louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03266822: T-cell Subsets in Rheumatoid Arthritis Patients on Long-term Anti-TNF or IL6-receptor-blocker Therapy
Official title: T-cell Subsets in Rheumatoid Arthritis Patients on Long-term Anti-TNF or IL6-receptor-blocker Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In the cross-sectional analysis, 92 RA patients (who had been treated with biological therapy for more than six months) were evaluated.

As a further control group (healthy controls), we enrolled 30 age- and gender-matched healthy volunteers.

Brief summary: Data on the impact of biological therapies, especially of IL6-blocker treatment, on the T-cell phenotype in rheumatoid arthritis (RA) are limited, inconclusive, and mainly involve short-term follow-up.

Here, the investigator prospectively measure the percentages of 15 circulating T-cell subtypes using flow cytometry. The investigators aim to obtained transversal and longitudinal data in 30 anti-TNF responders, 19 secondary anti-TNF-non-responders, 43 IL6R-antagonist-responders before, 8 weeks and, after, at least, 6 months of biological therapy. These are then compared with results obtained in early, untreated RA patients and gender-and-age matched healthy controls.


Eligibility criteria: Inclusion Criteria for patients:

* Diagnosis of rheumatoid arthritis classified according to the 2010 ACR/EULAR classification criteria for RA
* Biological treatment with anti-TNF therapy (adalimumab or certolizumab pegol or etanercept or infliximab or golimumab) or anti-IL-6R agent (tocilizumab)

Inclusion Criteria for healthy controls:

* negative history of RA symptoms
* negative status upon detailed physical and laboratory examination including normal CRP and ESR values

Exclusion Criteria:

* other autoimmune comorbidity
* lack of informed consent

Primary outcomes:
measure: Flow cytometry for the assessment of change in T cell subtypes
timeFrame: Before, after 8 weeks and after at least 6 months of the initiation of biological therapy.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Dulic S, Vasarhelyi Z, Sava F, Berta L, Szalay B, Toldi G, Kovacs L, Balog A. T-Cell Subsets in Rheumatoid Arthritis Patients on Long-Term Anti-TNF or IL-6 Receptor Blocker Therapy. Mediators Inflamm. 2017;2017:6894374. doi: 10.1155/2017/6894374. Epub 2017 Oct 25.
Clinical trial NCT05236322: Management of Plasma Cell Gingivitis by Two Surgical Techniques
Official title: Management of Plasma Cell Gingivitis by En-block Removal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plasma Cell Gingivitis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient suffering from plasma cell gingivitis

Brief summary: Two surgical protocols for management of Plasma cell Ginigivitis; either by surgical enblock resection of cold laser resection

Detailed description: Tow groups will be included the first will have six cases and second will have six cases. the first will be treated by ordinary surgical resection and second will be removed using soft tissue laser.

Eligibility criteria: Inclusion Criteria:

- patients suffering from the plasma cell gingivitis

Exclusion Criteria:

- Patient not eligible for maxillofacial surgery

Primary outcomes:
measure: complete removal
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams University
Study officials:
affiliation: Ain Shams University
name: mohamed diaa, professor
role: STUDY_CHAIR
References:
Clinical trial NCT06970925: Pilot Study Evaluating the Advantages of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care After Cardiac Surgery
Official title: Pilot Study Evaluating Efficacy and Economic Advantage of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care in Patients After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Cardiac Surgery
Lead sponsor: Englewood Hospital and Medical Center
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 40
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: Primary objective: to evaluate the non-inferiority in terms of improvement of hemoglobin (Hg) levels within 30 days postoperatively between two proposed treatments.

Secondary objective: to evaluate the financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV), while demonstrating non-inferiority in the improvement of hemoglobin levels, reduction in transfusion requirements, and reduction of hospital/ICU stay length


Eligibility criteria: Inclusion Criteria:

* ICU hospitalized patients who underwent non-emergent cardiac surgery
* Post operative iron deficient or anemic patients (Hb\< 12 for both men and women).
* Patients following the same pre-operative protocol
* Age \>18 years

Exclusion Criteria:

* Post operative day 1 Hg \<9
* Age \>90 years
* Patients with cancer or other chronic conditions that impair erythropoiesis (e.g. MDS)
* Stage 3, 4 renal disease
* Intraoperative transfusion of PRBC

Primary outcomes:
measure: Change in hemoglobin levels
timeFrame: 30 days
measure: Financial Cost
timeFrame: 30 Days
Secondary outcomes:
measure: Transfusion requirements
timeFrame: 30 Days
measure: Length of Stay
timeFrame: 30 Days
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Hospital
state: New Jersey
Study officials:
References:
Clinical trial NCT04503525: Nutritional Assessment of Hospitalized Patients With COVID-19
Official title: Nutritional Assessment of French Hospitalized Patients Infected With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV
Nutrition Disorders
Keywords: COVID-19
Nutrition disorders
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with COVID 19 disease

Brief summary: The nutritional consequences of the infection by the SARS-CoV-2 are as follows:

* A severe respiratory infection induces an inflammatory syndrome and hypercatabolism, as well as an increase in energy expenditure related to ventilatory work; nutritional requirements (calories and protein) are therefore increased.
* Food intake is often reduced by several factors: anorexia secondary to infection, respiratory discomfort, anosmia, ageusia, obesity, stress, confinement, organizational problems limiting meal assistance.

Then, it is important to asses the nutritional status of COVID patients hospitalized in conventional COVID units (excluding intensive care).


Eligibility criteria: Inclusion Criteria:

* Patient on conventional hospitalization (duration less than 72 hours)
* Age \> 18 years old
* COVID 19 diagnosed by Real Time Polymerase Chain Reaction (RT-PCR)
* Patient agreed to participate in the study
* Patient affiliated to French social security

Exclusion Criteria:

* Patient hospitalized in intensive care units during more than 72 hours

Primary outcomes:
measure: Nutritional status of COVID infected patients
timeFrame: Up to 72 hours
Secondary outcomes:
measure: Correlation between the nutritional status and the supplemental oxygen requirement
timeFrame: Up to 72 hours
measure: Correlation between the nutritional status and the prognostic after hospitalization
timeFrame: Up to 72 hours
Other outcomes:
Locations:
city: Lille
country: France
facility: Saint-Vincent Hospital
state: Haut-de-France
Study officials:
affiliation: GHICL
name: Arnaud Cortet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00394225: Helium-Hyperoxia and 6MWT Distance in COPD
Official title: The Effects of Helium-Hyperoxia on 6-Minute Walking Distance in Chronic Obstructive Pulmonary Disease - A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: 6-Minute Walk Test
COPD
Helium-Hyperoxia
Exercise
Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Authority
First posted: 2006-10-31
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We assessed the effect of altering inspired gas on the 6MWT distance in COPD. We hypothesized that HeO2 would improve walking distance and reduce shortness of breath compared to both RA and O2, and potentially improve quality of life for COPD patients.

Detailed description: We hypothesized that inspiring helium-hyperoxia (HeO2) would significantly improve 6-minute walking test (6MWT) distance in Chronic Obstructive Pulmonary Disease (COPD) subjects.

This was a blinded, randomized crossover study. At Visit 1 we assessed pulmonary function, exercise capacity and 6MWT distance. Visits 2 and 3 consisted of four 6MWT with different inspired gases: room air by mask (RA), 100% O2 by mask (Mask O2), 100% O2 by nasal prongs (Nasal O2), and 70% He/30% O2 by mask (HeO2). Walking distance, shortness of breath, leg fatigue, O2 saturation and heart rate (HR) were assessed

Eligibility criteria: Inclusion Criteria:

* Exertional dyspnea
* Activity limitation
* COPD

Exclusion Criteria:

* Recent exacerbation (\< 4 wks)
* Supplemental O2
* Significant cardiovascular/musculoskeletal abnormalities

Primary outcomes:
measure: 6 minute walking distance
Secondary outcomes:
measure: shortness of breath
measure: leg fatigue
measure: arterial oxygen saturation
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Edmonton General Hospital, Caritas Lung HEalth Centre
state: Alberta
Study officials:
affiliation: University of Saskatchewan
name: Darcy D Marciniuk, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00920725: Subcutaneous Aspart Insulin to Treat Diabetic Ketoacidosis (DKA) and Beta-Hydroxybutyrate Testing in DKA
Official title: Subcutaneous Aspart Insulin and Point of Care Beta Hydroxybutyrate Testing: A New Paradigm for the Management of Diabetic Ketoacidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Ketoacidosis
Keywords: DKA
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2009-06-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether insulin administered by a subcutaneous injection is effective in the treatment of a diabetic crisis and to determine if beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis.


Eligibility criteria: Inclusion Criteria: age 18 or older

* venous pH \< 7.3 or arterial \< 7.35
* at least 2 of the following 3:

  1. serum HCO3 \< 18/anion gap \> 16
  2. serum glucose \> 300 mg/dl
  3. serum acetone positive

Exclusion Criteria:

* pregnant
* less than age 18

Primary outcomes:
measure: Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6
timeFrame: q 2 hours
measure: Hours to achieve blood glucose less than 200mg/dl
timeFrame: q 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Rema A Gupta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: David Baldwin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04084925: HOMA-IR as a Screening Test in NAFLD
Official title: Is HOMA-IR(Homeostatic Model Assessment for Insulin Resistance) a Potential Screening Test for Non-alcoholic Fatty Liver Disease in Adults With Type 2 DM?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NAFLD
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes mellitus from the outpatient clinic of internal medicine department at Fayoum University Hospital

Brief summary: The aim of this study is to evaluate the role of HOMA-IR in diagnosis of NAFLD in patients with type 2 DM.

Detailed description: this study is a retrospective cohort study included 100 patients with type 2 DM from the outpatient clinic of internal medicine department at Fayoum University Hospital. They were divided into two equal groups according to the presence of NAFLD by ultrasound. All patients were subjected to history taking, clinical examination and investigations which included: ALT, AST, total cholesterol, TG, FBG and fasting insulin level,HOMA-IR(Homeostatic Model Assessment for Insulin Resistance) assessment.

Eligibility criteria: Inclusion Criteria:

- Diabetes obesity

Exclusion Criteria:

* use of alcohol

Primary outcomes:
measure: The correlation between HOMA-IF and NAFLD
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum university hospital
Study officials:
affiliation: Faculty of medicine Fayoum university
name: Mohammed A Mashaheet, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01158625: Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes
Official title: Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypertension
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Silkeborg
name: The Ministry of Science, Technology and Innovation, Denmark
name: Central Denmark Region
First posted: 2010-07-08
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if it is possible to lower the nighttime blood pressure in patients with type 2 diabetes mellitus by shifting the administration of antihypertensive drugs from morning to nighttime.

Detailed description: In recent years several studies have shown that high nighttime blood pressure is associated with increased cardiovascular risk independently of the average 24 hour blood pressure. As a consequence there has been increasing focus on nighttime blood pressure and how to lower it. One way of addressing the problem is to shift the administration of antihypertensive drugs from morning to nighttime. Studies on non-diabetic patients show that by doing this the nighttime blood pressure can be lowered with 3-5 mm Hg without negative effect on the 24 hour blood pressure.

Only recently a study was made on diabetic patients. This showed similar results as for non-diabetic patients.However this study was based on diabetic patients who did not receive any antihypertensive drugs before.

This study will investigate the effects on nighttime blood pressure when shifting administration of antihypertensive drugs from morning to nighttime. The population is diabetic patients who are already in antihypertensive treatment.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Systolic nighttime blood pressure above 120 mm Hg
* Systolic daytime blood pressure not exceeding 150 mm Hg
* Antihypertensive treatment which must include
* once-daily drugs
* at least one drug must be a Angiotensin-Converting Enzyme Inhibitor, Angiotensin II Receptor Blocker or Renin Inhibitor.

Exclusion Criteria:

* MI or stroke within 6 months
* heart failure (EF \< 45 %)
* atrial fibrillation
* eGFR \< 30 ml/min

Primary outcomes:
measure: Blood pressure, nighttime blood pressure and 24 h blood pressure
timeFrame: After 16 weeks
Secondary outcomes:
measure: Urine albumin excretion
timeFrame: After 16 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Silkeborg
country: Denmark
facility: Regional Hospital Silkeborg
Study officials:
affiliation: Department of Medicine, Regional Hospital Silkeborg
name: Klavs W Hansen, MD, DrMedSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT02857725: Sun Protection Factor (SPF) Assay
Official title: Sun Protection Factor (SPF) Assay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreen Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-08-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.


Eligibility criteria: Inclusion Criteria:

* Male or female of an age of 18 to 70 years inclusive;
* Fitzpatrick Skin Type I, II and/or III for SPF testing;
* Good health as determined from the CRO Subject History Form (SHF);
* Signed and dated Informed Consent Form;
* Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form;
* An unambiguous minimal erythema dose (MED).

Primary outcomes:
measure: Evaluation of water resistant SPF in accordance to 21 CFR (Code of Federal Regulations) 207.327
timeFrame: 16-24 h post exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05423925: Comparison of Perioperative Outcome Between Monopolar and Bipolar Hysteroscopic Myomectomy
Official title: Comparison of Perioperative Outcome Between Monopolar and Bipolar Hysteroscopic Myomectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hysteroscopic Myomectomy
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 250
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: \> 20 years old women who received hysteroscopic myomectomy

Brief summary: Objective:

To evaluate clinical outcome between monopolar and bipolar hysteroscopic myomectomy.

Detailed description: Methods:

Hysteoscopic myomectomy is a safe and effective procedure to remove submucosal myoma. Distension media is needed to distend the uterine cavity during the procedure. The electric cutting loops included monopolar and bipolar electrodes, and have their corresponding distension media. Medical records, including outpatient and inpatient records, operation note, and laboratory data, of all consecutive women who received hysteroscopic myomectomy between July 2008 and April 2022 will be reviewed.

Expected result: The investigatorscan get the differences between monopolar and bipolar hysteroscopic myomectomy, and the result can be used as a reference in clinical practice.

Eligibility criteria: Inclusion Criteria:

* women who received hysteroscopic myomectomy between July 2008 and April 2022 will be reviewed.

Exclusion Criteria:

* \< 20 years old women
* Cervical fibroids were excluded.

Primary outcomes:
measure: Infused volume of distension medium
timeFrame: 3 months
Secondary outcomes:
measure: Operation time
timeFrame: 3 months
measure: Pain score after the procedure
timeFrame: 3 months
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT01005225: Genetic Investigation of Solid Tumors Cohort
Official title: Genetic Investigation of Solid Tumors Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Colon Cancer
Keywords: Solid tumor
prostate cancer
colon cancer
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
First posted: 2009-10-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient clinic, physician referral

Brief summary: The objective of this study is to obtain blood samples, solid tumor and/or benign hyperplasia samples to learn more about genetic differences that are linked to the formation of solid tumors.

Detailed description: Recent studies in human genetics have discovered several intervals in the human genome containing inherited variants that are statistically associated with the propensity to develop solid tumors. Even though it has been firmly established that if an individual carries these DNA variants they have an increased chance of developing a solid tumor the underlying biological mechanisms for most of these associations are largely unknown.

In addition to inherited DNA variants that are associated with the development of solid tumors it is well established that during the development and growth of solid tumors the DNA in these cancer cells undergo somatic changes (mutations). These somatic DNA changes have been studied over the past decade and frequently are specific chromosomal translocations and amplifications associated with the development of particular solid tumors. In some instances, examining the chromosomal translocation and amplification has lead to the discovery of proteins contributing to solid tumor pathology.

the human 8q24 interval that has strong genetic associations with solid tumor development has also been noted as frequently amplified in solid tumors and serves as a predictor of poor survival in prostate cancers.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Eligible to have their blood drawn
3. Be reliable, cooperative and willing to comply with all protocol-specified procedures
4. Able to understand and grant informed consent
5. Diagnosis of a solid tumor

Exclusion Criteria:

1. Has a significant chronic medical condition which would potentially confound interpretation of the individual's phenotype.
2. Treatment with any investigational agents or devices within thirty days preceding enrollment in the study.
3. Been administered or taken any CNS sedatives or depressants in the 12 hours prior to informed consent process

Primary outcomes:
measure: Solid tumor biological insights
timeFrame: Study completion
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Health
state: California
Study officials:
affiliation: Scripps Health
name: James Mason, MD
role: PRINCIPAL_INVESTIGATOR
References: