louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06112769: A Correlation Study of Internal Jugular Vein Variability Under Deep Inhalation and Propofol-induced Hypotension
Official title: A Correlation Study of Internal Jugular Vein Variability Under Deep Inhalation and Propofol-induced Hypotension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamic
Keywords: Internal jugular vein
propofol
hypotension
hemodynamic
Lead sponsor: Affiliated Hospital of Jiaxing University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing intravenous general anesthesia surgery at Jiaxing First Hospital

Brief summary: The correlation between internal jugular vein variability during deep inhalation and the decrease in blood pressure during propofol induction.

Detailed description: 1. Ultrasound records at least one quiet breathing cycle and one deep inhalation cycle to calculate IJVV
2. Propofol was infused target-controlled at 4 μg/ml, and changes in arterial blood pressure within 3 minutes of propofol induction were observed.
3. Aim to conduct a prospective observational study to evaluate the correlation between internal jugular vein variability during deep inhalation and the decrease in blood pressure during propofol induction.

Eligibility criteria: Inclusion Criteria:

* age over 60 years
* American Society of Anesthesiology (ASA) status Ⅱ-Ⅲ
* Surgery with radial artery puncture
* Propofol induction

Exclusion Criteria:

* BMI≥30kg/m2
* People with short necks;
* Previous hypotension (systolic blood pressure \<90mmHg or mean arterial pressure \<65mmHg)
* Previous poorly controlled hypertension
* Cardiac insufficiency , EF value\<50%
* Upper limb deep vein thrombosis
* History of radiotherapy or neck surgery
* Inability to maintain a supine position for necessary measurements
* Mechanical ventilation status or inability to take deep breaths patients
* gastrointestinal surgery
* patients allergic to propofol.

Primary outcomes:
measure: IJVV during deep inhalation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jiaxing
country: China
facility: Affiliated Hospital of Jiaxing University
state: Zhejiang
Study officials:
affiliation: Affiliated Hospital of Jiaxing University
name: Qinghe Zhou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01138969: Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer
Official title: Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer and Gastrointestinal Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peptic Ulcer
Keywords: proton pump inhibitor
peptic ulcer
clopidogrel
prevention
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2010-06-08
Enrollment: 165
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Proton Pump Inhibitors (PPI) can prevent the recurrence of peptic ulcer in clopidogrel users.

Detailed description: The aim of the prospective, randomized study is to investigate the efficacy of PPI in prevention of ulcer recurrence for clopidogrel users. We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months. The ulcer recurrence rate between the treatment groups will be compared.

Eligibility criteria: Inclusion Criteria:

* We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months.

Exclusion Criteria:

* 1.serious disease 2.refuse informed consent

Primary outcomes:
measure: Recurrent Peptic Ulcer
timeFrame: 6 months
Secondary outcomes:
measure: Peptic Ulcer Bleeding
timeFrame: 6 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Kwok-Hung Lai, MD
role: STUDY_CHAIR
References:
citation: Hsu PI, Lai KH, Liu CP. Esomeprazole with clopidogrel reduces peptic ulcer recurrence, compared with clopidogrel alone, in patients with atherosclerosis. Gastroenterology. 2011 Mar;140(3):791-8. doi: 10.1053/j.gastro.2010.11.056. Epub 2010 Dec 7.
Clinical trial NCT00092469: Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED)
Official title: A Registration Study of the Safety, Tolerability, and Immunogenicity of V441 in Healthy Infants in Taiwan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 151
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and immune response of an investigational vaccine being evaluated to reduce the incidence of diphtheria, pertussis, tetanus, hepatitis B, poliomyelitis, and Haemophilus influenza type b.

Detailed description: The duration of treatment is 65 weeks.

Eligibility criteria: Inclusion Criteria:

* Healthy infant who received Hepatitis B vaccine within 5 days of birth and whose mother is negative to Hepatitis B surface antigen

Exclusion Criteria:

* Problems with immune system
* Recent illness with fever

Primary outcomes:
measure: Tolerability and immune responses adequate to be protective against diphtheria, tetanus, pertussis, polio, Haemophilus Influenzae Type B, and Hepatitis B.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06523569: Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy
Official title: Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension in Pregnancy
Pre-Eclampsia
Eclampsia
Gestational Hypertension
Keywords: digital health
echocardiogram
blood pressure
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Friends of Prentice
name: Senior Faculty Academy
First posted: 2024-07-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to study digital health interventions to prevent cardiovascular disease in individuals who have had a hypertensive disorder of pregnancy (HDP).

Detailed description: The purpose of this research is to test the effect of two digital health interventions on cardiovascular health and subclinical cardiac dysfunction in postpartum individuals after pregnancies complicated by new-onset hypertensive disorder of pregnancy (HDP). All participants will undergo echocardiography and have their blood pressure/weight captured at 3 months and 12 months postpartum. If randomized to the intervention arm, the participant will be given a subscription to a mobile health application and a digital blood pressure monitoring system, and asked to utilize these at home during the one year of the study along with usual care. If randomized to the control arm, the participant will receive care as usual.

Eligibility criteria: Inclusion Criteria:

* Delivery at Northwestern Memorial Hospital (Prentice Women's Hospital)
* Live birth at any gestational age
* Pregnancy complicated by new-onset HDP (pre-eclampsia, eclampsia, or gestational hypertension)

Exclusion Criteria:

* HELLP syndrome
* History of chronic diseases pre-pregnancy (hypertension, diabetes, cardiovascular disease, chronic renal disease)
* Current Omron remote patient monitoring or Noom user
* BMI\<18.5 kg/m2 at enrollment
* Inadequate gestational weight gain or gestational weight loss

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 3 months postpartum; 12 months postpartum
Secondary outcomes:
measure: Weight
timeFrame: 3 months postpartum; 12 months postpartum
measure: Subclinical cardiovascular dysfunction via echocardiography
timeFrame: 3 months postpartum; 12 months postpartum
measure: Study feasibility
timeFrame: 12 months postpartum
measure: Participant engagement
timeFrame: 12 months postpartum
measure: Anti-hypertensive medication use (%)
timeFrame: 3 months postpartum; 12 months postpartum
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University, Dept. of Cardiology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Priya M Freaney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00076869: MK0991 in Combination With Standard Antifungal Agent(s) for the Treatment of Salvage Invasive Aspergillosis (0991-037)
Official title: A Multicenter, Open, Noncomparative Study to Estimate the Safety, Tolerability, and Efficacy of MK0991 in Combination With Amphotericin B, Lipid Formulations of Amphotericin B, or Azoles in the Treatment of Invasive Aspergillus Infection in Adults Who Are Refractory to or Intolerant of Standard Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aspergillosis
Keywords: Definite or probable Invasive Aspergillosis either refractory or intolerant to prior antifungal treatment.
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-02-06
Enrollment: 55
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Invasive aspergillosis is a type of fungal infection typically identified in very sick patients (for example, patients with cancer or who have had a bone marrow or organ transplant). This study will seek to enroll patients (16 years of age or older) with invasive aspergillosis infections (involving organs or deep tissues) who are failing or could not tolerate standard antifungal therapy. Your doctor will make this determination based upon specific study criteria. Patients that fulfill all study criteria will be treated daily with both the investigational drug and another antifungal agent. The choice of the other agent is up to your doctor. This investigational drug is approved for the treatment of invasive aspergillosis by itself. The safety and efficacy of this investigational drug, in combination with other agents is not known.

Detailed description: The duration of treatment is 12 months.

Eligibility criteria: * Patients must meet a specific definition of probable or definite invasive aspergillosis and be considered to have failed or be intolerant of standard antifungal therapy.
* The patient must be at least 16 years old and if a woman of childbearing potential, must have a negative serum or urine pregnancy test sensitive to 25 IU hCG prior to enrollment.

Primary outcomes:
measure: Tolerability.
Secondary outcomes:
measure: Clinical response
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Maertens J, Glasmacher A, Herbrecht R, Thiebaut A, Cordonnier C, Segal BH, Killar J, Taylor A, Kartsonis N, Patterson TF, Aoun M, Caillot D, Sable C; Caspofungin Combination Therapy Study Group. Multicenter, noncomparative study of caspofungin in combination with other antifungals as salvage therapy in adults with invasive aspergillosis. Cancer. 2006 Dec 15;107(12):2888-97. doi: 10.1002/cncr.22348.
Clinical trial NCT02972268: Clinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH
Official title: Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-11-23
Enrollment: 780
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy with Tamsulosin Monotherapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia


Eligibility criteria: Inclusion Criteria:

* Over 45 years
* Benign Prostate Hyperplasia diagnosed by 20 mL \< TRUS
* Lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form

Exclusion Criteria:

* Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 3 years
* Subjects who have acute urinary retention within 12 weeks before screening
* Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 24 weeks before screening
* Subjects who have hypersensitivity to investigational product
* Subjects who were suspected or confirmed neurogenic bladder, bladder neck structure, bladder diverticulum
* Subjects who have myasthenia gravis, narrow angle glaucoma
* Subjects who have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* SBP \> 180 mmHg or DBP \> 100 mmHg
* HbA1c \> 9.0 %
* Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.

Primary outcomes:
measure: change of TUFS
timeFrame: 12 weeks from baseline
measure: change of total IPSS
timeFrame: 12 weeks from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Myung Soo Choo, MD., Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT00425568: Transdermal Testosterone Gel/Effect on Erection Quality as Measured by DIR
Official title: Phase I Study of Transdermal Testosterone Gel and Its Effect on Erection Quality as Measured by a Digital Inflection Rigidometer (DIR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypogonadism
Keywords: hypogonadism
low testosterone level
gonadal deficiency
Lead sponsor: Lamm, Steven, M.D.
Sponsor class: INDIV
Collaborators: name: Solvay Pharmaceuticals
First posted: 2007-01-23
Enrollment: 30
Sex: MALE
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Low testosterone may be responsible for "soft" erections in men. The purpose of our study is to see whether the daily application of a testosterone gel to raise testosterone levels will also increase the "hardness" of a man's erection.


Eligibility criteria: Inclusion Criteria:

* Testosterone \<350 ng/dL,
* 21-59 years of age,
* BMI \<30

Exclusion Criteria:

* Those with carcinoma of the breast or known or suspected carcinoma of the prostate or with known hypersensitivity to any of the ingredients in AndroGel.
* Men will be excluded if they have unstable angina, hypertension, diabetes, heart failure, or coronary artery disease.
* Men will agree to discontinue use of current testosterone replacement, as well as Viagra or any other PDE5 inhibitors for 30 days.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Steven Lamm, M.D.
state: New York
Study officials:
name: Steven Lamm, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01143168: Stem Cell Therapy for Type 1 Diabetes Mellitus
Official title: A Pilot Study on Transplantation Therapy Using Autologous Bone Marrow Mononuclear Cells and Umbilical Cord Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Keywords: stem cells;
diabetes mellitus;
treatment.
Lead sponsor: Cellonis Biotechnology Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2010-06-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with type 1 diabetes mellitus

Detailed description: To evaluate the feasibility, safety and efficacy of transplantation using autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells in patients with type 1 diabetes mellitus.

Eligibility criteria: Inclusion Criteria:

1. Free will taking part in the study and ability to provide written informed consent.
2. Confirmed diagnosis of type I diabetes for at least 2 years
3. Insulin-dependent.
4. Age 18-50 years, Male/Female.
5. FBG≥7.0 mmol/L, and HbAc1≥7％.
6. Not pregnant or nursing.
7. Negative pregnancy test.
8. Fertile patients will use effective contraception.

Exclusion Criteria:

1. Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
2. Severe concurrent medical condition (e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
3. Active infection requiring treatment.
4. Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.

Primary outcomes:
measure: Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels.
timeFrame: 1 year
Secondary outcomes:
measure: Serious adverse event frequency and severity
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Armed Police General Hospital, P. R. China
Study officials:
affiliation: Armed Police General Hospital, P. R. China
name: Shi X Y, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00861068: A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Pilot Trial to Assess the Efficacy, Safety, and Tolerability of SPM 927 in Subjects With Postherpetic Neuralgia (PHN).
Official title: A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Pilot Trial to Assess the Efficacy, Safety, and Tolerability of SPM 927 in Subjects With Postherpetic Neuralgia (PHN).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Keywords: Lacosamide, Vimpat®
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2009-03-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the trial is to investigate the analgesic efficacy of SPM 927 in subjects with moderate to severe neuropathic pain due to Postherpetic Neuralgia (PHN)


Eligibility criteria: Inclusion Criteria:

* Subject has clinically diagnosed painful postherpetic neuralgia present at least six months after healing of a herpes zoster skin rash and has at least one form of allodynia
* Subject must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).

Exclusion Criteria:

* Subject has other conditions that cause pain at least as severe as the postherpetic neuralgia.
* Subject has had any surgical treatment or any neurolytic injections for PHN
* Subject has clinically significant ECG and laboratory abnormalities.
* Subject is receiving treatment with anti-epileptic drugs (AEDs), muscle relaxants, mexiletine, topical analgesics, antidepressants, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, benzodiazepines, and antiviral agents.
* Subject has liver function tests (AST, ALT, alkaline phosphatase, total bilirubin and GGT out of the reference range) \> 1,5 x ULN (upper limit of normal) at visit 1
* Subject has serum creatinine ≥ 2 times the upper limit of reference range at Visit 1.

Primary outcomes:
measure: Within-subject change in average daily pain score (Likert categorical scale) from the baseline week to the maintenance phase
timeFrame: Daily Assessments via patient diary and during patient's visit at the site
Secondary outcomes:
measure: Different qualities of pain due to PHN, sleep and activity (daily assessment during entire trial participation)
timeFrame: Daily assessment during entire trial participation including visits at the site
measure: Investigate the tolerability and safety of SPM927 (assessments and reporting during entire trial participation).
timeFrame: Daily assessment during entire trial participation including visits at the site
measure: To examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation)
timeFrame: Daily assessment during entire trial participation including visits at the site
Other outcomes:
Locations:
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: