louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04485988: Influence of Beta Blockers on Prognosis in Patients With Acute Myocardial Infarction Complicated With Normal Ejection Fraction
Official title: Influence of Beta Blockers on Prognosis in Patients With Acute Myocardial Infarction Complicated With Normal Ejection Fraction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: AMI
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The enrolled patients were from the First Affiliated Hospital of Chongqing Medical University, and the patient information was obtained from the medical record system

Brief summary: To understand the effect of beta blockers on the prognosis of patients with acute myocardial infarction with preserved ejection fraction.

Detailed description: The use of beta blockers is an important component of drug therapy for myocardial infarction, but in some exceptional cases, evidence-based evidence for their use is insufficient, and we seek to understand the prognostic impact of beta blockers on patients enrolled in long-term follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients with acute myocardial infarction

Exclusion Criteria:

* Previous history of heart failure admission Killip class \> I class cancer pregnant

Primary outcomes:
measure: Death
timeFrame: The median time of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: dongying zhang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02480088: Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery; Association With ABCB1 Polymorphism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Opioid-based intravenous patient-controlled analgesia (IV-PCA) offers excellent pain control, however, its use inevitably increases the incidence of postoperative nausea and vomiting (PONV). Ramosetron and palonosetron are commonly used 5-HT3 antagonists for the prevention and treatment of PONV. It is not clear which one has superior antiemetic efficacy for the prevention of PONV in patients using opioid-based IV-PCA. The antiemetic efficacy of 5HT3 antagonists may be influenced by polymorphism of ABCB1, a drug-transporter gene. This study evaluates relative antiemetic efficacy of ramosetron and palonosetron in patients using IV-PCA after spinal surgery and impact of ABCB1 polymorphism on the antiemetic efficacy of the ramosetron and palonosetron. The incidence and intensity of PONV during postoperative 48 h will be assessed. ABCB1 polymorphisms 3435C\>T and 2677G\>T/A will be evaluated in all patients.


Eligibility criteria: Inclusion Criteria:

* Patients aged 20-85 yr
* undergoing spine surgery

Exclusion Criteria:

* Taking steroids or opioids preoperatively
* GI motility disorder
* Uncontrolled diabetes
* Severe renal or hepatic disease
* Transfer to ICU postoperatively
* Obesity (BMI\>35 kg/m2)
* Use of antiemetic agent within 24 h preoperatively
* Pregnancy
* Psychiatric disease
* Drug or alcohol abuser
* Malignancy

Primary outcomes:
measure: number of postoperative nausea and vomiting incidence
timeFrame: during postoperative 48h
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia
Study officials:
References:
Clinical trial NCT00624988: The Effect of Vibration Therapy on the Bone Density of the Tiba in Patients With Spinal Cord Injury
Official title: The Effect of Vibration Therapy on the Bone Density of the Tiba in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injury
Keywords: Spinal cord injury
vibration therapy
bone density
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2008-02-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this investigation is to determine the effect of lower limb vibration therapy on bone density in the tibia in patients with spinal cord injury. The second purpose is to assess the neuromuscular junction variability at the motor units of the tibialis anterior muscle after a sequence of lower limb vibration therapy


Eligibility criteria: Inclusion Criteria:

* Over the age of 18 years
* A spinal cord injury patient with injury above T12
* Injury below T4 to avoid respiratory complication.
* An ASIA classification of A or B

Exclusion Criteria:

* Non complicating organic factors such as heart disease, high blood pressure, stroke
* Exercise where electrical therapy is used while the trial is being conducted
* A bone density measure 3 times below normal mineralization levels as measured on the first bone density scan prior to entry in to the study
* Surgical implants below the level of T12
* Local infection, acute inflammation, injury, tumors or other malignancy, recent wounds, diabetes
* Any unstable joints of the lower extremity, recent hip and knee joints or fitted hip or knee pins, bolts and/or plates
* Acute thrombosis
* Severe migraine, epilepsy
* Serious cardiovascular disease, wearing a pacemaker
* Any Spinal manipulation within one year of the study
* Any implanted device or prosthesis or intrauterine IUD type of device pregnancy

Primary outcomes:
measure: Bone density scan
timeFrame: within 7 days pre/post intervention
Secondary outcomes:
measure: Single fiber EMG at neuromuscular junction
timeFrame: 7 days pre/post intervention
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College of Chiropractic
state: Missouri
city: Chesterfield
country: United States
facility: Logan College of Chiropractic
state: Missouri
Study officials:
affiliation: Logan College of Chiropractic
name: David V Lenihan, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05475288: Incidence, Risk Factor, Treatment and Overall Survival of Locoregionally Recurrent Colon Cancer
Official title: Incidence, Risk Factor, Treatment and Overall Survival of Locoregionally Recurrent Colon Cancer: a Retrospective, Population-based Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Neoplasms
Neoplasm Recurrence, Local
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 3554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with stage I-III primary colon cancer in the first half of 2015.

Brief summary: Data on disease recurrence was collected for all primary colon cancer patients diagnosed in the Netherlands over the first six months of 2015. Three-year cumulative incidence, risk factors, treatment and three-year OS of locoregionally recurrent colon cancer were determined.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed stage I-III primary colon carcinoma;
* Diagnosed between January 1st and June 30th of 2015;
* Surgical resection of primary colon carcinoma.

Exclusion Criteria:

* Appendiceal localization;
* Neuroendocrine tumor morphology;

Primary outcomes:
measure: Cumulative incidence of patients with locoregionally recurrent colon cancer in curatively treated primary colon cancer patients
timeFrame: Three years
measure: Risk factors for development of locoregionally recurrent colon cancer in primary colon cancer patients
timeFrame: Three years
measure: Proportions of treatment given to patients with locoregionally recurrent colon cancer
timeFrame: Three years
measure: Overall survival of patients with locoregionally recurrent colon cancer;
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Swartjes H, van Lankveld DWP, van Erning FN, Verheul HMW, de Wilt JHW, Koeter T, Vissers PAJ. Locoregionally Recurrent Colon Cancer: How Far Have We Come? A Population-Based, Retrospective Cohort Study. Ann Surg Oncol. 2023 Mar;30(3):1726-1734. doi: 10.1245/s10434-022-12689-5. Epub 2022 Oct 19.
Clinical trial NCT03000088: Stylet Angle for McGrath Videolaryngoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients scheduled for elective surgery requiring orotracheal intubation in our hospital

Brief summary: The McGrath videolaryngoscope (VL) provides excellent laryngoscopic views, but directing an endotracheal tube is not easy, so routine using of stylet is recommended. The goal of this study is to determine the appropriate angle of stylet by comparing time to intubation (TTI).


Eligibility criteria: Inclusion Criteria:

* an American Society of Anesthesiologists physical status (ASA) 1 or 2

Exclusion Criteria:

* a suspected difficult airway (Mallampati score Ⅳ)
* known cervical spine injury
* required rapid sequence induction
* emergency operation

Primary outcomes:
measure: Time to Intubation
timeFrame: 10 minutes around intubation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
name: Jiyoung Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03222388: Electronic IIEF Validation
Official title: Electronic Validation of the International Index of Erectile Function Questionnaire (IIEF) 5 and 15.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Keywords: IIEF
electronic validation
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Société Internationale d'Urologie
First posted: 2017-07-19
Enrollment: 173
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be included at the outpatient clinic of the urology department at the Academic Medical Center in Amsterdam.

Brief summary: Questionnaires are used within urology to objectify disease burden and symptom changes during therapy. Recent technological improvements, as the smartphone and tablet, create new fill-out possibilities. However, questionnaires are only validated on paper. In order to use questionnaires for multiple platforms, electronic validation is needed. The International Prostate Symptom Score has already been validated on the smartphone. The International Index of Erectile Function (normal version of 15 questions and short version of 5 questions) is widely used within urology, however electronic validation is required for usage on electronic platforms in the future.


Eligibility criteria: Inclusion criteria:

* Male patients, ≥40 years of age, presenting at the outpatient clinic of Urology of the Academic Medical Center in Amsterdam.
* In possession of a smartphone, tablet or laptop/computer with internet connection.
* Access to email.
* Fluent speaking and reading the Dutch language.

Exclusion criteria:

* Change in treatment, especially erectile dysfunction at consultation which could impact the short term IIEF outcome during the cross-over time.
* Unable to provide informed consent.
* Unfit according to the medical doctor (for example cognitive problems, leading to inadequate follow-up of instructions).

Primary outcomes:
measure: Reliability
timeFrame: Per subject, thus 7 days.
Secondary outcomes:
measure: Preference for paper or electronic
timeFrame: Per subject, after 7 days.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: AMC University Hospital
state: Noord-Holland
Study officials:
References:
citation: van Kollenburg RAA, de Bruin DM, Wijkstra H. Validation of the Electronic Version of the International Index of Erectile Function (IIEF-5 and IIEF-15): A Crossover Study. J Med Internet Res. 2019 Jul 2;21(7):e13490. doi: 10.2196/13490.
Clinical trial NCT01956188: Omega 3 in LES and APS
Official title: Efficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Lupus Erythematosus
Primary Antiphospholipid Syndrome
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 22
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It has been demonstrated that EPA and DHA supplementation may have anti-inflammatory properties in several chronic diseases, namely, diabetes, obesity, and in rheumatoid arthritis, although not with controversy. Systemic lupus erythematosus (SLE) and Antiphospholipid Antibody Syndrome (AAS) are autoimmune diseases characterized by a chronic inflammatory state which is associated with the disease´s clinical symptoms. Thus, we hypothesized that EPA and DHA supplementation may beneficially affect the inflammatory cytokine profile and clinical features of LES and AAS patients.


Eligibility criteria: Inclusion Criteria:

• Age between 7 and 40 years

Exclusion Criteria:

* Cardiovascular dysfunction
* Rhythm and conduction disorders
* Musculoskeletal disturbances
* Kidney and pulmonary involvements
* Peripheral neuropathy
* Use of tobacco
* Treatment with lipid-lowering or hypoglycemic drugs
* Fibromyalgia
* Use of chronotropic or antihypertensive drugs
* Physically active subjects

Primary outcomes:
measure: Cytokine profile (serum levels of IL-1B, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-alpha, IFN-y)
timeFrame: 4 months
measure: Endothelial function
timeFrame: 4 months
Secondary outcomes:
measure: Clical features
timeFrame: 4 months
measure: Clinical features
timeFrame: 4 months
measure: Clinical features
timeFrame: 4 months
measure: Clinical features
timeFrame: 4 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: General Hospital - University of Sao Paulo
state: SP
Study officials:
References:
citation: Felau SM, Sales LP, Solis MY, Hayashi AP, Roschel H, Sa-Pinto AL, Andrade DCO, Katayama KY, Irigoyen MC, Consolim-Colombo F, Bonfa E, Gualano B, Benatti FB. Omega-3 Fatty Acid Supplementation Improves Endothelial Function in Primary Antiphospholipid Syndrome: A Small-Scale Randomized Double-Blind Placebo-Controlled Trial. Front Immunol. 2018 Mar 2;9:336. doi: 10.3389/fimmu.2018.00336. eCollection 2018.
Clinical trial NCT05500378: The Effects of a Specific Exercise Program on Subjects With Cervicogenic Headache
Official title: The Effects of a Specific Exercise Program on Subjects With Cervicogenic Headache
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervicogenic Headache
Keywords: Cervicogenic headache
MSK Ultrasound
Obliquus capitis minor
Rectus capitis major
Exercise
Lead sponsor: Florida Gulf Coast University
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group design
Primary purpose: TREATMENT

Brief summary: This study explores with the use of MSK Ultrasound imaging if the obliquus capitis minor and the rectus capitis major can be contracted with specific exercises.

Detailed description: This study explores if a subject with the neck in full maximal flexion is able to selective contract the the obliquus capitis minor and the rectus capitis major by head extension and rotation while maintaining the spine position. MSK Ultrasound imaging will be used to measure changes both in length and width.

Eligibility criteria: Inclusion Criteria:

* No history of surgery, No current neck pain, Being able to move the neck actively, being able to read English, between ages 18-65

Exclusion Criteria:

* Neck pain, History of surgery, unable to move the head into extension, outside age requirements, unable to read English

Primary outcomes:
measure: MSK US image
timeFrame: The change in muscle length and diameter will be measured during head movement
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Florida Gulf Coast University
state: Florida
Study officials:
affiliation: Florida Gulf Coast University
name: Rob Sillevis, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00104078: Study Evaluating MYO-029 in Adult Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Becker Muscular Dystrophy
Facioscapulohumeral Muscular Dystrophy
Limb-Girdle Muscular Dystrophy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-02-23
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this phase I/II, multicenter, safety trial is to study MYO-029 in adult patients with muscular dystrophy.


Eligibility criteria: Inclusion Criteria:

* Written informed consent.
* Confirmed clinical and molecular diagnosis of Becker Muscular Dystrophy (BMD), Facioscapulohumeral Muscular Dystrophy (FSHD), or Limb-Girdle Muscular Dystrophy (LGMD)
* Independently ambulatory

Exclusion Criteria:

* Patients with certain clinical conditions
* Patients using steroids or other medications with the potential to affect muscle function
* History of sensitivity to monoclonal antibodies or protein pharmaceuticals
* Pregnant or lactating women.

Primary outcomes:
measure: Safety assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
state: District of Columbia
city: Kansas City
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: Rochester
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04180878: Promoting Appropriate Weight Gain Pregnant Women
Official title: Promoting Appropriate Weight Gain Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Gestational weight gain
Physical activity
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2019-11-29
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to learn if engaging in group based phone counseling (GBPC) and an interactive physical activity monitoring system can help pregnant women gain an appropriate amount of weight during pregnancy.


Eligibility criteria: Inclusion Criteria:

* 12-16 weeks pregnant
* Pre-pregnancy BMI between 22 kg/m2 to 45 kg/m2

Exclusion Criteria:

* Diabetes
* Pre-eclampsia
* Hypertension
* Other metabolic abnormalities

Primary outcomes:
measure: Excessive gestational weight gain
timeFrame: During Pregnancy - 18-36 week gestational age
Secondary outcomes:
measure: Gestational weight gain
timeFrame: During Pregnancy - 18-36 week gestational age
measure: Infant fat mass
timeFrame: 1-4 days after birth
Other outcomes:
Locations:
Study officials:
affiliation: The University of Kansas Medical Center
name: Holly R Hull, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00219778: A Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas
Official title: A Placebo Controlled Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Leiomyoma
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 20
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The first indication of hysterectomies in France are uterine leiomyomas. When they are symptomatic leiomyomas are particularly responsables of an increase of menstruations duration and volume. Echography is the reference exam for the diagnosis. It exists two treatments ways:-firstly progestatives and antifibrinolytics for the treatment of hemorragic symptoms, -secondly LH-RH analogs for the treatment of leiomyomas volume and hemorragic symptoms but just used for a small period because of the risk of osteoporosis.

Different studies with different doses of mifepristone were released. The authors observe a decrease of leiomyomas volume. Based on this experience the present placebo controlled study has for objectives:-to confirm the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease and in symptoms of leiomyomas, - to assess the safety of the treatment. The aim is to avoid or delay the hysterectomy of non menopausal patients. During the study patients will be evaluated with biological exams, clinical exams, echographies, medical interrogations and their diary cards.


Eligibility criteria: Inclusion Criteria:

* patients who are willing and able to participate in the study
* patients from whom written informed consent has been obtained
* patients who contribute to the National Insurance Scheme
* patients with an age between 25 and 49 years old
* non menopausal patients
* patients who use a non hormonal contraception
* patients with one or several , interstitial or subserous, uterine leiomyomas
* echographic diameter of leiomyomas must be equal or higher than 30 mm
* leiomyomas must be symptomatic

Primary outcomes:
measure: To determine the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease of symptomatic uterine leiomymomas
Secondary outcomes:
measure: -To determine the efficacy of 10 mg oral mifepristone in symptoms of non menopausal patients with uterine leiomyomas
measure: -To determine the safety of oral mifepristone at the dose of 10 mg per day during 24 weeks
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Poitiers University Hospital
Study officials:
affiliation: Poitiers University Hospital
name: Guillaume Magnin, Professor
role: PRINCIPAL_INVESTIGATOR
References: