louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06623929: Topical Treatments for Ankle Sprains
Official title: Evaluation of Topical Analgesia Treatments for Ankle Sprains
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ankle Sprain
Keywords: local anesthesia
emergency
Nonsteroidal Anti-Inflammatory Drug
Ankle sprain
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases presenting to the emergency department with an ankle sprain within the first 48 hours

Brief summary: Our aim was to evaluate the effects of topical analgesic drugs on rapid recovery of joint functions and pain relief in acute ankle injuries.

A total of 100 patients were included in the study and divided into 2 groups as Diclofenac and Etofenamate. The pain scores of the patients were evaluated with the Numeric Rating scale and Wong-Baker scale before and after treatment. Dorsiflexion and plantarflexion active joint movements were measured with a hand-held goniometer for joint function before and after treatment.

We found that ankle sprains were more common in men. In our study, we found that both topical analgesics were effective in improving joint movements and reducing pain.


Eligibility criteria: Inclusion Criteria:Those over the age of 18, who applied to the emergency room within the first 48 hours after an ankle sprain, who have grade 1/mild and grade 2/moderate ankle sprains, who have excluded fractures and dislocations, who have no muscle-tendon ruptures, no vascular or nerve injuries, no open wounds or burns, whose vital signs are stable, and who give written and verbal consent.

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Exclusion Criteria:Those who did not present within the first 48 hours of ankle sprain, grade 3/severe ankle sprain, multiple trauma, pregnancy, suspected pregnancy, foot and ankle fractures and dislocations, those who had a previous ankle operation or fracture, and cases who did not accept to participate in the study

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Primary outcomes:
measure: Drugs and Pain
timeFrame: 0., 1. hour
Secondary outcomes:
measure: Drugs and movement
timeFrame: 0., and 1. hour
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
References:
Clinical trial NCT05178329: Lifting Effect on Recovery After Mastectomy
Official title: Lifting Effect on Recovery After Mastectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Seroma Complicating A Procedure
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2022-01-05
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Breast cancer surgery has evolved towards ever more breast conserving direction. Even thought the surgical regime has become easier for the patient, many instructions given to the patient after the operation base on instructions, which have been used when the performed operations have been more burdensome.

Previously the patients have been instructed to lift only light objects after the operation, but according to the current knowledge, this instruction might be unnecessary.

The meaning of this study is to compare two patient groups to each other. The other group is instructed to avoid lifting, and the other group is given instructions to lift light weights several times daily.

In the study we compare will this have an effect on

1. incidence of upper limb lymphedema
2. seroma formation after surgery
3. quality of patients life after the surgery

Inclusion criteria is patients underoing mastectomy but no axillary clearance on day-care basis. Patietns will be randomized in two groups, the other as an intervention group and other as an control group. The patients are asked to fill a questionnaire considering recovery from the operation and possible wound healing problems. The amount of seroma is recorded. The volume of upper limbs is measured before and after the surgery.

The study is started in January 2022 and finished in December 2024.


Eligibility criteria: Inclusion Criteria:

* patients with breast cancer diagnosis requiring mastectomy
* patients being operated in day-care regime

Exclusion Criteria:

* patients not eligible for day-care mastectomy
* patients undergoing axillary clearance operation

Primary outcomes:
measure: Volume of seroma formation after mastectomy.
timeFrame: 30 days
Secondary outcomes:
measure: Number of wound problems requiring intervention.
timeFrame: six months
measure: Rate of lymphedema
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: TYKS
name: Ilkka Koskivuo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02389829: Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine
Official title: Hydromorphone Versus Prochlorperazine + Diphenhydramine for Treatment of Acute Migraine. A Randomized, Emergency Department Based, Comparative Efficacy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 127
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Opioids are commonly used to treat migraine in North American Emergency Departments. We are comparing efficacy and adverse events of hydromorphone, an opioid, to that of prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine will be combined with diphenhydramine to prevent adverse events.


Eligibility criteria: Inclusion Criteria:

* Migraine headache (International Classification of Headache Disorders 3B criteria)

Exclusion Criteria:

* Brain imaging ordered
* Fever
* Objective neurological findings
* Pregnancy/ breast feeding
* Allergy/ contraindication to investigational medication
* History of addiction to opioids, use of methadone, any use of opioids previous 30 days

Primary outcomes:
measure: Number of Participants With Sustained Headache Relief Assessed by Self-evaluation
timeFrame: up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department
Secondary outcomes:
measure: Number of Participants Needing Rescue Medication as Assessed by Questionnaire
timeFrame: 48 hours after discharge from Emergency Department
measure: Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire
timeFrame: 48 hours after discharge from Emergency Department
measure: Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire
timeFrame: 48 hours after discharge from Emergency Department
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center--Einstein
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Benjamin W Friedman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen F, Friedman BW. A randomized study of IV prochlorperazine plus diphenhydramine versus IV hydromorphone for migraine-associated symptoms: A post hoc analysis. Headache. 2021 Sep;61(8):1227-1233. doi: 10.1111/head.14185. Epub 2021 Aug 7.
citation: Friedman BW, Irizarry E, Solorzano C, Latev A, Rosa K, Zias E, Vinson DR, Bijur PE, Gallagher EJ. Randomized study of IV prochlorperazine plus diphenhydramine vs IV hydromorphone for migraine. Neurology. 2017 Nov 14;89(20):2075-2082. doi: 10.1212/WNL.0000000000004642. Epub 2017 Oct 18.
Clinical trial NCT01932229: An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib
Official title: An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: NSCLC
Keywords: Advanced NSCLC
EGFR mutation
TKIs
Tyrosine Kinase Inhibitors
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-08-30
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Advanced lung cancer (non-small cell lung cancer) with a mutation in the EGFR (epidermal growth factor receptor) gene, which have disease progression after treatment with an EGFR inhibitor (erlotinib or gefitinib), and have progression of disease also after treatment with chemotherapy will be recruited. The trial has only one arm, of afatinib daily treatment. Blood and exhaled breath samples will be collected for investigations aiming to identify factors that predict response to afatinib.


Eligibility criteria: Inclusion Criteria:

* Advanced NSCLC
* EGFR mutation or six months or longer benefit from EGFR TKIs
* Disease progression on chemotherapy, or inability to receive chemotherapy for medical reasons.
* Disease progression on EGFR TKI, or the presence of an EGFR mutation that does predicts for poor response to first generation EGFR TKIs.

Exclusion Criteria:

* Inability to take oral drugs

Primary outcomes:
measure: Progression free survival
timeFrame: One year
Secondary outcomes:
measure: Overall survival
timeFrame: One year
Other outcomes:
Locations:
city: Ramat Gat
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT02531529: Dexmedetomedine Infusion Versus Fentanyl Infusion for Donor Anlgesia During Living Donor Hepatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Donor Hepatectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-08-24
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare between the analgesic effect of dexmedetomedine infusion versus Fentanyl infusion during donor hepatectomy.


Eligibility criteria: Inclusion Criteria:

* donors of living donor liver transplantation

Exclusion Criteria:

* patient refusal Known allergy to dexmedetomedine

Primary outcomes:
measure: postoperative VAS scale
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dkahleya
Study officials:
References:
Clinical trial NCT00959829: Use of Music and Voice Stimulus on Coma Patients
Official title: Use of Music and Vocal Stimulus in Patients in Coma State - Relations Between Auditory Stimulus, Vital Signs, Face Expression and Glasgow Coma Scale or Ramsay Scale
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coma
Keywords: Communication
Complementary Therapies
Intensive Care
Ethics
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-08-17
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objectives: (1) To check music and voice message influence on vital signs and facial expressions of patients in physiological or induced comas; (2) To connect the existence of patient's responsiveness with the Glasgow Coma Scale or with the Ramsay Sedation Scale.

Method: This was a randomized controlled clinical trial with 30 patients, from two Intensive Care Units, being divided in 2 groups (control and experimental). Their relatives recorded a voice message and chose a song according to the patient's preference. The patients were submitted to 3 sessions for 3 consecutive days.

Detailed description: The relatives elaborated a voice recorded message and choose a music according to the patient preference, which were recorded in the same Compact Disc. Two identical CD's were made at the same recorded time; one with and another one without stimulus in order to make the random division of the groups. The patients were evaluated according to one of the Scales; they used earphones. During the sessions, the data relating to the vital signs and the face expression were recorded in a data collection instrument.

Eligibility criteria: Inclusion Criteria:

* To be in coma;
* To be evaluated according to one of the Scales and to have a score in the study range: in physiological comas, score between 3 to 8 Glasgow Coma Scale (GCS); in induced coma, one of the last two scores of Ramsay Sedation Scale (RSS), R5 or R6;
* To have hearing function preserved according to family;
* To have written consent from the family or responsible party for the patient's participation in the research.

Exclusion Criteria:

* Score between 9 to 15 in GCS or scores R1, R2, R3 or R4 in RSS

Primary outcomes:
measure: Vital signs
timeFrame: 3 days; before and after stimulus or silence
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: HCFMUSP - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
References:
citation: Puggina AC, Silva MJ. [Vital signs and facial expression of patients in coma]. Rev Bras Enferm. 2009 May-Jun;62(3):435-41. doi: 10.1590/s0034-71672009000300016. Portuguese.
Clinical trial NCT00593229: International Registry and Biorepository for TMA(Thrombotic Microangiopathy)
Official title: An Observational Study of All Forms of Thrombotic Microangiopathy in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Thrombotic Microangiopathy
Hemolytic Uremic Syndrome
Thrombotic Thrombocytopenic Purpura
Keywords: Thrombotic microangiopathy (TMA)
Hemolytic uremic syndrome (HUS)
Thrombotic thrombocytopenic purpura (TTP)
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: Mario Negri Institute for Pharmacological Research
name: Icahn School of Medicine at Mount Sinai
name: University of Virginia
name: Montreal Children's Hospital of the MUHC
name: University of Utah
name: Stollery Children's Hospital
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-01-14
Enrollment: 6
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients, 6 months - 18 years

Brief summary: This registry will collect clinical data and store biosamples (seru, plasma, urine, and DNA) annually from pediatric patients with thrombotic mcroangiopathy

Detailed description: Children age, 6 months - 18 years, are eligible if they have one of the following categories of thrombotic microangiopathy (TMA):(1) severe D+HUS; (2) non-familial atypical HUS; (3) familial atypical HUS; or (4) TTP

Patients are seen intially and annually thereafter

Biosamples are collected for storage annually.

Eligibility criteria: Inclusion Criteria:

* Severe HUS, familial or non-familial atypical HUS, TTP

Exclusion Criteria:

* None

Primary outcomes:
measure: Determine epidemiology and outcomes of the various forms of TMA
timeFrame: Ongoing
measure: Determine genetic causes of TMA
timeFrame: Ongoing
Secondary outcomes:
measure: Initiate clinical trials in TMA
timeFrame: In the future
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Schneider Chldren's Hospital
state: New York
Study officials:
affiliation: Schneider Children's Hospital
name: Howard Trachtman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01053429: A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule
Official title: Post-Marketing Surveillance (PMS) Study to Evaluate Safety and Efficacy of Zeldox Capsule
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Schizophrenia
Keywords: Regulatory Post-Marketing Surveillance
Regulatory Pharmacovigilance
ziprasidone
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-21
Enrollment: 3391
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features will be included in the study.

Brief summary: This is a regulatory-required non-interventional pharmacovigilance study exploring the safety profile of ziprasidone HCL monohydrate 20mg, 40mg, 60mg, 80mg in the real world patient population, thus, safety (and/or efficacy) signals will be checked at every visit during the contracted study period until the maximum study end date, per the protocol, of April 2010.

Detailed description: All patients diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features will be included in the study.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with schizophrenia

Exclusion Criteria:

* Patients who have known hypersensitivity to any ingredient of the product
* Patients who have had a recent acute myocardial infarction
* Patients who have uncompensated heart failure
* Patients who have conditions with a potential to increase QT interval (QT-interval prolongation or history of QT prolongation; congenital long QT syndrome; use with other drugs known to increase the QT interval; arrhythmias treated with class I and III antiarrhythmic drugs)

Primary outcomes:
measure: Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population
timeFrame: Baseline up to Week 8
measure: Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population
timeFrame: Baseline up to Week 8
measure: Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT
timeFrame: Baseline up to Week 8
measure: Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP
timeFrame: Baseline up to Week 8
Secondary outcomes:
Other outcomes:
measure: Change From Baseline in Brief Psychiatric Rating Scale (BPRS ) - Improvement
timeFrame: Baseline up to Week 8
measure: Change From Baseline in Drug Attitude Inventory (DAI-10) - Improvement
timeFrame: Baseline up to Week 8
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00702429: Immunoregulation of Periodontal Disease
Official title: Immunoregulation of Periodontal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Disease
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2008-06-20
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Our design is to test in hospital practice a selection of immune parameters that could assess the pathophysiology and progression of periodontal lesions.

Detailed description: These parameters will be measured in 25 healthy volunteers and 25 moderate-to severe periodontal disese patients. Phagocytes will be tested phenotypically and functionally, both ex vivo and in vitro.

Eligibility criteria: Inclusion Criteria:

* Persons appearing spontaneously at the consultation of parodontologie for parodontale disease,
* persons agreeing to undergo a sampling of blood intended for the search

Exclusion Criteria:

* Presence of a chronic or pointed pathology,
* an age 18-year-old subordinate or 65-year-old superior,
* pregnant women,

Primary outcomes:
measure: Percentage of positive cells and intensity of expression for the molecules of surface studied there cytometric in stream
timeFrame: 24 months
Secondary outcomes:
measure: Rate of secretion of cytokines and the other substances
timeFrame: 24 months
measure: Detection and quantification of ARN messengers
timeFrame: 24 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital de la Conception- Laboratoire d'Immunologie
Study officials:
affiliation: Assistance Publique des Hôpitaux de Marseille
name: Joana VITTE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05637229: A Serosurvey Study of Hand, Foot, and Mouth Disease in Indonesia
Official title: A Serosurvey Study of Hand, Foot, and Mouth Disease in Healthy Children Aged 6 to 71 Months Old in Bandung and West Bandung District, Indonesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hand, Foot and Mouth Disease
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-12-05
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population are children aged between 6 to 71 months in Bandung, sampled from urban and rural Primary Health Center in Bandung, Indonesia

Brief summary: This study is a sero-survey study of infants aged 6 months to 71 months in Bandung City and West Bandung District. As initial data to find out how many children have been exposed to human enterovirus type 71 (HEV-71) which causes Hand, foot, and mouth disease (HFMD).

Detailed description: This study is a cross-sectional seroprevalence survey of EV-71, associated with HFMD, among children aged between 6 to 71 months in Bandung, sampled from urban and rural Primary Health Center in Bandung, Indonesia. This study was implemented by Department of Child Health Hasan Sadikin General Hospital/Medical Faculty Universitas Padjadjaran Bandung, West Java. Age-stratified sample of 600 children aged 6-71 months will be conducted from these sites. Samples testing includes routine blood counts, enzyme-linked immunosorbent assays (ELISAs) for enterovirus type 71 (EV71) IgG and ELISAs for other HFMD-associated enteroviruses.

Eligibility criteria: Inclusion Criteria:

* Children aged 6 months to 71 months.
* The participant's parent/guardian receives an explanation and receives a Letter of Consent after the explanation (informed consent) and provided a documented informed consent by parents/legally accepted representative (LAR) participants prior to the study procedures.
* Domicile in Bandung and West Bandung District for at least 6 months.

Exclusion Criteria:

* Children with difficulty to withdraw the blood during blood collection
* Children with severe illness who require further treatment

Primary outcomes:
measure: Seroprevalence of EV71 antibodies
timeFrame: Immediately after sampling
Secondary outcomes:
measure: Proportion of abnormality result for Routine blood tests
timeFrame: Immediately after sampling
measure: seroprevalence of other HFMD-associated enteroviruses antibodies
timeFrame: Immediately after sampling
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Garuda Health Center
city: Bandung
country: Indonesia
facility: Padalarang Health Center
Study officials:
affiliation: Hasan Sadikin Hospital/School of Medicine, Padjadjaran University, Bandung
name: Rodman Tarigan, Doctor
role: PRINCIPAL_INVESTIGATOR
References: