louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04457648: Manuka Honey Eye Drops VS Conventional Treatment of Meibomian Gland Dysfunction Related Dry Eye Disease
Official title: Randomized Assessor Masked Trial Comparing Manuka Honey Eye Drops to Conventional Treatment of Meibomian Gland Dysfunction Related Dry Eye Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 59
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: Assessor-masked (Single blind, randomized controlled trial comparing the conventional treatment group to an interventional group using 16% Manuka Honey topical eye drops.

Detailed description: Purpose To evaluate the effects of conventional treatment compared to use of Manuka Honey eye drops in the treatment of meibomian gland dysfunction related dry eye disease.

Design Assessor-masked (Single blind, randomized controlled trial comparing the conventional treatment group to an interventional group using 16% Manuka Honey topical eye drops.

Methods Patients were randomized into two groups, one group given conventional treatment for meibomian gland dysfunction. The other group was given additional manuka honey 16% eye drops which are registered as a medical device by the australian FDA. SPEED score was taken at baseline and upon follow up. Multiple parameters were graded from slit lamp examination by a masked assessor. Results were compared from baseline to follow up date 3 weeks later.

Eligibility criteria: Inclusion Criteria:

* meibomian gland dysfunction stage 2-4

Exclusion Criteria:

* \<18 years old Unable to consent Recent ophthalmic surgery \<6m Abnormalities of lid position Allergy to honey/bee products Contact lens wearers Patients on long term topical medications apart from lubricants

Primary outcomes:
measure: speed score
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: chinese university of Hong kong
Study officials:
References:
citation: Li AL, Li SL, Kam KW, Young AL. Randomised assessor-masked trial evaluating topical manuka honey (Optimel) in treatment of meibomian gland dysfunction. Br J Ophthalmol. 2022 Jun;106(6):777-780. doi: 10.1136/bjophthalmol-2020-317506. Epub 2021 Jan 8.
Clinical trial NCT03067948: Improving Identification of Mental Health/Substance Use Disorders in HIV Primary Care: Pilot Clinical Response
Official title: Improving Identification of Mental Health/Substance Use Disorders in HIV Primary Care: Pilot Clinical Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-03-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research is a feasibility pilot of an intervention to respond to positive screening tests for mental health(MH) and substance use (SU) captured through the Patient Reported Outcomes questionnaires (PROs). The PROs are currently performed in the clinic, however, the results are neither reviewed with patients nor transmitted to providers. This pilot assesses the feasibility of moving the PROs into the clinical realm by having patients review the PRO results, identifying an issue to discuss at the patient's next HIV primary care visit, and determining whether this process increases discussion of MH and SU disorders in the subsequent clinical visit and/or increases referrals to MH and/or SU treatment.


Eligibility criteria: Inclusion Criteria:

* must be enrolled in the Johns Hopkins Clinical Cohort at the Johns Hopkins Moore Clinic
* must be living with HIV

Exclusion Criteria:

-

Primary outcomes:
measure: Mental Health or Substance Use Issue Raised in Visit
timeFrame: Visit following intervention which will occur on the same day or up to 1 week after the intervention
measure: Audio Recording Data - Mental Health/Substance Use Action Taken
timeFrame: Visit following intervention which will occur on the same day or up to 1 week after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Moore Clinic for HIV Care
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Anne Monroe, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01367548: Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus
Official title: A Phase II Double-Blind Randomized Parallel Group Study of Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Ileus
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 65
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: A double-blind, randomized, parallel-group study designed to evaluate the safety and activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental colectomies via laparotomy.


Eligibility criteria: Inclusion Criteria:

1. Males and females, 18 yrs or older
2. Patients who have undergone a segmental colectomy
3. Must be receiving opioids via IV.

Exclusion Criteria:

1. Patients who received any experimental drug in the last 30 days
2. Patients receiving spinal medication for post-operative pain relief
3. Patients who have undergone operations for complications related to inflammatory bowel disease
4. Patients with recent history of abdominal radiation therapy.

Primary outcomes:
measure: Time to tolerance of liquids
timeFrame: 7 days
Secondary outcomes:
measure: Time to first bowel movement
timeFrame: 7 days
measure: Time to tolerance of solid foods
timeFrame: 7 days
measure: Time to first micturition post foley catheter removal
timeFrame: 7 days
measure: Time to hospital discharge
timeFrame: 7 days
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04536948: Cold Application in Lateral Epicondylitis
Official title: Which Cold Application is More Effective in Patients With Lateral Epicondylitis?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: Kinesio Tape
Thermal Analysis
Cold
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Fifty-four volunteers diagnosed with lateral epicondylitis were included in our study and were randomly divided into two groups.
Primary purpose: TREATMENT

Brief summary: Purpose: The purpose of this study was to investigate which cold application is more effective to regulate skin temperature in patients with lateral epicondylitis. Materials and Methods: Fifty-four patients with lateral epicondylitis were randomly divided into 2 groups as cooling gel (n=27) group and cold pack (n=27) group. Cooling gel and cold pack applications were applied on painful lateral epicondyle region for 15 minutes. Patients were assessed before and after the application. Assessments included the severity of pain during wrist extension, evaluated by Visual Analog Scale (VAS) and thermal imaging of lateral epicondyle region evaluated by Infrared Thermography (FLIR5 Thermal Camera).


Eligibility criteria: Inclusion Criteria:

* Subjects with elbow pain for at least 3 months
* those between 20 and 40 years of age
* who did not have cold allergies

Exclusion Criteria:

* With a different elbow problem or multiple elbow problems,
* having cervical or other upper extremity problems,
* elbow joint operation,
* tendon rupture,
* limited range of motion due to humerus, radius or ulna fracture
* individuals with a history of osteoporosis, malignancy, hemophilia, neurological effect, and cognitive dysfunction

Primary outcomes:
measure: Pain Severity
timeFrame: 15 minutes
measure: Thermographic Assessment
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
References:
Clinical trial NCT00679848: Transoral Gastric Volume Reduction as an Intervention for Weight Management
Official title: Transoral Gastric Volume Reduction as an Intervention for Weight Management (TRIM): A Non-Randomized Multicenter Feasibility Study of Subjects With Class II or Low Grade Class III Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Weight Loss
Transoral Suturing
Experimental
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2008-05-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, technical feasibility, and initial effectiveness (i.e., weight loss primarily measured as percent excess weight loss) of TGVR performed using the Bard RESTORe Suturing System


Eligibility criteria: Inclusion Criteria:

* Male, Female; ages \>18yrs - £ 60 yrs
* BMI 30-45 kg/m2
* History of obesity for 5 yrs; attempts at weight control ineffective
* Weight stable
* Willing to comply with study requirements
* Agrees to not have any additional weight loss surgery, reconstructive surgery or liposuction for one year following procedure
* Sign informed consent form

Exclusion Criteria:

* Women of childbearing age not practicing effective birth control method or pregnant or lactating
* Mallampati score = 4
* Uncontrolled hypothyroidism
* Previous interventional/surgical treatment of obesity; any prior gastric surgery
* History of diabetes for \> 10 yrs or difficult to control diabetes
* Presence of hiatal hernia
* Congenital or acquired anomalies of the GI tract
* Severe cardiovascular, cerebrovascular, or cardiopulmonary disease
* Chronic or acute upper gastrointestinal bleeding conditions
* Helicobacter pylori positive
* Immunocompromised
* Subjects with eating disorders
* Acute or chronic infection
* Significant movement limitations
* Not a candidate for conscious or general anesthesia
* Active substance abuse
* Life expectancy \< 2 years
* Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this study

Primary outcomes:
measure: Weight Loss
timeFrame: 24 Months
Secondary outcomes:
measure: Technical success of test procedure.
timeFrame: 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
Clinical trial NCT01832948: Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer
Official title: Study of Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer and Efficacy Prediction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to assess the efficacy and safety of Endostar combined with mFOLFOX6 in untreated metastatic colorectal cancer patients, and to find the markers that may predict the efficacy.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed metastatic colorectal cancer (adenocarcinoma)
* At least one measurable lesion (RECIST criteria)
* Life expectancy ≥ 3 months
* ECOG performance status 0-2
* Adequate hematologic function: ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L
* Adequate renal function: Cr ≤ 1.25×ULN or Creatinine clearance ≥ 60 ml/min
* Adequate hepatic function: BIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 5×ULN
* Patients have not previously received palliative chemotherapy, immunological/ biological treatment
* No adjuvant chemotherapy in last six months
* Target lesion has not received local radiotherapy
* Written informed consent

Exclusion Criteria:

* Diagnosis of colorectal neuroendocrine tumor, undifferentiated carcinoma, adenosquamous carcinoma, squamous cell carcinoma
* Evidence of serious or uncontrolled infection
* Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
* Pregnant or lactating women
* Women of childbearing potential refused to practice acceptable methods of birth control to prevent pregnancy
* Allergic to any of the study drug
* Intestinal obstruction, intestinal perforation, or stroke within 3 months
* Participation in other clinical studies

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: the end of the 3rd cycle
Secondary outcomes:
measure: Blood perfusion in tumor tissue
timeFrame: baseline, the end of the 3rd cycle
measure: Ratio of blood perfusion in tumor tissue to blood perfusion in surrounding normal tissue
timeFrame: baseline, the end of the 3rd cycle
measure: Incidence of Adverse Events
timeFrame: up to 1 month after the last cycle
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Liming Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03140748: Kinetics of Serum β-D-glucan During Peritonitis With Candida in Resuscitation
Official title: Kinetics of Serum β-D-glucan During Peritonitis With Candida in Resuscitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritonitis Infectious
Candida Infection
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Intraabdominal fungal infections with Candida are constantly increasing. Their diagnosis and treatment is difficult. Morbidity and mortality are high. Β-D-Glucan has been proposed as a marker of systemic fungal infection in candidemia. Moreover, its kinetics is associated with therapeutic success. On the other hand, there are no data on intraabdominal infections that are much more frequent. The objective of the study is to evaluate the initial levels of β-D-glucan and its daily kinetics during the treatment of fungal peritonitis in resuscitation compared to a control group with a yeast-free peritonitis.


Eligibility criteria: Inclusion Criteria:

* Major Patient (age ≥ 18 years)
* Community or associated peritonitis, operated and hospitalized in resuscitation
* Affiliation to a social security scheme

Exclusion Criteria:

* Allergy known to echinocandins
* Dying Patient
* Limitation of care
* Predictable duration of follow-up ≤ 10 days
* Transfusion within 3 months
* Patient minor, patient under guardianship or curatorship

Primary outcomes:
measure: Blood determination of serum β-D-glucan kinetics in patients with peritonitis
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT01249248: PD2i Analysis of Heart Rate Variability in Competitive Sports
Official title: PD2i Analysis of Heart Rate Variability in Competitive Sports
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autonomic Dysfunction
Keywords: Heart rate variability
Autonomic dysfunction
Exercise
Sports
Competition
Athletes
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Vicor Technologies, Inc.
First posted: 2010-11-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: College athletes on competitive teams.

Brief summary: This is a double blind observational analysis of changes in heart rate variability using PD2i analyser in competitive athletes during strenuous exercise and competition.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years, as determined by birth date given on participation form.
* Actively involved in competitive athletics
* Able to give informed consent

Exclusion Criteria:

* Any known prior autonomic dysfunction
* History of seizures or taking anti-seizure medication
* Known learning disability or attention deficit disorder
* Chronic heart conditions such as arrhythmias or valvular disease
* History of diabetes mellitus
* Taking any prescription stimulants such as Ritalin, Focalin, etc.
* Use of any performance-enhancing drugs
* Any deviation from normal found on the pre-participation physical exam such as the presence of a murmur or hypertension.

Primary outcomes:
measure: Change in PD2i following strenuous exercise bout of 45 minutes
timeFrame: Baseline at zero minutes and within 60 minutes of completion of strenuous exercise bout.
Secondary outcomes:
measure: Change in PD2i following an injury during competitive sports.
timeFrame: Baseline PD2i at zero and within 60 minutes of cessation of exercise bout.
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Steve A Watts, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01579448: Evaluation of a Boosting Regimen With Oral Cholera Vaccine
Official title: A Open Labeled Controlled Trial to Evaluate the Immune Response of a Boosting Regimen With Shanchol™, a Killed Whole Cell Oral Cholera Vaccine (WC-OCV), in Previously Immunized Adults and Children in Eastern Kolkata, India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholera
Keywords: killed oral cholera vaccine
boosting vaccine regimen
safety and immunogenicity
Lead sponsor: International Vaccine Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Cholera and Enteric Diseases, India
name: Indian Council of Medical Research
First posted: 2012-04-18
Enrollment: 426
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Data demonstrates that Shanchol™ (killed bivalent oral cholera vaccine) provides protection over 3 years and data regarding the protective efficacy over five years is anticipated for 2012. Regardless at the end of five years, it may still be necessary to provide a booster dose or reimmunize with two doses to maintain protection in previously immunized populations. This study examines the immune protection and safety of providing a one and two dose boosting regimen of Shanchol™ given five years after the initial dose.


Eligibility criteria: Inclusion Criteria:

All subjects must be presently enrolled in the Phase 3 NICED RCT of Shanchol™ and satisfy the following criteria at study entry:

1. Male or female adults aged 6 years and above, who are available for follow-up visits and specimen collection.

   * The subject should be able to continue in the study for the next 6 weeks
   * The subject (or parent/guardian) should be willing to provide 3 blood samples
2. Written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 - 17 years.
3. Healthy subjects as determined by:

   * Medical history
   * Physical examination
   * Clinical judgment of the investigator

Exclusion Criteria:

1. individuals who are too weak to get out of bed to receive the vaccine
2. pregnant women (identified through verbal screening)
3. those less than 6 years of age
4. Receipt of cholera vaccine following 2009 (time of licensure and availability of Shanchol™ in India)

Primary outcomes:
measure: Immunogenicity provided by a two dose boosting regimen of Shanchol™
timeFrame: 28 days
Secondary outcomes:
measure: Immunogenicity provided by a one dose boosting regimen of Shanchol™
timeFrame: 28 days
measure: Rises in serum IgA and IgG following boosting regimens
timeFrame: 28 days
measure: Proportion of subjects with adverse events
timeFrame: 42 days
Other outcomes:
Locations:
city: Kolkata
country: India
facility: National Institute of Cholera and Enteric Diseases
state: West Bengal
Study officials:
affiliation: National Institute of Cholera and Enteric Diseases, India
name: Suman Kanungo, MBBS
role: PRINCIPAL_INVESTIGATOR
References: