louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04099589: Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma
Official title: Multicenter Phase II Study of Gemcitabine/Cisplatin (GC) Chemotherapy Combined With PD-1 Inhibitor (Toripalimab) in the Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Upper Tract Urinary Carcinoma
Muscle-invasive Bladder Cancer
Keywords: upper tract urinary carcinoma
muscle-invasive bladder cancer
neoadjuvant
chemotherapy
immunotherapy
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: China-Japan Friendship Hospital
First posted: 2019-09-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Few previous studies focused on the neoadjuvant treatments of upper urinary or bladder cancer, especially chemotherapy combined with immunotherapy, however, available data of retrospective studies showed this neoadjuvant treatment model might benefit patients. So This prospective Phase II clinical trial was designed to explore the efficacy of chemotherapy combined with PD-1 inhibitor as neoadjuvant therapy in upper urinary and muscle-invasive bladder urothelial carcinoma, then to improve the rate of complete pathological remission, survival and provide medical evidence.


Eligibility criteria: Inclusion Criteria:

1. bladder cancer of T2-4aN0M0
2. upper tract urinary carcinoma of T1-3N0M0 and high grade
3. ECOG 0-1
4. good organ function
5. no previous chemotherapy or immunotherapy
6. Informed consent form signed

Exclusion Criteria:

1. unable to receive chemotherapy or surgery due to physical abnormalities
2. previous cancer history
3. active tuberculosis
4. HIV
5. autoimmune disease
6. anticipating other clinical studies

Primary outcomes:
measure: pathological complete response rate
timeFrame: through study completion of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Jianzhong Shou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02154789: An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cyst
Official title: An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cysts
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ganglion Cysts
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
name: Foundation for Skin Research
First posted: 2014-06-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Digital myxoid cysts arise from degeneration in the connective tissue of the digit joint, usually the last joint of the finger or toe, often due to underlying joint arthritis. They may connect with the joint. Pressure from the cyst can result in deformity of the digit's nail and trauma to the cyst results in leakage of the fluid, representing a potential source of entry for infection. Cysts can be tender and interfere with the digit's function. A variety of treatments are available, from simple extrusion which is rarely successful, to more destructive cryotherapy, infra-red coagulation and formal excision under local anaesthetic. These latter three approaches can result in considerable scarring. Sclerosant injection of polidocanol in one small non-randomised trial has been reported to be a well tolerated efficacious treatment with minimal scarring and long-term resolution. Following a pilot study, the investigators aim to trial this treatment to assess efficacy in a larger population.


Eligibility criteria: Inclusion Criteria:

* All patients referred to dermatology in NHS Lothian or NHS Fife who have a visible Digital Myxoid Cyst affective the dital phalynx of the toes or fingers.
* The patient must have the ability to give informed consent

Exclusion Criteria:

* History of sensitivity to polidocanol or other sclerosants
* Age less than 18
* Inability to give informed consent
* Inability to report side effects experienced
* Cyst not clearly visible
* Cyst not fluid-filled

Primary outcomes:
measure: cyst resolution at 6 weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: cyst resolution at 12 and 52 weeks
timeFrame: 1 year
measure: difference in scarring
timeFrame: 1 year
measure: pain scores on a visual analogue scale
timeFrame: 1 year
measure: procedure satisfaction on a visual analogue scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Dunfermline
country: United Kingdom
facility: Queen Margaret Hospital, Whitefield Road
state: Fife
city: Edinburgh
country: United Kingdom
facility: Department of Dermatology, Royal Infirmary
state: Midlothian
Study officials:
affiliation: University of Edinburgh
name: Stephen A Holme, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01251289: The Prevalence of Group B Streptococcus Positive Pregnant Patients in an Inner City Tertiary Care Center
Official title: The Prevalence of Group B Streptococcus Positive Pregnant Patients in an Inner City Tertiary Care Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Group B Streptococcus
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2010-12-01
Enrollment: 628
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Group B streptococcus positive pregnant women

Brief summary: A retrospective review of the prevalence of Group B Streptococcus Positive Pregnant Patients in an Inner City Tertiary Care Center

Detailed description: This is a retrospective chart review of the prevalence of Group B Streptococcus (GBS) positive patients

Eligibility criteria: Inclusion Criteria:

* GBS positive pregnant women

Exclusion Criteria:

* n/a

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Unity Health Toronto
name: Mark Yudin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01246089: Ranibizumab for Myopic Neovascularization
Official title: Ranibizumabe Intravitreal Injection for Myopic Choroidal Neovascularization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myopic Choroidal Neovascularization
Keywords: Ranibizumab
Myopia
Complications
Neovascularization
OCT
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2010-11-23
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).

Detailed description: Twenty consecutive patients (30 eyes) with subfoveal PM-CNV, 9 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 0.5mg ranibizumab. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. IVTs were repeated only in case of persistent angiographic leakage and if OCT scans showed retinal thickening or edema and serous retinal detachment. The follow-up period was at least 6 months.

Eligibility criteria: Inclusion Criteria:

* Myopic and CNVM

Exclusion Criteria:

* Patients with poor compliance

  * Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (\< one year). (Physician clearance was obtained for all patients).
  * Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
  * Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.
  * Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
  * Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.
  * Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Instituto de Olhos de Goiania
state: GO
Study officials:
References:
Clinical trial NCT05949489: Psychological and Pain Factors in Knee Osteoarthritis
Official title: Associations Between Psychological Factors, Pain Sensitivity, and Physical Function in Knee Osteoarthritis: a One-year Follow up Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Osteoarthritis
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinical knee osteoarthritis experiencing persistent knee pain.

Brief summary: This study aims to determine if baseline measures of psychology and pain sensitivity can predict changes in physical function at 1 year in patients with knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Physician diagnosis of knee OA based on clinical and radiographic ACR criteria
* Pain in or around the knee on most days of the past month
* Aged 40 years or above
* Ambulatory with or without walking aid

Exclusion Criteria:

* Inflammatory arthritis (rheumatoid arthritis, lupus, etc.)
* Recent knee injury or surgery (past 3 months)
* Severe comorbidity likely to prevent study completion (dementia, terminal illness)
* inability to comply with study procedures or follow up

Primary outcomes:
measure: Change in Physical Function from Baseline to 1 year (WOMAC)
timeFrame: Change from baseline at 1 year
Secondary outcomes:
measure: Pain Catastrophizing Scale
timeFrame: Change from baseline at 1 year
measure: Kinesiophobia
timeFrame: Change from baseline at 1 year
measure: Change in Sleep Quality from Baseline to 1 year (Pittsburgh Sleep Quality Index)
timeFrame: Change from baseline at 1 year
measure: Change in Pain Self-efficacy from Baseline to 1 year (Pain Self-Efficacy Questionnaire)
timeFrame: Change from baseline at 1 year
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_CHAIR
References:
Clinical trial NCT03509389: The Prone XLIF. A Pilot Study
Official title: The Prone XLIF. An Observational Pilot Study Based on Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Diseases
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 25
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: Patients affected by a lumbar spinal disease, indicated for surgery requiring a lateral XLIF approach to the lumbar spine, eligible to perform the approach in a prone position.

Brief summary: Observational prospective study to evaluate the feasibility, effectiveness and the rate of complications of the XLIF (Extreme Lateral Interbody Fusion) performed in prone position to treat spinal diseases of the lumbar region.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Patients suffering from lumbar spinal disease that requires a circumferential fusion
* Patients suitable to undergo spinal fusion with an XLIF technique (according to the label indication/contraindications)
* Patients who are willing and able to provide written informed consent to surgery and study

Exclusion Criteria:

* a congenital or post-traumatic vertebral abnormality at the target level
* patients with a previous abdominal retroperitoneal surgery
* patients that refuses/not suitable to undergo a XLIF surgery in prone position
* subjects that are unable to provide a written informed consent to surgery and study
* subjects that are unable to will or intend
* pregnant women (declared before surgery)

Primary outcomes:
measure: Complication rate
timeFrame: intraoperative
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: in 5 days from surgery - 6 months follow-up
measure: Length of surgery
timeFrame: intraoperative
measure: Subsidence rate
timeFrame: in 5 days from surgery
measure: Visual Analogic Score (VAS) leg and back
timeFrame: in 5 days from surgery - 6 months follow-up
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
References:
Clinical trial NCT02880189: EUS Guided Core Liver Biopsy and IGB Placement for the Diagnosis and Management of NASH and Obesity
Official title: Combined Endoscopic Ultrasound Guided Core Liver Biopsy and Intragastric Balloon Placement for the Diagnosis and Management of Nonalcoholic Steatohepatitis and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Non-Alcoholic Steatohepatitis
Keywords: Non-Alcoholic Steatohepatitis (NASH)
NASH with Fibrosis
Intragastric Balloon
Orbera
Orbera Intragastric Balloon
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 21
Sex: ALL
Minimum age (years): 22
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to investigate the impact of weight loss achieved with the IGB on NASH with early fibrosis in a select cohort of patients with obesity preselected to have a high pre-test probability of having NASH with early fibrosis based on magnetic resonance elastography (MRE)-Hepatogram. In addition, this study will explore potential non-invasive imaging criteria for NASH and early fibrosis using EUS-Elastography.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Non-alcoholic Steatohepatitis with early evidence of fibrosis as seen on MRE-hepatogram
* Referred clinically for an intragastric balloon placement for weight loss

Exclusion Criteria:

* Women who are pregnant or plan to be pregnant or are breastfeeding
* Previous history of gastric surgery
* Current or recent (within 6 months) gastric or duodenal ulcers
* Gastroparesis
* Liver cirrhosis
* Coagulopathy or active use of coagulation
* Inability to provide a written informed consent

Primary outcomes:
measure: Weight Loss Achieved With Intragastric Balloon (IGB)
timeFrame: Baseline to 6 months post-procedure
Secondary outcomes:
measure: Diagnosis of NASH and Early Fibrosis by Endoscopic Ultrasound (EUS) Guided Liver Core Biopsies
timeFrame: Baseline to 6 months post-procedure
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Barham Abu Dayyeh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bazerbachi F, Vargas EJ, Rizk M, Maselli DB, Mounajjed T, Venkatesh SK, Watt KD, Port JD, Basu R, Acosta A, Hanouneh I, Gara N, Shah M, Mundi M, Clark M, Grothe K, Storm AC, Levy MJ, Abu Dayyeh BK. Intragastric Balloon Placement Induces Significant Metabolic and Histologic Improvement in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2021 Jan;19(1):146-154.e4. doi: 10.1016/j.cgh.2020.04.068. Epub 2020 Apr 30.
citation: Bazerbachi F, Vargas EJ, Matar R, Storm AC, Mounajjed TM, Topazian MD, Levy MJ, Chandrasekhara V, Abu Dayyeh BK. EUS-guided core liver biopsy sampling using a 22-gauge fork-tip needle: a prospective blinded trial for histologic and lipidomic evaluation in nonalcoholic fatty liver disease. Gastrointest Endosc. 2019 Dec;90(6):926-932. doi: 10.1016/j.gie.2019.08.006. Epub 2019 Aug 19.
Clinical trial NCT04584489: Iron Metabolism in Cystic Fibrosis
Official title: Prevalence and Incidence of Iron Deficiency in Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iron Metabolism, Cystic Fibrosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-10-14
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: consecutive patients followed at the referral center for cystic fibrosis of Lyon (France).

Brief summary: Iron is a biologically essential micronutrient. Iron deficiency alters erythropoiesis and is considered as a major cause of disability worldwide. Interestingly, iron overload is never observed in cystic fibrosis contrarily to others chronic respiratory diseases. Moreover, iron deficiency reported prevalence in CF is very high (up to 60% in retrospective series) and is correlated to an alteration of respiratory function.

Cystic fibrosis patients should be tested annually for iron deficiency. Serum ferritin is the best diagnosis tool for iron deficiency (specificity 87% for a threshold \< 30 µg/L). Previously published studies used less performant markers such as serum iron (\< 12 µmol/L) or transferrin saturation (\< 12%), which are markedly influenced by the systemic inflammation. CF patients experiences frequent pulmonary exacerbations leading to systemic inflammation: iron stores should therefore be assessed at optimal time with no inflammation.

The I-MUCO study aims to determine the exact prevalence of iron deficiency in CF patients. We aimed to identify risk factors for iron deficiency onset.


Eligibility criteria: Inclusion Criteria:

* Cystic fibrosis genetically proven.
* Age ≥ 18 years
* Systematic annual follow-up.

Exclusion Criteria:

* Dietary or drugs iron supplements
* Systemic inflammation or pulmonary exacerbation
* Lung transplantation

Primary outcomes:
measure: prevalence of iron deficiency defined by serum ferritin ≤ 30 µg/L without inflammatory syndrome (C-reactive protein < 5 mg/L).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre de Ressources et de Compétences de la Mucoviscidose adulte de Lyon - Centre Hospitalier Lyon Sud
Study officials:
References:
Clinical trial NCT02885389: Molecular Genetics in Infantile Spasms
Official title: Molecular Characterization of a Cohort of 73 Patients With Infantile Spasms Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infantile Spasms
West Syndrome
Keywords: Infantile spasms
West syndrome
variant
mutation
CNV
sequencing
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 41
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infantile spams or West syndrome

Brief summary: Infantile Spasms syndrome (ISs) is a characterized by epileptic spasms occurring in clusters with an onset in the first year of life. West syndrome represents a subset of ISs that associates spasms in clusters, a hypsarrhythmia EEG pattern and a developmental arrest or regression. Aetiology of ISs is widely heterogeneous including many genetic causes. Many patients, however, remain without etiological diagnosis, which is critical for prognostic purpose and genetic counselling. In the present study, the investigators performed genetic screening of 73 patients with different types of ISs by array-CGH and molecular analysis of 5 genes: CDKL5, STXBP1, KCNQ2, and GRIN2A, whose mutations cause different types of epileptic encephalopathies, including ISs, as well as MAGI2, which was suggested to be related to a subset of ISs.


Eligibility criteria: Inclusion Criteria:

* Infantile spams or West syndrome

Exclusion Criteria:

* brain malformation
* clinical features of tuberous sclerosis
* abnormal metabolic assays

Primary outcomes:
measure: Presence of deleterious gene variants in candidate genes for infantile spasms/west syndrome and for deleterious Copy-Number variations (CNV). A pan-genome analysis by microarray
timeFrame: Day one
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: