louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01542606: Performance Proof of Product Developed to Detect Abnormal Vaginal pH
Official title: Performance Proof of The Norma-Sense Gen 3 - Wearing Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vaginal Infection
Keywords: PH
SCREENING
EARLY WARNING
VAGINAL HEALTH
VAGINAL SECRETION
VAGINAL PH
Lead sponsor: Common Sense
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study was designed to validate the color appearance on the NORMA-SENSE gen 3 when comes into contact with vaginal secretions having an elevated pH level

Detailed description: This study was designed to validate the color appearance on the NORMA-SENSE gen 3. The NORMA-SENSE gen 3 changes color when worn by the user and comes into contact with vaginal secretions having an elevated pH level, without false positives due to urine remains or incontinence. The study will also asses the physical comfort in using NORMA-SENSE gen 3 and the result reading clarity which includes the ability to visualize and interpret the NORMA-SENSE gen 3 results.

Eligibility criteria: Inclusion Criteria:

1. Women, age 18 years or greater with or without symptoms of vaginal infection.
2. Subject is ready to sign the informed consent form.

Exclusion Criteria:

1. Subject is unable or unwilling to cooperate with study procedures.
2. Subject is currently participating in another clinical study.
3. Subject suffers from vaginal bleeding or is menstruating.
4. Subject that have had sexual relations within the last 12 hours.
5. Subject that applied local antiseptic or antibiotic or vaginal treatment within the last 3 days.
6. Subject that applied vaginal douching within 12 hours prior to the visit at the clinic.

Primary outcomes:
measure: color status of the NORMA-SENSE gen 3 and the pH measurement.
timeFrame: 3 days
Secondary outcomes:
measure: physical comfort in using NORMA-SENSE gen 3 and the result reading clarity
timeFrame: 3 days
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Lin Medical Center Clalit health care
Study officials:
affiliation: Common Sense
name: Hadar Kessary, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00589706: A Phase II Study of Adjuvant Use of Anti-Epidermal Growth Factor Receptor EGFR-425 in High Grade Gliomas
Official title: A Phase II Study o the Adjuvant Use of Anti-Epidermal Growth Factor Receptor-425 (Anti-EGFR-425) Monoclonal Antibody Radiolabeled With I-125 for High Grade Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gliomas
Keywords: high grade gliomas of the brain
anti-body treatment
survival
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2008-01-10
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Data from the wistar institute indicated that this anti-body labeled with iodine-125 would localized in the tumor cells of high grade gliomas of the brain. the project combines surgery, radiation therapy, chemotherapy with the labeled antibody in a prospective phase II trial in this disease entity.

Detailed description: This is an open-label Phase II study of postoperative radiation therapy followed by Iodine-125 radiolabeled anti-epidermal-growth-factor-receptor monoclonal antibody (125I-MAB 425) derived from cell cultures for high grade malignant gliomas. Each subject will receive postoperative radiation therapy followed by 6.4 mg of 50 mCi labeled 125I-MAB 425 by injection. This dosing regimen will be given three times generally within a two-week period (days one, eight and 15 of therapy) for a total dose of 19.2 mg of 150 mCi labeled 125I-MAB 425 for each course of therapy. The main objective of this study is to determine if the addition of 125I-MAB 425 to postoperative radiotherapy, with or without change, prolongs absolute survival compared to historical control (postoperative radiation therapy alone) in subjects with histologically proven high grade gliomas. The primary efficacy variable is absolute survival and the secondary target variable will be time to progression of the tumor. Multiple courses will be considered based on the subject's clinical status.

Eligibility criteria: Inclusion Criteria:

* all cases above 18 years of age

Exclusion Criteria:

Primary outcomes:
measure: Survival
timeFrame: More than a year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hahneman Hospital
state: Pennsylvania
Study officials:
affiliation: Drexel University College of Medicine
name: Luther W Brady, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li L, Quang TS, Gracely EJ, Kim JH, Emrich JG, Yaeger TE, Jenrette JM, Cohen SC, Black P, Brady LW. A Phase II study of anti-epidermal growth factor receptor radioimmunotherapy in the treatment of glioblastoma multiforme. J Neurosurg. 2010 Aug;113(2):192-8. doi: 10.3171/2010.2.JNS091211.
Clinical trial NCT01179906: Lifestyle Modifications and the Progression of Chronic Kidney Disease
Official title: Effect of Lifestyle Interventions on the Progression of Kidney Disease in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Stage 2-4 Chronic Kidney Disease
Keywords: CKD
Lead sponsor: Springfield College
Sponsor class: OTHER
Collaborators: name: Western New England Renal & Transplant Associates
First posted: 2010-08-11
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aerobic training has been shown to favorably alter several of the known risk factors for coronary artery disease including hypertension, dyslipidemia, obesity, and diabetes (1). It seems logical that if these risk factors were aggressively controlled in patients with chronic kidney disease (CKD) by implementing lifestyle changes (e.g., diet and exercise training) to support the pharmacologic interventions that are necessary for the control of the disease, then the rate of progression of the disease may be altered. However, to date, there is no clear research evidence to support this hypothesis. Therefore the aims of the proposed study are:

1. To test the hypothesis that lifestyle interventions (i.e., dietary modification and regular, long-term aerobic exercise training) will favorably alter the natural progression of CKD in a sample of patients compared to a control group who will receive the current standard care.
2. To explore possible mechanisms that could contribute to the observed changes.


Eligibility criteria: Inclusion Criteria:

* Stages 2-4 CKD

Exclusion Criteria:

* CAD
* MI

Primary outcomes:
measure: Glomerular filtration rate (GFR)
timeFrame: 48 weeks
Secondary outcomes:
measure: 24 hour urine protein output
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Springfield College
state: Massachusetts
Study officials:
affiliation: Springfield College
name: Sam A Headley, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01774006: Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments
Official title: Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Other Complications Associated With Artificial Fertilization
Keywords: In vitro fertilization
Embryo transfer
Embryo culture
individual culture
Group culture
embryo quality
Pregnancy rate
Implantation
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 532
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients entering in vitro fertilization and embryo transfer treatment

Brief summary: Prospective randomized comparison of two widely used in vitro culture system in human IVF treatments. In vitro fertilized oocytes and embryos are cultured in individual culture media droplets using conventional petridish or in group culture using WOW (well of the well) petridish.

Primary outcome: implantation and pregnancy rates Secondary outcome: fertilization rate and embryo quality


Eligibility criteria: Inclusion Criteria:

* Infertile patients entering in vitro fertilization treatment
* at least 1 oocyte collected

Exclusion Criteria:

* no oocytes collected

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 4 weeks after the embryo transfer
measure: Implantation rate
timeFrame: 4 weeks after embryo transfer
Secondary outcomes:
measure: Fertilization rate
timeFrame: 18 hours after sperm injection
measure: Embryo quality
timeFrame: 36 and 72 hours after fertilization
Other outcomes:
measure: Time needed for evaluation of zygotes and embryos
timeFrame: 18, 24, 36 and 72 hours after fertilization
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University First Department of Obstetrics and Gynecology
Study officials:
affiliation: Semmelweis University First Department of Obstetrics and Gynecology
name: Janos Urbancsek, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis University First Department of Obstetrics and Gynecology
name: Peter Fancsovits, Ph.D.
role: STUDY_CHAIR
affiliation: University of Veterinary Sciences, Budapest
name: Csaba Pribenszky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmelweis University First Department of Obstetrics and Gynecology
name: Adam Lehner, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fancsovits P, Pribenszky C, Lehner A, Murber A, Kaszas Z, Nemes A, Urbancsek J. Prospective-randomized study comparing clinical outcomes of IVF treatments where embryos were cultured individually or in a microwell group culture dish. Biol Futur. 2022 Jun;73(2):229-236. doi: 10.1007/s42977-022-00113-8. Epub 2022 Mar 12.
Clinical trial NCT01082406: Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects
Official title: A Single Centre, Randomised, Double-blind, Cross-over Trial in Healthy Male Subjects Investigating Bioequivalence and Pharmacokinetics of rFXIII (Avecia DS) to rFXIII (Novo Nordisk DS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Congenital FXIII Deficiency
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-03-08
Enrollment: 51
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this clinical trial is to compare the metabolism of a blood-clotting drug (recombinant Factor XIII)) produced by two different manufacturers (Novo Nordisk and Avecia) in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) between 18.5 and 30 kg/m2
* Good general health based on assessment of medical history, physical examination, ECG (electrocardiogram), and clinical laboratory data at screening, as judged by the physician
* Non-smokers

Exclusion Criteria:

* Known history of thromboembolic event(s) or potential thromboembolic risk as judged by the physician
* Blood transfusion within 3 months of trial start
* Positive for hepatitis B or C infection
* Positive for Human Immunodeficiency Virus (HIV) infection
* Excessive consumption of a diet deviating from a normal diet as judged by the physician
* Blood or plasma donation within the last 3 months prior to trial start
* Subjects with any history of migraine

Primary outcomes:
measure: Plasma concentration-time curve (Area under Curve 0-28 days) for factor XIII activityfor both drug substances measured by the Berichrom® assay
timeFrame: after 4 weeks of treatment
Secondary outcomes:
measure: Number of adverse events (serious and non-serious)
timeFrame: over 8 weeks of treatment
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05183906: Evaluation of Next-Generation Sequencing-based Metabarcoding Versus Culturing for Microbiological Assessment in Infectious Keratitis
Official title: Evaluation of Next-Generation Sequencing-based Metabarcoding Versus Culturing in Infectious Keratitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Keratitis
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with keratitis admitted to tertiary ophthalmological unit

Brief summary: Infectious keratitis is a potential sight threatening condition. In conventional clinical practice culturing is performed in order to identify the causative microbial organism; however in recent years Next Generation Sequencing for the presence of ribosomal DNA from bacteria, fungi, or amoeba has become available. The present study aims to compare conventional culturing with Next Generation Sequencing for identifying microorganism causing keratitis.

Detailed description: Patients admitted with microbial keratitis to the department of ophthalmology at Aarhus University Hospital is evaluated with both conventional culturing at agar plates, broth culture, and Next Generation Sequencing for ribosomal DNA.

Only patients with a corneal infiltrate of a minimum of 2 mm or of 1 mm within the central 6 mm of the cornea will be included in the study.

Sampling includes two samples from the contralateral healthy eye to control for the patient's normal microbiome, evaluated with culturing in broth and with NGS.

From the infiltrate, samples include culturing on Sabouraud agar, chocolate agar, and blood agar, culturing in broth medium, and samples for NGS.

A total of 100 patients will be included.

Eligibility criteria: Inclusion Criteria:

- Patients with a corneal infiltrate of minimum 2 mm in diameter or of 1 mm diameter within the central 6 mm of the cornea

Exclusion Criteria:

- Patients below 18 years of age

Primary outcomes:
measure: Number of clinically relevant microorganisms identified using culture or next generation sequencing
timeFrame: 1 year
measure: Comparison of clinically relevant identified microorganisms on a genus level
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Ophthalmology, Aarhus University Hospital
Study officials:
References:
Clinical trial NCT00974506: Pilot Study: Complementary Therapies in Geriatric Patients
Official title: Pilot Study Complementary Therapies in Geriatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatric Patients
Keywords: geriatric patients living in residential community (shared flats), multiple disease-conditions
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Homöopathie Stiftung
name: omoeon e.V.
First posted: 2009-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a randomized controlled pilot study the investigators include geriatric patients living in a geriatric residential community. Two interventions are compared:

1. a complex intervention containing exercise therapy, nutritional advice, homeopathy and naturopathy in addition to routine therapy by the general practitioner
2. routine care by general practitioner

The investigators assess the effect of the complex intervention on activities of daily living (AMPS, Barthel Index, Nosger), quality of life (Qualidem, Profile of Wellbeing), risk of falls (Tinetti), falls, cognition (Minimental Status Test), hospital admissions, medication use.

The results of this exploratory study are needed to plan a randomized controlled trial (RCT) with confirmatory design in the future.


Eligibility criteria: Inclusion Criteria:

* living in shared flat/residential community
* informed consent of patient or authorized representative

Exclusion Criteria:

* participation in another study within the last 6 months
* acute or chronic disease condition that does not allow participation
* actual use of complementary therapies

Primary outcomes:
Secondary outcomes:
measure: Assessment of motor and process skills (AMPS)
timeFrame: 3, 6, 12 months
measure: Qualidem
timeFrame: 3, 6, 12 months
measure: Barthel Index
timeFrame: 3, 6, 12 months
measure: Nurses Observation Scale for Geriatric Patients
timeFrame: 3, 6, 12 months
measure: Minimental Status Test
timeFrame: 12 months
measure: Tinetti Test
timeFrame: 3, 6, 12 months
measure: Profile of Wellbeing
timeFrame: 3, 6, 12 months
measure: Medication use and Potentially Inappropriate Medication Use (Beers Criteria 2003)
timeFrame: 3, 6, 12 months
measure: Falls (Esslinger Sturzprotokoll)
timeFrame: 12 months
measure: hospital admissions
timeFrame: 12 months
measure: Adverse effects
timeFrame: 12 months
measure: Interviews with health care team and relatives.
timeFrame: 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
Study officials:
affiliation: Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
name: Claudia M Witt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06134206: Burr Hole Ultrasound Study
Official title: Evaluation of the Feasibility of Measuring Chronic Subdural Hematoma Thickness Via Trans-burrhole Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Subdural Hematoma
Keywords: Burr hole
Ultrasound
Trans-burr hole
TBUS
Sonography
Chronic Subdural hematoma
Lead sponsor: Kepler University Hospital
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 1 Group of 20 patients who all underwent the same examination
Primary purpose: DIAGNOSTIC

Brief summary: Chronic subdural hematoma (CSDH) is commonly managed through burr hole evacuation. This study evaluates the feasibility of trans burr hole sonography as an alternative postoperative imaging modality.

A pilot study on 20 patients who underwent burr hole surgery for CSDH was therefore planned. Postoperative imaging included both CT and sonographic examinations through the burr hole. We assessed the ability to measure residual subdural fluid thickness sonographically compared to CT.


Eligibility criteria: Inclusion Criteria:

* Burr hole surgery due to chronic subdural hematoma
* Routine performance of an computed tomography scan within 3-7 days postoperative
* Ability to give informed consent

Exclusion Criteria:

* Performance of prior craniotomy
* Performance of prior revision surgery

Primary outcomes:
measure: cSDH thickness
timeFrame: 1 measurement on day 3-7 postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Department of Neurosurgery, Kepler University Hospital
state: Upper Austria
Study officials:
affiliation: Department of Neurosurgery, Kepler University Hospital Linz, Austria
name: Harald Stefanits, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00398606: A Study to Compare the Efficacy of Alendronate With and Without Calcium or Calcium Alone In the Treatment of Osteoporosis in Postmenopausal Women (0217-088)(COMPLETED)
Official title: A Triple-Blind, Randomized, Active-Controlled, Parallel-Group, Multicenter Study to Evaluate and Compare the Efficacy and Tolerability of Alendronate Sodium With Calcium Supplementation in the Treatment of Osteoporosis in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-11-14
Enrollment: 650
Sex: FEMALE
Minimum age (years): 45
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 see how well alendronate and calcium as compared to calcium alone increase bone density in postmenopausal women with osteoporosis


Eligibility criteria: Inclusion Criteria :

* Patient is postmenopausal (or surgically menopausal) for at least 5 years.
* Patient must be diagnosed with osteoporosis
* Patient has spinal anatomy suitable for DEXA of the lumbar spine

Exclusion Criteria :

* Patient is receiving or has received treatment prior to randomization which might influence bone turnover
* Patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss)
* Patient is receiving or is expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism

Primary outcomes:
measure: BMD of the lumbar spine determined by a DEXA scan at 2 years
Secondary outcomes:
measure: BMD of the hip trochanter and femoral neck determined by a DEXA scan and biomarkers of bone turnover (BAP, NTX) at 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Bonnick S, Broy S, Kaiser F, Teutsch C, Rosenberg E, DeLucca P, Melton M. Treatment with alendronate plus calcium, alendronate alone, or calcium alone for postmenopausal low bone mineral density. Curr Med Res Opin. 2007 Jun;23(6):1341-9. doi: 10.1185/030079907X188035.