louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06476379: Can the Origin of Sperm Affect Embryo Ploidy in Patients with Severe Male Factor Infertility?
Official title: Can the Origin of Sperm - Ejaculated or Testicular- Affect Embryo Ploidy in Patients with Severe Male Factor Infertility?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Male Infertility
Keywords: ICSI
Male infertility
PGT-A
TESE
Lead sponsor: Ganin Fertility Center
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is evidence indicating that sperm plays a role in determining blastocyst ploidy status. In our study, we aim to compare the outcomes of preimplantation genetic testing for aneuploidy (PGT-A) and the subsequent clinical outcomes following transfers of euploid embryos. This comparison will be conducted between cases where ejaculated sperm and cases where testicular sperm were used for intracytoplasmic sperm injection (ICSI), specifically focusing on severe male factor infertility patients.


Eligibility criteria: Inclusion Criteria:

* Cases planned to have ICSI PGT-A cycles
* Males diagnosed as severe male factor infertility
* Normo responder female partners

Exclusion Criteria:

* Leukocytospermia
* Presence of varicocele.
* Known genetic abnormality
* Use of sperm or oocyte donors
* Use of gestational carrier
* Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection
* Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

Primary outcomes:
measure: Euploidy rate
timeFrame: 15 days post ICSI
measure: Aneuploidy rate
timeFrame: 15 days post ICSI
measure: Low mosaic rate
timeFrame: Time Frame: 15 days post ICSI
measure: High mosaic rate
timeFrame: Time Frame: 15 days post ICSI
measure: Implantation rate
timeFrame: 6-9 weeks post-embryo transfer
measure: Ongoing pregnancy rate
timeFrame: 12 weeks of gestation
measure: Miscarriage rate
timeFrame: after 6 weeks of gestation
measure: Clinical pregnancy rate
timeFrame: 6-9 weeks post-embryo transfer
Secondary outcomes:
measure: Fertilization rate
timeFrame: 1 day
measure: Cleavage rate
timeFrame: 3 days
measure: Blastocyst development rate
timeFrame: 5-6 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ganin Fertility Center
state: Maadi
Study officials:
affiliation: Ganin Fertility Center
name: Eman Hasanen
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hosam Zaki, FRCOG
role: STUDY_CHAIR
affiliation: Faculty of Science, Cairo University
name: Refaat Gabre, PhD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Mohamed Abbas
role: STUDY_CHAIR
affiliation: Faculty of Science, Cairo University
name: Nahla Osama, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT05786079: Effects of Footstrike Transition on Tibial Stress Fracture Risk
Official title: Effects of Footstrike Transition on Tibial Stress Fracture Risk Using Musculoskeletal Simulation, Finite Element Analysis and Probabilistic Modelling - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tibial Stress Fracture
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Biomechanical literature suggests that runners who utilize a mid or forefoot strike pattern may suffer from a reduced incidence of chronic injuries compared to a rearfoot strike. This investigation examined the effects of a 10-week footstrike transition intervention on tibial stress fracture risk in runners.


Eligibility criteria: Inclusion Criteria:

* Recreational runner
* 3-years minimum of running experience
* Injury free for 12-months

Exclusion Criteria:

* Injury at baseline

Primary outcomes:
measure: Stress fracture probability
timeFrame: Baseline
measure: Stress fracture probability
timeFrame: 10-weeks
Secondary outcomes:
measure: Three-dimensional tibial loading
timeFrame: Baseline
measure: Three-dimensional tibial loading
timeFrame: 10-weeks
measure: Tibial strain
timeFrame: Baseline
measure: Tibial strain
timeFrame: 10-weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00046579: Psychosocial Determinants of Nutrient Intake in Girls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Obesity
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2002-10-01
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: To better understand the determinants of nutrient intake in black and white adolescent girls and to examine the effects of nutrient intake and eating behaviors on obesity, a significant risk factor for CVD.

Detailed description: BACKGROUND:

Studies have documented the importance of eating behavior as a modifiable risk factor for the development of obesity and cardiovascular disease (CVD). The burden of obesity and CVD is not equally distributed in the population; women from ethnic minority populations are particularly likely to be obese and to have higher rates of CVD and stroke than white women.

DESIGN NARRATIVE:

The study determines the extent to which psychological and familial factors contribute to nutrient intake in black and white girls, beyond the well-established effects of ethnicity and socioeconomic factors. Specifically, the aims of the project are the following: 1) to provide a detailed developmental description of eating behaviors and nutrient intake in black and white girls and to examine the "clustering" of certain eating behaviors (e.g., skipping meals and snacking) into eating patterns; 2) to determine the clinical significance of eating behaviors and eating patterns by examining their contribution to nutrient intake and the development of obesity; 3) to examine the role of psychological and familial factors as determinants of eating behaviors, eating patterns, nutrient intake, and obesity in black and white girls. Capitalizing upon the availability of extensive data collected prospectively among an exceptionally well-maintained cohort of 2,379 black and white females over a 12-year period (from ages 9-10 to ages 21-23), the study applies innovative analytic procedures to further the scientific understanding of the determinants of nutrient intake and eating behaviors in adolescent girls. Participants were assessed annually for ten years as part of the National Heart, Lung and Blood Institute Growth and Health Study (NGHS) with measurements of anthropometry, food intake, eating and weight related attitudes and behaviors and family cohesion. Parents also provided information about weight, eating, and family environment at two assessments. In a subsequent study with the same sample, structured clinical interviews were conducted to determine history of psychiatric disorders and risk factors for eating disorders. Adult weight was also measured.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wesleyan University
name: Ruth Striegel-Moore
References:
Clinical trial NCT04881279: Maintaining Optimal Trauma Outcomes: Resilience in the Midst of a Ransomware Attack
Official title: Maintaining Optimal Trauma Outcomes: Resilience in the Midst of a Ransomware Attack
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Electronic Health Record
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 846
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trauma patients being served by the level I trauma center catchment area in Western New York, Southern Ontario (Canada), and Northern Pennsylvania

Brief summary: Retrospective review of de-identified hospital emergency room and trauma registry data and operating room case logs from April 9th through June 9th, 2016, 2017 examining outcomes as affected by a ransomware attack in a level I trauma center

Detailed description: On April 9, 2017, Erie County Medical Center, Western New York's sole level I trauma center was under cyberattack. The perpetrators utilized ransomware that gained access to the hospital's web server and encrypted hospital data, forcing a system-wide downtime for nearly 2 months. Electronic medical records, imaging, and interdepartmental communication were severely affected, forcing the hospital to temporarily return to pre-EMR era operations. We examined the impact of this cyber disaster on the outcomes of trauma care.

Retrospective review of de-identified hospital emergency room and trauma registry data and operating room case logs from April 9th through June 9th, 2016, 2017, and 2018. Baseline characteristics of study cohort for each period will be examined using the chi-square test for categorical variables and the Student's t-test for continuous variables that are normally distributed.

This was an exempt study in our institution.

Eligibility criteria: Inclusion Criteria:

* All trauma patient admissions that were seen through the ECMC Trauma Center from April to June 2016 and April to June 2017
* Adult patients \>13 years old

Exclusion Criteria:

-Patients who came through the emergency department that were not categorized as trauma patients

Primary outcomes:
measure: Hospital and ICU length of stay (LOS), and in-hospital mortality
timeFrame: April to June 2016 and 2017
Secondary outcomes:
measure: Disposition at discharge and AHRQ patient safety indicators: DVT/PE, CLABSI, CAUTI, and organ/space surgical infection.
timeFrame: April to June 2016 and 2017
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
Study officials:
affiliation: State University of Buffalo
name: W. Alan Guo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02767479: Comparison of Rabeprazole and Esomperazole for the Eradication of H. Pylori
Official title: Comparison of Rabeprazole and Esomperazole for the Eradication of H. Pylori (CREATION Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: H. Pylori Infection
Keywords: eradication rates
rabeprazole
esomeprazole
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients infected with H. pylori are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and CAM 200 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and CAM 200 mg bid. Eradication rates are compared. Patients who have ever failed in eradication by CAM-based regimen are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and MNZ 250 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and MNZ 250 mg bid.

Detailed description: Patients infected with H. pylori are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and CAM 200 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and CAM 200 mg bid. Eradication rates are compared. Patients who have ever failed in eradication by CAM-based regimen are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and MNZ 250 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and MNZ 250 mg bid. CYP2C19 genotypes and susceptibility to CAM are genetically measured. Other factors are also analyzed with reference to eradication rates.

Eligibility criteria: Inclusion Criteria:

* Patients infected with H. pylori who can undergo the eradication therapy

Exclusion Criteria:

* Patients with severe other disorders, cannot undergo eradication therapy, refuses to participate to the study.

Primary outcomes:
measure: Eradication rates of H. pylori
timeFrame: At 4 weeks after treatment
measure: influence of CYP2C19 genotypes on the eradication rates of H. pylori
timeFrame: At 4 weeks after treatment
measure: Influences of susceptibility of H. pylori strains to clarithromycin (CAM) on the eradication rates of H. pylori
timeFrame: At 4 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
state: Shizuoka
Study officials:
References:
Clinical trial NCT04829279: Evaluation of Effectiveness for Connected Network for EMS Comprehensive Technical-support Using Artificial Intelligence (CONNECT-AI) System by Community Intervention
Official title: Evaluation of Effectiveness for Connected Network for EMS Comprehensive Technical-support Using Artificial Intelligence (CONNECT-AI) System by Community Intervention: A Prospective Crossover Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergency Patient Transported by Ambulance
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 15392
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to verify the effectiveness of the connected network for EMS comprehensive technical-support using artificial intelligence (CONNECT-AI) system through demonstration in the local community. The study was designed as a prospective non-random cross-intervention study design in two preselected communities. The subjects of the study are patients transferred to the local emergency department(ED) through an ambulance of a fire department in the selected community. If the storage and transmission of information collected by an ambulance fails or the information of the transferred patient cannot be verified in the transferred ED, it is excluded from the study. In this study, the developed CONNECT-AI system was installed in all emergency vehicles and EDs in two regional cohorts, and the effectiveness was measured by operating an intersection for the same period. The primary outcome is the transfer time spent in the pre-hospital stage, and the secondary outcome is whether the optimal transfer hospital is selected.


Eligibility criteria: Inclusion Criteria:

* patients transferred to the local emergency department(ED) through an ambulance of a fire department in the selected community.

Exclusion Criteria:

* If the storage and transmission of information collected by an ambulance fails or the information of the transferred patient cannot be verified in the transferred ED

Primary outcomes:
measure: transfer time spent in the pre-hospital stage
timeFrame: up to 1 month
Secondary outcomes:
measure: Whether to select the optimal transfer hospital
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University
Study officials:
affiliation: Division of Cardiology, Yonsei university college of medicine
name: Hyuk-Jae Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02623179: Conventional and Molecular Diagnostic Method for Patients With Suspected UTI
Official title: Conventional and Molecular Diagnostic Method for Patients With Suspected Urinary Tract Infections: Clinical, Economic, and Quality of Life Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections-UTI
Lead sponsor: Southwest Regional PCR, LLC
Sponsor class: INDUSTRY
First posted: 2015-12-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this protocol, the investigators are examining the use of a novel pathogen testing technology and method of identification of antibiotic susceptibility against the conventional C \& S testing for patients with both complicated and uncomplicated UTIs. The investigators will examine the two modes in terms of objective patient related outcomes, i.e. 1) diagnostic accuracy and degree of detail of final analysis; 2) time to resolution of symptoms; 3) quality of life as defined by particularly symptomology and "bothersomeness" of the symptoms; and 4) overall cost.


Eligibility criteria: Inclusion Criteria:

* • Age greater than or equal to 18 and less than or equal to 89 years.

  * The PI suspects the patient has a complicated or uncomplicated UTI that requires urine testing to confirm diagnosis
  * Able to provide at least 8 ml urine total (urine for 2 pathology tests).
  * Is willing to complete one follow up surveys and send back to FH.

Exclusion Criteria:

* • Unable or unwilling to provide written informed consent.

  * Unable to read and write English (surveys are not available or validated in any other language than English).
  * Currently on any antibiotic for any clinical indication.

Primary outcomes:
measure: To quantify differences in the relative abundance and presence of microbial lineages as determined by culture and sequencing technologies.
timeFrame: 1 year
Secondary outcomes:
measure: Time (as measured in hours) to preliminary and final identification of organism(s) and antibiotic sensitivity(s) results
timeFrame: 1 year
measure: Time from participant reported start of UTI symptoms to resolution.
timeFrame: 1 year
measure: Participant Quality of Life as measured by a UTI specific severity and bothersome of symptoms survey taken at baseline (at clinic visit) and at set time points post urine testing
timeFrame: 1 year
measure: Overall cost
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Florida Hospital Celebration Health
name: Michael McDonald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05207579: Urdu Version of Lower Extremity Functional Scale: Reliability and Validity Study
Official title: Psychometric Analysis of Urdu Version of Shoulder Pain and Disability Index: A Reliability and Validity Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Disorder
Keywords: Lower Extremity Functional Scale
Musculoskeletal Disorder
Cultural adaptation
Validity
Urdu Version
Reliability
Lower Extremity
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pakistani population with Lower extremity musculoskeletal disorders was included in the study.

Brief summary: The objective of the research is to translate and to culturally familiarize the Lower extremity functional scale into the Urdu language along the investigation if the Lower Extremity Functional Scale is reliable and validate in the Pakistani population with Lower extremity musculoskeletal disorders and to check the correlation with Short Form - 36.

Detailed description: The questionnaire will be translated into Urdu and cross-culturally modified. Internal consistency, test-retest reliability, conceptual validity, discriminative validity, responsiveness, and concurrent validity will be examined in 150 participants seeking treatment for lower extremity dysfunction using the Urdu version of the Lower Extremity Functional Scale.

Eligibility criteria: Inclusion Criteria:

* From16 years Old to 60 Years Old
* Presence of an Lower extremity musculoskeletal disorders like soft tissue injuries, joints and muscles injuries
* No intervention between the test-retest assessments

Exclusion Criteria:

* To complete the forms because of a psychological Impairment.
* Illiteracy or lack of understanding of Urdu Language
* The presence of any kind of bone fracture

Primary outcomes:
measure: Lower Extremity Functional Scale
timeFrame: 1st day
measure: Short Form-36
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT00933179: FC Patch Low: Metabolism Study
Official title: A Single-Center, Open-Label, Crossover, Randomized Study to Investigate the Impact of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene (Material no. 80876395) in a 21-day Regimen as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (0.03mg/0.15mg) in a 21-day Regimen on Hemostatic Parameters in 30 Women Aged 18 182 35 Years Over 3 Treatment Cycles in Each Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Keywords: Prevention of pregnancy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of the present study is to investigate the effects of the transdermal patch on the parameters of hemostasis (blood clotting), lipid (fat), and carbohydrate (sugars) metabolism in healthy women who require contraception.


Eligibility criteria: Inclusion Criteria:

* Healthy woman requesting contraception
* Normal cervical smear not requiring further follow-up
* History of regular cyclic menstrual periods
* Willingness to use non-hormonal contraception during the two wash-out cycles both before the start of treatment and between the two treatment periods

Exclusion Criteria:

* Pregnancy or lactation - Obesity (Body Mass Index \[BMI\] \> 30.0 kg/m2)
* Any diseases or conditions that can compromise the function of the body systems
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Any disease or condition that may worsen under hormonal treatment
* Undiagnosed abnormal genital bleeding
* Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results

Primary outcomes:
measure: Prothrombin fragment 1+2, D-dimer
timeFrame: Screening, visit 3-7
Secondary outcomes:
measure: Procoagulatory parameters
timeFrame: Screening, visit 3-7
measure: Anticoagulatory parameters
timeFrame: Screening, visit 3-7
measure: Thrombin and Fibrin turnover parameters
timeFrame: Screening, visit 3-7
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Junge W, Heger-Mahn D, Trummer D, Merz M. Investigation of the hemostatic effect of a transdermal patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene compared with a monophasic oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel: an open-label, randomized, crossover study. Drugs R D. 2013 Sep;13(3):223-33. doi: 10.1007/s40268-013-0028-2.