louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01755455: Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis
Official title: Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Anemia, Iron-Deficiency
Keywords: Cystic fibrosis
Iron
Hepcidin
Anemia
Erythropoiesis
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2012-12-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study questions whether low-dose ferrous sulfate taken by mouth daily for 6 weeks increases hemoglobin concentration in adult subjects with cystic fibrosis and hypoferremic anemia.


Eligibility criteria: Inclusion Criteria:

* History of Pseudomonas aeruginosa colonization of the lung
* Transferrin saturation (TSAT) less than or equal to 21%
* Hemoglobin concentration \<15.5 gm/dl (men)
* Hemoglobin concentration \<13.6 gm/dl (women)

Exclusion Criteria:

* Use of iron-containing vitamin or supplement
* Pregnancy
* Lactation
* Cirrhosis
* History of chronic visible (gross) hemoptysis
* Hereditary hemochromatosis
* History of transfusion-related iron overload
* Use of iron chelator(s)
* Withdrawal of informed consent
* Contraindication to phlebotomy

Primary outcomes:
measure: Change From Baseline in Hemoglobin Concentration (gm/dl)
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change From Baseline in Serum Iron (mcg/dl)
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in Transferrin Saturation (%)
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in Sputum Iron (ng/mg)
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Alex H Gifford, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gifford AH, Alexandru DM, Li Z, Dorman DB, Moulton LA, Price KE, Hampton TH, Sogin ML, Zuckerman JB, Parker HW, Stanton BA, O'Toole GA. Iron supplementation does not worsen respiratory health or alter the sputum microbiome in cystic fibrosis. J Cyst Fibros. 2014 May;13(3):311-8. doi: 10.1016/j.jcf.2013.11.004. Epub 2013 Dec 13.
Clinical trial NCT04213755: ROTEM in Patients With Placenta Previa
Official title: Rotational Thromboelastometry During Cesarean Section as a Predictive Evaluation for Progression of Intraoperative Massive Hemorrhage in Parturients With a Potential Risk of Perioperative Hemorrhage: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta Previa
Placenta Accreta
Placenta Increta
Placenta Percreta
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women over 20 years old who are scheduled for cesarean section under spinal anesthesia after diagnosis of placenta previa/increta/percreta/accreta

Brief summary: The rotational thromboelastogram (ROTEM) test can be performed on patients with placenta previa/accreta/increta/percreta who have a high likelihood of massive bleeding, and the predictors can be identified by comparing the patients who actually show massive bleeding with those who do not.

Applying these predictive factors to pregnant women undergoing cesarean section after diagnosis of placenta previa/accreta/increta/percreta, it will be advantageous for the perioperative management because it is possible to select pregnant women with a factor of massive bleeding.


Eligibility criteria: Inclusion Criteria:

* Cesarean section under spinal anesthesia
* Placenta previa
* Placenta accreta
* Placenta increta
* Placenta percreta

Exclusion Criteria:

* Coagulopathy
* Medication with antiplatelets or anticoagulants

Primary outcomes:
measure: Blood loss
timeFrame: 1 min after finishing an operation
measure: Change of INTEM
timeFrame: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation
measure: Change of EXTEM
timeFrame: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation
measure: Change of APTEM
timeFrame: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation
measure: Change of FIBTEM
timeFrame: 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT02062255: Impact of COX2 on Sera Biomarkers From Obese Subjects
Official title: A Phase 0, Investigator Initiated Study, Evaluating the Impact of COX2 Inhibition on Human Sera Biomarkers From Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer Survivors
Keywords: Asprin
Omega-3 Free Fatty Acids
Obesity
COX-2 inhibitor
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Obesity promotes worse outcome for post-menopausal breast cancer patients.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Post-menopausal as confirmed by medical history
* Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee

Exclusion Criteria:

* Evidence of active cancer (patients with a prior history of malignancy are encouraged to participate, but due to cytokine levels associated with malignancy there must be no evidence of disease)
* Cachexia
* Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
* Chronic use of aspirin of omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
* Known hypersensitivity to aspirin and/or omega-3 fatty acids
* Actively receiving a physician-directed regimen of aspirin and/or receiving herapeutic/prophylactic anticoagulation
* Any aspirin or omega-3 free fatty acid supplementation within the last 14 days
* Subjects who are pregnant
* History of medical noncompliance

Primary outcomes:
measure: Biomarker levels
timeFrame: 29 days
Secondary outcomes:
measure: BMI
timeFrame: 29 Days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center at UTHSCSA
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Andrew Brenner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05414955: Boom-IBD Clinical Trial
Official title: Boom-IBD Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: IBD
Lead sponsor: Boomerang Medical
Sponsor class: INDUSTRY
First posted: 2022-06-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Feasibility study of neuromodulation in patients with IBD.

Detailed description: The study will evaluate responses of patients with IBD treated with neuromodulation at various intervals.

Eligibility criteria: General Inclusion Criteria:

* Male or female
* 18 to 75 years of age
* Diagnosed with Crohn's Disease or ulcerative colitis
* Ability and willingness to consent to participate by signing the informed consent form
* Ability to comply with the protocol and willingness to comply with all follow-up requirements
* Still have part or all of their colon

General Exclusion Criteria (The subject must not meet ANY of the following criteria):

* Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study
* Any psychiatric or personality disorder at the discretion of the study investigator
* Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)
* Active clostridium difficile infection of the colon
* Active cytomegalovirus (CMV) infection of the colon
* Evidence of colonic perforation
* Fulminant colitis requiring emergency surgery
* Microscopic, ischemic or infectious colitis
* Unresected neoplasia of the colon
* Colonic stricture unable to pass a colonoscope
* History of cancer including melanoma (except for localized skin cancers) within 2 years
* Participation in another clinical trial within the past 30 days of device implant
* Investigational drug for the treatment of inflammatory bowel disease within 6 months of device implant
* Inability to operate the patient programmer

Primary outcomes:
measure: Disease Activity Index
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Phillip Fleshner, Inc.
state: California
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation Research Institute
state: California
city: Aurora
country: United States
facility: CU Anschutz
state: Colorado
city: Wichita
country: United States
facility: Kansas Gastroenterology
state: Kansas
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: New York
country: United States
facility: The Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania, Perelman School of Medicine Division of Colorectal Surgery
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01933555: Impact of Women's Empowerment Program for Abused Pregnant Women
Official title: Impact of Women's Empowerment Program for Abused Pregnant Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Abuse Physical Battered Woman Syndrome
Lead sponsor: Macmillan Research Group UK
Sponsor class: INDUSTRY
First posted: 2013-09-02
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Although domestic violence is recognized as major threat in pregnancy, there is no intervention has been developed or test to support women in India. To evaluate the effect of women's empowerment program administered to abused women in order to reduce domestic abuse, improving health status and safety behavior.


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age,
* victims of intimate partner violence, and
* willing to participate

Exclusion Criteria:

* women whose abuser was not their intimate partner or
* who were unable to consent

Primary outcomes:
measure: Quality of life(Sf-36)
timeFrame: Five Months
Secondary outcomes:
measure: Post natal depression
timeFrame: 5 months
Other outcomes:
measure: Domestic Violence Inventory and safety seeking behavior
timeFrame: 5 months
Locations:
city: Jaipur
country: India
facility: NMP medical research institute
state: Rajasthan
Study officials:
affiliation: Macmillan research group
name: Neha Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00043355: Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Safety and Efficacy of Inhaled Interferon Gamma-1b With Antimycobacterials in Previously Treated or Mod-to-Sev Pulmonary Mycobacterium Avium Complex Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Infection
Keywords: pulmonary
mycobacterium avium complex infection
MAC
nontuberculous
mycobacteria
lung
Lead sponsor: InterMune
Sponsor class: INDUSTRY
First posted: 2002-08-12
Enrollment: 100
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: The purpose of this research study is to test the safety and effectiveness of inhaled Interferon gamma-1b (IFN-g 1b), when administered for 48 weeks and in combination with oral antibiotics which may be administered for up to 72 weeks for the treatment of a lung infection caused by a bacterium called Mycobacterium avium complex .

FDA has not approved Interferon gamma-1b for use in patients with MAC infection of the lungs, which is the purpose of this study.Interferon gamma-1b and similar proteins play important roles in establishing and maintaining protective immune responses against a variety of microorganisms.

Detailed description: Laboratory research has shown that a mouse form of interferon gamma is effective in treating mice with infections caused by bacteria similar to MAC as well as MAC infection.

Eligibility criteria: Male and female patients, 18 years of age or older, with bacteriologically and radiographically confirmed pulmonary MAC infection who have been treated for their infection for at least 6 months within the previous 2 years, as well as patients with moderate or severe pulmonary disease due to MAC, not previously treated for this infection. Patients with recurrent pulmonary MAC infection after previous successful treatment for pulmonary MAC disease are also eligible.

In addition, various laboratory testing must confirm conditions. Patients cannot be positive for HIV or have an extra-pulmonary (in general, outside of the lungs) infection of MAC. Other preconditions related to health or other conditions exist as factors for inclusion or exclusion from this study.

Primary outcomes:
measure: sustained culture conversion
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: InterMune
name: Steven Porter, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03197155: Direct-acting Antivirals and Hepatocellular Carcinoma Recurrence
Official title: Direct-acting Antiviral Therapy Decreases Hepatocellular Carcinoma Recurrence Rate in Cirrhotic Patients With Chronic Hepatitis C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Hepatitis C
Direct Acting Antivirals
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All HCV infected patients from the Department of Hepatology, Croix-Rousse Hospital, Lyon, France developing a first HCC and receiving or not a direct-acting antiviral combination therapy after HCC remission between January 2009 and March 2016 were considered.

Brief summary: Background and Aims: Arrival of direct-acting antiviral (DAA) agents against hepatitis C virus (HCV) with high-sustained virological response (SVR) rates and very few side effects has drastically changed the management of HCV infection. The impact of DAA exposure on hepatocellular carcinoma (HCC) recurrence after a first remission in patients with advanced fibrosis remains to be clarified.

Methods: 68 consecutive HCV patients with a first HCC diagnosis and under remission, subsequently treated or not with a DAA combination, were included. Clinical, biological, and virological data were collected at first HCC diagnosis, at remission and during the surveillance period.


Eligibility criteria: Inclusion Criteria:

* first HCC diagnosed by invasive or non-invasive criteria following the American Association for the Study of Liver Diseases (AASLD) guidelines during the study time horizon
* complete remission after hepatocellular carcinoma treatment defined by the European Association for the Study of the Liver (EASL) criteria as absence of residual tumor/complete necrosis at imaging one month after the end of hepatocellular carcinoma treatment

Exclusion Criteria:

* prior history of hepatocellular carcinoma before January 2009
* liver transplantation before hepatocellular carcinoma diagnosis
* presence of "non-characterized nodules" after hepatocellular carcinoma treatment at imaging
* history of direct-acting antivirals treatment before the first hepatocellular carcinoma diagnosis
* hepatic decompensation
* human immunodeficiency virus (HIV) coinfection.

Primary outcomes:
measure: Hepatocellular recurrence event
timeFrame: From date of HCC remission until the date of HCC recurrence, assessed up to January 1st, 2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05544955: Protein Ingestion Timing on Body Composition and Biochemical Markers in Resistance-trained Males
Official title: Comparison of Protein Ingestion Timing on Body Composition, Physical Performance, and Biochemical Markers in Resistance-trained Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophy
Physical Performance
Lead sponsor: Marymount University
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2022-09-19
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Protein ingestion timing is an important component for muscle accretion. The investigators hypothesized that protein ingestion timing could affect muscular adaptations and performance in resistance-trained men.


Eligibility criteria: Inclusion Criteria:

* performing resistance training at least three times a week for 1 year prior to the start of the study
* not taking any steroids or any illegal agents known to increase muscle size for at least 1 year prior to the start of the study
* no known medical issues
* sleeping for at least seven to eight hours during the 24-hour day

Exclusion Criteria:

* non-willingness to continue protein ingestion or exercise protocols
* participation in exercise other than the prescribed resistance training program
* consumption of dietary supplement (other than the protein intervention) during the study period
* Missing more than one resistance training session or protein ingestion throughout the study period

Primary outcomes:
measure: Body Composition
timeFrame: 12 weeks
Secondary outcomes:
measure: Muscular Strength
timeFrame: 12 weeks
measure: Muscular Endurance
timeFrame: 12 weeks
measure: Jump testing
timeFrame: 12 weeks
measure: Pull-ups
timeFrame: 12 weeks
measure: Liver enzymes (ALT, AST, and GGT)
timeFrame: 12 weeks
measure: Creatinine and Urea Nitrogen
timeFrame: 12 weeks
measure: Cholesterol Levels
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Arlington
country: United States
facility: Marymount University
state: Virginia
Study officials:
References:
Clinical trial NCT00783055: Autonomy Among Physically Frail Older People in Nursing Homes
Official title: Autonomy Among Physically Frail Older People in Nursing Homes: a Study Protocol for an Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Keywords: Autonomy
Older people
Physically frail
Nursing home
Intervention study
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the status of perceived autonomy and to evaluate the effectiveness of individually tailored programmes on perceived autonomy in physically frail older people living in nursing homes.

Detailed description: Experiencing autonomy is recognised to promote health and well-being for all age groups. Perceived lack of control has been found to be detrimental to physical and mental health. There is a lack of evidence-based knowledge elucidating how frail older people in nursing home settings perceive autonomy. Further, there are no studies on the extent to which this perception can be influenced positively by participating in an individually tailored programme based on individual wishes for daily activities.

The purpose of this study was to evaluate the effectiveness of individually tailored programmes on perceived autonomy in physically frail older people in nursing homes.

Eligibility criteria: Inclusion Criteria:

* Aged 65 years or older
* All kinds of diseases leading to physical frailty
* Dependent on assistance in minimum one P-ADL activity
* Able to understand verbal instructions
* Willing to participate
* Expected to live in the nursing home during the 24 weeks
* Both men and women

Exclusion Criteria:

* Terminal stages of disease
* MMSE-score below 16

Primary outcomes:
measure: The Autonomy Sub-dimension
timeFrame: baseline, after 12 weeks, anfter 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Centre of Applied and Clinical Excercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Lis Puggaard, PhD
role: STUDY_DIRECTOR
References:
citation: Andresen M, Puggaard L. Autonomy among physically frail older people in nursing home settings: a study protocol for an intervention study. BMC Geriatr. 2008 Dec 1;8:32. doi: 10.1186/1471-2318-8-32.