louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03138694: Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies
Official title: Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ectopic Pregnancies
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-05-03
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted and treated for a diagnosis of Ectopic pregnancy in The Department of Gynecology, Lis Maternity Hospital

Brief summary: Ectopic pregnancies are a common morbidity in the gynaecological field. Previous work done by our team has shown the benefits of conservative treatment with only BHCG (Beta-Human Chorionic Gonadotropin) monitoring, proving that a vast number of patients will have a self resolution without the need for any further medical intervention. In addition, our working hypothesis is that this process in contrast to Methotrexate is a more physiologic one with less inflammatory and necrosis reaction.

OBJECTIVE To measure and compare the size of the ectopic mass and monitor BHCG levels of women treated with Methotrexate and those that had a self resolution process of their ectopic pregnancy.

Investigators aim to prove that the mass will have an enlargement trend after Methotrexate in contrast to being stable or decrease in size with conservative treatment.

Detailed description: Ectopic pregnancies are a common morbidity in the gynaecological field. Previous work done by our team has shown the benefits of conservative treatment with only BHCG (Beta-Human Chorionic Gonadotropin) monitoring, proving that a vast number of patients will have a self resolution without the need for any further medical intervention. In addition, our working hypothesis is that this process in contrast to Methotrexate is a more physiologic one with less inflammatory and necrosis reaction.

OBJECTIVE To measure and compare the size of the ectopic mass and monitor BHCG levels of women treated with Methotrexate and those that had a self resolution process of their ectopic pregnancy.

Investigators aim to prove that the mass will have an enlargement trend after Methotrexate in contrast to being stable or decrease in size with conservative treatment.

PATIENTS \& METHODS Patients that will be offered to join the study are those that will be with either treated by a Methotrexate injection or those that had signs of self resolution with our "Watchful waiting" protocol.

Eligibility criteria: Inclusion Criteria:

All patients admitted and treated for a diagnosis of Ectopic pregnancy in The Department of Gynecology, Lis Maternity Hospital.

Exclusion Criteria:

none

Primary outcomes:
measure: ectopic mass size
timeFrame: up to 6 weeks.
Secondary outcomes:
measure: BHCG values
timeFrame: up to 6 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Medical Center
name: Ishai Levin, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00181194: Reducing Asthma Disparities by Improving Provider-Patient Communication
Official title: Reducing Asthma Disparities by Improving Provider-Patient Communication About Asthma Severity and Adherence With Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-09-16
Enrollment: 350
Sex: ALL
Minimum age (years): 12
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study will be to assess the impact of a culturally-sensitive, patient-focused asthma communication instrument (ACCI) designed to enhance provider-patient communication by prompting and guiding providers in assessments of disease severity and discussion of adherence behaviors with minority patients with asthma.

Detailed description: Improving communication between health care providers and their patients is the critical first step in efforts designed to reduce asthma-related health disparities in urban areas. Improving communication will help providers tailor asthma therapies to their patients' needs, and help providers and patients to overcome barriers (e.g., concerns about adverse effects) to adherence with those asthma treatment plans.

Eligibility criteria: Inclusion Criteria:

* are able to provide informed consent;
* report physician-diagnosed asthma;
* report asthma symptoms and/or use of short-acting reliever medication at least twice weekly in the past month.

Exclusion Criteria:

* state they do not have asthma;
* have mild intermittent disease
* no recent evidence of disease activity.

Primary outcomes:
measure: Accuracy of Provider Assessment of Asthma Severity
measure: Accuracy of Clinician Assessment of Patient Adherence
measure: Assessment of appropriateness of asthma treatment (consistency of care with asthma guidelines
measure: Patient satisfaction with provider-patient communication and medical care
Secondary outcomes:
measure: These outcomes include indicators of poor asthma control such as health care service use for asthma exacerbations (unscheduled office visits, ER visits, hospitalizations) and use of oral corticosteroid and overuse of inhaled beta-agonist medications.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Asthma And Allergy Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Gregory B Diette, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05802394: The Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced Pancreatic Cancer
Official title: The Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Locally Advanced
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to explore the value of molecular residual disease (MRD) monitoring based on ctDNA in borderline resectable or locally advanced pancreatic cancer. The main questions it aims to answer are:

* prognostic value of baseline MRD;
* the role of MRD dynamic changes after treatment in guiding treatment. Peripheral blood derived from participants will be obtained for MRD test before conversion therapy initiation and at the first imaging assessment after chemotherapy.


Eligibility criteria: Inclusion Criteria:

* patients with histologically confirmed borderline resectable or locally advanced pancreatic cancer;
* conversion therapy was planned;
* both sexes, age ≥18 years old;
* ECOG performance status score ≤2;
* the expected survival time was ≥3 months.

Exclusion Criteria:

* a known diagnosis of pancreatic cancer other than ductal adenocarcinoma;
* treated with any systemic antitumor treatment before first-line chemotherapy onset;
* died or lost to follow-up within one month after the initiation of first-line chemotherpay;
* combined with other primary malignances.

Primary outcomes:
measure: Resection rate
timeFrame: Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)
Secondary outcomes:
measure: Overall survival
timeFrame: Baseline until PD or death, whichever occurs first (up to approximately 24 months)
measure: Progression-free survival
timeFrame: Baseline until PD or death, whichever occurs first (up to approximately 24 months)
measure: R0 resection rate
timeFrame: Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)
measure: Major pathological response
timeFrame: Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)
Other outcomes:
measure: The prognostic value of MRD
timeFrame: Baseline until PD or death, whichever occurs first (up to approximately 24 months)
measure: The prognostic role of targeted therapy selected based on MRD
timeFrame: Baseline until PD or death, whichever occurs first (up to approximately 24 months)
Locations:
city: Beijing
country: China
facility: Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: Peking Union Medical College Hospital
name: Chunmei Bai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05092594: Prognostic Value of IgM in Covid-19 Infection
Official title: The Prognostic Value of IgM in Covid-19 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: Covid-19
anti SARS-Co-V-2 IgM
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 500
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: Adult SARS-CoV-2 positive patients who have blood sampling between 1 day and 14 days from the first clinical syndromes and their collections of serum or plasma are accessible.

Brief summary: The primary objective of the research is to study the relation between the presence and /or the anti SARS-Co-V-2 IgM level in an early stage of COVID-19 infection, and the evolution of the illness.

Detailed description: The secondary objective is to determinate in what manner response of IgM anti-SARS-Co-V-2 relates to patient's immunity statute, in regards to the other so-called humain "seasonal coronavirus".

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years;
* Have been diagnosed positive of SARS-CoV-2 in the Virological Laboratory of Ambroise Paré hospital;
* Have been blood sampled between 1 day and 14 days from the first clinical syndromes, and their collections of serum or plasma are conserved and accessible;
* Affiliated to the social security scheme or entitled;
* Informed and non-opposed to participating to the study.

Exclusion Criteria:

* Opposition of patient to participation to the study;
* Foreign patients under french AME scheme.

Primary outcomes:
measure: Hospitalization
timeFrame: through study completion, an average of 1 month
measure: Ventilation
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: Hospitalization at Ambroise Paré hospital
timeFrame: through study completion, an average of 1 month
measure: Oxygenotherapy
timeFrame: through study completion, an average of 1 month
measure: Ventilation
timeFrame: through study completion, an average of 1 month
measure: Thoracic CT
timeFrame: through study completion, an average of 1 month
measure: Patient's vital statute
timeFrame: through study completion, an average of 1 month
measure: IgM anti-SARS-Co-V-2 presence
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Microbiological Laboratory - CHU Ambroise Paré - APHP
name: Jean-Louis Gaillard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03476694: Ultrasound Guided Supraclavicular Brachial Plexus Block, Volume Comparison of Local Anaesthetics and Diaphragmatic Motility.
Official title: Effects of Various Volume of Local Anaesthetic Use for Ultrasound Guided Supraclavicular Brachial Plexus Block on Successful Blockade and Diaphragmatic Motility.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sucessful Block With Less Hemidiaphragmatic Paresis in Distal Upper Arm Fracture
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Brachial plexus block as done by landmark technique use large volume of local anaesthetics (at least 30-40 ml), leading to higher incidence of phrenic nerve involvement and diaphragmatic dysfunction. With use of ultrasound dose of local anaesthetic can be reduced. Volume as low as 20 ml when use by ultrasound guidance has shown to provide successful block with no hemidiaphragmatic palsy when compared with nerve stimulation technique. But no study has compared the different volumes of drug on success rate and diaphragmatic motility.So in this study , the investigators want to compare the incidence of hemidiaphragm paralysis and success of block with different volumes of local anaesthetic , so that the lowest effective dose with higher safety profile can be determined.


Eligibility criteria: Inclusion

* Age between 18 and 60 years undergoing distal arm surgery
* American Society of Anesthesiologists physical status 1 to 3
* Able to give informed consent
* Body weight greater than 50 kg

Exclusion

* Patient refusal for supraclavicular block.
* Inability to obtain informed consent.
* Contraindication to Brachial plexus block
* Pulmonary and cardiac disorders
* Pregnancy
* Allergy to local anesthetic
* Chest or shoulder deformities

Primary outcomes:
measure: hemidiaphragmatic paralysis
timeFrame: within 30 minutes after sucessfull blocade
Secondary outcomes:
measure: sucessful blocade
timeFrame: within 30 minutes of block
Other outcomes:
Locations:
city: Dharān Bāzār
country: Nepal
facility: B P Koirala Institute of Health science (BPKIHS)
state: Koshi Zone
Study officials:
References:
Clinical trial NCT00000194: Neurobiology of Opioid Dependence: 3 - 3
Official title: Neurobiology of Opioid Dependence: 3
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Opioid-Related Disorders
Keywords: opioid disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the effects of cycloserine on naloxone-precipitated opiate withdrawal.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Behavioral, subjective, measures of naloxone-preci
measure: Phsyiological, neuroendocrine measures of naloxone
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Marc I Rosen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00797394: Efficacy of Natural Extract 2007RD01 Combined With Saw Palmetto in Benign Prostatic Hyperplasia Patients Compared to Saw Palmetto
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Benign Prostatic Hyperplasia
Keywords: prostate
dietary supplements
saw palmetto
canada
Lead sponsor: innoVactiv Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-25
Enrollment: 110
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
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 if the combination of 2007RD01, a natural extract, and saw palmetto lipidic extract, is more effective at treating lower urinary tract symptoms associated with benign prostatic hyperplasia than saw palmetto lipidic extract alone.


Eligibility criteria: Inclusion Criteria:

* Patient must be an adult man aged between 50 and 75
* Patient must have Benign Prostatic Hyperplasia symptoms

Exclusion Criteria:

* Patient has a malfunction of the urinary tract, is suffering from acute urinary retention, or is suffering from prostate cancer or urinary tract infection
* Patient has been subjected to surgery of the prostate, bladder or urethra
* Patient has taken a 5-alpha-reductase inhibitor in the 6-month period preceding screening
* Patient has taken an alpha-blocker in the 2-week period preceding screening

Primary outcomes:
measure: Absolute and relative (%) change in IPSS between baseline and end of study
timeFrame: 90 days ±7 days
Secondary outcomes:
measure: Absolute and relative (%) change in IPSS between baseline and day 30 of follow-up
timeFrame: 30 days ±7 days
measure: Absolute and relative (%) change in peak urinary flow between baseline and after 30 or 90 days of follow-up
timeFrame: 30 days ±7 days , 90 days ±7 days
measure: Absolute and relative (%) change in post-void residual volume between baseline and after 30 or 90 days of follow-up
timeFrame: 30 days ±7 days , 90 days ±7 days
measure: Change in health related quality of life between baseline and after 30 or 90 days of follow-up
timeFrame: 30 days ±7 days , 90 days ±7 days
measure: Change in sexual function between baseline and after 30 or 90 days of follow-up
timeFrame: 30 days ±7 days , 90 days ±7 days
Other outcomes:
Locations:
city: Granby
country: Canada
facility: Recherches Cliniques Theradev
state: Quebec
city: Greenfield Park
country: Canada
facility: Urology South Shore Research
state: Quebec
city: Montreal
country: Canada
facility: Les Urologues Associés du CHUM
state: Quebec
city: Quebec
country: Canada
facility: Clinique d'urologie Berger
Study officials:
References:
Clinical trial NCT04885894: An Examination of Cognitive Fatigue Using Functional Neuroimaging
Official title: An Examination of Cognitive Fatigue Using Functional Neuroimaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: Celgene
name: Hackensack Meridian Health
name: St. Barnabas Medical Center
First posted: 2021-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with Relapsing Remitting Multiple Sclerosis and Healthy Controls

Brief summary: The purpose of this research study is to investigate the effectiveness of MS Disease modifying medications on cognitive fatigue in persons with relapsing remitting multiple sclerosis (RRMS). Cognitive fatigue is the kind of fatigue that occurs after intense mental concentration as after a session of problem solving.

Detailed description: The researchers aim is to investigate the effects of disease modifying treatments on cognitive fatigue and on specific brain areas that have been shown to underlie cognitive fatigue in individuals with Multiple Sclerosis (MS). The researchers will investigate the effects on the cognitive fatigue that develops during the performance of a demanding task, and also on how cognitive fatigue changes as a function of duration of treatment.

Eligibility criteria: Inclusion Criteria:

* Age between 18-64.
* Relapsing remitting multiple sclerosis
* Been newly prescribed a new disease modifying medication for MS (either Zeposia or other high dose oral efficacy medication)
* or healthy volunteer who can speak English fluently.

Exclusion Criteria:

* History of head injury, stroke, seizures, or any other significant neurological event other than MS
* Flare up of MS symptoms within the past month.
* History of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder.
* Pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids \[cochlear implants\]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments.
* left handed.
* Not able to have an MRI

Primary outcomes:
measure: Brain activation (BOLD signal)
timeFrame: Measured for change at 3 time points (before, six months and 12 months after intervention)
Secondary outcomes:
measure: Fatigue Onset
timeFrame: Measured for change at 3 time points (before, six months and 12 months after intervention)
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: John DeLuca, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01616394: Postoperative Troponin in Children With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2012-06-11
Enrollment: 180
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children with congenital heart disease admitted for surgery

Brief summary: The aim of the study is to evaluate the value of postoperative troponin in the prediction of mid term and long term mortality and morbidity in children with congenital heart disease undergoing cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* all children with congenital heart disease between 0-10 years admitted for elective or emergency corrective or palliative cardiac surgery

Exclusion Criteria:

* parental refusal
* children older than 10 years

Primary outcomes:
measure: mortality
timeFrame: 3 months
Secondary outcomes:
measure: morbidity and mortality and length of stay in the PICU and in the hospital
timeFrame: in hospital; 3 months; 6 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires saint Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Mona MOMENI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Momeni M, Poncelet A, Rubay J, Matta A, Veevaete L, Detaille T, Houtekie L, Clement de Clety S, Derycke E, Moniotte S, Sluysmans T, Veyckemans F. Does Postoperative Cardiac Troponin-I Have Any Prognostic Value in Predicting Midterm Mortality After Congenital Cardiac Surgery? J Cardiothorac Vasc Anesth. 2017 Feb;31(1):122-127. doi: 10.1053/j.jvca.2016.02.018. Epub 2016 Feb 23.