louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04581044: Impact of COVID-19 on Psoriasis Practice
Official title: Impact of COVID-19 on Psoriasis Practice: A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Covid19
Keywords: Psoriasis
coronavirus
Sars-Cov-2
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 197
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian Dermatologists

Brief summary: COVID-19 had a major impact on dermatology practice globally with special emphasis on chronic diseases e.g. psoriasis. The main objective of this work is to investigate the effect of COVID-19 pandemic on psoriasis management.

This work is designed as a cross-sectional survey based on a questionnaire directed to Egyptian dermatologists.


Eligibility criteria: Inclusion Criteria:

* Egyptian Dermatologists

Primary outcomes:
measure: Questionnaire to assess 1) Prescription pattern for Psoriasis patients during COVID-19 2) Management pattern for Psoriasis patients during COVID-19
timeFrame: 2-4 weeks
measure: Questionnaire to assess 1) Impact of COVID-19 on the course of psoriasis in patients 2) Impact of COVID-19 on the psoriasis patients behaviour
timeFrame: 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mona El-Kalioby
Study officials:
References:
Clinical trial NCT02568644: Ginger Capsules for the Acute Treatment of Migraine Attacks
Official title: Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) Addition to Ketoprofen for the Acute Treatment of Migraine Attacks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Migraine
Ginger
Acute treatment
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2015-10-06
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: The main objective of the study was to evaluate ginger efficacy as an adjuvant to ketoprofen for the treatment of headache and other symptoms related with migraine attacks.

Detailed description: Patients with the diagnosis of migraine according to the International Headache Society (IHS) criteria were enrolled in the study during a migraine attack. Patients received two 200 mg capsules of dry ginger extract (5% active ingredient) or two capsules of placebo (cellulose) in addition to an intravenous dose of ketoprofen (100 milligrams - mg) to treat the migraine attack.

Eligibility criteria: * Inclusion Criteria:

  * Migraine diagnosis for at least one year;
  * Migraine attack with moderate or severe pain intensity;
  * One to six migraine attacks per month.
* Exclusion Criteria:

  * Patients with headaches not characterized as migraine;
  * Pregnant or lactating women;
  * Fertile and sexually active women who do not use contraception;
  * Abuse of painkillers, alcohol or drugs;
  * People with hypersensitivity to ginger;
  * People with other neurological diseases;
  * People in use of anticoagulant drugs;
  * People who have started the disease after 50 years old.

Primary outcomes:
measure: Change in Headache Severity.
timeFrame: 2 hours
measure: Change in Headache Severity.
timeFrame: 2 hours
measure: Change in Headache Severity.
timeFrame: 2 hours
Secondary outcomes:
measure: Change in Serum Levels of Biomarkers.
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Minas Gerais
name: Adaliene VM Ferreira, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of Minas Gerais
name: Laís B Martins, Ma
role: STUDY_CHAIR
affiliation: Federal University of Minas Gerais
name: Antônio L Teixeira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martins LB, Rodrigues AMDS, Rodrigues DF, Dos Santos LC, Teixeira AL, Ferreira AVM. Double-blind placebo-controlled randomized clinical trial of ginger ( Zingiber officinale Rosc.) addition in migraine acute treatment. Cephalalgia. 2019 Jan;39(1):68-76. doi: 10.1177/0333102418776016. Epub 2018 May 16.
Clinical trial NCT04635644: Ultrasound Guided ESP Block Versus Intrathecal Morphine for Postoperative Analgesia in Major HPB Surgery.
Official title: Ultrasound Guided Erector Spinae Block Versus Intrathecal Morphine for Postoperative Analgesia in Major Hepatopancreaticobiliary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 40
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: PREVENTION

Brief summary: To compare the efficacy of USG-guided bilateral Erector spinae plane block (ESPB) with intrathecal morphine (ITM) for postoperative analgesia after major hepatopancreaticobiliary surgery (HPB)


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2,
* patients with the American Society of Anesthesiologists (ASA) physical status I - II,
* Patients scheduled for elective major hepatopancreaticobiliary surgery for benign or malignant disease; major surgery is defined as an operation of anticipated duration of more than one hour.

Exclusion Criteria:

* Patient's refusal
* Allergy or contraindications to the study drugs,
* Infection at the site of injection,
* Coagulopathy,
* Psychiatric disorders
* Severely co-morbid patients,
* Chronic pain syndromes,
* Prolonged opioid medication,

Primary outcomes:
measure: Cumulative opioid consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Nalbuphine consumption in mg
timeFrame: at 8, 48, and 72 hours postoperatively.
measure: Analgesic drug consumption other than nalbuphine
timeFrame: at 8, 24, 48, and 72 hours postoperatively.
measure: Numerical Rating Scale (NRS) at rest and when coughing
timeFrame: at 1, 2, 4, 8, 12, 24, 48 and 72 hours postoperatively
measure: Heart Rate
timeFrame: Intraoperatively
measure: Mean Arterial Pressure
timeFrame: Intraoperatively
measure: Incidence of Postoperative nausea & vomiting (PONV)
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
state: Asyut Governorate
Study officials:
References:
Clinical trial NCT03045640: Family Strengthening Intervention for Early Childhood Development (ECD)
Official title: Adapting a Family Strengthening Intervention (FSI) to Improve Early Childhood Development (ECD) Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Keywords: ECD
parenting program
home visiting
Lead sponsor: Boston College
Sponsor class: OTHER
Collaborators: name: World Bank
First posted: 2017-02-07
Enrollment: 55
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study activities were carried out to adapt and test a family-strengthening intervention to improve child development outcomes among families facing adversity in Rwanda.

Detailed description: Qualitative research from past studies was used to adapt an existing family-strengthening intervention for HIV-AIDS affected families to extremely vulnerable families with children 0-3 in order to improve early childhood development outcomes. This small scale pilot was carried out to test the feasibility and acceptability of the intervention for extremely vulnerable families with young children in Rwanda.

In the first 10 families the intervention consisted of 21 modules, in the second iteration of the study with an additional 10 families, the curriculum was summarized into 15 modules. Modules were delivered by trained bachelor-level interventionists/home-visiting coaches and were delivered to families one on one in their respective homes. Modules were delivered on a weekly to biweekly basis and were flexible to the families needs and other responsibilities.

Eligibility criteria: Inclusion Criteria:

* Potential participants must live in the study catchment area
* Caregiver(s) raising a child between 6 and 3 years old and Ubudehe 1 or 2 (Rwanda's poverty classification system)
* We will enroll both single and dual caregiver families to reflect population dynamics.
* Legal guardians may be aunts, uncles, grandparents, or foster parents

Exclusion Criteria:

* Potential participants that do not live in the study catchment area
* Do not have at least one child between the ages of 0 and 3 living in their household for whom they are the primary caregiver
* Are not classified as Ubudehe 1 or 2
* Have severe cognitive impairments which preclude their ability to speak to the research questions under study

Primary outcomes:
measure: Change: Ages and Stages Questionnaire
timeFrame: 12 months/18 months
Secondary outcomes:
measure: Change: Hopkins Symptoms CheckList
timeFrame: 12 months/18 months
measure: Change: MICS-5
timeFrame: 12 months/18 months
measure: Change: Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey
timeFrame: 12 months/18 months
measure: Change: Locally Derived Scale
timeFrame: 12 months/18 months
Other outcomes:
Locations:
Study officials:
affiliation: Boston College
name: Theresa Betancourt, Sc.D, M.A.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04486040: Closed Suction Drainage After Revision Hip Arthroplasty
Official title: Closed Suction Drainage After Revision Hip Arthroplasty - Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Bleeding
Keywords: Hip
Revision
Arthroplasty
Drainage
Lead sponsor: Prof A Gruca Teaching Hospital
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomized trial. 40 patients who underwent revision hip arthroplasty, divided in to two groups with or without drainage. All patients was assessed with ultrasonography on 3rd day after surgery. Bleeding, need for blood transfusion and laboratory test was analyzed after surgery. Patients was assessed with Harris Hips Score and Visual Analog Scale after surgery.

Detailed description: Inclusion criteria: aseptic loosening, head or insert damage, girdlestone hip. Exclusion criteria: septic loosening, primary or secondary coagulopathy, renal or hepatic failure, thromboembolism in past history. At the end of operation information of drainage was get out from the envelope. On 3rd day all patient get ultrasonography with level of fluid in the joint and hematoma in soft tissue measurement. We analyzed hemoglobin, C-reactive protein, erythrocyte sedimentation rate on 1st and 3rd day after surgery. Visual analog scale was taken on 3rd day after surgery and Harris Hip Score 6 weeks after.

Eligibility criteria: Inclusion Criteria:

* aseptic loosening,
* head or insert damage,
* girdlestone hip

Exclusion Criteria:

* septic loosening,
* primary or secondary coagulopathy,
* renal or hepatic failure,
* thromboembolism in past history

Primary outcomes:
measure: Hematoma size
timeFrame: 3 days after surgery
measure: Hemoglobin level
timeFrame: 3 days after surgery
measure: Blood loss
timeFrame: 1 day after surgery
measure: Reinfection
timeFrame: 2 years after surgery
Secondary outcomes:
measure: Soft tissue hematoma
timeFrame: 3 days after surgery
measure: C-reactive protein level
timeFrame: 3 days after surgery
measure: Blood transfusion
timeFrame: 5-14 days after surgery
measure: Visual Analog Scale
timeFrame: 3 days after surgery
measure: Harris Hip Score
timeFrame: 6 weeks after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Gruca Teaching Hospital, Centre of Postgraduate Medical Education in Otwock
name: Pawel Bartosz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05051540: The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency
Official title: The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Venous Insufficiency
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this protocol is to measure the effect of the use of an inelastic compression system (ICS) on quality of life (QOL) in patients with chronic venous insufficiency (CVI) who have demonstrated limited or no compliance with prescribed compression stockings or bandage wraps.


Eligibility criteria: Inclusion Criteria:

* Subject is age 18 or older, able and willing to provide consent and agrees to comply with the study procedures
* Subject must have chronic venous insufficiency of stages C3, C4, or C5 according to the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification system
* Not compliant with their currently prescribed compression system

Exclusion Criteria:

* Active malignancy other than non-melanoma skin cancer
* Study ulcer suspicious for cancer
* Subjects who are pregnant and/or breastfeeding
* In the opinion of the PI the subject cannot comply with study procedures

Primary outcomes:
measure: Change in the Quality of Life as Measured by CIVIQ-20
timeFrame: Baseline to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Hadar Lev-Tov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04453540: FilmArray and Management of ICU Patients With Pneumonia in the Covid-19 Context
Official title: Impact of the Syndromic PCR System FilmArray on Management of ICU Patients With Severe Pulmonary Disease in the Context of the Covid-19 Pandemic.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infectious Disease
Pneumonia
Molecular Diagnosis
Covid-19
Antibiotic Stewardship
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Reims University hospital
First posted: 2020-07-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed in ICU at the hospitals of Nancy and Reims for severe respiratory diseases during the first half of 2020

Brief summary: The research aims to determine the impact of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalized in ICU for severe respiratory disease.

During the SARS-CoV-2 outbreak, the diagnosis of pneumonia has become considerably more complex as the biological, radiological and clinical criteria of covid-19 interfere with the standard criteria for the diagnosis of severe respiratory diseases. Moreover, patients with COVID-19 are at higher risk of developing other associated infections and thus, patients have therefore often been treated with antibiotics, adequately or not, due to difficulty to quickly identify the etiology of their symptoms with conventional methods.

In order to improve their treatment, both diagnostic and therapeutic, we set up a new syndromic molecular test in our laboratories to accelerate and improve the pneumonia management and antibiotic stewardship. This research will include 100 to 150 adult patients hospitalized in ICU during the first half of 2020. It will take place within the Nancy University Hospital and the Reims University Hospital, France.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years affiliated to a social security system
* Patients who have received complete information about the research and who have not objected to the use of its data
* Patients with suspected SARS-Cov-2 infection
* Patients for which a FilmArray test has been realized on its respiratory samples between 1st of March and 1st of July 2020.

Exclusion Criteria:

* None

Primary outcomes:
measure: Therapeutic decision
timeFrame: 24 h following the FilmArray results
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Novy E, Goury A, Thivilier C, Guillard T, Alauzet C. Algorithm for rational use of Film Array Pneumonia Panel in bacterial coinfections of critically ill ventilated COVID-19 patients. Diagn Microbiol Infect Dis. 2021 Nov;101(3):115507. doi: 10.1016/j.diagmicrobio.2021.115507. Epub 2021 Jul 23.
Clinical trial NCT03481140: Case Series Comparing Drains to TissuGlu® in a Donor Site DIEP Flap Breast Reconstruction Procedure
Official title: Post-Market, Investigator Initiated, Retrospective, Audited Observational Case Series Comparing SWC With Drains to SWC With TissuGlu® and no Drains in a Donor Site DIEP Flap Breast Reconstruction Procedure in 58 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Inferior Epigastric Perforator Flap Reconstruction
Lead sponsor: Cohera Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing a DIEP flap breast reconstruction at the Sana Klinik in Düsseldorf, Germany.

Brief summary: To evaluate the safety and effectiveness of a lysine-derived urethane adhesive (TissuGlu® Surgical Adhesive) as a less invasive alternative to surgical drains in the abdominal donor site for deep inferior epigastric perforator (DIEP) flap reconstruction.


Eligibility criteria: Inclusion Criteria:

* be 18 years of age or older
* be in good general health (with no conditions that would, in the opinion of the surgeon, exclude them from a drain-free donor site approach)
* have a body mass index (BMI) \< 28
* have received a DIEP flap breast reconstruction procedure

Exclusion Criteria:

* current smoker
* have a body mass index (BMI) \> 28
* taking active SSRI medication prescriptions

Primary outcomes:
measure: number of post-operative clinical interventions related to wound fluid management at the donor site
timeFrame: 6 weeks post-operatively
Secondary outcomes:
measure: total wound drainage
timeFrame: 6 weeks post-operatively
measure: cumulative drain volume
timeFrame: 6 weeks post-operatively
measure: aspiration volume
timeFrame: 6 weeks post-operatively
measure: cumulative days of invasive treatment
timeFrame: 6 weeks post-operatively
measure: days to drain removal
timeFrame: 6 weeks post-operatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05240040: Treat Primary and Metastatic Liver Tumors
Official title: Radioembolization to Treat Primary and Metastatic Liver Tumors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Intrahepatic Cholangiocarcinoma
Liver Tumor
Metastatic Cancer
Metastatic Liver Cancer
Keywords: Intrarterial glass
Radiospheres
Liver Cancer
Intrahepatic
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 0
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: Patients who have the diagnosis of intrahepatic cholangiocarcinoma and were treated at MDMC .

Brief summary: The use of Radiospheres in the management of intrahepatic cholangiocarcinoma is largely unknown and not reported in the medical literature. Methodist Dallas Medical Center has a large volume of IR procedures with Radioembolization and the investigators feel it is imperative to understand the outcomes, risks and benefits of the therapy in order to formulate recommendation to other centers.

Detailed description: A retrospective chart review of patients who have the diagnosis of intrahepatic cholangiocarcinoma. Only patients treated at MDMC are included and data will be obtained from Meditech and Epic. A non-identified database of cases with the diagnosis of intrahepatic cholangiocarcinoma already treated with radiospheres will be created and compared with cases treated by other means.

Intrahepatic cholangiocarcinoma is the second most common primary malignancy of the liver. The standard therapy has been resection but many cases are not resectable due to comorbidities or other poor surgical candidacy factors. Most of these patients end up getting chemotherapy which can be toxic and sometimes poorly tolerated. Intrarterial glass or resin radioembolization has been used and published from only 3 centers in the medical literature and it has been shown to be a reasonable alternative to the above options. At MDMC, this therapy has been used effectively and it is important to describe the investigator's experience.

Eligibility criteria: Inclusion Criteria:

* Patients with the diagnosis of intrahepatic cholangiocarcinoma from January 2006 until April 2017 at Methodist Dallas Medical Center (MDMC)
* Patients 18 years old or older

Exclusion Criteria:

* Patients without the diagnosis of intrahepatic cholangiocarcinoma
* Patients under 18 years of age

Primary outcomes:
measure: review the outcomes of patients treated with radiospheres
timeFrame: January 2006 until April 2017
measure: time to recurrence
timeFrame: January 2006 until April 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Alejandro Mejia, MD
role: PRINCIPAL_INVESTIGATOR
References: