louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03960632: Performance Evaluation of Malaria Plus RDTs
Official title: Clinical Performance Evaluation of Malaria Pf Plus RDT and Malaria Pf/Pv Plus RDT for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malaria
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 6546
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptoms suggestive of malaria seeking clinical care in health facilities

Brief summary: Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have dramatically improved our ability to control malaria, but proved insufficient to support elimination efforts because of their limited sensitivity, especially for P. vivax. In addition, the spread of P. falciparum parasites lacking hrp2 gene jeopardizes the long-term use of P. falciparum-specific HRP2-based RDTs. An existing partnership between Standard Diagnostics (SD), FIND, PATH, and Bill and Melinda Gates Foundation (BMGF) is addressing these limitations by developing two novel malaria RDTs with an analytical sensitivity ten times higher than the currently available malaria RDTs: a P. falciparum-specific test targeting both the HRP2 and PfLDH antigens (Pf Plus), and a P. falciparum/P. vivax combo test additionally targeting the PvLDH antigen (Pf/Pv Plus).

These new combo tests with improved sensitivity may become promising diagnostic tools for the detection of malaria, especially in settings where current tests prove to be insufficient due to hrp2 deletion or high burden of P. vivax malaria.

In this study, the investigators will perform a prospective evaluation of Pf Plus and Pf/Pv Plus tests in malaria-endemic countries to assess their clinical performance for detection of malaria in their intended-use settings.


Eligibility criteria: Inclusion Criteria:

* Presenting at the study site with fever (axillary temperature ≥37.5°C) or a history of fever during the preceding 72 hours period
* Presence of symptoms and signs other than fever suggestive of malaria
* Aged 5 years or older
* Freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17)
* Willing to provide finger prick blood sample at enrolment

Exclusion Criteria:

* Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines

Primary outcomes:
measure: Estimates of clinical performance characteristics of Pf Plus
timeFrame: Enrolment
measure: Estimates of clinical performance characteristics of Pf/Pv Plus
timeFrame: Enrolment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04346732: Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors
Official title: Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venipuncture
Pain
Keywords: Vapocoolant Spray
Venipuncture
Pain
Donors
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 88
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants were separated into two groups with the randomisation method.These groups were named the vapocoolant spray group and the control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: The aim of this study is to assess the effectiveness of vapocoolant spray in reducing pain related to venipuncture in young, healthy male blood donors.

Hypotheses:

H1: Vapocoolant spray reduces venipuncture pain during blood donation. H0: Vapocoolant spray does not reduce venipuncture pain during blood donation.

Detailed description: After being informed about the study and potential risks, all patients giving written informed consent. Before the procedure was begun, the donors who agreed to participate in the study were met face-to-face and asked to fill in the "Informative Characteristics Form", the "VAS", the "Blood/Injection Fear Scale" and the "STAI-I" forms.Then the donors were assigned to their groups by the researcher.The donors in the control group were not given any intervention during the blood collection process. Vapocoolant spray was applied to the donors in the vapocoolant spray group. During the blood collection procedure, after the donors' skin was cleaned with antiseptic solution, spray was applied to the application site for a maximum of 10-15 seconds from a distance of 25 cm. In both groups, immediately following venipuncture, pain assessment was made with the VAS by the researcher, who did not know which group each participant belonged to.

Eligibility criteria: Inclusion Criteria:

* aged between 18 and 35
* BMI between 18.5 and 24.9 kg/m2
* speaks turkish
* male donor
* individuals who applied to make voluntary blood donations
* volunteers to participate in the study

Exclusion Criteria:

* donors who did not agree to take part in the study,
* donors with open wound, scar, infection, dermatitis, eczema or lesion at the venipuncture site, or donors with cold allergy

Primary outcomes:
measure: Change from baseline in venipuncture pain on the Visual Analogue Scale(VAS) during blood donation
timeFrame: immediately following venipuncture procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02199132: Retrospective Study About Nasopharyngeal Carcinoma at C. S. Parc Tauli
Official title: Retrospective Study About Nasopharyngeal Carcinoma at C. S. Parc Tauli
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed of Nasopharyngeal Carcinoma at Ear-Nose-Throught Department at Corporació Sanitària Parc Taulí from 1993 to 2013

Brief summary: Retrospective study of patients diagnosed with a nasopharyngeal carcinoma included in our data base care between June 1990 and September 2013.

Our hypothesis is:

Our series of patients with a history of nasopharyngeal carcinoma presents epidemiological, response rates to the different treatments and survival similar to those described in the literature

Detailed description: Retrospective study of 50 patients diagnosed with nasopharyngeal carcinoma. The following variables will be studied: age, sex, toxic habits , associated pathology, patient origin , first symptom , duration , histology, stage , second malignancies , recurrences , metastases , treatments performed , the response thereto and survival.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed of Nasopharyngeal Carcinoma at Ear-Nose-Throat Department at Corporació Sanitària Parc Taulí from 1993 to 2013

Exclusion Criteria:

* None

Primary outcomes:
measure: Description of Nasopharyngeal Carcinoma Patients
timeFrame: 1 year after diagnostic
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
Study officials:
References:
Clinical trial NCT04803032: Trident Landmark as a Safe and Easy Method for Facial Nerve Trunk Identification During Superficial Parotidectomy
Official title: Trident Landmark as a Safe and Easy Method for Facial Nerve Trunk Identification During Superficial Parotidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parotid Tumor
Parotid Neoplasms
Surgery
Head and Neck Disorder
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
Collaborators: name: Fayoum University
First posted: 2021-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The parotid has a close relationship with the extra temporal course of the facial nerve. The study aimed to evaluate the accuracy and safety of trident landmark during superficial parotidectomy in the identification of the facial nerve trunk.

Detailed description: A prospective study was conducted between January 2018 and January 2020 at Kafr El-Sheikh university hospital (KUH) and Al Fayoum University Hospital (FUH), Egypt, on 60 patients with benign parotid tumors in the superficial lobe. All patients were subjected to superficial parotidectomy. The outcome was evaluated regarding the clinical success of facial nerve identification by trident landmark and early postoperative complications.

Eligibility criteria: Inclusion Criteria:

* patients with benign tumors of the superficial lobe of the parotid gland

Exclusion Criteria:

* cancers
* unfit patients for surgery

Primary outcomes:
measure: Number of cases with successful identification of the facial neve by trident landmark
timeFrame: 60 min
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Reda F Ali
state: Kafr Al Sheikh
Study officials:
References:
Clinical trial NCT01636232: Vitamin D and Critically Ill Patients
Official title: Vitamin D Levels and Risk of Infection, Assessment for Disease Severity, and Predictor of Mortality in the Chinese Intensive Care Units: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Inflammatory Response Syndrome
Sepsis
Keywords: Vitamin D
infection
disease severity
mortality
critically ill
sepsis
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the subjects were selected from among inpatients who were hospitalized between October-December, 2011 in the Surgical ICU, Respiratory ICU, and Emergency ICU, Chinese PLA General Hospital.

Brief summary: The higher rate of vitamin D deficiency is spotted among patients being hospitalized or in critical condition. Especially, vitamin D level below normal prolongs hospital stay and increases incidence of adverse prognosis and pushing up mortality of a number of diseases. However, it is remain unclear the relationship between vitamin D levels and critically ill, especially infection or sepsis. In this study, the investigators evaluate the significance of vitamin D for diagnosis and other relevant assessments of ICU cases, including vitamin D's relevance to sepsis, as well as its value in severity and prognosis assessment, high-performance liquid chromatography and tandem mass spectrometry was used to detect the quantification of the total 25(OH)D in serum of critically ill patients. The investigators speculate that measurement of vitamin D could be taken as an indicator for diagnosis and assessment in critically ill patients.


Eligibility criteria: Inclusion Criteria:

* Male and female aged 18 years old and over;
* Entered ICU;
* Fulfilled at least two criteria of systemic inflammatory response syndrome

  * core temperature higher than 38 °C or lower than 36 °C
  * respiratory rate above 20/min, or PCO2 below 32 mmHg
  * pulse rate above 90/min, and
  * white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands.

Exclusion Criteria:

* patients or their relatives refused

Primary outcomes:
measure: Patients Outcome
timeFrame: 28 days
measure: Patients Outcome
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Department Of Respiratory Diseases, Chinese PLA General Hospital
name: Lixin Xie, MD
role: STUDY_DIRECTOR
References:
citation: Su LX, Jiang ZX, Cao LC, Xiao K, Song JP, Li H, Zhang X, Yan P, Feng D, Liu CT, Li X, Xie LX. Significance of low serum vitamin D for infection risk, disease severity and mortality in critically ill patients. Chin Med J (Engl). 2013 Jul;126(14):2725-30.
Clinical trial NCT06495632: Scheduled or As Needed Pain Regimen?
Official title: Scheduled or As Needed Regimen? a Pilot Feasibility Study on Multimodal Pain Control and Post-Operative Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: surgery
acute pain
post-operative pain
Lead sponsor: Cape Fear Valley Health System
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine feasibility of a randomized controlled trial and estimates of efficacy for pain control of a scheduled pain regimen versus an as needed pain regimen for participants undergoing same day surgery procedures.


Eligibility criteria: Inclusion Criteria:

* Any outpatient surgeries performed at Cape Fear Valley Medical Center by Dr. Van Fossen during the duration of the study, including: laparoscopic cholecystectomy, laparoscopic appendectomy, laparoscopic ventral/umbilical/incisional hernia repair, open ventral/umbilical/incisional hernia repair, laparoscopic inguinal hernia repair, open inguinal hernia repair, lumpectomy, sentinel lymph node biopsy, lymph node biopsy, mass excision skin or subcutaneous, diagnostic laparoscopy, laparoscopic lysis of adhesions, pilonidal cyst excision, hemorrhoidectomy, anal fissure/sphincterotomy, anal fistulectomy, rectal exam under anesthesia, wound debridement, and wound closure
* Outpatients who are medically eligible to receive the standard post surgery medication protocol (the scheduled pain protocol used in this study).
* Age 18-65

Exclusion Criteria:

* Participants with the following conditions will be excluded from our study: fibromyalgia, chronic pain, cancer (except for breast cancer). This is because these participants have pain at baseline and it will be difficult to discern if their pain is from surgery or their chronic condition.
* Participants on chronic pain medications will also be excluded from our study because it will be difficult to tell if their pain control is related to their established regimen or the one we are implementing.
* If participants who are not fluent in English, because all study materials are in English.
* Participants with stage 3 Chronic Kidney Disease or higher will also be excluded from the study as they cannot take ibuprofen (according to National Kidney Foundation), which is included in our pain regimen.

Primary outcomes:
measure: Feasibility of trial
timeFrame: 2 weeks
Secondary outcomes:
measure: Estimate of effect size pain control
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Cape Fear Valley Medical Center
state: North Carolina
Study officials:
affiliation: Cape Fear Valley Health
name: Kelly Van Fossen, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03012932: HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women
Official title: HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer Screening
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 10
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The proposed study will examine the implementation of a Human Papilloma Virus (HPV) self-sampling intervention for under screened LBQ women living in South Florida. The study will enroll participants to receive the self-sampling intervention in community venues. The purpose of this study is to pilot the self-sampler for feasibility and acceptability within this underserved population.


Eligibility criteria: Inclusion Criteria:

* Self-identify as lesbian, bisexual, or queer woman
* Assigned female sex at birth
* English speaking
* ages 25-65 years
* report not having had a pap smear in the last three years (per USPSTF guidelines)
* if age 30 or over, report not having a pap smear/HPV co-test within the past 5 years (per USPSTF guidelines)

Exclusion Criteria:

* report having had a hysterectomy
* report having history of cervical cancer
* unable to consent
* Pregnant women
* Prisoners

Primary outcomes:
measure: HPV Self-sampling uptake
timeFrame: through study completion, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Julia Seay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01259232: The Imaging Genetic Study of Schizophrenia and Family
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Lead sponsor: Kunming Medical University
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Sciences
First posted: 2010-12-14
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: schizophrenia patients and their relatives

Brief summary: To investigate the brain abnormalities and the association with gene in schizophrenia patients and their relatives.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of schizophrenia（DSM-IV）
* total score of PANSS\>64

Exclusion Criteria:

* other psychiatric disease,
* organic disease
* neurological disease
* unstable physiological status
* age\>65
* pregnant

Primary outcomes:
measure: the association between gene and fMRI in schizophrenia patients
timeFrame: 30 days after diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: Psychiatry department, The 1st Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: Psychiatry Department
name: Xiufeng Xu
role: STUDY_DIRECTOR
References:
Clinical trial NCT01242332: Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction
Official title: Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction: Does it Help to Relieve Postoperative Pain?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain Management
Keywords: perioperative
pregabalin
arthroscopic anterior cruciate ligament reconstruction
postoperative pain management
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2010-11-17
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: To prove pregabalin's efficacy and safety in Thai patients scheduled for arthroscopic ACL reconstruction

Detailed description: Only eligible patients with willingness to join this study are included. Eligible patients are those aged 18-65 years of either sex, American Society of Anesthesiologists (ASA) physical status I \& II, and body mass index (BMI) between 16-35. The exclusion criteria are patients who are allergic to pregabalin, with impaired hepatic and renal functions, alcohol or substance abuse, chronic pain (except pain in the knee joint) or daily intake of analgesics, uncontrolled medical disease (hypertension and diabetes mellitus) and inability to operate patient-controlled analgesia (PCA) device.

Data analysis

* Student t-test for continuous data with normal distribution
* Mann-Whitney U test for continuous data with non-normal distribution
* Chi-square test for categorical data

Eligibility criteria: Inclusion Criteria:

* Eligible patients are those aged 18-65 years of either sex,
* American Society of Anesthesiologists (ASA) physical status I \& II, and body mass index (BMI) between 16-35.

Exclusion Criteria:

* patients who are allergic to pregabalin,
* impaired hepatic and renal functions,
* alcohol or substance abuse,
* chronic pain (except pain in the knee joint) or daily intake of analgesics, uncontrolled medical disease (hypertension and diabetes mellitus)
* inability to operate patient-controlled analgesia (PCA) device

Primary outcomes:
measure: efficacy
timeFrame: August 2009 - January 2011
Secondary outcomes:
measure: safety
timeFrame: August 2009 - January 2011
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: Faculty of Medicine, Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University
name: Sasikaan Nimmaanrat, MD, MMed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang SH, Lee HW, Kim HK, Kim SH, Kim DK. An evaluation of perioperative pregabalin for prevention and attenuation of postoperative shoulder pain after laparoscopic cholecystectomy. Anesth Analg. 2009 Oct;109(4):1284-6. doi: 10.1213/ane.0b013e3181b4874d. Epub 2009 Jul 29.
Clinical trial NCT06402032: Clinical and Histological Evaluation of Hesperidin as a Direct Pulp Capping Material
Official title: Clinical and Histological Evaluation of Hesperidin Versus Mineral Trioxide Aggregate (MTA) as a Direct Pulp Capping Material: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulp Exposure, Dental
Dental Pulp Capping
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Direct pulp capping technique is one of the oldest known treatments for exposed pulp tissue, and there is a continuous requirement for the most efficient materials to be used in this approach. Successful pulp capping is the usual way to preserve the vitality of tooth and avoid root canal treatment or surgical tooth extraction.


Eligibility criteria: Inclusion Criteria:

* Good oral hygiene,
* Sound wisdom teeth with closed apices with normal pulp vitality response
* No periodontal disease or periapical lesions on periapical radiograph
* Cooperative patients approving to participate in the study

Exclusion Criteria:

* Medically compromised participants
* Evidence of parafunctional habits
* Heavy smokers
* Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis
* Severe periodontal problems or pathological periapical changes
* Teeth with open apex or pulp calcification

Primary outcomes:
measure: Success Rate (Clinical evaluation)
timeFrame: after 12 weeks
Secondary outcomes:
measure: Histomorphometric analysis (Histologic evaluation)
timeFrame: after 12 weeks
measure: Histomorphometric analysis (Histologic evaluation)
timeFrame: after 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Cairo University
Study officials:
References: