louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03943199: Comparison of Lysine Clonixinate, Ketorolac and Metamizole Sodium in Scorpion Stings
Official title: Randomized Clinical Trial: Comparison of Lysine Clonixinate, Ketorolac and Metamizole Sodium in Poisoning by Scorpion Stings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scorpion Stings
Pain
Analgesic
Lead sponsor: Mexican Red Cross
Sponsor class: OTHER
Collaborators: name: Instituto Bioclon S.A. de C.V.
First posted: 2019-05-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The cases of scorpion stings are matters of medical importance, where Mexico is considered as one of the main countries of such public health problem.

Detailed description: The states with the highest incidence of cases in 2018 were Jalisco with 47370 bite reports, Guerrero with 40672 cases and Guanajuato with 40331, according to the national epidemiological surveillance system.

Due to the high affinity on ion channels, where a cystine inhibitor BmP01, it is directed to the nociceptive ion channel TRPV1 to produce pain.Pain has been reported to occur in approximately 97% of patients They are seen in the emergency room.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of pain by scorpion stings
* Patients\> 18 years old
* Clinical diagnosis of scorpion sting poisoning grade I, II and III.
* Chronic degenerative diseases (renal failure, hypertension, liver damage)

Exclusion Criteria:

* Patients who reject the continuation of medical treatment
* Patients who are transferred to a unit of second level of care.
* Patients with pharmacological treatment prior

Primary outcomes:
measure: Evaluate the efficacy of antivenom as a pain treatment by the visual analogue scale of pain in poisoning by scorpion stings.
timeFrame: 18 hours after drugs in study
Secondary outcomes:
measure: Evaluate the analgesic efficacy of clonixinate of lysine, ketorolac and sodium metamizol, by the visual analogue scale of pain in poisoning by scorpion stings.
timeFrame: 0, 30, 60 and 90 minutes after administered the drug
Other outcomes:
Locations:
city: León
country: Mexico
facility: Cruz Roja Mexicana, Delegación León
state: Guanajuato
Study officials:
affiliation: Investigator
name: Alfredo Luis H Chávez Haro
role: STUDY_DIRECTOR
affiliation: Investigator
name: Josue Saul H Almaraz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06114199: Enhancing the Effectiveness of Home-delivery Based Produce Prescription Program Implementation Strategies
Official title: Enhancing the Effectiveness of Home-delivery Based Produce Prescription Program Implementation Strategies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nutritional Deficiency in Pregnancy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2023-11-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Harris Health System is currently participating, along with two other partners, GoldiFresh Inc., and Brighter Bites, in a cross-sector collaborative home delivery-based Produce Prescription Program (PPRx) pilot initiative that provides consistent access to healthy food plus nutrition education to Medicaid-eligible pregnant women in Harris County, TX, deemed to be at high risk of adverse pregnancy or birth outcomes. The objectives of this study are two-fold: (a) to examine utilization of food basket contents and improvements in diet quality in this home delivery based PPRx program, and (b) to evaluate if and the extent to which utilization of food basket contents outcomes improves with support from an interactive AI-based conversational agent to convert food into healthy meals.


Eligibility criteria: Inclusion Criteria:

* receiving prenatal care at high-risk obstetric clinics
* \<= 20 weeks medically-confirmed viable pregnancy
* designated as high risk \[Age\>=35 years, or obese or overweight (BMI\>=25.0 at pre pregnancy self-report), or prior history of pregnancy hypertension or gestational diabetes\]
* within the zip code delivery radius

Exclusion Criteria:

* women who were medically recommended bed rest through pregnancy
* substance users

Primary outcomes:
measure: Change in consumption of home-delivered produce from baseline to 6 months
timeFrame: Measures will be collected at baseline, and 6 times at random intervals over the next 6 months
measure: Change in usual consumption of fruits and vegetables from baseline to 6 months
timeFrame: Measures will be collected at baseline, and after 6 months of exposure to program
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nanlini Ranjit, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05178199: The Effectiveness of RPSG Intervention for Nurses During the COVID-19
Official title: The Effectiveness of "Remote Psychological Support Group" Intervention for Nurses During the COVID-19 Outbreak
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Keywords: psychological support group
nurse
COVID-19
quality of life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The cases of COVID-19 are continuing to be confirmed around the world. In the clinical settings, the nurses in evacuation acute wards are main responsibility to undertake the care of emergency patient follow-up and suspected or confirmed COVID-19 cases. Those nurses have to face the high psychological pressure, unknown panic, fear and so on. Thus, the study plans to invite nurses who are working in evacuation acute wards to participate the project called "Remote Psychological Support Group (RPSG)". The study supposes "RPSG" could improve nurses' self-efficacy, fear of COVID-19, psychological distress, and quality of life.

Detailed description: The cases of COVID-19 are continuing to be confirmed around the world. In the clinical settings, the nurses in evacuation acute wards are main responsibility to undertake the care of emergency patient follow-up and suspected or confirmed COVID-19 cases. Those nurses have to face the high psychological pressure, unknown panic, fear and so on. Thus, the study plans to invite nurses who are working in evacuation acute wards to participate the project called "Remote Psychological Support Group (RPSG)". The results of this study will establish the effectiveness of RPSG intervention for nurses on self-efficacy, fear of COVID-19, psychological distress, and quality of life and identify the feasibility of the RPSG. The results are also critical to improving the quality of care for nurses during the COVID-19 outbreak and the RPSG model will establish an important basis for support group in the event of other Severe Pneumonia with Novel Pathogens in the future.

Eligibility criteria: Inclusion Criteria:

* The nurses have to above 20 years old.
* The nurses who work in evacuation acute wards.

Exclusion Criteria:

* The nurses who have any mental illness.

Primary outcomes:
measure: compare self-efficacy of nurses before and after RPSG
timeFrame: 8 weeks
measure: compare fear of COVID-19 for nurses before and after RPSG
timeFrame: 8 weeks
measure: compare psychological distress for nurses before and after RPSG
timeFrame: 8 weeks
measure: compare quality of life for nurses before and after RPSG
timeFrame: 8 weeks
Secondary outcomes:
measure: satisfaction for RPSG
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: NTUH
name: Wang Hsuan Wen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04896099: Feasibility of Supportive Care Needs in Patients With Advanced Solid Cancer in a Therapeutic Trial
Official title: Prospective, Observational Study Evaluating the Feasibility of a Systematic and Standardized Assessment of Supportive Care Needs in Patients With Advanced Solid Cancer at the Inclusion in a Therapeutic Trial at the Institut Curie
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supportive Care
Metastatic Cancer
Clinical Trial
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all comers for a clinical trial

Brief summary: The purpose of the study is to assess the supportive care needs of patients enrolled in a therapeutic trial for metastatic cancer.

Detailed description: All patients included in a therapeutic trial will be offered an analysis of their supportive care needs from the following options:

* dietetics
* psychological
* pain management
* Palliative medicine consultation or day hospital
* onco-geriatrics
* social assistance
* Physiotherapist care If an intervention(s) is selected, it will be offered in addition to the patient's participation in the therapeutic trial.

Eligibility criteria: Inclusion Criteria:

* metastatic cancer
* patient included in a clinical trial

Exclusion Criteria:

- patient deprived of his freedom

Primary outcomes:
measure: EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: 3 months
measure: National Comprehensive Cancer Network (NCCN) Distress thermometer
timeFrame: 3 months
measure: Questionnaire G8 oncodage
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
affiliation: Institut Curie
name: Pauline du Rusquec, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01824199: CYP2C19 Genotype Predictor of Gastric Acid Suppression
Official title: CYP2C19 Genotype as a Predictor of Gastric Acid Suppression and Healing of Erosive Esophagitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Esophagitis
Keywords: Esophagitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 0
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: If CYP2C19 genotype can predict the efficacy of healing erosive esophagitis and gastric acid secretion in patients taking once a day omeprazole.

Detailed description: Proton pump inhibitors are metabolized through the CYP2C19 hepatic enzyme system. Several variant genotypes of this enzyme exist which may lead to decreased, normal or increased metabolism of the proton pump inhibitor. With alteration of metabolism, the degree of gastric acid suppression achieved and efficacy in treating reflux could be affected. For example, Asian populations who have low activity of CYP2C19, commonly need lower doses of proton pump inhibitors to manage gastroesophageal reflux because of more sustained blood levels and availability of the drug. Theoretically, those patients who are rapid metabolizers would receive less effective treatment with proton pump inhibitors

Eligibility criteria: Inclusion criteria:

* Age 18 or older
* Have either mild-to-moderate Los Angeles (LA) Classification System grade B, moderately severe LA grade C, or severe LA grade D erosive reflux esophagitis
* Or patients having a clinically indicated pH/impedance monitoring on proton pump inhibitor therapy for indications of gastroesophageal reflux disease.

Exclusion criteria:

* Neoplasm of the esophagus or stomach
* Use of drugs that interfere with CYP2C19 metabolism Diazepam, phenytoin, amitriptyline, clomipramine, clopidogrel Cyclophosphamide, progesterone, fluoxetine, fluvoxamine, ketoconazole Lansoprazole, omeprazole, ticlopidine
* Evidence of active H. pylori infection
* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
* Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss

Primary outcomes:
measure: The correlation specific to CYP2C19 genotype with gastric acid suppression by omeprazole.
timeFrame: 8 weeks
Secondary outcomes:
measure: To assess patients gastrointestinal symptoms, in patients with EoE by means of standard validated questionnaires
timeFrame: 30 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Katzka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03208699: EXPert System, ALImentary
Official title: Screening and Diagnosis Help of Eating Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eating Disorder Symptom
Keywords: anorexia
bulimia
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2017-07-05
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recruited in the Nutrition Department of Rouen University Hospital (France) for suspicion of Eating disorders

Brief summary: Eating disorders (ED) are often undetected in the general population resulting in delayed treatment. The SCOFF questionnaire has been validated for eating disorders screening in primary care, but does not identify the type of eating disorder.

Objective: Investigators evaluated the performance of a clinical algorithm (ExpaliTM) combining answers to SCOFF questionnaire with Body Mass Index (BMI) to identify four Broad Categories of ED derived from DSM-5.

Design: Clinical algorithm (ExpaliTM) was developped from 104 combinations of BMI levels and answers to five SCOFF questions. Two senior ED specialists allocated each combination to one of the four Broad Categories of ED (DSM-5 diagnostics): restrictive disorder (anorexia nervosa typical, atypical and restrictive food intake disorders), bulimic disorder (typical and with low frequency or duration), hyperphagic disorder (binge eating disorders typical and with low frequency or duration) and other specified ED. The performance of ExpaliTM was evaluated on data from patients referred to the Nutrition Department including a precise DSM-5 diagnosis of ED, a positive SCOFF test (at least 2 "yes" answers) and BMI. Sensitivity, specificity values with a 95% confidence interval (95% CI) and Youden index were calculated for each category.


Eligibility criteria: Inclusion Criteria:

* eating disorders
* SCOFF test = 2 or more

Exclusion Criteria:

* no eating disorders
* SCOFF test = 0 or 1

Primary outcomes:
measure: Sensivity and specificity of the clinical algorithm
timeFrame: inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06476899: A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy
Official title: A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy in Previously Untreated CLL/SLL
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: CLL/SLL
Lead sponsor: The First Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Prospective, interventional, and practical clinical studies


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 70 years, with no gender restrictions;
* Patients with CLL/SLL who meet the iwCLL2018 diagnostic criteria;
* Indications for treatment
* ECOG performance score of 0-2;
* Patients are untreated or have not received standardized treatment
* Before the trial screening, the subject or their legal representative voluntarily signs a written informed consent form, indicating that they understand the purpose of the study and the necessary research steps, and are able to comply with the protocol and follow-up.

Exclusion Criteria:

* Has been diagnosed or treated for malignancies other than CLL (including active central nervous system lymphoma) within the past year;
* there is clinical evidence of Richter transformation;
* Participant cannot receive or plan to receive another treatment during study participation
* Other conditions that the investigator considers inappropriate for participation

Primary outcomes:
measure: TTNTD rate at 30 months
timeFrame: 30 months
Secondary outcomes:
measure: PFS
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02756299: Patient Education and PAP Compliance in OSA
Official title: Patient Education and PAP Compliance in OSA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Sleep Apnea
Positive Airway Pressure
Patient Education
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Obstructive sleep apnea (OSA) is a common disorder with serious complications. Positive airway pressure (PAP) is the first line treatment of OSA, which eliminates obstructive events, reduces daytime sleepiness, and improves quality of life, especially in those with excessive daytime sleepiness. However, despite the benefits of the PAP treatment, overall acceptance and adherence rates are not fully promising. Less is known regarding the PAP adherence rates in Turkey. In the current study, the researchers primarily addressed if an intensified patient education strategy including the polysomnography (PSG) charts viewing followed by frequent follow-ups would improve the compliance rates at long-term in patients with OSA.

Detailed description: OSA is a common disorder with serious complications. PAP is the first line treatment of OSA, but overall acceptance and adherence rates are not fully promising. In the current study, the researchers primarily addressed if an intensified patient education strategy including the PSG charts viewing followed by frequent follow-ups would improve the compliance rates at long-term in patients with OSA.

METHOD:

This single-center, randomized, controlled study was conducted at the Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital in Istanbul between June 2014 and April 2015. Eligible OSA patients were randomized to Standard Support (SS) group (general information about OSA and PAP treatment at baseline), or to Educational Support (ES) group (additional polysomnography chart viewing from both diagnostic and titration nights). All patients were scheduled to five PAP control visits between 2 weeks and 6 months after the PAP prescription. Primary outcome was the PAP compliance (4 h/night for 70% of all the nights) at the last visit.

Eligibility criteria: Inclusion Criteria:

* Consecutive adult patients with newly diagnosed obstructive sleep apnea (apnea-hypopnea index ≥5 events/h), who were offered PAP treatment.
* Must be able to give informed consent

Exclusion Criteria:

* Disabled to come to follow-ups.

Primary outcomes:
measure: Positive Airway Pressure usage (hours/night)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul Sureyyapasa Chest Diseases and Chest Surgery Hospital
name: Sema Sarac, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04867499: Epidemiology of Acute Mesenteric Ischemia
Official title: Retrospective Population-based Study on Epidemiology of Acute Mesenteric Ischemia in Estonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Mesenteric Ischemia
Lead sponsor: Tartu University Hospital
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 577
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: All at least 18-year-old patients with acute mesenteric ischemia during years 2016-2020 in Estonia.

Brief summary: Retrospective population-based study on epidemiology of acute mesenteric ischemia in Estonia Study objective is to describe epidemiologic features in adult patients with acute mesenteric ischemia during years 2016-2020. Patients from all hospitals in Estonia are included.


Eligibility criteria: Inclusion Criteria:

All at least 18-year-old patients with acute mesenteric ischemia during years 2016-2020.

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence
timeFrame: 2016-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
Study officials:
References:
citation: Kase K, Reintam Blaser A, Tamme K, Mandul M, Forbes A, Talving P, Murruste M. Epidemiology of Acute Mesenteric Ischemia: A Population-Based Investigation. World J Surg. 2023 Jan;47(1):173-181. doi: 10.1007/s00268-022-06805-5. Epub 2022 Oct 19.
Clinical trial NCT00528099: Study Evaluating IMA-026 in Healthy Japanese Males
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IMA-026 Administered Subcutaneously or Intravenously to Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-09-12
Enrollment: 50
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending, single subcutaneous or intravenous doses of IMA-026 in healthy Japanese male subjects


Eligibility criteria: Inclusion Criteria:

* Men ages 20 to 40 years, inclusive, at screening
* Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight \> 45 kg
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vitals signs, and 12 lead ECG.

Primary outcomes:
measure: To assess the safety and PK profile of IMA-026 administered as single ascending subcutaneous or intravenous doses.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toshima-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: