louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03091647: Acupressure for Cancer-Related Fatigue
Official title: Acupressure Intervention to Improve Fatigue and Physical Functioning of Chinese Immigrant Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Chinese women
Cancer-related fatigue
Acupressure
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 124
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study develops and pilot tests the efficacy of a home-based, self-administered acupressure intervention in improving cancer-related fatigue (proximal outcome), and physical functioning and other quality of life outcomes (distal outcomes) of Chinese immigrant breast cancer survivors (versus usual care control group).

Detailed description: We will enroll 124 foreign-born, Chinese-speaking women from Southern California and Maryland areas with moderate to severe levels of fatigue, diagnosed with stage 0-IV breast cancer, aged 21-74, and 1-5 years post-primary treatment. Using an adaptive treatment strategy design, participants will be randomized to either the acupressure intervention or control groups. The acupressure group will learn how to press three chief energy acupoints on each side of the body through de novo 11-minute Chinese-language video and practice acupressure every day (one minute per acupoint; a total of 6 minutes per day) for an 8-week intervention period. Participants will be telephone interviewed twice: at baseline and 8-weeks post-intervention follow-up.

Eligibility criteria: Inclusion Criteria:

* 1) be between ages 21 to 74
* 2) be first-generation immigrants
* 3) speak Chinese (Mandarin and/or Cantonese)
* 4) be diagnosed with breast cancer at stage 0, I, II III or IV
* 5) have completed primary treatments (including surgery, radiation, and chemotherapy) 1-5 years prior to recruitment
* 6) have not had recurrence
* 7) have moderate to severe levels of fatigue.

Exclusion Criteria:

* have hypothyroidism and anemia
* being using acupuncture

Primary outcomes:
measure: Cancer-related fatigue (proximal outcome)
timeFrame: 8 weeks post-intervention
Secondary outcomes:
measure: Physical functioning (distal outcomes)
timeFrame: 8 weeks post-intervention
measure: Sleep disturbance
timeFrame: 8 weeks post-intervention
measure: Anxiety
timeFrame: 8 weeks post-intervention
measure: Depression
timeFrame: 8 weeks post-intervention
measure: Pain interference
timeFrame: 8 weeks post-intervention
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Judy Wang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01791647: Myo-inositol Versus Metformin in Obese Women With Polycystic Ovary Syndrome
Official title: Myo-inositol Versus Metformin: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic ovary syndrome
myoinositol
metformin
glucose-insulinemic metabolism
menstrual pattern
insulin-lowering therapies
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effects of six months treatment of two insulin-lowering therapies on the clinical and endocrine-metabolic parameters in obese women affected by polycystic ovary syndrome. The study group includes 40 patients, randomly allocated to subgroup A (metformin 1500 mg/day) and subgroup B (myo-inositol 1500 mg/day). The investigations include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipid profile at baseline and after six months of treatment.


Eligibility criteria: Inclusion Criteria:

* women with Polycystic Ovary Syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003;
* BMI\>25 kg/m2;
* age 18-35 years.

Exclusion Criteria:

* pregnancy;
* significant liver or renal impairment;
* other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs);
* neoplasms;
* unstable mental illness;
* diagnosis of diabetes mellitus or impaired glucose tolerance;
* use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior to entering the study.

Primary outcomes:
measure: number of cycles
timeFrame: six months
Secondary outcomes:
measure: effects of two therapies on glyco-insulinemic metabolism
timeFrame: six months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of Sacred Heart
Study officials:
References:
Clinical trial NCT06482047: Boosting Executive Function With Brain Exercise
Official title: Rejuvenating the Brain and Boosting Executive Function With Exercise Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sedentary Behavior
Lead sponsor: Shenzhen University
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study used a within-participant cross-over design with pre-and post-test comparisons. Participants completed the three following experimental conditions in pseudo-counterbalanced (cannot be completely counterbalanced given that an odd number of participants - hence, was pseudo-counterbalanced) order (odd number of participants) with at least a 7-day washout period between conditions: (i) 115-minute uninterrupted sitting \[control\]; (ii) 50-minute sitting + 15-minute moderate-intensity cycling + 50-minute sitting \[experimental condition 1\]; (iii) 50-minute sitting + 15-minute vigorous-intensity cycling + 50-minute sitting \[experimental condition 2\]. A familiarization session was completed about three days before the experiment started, during which participants were familiarized with the cognitive assessment and cycling protocols.
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to explore the impact of a 15-minute exercise break on brain function and cognitive performance in a simulated classroom setting. The main questions it aims to answer are:

1. How do short exercise breaks affect executive function in college students?
2. What changes occur in brain connectivity and microcirculation after these exercise breaks? Participants were college students who engaged in sessions of continuous sitting or sitting interspersed with exercise. The study used cognitive tasks and brain imaging techniques to measure the effects. The findings reveal improvements in cognitive performance and brain function, suggesting that short exercise breaks are beneficial in educational contexts.


Eligibility criteria: Inclusion Criteria:

-right-handed (how was handedness assessed; i.e., "What hand do you write with?") with normal or corrected-to-normal vision and normal color vision

Exclusion Criteria:

-reported a history of cardiovascular, metabolic, gastrointestinal, neurological, or psychiatric disorders, medical conditions requiring medical care, substance addiction, strict diets (e.g., low- carbohydrate and Mediterranean diet), pregnancy, or lactation.

Primary outcomes:
measure: Cognitive function
timeFrame: 3 weeks
measure: Retinal Vessel Diameter
timeFrame: 3 weeks
measure: Brain Connectivity
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Body-Brain-Mind Laboratory, School of Psychology, Shenzhen University
Study officials:
References:
Clinical trial NCT02566447: "Solana™ Trichomonas Assay Field Study"
Official title: "Solana™ Trichomonas Assay Field Study"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trichomonas Vaginalis
Lead sponsor: Quidel Corporation
Sponsor class: INDUSTRY
First posted: 2015-10-02
Enrollment: 750
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female subjects symptomatic for Trichomonas vaginalis infection.

Brief summary: The Solana® Trichomonas Assay is an in vitro qualitative nucleic acid amplification test for the detection of Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Helicase-Dependent Amplification (HDA) technology and the Solana instrument.

Detailed description: This study is to establish the clinical performance of the Solana® Trichomonas Assay for the detection of Trichomonas vaginalis in vaginal swabs and urine samples as compared to a combined reference method of direct wet mount microscopy and a FDA-cleared device.

Eligibility criteria: Inclusion Criteria:

* Female subjects will be recruited from the general population as they present to the clinical facility. Subjects will be categorized by the clinician as either asymptomatic or symptomatic for Trichomonas vaginalis infection.

Symptoms in women can include:

* Greenish-yellow, frothy vaginal discharge with a strong odor
* Painful urination
* Vaginal itching and irritation
* Discomfort during intercourse
* Lower abdominal pain (rare)

Exclusion Criteria:

1. The study is limited to females. Male subjects are not accepted.
2. At clinical sites informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

Primary outcomes:
measure: Trichomonas Test Result
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Chapel Hill
country: United States
facility: University of North Carolina, Div. of Infectious Diseases
state: North Carolina
city: Seattle
country: United States
facility: University of Washington in Seattle
state: Washington
Study officials:
References:
Clinical trial NCT04793347: Effect of Shock Waves Therapy on Chronic Anal Fissure
Official title: Effect of Shock Waves Therapy on Anal Fissure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Anal Fissure
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2021-03-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: the study conducted to assess if there is an effect of Extracorporeal Shock Wave Treatment on anal fissure

Detailed description: Design of the study:

A prospective, randomized, blind, paired (right/left) comparison.

Materials:

Measurement tool:

* healing of anal fissure,
* Wexner Constipation Scoring System
* anal pain intensity by means of a 10-point visual analogue scale (VAS)

Therapeutic instruments:

•. shock waves

• topical application of 0.4% glyceryl trinitrate (GTN) ointment

Methods:

• Testing procedures: The assessment will be performed before commencing treatment, after 4 and 8 weeks of the treatment.

• Treatment procedures: Patients will be assigned randomly into two groups equal in number: shock waves Group: twenty patients will receive the shockwaves on perianal area of for 4 weeks (3 sessions /week). control Group: twenty patients will receive the recommended routine medical treatment include topical application of 0.4% glyceryl trinitrate (GTN) ointment only..

Eligibility criteria: Inclusion Criteria:

* patient with chronic anal fissure
* symptomatic for at least 6 months
* failed conservative measures

Exclusion Criteria:

* Pregnant women,
* cardiac patients,
* patients with a pacemaker,
* low molecular heparin or warfarin treatment,
* neurological disease,

Primary outcomes:
measure: VAS
timeFrame: up to 3 months
Secondary outcomes:
measure: wexener scale
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Amr
Study officials:
References:
Clinical trial NCT02576847: Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
Official title: A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects With Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rosacea
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-10-15
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the long-term safety of once-daily application of Omiganan topical gel in subjects with severe papulopustular rosacea.


Eligibility criteria: Inclusion Criteria:

1. Healthy, male and nonpregnant female subjects, 18 years of age or older.
2. A diagnosis of severe papulopustular rosacea using the Investigator Global Assessment grading scale at baseline
3. Subjects with the presence of telangiectasia at Baseline
4. Subjects with the presence of facial erythema associated with their rosacea at Baseline

Exclusion Criteria:

1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
2. Subjects with nodular rosacea
3. Standard exclusion criteria.

Primary outcomes:
measure: Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fremont
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Miramar
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Arlington Heights
country: United States
state: Illinois
city: Carmel
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Plainfield
country: United States
state: Indiana
city: Watertown
country: United States
state: Massachusetts
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Pflugerville
country: United States
state: Texas
city: Webster
country: United States
state: Texas
city: Sydney
country: Australia
state: New South Wales
city: Woolloongabba
country: Australia
state: Queensland
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Drummondville
country: Canada
state: Quebec
city: Cannes
country: France
city: Nice
country: France
city: Bergen Op Zoom
country: Netherlands
city: Hamilton
country: New Zealand
city: Wellington
country: New Zealand
city: Gothenburg
country: Sweden
city: Lanarkshire
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
References:
Clinical trial NCT05559047: Field Usability Study of Eclipse Mask
Official title: Field Usability Study of Eclipse CPAP Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Bleep, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-09-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device will be randomized.


Eligibility criteria: Inclusion Criteria:

•Male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device.

Exclusion Criteria:

* Diagnosis of any medical or behavioral conditions that would compromise subject safety.
* Under the age of 18: target for this current version of the platform is the adult population.

Primary outcomes:
measure: Time to complete each setup
timeFrame: 1 day
measure: Number of technical issues
timeFrame: 1 day
measure: Number of times participant needs assistance
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Asheville
country: United States
facility: AeroFlow Sleep
state: North Carolina
city: Huntersville
country: United States
facility: Advanced Respiratory and Sleep Medicine
state: North Carolina
city: Murfreesboro
country: United States
facility: Sleep Centers of Middle Tennessee
state: Tennessee
Study officials:
affiliation: Bleep, LLC
name: Stuart Heatherington
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03622047: Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil
Official title: Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pharmacological Action
Keywords: Labor, Analgesia, Dexmedetomidine, Sufentanil
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Women and children's hospital of Jiaxing university
name: Shanghai First Maternity and Infant Hospital
First posted: 2018-08-09
Enrollment: 1800
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The participants: 1800 full-term primiparas will be selected with ASA I-Ⅱgrade, 20 to 35 years old and weighing 55 to 90 kg in the investigator's hospital from may 2018 to December 2018. 1200 primiparas were divided into A and B according to the computer randomized numbers, and 600 parturients without labor analgesia in the same period were selected as group C, with 600 patients in each group. All parturients signed the informed consent form and were approved by the hospital ethics Committee.

Detailed description: 1200 primiparas were divided into A and B according to the computer randomized numbers, and 600 parturients without labor analgesia in the same period were selected as group C, with 600 patients in each group. All parturients signed the informed consent form and were approved by the hospital ethics Committee.

Eligibility criteria: Inclusion Criteria:

* ASA I-Ⅱ, aged 22 - 42,
* gestational age ≥ 37, weight 55 - 90 kg,
* labor analgesia is required by full-term primiparas.

Exclusion Criteria:

* serious cardiovascular and cerebrovascular system diseases,
* bradycardia, conduction block
* fetal distress
* contraindications of intraspinal anesthesia.

Primary outcomes:
measure: The onset time
timeFrame: 30 minutes
Secondary outcomes:
measure: analgesic effect
timeFrame: 1 day
Other outcomes:
Locations:
city: Shanghai
country: China
facility: International Peace Maternity and Child Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Yongtao Gao, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06285747: A Correlational Study: Breast Cancer-related Chest Wall Lymphedema, Quality of Life, and Shoulder Function
Official title: A Correlational Study: Breast Cancer-Related Chest Wall Lymphedema, Quality of Life, and Shoulder Function
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 85
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have undergone surgical intervention for treatment of breast cancer.

Brief summary: This study evaluates how swelling in the chest following breast cancer treatment may affect patients' quality of life and shoulder function.

Detailed description: PRIMARY OBJECTIVES:

I. Determine if there is a correlation to Delfin Moisture Meter Compact D reading and quality of life as measured by the LymQOL-midline.

II. Determine if there is a correlation to Delfin Moisture Meter Compact D reading and DASH measure of shoulder function.

III. Determine how the presence of chest wall lymphedema as determined by physical exam may affect an individual's quality of life as measured by the LymQOL-midline assessment.

IV. Determine how the presence of chest wall lymphedema as determined by physical exam may shoulder function on the effected side, as measured by the Disabilities of the Arm, Shoulder, and Hand questionnaire.

OUTLINE: This is an observational study.

Patients complete questionnaires and undergo chest wall and breast lymphedema measurements by clinical assessment and using the Delfin Moisture Meter D Compact and have their medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* Women of any age with diagnosis of any type of breast cancer

  * Breast cancer on unilateral or bilateral side
  * Surgical intervention for treatment of breast cancer

Exclusion Criteria:

* Previous shoulder injury or known shoulder limitation on affected side

Primary outcomes:
measure: Chest wall lymphedema
timeFrame: Baseline
measure: Quality of life - Limb Lymphoedema Quality of Life (LymQOL)
timeFrame: Baseline
measure: Disability of the shoulder - Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Kayla A. Van Der Weerd, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References: