louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00189241: A Study to Evaluate Effectiveness of Imiquimod 5% Cream in Superficial Basal Cell Carcinoma
Official title: An Open-Label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 5 Days Per Week for 6 Weeks in the Treatment of Superficial Basal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Basal Cell Carcinoma
Keywords: Aldara
Superficial Basal Cell Carcinoma
Long-Term Study
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 160
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 purpose of this study is to evaluate the long-term sustained clearance rate of superficial basal cell carcinoma during a 5 year period following treatment with imiquimod


Eligibility criteria: Inclusion Criteria:

* Have one superficial BCC - primary tumour
* Minimum tumour area of 0.5cm2, maximum diameter of 2.0cm.
* If female and of child bearing potential, negative pregnancy test and willing to use medically acceptable method of contraception.

Exclusion Criteria:

* Evidence of clinically significant, unstable medical conditions.
* Evidence of Gorlin syndrome, metastatic tumour or tumour with high probability of metastatic spread, have or have had within last 5 years other malignant cancers of the skin at target tumour site.
* Have received defined treatments in tumour site or surrounding area.
* Any dermatological disease in the target tumour site or surrounding area.
* Have had a systemic bacterial or viral infection within 2 weeks prior to study initiation.

Primary outcomes:
measure: To evaluate the long-term sustained clearance rate, defined as the proportion of subjects who are clinically clear of sBCC at the treated sBCC target tumour site at the 12 week posttreatment visit and remain clear during the 5 year follow-up period.
Secondary outcomes:
measure: To evaluate the safety and cosmetic outcome of once daily 5 days per week dosing for 6 weeks with imiquimod 5% cream in the treatment of sBCC
Other outcomes:
Locations:
city: Magedeburg
country: Germany
facility: Univertätsklinik für Dermatologie und Venerologie
Study officials:
References:
Clinical trial NCT01174017: Ability of a New Design of Iodine 125 Seed to Maintain Intended Position When Implanted in the Prostate
Official title: A Study Assessing the Ability of AnchorSeed Iodine-125 Sources to Hold Fast in Tissue When Implanted for Treatment of Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: prostate cancer
Iodine 125 brachytherapy
seed migration
seed migration in the first month after brachytherapy
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: Biocompatibles UK Ltd
First posted: 2010-08-03
Enrollment: 41
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the ability of a new design of brachytherapy seed for prostate seed implants for treatment of prostate cancer to maintain their intended position in the prostate after being deposited. Standard seeds, especially in apical locations, have a tendency to migrate distally in response to muscular forces. AnchorSeeds have a textured coating which is designed to prevent migration. 40 patients who are eligible and suitable for prostate brachytherapy will be randomly assigned to receive either standard seeds or AnchorSeeds.

Detailed description: Standard post implant prostate brachytherapy quality assurance at the Center for the Southern Interior is usually performed at one month after the procedure with CT and MR imaging. In order to test the ability of the new design of prostate brachytherapy seeds (AnchorSeeds) to hold their position in the prostate, 40 men who have been randomly assigned to receive either standard seeds or AnchorSeeds will have an additional CT scan immediately after the procedure to record seed position for comparison to positions one month later. The magnitude and frequency of seed displacement will be determined.

Eligibility criteria: Inclusion Criteria:

* localized prostate cancer
* favorable or intermediate risk
* suitable for permanent seed implant by functional and technical criteria

Exclusion Criteria:

* patient unwilling to have a second CT scan for study purposes
* claustrophobic patient unable to have CT scan
* patient unsuitable for brachytherapy because of prostate size or poor voiding function
* patient medically unable to stop anticoagulants for procedure

Primary outcomes:
measure: seed displacement
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Cancer Center for the Southern Interior
state: British Columbia
Study officials:
References:
citation: Badwan HO, Shanahan AE, Adams MA, Shanahan TG, Mueller PW, Markwell SJ, Tarter TH. AnchorSeed for the reduction of source movement in prostate brachytherapy with the Mick applicator implant technique. Brachytherapy. 2010 Jan-Mar;9(1):23-6. doi: 10.1016/j.brachy.2009.07.002. Epub 2009 Sep 17.
Clinical trial NCT04128917: Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT
Official title: A Randomized, Double-Blind, Active-controlled, Multicenter, Pilot Study to Investigate the Safety and Efficacy of a Triple Therapy With Tegoprazan, Amoxicillin and Clarithromycin in H. Pylori Positive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2019-10-16
Enrollment: 102
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare safety and efficacy in an exploratory manner between a Tegoprazan triple therapy and a RAPAE01 triple therapy in H. pylori positive patients.

Detailed description: A Randomized, Double-Blind, Active-controlled, Multicenter, Pilot Study to Investigate the Safety and Efficacy of a Tegoprazan triple therapy and a RAPAE01 triple therapy in H. pylori positive patients.

Eligibility criteria: Inclusion Criteria:

* H. pylori positive at screening
* Subjects who have upper gastrointestinal disease

Exclusion Criteria:

* Having received prior therapy for eradication of H. pylori
* Prior use of P-CAB, proton pump inhibitors (PPIs), H2 receptor blockers within 14 days
* Prior use of H. pylori eradication effective antibiotics, bismuth within 28 days

Primary outcomes:
measure: H. pylori eradication rate
timeFrame: Day 49
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hosptial
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: JAEGYU KIM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01093417: Study of Vitamin D and Effect on Heart Disease and Insulin Resistance
Official title: The Effect of Vitamin D Supplementation on Endothelial Function, Inflammation and Insulin Resistance in HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Human Immunodeficiency Virus (HIV)
Vitamin D Deficiency
HIV Infections
Keywords: Vitamin D
Human Immunodeficiency Virus (HIV)
Complementary Therapies
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate how Vitamin D affects endothelial function, inflammation, lipids, insulin resistance, vitamin D levels, and parathyroid hormone (PTH).

Detailed description: Randomized placebo controlled trial of vitamin D supplementation in HIV infected subjects with vitamin D deficiency

Eligibility criteria: Inclusion Criteria:

* HIV infected
* HIV-RNA \< 400 copies/ml at study entry and for 12 wks. prior
* 25-hydroxyvitamin D level \<20
* On a stable anti-retroviral (ARV) regimen for at least 12 weeks prior to study entry

Exclusion Criteria:

* Pregnancy or Breast Feeding
* Diabetes
* Creatinine Clearance \<50
* Any active infectious or inflammatory condition
* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 within 6 months prior to study entry

Primary outcomes:
measure: Change in Endothelial Function
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in Serum 25-hydroxyvitamin D Concentration in Both Groups
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Case Medical Center
state: Ohio
Study officials:
References:
citation: Longenecker CT, Hileman CO, Carman TL, Ross AC, Seydafkan S, Brown TT, Labbato DE, Storer N, Tangpricha V, McComsey GA. Vitamin D supplementation and endothelial function in vitamin D deficient HIV-infected patients: a randomized placebo-controlled trial. Antivir Ther. 2012;17(4):613-21. doi: 10.3851/IMP1983. Epub 2011 Nov 17.
Clinical trial NCT01296217: Sentinel Lymph Node Detection in Prostate Surgery by Laparoscopy
Official title: "Evaluation of the Sentinel Lymph Node Technic of the Prostate by Laparoscopy"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: Patients with infiltrant prostatic carcinoma
Lead sponsor: Centre René Gauducheau
Sponsor class: OTHER
First posted: 2011-02-15
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: In this study the investigators want to determine if the detection of lymph node is applicable in prostatectomy by laparoscopy.


Eligibility criteria: Inclusion Criteria:

* Age\> 18 years
* Diagnosis of invasive cancer of the prostate (T1 or T2 or T3)
* PSA ≥ 4,
* Gleason ≥ 6
* No treatment prior to surgery
* Indication of lymphadenectomy by coeliscopique
* ECOG or Karnofsky index 2
* Patient information and signed informed consent

Exclusion Criteria:

* neoadjuvant hormone therapy
* Interventions prior pelvic
* Patients who received anterior resection of part of prostate
* Patient or denied having an altered mental status
* Any contre indication to laparoscopy

Primary outcomes:
measure: detection rate and false-negative rate for the sentinel lymph node detection
timeFrame: The day of at laparoscopy (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Centre René Gauducheau
Study officials:
References:
Clinical trial NCT03407417: A Patient-centered Intervention Using Technology to Reduce Colorectal Cancer Disparities in Primary Care
Official title: A Patient-centered Intervention Using Technology to Reduce Colorectal Cancer Disparities in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colo-rectal Cancer
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-01-23
Enrollment: 960
Sex: ALL
Minimum age (years): 45
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this proposal is to test the efficacy of a patient-centered, tailored message intervention delivered via virtual technology for increasing colorectal cancer (CRC) screening within guidelines among racial/ethnic minority and rural patients. This protocol focuses on the clinical portion of grant NCI 1RCA207689-01A1

Detailed description: Patients will be recruited via a secure, clinical data warehouse to complete a patient-randomized test of the efficacy of the intervention for promoting initial and repeat FIT testing. Patients identified as eligible will be contacted through MyChart to test a web-based, culturally-sensitive virtual human intervention for CRC screening. The web-application will provide information to encourage CRC screening. Therefore, this study is a minimal risk study.

Eligibility criteria: Inclusion Criteria:

* able to read English or Spanish at least at eighth-grade level
* have an email account or the ability to receive texts
* willingness to be re-contacted
* consent to MRR related to CRC screening
* not remember completing any CRC screening within recommended guidelines (i.e., \<10 years for colonoscopy, \<1 year for stool test).
* complete a FIT test:
* a) with a negative result only
* b) complete a FIT test with a positive result AND undergo a completion screening colonoscopy,
* Or c) complete a colonoscopy only.

Exclusion Criteria:

* unable to read English at least at eighth-grade level
* doesn't have an email account or the ability to receive texts
* unwilling to be re-contacted
* Unable to consent to MRR related to CRC screening
* have not had \<10 years for colonoscopy, or 1 year for stool test

Primary outcomes:
measure: Intention to Screen for Colorectal Cancer (CRC)
timeFrame: within the first 12 months
Secondary outcomes:
measure: Communication With a Provider About Colorectal Cancer (CRC)
timeFrame: Assessed after 24 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Benjamin Lok
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02255617: Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study
Official title: A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatic Encephalopathy
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2014-10-02
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole.

Detailed description: Subjects receive FMT from a single donor by colonoscopy at Week 0 and by enema at Weeks 1-4. HE is measured by Inhibitory Control Test and Stroop as well as serum ammonia levels.

Eligibility criteria: Inclusion Criteria:

1. adult (age \> 18 years of age) cirrhotic patients of various etiology, on lactulose and/or rifaximin or flagyl for at least 4 weeks as secondary prophylaxis
2. abnormal inhibitory control test, defined as greater than 5 lures.
3. an infectious etiology which may cause HE has been ruled out

Exclusion Criteria:

1. those with tense ascites
2. those who do not provide assent
3. those who are judged to have a life expectancy of less than 3 months,
4. those who had TIPS within 3 months,
5. those with neurologic diseases such as dementia, Parkinson's disease, and structural brain lesions
6. pregnancy
7. those with intestinal obstruction
8. those with alcoholic hepatitis
9. those with active alcohol or substance abuse
10. those without stable social support
11. those who have a concurrent infection, such as SBP, pneumonia or UTI
12. those with creatinine clearance less than 50% compared to baseline
13. those with recent hospital admission, defined as within one month of enrollment, for hepatic encephalopathy

Primary outcomes:
measure: Portion of participants with normailzation of ICT or Stroop Test during the study
timeFrame: 8 weeks
Secondary outcomes:
measure: Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8
timeFrame: 8 weeks
measure: Changes in serum ammonia level pre and post FMT
timeFrame: 8 weeks
measure: Changes in Quality of Life measured by Chronic Liver Disease Questionnaire (CDLQ) pre and post FMT
timeFrame: 8 weeks
measure: Changes in Intestinal Microbiota pre and post FMT
timeFrame: 8 weeks
measure: Serious Adverse Events
timeFrame: 8 weeks
measure: Changes in stool bile acids composition pre and post FMT
timeFrame: 8 Weeks
measure: Changes in stool short chain fatty acids pre and post FMT
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
References:
Clinical trial NCT02294617: E-cigarette vs. Nicotine Inhaler Comparisons
Official title: Comparative Evaluation of the Perceptions and Utilization of Nicotine Inhalation Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2014-11-19
Enrollment: 41
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The goal of this study is to get information from current smokers about how they feel towards both the electronic cigarette (e-cigarette) and the nicotine oral inhaler. This will include beliefs, harms, appeal, ease of use, enjoyment, and their use for helping people stop smoking.

Detailed description: Subjects will be seen at Baseline, then 3-days post-baseline, then 9 days post-baseline for post product use questionnaires and carbon monoxide monitoring. The time frame for follow up is 6 months post Baseline visit.

Eligibility criteria: Inclusion Criteria:

* Subjects will be smokers 18 years or older, who have had no previous experience with either the e-cigarette or the nicotine oral inhaler, and will be recruited from the local community. They can currently smoke any amount or frequency and with any level of motivation to stop smoking.

Exclusion Criteria:

* Exclusion criteria include recent (within 2 weeks) myocardial infarction or angina, poorly controlled asthma/chronic obstructive pulmonary disease , active substance abuse, pregnancy, or current use of any other cessation medications

Primary outcomes:
measure: Satisfaction of devices on Likert Scale
timeFrame: 6 months (August 2012-December 2013)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04676217: Position Related Changes in Macular Hole Morphology Before and After Surgery
Official title: Position Related Changes in Macular Hole Morphology Before and After Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Holes
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Helse-Bergen HF
First posted: 2020-12-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: Macular hole is a full thickness retinal defect in the very centre of the retina that gives the sharpest vision. The condition causes a substantial deterioration of visual acuity, and operative measures are necessary in order to close the defect and improve the visual function. A macular hole has varying degrees of retinal oedema surrounding the hole edges. The oedema is maintained by continuous of liquid into the tissue and effectively prevents spontaneous closure. For that reason it is essential for macular hole closure that the macula has minimal contact with intraocular fluid in the very early postoperative phase. This is why the treatment included a long-lasting intraocular gas tamponade and typically, one week of face-down positioning (FDP) after surgery.Our aim is to investigate the impact of diurnal, orthostatic, and gravitational variations on macular hole morphology before and after surgery. The participants will be examinated with optical coherence tomography 8-10 am, 1 pm, and 3 pm. Between 8 am and 1 pm ,the patient is encouraged to an upright position. After the 1 pm examination, the patient will be positioned flat on the side of the eye with macular hole until the 3 pm examination. The surgery will be performed before 10 am. Postoperatively a randomization to face down positioning or no positioning until 3 am. Optical coherence tomography images through gas tamponade is made at 3 am.


Eligibility criteria: Inclusion Criteria:

* Primary macular hole
* Able to sign informed consent
* Signed informed consent

Exclusion Criteria:

* Previous vitreoretinal surgery in the study eye
* Secondary macular holes caused by other conditions than vitreomacular traction
* Myopic macular hole, i.e. excessive myopia (more than -6 dioptres)
* Posttraumatic macular hole
* Macular holes secondary to retinal detachment or other retinal diseases

Primary outcomes:
measure: Macular hole mid diameter
timeFrame: 1 day
measure: Macular hole basal diameter
timeFrame: 1 day
measure: Macular hole mid area
timeFrame: 1 day
measure: Central retinal thickness
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital, Department of Ophthalmology
Study officials:
References:
Clinical trial NCT00215917: D-Serine Monotherapy for Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
NMDA
D-serine
Lead sponsor: Herzog Hospital
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: N-methyl-D-aspartate receptor (NMDAR) agonist, added to classical or atypical antipsychotic medication, has reduced negative, depressive, and cognitive symptomatology. We will be investigating the effect of D-serine, (DSR), a selective and potent NMDAR agonist, as monotherapy for treatment resistant schizophrenics.

40 subjects on stable doses of risperidone will be randomized under double-blind conditions into a treatment group, which will receive D-serine 2100 mg, or a control group, which will continue to receive risperidone. Treatment will continue for 14 weeks.

Symptoms and side effects will be rated biweekly with the CGI, PANSS, BPRS, SAS, AIMS, and UKU. Before and after the trial subjects will undergo neuropsychological assessments. Baseline and post-trial levels of amino acids relevant to glutamatergic neurotransmission (glutamate, glutamine, aspartate, glycine, serine, alanine) will be assessed.

The primary outcome measures of the study will be the PANSS total scores and the positive and negative symptom cluster scores.


Eligibility criteria: Inclusion Criteria:

1. DSM-IV criteria for chronic schizophrenia
2. Treatment resistant
3. aged 18-70
4. Two months on stable risperidone dose
5. PANSS positive symptom cluster score \>20
6. PANSS negative symptom cluster score \>22

Exclusion Criteria:

1. Substance abuse
2. Concurrent DSM IV axis I disorder
3. Serious medical disorder
4. Concurrent drug therapy that can obscure the effect of risperidone or DSR.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Herzog Hospital, Department of Psychiatry
Study officials:
affiliation: Herzog Hospital, and Hadassah Medical School--the Hebrew University of Jerusalem, Israel
name: Pesach Lichtenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: