louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05793463: Anti-mullerian Hormone in Acute Lymphoblastic Leukemia
Official title: Anti-mullerian Hormone in Pediatric Patients Treated for Acute Lymphoblastic Leukemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lymphoblastic Leukemia
Keywords: Acute Lymphoblastic Leukemia
Fertility preservation
Anti-Mullerian hormone
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 10
Sex: FEMALE
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female less than 18 years of age with ALL

Brief summary: Acute lymphoblastic leukemia (ALL) is the most common childhood malignancy, with current survival rates exceeding 90%. As cure rates improve, increasing attention is focused on survivor quality of life, including fertility. It is generally accepted that cancer treatments in childhood may interfere with gonadal function, reducing the pool of primordial follicles and consequently causing premature menopause in women. Anti-Mullerian hormone (AMH) levels is a valuable quantitative indicator of ovarian reserve, being directly related to the number of antral follicles. The evaluation of this hormone makes it possible to identify women at risk of early menopause and to propose them interventions for monitoring and preservation of oocytes, allowing girls to be able to have children once they reach adulthood. The objective of this study is to determine ovarian reserve in girls with ALL before and after treatment by means of the evaluation of the AMH assay.


Eligibility criteria: Inclusion Criteria:

* Female less than 18 years of age
* Diagnosis of acute lymphoblastic leukemia
* enrollment within the first month after diagnosis

Exclusion Criteria:

* Previous treatments with cytostatics drugs
* ALL as a second malignancy
* Syndromic patient or primary hypogonadism

Primary outcomes:
measure: Evaluation of blood AMH levels before ALL treatment
timeFrame: Within one months from ALL diagnosis
measure: Evaluation of blood AMH levels after ALL treatment
timeFrame: 24 months after ALL diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
Study officials:
affiliation: IRCCS materno infantile Burlo Garofolo
name: Nagua Giurici, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05089422: Study of Clinical Types and Surgical Out Come of Pediatric Exotropia
Official title: Study of Clinical Types and Surgical Out Come of Pediatic Exotropia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exotropia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 30
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: study aiming to evaluate all children presented to strabismus clinic in ophthalmology department at sohag university hospital with divergent squint (exotropia) and to record surgical outcome of those who underwent strabismus surgery in our hospital

Detailed description: A hospital-based, prospective, interventional study include infants and children up to the age of 15 years with Primary Concomitant divergent squint (1ry concomitant exotropia),Candidate for surgical correction of squint.

Each patient will be subjected to Detailed history and Full preoperative ophthalmic \& orthoptic evaluation including: Visual acuity , ocular motility in the 6 cardinal directions, Hirschberg test \& angle of deviation.

,Cover test \& prism cover test for distant \& near fixation,Cycloplegic refraction , Anterior segment examination, fundus examination.

_ post operative Follow-up regimen:

1. Children will be examined after surgery on: 1st postoperative day, 1st week, 1st month, 3rd month, and 6 months postoperatively.
2. The following will be recorded for each patient: Visual acuity, cover test, ocular motility testing, cover test and prism cover test, the degree of postoperative eye position, presence of over-correction or under-correction, and presence of any other complications.

Eligibility criteria: Inclusion Criteria:

1. Infants and children up to the age of 15 years.
2. Primary Concomitant divergent squint (1ry concomitant exotropia)
3. Candidate for surgical correction of squint

Exclusion Criteria:

1. Children with:

   1. Paralytic squint
   2. Consecutive exotropia
   3. Any neurological disorder
   4. History of previous squint surgery
   5. History of previous other ocular surgery (e.g. congenital cataract \& glaucoma)
2. Children who missed follow up.

Primary outcomes:
measure: The number of children who become corrected post operatively
timeFrame: Six months
measure: The number of children with post operative residual squint
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05614622: Mydriatic Drops After Combined Surgery
Official title: The Effect of Mydriatics on Posterior Synechia After Combined Surgery of Pars Plana Vitrectomy, Phacoemulsification, and Intraocular Lens Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Synechiae of Iris
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study goal is to evaluate the influence of mydriatic drops on the development of posterior synechia after combined cataract and vitrectomy surgery.

Detailed description: Cataract and vitreoretinal disorders often coexist, and with up to 80 percent chance for cataract formation following vitreoretinal surgery within the first year, combined surgery of phacoemulsification, pars plana vitrectomy (PPV) and intraocular lens (IOL) implantation has become increasingly accepted.

The main advantages of combined surgery include better visualization during surgery and the elimination of the need for additional surgery, which translates to overall quicker visual recovery and cost-effectiveness. Like the more exercised, two-step procedure, the combined surgery was shown to be safe and effective with relatively few complications. However, one complication seen more frequently after the combined surgery is postoperative anterior chamber inflammatory response, and with it, the formation of posterior synechia, reaching an average of 18 percent.

The development of posterior synechia interferes with postoperative visualization of the fundus, thus diminishing an important advantage of the combined procedure. Moreover, in a few cases, it can even be complicated by angle closure glaucoma.

Currently, there is no consensus on whether postoperative treatment after combined surgery should include additional treatment to help prevent the formation of synechia. The frequency and severity of posterior synechia after a combined operation may be reduced using short-acting mydriatics. However, there is no sufficient data nor a prospective study to support this as common practice. It is, therefore, we sought to better evaluate the effect of topical short-acting mydriatics on the formation of posterior synechia after combined surgery and compare it with standard postoperative treatment.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent combined cataract and vitrectomy surgery with IOL implantation.

Exclusion Criteria:

* History of uveitis prior to surgery.

Primary outcomes:
measure: Number of participants developed iris posterior synechiae after surgery
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
References:
Clinical trial NCT01579422: Social Cognitive Training for Psychosis: Treatment Development
Official title: Social Cognitive Training for Psychosis: Phase I Treatment Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Psychosis
Keywords: schizophrenia
treatment
social cognition
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-04-18
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim of this proposal is to develop, refine, manualize and assess the feasibility and preliminary efficacy of a brief, narrowly-focused social cognitive intervention for individuals with psychosis. The intervention will focus on helping individuals interpret social situations, specifically the intentions and feelings of others.

Study methods include preliminary treatment and manual development based on series of uncontrolled cases, manual refinement, and a small feasibility/efficacy trial of the newly developed intervention.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia or other psychotic disorder
* Age between 18 and 55
* Psychiatrically stable
* Clinician agrees to individual's participation in study
* English as primary language

Exclusion Criteria:

* current (past 30 days) symptoms of alcohol abuse/dependence
* developmental disability
* severe auditory/visual impairment or known neurological disorder
* participant has a legal conservator

Primary outcomes:
measure: social cognition
timeFrame: change from baseline to approximately 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
References:
Clinical trial NCT01219322: Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Anesthetized Children
Official title: Intravenous Bicarbonate Identifies the Correct Position of Intravenous Catheter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: General Anesthesia
Keywords: general endotracheal anesthesia
ASA I or II
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Extravasation is an unintentional injection or leakage of fluids in the perivascular or subcutaneous space. Extravasation can be associated with tissue injury with various level of severity and long term consequences. Currently the confirmation of intravenous location of the Intravenous (IV) catheter requires close observation of the insertion site with sufficient infiltration in the perivascular area to allow detection of swelling, discoloration and discomfort. Under Anesthesia direct observation is frequently prohibited. IV sodium bicarbonate (SB) is used frequently to treat different metabolic conditions and is known to cause a temporary elevation of exhaled carbon dioxide. This study aim is to evaluate the safety and efficacy of intravenous SB as a detector of intravenous placement of an IV line in anesthetized patients.

Patients and Methods: The study has three parts, in part 1, the safety of subcutaneous injection of sodium bicarbonate was evaluated in 6 rats. In each animal the macroscopic and microscopic effects were evaluated and a safe dilution was determined. In the second part of the study the investigators will evaluated the efficacy of IV diluted SB to detect the proper location of IV catheters. 20 adult patients age 20 to 50 years will be enrolled. Patients all under general anesthesia with standard controlled ventilation via endotracheal tube. The correct placement of IV catheter will be confirmed by easy aspiration of blood from newly placed IV catheter. In each patient a bolus of 50 cc of 0.5 meq/cc SB or volume equivalent of normal saline will be injected in random order. The data collection will include patient's demographics, the presence or absence of an increase in the expired end-tidal carbon dioxide, onset and peak changes of end-tidal carbon dioxide as well as the hemodynamic changes after each injection.


Eligibility criteria: Inclusion Criteria:

* Healthy (American Society of Anesthesiologists \[ASA\] I or II) volunteers

Exclusion Criteria:

* respiratory disease
* active smoking
* cardiovascular disease
* renal disease

Primary outcomes:
measure: change in end-tidal carbon dioxide
timeFrame: 0.5-2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT05309122: Cervical Cancer Screening Strategies
Official title: A Retrospective Cohort Study on the Effectiveness of Various Screening Strategies for Uterine Cervical Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Cervical Intraepithelial Neoplasia
Human Papillomavirus Infection
Cervical Cytology
Cancer Screening
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 10000
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: Participants who accepted cervical cancer screening in the study center

Brief summary: This study is to investigate retrospectively the results of cervical cytology and high-risk human papillomavirus in the past 20 years recorded in Peking Union Medical College Hospital. The histological findings after cervical cancer screening were reviewed. The diagnostic values of different screening strategies were compared based on the results of cervical histology. The primary endpoint is the diagnosis of grade 2 cervical intraepithelial neoplasia (CIN2) or more severe lesions (CIN2+). The secondary endpoints include following objectives: (1) the invasive procedures needed according to the screening results; (2) the diagnosis of vaginal and/or vulval intraepithelial neoplasia; (3) the persistence and recurrence of human papillomavirus infection; and (4) the cost-effectiveness of screening strategies for CIN2+.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* With definite cervical histology after cervical cancer screening, ore with at least one screening test after first testing

Exclusion Criteria:

- Not meeting all of the inclusion criteria

Primary outcomes:
measure: CIN2+
timeFrame: One year
Secondary outcomes:
measure: Invasive procedures
timeFrame: One year
measure: Vaginal intraepithelial neoplasia (VaIN)
timeFrame: One year
measure: Vulval intraepithelial neoplasia (VIN)
timeFrame: One year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06298422: Oxygen Saturations Across Tones of Skin
Official title: Addressing Race-Based Limitations in Pulse Oximetry Through Colorimeter or Spectrophotometer-Integrated Corrections
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Generalised Melanin Pigmentation
Pulse Oximetry
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients on mechanical ventilation.

Brief summary: Pulse oximetry, or SpO2, is a vital sign used across healthcare systems to gauge how much oxygen blood is carrying as a percentage of the maximum it could carry. Recent research has suggested that current SpO2 monitors may inaccurately report high SpO2 in patients with darker skin tones when the actual oxygenation is at unsafe, low levels. Additionally, this new research suggests as the SpO2 levels decrease, the risk of occult hypoxia rises. The investigators hypothesize melanin interferes with the pulse oximetry accuracy. Investigators will use spectrophotometry to measure melanin indices and other variables to test this hypothesis.


Eligibility criteria: Inclusion criteria:

1. \>18 years old
2. Any gender
3. Any ethnic background
4. Admitted to UC San Diego La Jolla or Hillcrest campus ICU
5. Mechanically ventilated
6. Has a clinical ABG ordered by the critical care team responsible for clinical care

Exclusion Criteria a. \<18 years old b. Medical history of or acute diagnosis of sickle cell disease c. Normally protected individuals under 45 CFR 46 (pregnant individuals, prisoners, and children)

-

Primary outcomes:
measure: Difference observed between SpO2 and SaO2.
timeFrame: Through study completion, approximately one year
measure: Melanin Index
timeFrame: Through study completion, approximately one year
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Health
state: California
Study officials:
References:
Clinical trial NCT00854022: Genetic Susceptibility to Kidney Cancer
Official title: Genetic Susceptibility to Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Renal Cell Carcinoma
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2009-03-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with newly diagnosed (diagnosed within the year of enrollment) with possible Renal Cell Carcinoma (RCC)

Brief summary: This study will further the understanding of the genetic events leading to the development of RCC.

Detailed description: This study will further the understanding of the genetic events leading to the development of RCC; explore the genetic basis for genetic instability and how it affects cancer risk; and eventually provide a means of identifying a subgroup of individuals who are most likely to develop RCC. Such individuals may then be targeted for intervention programs such as chemoprevention or dietary modification.

Eligibility criteria: Inclusion Criteria:

* Adult patients of any ethnicity or sex, who have a been diagnosed with possible Renal Cell Carcinoma within the past year.

Exclusion Criteria:

* Must not have received chemotherapy, biological therapy or radiation therapy in the 6 months preceding enrollment will
* Must not have had RCC, or metastatic RCC,
* Must not have had a renal transplantation

Primary outcomes:
measure: To identify interindividual differences in inherited genetic instability
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Seth P. Lerner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02871622: BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM
Official title: A Post-market Registry of the BioMatrix Alpha TM (Cobalt Chromium Biolimus A9TM (BA9TM) Drug-eluting Stent)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Stable Angina
Ischemia
Acute Coronary Syndrome
NSTEMI
STEMI
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
Collaborators: name: European Cardiovascular Research Center
First posted: 2016-08-18
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: "Real world, all comers" patient population: Patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions.

Brief summary: Prospective, multi-center, registry designed to enrol up to 2,000 patients in up to 35 International centers. All patients will receive a BioMatrix AlphaTM stent as per clinical practice and will be followed for 2 years for data collection. Major adverse cardiac events (MACE) results at 9 months will be compared to the results obtained from the BioMatrix FlexTM arm of the LEADERS trial.


Eligibility criteria: Inclusion Criteria:

* Patients treated with the BioMatrix AlphaTM stent per clinical indication and physician's choice;
* Patients who agree to comply with the follow up requirements;
* Patients with a life expectancy of \> 1 year at time of consent;
* Patients eligible to receive dual anti platelet therapy (DAPT) according to guidelines;
* Hemodynamically stable patients.

Exclusion Criteria:

* Inability to provide informed consent;
* Currently participating in another trial before reaching primary endpoint;
* Planned surgery within 6 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the perisurgical period;
* Patient has received an additional stent different from a BioMatrix AlphaTM stent during the index procedure.

Primary outcomes:
measure: Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or clinically driven target vessel revascularization (TVR).
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Craigavon
country: United Kingdom
facility: Craigavon Cardiac Center
Study officials:
affiliation: Craigavon Cardiac Centre
name: Ian BA Menown, Dr
role: PRINCIPAL_INVESTIGATOR
References: