louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00367042: Study to Determine if Tissue Scored With a Scalpel Results in Any Noticeable Marks
Official title: Prospective Study To Determine Whether Tissue Scoring Results In Noticeable Marks Following Mohs Micrographic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Skin Cancer
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2006-08-22
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Mohs Micrographic Surgery is a well established method for treatment of cutaneous malignancies. Part of this technique requires marking skin surrounding the tumor. There are two ways of marking the tissue, lightly scoring it with a scalpel or marking it with a surgical marker.

This study is to determine if there is a noticeable difference in outcome between patients who have their tissue lightly scored with a scalpel or marked with a surgical marking pen.

Detailed description: Mohs Micrographic Surgery is a well established method utilizing microscopic margin controlled excision for treatment of cutaneous malignancies (See Appendix A). It has the highest cure rate of any of the methods used to treat common cutaneous malignancies and is a proven safe outpatient procedure. Part of the technique requires marking skin surrounding the tumor to correspond with tissue that has been removed and divided into pieces for processing and microscopic examination. Currently there are two established ways of marking the tissue; lightly scoring it with a scalpel or marking it with a surgical marker. Scoring tissue is faster, more accurate, and there is no risk of having the marking washed or rubbed away.

Eligibility criteria: Inclusion Criteria:

* Patients who are able to legally consent to study and are scheduled for Mohs Micrographic Surgery to remove their malignancies

Exclusion Criteria:

* Patients who are unable to legally consent themselves, do not wish to participate or who are not scheduled to undergo Mohs Micrographic Surgery.
* Children, those with mental handicaps, pregnant women, prisoners, those with cognitive impairments, and life-threatening diseases will be excluded.

Primary outcomes:
measure: The goal of the study is to determine if there are any noticeable differences in outcomes between patients who have their skin scored and those who have their skin marked with a surgical marking pen
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Daniel Eisen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Thomas King, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00461942: Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease Patients
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Neuroprotection Effect of Green Tea Polyphenol in De Novo Parkinson's Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Health Food;
Green Tea;
Neuroprotection
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Ministry of Health, China
name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2007-04-18
Enrollment: 480
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Green Tea Polyphenol, an extraction from Green Tea is effective and safe in the treatment of De Novo Parkinson's disease Patients without taking any antiparkinsonism drug

Detailed description: The primary outcome measurement is UPDRS using a delay start design. Total 480 de novo PD patients divided into three dosage groups of green tea polyphenol and one placebo control group. Patients will be treated for one year.

Eligibility criteria: Inclusion Criteria:

* Willing and able to give informed consent
* Age 30 years or older at time of diagnosis of Parkinson's disease
* Diagnosed as having typical PD
* Parkinson's disease duration of no more than 5 years
* No current dopaminergic or other forms of anti-parkinsonism therapy
* Hoehn and Yahr stage \< 3

Primary outcomes:
measure: Delay of progression of Motor dysfunction
Secondary outcomes:
measure: Cognition;
measure: Mood;
measure: Quality of Daily life
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Institute of Geriatrics, Xuanwu Hospital
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Piu Chan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02755142: Clinical Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas
Official title: Clinical Phase I/II Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Brain Neoplasm
Lead sponsor: medac GmbH
Sponsor class: INDUSTRY
Collaborators: name: IKP
First posted: 2016-04-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is planned to detect a dose-efficacy relationship between the chosen dose levels of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with newly diagnosed malignant glioma.


Eligibility criteria: Inclusion Criteria:

* Radiological suspicion of a malignant glioma with distinct ring- or garland shaped, contrast agent-enhancing tumour structures and a core area of reduced intensity in the MRI (tumour necrosis)
* Indication for surgical tumour resection
* First operation of the tumour, no other tumour-specific pre-treatment
* Karnofsky Performance Scale 70%
* Patient's written informed consent
* Age 18-75 years

Exclusion Criteria:

* Porphyria, hypersensitivity to porphyrins
* Renal insufficiency:

  * Creatinine \> 2.0 mg/dl
* Hepatic insufficiency:

  * Bilirubin \> 3 mg/dl
  * Quick test \< 60 %
  * GT \> 100 U/I
* Other known malignancy (except basaliomas)

Women:

* Existing/planned pregnancy (to be checked by a pregnancy test if of child-bearing age)/lactation or inadequate contraception (hormone cycle regulation pill or condom)

Men:

* Inadequate contraception (condom)
* Dementia or mental condition making it impossible to understand the therapy and therefore prohibiting written consent
* Simultaneous participation or participation in another clinical trial in the preceding 30 days

Primary outcomes:
measure: Detection of a dose-efficacy relationship between the dose levels and the extent and quality of fluorescence in the tumour core (of newly diagnosed malignant glioma).
timeFrame: Within 3 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03433742: Metal Ion Levels in Stryker Trident II Tritanium System with Modular Dual Mobility (MDM) Liner, Ceramic Head, and SecurFit Advanced Stems
Official title: Metal Ion Levels in Stryker Trident II Tritanium System with MDM Liner, Ceramic Head, and SecurFit Advanced Stems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Pain
Keywords: metal ion levels, total hip replacement, Trident II cup.
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Stryker Nordic
First posted: 2018-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Metal Ions levels of cobalt, chromium, and titanium in 40 patients preoperatively and at least 1 year status post total hip replacement with the Trident II Tritatnium system using an MDM liner and ceramic head. Are cobalt, chromium, and titanium levels in patients who undergo a total hip replacement with a Trident II Tritanium system, MDM liner, and ceramic head normal one year after surgery? Investigators expect to find normal levels of metal ions (cobalt, chromium, and titanium) after total hip replacement using Trident II Tritanium cups with an MDM liner and a ceramic head. The primary outcome (PO) is blood metal ion levels of cobalt, chromium, and titanium (concentration of metal ions in blood). Blood will be drawn in the 3rd Floor West of the Main Building, and then tested for metal ions in the Hospital for Special Surgery laboratory. The bloods will be drawn at a preoperative visit and at a one year visit.


Eligibility criteria: Inclusion Criteria:

1. Patients who will be undergoing a total hip replacement with a Stryker Trident II cup
2. Patients have signed an Institutional Review Board (IRB) approved consent form
3. Patient is 21-80
4. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease
5. Patient is willing and able to comply with postoperative scheduled clinical evaluations.

Exclusion Criteria:

1. Patients who have not been consented as part of the Collaborative Orthopaedic Replacement Registry (CORRe) database
2. Patients with other joint replacements (shoulder/knee)
3. Patients with bilateral hip replacements
4. Prisoners
5. International Patients

Primary outcomes:
measure: Metal Ion levels before and 1 year after a total hip replacement with a Trident II Cup
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References:
Clinical trial NCT01598142: Single-operator Wire-guided Endoscopic Retrograde Cholangiopancreatography Cannulation Technique
Official title: Single-operator Wire-guided ERCP Cannulation Technique: a Single-center Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Diseases
Pancreas Diseases
Keywords: Endoscopic retrograde cholangiopancreatography (ERCP)
Guidewires
Cannulation
Single-operator
C-Hook
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 465
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The single-operator wire-guided cannulation technique doesn't require an experienced assistant and precise coordination between the assistant and endoscopist.

Detailed description: A new single-operator wire-guided cannulation technique was performed on all patients. All procedures were performed by the same experienced endoscopist, but with different assistants in two groups (with an experienced one in Group A, and a new trained one in Group B). The number of attempts at cannulation, cannulation time, success rate, and procedure-related complications were compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* hospitalized patients with pancreas and biliary diseases referred to the authors for ERCP

Exclusion Criteria:

* previous endoscopic sphincterotomy,
* surgically altered anatomy (e.g. Billroth II gastrectomy) or
* diagnostic duodenoscopy

Primary outcomes:
measure: Cannulation success rate
timeFrame: two years
Secondary outcomes:
measure: Incidences of post-ERCP pancreatitis
timeFrame: two years
measure: Incidences of bleeding
timeFrame: two years
measure: Incidences of perforation
timeFrame: two years
measure: Incidences of infection
timeFrame: two years
measure: Number of attempts at cannulation
timeFrame: two years
measure: Cannulation time
timeFrame: two years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Qi-Yong Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01631370: The Effects of Renal Denervation on Insulin Sensitivity
Official title: The Effects of Renal Sympathetic Denervation on Insulin Sensitivity in Patients With Resistant Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Resistant Essential Hypertension
Insulin Resistance
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 8
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Renal sympathetic nerves contribute to development of hypertension. Sympathetic overactivity also induces insulin resistance and it could therefore be assumed that a renal denervation might improve insulin sensitivity. Studies have shown that glucose metabolism is improved in patients with treatment resistant essential hypertension both 1 and 3 months after renal denervation compared to a control group with treatment resistant essential hypertension. Fasting glucose, insulin and C-peptide decreased significantly as did insulin resistance assessed by HOMA-IR. The investigators wish to investigate the effect of renal denervation on insulin sensitivity using the gold standard - the hyperinsulinemic euglycemic clamp and to investigate the degree of insulin resistance in muscle, liver and adipose tissue.


Eligibility criteria: Inclusion Criteria:

* Systolic daytime ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic

Exclusion Criteria:

* Diabetes
* Pregnancy
* Non compliance
* Heart Failure (NYHA 3-4)
* LV ejection fraction \< 50 %
* Renal insufficiency (eGFR\<30)
* Unstable coronary heart disease
* Coronary intervention within 6 months
* Myocardial infarction within 6 months
* Claudication
* Orthostatic syncope within 6 months
* Secondary Hypertension
* Permanent atrial fibrillation
* Significant Heart Valve Disease
* Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH
* Second and third degree heart block
* Macroscopic haematuria
* Proximal significant coronary stenosis
* Renal artery anatomy not suitable for renal artery ablation (Stenosis, small diameter \< 4 mm, length \< 2 cm, multiple renal arteries, severe calcifications)

Primary outcomes:
measure: Insulin sensitivity expressed as an M-value
timeFrame: 4 hours
Secondary outcomes:
measure: Insulin signaling
timeFrame: 6 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medical Research Laboratories, Aarhus University Hospital
Study officials:
affiliation: Department of Endocrinology and Internal Medicine, Aarhus University Hospital
name: Per Løgstrup, MD Dr Sci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02022670: Sodium Nitrite to Treat Arterial Aging
Official title: Clinical Translation of Nitrite Therapy to Treat Arterial Aging in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Vascular Aging
Keywords: endothelial function
arterial stiffness
flow-mediated dilation
pulse wave velocity
sodium nitrite
aging
vascular diseases
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: TheraVasc Inc.
First posted: 2013-12-30
Enrollment: 33
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed research will determine the effectiveness of nitrite, a naturally occurring compound in the body, for improving the health and function of arteries in middle-aged and older adults. The study also will provide insight into how sodium nitrite therapy improves artery health by determining the physiological mechanisms (biological reasons) involved. Overall, the proposed research will provide important new scientific evidence on the effectiveness of sodium nitrite for decreasing the risk of developing cardiovascular diseases with aging.

Detailed description: The improvement in blood vessel function and stiffness will be determined over a 10 week period. Subjects will be randomly assigned to either placebo (0 mg/day), low dose (80 mg/day) or high dose (160 mg/day) sodium nitrite. Main outcome measures will be performed at baseline and week 10.

Eligibility criteria: Inclusion Criteria:

* 50-79 years of age
* Ability to provide informed consent
* Score greater than 22 on the mini mental state exam
* Blood pressure greater than 100/60 mmHg for past 3 months

Exclusion Criteria:

* Are taking any of the following medications/drugs: hormone replacement therapy, anti-hypertensives, nitrates, nervous system depressants, allopurinol, phosphodiesterase-5 inhibitors, blood thinners
* Are currently sick/have chronic clinical diseases such as kidney disease, diabetes, or unstable cardiovascular disease
* Are hypersensitive to nitrates or nitrites
* Have glucose-6-phosphate dehydrogenase deficiency
* Have blood methemoglobin greater than 2%
* Have a BMI greater than 40 kg/m\^2
* Have a baseline FMD of greater than 6%
* Have not been post-menopausal for at least 1 year
* Perform regular vigorous aerobic/endurance exercise

Primary outcomes:
measure: Baseline and Week 10 Flow-Mediated Dilation
timeFrame: Baseline (Week 0), Week 10
Secondary outcomes:
measure: Baseline and Week 10 Plasma Nitrite Concentrations
timeFrame: Baseline (Week 0), Week 10
measure: Baseline and Week 10 Aortic Pulse Wave Velocity
timeFrame: Baseline (Week 0), Week 10
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Clinical Translational Research Center
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Douglas R Seals, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Boulder
name: Allison E DeVan, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03491670: Free Iron and Out of Hospital Cardiac Arrest
Official title: Iron Metabolism After Out of Hospital Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrest Cardio Respiratory
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 25
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 admitted to ICU for out of hospital cardiac arrest

Brief summary: Out of hospital cardiac arrest is associated with a poor prognosis. The aim of this study is to provide a better understanding of perturbations of iron metabolism after cardiac arrest and to analyze the impact on clinical centered outcome.


Eligibility criteria: Inclusion Criteria:

* Patient admitted to ICU for out of hospital cardiac arrest
* Therapeutic hypothermia

Exclusion Criteria:

* Absence of consent

Primary outcomes:
measure: Mortality
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Neurologic outcome
timeFrame: 6 months post cardiac arrest
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT05990270: The Effect of Education Given to Women on Cervical Cancer on Knowledge, Attitude and Belief
Official title: The Effect of Education Given to Women on Knowledge, Attitudes and Beliefs on Cervical Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Cervix
HPV Infection
Keywords: Cervical cancer,
early diagnosis,
Pap smear,
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 102
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: The aim of this study is to reveal the effect of education given to women about cervical cancer on knowledge, attitude and belief.

Material and Method: This randomized controlled study was conducted with 130 who had a public hospital located in Southeast Turkey (51 experimental, 51 control).

Detailed description: Aim: The aim of this study is to reveal the effect of education given to women about cervical cancer on knowledge, attitude and belief.

Material and Method: This randomized controlled study was conducted with 130 who had a public hospital located in Southeast Turkey (51 experimental, 51 control).

In the first stage, the researcher participants were informed about the purpose of the researcher and the questionnaire, and their consent was obtained for participation in the study.

In the second stage, pre-test data will be obtained with the face-to-face interview method of the research data and a questionnaire form. Cervical cancer education will be provided. (The training is in three sessions, each session will last 20-30 minutes. In the training; Cervical cancer, ppt presentation on HPV virus, question-answer method, female pelvic anatomy on the gynecological examination model, gynecological examination, how the Pap Test is done, and cervical cancer pathologies. will be explained )) After the training, the post-test data will be obtained by applying the questionnaire again.

Eligibility criteria: Inclusion Criteria:

* least literate, no communication problem women who agreed to participate in the study

Exclusion Criteria:

* literate are women who do not have communication problems (hearing impairment, visual impairment)

Primary outcomes:
measure: First Measurement: Human Papilloma Virus (HPV) Knowledge Scale
timeFrame: Measurement at the second encounter (1 WEEK AFTER TRAINING) for each group.
measure: Second Measurement:Cervical Cancer and Pap-Smear Test Health Belief Model Scale
timeFrame: Measurement at the second encounter (1 WEEK AFTER TRAINING) for each group.
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaraş ISU
state: K.Maraş
Study officials:
affiliation: KahramanmaraşISU
name: HATİCE GÜL ÖZTAŞ
role: STUDY_DIRECTOR
References: