louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01735773: Role of Prohepcidin in Uremic Patients
Official title: The Relationship of Prohepcidin Levels With Anemia and Inflammatory Markers in Non-diabetic Uremic Patients: A Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Chronic Kidney Disease
Keywords: hemodialysis
inflammation
iron
peritoneal dialysis
prohepcidin
uremia
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We selected three groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4 chronic kidney disease. A control group was formed from healthy volunteers also.

Brief summary: The investigators aimed to study the effect of prohepcidin levels on hematologic parameters and inflammatory markers in non-diabetic uremic patients. The investigators selected three groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4 chronic kidney disease. A control group was formed from healthy volunteers also. Each group has been planned to be formed of about 25 patients. Diabetic patients were excluded. Prohepcidin, hsCRP, IL-6, fibrinogen have been planned to be studied besides other routine biochemical analysis including hematological ones.


Eligibility criteria: Inclusion Criteria:

* hemodialysis and peritoneal dialysis patients who had been on dialysis therapy for more than 3 months,
* age between 18-80 years,
* patients with creatinine clearance between 15-30 ml/min.

Exclusion Criteria:

* age less than 18 or more than 80,
* diabetic patients,
* current active infectious or inflammatory disease.

Primary outcomes:
measure: prohepcidin level
timeFrame: Six months
Secondary outcomes:
measure: Anemia and inflammatory markers
timeFrame: Six months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haseki Training and Research Hospital
Study officials:
References:
Clinical trial NCT00801073: Comparison Amongst Scleral, Corneal and Amniotic Membrane Grafts to Restore Scleral Thinning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Scleral Thinning
Keywords: Amniotic membrane
Cornea
Scleral thinning
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-12-03
Enrollment: 49
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the use of preserved scleral, corneal and amniotic membrane graft for the surgical repair of scleral thinning of different sizes in patients underwent surgery of pterygium with associated beta therapy .

Detailed description: Scleral thinning may occur secondary to different ocular surface conditions, especially in rheumatologic diseases and after surgeries as in pterygium. There are different methods to treat this condition, as to use scleral, corneal and more recently amniotic membrane graft.

Eligibility criteria: Inclusion Criteria:

* Patients with corneal scleral defects that have persisted for 1 years or longer, regardless of their cause. These patients will have received corneal-scleral or amniotic membrane transplant in order to correct scleral thinning
* Patients with history of pterygium surgery associated with beta therapy followed by scleral thinning

Exclusion Criteria:

* Ocular infection
* Acute ocular inflammatory condition
* Previous ocular surgery in the eye study
* Non-controlled systemic disease such as rheumatoid arthritis

Primary outcomes:
measure: The surgical procedure was randomized in scleral, corneal or amniotic membrane graft. Nine patients underwent surgery with scleral graft that was covered by conjunctival flap; ten with corneal graft and ten with amniotic membrane transplantation.
timeFrame: Patients were followed for 180 days.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02930473: Evaluation of a Psychotherapeutic Intervention Model in Nursing
Official title: Short-term Efficacy Evaluation of a Psychotherapeutic Intervention Model in Nursing on Nursing Diagnosis "Anxiety": A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Psychotherapy
Nursing
Nursing Care
Nursing Model
Randomised Controlled Trial
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on the nursing diagnosis "Anxiety". A randomised controlled trial will be carried out to do so.

Detailed description: This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on nursing diagnosis "Anxiety" (according to International Classification for Nursing Practice (ICNP)/North American Nursing Diagnoses Association (NANDA) standardized nursing language). A randomised controlled trial will be carried out to do so. In a single-blinded nurse-led 6 months controlled trial, conducted at a hospital outpatient setting in Portugal, approximately 60 patients with anxiety will be randomised to the intervention (n=30) or control groups (n=30). The objective is to compare the outcomes associated with "treatment-as-usual" and the benefits of implementing the psychotherapeutic intervention model in nursing previously developed (5 sessions), which will be evaluated using Nursing Outcomes Classification (NOC) outcomes "Anxiety Level" and "Anxiety Self-Control" (Portuguese version).

Eligibility criteria: Inclusion Criteria:

* 18-64 years old;
* Nursing Diagnosis "Anxiety" (according to ICNP/NANDA standardized nursing language) - assessment using NOC outcome "Anxiety Level" (Portuguese version);
* Elementary education (completed).

Exclusion Criteria:

* Psychiatric diagnosis of dementia or psychotic spectrum disorder;
* Being in therapy provided by a psychologist (at the moment of the session 0);
* Cognitive impairment (assessment using Mini-Mental State Examination);
* Moderate or severe intellectual disability;
* Confusional state;
* Psychomotor agitation.

Primary outcomes:
measure: Change in the Level of Anxiety (NOC outcomes "Anxiety Level" and "Anxiety Self-Control" - Portuguese version)
timeFrame: At the beginning of the study (Session 0) and one week after session 5 (approximately 6 weeks after the beginning of the study)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Instituto de Ciências Biomédicas Abel Salazar da Universidade do Porto
name: Francisco Sampaio, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sampaio FMC, Araujo O, Sequeira C, Lluch Canut MT, Martins T. A randomized controlled trial of a nursing psychotherapeutic intervention for anxiety in adult psychiatric outpatients. J Adv Nurs. 2018 May;74(5):1114-1126. doi: 10.1111/jan.13520. Epub 2018 Jan 25.
Clinical trial NCT02323373: Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty
Official title: Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty: a Randomized Clinical Trial With 90 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthrosis
Keywords: Arthroplasty, Replacement, Knee
Tranexamic Acid
Drug Administration Routes
Lead sponsor: Irmandade da Santa Casa de Misericordia de Sao Paulo
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This clinical trial investigated two different routes of administration of tranexamic acid in total knee arthroplasty: topical compared to intravenous.

Detailed description: Intravenous administration of tranexamic acid (TA) is common in orthopedic surgery. The ideal dose and administration route of the drug in total knee arthroplasty (TKA) is under investigation.

The objective of this randomized clinical trial was to verify differences between topical and intravenous administration of TA in TKA regarding blood loss and coagulation variables.

Patients undergoing TKA were randomized to receive TA intravenously (20 mg in 100 ml of saline), topically (1.5 g in 50 ml of saline, sprayed over the operated site, before closure) or intravenous saline (100 ml). Suction drains were maintained for 48 hours, in order to measure blood loss. Data analysis is being undertaken now, in order to compare the two routes of administration of the drug.

Eligibility criteria: Inclusion Criteria: Patients in need of unilateral total knee arthroplasty (TKA) due to arthrosis, Albach grades III and IV were eligible

Exclusion Criteria:

* history or identified risk for deep vein thrombosis or pulmonary embolism
* history of coagulation or cardiovascular disorders
* vascular diseases
* pregnancy
* current use of anticoagulation drugs
* previous orthopedic surgery in the legs.

Primary outcomes:
measure: Blood loss
timeFrame: up to 48 hours from the end of surgery, with drained volume registered every 6 hours.
Secondary outcomes:
measure: Thrombosis
timeFrame: up to 15 days after surgery
measure: Need for transfusion
timeFrame: during or after surgery, during hospital stay (hospital discharge took place in four days, in average)
Other outcomes:
Locations:
Study officials:
affiliation: Santa Casa de São Paulo
name: Zekcer Ari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04274231: Cancer-associated Gene Mutations in CML Treatment With TKIs by NGS
Official title: Integrative Genomic Analysis Reveals Cancer-associated Gene Mutations in Chronic Myeloid Leukemia Patients With Tyrosine Kinase Inhibitor Resistance or Intolerance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Different Gene Between Different TKIs Effection
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Best effect to TKI group Intolerance to TKI group Resistance to TKI group

Brief summary: We performed targeted-capture sequencing of 127 known and putative cancer-related genes of patients who best effect to TKIs ,or intolerance to TKIs,or resistance to TKIs by next-generation sequencing (NGS) .


Eligibility criteria: Inclusion Criteria:

1. Chronic myeloid leukemia-Chronic phase(CML-CP) patients treated with receiveTyrosine kinase inhibitor -TKI(including imatinib, dasatinib and nilotinib) for more than 1 years
2. best effect to TKIs ,or intolerance to TKIs,or resistance to TKIs according to Q-pcr detected BCR/ABL(IS) in peripheral blood and hematologic response and cytogenetic response
3. Informed consent of the patient or his legal representative

Exclusion Criteria:

1. Patients had history of CML-AP or CML-BC
2. CML Patients who have received allogeneic hematopoietic stem cell transplantation
3. CML Patients who have received immunotherapy (except interferon, including car-t and other cellular immunotherapy)
4. Woman who is pregnant or nursing

Primary outcomes:
measure: cancer-associated gene mutations in CML treatment with TKIs by NGS
timeFrame: 1 year after TKI treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: NanfangH
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: H Nanfang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02242331: Post-marketing Study to Supplement Data on Safety, Tolerability and Efficacy of Micardis® With Special Emphasis on the Control of Blood Pressure
Official title: Risk of Morning Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-17
Enrollment: 19805
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of essential hypertension recruited at general practitioners and specialists in internal medicine in non-hospital practice

Brief summary: This post-marketing surveillance study is designed to supplement under conditions of normal clinical practice data on safety, tolerability and efficacy of Micardis® collected in clinical studies with special emphasis on the control of blood pressure in the morning before intake of the next antihypertensive drug


Eligibility criteria: Inclusion Criteria:

* Essential hypertension
* At least 18 years of age

Exclusion Criteria:

* NA

Primary outcomes:
measure: Change from baseline in blood pressure
timeFrame: Baseline, after 3 months
measure: Number of patients with adverse events
timeFrame: up to 3 months
measure: Changes from baseline in pulse rate
timeFrame: Baseline, after 3 months
Secondary outcomes:
measure: Assessment of efficacy by investigator on 5- point scale
timeFrame: after 3 months
measure: Assessment of tolerability by investigator on a 5-point scale
timeFrame: after 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06862531: A Single-center, Interventional Diagnostic Study With Minimal Risks and Constraints, Aimed at Longitudinally Evaluating Serum Antibody Levels in Patients With COVID-19 According to the Severity of Their Symptoms.
Official title: COVERT : A Single-center, Interventional Diagnostic Study With Minimal Risks and Constraints, Aimed at Longitudinally Evaluating Serum Antibody Levels in Patients With COVID-19 According to the Severity of Their Symptoms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: Bioaster
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 40
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: The COVERT protocol was designed to assess, through a longitudinal analysis, the level of antibodies present in the serum of patients with COVID-19, the duration and the persistence of the humoral response in correlation with the severity of the disease.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old,
* Patient whose Covid-19 diagnosis has been confirmed by RT-PCR test (SARS-CoV-2 positive) from a nasopharyngeal swab/broncho alveolar lavage
* Patient whose severity of Covid-19 required hospital treatment
* Patient whose Covid-19 form is defined as moderate (stay in general ward) or severe (stay in ICU), based on the clinical evaluation conducted by the doctor
* Patient agreeing to participate in the study and having signed the informed consent.

Exclusion Criteria:

* Adult person subject to legal protection,
* Pregnant, parturient or breastfeeding woman
* Person not affiliated to a social security scheme or not beneficiary of such a scheme
* Person subject to a safeguard measure
* Person deprived of liberty by a judicial or administrative decision and woman hospitalized without consent under Articles L.3212-1 and 3213-1, which do not fall under Article L.1122-8 of the Public Health Code.

Primary outcomes:
measure: The correlation between serum antibody levels (IgM/IgG), the stage of the disease (in relation to the onset date of symptoms), and the severity of the disease (severe form versus moderate form)
timeFrame: 10month after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Metz-tessy
country: France
facility: CH ANnecy-GEnevois (CHANGE)
state: Rhône Alpes
Study officials:
References:
Clinical trial NCT01698931: Efficacy of Repaglinide in Subjects With Type 2 Diabetes
Official title: Efficacy of Repaglinide Compared to Glyburide and Placebo on Hepatic Glucose Metabolism in Type 2 Diabetic Subjects Treated With Diet or With Antidiabetic Oral Agents. A Randomized, Open, Cross-over Single-centre Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-10-03
Enrollment: 9
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare the efficacy of repaglinide to glyburide and placebo on hepatic glucose metabolism in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* HbA1c (glycosylated haemoglobin A1c) above 7 %
* BMI (body mass index) below 32 kg/m\^2
* FBG (fasting blood glucose) after wash out period 130-220 mg/dl
* Currently treated with diet or OHA (oral hypoglycaemic agent)

Exclusion Criteria:

* Current systemic treatment with concomitant medication
* Known or suspected history of drug or alcohol dependence
* Any other significant concomitant disease such as cerebrovascular or symptomatic peripheral vascular disease, malignant, disease or severe treated or untreated hypertension
* Hepatic disease
* Cardiac problems
* Active proliferative retinopathy
* Known or suspected allergy to trial product or related products
* Women in fertile age and women having the intention of becoming pregnant
* Body Mass Index (BMI) above 32 kg/m\^2

Primary outcomes:
measure: Basal hepatic glucose production
timeFrame: Day 0; day 44
Secondary outcomes:
measure: Number of hypoglycaemic episodes
timeFrame: Day 0; day 44
measure: Change in body weight
timeFrame: Day 0; day 44
measure: Number of adverse events
timeFrame: Day 0; day 44
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Ciccarone A, Mari A, Pulizzi N, Bianchi C, Palumbo F, Benzi L, Del Prato S. Assessment of insulin secretion in response to a mixed meal in type 2 diabetes. Effects of short-term repaglinide and glibenclamide administration. Diabetologia 2005; 48 (Suppl. 1): A284 (Abstract No. PS65-781)
Clinical trial NCT00044031: Safety and Efficacy of G17DT Immunogen Combined With Gemcitabine vs. Gemcitabine in the Treatment of Advanced Pancreatic Carcinoma
Official title: Prospective, Randomized, Controlled, Double-Blind, Multi-National, Multi-Center Study of G17DT Immunogen in Combination With Gemcitabine Versus Placebo in Combination With Gemcitabine in Previously Untreated Subjects With Locally Advanced (Nonresectable Stage II and III), Recurrent Disease Following Primary Resection, or Metastatic (Stage IV) Adenocarcinoma of the Pancreas (Protocol No. PC4)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
G17DT
gemcitabine
Lead sponsor: Cancer Advances Inc.
Sponsor class: INDUSTRY
First posted: 2002-08-20
Enrollment: 394
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: This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer.


Eligibility criteria: Inclusion criteria:

* Clinical diagnosis of pancreatic adenocarcinoma and unsuitable for pancreatic tumor resection
* Life expectancy of at least 3 months
* Functional status by Karnofsky Index of at least 70

Exclusion criteria:

* Prior treatment with chemotherapy, radiotherapy, or anti-cancer immunotherapy
* Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease
* Immunodeficiency
* Bone marrow transplant within past year
* Brain metastasis

Primary outcomes:
measure: Survival
timeFrame: Up to 12 months
Secondary outcomes:
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Christie Hospital, Manchester
name: R Hawkins, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02074527: CHAIN_brazilian Registry of Congenital HeArt Disease INtervention and Angiography
Official title: Phase 0 _ Brazilian Registry of Congenital HeArt Disease INtervention and Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Cardiac Catheterization
Brazilian Electronic Registration
Catheterization Diagnostic or Therapeutic
Keywords: congenital heart disease
cardiac catheterization
brazilian electronic registration
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2014-02-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the hemodynamic sector with diagnosed or suspected congenital cardiopathy and undergoing diagnostic or therapeutic cardiac catheterization.

Brief summary: Design: Observational - Cross study with followed up for 30 days. The Primary Objective is to realize a record that reflects a national overview of the role of cardiac catheterization in patients with congenital heart disease in hospitals distributed by geographic density of each region of Brazil.

Detailed description: Patients admitted in the hemodynamic sector with diagnosed or suspected congenital cardiopathy and undergoing diagnostic or therapeutic cardiac catheterization. Participants release the data in (e-CRF) electronics system. Sample: 2000 records.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the hemodynamic sector with diagnosed or suspected congenital cardiopathy and undergoing diagnostic or therapeutic cardiac catheterization.

Exclusion Criteria:

* Patients undergoing hybrid approach to intervention, with the aid of cardiac surgery to realization of cardiac catheterization.

Primary outcomes:
measure: Occurrence of serious complications of cardiac catheterization in congenital heart
timeFrame: December 2014
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Otavio Berwanger
Study officials:
References: