louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03854890: Fluorescent Lymphography-Guided Lymphadenectomy In Laparoscopic Proctectomy
Official title: Fluorescent Lymphography-Guided Lymphadenectomy Using Indocyanine Green During Laparoscopic Radical Resection Of Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the number of lymph nodes retrieved with or without the use of intraoperative fluorescence lymphography in laparoscopic radical resection of rectal cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of rectal carcinoma.
* Without multiple primary cancer.
* Without receiving neoadjuvant chemoradiotherapy.
* Sufficient organ function.
* Able to provide written informed consent.

Exclusion Criteria:

* Younger than 18 years or older than 75 years
* Synchronous or metachronous malignancy within 5 years.
* Patients with Intestinal obstruction or perforation or bleeding who require emergency surgery.
* Patients with a history of pelvic irradiation.
* ASA (American Society of Anesthesiologists) grade IV or V.
* Women who are pregnant (confirmed by serum β-Human Chorionic Gonadotropin in women of reproductive age) or breast feeding.
* Severe mental illness.
* Patients with severe emphysema, interstitial pneumonia, or ischemic heart disease who can not tolerate surgery.
* Patients who received steroid therapy within one month.
* Patients or family members misunderstand the conditions and goals of this study.

Primary outcomes:
measure: The total number of lymph nodes retrieved
timeFrame: During the surgery
measure: The positive number of lymph nodes retrieved
timeFrame: During the surgery
Secondary outcomes:
measure: The duration of the operation to remove the lymph nodes
timeFrame: During the surgery
measure: Detection rate of indocyanine green-positive para-aortic lymph node
timeFrame: During the surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT05650190: Spectacle Lens Visual Acuity Assessments Study
Official title: Spectacle Lenses Visual Acuity Assessments Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia
Myopia Progression
Juvenile Myopia
Lead sponsor: SightGlass Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-14
Enrollment: 51
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a two-arm parallel group, non-dispensing study. Participants will be existing active CYPRESS Extension (CPRO-1802-002) subjects. Subjects will undergo additional visual performance assessments.


Eligibility criteria: Inclusion Criteria:

* Existing subject from the CYPRESS Extension study (CPRO-1802-002)
* Ability to comply with study assessments
* The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed coy of the form

Exclusion Criteria:

* Any current ocular infection, inflammation or irritation likely to affect vision

Primary outcomes:
measure: Visual Acuity
timeFrame: 15 minutes
Secondary outcomes:
measure: Near Visual Acuity with Glare
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Longwood
country: United States
facility: Sabal Eye Care
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Raytown
country: United States
facility: Advanced Eyecare PC
state: Missouri
city: New York
country: United States
facility: SUNY School of Optometry
state: New York
city: Houston
country: United States
facility: Vision Optique
state: Texas
city: Salt Lake City
country: United States
facility: William J Bogus, OD, FAAO
state: Utah
Study officials:
References:
Clinical trial NCT06445790: Efficacy of Cognitive Behavior Therapy in the Treatment of Chronic Pelvic Pain in Women
Official title: Efficacy of Cognitive Behavior Therapy in the Treatment of Chronic Pelvic Pain in Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pelvic Pain Syndrome
Keywords: Chronic Pelvic Pain, Pelvic Pain, Women
Lead sponsor: Islamia University of Bahawalpur
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be the pilot study trial. The target population will be 30 individuals with Chronic Pelvic Pain (CCP). There will be 02 groups, Experimental Group and Control Group. The primary outcome measure will be Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ). The experimental group will receive CBT spread over 12 sessions.


Eligibility criteria: Inclusion Criteria:

1. Women of reproductive age.
2. Women with Chronic Pelvic Pain having no pathological or anatomical causes.
3. Women with Overactive Bladder Syndrome.
4. Women with Vulvodynia. -

Exclusion Criteria:

1. Women experiencing perimenopause or menopause.
2. Women with medical, or gynecological or hormonal abnormalities.
3. Women with mental disorders.
4. Women who use substances. -

Primary outcomes:
measure: Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ)
timeFrame: Up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03119090: Fontan Imaging Biomarkers (FIB) Study
Official title: Cross-sectional Analysis of Non-invasive Measures of Ventricular Systolic and Diastolic Function and Biomarkers in the Fontan Circulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Single-ventricle
Congenital Heart Disease
Keywords: biomarkers
Fontan operation
Single ventricle
congenital heart disease
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Evan's Heart Fund
name: Mend a Heart Foundation
name: Matthew Hearts of Hope Foundation
First posted: 2017-04-18
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after the Fontan operation

Brief summary: The goal of the Fontan Imaging Biomarkers (FIB) study is to identify the associations of blood and urine biomarkers to imaging parameters of ventricular mechanics.

Detailed description: This study has the following research questions:

1. What is the reproducibility of ventricular systolic function measurements (including ventricular strain) in Fontan patients using echocardiography (Echo) and cardiac magnetic resonance imaging (CMR)?
2. What is the reproducibility of ventricular diastolic function measurements (including tissue Doppler and strain rate) in Fontan patients using Echo and CMR?
3. Is there a correlation between ventricular function measurements and circulating biomarkers (including galectin-3 levels, NT-proBNP, ST2, and MELD-XI score)?

Eligibility criteria: Inclusion Criteria:

* All patients with Fontan circulation undergoing clinically indicated CMR at Boston Children's Hospital will be considered for the study

Exclusion Criteria:

* Inadequate imaging quality to perform proposed analysis
* Patients \<15 kg will be excluded to simplify compliance with BCH minimal risk research blood draw volume guidelines (minimal risk is defined as \< 5% total blood volume)

Primary outcomes:
measure: Biomarkers
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: Diastolic function
timeFrame: Through study completion, an average of 3 years
measure: Systolic function
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Rahul H Rathod, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05685290: The Effect of Pushing Technique With Saline on Success of Peripheral Intravenous Catheter Placement
Official title: The Effect of Pushing Technique With Saline on Success of Peripheral Intravenous Catheter Placement: A Randomized Controlled Study in a Pediatric Hematology and Oncology Sample
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Keywords: Pediatric oncology
Intravenous Catheter Placement
nursing
randomized controlled study
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this project is to determine the effect of pushing with saline technique on the success of peripheral IV catheter placement in a pediatric hematology and oncology sample. This research is a randomized controlled experimental study.

Detailed description: The sample of the study consists of children who aged 0-17. It is planned to collect the research data in Akdeniz University Hospital Pediatric Hematology and Oncology Outpatient Clinic. Data Collection Tools are 'Personal Information Form for Children', 'Catheterization Description Form' and 'The Difficult Intravenous Access (DIVA) Score for children '. DIVA Score will be used pre-intervention to determine whether patients have a difficult vein. Children with DIVA score of 4 and above will be randomly assigned to the intervention and control groups. The attempt to place an IV catheter in children in the intervention group will be carried out by "pushing with saline" (SF) technique. In this way, it is predicted that the success of IV intervention in difficult vascular access will increase and the number of attempts will decrease significantly. Peripheral catheter placement in the control group will be performed with the traditional method routinely implemented by nurses.

Eligibility criteria: Inclusion Criteria:

* The child who ages of 0-17.
* The child's need for peripheral IV catheter placement for treatment.
* A score of 4 or higher on the Difficult Intravenous Access Score for Children

Exclusion Criteria:

* None.

Primary outcomes:
measure: Catheterization Description Form
timeFrame: Immediately after the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Konyaaltı
country: Turkey
facility: Meltem Gürcan
state: Antalya
Study officials:
affiliation: Assistant Professor
name: Sevcan ATAY TURAN, PhD
role: STUDY_DIRECTOR
affiliation: Research Assistant
name: Ayla KAYA, PhD
role: STUDY_DIRECTOR
affiliation: Professor
name: Elif GÜLER, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00758290: Clinical Study to Evaluate Dental Plaque
Official title: Clinical Study to Evaluate Dental Plaque
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingival Diseases
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.


Eligibility criteria: Inclusion Criteria:

* Male or female volunteers at least 20 - 51 years of age
* Good general health
* Must sign informed consent form
* Minimum of 15 natural uncrowned teeth (excluding third molars) must be present
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

* Subjects unable or unwilling to sign the informed consent form
* Medical condition which requires pre-medication prior to dental visits/procedures
* Moderate or advanced periodontal disease or heavy dental tartar (calculus)
* 5 or more decayed untreated dental sites at screening (cavities)
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that are currently affecting salivary function
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1
* Pregnant or nursing women
* Participation in any other clinical study within 1 week prior to enrollment into this study
* Use of tobacco products
* Subjects who must receive dental treatment during the study dates
* Current use of Antibiotics for any purpose
* Presence of an orthodontic appliance which interferes with plaque scoring
* History of allergy to common toothpaste ingredients
* History of allergy to arginine (amino acid)
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Primary outcomes:
measure: Dental Plaque Index
timeFrame: 4 Day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Bluestone Center for Clinical Research, NYU College of Dentistry
state: New York
Study officials:
name: Patricia Corby, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06161090: Study of CM310 in Healthy Subjects
Official title: Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2023-12-07
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a single center, randomized, double-blind, placebo-controlled, dose escalation study.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers.
* aged ≥ 18 and ≤ 65 years old.
* With all clinical laboratory examination normal.
* Voluntary signing of the informed consent form.

Exclusion Criteria:

* With a history of asthma and allergic reactions.
* With a history of conjunctivitis and keratitis, as well as previous medical conditions.
* With positive results from alcohol breath or urine drug abuse testing.

Primary outcomes:
measure: Adverse event
timeFrame: up to Week 9
Secondary outcomes:
Other outcomes:
Locations:
city: Zibo
country: China
facility: PKUCare Luzhong Hospital
Study officials:
References:
Clinical trial NCT03459690: EEG Changes With Guided Online Meditation
Official title: EEG Changes With Meditation: A Proposal to Analyze EEG Changes With a Simple, Online, Guided Meditative Tool.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meditation
Keywords: Meditation, EEG
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective trial enrolling healthy volunteers, including novice meditators and experienced meditators. Subjects will undergo an EEG at baseline and again after 6 weeks. During the 6 weeks, subjects will be asked to meditate twice a day, 12 minutes each time.
Primary purpose: OTHER

Brief summary: Simple meditation and EEG changes

Detailed description: This is a prospective trial enrolling healthy volunteers, including novice meditators and experienced meditators. Subjects will undergo an EEG at baseline and again after 6 weeks. During the 6 weeks, subjects will be asked to meditate twice a day, at least 12 minutes each time.

Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. Novice or expert meditator

Novice meditator: No meditation practice in the previous year and \< 20 entire lifetime hours

Expert meditator: Meditation ≥ 30 min per day for at least 5 days per week over the past 1 year

Exclusion Criteria:

1. History of any neurological condition (i.e. Parkinson's disease, Alzheimer's disease, Huntington's disease, brain tumors, brain surgery, or multiple sclerosis)
2. History of depression, currently being treated with antidepressants
3. History of any psychiatric disorder, within last 5 years (i.e. anxiety, psychosis, posttraumatic stress disorder, attention deficit hyperactive disorder)
4. Current use of cognition-enhancing medications
5. Active history (within the last 5 years) of alcohol or drug abuse (\> 10 drinks per week)
6. History (within the last 5 years) of stroke/aneurysm
7. Recent history (\< 3 months) of seizures
8. Non-English speaking

Primary outcomes:
measure: Number of Participants With EEGs to Measure Changes in Wave Oscillations
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Participants With Evaluable EEGs to Measure Changes in Wave Amplitude
timeFrame: 6 weeks
measure: Number of Participants With Evaluable EEGs to Measure Changes in Wave Latency
timeFrame: 6 weeks
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: Balachundhar Subramaniam
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00065403: Acupuncture for Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Acupuncture
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2003-07-23
Enrollment: 260
Sex: ALL
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: Little is known about acupuncture's efficacy for Irritable Bowel Syndrome (IBS). This trial uses a manualized acupuncture treatment format that closely follows clinical practice and allows flexibility in designing individualized treatments. In addition, a second parallel qualitative study will follow a subgroup of patients throughout the trial to explore the relationships between patients' interpretations and understandings (what anthropologists call "meaning") of irritable bowel and their response to treatment. Cortisol levels (an important stress hormone) will also be assessed.

This will be a 3-arm trial: Active acupuncture, placebo acupuncture, and wait list.


Eligibility criteria: Inclusion criteria:

Diagnosis of Irritable Bowel Syndrome based on Rome II criteria, including at least 12 weeks of abdominal discomfort or pain in the last 12 months with at least 2 of the following features:

* Relief with defecation
* Onset associated with a change in stool frequency
* Onset associated with a change in form/appearance of stool

Exclusion criteria:

* History of severe or intractable IBS, defined as continuous, unremitting and several abdominal pain greater than 12 hours/day
* Previous acupuncture treatment
* Concurrent diagnosis of any bowel disturbance that would interfere with the assessment or safety of the study
* History of laxative abuse
* Previous abdominal surgery (uncomplicated appendectomy, hysterectomy or cholecystectomy at least 6 months prior to entry acceptable)
* History of metabolic or inflammatory disease that may affect bowel motility, eg.g., inflammatory bowel disease, diabetes mellitus, sarcoidosis
* Other significant illness as determined by Investigator
* History of drug or alcohol abuse w/in 2 years;
* Insufficient knowledge of English to complete self-assessments to participate in study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Medical School
state: Massachusetts
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Ted Kaptchuk, OMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, Kirsch I, Schyner RN, Nam BH, Nguyen LT, Park M, Rivers AL, McManus C, Kokkotou E, Drossman DA, Goldman P, Lembo AJ. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ. 2008 May 3;336(7651):999-1003. doi: 10.1136/bmj.39524.439618.25. Epub 2008 Apr 3.
Clinical trial NCT00651703: Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients
Official title: Safety, Tolerability, and Immunogenicity of CYT004-MelQbG10 Vaccine With or Without Immunostimulating Adjuvant in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Melanoma
Lead sponsor: Cytos Biotechnology AG
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 21
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 purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine alone or in combination with different adjuvants.


Eligibility criteria: Inclusion Criteria:

* Histological confirmed Stage III or IV malignant melanoma
* HLA-A\*0201 haplotype
* Expected survival of at least 9 months
* Willing and able to comply with all trial requirements (e.g. diaries, CTs)
* Given written informed consent
* Females only if non-reproductive or if they agree to consistently practice an effective and accepted method of contraception

Exclusion Criteria:

* Any contraindication to any study related test or assessment
* Current or planned use of contraindicated concomitant medication
* Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological and psychiatric disease
* Infection with HIV, HBV or HCV
* Pregnancy or lactation or females planning to become pregnant during the study
* Abuse of alcohol or other drugs
* Use of investigational drug within 30 days before enrolment
* Previous participation in a clinical trial with a Qb-based Cytos vaccine.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Ludwig Institute for Cancer Research; CHUV
state: VD
city: Zurich
country: Switzerland
facility: Dermatologische Klinik, UniversitätsSpital Zürich
Study officials:
References: