louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01668251: Turner Syndrome Prenatal Diagnosis Study
Official title: National Collaborative Study of Girls Prenatally Diagnosed With Turner Syndrome Karyotypes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Turner Syndrome
Keywords: Turner syndrome
Diagnosis, prenatal
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2012-08-20
Enrollment: 60
Sex: FEMALE
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Girls who are diagnosed with Turner syndrome prenatally.

Brief summary: The goal of this study is to compare the features of Turner syndrome in girls who are diagnosed before birth because of fetal concerns versus those who are diagnosed when their mother has an amniocentesis for another reason.

Detailed description: This is an observational study which will look at girls who are diagnosed with Turner syndrome before they are born. Girls will be divided into two groups: 1) those diagnosed because of features seen on ultrasound which raised the question of Turner syndrome and 2) those diagnosed incidentally when their mother had an amniocentesis for another reason such as advanced maternal age.

No clinical procedures nor interventions will be done as part of this data collection study which will occur for the first 3 to 6 years of the girl's life. The investigators will be looking to see if girls who are diagnosed incidentally have less features of Turner syndrome than those girls who are diagnosed because of fetal ultrasound.

Eligibility criteria: Inclusion Criteria:

* Turner syndrome diagnosed prenatally
* Less than 4 months of age at time of enrollment

Exclusion Criteria:

* Turner syndrome diagnosed postnatally
* Older than 4 months of age at time of enrollment

Primary outcomes:
measure: Number of signs of Turner syndrome
timeFrame: three to six years
Secondary outcomes:
measure: Growth
timeFrame: three to six years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Patricia Fechner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gunther DF, Eugster E, Zagar AJ, Bryant CG, Davenport ML, Quigley CA. Ascertainment bias in Turner syndrome: new insights from girls who were diagnosed incidentally in prenatal life. Pediatrics. 2004 Sep;114(3):640-4. doi: 10.1542/peds.2003-1122-L.
Clinical trial NCT00417651: Testing for Bacterial Contamination During Gastric Surgeries
Official title: Transgastric Bacterial Contamination of the Abdomen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Surgery
Keywords: Bacterial
contamination
gastrotomy
Complications
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2007-01-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: observational studies patients morbidly obese.

Brief summary: The purpose of this study is to evaluate whether creating a gastrotomy (hole in the stomach) during gastric surgery increases a patient's risk of intra-abdominal infection.

We hypothesize that a gastrotomy does not contaminate the abdomen with clinically significant bacterial pathogens.

Detailed description: We propose to investigate the bacterial load and contamination patients experience during laparoscopic roux-en-y gastric bypass while having their gastrotomy for gastrojejunostomy. In all patients who undergo laparoscopic roux-en-y gastric bypass, the stomach must be opened to the peritoneal cavity while placing an anvil for gastrojejunostomy.

Samples of gastric fluid will be collected and sent for analysis in all patients. Samples of peritoneal fluid will be collected prior to and after the creation of the gastrotomy, using intraperitoneal irrigation with approximately 500 cc of normal saline. Bacterial counts and identification will be recorded for each sample.

Eligibility criteria: Inclusion Criteria:

* any patient undergoing roux-en-y gastric bypass

Exclusion Criteria:

* lack of consent

Primary outcomes:
measure: Quantitative and qualitative measure of the bacterial load and bacterial contamination of the abdomen during laparoscopic roux-en-y gastric bypass surgery while the gastrotomy is open to the abdominal cavity.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Center for Minimally Invasive Surgery
state: Ohio
Study officials:
affiliation: OSU
name: Jeffrey W Hazey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: OSU
name: William S Melvin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01486251: Assessment of Tumor Vascular Effects of Axitinib With Dynamic Ultrasonography in Patients With Metastatic Colorectal Cancer
Official title: Assessment of the Tumor Vascular Effects of the Pan-vegfr Tyrosine Kinase Inhibitor Axitinib Using Dynamic Contrast-enhanced Ultrasonography (Dce-us) in Patients With Refractory Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Carcinoma
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate and quantify the dynamic modifications of tumor blood perfusion on axitinib therapy in patients with refractory mCRC for each dose of Axitinib.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed diagnosis of CRC
* Measurable metastatic disease to the liver in proven disease progression (according to RECIST criteria) at baseline (within 4 weeks prior to study entry), with at least one lesion \> 2cm considered appropriate for DCE-US examination
* Previously exposed to at least, irinotecan, oxaliplatin and a fluoropyrimidine, all 3 administered at optimal doses, over one or two chemotherapy (CT) lines for metastatic disease with a clear resistance to these drugs. Previous exposure to bevacizumab and/or anti-EGFR monoclonal antibody is allowed.
* Age ≥18 years; Performance Status (PS) 0-2 and life expectancy \> 3 months.
* Adequate biological functions: Neutrophils ≥ 1.5 x 109/L; Platelets ≥ 100 x 109/L; Hemoglobin \> 9 g/dl; Creatinine clearance \> 30 ml/min (cockcroft \& Gault formula). Serum bilirubin \< 1,5 x the upper normal limit (UNL) and AST/ALT \< 5 x UNL.
* Signed written informed consent
* Female patients with childbearing potential (\<2 years after last menstruation) and male must use effective means of contraception during the study treatment and at least 6 months after the last study drug administration.

Primary outcomes:
measure: Echography measure
timeFrame: baseline and on day 2, day 7, day 15, day 29, day 35 and day 43
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut gustave roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Michel Ducreux
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05564351: Ear Plug and Eye Mask Use on Sleep Quality in Intensive Care Patients
Official title: Evaluation of the Effect of Ear Plug and Eye Mask Use on Sleep Quality in Intensive Care patıents: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Keywords: Nursing, intensive care unit, ear plug, eye mask, sleep quality
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted as a pre-test and post-test randomized controlled single center study to evaluate the effect of ear plugs and eye mask application on sleep quality in patients hospitalized in the intensive care unit. 120 patients who received inpatient treatment in Siirt State Hospital general intensive care unit constitute the sample of the study. The sample consist of four groups: ear plug group (n=30), eye mask group (n=30), earplug-eye mask group (n=30) and control group (n=30). Data were collected using the "Patient Identification Form, Glasgow Coma Skale, Visual Analog Scale, Richards-Campbell Sleep Questionnaire (RCSQ), ear plug and eye mask". As a preliminary test, RCSQ was applied in the morning of the second day after the first night sleep of the patients. Then, according to the group they were assigned to, the patients were allowed to sleep by applying only ear plug, eye mask only and simultaneous ear plug-eye mask between 22:00-06:00. As a final test, RCSQ was readministered to patients on the morning of the third day after the second night's sleep. During the analysis of the data, frequency, number, mean, Student t test and/or Mann- Whitney U test, ANOVA and/or Kruskal- Wallis test, t test or Wilcoxon Sign test, chi-square test were used.


Eligibility criteria: Inclusion Criteria:

Being 18 years or older

* Being literate
* No hearing impairment
* Ability to communicate verbally
* Receiving inpatient treatment in the GICU for at least 3 days
* Have 15 Glasgow Coma Scale (GCS) scores (Minimum scores will be as follows. 3 points from eye response; 5 points from motor response; 2 points from verbal response)
* Agreeing to participate in the research

Exclusion Criteria:

Having a Visual Analog Scale (VAS) score above 7

* Using sleeping pills or sedative drugs
* Being treated with a diagnosis of sleep disorder
* Being on mechanical ventilation
* Having an active ear or eye infection
* Having a diagnosed psychiatric illness

Primary outcomes:
measure: Richards Campbell Sleep Scale
timeFrame: Three day
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: Three day
Other outcomes:
measure: Glasgow Coma Scale
timeFrame: Three day
measure: Patient Information Form
timeFrame: one day
Locations:
city: Siirt
country: Turkey
facility: Siirt State Hospital
Study officials:
References:
Clinical trial NCT06172751: TrinetX Study of Hypereosinophilic Syndrome (HES) Without an Identifiable Non-haematological Secondary Cause
Official title: TrinetX Study of Hypereosinophilic Syndrome (HES) Without an Identifiable Non-haematological Secondary Cause
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypereosinophilic Syndrome (HES)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-12-15
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is patients with HES during the period 01 October 2020 to 30 June 2023 available in TrinetX database (US).

Brief summary: The purpose of this study is to build the knowledge base on clinical characteristics, clinical management, and treatment outcomes of HES.

Detailed description: Retrospective database analysis using TriNetX database to describe HES patient characteristics, journey, and disease burden.

Eligibility criteria: Inclusion Criteria:

* Diagnosis record of HES (ICD-10-CM D72.11) anytime during 01 October 2020 to 30 June 2023
* At least 12 months of patient insurance record prior to first HES record.

Exclusion Criteria:

* Any mutation in PDGFRA, PDGFRB or FGFR1 genes (to exclude clonal HES).
* History of BCR-ABL tyrosine kinase inhibitor use: imatinib, dasatinib, nolitinib, bosutinib, ponatinib, asciminib (to exclude clonal HES)
* History of myeloid leukemia, myeloproliferative disorder, myelodysplastic disorder, myelomonocytic leukemia, acute erythroid leukemia, acute megakaryoblastic leukaemia, acute panmyelosis with myelofibrosis, and other specified leukaemias (to exclude reactive HES)
* History of helminthiasis or use of anthelmintic medication (to exclude reactive HES)
* History of autoimmune disease (to exclude reactive HES)
* History of use of specific drugs: antiepileptics, sulfonamides, allopurinol, and immune checkpoint inhibitors (to exclude reactive HES)

Primary outcomes:
measure: Comorbidities prior to first HES record
timeFrame: 01 October 2020- the most recent data available in 2023
measure: Other eosinophilic conditions
timeFrame: 01 October 2020- the most recent data available in 2023
measure: Organ system with HES signs and/or symptoms
timeFrame: 01 October 2020- the most recent data available in 2023
measure: Number of organ systems with HES signs and/or symptoms
timeFrame: 01 October 2020 - the most recent data available in 2023
Secondary outcomes:
measure: Demographic characteristics
timeFrame: 01 October 2020- the most recent data available in 2023
measure: Patient journey in diagnostic phase
timeFrame: 01 October 2020 - the most recent data available in 2023
measure: HES and non-HES therapies & treatment pattern
timeFrame: 01 October 2020 - the most recent data available in 2023
measure: Clinical outcomes
timeFrame: 01 October 2020 - the most recent data available in 2023
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Research Site
state: Massachusetts
Study officials:
References:
Clinical trial NCT03720977: Diagnostic Value and Biological Significant of cd71 in Lymphoid Disorders
Official title: Diagnostic Value and Biological Significant of cd71 in Lymphoid Dis Order
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lyphoid Disorders
cd71
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 139
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: confidence level 95 sample size 139

Brief summary: CD71 is expressed on activated B and T cells, macrophages, reticulocytes, erythroid precursors, and malignant tissues. , reflecting the requirement for iron in hemoglobin. , CD71 expression is upregulated on immature proliferating cells and low levels on resting mature lymphocytes. In addition to this general function, CD71 appears to play a costimulatory role in T cell activation and receptor for IgA1 antibodies So it is growth receptor that may help in diagnosis of lymphoid disorder and in differentiation of malignant and benign that will be studied investigate CD71 expression in lymphoid disorders and its diagnostic value ,we from collect data patient and do rotune examination

Detailed description: 1. Routine investigations for diagnosis:

   * CBC.
   * Bone marrow aspiration morphology.
   * Cytochemistry.
   * Flow cytometry immunophenotyping.
   * Bone marrow biopsy when indicated.
2. Special investigation is flow cytometry examination of CD71 expression.

sample size calculation ; sample size cases 39 sample size controls 39 total sample size 79 sample will be collected from patient in hospital university ,Data will be analysed by SPSS program

Eligibility criteria: Inclusion Criteria:

* all patients wiil be diagnosed lymphoid disorders

Exclusion Criteria:

* not present

Primary outcomes:
measure: determin diagnostic value of cd71 in lymphoid disorder
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University .clinical pathologydepartment
name: Maged Salah, Prof
role: STUDY_DIRECTOR
References:
citation: Zhang Q, Steensma DP, Yang J, Dong T, Wu MX. Uncoupling of CD71 shedding with mitochondrial clearance in reticulocytes in a subset of myelodysplastic syndromes. Leukemia. 2019 Jan;33(1):217-229. doi: 10.1038/s41375-018-0204-z. Epub 2018 Jul 26.
citation: Salzberger W, Martrus G, Bachmann K, Goebels H, Hess L, Koch M, Langeneckert A, Lunemann S, Oldhafer KJ, Pfeifer C, Poch T, Richert L, Schramm C, Wahib R, Bunders MJ, Altfeld M. Tissue-resident NK cells differ in their expression profile of the nutrient transporters Glut1, CD98 and CD71. PLoS One. 2018 Jul 20;13(7):e0201170. doi: 10.1371/journal.pone.0201170. eCollection 2018.
citation: Dunsmore G, Koleva P, Ghobakhloo N, Sutton R, Ambrosio L, Meng X, Hotte N, Nguyen V, Madsen KL, Dieleman LA, Huang V, Elahi S. Lower Abundance and Impaired Function of CD71+ Erythroid Cells in Inflammatory Bowel Disease Patients During Pregnancy. J Crohns Colitis. 2019 Feb 1;13(2):230-244. doi: 10.1093/ecco-jcc/jjy147.
Clinical trial NCT00311077: Insulin Glulisine in Healthy Lean and Obese Subjects
Official title: Pharmacodynamic and Pharmacokinetic Properties of Insulin Glulisine (Apidra) in Comparison to Insulin Lispro (Humalog) in Healthy Lean and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-04-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary objective

* To investigate pharmacodynamic and pharmacokinetic parameters after s.c. administration of two different doses (low dose, 0.2 IU/kg and high dose, 0.4 IU/kg) of insulin glulisine across healthy subjects in 4 different BMI-classes (lean, overweight, moderately obese, severely obese), using the euglycemic clamp technique with the Biostator™.

Secondary objective

* To investigate the pharmacodynamic and pharmacokinetic properties after subcutaneous administration of insulin glulisine in comparison to insulin lispro and to investigate the safety and tolerability after subcutaneous administration of insulin glulisine in comparison to insulin lispro.


Eligibility criteria: Inclusion criteria :

* Normal HbA1c
* Women have to either be postmenopausal, surgically sterilized, or not pregnant and using adequate contraception.

Exclusion criteria :

* Systemic concomitant medication

Primary outcomes:
measure: To evaluate the serum insulin glulisine concentration and insulin lispro concentration
timeFrame: During the Study Conduct
Secondary outcomes:
measure: To measure blood glucose
timeFrame: During the study conduct
measure: To measure glucose infusion rate
timeFrame: During the study conduct
measure: To measure the serum C-peptide
timeFrame: During the study conduct
measure: Adverse events collection
timeFrame: from the inform consent signed up to the end of the study
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Valérie Pilorget, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06848777: The Effect of Mobilising Patients Using Nature Sounds on Anxiety, Pain and Stress Levels
Official title: The Effect of Mobilising Patients Using Nature Sounds on Anxiety, Pain and Stress Levels of Patients After Laparoscopic Cholecystectomy Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Pain
Stress
Laparoscopic Colecctomy
Mobilization
Nature Sound
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Effect of Mobilization Using Nature Sounds on Patients' Anxiety, Pain and Stress Levels


Eligibility criteria: Inclusion Criteria:

* Individuals who are willing to participate in the study,
* Patients undergoing their first laparoscopic surgery due to gallbladder stones,
* Patients scheduled for elective surgical procedures,
* Patients with no hearing impairment,
* Patients with no vision impairment,
* Mentally stable individuals,
* Individuals who are open to communication and cooperation,
* Patients aged 18 years and older will be included in the study.

Exclusion Criteria:

* Individuals with mental health issues,
* Individuals who are unwilling to participate,
* Patients with hearing impairment,
* Patients undergoing their second surgery (recurrent) due to gallbladder stones,
* Patients using hearing aids,
* Individuals who are uncooperative or unwilling to communicate,
* Patients who require emergency surgery will not be included in the study.

Primary outcomes:
measure: Before Mobilization Pain value
timeFrame: Before mobilization 5 minutes
measure: Anxiety
timeFrame: Before mobilization 5 minutes
measure: Stress, pulse, saturation levels
timeFrame: Before mobilization 5 minutes
Secondary outcomes:
measure: After Mobilization Pain Value
timeFrame: After mobilization 10 minutes
measure: Anxiety
timeFrame: After mobilization 10 minutes
measure: Stress, pulse, saturation levels
timeFrame: After mobilization 10 minutes
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Kumluca State Hospital
state: Kumluca
Study officials:
References:
Clinical trial NCT02842177: Evaluation of a Novel Technique for Intrauterine Contraceptive Devices Insertion
Official title: Classic vs. Uterine Sound-sparing Approach for Insertion of Copper T380A Intrauterine Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 92
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The intrauterine devices are a safe, reliable, long-acting and reversible contraceptive method. It is also sound safe and cheap contraceptive methods available and is nearly maintenance free for up to 10 years.

The fear and the pain associated with intrauterine devices insertion consider barriers to using this contraception method, this is because that the mucosal lining of female genital tract is highly sensitive to touch and pain. However; most of small procedures done in this sensitive area are performed without analgesia.

The pain during intrauterine devices insertion is due to application of the tenaculum , traction of the cervical canal, passing the uterine sound, insertion of the intrauterine devices through the cervix, and irritation of the endometrial lining by the intrauterine devices .

Previous studies have reported different lines to decrease pain during intrauterine device insertion starting by simple methods such as pre-insertion ibuprofen use, intracervical or intrauterine lidocaine and misoprostol up to paracervical blocks.

Previous studies, in literature, have found that the most painful steps during intrauterine devices insertion were uterine sounding then intrauterine device insertion itself, followed by tenaculum placement. One recent study addressed pain effect using an atraumatic vulsellum and a single-tooth tenaculum on pain perception during intrauterine devices and found no difference in reported pain.


Eligibility criteria: Inclusion Criteria:

* Women requesting intrauterine contraceptive device as a contraction

Exclusion Criteria:

* Uterine abnormalities
* Endometrial lesions,
* Adenomyosis
* Fibroids
* Intrauterine adhesions.
* Chronic pelvic pain
* Spasmodic dysmenorrhea
* History of cervical surgery

Primary outcomes:
measure: Successful intrauterine device insertion
timeFrame: 5 minutes
Secondary outcomes:
measure: The degree of pain during intrauterine device insertion
timeFrame: 5 minutes
measure: the duration of intrauterine device insertion
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References: