louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05194436: Wheeze Detection Using Aevice Medical Device
Official title: A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric Subjects and Use for Remote Auscultation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subject Presenting Wheeze
COPD
Asthma
Keywords: Wheeze
Auscultation
Lead sponsor: Aevice Health Pte. Ltd.
Sponsor class: OTHER
Collaborators: name: National University Hospital, Singapore
First posted: 2022-01-18
Enrollment: 35
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study will include 35 patients who are admitted for exacerbations of chronic airway disease (i.e. Asthma)

Brief summary: The primary objective of this study is to determine if Aevice Medical Device can detect wheeze as accurately as a physician through auscultation. The secondary objective is to investigate if Aevice Medical Device can be used for remote auscultation of the lung.


Eligibility criteria: Inclusion Criteria:

* The subject is willing and parents/guardians are able to give informed consent for participation in the study.
* Male or Female, aged 3 -18 years.
* Presenting with wheeze.
* Able (in the Investigators opinion) and willing to comply with all study requirements

Exclusion Criteria:

* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subjects at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.

Primary outcomes:
measure: Wheeze is detected by physician and AeviceMD
timeFrame: 60 Seconds
Secondary outcomes:
measure: Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician
timeFrame: 150 Seconds
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
Clinical trial NCT02118636: Observational Study to Evaluate Mechanisms of Aromatase Inhibitor Associated Musculoskeletal Symptoms
Official title: Prospective Observational Study of Breast Cancer Patients Starting Therapy With an AI to Evaluate Mechanisms Underlying Development of Aromatase Inhibitor Associated Musculoskeletal Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Arthralgia
Keywords: Joint pain
Hormone receptor positive breast cancer
Estrogen
Androgen
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 75
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women with hormone receptor positive breast cancer who are initiating therapy with an aromatase inhibitor

Brief summary: Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. This observational study is designed to collect patient-reported outcomes and serial serum samples in order to investigate potential etiologies of this bothersome toxicity.


Eligibility criteria: Inclusion Criteria:

* Stage I-III breast cancer who are scheduled to receive endocrine therapy with an aromatase inhibitor
* All prior surgery, chemotherapy, and radiation therapy should be complete or should be completed by the time of AI treatment initiation (within 28 days of study enrollment)
* Age 21 and above and postmenopausal

Primary outcomes:
measure: Change in estradiol and development of musculoskeletal symptoms between baseline and 3 months
timeFrame: 12 months
Secondary outcomes:
measure: Change in sex hormones and development of musculoskeletal symptoms between baseline and 3 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Norah L Henry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00277836: Study Evaluating MST-997 in Advanced Malignant Solid Tumors
Official title: A Phase 1 Dose-Escalation Study of Intravenous MST-997 Formulated in Polysorbate 80 Diluent Administered Weekly in Subjects With Advanced Malignant Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasms
Keywords: malignant tumor
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: MST-997 is a taxane analog with the potential to treat subjects with a variety of tumor types. Preclinical data demonstrated that MST-997 inhibited tumor growth when administered intravenously (IV). This phase 1 dose escalation study is designed to evaluate the safety and tolerability of if IV MST-997 formulated in Polysorbate 80 Diluent can be safely administered on a weekly basis.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of malignant solid tumor with measurable disease
* Life expectancy of at least 12 weeks
* ECOG (Eastern Cooperative Oncology Group) performance status of 0,1,or 2

Exclusion Criteria:

* Recent major surgery, radiation therapy or anti-cancer treatment
* History of any other prior malignancy within last 5 years

Primary outcomes:
measure: To evaluate the safety, tolerability and MTD (maximum tolerated dose) of MST-997.
Secondary outcomes:
measure: Preliminary pharmacokinetic information on the pharmacokinetics (during cycle 1) abd anti-tumor activity (assessed approximately every 8 weeks) of on MST-997
Other outcomes:
Locations:
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Poland, WPWZMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Netherlands, trials-NL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02335736: Antagonist Protocol in IVF
Official title: Can Antagonist Protocol be the Protocol of Choice in in Vitro Fertilization Patients?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Infertility
Keywords: infertility
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2015-01-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The antagonist protocol in a novel method of stimulation in the in vitro fertilization (IVF) patients. It has been tried in poor responders, polycystic ovary (PCO) patients and normal females undergoing IVF. Can it be used with the same efficacy in all patients?


Eligibility criteria: Inclusion Criteria:

* age: 20- 44 years
* Poor responder females according to Bologna criteria
* Polycystic ovarian disease females according to Rotterdam criteria
* Females with infertility causes other than poor responders, or PCO; male factor or tubal block

Exclusion Criteria:

* refusal to get enrolled in the study
* cases of infertility due to severe male factor

Primary outcomes:
measure: number of oocytes collected and fertilized
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el aini hospital
Study officials:
affiliation: Cairo University
name: Dina M Dakhly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06940336: To Evaluate the Efficacy and Safety of Tafamidis Meglumine Soft Capsules in the Treatment of Adult Patients With Transthyretin Amyloid Polyneuropathy
Official title: A Single Arm, Multicenter, Open-label,Phase IV Clinical Study to Evaluate the Efficacy and Safety of Tafamidis Meglumine Soft Capsules in the Treatment of Adult Patients withTransthyretin Amyloid Polyneuropathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Transthyretin Amyloid Polyneuropathy
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Tafamidis Meglumine Soft Capsules in the Treatment of Adult Patients with Transthyretin Amyloid Polyneuropathy


Eligibility criteria: Inclusion Criteria:

* Male or female participants between the ages of 18 and 80 years.
* Participant has amyloid deposits confirmed by biopsy (Biopsy must have been performed within 5 years prior to enrollment).
* Participant must have a TTR mutation that is associated with ATTR-PN (TTR mutation test must have been performed within 5 years prior to enrollment).
* Participant has peripheral neuropathy at screening.
* Participant has a Karnofsky Performance Status Score ≥50.
* Stages of disease according to symptom severity-stage 1.

Exclusion Criteria:

* Participant has other causes of amyloidosis, such as light chain amyloidosis, AA amyloidosis.
* Participant has used tafamidis within 2 months prior to enrollment.
* Participant has used diflunisal, patisiran, inotersen, or other agents for familial amyloidosis within 30 days prior to enrollment or plan to use them during the study period.
* Participant has used non-protocol NSAIDs more than 4 times within 30 days prior to enrollment or plan to use them more than 4 times per month during the study period.
* Participant has used doxycycline,tauroursodeoxycholate within 14 days prior to enrollment or plan to use them during the study period.
* Participant has sensory motor neuropathy caused by other causes, such as chronic inflammatory demyelinating polyradiculopathy, chronic idiopathic axonal neuropathy, diabetic neuropathy, chronic alcoholic neuropathy, paraneoplastic neuropathy,Guillain-Barre syndrome, vitamin B12 deficiency.
* Participant has received liver or any other organ except cornea transplantation.

Primary outcomes:
measure: Change from Baseline Neuropathy Impairment Score-Lower Limb (NIS-LL) at Week 72
timeFrame: Baseline to 72 Weeks
Secondary outcomes:
measure: Change from Baseline NIS-LL at Week 24 and Week 48
timeFrame: Baseline to 24 and 48 Weeks
measure: Change from Baseline Modified Body Mass Index(mBMI) at Week 4, Week 8, Week 12,Week 24, Week 36,Week 48 and Week 72
timeFrame: Baseline to 4, 8, 12, 24, 36, 48 and 72 Weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00914836: Comparison of 2 Doses of Corticosteroid Subacromial Injections for the Treatment of Painful Shoulder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tendonitis
Bursitis
Keywords: shoulder
subacromion
corticosteroid
bursitis
tendinitis
calcific tendonitis
subacromial bursitis
rotator cuff tendinitis
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2009-06-05
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of corticosteroid subacromial injections have been found to be effective for the treatment of shoulder pain. Higher doses may be better than lower doses for subacromial corticosteroid injection for rotator cuff tendonitis. The investigators aim this study to compare 2 doses of corticosteroids.


Eligibility criteria: Inclusion Criteria:

* subacromial bursitis
* tendinitis
* Calcific Tendonitis

Exclusion Criteria:

* rotator cuff tear
* osteoarthritis
* pregnancy
* local or systemic infection
* steroid or lidocaine sensitivity

Primary outcomes:
measure: constant score
timeFrame: 9 month
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
References:
citation: van der Heijden GJ, van der Windt DA, Kleijnen J, Koes BW, Bouter LM. Steroid injections for shoulder disorders: a systematic review of randomized clinical trials. Br J Gen Pract. 1996 May;46(406):309-16.
Clinical trial NCT03516136: Safety and Performance of the EndoFast Reliant SCP in Vaginal Wall Reinforcement
Official title: A Retrospective Study for Collecting Data on the Safety and Performance of the EndoFast Reliant SCP in Vaginal Wall Reinforcement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Lead sponsor: Allium, Ltd.
Sponsor class: INDUSTRY
First posted: 2018-05-04
Enrollment: 84
Sex: FEMALE
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 Female subjects \>18 years old that underwent Pelvic Organ Prolapse repair utilizing the EndoFast Reliant SCP

Brief summary: A Single arm, single site, retrospective cohort Post Marketing Clinical Follow up Study Evaluating the Safety and Performance of the EndoFast Reliant SCP for apical support.


Eligibility criteria: Inclusion Criteria:

1. Female subjects \>18 years old that underwent Pelvic Organ Prolapse repair utilizing the EndoFast Reliant SCP

Exclusion Criteria:

1. Patients without follow-up

Primary outcomes:
measure: Safety- procedure and device related complication rate
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03872336: Acute Labetalol Use in Preeclampsia
Official title: Acute Labetalol Use in Preeclampsia Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Preeclampsia With Severe Features
Keywords: Hypertension
Labetalol
Obesity
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 15
Sex: FEMALE
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 study is to understand if administration of a personalized dose of the anti-hypertensive medication, labetalol, based on patient's body-mass index, will be more effective at controlling severe hypertension during pregnancy, compared to the current standard dosing.

Detailed description: The investigators seek to asses the effect of obesity (BMI\>30) on severe hypertension control in patients with preeclampsia with severe features. The investigators hypothesize that successive administration of 40-60-80 mg of labetolol will reduce time to blood pressure control versus the standard dosing, 20-40-80 mg labetolol, recommended by the American College of Obstetricians and Gynecologists in 2015.

Eligibility criteria: Inclusion Criteria:

* BMI ≥ 30
* Age ≥ 18 years
* Gestational age ≥ 24 weeks
* Singleton gestation
* One sustained severe range blood pressure at Albany Medical Center

Exclusion Criteria:

* Known allergic reaction to labetlol
* Persistent mild-moderate asthma (≥ 2 rescue inhaler uses per week in the previous month)
* Obstructive airway disease
* Bradycardia \< 70 beats/min
* Heart block \> 1st degree or history of heart failure

Primary outcomes:
measure: Time to blood pressure control
timeFrame: 4 hours after last labetalol dosing
Secondary outcomes:
measure: Differences in racial response
timeFrame: 4 hours after last labetalol dosing
measure: Maternal adverse events
timeFrame: within 3 months of delivery
measure: Neonatal adverse events
timeFrame: within 28 days of delivery
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center Obstetrics and Gynecology
state: New York
Study officials:
References:
citation: Committee Opinion No. 623: Emergent therapy for acute-onset, severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2015 Feb;125(2):521-525. doi: 10.1097/01.AOG.0000460762.59152.d7.
Clinical trial NCT02678936: Anal Fistula Repair With Platelet-rich Plasma
Official title: Anal fistUla Repair With Platelet-Rich plasmA (AURoRA)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Rectal Fistula
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anal fistula is a very common disease with a high impact on life quality. The only commonly accepted treatment option is surgery. A wide range of operations and techniques have been developed all suffering from a relatively high recurrence rate.

The investigators propose the combination of the mucosal advancement flap with application of platelet-rich plasma (PRP) in the fistulectomy site. This study aims to test the hypothesis that by applying PRP the healing rate of complicated anal fistulas can be improved in comparison to a control group where the operation is performed without addition of PRP.


Eligibility criteria: Inclusion Criteria:

* complicated anal fistula with patient fit for surgical treatment
* minimum 6 weeks after
* written informed consent

Exclusion Criteria:

* age \<18
* pregnancy
* drug abuse, drug substitution program
* homeless (follow-up difficult)
* restricted in legal capacity
* simple fistulas requiring fistulotomy
* complicated fistulas requiring an anus praeter naturalis

Primary outcomes:
measure: Healing rate
timeFrame: 2 Years
Secondary outcomes:
measure: Influence of risk factor smoking on healing rate
timeFrame: 2 years
measure: Influence of risk factor high BMI on healing rate
timeFrame: 2 years
measure: Influence of risk factor chronic renal failure on healing rate
timeFrame: 2 years
measure: Influence of sex on healing rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital of Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Andreas Lorenz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03977636: Determinants of Time Required by Medical Information Technicians for Quality Control of Hospital Activity Coding
Official title: Determinants of Time Required by Medical Information Technicians for Quality Control of Hospital Activity Coding, in French Medico-administrative System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality Control
Keywords: Diagnosis-related groups
Activity-based funding
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 5431
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the Regional Hospital of Metz-Thionville

Brief summary: Since 2008, in France, hospital funding is determined by the nature of activities provided (activity-based funding). Quality control of hospital activity coding is essential to optimize hospital remuneration. There is a need for reliable tools to allocate human resources wisely in order to improve these controls.

Detailed description: The main objective of this study was to identify the determinants of time needed by medical information technicians to control hospital activity coding in a Regional Hospital Center.

From March 2016 to the beginning of January 2017, medical information technicians reported the time they spent on each quality control, and the time they needed when they had to code the entire stay. Multiple linear regressions were performed to identify the determinants of quality control or coding duration. A split sample validation was used: model was created on one half of the sample and validated on the remaining half.

Eligibility criteria: Inclusion Criteria:

* To be admitted to a medical unit of the CHR Metz Thionville

Exclusion Criteria:

* Any exclusion criteria

Primary outcomes:
measure: Time for quality control
timeFrame: Day 1
Secondary outcomes:
measure: Time to code the entire stay
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05167136: Green Hospital Awareness
Official title: "Green Hospital" Awareness Level and Satisfaction of Health Practitioners - A Private Hospital Experience in Turkey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Satisfaction, Personal
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 280 people, consisting of health professionals and employees in a small private hospital that does not have a "green hospital" certificate in the province of Istanbul.

Brief summary: Environmentally conscious hospitals plan their designs as green hospitals and aim to use resources efficiently. Green buildings are defined as buildings that respect nature, are ecological, comfortable and reduce energy consumption. The aim of our study is to investigate the awareness level and satisfaction of the employees of a small private hospital in the city center without a "green hospital" certificate regarding the "green hospital" elements.


Eligibility criteria: Inclusion Criteria:

* consisting of health professionals and employees
* working in a small private hospital that does not have a "green hospital" certificate

Exclusion Criteria:

* who refused to participate in the survey

Primary outcomes:
measure: level of awareness
timeFrame: 15 DAYS
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ilke Kupeli
Study officials:
References:
citation: Abbaszadeh, S., Zagreus, L., Lehrer, D., Huizenga, C. (2006). Occupant Satisfaction with Indoor Environmental Quality in Green Buildings. Proceedings of Healthy Buildings. 3: 365-370.
citation: Khairunnisa, R. A., Ulfa, M., Azizi, M. R., & Setyonugroho, W. (2021). A FUTURE GREEN AND HEALTHY HOSPITAL: A REVIEW ARTICLE. Proceedings of International on Healthcare Facilities, 1(1), 82-94