louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00006158: AIDS Wasting in Women: Anabolic Effects of Testosterone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: AIDS Wasting Syndrome
Keywords: AIDS
HIV
weight loss
Wasting Syndrome
testosterone
androgen levels
hormones
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2000-08-09
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The study is a 6 month, placebo-controlled study of transdermal testosterone for women with HIV-associated weight loss. Women with AIDS wasting have been found to have low testosterone levels. This study is designed to test the efficacy of physiologic testosterone dosing to improve weight, muscle mass and quality of life indices, including energy level, appetite and libido, in androgen deficient women with AIDS wasting. After 6 months, all women receive open label transdermal testosterone for an additional 6 months.


Eligibility criteria: Inclusion Criteria:

* Females using acceptable form of birth control during study, including barrier contraception or IUD but excluding oral contraceptives or Depo-Provera
* Documented HIV infection
* Free testosterone level 3.0 pg/mL
* Weight \< 90% or weight loss \> 10% of pre-illness weight

Exclusion Criteria:

* Pregnant or actively seeking pregnancy
* Breast feeding
* New opportunistic infection diagnosed within 4 weeks of the study
* Requiring parenteral nutrition or pharmacologic glucocorticoid therapy
* Intractable diarrhea (6 stools/day)
* Androgen, estrogen, progestational derivative, or glucocorticoid administration within 3 months of the study, including Megace
* New retroviral therapy within 6 weeks of study
* SGOT \> 5 X normal and/or clinically significant liver disease
* Creatinine \> 2.0 mg/dL and/or clinically significant renal disease
* Hgb \< 8.0 g/dL
* Active substance abuse or alcoholism

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven Grinspoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller K, Corcoran C, Armstrong C, Caramelli K, Anderson E, Cotton D, Basgoz N, Hirschhorn L, Tuomala R, Schoenfeld D, Daugherty C, Mazer N, Grinspoon S. Transdermal testosterone administration in women with acquired immunodeficiency syndrome wasting: a pilot study. J Clin Endocrinol Metab. 1998 Aug;83(8):2717-25. doi: 10.1210/jcem.83.8.5051.
citation: Corcoran C, Grinspoon S. Treatments for wasting in patients with the acquired immunodeficiency syndrome. N Engl J Med. 1999 Jun 3;340(22):1740-50. doi: 10.1056/NEJM199906033402207. No abstract available.
Clinical trial NCT01521858: THRA_hematologic Variables
Official title: Relations Between Hematologic Variables and Postoperative Bleeding in Total Hip Replacement Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Avascular Necrosis of Hip
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2012-01-31
Enrollment: 73
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagosed with avascular necrosis of hip and undergoing total hip replacement arthroplasty

Brief summary: Total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. The investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume.


Eligibility criteria: Inclusion Criteria:

* avascular necrosis of hip
* total hip replacement arthroplasty

Exclusion Criteria:

* revision operation
* hematologic disease
* anticoagulant medication
* preoperative hemoglobin \< 10 g/dl
* preoperative transfusion of red blood cells

Primary outcomes:
measure: postoperative bleeding volume
timeFrame: at first postoperative day
measure: Hemoglobin
timeFrame: preoperative 1 day and postoperative 1 day
measure: hematocrit
timeFrame: preoperative 1 day and postoperative 1 day
measure: platelet
timeFrame: preoperative 1 day and postoperative 1 day
measure: prothrombin time_international normalized ratio
timeFrame: preoperative 1 day and postoperative 1 day
measure: activated partial prothrombin time
timeFrame: preoperative 1 day and postoperative 1 day
measure: fibrinogen concentration
timeFrame: preoperative 1 day and postoperative 1 day
measure: Rotational thromboelastometry
timeFrame: preoperative 1 day and postoperative 1 day
Secondary outcomes:
measure: volume of infused fluid during operation
timeFrame: Period from starting to finishing the operation (During operaiton, an expected average of 3 hours)
measure: intraoperative urine output
timeFrame: Period from starting to finishing the operation (During operaiton, an expected average of 3 hours)
measure: transfusion units
timeFrame: Period from starting to finishing the operation (During operaiton, an expected average of 3 hours) and postoperative first day
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyounggi
Study officials:
References:
Clinical trial NCT00355758: UCI 03-72 Prostate Cancer Detection by Serum Proteomic Profiling
Official title: Prostate Cancer Detection by Serum Proteomic Profiling
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Keywords: Prostate Cancer Detection by Serum Proteomic Profiling
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2006-07-25
Enrollment: 200
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those who have prostate cancer and are scheduled for robotic prostatectomy to treat the disease and are seen at the Urology Clinic of the University of California, Irvine.

Brief summary: : Researchers would like to see if a new test called SELDI (Surface Enhanced Laser Desorption Ionization) analysis can predict biopsy results better than PSA tests.

Detailed description: A blood sample of approximately 30 cc will be collected prior to the patients standard of care radical prostatectomy surgery. This blood will be used for the SELDI analysis. The remainder of the blood sample will be stored and may be used for the PSA test at a later date. The patient will have a final blood draw 3 months to 1 year following surgery.

Eligibility criteria: Inclusion Criteria:

* For all subjects:

  * Men 50 years of age or older.
  * Serum PSA greater than or equal to 2.5 ng/ml and less then or equal to 10.0 ng/ml determined by a measurement within the past six months, and/or digital rectal exam suspicious for prostate cancer as determined by the patient's Urologist.
  * It has been determined by the treating physician that a prostate biopsy is clinically indicated.
  * Patients will have already been diagnosed with prostate cancer and scheduled for a radical prostatectomy.

For study on treatment effect

* Men with clinically localized prostate cancer (total PSA \< 20 ng/ml and clinical T2b or less).
* Men with organ confined prostate cancer as determined by final pathologic diagnosis.

Exclusion Criteria:

* Exclusion criteria for all subjects:

  * Known prostate cancer or prior treatment for prostate cancer.
  * Acute prostatitis.
  * Untreated urinary tract infection.
  * Presence of Foley catheter or any urethral instrumentation in the previous 48 hours.
  * Hormonal therapies including LHRH agonists, oral anti-androgens, estrogenic compounds, Proscar or any phytotherapies within the previous 6 months.

Exclusion Criteria (for study on treatment effect)

* Men with non-organ confined prostate cancer.
* Men with detectable serum PSA levels more than 1 months following radical prostatectomy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California
name: Atreaya Dash, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06977958: NASM OPT for Gluteal Enhancement in Non-Athletic Women: An RCT
Official title: Efficacy of a 12-Week NASM Optimum Performance Training Program on Gluteal Muscle Strength, Hip Aesthetics, and Low Back Pain in Non-Athletic Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Low Back Pain
Muscle Weakness
Body Image Disturbance
Keywords: NASM OPT
Gluteal Muscles
Hip Aesthetics
Non-Athletic Women
Resistance Training
Lead sponsor: University of Sistan and Baluchestan
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This RCT evaluates a 12-week NASM OPT program targeting gluteal muscle strength, hip aesthetics (shape, lift, circumference), and low back pain in 120 non-athletic women. The intervention group performed structured resistance training, while the control group engaged in general exercise. Outcomes included gluteal strength (dynamometer), aesthetic satisfaction (Likert scale), and functional performance (squat test).

Detailed description: Participants were randomized to NASM OPT (3 weekly sessions: stabilization, strength, and hypertrophy phases) or general exercise (brisk walking/aerobics). Measurements at baseline and 12 weeks included gluteal strength, hip circumference, low back pain (VAS), and perceived aesthetics.

Eligibility criteria: Inclusion Criteria:

* Non-athletic women (no exercise in prior 6 months).
* Interest in improving hip aesthetics.
* No musculoskeletal injuries.

Exclusion Criteria:

* Pregnancy
* Chronic illness
* Exercise contraindications

Primary outcomes:
measure: Gluteal Strength
timeFrame: Baseline, 12 weeks (post-intervention)
measure: Perceived Hip Shape/Lift
timeFrame: Baseline, 12 weeks (post-intervention)
measure: Hip Circumference
timeFrame: Baseline, 12 weeks (post-intervention)
Secondary outcomes:
measure: Aesthetic Satisfaction
timeFrame: Baseline, 12 weeks
measure: Functional Performance
timeFrame: Baseline, 12 weeks
measure: Low Back Pain
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Ferdows
country: Iran, Islamic Republic of
facility: Ferdows Shafa Center
state: South Khorasan
Study officials:
affiliation: Assoc.Prof.Dr. of University of Sistan and Baluchestan, Zahedan, Iran
name: Mohammadreza Rezaeipour, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02205658: Sensory Processing Difficulties in Adults and Adolescents
Official title: Standardization of the Adult/ Adolescent Sensory History
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sensory Processing Dysfunction
Keywords: Sensory Processing
Autism
Lead sponsor: The Spiral Foundation at OTA Watertown
Sponsor class: OTHER
Collaborators: name: Maxwell Hurston Charitable Foundation
First posted: 2014-07-31
Enrollment: 1300
Sex: ALL
Minimum age (years): 13
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals will be a nationally representative sample of US residents

Brief summary: The purpose of this study is to establish normative data for the Adult/Adolescent Sensory History (ASH) and to determine if the ASH is able to discriminate between individuals aged 13-95 years, with Autism Spectrum Disorder (ASD) with or without co-morbid Sensory processing Disorder (SPD), individuals with SPD with no co-morbid ASD, and individuals who are typically functioning.

It is anticipated that individuals with ASD will have the most problems with sensory processing, those with SPD will also have problems in comparison to typical individuals. It is also hypothesized that the measure will be able to discriminate between the three groups.


Eligibility criteria: Inclusion Criteria:

* Autism and Sensory Processing groups aged 18-95 years, Typical group aged 13-95 years
* Have no self-reported diagnosed neurological motor coordination problem (e.g. cerebral palsy)
* Have no mental health diagnoses involving psychosis (e.g. manic-depression or schizophrenia)
* Be able to read and speak sufficient English as survey is only available in English.

Exclusion Criteria:

* Outside of the designated age range
* Unable to complete the survey independently

Primary outcomes:
measure: Sensory processing difficulties
timeFrame: 15-20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Newton
country: United States
facility: The Spiral Foundation
state: Massachusetts
Study officials:
affiliation: The Spiral Foundation
name: Teresa A May Benson, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05091658: Period Tracker Lay User Study
Official title: Period Tracker Lay User Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstrual Cycles
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between the ages of 18 to 45 represent the intended user of the product

Brief summary: This study will assess the ability of the lay user to obtain and record a result. Comprehension of the instructions for use of the product will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Female
* Aged 18 to 45 years
* Willing to give informed consent and comply with the investigational procedures

Exclusion Criteria:

* Used Clearblue® me Period Tracker app Persona or FAM within the last six months
* Currently or previously employed by SPD, Abbott, Alere, Unipath, P\&G or affiliates
* Has an immediate\* relative currently or previously (within past 5 years) employed by SPD, Abbott, Alere, Unipath or P\&G, or affiliates
* Is a qualified or trainee healthcare professional (HCP)
* Has professional experience of using dipstick type tests or lateral flow devices
* Currently breastfeeding, pregnant or seeking to conceive
* Currently menstruating∆ \*Immediate relatives are defined as parents, children, siblings or partner/spouse ∆Volunteer can start the study when their period has ended.

Primary outcomes:
measure: Lay user usage
timeFrame: 1 hour
Secondary outcomes:
measure: Comprehension of instructions for use
timeFrame: 1 hour
Other outcomes:
measure: Lay user ability to read a high and a low result
timeFrame: 1 hour
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd
state: Bedfordshire
Study officials:
affiliation: SPD Development Company
name: Sharon Bond
role: PRINCIPAL_INVESTIGATOR
affiliation: SPD Development Company
name: Raniero Zazzeroni
role: STUDY_DIRECTOR
References:
Clinical trial NCT02355496: The Impact of Charge Displays on Inpatient Laboratory Test Ordering
Official title: The Impact of Charge Displays on Inpatient Laboratory Test Ordering
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Cost Control
Data Display
Diagnostic Tests, Routine
Physician's Practice Patterns
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 98529
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a clinical trial to evaluate the impact of presenting medicare fee data for inpatient laboratory tests in the electronic health record on provider ordering behavior at a tertiary care hospital.

Detailed description: This study is a clinical trial to determine the impact on inpatient laboratory test ordering of presenting providers with medicare fee data at the time of order entry. We will randomly assign 60 laboratory tests to an active arm (medicare fee data displayed) or to a control arm (medicare fee data not displayed). The primary outcome will be the change in the ratio of tests ordered per patient day over 12 months by study group (intervention vs. control).

Eligibility criteria: Inclusion Criteria:

* Not applicable

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: The ratio of tests ordered per patient-day
timeFrame: 12 months
Secondary outcomes:
measure: The total associated fees of tests ordered per patient-day
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Mina Sedrak, MD
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Mitesh Patel, MD, MBA, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sedrak MS, Myers JS, Small DS, Nachamkin I, Ziemba JB, Murray D, Kurtzman GW, Zhu J, Wang W, Mincarelli D, Danoski D, Wells BP, Berns JS, Brennan PJ, Hanson CW, Dine CJ, Patel MS. Effect of a Price Transparency Intervention in the Electronic Health Record on Clinician Ordering of Inpatient Laboratory Tests: The PRICE Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;177(7):939-945. doi: 10.1001/jamainternmed.2017.1144.
Clinical trial NCT01905696: The Role of S-nitrosohemoglobin in Regulating Systemic Blood Flow During Hypoxia and Normoxia
Official title: The Role of S-nitrosohemoglobin in Regulating Systemic Blood Flow Under Hypoxic and Normoxic Conditions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Focus is Determination of the Role of SNO-Hb in Forearm Blood Flow Regulation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Nitric oxide is believed to contribute to regulation of blood flow by its selective binding to circulating hemoglobin (forming S-nitrosohemoglobin, SNO-Hb) and release in a PO2-dependent manner. This study is designed to test that hypothesis by measuring the effect of hypoxia and exercise on forearm blood flow before and after depletion of SNO-Hb using oral N-acetylcysteine.

Detailed description: NO has been shown to associate with erythrocytes in the form of SNO-Hb and can deliver vasomotor changes as erythrocytes pass through a physiologic O2 gradient. The aim of this study is to transiently deplete circulating SNO-Hb levels to prove that these levels are directly linked with the normal physiological vasodilation that occurs in response to brief hypoxia that occurs in moderate exercise. This study will be performed on healthy volunteers especially with no predisposing cardiovascular or respiratory conditions that may change their vasomotor response to hypoxia. Systemic blood flow will be approximated using non-invasive forearm venous occlusion plethysmography which will be performed initial to gather baseline data. The participants will then undergo 4 days of 600 mg BID oral N-acetylcysteine (NAC) solution treatment which acts as a bait reactant for NO groups bound to hemoglobin (SNO-Hb) and will then undergo retesting with forearm plethysmography. At the time of both blood flow measurements, arterial blood samples will also be gathered via an arterial catheter inserted on each of two testing days to determine SNO-Hb levels. Statistical analysis will include measuring the blunting of the hypoxia response and SNO-Hb levels using baseline testing as a self-control for each participant. Large scale human placebo-controlled trials with high-dose oral NAC (up to 8000 mg/day) for periods up to 12 months have shown no clinically significant adverse reactions, much less than in the proposed study.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Pregnancy
* smoking
* pulmonary disease
* cardiovascular disease

Primary outcomes:
measure: Forearm blood flow
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT03074396: Usefulness of a Mobile Information Management System for Haemodialysis Patient
Official title: Usefulness of a Mobile Information Management System for Haemodialysis Patients and the Prospect of Participatory Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Drug Habit
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators developed and used the DialysisNet mobile application for physicians and Avatar Beans mobile application for haemodialysis patients. Patient-centred data integration and exchange were based on the American Society for Testing and Materials Continuity of Care Record standard. The investigators enrolled 10 patients and 4 physicians. Questionnaires to evaluate user experience and usefulness were administered before and after use.


Eligibility criteria: Inclusion Criteria:

* patients who have maintenance hemodialysis treatment
* accept consent form

Exclusion Criteria:

* pregnant

Primary outcomes:
measure: The change of Short Form 36 questionnaire for quality of life
timeFrame: 3 month after the use of DialysisNet (for doctors) and Avatar Beans (for patients)
Secondary outcomes:
measure: The change of morisky medication adherence scale (MMAS) for drug compliance
timeFrame: 3 month Before and after the use of DialysisNet (for doctors) and Avatar Beans (for patients)
Other outcomes:
Locations:
Study officials:
References: