louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06953830: Optimal Measurement of Spleen Stiffness Among Veterans With Metabolic Dysfunction-Associated Steatotic Liver Disease
Official title: Optimal Measurement of Spleen Stiffness Among Veterans With Metabolic Dysfunction-Associated Steatotic Liver Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)
Lead sponsor: William Jennings Bryan Dorn VA Medical Center
Sponsor class: FED
First posted: 2025-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A growing number of people are being diagnosed with fatty liver disease, also known as metabolic-dysfunction associated liver disease (MASLD). Fatty liver disease can unknowingly progress to serious liver disease and even permanent scarring (cirrhosis).The purpose of this research is to learn the best way to detect serious liver disease as early as possible in patients with fatty liver disease by measuring the stiffness of the spleen. Secondarily, the study hopes to understand how the stiffness of the spleen relates to the severity of liver disease.


Eligibility criteria: Inclusion Criteria:

* Able to consent for participation in a clinical study
* Able to read and comprehend English
* Evidence of fatty liver disease on previous liver biopsy, imaging or clinical documentation

Exclusion Criteria:

* Pregnant
* Known decompensated cirrhosis or hepatocellular carcinoma
* Absence of spleen
* Documentation of alcohol use disorder or alcohol use greater than 20g/day for women or greater than 30 g/day for men
* Unable to provide informed consent

Primary outcomes:
measure: Spleen Stiffness measurement
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: WJB Dorn VA Medical Center 6439 Garners Ferry Road Columbia, South Carolina 29209
state: South Carolina
Study officials:
affiliation: Columbia VA Healthcare System
name: Nicholas Hoppmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04643730: The Effects on Pain of Acupressure and Foot Reflexology Before Heel Lancing in Newborns
Official title: Randomised Controlled Study: The Effects on Pain of Foot Reflexology and Acupressure During Heel Lancing In Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interventions Pain
Keywords: Newborn,
pain,
heel lance,
foot reflexology,
acupressure,
nurse
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 105
Sex: ALL
Minimum age (years): 24
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study aimed to determine the effects of foot reflexology and acupressure on the KI3 and St36 points on pain during interventions when these procedures were administered before heel lancing in term newborns.


Eligibility criteria: Inclusion Criteria:

1. Being born by cesarean section,
2. Being a term newborn,
3. Being completed the 24th hour of the postnatal period,
4. Staying with birth mother,
5. Being fed in the last half hour before the procedure,
6. Having a heel prick performed by the same nurse,
7. Giving blood on the first try (because pain level may change on the second try),
8. Having a mother who gave written informed consent

Exclusion Criteria:

1. Having no health problem,
2. Being underwent more than 2 invasive interventions,
3. Receiving an analgesic/sedative drug in the 8 hours before the application.

Primary outcomes:
measure: Pain levels of the newborns
timeFrame: Before the pain procedure, during the pain procedure (the pain levels of the infants when the needle pricked the heel were evaluated using the N-PASS) and After the pain procedure. (Having completed the 24th hour of the postnatal period)
Secondary outcomes:
measure: Changes in oxygen saturation
timeFrame: 2 Minutes
measure: Changes in heart rates
timeFrame: 2 Minutes
measure: Percentage of crying during heel prick in healthy term neonates
timeFrame: During heel prick and immediately after intervention
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Public Hospital
Study officials:
References:
citation: Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008 Jan;28(1):55-60. doi: 10.1038/sj.jp.7211861. Epub 2007 Oct 25.
citation: Hummel P, Lawlor-Klean P, Weiss MG. Validity and reliability of the N-PASS assessment tool with acute pain. J Perinatol. 2010 Jul;30(7):474-8. doi: 10.1038/jp.2009.185. Epub 2009 Nov 19.
citation: Açıkgöz, A., Çiğdem, Z., Yıldız, S., Demirüstü, C., Yarar, M., & Aksit, A. (2017). A Turkish Adaptation of the Neonatal Pain/Agitation, Sedation Scale (N-PASS) and its Validity and Reliability, Indian Journal of Fundamental and Applied Life Sciences, 7(2): 5-11
Clinical trial NCT06706830: The Role of Lung and Diaphragm Ultrasonography in Predicting Clinical Progression in Hypoxemic Respiratory Failure
Official title: The Role of Lung and Diaphragm Ultrasonography in Predicting Clinical Progression in Patients Receiving High-Flow Nasal Oxygen and Non-Invasive Mechanical Ventilation Support for Hypoxemic Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaphragm Ultrasonography
Lung Ultrasound
Hypoxemic Respiratory Failure
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypoxemic patients in intensive care unit

Brief summary: The goal of this observational study is to evaluate whether the risk of intubation in patients with hypoxemic respiratory failure who were monitored in the intensive care unit and received non-invasive mechanical ventilation and high-flow nasal oxygen treatment could be predicted using lung and diaphragm ultrasound.

The main question it aims to answer is:

Can lung and diaphragm ultrasound predict the risk of intubation in patients with hypoxemic respiratory failure?

Detailed description: Between January 1, 2024, and May 1, 2024, the diaphragm thickness fraction, excursion, LUS score, ROX index, and the LUSS/ROX index ratio were evaluated using lung and diaphragm ultrasound in 91 patients admitted to the intensive care unit with a diagnosis of hypoxemic respiratory failure. These evaluations were performed at the 6th, 12th, 24th, and 48th hours of their ICU stay, and during intubation if the decision for intubation was made

Eligibility criteria: Inclusion Criteria:

-PaO2 \<60 mmHg detected in arterial blood gas samples at the time of admission to the intensive care unit

Exclusion Criteria:

* Under the age of 18
* History of lung and diaphragm surgery
* Congenital, acquired or traumatic diaphragmatic hernia
* Diaphragm paralysis
* Hemodynamic instability requiring vasoactive drug support
* Do not agree to participate in the study

Primary outcomes:
measure: Lung and diaphragm ultrasound evaluation for risk of intubation
timeFrame: 48 hours
Secondary outcomes:
measure: ROX index evaluation for risk of intubation
timeFrame: 48 hours
measure: LUSS/ROX index ratio evaluation for risk of intubation
timeFrame: 48 hours
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Prof. Dr. Cemil Tascıoglu City Hospital
state: Şişli
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
state: Şişli
Study officials:
affiliation: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
name: Namigar Turgut
role: STUDY_DIRECTOR
References:
Clinical trial NCT06002230: Use of Homeopathy in Patients Suffering From Long COVID-19
Official title: Use of Homeopathy in Patients Suffering From Long COVID-19 (LONGCOVIHOM): A Retrospective Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adjustment Reaction With Physical Symptoms
Keywords: Complementary therapy
Homeopathy
COVID-19
Long-COVID-19
SARS-CoV-2
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Sigmund Freud PrivatUniversitat
First posted: 2023-08-21
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from Long COVID-19 symptoms following recovery from SARS-CoV-2 infection.

Brief summary: In some patients, coronavirus (COVID-19) can cause symptoms that last weeks or even months after the infection has gone. The aim of this study was to describe the effect of adjunctive individualized homeopathic treatment delivered to Long-COVID-19 patients with previously confirmed symptomatic SARS-CoV-2 infection.

Detailed description: All patients had been tested positive for SARS-CoV-2 before having developed Long-COVID-19 symptoms. Several testing methods were carried out in each patient to analyze a SARS-CoV-2 infection. For a confirmed infection, at least 3 out of these 5 tests had to be positive. Tests for the orthomyxoviruses influenza A and B, human metapneumovirus (hMPV) and paramyxoviruses were negative unless stated otherwise.

The homeopathic physician treated all Long-COVID-19 patients by individualized homeopathy. Repertorization of the symptoms of the current pandemic and a search in the current homeopathic literature on COVID-19 was performed using computer program. All available homeopathic medicinal products (HMPs) could be chosen by the treating physician.

Modified MONARCH criteria were assessed post hoc by all authors. Deviations were solved by discussion in person. Clinical outcome of case reports was evaluated using the "Modified Naranjo Criteria for Homeopathy-Causal Attribution Inventory". Eight points is assumed as the limit for potential correlation between homeopathic therapy and amelioration of the symptoms or healing in chronic cases.

Eligibility criteria: Inclusion Criteria:

Long COVID-19 symptoms following recovery from SARS-CoV-2 infection

Exclusion Criteria:

Patients not signing informed consent

Primary outcomes:
measure: Modified Naranjo criteria
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Sigmund Freud Private University
Study officials:
affiliation: Institute for Homeopathic Research
name: Michael Frass, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04361630: Recombinant Human Fibroblast Growth Factor-2 (rhFGF-2) In Gingival Recession Defects
Official title: Recombinant Human Fibroblast Growth Factor-2 (rhFGF-2) In Absorbable Collagen Membrane With Coronally Advanced Flap In Class I And II Gingival Recession Defects -A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Periodontitis
Keywords: Gingival Recession
Fibroblast Growth Factor 2
Periodontal Atrophy
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study was a single-arm trial to obtain preliminary data on the efficacy of collagen membranes impregnated with recombinant human fibroblast growth factor (rhFGF-2) in the treatment of Miller's class I and class II gingival recessions.
Primary purpose: PREVENTION

Brief summary: This study was a single-arm trial to obtain preliminary data on the efficacy of collagen membranes impregnated with recombinant human fibroblast growth factor (rhFGF-2) in the treatment of Miller's class I and class II gingival recessions.

Detailed description: Soft tissues can be regenerated to cover root exposure and a thin biotype can be converted into a thick biotype by using recombinant human growth factor technology. A recent review stated that growth factors could enhance soft tissue regeneration which includes restoration of mucogingival architecture and regeneration of periodontal hard and soft tissues including bone, cementum and periodontal ligament fibers. Fibroblast growth factor-2 (FGF-2), a heparin-binding cytokine with strong angiogenic activity stimulates the proliferation of undifferentiated mesenchymal cells. These functions can be applied in mucogingival surgery as FGF-2 promotes bone and cementum formation and exhibits an increased potential to promote periodontal regeneration in recession defects.

Eligibility criteria: Inclusion Criteria:

* systemically healthy subjects between 20-55 years presenting with Miller's class I or class II gingival recession\[

Exclusion Criteria:

* 1. Recessions associated with root demineralization/caries, deep cervical abrasion or pulpal pathology, 2. Patients with history of systemic conditions affecting periodontium and, 3. Smokers.

Primary outcomes:
measure: Width of keratinized gingiva (wKG)
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: SVS Institute of Dental Sciences, Mahabubnagar
state: Andhra Pradesh
Study officials:
References:
Clinical trial NCT06132230: Potential Value of Immunohistochemical Expression of SOX17 and E-Cadherin in Variable Endometrial Lesions
Official title: Potential Value of Immunohistochemical Expression of SOX17 and E-Cadherin in Variable Endometrial Lesions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Variable Endometrial Lesions
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 70
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Formalin-fixed paraffin blocks from 70 patients

Brief summary: Endometrial carcinoma (EC) is the 6th most commonly occurring cancer in women and the 15th most common cancer overall According to facts derived from Globocan for the year 2020.The overall incidence was 417,367 and 97,370 died due to it. There were more than 417,000 new cases of endometrial cancer in 2020 .EC incidence is predicted to continue to rise in the coming decades, in particular among low and middle-income countries.

SOX17 protein (SRY-box 17) is a member of the SRY-related HMG-box (SOX) family of transcription factors that controls the first step of gene expression and regulates cellular growth and differentiation in the endoderm, during hematopoiesis, and in the cardiovascular system E-Cadherin is a calcium-dependent cell adhesion protein (predicted molecular weight of 97 kDa) that plays a vital role in cell migration and proliferation. The E-cadherin epithelial cell adhesion protein is a tumor suppressor that has an important role in tumor metastasis The loss of expression of E-Cadherin during the epithelial mesenchymal transition (EMT) is often thought to promote metastasis by allowing the dissociation and invasion of cancer cells

The aim of this study is:

1. To evaluate accuracy of SOX17 expression in neoplastic and hyperplastic endometrial lesions.
2. To correlate SOX17 expression with some clinical and pathological parameters of endometrial carcinoma.
3. To evaluate E-Cadhrin expression and its relation to SOX17 in neoplastic and hyperplastic lesions


Eligibility criteria: Inclusion Criteria:

* 1. Specimens of total abdominal hysterectomy and bilateral salpingio-oopherectomy of endometrial carcinoma patients 2. D\&C of endometrial tissue suspected of hyperplastic or neoplastic lesions

Exclusion Criteria:

* • Specimens with insufficient clinical data.

  * Specimens with extensive necrosis

Primary outcomes:
measure: Potential Value of Immunohistochemical Expression of SOX17 and E-Cadherin in Variable Endometrial Lesions
timeFrame: one or two days after staining sections with markers
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag faculty of Medicine
Study officials:
affiliation: Sohag faculty of Medicine
name: Gehad Bahgat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01450930: Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency
Official title: Pharmacokinetics of Hydrocortisone After Subcutaneous Administration Compared With Intramuscular Injection in Chronic Adrenal Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Adrenal Insufficiency
Keywords: Adrenal insufficiency
Addison's disease
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
First posted: 2011-10-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients with chronic adrenal insufficiency need to adapt their hydrocortisone replacement dose in conditions of physical or psychological stress to prevent life threatening adrenal crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g. gastroenteritis, severe infectious disease), parenteral administration of the hydrocortisone dose is crucial. The study is conducted to offer patients the possibility to perform hydrocortisone self administration in emergency situations in a way of administration which is easy to perform and accepted by the patient. Therefore, pharmacokinetics and safety of subcutaneous hydrocortisone administration will be studied and compared to intramuscular administration.


Eligibility criteria: Inclusion Criteria:

* Primary adrenal insufficiency under standard glucocorticoid replacement therapy due to autoimmune adrenalitis or bilateral adrenalectomy (disease duration at least 12 months),
* age ≥ 18 years,
* Patient´s written informed consent,
* Ability to comply with the protocol procedures

Exclusion criteria

* Diabetes mellitus,
* Infectious disease with fever at time of investigation,
* Known intolerance to the study drug or constituents oft he study drug,
* Oral contraception,
* Known pregnancy or breast feeding,
* Renal failure (creatinine \> 2.5 ULN)

Primary outcomes:
measure: Bioequivalence Study
timeFrame: 4 hours
Secondary outcomes:
measure: safety
timeFrame: 3 days
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: Dept of Medicine I, Endocrinology and Diabetology, University Hospital Wuerzburg
Study officials:
affiliation: University Hospital Wuerzburg, Germany
name: Stefanie Hahner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hahner S, Burger-Stritt S, Allolio B. Subcutaneous hydrocortisone administration for emergency use in adrenal insufficiency. Eur J Endocrinol. 2013 Jun 29;169(2):147-54. doi: 10.1530/EJE-12-1057. Print 2013 Aug.
Clinical trial NCT02052830: Impact Evaluation of the Wise Guys Program
Official title: Impact Evaluation of the Wise Guys Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sexual Behavior
Sexually Transmitted Infections
Lead sponsor: Mathematica Policy Research, Inc.
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 737
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the impact of the Wise Guys program on the delaying sexual initiation on adolescent males in Eastern Iowa.

Detailed description: This study uses a randomized controlled design to compare the impacts of the Wise Guys Program to the "business-as-usual" school curriculum. The Wise Guys multi-session curriculum is delivered in different formats that range in length from 5 to 12 weeks and topics covered include communication and masculinity, dating violence, abstinence and contraception, and sexually transmitted infections. Study participants are 7th grade boys attending a participating school in either the Davenport Iowa or North Scott Community school districts. This study is being conducted as part of the national Personal Responsibility Education Program evaluation funded by Administration for Children and Families within the U.S. Department of Health and Human Services.

Eligibility criteria: Inclusion Criteria:

* 7th grade student in participating schools
* Male

Primary outcomes:
measure: Sexual initiation
timeFrame: 24 months post-intervention
Secondary outcomes:
measure: Sexual initiation
timeFrame: 6 months post-intervention
Other outcomes:
Locations:
Study officials:
affiliation: Mathematica Policy Research
name: Robert Wood, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01346930: Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis
Official title: Long Term, Single-arm, Open-label Extension Study of the MUSIC Study to Assess the Safety and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic pulmonary fibrosis
IPF
pulmonary fibrosis
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2011-05-04
Enrollment: 0
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 MUSIC OL study is an open-label extension study, in which all eligible patients having completed the double-blind AC-055B201/MUSIC study as scheduled receive macitentan 10 mg once daily. The study objective is to assess the long-term safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis (IPF).


Eligibility criteria: Inclusion Criteria:

* Signed informed consent prior to initiation of any study-related procedure.
* Patients with IPF and having completed the double-blind AC-055B201/MUSIC study as scheduled, i.e., having remained in the study until the sponsor-declared end-of-study (EOS), whether or not study treatment was prematurely discontinued.
* Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.

Exclusion Criteria:

* Any major violation of protocol AC-055B201/MUSIC.
* Premature discontinuation of study treatment during the AC-055B201/MUSIC study due to an adverse event (AE) assessed as related to the use of macitentan, excluding events of IPF worsening.
* Pregnancy or breast-feeding.
* AST and/or ALT \> 3 times the upper limit of the normal range.
* Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
* Known hypersensitivity to drugs of the same class as macitentan, or any of the excipients.

Primary outcomes:
measure: Adverse Events leading to premature discontinuation of study drug
timeFrame: 5 years
Secondary outcomes:
measure: Treatment-emergent Severe Adverse Events & occurrence of AST and/or ALT > 3 times the upper limit of the normal range up to 28 days after study drug discontinuation
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Actelion
name: Loic Perchenet, PhD
role: STUDY_CHAIR
References: