louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01000818: A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)
Official title: An Open-Label, 3-Period, Fixed-Sequence Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 Pharmacokinetics in HIV-Infected Patients on a Stable MK0518-Containing Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV-1 Infection
HIV Infections
Keywords: Treatment experienced
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-10-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label, 3-period, fixed-sequence study in a panel of 18 HIV-infected patients on MK0518 as part of a stable treatment regimen for HIV.


Eligibility criteria: Inclusion Criteria:

* Patient is Human immunodeficiency virus (HIV) positive
* Patient is taking an MK0518 (Raltegravir) containing regimen
* Patient has not had any changes to his/her antiviral regimen in the last 2 weeks
* Patient who is of reproductive potential agrees to use an acceptable method of birth control
* Patients baseline health is stable

Exclusion Criteria:

* Patient has a history of stroke or chronic seizures.
* Patient has a history of gastric bypass surgery
* Patient is pregnant of breastfeeding
* Patient consumes excessive amounts of caffeinated beverages daily
* Patient has had major surgery, donated blood, or participated in another investigational study in the past 4 weeks

Primary outcomes:
measure: Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir
timeFrame: 12 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02131818: Necessity of Antibiotics for Prevention of Delivery-associated Infections After Spontaneous Vaginal Delivery at Term
Official title: Necessity of Antibiotics for Prevention of Delivery-associated Infections After Spontaneous Vaginal Delivery at Term
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Perineal Wound Infection
Keywords: amoxicillin
postpartum infections
puerperal infection
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine amoxicillin is effective in the prevention of wound infection in normal labor.

Detailed description: When the pregnant women is admitted due to first stage of labor , the investigator will inform the patients. If the patients give consent, the patient's data will be collect in case record form. the patients will be swab at posterior fornix and around anus to collect specimen and send to microbiology lab before per vaginal examination. After the patients finish in labor, perineal wound will be swab to collect specimen and send to microbiology lab. Then the patients are randomized in two group, the first one will receive amoxicillin and the second one will receive placebo. During admission the patients will be exam by investigator every day. After the patients are discharge, the follow up will be appoint on 6 weeks later. The infant will be swab at rectum to collect specimen and send to microbiology lab when the patient's discharge day. Every specimen will be culture for bacteria and perform antimicrobial susceptibility test for amoxicillin.

Eligibility criteria: Inclusion Criteria:

* Term pregnancy
* Normal labor

Exclusion Criteria:

* Penicillin allergy
* Previous history antibiotic using within 2 weeks
* Patients cannot take oral medication
* Patients have underlying disease eg. diabetes mellitus, hypertension, HIV infection
* Premature rupture of membranes

Primary outcomes:
measure: Incidence of perineal wound infection
timeFrame: within 6 weeks after normal labor
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hoapital Mahidol University
Study officials:
affiliation: Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
name: Vitaya Titapant, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01238718: Use of Lidocaine in Rapid Sequence Induction
Official title: Impact of Lidocaine on Anesthetic Depth During Rapid Sequence Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Response
Keywords: lidocaine
anesthetic depth
hemodynamics
rapid sequence induction
BIS
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Lidocaine has been shown to blunt the cardiovascular response to endotracheal intubation. The incidence of hypertension, tachycardia and dysrhythmias due to laryngoscopy may be increased in patients that receive rapid sequence induction and intubation, where opioids are spared and intravenous anesthetic agents are not titrated step by step. Our hypothesis was that lidocaine when administered intravenously in patients who undergo rapid sequence induction may not only blunt the hemodynamic response to intubation, but may also increase the anesthetic depth (as assessed by BIS), thus further reducing the possibility of hypertension, arrhythmias and also awareness.


Eligibility criteria: Inclusion Criteria:

* reason for rapid sequence induction (emergency, reflux),
* ASA I-II,
* no antihypertensive drugs,
* no antiarrhythmic drugs

Exclusion Criteria :

Primary outcomes:
measure: BIS changes after lidocaine administration in rapid sequence induction
timeFrame: change from baseline in BIS values during 10 minutes
Secondary outcomes:
measure: change in blood pressure
timeFrame: change from baseline in blood pressure during 10 minutes
measure: change in Heart rate
timeFrame: change from baseline in heart rate durng 10 minutes
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieio Hospital, University of Athens
state: Attiki
Study officials:
References:
Clinical trial NCT00640718: Evaluation of EverOn™ System in Medical / Surgical Ward
Official title: Evaluation of EarlySense EverOn™ System in Medical / Surgical Ward
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Post Operative Patient
Patients Requiring PCA
Respiratory Patients
Patients in Risk of Fall
Keywords: heart and respiratory monitoring
Lead sponsor: EarlySense Ltd.
Sponsor class: INDUSTRY
First posted: 2008-03-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults hospitalized in medical surgical units and are willing to sign consent form

Brief summary: The EverOn™ system developed by EarlySense, Ltd., the sponsor of this study, is intended to assist hospitals to better address and improve recognition and response to changes in a patient's condition.

The system, monitors the patient while in bed consists of a contact-free sensor that is placed under the bed mattress and identifies respiratory and heart rates, degree of patient's movement or agitation while in bed as well as patient's actual exit out of the bed. The EverOn system does not require a physical contact with the patient, eliminating the need for any direct contact electrodes, leads, cuffs or nasal cannulae.


Eligibility criteria: Inclusion Criteria:

1. Age above 18 years.
2. Patients not monitored continuously by telemetry, vital sign monitor or oximetry.
3. Patients not requiring special mattresses (e.g. airflow).
4. The patient or a legal guardian is ready to sign the Informed Consent.

Exclusion Criteria:

1. Patients that at the judgment of the staff in the evaluating unit, are not able to communicate coherently and respond to nurses' questions.
2. Patients monitored continuously by telemetry, vital sign monitor or oximetry.
3. Patients requiring special mattresses.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Framingham
country: United States
facility: MetroWest Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT06276218: Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study
Official title: Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Clavicle Fracture
Keywords: Clavicle fracture, treatment of clavicle fracture, clavicular brace, figure of eight bandage
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized control trial was conducted to compare the outcomes of conservative management for closed midshaft clavicular fractures using self-adjustable clavicular brace and standard clavicular brace.

Detailed description: Ten patients aged 18-75 years with midshaft clavicle fractures were enrolled in the study during February 2022 to February 2023. 6 patients were managed with standard clavicular brace and 4 patients with self-adjustable clavicular brace. All patients were scheduled for follow-up appointments at 1 week, 2 weeks, 4 weeks, 6 weeks and 12 weeks. Results were assessed based on clinical, functional and radiographic outcomes using the DASH questionnaire, pain, measured by VAS, analgesic usage, displacement, shortening, time to union, and patient satisfaction,

Eligibility criteria: Inclusion Criteria:

* Patient with aged between 18 - 75 years old
* Closed isolated fracture midshaft of clavicle within 9 days after the injury date

Exclusion Criteria:

* After bracing, fracture displacement and/or shortening \> 2 cm or fracture comminution \> 3 fragments
* Segmental fracture
* Open fracture
* Impending open fracture (soft tissue compromise/skin lesion)
* Ipsilateral upper extremities fracture which disturbs clavicular bracing
* Floating shoulder which surgical treatment is indicated.
* Patients with other injuries (e.g. head injury, chest and abdomen injury) which interrupted clavicular bracing
* Pathologic fracture
* Patient has limitation for clavicular brace application
* Pregnant women

Primary outcomes:
measure: DASH
timeFrame: 1, 2, 4, 6, 12 week
Secondary outcomes:
measure: Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction
timeFrame: 1, 2, 4, 6, 12 week
Other outcomes:
Locations:
city: Songkla
country: Thailand
facility: Prince of Songkla University
state: Hatyai
Study officials:
References:
Clinical trial NCT02854618: Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus
Official title: Study of the Immune Response T Anti-tumoral Cluster of Differentiation 4 (CD4) for Patients Treated for a Metastatic Breast Cancer by Everolimus Within the Framework of Its Marketing Authorization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the immune response for patients affected by metastatic breast cancer treated by everolimus


Eligibility criteria: Inclusion Criteria:

* patients eligible for a treatment by everolimus in association with the exemestane
* Performance status of 0,1 or 2 according to the WHO
* Patients affected of a breast cancer advanced and\\or metastatic HER2 negative expressing the hormonal receptor RH +
* menopausal Patients

Exclusion Criteria:

* Psychiatric disease compromising the understanding of the information or the realization of the study
* Vulnerable people according to the law (minors, adults under protection, private persons of freedom)
* Histories of cancer in 5 years preceding the diagnosis (except breast cancer, squamous-cell)
* Not menopausal women
* Unaffiliated people to the Social Security
* People being for the period of exclusion from another study
* Hypersensitivity in the active substance, in the other by-products of the rapamycin or in one of the excipients.
* Symptomatic visceral achievement
* Legal incapacity or limited legal capacity

Primary outcomes:
measure: level of the spontaneous anti-telomerase response
timeFrame: 12 months
Secondary outcomes:
measure: T lymphocytes level
timeFrame: 12 months
measure: everolimus level in serum patients
timeFrame: 12 months
measure: angiopoietin 2 level
timeFrame: 12 months
measure: CD138 level
timeFrame: 12 months
measure: ps6K expression
timeFrame: 12 months
measure: Merlin expression
timeFrame: 12 months
measure: neuropilin 2 expression
timeFrame: 12 months
measure: quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire
Study officials:
References:
Clinical trial NCT03360318: Brace Versus Casting in Pediatric Radial Head Fractures
Official title: Brace Versus Casting in Pediatric Radial Head Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radial Fracture
Keywords: pediatric
elbow fractures
management
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Commare the pain and function of Brace Versus Casting in Pediatric Radial Head Fractures after 1 month

Detailed description: Radial Head Fractures are common injury in children. In this study, healthy children with Mason type I or II radial head fractures are planned to be included.

Outcome Measures: The primary outcome measure will be an assessment of functional daily activities as measured by the MAYO score at four weeks post injury. Secondary outcomes will include an assessment of pain scores using VAS.

Sample Size and Analysis: Assuming a standard deviation of 10%, alpha = 0.05, beta = 0.2 and 10% dropout rate yields a sample size of 150 patients. Secondary analyses will include Fisher's Exact test to compare proportions of children with full range of motion of the injured ankle at four weeks and with full baseline activity level at four months, and the area under the curve of a pain-time profile curve will be compared using a Student's t-test.

Eligibility criteria: Inclusion Criteria:

5 to 18 years of age with one of the following fracture Undisplaced Maoson types I and II fractures of the radial head

Exclusion Criteria:

The diagnosis of elbow sprain or contusion; they occur primarily in adolescents with closed epiphyseal plates.

All open fractures which require surgical debridement. All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease.

Congenital anomalies of the elbow. Patients with coagulopathies. Multisystem trauma and multiple fractures of the same or opposite limb. Patients cognitively and developmentally delayed with inability to express pain and/or difficult assessment of baseline activity level.

Injuries greater than 72 hours old. Past history of surgery or closed reduction of the same elbow within the last 6 months or ankle trauma of the same ankle within 3 months.

Primary outcomes:
measure: Mayo score
timeFrame: 1 month
Secondary outcomes:
measure: pain
timeFrame: 1 month
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: peng zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06446518: Assessing Virtual Reality for Perioperative Anxiolysis and Postoperative Pain Modulation in Adolescents Undergoing MIRPE Surgery
Official title: A Randomized Control Trial for Assessing Virtual Reality for Perioperative Anxiolysis and Postoperative Pain Modulation in Adolescents Undergoing MIRPE Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pectus Excavatum
Pectus Deformity
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: Új Nemzeti Kiválóság Program
First posted: 2024-06-06
Enrollment: 70
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test virtual reality in adolescents undergoing minimally invasive repair of pectus excavatum surgery. The main questions it aims to answer are:

* Can virtual reality decrease anxiety in adolescents on the day of the surgery?
* Can virtual reality be used as a pain modulator in adolescents in postoperative care? Participants will be asked to wear a VR headset for a minimum of 1 hour before and after the surgery. Patients will be asked to fill out three anxiety tests: on admission, in the operating room and on the surgical ward on the day after surgery.

Researchers will compare VR group to control group to see if anxiety and pain was different among those who recieved the VR headset.


Eligibility criteria: Inclusion Criteria:

* Patient between 14-18 years old
* reported chest deformity (pectus excavatum/ carinatum)
* patients undergoing MIRPE surgery in general anesthesia
* Hungarian fluency
* willing to comply with study procedures.

Exclusion Criteria:

* gross cognitive impairment that would interfere with the ability to consent or complete study procedures.
* Head injury
* Head infection
* Altered mental status (independently from midazolam)
* Scabies or louse
* Dizziness or vertigo
* Blindness or severe vision loss
* Lack of parental/ guardian or patient consent
* Those, who has a head deformity, so VR headset does not fit well

Primary outcomes:
measure: Decrease in anxiety
timeFrame: 1-2 days
Secondary outcomes:
measure: Decrease in pain
timeFrame: 1-2 days
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Department of Paediatrics, Semmelweis University
Study officials:
References:
Clinical trial NCT02039518: Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients
Official title: Randomized Controlled Trial of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined With Platinum Based First-line Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: Progression free Survival
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2014-01-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to Evaluate and compare safety and efficacy of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined With Platinum Based First-line Chemotherapy

Detailed description: from the first cycle of treatment (day one) to two month after the last cycle

Eligibility criteria: Inclusion Criteria:

1. ≥18 years
2. PS=0,1,2
3. Patients who were diagnosed by the histologic, cytologic diagnosis of extensive small cell lung cancer
4. Patients received Etoposide combined with platinum based first-line chemotherapy 6 cycles and there is evidence show the patent is PR/CR/SD
5. Expected lifetime\>12 weeks
6. Signed written informed consent

Exclusion Criteria:

Small cell lung cancer non small cell hybrid Women during pregnancy or lactation previously treated with two or more than two kinds of treatment Any non remission of \>CTCAE caused tumor treatment past grade 2 toxicity Ccr\<30 ml/min (calculated by Cockcroft-Gault formula) hepatic insufficiency：

1. Tbil\> 1.5×ULN
2. ALT and AST \> 2.5×ULN (Patients with liver metastasis\>5×ULN) Alkaline phosphatase\>2.5 ×ULN(Patients with liver metastasis\>5×ULN)
3. Severe symptomatic heart disease
4. Symptomatic brain metastases
5. In the last 5 years have been or are suffering from other histological types of malignant tumor
6. There are serious or uncontrolled systemic diseases
7. During the study period planned radiotherapy on target lesion
8. During the study period, plans to use other antineoplastic therapy
9. Clinical study on treatment of 30 days beginning period prior to participate in any study drug

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: from the first cycle of treatment (day one) to two month after the last cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: WU X HUA, DOCTOR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00742118: Effects of the Soluble Mediators of Mastocytes on the Intestinal Epithelial Barrier and of the Enteric Nervous System During the Syndrome of the Irritable Bowel
Official title: Effects of the Soluble Mediators of Mastocytes on the Intestinal Epithelial Barrier and of the entérique Nervous System During the Syndrome of the Irritable Bowel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir
First posted: 2008-08-27
Enrollment: 200
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: BASIC_SCIENCE

Brief summary: Patients with irritable bowel syndrome (IBS) have increased intestinal permeability. In addition, mucosal soluble mediators are involved in the pathophysiology of pain in IBS. The investigators aimed to investigate:

1. paracellular permeability in colonic biopsies of IBS patient
2. the ability of soluble factors from colonic biopsies to reproduce in vitro these alterations


Eligibility criteria: Inclusion Criteria:

* Patients needing coloscopy

Exclusion Criteria:

* Disrupted coagulation results
* Cancer even healed
* Known food allergy.
* Alcohol consumption \>30g/day

Primary outcomes:
measure: Para-cellular permeability
timeFrame: at time=0
measure: Gap junction protein expression
timeFrame: at time=0
measure: Inflammation molecule expression
timeFrame: at time=0
measure: Digestive discomfort degree
timeFrame: at time=0
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Department of gastroenterology, Hopital Archet 2
Study officials:
affiliation: Department of Gastroenterology
name: Thierry PICHE, PhD
role: PRINCIPAL_INVESTIGATOR
References: