louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06411470: Gastrointestinal Microflora and Serum Metabolomics in Patients With Pancreatic Cancer and Chronic Pancreatitis
Official title: Gastrointestinal Microflora and Serum Metabolomics in Patients With Pancreatic Cancer and Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Chronic Pancreatitis
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pancreatic cancer,chronic pancreatitis,healthy people

Brief summary: The investigators plan to collect throat swabs, saliva, feces and serum samples from pancreatic cancer patients, chronic pancreatitis patients and healthy people and clarify the characteristics of oral flora and serum metabolome of pancreatic cancer patients.


Eligibility criteria: Inclusion Criteria:

1.Pathologic diagnosis of pancreatic ductal adenocarcinoma；Diagnosis of CP defined as having obvious morphological features of CP (i.e., the presence of pancreatic calcifications on CT scan and/or magnetic resonance cholangiopancreatography)；Other benign disease populations without pancreatic lesions.

Exclusion Criteria:

1. Pregnant women.
2. Patients with coagulation disorders who are unable to undergo blood tests.
3. Have a history of using antibiotics or probiotics within the past 3 months.

Primary outcomes:
measure: serum metabolites
timeFrame: Baseline
measure: Gastrointestinal microbiota
timeFrame: Baseline
measure: Overall Survival
timeFrame: up to 2 years
measure: Predictive model
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06017570: Risk Factors for Distal Caries of Second Molars Adjacent to Mandibular Impacted Third Molars
Official title: Risk Factors for Distal Caries of Second Molars Adjacent to Mesioangular or Horizontal Partially Erupted Mandibular Third Molars, A Cross-Sectional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decay, Dental
Impacted Third Molar Tooth
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 639
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Distal surfaces of second molars adjacent to wisdom teeth are always at risk for caries and external root resorption. The incidence of caries is high, especially in partially impacted third molars in mesioangular and horizontal positions. In this study, investigators aimed to examine the caries correlation in the distal second molar with the age, gender, side and DMFT scores of the participants.


Eligibility criteria: Inclusion Criteria:

* being between 20 and 40 years old
* having a surgery appointment for removal of the partially impacted third molar which is mesioangular or horizontal position
* having an orthopantomogram on the database
* and having a second molar adjacent to the impacted third molar

Exclusion Criteria:

* crowned or restored the second molar
* any surgery related to the contact area
* any pathology related to the second or third molar
* a radiological artifact on the contact area
* insufficient radiological quality for the evaluation.

Primary outcomes:
measure: Radiologic examination
timeFrame: 10 minute before the start of surgery
measure: Intra-oral examination
timeFrame: 10 minute before the start of surgery
measure: Clinical examination
timeFrame: 1 minutes after the removal of third molar
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University, Faculty of Dentistry
state: Selçuklu
Study officials:
affiliation: Selcuk University, Faculty of Dentistry
name: Gökhan Gürses
role: STUDY_CHAIR
References:
Clinical trial NCT01780870: Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss
Official title: Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: Overweight
Obesity
Obese
Weight loss
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to assess factors mediating the changes in insulin sensitivity and glucose tolerance before and after 10 lbs ± or 2% weight loss reduction as well as 2, 3, 6, 12, and 24 months after initiation of a low calorie diet.

The investigators will also study the following:

1. The impact of diet induced weight loss on hormones/adipokine levels
2. The impact of diet induced weight loss on leptin tolerance


Eligibility criteria: Inclusion Criteria for interventional group:

1. Adult men and women, age 18-50
2. English speaking
3. Body mass index (pre weight loss) ≥30 kg/m2 but \<40 kg/m2
4. Willing to enroll in a low calorie full meal replacement weight loss program
5. Willing and able to take part in a multi year study involving visits

Inclusion Criteria for control group:

1. Adult men and women, age 18-50
2. English speaking
3. Body mass index (pre weight loss) ≥30 kg/m2 but \<40 kg/m2
4. Willing and able to take part in a multi year study involving visits

Primary outcomes:
measure: The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks
timeFrame: 8 weeks
measure: The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks
timeFrame: 8 weeks
measure: The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Christos Mantzoros, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06533670: TME Alteration in HER2 Positive Breast Cancer
Official title: Tumor Microenvironment Alteration During Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
HER2-positive Breast Cancer
Chemotherapy Effect
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 30
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: HER2 positive breast cancer patients undergoing curative treatment including neoadjuvant chemotherapy after confirmation of breast cancer without distant metastases

Brief summary: Evaluate for changes in the tumor microenvironment before/during neoadjuvant chemotherapy and after treatment in patients diagnosed with HER2-positive advanced breast cancer and receiving neoadjuvant cancer therapy and surgery for curative purposes.


Eligibility criteria: Inclusion criteria i. Adult patients over 18 years of age ii. Patients undergoing curative treatment including neoadjuvant chemotherapy after confirmation of breast cancer without distant metastases iii. Clinical T stage II-IV patients iv. HER2 positive breast cancer patients

Exclusion criteria If you have other comorbidities that, according to the researcher's judgment, may affect the results of the study

Primary outcomes:
measure: tumor microenvironment alteration
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00005770: Investigation of the Effect of Acupuncture Needling on Connective Tissue Using Ultrasound Elastography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: elastic property of skin
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-06-02
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY
Time perspective: CROSS_SECTIONAL

Brief summary: During acupuncture treatment, acupuncture needles are inserted and manipulated until a characteristic local tissue reaction termed "de qi" is observed. De qi can be perceived by the acupuncturist in the form of "needle grasp", a mechanical gripping of the needle by the tissue. De qi is considered essential to the therapeutic effect of acupuncture. Therefore, the investigator proposes that understanding this local tissue reaction will lead to an understanding of how the therapeutic effect of acupuncture therapy arises. Specifically, it is hypothesized that needle manipulation causes winding of collagen and elastic fibers around the needle. This action induces tension in the collagen network surrounding the needling site and results in a mechanical signal that is transduced into local cells. The objective of the current work is to use ultrasound elastography, a recently developed ultrasound imaging technique, to visualize and quantify changes in the elastic properties of skin and subcutaneous tissue in 12 healthy human volunteers as a result of acupuncture needle manipulation.


Eligibility criteria: Inclusion Criteria:

* Healthy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References:
Clinical trial NCT01268670: The Addition of Oral Analgesics to LET During Laceration Repair
Official title: Adjunctive Oral Analgesia for Laceration Repair: Assessing Pain in a Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Laceration
Pain
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
First posted: 2010-12-31
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background Approximately 30 million children are treated in emergency departments each year in the United States, of which two to three million are children presenting with lacerations. Topical numbing medication is the standard of care in children with regard to pain control during laceration repair. While topical numbing medications are effective, children often require further pain control during laceration repair in the form of an injected numbing medication, which in itself is painful. No evidence currently exists regarding the concurrent use of oral pain medications to combat laceration procedural pain.

Research Question Does the addition of ibuprofen or oxycodone to lidocaine, epinephrine, and tetracaine (LET) topical anesthetic provide more effective pain control than LET alone during laceration repair?

Design This is a double-blinded, randomized-controlled study.

Methods Subjects in all three groups will receive topical anesthetic. In addition to topical anesthetic, two groups of children will receive either of two oral analgesics, ibuprofen or oxycodone, while the third group will receive a placebo.


Eligibility criteria: Inclusion Criteria:

* English-speaking patients
* Patients 4 years of age up to 10 years of age
* Patients seen in the ED needing simple facial laceration repair
* Patients with no chronic medical problems

Exclusion Criteria:

* Any patient who's parent or primary caretaker refuses consent
* Any patient who's parent or primary caretaker needs an interpreter
* Any child with complex laceration(s) or bites
* Any child who has received pain medication at home in response to the facial laceration.
* Children needing procedural sedation
* Children with a known allergy to lidocaine, epinephrine, tetracaine, ibuprofen, or oxycodone
* Patients with known or pre-existing medical conditions where the study protocol cannot be used
* This includes any patient with a medical condition that prevents appropriate use of the pain scale
* It also includes patients with medical conditions that warrant the use of chronic medications

Primary outcomes:
measure: Pain scores
timeFrame: At Triage, after first suture, and the worst during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis and St Paul
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT04214470: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in IBS
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Irritable Bowel Syndrome
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Irritable Bowel
Irritable Bowel Syndrome
Irritable Bowel Syndrome With Diarrhea
Irritable Bowel Syndrome Mixed
Irritable Bowel Syndrome With Constipation
Irritable Bowel Syndrome Without Diarrhea
Irritable Bowel Syndrome Aggravated
Irritable Bowel Syndrome Characterized by Constipation
Irritable Bowel Syndrome Characterised by Alternating Bowel Habit
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2020-01-02
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 with IBS

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

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to IBS.

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

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages
3. Diagnosis of IBS

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

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02580370: Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Aging
Keywords: REALISE 1
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-20
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study of botulinum toxin type A in subjects with lateral canthal lines.


Eligibility criteria: Inclusion Criteria:

* In good general health
* Moderate to severe lateral canthal lines when evaluated at rest based on the investigator's global assessment
* Moderate to severe lateral canthal lines when evaluated at rest based on the patient assessment of severity

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
* Muscle weakness or paralysis, particularly in the area receiving study treatment
* Active skin disease or irritation or disrupted barrier at the treatment area
* Active eye disease or irritation
* Eyelid ptosis, excessive dermatochalasis, deep dermal scarring, or inability to substantially effect the LCL to be treated by manually spreading the skin apart
* Use of topical prescription retinoid product(s) in the lateral canthal areas during the 3 months prior to Screening
* Undergone any procedures that may affect the lateral canthal region during the 12 months prior to Screening
* Treatment with botulinum toxin type A in the lateral canthal areas in the 6 months prior to Screening or 3 months anywhere else in the body

Primary outcomes:
measure: Composite endpoint based upon the investigator global assessment (IGA-LCL) and patient assessment of severity (PSA) of lateral canthal lines
timeFrame: Week 4
Secondary outcomes:
measure: Investigator Global Assessment with 2 points or greater improvement from baseline
timeFrame: Week 4
measure: Investigator Global Assessment with 1 point or greater improvement from baseline
timeFrame: Week 4
measure: Patient Severity Assessment with 2 points or greater improvement from baseline
timeFrame: Week 4
measure: Patient Severity Assessment with 1 points or greater improvement from baseline
timeFrame: Week 4
Other outcomes:
Locations:
city: Coral Gables
country: United States
state: Florida
Study officials:
References:
Clinical trial NCT00638170: Cranberry Juice in the Prevention of Urinary Tract Infections in Children
Official title: The Efficacy of Cranberry Juice in the Prevention of Urinary Tract Infections in Children - Randomized, Placebo Controlled Multi-Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Keywords: Urinary Tract Infections
Cranberry
Prevention
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Ocean Spray, Inc.
First posted: 2008-03-18
Enrollment: 262
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is to determine whether recurrences of urinary tract infection in children can be prevented with cranberry juice.

Detailed description: Five percent of children have at least one UTI episode and 30% of these episodes recur. Recurrences and the risk of renal damage are indications for long term antimicrobial prophylaxis, but emerging antimicrobial resistance underlines the need for alternatives. The bacteria causing urinary tract infection arise from the stools. Dietary changes can alter the balance of faecal bacteria. Vaccinium berries and products containing lactobacilli have been shown to act against the coliform bacteria that cause most urinary tract infections. In our previous study cranberry juice was effective in preventing symptomatic recurrences of urinary tract infections in women. The objective of our study is to determine whether recurrences of urinary tract infection in children can be prevented with cranberry juice.

Eligibility criteria: Inclusion Criteria:

* Urinary Tract Infection 0-2 months priorly

Exclusion Criteria:

* Antibiotic Prophylaxis

Primary outcomes:
measure: Occurrence of the first recurrence
timeFrame: 12 months
Secondary outcomes:
measure: Total number of UTI episodes and use of antimicrobials
timeFrame: 12 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: University of Oulu
Study officials:
affiliation: University of Oulu
name: Matti Uhari, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02107170: Effects of Anesthetics on Postoperative Cognitive Function of Patients Undergoing Endovascular Repair of Aortic Aneurysm and Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities.
Official title: Comparison of Intravenous Anesthetics and Volatile Anesthetics on Postoperative Cognitive Dysfunction of Patients Undergoing Endovascular Repair of Aortic Aneurysm and Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endovascular Repair of Aortic Aneurysm
Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Endovascular repair of aortic aneurysm and endovascular treatment of arteriosclerosis obliterans of lower extremities are two kinds of common surgeries in the investigators' hospital. The effects of anesthetic agents on postoperative outcome, especially cognitive function, are not clear. In this study investigators propose to measure postoperative cognitive function and other outcome of patients who are undergoing these two kinds of surgeries, and try to identify whether there is an association between different kinds of anesthetics and postoperative outcome. Investigators will also observe whether changes in plasma levels of VEGF, TGF-1, TNF-α, IL-1β, and IL-6, are associated with postoperative delirium or cognitive change.


Eligibility criteria: Inclusion Criteria:

* age 18-100 years of age
* Patients presenting for Endovascular repair of aortic aneurysm and endovascular treatment of arteriosclerosis obliterans of lower extremities

Exclusion Criteria:

* Patients with pre-existing delirium
* Inablility to converse

Primary outcomes:
measure: Number of patients with postoperative cognitive dysfunction
timeFrame: 7 days after surgery
Secondary outcomes:
measure: Number of patients with postoperative cognitive dysfunction
timeFrame: 3 months after surgery
measure: Changes in plasma levels of VEGF, TGF-1, TNF-α, IL-1β, and IL-6 (a composite outcome measure)
timeFrame: 3 days after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
References: