timeFrame: one week
measure: Pain score
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Mahinbakhshi@Sbmu.Ac.Ir
Study officials:
References: