louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03478449: The Criteria for Lymph Node Sorting for Pathological Examination in Gastric Cancer
Official title: A Single Center Randomized Prospective Study on the Criteria for Lymph Node Sorting for Pathological Examination After Curative Surgery for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymph Node Metastases
Gastric Cancer
Exanimation
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is intending to provide the optimal procedures of lymph node sorting for pathological examination after curative surgery for gastric cancer, which can discriminate the differences of the status of lymph node metastasis, pTNM classification and prognostic outcome of gastric cancer patients.


Eligibility criteria: Inclusion Criteria:

* 1) Physical conditions compliance with the requirements for curative gastrectomy
* 2) Consent to undergo the D2 lymphadenectomy
* 3) Comply with the protocol during the whole study period
* 4) No neoadjuvant therapy administration
* 5) Sign informed consent and permission of withdraw in the whole study period
* 6) Consent to provide the tissue specimens after surgery for this study
* 7) Pathological examination confirmation the adenocarcinoma of stomach before surgery
* 8) Estimation the overall survival after surgery no less than 6 months
* 9) No anesthesia or operation contraindication disease
* 10) cTanyNanyM0 stage demonstration by CT and endoscopic ultrasonography examinations
* 11) Negative cytological detection in operation
* 12) No seriously concomitance's diseases
* 13) Karnofsky Performance Scores (KPS) more than 60

Exclusion Criteria:

* 1) Women during pregnant stage and breast-feed stage
* 2) Women of childbearing age without any contraceptive measures
* 3) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
* 4) Immunosuppressive therapists for organ transplantation
* 5) Seriously uncontrolled recurrent infection
* 6) other malignant tumors
* 7) No abilities of self-knowledge or mental disorders
* 8) Participating in other clinical trials
* 9) Siewert I and II esophagogastric junction tumors
* 10) Serious internal diseases obstruction surgery

Primary outcomes:
measure: Migration of pN stage in gastric cancer patients
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Cancer Hospital of Tianjin Medical University
Study officials:
References:
Clinical trial NCT01074749: Optimal Sensing in Atrial Tachyarrhythmia's Study
Official title: OSAT: Optimal Sensing in Atrial Tachyarrhythmia's Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sick Sinus Syndrome
Paroxysmal Atrial Fibrillation
Keywords: AF
Automatic Mode Switch
FFRW
paroxysmal AF
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-02-24
Enrollment: 111
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 aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal atrial fibrillation (AF) and atrial tachyarrhythmia (AT), and the rejection of far field sensing of the far field R-wave (FFRW).

Detailed description: The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal AF and AT and the rejection of far field sensing of the far field R-wave (FFRW). The study aims to evaluate the accuracy of the detection of atrial tachyarrhythmias (ATAs). An improved detection can potentially increase the accuracy of clinical treatment decisions, based on device derived data.

Eligibility criteria: Inclusion Criteria:

* Patients with class I or II pacing indications for Sick Sinus Syndrome with suspected paroxysmal atrial tachyarrhythmias over the last 6 months
* Signed informed consent
* Age \>18 yrs

Exclusion Criteria:

* Severe valvular heart disease (echocardiogram less than 6 months old)
* Angina Pectoris class ≥ III
* Congestive heart failure - NYHA class ≥ III
* Left Ventricular Ejection Fraction \< 35% (less than 6 months old)
* Hypertrophic Cardiomyopathy

Primary outcomes:
measure: Number of undersensing of paroxysmal AF and AT from Holter recording.
timeFrame: 1-3 months
Secondary outcomes:
measure: Number and duration of inappropriate mode switches due to FFRW sensing during sinus rhythm.
timeFrame: 1-3 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Lucas Andreas Ziekenhuis
Study officials:
affiliation: St Lucas Andreas Hospital Amsterdam, Netherlands
name: Willem De Voogt, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pakarinen S, Lehto M, Ruiter J, de Voogt WG. Enhanced detection of atrial tachyarrhythmias with pacing devices by using more accurate atrial sensing. J Interv Card Electrophysiol. 2022 Apr;63(3):601-609. doi: 10.1007/s10840-021-01066-z. Epub 2021 Oct 1.
Clinical trial NCT04160949: A Pilot Study to Explore the Role of Gut Flora in Fatty Liver
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Fatty Liver
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Fatty Liver
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Fatty Liver

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Fatty Liver.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Fatty Liver.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with mothers)
3. Diagnosis of fatty liver

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01788449: Study Evaluating the Association of Antibiotic Measures and Control of Bacterial Resistance
Official title: Association of Antibiotic Measures and Control of Bacterial Resistance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infections
Keywords: Antibiotic Bacterial Resistance
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2013-02-11
Enrollment: 335
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive Care Unit (ICU)

Brief summary: Assess efficacy of piperacillin/tazobactam in reducing the cases of colonization and infection of bacteria.

Detailed description: Primarily, this study is designed to assess the efficacy of piperacillin/tazobactam in reducing the cases of colonization and infection of extended-spectrum betalactamases (ESBLs) producing E.coli or K pneumoniae, S aureus methicillin resistant (MRSA) and Enterococcus vancomycin resistant (VRE). Secondly, this study plans to determine the acquisition rate of ESBL producing E Coli or K pneumoniae, methicillin resistant S Aureus (MRSA) and vancomycin resistant Enterococcus spp (VRE), both pre- and post-intervention.

Eligibility criteria: All patients admitted in ICU will be enrolled (who qualify for treatment).

Primary outcomes:
measure: Endpoints will be efficacy of piperacillin/tazobactam in reducing colonization rates and infection of E coli or K pneumoniae, vancomycin resistant enterococcus and methicillin resistant S aureus
timeFrame: 8 months
Secondary outcomes:
measure: Endpoints will be acquisition and infection rate of ESBL producing E coli or K pneumoniae, vancomycin resistant enterococcus and methicillin resistant S aureus
timeFrame: 8 months
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01791049: TD-1607 SAD Study in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1607, a Glycopeptide-Cephalosporin Heterodimer Gram-Positive Antibiotic, in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Serious Infections Due to Known or Suspected Gram-positive Pathogens
Keywords: Gram-positive
Infections
Bacterial infections
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2013-02-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: TD-1607, administered intravenously as single doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.


Eligibility criteria: Inclusion Criteria:

* Subject is a healthy nonsmoking male or a female of non-child bearing potential and 18 to 50 years old, inclusive, at Screening. Females are considered to be of non-childbearing potential if they have had a hysterectomy or tubal ligation or are postmenopausal (amenorrheic for at least 2 years) with a follicle-stimulating hormone (FSH) level \>20 IU/L.
* Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg

Exclusion Criteria:

* Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
* Subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin), penicillin, or cephalosporin antibiotics.
* Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives, whichever is longer) prior to Screening or is currently participating in another trial of an investigational drug (or medical device).

Primary outcomes:
measure: Safety and tolerability
timeFrame: 11 days
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 96 hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase 1
state: Texas
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04194749: Digital Media Based Physical Therapy Post Distal Radius Fracture
Official title: Physical Therapy After Distal Radius Fracture; Traditional Versus Digital Media Based Therapy Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 51
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: This trial aims to develop and test the efficacy of a digital media based physical therapy protocol on patients after surgical fixation and non-operative treatment of distal radius fractures.It is hypothesized that there will not be a difference in outcomes for patients after surgical fixation of distal radius fractures with traditional physical therapy and digital media based therapy


Eligibility criteria: Inclusion Criteria:

* Patients undergoing operative treatment for distal radius fractures.

Exclusion Criteria:

* Poly-trauma patients with significant previous diagnosis of dementia, previous traumatic brain injury, or other reason for significant altered mental status that would interfere with their participation in therapist directed or digital based therapy will be excluded.
* Patients who present to Oregon Health \& Science University for physical therapy who will be treated by a physician at another non Oregon Health \& Science University facility will be excluded.
* Patients who are not proficient in the English language will be excluded.

Primary outcomes:
measure: Abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH)
timeFrame: 12 weeks
Secondary outcomes:
measure: Abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH)
timeFrame: 6 weeks, 6 months
measure: Visual Analog Pain Scale
timeFrame: 6 weeks, 12 weeks, and 6 months
measure: Veterans RAND 12-item Health Survey (VR-12)
timeFrame: 6 weeks, 12 weeks, and 6 months
measure: Wrist Range of Motion
timeFrame: 6 weeks, 12 weeks, and 6 months
measure: Hand Grip Strength
timeFrame: 6 weeks, 12 weeks, and 6 months
measure: Wrist Circumference
timeFrame: 6 weeks, 12 weeks, and 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03401749: Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients
Official title: Efficacy of Preadmission Theraworx Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Surgical Site Infection
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intervention: This study will involve three different study arms with different interventions prior to surgery: (1) shower only, (2) shower plus Theraworx wipes, (3) shower plus chlorhexidine wipes

Study Design: Single center RCT

Sample Size: 500 patients, aged 18+

Objectives: Primary Objectives:

1. Monitor for safety and adverse effects.
2. Evaluate for differences in peri-operative skin cultures between treatment groups;
3. Compare surgical site infection rates between groups.

Secondary Objectives:

1. Assess for patient compliance for each different treatment arms.
2. Measure patient satisfaction.
3. Measure nurse satisfaction.
4. Visual assessment of wound healing

Expected Results: We expect no statistically significant difference in peri-operative cultures or surgical site infection rates between groups.


Eligibility criteria: Inclusion Criteria:

* Adult patient between ages 18-64
* Scheduled and deemed healthy enough to undergo orthopaedic surgery
* Willing and able to comply with protocol

Exclusion Criteria:

* Clinical signs of infection
* Contraindication to CHG or Theraworx
* Previous allergic reaction to CHG or Theraworx
* Surgeon's Discretion

Primary outcomes:
measure: Number of Participants That Developed a Surgical Site Infection
timeFrame: Within 1 year of Surgery
Secondary outcomes:
measure: Number of Patients Compliant With the Requirement of Their Study Group
timeFrame: Day before and day of surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Highlands Hospital
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: ashish shah, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03202849: A Randomized Trial of Vitamin D Supplementation With or Without Vitamin A in Stem Cell Transplantation
Official title: A Randomized Double Blinded Trial of Vitamin D Supplementation With or Without Vitamin A Supplementation in Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplant
Keywords: hematopoietic stem cell transplant
vitamin a
vitamin d
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 83
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that supplementation with vitamins A and D will reduce the incidence of acute gastrointestinal graft versus host disease (GI GVHD) compared with supplementation with vitamin D alone.

Detailed description: The investigators' preliminary data suggest that low levels of vitamin A directly impact risk of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) and they believe supplemental vitamin A at the time of hematopoietic stem cell transplantation (HSCT) can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). In addition, the investigators' preliminary data suggest that a significant number of patients requiring HSCT have vitamin D deficiency even prior to transplantation, and that persistent and newly developed deficiency post-HSCT resulted in worse outcomes.

This study is a comparison of vitamin D supplementation comparing a single large dose of vitamin D "stoss therapy" with a placebo in the standard care arm with supplementation with single large doses of both vitamins D and A in the experimental arm. Participants will be randomly assigned to either the standard care arm or the experimental arm.

Eligibility criteria: Inclusion Criteria:

* Scheduled for allogeneic stem cell transplant
* Vitamin D level \< 50 ng/ml
* Vitamin A level \< 75th centile for age
* Able to tolerate enteral vitamin dose administration

Exclusion Criteria:

* History of pathologic fractures
* Known history of nephrocalcinosis or nephrolithiasis
* Current granulomatous disease
* ALT \> 10X ULN for age prior to administration of vitamin A
* Ongoing raised intracranial pressure
* Pregnancy

Primary outcomes:
measure: GI GVHD
timeFrame: 100 days after transplant
Secondary outcomes:
measure: MBI-LCBI
timeFrame: 100 days after transplant
measure: Treatment Related Mortality
timeFrame: 100 days after transplant
measure: Overall Survival
timeFrame: 1 year after transplant
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Stella Davies, MBBS, PhD, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04651049: Systemic Propranolol for the Treatment of Paediatric Patients With Infantile Hemangiomas
Official title: Influence of Systemic Propranolol Treatment on the Physical Development of Paediatric Patients With Infantile Hemangiomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infantile Haemangiomas
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 128
Sex: ALL
Minimum age (years): 2
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overall, 52 males and 76 females, with a male-to-female ratio of 1:1.46, were included in this study. Of the 128 patients, 16 (12.5%) were born prematurely. The median age at the start of propranolol therapy was 3.75 months (0.5-12.5 months). Propranolol was administered for a median duration of 10.52 months (2-24 months).

Brief summary: This is retrospective study. The patients treated with oral propranolol at a dose of 2.0 mg/kg per day. Growth parameters (height and weight) were measured at the beginning, the end of treatment and 2 years after treatment. The weight-for-age Z-score (WAZ), height-for-age Z-score (HAZ) and weight-for-height Z-score (WHZ) calculated by the WHO Anthro software were used to assess physical development, and the WHO Child Growth Standards were used as the standards.


Eligibility criteria: Inclusion Criteria:

* IHs diagnosed by medical history and physical examination
* no previous treatment with other medications

Exclusion Criteria:

* a history or risk of asthma, reactive airway disease, impaired renal or liver function, heart defects or arrhythmia, hypotension and hypersensitivity to propranolol
* Infants who did not adhere to the treatments or attend follow-up visits
* Infants with other known risk factors for developmental delay or growth restriction, such as prematurity, small for gestational age, or other major congenital malformations, were also excluded
* No other treatment was used during the oral propranolol course

Primary outcomes:
measure: Change on the height of the patients
timeFrame: at the beginning of the treatment, at the end of treatment and 2 years after the treatment
measure: Change on the weight of the patients
timeFrame: at the beginning of the treatment, at the end of treatment and 2 years after the treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Shaohua Liu, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen ZY, Wang QN, Zhu YH, Zhou LY, Xu T, He ZY, Yang Y. Progress in the treatment of infantile hemangioma. Ann Transl Med. 2019 Nov;7(22):692. doi: 10.21037/atm.2019.10.47.
citation: Hoeger PH, Harper JI, Baselga E, Bonnet D, Boon LM, Ciofi Degli Atti M, El Hachem M, Oranje AP, Rubin AT, Weibel L, Leaute-Labreze C. Treatment of infantile haemangiomas: recommendations of a European expert group. Eur J Pediatr. 2015 Jul;174(7):855-65. doi: 10.1007/s00431-015-2570-0. Epub 2015 May 29.