louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00302874: In-Hospital Hyperglycemia: Effects of Treatment on Glycemic Control and Clinical Outcome
Official title: In-Hospital Hyperglycemia: Effects of Treatment on Glycemic Control and Clinical Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hyperglycemia
Keywords: diabetes
hyperglycemia
hospital
medicine ward
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-03-15
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: To improve glycemic control of inpatients admitted to the internal medicine wards, the researchers generated a protocol based on intensive insulin treatment for use in all inpatients with hyperglycemia.

The researchers hypothesize that intensive insulin treatment will improve the glycemic control and the outcome of hospitalized patients.

Study Information:

* All patients with a history of diabetes admitted to the internal medicine ward were enrolled in the study.
* At baseline, demographic and clinical information were obtained, including information necessary to determine the severity of the illness. Venous capillary blood glucose levels were checked 4 times a day by glucometer.
* During the pre-intervention period, patients were treated according to the common practice in the hospital without any intervention. The study team collected the baseline data on the glycemic control and treatment of patients admitted with hyperglycemia.
* During the intervention period, the study team visited the ward daily and guided the medical staff as to the use of the treatment protocol.
* During the post-intervention period, the study team collected the data without active intervention in the implementation of the protocol.
* Data was collected on the mode of treatment and glycemic control of all hyperglycemic patients throughout the study. The incidence of hypoglycemia, complications (myocardial infarction, stroke, infections), mortality, transfer to intensive care unit (ICU), length of hospitalization, and disposition at discharge were noted.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to the internal medicine ward with hyperglycemia

Exclusion Criteria:

* Patients admitted due to hypoglycemia, hyperosmolar state, and ketoacidosis

Primary outcomes:
measure: Mean blood glucose during hospitalization
Secondary outcomes:
measure: Hypoglycemic events
measure: Length of in-hospital stay
measure: Infections
measure: Complications (myocardial infarction, stroke)
measure: Disposition at discharge (home, nursing home)
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Gil Leibowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01281774: A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers
Official title: An Adaptive, Phase I, Randomised, Placebo-controlled, Sponsor-unblinded, Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous CSL112 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: CSL Limited
Sponsor class: INDUSTRY
First posted: 2011-01-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CSL112 in healthy volunteers after multiple infusions.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females aged 18 years to less than 55 years
* Body weight 50kg or greater
* Body mass index (BMI) between 18 and 42.0 kg/m2

Exclusion Criteria:

* Evidence of a clinically significant medical condition, disorder or disease
* Evidence of hepatobiliary disease
* Any clinically relevant abnormal laboratory test result
* Evidence or history of alcohol or substance abuse

Primary outcomes:
measure: The frequency of drug-related adverse events
timeFrame: Up to 6 days after each infusion
measure: The frequency of redness and swelling at the infusion site
timeFrame: up to 24 hours after each infusion
measure: Clinically important elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
timeFrame: up to 6 days after each infusion
Secondary outcomes:
measure: Pharmacokinetic profile of apoA-I after multiple intravenous infusions
timeFrame: up to 7 days after each infusion
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Q-Pharm
state: Queensland
Study officials:
affiliation: CSL Limited
name: Senior Director, Cardiovascular
role: STUDY_DIRECTOR
References:
citation: Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23.
citation: Easton R, Gille A, D'Andrea D, Davis R, Wright SD, Shear C. A multiple ascending dose study of CSL112, an infused formulation of ApoA-I. J Clin Pharmacol. 2014 Mar;54(3):301-10. doi: 10.1002/jcph.194. Epub 2013 Oct 22.
Clinical trial NCT01931774: Is Acne a Skin Disease Affecting the Brain Functions? Neurocognition in Patients With Acne Vulgaris
Official title: Is Acne a Skin Disease Affecting the Brain Functions? Neurocognition in Patients With Acne Vulgaris
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne Vulgaris
Keywords: acne vulgaris cognitive functions
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acne patients referred to the dermatology outpatient clinic of our university and healthy controls matched with the patient group for age, gender and years of education. Controls will be taken from the general population

Brief summary: Acne vulgaris usually causes psychological distress, depression, and anxiety disorders that may impair neurocognitive functions such as memory, attention, psychomotor speed, and executive functions, which are also common psychiatric disorders in patients with acne.

The purpose of this study is to determine cognitive functioning in treatment naive acne patients, without a history of any psychiatric disorder.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

The participants that had a symptom or a history of mental retardation (IQ \< 70), serious head trauma, seizures or any other mental disorder, and participants on any medical treatment will be excluded. Participants with a family history (first degree relatives) of schizophrenia, bipolar disorder or schizoaffective disorder will also be excluded to avoid the negative effect of these disorders on cognitive functions. The same exclusion criteria will also be applied to the control group.

Primary outcomes:
measure: Cognitive functions
timeFrame: baseline
Secondary outcomes:
measure: anxiety
timeFrame: baseline
Other outcomes:
measure: depression
timeFrame: baseline
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University Hospital
Study officials:
affiliation: Bezmialem Vakif University
name: Erdem Deveci, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06507774: The Development and Study of a 3D-Printed Model for Surgical Planning of Lung Cancer with Realistic Subsegmental Boundaries and Complete Tissue Structures
Official title: The Development and Study of a 3D-Printed Model for Surgical Planning of Lung Cancer with Realistic Subsegmental Boundaries and Complete Tissue Structures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Affiliated Hospital of Hebei University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study includes all lung cancer patients who underwent surgery at the Affiliated Hospital of Hebei University from 2020 to 2023.

Brief summary: This project focuses on the development of a precision multi-organ surgical planning model aided by artificial intelligence (AI), computer-aided design (CAD), multi-material 3D printing, and multimodal 3D modeling. The integration of these advanced technologies aims to enhance the accuracy and efficiency of preoperative planning for complex surgical procedures involving multiple organs. By leveraging AI and CAD, the project seeks to create detailed, patient-specific 3D models that incorporate various imaging modalities. These models will be used to guide multi-material 3D printing, producing highly accurate replicas of anatomical structures. The ultimate goal is to improve surgical outcomes by providing surgeons with precise and comprehensive tools for planning and executing intricate surgeries.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with lung cancer
* Complete clinical case data;
* All patients underwent surgical treatment;
* Voluntarily participate in the study and sign the informed consent.

Exclusion Criteria:

* Severe comorbidities, such as uncontrolled heart disease or diabetes
* History of major surgeries or other interventions
* Unwillingness to participate in the study

Primary outcomes:
measure: Operation Time
timeFrame: During the surgery
measure: Blood Loss
timeFrame: During the surgery
measure: Postoperative Complications
timeFrame: Within 30 days post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
state: Hebei
Study officials:
References:
Clinical trial NCT01910974: Multicentric Study an Endoscopic Treatment of Digestive Neoplasia by Submucosal Dissection Evaluation of a New Water Jet System
Official title: TRESTIS: Multicentric Study With a Curative Endoscopic Treatment of Superficial Neoplasia of a Digestive Tract by Endoscopic Submucosal Dissection: Evaluation of a New Water Jet System Injecting Glycerol Mix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Neoplasm
Intestinal Neoplasm
Rectal Neoplasm
Keywords: oesophagus
stomach
intestine
rectum
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system is a new water jet system which allows to perform Endoscopic submucosal dissection with a bifunctional catheter (injection and cutting).

Detailed description: Evaluation of the ability of this system to have a complete resection of superficial tumors of the digestive tract (that is to say a resection with free lateral and deep margins without residual tumor tissue)

Evaluation of the ability of such system to inject a viscous macromolecular solution of glycerol (glycerol mix: Glycerol 10 %, Fructose 5 %, saline solution 0.9%)(27. Fujishiro M, Yahagi N, Kashimura K, et al. Comparison of various submucosal injection solutions for maintaining mucosal elevation during endoscopic mucosal resection. Endoscopy. 2004;36:579-583.)

Eligibility criteria: Inclusion Criteria:

* OVER 18 YEARS OLD
* PATIENTS AGREED WITH THE STUDY
* SCORE ASA 1 OR 2
* Patient recorded in a social safety organism
* patients presenting with superficial lesions with an endoscopic indication of resection

Exclusion Criteria:

* under 18 years old
* Patients not agreed with the study
* pregnant women
* patient included in an another study
* medical treatments (radiotherapy, surgery endoscopis treatements) before the intervention
* coagulation disorders
* score asa over 3
* patients with another neoplasic lesion

Primary outcomes:
measure: SAFETY THAT IS TO SAY PERFORATION RATE AND delayed BLEEDING ONE
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: NESTIS
state: Rhone Alpes
Study officials:
affiliation: SPONSOR DIRECTOR
name: PINSET CHRISTIAN, CEO
role: STUDY_DIRECTOR
References:
Clinical trial NCT00293774: Alberta Hip Improvement Project
Official title: A Provincial Initiative to Examine the Efficacy, Cost-effectiveness and Long-term Safety of Alternative Hip Bearing Surfaces Versus Conventional Therapy for Degenerative Joint Disease of the Hip
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty, Replacement, Hip
Keywords: Prospective
Conventional therapy
Registry
Metal-on-metal
Ceramic-on-ceramic
Hip Arthroplasty
Lead sponsor: Alberta Bone and Joint Health Institute
Sponsor class: OTHER
First posted: 2006-02-20
Enrollment: 1632
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Males between the ages of 18-65 and females between the ages of 18-55

Brief summary: A study to determine the effectiveness and safety of the use of metal-on-metal hip resurfacing (for example the birmingham hip) when compared to conventional total hip replacement.

Detailed description: This study is designed to provide orthopedic surgeons and decision makers with evidence-based health measures for patients that are treated by orthopedic surgeons for degenerative joint disease of the hip in Alberta. This study is provincial initiative to determine whether new alternative hip bearing surfaces improve patient outcomes and/or decrease health resource utilization in patients with degenerative joint disease of the hip in Alberta. The primary objective is to compare time to revision for patients receiving alternative hip bearing surfaces to patients receiving conventional total hip replacements. Secondary objectives are to evaluate long-term safety; to evaluate costs; to determine if alternative hip bearing surfaces improve patient function; to develop evidence base guidelines for the implementation of alternative hip bearing surfaces in Alberta; do develop a modal to assess other technologies and health advances; to develop an Alberta HIP registry

Eligibility criteria: Inclusion Criteria:

* documentation of DJD of hip
* patient at least 18 years
* patient able to provide written consent
* Male under 65 years, female under 56 years
* Orthopedic surgeon has received appropriate training to implant an alternative device

Exclusion Criteria:

* renal failure (MOM only)
* child bearing potential (MOM only)
* inappropriate femoral anatomy, including evidence of osteoporosis
* inflammatory arthritis (MOM)
* Unwilling to consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Bone and Joint Health Institute
state: Alberta
Study officials:
affiliation: University of Calgary
name: James MacKenzie, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Greg O'Connor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04975074: Iron Deficiency Anemia in Twin Pregnancies
Official title: Prospective Study of Iron Deficiency Anemia in Twin Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anemia, Iron-Deficiency
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: All pregnant women with twin pregnancies were given oral iron according to the current recommended dose. Blood routine and ferritin were monitored during pregnancy to understand the therapeutic effect of oral iron on iron deficiency anemia and iron deficiency in pregnant women with twin pregnancies

Detailed description: All pregnant women with twin pregnancies were given oral iron according to the current recommended dose. Blood routine and ferritin were monitored every 2-4 weeks during pregnancy to understand the therapeutic effect of oral iron on iron deficiency anemia and iron deficiency in pregnant women with twin pregnancies.After delivery, we will test the neonatal ferritin and hemoglobin status. Our aim was to investigate the effects of iron supplementation during twin pregnancy on maternal and neonatal ferritin and anemia.

Eligibility criteria: Inclusion Criteria:

* Chinese
* Pregnant women with twin pregnancies

Exclusion Criteria:

* Single pregnancy
* Types of anemia other than iron deficiency anemia

Primary outcomes:
measure: Routine blood
timeFrame: 2-4 weeks after antenatal care
Secondary outcomes:
measure: serum ferritin
timeFrame: 2-4 weeks after antenatal care
Other outcomes:
Locations:
Study officials:
affiliation: Shengjing Hospital of CMU
name: Caixia Liu
role: STUDY_CHAIR
References:
Clinical trial NCT04404374: Treatment of Periodontal Intrabony Defects With A-PRF+ or EMD
Official title: Efficacy of a New-generation Platelet-rich Fibrin vs. Enamel Matrix Derivatives in the Treatment of Periodontal Intrabony Defects : a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: Intrabony Defects
New-Generation Platelet-Rich Fibrin
Enamel Matrix Derivatives
Periodontal Regeneration
EMD
A-PRF+
Advanced Platelet-Rich Fibrin
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized clinical trial was to clinically evaluate and compare the healing of intrabony defects after treatment with advanced platelet-rich fibrin (A-PRF+) to enamel matrix derivatives (EMD) in periodontitis patients.

Detailed description: Thirty (30) intrabony defects of 18 patients (9 males, 9 females) were randomly divided in two treatment groups: test (n = 15) and control (n = 15). The intrabony defects were filled with A-PRF+ (n=15) in the test group, respectively with EMD in the control group, and fixed with sutures to ensure wound closure and stability.

Eligibility criteria: Inclusion Criteria:

* no systemic diseases that could influence the outcome of the therapy, a good level of oral hygiene, he presence of a 2-, 3-, or combined 2-3-wall intrabony defect with a defect angle of 20-40 (+/- 5) degrees, with a minimum PPD of 6 mm and intrabony component of a minimum 4 mm as detected on radiographs, no smoking

Exclusion Criteria:

* systemic diseases that could influence the outcome of the therapy, poor oral hygiene, smoking, horizontal bone loss

Primary outcomes:
measure: Periodontal clinical parameters - to determine the clinical attachment level (CAL)
timeFrame: Change from baseline after 6 month and after 12 month
measure: Periodontal clinical parameters
timeFrame: Change from baseline after 6 month and after 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Periodontology
Study officials:
affiliation: Semmelweis University
name: Ferenc Dr.Dőri, professor
role: STUDY_DIRECTOR
References:
citation: Csifo-Nagy BK, Solyom E, Bognar VL, Nevelits A, Dori F. Efficacy of a new-generation platelet-rich fibrin in the treatment of periodontal intrabony defects: a randomized clinical trial. BMC Oral Health. 2021 Nov 15;21(1):580. doi: 10.1186/s12903-021-01925-1.
Clinical trial NCT06700174: Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study
Official title: A Multicenter, Prospective, Single-arm, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Septal Defect (ASD)
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-21
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with echocardiographic confirmation of a single secundum atrial septal defect (ASD) who are scheduled to undergo ASD closure.

Brief summary: The objective of this PMCF study is to:

* confirm the safety and performance of the AcuMarkTM Sizing Balloon
* identify previously unknown side-effects
* monitor the identified side-effects (related to the procedure or to the medical devices)


Eligibility criteria: Inclusion Criteria:

1. Patients who have been confirmed with single secundum atrial septal defect (ASD) by echocardiography;
2. The anatomy of ASD is suitable for percutaneous closure;
3. Patients are scheduled to perform ASD closure;
4. Patients or legally authorized representative(s) who are willing and capable of providing informed consent.

Exclusion Criteria:

1. Any contraindication for ASD closure;
2. Patients have ostium primum ASD or coronary sinus ASD;
3. Patients who are pregnant or breastfeeding;
4. Patient is currently participating in another clinical trial that has not yet completed its primary endpoint.

Primary outcomes:
measure: Sizing success rate
timeFrame: At procedure
measure: Incidence of major adverse events (MAEs)
timeFrame: From attempted procedure to discharge, up to 14 days
Secondary outcomes:
measure: Device success rate
timeFrame: At procedure
measure: Incidence of procedure and/or device-related complications
timeFrame: From attempted procedure to discharge, up to 14 days
measure: Incidence of Serious Adverse Events
timeFrame: From attempted procedure to discharge, up to 14 days
measure: Incidence of Device Deficiency (DD)
timeFrame: From attempted procedure to discharge, up to 14 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara (Bilkent) City Hospital
city: Diyarbakir
country: Turkey
facility: Gazi Yasargil Woman and Child Hospital
city: Gaziantep
country: Turkey
facility: Gaziantep University Hospital
city: Istanbul
country: Turkey
facility: SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital
city: Izmir
country: Turkey
facility: Tepecik Training and Research Hospital
Study officials:
References: