louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02934789: Effectiveness of Truclear on Patient Quality of Life
Official title: Randomized Prospective Study of the Effectiveness of the Truclear Device for Hysteroscopic Myomectomy on Patient Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy Menstrual Bleeding
Keywords: submucosal fibroids
heavy menstrual bleeding
quality of life
Lead sponsor: All For Women Healthcare, Illinois
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-10-17
Enrollment: 69
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the quality of life in patients treated for submucosal leiomyomas using the Truclear hysteroscopic morcellator compared to women managed medically. Study population includes women age 18 and older with symptomatic submucosal myomas. Patients will be asked to complete the Uterine Myoma Symptom and Health-related Quality of Life Questionnaire (UFS-QOL) at enrollment and at 1, 3, and 6 months after treatment.

Detailed description: Submucosal myomas are a common cause of pelvic complaints and abnormal uterine bleeding (AUB) and there are many available modalities for treatment. Hysteroscopic myomectomy is a minimally invasive approach for removal of submucosal leiomyomas. Alternatively, medical management can be attempted. This study aims to evaluate the quality of life in patients treated for submucosal leiomyomas using the Truclear hysteroscopic morcellator compared to women managed medically. Study population includes women age 18 and older with symptomatic submucosal myomas. Patients will be asked to complete the Uterine Myoma Symptom and Health-related Quality of Life Questionnaire (UFS-QOL) at enrollment and at 1, 3, and 6 months after treatment.

Eligibility criteria: Inclusion Criteria:

* Patients with abnormal uterine bleeding and submucosal fibroid(s) undergoing hysteroscopic myomectomy or medical therapy with oral contraceptive pills
* Patients with Type 0, 1 or 2 submucosal myomas

Exclusion Criteria:

* Pregnant women
* Patients with suspicion of uterine malignancy
* Patients without submucosal fibroid seen during planned hysteroscopic myomectomy
* Patients with active vaginal infection
* Patients with contraindication to hysteroscopic myomectomy
* Patients with cognitive impairment who are unable to provide consent and adequately complete the questionnaire.

Primary outcomes:
measure: Quality of life score
timeFrame: Two years
Secondary outcomes:
measure: Secondary surgical outcomes
timeFrame: Two years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: All For Women Healthcare
state: Illinois
Study officials:
affiliation: All For Women Healthcare
name: Teresa Tam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spies JB, Bradley LD, Guido R, Maxwell GL, Levine BA, Coyne K. Outcomes from leiomyoma therapies: comparison with normal controls. Obstet Gynecol. 2010 Sep;116(3):641-652. doi: 10.1097/AOG.0b013e3181ed36b3.
Clinical trial NCT01963689: Aromatherapy for Anxiety and Self-esteem: Clinical Trial
Official title: Aromatherapy for Anxiety and Self-esteem: Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Self Esteem
Keywords: Anxiety
Self-Esteem
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 34
Sex: ALL
Minimum age (years): 34
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to determine whether the use of Ylang Ylang essential oil through dermal application or inhalation alters the perception of anxiety and self-esteem and physiological parameters such us blood pressure and temperature.

Detailed description: 34 nurses from the University Hospital participated in this study and were randomized into three groups: one that received the Ylang Ylang Essential Oil cutaneous route, the second received the Essential Oil inhalation and the third (placebo) received the essence of Ylang ylang cutaneous route.

Eligibility criteria: Inclusion Criteria:

* be an employee of the nursing team and not be on probation
* accept make use gel or freshener containing essential oil or essence ylang ylang
* respond Anxiety Inventory(STAI)and Self-esteem scale and present moderate, high or very high anxiety on the STAI, medium or low self-esteem on the scale Self-esteem
* accept not wear perfume during the survey period
* accept the smell of Ylang Ylang.

Exclusion Criteria:

* Self reported Hypotension
* Medical License or vacation during the period

Primary outcomes:
measure: State-Trait Anxiety Inventory
timeFrame: after 60 days
Secondary outcomes:
measure: Self-Esteem Scale
timeFrame: after 60 days
Other outcomes:
Locations:
Study officials:
affiliation: Nursing School of São Paulo University
name: Maria Júlia P da Silva
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02988089: Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment
Official title: Efficacy of Two Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Antimicrobial Susceptibility Testing
Keywords: Helicobacter Pylori Infection
Antimicrobial susceptibility testing (AST)
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
name: General Hospital of Jinan Military Region
name: Binzhou People's Hospital
name: Liaocheng People's Hospital
First posted: 2016-12-09
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients who are 18-70 years old with persistent H. pylori infection after first or second line treatment attempts.

Exclusion Criteria:

* Enable to undergo upper endoscopy;
* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
* Known or suspected allergy to study medications;
* Taking bismuth and antibiotics in the previous four weeks, or taking proton pump inhibitor and H2-receptor blockers in the previous two weeks;
* Currently pregnant or lactating
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Primary outcomes:
measure: Eradication rates in 2 groups
timeFrame: 6 months
Secondary outcomes:
measure: the rate of improving dyspepsia symptoms after H. pylori eradication
timeFrame: 6 months
measure: the rate of adverse events happening
timeFrame: 6 months
measure: the rate of good compliance (take pills more than 90%)
timeFrame: 5 months
measure: difference of cost per patient for each eradication achieved in 2 groups
timeFrame: 6 months
Other outcomes:
Locations:
city: Ji'nan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Li Yanqing, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03496389: Does Gabapentin Reduce Quadriceps Muscle Weakness After Anterior Cruciate Ligament Reconstruction?
Official title: Does Gabapentin Reduce Quadriceps Muscle Weakness After Anterior Cruciate Ligament Reconstruction? A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Muscle Weakness
Anterior Cruciate Ligament Rupture
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2018-04-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Anterior cruciate ligament (ACL) injury is a common sport injury in both professional and recreational athletes. Furthermore, persistent quadriceps weakness and wasting are frequently observed after anterior cruciate ligament reconstruction (ACLR). Several studies have demonstrated that muscular rehabilitation to normal strength is difficult, protracted, and often not achieved due to the inability to fully activate the quadriceps voluntarily. Pain and disuse are often blamed for the inhibition of muscle activation following joint injury. However, arthrogenic muscle inhibition (AMI) is often overlooked and not addressed. Thus, the magnitude of strength restoration of the quadriceps is frequently restricted despite solid rehabilitation protocols. As AMI is a reflex inhibition of musculature involving the neurotransmitter γ-aminobutyrate (GABA), Gabapentin may have a potential role in modulating AMI, therefore limiting muscle weakness after ACLR.


Eligibility criteria: Inclusion Criteria:

1. Age 18-50
2. Unilateral isolated ACL tear for primary ACLR confirmed clinically and radiologically
3. No concomitant ligamentous, meniscal or chondral injuries.

Exclusion Criteria:

1. Concomitant multiple ligament injuries including posterior cruciate ligament, medial collateral ligament ligament, or lateral collateral ligament
2. Concomitant meniscal injuries
3. Concomitant chondral injuries
4. preoperative radiographic signs of arthritis
5. Revision ACL surgery
6. Contralateral knee with
7. Medical co-morbidities including Diabetes Mellitus, chronic renal failure
8. Documented hypersensitivity to Gabapentin
9. History of epilepsy
10. History of depression
11. Non-compliance to rehabilitation protocol.

Primary outcomes:
measure: Change in from baseline quadriceps muscle strength
timeFrame: at postoperative 4, 6, 9, 12 months
Secondary outcomes:
measure: Anterior-posterior knee stability
timeFrame: at postoperative 4, 6, 9, 12 months
measure: Anterior-posterior knee stability
timeFrame: at postoperative 4, 6, 9, 12 months
measure: Anterior-posterior knee stability
timeFrame: at postoperative 4, 6, 9, 12 months
measure: Rotational laxity
timeFrame: at postoperative 4, 6, 9, 12 months
measure: Functional outcome
timeFrame: at postoperative 4, 6, 9, 12 months
measure: Functional outcome
timeFrame: at postoperative 4, 6, 9, 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01269489: Health-related Quality of Life in General Slovenian Population
Official title: Health-related Quality of Life in General Slovenian Poplation Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality-of-Life Questionnaire QLQ-C30
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Health-related Quality of Life
Keywords: quality of life
general Slovenian population
EORTC QLQ C30
Lead sponsor: Institute of Oncology Ljubljana
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: sample from general Slovenian population

Brief summary: The purpose of the study is to obtain reference data on health-related quality of life for the functional and symptom scales and single items of the European Organisation for Research and Treatment of Cancer Core Quality-of-Life Questionnaire (EORTC QLQ C30) in a representative sample of Slovenian general population.

Detailed description: A sample of at least 600 people from the Slovenian population, randomly selected, age 18 years and more, representing geografic diversity, will take part in this postal survey. The EORTC QLQ C30 and a questionnaire about demografic data will be send by mail. This is the first study to obtain reference data from the EORTC QLQ C30 in a sample from the general Slovenian population. The results will serve as guidelines for interpreting health-related quality-of-life of different groups of patients.

Eligibility criteria: Inclusion Criteria:

* age 18 y and more

Exclusion Criteria:

* serious comorbidity
* previously treated for cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Institute of Oncology
Study officials:
affiliation: Institute of Oncology Ljubljana Slovenia
name: Vaneja Velenik, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cocks K, King MT, Velikova G, Fayers PM, Brown JM. Quality, interpretation and presentation of European Organisation for Research and Treatment of Cancer quality of life questionnaire core 30 data in randomised controlled trials. Eur J Cancer. 2008 Sep;44(13):1793-8. doi: 10.1016/j.ejca.2008.05.008. Epub 2008 Jul 1.
citation: Fayers P, Bottomley A; EORTC Quality of Life Group; Quality of Life Unit. Quality of life research within the EORTC-the EORTC QLQ-C30. European Organisation for Research and Treatment of Cancer. Eur J Cancer. 2002 Mar;38 Suppl 4:S125-33. doi: 10.1016/s0959-8049(01)00448-8.
Clinical trial NCT02133989: Clopidogrel Resistance and Embolism in Carotid Artery Stenting
Official title: Ticlopidine+Ginkgo Biloba Versus Clopidogrel in Clopidogrel Resistant Patients Undergoing Cartoid Artery Stent Placement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Carotid Stenosis
Keywords: Carotid stenosis
Stenting
Clopidogrel resistance
Stroke, ischemic
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Yuyu Pharma, Inc.
First posted: 2014-05-08
Enrollment: 86
Sex: ALL
Minimum age (years): 20
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 evaluate the efficacy and safety of the ticlopidine + ginko biloba compared to clopidogrel in clopidogrel resistant patients undergoing carotid artery stent placement. The investigators hypothesized that ticlopidine + ginko biloba is superior than clopidogrel in terms of post-stent ischemic lesions in these patients without serious complications.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for stent implantation due to carotid stenosis
* Patients resistant to clopidogrel defined by platelet inhibition rate \<20% measured by Verify Now before carotid stenting
* Patients with informed consent

Exclusion Criteria:

* Antiplatelet therapy other than aspirin, clopidogrel, or ticlopidine
* Unable to perform MRI scans
* Patients with hematologic abnormalities including neutrophil \<1500/ul, platelet \<100,000/uL, or AST/ALT \>120 U/L
* Unsuitable for participation

Primary outcomes:
measure: New ischemic lesion on diffusion-weighted imaging (DWI)
timeFrame: within 24 hours after carotid stenting
Secondary outcomes:
measure: Number and Volume of new ischemic lesions on DWI
timeFrame: within 24 hours after carotid stenting
measure: Benign and malignant microembolic signals (MES) on transcranial Doppler (TCD)
timeFrame: within 24 hours after carotid stenting
measure: Ischemic stroke or transient ischemic attack (TIA)
timeFrame: within 30 days after carotid stenting
measure: Change of clopidogrel resistance
timeFrame: 1 day after carotid stenting
measure: Pucture site hematoma
timeFrame: within 30 days after carotid stenting
measure: Mycocardial infarction
timeFrame: within 30 days after carotid stenting
measure: Death
timeFrame: within 30 days after carotid stenting
measure: Hematological abnormalities
timeFrame: within 30 days after carotid stenting
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Oh Young Bang
Study officials:
affiliation: Samsung Medical Center
name: Oh Young Bang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chung JW, Kim SJ, Hwang J, Lee MJ, Lee J, Lee KY, Park MS, Sung SM, Kim KH, Jeon P, Bang OY. Comparison of Clopidogrel and Ticlopidine/Ginkgo Biloba in Patients With Clopidogrel Resistance and Carotid Stenting. Front Neurol. 2019 Jan 30;10:44. doi: 10.3389/fneur.2019.00044. eCollection 2019.
Clinical trial NCT04428489: Follow-up Study of ICUS and CCUS Patients
Official title: A Follow-up Observational Study of ICUS and CCUS Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Myelodysplastic Syndromes
Keywords: Idiopathic cytopenia of undetermined significance (ICUS)
Clonal cytopenia of unknown significance (CCUS)
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 300
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 diagnosed with ICUS and CCUS based on the proposed minimal diagnostic criteria for myelodysplastic syndromes (MDS) and potential pre-MDS conditions

Brief summary: The proposed minimal diagnostic criteria for myelodysplastic syndromes (MDS) and potential pre-MDS conditions has been released by an international consensus group. Based on the criteria, patients with persistent cytopenia could be diagnosed with MDS, CCUS and ICUS. However, the process and outcome of pre-MDS conditions (CCUS, ICUS) is still to be characterized in Chinese population. We design this prospective observational study to explore the disease process and outcome in ICUS and CCUS patients.


Eligibility criteria: Inclusion Criteria:

* Patients with cytopenia of any degree in one or more lineages: erythrocytes, neutrophils, or platelets. And the cytopenia has to be persistent (≥ 4 months) and lacking minimal diagnostic criteria of MDS.

Exclusion Criteria:

* Patients with cytopenia which could be explained by any other hematologic or non-hematologic disease.

Primary outcomes:
measure: Culumative transformation rate
timeFrame: 5 years
Secondary outcomes:
measure: Event-free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affliated Hospital of Soochow University
state: Jiangsu
Study officials:
References:
Clinical trial NCT06431789: Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in Patients With Moderate to Severe Renal Insufficiency
Official title: Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in Patients With Moderate to Severe Renal Insufficiency
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gene Polymorphism
Edoxaban
Renal Insufficiency
Keywords: Anti-factor Xa activity
Edoxaban
Moderate to severe renal insufficiency
Solute carrier organic anion transporter family member 1B1
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
Collaborators: name: Qianfoshan Hospital
First posted: 2024-05-29
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with edoxaban at the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfo Hospital).

Brief summary: 1. To provide reference for clinical rational use of edoxaban;
2. Optimize the individualized dosing regimen of edoxaban.

Detailed description: In this study, patients with moderate and severe renal insufficiency receiving edoxaban were selected as research objects. The potential safety of edoxaban in patients with different genotypes was evaluated by detecting the anti-XA factor activity and SLCO1B1 genotyping, so as to optimize the individualized administration regimen of edoxaban.

Eligibility criteria: Inclusion Criteria:

* Creatinine clearance of 15-50ml/min was calculated according to the Cockcroft-Gault formula
* Patients who received edoxaban 30mg once daily for more than 5 days for non-valvular atrial fibrillation (CHADS2VAS2 score ≥2) and deep vein thrombosis prevention or treatment
* Patients voluntarily participate and sign informed consent

Exclusion Criteria:

* Age \< 18 years old
* Moderate/severe mitral stenosis combined with valvular heart disease, mechanical valve replacement, or rheumatic heart disease
* The patient had used a combination of cyclosporine, erythromycin or ketoconazole or other P-glycoprotein inhibitors within 30 days prior to use or inclusion; Patients were using or had used amiodarone or dronedarone within 30 days prior to inclusion

Primary outcomes:
measure: Anti-factor Xa activity
timeFrame: six months
Secondary outcomes:
Other outcomes:
measure: Safety index:Thrombotic and bleeding events.
timeFrame: six months
Locations:
city: Jinan
country: China
facility: First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Yi Han, doctorate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02798289: Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator
Official title: A Single Arm, Multicenter, Open-Label Study Designed to Evaluate Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Keratoconjunctivitis Sicca
Lead sponsor: Oculeve, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-14
Enrollment: 55
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective of this study is to evaluate acute tear production as measured by tear meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.

Detailed description: This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the OIN once following study enrollment.

Eligibility criteria: Inclusion Criteria:

* Subjects with dry eye disease
* Literate, able to speak English or Spanish, and able to complete questionnaires independently
* Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

Exclusion Criteria:

* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
* Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma
* Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
* Corneal transplant in either or both eyes
* Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit
* Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit

Primary outcomes:
measure: Tear Meniscus Height Captured by Optical Coherence Tomography
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Newport Beach
country: United States
facility: Aesthetic Eyecare Institute
state: California
Study officials:
affiliation: Mid-Peninsula Ophthalmology Medical Group
name: Neil Friedman, MD
role: STUDY_DIRECTOR
References: