louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03169686: 'WeChat WeQuit' Smoking Cessation Program
Official title: The Efficacy of WeChat Based Interventions ('WeChat WeQuit' Program) for Smoking Cessation in China: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Smoking Cessation
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This proposed project is to assess whether WeChat-based smoking cessation interventions ('WeChat WeQuit' program) will be effective at helping people in China who smoke, to quit.


Eligibility criteria: Inclusion Criteria:

1. Daily Chinese cigarette smokers.
2. 18 years of age and older living.
3. Being able to read and write in Chinese.
4. Owning a smartphone and knowing how to use WeChat.
5. Willing to make an attempt to quit smoking in the next month.
6. Willing to provide informed consent to participate in the study.

Exclusion Criteria:

1. Nonsmokers.
2. Smokers without attempt to quit.
3. Below 18 years old.
4. Unable to use smartphone and WeChat.
5. Unable to read and write in Chinese.

Primary outcomes:
measure: Biochemically Validated Continuously Abstinence
timeFrame: 26 weeks
Secondary outcomes:
measure: Self-reported 7-day Point Abstinence
timeFrame: 26 weeks
measure: Self-reported Continuous Abstinence
timeFrame: 26 weeks
Other outcomes:
measure: Smoking Reduction and Participation
timeFrame: 26 weeks
Locations:
city: Hanzhou
country: China
facility: Yanhui Liao
state: Zhejiang
Study officials:
References:
Clinical trial NCT05828186: CRUSTAL Study in China
Official title: Calcification Remodeling Utilizing Shockwave LiThotripsy in Coronary Artery CaLcification (Guangxi Real-World Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Calcification
Lead sponsor: First Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 200
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: All patients with coronary artery calcification who are planned to undergo percutaneous coronary intervention (PCI) and are deemed suitable to receive Shockwave IVL catheter treatment by their physicians.

Brief summary: This is a prospective, multicenter, single-arm registry study, aimed to evaluate the clinical outcomes of using Shockwave IVL catheter in the treatment of coronary artery calcification in real-world clinical practice.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years.
* Patients with coronary artery calcification who are planned to undergo PCI and are deemed in need of Shockwave IVL catheter treatment by their physicians.
* The subject or their legal representative agrees to sign the informed consent form.

Exclusion Criteria:

* The physician evaluates that the subject's expected lifespan is \<1 year.
* The subject did not receive IVL treatment in the index procedure.
* The subject is pregnant or lactating.
* The subject is currently participating in another clinical study.

Primary outcomes:
measure: Procedure success
timeFrame: in 48 hours post-procedure or prior to discharge, whichever comes first
measure: Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure
timeFrame: 30 days post index procedure
Secondary outcomes:
measure: Vascular complications in the proudure
timeFrame: Immediately post index procedure
measure: Incidence of target lesion revascularization
timeFrame: 30 days post index procedure
measure: Incidence of target lesion revascularization
timeFrame: 6 months post index procedure
measure: 30 days post index procedure
timeFrame: 9 months post index procedure
measure: Incidence of target lesion revascularization
timeFrame: 12 months post index procedure
Other outcomes:
Locations:
city: Liuzhou
country: China
facility: liuzhou People's Hospital
state: Guangxi
city: Yulin
country: China
facility: Yulin First People's Hospital
state: Guangxi
city: Nanjing
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guanxi
city: Guilin
country: China
facility: Guilin People's Hospital
city: Guiping
country: China
facility: Guiping People's Hospital
city: Liuzhou
country: China
facility: Liuzhou labors' Hospital
Study officials:
References:
Clinical trial NCT03759886: Oral Antibiotic Prophylaxis in Colorectal Surgery
Official title: Mechanical Bowel Preparation and Oral Antibiotic Prophylaxis vs. Mechanical Bowel Preparation in Colorectal Surgery With i.v. Antibiotic Prophylaxis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Site Infection
Anastomotic Leak
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Patients wich receive elective colorectal surgery.

Brief summary: The investigators perform a case-control study to compare preparation before elective colorectal surgery. The first group is a prospective patient - registry in all patients with mechanical bowel preparation (MBP) and oral antibiotic prophylaxis the day before colorectal surgery. The second group is a historic collective of patients with MBP only and colorectal surgery. The cases were matches in American Society of Anesthesiologists (ASA) physical status classification system, BMI, operative procedure and risk factors.


Eligibility criteria: Inclusion Criteria:

* all colorectal resections

Exclusion Criteria:

* allergy

Primary outcomes:
measure: Surgical Site Infections
timeFrame: 30 days (exact 30 days after the Operation date)
Secondary outcomes:
measure: Anastomotic Leak
timeFrame: 30 days (exact 30 days after the Operation date)
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig - AöR
state: Sachsen
Study officials:
affiliation: University of Leipzig
name: Boris Jansen-Winkeln, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehdorn M, Lubbert C, Chaberny IF, Gockel I, Jansen-Winkeln B. Mechanical plus oral bowel preparation with paromomycin and metronidazole reduces infectious complications in elective colorectal surgery: a matched case-control study. Int J Colorectal Dis. 2021 Sep;36(9):1839-1849. doi: 10.1007/s00384-021-03931-9. Epub 2021 Apr 25.
Clinical trial NCT01947686: Survivorship and Outcomes of Robotically Assisted Patellofemoral UKA
Official title: Survivorship and Outcomes of Robotically Assisted Patellofemoral UKA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patellofemoral Knee Arthroplasty
Keywords: osteoarthritis, patellofemoral
Lead sponsor: St. Helena Hospital Coon Joint Replacement Institute
Sponsor class: OTHER
Collaborators: name: Rebound Orthopedics and Neurosurgery
First posted: 2013-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent a primary robotically guided UKA and received an isolated patellofemoral implant.

Brief summary: The purpose of the study is to determine the survivorship rate of robotically guided isolated patellofemoral implants at 2, 5 and 10 year postoperative.

Detailed description: The purpose of the study is to determine the survivorship rate of robotically guided isolated patellofemoral implants at 2, 5 and 10 year postoperative.

Eligibility criteria: Inclusion Criteria:

* Over 21 years of age underwent primary robotically guided UKA and received an isolated patellofemoral implant at least 24 months post operative as of February 2013

Exclusion Criteria:

* Patient will be excluded from participation in the study if they are cognitively unable to answer study questions.

Primary outcomes:
measure: 10 year survivorship of robotically guided isolated patellofemoral implants.
timeFrame: 10 years after surgery
Secondary outcomes:
measure: 2 year survivorship of robotically guided isolated patellofemoral implants.
timeFrame: 2 years after surgery
measure: 5 year survivorship of robotically guided isolated patellofemoral implants.
timeFrame: 5 years after surgery
Other outcomes:
Locations:
city: Saint Helena
country: United States
facility: St. Helena Hospital Coon Joint Replacement Institute
state: California
city: Vancouver
country: United States
facility: Rebound Orthopedics and Neurosurgery
state: Washington
Study officials:
affiliation: St. Helena Hospital Coon Joint Replacement
name: Thomas Coon, MD
role: STUDY_DIRECTOR
affiliation: Rebound Orthopedics and Neurosurgery
name: Todd Borus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04030286: Evaluation of Malondialdehyde in Periodontal and Cardiovascular Disease
Official title: Analysis of Serum and Salivary Malondialdehyde and Lipid Profile Levels in Patients With Periodontal and Cardiovascular Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Disease
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 133
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 32 healthy subjects, 34 patients with CP, 33 patients with CHD and 34 patients with CP and CHD. Lipid profile and levels of MDA and C-reactive protein (CRP) were evaluated.

Brief summary: Malondialdehyde (MDA) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and coronary heart disease (CHD). The investigators compared the impact of gingival health, periodontitis (CP), CHD or of both diseases (CP+CHD) on saliva and serum MDA levels.

Detailed description: The aim of this study was to evaluate a possible association between both saliva and serum MDA levels in patients with CP and with CHD and if the serum MDA levels are mediated by serum CRP

Eligibility criteria: Inclusion Criteria:

* Presence of at least twenty teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Primary outcomes:
measure: Malondialdehyde levels
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
References:
Clinical trial NCT05098886: Phamacokinetics and Safety Profiles of DA-5210 10/1000mg in Healthy Subjects at Fed State
Official title: An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of DA-5210 10/1000mg in Healthy Subjects at Fed State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-28
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Phamacokinetics and safety profiles of DA-5210 10/1000mg in Healthy subjects at Fed State


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers
* BMI between 18 and 30 kg/m2
* Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria:

* Allergy or Drug hypersensitivity
* Clinically significant Medical History

Primary outcomes:
measure: AUCt
timeFrame: pre-dose~48 hours post-dose
measure: Cmax
timeFrame: pre-dose~48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
Study officials:
References:
Clinical trial NCT03835286: Vitamin C to Reduce Vasopressor Dose in Septic Shock
Official title: Vitamin C to Reduce Exogenous Vasopressor Dose in Septic Shock; a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Septic Shock
Sepsis
Keywords: critical care
vitamin C
vasopressor
intensive care unit
Lead sponsor: Hospital Español de Mexico
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 0
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: Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of the Hospital Español de México with a diagnosis of septic shock will be included.

Patients will be randomized to one of the study groups:

Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution every 24 hours, in continuous infusion for 72 hours.

Placebo Group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72 hours.

Detailed description: Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of the Hospital Español de México with a diagnosis of septic shock will be included.

Patients will be randomized to one of the study groups:

Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution every 24 hours, in continuous infusion for 72 hours.

Placebo Group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72 hours.

Bottles will be identical, only identified by the sequential number of the patient that has been included.

Primary objective is to demonstrate that the administration of intravenous Vitamin C decreases the dose of exogenous vasopressors in patients with septic shock

Eligibility criteria: Inclusion Criteria:

* Adults
* Septic Shock

Exclusion Criteria:

* Previous treatment exceeded 24 hours
* Refusal to participate
* Do Not Resuscitate
* Participation in another trial

Primary outcomes:
measure: Vasopressor dose
timeFrame: 72 hours
Secondary outcomes:
measure: Hours of vasopressor use
timeFrame: through study completion, an average of 30 days
measure: Days of mechanical ventilation
timeFrame: through study completion, an average of 30 days
measure: Days of Intensive Care Unit stay
timeFrame: through study completion, an average of 30 days
measure: Mortality in Intensive Care Unit
timeFrame: through study completion, an average of 30 days
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Español
Study officials:
affiliation: Hospital Español de Mexico
name: Ricardo Martinez-Zubieta, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01428986: Safety Study of Maraviroc's Effect on Human Osteoclasts
Official title: Safety Study of Maraviroc's Effect on Human Osteoclasts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
AIDS
Keywords: maraviroc
osteoclasts
Receptors, CCR5
Chemokine CCL5
Lead sponsor: National Center for Global Health and Medicine, Japan
Sponsor class: OTHER_GOV
First posted: 2011-09-05
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment group: primary care clinic, Non-treatment group: primary care clinic and community sample

Brief summary: This study is to investigate the safety of maraviroc by examining whether there is bone metabolism dysfunction in actual use of maraviroc in human body, or not, measuring bone mineral density and markers for bone formation, desorption and chemokine.

Detailed description: An observational study to investigate the safety of maraviroc by examining whether there is bone metabolism dysfunction in actual use of maraviroc in human body, or not, measuring bone mineral density and markers for bone formation, desorption and chemokine.

Eligibility criteria: Inclusion Criteria: Outpatients or inpatients that are treated for HIV infection at AIDS Clinical Center of National Center for Global Health and Medicine who meet all criteria following:

* Those whose primary care physician acknowledged the necessity of maraviroc treatment due to multi-resistance HIV strain that is confirmed to have CCR5 tropism.
* Those who are willing and able to consent to this study
* 20 years old or older

Exclusion Criteria: Cases applicable to ANY condition of the following:

* Those who are not suited for maraviroc (whose HIV strain to be CXCR4 tropism)
* Others who the principle investigator physician considered to be excluded

Primary outcomes:
measure: Evaluation of maraviroc's effect to bone metabolism and bone mineral density
timeFrame: 78 weeks
Secondary outcomes:
measure: Duration of the treatment efficacy
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Shinjuku
country: Japan
facility: National Center for Global Health and Medicine
state: Tokyo
Study officials:
affiliation: Vice Director-General of Research Institute
name: Kenji Yamamoto, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04257786: Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) in Epithelial Ovarian Cancer
Official title: Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) Followed by Surgery in Patients With Advanced Primary Epithelial Ovarian Cancer: A Pilot Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of efficacy of primary cyto-reductive surgery in patients with advanced primary epithelial ovarian cancer in Comparison to patients receiving neo-adjuvant chemotherapy (NAC) followed by surgery in complete excision of the tumor reaching R0 without significant morbidity.


Eligibility criteria: Inclusion Criteria:

Female patients diagnosed with epithelial ovarian cancer (By histopathology)

Age ≥ 18 years old

Advanced defined as (stage 2D or more ) by surgical staging.

Performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) ≤ 2

Chemotherapy naïve

Informed consent

Exclusion Criteria:

Patients previously received chemotherapy or radiotherapy to any part of the abdomen or pelvis.

Patients with uncontrolled infection.

Patients with active bleeding or conditions associated with high risk of bleeding.

contraindications for surgery

contraindications To chemotherapy - bevacizumab

Primary outcomes:
measure: Percentage of patient where complete resection of the tumor can be achieved
timeFrame: 3 month postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ali hussien Ali sayed
Study officials:
References:
Clinical trial NCT06487286: Levels of Visfatin/NAMPT in Human Milk
Official title: Levels of Visfatin/NAMPT in Human Milk.VISFAMILK
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Visfatin Levels in Maternal Milk Samples
Birth Weight
Keywords: Newborns
Visfatin
Breastfeeding
Lead sponsor: Paolo Manzoni
Sponsor class: OTHER
Collaborators: name: Università degli Studi del Piemonte Orientale Amedeo Avogadro
First posted: 2024-07-05
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 women, hospitalized after childbirth, with respective healthy, breastfed infants

Brief summary: Visfatin, released in maternal milk at different concentrations related to the maternal conditions, could act as a biomarker with a prognostic/predictive value to determine different newborn clinical conditions, particularly the weight loss of the neonate.

Detailed description: The aim of the study is to analyse a retrospective cohort of well characterized mothers in their post-partum period, and to measure Visfatin levels through collection of maternal milk samples. They will be collected in three different moments after the birth (48 hours, 7 days and 30 days) and Visfatin levels will be analysed through an ELISA kit Adipogen. In parallel, the levels of Visfatin will be evaluated in the maternal plasma/serum collected after 1-2 days postpartum.

Lastly, correlations between Visfatin levels and biological/clinical features of mothers and newborns will be explored.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female infants born after 37 weeks' gestation who do not have conditions related to congenital abnormalities
* Maternal hospitalization
* Acquisition of the informed consent form signed by the patient

Exclusion Criteria:

* Refusal of the patient to participate in the study
* Presence of hypogalactia or agalactia in the patient

Primary outcomes:
measure: Visfatin levels
timeFrame: 48 hours, 7 days and 30 days
measure: Visfatin levels
timeFrame: 1-2 days post-partum
Secondary outcomes:
measure: values of Visfatin
timeFrame: 6 months
measure: values of Visfatin
timeFrame: 6 months
Other outcomes:
Locations:
city: Ponderano
country: Italy
facility: Ospedale degli Infermi - ASL BI
state: BI
Study officials:
References: