louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00034918: This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Metastatic Breast Cancer
Official title: An Open-label, Multicenter Phase II Study to Assess the Response of Subjects With Metastatic Breast Cancer Previously Treated With Anthracycline and Taxane Therapy With or Without Capecitabine to ZD6474 (100-mg or 300-mg Daily Oral Dose).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Metastases, Neoplasm
Keywords: Metastatic breast cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of ZD6474 in patients with metastatic breast cancer at 2 dose levels.


Eligibility criteria: Inclusion Criteria:

* Histological and/or cytological confirmation of metastatic breast cancer which is refractory to anthracycline, taxane, with or without capecitabine therapies;
* WHO performance status 0, 1 or 2 on the day of registration;
* Females, aged \>= 18 years;
* No Gastrointestinal pathology which could affect the bioavailability of ZD6474.

Exclusion Criteria:

* Any evidence of severe or uncontrolled systemic diseases including known cases of Hepatitis B or C or human immunodeficiency virus (HIV).
* Significant cardiac event (including symptomatic heart failure or unstable angina) within 3 months of entry or any cardiac disease that in the opinion of the investigator increases risk for ventricular arrhythmia;
* History of clinically significant cardiac arrhythmia (multifocal PVCs, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTC grade 3) or asymptomatic sustained ventricular tachycardia;
* Chronic atrial fibrillation;
* Previous history of QT / QTc prolongation with other medication;
* Congenital long QT syndrome;
* Systemic anti-cancer therapy or other investigational agent within the last 4 weeks (6 weeks for nitrosoureas, mitomycin C, or suramin);
* Currently receiving drugs with known significant 3A4 inhibitory (ie, ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem, verapamil) or stimulatory (ie, phenytoin, carbamazepine, barbiturates, rifampicin) effects;
* Currently receiving therapeutic doses of warfarin (Coumadin?)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Barcelona
country: Spain
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT03907618: Evaluation of HbA1c Levels and Ovarian Reserve and Type 1 Diabetes
Official title: Evaluation of HbA1c Levels and Ovarian Reserve in Patients With Type 1 Diabetes Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Ovarian Failure
Keywords: Antral follicle count
Anti müllerian hormone
Ovarian reserve
HbA1c
type 1 diabetes mellitus
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female patients between 18 and 40 years of age who had consent and had gynecological examination in our polyclinic; study group for patients with type 1 diabetes mellitus

Brief summary: The human ovary is the target of an autoimmune attack, usually in organ or non-specific autoimmune disorders. Serum anti-Müllerian hormone (AMH) levels decrease early in menopause and menopause is seen in women with type 1 diabetes mellitus (DM1) at a young age. DM1 is aimed to show DM1 relationship with ovarian reserve based on the assumption that it will have lower AMH levels than controls, secondary to bad glycemic control and autoimmune attack in women.

Detailed description: The study was designed prospectively. Ovarian functions in healthy volunteer women and patients who use DM1 diagnosed between 18-40 years old will be examined. Gonadotropin and AMH levels will be measured in follicular phase. To calculate the number of antral follicles (AFC) and ovarian volume, ultrasound will be looked at. Fasting and satiety blood glucose, HbA1c and C-peptide levels will be evaluated.

Eligibility criteria: Inclusion Criteria:

* female patients between 18 and 40 years of age who had consent and had gynecological examination in our polyclinic;
* study group for patients with type 1 diabetes mellitus healthy volunteers control group

Exclusion Criteria:

* Other endocrine and / or autoimmune disorders, polycystic ovary syndrome (PCOS) and
* previous surgery, which may reduce ovarian reserves;
* medical and / or radiotherapy

Primary outcomes:
measure: Antral follicle count (AFC)
timeFrame: On the 3rd day of the menstrual cycle
measure: Anti müllerian hormone (AMH)
timeFrame: On the 3rd day of the menstrual cycle
measure: HbA1c
timeFrame: On the 3rd day of the menstrual cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT05728918: Effectiveness of Antrodia Cinnamomea Mycelia on Improving Immune Response in Subhealth People
Official title: Effectiveness of Antrodia Cinnamomea Mycelia on Improving Immune Response in Subhealth People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue Syndrome, Chronic
Cold
Lead sponsor: Greenyn Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-15
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to assess the effect of Antrodia cinnamomea mycelia on immune modulation in subhealth people.

Detailed description: This study aims to assess the effect of Antrodia cinnamomea mycelia on immune modulation in subhealth people: a randomized, double-blind, placebo-controlled, and parallel clinical investigation.

Eligibility criteria: Inclusion Criteria:

* Subjects are easy to feel fatigued
* Subjects have poor sleep quality

Exclusion Criteria:

* Pregnant women or preparing for pregnancy.
* Lactating women.
* Women gave birth 6 months before the study.
* Poor kindy and livers funcitons
* Severe cardiovascular or other chronic diseases
* Alcohol abuser
* Using immune-associated supplements

Primary outcomes:
measure: Immune analysis
timeFrame: Baseline up to 4 weeks
measure: Immune analysis
timeFrame: Baseline up to 4 weeks
measure: Antibody analysis
timeFrame: Baseline up to 4 weeks
measure: Antibody analysis
timeFrame: Baseline up to 4 weeks
measure: Antibody analysis
timeFrame: Baseline up to 4 weeks
measure: Antibody analysis
timeFrame: Baseline up to 4 weeks
measure: Antibody analysis
timeFrame: Baseline up to 4 weeks
measure: Cytokine analysis
timeFrame: Baseline up to 4 weeks
measure: Cytokine analysis
timeFrame: Baseline up to 4 weeks
measure: Cytokine analysis
timeFrame: Baseline up to 4 weeks
measure: Cytokine analysis
timeFrame: Baseline up to 4 weeks
measure: Cytokine analysis
timeFrame: Baseline up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: WanFang Hospital
Study officials:
affiliation: WanFang Hospital
name: Ming-Shun Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02766218: Mealtime Interactions and Risk of Toddler Obesity
Official title: Mealtime Interactions and Risk of Obesity in Toddlers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: toddler obesity
responsive feeding
behavioral weight control
pregnancy weight gain
early life risk factors
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: The Miriam Hospital
name: California Polytechnic State University-San Luis Obispo
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-05-09
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mothers and their 18-month-old toddlers who participated in clinical trial #NCT01545934 will be invited to participate in this observational study.

Brief summary: The purpose of this observational study is to conduct 18-, 24-, and 36-month assessments with mother-toddler dyads who participated in a study that is testing the effects of a multicomponent lifestyle intervention as a means to prevent excessive gestational weight gain in obese women. Specifically, dyads will be invited to participate in home-based assessments to videotape an evening meal, have anthropometric measures taken, and complete study questionnaires. The overall goal is to understand factors related prospectively to responsive feeding between mothers and toddlers at 18 months; determine whether responsive feeding at 18 and 24 months predicts change in zBMI and adiposity from 18-36 months; and explore which factors are most strongly predictive of child zBMI change from birth to 36 months.


Eligibility criteria: Inclusion Criteria:

* Mother participated in clinical trial #NCT01545934
* Child 18-36 months old

Exclusion Criteria:

* Child chronic health conditions that could affect feeding or growth (diagnosed feeding disorders, use of feeding tube) or could influence the mealtime interaction (significant food allergies or dietary restrictions, diagnosed psychiatric disorders, or pervasive developmental delays).

Primary outcomes:
measure: Responsive feeding
timeFrame: 18- and 24-months
Secondary outcomes:
measure: Child Weight Status
timeFrame: birth, 6-, 12-, 18-, 24- and 36-months
Other outcomes:
Locations:
Study officials:
affiliation: Temple University
name: Chantelle Hart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: California Polytechnic State University-San Luis Obispo
name: Suzanne Phelan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Miriam Hospital
name: Rena Wing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00989118: Randomized Study on Endometrioma Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Endometrioma
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2009-10-02
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL

Brief summary: This is a randomised study comparing the effect of two laparoscopic techniques for treatment of ovarian endometriomas on recurrence rate and ovarian reserve.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 40 years
* uni or bilateral symptomatic endometriotic cysts with a minimum diameter of 30 millimetres
* no counter-indication for the use of GnRH analogues

Exclusion Criteria:

* previous pelvic surgeries
* history of cancer
* suspected malignancy
* presurgical suspicion or evidence of deep endometriosis
* presurgical suspicion or evidence of premature ovarian failure
* use of oestrogen suppressive drugs in the preceding 6 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References:
citation: Carmona F, Martinez-Zamora MA, Rabanal A, Martinez-Roman S, Balasch J. Ovarian cystectomy versus laser vaporization in the treatment of ovarian endometriomas: a randomized clinical trial with a five-year follow-up. Fertil Steril. 2011 Jul;96(1):251-4. doi: 10.1016/j.fertnstert.2011.04.068. Epub 2011 May 14.
Clinical trial NCT03100318: Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout
Official title: Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 for Hyperuricemia With or Without Gout to Evaluate the Safety and Noninferiority of FYU-981 (Phase III Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperuricemia With or Without Gout
Lead sponsor: Fuji Yakuhin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Mochida Pharmaceutical Company, Ltd.
First posted: 2017-04-04
Enrollment: 201
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: FYU-981 or Benzbromarone are administrated to hyperuricemia patients with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose regimen.


Eligibility criteria: Inclusion Criteria:

* Hyperuricemic or gout patients
* Serum urate level:

\>= 7.0mg/dL in patients with history of gout, or \>= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or \>= 9.0mg/dL

Exclusion Criteria:

* Gouty arthritis within two weeks before start of study treatment
* Secondary hyperuricemia
* HbA1c: \>= 8.4%
* Uric acid-overproduction type in the classification of hyperuricemia
* History of, clinically significant cardiac, hematologic and hepatic disease
* Kidney calculi or clinically significant urinary calculi
* Hepatic dysfuction, or AST: \>=100 IU/L or ALT: \>=100 IU/L at the pre-examination
* eGFR: \< 30mL/min/1.73m\^2
* Systolic blood pressure: \>= 180 mmHg
* Diastolic blood pressure: \>= 110 mmHg

Primary outcomes:
measure: Percent reduction from baseline in serum urate level at the final visit
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Tokyo
Study officials:
References:
citation: Hosoya T, Sano T, Sasaki T, Fushimi M, Ohashi T. Dotinurad versus benzbromarone in Japanese hyperuricemic patient with or without gout: a randomized, double-blind, parallel-group, phase 3 study. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):62-70. doi: 10.1007/s10157-020-01849-0. Epub 2020 Jan 24.
Clinical trial NCT05296018: The Effect of Mandala on Coping With Fatigue, Psychological Well-Being and Stress in Patients Treated With Hemodialysis
Official title: The Effect of Mandala on Coping With Fatigue, Psychological Well-Being and Stress in Patients Treated With Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Keywords: Fatigue
Psychological Well-Being
Stress
Lead sponsor: Istanbul Sabahattin Zaim University
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an experimental study with pre-test and post-test control groups
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to examine the effect of mandala on coping with fatigue, psychological well-being and stress in patients treated with hemodialysis

Detailed description: The Effect of Mandala on Coping with Fatigue, Psychological Well-Being and Stress in Patients Treated with Hemodialysis

Eligibility criteria: Inclusion Criteria:

* be over 18
* Ability to communicate adequately
* Absence of psychiatric problems
* Volunteering to participate in the research
* Receiving hemodialysis treatment for at least 6 months

Exclusion Criteria:

* None

Primary outcomes:
measure: The fatigue severity scale
timeFrame: 1. week
measure: The fatigue severity scale
timeFrame: 4. week
measure: The fatigue severity scale
timeFrame: 8. week
measure: The psychological well-being scale
timeFrame: 1. week
measure: The psychological well-being scale
timeFrame: 4. week
measure: The psychological well-being scale
timeFrame: 8. week
measure: The Ways of Coping Inventory (WCI)
timeFrame: 1. week
measure: The Ways of Coping Inventory (WCI)
timeFrame: 4. week
measure: The Ways of Coping Inventory (WCI)
timeFrame: 8. week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Sabahattin Zaim University, Faculty of Health Sciences
state: Güneydoğu Anadolu Bölgesi
city: Istanbul
country: Turkey
facility: Istanbul Sabahattin Zaim University, Faculty of Health Sciences
state: Küçükçekmece
Study officials:
References:
citation: Choi H, Hahm SC, Jeon YH, Han JW, Kim SY, Woo JM. The Effects of Mindfulness-Based Mandala Coloring, Made in Nature, on Chronic Widespread Musculoskeletal Pain: Randomized Trial. Healthcare (Basel). 2021 May 28;9(6):642. doi: 10.3390/healthcare9060642.
Clinical trial NCT01450618: Comparative Tolerability of Protease Inhibitors
Official title: Comparative Tolerability of Protease Inhibitors and the Associated Impact on Persistence, Healthcare Utilization, and Healthcare Costs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-10-12
Enrollment: 26000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Employees and dependents with employer-based health insurance coverage

Brief summary: This study will be a retrospective observational study assessing identifiable tolerability problems in terms of their comparative incidence among Human Immunodeficiency Virus (HIV) patients treated with cART regimens including one of four different protease inhibitors \[Atazanavir sulfate (ATV), Darunavir (DRV), Fosamprenavir (FPV), or Lopinavir (LPV)\] and the impact of these identifiable tolerability problems on PI persistence, healthcare utilization, and healthcare costs.


Eligibility criteria: Inclusion Criteria:

* Initiated treatment with a Protease inhibitor (PI)-based Combination antiretroviral therapy (cART) regimen
* Between 18-64 years of age on the index date
* At least 6 months of continuous enrollment and pharmacy benefits prior to the index date
* At least 6 months of continuous enrollment and pharmacy benefits following the index date
* At least 1 medical claim during the 6-month follow-up period

Primary outcomes:
measure: Percent of patients.with new onset GI symptoms after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen
timeFrame: 6 months
Secondary outcomes:
measure: Percent of patients with new onset lipid abnormalities or new onset jaundice (separately) after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen
timeFrame: 6 months
measure: Healthcare utilization
timeFrame: 6 months
measure: Healthcare costs
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05465018: Performance Assessment Study VitalSigns Camera
Official title: Performance Assessment Study VitalSigns Camera
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Humans
Vital Signs Monitoring
Keywords: Pulse rate
Remote Photoplethysmography
Algorithms
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2022-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This Performance Assessment Study will focus on testing the performance of the VitalSigns Camera under various suboptimal use cases. The software makes it possible to measure the pulse rate (PR) and respiration rate (RR) without the device being in contact with the subject. The software delivers fast and accurate results (in less than one minute). Vital signs camera (VSC) product will be used via a demonstrator app on one of the smartphones during the study sessions (camera of the phone will be used by the VSC product). Devices will be provided by the researchers.

The subject will be asked to perform a number of assignments with the software application. The study involves taking a number of measurements of the subject's PR using the VitalSigns Camera software application (which is installed on a smartphone or laptop). In this study only PR is measured and not RR as the latter parameter is not affected by the designed test cases. The total duration of the session will be approximately 1 hour. In total, approximately 30 healthy volunteers will participate in this study.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer must 18 years or older
* Participants willing to give informed consent
* Willingness to have vital signs measured by a medical mobile application
* Willingness to put on sunglasses
* Willingness to put on facial makeup
* Willingness to put on a face mask covering mouth and nose
* Willingness to sit still up to 2 minutes per measurement

Exclusion Criteria:

* Individuals who are not able to read and understand the English language
* Known allergic reaction to facial make-up
* COVID-19 exclusion criteria:

  * Currently displaying COVID-19-related symptoms, namely a fever, cough and/or difficulty breathing
  * Having been positively tested as infected with COVID-19 in the past 14 days
  * Travelled to or from high risk COVID-19 areas in the past 14 days
  * Been in contact with a (suspected) COVID-infected person in the past 14 days

Primary outcomes:
measure: Primary endpoint
timeFrame: Each participants will have measurement for 1 hour on 1 day. Study will be completed within 1 week.
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Philips Research North America
state: Massachusetts
Study officials:
References: