louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05649579: Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid
Official title: Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid: a Multicenter Retrosepctive Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bullous Pemphigoid
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Chinese Academy of Medical Sciences
name: West China Hospital
name: Second Xiangya Hospital of Central South University
name: Shandong Provincial Institute of Dermatology and Venereology
First posted: 2022-12-14
Enrollment: 146
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 bullous pemphigoid patients treated with dupilumab between January 1, 2021, and July 31, 2022, at six leading dermatology departments in the Chinese Collaborative Network for Autoimmune Bullous Diseases.

Brief summary: This study was designed to be a retrospective, multicentre, observational study to evaluate the efficacy and safety of dupilumab in the treatment of bullous pemphigoid and to find predictors of efficacy.


Eligibility criteria: Inclusion Criteria:

* Adult bullous pemphigoid patients treated with dupilumab between January 1, 2021, and July 31, 2022, at six leading dermatology departments in the Chinese Collaborative Network for Autoimmune Bullous Diseases.
* The diagnosis of BP requires clinical manifestations and immunological or pathological evidences.
* Dupilumab treatment should continue for at least 4 weeks and possibly longer.

Exclusion Criteria:

* Drug-induced BP, γ-1 pemphigoid
* Patients with less than 4 weeks of follow-up
* Patients were given any other biologicals within 6 months before the first dupilumab administration

Primary outcomes:
measure: Proportion of patients reached disease control
timeFrame: within 4 weeks
Secondary outcomes:
measure: Complete remission rate
timeFrame: within 64 weeks
measure: Relapse rate
timeFrame: within 64 weeks
measure: Adverse events
timeFrame: within 64 weeks
measure: Changes in BPDAI scores
timeFrame: from 0 to 64 weeks
measure: Changes in itching NRS scores
timeFrame: from 0 to 64 weeks
measure: Changes in serum anti-BP180 antibodies
timeFrame: from 0 to 64 weeks
measure: Changes in serum anti-BP230 antibodies
timeFrame: from 0 to 64 weeks
measure: Changes in serum total IgE
timeFrame: from 0 to 64 weeks
measure: Changes in peripheral blood eosinophil count
timeFrame: from 0 to 64 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Mingyue Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01502579: An Observational Study of IgA Nephropathy: Pathological Variants and Clinical Data
Official title: An Observational Study of the Relationship Between Pathological Variants and Clinical Data at Presentation and Follow-up in IgA Nephropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IgA Nephropathy
Keywords: IgA nephropathy
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2011-12-30
Enrollment: 603
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population from which the cohort will be selected is these who have received renal biopsy in Guangdong General Hospital

Brief summary: The pathological variants of IgA nephropathy identified by the Oxford classification may be related to the clinical data at presentation and follow-up, including proteinuria and renal function. This study is aimed to identify the potential relationship between pathological variants and clinical data in IgA nephropathy.


Eligibility criteria: Inclusion Criteria:

* biopsy-proven IgA nephropathy;

Exclusion Criteria:

Primary outcomes:
measure: glomerular filtration rate decline or end-stage renal disease or doubling of serum creatinine
timeFrame: after the biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Wei Shi, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04201379: Determines of Quality of Life in Patients
Official title: Nonspecific Neck Patients's Quality of Life and Their Predictors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Neck Pain
Keywords: chronic
neckpain
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: people with a diagnosis of neck disease living in Ankara and who can answer the study questions

Brief summary: Pain, muscle spasm, loss of muscle strength and impaired posture adversely affect the daily life activities and quality of life of neck pain patients.However, the quality of life; It is a multifaceted concept that includes not only the age, sex, marital status, educational status and duration of pain, but also the number of children, BMI, depression, sleep quality, pain-related inadequacy and fatigue. Therefore, considering all these; quality of life; The aim of our study was to determine the factors affecting the quality of life in nonspesific neck patients with the effect that the determinants affecting physical, physical role difficulty, pain, general health, vitality, social function, emotional role difficulty and mental health may be different.

Detailed description: The study will include 93 people with a diagnosis neck disease who apply to the physical therapy outpatient clinic. After recorded sociodemographic and clinical characteristics of the individuals, some evaluations will be done only once. The evaluations to be used in the study are as follows: Pain Assesment will be evaluated with McGill Pain Questionnaire, Sleep disorders will be evaluated with Pitsburgh Sleep Quality Index (PSQI), Fatigue level will be assessed by the Fatigue Questionnaire, Beck Depression Inventory (BDI) will be used to determine depression levels. The quality of life of the subjects wiil be evaluate by using the Short Form-36 questionnaire.

Eligibility criteria: Inclusion Criteria:

1) People 18 years and older

Exclusion Criteria:

1. Hospitalized people
2. Newly Operated People
3. People with psychological diagnosis

Primary outcomes:
measure: DETERMINING FACTORS AFFECTING THE QUALITY OF LIFE
timeFrame: 27 february 2020
measure: IS PAIN DETERMINING THE QUALITY OF LIFE
timeFrame: 27 february 2020
measure: IS PAIN INTENSITY DETERMINING THE QUALITY OF LIFE
timeFrame: 27 february 2020
measure: IS SLEEP QUALİTY DETERMINING THE QUALITY OF LIFE
timeFrame: 27 february 2020
measure: IS FATIGUE DETERMINING THE QUALITY OF LIFE
timeFrame: 27 february 2020
measure: IS DEPRESSION DETERMINING THE QUALITY OF LIFE
timeFrame: 27 february 2020
measure: IS Anxıety DETERMINING THE QUALITY OF LIFE
timeFrame: 27 february 2020
measure: Is pain disability DETERMINING THE QUALITY OF LIFE
timeFrame: 27 february 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ayça Aytar
Study officials:
References:
Clinical trial NCT02955979: Incidence of Acute Renal Failure Associated With Iodinated Contrast Agents in Pediatrics
Official title: Incidence of Acute Renal Failure Associated With Iodinated Contrast Agents in Pediatrics. Study CANOPY. Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Renal Insufficiency
Keywords: acute renal insufficiency
Iodinated Contrast Agents
pediatric
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-11-04
Enrollment: 4
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients less than 16 years and who enjoys receiving an injected CT.

Brief summary: Iodinated contrast media are now frequently used in diagnostic imaging exams, including pediatrics.

In adults, the acute renal failure (ARF) associated with contrast agents (CA-AKI) occur in 3-33% of exposed patients, especially as the patient is fragile, has comorbidities or pre-existing renal aggression .

In children, the prevalence of this little known disease is probably underestimated.

The investigators intend to conduct a prospective epidemiological study, to estimate the impact of the acute renale failure to iodinated contrast agents in pediatrics.

Detailed description: Patients will be included those of pediatric emergencies, Hospitalization Unit of Short Duration pediatric, pediatric intensive care and pediatric resuscitation. The acute renale failure will be estimated on the basis of criteria KDIGO (score of kidney disease) group in 2012 to 48 hours a computed tomography (CT) scan with injection of contrast media, based on a change in creatinine clearance of the estimated according to the formula Schwartz revised in 2009 and / or diuresis.

Patient characteristics will be identified in order to establish risk factors.

Eligibility criteria: Inclusion Criteria:

* Patients under 16 years admitted to a participating service
* Patient receiving an injected CT scan

Exclusion Criteria:

* Prior Inclusion in the study during an earlier review.
* Opposition of parents.
* Chronic renal failure or end-stage requiring renal replacement in the long term.

Primary outcomes:
measure: Creatinine
timeFrame: change from baseline creatinine at 7 days
measure: Diuresis
timeFrame: change from baseline diuresis at 7 days
Secondary outcomes:
measure: Readmission
timeFrame: at 7 days
measure: Hospitalization in intensive care
timeFrame: at 7 days
measure: Renal replacement
timeFrame: at 7 days
measure: Death
timeFrame: at 7 days
Other outcomes:
Locations:
city: Lyon
country: France
facility: CHU de Lyon
city: Saint Etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Olivier MORY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05845879: Obstetrical Outcomes for Planned Deliveries in a French Birth Center
Official title: Obstetrical Outcomes for Planned Deliveries in a French Birth Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delivery Complication
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women who want to deliver at the birth center "Un nid pour naître" since 01/01/2020 to 31/12/2022

Brief summary: The main objective of this work is to study the obstetrical and neonatal outcomes of women who planned to deliver in the birth centre of Nancy.

The birth centre of Nancy is one of the nine french birth centres opened since 2015 on an experimental basis.

The women who plan to deliver at the birth centre must meet several conditions according to their medical history, pregnancy follow-up, and delivery progress.

The women can be transferred before, during or after (pre-, per- or post-) delivery to the hospital.


Eligibility criteria: Inclusion Criteria:

* women who want to deliver at the birth center "Un nid pour naître"

Exclusion Criteria:

* Refusal to participate in the study.

Primary outcomes:
measure: Comparison of the cesarean birth rate of women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
timeFrame: 4 years
measure: Comparison of the instrumental birth rate of women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
timeFrame: 4 years
measure: Comparison of the post-partum haemorrhage rate of women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
timeFrame: 4 years
Secondary outcomes:
measure: Comparison of the antepartum or peripartum stillbirth rate of women who planned to deliver in the birth center according to the final place of labor (hospital or birth centre).
timeFrame: 4 years
measure: Comparison of the hypoxemic encephalopathy rate of women who planned to deliver in the birth center according to the final place of labor (hospital or birth centre).
timeFrame: 4 years
measure: Comparison of the five-minute Apgar score of babies from women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
timeFrame: 4 years
measure: Comparison of the umbilical artery blood pH score of babies from women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05328479: Plasma Immunity of Mild SARS-CoV-2 Omicron and Delta Pandemic in Thailand
Official title: The Study of Treatment Outcome and Immunogenicity of mild-to Moderate COVID-19 Patients During the Delta vs. the Omicron Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
antibody
immunity
home isolation
vaccine
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 5181
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The COVID-19 patients who confirmed by RT-PCR at Siriraj hospital since July 8, 2021 with mild to moderate symptoms and isolated in patients' own home so-called "Siriraj Home isolation".

Brief summary: The investigators assessed the effect of treatment for COVID and immunity of the volunteers who admitted to the home isolation.

Detailed description: The investigators aimed to assess the effect of treatment for COVID and immunity of the volunteers who admitted to the home isolation. The investigators compared the population between the age groups 12-18 years, 18-45 years and over 45 years to monitor the symptoms of coronavirus patients treated in home isolation and long-term symptoms including factors related to the patient's recovery in the past, present, and future.

Eligibility criteria: Inclusion Criteria:

1. patient with infected with the novel coronavirus disease 2019 (COVID-19) who has been end of self-quarantine at Siriraj Hospital more than 21 days.
2. Thai nationality, able to read and write Thai language
3. able to use telephone and line to communicate

Exclusion Criteria:

1. people who received additional vaccination after leaving quarantine before the day of the immunization test

Primary outcomes:
measure: Anti-SARS-CoV-2 RBD IgG
timeFrame: Baseline
measure: Anti-SARS-CoV-2 NP
timeFrame: Baseline
measure: Cycle threshold of the first PCR test
timeFrame: Baseline
Secondary outcomes:
measure: Number of vaccine injection
timeFrame: Baseline
measure: Type of vaccine injection
timeFrame: Baseline
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Doctor in Family Medicine
name: Korapat Mayurasakorn, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05399979: Fetal Heart Rate Changes and Labor Neuraxial Analgesia: a Machine Learning Approach
Official title: Fetal Heart Rate Changes and Labor Neuraxial Analgesia: a Machine Learning Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Bradycardia
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 1077
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -Pregnant patients admitted to the labor and delivery unit of an academic center

Brief summary: This study aims to perform statistical inference and prediction of changes in fetal heart rate during active labor in healthy pregnant women by comparing three different machine learning methods

Detailed description: Purpose: This study aims to perform statistical inference and prediction of changes in fetal heart rate during active labor in healthy pregnant women by comparing three different machine learning methods. Methods: A retrospective analysis of 1077 healthy laboring parturients receiving neuraxial analgesia was conducted. We compared a principal components regression model with treebased random forest, ridge regression, multiple regression, a general additive model, and elastic net in terms of prediction accuracy and interpretability for inference purposes.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* Pregnancy requiring labor analgesia
* Active labor
* Request of neuraxial analgesia per patient and/or obstetrician
* Received combined spinal-epidural technique

Exclusion Criteria:

* Uterine tachysystole before neuraxial analgesia.
* Baseline blood pressure \<90/60 mmHg.
* Third trimester hemorrhage
* Eclampsia
* Allergies to local anesthetics or fentanyl.
* Maternal fever.
* Pruritus before performance of neuraxial analgesia

Primary outcomes:
measure: fetal bradycardia
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
Study officials:
References:
Clinical trial NCT04720079: Paravertebral Block With Brachial Plexus Block for Upper Arm Arteriovenous Fistula Surgery
Official title: The Effectiveness of Thoracic Paravertebral Block in Improving the Anesthetic Effects of Regional Anesthesia for Upper Extremity Arteriovenous Fistula Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Anesthesia Success
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of this quality improvement project is to find the optimal surgical conditions for patients undergoing upper arm arteriovenous graft surgery. Currently, there are two anesthetic techniques used in clinical practice. The goal is to standardize future practice and improve the care of patients postoperatively. The two techniques used in conjunction with a brachial plexus block are paravertebral nerve block and subcutaneous infiltration.

Detailed description: This study is designed to test the null hypothesis that paravertebral nerve block or subcutaneous infiltration provide similar operating conditions when combined with supraclavicular nerve block for upper arm arteriovenous fistula surgery. The results will help determine which approach to use and guide future research in this area.

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years) undergoing upper limb arteriovenous fistula surgery at UNC Chapel Hill hospital

Exclusion Criteria:

* Contraindication to regional anesthesia
* Significant peripheral neuropathy or neurological disorder of the upper extremity
* Cognitive or psychiatric condition that will interfere with patient assessment

Primary outcomes:
measure: Number of Participants with Successful Regional Anesthesia
timeFrame: By end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Stuart A Grant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02732379: Effect of Aromatherapy on Postoperative Nausea, Vomiting
Official title: Evaluating the Efficacy of Aromatherapy on Postoperative Nausea, Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: Postoperative Nausea and Vomiting
Aromatherapy
Quality of Health Care
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of the aromatherapy with lavender, rose or ginger essential oils on nausea, vomiting and postoperative quality of recovery scores in patients with postoperative nausea and vomiting.

Detailed description: Postoperative Nausea and Vomiting (PONV) relief is still challenge for the anesthesiologist. Pharmacological therapies is also cornerstone for treatment of PONV. Although future researches are needed, there is some proofs about the aromatherapy could provide an inexpensive, noninvasive and effective treatment for PONV.

Eligibility criteria: Inclusion Criteria :

* Be scheduled for elective surgery
* Have a postoperative nausea and vomiting

Exclusion Criteria:

* Age \> 65years or \<18 years
* Not accepted to inhale lavender, rose or ginger oil
* Preoperative predications with anti emetic drugs
* Pregnancy or breastfeeding
* Asthma, Chronic obstructive pulmonary disease
* Poor sense of smell
* Allergy to the lavender, rose or ginger oil

Primary outcomes:
measure: The change of the nausea scores
timeFrame: During postoperative 24 hours
measure: The change of the vomiting score
timeFrame: During postoperative 24 hours
Secondary outcomes:
measure: The consumption of the antiemetic drug
timeFrame: During postoperative 24 hours
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University Medical School Hospital
Study officials:
affiliation: Gaziosmanpasa University
name: Tugba Karaman, MD
role: PRINCIPAL_INVESTIGATOR
References: