louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00005883: Phenethyl Isothiocyanate in Preventing Lung Cancer in People Who Smoke
Official title: A Phase I - Part B Multiple Dose Trial of Phenethyl Isothiocyanate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer
Keywords: non-small cell lung cancer
small cell lung cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-04-28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Phenethyl isothiocyanate may be effective in preventing lung cancer in smokers.

PURPOSE: Phase I trial of phenethyl isothiocyanate in preventing lung cancer in people who smoke.

Detailed description: OBJECTIVES: I. Determine the maximum tolerated dose of oral phenethyl isothiocyanate in smokers. II. Measure the steady state pharmacokinetics of phenethyl isothiocyanate required to maintain a steady state of this substance during the hours of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) exposure in these patients. III. Obtain preliminary data on the perturbation of NNK metabolism by phenethyl isothiocyanate in these patients.

OUTLINE: Patients complete a questionnaire containing a smoking and dietary log to assess cigarette and cruciferous vegetable consumption. Patients receive phenethyl isothiocyanate orally 4 times a day for 30 days. Cohorts of 3-6 patients receive escalating doses of phenethyl isothiocyanate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed on days 35, 36, and 43.

PROJECTED ACCRUAL: A total of 15-27 patients will be accrued for this study over 4-6 months.

Eligibility criteria: DISEASE CHARACTERISTICS: Asymptomatic smokers who either refuse to or cannot stop smoking Urinary cotinine levels greater than 100 ng/mL Willing to adhere to certain dietary restrictions limiting intake of cruciferous vegetables (watercress, broccoli, radishes, mustard, brussels sprouts) while on study

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.6 mg/dL Transaminases less than 2 times normal Renal: Creatinine less than 1.6 mg/dL Urinary RBC levels 0-2 Urinary WBC levels at least 0-2 Pulmonary: No dyspnea at rest Other: No concurrent illness, condition, or symptom that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Leonard Liebes, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01727583: Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients
Official title: Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2012-11-16
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This pilot study is aimed at assessing the acute effect of several combinations of lipids differing in their fatty acid composition on glucagon-like-peptide (GLP)-2 and GLP-1 secretion in healthy subjects.

Detailed description: In this study, the investigators aim to investigate the effect of various lipid types on GLP-2 and GLP-1 secretion. This will allow to determine the importance of lipids in nutritional solutions. Moreover, this will allow us to assess whether existing clinical formulas can be improved in order to stimulate GLP-2 and accelerate intestinal recovery.

Eligibility criteria: Inclusion Criteria:

* BMI : 19 - 24.9 kg.m-2
* Normal fasting glycemia
* Having obtained his informed consent.

Exclusion Criteria:

* Gastro-intestinal disease (ulcer), pancreatic disease, hepatic disease, metabolic diseases / disorders (diabetes, dyslipidemia), renal disease, cardiovascular disease (arterial hypertension), as determined by the medical screening visit and a blood analysis.
* Have had a gastrointestinal surgery (with the exception of appendices resection).
* Malabsorption disorders
* Lactose intolerance
* Significant weight loss during the past three months (more than 5% of initial weight)
* Have a regular consumption of medication
* Regular supplements (vitamins and minerals) intake during the previous month
* Have an alcohol intake: \> 2 units a day
* Smoker (more than 2 cigarettes a day)
* Illicit substances intake, as stated on the medical screening questionnaire
* Allergy to any food or medication
* Anaemia defined by a number of erythrocytes or hemoglobin Hb or hematocrit Ht which are inferior to laboratory normal ranges
* Having given blood in the past three months or willing to give blood in the 3 months following the completion of the study
* Intense physical activity \> 3 hours per week
* Currently participating or having participated in another clinical trial during the past month.
* Volunteer who cannot be expected to comply with the protocol, including consuming rapidly the study products, chronic medication intake

Primary outcomes:
measure: GLP-2 and GLP-1 kinetics
timeFrame: changes from baseline to 4 hours following meal intake
Secondary outcomes:
measure: Intestinal and metabolic hormones
timeFrame: Changes from baseline to 4 hours following meal intake
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Nestlé CDU / Metabolic Unit
Study officials:
affiliation: Nestlé / CDU / Metabolic Unit
name: Maurice Beaumont, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00662883: Assessing the Effects of a Nasal Corticosteroid on PMI-150 (Intranasal Ketamine)
Official title: A Randomized, Open Label Study to Assess the Effects of a Nasal Corticosteroid on the Pharmacokinetics, Safety, and Tolerability of PMI-150 (Intranasal Ketamine Hydrochloride) 30 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ketamine
corticosteroid
intranasal
phase I
Healthy volunteers
Lead sponsor: Javelin Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine HCl)

Detailed description: Subjects will participate in a two-period, single-sequence study to assess the effects of administration of a nasal corticosteroid, Nasonex (mometasone furoate), on the pharmacokinetics, safety and tolerability of PMI-150 (intranasal ketamine HCl) in healthy adult volunteers.

Eligibility criteria: Inclusion Criteria:

* healthy adults
* nonsmoker
* no drug use

Exclusion Criteria:

* nasal abnormalities
* airway abnormalities

Primary outcomes:
measure: Pharmacokinetic parameters
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
state: Maryland
Study officials:
affiliation: Javelin Pharmaceuticals
name: Javelin Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References:
Clinical trial NCT06416683: Atezolizumab and Bevacizumab Combination Recommended in a Multidisciplinary Consultation Meeting in Caen for Hepatocellular Carcinoma (ABCHCaen)
Official title: Study of the Atezolizumab and Bevacizumab Combination Recommended in a Multidisciplinary Consultation Meeting in Caen for Hepatocellular Carcinoma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atezolizumab and Bevacizumab in Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
immunotherapy
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with advanced hepatocellular carcinoma whose treatment with Atezolizumab and Bevacizumab has been validated in a multidisciplinary consultation meeting

Brief summary: In France primary liver cancers (PLC) is the fourth leading cause of cancer-related death in men, and the seventh in women. The number of new cases per year is predicted to increase by 26.5% between 2020 and 2040. Hepatocellular carcinoma (HCC) account for 75% to 85% of PLC. It occurs mostly on cirrhotic livers. Diagnosis remains late in almost half of the patients so that a palliatif treatment is frequent. In advanced cases sorafenib has been so far the first line systemic therapy since 2008. In 2020 a phase 3 study has demonstrated a better overall survival in patients treated with bevacizumab associated with atezolizumab as compared to sorafenib (19.2 months vs 13.4 months) and a better quality of life. Noweday immunotherapy is recommended in first line in cases of ECOG 0/1 unresectable HCC without liver insufficiency. However the study included 70% of viral liver diseases while HCC are related to alcohol and steatohepatitis in 50% of cases in France. Moreover patients with high risk of oesophageal variceal bleeding were excluded. Recent real life data published worldwide confirm the bitherapy efficacy and good tolerability. By contrast french data are scarces, with a single serie of 43 patients in which median overall survival was estimated to 12 months. Our main aim is to determine the overall survival of HCC patients treated with atezolizumab and bevacizumab in Caen from april 2021.


Eligibility criteria: Inclusion Criteria:

* age superior or equal to 18 years
* patients with advanced hepatocellular carcinoma
* treatment validated in multidisciplinary consultation meeting

Exclusion Criteria:

* patients with another kind of liver cancer

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: progression-free survival
timeFrame: 3 years
measure: predictors of response to treatment
timeFrame: 3 years
measure: treatment tolerance
timeFrame: 3 years
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
state: France/Normandie
Study officials:
References:
Clinical trial NCT03128983: Physiological Data in the Menstrual Cycle
Official title: Variations of Physiological Data Throughout the Menstrual Cycle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertility
Lead sponsor: Ava AG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Zürich
name: Centre Suisse d'Electronique et de Microtechnique (CSEM), Switzerland
name: Empa, Swiss Federal Laboratories for Materials Science and Technology
First posted: 2017-04-25
Enrollment: 41
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A maximum of 50 healthy, 20-40 years old, non-pregnant women will be included in the study.

Brief summary: Research results suggest changes of physiological parameters such as heart rate, respiration, skin conductance response, sleep duration, sleep quality and skin perfusion during the menstrual cycle. Latest fitness trackers allow to conveniently and non-invasively record these parameters. The present study aims to evaluate whether there is a correlation between physiological parameters and the menstrual cycle i.e. ovulation as measured by a urine ovulation test and the onset of menses. To collect data women will wear two smartwatches and a smartshirt at night. All three devices are CE-approved for sports and fitness.


Eligibility criteria: Inclusion Criteria:

* Healthy, non-pregnant women aged 20-40 years (healthy volunteers)
* Regular cycling (28 days +/- 2)
* Non-hormonal contraception methods used
* German-speaking
* Written informed consent to participate in the study

Exclusion Criteria:

* Any health-related issues that may affect menstrual cycle
* Any consumption of medication or other substances that may affect the menstrual cycle or any of the physiological parameters investigated
* Frequent travel between time zones
* Sleeping disorders

Primary outcomes:
measure: Correlation between menstrual cycle dynamics and physiology
timeFrame: During 1 menstrual cycle between 24 days and 35 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01879683: A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions
Official title: A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of LiRIS® 400 mg in Women With Ulcerative Interstitial Cystitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Interstitial Cystitis
Keywords: Hunner's lesion
Lead sponsor: Allergan
Sponsor class: INDUSTRY
Collaborators: name: TARIS Biomedical, Inc.
First posted: 2013-06-18
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any change in the bladder or in IC symptoms, following LiRIS administration.


Eligibility criteria: Inclusion Criteria:

* Women age 18 and older
* Interstitial Cystitis with history of Hunner's lesions in the bladder
* Moderate to severe bladder discomfort
* Confirmation of Hunner's lesions in Bladder
* Able to report symptom (pain and voiding frequency) in a diary throughout the study

Exclusion Criteria:

* Pregnant women
* History or presence of bladder cancer
* History or presence of any condition that would make it difficult to evaluate bladder symptoms

Primary outcomes:
measure: Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14
timeFrame: Baseline, Day 14
measure: Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28
timeFrame: Baseline, Day 28
Secondary outcomes:
measure: Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain
timeFrame: Baseline, during treatment (Days 7, 14, 20, 28) and during follow up (Weeks 1, 2, 4, 8, 12)
measure: Change From Baseline in Patient Reported IC Symptom: Daily Total Voids
timeFrame: Baseline, during treatment (Days 7, 14, 20, 28) and during follow-up (Weeks 1, 2, 4, 8, 12)
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Advance Urology Institute
state: Florida
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00145483: Sildenafil For Meniere's Disease
Official title: A Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study Of The Efficacy and Safety Of Sildenafil Given For The Acute Treatment Of Meniere's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meniere's Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 163
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: Meniere's disease affects a person's sense of balance. An attack can last 20 minutes to 2 hours or longer. Symptoms include rotational vertigo, hearing loss, tinnitus and a sensation of fullness in the affected ear and may be associated with nausea and vomiting. One hypothesis is that Meniere's disease is caused by the excessive accumulation of fluid in the balance tubes within the inner ear. Sildenafil may alleviate the symptoms due to its vasodilatory activity. The purpose of this study is to assess the safety and efficacy of sildenafil (Viagra) compared with placebo on symptoms during one acute attack.


Eligibility criteria: Inclusion Criteria:

* Active Meniere's disease (2 or more definitive spontaneous episodes of vertigo 20 minutes or longer, plus hearing loss on at least 1 occasion, tinnitus or aural fullness) with confirmed diagnosis

Exclusion Criteria:

* Pregnant or breast feeding females or fertile females unwilling to use agreed contraceptive methods
* severe Meniere's diseased (more than 8 attacks per month)
* previous ear surgery
* intratympanic perfusions of steroids or gentamicin; requiring other medications contraindicated for Viagra (eg. nitrates)
* with medical conditions that make Viagra contraindicated

Primary outcomes:
measure: Vertigo Response (4 x 6 point scale); Balance (6 point scale)
Secondary outcomes:
measure: Hearing/Tinnitus; Ear, Nose & Pressure/Fullness; Perf. daily activities; Nausea; Vomiting; Func. Response; Duration of the Attack and Vertigo; Rescue Medications Use; Acceptability to subject; Composite Assessment Score; Comparison to Previous Attack
Other outcomes:
Locations:
city: Bondi Junction
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Brisbane
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: East Melbourne
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: Pfizer Investigational Site
state: Victoria
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01003483: Metformin Versus Orlistat in Obese Polycystic Ovary Syndrome (PCOS) Patients
Official title: Orlistat Administration Facilitates the Obesity Treatment Among Obese PCOS Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: metformin
orlistat
pcos
obese
Lead sponsor: Yazd Research & Clinical Center for Infertility
Sponsor class: OTHER
Collaborators: name: Yazd Medical University
First posted: 2009-10-28
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the influence of Orlistat and Metformin on obesity treatment in obese PCOS women.

Detailed description: In a randomized clinical trial study, 80 obese women with BMI≥30, oligomenorrhae, hirsutism and presence of \> 12 ovarian follicles (2-10mm diameter), were evaluated. In metformin group , metformin was administered for patients 1500 mg daily for three months. In orlistate group, patients used orlistat tablets (120 mg, 3 times a day) for three months. BMI, serum LH and FSH levels, serum triglyceride and cholesterol levels and also patients' ovulation was compared before and after treatment.

Eligibility criteria: Inclusion Criteria:

* BMI\>= 30
* PCOS

Exclusion Criteria:

* Drug use during last three months

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 3 months
Secondary outcomes:
measure: Ovulatory
timeFrame: 3 months
Other outcomes:
Locations:
city: Yazd
country: Iran, Islamic Republic of
facility: Research and Clinical Center for Infertility
Study officials:
affiliation: Research and Clinical center for Infertility
name: Abbas Aflatoonian, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05832983: Aromatherapy and Anxiety Study
Official title: The Effect of Aromatherapy on Situational Anxiety in Adults Receiving Intra-Articular Injections in the Ambulatory Clinic Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Related to Pain Related to an Intraarticular Injection
Pain Related to an Intraarticular Injection
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: While intra-articular injections can alleviate pain in orthopedic patients, this can be an anxiety-provoking experience. Adult patients scheduled to receive an injection at the study location will be randomly assigned to one of three groups. The control group (C) will receive the current standard of nursing care. The first experimental group (A) will receive a guided meditation prior to receiving the injection. The second experimental group (B) will receive an Elequil Aromatab and the same guided meditation prior to receiving the injection.

Detailed description: The objective of the study is to measure the difference in anxiety levels of adult orthopedic patients in need of intra-articular injections who receive a guided meditation only prior to their injection, compared to those who receive a guided meditation and an aromatherapy Elequil Aromatab prior to injection, as well as compared with those who receive the usual standard of care

Eligibility criteria: Inclusion Criteria:

* Patient has an in-office appointment at the NYU Langone Ambulatory Care-23rd Street location with either the Ortho A \& B (primarily those patients who may be seeking knee or hip replacement surgery), Hand, or Primary Sport clinics.
* Patient has an order for an intra-articular injection (as determined by clinic MD) and has consented to receiving that treatment.
* Patient is English speaking.

Exclusion Criteria:

* Patient has a cognitive or physical disability that would interfere with their ability to complete the study's pre and post assessments with RN.
* Patient is found on the pre-injection assessment form to have an intolerance or allergy to lavender, sandalwood, or strong scents in general.

Primary outcomes:
measure: Change in Short-Version Spielberger State-Trait Anxiety Inventory (SSTAI) Score
timeFrame: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
measure: Change in Pain Score
timeFrame: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
measure: Change in Blood Pressure
timeFrame: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
measure: Change in Heart Rate
timeFrame: 10-15 minutes prior to injection, 5 minutes post-injection (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jennifer Withall, PhD
role: PRINCIPAL_INVESTIGATOR
References: