louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01763528: High Protein Weight Loss Diet, High Sensitivity C-Reactive Protein and Cardiovascular Risks Among Obese Women
Official title: High Protein Diet , CRP and CVD Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Body Mass Index Quantitative Trait Locus 8 Disorder
Tangier Disease
Keywords: body weight
Low-density-lipoprotein-type
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 63
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators aimed to determine the effects of HP diet on CVD risk factors and hs-CRP among overweight and obese women.

Detailed description: Background: Studies regarding the effects of high protein (HP) diet on cardiovascular (CVD) risk factors have reported contradictory results.

Objective: In present study, we aimed to determine the effects of HP diet on CVD risk factors and hs-CRP among overweight and obese women.

Design: In this randomized controlled trial, we recruited 60 overweight and obese women, aged 20-65 years into HP or control energy restricted diets for three months (protein, carbohydrate, fat: 25%, 45%, 30% vs. 15%, 55%, 30%, respectively). Total protein amount, divided to animal and plant sources in 50%-50% and animal sources distributed (half/half) between meats and dairy products. Fasting blood samples, hs-CRP, lipid profile, systolic and diastolic blood pressure and anthropometric measurements were measured based on the standard guidelines.

Eligibility criteria: Inclusion Criteria:

* women aged between 20-65 years
* BMI \> 25 kg/m2
* were no smoker
* no history of renal, liver, metabolic diseases or type 1 or 2 diabetes

Exclusion Criteria:

* had gastrointestinal, respiratory, cardiovascular, metabolic, liver and renal -diseases
* had macroalbuminuria
* were pregnancy or lactating

Primary outcomes:
measure: the amount of weight reduction in two dietary groups
timeFrame: 3 months
Secondary outcomes:
measure: LDL-C (mg/dl
timeFrame: 3 months
measure: HDL-C (mg/dl)
timeFrame: 3 months
measure: total cholesterol (mg/dl)
timeFrame: 3 months
measure: fasting blood glucose(mg/dl)
timeFrame: 3 months
measure: blood pressure (mmHg)
timeFrame: 3 months
measure: C-reactive protein (mc/dl)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Isfan University of Medical Sciences
name: Leila Azadbakht, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azadbakht L, Izadi V, Surkan PJ, Esmaillzadeh A. Effect of a High Protein Weight Loss Diet on Weight, High-Sensitivity C-Reactive Protein, and Cardiovascular Risk among Overweight and Obese Women: A Parallel Clinical Trial. Int J Endocrinol. 2013;2013:971724. doi: 10.1155/2013/971724. Epub 2013 Aug 6.
Clinical trial NCT01472328: Effects of HBO Therapy on Muscular Insulin Resistence in Type 2 Diabetes
Official title: Effects of HBO Therapy on Muscular Insulin Resistence in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Non-insulin-dependent Diabetes Mellitus
Keywords: Oxidative stress
Insulin resistance
Lead sponsor: German Diabetes Center
Sponsor class: OTHER
Collaborators: name: Heinrich-Heine University, Duesseldorf
First posted: 2011-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Hyperbaric oxygen therapy (HBO) is applied for several diseases. The effect on insulin sensitivity is yet unknown. Hypothesis: HBO therapy improves insulin sensitivity in patients.

Detailed description: HBO therapy is applied to improve wound healing in diabetic patients with foot ulcera. However, it might induce oxidative stress as well as improve antioxidative capacity. The effects on insulin sensitivity in humans and will be tested in the study.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 30 years- ≤ 70 years
* Balanced sex (50: 50)
* BMI 20- 25 kg/m 2 normal- weight group
* BMI 35- 39,9 kg/m 2 (Obese typ II)

Exclusion Criteria:

* Acute illness 2 weeks before start of examination
* Autoimmune or Immune disorder deseases (Leukozyten \< 5000/µl
* Renal insufficiency (Kreatin \> 1,5 mg/dl)
* Heart disease, condition after heart attack
* Anemia (Hb \<12g/l, contolled before every day of eximination) or blood donations 4weeks before eximinatin.
* Participation in another trial within the last 2 weeks
* Pharmacological- immuno therapy (Cortisol, Antihistaminika, ASS)
* Thyroid disorders
* Glitazone or Insulin- Therapy
* Pragnancy, Lactation, Menstruation
* Smoking cigaretts, Alcohol- and drug abuse
* Psychiatric disorders
* Risk for/ or diagnosed HIV/ AIDS or Hepatitis B/C
* Liver disease, which are not caused by non- alcoholic steato- hepatitis
* Working on night shifts or irregular rhythem of night- day
* Impaired wound healing or clotting disorders
* Allergic reaction to local anesthetics
* Malignant cancer

Primary outcomes:
measure: Skeletal muscle insulin sensitivity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: German Diabetes Center
Study officials:
affiliation: German Diabetes Center
name: Michael Roden, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04857528: Detecting HPV DNA in Anal and Cervical Cancers
Official title: Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Cervical Cancer
Anal Cancer
HPV-Related Anal Squamous Cell Carcinoma
HPV-Related Cervical Carcinoma
HPV-Related Carcinoma
Uterine Cervical Cancer
Keywords: HPV
radiation treatment
cervical cancer
anal cancer
uterine cervix
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be identified and selected from patients receiving treatment in the Departments of Radiation Oncology at University of Chicago and all participating sites where this study is being conducted including. Individuals from the public who have an HPV-associated cancer and fit the listed inclusion criteria can also be considered for participation in this study.

Brief summary: This is a research study for individuals who have cancer associated with human papillomavirus (HPV) and are being treated with radiation as part of standard care for their cancer. Doctors leading this study will use blood tests to find out if they can detect the HPV virus in the blood of study participants before, during, and after radiation treatment. They will also collect blood and archival tumor tissue (from a previous biopsy) to perform other tests in the future that could provide more information about HPV-associated cancers and how they respond to treatment. Participation in this study will last approximately 2 years.


Eligibility criteria: Inclusion Criteria:

* Stage I-III anal cancer or stage I-IVA cervical cancer that is p16+ based on immunohistochemistry.
* Age ≥ 18 years
* Planned to undergo radiation therapy as definitive treatment, with or without concurrent systemic therapy

Exclusion Criteria:

* Anal carcinoma not associated with HPV-16, 18, 31, 33, or 35 will be removed from the
* Planned to undergo radiation therapy as an adjuvant or post-operative therapy

Primary outcomes:
measure: Rate of Participants With Detectable Circulating HPV DNA in Blood/Tumor Samples
timeFrame: 25 months
Secondary outcomes:
measure: Accuracy of HPV DNA Levels in Predicting Cancer Recurrence at 24 Months
timeFrame: 24 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Christina Son, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00311428: Safety and Immunogenicity of Three Commercially Available Influenza Vaccines in Children Aged 6 to <36 Months
Official title: A Phase IV, Observer-Blind, Randomized, Parallel Groups, Single-Center, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of Two 0.25 mL Intramuscular Doses of Three Commercially Available Influenza Vaccines in Healthy Subjects Aged 6 to <36 Months.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
Children
Vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2006-04-06
Enrollment: 270
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This phase IV protocol is designed to evaluate the safety, clinical tolerability and immunogenicity of the 2005-2006 formulation of three widely used conventional influenza vaccines in children aged 6 to 35 months


Eligibility criteria: Inclusion Criteria:

* children of 6 months to \<36 months of age, whose parents or legal guardians have given written informed consent prior to study entry

Exclusion Criteria:

* Any severe acute respiratory disease and infections requiring systemic antibiotic or antiviral therapy ongoing or resolved within 30 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)
* Other serious diseases such as: cancer, autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic or renal disease, surgery planned during the study period.
* Known or suspected impairment/alteration of immune function
* History of hypersensitivity to any component of the study vaccine, egg products or other vaccine component, or impairment/alteration of immune function

Primary outcomes:
measure: Seroprotection, GMR's and Seroconversion rate at day 0 and day 50 following vaccination.
Secondary outcomes:
measure: Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study.
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: University of Tampere Medical School
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Novartis Vaccines Information Services
role: STUDY_CHAIR
References:
Clinical trial NCT05575128: Behavioral Activation and Medication Optimization In Older Adults Undergoing Cardiac Procedures
Official title: Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Cardiac Procedures
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Surgery
Older Adults
Depression
Anxiety
Keywords: Behavioral activation
medication optimization
cardiac surgery
perioperative mental health
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-10-12
Enrollment: 102
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hybrid Type 1 effectiveness-implementation randomized controlled trial design
Primary purpose: TREATMENT

Brief summary: This Hybrid 1 Study will test the effectiveness of a bundled intervention comprised of behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing cardiac surgery (compared with usual care), while examining implementation outcomes.


Eligibility criteria: Inclusion criteria:

* Adults ≥ 60 years
* Scheduled major cardiac procedure
* PHQ-ADS ≥ 10, indicating clinically significant depression or anxiety symptoms

Exclusion criteria:

* Barrier to communication (Unable to read, speak, and understand English)
* Severe cognitive impairment screened by the SBT (Short Blessed Test) \>10
* Acutely suicidal
* Previous participation in this study or CPMH feasibility study 202101103.

Primary outcomes:
measure: PHQ-ADS
timeFrame: 3 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Simon Haroutounian, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02144428: Hypoallergenicity To Substitutive Formulas In Children With Cow's Milk Allergy
Official title: DETERMINATION OF HYPOALLERGENICITY TO SUBSTITUTIVE FORMULAS IN CHILDREN WITH COW'S MILK ALLERGY
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cow's Milk Allergy
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 300
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with cow's milk allergy diagnosed by family pediatrician operating in Italy

Brief summary: The management of children with confirmed cow's milk allergy is based on complete avoidance of cow's milk proteins and leaves the physician with several dietary options, none of which, given the prevalence, spectrum and potential seriousness of the condition, can be recommended to all patients. In the absence of an alternative to cow's milk, the management of cow's milk allergy is based on the use of safe, affordable and nutritionally adequate formulas. Extensively hydrolyzed cow's milk protein formulas, which are considered as safe for most children with cow's milk allergy, are still liable to contain residual peptides, and hypersensitivity reactions may occur in infants allergic to cow's milk protein. Thus, specific product allergenicity must be addressed on an individual basis before recommending a formula as a substitute for cow's milk. Soy-based formula can also concomitant sensitize cow's milk allergy children to soy. Amino acid-based formulas have been studied from safety and nutritional efficacy perspectives. These formulas have been proposed for subjects highly sensitive to cow's milk protein and that cannot be managed using extensively hydolyzed formula and for children with multiple food allergies. In these conditions aminoacid based formulas are able to effectively cure allergic symptoms and to improve body growth.


Eligibility criteria: Inclusion Criteria:

* subjects with a cow's milk allergy
* age between 0 to 36 months

Exclusion Criteria:

* age more than 36 months
* eosinophilic disorders of the gastrointestinal tract,
* food protein induced enterocolitic syndrome,
* concomitant chronic systemic diseases,
* congenital cardiac defects,
* active tuberculosis,
* autoimmune diseases,
* immunodeficiency,
* chronic inflammatory bowel diseases,
* celiac disease,
* cystic fibrosis,
* metabolic diseases,
* lactose intolerance,
* malignancy,
* chronic pulmonary diseases,
* malformations of the gastrointestinal tract.

Primary outcomes:
measure: Number of subjects with cow's milk allergy tolerant substitutive formulas
timeFrame: At diagnosis and for at least 1 months after the diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References:
Clinical trial NCT01502228: PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma
Official title: PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Renal Cell Carcinoma
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2011-12-30
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Given the growing importance of anti-angiogenic therapies in the treatment of metastatic renal carcinoma, it is expected that this trial will establish the preliminary data needed to apply for funding of a larger clinical investigation of the potential role of PET perfusion imaging in management of renal carcinoma, and potentially other cancers.


Eligibility criteria: Inclusion Criteria:

* Ability to understand and willingness to sign a witnessed, informed consent and authorization for the release of health information.
* Patients with a diagnosis of relapsed Stage IV renal cell cancer that are medically unresponsive to prior treatment or surgically unresectable and with metastases that fall within the PET/CT field-of-view that can include the heart.
* Being considered for systemic therapy with Sunitinib

Exclusion Criteria:

* Women who are pregnant, breast-feeding, or of childbearing potential and not using birth control
* Having no telephone or a reliable way in which study personal can contact them
* Subjects who are claustrophobic and cannot tolerate imaging procedures
* Subjects who weigh \> 350 lb. (upper weight limit of scanner beds)

Primary outcomes:
measure: Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained
timeFrame: Baseline
Secondary outcomes:
measure: Maximum Standard Uptake Value (SUV) for Lesion Data
timeFrame: Baseline and 14-28 days after initiation of Sunitinib
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University, Radiology
name: James Fletcher, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University, Dept. Medicine (Hem/Onc)
name: Theodore Logan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00013728: Asthma & Exposure to Peaks in Particulate Air Pollution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma
particulate matter
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-03-30
Enrollment: 24
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: We are testing the following two hypotheses: 1) Peaks in hourly exposures to airborne particulate matter (PM) of outdoor origin will be more closely associated with acute asthmatic responses to particles than 24-hour average exposures in susceptible individuals; 2) Personal exposure to PM, and estimated particle dose to the lungs, will be more closely associated with daily asthma severity than standard outdoor particle concentrations measured as 24-hour averages at governmental monitoring sites.

Detailed description: We are testing the following two hypotheses: 1) Peaks in hourly exposures to airborne particulate matter (PM) of outdoor origin will be more closely associated with acute asthmatic responses to particles than 24-hour average exposures in susceptible individuals; 2) Personal exposure to PM, and estimated particle dose to the lungs, will be more closely associated with daily asthma severity than standard outdoor particle concentrations measured as 24-hour averages at governmental monitoring sites. Toxicological data for asthma exacerbations from particulate matter (PM) suggests that particle deposition in the lower respiratory tract can cause inflammatory and lung function changes suggestive of asthma pathology. There is now a scientific need to explain epidemiological findings of ambient PM effects on asthmatics at mass concentrations below what is expected (from toxicological data) to be harmful. One possibility is that study participants are encountering unmeasured short-term excursions of particle mass levels capable of inducing adverse reactions in the lung, but this effect is only captured somewhat by the regulatory standard of 24-hour averages. Our research in southern California is vital to the current controversy regarding regulatory standards given that a health-based scientific rationale for any specific PM averaging time is not established.

Eligibility criteria: 1) physician-diagnosed asthma, at least a 1 yr. history, including episodic symptoms of wheezing, cough and dyspnea; 2) mild to moderate severity of asthma: i) a history of at least several weeks during the warm seasons (Mar-Oct) during which the subject required regular daily use of prescribed prophylactic asthma medications; \& ii) asthma exacerbations at least 2 days/week requiring as-needed bronchodilators during an extended period of 1-2 warm season months; 3) age from 9-18; 4) home, school or work addresses in Alpine, CA area; 5) no history of smoking by the subjects and no person smoking in the subject?s home.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: