louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05868252: Molecular Analysis of the Sloane Project
Official title: Molecular Analysis of Screen Detected Non-invasive Breast Cancer and Atypical Breast Hyperplasias Identified by the Sloane Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: DCIS
LCIS
Atypical Ductal Hyperplasia
Atypical Lobular Hyperplasia
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 1500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those who have undergone breast screening and were part of the Sloane Project audit

Brief summary: The Sloane Project is a UK wide prospective audit of screen detected non-invasive and atypical breast hyperplasias named after John Sloane an eminent pathologist interested in the field. Non invasive breast neoplasia accounts for 25% of all 'breast cancers' detected through breast screening and includes ductal carcinoma in situ (DCIS) and lobular carcinoma in situ (LCIS). Atypical hyperplasias are high risk but benign lesions found in 10% of benign biopsies performed through the NHS breast screening programme. The importance of these lesions rests on the increased risk of subsequently developing invasive breast cancer, with DCIS at highest risk (20 times greater than the general population) followed by LCIS (10 times greater) and atypical breast hyperplasia (4 times greater).

The Sloane Project data are held by Public Health England (PHE) and provide full and detailed information about the patients' journey from diagnosis to treatment and outcome. The project aims to increase the understanding of how best to manage these early lesions which can lead to breast cancer.

All NHS breast screening units in the UK are invited to submit data for the Sloane Project. Historically an exceptional \~90% of centres in England, Scotland, Wales and Northern Ireland have participated on a voluntary basis.

The objective of this research protocol is the collection of anonymised formalin fixed paraffin embedded (FFPE) tissue blocks from women whose data is held within the Sloane Project database in order to allow detailed analysis of the biological, molecular and genomic changes in these cases of in situ carcinoma and atypical hyperplasia and how these relate to the corresponding annotated clinical, pathological and radiological data already collected by and held in PHE. We seek to identify particular signature(s) that define which patients are likely to develop invasive disease, distinguishing the worrisome from indolent, non-worrisome lesions.


Eligibility criteria: Inclusion Criteria:

* DCIS (Ductal Carcinoma in situ)
* LCIS (Lobular Carcinoma in situ)
* Atypical hyperplasias

Primary outcomes:
measure: Progression of breast disease
timeFrame: From diagnosis to end of 2016
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Elinor Sawyer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05681052: Mottling Score and Central Venous Oxygen Saturation in Septic Shock Patients
Official title: Mottling Score and Central Venous Oxygen Saturation in Septic Shock Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Central Oxygen Saturation
Microcirculation
Mottling Score
Septic Shock
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 62
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: All patients aged ≥ 18 years in septic shock

Brief summary: Mottling score and central venous oxygen saturation are described as a clinical evaluation of tissue perfusion. This study describes mottling incidence and mottling score in septic shock patients according to central venous oxygen saturation.

Detailed description: This study prospectively analyzed the data of patients admitted to our ICU between October 2022 to December 2022. All septic patients in whom the ScvO2 was measured and mottling scores were evaluated were included. This study enrolled patients aged ≥ 18 years in septic shock. Those excluded have peripheral arterial disease, black skin, cutaneous infection of the lower limbs, pregnancy, and relative refusal. The characteristics of patients were recorded at admission (H0), including demographics (age, sex, body mass index (BMI), admission the Acute Physiology and Chronic Health Evaluation (APACHE II) score, Glasgow Coma Scale (GCS) and sequential organ failure assessment (SOFA) score. Variables such as plasma lactate level, daily urine output, plasma creatinine level, the ratio of arterial oxygen pressure related to inspired oxygen fraction (PaO2/FiO2), hemoglobin level, heart rate, mean arterial pressure, pulsatile saturation in oxygen (SpO2) and body temperature were recorded at H0 and 6 hours after initial resuscitation (H6).

Eligibility criteria: Inclusion Criteria:

* patients aged ≥ 18 years in septic shock.

Exclusion Criteria:

* patients having the peripheral arterial disease
* black skin,
* cutaneous infection of the lower limbs
* pregnancy
* relative refusal

Primary outcomes:
measure: Difference in mottling incidence according to ScvO2 level during a septic shock.
timeFrame: at 0th hour, admission; at 6th hour after initial treatment
measure: Difference in mottling score according to ScvO2 level during a septic shock.
timeFrame: at 0th hour, admission; at 6th hour after initial treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Erzi̇ncan
country: Turkey
facility: Nurcan Kutluer Karaca
Study officials:
References:
Clinical trial NCT01098552: Participation in Procurement of Tissue, Serum, Plasma, Cell Bank, DNA and RNA Samples, and Urine for Biological Studies Related to Prostate Cancer and Prostate Cancer Treatment Follow Up
Official title: Participation in Procurement of Tissue, Serum, Plasma, Cell Bank, DNA and RNA Samples, and Urine for Biological Studies Related to Prostate Cancer and Prostate Cancer Treatment Follow Up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-04-02
Enrollment: 4900
Sex: MALE
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: There are six patient cohorts which are being recruited to the Prostate Clinical Follow-up Core in support of the Specialized Program of Research Excellence (SPORE). The six groups are: 1. High-risk radical prostatectomy patients, 2. Primary external beam radiotherapy patients, 3. Primary prostate brachytherapy patients, 4. Hormone refractory prostate cancer patients, 5. Active Surveillance. 6. Prostate biopsy patients. The inclusion criterion for group 6 is that the patient is scheduled to undergo a prostate biopsy for the purposes of definitive prostate cancer diagnosis. There are no exclusion criteria for group 6.

Brief summary: This research study is being done to collect regular and routine follow-up information related to the outcome of treatment for prostate cancer.

This study is also being done to relate treatment outcome to measurement of substances in the blood such as prostate-specific antigen (PSA) and other markers. Also environmental and genetic factors that might be responsible for prostate cancer are being investigated.


Eligibility criteria: Inclusion Criteria:

1. Informed consent explained and signed prior to any study related procedures.
2. Age ≥18 years
3. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better, or Karnofsky performance of 60% or better.
4. Histologically confirmed adenocarcinoma of the prostate within 10 years of study entry.
5. Willingness to return to Mayo Clinic Rochester for follow-up or participate in mail-in PSA processing.
6. Must be disease-free from a previous diagnosis of cancer for a period of time = 5 years excluding cutaneous malignancies of squamous cell or basal cell carcinoma.

Exclusion Criteria:

1. Life expectancy \< 5 years.
2. Inability to return to Mayo Rochester for follow-up appointments, sera, and urine collection per protocol.
3. Previous or a concurrent diagnosis of cancers other than basal cell or invasive squamous cell carcinoma of skin within the past 5 years.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: R. J. Karnes, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05814952: Safety and Efficacy Study of LX103 Treatment of X-Linked Retinoschisis (XLRS)
Official title: An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Efficacy of LX103 in Patients With X-Linked Retinoschisis (XLRS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: X-linked Retinoschisis
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Innostellar Biotherapeutics
First posted: 2023-04-18
Enrollment: 12
Sex: MALE
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the safety and efficacy of LX103 treatment of X-linked retinoschisis. This study will enroll subjects aged ≥ 6 years old to receive a single unilateral intravitreal (IVT) injection of LX103 to evaluate its safety and efficacy.


Eligibility criteria: Inclusion Criteria:

1. Willing to sign the informed consent, and willing to attend follow-up visits.
2. Male individual at least 6 years of age with a diagnosis of XLRS and documented mutations in the RS1 gene.
3. The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 63.

Exclusion Criteria:

1. Any eye with disease that would interfere with the fundus examinations.
2. The study eye is receiving topical carbonic anhydrase inhibitor, or has received topical carbonic anhydrase inhibitors in the past three months.
3. The study eye has undergone intraocular surgery within six months prior to enrollment.
4. Participant has uncontrolled hypertension or diabetes.

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: 24 weeks
measure: Incidence of serious adverse events (SAEs)
timeFrame: 24 weeks
Secondary outcomes:
measure: Mean change from baseline in BCVA (LogMAR) in the study eye
timeFrame: 24 weeks, 52 weeks
measure: Mean change from baseline in central subfield thickness (CST) in the study eye
timeFrame: 24 weeks, 52 weeks
measure: Change from baseline in Electroretinogram (ERG) parameters in the study eye
timeFrame: 24 weeks, 52 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital, Shanghai Jiao Tong University
Study officials:
References:
Clinical trial NCT07003152: Relationship Between Hydrocephalus and Endolymphatic Hydrops
Official title: Prevalence of Endolymphatic Hydrops Among Patients With Hydrocephalus
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hydrocephalus
Keywords: Hydrocephalus, endolymphatic hydrops
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hydrocephalic patients

Brief summary: The goal of this observational study is to assess the prevalence of endolymphatic hydrops in patients with hydrocephalus and assess the auditory functions in patients with hydrocephalus including male and female with 20-60 year age groups. it aims to assess the prevalence of endolymphatic hydrops in patients with hydrocephalus and to assess the auditory functions in patients with hydrocephalus


Eligibility criteria: Inclusion Criteria: Patients will be diagnosed with hydrocephalus through the neurosurgery department of the same hospital,

Exclusion criteria:

* History of ear diseases
* History of DM or Hypertension
* History of Ototoxic drug intake.
* Congenital anomalies of the auricle or external auditory meatus.
* History of hereditary hearing loss in the family
* History of noise exposure
* Other neurological problems apart from hydrocephalus

Exclusion Criteria:

-

Primary outcomes:
measure: hearing assessment
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05015452: The Leipzig TAVI Registry
Official title: An Observational Follow-up Assessment of Transcatheter Aortic Valve Implantation in Leipzig
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Lead sponsor: Helios Health Institute GmbH
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All comers patient population treated with TAVI

Brief summary: A single-center registry including all patients treated with TAVI at the Heart Center, Leipzig, Germany

Detailed description: A single-center registry including all patients treated with transcatheter aortic valve implantation (TAVI) at the Heart Center, Leipzig, Germany. Patients undergo a routine clinical and echocardiographic follow-up schedule, including a long-term follow-up plan up to 10 years to assess valve durability.

Eligibility criteria: Inclusion Criteria:

* All patients treated with TAVI

Exclusion Criteria:

* None

Primary outcomes:
measure: Mortality
timeFrame: Up to 10 years
Secondary outcomes:
measure: Structural valve deterioration
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
Study officials:
References:
citation: Abdel-Wahab M, Kitamura M, Fitzgerald SJ, Dumpies O, Wilde J, Gohmann RF, Majunke N, Gutberlet M, Kiefer P, Noack T, Lurz P, Desch S, Frawley C, Ward K, Borger MA, Holzhey D, Thiele H. Neo-Commissural Alignment Technique for Transcatheter Aortic Valve Replacement Using the ACURATE Neo Valve. Circ Cardiovasc Interv. 2022 Jul;15(7):e011993. doi: 10.1161/CIRCINTERVENTIONS.122.011993. Epub 2022 Jul 1. No abstract available.
Clinical trial NCT02688452: Water Oxygenation and Brain Activity
Official title: Water Oxygenation and Brain Activity: A Magnetoencephalographic (MEG) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Damage
Keywords: strenuous exercise
muscle soreness
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this interventional, placebo controlled, crossover, double blind, basic science exploratory study is to investigate whether there is a difference in brain electrophysiological oscillatory activity in healthy adults before and after oral consumption of water containing very small bubbles of oxygen (electrokinetically modified water).


Eligibility criteria: Inclusion Criteria:

* Men or women of any ethnic background;
* living in New York tri-state area;
* fluent in English;
* normal or corrected to normal vision and hearing;
* willing to complete all study procedures; and
* capable of giving written informed consent.

Exclusion Criteria:

* A history of gross brain abnormalities such as stroke, severe ventriculomegaly or severe periventricular white matter abnormalities;
* a history of serious psychiatric or neurological disorders, including psychosis or major depression, alcohol or drug abuse, brain injury, seizure disorder, brain tumor, etc.;
* taking psychoactive medications, including antipsychotics, anxiolytics and antidepressants, or cognitive enhancers such as cholinesterase inhibitors;
* presence of contraindications for MEG or MRI recording, including any of the following: cardiac pacemaker, intracranial clips, metal implants, or external clips within 10 mm of the head, metal in eyes, claustrophobia, obesity and/or any other reason leading to difficulty staying in the MEG or MRI for up to one hour.

Primary outcomes:
measure: Changes in spectral properties measured before and after drinking the test products using Magnetoencephalography (MEG) measurements
timeFrame: 1 Week
measure: Changes in localization of spontaneous brain activity measured before and after drinking the test products using Magnetoencephalography (MEG) measurements
timeFrame: 1 Week
Secondary outcomes:
measure: Self reported changes in behavioral state before and after drinking test product
timeFrame: 1 Week
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Rodolfo Llinás, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01870752: Ovarian Tissue Transplantation
Official title: Autologous Orthotopic Transplantation of Previously Cryopreserved Ovarian Tissue
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertile Females or Females With Ovarian Insufficiency
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Thaw and surgical transplantation of previously collected cryopreserved ovarian cortical tissue
Primary purpose: TREATMENT

Brief summary: Chemotherapy and radiation therapy for the treatment of cancer can compromise fertility. Ovarian tissue cryopreservation is an experimental strategy offered at The University of Pennsylvania to preserve future fertility (protocol 806062). The primary objective of this study is to determine the efficacy and safety of autologous transplantation of previously cryopreserved ovarian cortical tissue in patients who experience infertility or ovarian insufficiency after cancer treatments.


Eligibility criteria: Inclusion Criteria:

* Female patient between the ages of 18 and 45 years
* Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation
* Ovarian insufficiency defined as an elevated FSH over 10
* Inability to conceive after 6 months of unprotected intercourse with male
* Reasonably good health
* Candidate for pregnancy
* Written clearance for the procedure from the patients oncologist

Exclusion Criteria:

* Patients considered to be high risk for surgical complications will be excluded from the research protocol
* Women who are known to be positive for the BRCA mutation
* Women with a history of leukemia, ovarian cancer or a cancer that likely involved the ovaries at the time of ovarian tissue collection
* Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
* Current pregnancy

Primary outcomes:
measure: Pregnancy
timeFrame: 5 years
measure: Return of menstrual function
timeFrame: 5 years
Secondary outcomes:
measure: Cancer recurrence
timeFrame: 5 years
measure: Surgical Complications of ovarian tissue transplantation
timeFrame: 5 years
measure: Acceptability
timeFrame: 5 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Clarisa R Gracia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05778552: The Intermediate and Long-term Follow up of Home Based Pelvic Muscle Training
Official title: The Intermediate and Long-term Follow up of Home Based Pelvic Muscle Training : Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Floor Disorders
Pelvic Organ Prolapse
Stress Urinary Incontinence
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2023-03-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with SUI and Pelvic organ prolapse could be enrolled for study

Brief summary: When participants present with symptoms of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the investigators will perform a comprehensive evaluation and initially provide conservative treatment. If conservative treatment fails, invasive treatment will be considered. The investigators will arrange a pelvic muscle training course two to three times a week for a duration of 1.5 months per course. However, participants may complain about the inconvenience of traffic, which may lead to discontinuation of the pelvic training course. Therefore, the investigators propose the development of a home-based pelvic muscle training device and will collaborate with information engineering specialists at Tamkang University to invent the device for home-based pelvic muscle training.

Detailed description: The investigators will enroll participants with SUI or POP and allocate them into either the home-based pelvic floor muscle training (PFMT) group or traditional PFMT group. Participant satisfaction will be evaluated using a questionnaire score.

Eligibility criteria: Inclusion Criteria:

* Age \> 18-year-old, non-pregnancy, SUI, bladder capacity \> 300ml, RU\<150ml, pelvic organ prolapse

Exclusion Criteria:

* recurrent UTI, cancer patients, chronic pelvic pain, psychologic problems

Primary outcomes:
measure: The satisfication of pelvic muscle training (UDI-6)
timeFrame: up to 2 years
measure: The satisfication of pelvic muscle training (ICIQ-SF)
timeFrame: up to 2 years
measure: The satisfication of pelvic muscle training (IIQ-7)
timeFrame: up to 2 years
measure: The satisfication of pelvic muscle training (POPDI-6)
timeFrame: up to 2 years
measure: The satisfication of pelvic muscle training (PISQ-IR)
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Huann-Cheng Horng
role: PRINCIPAL_INVESTIGATOR
References: