louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03668184: What Are the Predictive Factors for Preeclampsia in Oocyte Recipients? - PREROVE
Official title: What Are the Predictive Factors for Preeclampsia in Oocyte Recipients? - PREROVE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Oocyte Donation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a pregnancy of more than 22 weeks of amenorrhea resulting from an oocyte donation.

Brief summary: The main goal is to determine which risk factors develop preeclampsia in this specific group of oocyte recipients.


Eligibility criteria: Inclusion Criteria:

* All major patients with a pregnancy of more than 22 weeks of amenorrhea resulting from an oocyte donation in one of the study centers, having given birth between January 2010 and April 2017 and not opposed to participation in the study.

Exclusion Criteria:

* all pregnancies resulting from an oocyte donation abroad, persons of legal age subject to legal protection (safeguard of justice, guardianship, tutorship) and persons deprived of their liberty.

Primary outcomes:
measure: occurrence of pre-eclampsia
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
city: Rennes
country: France
facility: Clinique de la sagesse
Study officials:
affiliation: Rennes University Hospital
name: Solène DUROS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03727984: Re-hospitalized Patients With Acute Coronary Syndrome
Official title: Demographic, Clinical Characteristics and Medications of Re-hospitalized Patients for Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Myocardial infarction
Hospitalization
Coronary artery disease
Retrospective
Cohort study
Lead sponsor: Cardiovascular Academy Society, Turkey
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 577
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The aim of this retrospective multicenter study is to evaluate the demographic, clinical characteristics and medications of re-hospitalized for new cardiac event in patients with history of acute coronary syndrome within in 12 months. To the best of our knowledge, this is the first study to evaluate the characteristics of re-hospitalized patients for ACS. The case report forms which attached in excel must be filled by investigators case by case based on recorded data.

Brief summary: The predictors of re-hospitalization of patients with history of acute coronary syndrome

Detailed description: The aim of this retrospective multicenter study is to evaluate the demographic, clinical characteristics and medications of re-hospitalized for new cardiac event in patients with history of acute coronary syndrome within in 12 months.

Eligibility criteria: Inclusion Criteria:

Patients age \>18 years who had hospitalized for acute coronary syndrome within 12 months

Exclusion Criteria:

Patients whose previous hospitalizations data are not available Myocardial Infarction, type 2 patients

Primary outcomes:
measure: Clinical and demographics characteristics of patients re-admitted with acute coronary syndrome
timeFrame: Up to 1 year
measure: Cardiovascular Hospitalization
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Cardiovascular Academy Society
Study officials:
References:
Clinical trial NCT02853084: HL2351 CAPS Phase II Study
Official title: An Open Label, Single Arm Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of HL2351 in Patients With Cryopyrin Associated Periodic Syndromes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cryopyrin-Associated Periodic Syndromes (CAPS)
Keywords: Auto-inflammatory diseases
IL-1 inhibitors
HL2351
Cryopyrin-Associated Periodic Syndromes (CAPS)
Neonatal Onset Multisystem Inflammatory Disease (NOMID)
Muckle-Wells Syndrome (MWS)
Familial Cold Autoinflammatory Syndrome (FCAS)
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-02
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, single arm trial to evaluate the efficacy, safety, and pharmacokinetics of HL2351 in patients with cryopyrin associated periodic syndromes (CAPS).

Detailed description: This trial enrolls patients with CAPS being on stable dose of anakinra daily and then switch over HL2351 given once weekly. It consists of 4 phases, 6-week screening, single dose PK, 6-month multiple dose, and 18-month extension phase.

Eligibility criteria: Inclusion Criteria:

* Documented molecular diagnosis of NALP3 mutation or diagnosis of CAPS based on sign and symptom
* Diagnosis of CAPS based on signs and symptoms
* Current stable doses of anakinra, alone or in combination with methotrexate or corticosteroids

Exclusion Criteria:

* Patient been diagnosed with a hereditary periodic fever syndrome or autoinflammatory disease other than CAPS
* Patients whose disease is inadequately controlled on current stable doses of anakinra, alone or in combination with methotrexate or corticosteroids

Primary outcomes:
measure: Change in Diary Symptom Sum Score (DSSS)
timeFrame: from baseline to Month 6
measure: Change in SAA, CRP, ESR levels
timeFrame: from baseline to Month 6, from baseline to each visit up to Month 24
measure: Change in physician's global assessment of autoinflammatory using 100mm VAS score disease
timeFrame: from baseline to Month 6, from baseline to each visit up to Month 24
measure: Change in patient's(parents or legal guardians) global assessment of autoinflammatory using 100mm VAS score disease
timeFrame: from baseline to Month 6, from baseline to each visit up to Month 24
measure: Pharmacokinetic profile(Cmax)
timeFrame: 0,12,24,36,48,72,96,144,168 hr
measure: Pharmacokinetic profile(AUClast)
timeFrame: 0,12,24,36,48,72,96,144,168 hr
measure: Pharmacokinetic profile(AUCinf)
timeFrame: 0,12,24,36,48,72,96,144,168 hr
measure: Pharmacokinetic profile(Tmax)
timeFrame: 0,12,24,36,48,72,96,144,168 hr
measure: Pharmacokinetic profile(t1/2)
timeFrame: 0,12,24,36,48,72,96,144,168 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Handok Inc.
Study officials:
affiliation: Seoul National University Hospital
name: JOONG GON KIM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04836884: Vascular Anomaly Pathology and Genomics Biopsy Study
Official title: Validation of Core Biopsy of Vascular Anomalies for Clinical Pathology and Genomics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Malformations
Vascular Anomaly
Hemangioma
Arteriovenous Malformations
Venous Malformation
Klippel Trenaunay Syndrome
Lymphatic Malformation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research is to gather information on the safety and effectiveness of core biopsy of vascular anomalies for clinical pathology and clinical genomics studies.

Detailed description: Vascular anomalies or vascular malformations often are treated with minimally invasive sclerotherapy, embolization or ablation based on clinical and imaging features without acquisition of tissue. Over the last two decades there have been significant advancements in the understanding of the genetic basis for various vascular anomalies/malformations, which may guide use of therapies for individualized treatment.

As such, given the emergence of novel medications for treatment of vascular anomalies/malformations based on genetic information, acquisition of tissue for pathology and genomic characterization will be increasingly important as treatment of vascular anomalies/vascular malformations moves toward individualized medicine approach.

Eligibility criteria: Inclusion Criteria:

* Patients with a clinical and imaging diagnosis of a vascular anomaly.
* No prior treatment for the vascular anomaly.
* Subjects undergoing clinically indicated sclerotherapy, embolization and/or ablation.
* Male or female with age greater than or equal to 18 years.
* Capacity and willingness to provide a written informed consent..

Exclusion Criteria:

* Subjects with prior treatment for their vascular anomaly.
* Uncorrectable coagulopathy.
* Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the procedure.

Primary outcomes:
measure: Adequacy of core biopsy of vascular anomalies for clinical genomics studies
timeFrame: 18 months
measure: Adequacy of core biopsy of vascular anomalies for clinical pathology evaluation
timeFrame: 18 months
Secondary outcomes:
measure: Safety of vascular anomaly core biopsy
timeFrame: 30 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Emily Bendel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: David A Woodrum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04177784: Web Based Intervention to Reduce Weight Bias Among Dietitians
Official title: Web Based Intervention to Reduce Weight Bias Among Dietitians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention Video (I)
Weight Control Video (C1)
Weight Neutral Control Video (C2)
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 166
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Weight bias in dietitians is prevalent and may affect patient care. The investigators conducted a randomized controlled trial to test if explicit and implicit bias could be influenced by a short, 20 minute educational video.

Detailed description: This randomized controlled trial studied the effect of three different videos on weight bias in a nationally representative sample of dietitians. The "intervention" group (I) watched a video about the etiology of obesity, reasons for weight regain, and how to talk to patients about weight. The first "control" group (C1) received information about the role of the environment and individual behavior in weight gain, and tools to help patients control their weight. The second control group (C2) received a weight neutral video about the role of dieticians in society. Bias measures were taken before and just after watching the video, and again one month later.

Eligibility criteria: Inclusion Criteria:

* Any dietitian in the Clinical Dietitian Registry Database.

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in "Blame" explicit bias
timeFrame: Change from pre to immediately post intervention (1 hour)
measure: Change in "Blame" explicit bias
timeFrame: Change from pre to 1 month post intervention
Secondary outcomes:
measure: Change in "Social" explicit bias
timeFrame: Change from pre to immediately post intervention (1 hour)
measure: Change in "Social" explicit bias
timeFrame: Change from pre to 1 month post intervention
measure: Change in "Physical" explicit bias
timeFrame: Change from pre to immediately post intervention (1 hour)
measure: Change in "Physical" explicit bias
timeFrame: Change from pre to 1 month post intervention
measure: Change in Implicit Bias
timeFrame: Change from pre to immediately post intervention (1 hour)
measure: Change in Implicit Bias
timeFrame: Change from pre to 1 month post intervention
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University
state: Texas
Study officials:
References:
Clinical trial NCT06956079: Effect of End-inspiratory Pause on Gas Exchange During Mediastinal Mass Excision With CO2 Insufflation and One-lung Ventilation
Official title: Effect of End-inspiratory Pause on Gas Exchange During Mediastinal Mass Excision With CO2 Insufflation and One-lung Ventilation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mediastinal Mass Requiring Video-assisted Surgical Excision
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: " Mediastinal mass excision is typically performed via video-assisted thoracoscopic surgery (VATS). To secure a clear surgical field, the ipsilateral lung must be deflated, achieved through one-lung ventilation (OLV) and intrathoracic CO₂ insufflation. However, OLV increases intrapulmonary shunt due to continued perfusion of the non-ventilated lung, potentially leading to hypoxemia and hypercapnia.

When performed in the supine position, gas exchange becomes more challenging compared to lateral decubitus due to limited gravitational redistribution of blood flow. Although CO₂ insufflation aids surgical exposure through passive lung deflation, it may also increase CVP and PCWP, reduce cardiac output, and raise PaCO₂, contributing to respiratory acidosis.

End-inspiratory pause (EIP), a ventilatory setting that pauses airflow at end-inspiration, prolongs alveolar gas exchange and improves ventilation-perfusion matching. Prior studies show EIP can enhance gas exchange, reduce microatelectasis, and improve CO₂ clearance in patients with acute lung injury. We therefore aimed to assess the effect of EIP application during VATS mediastinal mass excicion.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged 20 to 80 years scheduled for video-assisted thoracoscopic mediastinal tumor resection.
* American Society of Anesthesiologists (ASA) physical status classification of II (patients with mild systemic disease) or III (patients with severe systemic disease limiting activity).

Exclusion Criteria:

* Moderate to severe chronic obstructive pulmonary disease (COPD) according to GOLD criteria: defined as FEV₁/FVC \< 0.7 and FEV₁ ≤ 80% of predicted on pulmonary function testing.
* Diffusion capacity of the lung for carbon monoxide (DLCO) \< 80% of predicted.
* History of pneumothorax or presence of bullae or blebs on preoperative imaging.
* Inability to read or understand the subject information sheet and consent form.

Primary outcomes:
measure: PaCO₂ at 20 minutes after each ventilation method
timeFrame: PaCO₂ is assessed at 20 minutes after each ventilation method
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT03095079: Rh-endostatin in Combination With Dacarbazine and Cisplatin as the First Line Therapy for Metastatic Melanoma
Official title: a Phase II Trial With Continuous Intravenous Infusion of Rh-endostatin in Combination With Dacarbazine and Cisplatin as the First Line Therapy for Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Melanoma
Keywords: endostar
dacarbazine
cisplatin
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The incidence of Melanoma is rapidly growthing,and in China,dacarbazine combined with cisplatin is conmendly used as the first-line chemotherapy of metastatic melanoma. But the response rate and survival results are very limited.This trial aim to add a safe and effective anti-angiogenesis drug,Human-recombinant endostatin,to find out a new strategy which may further extend the PFS and OS with a tolerated toxicity.


Eligibility criteria: Inclusion Criteria:

* 1. Histologically confirmed melanoma with metastases and has no received any systemic treatment.
* 2.At least one measurable site (diameter≥1cm) of disease (RECIST 1.1).
* 3.Estimated life expectancy of 12 weeks or greater
* 4. ECOG performance status 0, 1
* 5.Adequate organ function
* 6.Without symptoms of brain metastases and stable in neuro-functions

Exclusion Criteria:

* 1. Pregnant or lactation women
* 2. Acute infections without control.
* 3. Heart disease history, cardiac function class≥NYHA II.
* 4. HIV positive or chronic HBV/HCV in active stage.
* 5. Brain metastases or primary tumor with positive symptoms
* 6. Need anti-epileptic treatments
* 7. Organ transplantation history
* 8. Hemorrhagic tendency or related history
* 9. Renal dialysis patients
* 10. Diagnosis of any second malignancy within the last 3 years, except for adequately treated.
* 11. Current treatment on another clinical trial
* 12. The other improper situations which investigator judged.

Primary outcomes:
measure: progress-free survival(PFS)
timeFrame: From randomization up to 144 weeks
Secondary outcomes:
measure: Disease control rate(DCR)
timeFrame: From randomization up to 144 weeks
measure: adverse events
timeFrame: From randomization up to 144 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
citation: Cui C, Mao L, Chi Z, Si L, Sheng X, Kong Y, Li S, Lian B, Gu K, Tao M, Song X, Lin T, Ren X, Qin S, Guo J. A phase II, randomized, double-blind, placebo-controlled multicenter trial of Endostar in patients with metastatic melanoma. Mol Ther. 2013 Jul;21(7):1456-63. doi: 10.1038/mt.2013.79. Epub 2013 May 14.
Clinical trial NCT01061879: Expansion of Umbilical Cord Blood Using a Unique Bio-system
Official title: Ex Vivo Expansion of Umbilical Cord Blood Using a Unique Bio-system
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: umbilical cord
umbilical cord blood collection
pregnancy
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2010-02-03
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: umbilical cord collection from full-term caesarian section/normal vaginal delivery patients

Brief summary: By doing this study, researchers hope to develop a special technique and laboratory conditions to help support umbilical stem cell growth and multiplication.

In this project, researchers propose a three dimensional (3D) microenvironment that mimics the bone marrow stem cell microenvironment, with its supporting cells of osteoblasts and stromal cells. In theory, this will result in better expansion of cord blood stem cells ex vivo.

Detailed description: To successfully expand umbilical cord blood stem cells ex vivo, a microenvironment that resembles the stem cell microenvironment, or stem cell 'niche' should be created. In designing this bio-system, we make use of several observations. First, bone osteoblasts are important in promoting hematopoietic stem cell expansion, accordingly, this bio-system will ensure the physical proximity of the cord blood stem cells to a 3D bone tissue derived from mesenchymal stem cells (MSCs). These MSCs will be isolated from Wharton's jelly, and by using an osteogenic medium and special scaffolds, these MSCs will differentiate into osteogenic progenitors creating a 3D bone structure. The other observation is that, co-culture of cord blood stem cells with mesenchymal stem cells is superior to liquid cultures in terms of ex vivo expansion , accordingly, in this experiment, undifferentiated MSCs will be co-cultured with cord blood stem cells in this created 3D bone structure. This is a unique design that has the potential to expand cord blood stem cells more efficiently.

Eligibility criteria: Inclusion Criteria:

* females that consent to permit researchers collect the discarded umbilical cords from the placenta and use for research purposes.

Exclusion Criteria:

-

Primary outcomes:
measure: bio-system for ex-vivo expansion of umbilical cord blood stem cells
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Omar Aljitawi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06779279: Adjunctive Oral Hygiene Aids in Reducing Oral Hygiene Parameters Among Orthodontic Patients
Official title: Adjunctive Oral Hygiene Aids in Reducing Commonly Seen Oral Hygiene Parameters Among Orthodontic Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gingival Bleeding
Dental Plaque Accumulation
Keywords: waterflosser
superfloss
gingival bleeding
Dental Plaque
Lead sponsor: Ajman University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study comprised 18-35-year-old girls and boys planning orthodontic treatment. Participants had upper right tooth to lower left molar braces, a pocket depth of 3 mm, and had not flossed in 24 hours. Smoking, periodontal disease, missing teeth, voids between teeth in the arch, and systemic disorders disqualified participants.
Primary purpose: PREVENTION

Brief summary: Adult orthodontic patients aged 18-30 were included in a randomised, singleblind clinical research using a split-mouth design at a dental clinic. Both theWaterflosser® and the Super-Floss® water flossers are manufactured by Oral-B.

Detailed description: In order to reduce gingival inflammation and remove subgingival plaque, oral hygiene therapy is necessary. The available evidence indicates that mechanical plaque control, which patients administer themselves daily, is the most important factor in managing and reducing plaque accumulation. Aim: This research aimed to determine whether Waterflosser or Superfloss was more effective in lowering the gingival bleeding score and plaque. Methods: Adult orthodontic patients aged 18-30 were included in a randomised, single-blind clinical research using a split-mouth design at a dental clinic. Both the Waterflosser® and the Super-Floss® water flossers are manufactured by Oral- B.

Eligibility criteria: Inclusion Criteria:

* Participants aged 18-35 years undergoing orthodontic treatment and
* systemically healthy without habits

Exclusion Criteria:

* Participants not undergoing orthodontic treatment and participants undergoing orthodontic treatment in the included age category but with systemic conditions prevalent
* missing teeth and
* treated previously for periodontal conditions

Primary outcomes:
measure: Number of Participants with Gingival Bleeding
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: Number of Participants with Dental Plaque
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Ajman
country: United Arab Emirates
facility: Ajman university
Study officials:
affiliation: Ajman University
name: sudhir Rama Varma, MDS
role: PRINCIPAL_INVESTIGATOR
References: