louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00069524: Antihyperlipidemic Effects of Oyster Mushrooms
Official title: Antihyperlipidemic Effects of Oyster Mushrooms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Hyperlipidemia
Keywords: Highly active antiretroviral therapy (HAART)
Ritonavir
Oyster mushrooms
Non-HDL cholesterol
Complementary Therapies
Treatment Experienced
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
Collaborators: name: Office of Dietary Supplements (ODS)
First posted: 2003-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary goal of this study is to evaluate the short-term safety and potential efficacy of oyster mushrooms (Pleurotus ostreatus) for treatment of hyperlipidemia in HIV-infected patients who are taking Kaletra, a protease inhibitor (PI) that is commonly used in highly active antiretroviral therapy (HAART).

Detailed description: This is a single-arm, open-label, 8-week "proof of concept" pilot study in 20 subjects to determine if there are detectable lipid-lowering effects of oyster mushrooms in patients with HIV and hyperlipidemia who are taking Kaletra (a ritonavir-containing HAART regimen). The study will also assess whether the concurrent administration of oyster mushrooms and such regimens is safe, and investigate the mechanism of action whereby oyster mushrooms may exert their antihyperlipidemic effect.

Eligibility criteria: Inclusion criteria:

* Documented HIV infection (positive ELISA and Western Blot or measurable plasma HIV RNA).
* Taking Kaletra (ritonavir/lopinavir), a ritonavir-containing antiretroviral therapy, for at least 12 weeks
* Elevated non-HDL cholesterol \>= 160 mg/dl as defined by the National Cholesterol Education Program guidelines (within 30 days of enrollment)
* AST or ALT \<2.5 times the upper limit of normal (ULN) within 30 days of study entry.

Exclusion criteria:

* Currently receiving antihyperlipidemic treatment (e.g., statins, fibrates, bile sequestrants, niacin)
* Pregnancy or breastfeeding
* Documented history of myopathy or myalgias on HMG-CoA reductase inhibitors
* Documented history of rhabdomyolysis
* Documented diagnosis of diabetes mellitus
* Any condition that, in the judgment of the investigator, precludes successful participation in the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: General Clinical Research Center, San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Donald I Abrams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abrams DI, Couey P, Shade SB, Kelly ME, Kamanu-Elias N, Stamets P. Antihyperlipidemic effects of Pleurotus ostreatus (oyster mushrooms) in HIV-infected individuals taking antiretroviral therapy. BMC Complement Altern Med. 2011 Aug 10;11:60. doi: 10.1186/1472-6882-11-60.
Clinical trial NCT01084824: A Trial Examining the Treatment of Common Warts With Combination Liquid Nitrogen (LN2) and Cantharidin
Official title: A Randomized Clinical Trial Examining the Efficacy of Treatment of Cutaneous Verruca Vulgaris in Adult Patients With Combined Liquid Nitrogen Cryotherapy and Topically Applied Cantharidin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Verruca Vulgaris
Keywords: Warts
Verruca vulgaris
Liquid Nitrogen
Cantharidin
combination treatment
Lead sponsor: North Idaho Dermatology
Sponsor class: OTHER
First posted: 2010-03-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to see if liquid nitrogen, a commonly used treatment for warts, is more effective if it is used alone, or if it is more effective if combined with cantharidin, a topical treatment also commonly used for warts (verruca vulgaris).


Eligibility criteria: Inclusion Criteria:

1. common warts on non-genital, non-facial skin
2. otherwise healthy
3. between 18-65 and able to give informed consent
4. capable of tolerating treatment

Exclusion Criteria:

1. Ill-health
2. Poor tolerance or sensitivity to treatments in study
3. \<18 years old; \>65 years old
4. verruca plana or condyloma acuminata
5. immunosuppression or immune dysfunction
6. significant peripheral vascular disease
7. significant sensitivity to cold
8. epidermodysplasia verruciformis
9. mosaiform warts or periungual warts

Primary outcomes:
measure: Percentage of common warts cleared
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Coeur D'Alene
country: United States
facility: North Idaho Dermatology
state: Idaho
Study officials:
affiliation: TUI University; North Idaho Dermatology
name: Richard A Flygare, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berth-Jones J, Bourke J, Eglitis H, Harper C, Kirk P, Pavord S, Rajapakse R, Weston P, Wiggins T, Hutchinson PE. Value of a second freeze-thaw cycle in cryotherapy of common warts. Br J Dermatol. 1994 Dec;131(6):883-6. doi: 10.1111/j.1365-2133.1994.tb08594.x.
citation: Guidelines of care for cryosurgery. American Academy of Dermatology Committee on Guidelines of Care. J Am Acad Dermatol. 1994 Oct;31(4):648-53. No abstract available.
citation: Moed L, Shwayder TA, Chang MW. Cantharidin revisited: a blistering defense of an ancient medicine. Arch Dermatol. 2001 Oct;137(10):1357-60. doi: 10.1001/archderm.137.10.1357.
Clinical trial NCT04649424: COVID-19 Nasal Swab Trial
Official title: Comparative Evaluation of Nasopharyngeal Swabs for Sampling and Detection of SARS-CoV2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Orthopaedic Innovation Centre
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this trial is to compare 2 types of nasonasopharyngeal swabs (a new design to a conventional nylon-flocked nasopharyngeal swab) for effectiveness.

Detailed description: Compare the Precision ADM "CanSwab" nasopharyngeal swab to a conventional nylon-flocked nasopharyngeal swab on the basis of:

1. The amount of SARS-CoV2 virus (COVID-19) collected by swabs, measured in CT (thermal cycles)
2. Clinical concordance rate
3. Patient comfort during nasopharyngeal sampling procedure

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Ability to provide informed consent
* COVID-19 positive cohort only: a previous, positive COVID-19 test in the last 5 days and patient remains symptomatic

Exclusion criteria:

* Malformation of the base of the known skull
* Active nosebleed before the start of the sample

Primary outcomes:
measure: Amount of SARS-CoV2 virus (COVID-19) collected
timeFrame: Baseline
measure: Clinical concordance rate
timeFrame: Baseline
measure: Patient comfort
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: Health Sciences Centre
name: Anand Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04897724: Clinical Performance of Composites in Patients With Amelogenesis Imperfecta
Official title: The Clinical Performance of Direct Posterior Composite Restorations in Patients With Amelogenesis Imperfecta
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amelogenesis Imperfecta
Dental Caries
Dental Composite
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 15
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In AI patients, adhesion still remains the first option in order to achieve an early, minimally invasive intervention, and the altered enamel still represents an acceptable substrate for bonding in some AI variants. Many cases have revealed that the direct composite restorations provide satisfactory esthetic and functionality in restoring AI-affected teeth. The objective of this study was to evaluate the clinical performance of composite restorations in posterior teeth in patients afflicted with Amelogenesis Imperfecta using nanohybrid and nanofill composite materials


Eligibility criteria: Inclusion Criteria:

* the patient had to require treatment due to carious lesions in one or more surface of molars and premolars,
* AI diagnosis had to be made, which had to be verified clinically, and also confirmed by anamnestic family history, or clinical examination concerning Witkop's classification

Exclusion Criteria:

* patients with developmental enamel defects of other origins such as fluorosis, molar incisor hypomineralization;
* AI was associated with other oral developmental or systemic disorders, and dental abnormalities such as open-bite, deep-bite, and cross-bite;
* patients who were unable to provide their informed consent.

Primary outcomes:
measure: Number of failed restorations evaluated according to the modified USPSH criteria in patients with occlusal restorations.
timeFrame: an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01520324: Neoplasia Detection With Methylene Blue MMX Tablets in Patients With UC Undergoing Colonoscopy
Official title: Intraepithelial Neoplasia Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Patients With Long Standing Ulcerative Colitis Undergoing Colonoscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: CosmoTech
Sponsor class: UNKNOWN
First posted: 2012-01-27
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of the intraepithelial neoplasia detection rate in patients with long standing ulcerative colitis undergoing mucosal staining with oral methylene blue MMX tablets prior to colonoscopy.


Eligibility criteria: Inclusion Criteria:

* endoscopically verified UC signed written informed consent

Exclusion Criteria:

* Known or suspected GI obstruction or perforation Liver or renal impairment, malignancy, pregnancy or lactation, suppressed PT.

Primary outcomes:
measure: Detected Intraepithelial Neoplasia
timeFrame: During colonscopy (usually <15 min) and subsequent histological analysis
measure: Intraepithelial Neoplasia (IN) Detection Rate (True Positive Findings)
timeFrame: During colonscopy (usually <15 min) and subsequent histological analysis
measure: Intraepithelial Neoplasia (IN) Detection Rate (False Positive Findings)
timeFrame: During colonscopy (usually <15 min) and subsequent histological analysis
measure: Intraepithelial Neoplasia (IN) Detection Rate (True Negative Findings)
timeFrame: During colonscopy (usually <15 min) and subsequent histological analysis
measure: Intraepithelial Neoplasia (IN) Detection Rate (False Negative Findings)
timeFrame: During colonscopy (usually <15 min) and subsequent histological analysis
Secondary outcomes:
measure: The Extent and Severity of the Inflamed Mucosa
timeFrame: During colonscopy (usually <15 min) and subsequent histological analysis
measure: The Mucosal Staining Efficacy of Methylene Blue MMX® Tablets After a Total Oral Dose of 200 mg Administered During and at the End of the Intake of the Bowel Cleansing Preparation.
timeFrame: During colonscopy (usually <15 min) and subsequent histological analysis
measure: Bowel Cleansing Quality Evaluated by Boston Bowel Preparation Scale After Intake of Bowel Cleansing Formulation and of a Total Dose of 200 mg of Methylene Blue MMX Tablets Administered During and at the End of the Intake of the Bowel Cleansing Formulation
timeFrame: During colonscopy (usually <15 min)
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Centre for Research & Care of Intestinal Diseases
Study officials:
affiliation: Humanitas Hospital, Italy
name: Silvio Danese, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04229524: Quantitative Assessment of Blood Supply in the Gastic Conduit With Fluorescence Angiography for Esophageal Reconstruction
Official title: Quantitative Assessment of the Correlation Between Blood Supply in the Gastic Conduit and the Incidence of Anastomotic Fistula With Fluorescence Angiography for Esophageal Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: esophageal squamous cell carcinoma
blood supply
anastomotic fistula
fluorescence angiography
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 246
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: PREVENTION

Brief summary: A single-institution, randomize controlled trial is to be held to evaluate the correlation between blood supply in the gastic conduit and the incidence of anastomotic fistula during radical operation for esophageal squamous cell carcinoma by fluorescence angiography.


Eligibility criteria: Inclusion Criteria:

* 1.Histologically confirmed esophageal squamous cell carcinoma and and potential resection;
* 2.Intend to undergo thoracic laparoscopy combined with three-incision esophageal cancer radical operation;
* 3.The stomach is used as an esophageal substitute for reconstruction;
* 4.Enrolled patients will adopt the esophagus bed pathway and round neck anastomosis method;
* 5.Have a performance status of 0 or 1 on the ECOG Performance Scale; Adequate organ function;
* 6.Be willing and able to provide written informed consent/assent for the trial.

Exclusion Criteria:

* 1.Histologically confirmed non-squamous cell carcinoma of the esophagus ;
* 2.The ECOG score of patient's physics \>1;
* 3.Patients who use other organs instead of the esophagus;
* 4.Patients with vascular arch injury and need vascular anastomosis;
* 5.Patients with multiple complications such as heart disease or diabetes;
* 6.Other patients whom the medical practitioner considers inappropriate for inclusion.

Primary outcomes:
measure: The incidence of anastomotic fistula
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital and Research Institute
state: Sichuan
Study officials:
References:
Clinical trial NCT05417724: Utilizing Battlefield Acupuncture(BFA) to Treat Chronic Pain for Homeless and at Risk Veterans.
Official title: Utilizing Battlefield Acupuncture(BFA) to Treat Chronic Pain for Homeless and at Risk Veterans.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupuncture
Homelessness
Pain
Veterans
Lead sponsor: Edith Nourse Rogers Memorial Veterans Hospital
Sponsor class: FED
First posted: 2022-06-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Recruitment of veterans with chronic pain who are interested in being treated with Battlefield Acupuncture (BFA).
Primary purpose: TREATMENT

Brief summary: This research study will evaluate the effectiveness of utilizing Battlefield Acupuncture (BFA) on homeless and at risk for homelessness veterans with chronic pain for 12 weeks.

Detailed description: Methodology: This is a mixed methods prospective design study. A total of 35 subjects will be recruited for this study. The primary study outcome variables are: pain level- pre and post treatment, stress, mood and usual activity levels, sleep patterns and behavioral factors such as ; anxiety, depression, suicidal ideation, substance use and housing stability.

4. Findings: Pending

5. Clinical Relationships: This study is conducted to demonstrate whether or not BFA treatment will decrease pain and improve quality of life for homeless and at risk for homelessness veterans.

6. Impact/Significance: Pending

Eligibility criteria: Inclusion Criteria:

Eligibility criteria include:

* they are 18 years or older
* they are homeless or at risk for homelessness veterans who are enrolled in the VA Bedford Healthcare system and registered in one of the HUD-VASH or HCHV programs,
* history of chronic pain.
* Availability to participate in the study for 4 months.

If they meet these criteria, they will be asked to complete the Informed consent to enroll in the study.

Exclusion Criteria:

* female veterans who are pregnant
* history of bleeding disorders or currently on blood thinning medications
* currently being treated for an active infection of the outer ear.
* currently have a PICC line in their body or are receiving IV antibiotics.
* fear of needles/tacks
* undiagnosed pain complaint

Our recruitment plan invites all eligible veterans and is just, fair, and equitable.

Primary outcomes:
measure: Reduction in pain
timeFrame: 4 months
Secondary outcomes:
measure: Change in pain may impact behavioral health issues.
timeFrame: 4 months
measure: Change in pain may impact housing stability
timeFrame: 4 months
measure: Change in pain may impact substance use.
timeFrame: 4 months
Other outcomes:
Locations:
city: Bedford
country: United States
facility: Bedford VA Healthcare System
state: Massachusetts
Study officials:
affiliation: Edith Nourse Rogers Memorial Veterans Hospital
name: John Wells, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00736424: Brain Stimulation for Epilepsy Long Term Follow-up
Official title: Brain Stimulation for Epilepsy Long Term Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Epilepsy
SUDEP
DBS
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will initially include five sites that conducted physician-sponsored studies in the US and Canada. Centers may be added as additional patients are identified.

Brief summary: The purpose of this study is to collect subject data to evaluate the rate of sudden unexplained death in epilepsy (SUDEP) with bilateral neurostimulation of the anterior nucleus of the thalamus in people diagnosed with refractory epilepsy. The data obtained from the physician initiated studies will be pooled with data collected in Medtronic-sponsored studies to assess SUDEP risk.

Detailed description: Medtronic is conducting a pivotal clinical trial entitled Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy (SANTÉ). One of the requirements of the SANTÉ study is to evaluate the rate of sudden unexplained death in epilepsy (SUDEP). Medtronic is aware of approximately 18 subjects with various types of epilepsy that have been treated with neurostimulation of the anterior nucleus of the thalamus outside the SANTÉ trial under five physician-sponsored studies. This protocol will initially collect information regarding the physician-sponsored study subjects' status. The goal of this study is to pool these data with the SANTÉ data for the purpose of estimating the SUDEP rate.

This is a multi-center, retrospective and prospective clinical study in patients previously implanted with devices that provide bilateral neurostimulation of the anterior nucleus of the thalamus during non-Medtronic-sponsored studies.

Eligibility criteria: Inclusion Criteria:

* Have received bilateral AN stimulation of the anterior nucleus of the thalamus (AN) for epilepsy or are receiving it at the time of enrollment
* For patients with therapy active at the time of enrollment, ability of the patient or legal representative to understand and provide signed consent for participating in the study
* For patients with therapy permanently discontinued or died at time of enrollment, the IRB/REB has approved a waiver allowing collection of the data OR the ability of the patient or legal representative to understand and provide signed consent/medical authorization

Exclusion Criteria:

* None

Primary outcomes:
measure: The primary objective is to collect patient data that may be pooled with other data to estimate the SUDEP rate in people with refractory epilepsy receiving bilateral deep brain stimulation of the anterior nucleus of the thalamus.
timeFrame: 5 years (anticipated)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05650424: Infant Abdominal Massage on Postnatal Stress Level
Official title: The Effects of Infant Abdominal Massage on Postnatal Stress Level Among Chinese Parents in Hong Kong
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Stress
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized control trial is to find out the effects of infant abdominal massage on postnatal stress level among Chinese parents in Hong Kong with babies under 1 year old. The main question\[s\] it aims to answer are:

* examine the effects of infant abdominal massage on postnatal stress level among Chinese parents in Hong Kong
* the relationship between the compliance of the intervention and the change of parental stress level Participants in intervention group will receive a abdominal massage training session and will perform on their baby. Parental stress level will be assess week 0 and four weeks .

If there is a comparison group: Researchers will compare wait-listed control group to see if there is any change on their parental stress level

Detailed description: same as above

Eligibility criteria: Inclusion Criteria:

1. Parents aged 18 or above.
2. Parents with 0-1 year old full term babies without medical treatment of colic.
3. Able to communicate or read Chinese and have not tried applying infant massage on their babies.

Exclusion Criteria:

1. Parents with babies who had abdominal surgery.
2. Currently participating in any other massage related studies.

Primary outcomes:
measure: Parental stress level
timeFrame: week 4
Secondary outcomes:
measure: Difficult child
timeFrame: week 4
measure: Parental distress & Parent-child dysfunctional interaction
timeFrame: week 4
measure: Difference in parental stress with the presence of partner participation
timeFrame: week 4
measure: Correlation between parental stress and self-reported compliance of the intervention
timeFrame: week 4
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
References: