louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01422395: Effect of Oocyte Vitrification on Fertilization Rate, Embryo Quality and Development
Official title: A Study to Compare Vitrified/Warmed Oocytes vs. Fresh Sibling Oocytes Collected Following Controlled Ovarian Stimulation Using Follistim AQ and Ganirelix Acetate on Fertilization Rates, Zygote Quality, Embryo Quality and Embryo Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Fertility
Keywords: Vitrification
Egg Freezing
Oocyte Cryopreservation
Lead sponsor: Main Line Fertility Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-08-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Indications for oocyte (egg) vitrification (fast freezing) include the preservation of reproductive competence of young cancer patients who need chemotherapy, pelvic radiation, or surgical removal of ovaries for treatment. Furthermore, the ability to freeze oocytes allows patients to reduce the number of embryos frozen, thereby circumventing the moral and ethical dilemmas of having left-over embryos in cryostorage. In addition, oocyte cryopreservation could allow women to delay childbearing if they want or need to. Until recently, conventional cryopreservation protocols have remained too inefficient for practical application in an infertility center. Very little is known about the effects of vitrification on oocytes and subsequent embryo development, especially using the sibling model (group of oocytes from the same cohort of ovarian follicles within patient). The purpose of this study is to examine the effect of oocyte vitrification on fertilization rates, embryo quality and development.


Eligibility criteria: Inclusion Criteria:

* healthy women ages 21-37 (inclusive)undergoing IVF in an attempt to achieve pregnancy
* Day 2-4 FSH \< 10 IU/ml, LH \<12 IU/ml, and E2 \<50 pg/ml
* Antimullerian Hormone (AMH) \>1.5
* Between 5 and 20 basal antral follicles on day 2-4 of the menstrual cycle
* BMI \>18 and \<32

Exclusion Criteria:

* Smokers
* Polycystic Ovarian Syndrome (PCO)

Primary outcomes:
measure: fertilization rate
timeFrame: 18 hours after insemination
measure: Embryo Quality
timeFrame: day 3 and day 5
measure: Embryo Development
timeFrame: Day 3 and day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Bryn Mawr
country: United States
facility: Main Line Fertility Center
state: Pennsylvania
Study officials:
affiliation: Main Line Fertility Center
name: Glassner J Michael, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Main Line Fertility Center
name: Sharon H. Anderson, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT05049395: HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol
Official title: HFNO Reducing the Incidence of Hypoxia During the Procedure of Hysteroscopy Sedated With Propofol，a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometritis
Tuberculous Endometritis
Subseptate Uterus
Endometrial Polyps
Keywords: HFNO
Hysteroscopy
Sedation
Hypoxia
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 960
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine whether high-flow nasal cannula oxygen can reduce the incidence of hypoxia during the procedure of sedated hysteroscopy.


Eligibility criteria: Inclusion Criteria:

1. 20 years old ≤ age ≤ 50 years old, female.
2. Undergoing hysteroscopy sedated with propofol for diagnosis or treatment.
3. Informed consent
4. BMI≤28kg/m2.
5. ASA physical status Ⅰ\~ Ⅱ.

Exclusion Criteria:

1. Epistaxis, nasal congestion and nasal mucosal damage.
2. Confirmed brain disease (cranial trauma, tumor, stroke, cognitive dysfunction etc.).
3. Confirmed severe heart disease (heart failure, angina pectoris, myocardial infarction, arrhythmia, etc.).
4. Confirmed severe lung diseases (upper respiratory tract infection, asthma, bronchitis, COPD, bullae, pulmonary embolism, pulmonary edema, lung cancer, etc.).
5. Pregnant women.
6. Acute and chronic hepatitis or liver cirrhosis with severe abnormal liver function.
7. Acute and chronic nephritis with severe abnormal renal function or renal failure.
8. Needing oxygen inhalation for underlying diseases.
9. Emergency surgery.
10. Combined with multiple trauma.
11. Allergic to soybean

Primary outcomes:
measure: The incidence of hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes:
measure: The incidence of sub-clinical respiratory depression
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Other outcomes:
measure: The incidence of severe hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
measure: The incidence of other adverse events
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: Department of Anesthesiology
name: Su Diansan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02643095: Efficacy of Scleral Contact Lenses for Daily Wear for Regular and Irregular Refractive Errors Compared to Habitually Worn Scleral Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleral Lens Wearers
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month.


Eligibility criteria: Inclusion Criteria:

1. Subjects may be male or female, of any race, and at least 18 years old at the time of the pre-treatment examination.
2. Subjects must habitually wear scleral contact lenses for an average wearing time of 6 hours per day.
3. The prospective eye(s) must have refractive hyperopia or myopia from +20.00 to -20.00 diopters sphere (spectacle plane), with up to -10.00 diopters of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance).
4. Subjects must have best spectacle corrected visual acuity of at least 0.5 logMAR in each eye.
5. Subjects must be willing and capable to return for all scheduled follow-up visits for a period of at least 3 months (minimum of 1 month from initial dispensing).

Exclusion Criteria:

1. Female subjects who are pregnant, breast-feeding or intend to become pregnant over the course of the study.
2. Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.

   Note: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, will specifically exclude subjects from eligibility.
3. Subjects with active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection.
4. Subjects who are participating in any other clinical trial (FDA or other)

Primary outcomes:
measure: The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses
timeFrame: 1 month after lens is dispensed
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04819295: Latinx Teen Depression Treatment Study
Official title: Barriers, Facilitators, and Preferences Regarding Depression Treatment From the Perspectives of Latinx Adolescents, Parents, and Healthcare Providers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: Latinx adolescents
psychotherapy
Focus groups
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 32
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Latnix adolescents and their parents, including healthcare providers who are involved in psychotherapy treatments.

Brief summary: The purpose of this study is determine facilitators of and barriers to receiving evidence-based psychotherapy for depression for Latinx adolescents from multiple stakeholder perspectives.


Eligibility criteria: Inclusion Criteria:

* Aged 13-17
* self-identify as Hispanic/Latinx
* diagnosed with Major Depressive Disorder or Persistent Depressive Disorder/Dysthymia
* referred to psychotherapy or prescribed medication for depression.

Healthcare providers:

* Self-identify as regularly providing clinical care to Latinx adolescents with depression
* be in a role in which they can refer to or provide depression treatment.

Exclusion Criteria:

* Teens will be excluded if they are experiencing intense psychological distress or imminent thoughts of suicide or have any condition in which, in the opinion of the investigator, precludes the study team from obtaining informed assent of the teen

Primary outcomes:
measure: Number of preferences for depression treatment generated from focus groups
timeFrame: Baseline
Secondary outcomes:
measure: Number of barriers to depression treatment among Latinx Adolescents from focus groups
timeFrame: Baseline
Other outcomes:
Locations:
city: Durham
country: United States
facility: DUSON
state: North Carolina
Study officials:
affiliation: Duke University
name: Allison Stafford, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05579795: Surgical Management and Outcome of Tethered Cord Syndrome
Official title: Tethered Cord Syndrome: Surgical Management and Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tethered Cord Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 35
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and Females below 16 years old with Tethered cord syndome

Brief summary: The aim of this study is to assess surgical management and outcome of Tethered cord syndrome

Detailed description: Tethered cord syndrome (TCS) is a developmental abnormality of the neuroaxis which is usually diagnosed in childhood. The actual tethering has been attributed to a variety of pathologic entities, including a thickened tight filum terminale , intradural lipomas with or without a connecting extradural component, intradural fibrous adhesions, diastematomyelia, and adherence of the neural placode following previous closure of a myelomeningocele. However, sufficient differences in the mode of onset, clinical manifestations, and outcome exist between pediatric and adolescent patients with tethered cord to warrant a more detailed analysis of the adult syndrome. The most problematic technical consideration in surgery for the release of the tethered cord is how to preserve functioning neural elements and rebuild the dural sac to avoid CSF leak. The purpose of this study is to review causes of Tethered cord, clinical presentation, diagnostic tools, treatment options and outcome in school-aged children, adolescents, and young adults with Tethered cord.

Eligibility criteria: Inclusion Criteria:

* Patients with Tethered cord syndrome presenting at our institute
* Patients with spinal dysraphism
* Lipomyelomeningocele with Tethered cord
* patients presented with neurological deficit after lipomyelomeningocele repair due to Tethered cord
* patients presented with neurological deficit after myelomeningocele repair due to Tethered cord
* Diastematomyelia with Tethered cord - Tethered cord due to filum terminale.
* Tethered cord due to fibrous adhesions

Exclusion Criteria:

* Asymptomatic Patients with Tethered cord discovered accidentally

Primary outcomes:
measure: Motor power
timeFrame: Two years
measure: Sensations
timeFrame: Two years
measure: Sphincter's function
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02188095: Post Market Clinical Follow-Up Study of Excia T® Hip Prosthesis
Official title: Post Market Clinical Follow-Up Study of Excia T® Hip Prosthesis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hip Arthritis
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2014-07-11
Enrollment: 100
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: primary care clinic

Brief summary: Clinical and radiological 10 year results of Excia T® Hip Stem


Eligibility criteria: Inclusion Criteria:

* Patient gave written informed consent
* age ≥ 18 years

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Survival Rate of the Implant
timeFrame: 10 years
Secondary outcomes:
measure: Hip disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: preoperatively, intraoperatively + discharge, after 3 and 12 months 3, 5 and 10 years
measure: Change of functional outcome over follow-up period (Harris Hip Score (HHS))
timeFrame: at discharge, after 3 and 12 months 3, 5 and 10 years
measure: Pain Assessment
timeFrame: at 6 examinations during follow-up (discharge, after 3 and 12 months and 3, 5, and 10 years)
measure: Shaftposition ap and lateral
timeFrame: 10 years
measure: Stress Shielding
timeFrame: 10 years
measure: Hypertrophies
timeFrame: 10 years
Other outcomes:
Locations:
city: Bad Rappenau
country: Germany
facility: Vulpius Klinik
city: Stuttgart
country: Germany
facility: Diakonie Klinikum Stuttgart
Study officials:
affiliation: Diakonie-Klinikum Stuttgart
name: Peter Aldinger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04226495: Sufentanil Infusion vs Sufentanil Bolus
Official title: Sufentanil Infusion vs Sufentanil Bolus and Time to Extubation During Routine Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 65
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized single blind controlled clinical trial to test the benefit of sufentanil infusion over bolus dosing to reduce time to extubation and reduced length of ICU stay.

Detailed description: This study will compare Sufentanil bolus vs infusion and analyze which has a faster extubation time in participants who undergo routine cardiac surgery. The hypothesis is that routine cardiac surgery patients receiving sufentanil infusion will have a lower sufentanil concentration at the end of surgery and have a shorter time to extubation than participants receiving sufentanil bolus dosing even with similar total doses of sufentanil. The intervention will be Sufentanil infusion during surgery and evaluations will include Sufentanil blood concentrations, ICU and hospital length of stay and re-intubation rate. We will follow up with the participants through their ICU stay (primary objective) and hospital length of stay (secondary objective).

Eligibility criteria: Inclusion Criteria:

* Scheduled non-emergency cardiac surgical patients including those with planned procedures of CABG, AVR, and combined CABG and AVR
* 19 to 80 years old
* Planned pre-operative anesthesia screening visit and/or preoperative surgical clinic visit.
* Inpatient subject that is scheduled (greater than 24hrs in advance) for a non-emergency cardiac surgical case

Exclusion Criteria:

* Sufentanil allergy
* EF less than or equal to 30%
* Moderate or severe right ventricular dysfunction,
* Moderate pulmonary dysfunction, to include patients with at home 02 and/or daily bronchodilator therapy.
* End Stage Renal Disease on Dialysis
* Chronic Kidney Disease with GFR \<30
* Sternotomy Re-do
* Emergency surgery
* Greater than 4 units of RBCs or FFP combined
* Mechanical circulatory support post-operatively such as ECMO, IABP, Impella
* Not eligible for rapid wean extubation protocol
* Requires infusion of sedative medication required during ICU admission
* Greater than or equal to 15 minute ICU hold within PACU

Primary outcomes:
measure: Time to Extubation
timeFrame: Amount of time in minutes from procedure finish to time of extubation, up to 800 minutes.
Secondary outcomes:
measure: Plasma Concentration
timeFrame: Lab concentration is drawn when patient arrives to ICU, an average of 1 hour after procedure.
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Jeffrey C Songster, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00972595: Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)
Official title: An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study to Determine the Bioequivalence of 2 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chemotherapy-Induced Nausea and Vomiting
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-09-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a non-U.S. marketed formulation of ondansetron.


Eligibility criteria: Inclusion Criteria:

* If female, subject is not pregnant or breast-feeding
* Subject has been a nonsmoker for at least 6 months
* Subject is in good health

Exclusion Criteria:

* Subject has a history of high blood pressure, asthma, other pulmonary disease, Gastrointestinal (GI) abnormalities/peptic ulcers, or cardiovascular, liver, neurologic, or kidney disease
* Subject is a habitual and heavy consumer of caffeine

Primary outcomes:
measure: Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose
measure: Peak Plasma Concentration (Cmax) for Ondansetron
timeFrame: 24 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02377895: Allergen Biocube Study Evaluating Efficacy and Safety of Nasapaque Nasal Solution in Adult Subjects With Allergic Rhinitis
Official title: A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Parallel-Group Allergen BioCube Study Evaluating the Efficacy and Safety of Nasapaque Nasal Solution in a Population of Adult Subjects With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: 3E Therapeutics Corporation
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2015-03-04
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and safety study using the Allergen BioCube (ABC).


Eligibility criteria: Key Inclusion Criteria:

* Must be 18 years of age and provide written informed consent and sign the HIPAA form
* Must have history of allergic rhinitis
* Must have positive response to Allergen BioCube

Key Exclusion Criteria:

* Must not have a significant illness such as moderate to severe allergic asthmatic reactions
* Must not have compromised lung function
* Must not use any disallowed medications
* Must not have been in an investigational study in the last 30 days

Primary outcomes:
measure: TNSS Total Nasal Symptom Score
timeFrame: Day 1 and Day 8
Secondary outcomes:
measure: Nasal Inspiratory Flow
timeFrame: Day 1 and Day 8
measure: Nasal Inflammation Score
timeFrame: Day 1 and Day 8
Other outcomes:
Locations:
Study officials:
References:
citation: Gomes PJ, Abelson MB, Stein L, Viirre E, Villafranca JE, Lasser EC. Iodixanol nasal solution reduces allergic rhinoconjunctivitis signs and symptoms in Allergen BioCube(R): a randomized clinical trial. J Asthma Allergy. 2019 Mar 1;12:71-81. doi: 10.2147/JAA.S150251. eCollection 2019.
Clinical trial NCT05760495: Analysis of Oxidative Stress Biomarkers and Their Determinants in ART-experienced PLWH
Official title: Analysis of Oxidative Stress Biomarkers and Their Determinants in ART-experienced PLWH
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 543
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: aviremic, HIV outpatients on long-term ART

Brief summary: The project aims to assess the level of oxidative stress biomarkers in HIV patients on effective antiretroviral treatment in correlation with other therapeutic, clinical, and viro- immunological parameters. The analysis aims to better characterize the patient on treatment through an innovative approach based on two specific tests for complementary assessment of total oxidant and anti-oxidant plasma capacity.


Eligibility criteria: Inclusion Criteria:

* ART-treated PLWH
* HIV-1 RNA\< 50 copies/mL
* Stable ART therapy (at least 48 weeks)
* Signature of informed consent for study participation

Exclusion Criteria:

* none

Primary outcomes:
measure: Assessment of the levels of total oxidant and antioxidant plasma capacity
timeFrame: 1 year
Secondary outcomes:
measure: Correlation between level of oxidative stress biomarkers and several factors
timeFrame: 1 year
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Francesca Lombardi
state: RM
Study officials:
References: