louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01771094: Effect of Sweetness of the Beverage in Thirst Sensation
Official title: Effect of Sweetness of the Beverage in Thirst Sensation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thirst
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if water and diet soft drinks with different levels of sweeteners have the same effect on thirst.

Detailed description: Participants should be in the laboratory at 8.00 in order to collect the values of weight, height, total body water, intracellular water and extracellular water in a Segmental Multi Frequency Body Composition Monitor (TANITA MC 180 MA®). Then, a blood sample will be collected for analysis of blood glucose and osmolality. They will sit at individual tables for the duration of the session and were allowed to read, listen to music with earphones, or use their portable computers with the exception of internet access to minimize visual cues (e.g., unwanted publicity for beverages or visiting Web sites showing pictures of food and drinks), which may have effect on thirst. Breakfast will be served at 9.30 on every occasion and preload stimuli will be offered exactly 60 minutes after breakfast (at 10.30). Lunch will be provided at 13.00. Motivational ratings will be first obtained at the end of collection of blood sample (baseline or time 0) and every 30 minutes thereafter until the lunch time (times 1 through 7). After lunch (time 8), participants will complete the last set of ratings and will bring a food diary to record all food and fluid intake until 00.00 that day.

Eligibility criteria: Exclusion Criteria:

* pregnant and nursing women
* smokers
* athletes
* subjects under medication(except oral contraceptives in women)

Inclusion Criteria:

* body mass index(BMI) between (18,5 - 27,5 kg/m2)
* regular consumers of breakfast
* stable in weight for the past 6 months
* not dieting to gain or lose weight
* like all drinks and food available in study

Primary outcomes:
measure: Motivational Ratings
timeFrame: 1 day
Secondary outcomes:
measure: Food Behavior After Intervention
timeFrame: 1 day
measure: Physiological Parameters
timeFrame: 1 day
measure: Amount of water ingested
timeFrame: 1 day
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Faculty of Nutrition and Food Sciences - University of Porto
Study officials:
affiliation: FCNAUP
name: Pedro R Carvalho, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00780260: Case Management Alternatives for African American Women at High Risk for HIV
Official title: Case Management Alternatives for African American Women at High Risk for HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
Keywords: HIV/AIDS
African Americans
Women
Case Management
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-10-27
Enrollment: 562
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to test two innovative case management approaches designed to increase linkages and engagement with drug abuse treatment, HIV-related care, and other health services among an underserved population of African American women at risk for HIV.

Detailed description: The study is fundamentally concerned with the implementation and evaluation of theoretically-based, culturally appropriate case management interventions targeting individual, social and environmental factors among highly vulnerable African American women. The research is designed to test innovative, comprehensive approaches to HIV prevention/intervention through case management driven service linkage and engagement. Testing new approaches to intervention with African-American women at high risk for HIV addresses a particularly urgent public health need in Miami, as well as other large metropolitan areas, where officials continue to document epidemic rates of HIV/AIDS clustered in urban, impoverished African-American communities.

Comparison: Participants will be randomly assigned to: a Strengths-Based / Professional Only Condition in which clients participate in a "strengths-based" case management approach; or, a Strengths-Based / Professional/Peer Condition in which a team composed of: a) a credentialed, professional case manager and b) a recovering addict peer - both trained in "strengths-based" case management techniques - develop and facilitate the implementation of a service plan.

Eligibility criteria: Inclusion Criteria:

* Current substance abuse
* Current high-risk sexual behavior
* African American racial identification

Exclusion Criteria:

* Non resident of Miami-Dade county

Primary outcomes:
measure: Substance abuse treatment linkage at 3 months
timeFrame: 3 months
measure: Substance abuse treatment engagement at 6 months
timeFrame: 6 months
measure: HIV related care at 3 and 6 months
timeFrame: 3 and 6 months
measure: Other health service utilization at 3 and 6 months
timeFrame: 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Nova Southeastern University
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: Hilary L Surratt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00141960: Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease
Official title: YM1170 Phase 2/3 Study: A Double Blind, Placebo Controlled, Group-comparison Study in Patients With Non-erosive Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Gastroesophageal Reflux
Keywords: Treatment efficacy
Treatment effectiveness
Gastrointestinal Diseases
Reflux, Gastroesophageal
GERD
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 480
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: Gastroesophageal reflux disease (GERD) considered to be associated with mucosal damages in the esophagus and heartburn, which may sometimes interfere with daily activities due likely to reflux of acid gastric contents. While most of the patients given the diagnosis of GERD do not exhibit endoscopically obvious impairment in esophageal mucous membrane, they have subjective symptoms of non-erosive GERD including heartburn. But no drug has been launched in Japan, which targets non-erosive GERD. This study will examine the efficacy and safety of famotidine in subjects with non-erosive GERD.


Eligibility criteria: Inclusion Criteria:

* Patients have heartburn with non-erosive gastroesophageal reflux disease.

Exclusion Criteria:

* Patients have diseases which interfere with evaluation of the efficacy and safety in this study.
* Patients are receiving and/or have received prior to the enrollment the treatment which interfere with evaluation of the efficacy and safety in this study.
* Patients have severe cardiovascular, hepatic, renal and hematological disorders.
* Patients are allergic to or have a history of drug allergy to H2RA.
* Patients have or have a history of malignant tumors.
* Patients are pregnant or a lactating mother.
* Patients have participated in other clinical studies less than 12 weeks prior to submitting the informed consent.

Primary outcomes:
measure: Rate of days with no heart burn in the treatment period
Secondary outcomes:
measure: Disappearance of heart burn
measure: Severity of heart burn
measure: Frequency of heart burn
measure: Patient's final global improvement rating
measure: Other symptoms (e.g.,reflux sensation of gastric fluid, discomfort of pharynges)
Other outcomes:
Locations:
city: Hokkaido region
country: Japan
city: Kanto region
country: Japan
city: Kinki region
country: Japan
city: Kyushu region
country: Japan
city: Shikoku region
country: Japan
city: Tohoku region
country: Japan
city: Tokai region
country: Japan
Study officials:
affiliation: Clinical Development III, Astellas Pharm. Inc.
name: Study Director
role: STUDY_CHAIR
References:
citation: Hongo M, Kinoshita Y, Haruma K. A randomized, double-blind, placebo-controlled clinical study of the histamine H2-receptor antagonist famotidine in Japanese patients with nonerosive reflux disease. J Gastroenterol. 2008;43(6):448-56. doi: 10.1007/s00535-008-2186-5. Epub 2008 Jul 4.
Clinical trial NCT00963560: Presbyopia-Correcting Intraocular Lenses (IOLs)
Official title: A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: ReSTOR +3
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-08-21
Enrollment: 132
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).


Eligibility criteria: Inclusion Criteria:

* diagnosed with bilateral cataracts
* candidate for presbyopic lens

Exclusion Criteria:

* \> 1 Diopter preoperative astigmatism by Keratometry readings
* pre-existing conditions that could skew the results

Primary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: 6 Months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center For Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT05135260: Virtual Reality on Pain, Stress, and Affect in the Infusion Clinic
Official title: The Effects of Virtual Reality on Pain, Stress, and Affect in the Infusion Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Chemotherapy
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will investigate the ability of virtual reality to function as a novel distraction intervention and improve the experience of patients who are receiving chemotherapy in the infusion clinic.

Detailed description: Objectives:

Primary Objective:

- To deploy and evaluate virtual reality as an intervention for stress, pain, and negative affect

Secondary Objective:

- To evaluate cyber sickness and patient satisfaction related to the virtual reality treatment

Eligibility criteria: Inclusion Criteria:

* At or above the age of 18
* English Speaking
* Diagnosed with cancer
* No previous history of seizures, losses of awareness, or other symptoms linked to an epileptic condition
* Not sensitive to motion sickness
* Not currently experiencing any contagious conditions, infections, or diseases (particularly of the eyes, skin, or scalp)
* Does not use a device to regulate heart rate or rhythm (such as a pacemaker)
* Not taking antiarrhythmic medications
* Not actively receiving radiopharmaceutical therapy

Exclusion:

* To ensure that there is sufficient time to complete the virtual reality treatment, patients who are scheduled for visits for periods of less than one hour will not be included in this study. Additionally, patients must consent to participating in the study on the day of the experience.
* Patients who are asleep prior to consenting will not be asked to participate in the study

Primary outcomes:
measure: Positive or negative effect of Virtual Reality therapy on improving the experience of participants receiving chemotherapy
timeFrame: Approximately 12 months
measure: Measure the affect of Virtual Reality Therapy on improving stress
timeFrame: Approximately 12 months
measure: Measure the affect of Virtual Reality Therapy on improving pain
timeFrame: Approximately 12 months
Secondary outcomes:
measure: Rate of cyber sickness (Virtual Reality Therapy Arm Only)
timeFrame: Approximately 12 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Cody Stansel, MSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01488760: Abdominal Wall Evaluation in Low Back Pain
Official title: Deep Abdominal Wall Muscle Dysfunction During Calm Respiration in Chronic Low Back Pain Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abnormally Decreased Muscle Contraction
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 39
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The purpose of this study was to evaluate feed-forward contraction of the transversus abdominis and thickness of the transversus abdominis, obliquus internus, and obliquus externus during calm and standardized respiration in low back pain patients and pain-free subjects.

Detailed description: Low back pain patients have alterations in abdominal wall function, especially in the feed-forward activation of transversus muscle during limbs movements. However, there are no reports on the abdominal function in low back pain patients during physiological respiratory movement.

Eligibility criteria: Inclusion Criteria:

* For the low back pain group: women with history of non-specific chronic low back pain for more than three months
* For the pain-free group: pain-free women

Exclusion Criteria:

* For both groups were: pregnancy, neurological condition, obesity (body mass index: BMI \>30), or previous spine or abdominal surgery.
* For the low back pain group: rheumatology diseases other than low back pain.
* For the pain-free group: any rheumatology disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo, Brazil
Study officials:
affiliation: Full Professor - Department of Physical Therapy, Communication Science & Disorders, Occupational Therapy, Faculty of Medicine - USP
name: Clarice Tanaka, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo, Brazil
name: Patricia R Patarro
role: STUDY_CHAIR
affiliation: Institute of Radiology, School of Medicine: University of São Paulo, Brazil
name: Renato A Sernik
role: STUDY_CHAIR
affiliation: Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo, Brazil
name: Débora M Meira
role: STUDY_CHAIR
affiliation: Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo, Brazil
name: América C Fracini
role: STUDY_CHAIR
affiliation: Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo, Brazil
name: Cássio M Siqueira
role: STUDY_CHAIR
References:
Clinical trial NCT05075460: Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma
Official title: A Prospective, Multicenter, Phase III, Non-randomized Study of Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: T-cell Lymphoma
Keywords: Tucidinostat
Azacitidine
CHOP
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, multicenter, phase III study of Tucidinostat, Azacitidine combined with CHOP versus CHOP in patients with untreated peripheral T-cell lymphoma

Detailed description: Tucidinostat, a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. Azacytidine is a hypomethylating agent. The aim of this study is to compare the efficacy and safety of azacytidine, tucidinostat combined with CHOP regimen and classical CHOP regimen in the treatment of primary PTCL

Eligibility criteria: Inclusion Criteria:

* Patients with peripheral T-cell lymphoma confirmed by primary pathology;
* Age 18-70 years;
* ECOG performance status ≤ 2;
* Adequate bone marrow hematopoietic function: WBC \> 3.5 × 10\*9/L，ANC\>1.5 × 10\*9/L，HGB\>90g/L，PLT\>80 × 10\*9/L;
* Adequate organ function: cardiac function grade 0-2 (NYHA); SpO2 \> 88% (natural condition); ALT\<3UNL，TBil\<2ULN; SCr\>60ml/min/m2;
* Patients have signed the Informed Consent Form

Exclusion Criteria:

* ALK positive anaplastic T-cell lymphoma;
* NK / T cell lymphoma, nasal type;
* Uncontrolled active infection;
* Acute myocardial infarction or unstable angina pectoris within 6 months; uncontrolled hypertension, symptomatic arrhythmia, etc;
* Subjects who are known or suspected to be unable to comply with the study protocol;
* Pregnant or lactating women

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: 6 course of treatment (each cycle is 21 days)
Secondary outcomes:
measure: 2-year progression-free survival（PFS）
timeFrame: 2 years
measure: 2-year overall survival（OS）
timeFrame: 2 years
measure: Incidence and severity of adverse events, serious adverse events and other safety parameters
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Department of Hematology, Peking University First Hospital
name: Daobin Zhou
role: STUDY_CHAIR
References:
Clinical trial NCT02678260: Phase I Study of PDR001 in Patients With Advanced Malignancies.
Official title: A Phase-I Study of PDR001 Administered to Japanese Patients With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignancies
Keywords: Advanced malignancies
PDR001
Japanese patients
adults
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-02-09
Enrollment: 18
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 characterize the safety, tolerability, Pharmacokinetics (PK), and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to Japanese patients.


Eligibility criteria: Inclusion Criteria:

* Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by response evaluation criteria in solid tumors (RECIST) version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists
* ECOG Performance Status ≤ 2

Exclusion Criteria:

* Active autoimmune disease
* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Prior PD-1- or PD-L1-directed therapy

Other protocol defined inclusion/exclusion may apply.

Primary outcomes:
measure: Incidence of dose limiting toxicities (DLTs)
timeFrame: 28 days
Secondary outcomes:
measure: PK parameter: AUC
timeFrame: Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)
measure: Serum concentration vs. time profiles
timeFrame: C1D1, C3D1
measure: Presence and/or concentration of anti-PDR001 antibodies
timeFrame: Day 1 on from C1 to C6
measure: Objective response rate (ORR)
timeFrame: up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)
measure: Duration of response rate (DOR)
timeFrame: up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)
measure: Disease control rate (DCR)
timeFrame: up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)
measure: PK parameter: Cmax
timeFrame: Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)
measure: PK parameter: Tmax
timeFrame: Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)
measure: PK parameter: half-life
timeFrame: Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Kobe-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00252460: CT/MRI Co-registration Prostate Cancer
Official title: Evaluation of Planning Computed Tomography Scan and Magnetic Resonance Imaging Simulator Scan Co-Registration for Delineation of Gross Tumour Volume in Radiotherapy Treatment of Localized Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasm
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-11-11
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: prostate cancer patients

Brief summary: The target volume in prostate cancer radiotherapy typically consists of the entire prostate gland which is localized by contours drawn on axial computed tomography (CT) radiation planning images. Compared with CT, magnetic resonance (MR) can provide better definition of the prostate gland with respect to the surrounding tissues and the use of multi-plannar reconstruction avoids the problem of partial volume averaging inherent in CT. CT has been shown to significantly overestimate the volume of the gland using the MR-defined prostate volume as the gold standard. Co-registration of MR and CT datasets, matched on fixed bony landmarks, has enabled radiation planning using a MR-defined clinical target volumes, combined with CT-based electron density information necessary for radiation treatment planning.

Rationale and Hypothesis:

Co-registration may allow better delineation of tumour volumes in prostate cancer. This investigation is a fesibility study designed to evaluate and optimize imaging parameters and co-registration techniques for CT planning and MRI Simulator.


Eligibility criteria: Inclusion Criteria:

* Histological confirmation of Prostate Adenocarcinoma
* Undergoing RT with fiducial markers, IMRT or Escalated Dose Conformal RT

Exclusion Criteria:

* Contraindication for MRI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Andrew Bayley, MD
role: PRINCIPAL_INVESTIGATOR
References: