louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04591704: The Effect of Diabetes Mellitus on the Prognosis of Patients With COVID-19
Official title: The Effect of Diabetes Mellitus on the Morbidity and Mortality Rates in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Diabetes Mellitus
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged between 18-80 years, diagnosed and hospitalised for COVID-19 will be enrolled in to the study

Brief summary: All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study.

The patients will be divided into two groups, as diabetics and non-diabetics. The COVID-19 patients' medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.

Detailed description: All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study.

The patients will be divided into two groups, as diabetics and non-diabetics. The diagnosis of diabetes mellitus will be extracted from the medical records and medical history of the patients hospitalised with COVID-19.

The COVID-19 patients medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.

Eligibility criteria: Inclusion Criteria:

* Patients hospitalized for COVID-19

Exclusion Criteria:

* Patients with known malignancy
* Pregnant patients

Primary outcomes:
measure: Duration of Hospitalisation
timeFrame: 1 year
measure: The need for ICU
timeFrame: 1 year
measure: Mortality
timeFrame: 1 year
measure: Lung involvement
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Usak University Training and Research Hospital
Study officials:
affiliation: Uşak Üniversitesi Tıp fak
name: Cevdet Duran
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01028404: A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes
Official title: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0148-0000-0106 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 84
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: This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as tablets in healthy volunteers and subjects with type 1 and type 2 diabetes.

The trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2 diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and placebo.


Eligibility criteria: Inclusion Criteria:

* FOR TRIAL PART 1, THE FOLLOWING APPLIES:
* Gender: male
* Age: 18-55 years
* BMI (body mass index): 18-28 kg/m2
* Study participants considered to be healthy
* FOR TRIAL PART 2, THE FOLLOWING APPLIES:
* Gender: male or female of no childbearing potential
* Age: 18-65 years
* Type 1 diabetes: BMI (body mass index): 18-28 kg/m2
* Type 2 diabetes: BMI (body mass index): 22-35 kg/m2
* Type 1 or type 2 diabetes for at least 12 months
* Type 1 diabetes: Treatment with insulin for at least 12 months
* Type 2 diabetes: Treatment with insulin for at least 3 months

Exclusion Criteria:

* Known or suspected allergy to the trial product or related products
* Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator
* Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)

Primary outcomes:
measure: Number and severity of adverse events for trial part 1
timeFrame: from visit 1 to visit 3
measure: Number and severity of adverse events for trial part 2
timeFrame: from visit 1 to visit 6
Secondary outcomes:
measure: Area under the serum insulin concentration-time curve after a single dose
timeFrame: after 12 hours
measure: Area under the glucose infusion rate-time curve after a single dose
timeFrame: after 12 hours
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01449604: Stereotactic Radiation in Vestibular Schwannoma
Official title: Randomized Comparison of Steretotactic Radiosurgery and Hypofractionated Steretotactic Radiotherapy in the Treatment of Vestibular Schwannoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Vestibular Schwannoma
Keywords: Stereotactic radiotherapy
SRS
SRT
vestibular schwannoma
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
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 determine whether stereotactic radiosurgery (SRS)and stereotactic radiotherapy (SRT)are effective in the treatment of vestibular schwannoma (VS).

Detailed description: Vestibular schwannomas (VSs) are slow-growing tumors of the myelin-forming cells that cover cranial nerve VIII.The treatment options for patients with VSs include active observation, surgical management, and radiotherapy. However, the optimal treatment choice remain controversial.

Over the past 10 years, there has been rapid progress in the application of stereotactic radiotherapy to the treatment of VSs. The stereotactic radiotherapy program includes single fraction radiosurgery (SRS) and hypofraction stereotactic radiotherapy (HSRT) are commonly used for VSs treatment. Since SRS and SRT techniques differ significantly enough to raise questions of therapeutic advantage and until now, there is no prospective, randomized study comparing the outcomes for patients treated using both radiotherapy techniques. We designed the first prospective randomized protocol to compare SRS and SRT for answer this question.

Eligibility criteria: Inclusion Criteria:

* vestibular schwannoma tumor size not more than 3 cm.

Exclusion Criteria:

* NF 2 patient
* underlying cerebrovascular disease
* tumor compress and efface brain stem ( Koos 4)

Primary outcomes:
measure: audiogram
timeFrame: two year
Secondary outcomes:
measure: number of participant with adverse event
timeFrame: 2 year
measure: tumor size
timeFrame: 2 year
Other outcomes:
Locations:
Study officials:
affiliation: Ramathibodi Hospital
name: Putipun Puataweepong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07001904: Interleukin-6 in Plaque Psoriasis and Its Possible Role in Disease Severity
Official title: Interleukin-6 in Plaque Psoriasis and Its Possible Role in Disease Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interleukin-6
Plaque Psoriasis
Disease Severity
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This cross-sectional work had been performed on 30 individuals with plaque psoriasis and 20 sex- and age-matched healthy controls.

Brief summary: This study aimed to evaluate serum IL-6 levels in plaque psoriasis patients and investigate their correlation with disease severity.

Detailed description: Psoriasis is a chronic, immune-mediated inflammatory dermatological condition that impacts around 0.2% to 4.8% of the worldwide population.

Interleukin (IL)-6 is a pleiotropic cytokine that regulates immunity, hematopoiesis, and inflammation. It is produced by keratinocytes, endothelial cells, fibroblasts, and immune cells like macrophages and dendritic cells. Increased IL-6 expression has been observed in psoriatic lesions, suggesting its involvement in disease pathogenesis

Eligibility criteria: Inclusion Criteria:

* Age above 18 years.
* Both sexes.
* Patients clinically diagnosed with plaque psoriasis.

Exclusion Criteria:

* Patients who had received any treatment for psoriasis in the last three months.
* Patients with other types of psoriasis.
* Those currently receiving systemic treatment.
* Individuals with other inflammatory diseases.
* Pregnant or lactating women.
* Those using contraceptive pills.
* Patients with metabolic conditions like diabetes mellitus or thyroid disorders.

Primary outcomes:
measure: Disease severity
timeFrame: 3 months post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT05389904: Pre-emptive Prevention for Patients at High Risk for Hospital-onset Clostridioides Difficile
Official title: A Pre-emptive Prevention Bundle for Patients at High Risk for Hospital-onset Clostridioides Difficile
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: C. Difficile
Keywords: Prevention
Hospital-acquired infection
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Pilgrim Health Care Institute
name: Centers for Disease Control and Prevention
name: Massachusetts Host-Microbiome Center
name: Hatch Family Foundation
First posted: 2022-05-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief summary: Clostridioides difficile (C. difficile) is the most common healthcare-associated pathogen, causing \>500,000 infections and \>29,000 deaths per year in the US. Traditional approaches to reduce hospital-onset CDI focus on identifying, isolating, and treating symptomatic patients to prevent transmission to other patients. Recent genomic epidemiology studies, however, suggest that most hospital-onset CDI cases are attributable to asymptomatic carriers who either progress from colonization to active infection themselves or transmit C. difficile to other patients while asymptomatic. This trial will evaluate an intervention to pre-emptively identify asymptomatic C. difficile carriers and then implement a patient-tailored prevention package to protect the carrier from progression to active infection and to prevent transmission from the carrier to other patients.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to ICU or Oncology units and identified to carry C. Difficile via VRE swab

Exclusion Criteria:

* Patients not identified as carriers of C. difficile and patients not admitted to ICU or oncology units

Primary outcomes:
measure: Risk of C. difficile infection among patients colonized with C. difficile comparing the intervention to the control group
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
measure: Oncology and ICU C. difficile infection rates
timeFrame: 24 months
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Meghan A Baker, MD, SCD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02487004: The Study of Association Between Intradialysis Sodium Balance and Clinical Outcomes in Chronic Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End-stage Renal Disease
Lead sponsor: Chung-Ang University
Sponsor class: OTHER
Collaborators: name: Gambro Korea, LTD.
First posted: 2015-07-01
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with end-stage renal disease requiring chronic hemodialysis

Brief summary: The purpose of this study is to determine whether the change of serum and dialysate sodium level during hemodialysis can influence on blood pressure and intradialytic weight gain in chronic hemodialysis patients.


Eligibility criteria: Inclusion Criteria:

* age 20 years or more
* hemodialysis vintage over 3 months
* dialyzed for 4 hours three times per week
* hemodialysis adequacy (Kt/V) over 1.2

Exclusion Criteria:

* diagnosed with chronic hepatitis or infection

Primary outcomes:
measure: intradialytic sodium gradient
timeFrame: baseline and 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
References:
Clinical trial NCT06238804: Characteristic Analysis and Surgical Exploration for Acetabular Roof Fractures: Multicenter Retrospective Cohort Study
Official title: Characteristic Analysis and Surgical Exploration for Acetabular Roof Fractures: Multicenter Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acetabular Fracture
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients met the inclusion criteria were collected in this study.

Brief summary: Acetabular roof was a crucial structure for maintaining the stability of hip joint; however, its important role was not especially emphasized in the Letournel-Judet classification system. Acetabular roof was segmented into the roof column and roof wall in Three-column classification and fracture in this area alone was defined as A3 injury. Radiographic data and functional outcome of A3 injury patients were reviewed to explore the characteristics and surgical strategy.

Detailed description: Fracture data, surgical incision, operation time, blood loss, fracture healing， Reduction quality，functional outcome，and relevant complications

Eligibility criteria: Inclusion Criteria:

* 18-80 years, acute (\<14 days) closed roof column/wall acetabular fractures (A3.1, A3.2 or A3.3) in Three-column classification, normal activity of the affected hip before the injury, received surgical reduction and internal fixation

Exclusion Criteria:

* open fractures, pathologic fractures, limited range of motion (ROM) of the hip joint before the injury, conservative treatment, risk factors affecting bone healing (such as smoking and metabolic diseases) and noncompletion of the two-year follow-up

Primary outcomes:
measure: postoperative outcome
timeFrame: 4 months
Secondary outcomes:
measure: complication
timeFrame: 1 month
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei Medical University Third Hospital
state: Hebei
Study officials:
affiliation: Hebei Medical University Third Hospital
name: Zhiyong Hou, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06680804: Factors Affecting Success of Vaginal Birth After Cesarean Section
Official title: Factors Affecting Success of Vaginal Birth After Cesarean Section in Sohag University Hospitals
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vaginal Delivery
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 1
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted for vaginal delivery with previous lower segment cesarean section . Age from 20 to 40 years.Time interval more than 1.5 years from previous caesarean section.

Brief summary: Factors affecting Success of Vaginal Birth After Cesarean Section in Sohag University Hospitals

Detailed description: * Clinical data will be collected from the participants including demographic details such as age, maternal age, parity, BMI, gestational age based on last menstrual period or early ultrasound scans available.
* Full medical and surgical history, previous CS details as an indication, and previous complications.
* Patients' clinical abdominal and per vaginal examination on admission (cervical dilatation, effacement head station, and position).
* CTG attached on admission (to exclude fetal distress).
* Laboratory investigations that will be done before delivery and postpartum, Labor progress on the partogram will be assessed as regard duration of both first and second stages of labor if any instrumental delivery will be done.
* Radiology investigations such as US.
* Records for patients' vital signs, fetal cardiac activity during labor, vaginal bleeding, delivery notes, fetal weight, and 5 minutes APGAR score, and any recorded maternal or fetal complications.
* If failed VBAC: Causes of failure maternal and fetal outcomes will be recorded and immediate CS to be done

Eligibility criteria: Inclusion Criteria:

* • Age from 20 to 40 years.

  * Time interval more than 1.5 years from previous caesarean section.
  * Single viable full-term pregnancy in vertex presentation.
  * Reactive cardiotocography (CTG) on admission.
  * Spontaneous labor onset.
  * Clinically adequate pelvis.
  * Single fetus
  * Average AFI fetus

Exclusion Criteria:

* • Women with previous upper segment cesarean section or hysterotomy scar.

  * Any obstetric complications such as fetal malpresentation, placenta previa, or medical disorders like diabetes mellitus or preeclampsia.
  * Presence of any signs and symptoms of scar dehiscence or ruptured uterus, known uterine fibroid or anomaly.
  * Suspected fetal macrosomia (weight more than 4 kg).
  * Multifetal pregnancy.
  * Parturient women who refused the trial of vaginal birth after caesarean section.

Primary outcomes:
measure: successful vaginal delivery
timeFrame: From November 2024 to April 2025
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02332304: Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.
Official title: Amniotic Fluid Optical Density Determination Between 28 and 36 6/7 Weeks of Pregnancy and Its Relationship With the Diagnosis of Neonatal Respiratory Distress Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Distress Syndrome, Newborn
Keywords: Respiratory Distress Syndrome, Newborn
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To determine the relationship between the result of amniotic fluid optical density between 26 and 36 6/7 weeks of pregnancy and the risk of developing neonatal respiratory distress syndrome.


Eligibility criteria: Inclusion Criteria:

* Pregnancy between 26 and 36 6/7 weeks.

Exclusion Criteria:

* Problems in the handling of the amniotic fluid sample that prevented the calculation of the optical density.

Primary outcomes:
measure: Respiratory Distress Syndrome, Newborn
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Maternity Hospital
Study officials:
affiliation: Saint Thomas Hospital, Panama
name: Osvaldo Reyes, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00400504: Hypercoagulability and Thromboembolic Risk in Patients With Malignant Disease, Evaluated by Thrombelastograph (TEG®)
Official title: Hypercoagulability and Thromboembolic Risk in Patients With Malignant Disease, Evaluated by Thrombelastograph (TEG®)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Thrombelastograph
Cancer
Thromboembolism
Hypercoagulable
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-11-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Patients with malignancies are at high risk of developing a thromboembolic complication and their treatment with chemo- and or radiation therapy further enhances this risk.

Conventional haemostatic tests are not suitable as a screening tool of a hypercoagulable state. A hypercoagulable profile identified with the whole blood Thrombelastograph (TEG) Analyzer parameter maximal amplitude (MA) is reported to correlate with thrombotic events in patients undergoing major non-cardial surgery and recurrent ischemic events in patients undergoing percutaneous coronary intervention.

In this study we investigate the correlation between TEG measurements and thromboembolic events in patients with newly diagnosed malignancies.

The hypotheses of this study are:

1. Patients with malignancies and hypercoagulability, defined as a TEG MA\>69 mm and /or R\<4 min is at increased risk of developing thromboembolic complications as compared to those with a MA\<69 mm and/or a R\>4 min.
2. Hypercoagulability and hence TEG R and MA values are affected by the treatment instituted in these patients (chemo and radiation therapy) rendering the patients more hypercoagulable and hence at increased risk of developing thrombotic complications.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of cancer

Exclusion Criteria:

* Mamma cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Pär I Johansson, MD
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Gedske Daugaard, MD
role: STUDY_DIRECTOR
References: