louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05714280: PA4Health Physical Activity App Open Pilot Study for African American Women
Official title: Developing a Tailored, Theoretically-Driven Smartphone Physical Activity Intervention for African American Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Test Acceptability/Usability of a Physical Activity App Developed for African American Women
Keywords: PA4Health Open Pilot
Physical Activity App
African American Women
Lead sponsor: City University of New York, School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-02-06
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Test the acceptability of a smartphone physical activity app for African American women

Detailed description: The goal of this aim is to collect data that guide the refinement of intervention components and structure to increase appeal to AA women. Fifteen physically inactive AA women will participate in a 12-week study examining the feasibility, acceptability, and usage of the PA4Health app. They will receive a Fitbit tracker to be worn during the trial. Following the trial, participants will complete self-report measures as well as a semi-structured interview to learn about their experience in using the app, any experienced difficulties, and recommendations for improving the acceptance and usage of the app.

Intervention components: The intervention components include: tailored daily text intervention text message, educational feature, goal setting and monitoring, and an activity locator that allow participants to enter their zip code and view available resources for physical activity.

Eligibility criteria: Inclusion: Eligible participants must:

1. be ages 18-64
2. identify as AA and female
3. own a smartphone
4. be able to provide consent
5. not regularly physically active (i.e. less than 90 mins. of MVPA per week), 6) medically cleared for PA,

7) have a valid email address, and 9) no previous engagement in the study.

Exclusion: Individuals will be excluded if they report:

1. physical limitations to PA engagement
2. significant medical conditions (e.g., heart failure)
3. planned surgery in the next 6 months,
4. pregnant or plan to become pregnant in the next 6 months.

Primary outcomes:
measure: System usability scale (SUS)-- app satisfaction
timeFrame: 12 weeks study
measure: Metada; collected through app system
timeFrame: 12 weeks
Secondary outcomes:
measure: Accelerometer
timeFrame: Participants will wear this device for 7 consecutive days at baseline and at 12 weeks(end of the intervention)
measure: Fitbit data
timeFrame: Participants will wear this device daily during the 12-week intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: City University of New York School of Public Health & Health Policy
state: New York
Study officials:
References:
Clinical trial NCT03028480: Long Term Special Drug Use Investigation of Mepolizumab
Official title: Nucala® Subcutaneous Injection Special Drug Use Investigation (Long-Term)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Exacerbation
Mepolizumab
NUCALA
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-01-23
Enrollment: 1061
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications)

Brief summary: This study is a special drug use investigation program of NUCALA (a brand name for Mepolizumab) administered subcutaneously (SC). In this study the information regarding the safety and effectiveness of long term use of NUCALA after subcutaneous injection will be collected from Asthma subjects in daily clinical practice. The observation period per subject will be 52 weeks from the initiation of NUCALA treatment with follow-up investigation for 2 years after the observation period. NUCALA is a registered trademark of the GlaxoSmithKline \[GSK\] group of companies


Eligibility criteria: Inclusion Criteria:

* Subjects receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications)

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Number of Participants Whose Data Entered on Electronic Data Capture (EDC) System
timeFrame: Up to 14 days from the initiation of NUCALA treatment (Day 1)
measure: Percentage of Participants With Adverse Drug Reaction (ADR)
timeFrame: Up to 3 years
measure: Number of Participants Showing Response to the Treatment
timeFrame: Up to 1 year
measure: Number of Participants Excluded From Analysis Due to Exacerbation of Asthma
timeFrame: Up to 1 year
measure: Number of Participants With Adverse Drug Reactions (ADR)
timeFrame: Up to 3 years
measure: Percentage of Participants With Occurrences of Safety Specifications and Priority Investigation Matters
timeFrame: Up to 3 years
Secondary outcomes:
measure: Response Rate Assessed by Global Assessment of Effectiveness
timeFrame: Up to 1 year
measure: Rate of Exacerbation of Asthma
timeFrame: 52 weeks before the initiation of NUCALA treatment (Day 1) and at Week 52 post-treatment
measure: Total Score of Asthma Control Test (ACT) at Indicated Time Points
timeFrame: Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1)
measure: Mean Peak Expiratory Flow (PEF) at Indicated Time Points
timeFrame: Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1)
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01077180: Rheos Feasibility Trial
Official title: Rheos Feasibility Trial- A Study of Baroreflex Hypertension TherapyTM in Refractory Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: CVRx, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Rheos Feasibility Trial is designed to assess safety, device performance, and protocol parameters of the CVRx Rheos Baroreflex Therapy in patients with severe hypertension that are refractory to full drug therapy.


Eligibility criteria: Inclusion Criteria:

1. Be at least 21 years of age.
2. Have been assessed to have bilateral carotid bifurcations located at or below C3-C4.
3. Have an office cuff systolic blood pressure greater than or equal to 160 mmHg and a 24-hour ambulatory systolic blood pressure greater than or equal to 150 mmHg despite at least one month of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
4. Must be certified by the investigator hypertension specialist as compliant with taking full doses of medication.
5. Have signed a CVRx approved informed consent for participation in this study.

Exclusion Criteria:

1. Have been diagnosed with:

   * Baroreflex failure
   * Cardiac bradyarrhythmias
   * Chronic atrial fibrillation
2. Had a heart transplant
3. Have carotid atherosclerosis producing a 50% or greater reduction in linear diameter as determined by ultrasound or angiographic evaluation as determined within six months of enrollment in the trial.
4. Have Grade C ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.
5. Have prior surgery or radiation in either carotid sinus region.
6. Currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.
7. Are pregnant or contemplating pregnancy during the 13-month follow-up period.
8. Currently undergoing dialysis.
9. Have hypertension secondary to a treatable cause.
10. Have clinically significant cardiac valvular disease.
11. Are unable or unwilling to fulfill the protocol medication compliance and follow-up requirements.
12. Are unlikely to survive the protocol follow-up period.
13. Are enrolled in another concurrent clinical trial.

    -

Primary outcomes:
measure: Rheos Feasibility Study
timeFrame: 13 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01246180: Microcirculation & ASICs
Official title: Study of the Cutaneous Microcirculation: ASIC Involvement.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiological Conditions
Keywords: Skin, microcirculation; ASIC, pressure ulcer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2010-11-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Pressure ulcers are a common and costly problem. Advancing the understanding regarding the basic pathophysiological mechanisms mediating the development of pressure ulcers will allow for better delineation of populations at risk.

Healthy skin is protected from pressure-induced ischemic damage because of the presence of pressure-induced vasodilation (PIV). In contrast, in absence of PIV, such as in diabetic patients or older subjects with sensory neuropathy, the skin is exposed to severe cutaneous ischemia, which could lead to pressure ulcer formation.

Since Acid Sensing Ion channels (ASICs) appear to be involved in the cutaneous mechanosensitivity, the investigators hypothesized that PIV could be altered by treatments that block ASICs.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males or females aged between 18 and 40 years of age

Exclusion Criteria:

* no consent, diabetes, neuropathy.

Primary outcomes:
measure: evaluate the difference in the cutaneous microvascular response to local pressure application between treated (amiloride and diclofenac) and untreated skin.
timeFrame: Criteria will be measured 30 and 60 minutes following the injection of amiloride and the application of diclofenac, respectively.
Secondary outcomes:
measure: Evaluate difference in the cutaneous sensitivity and the cutaneous microvascular response to acetylcholine, sodium nitroprusside, electrical current and local heating between treated (amiloride and diclofenac) and untreated skin
timeFrame: Criteria will be measured 30 and 60 minutes following the injection of amiloride and the application of diclofenac, respectively.
Other outcomes:
Locations:
city: Pierre Bénite
country: France
facility: Pôle d'activité medicale-Centre Hospitalier Lyon Sud-Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Jean-Louis Saumet, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fromy B, Lingueglia E, Sigaudo-Roussel D, Saumet JL, Lazdunski M. Asic3 is a neuronal mechanosensor for pressure-induced vasodilation that protects against pressure ulcers. Nat Med. 2012 Aug;18(8):1205-7. doi: 10.1038/nm.2844. Epub 2012 Jul 29.
Clinical trial NCT01494480: The Clinical Trial on the Use of Umbilical Cord Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis
Official title: The Clinical Study on the Use of Umbilical Cord Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS
stem cell
Lead sponsor: General Hospital of Chinese Armed Police Forces
Sponsor class: OTHER
First posted: 2011-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis due to the continued loss of motoneurons that leads them to death in less than 5 years. No treatment has changed its natural history. Intrathecal injection of umbilical cord mesenchymal stem cells can secret trophic factors that keep the motorneurons functional. The investigators have designed a phase I/II clinical trial to check the feasibility of this approach in humans.

Detailed description: A total of 30 diagnosed ALS patients. The patients would got these symptoms such as gait difficulty and tremor, hand incoordination or speech difficulties.

Eligibility criteria: Inclusion Criteria:

* Diagnose established following the World Federation of Neurology criteria
* More than 6 and less than 36 months of evolution of the disease
* Medullar onset of the disease
* More than 20 and less than 65 years old
* Forced Vital Capacity equal or superior to 50%
* Total time of oxygen saturation \<90% inferior to 2% of the sleeping time
* Signed informed consent

Exclusion Criteria:

* Neurological or psychiatric concomitant disease
* Need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube
* Concomitant systemic disease
* Treatment with corticosteroids, immunoglobulins or immunosuppressors during the last 12 months
* Inclusion in other clinical trials
* Unability to understand the informed consent

Primary outcomes:
measure: Nerve functional evaluation
timeFrame: within one week before,1month,6months,12months and 24months after transplantation
measure: Forced vital capacity
timeFrame: within one week before,1month,6months,12months and 24months after transplantation
Secondary outcomes:
measure: Blood test
timeFrame: within one week before,1month,6months,12months and 24months after transplantation
measure: Urinal test
timeFrame: within one week before,1month,6months,12months and 24months after transplantation
measure: Electrophysiology examination
timeFrame: within one week before,1month,6months,12months and 24months after transplantation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yihua An
Study officials:
affiliation: Chinese People's Armed Police Force
name: YiHua An
role: STUDY_DIRECTOR
References:
Clinical trial NCT04202380: Azithromycin for Preterm Pre-labor Rupture of Membranes
Official title: Different Azithromycin Protocols for Management of Preterm Pre-labor Rupture of Membranes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Pre-labor Rupture of Membranes
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The preterm prelabour rupture of membranes is defined as the spontaneous rupture of the fetal membranes before 37 completed weeks. Preterm prelabour rupture of membranes complicates up to 3% of pregnancies and is associated with 30-40% of preterm births. preterm prelabour rupture of membranes can result in significant neonatal morbidity and mortality, primarily from prematurity, sepsis, cord prolapse, and pulmonary hypoplasia. In addition, there are risks associated with chorioamnionitis and placental abruption The diagnosis of spontaneous rupture of the membranes is made by maternal history followed by a sterile speculum examination. If on speculum examination, no amniotic fluid is observed, clinicians should consider performing an insulin-like growth factor-binding protein-1 or placental alpha microglobulin-1 test of vaginal fluid to guide further management.

One of the risks associated with preterm prelabour rupture of membranes is ascending infection leading to chorioamnionitis, and subsequent fetal and neonatal infection.


Eligibility criteria: Inclusion Criteria:

1. Gestational age is between 28 wks and 37wks
2. Singleton living pregnancy.
3. Confirmed Premature Pre-labor rupture of membranes (PPROM).

Exclusion Criteria:

1. previable rupture of membranes (\<23+6wks)
2. Multiple gestations
3. Macrolide allergy
4. patient receiving combination macrolide therapy
5. lethal fetal anomalies
6. contraindications to expectant management of PPROM at time of diagnosis e.g. concurrent preterm labor, placental abruption, chorioamnionitis or non-reassuring fetal testing

Primary outcomes:
measure: Days from diagnosis of preterm pre-labor rupture of membranes to delivery.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT05722392: Safety and Efficacy of Two-step Radical Prostatectomy
Official title: An IDEAL Phase 2a, Single-arm, Single-center, Prospective Study of Two-step Radical Prostatectomy in the Treatment of Low- to Intermediate-risk Prostate Cancer Concomitant With Severe Benign Prostatic Hyperplasia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 30
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Low- to intermediate-risk localized prostate patient with enlarged prostate and severe benign prostatic hyperplasia

Brief summary: The goal of this observational study is to learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patient with enlarged prostate and severe benign prostatic hyperplasia. The main question it aims to answer are: 1. Whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. Whether the oncologic control is promising?


Eligibility criteria: Inclusion Criteria:

1. Diagnosed as prostate cancer pathologically by prostate biopsy
2. Evaluated as localized prostate cancer by imaging studies
3. Prostate volume\>70mL evaluated by transrectal ultrasonography or multi-parametric magnetic resonance imaging
4. Gleason score≤ 4+3=7
5. Preoperative PSA\<20ng/mL
6. Estimated survival\> 10 years；
7. Informed consent is obtained from the patient

Exclusion Criteria:

1. The patient has received other therapy including radical radiotherapy, transurethral resection of the prostate, cryoablation, HIFU, etc.
2. Any contraindication of surgery or anaesthesia

Primary outcomes:
measure: Biochemical Recurrence-free Survival
timeFrame: 5 years
Secondary outcomes:
measure: Surgical time
timeFrame: Intraoperative
measure: Estimated blood loss
timeFrame: Intraoperative
measure: Hospital stay
timeFrame: From date of surgery until the date of discharge, an average of 7 days
measure: Continence
timeFrame: 2 weeks, 1 months, 3 months, 6 months, 12 months after surgery
measure: Lower urinary tract symptoms
timeFrame: 1 months, 3 months, 6 months, 12 months after surgery
measure: Erectile function
timeFrame: 6 months, 12 months and 24 months after surgery
measure: Positive surgical margin rate
timeFrame: Through study completion, an average of 5 year
measure: Complication
timeFrame: Through study completion, an average of 5 year
measure: Overall survival
timeFrame: From date of randomization until the date of date of death from any cause, assessed up to 60 months
measure: Cancer-specific survival
timeFrame: From date of randomization until the date of date of death from cancer, assessed up to 60 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT03942692: What is the Allergy Follow-up for Children After Anaphylactic Reaction? AFCAR : Allergy Follow-up for Children After Anaphylactic Reaction
Official title: What is the Allergy Follow-up for Children After Anaphylactic Reaction? AFCAR : Allergy Follow-up for Children After Anaphylactic Reaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaphylaxis
Allergic Reaction
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 118
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children from 0 to 18 year old who underwent an anaphylactic reaction between the 1st July 2014 and the 31st June 2016 treated in Paediatric Emergency Department of Femme-Mère-Enfant Hospital in Lyon in France.

Brief summary: Anaphylaxis is an allergic reaction potentially fatal. The treatment is based on injection of epinephrin as soon as possible. Guidelines by the World Allergic Organisation highlight the importance of medical follow-up. This follow-up consists of an allergy consultation, the prescription and demonstration of epinephrin auto-injector and the implementation of specific measures in schools. There is no study about the recurrence of anaphylactic reaction outside the hospital.

The purpose of this study is to evaluate the allergy follow-up of children after anaphylactic reaction. The secondary objective is to evaluate the use of medical advice in case of recurrence of anaphylactic reaction.

Investigators will use a phone call questionnaire for parents of children who underwent an anaphylactic reaction between the 1st July 2014 and the 31st June 2016 treated in the Paediatric Emergency Department in Femme-Mère-Enfant Hospital in Lyon in France. 179 children could be included in the study.


Eligibility criteria: Inclusion Criteria:

* Age from 0 to 17
* Anaphylactic reaction meeting the criteria of Sampson et al. treated in Paediatric Emergency Department of Femme-Mère-Enfant Hospital in Lyon in France
* Anaphylactic reaction treated between the 1st July 2014 and the 31st June 2016

Exclusion Criteria:

- No agreement from patient or parents to participate in the study

Primary outcomes:
measure: Allergy follow-up
timeFrame: About 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Paediatric Emergency Department in Femme-Mère-Enfant Hospital
Study officials:
References: