louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02487121: Improving Weight Loss Maintenance Through Alternative Schedules of Treatment
Official title: Improving Weight Loss Maintenance Through Alternative Schedules of Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: weight loss
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 108
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project examines the effects of differing schedules of extended care contact following weight loss treatment in order to prevent weight regain following treatment.


Eligibility criteria: Inclusion Criteria:

* At least 21 years-old
* body mass index (BMI) = 28.0 - 45.0 kg/m2
* willing to provide informed consent and accept randomization

Exclusion Criteria:

* BMI \>45 kg/m2
* Illnesses requiring medical attention and/or conditions for which weight loss and moderate physical activity would be inadvisable: diabetes not under active treatment, myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases that limit physical activity; orthopedic injuries or conditions that significantly limit physical activity.
* Conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; unable to read English at the 5th grade level; unwilling to accept random assignment; unwilling or unable to travel to attend intervention (due to distance from clinic, work schedule or other scheduling conflicts); likely to relocate out of the service area in next 18 months.

Primary outcomes:
measure: body weight (kg)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Schneider-Worthington CR, Kinsey AW, Tan F, Zhang S, Borgatti AC, Davis AL, Dutton GR. Pretreatment and During-Treatment Weight Trajectories in Black and White Women. Am J Prev Med. 2022 Jul;63(1 Suppl 1):S67-S74. doi: 10.1016/j.amepre.2022.01.031.
citation: Dutton GR, Gowey MA, Tan F, Zhou D, Ard J, Perri MG, Lewis CE. Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance. Int J Behav Nutr Phys Act. 2017 Aug 15;14(1):107. doi: 10.1186/s12966-017-0564-1.
Clinical trial NCT03941821: Glecaprevir/Pibrentasvir Real-world Study in China
Official title: The Efficacy, Safety and Long-term Prognosis of Glecaprevir/Pibrentasvir in the Treatment of Chronic Hepatitis C Patients in China--A Real-world Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis c
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis C who will received Glecaprevir/Pibrentasvir treatment and meet the inclusion and exclusion criteria above

Brief summary: To evaluate the efficacy, adverse effect, short - and long-term outcomes of Glecaprevir/Pibrentasvir for the treatment of chronic hepatitis C (non-cirrhotic or compensatory cirrhosis)in China through a real-world study

Detailed description: This study is a multi-center, prospective, real-world study, aiming to investigate the use of Glecaprevir/Pibrentasvir in routine clinical management of chronic hepatitis C patients and evaluate its effectiveness and safety across a heterogeneous population in China.Approximately 800 patients will take part in this study, 20 sites will be included which distribute in China's major cities, thus each site will enroll 40 patients.

Eligibility criteria: Inclusion Criteria:

* \>18 years old
* Meet the standard of Glecaprevir/Pibrentasvir treatment

Exclusion Criteria:

* Patients have contraindications to Glecaprevir/Pibrentasvir
* Pregnancy or lactation
* Malignancy
* Decompensatory cirrhosis

Primary outcomes:
measure: SVR 12
timeFrame: 12 weeks after Glecaprevir/Pibrentasvir treatments
measure: progression of Chronic liver disease
timeFrame: 5 years after Glecaprevir/Pibrentasvir treatments
Secondary outcomes:
measure: long term outcome
timeFrame: 5 years
measure: HRQOL
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College HUST
name: Qin Ning, PHD,MD
role: STUDY_CHAIR
References:
Clinical trial NCT04119921: Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab
Official title: Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: DME
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 26
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Purpose: To evaluate the short-term effect of adding topical ketorolac to the management of diabetic macular edema (DME) with intravitreal bevacizumab (IVB).

Setting: Ophthalmology department of Imam Hossein and Torfe Medical Centers. Ophthalmic Epidemiology Research Center of Shahid Beheshti University of Medical Sciences Methods: In a randomized double-masked placebo-controlled crossover clinical trial, all eyes with DME with best-corrected visual acuity (BCVA) between 20/40 and 20/400 were included. They should have had at least one intravitreal anti-VEGF injection in the past 2 months. They were randomized into two groups. Both groups received two IVB injections with 6-week interval. One group received topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval. The other group received the opposite medications. Best-corrected visual acuity (BCVA) and central macular thickness (CMT) evaluations were repeated at the termination of each treatment period i.e. at 6 and 12 weeks. The main outcome measure was BCVA changes in logMAR and the second outcome was CMT changes. The interim analysis of this study is presented in this report.


Eligibility criteria: Inclusion Criteria:

* BCVA≤20/40 and BCVA 20/400 and better
* History of at least 1 intra-viteral bevacizumab (IVB) in the last 2 months
* Requires 2 IVB in the next 12 weeks
* Macular thickness \>300 μm
* NO Other eye diseases
* Media clarity , pupillary dilation, and subject cooperation sufficient for adequate fundus photographs

Exclusion Criteria:

* hgb A1c\> 8
* high risk PDR
* Macular edema due to a cause other than diabetic retinopathy
* Any other ocular condition that visual acuity would not improve from resolution of edema (eg.foveal atrophy)
* Prior treatment with intravitreal or peribulbar corticosteroid injection during last 3months
* History of macular photocoagulation during the last 6 months
* intraocular surgery(except cataract surgery)
* Cataract extractionin less than 6 months ago
* Uveitis ,NVG ,exudative AMD, HR PDR.
* Uncontrolled glaucoma
* Vitreomacular traction or epiretinal membrane

Primary outcomes:
measure: visual acuity
timeFrame: 6 weeks
Secondary outcomes:
measure: Centeral macular thickness
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT04851821: The Effectiveness of Phytotherapy in SARS-COV2(COVID-19)
Official title: The Effectiveness of Phytotherapy in the Treatment of SARS-COV2 (COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: a Randomized Double-blind Study
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
PHYTOTHERAPIE
Lead sponsor: Hôpital Universitaire Sahloul
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Quercetin is one of the flavonoids. Quercetin as well as rutin are recognized to be among the most active of the flavonoids. It is to quercetin that several medicinal plants, including ginkgo and St. John's Wort, owe part of their therapeutic effects. Often combined with vitamin C in supplements, it improves absorption by the body and delays its elimination.

Quercetin is extracted from a variety of plant sources, including the onion peel and seeds and pods of Dimorphandra mollis, a tree in the legume family native to South America.

At present, there is no scientific data to demonstrate the effectiveness of herbal medicine, regardless of the plant, to prevent or treat COVID-19. On the other hand, some plant-based food supplements have anti-inflammatory or immunomodulatory properties that may disrupt inflammatory defense mechanisms useful in fighting infections, and in particular against COVID-19.

Detailed description: Type of study: a randomized, double-blind study using the Quercetine in the treatment of patients with SARS COV2 (covid-19) Quercetin is extracted from a variety of plant sources, including the onion peel and the seeds and pods of Dimorphandra mollis, a legume tree native to South America.

Although we are far from knowing everything about quercetin, its antioxidant, anti-inflammatory, and antihistamine (antiallergic) properties have been observed in numerous in vitro and animal studies.

History on quercetin In 1937, Albert Szent-Gyorgyi received a Nobel Prize for discovering vitamin C and flavonoids, as well as for exploring their biochemical properties. Originally, he gave the flavonoids the name "vitamin P" because of their effectiveness in reducing the permeability of blood vessels. This name was abandoned when it was realized that these substances were not really vitamins.

Eligibility criteria: Inclusion Criteria:

* all patients attending the emergency department for influenza-like illness.
* Being over 18 years old

Exclusion Criteria:

* Any patient requiring admission
* Non-consenting patients

Primary outcomes:
measure: Number of patients
timeFrame: 10 DAYS
Secondary outcomes:
measure: disappearance of symptoms
timeFrame: 10 days
measure: adverse reaction
timeFrame: 10 days
Other outcomes:
Locations:
city: Sahloul
country: Tunisia
facility: Riadh Boukef
state: Sousse
Study officials:
affiliation: CHU Sahloul, Sousse, Tunisia
name: Riadh Boukef, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02942121: Application-based Perioperative Management of the Radical Cystectomy Patient
Official title: Application-based Perioperative Management of the Radical Cystectomy Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: surgery education
radical cystectomy
cystectomy
muscle-invasive bladder cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: University of Kansas
First posted: 2016-10-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to learn whether it is feasible to use the LifeScience Technologies application (LST app) in patients undergoing radical cystectomy with the eventual goal to reduce complications and readmissions to the hospital after surgery.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of recurrent Non-muscle invasive bladder cancer (NMIBC) or Muscle-invasive Bladder Cancer (MIBC) and are candidates for radical cystectomy
* Subjects must have an internet connection and be able and willing to use an applicable device. If patients do not have an applicable device, they must be willing to borrow an iPad from the study team (to be returned at the conclusion of the study).

Exclusion Criteria:

* No internet access

Primary outcomes:
measure: Compliance using LST app at home
timeFrame: 90 Days
Secondary outcomes:
measure: Patient-generated subjective global assessment (PG-SGA)
timeFrame: Baseline
measure: Edmonton Frail Scale (EFS)
timeFrame: Baseline
measure: Physician Office/Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Survey Research (HealthStream™)
timeFrame: Change from Baseline to Day 90
measure: Count of readmissions
timeFrame: Day 90
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Eugene Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06790264: Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer
Official title: Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer. a Phase II Study to Evaluate the Comparison of 68Ga-FAPi-46 and 18F-FDG Uptake in Patients with Different Breast Cancer Subtypes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Invasive
Node Positive Breast Cancer
Keywords: 68Ga-FAPi-46 PET/CT
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is a prospective, non-interventional, open-label study to evaluate the glucose metabolism and the expression of the imaging agent 68 Gallium-Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPi-46) with PET imaging, in woman affected by Breast Cancer (BC) and referred to diagnostic imaging work-up prior to primary therapy.

Detailed description: All patients affected by newly diagnosed, clinically N-positive BC that have already undergone a baseline 2-deoxy-2-\[fluorine-18\]fluoro-D-glucose (18F-FDG) PET/CT (T1) will be screened for eligibility. Patients who will meet all inclusion/exclusion criteria will be considered eligible and asked to participate to the study after signing the informed consent form. Patients' eligibility will be evaluated by the referent nuclear medicine physician (T2). Considering the clinical experience of the investigators, we expect to complete patient enrolment in 12 months after study accrual

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed, biopsy proven breast cancer;
* Diagnosis of invasive breast cancer;
* Tumor diameter more than 2 centimeters;
* Radiological evidence of axillary nodes involvement;
* 18F-FDG PET/CT performed as baseline diagnostic procedure, during routine diagnostic work-up;
* 68Ga-FAPi-46 PET/CT performed within 4 weeks from 18F-FDG PET/CT;
* Patients suitable to primary treatment (surgery or neo-adjuvant therapy);
* 68Ga-FAPi-46 PET/CT performed within 8 weeks from primary treatment;
* Female patients;
* Age ≥18;
* Willing to sign informed consent form.

Exclusion Criteria:

* Pregnant or nursing patients;
* Unable to stay flat and cannot tolerate PET scan;
* Sample tissue from biopsy unavailable for assessing Fibroblast Activation Protein (FAP) expression;
* Eastern Cooperative Oncology Group (ECOG) performance status ≥2.

Primary outcomes:
measure: Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT positivity rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Istitute of Oncology
name: Francesco Ceci, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01592864: The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity
Official title: A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dentine Hypersensitivity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over an eight week treatment period.


Eligibility criteria: Inclusion Criteria:

* Subjects who suffer from tooth sensitivity

Inclusion Criteria:

- none

Primary outcomes:
measure: Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8
timeFrame: Baseline to 8 weeks post administration of study treatment
Secondary outcomes:
measure: Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4
timeFrame: Baseline to 4 weeks post administration of study treatment
measure: Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8
timeFrame: Baseline to 8 weeks post administration of study treatment
measure: Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4
timeFrame: Baseline to 4 weeks post administration of study treatment
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: BioSci Research America, Inc.
state: Nevada
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03171064: Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment
Official title: Sportivumab - Feasibility of Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: PD-1 Antibodies
Exercise
Melanoma
Keywords: Exercise
Cancer
Melanoma
Feasibility
PD-1 antibodies
Checkpoint inhibitors
Immune system
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Department of Dermatology, Heidelberg University Hospital
First posted: 2017-05-31
Enrollment: 39
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: Checkpoint inhibitors like the PD-1 antibodies Pembrolizumab and Nivolumab represent standard of care for patients with metastasized melanoma. Numerous high quality studies demonstrate that endurance and resistance training in cancer patients is safe and elicits beneficial effects. However, there is no systematic experience with regard to exercise interventions in patients undergoing checkpoint inhibitor treatment. Therefore, the Sportivumab Study aimed to investigate safety, feasibility and effectivity of a 12 week combined resistance and endurance exercise intervention program during checkpoint inhibitor treatment. It is planned to enroll 40 patients. Participants will be randomized into an experimental and a wait-list control group (20 per group). The wait-list control group will receive the exercise intervention program after week 13 of enrollment.


Eligibility criteria: Inclusion Criteria:

* Patients at age ≥ 18 years
* Diagnosed with melanoma stage (independent of stage)
* Assigned to receive an immunotherapeutic regimen (PD-1 antibody +/- Ipilimumab)
* Sufficient German language skills
* Willing to train at the exercise facilities twice per week and to take part in the scheduled testing at the National Center for Tumor Diseases
* Signed informed consent

Exclusion Criteria:

* Any physical or mental conditions that would hamper the performance of the training programs or the completion of the study procedures
* Engaging in systematic intense exercise training (at least 1h twice per week)

Primary outcomes:
measure: Feasibility of the exercise intervention
timeFrame: During 12 week of the intervention
Secondary outcomes:
measure: Quality of life
timeFrame: During 12 week of the intervention
measure: Fatigue
timeFrame: During 12 week of the intervention
measure: Sleep Quality
timeFrame: During 12 week of the intervention
measure: Depression
timeFrame: During 12 week of the intervention
measure: Physical Activity Behavior
timeFrame: During 12 week of the intervention
measure: Cardiopulmonary Fitness
timeFrame: During 12 week of the intervention
measure: Muscle strength
timeFrame: During 12 week of the intervention
measure: Pain
timeFrame: During 12 week of the intervention
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University Clinic
Study officials:
References:
Clinical trial NCT01344564: Initiation of Androgen Deprivation Therapy for Prostate Cancer Using Degarelix Followed by Leuprolide
Official title: Initiation of Androgen Deprivation Therapy for the Treatment of Prostate Cancer Using Degarelix Acetate Followed by Leuprolide Acetate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Hormone therapy
Testosterone measures
Lead sponsor: Urology of Virginia
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2011-04-29
Enrollment: 50
Sex: MALE
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 determine if patients initiating androgen deprivation therapy (ADT) for prostate cancer can be transitioned from degarelix acetate to leuprolide acetate after an initial three-month period without a rise in serum testosterone. The investigators expect testosterone will quickly and reliably reach castrate levels after initiation of ADT and will remain castrate during the transition, and there will be no "testosterone surge" after leuprolide injection.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Histologically confirmed adenocarcinoma of the prostate
* Androgen deprivation therapy is indicated

Exclusion Criteria:

* Baseline screening serum testosterone \<150ng/dL
* Eastern Cooperative Oncology Group (ECOG) score \> 2
* Diagnosed spinal or brain metastases
* Hormonal manipulation within previous 6 months

Primary outcomes:
measure: Testosterone measurement
timeFrame: 11 times over 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
Study officials:
affiliation: Urology of Virginia
name: Robert Given, MD
role: PRINCIPAL_INVESTIGATOR
References: