louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05132933: Gas Exchange Derangement Physiopathology in Critically Ill Patients With COVID-19
Official title: Gas Exchange Derangement Physiopathology and Response to Different Levels of Positive End-expiratory Pressure in Critically Ill Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study was designed to understand the pathophysiology of gas exchange derangement in critically ill patients with COVID-19. Specifically we will evaluate the effect of 3 different levels of positive end-expiratory pressure (PEEP) and two different levels of inspiratory oxygen fraction (FiO2) on gas exchange by analyzing shunt and dead space. Furthermore, complete respiratory mechanics and distribution of ventilation and perfusion by electrical impedance tomography will be assessed at each level of PEEP.


Eligibility criteria: Inclusion Criteria:

* Patients admitted in intensive care unit for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring invasive mechanical ventilation

Exclusion Criteria:

* Pregnancy
* Hemodynamic instability (80-90 mmHg increase or 30-40 mmHg decrease systolic arterial pressure compared to baseline value or need of vasopressors to maintain systolic blood pressure higher than 85 mmHg or electrocardiogram evidence of ischemia/arrhythmias)
* Presence of pneumothorax and/or pneumomediastinum
* Contraindications to Electrical Impedance Tomography (pacemaker, implantable cardioverter defibrillator, thoracic drainages)

Primary outcomes:
measure: Shunt at three different levels of positive end expiratory pressure (PEEP)
timeFrame: 30 minutes after change of positive end expiratory pressure (PEEP) level
Secondary outcomes:
measure: Dead space at three different levels of positive end expiratory pressure (PEEP)
timeFrame: 30 minutes after change of positive end expiratory pressure (PEEP) level
measure: Shunt and dead space at two different levels of inspiratory oxygen fraction for each level of positive end expiratory pressure (PEEP)
timeFrame: 30 minutes after change of positive end expiratory pressure (PEEP) level
measure: Ventilation/perfusion at three different levels of positive end expiratory pressure (PEEP) assessed by electrical impedance tomography (EIT)
timeFrame: 30 minutes after change of positive end expiratory pressure (PEEP) level
measure: Respiratory mechanics at three different levels of positive end expiratory pressure (PEEP)
timeFrame: 30 minutes after change of positive end expiratory pressure (PEEP) level
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale Maggiore Policlinico
state: MI
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Giacomo Grasselli, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01199133: Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children
Official title: A Randomised,Double-blind,Placebo-controlled,Multi National,Phase III Trial to Assess the Efficacy and Safety of 300 IR Sublingual Immunotherapy Administered as Allergen-based Tablets Once Daily to Adolescents and Children Above the Age of 5 Years, Suffering From House Dust Mite Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Allergic Rhinitis Due to Dust Mite
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 471
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use.

Detailed description: After the screening period, the patients will be administered 300 IR house dust mite allergen based tablets or placebo, once a day, for a period of 36 months with two windows of 8 months and 6 months without treatment. The carry over effect will be evaluated after a treatment free follow up period of 24 months.

An independent Data Monitoring Committee will be constituted to evaluate the efficacy and safety data at the end of Year 1 and Year 3, and the post-treatment long-term efficacy data at the end of year 4.

Eligibility criteria: Inclusion Criteria:

* Male or female outpatients, aged 5-17 years inclusive
* History of house dust mite-related allergic rhinitis for at least 1 year requiring regular intake of symptomatic treatment(s)
* Sensitised to D. pteronyssinus and/or D. farinae (positive skin prick test with wheal diameter greater than 3 mm and specific IgE level ≥ 0.7 kU/L)

Exclusion Criteria:

• Co-sensitization associated with clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites to which the patient will be exposed during the study, i.e. will notably be excluded

* patients sensitised to cat or dog allergens and regularly exposed to these allergens
* patients sensitised to aspergillus, cladosporium, alternaria
* patients sensitised to parietaria , ragweed, or mugwort, if this allergen is endemic to the region

Primary outcomes:
measure: Average Adjusted Symptom Score (AASS) During the Treatment Period
timeFrame: Year 1 Primary Period = 01 OCT to 30 NOV 2010 The value was obtained by averaging the daily scores over the primary period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Charite- Campus Virchow klinikum
name: Ulrich Wahn, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05979233: One Session Vs Staged Management of Calcular Obstructive Jaundice
Official title: One Session Vs Staged Laropendoscopic Management of Calcular Obstructive Jaundice
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Calcular Obstructive Jaundice
Gall Bladder Disease
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to compare the outcomes between doing ERCP and laparoscopic cholecystectomy in one session Vs staged management

Detailed description: to compare the outcomes between 3 groups: in the 1st group we will do ERCP then laparoscopic cholecystectomy in the same session, in the 2nd group we will do laparoscopic cholecystectomy then ERCP in the same session in group 3 we will do staged management

Eligibility criteria: Inclusion Criteria:

* age from 18-70 year
* combined CBD and gall stone
* stone less than 1.5 cm
* fit for surgery
* no upper abdominal surgery

Exclusion Criteria:

* age \<18 and \>70
* unfit for surgery
* stone more than 1.5 cm
* upper abdominal surgery

Primary outcomes:
measure: total cost
timeFrame: 6 months
measure: hospital stay
timeFrame: 6 months
Secondary outcomes:
measure: complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medicine
Study officials:
References:
Clinical trial NCT01102751: Serum FGF-23 and Vitamin D Deficiency
Official title: Effects Of Vitamin D Replacement Therapy on Serum FGF-23 Concentrations in Vitamin D Deficient Women In Short Term
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteomalacia
Keywords: fibroblast growth factor 23
Osteomalacia
vitamin D
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2010-04-13
Sex: ALL
Minimum age (years): 9
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Group 1: Eighteen premenopausal female patients with a diagnosis of vitamin D deficient osteomalacia were included in this group. Vitamin D deficiency was diagnosed according to the serum 25 hydroxy vitamin D3 (25OHD) concentrations (\< 30 ng/mL). Reasons for vitamin D deficiency were verified as insufficient exposure to sunlight, frequent parturition and prolonged lactation. All of these patients received a standard treatment regimen; oral Vitamin D3 150 000 IU once for all and subsequently 880 IU D3 and 1000 mg calcium carbonate for six weeks. This group was also evaluated after replacement therapy at sixth week.

Group 2: Nineteen healthy premenopausal women who had normal levels of serum 25OHD Vitamin (\>30 ng/mL) composed the control group.

Group 3: Thirteen hypophosphatemic rickets (3 autosomal dominant and 10 X-linked; 9 female and 4 male) were included in this group.

Brief summary: We aimed to determine the effect of vitamin D replacement therapy on serum FGF-23 concentrations in vitamin D deficient women and to compare the FGF-23 concentrations of vitamin D deficient patients with healthy subjects and patients with genetically-determined hypophosphatemic rickets.

Detailed description: Study group was composed of vitamin D deficient females (n =18, mean age 29.1±9.9 yrs), vitamin D sufficient healthy females (control group; n = 19, mean age 28.5±5.2 yrs) and patients with genetically-determined hypophosphatemic rickets (n=13, mean age 26.5±15.1 yrs). Groups were compared for serum FGF-23, 1,25 dihydroxy vitamin D3, calcium, phosphate, bone turnover markers, intact parathyroid hormone and urinary excretion of calcium and phosphate. Vitamin D deficient group was re-evaluated after a standard treatment regimen.

Eligibility criteria: Inclusion Criteria:

* Serum 25OHD Vitamin \<30 ng/mL for group 1
* Serum 25OHD Vitamin \>30 ng/mL for control group

Exclusion Criteria:

* Receiving medication(s) affecting bone metabolism
* History of gastrointestinal disease and malabsorption
* History of renal and liver disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Istanbul Faculty of Medicine, Department of Internal Medicine, Division of Endocrinology and Metabolism
Study officials:
References:
Clinical trial NCT03704051: Breast Versus Bottle Study
Official title: Breast Versus Bottle Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breastfeeding
Bottle Feeding
Keywords: infant feeding
feeding interactions
maternal feeding practices
breastfeeding
bottle-feeding
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-10-12
Enrollment: 94
Sex: ALL
Minimum age (years): 0
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A convenience sample of mother-infant dyads residing within 50 miles of California Polytechnic State University.

Brief summary: The objective of the proposed research is to conduct a within-subject experimental study that will assess the effect of feeding mode (breast- versus bottle-feeding) on the quality and outcome of infant feeding interactions.


Eligibility criteria: Inclusion Criteria:

* Mothers 18-40 years of age
* Infants 0-24 weeks of age
* Infants who have not yet been introduced to complementary foods and beverages
* Dyads are breast- and bottle-feeding
* Mother is predominantly or solely responsible for infant feeding

Exclusion Criteria:

* preterm birth (i.e., gestational age \<37 weeks)
* low birth weight (\<2500 g)
* maternal smoking during pregnancy
* current or past medical conditions that interfere with oral feeding
* history of slow growth or failure to thrive
* weight for length percentile \<5th
* diagnosed developmental delay (e.g., Down's syndrome)

Primary outcomes:
measure: Infant Intake During the Observed Feeding (mL)
timeFrame: 2-hour period
measure: Maternal Sensitivity to Infant Cues
timeFrame: 2-hour period
Secondary outcomes:
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: Healthy Kids Laboratory within the French Hospital Copeland Health Education Pavilion
state: California
Study officials:
affiliation: Cal Poly
name: Alison K Ventura, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ventura A, Hupp M, Lavond J. Mother-infant interactions and infant intake during breastfeeding versus bottle-feeding expressed breast milk. Matern Child Nutr. 2021 Oct;17(4):e13185. doi: 10.1111/mcn.13185. Epub 2021 May 3.
Clinical trial NCT06335251: Radiotherapy Treatments for Neoplasms of the Limbs
Official title: Radiotherapy Treatments for Neoplasms of the Limbs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Neoplasms
Bone Metastases
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at European Institute of Oncology with radiotherapy to limbs

Brief summary: In this observational study patients treated at European Institute of Oncology with radiotherapy to limbs will be included

Detailed description: Approximately 60% of patients with neoplasms receive radiotherapy as part of their oncological treatment. Various primary tumors as well as metastases of various origins can be localized in the upper or lower limbs. Patients with such neoplastic localizations will therefore receive radiotherapy treatment possibly associated with other systemic or surgical treatments.

Treatment choice is usually established following multidisciplinary discussions, based on disease characteristics and stage, concurrent pathologies and pharmacological treatments, patient preferences, and functional aspects.

Data collection related to radiotherapy plays a crucial role in understanding various clinical aspects of the treatment itself. The availability of data from an increasing number of patients will allow the identification of clinical situations or technical parameters of radiotherapy correlated with treatment tolerance and effectiveness, aiming to identify the best treatment for these oncological pathologies.

This project aims to collect data related to radiotherapy treatments for primary or secondary neoplasms localized in the upper or lower limbs for scientific dissemination with the goal of establishing the basis for evaluating achieved results over time, and deriving from these elements useful for guiding the most effective treatment strategies and appropriate operational protocols.

Eligibility criteria: Inclusion Criteria:

1. Patients treated with radiotherapy for curative, palliative, neo-adjuvant, and adjuvant purposes in the upper and lower limbs for:

   Primary bone tumors, Primary soft tissue tumors, Primary tumors of the cardio-circulatory system, Primary tumors of the lymphatic system, Primary tumors of the nervous system and skin, Secondary metastases from various origins localized in that district.
2. Signed informed consent

Exclusion Criteria:

1. Radiotherapy in districts other than limbs.

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Barbara Alicja Jereczek
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01170351: Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis
Official title: Comparing Efficacy and Tolerability of Cyclosporine-A vs. Prednisolone for Induction of Remission in Auto-immune Hepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autoimmune Hepatitis
Keywords: autoimmune hepatitis
corticosteroids
cysclosporine-A
treatment
treatment-naive
induction of remossion
efficacy
tolerability
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 55
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Untreated Autoimmune hepatitis (AIH) is a progressive disease. Mainstay of treatment are corticosteroids (CS). In addition to being ineffective a substantial minority of cases, corticosteroid side-effects hamper effective therapy in another subgroup. Alternative options for induction of remission are limited. There are reports of successful salvage therapy with Cyclosporine-A (CsA) in steroid refractory cases. In addition, open-labeled studies have shown efficacy of Cyclosporine-A in treatment-naive AIH patients. There are no studies comparing CsA and CS in a head to head trial. The investigators aim to assess the efficacy and tolerability of CsA directly to the CS for induction of remission in treatment-naive AIH patients.


Eligibility criteria: Inclusion Criteria:

* 16-65 years old individuals with probable of definite AIH according to the revised AIH criteria.
* Willing and able to participate in the study

Exclusion Criteria:

* Non-consenting patients
* decompensated cirrhosis, i.e. clinical ascites, hepatic encephalopathy, history of variceal bleeding
* Presence of serious concomitant cardiovascular, pulmonary or renal condition
* Presence of active malignant disorder

Primary outcomes:
measure: Remission
timeFrame: 12 months
measure: Treatment failure
timeFrame: 3 months
Secondary outcomes:
measure: Frequency of adverse events
timeFrame: 12 months
measure: Serious adverse event
timeFrame: 12 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Digestive Disease Research Center, Shariati Hospital
Study officials:
References:
Clinical trial NCT06590051: AMG 335 Expanded Access Program for IgG4-Related Disease
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-09-19
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Expanded access requests for AMG 335 may be considered for adult patients with a confirmed diagnosis of IgG4-related disease. To request access, use Responsible Party contact information provided in this record.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02115451: Nonsurgical or Surgical Treatment of ACL Injuries
Official title: Dynamic Stability of the ACL Deficient Knee
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament Injury
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Delaware
First posted: 2014-04-16
Enrollment: 143
Sex: ALL
Minimum age (years): 13
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Athletically active anterior cruciate ligament injured patients

Brief summary: The aim of this study is to evaluate knee function, sports participation and knee reinjuries over 2 years in a group of patients who choose either nonsurgical or surgical treatment for an anterior cruciate ligament (ACL) injury

Detailed description: This study is a part study of an overall study with the title 'Dynamic stability of the ACL-injured knee'. The overall study prospectively follows a cohort of newly injured patients with total rupture of the anterior cruciate ligament in the knee.

Eligibility criteria: Inclusion Criteria:

* Anterior cruciate ligament rupture within 3 months of injury
* Preinjury participation in level I or II sports at least twice a week

Exclusion Criteria:

* Current or previous injury to the contralateral leg
* Another grade III ligament injury, fracture, full-thickness articular cartilage damage

Primary outcomes:
measure: Patient-reported knee function (IKDC 2000)
timeFrame: 2 years
Secondary outcomes:
measure: Isokinetic knee extensor and flexor muscle strength
timeFrame: 2 years
measure: Knee reinjury
timeFrame: 2 years
measure: Participation in level I, II and III sports
timeFrame: 2 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: NAR- Department of Orthopaedics, Oslo University Hospital & Nimi
Study officials:
affiliation: Norwegian Research Center for Active Rehabilitation
name: May Arna Risberg, PT PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04187651: PRP Use in Treatment of Fistula Ano
Official title: Use of Platelet Rich Plasma in Treatment of Perianal Fistula
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fistula in Ano
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: PRP gel will be applicated to all cases
Primary purpose: TREATMENT

Brief summary: In treatment of perianal fistula several methods are described. However, since the Hippocrates basics of surgical treatment has not changed very much. the aim of this study is to evaluate the effectiveness of PRP gel in treatment of perianal fistula.

Detailed description: Perianal fistula is a chronic condition that seriously affects the patients' quality of life. There are different treatment modalities used in treatment. Recently sphincter preserving methods are becoming more popular with low complication rates. Most of this methods aiming the closure of fistula tract by different pathways.

Platelet rich plasma (PRP) is used in a wide range of conditions in medicine. The investigator's team showed the effective treatment of pilonidal disease by use of PRP gel. In the recent study, aim to evaluate the effectiveness of PRP gel in treatment of perianal fistula.

Patients with perianal fistula will be evaluated for the study. After taking permission with informed consent; cases will be included in the study. Cases with inflammatory bowel disease, platelet function disorders or connective tissue disorders that may alter wound healing will be excluded from the study.

After, PRP application to the fistula tract patients will be taken to follow up. Perianal fistulas will be followed by magnetic resonance imaging 1 month after the application. Pre-application and post-application scans will be used for the evaluation of the treatment success.

Eligibility criteria: Inclusion Criteria:

* patients with perianal fistula
* signing the informed consent form
* above the age of 18

Exclusion Criteria:

* inflammatory bowel disease
* previous radiation therapy
* having connective tissue disorders

Primary outcomes:
measure: percentage of the cure rate
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Uşak
country: Turkey
facility: Uşak University
Study officials:
affiliation: Uşak University Medical School
name: Barış Sevinç, M.D.
role: PRINCIPAL_INVESTIGATOR
References: