louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00271440: Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal
Official title: Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Bacterial Infection
Keywords: chlorhexidine
neonatal
skin flora
skin cleansing
bacterial colonization
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Tribhuvan University, Nepal
name: Nepal Nutrition Intervention Project Sarlahi
First posted: 2006-01-02
Enrollment: 286
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the reductions in skin flora of newborns after a single cleansing of the body with three concentrations of chlorhexidine (0.25%, 0.5%, 1.0%) and to examine the safety of skin cleansing in neonates in Nepal.

Detailed description: Studies in Malawi, Egypt, and Nepal suggest that neonatal skin cleansing with chlorhexidine solutions may reduce the risk of infection and mortality. Cleansing with 0.25% chlorhexidine in Nepal resulted in a 28% reduction in mortality among low birth weight infants, while there was no impact on infants of normal weight. The mechanism of action for this observed benefit is not clear. Chlorhexidine may remove pathogens from the skin of the newborn and/or prevent exposure to pathogens that may otherwise cause infection and lead to sepsis. The benefit of chlorhexidine cleansing may be extended with higher concentrations of chlorhexidine.

Infants born at the Tribhuvan University Teaching Hospital in Katmandu, Nepal will be randomized to skin cleansing with chlorhexidine at one of three concentrations (0.25%, 0.50%, 1.00%). Skin swabs will be collected before wiping, and two and twenty-four hours after wiping in order to compare levels of bacteria on the skin across the treatment groups. A small quantity of blood will be collected at 24 hours after wiping to determine the potential for absorption of chlorhexidine

Eligibility criteria: Inclusion Criteria:

* babies born at Tribhuvan University Teaching Hospital
* greater than 1500 grams

Exclusion Criteria:

* less than 1500 grams
* requires major surgical procedure
* clinically evident skin infection
* generalized skin disease
* major congenital anomoly

Primary outcomes:
measure: Skin flora reduction across treatment groups
timeFrame: prior to wipe, 2hrs after, and 24hrs after
Secondary outcomes:
measure: Serum concentrations of chlorhexidine 24 hours after wipe
timeFrame: 24 hrs after wipe
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Tribhuvan University Teaching Hospital
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Luke C Mullany, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03748940: Study of LY3074828 in Healthy Participants
Official title: A Study to Investigate the Tolerability of Subcutaneous Injections of LY3074828 Compared to Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate different concentrations and formulations of LY3074828 compared to placebo ("dummy drug").

The study will consist of 2 parts: Part A and Part B. Screening is required within 28 days prior to the start of each study part. For each participant in Part A and Part B, the total duration of the clinical trial will be approximately 16 weeks, including screening.


Eligibility criteria: Inclusion Criteria:

- Have venous access sufficient to allow for blood sampling and administration of investigational product

Exclusion Criteria:

* Must not have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females)
* Must not show evidence of active or latent tuberculosis (TB)
* Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 1 month of screening or intend to receive during the study
* Must not be immunocompromised
* Must not have known hypersensitivity to hyaluronidases
* Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
* Must not have significant allergies to humanized monoclonal antibodies
* Must not have clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
* Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
* Must not have had breast cancer within the past 10 years

Primary outcomes:
measure: Visual Analog Scale (VAS) Pain Score
timeFrame: Within 1-minute post injection
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Ltd
state: West Yorkshire
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00907140: Fludeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) Cervical Heterogenity Imaging Study
Official title: Assessment of Changes in Pattern and Magnitude of Tumor FDG Uptake During Chemoradiation as a Predictor of Response to Concurrent Radiation Therapy and Chemotherapy in Patients With Cervical Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: Cervical Cancer
Positron Emission Tomography
Fluorodeoxyglucose
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2009-05-22
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Rationale: Diagnostic procedures, such as positron emission tomography (PET) using fluorodeoxyglucose (FDG), may help determine response to standard cancer therapy in patients with cervical cancer

The purpose of this study is to evaluate the change in cervical tumor heterogenity as measured by FDG-PET/CT imaging.


Eligibility criteria: Inclusion Criteria:

1. Biopsy-proven cervical cancer. (FIGO stage-Ib2-IVa)
2. Age ≥ 18
3. Able to receive chemoradiation therapy with Cisplatin.
4. Non-pregnant status in women of childbearing potential.
5. No other active cancer at the time of diagnosis of cervical cancer Patients cannot have received treatment for any malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
6. Patients with distant metastatic disease are eligible provided the estimated survival of the patient is at least 1 year.
7. Scheduled to undergo or have already undergone FDG-PET/CT imaging for clinical staging of cervical cancer at Barnes-Jewish Hospital Clinical PET Facility on a Biograph 40 PET/CT scanner
8. Able to give informed consent

Exclusion Criteria:

1. Age \< 18
2. Patients with a known active malignancy other than cervical carcinoma.
3. Pregnant and breastfeeding patients.
4. Subjects whose tumors are not FDG avid on baseline standard of care FDG-PET/CT imaging

Primary outcomes:
measure: The overall goal of this pilot study is to evaluate the change in cervical tumor FDG heterogeneity and SUVmax during chemoradiation.
timeFrame: FDG PET/CT imaging is performed at: Baseline, 2 & 4 weeks of therapy, and 3 months after completing therapy
Secondary outcomes:
measure: To correlate changed in FDG heterogeneity and SUVmax with response to therapy.
timeFrame: 5 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University at St. Louis
state: Missouri
Study officials:
affiliation: Washington University at St. Louis
name: Perry W Grigsby, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00232440: Reproducibility of an Immobilization Device (BodyFIX) - Hodgkins/Lymphoma
Official title: A Study to Examine the Reproducibility of an Immobilization Device (BodyFIX ) to Deliver High Precision Radiation Therapy for Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hodgkin's Disease
Lymphoma, Non-Hodgkin
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-10-04
Enrollment: 20
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: Radiation therapy has a well-established role in the treatment of Hodgkin's Disease and non-Hodgkin's Lymphoma. With technological developments, 3-D Dimensional (3D) planning has evolved as a highly precise treatment planning option. High-precision radiation therapy has the potential for more accurate dose delivery to the tumour volume and can result in a greater sparing of normal tissue. An important component of safe radiotherapy delivery is the feasibility and reproducibility of current and new immobilization devices for highly conformal treatment.

The purpose of this study is to determine the reproducibility of an immobilization device known as BodyFIX(TM) using conventional treatment techniques.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing curative or palliative treatment in whom it is considered that immobilization of part or all of an anatomical region would be of benefit to their care.

Exclusion Criteria:

* Any case where ideal treatment may be compromised with use of immobilization method.
* If the patient has any social issues, language barriers resulting in difficulties comprehending the nature of the study, or poor performance status, that could compromise compliance with the study guidelines.

Primary outcomes:
measure: The primary outcome for the study is the average deviation in set-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Alex Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00891540: Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section
Official title: Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Ropivakain 0,2 % Versus Placebo Efter Sectio Caesarea: et Prospektivt, Dobbeltblindet, Placebokontrolleret Studie.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Postoperative Nausea and Vomiting
Cesarean Section
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2009-05-01
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % versus Ropivacaine 0.2 % versus Placebo in patients undergoing elective caesarean section.

The hypothesis is that systemic local infiltration will reduce pain and postoperative opioid consumption.


Eligibility criteria: Inclusion Criteria:

* eligible for elective caesarean section
* able to speak and understand Danish
* able to give informed consent

Exclusion Criteria:

* alcohol or medical abuse
* allergies to local anesthetics
* age \< 18 years
* intolerance to opioids

Primary outcomes:
measure: Postoperative pain
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative nausea and vomiting (PONV)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
state: Hvidovre
Study officials:
References:
Clinical trial NCT02793440: Effectiveness of Lumbar Traction in Lumbar Disk Herniation
Official title: Clinical Results After Medical Therapy Alone or Medical Therapy Associated With Lumbar Traction in the Treatment of Nerve Root Pain of Lumbar Disc Herniation With Disco-radicular Conflict
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Disk Herniation
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 412
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 compare the clinical outcome of medical treatment associated with lumbar traction and medical treatment alone in the treatment of lumbar disk herniation.

Detailed description: This is a prospective and randomized study. Medical treatment = anti-inflammatory therapy and epidural Medical treatment associated with lumbar traction medical treatment = + 5 lumbar traction sessions.

Eligibility criteria: Inclusion :

* patient with lumbar disc herniation with radiculopathy, over 18 years and consenting

Exclusion :

* sciatic complicated (motor deficit or cauda equina syndrome), against indication for medical treatment and / or lumbar traction
* previous lumbar surgery
* sciatica without disc herniation

Primary outcomes:
measure: Decrease radicular pain (25%)
timeFrame: to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT06680440: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of ASC30 Tablets and ASC30 Tablets A1 in Participants With Obesity
Official title: A Phase I Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Tablets in Participants With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Weight Management
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2024-11-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of ASC30 Tablets or ASC30 Tablets A1 in participants with obesity.


Eligibility criteria: Inclusion Criteria:

1. Have provided informed consent before initiation of any study-specific procedures.
2. Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive).
3. No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.

Exclusion Criteria:

1. Have evidence of any clinically significant active or chronic disease.
2. Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or rare forms of diabetes mellitus.
3. Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
4. Have a history of acute or chronic pancreatitis.
5. Participants with a known clinically significant gastric emptying abnormality.
6. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
7. Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.

Primary outcomes:
measure: Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (SAD)
timeFrame: Up to Day 8
measure: Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (MAD)
timeFrame: Up to Day 28
Secondary outcomes:
measure: Cmax of ASC30 (SAD)
timeFrame: Up to Day 8
measure: Cmax of ASC30 (MAD)
timeFrame: Up to Day 28
measure: Change From Baseline in Body Weight (MAD)
timeFrame: Up to Day 28
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Ascletis clinical site
state: Utah
Study officials:
References:
Clinical trial NCT03650140: Pharmacokinetics and Pharmacodynamics of Anthocyanins
Official title: PKPD of Anthocyanins After Oral Cherry Juice Concentrate in Gout Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gout
Keywords: Gout
Tart Cherry
Pharmacokinetics
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of the study is to establish the pharmacokinetic parameters of cherry juice concentrate and identify its potential to alter inflammatory markers in gout patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of gout

Exclusion Criteria:

* Allergy to cherries or cherry products
* Any history of malignancy
* History of any pancreatic or biliary tract disease
* Significant Anemia
* History of significant renal (sCr \> 1.5 mg/dL)
* Hepatic disease (liver enzymes 3 times upper limit of normal)
* Any active gastrointestinal condition
* History of large bowel resection for any reason
* Use of cherry juice concentrate or consumption of cherries within 14 days
* Personal or inherited bleeding disorders or currently on anticoagulation
* Women of childbearing age not on oral contraceptives
* Women who are pregnant or nursing

Primary outcomes:
measure: Highly sensitive C-reactive protein (hs-CRP)
timeFrame: Maximal change in hs-CRP from baseline through study completion (during the 12 hours after a dose)
Secondary outcomes:
measure: Area under the curve (AUC)
timeFrame: Through study completion (during the 12 hours after a dose)
measure: Change in inflammatory marker expression
timeFrame: Through study completion (during the 12 hours after a dose)
measure: Peak plasma concentration (Cmax)
timeFrame: Through study completion (during the 12 hours after a dose)
measure: Time to peak plasma concentration (Tmax)
timeFrame: Through study completion (during the 12 hours after a dose)
measure: Half-life (t1/2)
timeFrame: Through study completion (during the 12 hours after a dose)
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Robert Wood Johnson Medical School/ Rutgers RWJMS Gout Center
name: Naomi Schlesinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00134940: Post-marketing Study to Collect Safety Data in Heart Transplant Patients Receiving Everolimus
Official title: A Non-interventional Protocol to Collect Prospective and Retrospective Data in Patients Receiving Everolimus to Prevent Acute Rejection Following Cardiac Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Keywords: Transplantation, heart
Organ transplant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The purpose of this observational protocol is to evaluate the use of everolimus in routine clinical practice for heart transplants.

Primary outcome measures: incidence of acute rejection episodes Secondary outcomes: safety


Eligibility criteria: Inclusion Criteria:

* Cardiac transplant recipients
* Discharged alive from hospital
* Must be receiving everolimus

Exclusion Criteria:

* Patients not treated with everolimus beginning within 2 weeks after receiving a heart transplant

Other inclusion/exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novarits
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
city: Wein
country: Austria
facility: Novartis
city: Bad Oeynhausen
country: Germany
facility: Novartis
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
Clinical trial NCT06616740: Effects of Paratracheal Compression and Cricoid Compression on LMA ProSeal Placement
Official title: Comparison of the Effects of Paratracheal Compression and Cricoid Compression on LMA ProSeal Placement: a Randomised Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management
Keywords: Airway management
LMA
Cricoid pressure
Paratracheal pressure
Supraglottic airway device
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two groups;

1. Experimental Group: Group P; paratracheal compression will be applied during LMA ProSeal insertion.
2. Sham Comparator: Group C; cricoid compression will be applied during LMA ProSeal insertion.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to compare the effect of paratracheal and cricoid pressure on LMA ProSeal insertion, insertion time, insertion difficulty, and the rate of optimal positioning of the device after insertion.


Eligibility criteria: Inclusion Criteria:

* Patients aged 19-70 years who are scheduled for general anaesthesia for whom LMA management would be appropriate.

Exclusion Criteria:

* with cervical spine disease
* expected difficult airway
* upper airway abnormalities
* body mass index (BMI) more than 35 kg/m2
* high risk of aspiration (hiatus hernia, gastro-oesophageal reflux disease and starvation)
* postoperative ventilator care
* surgeries requiring positions other than supine.

Primary outcomes:
measure: Duration of insertion
timeFrame: During intubation procedure
Secondary outcomes:
measure: Sensation of resistance during inserting of LMA ProSeal
timeFrame: During intubation procedure
measure: Anatomical location of the LMA ProSeal in the larynx and accuracy of insertion site.
timeFrame: 1 minutes after intubation
measure: Tidal volume and peak inspiratory pressure with or without each maneuver after LMA ProSeal insertion.
timeFrame: 2 minutes after intubation
measure: Oropharyngeal leak pressure
timeFrame: 5 minutes after induction of general anesthesia
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Taining and Research Hospital
Study officials:
affiliation: Karamanoglu Mehmetbey University, School of Medicine
name: Muhammet Korkusuz, MD
role: PRINCIPAL_INVESTIGATOR
References: