louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06936670: Effects of High-Resistance Inspiratory Muscle Strength Training on Cardiorenal and Vascular Function in Youth and Young Adults With Type 2 Diabetes
Official title: Effects of High-Resistance Inspiratory Muscle Strength Training on Cardiorenal and Vascular Function in Youth and Young Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus Type 2
Keywords: Type 2 Diabetes
Inspiratory Strength Training
Blood Pressure
Kidney Health
Cardiovascular Function
Diabetic Kidney Disease
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2025-04-20
Enrollment: 90
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High-resistance, short-duration inspiratory muscle strength training (IMST) is a novel lifestyle intervention involving 30 inhalations against a resistive load which requires only \~5 min/day and is thus ideal for youth with T2D (Y-T2D). Investigators seek to 1: assess changes in casual and 24-hr SBP, endothelial function, and arterial stiffness after 3 months of IMST vs. sham training in Y-T2D, 2: Define changes in eGFR andalbuminuria after 3 months of IMST vs. sham in Y-T2D, 3: Interrogate mechanisms of IMST by translational assessments of NO bioavailability, endothelial NO synthase (eNOS) activation, and ROS/oxidative stress, and determine the role of circulating factors.


Eligibility criteria: Inclusion Criteria: Aged 14-40, have had T2D for a least one year, HbA1C less than 12%.

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Exclusion Criteria: Have had type II diabetes for more than 18 years, estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2 or Albumin-to-creatinine ratio (ACR) greater than 2200mg/g, blood pressure greater than 160/100 mm Hg.

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Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 3 months
Secondary outcomes:
measure: Endothelial function
timeFrame: 3 months
measure: Arterial stiffness
timeFrame: 3 months
measure: Kidney Function
timeFrame: 3 months
measure: Body Composition
timeFrame: 3 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Seattle
country: United States
facility: University of Washington Medicine Diabetes Institute
state: Washington
Study officials:
References:
Clinical trial NCT00522470: Effects of Rosiglitazone on Serum Ghrelin and Peptide YY Levels
Official title: Effects of Rosiglitazone on Serum Ghrelin and Peptide YY Levels in Diabetic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Obesity
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2007-08-29
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: We aimed to evaluate the effects of rosiglitazone on serum ghrelin and peptide yy levels in diabetic women.


Eligibility criteria: Inclusion Criteria:

* newly diagnosed, drug naive women with type 2 diabetes

Exclusion Criteria:

* presence of severe cardiovascular disease (eg, New York Heart Association class III or IV congestive heart failure or a history of myocardial infarction or stroke)
* presence of thyroid, pituitary, nutritional, hepatic, renal, or neoplastic disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Hospital Department of Endocrinology
state: Bahçelievler
Study officials:
affiliation: Baskent University Faculty of Medicine
name: Zehra Berberoglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berberoglu Z, Yazici AC, Bayraktar N, Demirag NG. Rosiglitazone decreases fasting plasma peptide YY3-36 in type 2 diabetic women: a possible role in weight gain? Acta Diabetol. 2012 Dec;49 Suppl 1:S115-22. doi: 10.1007/s00592-011-0352-3. Epub 2011 Nov 19.
Clinical trial NCT04591470: Influence of Inguinal Hernia Repair on Sperm Autoimmunity
Official title: Influence of Inguinal Hernia Repair on Sperm Autoimmunity Using MAR Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Male Infertility Due to Antisperm Antibody
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 2415
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We collected data from all patients who had performed at least one MAR test and a basal spermiogram and who had performed an andrological visit at the Humanitas Clinical Institute in Rozzano (Milan) between February 2000 to September 2020.

Brief summary: Influence of inguinal hernia repair on sperm autoimmunity using MAR test

Detailed description: All infertile male patients, visited between February 2000 and September 2020 and which were tested with MAR (Mixed Autoglobulin Reaction) test, were included in this retrospective study. Sperm quality (number of spermatozoa, motility, vitality and normal forms) were also studied in this patients. The aim of the study is to evaluate if there is a higher incidence of positive MAR test among patients undergoing inguinal hernioplasty compared to the general population

Eligibility criteria: Inclusion Criteria:

* Patients undergone to correction of inguinal hernia

Exclusion Criteria:

* No specific exclusion criteria were set.

Primary outcomes:
measure: Evaluate if there is a higher incidence of positive MAR test among patients undergoing inguinal hernioplasty
timeFrame: 20 years
Secondary outcomes:
measure: Evaluate if there is a modification of seminal parameters among patients undergoing inguinal hernioplasty
timeFrame: 20 years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
References:
citation: Gupta S, Krishna A, Jain M, Goyal A, Kumar A, Chaturvedi P, Sagar R, Ramachandran R, Prakash O, Kumar S, Seenu V, Bansal V. A three-arm randomized study to compare sexual functions and fertility indices following open mesh hernioplasty (OMH), laparoscopic totally extra peritoneal (TEP) and transabdominal preperitoneal (TAPP) repair of groin hernia. Surg Endosc. 2021 Jun;35(6):3077-3084. doi: 10.1007/s00464-020-07697-z. Epub 2020 Jun 15.
citation: Stula I, Druzijanic N, Sapunar A, Perko Z, Bosnjak N, Kraljevic D. Antisperm antibodies and testicular blood flow after inguinal hernia mesh repair. Surg Endosc. 2014 Dec;28(12):3413-20. doi: 10.1007/s00464-014-3614-7. Epub 2014 Jun 25.
citation: Matsuda T, Hiura Y, Muguruma K, Okuno H, Horii Y, Yoshida O. Quantitative analysis of testicular histology in patients with vas deferens obstruction caused by childhood inguinal herniorrhaphy: comparison to vasectomized men. J Urol. 1996 Feb;155(2):564-7.
Clinical trial NCT04396470: tVNS in Children With Prader-Willi Syndrome
Official title: Transcutaneous Vagus Nerve Stimulation in Children With Prader-Willi Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Prader-Willi Syndrome
Social Behavior
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the current project is to test the impact of transcutaneous vagus nerve stimulation (tVNS) on social ability in children with Prader-Willi Syndrome (PWS). Social ability and blood neuropeptides associated with social functioning will be measured before and after engagement in 12 weeks of tVNS therapy.


Eligibility criteria: Inclusion Criteria:

* (1) be between the ages of 8-14 years; (2) have a confirmed diagnosis of PWS by genetic testing; (3) be minimally verbal and able to sit at a table to complete cognitive and behavioral testing; (4) be willing to provide blood samples; and (5) be willing to engage in a 16-week study period (baseline to intervention follow-up).

Exclusion Criteria:

* (1) currently taking oxytocin and/or arginine vasopressin or related analogs and (2) have a DSM-5 diagnosis of any severe mental or behavioral disorder (e.g. schizophrenia, bipolar disorder, conduct or oppositional defiant disorder) that significantly impacts daily functioning.

Primary outcomes:
measure: Social Responsiveness Scale, 2nd Edition (SRS-2)
timeFrame: pre-post 12 week intervention period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06328270: Comparison of the Therapeutic Effects of Intra-Articular Injection of Ozone and Corticosteroid in Knee Osteoarthritis
Official title: Comparison of the Therapeutic Effects of Intra-Articular Injection of Ozone and Corticosteroid in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial aimed to involve patients aged 40-85 years who had been experiencing knee pain for at least 6 months and had received a clinical diagnosis of knee osteoarthritis through radiologic imaging. The patients were randomly assigned to two groups. One group received a 3-week intra-articular injection of 15 mg/ml ozone, while the second group received a 1 ml intra-articular injection of betamethasone. All patients were evaluated before treatment, as well as 4 and 12 weeks after the first dose of treatment. The study evaluated treatment efficacy using the Visual Pain Score (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC).


Eligibility criteria: Inclusion Criteria:

* 40-85 years old,
* have experienced knee pain and/or limited joint range of motion for at least 6 months,
* have a diagnosis of KOA supported by radiographic imaging.

Exclusion Criteria:

* patients had undergone knee joint surgery,
* had a history of previous intra-articular injections,
* had any rheumatological disease or malignancy,
* being pregnant,
* had pain radiating to the knee and leg.

Primary outcomes:
measure: Visual Pain Score
timeFrame: 4 weeks after the first dose of treatment
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: 4 weeks after the first dose of treatment
Secondary outcomes:
measure: Visual Pain Score
timeFrame: 12 weeks after the first dose of treatment
measure: Western Ontario and McMaster Universities Arthritis Index
timeFrame: 12 weeks after the first dose of treatment
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital
Study officials:
References:
Clinical trial NCT02884570: Parental Mental Health After Tracheostomy in Early Childhood
Official title: Post-hospital Evaluation of Anxiety / Depression in Parents of Children Who Required Tracheostomy Before the Age of 1 Year
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheotomised Children
Anxiety of Parents
Depression of Parents
Keywords: Tracheotomy
Anxiety
Depression
Back Home
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents (mothers and fathers) of children with tracheotomy before the age of 1 year between 2000 and 2012.

Pre- selection will take place in Pediatric Neonatal and Reanimation services of Montpellier, Paris (Hôpital Robert Debré ) and Strasbourg

Brief summary: To assess the prevalence of anxiety / depression in post- hospital for parents (mothers and fathers) of children with tracheotomy before the age of 1 year between 2000 and 2012.

Detailed description: The goal of this study is to evaluate the level of anxiety / depression of families and to correlate to the lived parental of tracheotomy and indirectly that of the child (hetero - evaluation).

The information from this study should allow staff to refine and adjust their practices in terms of information and support for families with tracheotomised children. The information given to families before the establishment of a tracheotomy for their child may also be adapted.

Eligibility criteria: Inclusion criteria :

Families whose child :

* Has been tracheotomised before the age of 1 year between 2000 and 2012
* Came out of hospital with a tracheotomy tube
* Is or has been followed by one of three centers

Exclusion criteria :

* Children decannulated before hospital discharge .
* Death before the start of the study

Primary outcomes:
measure: Anxiety and Depression
timeFrame: Through study completion, up to 6 months
Secondary outcomes:
measure: Experienced of the care by the families
timeFrame: Through study completion, up to 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Gilles Cambonie, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02500875: Treatment of Infected Surgical Wounds With Negative Pressure Topical Therapy and Instillation (With or Without Antiseptic) Versus no Instillation
Official title: Treatment of Infected Surgical Wounds With Negative Pressure Topical Therapy and Instillation (With or Without Antiseptic) Versus no Instillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Infected Surgical Wound
Keywords: Negative-Pressure Wound Therapy
Topical Negative Pressure Therapy
Sodium Hypochlorite
Lead sponsor: Associazione Infermieristica per lo studio delle Lesioni Cutanee
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 120
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 objective of this study is to evaluate the effectiveness of PTNi therapy versus PTN therapy without instillation in the treatment of infected surgical wounds. Investigators mean to verify differences of effectiveness between the different types of instilled substances, normal saline versus Amukine Med 0.5%.


Eligibility criteria: Inclusion Criteria:

* Patients with infected surgical wounds.
* Patient age greater than or equal to 18 years.
* Patients who have given informed consent to the enrollment in the trial and to the processing of personal data.

Exclusion Criteria:

* Patients unable of consent.
* Patients affected by serious medical conditions that, according to the investigator's opinion, represent a contraindication to the study participation.
* Patients affected by wounds with exposition of blood vessels, sutures, organs or nerves and open wounds in mediastinum or abdomen.
* Patients with malignancy at the wound.
* Patients with untreated osteomyelitis.
* Patients with enteric and unexplored fistulas.
* Patients with necrotic tissue and eschar.
* Immunocompromised patients or in treatment with corticosteroids.
* Suspected or known allergic diathesis to the product of medication.
* Patients with coagulation disease.

Primary outcomes:
measure: Absence of clinical infection (according NHSN 2014)
timeFrame: 1 month
measure: Absence of clinical infection
timeFrame: 1 month
Secondary outcomes:
measure: Treatment days
timeFrame: 1 month
measure: Wound closure
timeFrame: 1 month
measure: Patient's discharge
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
measure: Patient's pain (Numeric Rating Scale (NRS)
timeFrame: 1 month
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola Malpighi
Study officials:
affiliation: Policlinico Sant'Orsola Malpighi Bologna
name: Paolo Chiari
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06883370: Analgesia Evaluation of an Ultrasound-guided Technique for Inguinal Hernia Surgery in Children in Children
Official title: Analgesic Evaluation of Ultrasound Guided Transversalis Fascia Plane (Tfp) Block With 0.4 ml/kg of Ropivacaine 0.375 % in Paediatric Laparoscopic Inguinal Hernia Repair.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inguinal Hernia
Surgery
Paediatric
Keywords: Ultrasound
transversalis fascia
ropivacaine
inguinal hernia
paediatric patients
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The basis for the transversalis fascia plane (TFP) block involves infiltration of local anaesthetic blocking the ilioinguinal and iliohypogastric nerve which are located between the fascia of the transversus abdominis muscle and the transversalis fascia. The fascia of the transversus abdominis muscle, also called the thoracolumbar fascia, is formed when the transversus abdominis and internal oblique muscles taper off posteriorly into a common aponeurosis and abuts the lateral border of quadratus lumborum muscle. The transversalis fascia is a thin aponeurotic membrane which lies between the transversus abdominis muscle and the extraperitoneal fascia, and is part of the general layer of fascia lining the abdominal cavity. Thus the TFP block is said to be suitable for lower abdominal surgery.

This study was designed obtain the analgesic efficacy of ropivacaine 0.375% for ultrasound-guided (USG) TFP block for paediatric patients undergoing laparoscopic inguinal hernia.

Detailed description: Methods: Thirty-two ASA 1 or 2 patients, aged 6 months to 12 years old undergoing laparoscopic inguinal hernia repair were recruited into this study. They were all given 0.4ml/kg of ropivacaine 0.375% after induction of anaesthesia. Intra operative heart rate (HR), mean arterial pressure (MAP), cumulative fentanyl consumption as well as post operative FLACC score, post operative nausea and vomiting incidence, time to first oral intake, parental satisfaction and complications were recorded.

Eligibility criteria: Inclusion Criteria: All ASA I or II patients undergoing inguinal hernia repair

Exclusion Criteria: Parent's refusal, allergic to study drug

Primary outcomes:
measure: Effectiveness of ultrasound-guided transversals fascia plane block in paediatric
timeFrame: immediate post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: The National University of Malaysia
Study officials:
affiliation: The National University of Malaysia
name: Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04253470: Debate on Progesterone Elevation on the Day of Triggering
Official title: The Neverending Debate on Progesterone Elevation: Possible Solutions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Progesterone
ART
Female Infertility
Embryo Transfer
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 8000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All fresh embryo transfers both at cleavage stage (Day 2 and Day3) and blastocyst stage (Day 5), and all thawed embryo transfer, except from the ones deriving from PGTA, performed from January 2012 to December 2016 in Humanitas Fertility Center were included.

Brief summary: The association between serum progesterone (P) levels, measured on the day of ovulation trigger, and the outcome of in vitro fertilization cycles, has been one of the major controversies in the field of ovarian stimulation endocrinology.

This is a single-center retrospective cohort study. Study duration period is from January 2012 to December 2016.

All fresh embryo transfer (ET) both at cleavage stage and blastocyst stage, performed in Humanitas Fertility Center during the study period, were included.


Eligibility criteria: Inclusion Criteria:

* All fresh embryo transfers both at cleavage stage (Day 2 and Day3) and blastocyst stage (Day 5)
* Thawed embryo transfer deriving from supernumerary embryos cycles, by P increase, by OHSS, by other reasons (i.e inadequate endometrium, medical complications, etc)

Exclusion Criteria:

* thawed embryo transfers deriving from PGTA.

Primary outcomes:
measure: Impact of PE on CPR and LBR
timeFrame: January 2012-December 2016
Secondary outcomes:
measure: Blastocyst embryo transfers' outcomes in PE
timeFrame: January 2012-December 2016
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Paolo Emanuele Levi Setti
state: MI
Study officials:
affiliation: Humanitas clinical and research hospital
name: Raffaella De Cesare
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Cesare R, Morenghi E, Cirillo F, Ronchetti C, Canevisio V, Persico P, Baggiani A, Sandri MT, Levi-Setti PE. The Role of hCG Triggering Progesterone Levels: A Real-World Retrospective Cohort Study of More Than 8000 IVF/ICSI Cycles. Front Endocrinol (Lausanne). 2020 Sep 23;11:547684. doi: 10.3389/fendo.2020.547684. eCollection 2020.