louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04234893: Bingo Drug-Coated Balloon in Real World
Official title: A Registry Study of Bingo Drug-Coated Balloon in Real World
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Stenosis
Drug-coated Balloon
De Novo Stenosis
Coronary Artery Disease in Transplanted Heart Accelerated
Keywords: Coronary Stenosis
Percutaneous Coronary Intervention
Drug-coated Balloon
Drug eluting Balloon
Paclitaxel
De novo
Bifurcation
Coronary Artery Disease
Lead sponsor: Yinyi(Liaoning) Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-21
Enrollment: 805
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PCI with Bingo drug-coated balloon

Brief summary: The purpose is to observe and evaluate the safety and efficacy of Bingo drug-coated balloon in the real world.


Eligibility criteria: Inclusion Criteria:

1. Age 18 or older, regardless of gender;
2. Patients suitable for PCI with paclitaxel drug-coated balloon;
3. Patients able to understand the purpose of this study, provide an informed consent and cooperate with clinical follow-up.

Exclusion Criteria:

General exclusion criteria

1. Contraindications to PCI;
2. In-stent restenosis;
3. Life expectation less than 1 year;
4. Patients not suitable for enrollment considered by investigator.

Angiographic exclusion criteria:

1. Target lesion with the following conditions after pre-dilatation:

1. Residual stenosis larger than 30% ;
2. TIMI flow grade less than 3;
3. Type C-F dissection (NHLBI grade).

Primary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: 12 months
Secondary outcomes:
measure: device success
timeFrame: immediately after the procedure
measure: lesion success
timeFrame: immediately after the procedure
measure: clinical success
timeFrame: immediately after the procedure， up to 7 days
measure: rate of Target lesion revascularization
timeFrame: 1, 6, 12 and 24 months
measure: Target lesion failure
timeFrame: 1, 6, 12 and 24 months
measure: Acute vessel closure
timeFrame: during the procedure and up to 24 hours
measure: Target lesion thrombosis
timeFrame: immediately after the procedure， up to 24 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jian-an Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03718793: Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes
Official title: Small Airway Inflammation and Dysfunction in Different Asthma Phenotypes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 160
Sex: ALL
Minimum age (years): 4
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Small airway inflammation and dysfunction will be measured in 40 children and 40 adults with asthma before and after 8 weeks of treatment with inhaled budesonide. The same measurements will be conducted once in 80 age and sex matched healthy controls.


Eligibility criteria: Inclusion Criteria:

* symptoms of asthma and objective evidence of variable or reversible airway obstruction according to at least one of the following criteria
* significant response to bronchodilator (in subjects 7 years or older: FEV1 (forced expiratory volume in 1st second) or FVC (forced vital capacity) increases at least 12 % and 200 ml; in 4-6 years old subjects R5 decreases at least 40 %)
* in at least 12 years old subjects significant diurnal variation (at least 20 % and 60 l/min on at least three days) or significant response to bronchodilator ( at least 15 % and 60 l/min on at least three occasions) in PEF (peak expiratory flow) during a two-week monitoring
* significant airway hyperreactivity (PD20 FEV1 of methacholine less than 600 µg in at least 16 years old subjects, FEV1 decreases at least 15 % in exercise test in 7-15 years old, or R5 increases at least 40 % during free-running test in 4-6 years old subjects)

Exclusion Criteria:

* current smoking
* regular anti-inflammatory asthma medication (will be paused for at least 4 weeks before enrollment)
* other chronic pulmonary disease
* other diseases that in the opinion of the treating physician prevents participation

Primary outcomes:
measure: Prevalence of small airway inflammation (measured by peripheral NO output) in untreated asthma
timeFrame: Baseline
measure: Prevalence of small airway dysfunction (measured by peripheral airway resistance) in untreated asthma
timeFrame: Baseline
Secondary outcomes:
measure: Difference in Eosinophil Cationic Protein (ECP)/B-Eos ratio between asthmatics and controls
timeFrame: Baseline
measure: Correlation between ECP/B-Eos ratio and peripheral NO output in untreated asthma
timeFrame: Baseline
measure: Correlation between ECP/B-Eos ratio and peripheral airway resistance in untreated asthma
timeFrame: Baseline
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Allergy Centre, Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Lauri Lehtimäki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01165593: Measurement of Left and Right Atria From CT Scans of Cardiac Rhythm Disorder Cases
Official title: Measurement of Left and Right Atria From CT Scans of Cardiac Rhythm Disorder Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Kardium Inc.
Sponsor class: INDUSTRY
Collaborators: name: St. Paul's Hospital, Canada
First posted: 2010-07-20
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with atrial fibrillation who are deemed suitable for treatment of atrial fibrillation by catheter-based ablation.

Brief summary: The purpose of this study is to gather information about the size and shape of patients' hearts in order to design a device.

Detailed description: Correct device design depends on getting good information about the shape and size of the different parts of the heart. Measurements from computed tomography images of hearts will be studied. By looking at measurements from a wide range of patients, an understanding of the differences in the size and shape of the heart chambers will be gained.

Eligibility criteria: Inclusion Criteria:

* Patients deemed suitable for treatment of atrial fibrillation by catheter-based ablation who have received cardiac CT imaging as part of normal care.

Exclusion Criteria:

* Patients who have not received cardiac CT imaging as part or normal care.

Primary outcomes:
measure: LA size measurements
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: St' Paul's Hospital Electrophysiology (Providence Health Care)
name: John A. Yeung-Lai-Wah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06641193: Clinical Trail of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Upper Limb Bradykinesia in Parkinson' Disease' Patients
Official title: A Randomized Sham-Controlled Trial of High-frequency RTMS in the Treatment of Upper Limb Bradykinesia in Patients with Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parkinson&#39;s Disease (PD)
Bradykinesia
Upper Limb Function
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University School of Medicine
First posted: 2024-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, sham-controlled unicenter clinical trial was used to investigate the effectiveness and neural mechanism of high-frequency repetitive transcranial magnetic stimulation in the treatment of upper limb bradykinesia in patients with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Hoehn and Yahr (HY) stage 1-2
* Able to understand and cooperate with the study
* Predominantly characterized by bradykinesia
* Onset on the left side

Exclusion Criteria:

* Contraindications for TMS including DBS surgery, Ventriculoperitoneal shunt, etc
* Other neurological disorders
* Significant resting tremor, with MDS-UPDRS-III tremor score ≥3
* Resting threshold cannot be measured
* Received other TMS treatments within the last 3 months

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: 2 weeks and 4 weeks
Secondary outcomes:
measure: cortical activation detected by fNIRS
timeFrame: 2 weeks and 4 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Study officials:
References:
Clinical trial NCT05733793: Molecular Data and Their Correlations With Clinical Outcomes in Gynecological Cancer Patients.
Official title: A Retrospective-prospective, Multicenter, Observational Study Aimed to Record Molecular Data and to Explore Their Correlations With Clinical Outcomes in Gynecological Cancer Patients. The MITO GYNecological Cancers GEnetic Profile Registry (GYNGER) Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gynecologic Cancer
Keywords: Next Genaration Sequencing (NGS)
Molecular profile
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 300
Sex: FEMALE
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: All patients diagnosed with a gynecological cancer with an available NGS report.

Brief summary: Gynger is a no profit, observational study, composed of a retrospective cohort (A) and a prospective cohort (B). The primary aim of this trial is to describe gene profile of Italian gynecological cancers patients, through the centralization of NGS reports performed in clinical practice or collected in clinical trials, and to correlation them with clinical and pathologic features.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent form;
2. Female sex;
3. Age ≥18 years;
4. Diagnosis of a gynecological malignancy (ovarian cancer, uterine cancer, vulvar-vaginal cancer, gestational trophoblastic tumor);
5. Availability of NGS report performed on solid tumor tissue from primary or recurrent disease or liquid biopsy; data from NGS assays both in-house (academic test) and commercials can be used regardless of the number of genes analyzed

Exclusion Criteria:

* Patients for which the NGS analysis has been performed of germline tissue

Primary outcomes:
measure: The proportion of different gene alterations found with NGS tests
timeFrame: 4years
Secondary outcomes:
measure: Progression-free-survival (PFS)
timeFrame: until progression disease (up to 4 years)
measure: Overall survival (OS)
timeFrame: 4 years
measure: ORR
timeFrame: 4 years
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Istituto Nazionale Tumori, IRCCS, Fondazione G Pascale
Study officials:
References:
Clinical trial NCT00522093: Efficacy and Safety of TJ-100 in the Treatment of Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Constipation
Keywords: constipation
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
Collaborators: name: Tsumura USA
First posted: 2007-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: TJ-100, a Japanese herbal medicine, is clinically effective in postoperative ileus. So it may activate bowel movement. This study will test the efficacy and safety of TJ-100 in the treatment of patients with chronic constipation.


Eligibility criteria: Inclusion Criteria:

* chronic constipation defined as less than 3 spontaneous bowel movement frequencies per week
* had symptoms of abdominal bloating or discomfort

Exclusion Criteria:

* mechanical bowel obstruction
* clinically systemic disease-induced constipation
* pregnancy

Primary outcomes:
measure: Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events
timeFrame: baseline (4 weeks)
measure: Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events
timeFrame: 6 weeks
measure: Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Komagane
country: Japan
facility: Showa Inan General Hospital
Study officials:
affiliation: Showa Inan General Hospital
name: Akira Horiuchi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03311893: Determine the Point of View of Society Society to Natural Orifice Surgeon
Official title: the Rate of Awareness and Acceptability of Natural Orifice Surgeon in Middle Eastern Society is Similar to Other Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health, Subjective
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 200 participants' perception and acceptability of natural hole surgeon

Detailed description: 100 participants health personnel 100 participants population two group's perception and acceptability of natural orifice surgeon

Eligibility criteria: Inclusion Criteria:

* all female (health personnel and population)

Exclusion Criteria:

* none

Primary outcomes:
measure: natural orifice surgery
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Inonu Unıversity- general surgery
name: Ersin Gündoğan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04355793: Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection
Official title: An Open-Label Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: COVID-19
Keywords: SARS-CoV-2
Cytokine Storm
ruxolitinib
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2020-04-21
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: To provide ruxolitinib through an expanded access program for the treatment of cytokine storm due to COVID-19 in the United States to patients who are eligible but not able to be hospitalized or who are hospitalized with a clinical diagnosis and/or positive test for SARD-CoV-2 infection.


Eligibility criteria: Inclusion Criteria:

* Male or female, 12 years of age or older.
* Clinical diagnosis of COVID-19 and/or locally accepted positive test; if feasible, swab should be taken and saved for quantitative testing to determine viral load.
* Disease severity making the patient eligible for hospitalization (whether or not hospitalization is available), with evidence of cytokine storm as determined by the treating physician. Manifestations of cytokine storm can include the following:
* Severe shortness of breath (respiratory rate \> 24 breaths/minute).
* SpO2 of \< 90% on ambient air.
* Need for invasive or noninvasive mechanical ventilation.
* Acute respiratory distress syndrome.
* Multiple organ failure.
* Be willing to avoid pregnancy or fathering children
* Able to provide written informed consent, consent from the patient's legally authorized representative, and/or assent from the patient, parent, or guardian.

Exclusion Criteria:

* Patients, patient's legally authorized representative, or legal guardians unable to review and sign ICF.
* Females who are pregnant or breastfeeding, and males and females who cannot comply with requirements to avoid fathering a child or becoming pregnant.
* Patients with inadequate liver function (ALT above 4 × ULN or direct bilirubin 4 × ULN and the laboratory abnormalities are considered to be due to underlying liver dysfunction).
* Patients with platelet counts \< 50 × 109 /L
* Any underlying or current medical or psychiatric condition that, in the opinion of the treating physician, would place the patient at an unacceptable risk if he or she were to participate in the program.
* Previous allergic reactions to JAK inhibitors or excipients.
* Concomitant use of any other JAK inhibitor.
* Is eligible or able to access ruxolitinib through an Incyte-sponsored clinical study or is eligible for another therapeutic clinical trial for cytokine storm at the treating institution..

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00466193: A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of the Zolpidem Tartrate Sublingual Tablet in Adult Subjects With Insomnia Characterized by Difficulty Returning to Sleep After Awakening in the Middle-of-the-Night (MOTN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Keywords: Insomnia
Lead sponsor: Transcept Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-04-27
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.


Eligibility criteria: Inclusion Criteria:

* Adults with history of sleeplessness

Exclusion Criteria:

* Allergic to investigational drug
* Any conditions and medications that may interfere with study drug evaluation

Primary outcomes:
measure: Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline
timeFrame: Weeks -1 to 0
measure: Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment
timeFrame: Weeks 1 to 4
Secondary outcomes:
measure: Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline
timeFrame: Weeks -1 to 0
measure: Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment
timeFrame: Weeks 1 to 4
measure: Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.
timeFrame: Weeks -1 to 0
measure: Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment
timeFrame: Weeks 1 to 4
measure: Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline
timeFrame: Weeks -1 to 0
measure: Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment
timeFrame: Weeks 1 to 4
measure: Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline
timeFrame: Weeks -1 to 0
measure: Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment
timeFrame: Weeks 1 to 4
Other outcomes:
Locations:
city: Durham
country: United States
facility: Transcept Investigational Site
state: North Carolina
Study officials:
affiliation: Clinical Neurophysiology Training Program, Duke University
name: Andrew Krystal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sleep Disorders and Research Center, Henry Ford Hospital
name: Thomas Roth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03410511: Propylene Glycol/Glycerol Intake and Cardiorespiratory Function
Official title: Reversibility of Propylene Glycol/Glycerol Intake Effects on Cardiorespiratory Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Injury
Lead sponsor: Université Libre de Bruxelles
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Propylene glycol/Glycerol intake is increasingly popular. The propylene glycol/glycerol intake effects on cardiorespiratory function are unknown.

Detailed description: Background. Propylene glycol/Glycerol intake is increasingly popular. The propylene glycol/glycerol intake effects on cardiorespiratory function are unknown. Weaning of propylene glycol/glycerol could allows a quick clearance of propylene glycol/glycerol from the body, with subsequent recovery of cardiorespiratory function.

Specific aim of the research. This research proposal tests the following hypothesis regarding the reversibility of propylene glycol/glycerol and nicotine intake:

* Propylene glycol/glycerol cessation restores cardiorespiratory function.
* Chronic propylene glycol/glycerol and propylene glycol/glycerol/nicotine intake induces specific serum and urine proteomics profile, which are partially reversed after cessation.
* Chronic propylene glycol/glycerol and propylene glycol/glycerol/nicotine intake induces specific serum and urine metabolomics profile, which are partially reversed after cessation.

Eligibility criteria: Inclusion Criteria:

* Subject must be regular propylene glycol/glycerol/nicotine intake users since at least 1 year
* Subject must be former smokers

Exclusion Criteria:

* Chronic or acute illness
* Substance abuse
* Chronic medication intake

Primary outcomes:
measure: Change in cardiorespiratory function
timeFrame: 4 hours
Secondary outcomes:
measure: Change in serum and urine proteomics profiles
timeFrame: 1 hour
Other outcomes:
measure: Change in serum and exhaled breath condensate metabolomics profiles
timeFrame: 1 hour
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
state: Anderlecht
Study officials:
affiliation: Université Libre de Bruxelles
name: Philippe van de Borne, MD, PhD
role: STUDY_DIRECTOR
References: