louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00704002: Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal
Official title: Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fifth Metacarpal Neck Fracture
Keywords: neck fracture of the fifth metacarpal
displacement
antegrade intramedullary splinting
conservative treatment
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2008-06-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, multi-center pilot study of isolated, displaced neck fractures of the fifth metacarpal. The patients are randomly assigned to osteosynthesis with antegrade intramedullary splinting or conservative treatment.

Detailed description: The aim of this study is to provide criteria for treatment decisions in patients with isolated, displaced neck fractures of the fifth metacarpal. The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters.

Eligibility criteria: Inclusion Criteria:

* displaced neck fracture of the fifth metacarpal (at least 30° angulation)
* isolated injury
* age between 18 and 75 years
* informed consent

Exclusion Criteria:

* rotational displacement
* open fracture
* injury older than one week
* treatment other than within this study
* other relevant injuries of the upper extremities
* other injury or disease of the hand
* pregnancy
* missing informed consent
* incompliance
* coagulopathy
* allergy to metallic implants
* Patients who have participated in any other device or drug clinical trial within the previous month

Primary outcomes:
measure: Disability of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: pain
timeFrame: 3 months
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Department of Trauma and Hand Surgery
Study officials:
affiliation: Department of Trauma and Hand Surgery, University Hospital, Düsseldorf, Germany
name: Michael Schädel-Höpfner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01734902: Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers
Official title: Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide, Following Oral Administration in Healthy Male and Female Volunteers (an Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-11-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the current trial is to establish the bioequivalence of 2 hyoscine butylbromide dose forms following oral administration.


Eligibility criteria: Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Maximum Measured Concentration of the Hyoscine Butylbromide in Plasma (Cmax)
timeFrame: Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.
measure: Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
timeFrame: Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.
Secondary outcomes:
measure: Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞ )
timeFrame: Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.
Other outcomes:
Locations:
city: Ingelheim
country: Germany
facility: 202.846.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT05410002: Diet Effect on Cancer Treatment Outcome
Official title: A Study on the Effect Diet Has Affecting the Response of Patients Taking N-111 Who Are on a Vegetarian Diet Vs a Non-vegetarian Diet or a Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer Breast
Cancer Prostate
Keywords: Cancer
Lead sponsor: Optimal Health Research
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 160
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized interventional parallel study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will look at the end result of 2 types of diets effect on treatment outcome of cancer patients using N-111.

Detailed description: The study will be evaluated during a double blind, placebo-controlled evaluation of the effect diet has on the response of patients taking N-111 who are on a vegetarian diet vs a non-vegetarian diet or a placebo. This will involve assessing the patients progress or lack thereof over a 3-month period of time as outlined in Outcome Measures section below.

Eligibility criteria: Inclusion Criteria:

* A positive diagnosis of breast cancer as determined by Fine Needle Biopsy or open biopsy with associated Cancer Antigen blood markers.
* Prostate cancer as determined by a Transrectal Biopsy with associated Prostate- specific antigen blood work.

Exclusion Criteria:

* •Patients without the positive diagnosis of breast or prostate cancer.

Primary outcomes:
measure: Active Comparator: Vegetarian N-111 group
timeFrame: End of month 3.
measure: Active Comparator: Non-vegetarian N-111 group.
timeFrame: End of month 3.
Secondary outcomes:
measure: Placebo Comparator: Vegetarian placebo group
timeFrame: End of month 3.
measure: Placebo Comparator: Non-vegetarian placebo control group
timeFrame: End of month 3.
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Optimal Health Research
state: Utah
city: Belagave
country: India
facility: KLE Academy of Higher Education & Research
state: Karnataka
city: Mumbai
country: India
facility: Indian Institute of Research
Study officials:
affiliation: Optimal Health Research
name: EA Jeppsen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02026479: Sudden Hearing Loss Multi-center Clinical Trial
Official title: Glucocorticoid Postauricular Injection Treatment for Sudden Hearing Loss: a Multi-center, Opened, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Full-frequency Sudden Hearing Loss
Keywords: full-frequency sudden hearing loss
post auricular injection
glucocorticoid
multi-center
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The incidence of sudden hearing loss is rising obviously resent year, Glucocorticoids have obtained obvious effect in the treatment of sudden deafness. Postauricular hypodermic injection is the latest findings in clinical work and a new noninvasive way of administration which is gradually expanding research. The aim of this experiment is to verify and explore the efficacy and safety of the postauricular injection treatment with different doses of Glucocorticoids.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years, less than 60 years old;
* patient with unilateral or bilateral（occured successively) acute sensorineural hearing loss(ASNHL) with onset 72hours or less ago. Mean hearing loss compared with the unaffected contralateral ear of at leat 60 dB;
* Primary presentation within 2weeks; standard treatment for 2 weeks;
* After 2weeks of standard treatment, sensorineural hearing loss (SHL) curative effect evaluation damaged frequencies \>/=30 dB better than before;
* Written informed consent before participation in the study.

Exclusion Criteria:

SYSTEMIC DISEASE

* History of tuberculosis or positive purified protein derivative (PPD);
* Insulin-dependent diabetes mellitus;
* Hypertension, poor control of BP(SBP/DBP)\>=140mmHg);
* History of rheumatic disease, e.g. rheumatoid arthritis, scleroderma, lupus, etc;
* Serious psychiatric disease or psychiatric reaction to corticosteroids;
* History of heart disease or transient ischemic attacks(TIAs);
* Prior treatment with chemotherapeutic or immunosuppressive drugs;
* Pancreatitis;
* Active peptic ulcer disease or history of gastrointestinal bleeding;
* History of HIV, Hepatitis B or C;
* Chronic kidney failure;
* Alcohol abuse;
* Active shingles;
* Severe osteoporosis or non-surgical aseptic necrosis of the hip;
* Without contraindication with glucocorticoid, ginaton, Batroxobin.

OTOLOGIC DISEASE

* History of Meniere's disease;
* History of chronic ear infection;
* Prior history of sudden sensorineural hearing loss (SSNHL);
* History of fluctuating hearing loss.

Primary outcomes:
measure: Pure tone audiometry test
timeFrame: Days 30
Secondary outcomes:
measure: Tinnitus with Evaluation questionnaire
timeFrame: days 14,30,90
measure: Vertigo with Evaluation questionnaire
timeFrame: Day 14,30,90
Other outcomes:
measure: the records of adverse reaction and event
timeFrame: Day 2,4,7,14,30,90
Locations:
Study officials:
References:
Clinical trial NCT02870179: Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry
Official title: Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Keywords: Pulse Oximetry
Temperature
Respiratory Rate
Respiratory Gases
This study determines the measurement accuracy of the physiological parameters
Lead sponsor: Oxitone Medical Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Clinimark, LLC
First posted: 2016-08-17
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of the Denver metropolitan area

Brief summary: The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse Oximeter.

The study is observational in nature which quantifies device performance and accuracy in compassion to a Reference Pulse Oximeter.

Detailed description: The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse Oximeter. The end goal is to show the SpO2 accuracy performance of the Oxitone 1000 and if needed, use the data to make improvements prior to an arterial blood hypoxia study.

A Clinimark 3900 Reference Pulse Oximeter or Nellcor N-600x will be used for the SpO2 calibration. There are no risks or adverse device effects to be assessed. There are no contraindications for use in the proposed study / study population

The Control Pulse Oximeter, GE Healthcare (Datex-Ohmeda) 3900, an FDA cleared device, is used to monitor the oxygen saturation levels real time throughout the study for subject safety and to target stable plateaus. This device is used to assess the stability of the data.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals between the age of 18-50

Exclusion Criteria:

* Clotting disorders, diabetes, currently taking psychotropic medications

Primary outcomes:
measure: Collect SpO2 data for accuracy statistical analysis by 12 subjects
timeFrame: 2 months
measure: Accuracy data analysis
timeFrame: 2 months
Secondary outcomes:
measure: Error plots
timeFrame: 2 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Clinimark Laboratories
state: Colorado
Study officials:
affiliation: Oxitone Medical Ltd.
name: Leon Eisen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02946879: Long-Term Follow-Up Gene Therapy Study for Leber Congenital Amaurosis OPTIRPE65 (Retinal Dystrophy Associated With Defects in RPE65)
Official title: Long-term Follow-up Study of Participants Following an Open Label, Multi-centre, Phase I/II Dose Escalation Trial of an Adeno-associated Virus Vector (AAV2/5-OPTIRPE65) for Gene Therapy of Adults and Children With Retinal Dystrophy Owing to Defects in RPE65 (LCA2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leber Congenital Amaurosis (LCA)
Eye Diseases
Eye Diseases, Hereditary
Retinal Diseases
Lead sponsor: MeiraGTx UK II Ltd
Sponsor class: INDUSTRY
First posted: 2016-10-27
Enrollment: 15
Sex: ALL
Minimum age (years): 3
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient population are those with Leber Congenital Amaurosis (LCA) with gene mutation RPE65 who have participated in the OPTIRPE65 trial.

Brief summary: This study is a longer-term follow-up study for patients who have been administered AAV2/5-OPTIRPE65 in the Phase I/II, open label, non-randomised, two-centre, dose escalation trial in adults and children with retinal dystrophy associated with defects in RPE65.

Detailed description: The follow up study is designed to collect data on longer-term safety and efficacy of AAV2/5-OPTIRPE65 administration in the OPTIRPE65 trial.

Eligibility criteria: Inclusion Criteria:

* Were enrolled and treated in the prior open-label, Phase I/II, dose escalation study involving intraocular administration of AAV2/5-OPTIRPE65

Exclusion Criteria:

* Individuals will be excluded if they are unwilling or unable to meet with the requirements of the study.

Primary outcomes:
measure: Incidence of Adverse Events related to the treatment
timeFrame: 5 years
Secondary outcomes:
measure: Improvement in the retinal function
timeFrame: 5 years
measure: Improvement in the visual function
timeFrame: 5 years
measure: Improvement in quality of life
timeFrame: 5 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Kellogg Eye Center, University of Michigan Health
state: Michigan
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
Study officials:
References:
Clinical trial NCT02677779: CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers
Official title: A Randomised, Open Label, Controlled Clinical Study to Evaluate the Efficacy and Safety of CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 20
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 study is aimed at comparing debridement either with CO2 laser or traditional surgery in patients with infected diabetic foot ulcers. The principal endpoint is bacterial load immediately after treatment.

Detailed description: The present study is designed to assess the antimicrobial effect of a single CO2 laser beam (DEKA SmartXide2 c80-El.En, Florence Italy) in the treatment of diabetic infected foot ulcers. CO2 laser debridement will be compared with standard surgical care. The primary efficacy endpoint will be the reduction of bacterial load between pre- and immediately after debridement. Secondary endpoints will be adverse events and pain during treatment. Two bacterial sample with a flocked nylon swab will be collected before and after debridement.

Eligibility criteria: Inclusion Criteria:

* Diabetes
* Infected foot ulcer (with clinical signs of infection)
* Ulcer area between 0.5 and 150 cm2
* More than 50% of ulcer area covered by fibrin and/or necrosis
* Texas score \<3

Exclusion Criteria:

* Need for revascularization
* Pregnancy or lactation

Primary outcomes:
measure: Bacterial Load
timeFrame: Percent change in bacterial colonies from baseline. Variation from baseline and immediately after the end of procedure.
Secondary outcomes:
measure: Pain: Scores of Brief Pain Inventory
timeFrame: During procedure.
measure: Fibrin: Percent of Ulcer Area Covered by Fibrin
timeFrame: Baseline and immediately after the end of procedure
measure: Granulation: Percent of Ulcer Area Covered by Granulation.
timeFrame: Baseline and immediately after procedure
measure: Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis
timeFrame: during procedure
Other outcomes:
Locations:
Study officials:
affiliation: University of Florence
name: Edoardo Mannucci, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01723579: Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017)
Official title: An Open-label, Multi-center Trial to Evaluate the Contraceptive Efficacy, Safety and Acceptability of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) in Indian Women. Protocol MK-8175A-017-00
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2012-11-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the efficacy and safety of the monophasic

combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in

healthy fertile Indian women.


Eligibility criteria: Inclusion Criteria:

* Sexually active and at risk for pregnancy
* Of Indian descent, born in India, never emigrated out of India, with Indian

home address

* Body mass index (BMI) ≥17 and ≤35 kg/m\^2

Exclusion Criteria:

* Presence or history of venous or arterial thrombotic/thromboembolic events

or cerebrovascular accident

* Presence or history of prodromi of a thrombosis
* History of migraine with focal neurological symptoms
* Diabetes mellitus with vascular involvement
* Presence of a severe or multiple risk factor(s) for venous or arterial

thrombosis

* Severe hypertension
* Severe dyslipoproteinemia
* Presence or history of pancreatitis associated with severe

hypertriglyceridemia

* Presence or history of severe hepatic disease
* Undiagnosed vaginal bleeding
* Known or suspected pregnancy
* Currently breastfeeding or breastfeeding within 2 months of starting

trial medication

- Investigational drug use or participation in another clinical trial within

2 months of signing Informed Consent Form for current trial

Primary outcomes:
measure: Number of In-treatment Pregnancies
timeFrame: Day 1 of Treatment Cycle 1 Through Day 28 of Treatment Cycle 13, plus up to 2 additional days (Study Days 1-366)
Secondary outcomes:
measure: Number of Participants Experiencing an Adverse Event (AE) or Serious AE
timeFrame: "From Visit 1 up to 30 days after the last dose of study medication (up to Study Day 394).
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02016079: Effect of Omega-3 Supplementation on Child Behavior Problems
Official title: Randomized Controlled Trial of Omega-3 on Child Behavior Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Antisocial
Aggressive
Externalizing Behavior Problems
Internalizing Behavior Problems
Keywords: randomized controlled trial
omega-3
nutrition
behavior problems
externalizing
internalizing
antisocial
aggressive
Lead sponsor: Joint Child Health Project, Mauritius
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study was to assess the effectiveness of omega-3 supplementation on behavior problems in children.

Detailed description: This study consists of a randomized, placebo-controlled, double-blind trial of omega-3 on behavior problems in children. All behavior problem outcomes were assessed, although the primary focus was on antisocial and aggressive behavior.

Eligibility criteria: Inclusion Criteria:

* child
* age between 8 and 16 years
* residing in the community

Exclusion Criteria:

* fish allergy
* diagnosed mental disorder
* mental retardation
* on medication that may modify lipid metabolism
* extensive use of nutritional supplements within the previous 3 months

Primary outcomes:
measure: Child Behavior Checklist
timeFrame: 6 months
measure: Reactive-Proactive Aggression Questionnaire
timeFrame: 6 months
measure: Antisocial Personality Screening Device
timeFrame: 6 months
Secondary outcomes:
measure: WISC
timeFrame: 6 months
Other outcomes:
Locations:
city: Quatre Bornes
country: Mauritius
facility: Joint Child Health Project
Study officials:
affiliation: Joint Child Health Project
name: Tashneem Moohamed, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Action Research Program, Educational Priroity Areas, Mauritius
name: Cyril Dalais, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raine A, Portnoy J, Liu J, Mahoomed T, Hibbeln JR. Reduction in behavior problems with omega-3 supplementation in children aged 8-16 years: a randomized, double-blind, placebo-controlled, stratified, parallel-group trial. J Child Psychol Psychiatry. 2015 May;56(5):509-20. doi: 10.1111/jcpp.12314. Epub 2014 Aug 22.