louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04843189: Prospective Registration Study of Robtic Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery
Official title: Prospective Registration Study of Robtic Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Da Vinci Robot
Colon Cancer
Surgery
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 648
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with colon cancer

Brief summary: The purpose of this study is to compare the clinical data of patients with colon cancer who received robotic or laparoscopic surgery, and to compare the short-term and long-term effects of robotic surgery in the treatment of colon cancer. To verify the safety and effectiveness of the corresponding surgical methods, and provide better guidance for the following clinical practice.


Eligibility criteria: Inclusion Criteria:

1. Age: 18-80 years old, male or female;
2. Colon cancer (ascending colon, transverse colon, descending colon, sigmoid colon) is diagnosed by histology or cytology;
3. The clinical stage is T1-4aN0-2M0; 4 No multiple distant metastases;

5. ECOG score 0-2; 6. Heart, lung, liver, and kidney functions can tolerate surgery; 7. Patients and their families can understand and are willing to participate in this clinical study, and sign an informed consent.

Exclusion Criteria:

1. Past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors;
2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;
3. Neighboring organs need to be combined with organ resection;
4. New adjuvant therapy before surgery;
5. ASA grade ≥ grade IV and/or ECOG physical status score\> 2 points;
6. Those who have severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery;
7. Have a history of severe mental illness;
8. Pregnant or lactating women;
9. Patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial.

Primary outcomes:
measure: Number of lymph nodes harvested
timeFrame: During the operation
Secondary outcomes:
measure: Operation time
timeFrame: During the operation
measure: Length of surgical incision
timeFrame: During the operation
measure: Intraoperative blood loss
timeFrame: During the operation
measure: Intraoperative concversion rate
timeFrame: During the operation
measure: Postoperative recovery
timeFrame: During the postoperative hospital stay
measure: 3-year disease-free survival
timeFrame: 3 years after surgery
measure: 5-year overall survival
timeFrame: 5 years after surgery
Other outcomes:
Locations:
city: Changchun
country: China
facility: Jilin University First Hospital
state: Jilin
Study officials:
References:
Clinical trial NCT02035189: Observational Study Evaluating the Potential Impact of Procalcitonin Testing on Care of Stemcell Transplant Recipients
Official title: Observational Study Evaluating the Potential Impact of Procalcitonin Testing on Care of Stemcell Transplant Recipients and Its Performance as an Adjunct in the Diagnosis and Prognostication of Infectious Processes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Multiple Myeloma at UAMS receiving Stem Cell transplantation

Brief summary: An observational study in evaluating the clinical impact of procalcitonin on the care of Stem cell transplant recipient and its performance as an adjunct in the diagnosis and prognostication of Infectious processes

Detailed description: The overall goal of this project will be to provide new insights into the use of biomarkers in surveillance for infectious processes in Stem Cell Transplant recipients by evaluating the added impact of procalcitonin testing on detection of infectious processes

Eligibility criteria: Inclusion Criteria:

* Patients age 18-95 years with Multiple Myeloma (MM) undergoing stem cell transplantation

Exclusion Criteria:

* None

Primary outcomes:
measure: Levels of Procalcitonin
timeFrame: Daily up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Little rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Senu Apewokin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arkansas
name: Naveen Sanathkumar, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00464789: Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Healthy Postmenopausal Women
Official title: An Open-Label, Single-Dose, Randomized, 3-Period, Crossover, Bioequivalence Study Between Bazedoxifene/Conjugated Estrogens (Premarin Current Process) And Bazedoxifene/Conjugated Estrogens (Premarin New Process) In Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Menopause
Keywords: Postmenopausal
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-24
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Bazedoxifene/Conjugated Estrogens (BZA/CE) is an investigational drug that is being developed for treatment of menopause. The purpose of this trial is to compare a new manufacturing process for making BZA/CE to the current process by assessing the way it is absorbed into the blood.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women aged 35 to 70 years
* Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight greater than or equal to 50 kg
* Healthy as determined by the investigator on the basis of medical history, physical examination, breast and gynecologic examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* Any clinically important active condition of gynecologic, cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies.
* History of any clinically important drug allergy to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs).

Primary outcomes:
measure: PK results
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02152189: Screening for Fabry Disease in a Pediatric Population at Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain in the Extremities
Chronic Abdominal Pain
Fabry Disease
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 1422
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children with rheumatological disorders or chronic abdominal pain

Brief summary: The purpose of this study is to assess the frequency of Fabry disease in children with chronic abdominal pain or chronic pain in the extremities


Eligibility criteria: Inclusion Criteria:

* Age below 18 years
* One of the following criteria:

  * Diagnosis or suspicion of a rheumatological disorder with recurrent complaints for more than 6 months
  * Chronic, recurrent abdominal pain for more than 6 months
* Planned blood sample for routine diagnostics
* Written informed consent

Exclusion Criteria:

- Patient and/or the patient's parent(s) or legal guardian(s) are unable to understand the nature, scope, and possible consequences of the screening.

Primary outcomes:
measure: Prevalence of Fabry disease
timeFrame: day 1
Secondary outcomes:
measure: Prevalence of Fabry disease in predefined sub-populations
timeFrame: day 1
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Zentrum für Kinder- und Jugendmedizin
Study officials:
References:
citation: Ries M, Gupta S, Moore DF, Sachdev V, Quirk JM, Murray GJ, Rosing DR, Robinson C, Schaefer E, Gal A, Dambrosia JM, Garman SC, Brady RO, Schiffmann R. Pediatric Fabry disease. Pediatrics. 2005 Mar;115(3):e344-55. doi: 10.1542/peds.2004-1678. Epub 2005 Feb 15.
citation: Kastner B, Behre S, Lutz N, Burger F, Luntz S, Hinderhofer K, Bendszus M, Hoffmann GF, Ries M. Clinical Research in Vulnerable Populations: Variability and Focus of Institutional Review Boards' Responses. PLoS One. 2015 Aug 14;10(8):e0135997. doi: 10.1371/journal.pone.0135997. eCollection 2015.
Clinical trial NCT00909389: Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)
Official title: Post - Marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-05-28
Enrollment: 4748
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: Patients 18 years old and above seen in the outpatient clinic who were diagnosed to have hypercholesterolemia. Patients with primary (heterozygous familial and non - familial) hypercholesterolemia or homozygous familial hypercholesterolemia were also included.

Brief summary: This study aims to establish the safety, tolerability, and efficacy of Vytorin (R) (Ezetimibe + Simvastatin) (SCH 465981) on a select population of Filipinos with hypercholesterolemia.


Eligibility criteria: Inclusion Criteria:

* Outpatient men or women, age 18 years and above
* Patients with primary (heterozygous familial and non-familial) hypercholesterolemia

Exclusion Criteria:

* Known hypersensitivity to Ezetimibe and Simvastatin
* Moderate to severe hepatic insufficiency
* Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal
* Pregnancy or lactation
* Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine

Primary outcomes:
measure: Number of Participants Who Had an Adverse Event (AE).
timeFrame: Throughout study up to Day 29 (Final Visit)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00765089: Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation
Official title: Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Atrial Fibrillation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Atrial Fibrillation (AF) is one of the most common postoperative complications after coronary artery bypass grafting (CABG). Postoperative AF produces a substantial impact on hospital resources with an estimated annual expenditure of over $1 billion. This includes the cost of pharmacological treatment and the cost of the increased length of stay. The incidence of AF is about 30-40% in CABG patients and increases with age of the patient. As the average age of the patient that undergoes CABG surgery is increasing, it is critical to find a way to prevent or reduce the incidence of this complication.

We propose a prospective, randomized, controlled study to determine the role of pulmonary vein isolation by bipolar ablation in the prevention or reduction of postoperative AF. The block- randomization plan will be used to maintain balance of the study and control arms throughout the study.


Eligibility criteria: Inclusion Criteria:

1. Patients who require an isolated elective CABG surgery on CPB.
2. Both male and female patients of age 18 years to 90 years.

Exclusion Criteria:

1. Pre existing atrial fibrillation or history of previous atrial fibrillation.
2. Inability to provide informed consent.
3. Pregnant or nursing patients.
4. Reoperative sternotomy
5. Emergency CABG surgery.

Primary outcomes:
measure: Reduced incidence of Postoperative Atrial fibrillation
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00065689: High Intensity Light Therapy in Alzheimer's Disease
Official title: High Intensity Light Therapy in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Dementia
Keywords: Alzheimer's disease
light therapy
long-term care
depression
sleep
agitation
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-08-01
Enrollment: 107
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether bright light improves the sleep, mood, and behavior of persons with Alzheimer's disease and related dementias (AD) who live in long-term care settings and, if so, to determine the best timing for the light therapy. The light levels being used in the study have been shown to improve depression in persons with seasonal affective disorder (SAD) and to relieve sleep problems in persons with jet lag and other body rhythm disturbances. Because persons with AD often will not remain still in front of a fluorescent panel, this project has involved renovations in the study units that provide for even, regulated, high-intensity light in all public areas of the study settings.

Detailed description: See Brief Summary

Eligibility criteria: Inclusion criteria:

* Diagnosis of dementia
* Residence on study units

Exclusion criteria:

* Bipolar disorder
* Severe retinal (eye) disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Butner
country: United States
facility: John Umstead Hospital
state: North Carolina
Study officials:
name: Philip D. Sloane, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06605989: Nostril Side on Epistaxis
Official title: The Effect of Nostril Side on Epistaxis During Nasotracheal Intubation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nasotracheal Intubation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2024-09-20
Enrollment: 288
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to investigate the effect of the nostril side on epistaxis during nasotracheal intubation.

Detailed description: This prospective randomized controlled study was approved by the IRB of our institute.

Patients requiring nasotracheal intubation will be screened for eligibility for the study. Then, patients will be randomized to one of two groups; (Group I: tube will be inserted through the left nostril and advanced into the oral cavity / Group II: tube will be inserted through the right nostril and advanced into the oral cavity). After induction of anesthesia and muscle relaxation, the preformed nasal RAE (Ring-Adair-Elwyn) tube will be inserted via the nostril, which is assigned to each patient according to the group, approximately 3-4 cm. Next, an anesthesiologist will advance the tube into the oral cavity. After the tube is placed in the oral cavity, the anesthesiologist will perform nasotracheal intubation with Magill forceps. After that, an investigator will check the occurrence of epistaxis due to nasotracheal intubation and its severity with a fiberoptic bronchoscope. After obtaining all data, investigators will analyze the incidence of epistaxis and its severity between the two groups.

Eligibility criteria: Inclusion Criteria:

* adult patients requiring nasotracheal intubation for elective surgery

Exclusion Criteria:

* refuse to participate in the study
* severe deformity in the nose
* current severe epistaxis
* cannot insert the tube into a specific nostril side due to any reason

Primary outcomes:
measure: epistaxis
timeFrame: during nasotracheal intubation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sanuki T, Hirokane M, Kotani J. Epistaxis during nasotracheal intubation: a comparison of nostril sides. J Oral Maxillofac Surg. 2010 Mar;68(3):618-21. doi: 10.1016/j.joms.2009.04.097. Epub 2009 Nov 22.
Clinical trial NCT03423589: Modulation of Type 1 Diabetes Susceptibility Through the Use of Probiotics
Official title: Modulation of Type 1 Diabetes Susceptibility Through VSL#3 Probiotic-induced Alterations in the Intestinal Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Type1 Diabetes Mellitus
Keywords: Siblings
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Investigators aim to further the understanding of environmental factors that underlie the progression to Type 1 diabetes (T1D). Dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing T1D in those with genetic susceptibility. Dysbiosis may result from modern dietary habits, such as broad consumption of the highly processed Western Diet, or by widespread use of antibiotics. Here, investigators propose to examine the impact of dysbiosis on the endogenous innate inflammation known to exist within families affected by T1D and if probiotic supplementation may beneficially modulate this inflammatory state.

Participants will be asked to take the probiotic VSL#3 daily for six weeks. Stool and blood samples will be analyzed before and after the six week course of probiotics.


Eligibility criteria: Inclusion Criteria:

1. Males and females 5-17 years of age
2. Full-sibling of an individual with a clinical diagnosis of Type 1 diabetes
3. Treatment naïve of any immunomodulatory agent
4. Naïve of any probiotic supplement within the past 12 months

Exclusion Criteria:

1. Presence of severe/active disease that interferes with dietary intake
2. Chronic use of medications known to affect gastrointestinal function, such as stool softeners or laxatives
3. Diagnosis of celiac disease and/or following a gluten-free diet
4. Presence of significant and sustained gastrointestinal symptoms within the prior 6 weeks (e.g., severe abdominal pain, worsening constipation, diarrhea, or recurrent nausea +/- vomiting)
5. Chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids
6. Use of any medications that could affect intestinal microbiota within the previous 3 months (e.g., antibiotics, prebiotics, or probiotics)
7. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
8. Female participants of child-bearing age must not be pregnant

Primary outcomes:
measure: Alterations in Plasma-Induced Transcriptional Analysis
timeFrame: 2 years (study duration)
Secondary outcomes:
measure: Intestinal Microbiota
timeFrame: 2 years (study duration)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT03631589: MSC for Severe aGVHD
Official title: Treatment of Steroid-resistant Severe Acute Graft-versus-host Disease With Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Steroid-resistant Severe aGVHD
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 50
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Steroid-resistant acute graft-versus-host disease (aGVHD) is one of the most severe complications in the setting of allogeneic hematopoietic stem cell transplantation (HSCT), which cannot be significant benefit from the second-line therapies.The mesenchymal stem cells (MSCs) possess extensive immunomodulatory properties and are very promising to rescue the refractory aGVHD.This study aims to assess the efficacy and safety of MSCs for the treatment of the refractory aGVHD.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Aged \<65 years
* Patients with steroid-resistant severe aGVHD
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of MSCs.

Primary outcomes:
measure: complete and partial response rate
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events that are related to treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References: