louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06492785: Hyaluronic Acid-enriched Transfer Medium in Single Blastocyst Transfer
Official title: Use of Hyaluronic Acid-enriched Transfer Medium in Women Undergoing Single Blastocyst Transfer : a Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Keywords: Hyaluronate-enriched medium
live birth
Single blastocyst transfer
Lead sponsor: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Sponsor class: OTHER
Collaborators: name: Jiangxi Maternal and Child Health Hospital
name: Gansu Provincial Maternal and Child Health Care Hospital
name: Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
First posted: 2024-07-09
Enrollment: 858
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the live birth rates of high concentration of Hyaluronic Acid (0.5 mg/ml) transfer medium (EmbryoGlue®) to those containing low Hyaluronic Acid concentrations (0.125 mg/ml) (G2 medium) in women undergoing single fresh and frozen blastocyst transfer.

Detailed description: The single blastocyst-stage embryo transfer cycles will be randomised in a 1:1 allocation, with block sizes of 2 and 4 on the day of Embryo Transfer (ET). This randomisation process will be centrally managed via a web-based electronic data capture system and will be stratified according to the treatment center. The allocation sequence and the designated treatment will be completely concealed from the participating couples, clinicians - including those conducting the transfer procedures - and outcome assessors. Given the intrinsic viscous nature of EmbryoGlue, embryologists, who who are responsible for the procedures in the laboratory will not be subjected to blinding. Only at the end of the study, when data collection is completed, the allocation sequence will be revealed to the primary investigators.

Eligibility criteria: Inclusion Criteria:

1. All cycles with single blastocyst transfer will be considered eligible
2. Both fresh and cryopreserved embryo transfer cycles utilizing autologous oocytes
3. No age restriction will be applied
4. Informed consent was signed

Exclusion Criteria:

1. Uterine anatomic anomalies
2. Women with untreated hydrosalpines
3. Once couples have been enrolled in the trial, subsequent cycles will not be incorporated.

Primary outcomes:
measure: Live birth rate
timeFrame: Live birth is defined as the birth of at least one live baby after 24 weeks of gestation.
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: IVF laboratory
state: Shaanxi
Study officials:
affiliation: Center for Reproductive Medicine, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, China
name: Juanzi Shi, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01841385: Effects of Pilates on Respiratory Mechanics
Official title: Influence of Application of the Pilates Method on Pulmonary Function, Thoracic Mobility and Respiratory Muscle Strength
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Keywords: Exercise
spirometry
muscle strength
physical therapy modalities
Lead sponsor: Universidade Metodista de Piracicaba
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 21
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the influence of a fitness program from the application of Pilates on lung function, thoracoabdominal mobility and respiratory muscle strength in women.

Detailed description: Study in the Cardiorespiratory Physiotherapy laboratory and clinics of Pilates in the region, in which the voluntary of the Pilates group would start the Pilates method.

The study included women with body mass index (BMI) ≤ 29 kg/m2 were not engaged in regular physical activity, or sedentary lifestyle with scores up to eight, according to Baecke et al., non-smoker, non-alcoholic, without any abnormalities of the cardiovascular, respiratory and neuromuscular.

The study excluded women with disabling diseases, pregnancy, postpartum less than a year, inability to understand the tests and exercises proposed or refuse to participate in the study.

The volunteers, aged between 25 and 55 years, were allocated in to two groups:

1. Pilates Group (n = 16): sedentary volunteers, but that would begin activities with the Pilates method and evaluated three months.
2. Control group (n = 13): sedentary volunteers and remain sedentary and evaluated in three months.

Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) ≤ 29 kg/m2
* not physically active on a regular basis, ie, sedentary lifestyle with scores up to eight, according to Baecke et al.
* nonsmokers
* non-alcoholic
* without any abnormalities in the cardiovascular, respiratory or neuromuscular

Exclusion Criteria:

* disabling diseases
* gestation
* puerperium there is less than a year
* inability to understand the tests and exercises proposed

Primary outcomes:
measure: Pulmonary function
timeFrame: Three months
measure: Thoracoabdominal mobility
timeFrame: Three months
measure: Respiratory muscle strength
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Universidade Metodista de Piracicaba (UNIMEP)
state: São Paulo
Study officials:
References:
Clinical trial NCT02230085: Adherence Risk Indicator Validation Study
Official title: A Validation Study of an Adherence Risk Indicator Statistical Prediction Model.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2014-09-03
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient recieving CPAP for OSA.

Brief summary: While continuous positive airway pressure (CPAP) is the gold standard treatment of obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally. The adherence risk indicator (ARI) is a statistical model based on answers from a questionnaire. The data collected from this trail allows for closer monitoring of at-risk patients. For the study, participants are provided with a questionnaire prior to starting CPAP therapy for OSA. Participants will be provided with a GSM (Global System for Mobile communication) modem to allow transmission of their CPAP data. Participants data will be retrieved at 7, 14, 21, 30 and 90 days to test the accuracy of the ARI prediction. At the conclusion of the study the GSM unit is returned, and participants continue with CPAP therapy as instructed by their healthcare provider.


Eligibility criteria: Inclusion Criteria:

* ≥ 18years of age
* Diagnosed with OSA (AHI \>5 events/hour) and eligible for CPAP (fixed or auto) treatment under local requirements
* Naïve to CPAP therapy, i.e. have not been prescribed CPAP in the past 5 years

Exclusion Criteria:

* Contraindicated for CPAP therapy
* Medically unstable condition/diagnosis that is not yet under control
* Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study)
* PLMA (Periodic Limb Movement Activity) Index greater than 15/hr
* Home titration of longer than 5 days

Primary outcomes:
measure: CPAP Therapy Adherence
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boise
country: United States
facility: EverythingCPAP
state: Idaho
Study officials:
References:
Clinical trial NCT04642885: Families Coping Together With Alzheimer's Disease
Official title: Families Coping Together With Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Family Research
Dementia
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Institutes of Health (NIH)
name: Department of Health and Human Services
First posted: 2020-11-24
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, adult children of a parent over 55 with early stage dementia who are responsible for helping parent with at least one task will be recruited

Brief summary: Two remote phone/zoom calls are required to assess experiences as a family coping with dementia.

Detailed description: Using a combination of paper or online surveys in addition to interactive visits with blood pressure monitoring, participants are observed interacting with each other. Blood pressure devices are mailed to their homes and only worn for six minute intervals. The first visit generally lasts one hour and the second visit 90 minutes.

Eligibility criteria: Inclusion Criteria:

* Parent must be 55 plus with symptoms or a diagnosis of dementia
* Adult child must be over 18 and involved in some way with assisting parent.

Exclusion Criteria:

-

Primary outcomes:
measure: Caregiver demand appraisals
timeFrame: Baseline and one year
measure: Caregiver perceived stress
timeFrame: Baseline and one year later
measure: Caregiver negative Coping
timeFrame: Baseline and one year later
Secondary outcomes:
measure: Relational Functioning
timeFrame: Baseline and one year later
measure: Health
timeFrame: Baseline and one year later
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale school of Public Health
state: Connecticut
Study officials:
affiliation: Yale University
name: Joan Monin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05481385: Bioequivalence Study of Ezetimibe Tablets Under Fed Conditions in Healthy Subjects
Official title: Single Oral Administration, Randomized, Open, Crossover and Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pharmacokinetics
Safety
Keywords: Ezetimibe
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The fed bioequivalence test adopts the experimental design of single center, single oral administration, random, open, two sequence, two cycle crossover and self-control.

Detailed description: To investigate the in vivo pharmacokinetic characteristics of ezetimibe tablets (specification 10mg) in Chinese healthy subjects after a single oral administration under fed conditions, and to evaluate the bioequivalence of ezetimibe tablets produced by Changzhou Pharmaceutical Factory Co., Ltd. and the licensee MSD Pharma (Singapore) PTE. Ltd. To study the safety of single oral ezetimibe tablets (specification 10mg) in Chinese healthy subjects.

Eligibility criteria: Inclusion Criteria:

* • Healthy male or female aged 18 and above.

  * The body mass index is in the range of 18.6-28.5 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.
  * The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test.
  * The subjects have no family planning within 3 months and could select contraceptive method.
  * Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.

Exclusion Criteria:

* • Being allergy to the study medications, smoking, alcohol abuse.

  * Participation in another clinical trial within 3 months.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 96 hours
measure: Area under the plasma concentration versus time curve (AUC)0-t
timeFrame: 96 hours
measure: Area under the plasma concentration versus time curve (AUC)0-∞
timeFrame: 96 hours
Secondary outcomes:
measure: Incidence of abnormal blood pressure
timeFrame: 33 days
measure: Incidence of abnormal temperature
timeFrame: 33 days
measure: Incidence of abnormal pulse
timeFrame: 33 days
measure: Incidence of abnormal electrocardiogram waveform
timeFrame: 33 days
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Phase I clinical research center
state: Shandong
Study officials:
References:
Clinical trial NCT05641285: Diagnostic Utility of Otosight Middle Ear Scope
Official title: Diagnostic Utility of the Otosight Middle Ear Scope in Acute Otitis Media
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ear Infection
Middle Ear Infection
Otitis Media
Keywords: Otoscope
Tympanogram
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 165
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 6 months to 12 years old who are seen in the outpatient Otolaryngology clinic at Texas Children's Hospital main and west campuses who have no history of ear tube placement.

Brief summary: Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic.

Detailed description: The purpose of this study is to compare the successful exam completion rate, the detection of middle ear fluid (versus no fluid), and the categorization of middle ear fluid (purulent vs. serous vs mucoid,) of routine otoscopy examination versus otosight examination versus tympanogram.

Eligibility criteria: Inclusion Criteria:

* Patients aged 6 months to 12 years old who are seen in the outpatient Otolaryngology clinic at Texas Children's Hospital main and west campuses.

Exclusion Criteria:

* Patients who have a history of ear tube placement

Primary outcomes:
measure: Exam Completion Rate
timeFrame: 6 months
measure: Detection of middle ear fluid
timeFrame: 6 months
measure: Categorization of middle ear fluid
timeFrame: 6 months
Secondary outcomes:
measure: Timed Evaluation of Clinic Flow
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Anna Messner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Yi-Chun Liu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01706185: Incidence of Expression of Tumor Antigens in Cancer Tissue From Patients With Pathologically Demonstrated Bladder Cancer
Official title: Analysis of the Incidence of Expression of Tumor Antigens in Cancer Tissue From Patients With Pathologically Demonstrated Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms, Urinary Bladder
Keywords: Patients
Tumor antigens
Bladder cancer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-10-15
Enrollment: 156
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously collected samples and data of patients with pathologically demonstrated bladder cancer.

Brief summary: This study aims to analyze the incidence of expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME tumor antigens in cancer tissue from patients with pathologically demonstrated bladder cancer.

Detailed description: There will be no procedure(s) or treatment(s) carried out on patients. All data and samples will be taken from those already stored at the investigation sites. Clinical data collected will include patient demographics (age, gender), Tumor, Node, Metastasis (staging system) \[TNM stage\], and histopathologic description only. Strict anonymity of patient data will be maintained.

This retrospective study is based upon the analysis of archived formalin-fixed paraffin-embedded tissue samples and patient-related data already available at the investigational site.

Eligibility criteria: Inclusion Criteria:

For inclusion of a tissue sample, all of the following criteria must be met:

* The patient had pathologically proven bladder cancer (any stage).
* All the data required are available from patient's records.

There are no restrictions regarding operative technique (cystectomy or cystoscopy).

- Many patients may no longer be alive, or no longer be in contact with the investigation sites. Thus, patients will not be required to give their informed consent before inclusion in the study.

Exclusion Criteria:

* Not applicable.

Primary outcomes:
measure: To determine the gene expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME antigens in pathologically demonstrated bladder cancer.
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lerut E, Van Poppel H, Joniau S, Gruselle O, Coche T, Therasse P. Rates of MAGE-A3 and PRAME expressing tumors in FFPE tissue specimens from bladder cancer patients: potential targets for antigen-specific cancer immunotherapeutics. Int J Clin Exp Pathol. 2015 Aug 1;8(8):9522-32. eCollection 2015.
Clinical trial NCT01755585: Irradiation Modulates the Pharmacokinetics of Anticancer Drugs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer
Cervical Cancer
Keywords: Radiation therapy
5-fluorouracil
Cisplatin
Pharmacokinetics
Matrix Metalloproteinase
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2012-12-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chemotherapy-naive patients with histologically confirmed, locally advanced rectal adenocarcinoma and cervical cancer, who were prepared for concurrent chemoradiation therapy, were consecutively enrolled in this study

Brief summary: Radiation therapy (RT) is used as an effective local treatment modality to inhibit cell proliferation, induce cell death and suppress tumor growth. To improve the treatment outcome, in terms of both locoregional control and survival, the concurrent use of chemotherapy during radiation therapy (CCRT) is now the standard treatment for various malignancies, especially locally advanced cancers. Among the drugs used to enhance RT effect, 5-fluorouracil (5-FU) is one of the most commonly used chemotherapeutic agents of CCRT.

In the past, RT was solely used as a local treatment and its effect was estimated by local effect model. However, growing evidence shows that irradiation has direct DNA damage-dependent effects as well as sending signals to neighboring cells. Recently, we reported that abdominal irradiation could significantly modulate the systemic pharmacokinetics of 5-FU at 0.5 Gy, off-target area in clinical practice, and at 2 Gy, the daily treatment dose for target treatment in an experimental rat model. Additionally, the results from a clinical investigation showed that colorectal cancer patients with lower AUC of 5-FU during adjuvant chemotherapy had lower disease-free survival. Taken together, these lines of evidence support the importance and necessity to search for the mediators responsible for the unexpected effect of local RT on systemic pharmacokinetics of chemotherapeutic agents, such as 5-FU.

In the present study, the investigators investigated whether the phenomena and mechanism of RT-PK is a fact for different anticancer drugs in human.


Eligibility criteria: Inclusion Criteria:

* World Health Organization (WHO) performance status of 0 or 1
* Age 18-80 years
* Locally advanced rectal cancer
* Locally advanced cervical cancer

Exclusion Criteria:

* Cancer history
* Abnormal liver and renal disease
* Immune disease
* Hematological disease

Primary outcomes:
measure: all cause mortality
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hsieh CH, Hou ML, Chiang MH, Tai HC, Tien HJ, Wang LY, Tsai TH, Chen YJ. Head and neck irradiation modulates pharmacokinetics of 5-fluorouracil and cisplatin. J Transl Med. 2013 Sep 26;11:231. doi: 10.1186/1479-5876-11-231.
Clinical trial NCT05012085: Google Trends of Global Surgery
Official title: Using Google Trends to Gauge the Popularity of Global Surgery Worldwide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Global Surgery
Global Health
Lead sponsor: Association of Future African Neurosurgeons, Yaounde, Cameroon
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 209
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any data point included in the Google Trends database relevant to global surgery or global health.

Brief summary: Introduction Global surgery is a growing movement worldwide, but its expansion has not been quantified. Google Search is the most popular search engine worldwide, and Google Trends analyzes its queries to determine popularity trends. The investigators used Google Trends to analyze the regional and temporal popularity of global surgery (GS). Furthermore, the investigators compared GS with global health (GH) to understand if the two were correlated.

Methods The investigators searched the terms "global surgery" and "global health" on Google Trends (Google Inc., CA, USA) from January 2004 to May 2021. The investigators identified time trends and compared the two search terms using SPSS v26 (IBM, WA, USA) to run summary descriptive analyses and Wilcoxon rank-sum tests.


Eligibility criteria: Inclusion Criteria:

* Data point from Google Trends concerning Global Surgery
* Data point from Google Trends concerning Global Health
* Data point from Google Trends between January 2004 and May 2021

Exclusion Criteria:

* Data point from Google Trends before January 2004
* Data point from Google Trends after May 2021
* Data point from Google Trends outside the scope of Global Surgery or Global Health

Primary outcomes:
measure: Interest Levels
timeFrame: January 2004 to May 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Yaoundé
country: Cameroon
facility: Research Department, Association of Future African Neurosurgeons
Study officials:
References: