louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04937335: Craniopharyngioma With Tumoral Hemorrhage
Official title: Clinical Features and Risk Factors of Craniopharyngioma With Tumoral Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniopharyngioma
Apoplexy
Keywords: craniopharyngioma
endocrine
risk factor
tumoral hemorrhage
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 185
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with a pathological diagnosis of craniopharyngioma

Brief summary: Clinical data of 185 consecutive patients receiving resective operation with a pathological diagnosis of craniopharyngioma in our hospital between January 2013 and February 2021 were collected. Among these patients, 18 of them were recognized as craniopharyngioma with tumoral hemorrhage during the operation.

Detailed description: For each case, age, gender, smoking status, alcohol intake, past history, symptoms, blood pressure, blood cell count, blood biochemical tests, coagulation tests, hormone tests, radiological results, surgical treatment and the outcome at discharge were collected. The first test result after admission and before the operation was taken for the items of blood tests with multiple times in the analysis.

Eligibility criteria: Inclusion Criteria:

* receive resective operation with a pathological diagnosis of craniopharyngioma in our hospital
* enter our hospital between January 2013 and February 2021

Exclusion Criteria:

* have a non-craniopharyngioma or unverified pathological diagnosis at discharge
* have received surgical or radiological treatment on the sellar region
* receive treatment of coagulation modulation, immunosuppressive agents or chemotherapeutic drugs
* combine with other clinical emergencies including acute myocardial infarction, cerebral stroke, trauma and sepsis at admission
* have been diagnosed with other tumors, hematological diseases, autoimmune diseases, liver failure or renal failure

Primary outcomes:
measure: craniopharyngioma with tumoral hemorrhage
timeFrame: during the operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tongji Hospital
name: Kai Shu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03936335: An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Official title: Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adverse Pregnancy Outcomes
Atopic Dermatitis
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2019-05-03
Enrollment: 3930
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women with AD who are pregnant between 01 April 2017 and 31 March 2024 (with the start of pregnancy to be defined by the estimated last menstrual period (LMP))

Brief summary: The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of infant outcomes (major congenital malformations \[MCMs\], small for gestational age \[SGA\]) in women with AD who are treated with dupilumab during pregnancy relative to women with AD who are not treated with dupilumab during pregnancy.


Eligibility criteria: Key Inclusion Criteria:

* Continuous medical and pharmacy benefit coverage for at minimum 6 months prior to and including the estimated LMP
* Diagnosis code indicative of AD in the period from up to 1 year prior to the estimated LMP through the end of the pregnancy

Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Primary outcomes:
measure: Incidence of major congenital malformations
timeFrame: Up to 21 months
Secondary outcomes:
measure: Incidence of spontaneous abortion or miscarriage
timeFrame: Up to 9 months
measure: Incidence of stillbirth
timeFrame: Up to 9 months
measure: Incidence of small for gestational age
timeFrame: Up to 21 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Regeneron Research Site
state: Massachusetts
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT00561535: Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS Patients
Official title: Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: IBS
Diarrhea
Rome III
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Association pour l'Etude des Fonctions Digestives
First posted: 2007-11-21
Enrollment: 60
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: Probiotics may improve symptoms in IBS patients. The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.

Detailed description: The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.

Eligibility criteria: Inclusion Criteria:

* Diarrhea predominant IBS
* Less than 5-year duration
* Pain intensity between 2 and 7 on VAS

Exclusion Criteria:

* Celiac disease
* Antibiotic treatment within the 1-month period preceding inclusion
* Digestive organic disease
* Any severe non digestive organic disease

Primary outcomes:
measure: Overall subject's assessment
timeFrame: 4 weeks
Secondary outcomes:
measure: Decrease in abdominal pain, stool form and consistency, modifications in intestinal permeability, modification in fecal serine protease activity, modifications in interleukin seric concentrations
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Colombes
country: France
facility: Hopital Louis Mourier, GI Unit
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Benoit Coffin, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Yoram Bouhnik, Prof
role: STUDY_DIRECTOR
References:
citation: Camilleri M, Chang L. Challenges to the therapeutic pipeline for irritable bowel syndrome: end points and regulatory hurdles. Gastroenterology. 2008 Dec;135(6):1877-91. doi: 10.1053/j.gastro.2008.09.005. Epub 2008 Oct 9.
Clinical trial NCT00545935: Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso
Official title: Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso: RCT in the Frame of the A8 Project of SFB 544
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malaria
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2007-10-17
Enrollment: 186
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.


Eligibility criteria: Inclusion Criteria:

* 0.5-5 year (6-59 months) old children
* uncomplicated malaria caused by P. falciparum
* asexual parasites ≥ 2000/µ and ≤ 200000/µ
* axillary temperature ≥ 37.5 Celsius or a history of fever during last 24 hours
* Burkinabe nationality
* informed consent

Exclusion Criteria:

* complicated or severe malaria
* any apparent significant disease
* anaemia (haematocrit \< 21%)
* treated in the same trial before
* modern antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine

Primary outcomes:
measure: Incidence of observed and self-reported non-serious adverse events over the 28 days observation period
timeFrame: 28 days
Secondary outcomes:
measure: Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR)
timeFrame: 28 days
measure: Early treatment failure (ETF) rate
timeFrame: 28 days
measure: Late clinical failure (LCF) rate at D14 and D28
timeFrame: 28 days
measure: Late parasitological failure (LPF) rate at D14 and D28
timeFrame: 28 days
measure: Fever clearance time
timeFrame: 28 days
measure: Parasite clearance time
timeFrame: 28 days
measure: Change in haematocrit after 2,14 and 28 days compared to baseline
timeFrame: 28 days
measure: MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose
timeFrame: 28 days
Other outcomes:
Locations:
city: Nouna
country: Burkina Faso
facility: Centre de Recherche en Sante de Nouna
Study officials:
affiliation: Heidelberg University
name: Olaf Mueller, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03291535: Virtual Hypertension Management Pilot
Official title: Virtual Hypertension Management Pilot: Randomized Evaluation of Electronic Health Record-connected Blood Pressure Cuffs in a Clinical Pharmacist Panel.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Electronic Health Record
Digital Health
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Investigators are examining the quality improvement impact of providing patients with a an electronic health record-connected blood pressure cuff. Investigators will give half of patients already eligible for hypertension management within a clinical pharmacist panel, the ability to upload their blood pressure data into Stanford's electronic health record.


Eligibility criteria: Inclusion Criteria:

* Hypertension as defined by clinical pharmacist usual care panel (2 or more readings of blood pressure \>140/90)

Exclusion Criteria:

* Pregnancy
* Chronic kidney disease III or IV
* Systolic heart failure with ejection fraction \<35%
* Current use of 3 or more anti-hypertension drugs

Primary outcomes:
measure: Change in blood pressure over time in control group vs. the intervention group
timeFrame: From enrollment to 6 months later
Secondary outcomes:
measure: Patient visits
timeFrame: From enrollment to 6 months later
measure: Patient remote interactions
timeFrame: From enrollment to 6 months later
measure: Medication changes
timeFrame: From enrollment to 6 months later
measure: Blood pressure control
timeFrame: From enrollment to 6 months later
Other outcomes:
Locations:
city: Portola Valley
country: United States
facility: Stanford Primary Care
state: California
city: Santa Clara
country: United States
facility: Stanford Primary Care Clinic
state: California
Study officials:
References:
Clinical trial NCT02788435: The Role of Voice Rest on Voice Outcomes Following Phonosurgery
Official title: The Role of Voice Rest on Voice Outcomes Following Phonosurgery: A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Unilateral Vocal Cord Lesions
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients undergoing vocal cord surgery (phonosurgery) are often prescribed voice rest postoperatively. However, no clinical trials have ever been conducted to ascertain the efficacy of using voice rest and its impact on functional voice outcomes. The purpose of this randomized-clinical trial is to determine if the prescription of voice rest has an impact on voice outcomes following phonosurgery.

Detailed description: The study will seek to determine if a 7-day period of absolute voice rest alters voice-related quality of life following phonosurgery

Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* Unilateral vocal cord lesion
* Consented for phonosurgery

Exclusion Criteria:

* Age less than 18 years
* Bilateral vocal cord lesions
* Prior vocal cord surgery

Primary outcomes:
measure: Voice Handicap Index (VHI)-10
timeFrame: 4 weeks post-operative
measure: Voice Handicap Index (VHI)-10
timeFrame: 12 weeks post-operative
Secondary outcomes:
measure: Frequency perturbation (jitter)
timeFrame: 4 weeks post-operative
measure: Frequency perturbation (jitter)
timeFrame: 12 weeks post-operative
measure: Amplitude perturbation (shimmer)
timeFrame: 4 weeks post-operative
measure: Amplitude perturbation (shimmer)
timeFrame: 12 weeks post-operative
measure: Fundamental frequency
timeFrame: 4 weeks post-operative
measure: Fundamental frequency
timeFrame: 12 weeks post-operative
measure: Maximum phonation time
timeFrame: 4 weeks post-operative
measure: Maximum phonation time
timeFrame: 12 weeks post-operative
measure: Perceptual grading of voice using the Grade, Roughness, Breathiness, Asthenia, Strain, Instability (GRBASI)-scale
timeFrame: 4 weeks post-operative
measure: Perceptual grading of voice using the Grade, Roughness, Breathiness, Asthenia, Strain, Instability (GRBASI)-scale
timeFrame: 12 weeks post-operative
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Department of Otolaryngology - Head & Neck Surgery, Western University
name: Kevin Fung, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhaliwal SS, Doyle PC, Failla S, Hawkins S, Fung K. Role of voice rest following laser resection of vocal fold lesions: A randomized controlled trial. Laryngoscope. 2020 Jul;130(7):1750-1755. doi: 10.1002/lary.28287. Epub 2019 Sep 9.
Clinical trial NCT03983135: Revisional Bariatric Surgery Experience
Official title: Results of Revisional Bariatric Surgery: A Single Center Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Revisional Bariatric Surgery
Obesity Associated Disorder
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2019-06-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the indications for revisional bariatric surgery and short-term revisional surgical outcomes such as weight loss, BMI variation, % excessive weight loss and % excessive BMI loss .Prospectively-collected patient data will retrospectively reviewed. Patient demographics, body mass index (BMI), primary and revision surgery types, indications of revision, outcomes of revisional surgery and follow-up data for comorbidities will investigated.


Eligibility criteria: Inclusion Criteria:

* Between 18 to 65 years old,
* Patients who undergo revisional bariatric surgery due to renewed weight gain, stenosis or alkaline reflux after primary bariatric surgery

Exclusion Criteria:

* Eating disorders,
* Alcoholic
* Cancer

Primary outcomes:
measure: Weight loss (kilograms)
timeFrame: 3 years
Secondary outcomes:
measure: Resolution of comorbidities
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05786235: Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome
Official title: Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preeclampsia
Immunologic Disease
Antiphospholipid Antibody Syndrome Primary
Pregnancy Complications
Pregnancy, High Risk
Rheumatic Diseases
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least 60 patients aged 18-45 years will be enrolled between the first and third trimester of gestation, specifically 40 pregnant patients with primary APS (Group 1) and 20 pregnant patients without APS (Group 2) followed at the outpatient clinics of Obstetrics and Pregnancy Pathology of the participating centers. All patients will be asked to sign an informed consent prior to the collection of data and biological material.

Brief summary: The purpose of the study is to evaluate the ability of placental angiogenesis markers to predict the risk of PE in pregnancy in women with primary APS.

To construct reference intervals of placental angiogenesis markers specific to women affected by primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1/PlGF ratio during the trimesters of gestation (I TM, II TM and III TM).

For this aim the study will involve recruiting two groups of subjects, one will be cases and one will be controls.


Eligibility criteria: Inclusion Criteria:

* Group 1

  1. Pregnant patients between the ages of 18 and 45 years.
  2. Diagnosis of primary APS, according to international classification criteria.
* Group 2

  1. Pregnant patients between the ages of 18 and 45 years.
  2. Patients with at least one previous full-term pregnancy.
  3. No diagnosis of APS, according to international classification criteria.

Exclusion Criteria:

* Group 1

  1. PMA pregnancies.
  2. Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology
  3. Previous thrombotic event
  4. Chronic renal failure not related to AD
  5. Previous history of oncology
* Group 2

  1. Pregnancy by PMA.
  2. Previous history of polyabortion and/or late pregnancy complications.
  3. Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology
  4. Previous thrombotic event
  5. Previous history of oncology

Primary outcomes:
measure: To construct reference ranges of placental angiogenesis markers specific to women with primary APS in pregnancy
timeFrame: six month after the end of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital
Study officials:
References:
Clinical trial NCT00421135: A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced Cancer
Official title: A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Alaunos Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced cancer.


Eligibility criteria: Inclusion Criteria:

* Metastatic and /or unresectable disease state after previous standard chemotherapy

Primary outcomes:
measure: toxicities
timeFrame: 6 months
Secondary outcomes:
measure: pharmacokinetics
timeFrame: 6 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
state: California
city: Detroit
country: United States
state: Michigan
Study officials:
affiliation: ZIOPHARM Oncology, Inc
name: Jonathan Lewis, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03119935: Amflow-device Can Help Proper Ambu-bag Ventilation
Official title: Evaluation of an Amflow-device Assist Ambu-bagging to Improve Accuracy of Tidal Volumes Delivered.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilation Therapy; Complications
Keywords: ambu bag, ventilation, tidal volume
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a simulation study with a prospective randomized cross-over design. The aim of this study is to evaluate whether Amflow-assisted ambu-bag can delivery the accurate tidal volume compare to ordinary ambu-bag

Detailed description: Ambu-bag ventilation is an essential skill to the patients who needed ventilatory support. However, the delivery of appropriate amount of tidal volume by ordinary manual bag ventilation may be difficult. In addition, it require adequate training to rescurer.

We hypothesised that an Amflow assist ambu bag may be helpful to delivery accurate tidal volumes to the patients.

Participants performed bag-valve ventilation to manikin by ordinary technique and Amflow assist technique in our simulation centre. We measured each ventilation rate and ventilation volume in simulated scenario and we compare those between two technique.

Eligibility criteria: Inclusion Criteria:

* A healthy senior medical students who agree attend this study.

Exclusion Criteria:

* A participants who does not agree attend this study

Primary outcomes:
measure: Tidal volume
timeFrame: 6 minutes
Secondary outcomes:
measure: Ventilation Rate
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Emergency Medicine, Konkuk University Medical center
Study officials:
affiliation: Department of Emergency Medicine, School of Medicine, Konkuk University, Konkuk University Medical Center
name: Sang O Park, Dr
role: PRINCIPAL_INVESTIGATOR
References: