louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06488924: An Open-label Phase I/II Study of JR-446 in Mucopolysaccharidosis Type IIIB
Official title: An Open-label Phase I/II Study of JR-446 in Mucopolysaccharidosis Type IIIB
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Mucopolysaccharidosis III-B
Lead sponsor: JCR Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 10
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase I/ II, open-label study, designed to evaluate the safety and explore efficacy of the study drug in development for the treatment of MPS IIIB patients.


Eligibility criteria: Inclusion Criteria:

* Chronological age of \<18 years
* Confirmed diagnosis of MPS IIIB

Exclusion Criteria:

* Prior experience to gene therapy or HSCT with successful engraftment
* Past use of another investigational drug or product in last 4 months or 5 half-lives (whichever is longer) before signing ICF
* Current participation in a clinical trial or past participation (within 30 days of enrolment into this study) in a study involving invasive procedures
* Past use of Genistein or Kineret (anakinra) within 4 months before signing ICF
* Serious drug allergy or hypersensitivity
* Contraindication for lumbar puncture or MRI
* History of bleeding disorder or current use of medications that, in the opinion of the investigator, place them at risk of bleeding following lumbar puncture

The above information is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial.

Primary outcomes:
measure: To evaluate the tolerability of JR-446 in MPSIIIB patients
timeFrame: up to 4 years (multiple visits)
measure: To explore the potential efficacy of JR-446
timeFrame: up to 4 years (multiple visits)
Secondary outcomes:
measure: Change from baseline in cognitive function
timeFrame: up to 4 years (multiple visits)
measure: Change from baseline in HS concentration in serum and urine
timeFrame: up to 4 years (multiple visits)
measure: Plasma drug concentration
timeFrame: up to 4 years (multiple visits)
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Okinawa
country: Japan
facility: University of the Ryukyus Hospital
city: Tokyo
country: Japan
facility: National Center for Child Health and Development
Study officials:
References:
Clinical trial NCT00890734: CYT003-QbG10 for Treatment of Allergic Asthma Bronchial
Official title: A Double-blind, Placebo-controlled Study to Assess Pharmacodynamic and Clinical Efficacy of CYT003-QbG10 in Patients With Persistent Allergic Asthma Bronchial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Bronchial Asthma
Lead sponsor: Cytos Biotechnology AG
Sponsor class: INDUSTRY
First posted: 2009-04-30
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test whether treatment with CYT003-QbG10 can improve asthma symptoms in patients with allergic bronchial asthma. The active treatment will be compared against placebo.


Eligibility criteria: Inclusion Criteria:

* Persistent allergic asthma bronchial requiring long-term treatment with inhaled corticosteroids
* Further criteria as defined in the study protocol

Exclusion Criteria:

* Use of oral corticosteroids within past 3 months
* Hospitalization for asthma exacerbation within past 6 months
* Uncontrolled asthma
* Contraindication to any study test or procedure
* Further criteria as defined in the study protocol

Primary outcomes:
measure: Markers for inflammation and asthma
timeFrame: 1-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Luebeck, Berlin, Wiesbaden, Rodgau, Eisenach
country: Germany
facility: Cytos Investigator Sites
Study officials:
References:
citation: Beeh KM, Kanniess F, Wagner F, Schilder C, Naudts I, Hammann-Haenni A, Willers J, Stocker H, Mueller P, Bachmann MF, Renner WA. The novel TLR-9 agonist QbG10 shows clinical efficacy in persistent allergic asthma. J Allergy Clin Immunol. 2013 Mar;131(3):866-74. doi: 10.1016/j.jaci.2012.12.1561. Epub 2013 Feb 4.
Clinical trial NCT00083434: Treatment of Anemic Patients With Cancer Who Are Not Receiving Chemotherapy or Radiotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anemia
Cancer
Keywords: Anemia
Cancer
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2004-05-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effectiveness of epoetin alfa in treating anemia in patients who have cancer or who no longer have any signs of the cancer, but remain anemic as a result of their treatment.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Body weight \>/= 99lbs
* ECOG 0-2
* Anemia results from cancer, chemotherapy, radiotherapy or an association with hormonal therapy or immunotherapy
* Screening hemoglobin level of \</= 11.0 g/dL for men or \</= 10.0 for women

Exclusion Criteria:

* History of or concurrent second malignancy
* Evidence of primary or metastatic malignancy involving the Central Nervous System

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Urology Medical Center
state: California
city: Arcadia
country: United States
facility: Shapiro, Stafford & Yee
state: California
city: Fresno
country: United States
facility: California Cancer Center
state: California
city: North Miami
country: United States
facility: Tukoi Research
state: Florida
city: Wilmington
country: United States
facility: Hanover Medical Specialists, PA
state: North Carolina
city: Tacoma
country: United States
facility: Madigan Army Medical Center Urology Services
state: Washington
Study officials:
References:
Clinical trial NCT06742034: Translation and Validation of the Visual Analysis of Swallowing Efficiency and Safety Into European Portuguese
Official title: Translation and Validation of the Visual Analysis of Swallowing Efficiency and Safety Into European Portuguese
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deglutition Disorders
Deglutition
Keywords: Dysphagia
Instrumental Assessment
Swallowing Disorders
Fiberoptic Endoscopic Evaluation of Swallow
Lead sponsor: Centro Hospitalar de Entre o Douro e Vouga
Sponsor class: OTHER
Collaborators: name: Aveiro University
First posted: 2024-12-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent FEES at the ULSEDV and met the study's inclusion and exclusion criteria.

Brief summary: The goal of this observational study is to translate and validate to European Portuguese "Visual Analysis of Swallowing Efficiency and Safety - VASES".


Eligibility criteria: Inclusion Criteria:

* Patient's FEES recording that allowed good visualization of the pharynx and larynx;
* FEES recording from patients after head and neck surgery who had structural alterations but still did not interfere with a clear visualization of the residues.
* Patient's tracheostomized or under enteral nutrition.

Exclusion Criteria:

* Under 18 years of age

Primary outcomes:
measure: Reliable and validated European Portuguese version of the VASES
timeFrame: patients with neurological and/or mechanical oropharyngeal dysphagia evaluated FEES up to 3 months after the first symptomatology
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Maria Da Feira
country: Portugal
facility: Centro Hospitalar de Entre Douro e Vouga
Study officials:
affiliation: Unidade Local de Saúde de Entre Douro e Vouga
name: Daniela Filipa Brás Ferreira, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05917834: Comparison of Nipple-areolar Complex Sensation According to Incision Types in Nipple-sparing Mastectomy
Official title: Comparison of Nipple-areolar Complex Sensation According to Incision Types in Nipple-sparing Mastectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Nipple Sparing Mastectomy
Keywords: NAC sensory
Mastectomy
NSM
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 105
Sex: FEMALE
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 with breast cancer undergoing nipple sparing mastectomy

Brief summary: This study aims to assess nipple areolar complex sensation after nipple sparing mastectomy and compare the results according to different incisional approaches; specifically, inframammary fold (IMF) versus peri-areolar/radial. One-hundred-and-five post NSM patients from Oct 2019 to Nov 2021 have been recruited prospectively and evaluated for NAC sensory. A total of 97 patients (IMF 65 and peri-areolar/radial 32) were included in the analyses for comparison during follow up from 24 to 48 months after surgery. It was hypothesized that patients with IMF would have better outcomes for NAC senroy.


Eligibility criteria: Inclusion Criteria:

1. Females who are older than 18
2. Patients who underwent nipple sparing mastectomy in Gangnam Severance Hospital

Exclusion Criteria:

1. Loss or excision of NAC due to post-surgical necrosis
2. Diagnosis of other conditions that may interfere with cutaneous sensation

Primary outcomes:
measure: Loss of NAC sensory by pinprick test
timeFrame: 2-4 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References:
Clinical trial NCT06054334: Relevance of Isoniazid Dosage in Adults Treated for Tuberculosis
Official title: Relevance of Isoniazid Dosage in Adults Treated for Tuberculosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tuberculosis
Keywords: Isoniazid
tuberculosis
acetylation
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This clinical study aims to examine the relevance of isoniazid dosage in adults treated for tuberculosis.

Brief summary: Tuberculosis is the third leading infectious killer. In 2021, an estimated 10,6 million people fell ill with tuberculosis worldwide. Drug resistance emerges with the increase of antibiotherapy use. Among the four antimicrobial drugs used for tuberculosis, isoniazid is a first line treatment. It has a bactericidal activity against the tuberculosis complex. Nevertheless, the hepatic metabolism of isoniazid shows variation between individuals. There is a real risk of hepatotoxicity and neurotoxicity induced by isoniazid. The peak measurement (Cmax) of serum isoniazid is recommended to adjust the treatment and to allow recovery. Moreover, several samples allow a kinetics of isoniazid elimination so as to distinguish slow and fast acetylators. Few data are available on isoniazid acetylation. It could be useful to know the proportion of patients treated by isoniazid at a standard dose, associated with a risk of overdosing or underdosing. Inadequate exposures should be studied to understand if there is an impact in the medical care.


Eligibility criteria: Inclusion Criteria:

* to be an adult,
* to have a diagnosis of tuberculosis

Exclusion Criteria:

* pregnancy,
* disagreement to participate

Primary outcomes:
measure: Serum isoniazid Cmax
timeFrame: between day 15 and day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT04099134: PACAREG: a Multicenter Registry Trial in Pancreatic Ductal Adencarcinoma
Official title: PaCaReg: A Multicenter Registry Trial for the Assessement of Clinical, Epidemiological and Biological Profiles in Patients With Pancreatic Ductal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Adenocarcinoma
Pancreas Cancer
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult newly diagnosed patients with a PDAC could be included in the registry trial.

Brief summary: PaCaReg is a multicenter registry trial aiming in the assessement of clinical, epidemiological and biological profiles in patients with pancreatic ductal adenocarcinoma


Eligibility criteria: Inclusion Criteria:

* Treatment naive histologically or cytologically proven pancreatic ductal adenocarcinoma (PDAC) or highly suspicious diagnosis (only pre-curative-intended resection)
* Age =\>18 years
* written informed consent

Exclusion Criteria:

* papillary cancer
* neuroendocrine pancreatic tumors

Primary outcomes:
measure: General assessment of applied therapy modalities in pancreatic cancer
timeFrame: First diagnose to death or end of surveillance (5 years after curative resection)
measure: Quality of life in pancreatic cancer patients
timeFrame: First diagnose to death or end of surveillance (5 years after curative resection)
Secondary outcomes:
measure: General epidemiologic assessment
timeFrame: First diagnose to death or end of surveillance (5 years after curative resection)
measure: Assessment of tumor surveillance in pancreatic cancer patients
timeFrame: First diagnose to death or end of surveillance (5 years after curative resection)
measure: Evaluation of predictive and prognostic markers
timeFrame: First diagnose to death or end of surveillance (5 years after curative resection)
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
affiliation: Ulm University Hospital
name: Thomas Seufferlein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04680234: Superficial Cryotherapy Versus Microneedling in Alopecia Areata
Official title: Comparative Study Between the Effect of Superficial Cryotherapy Using Dimethyl Ether and Propane Mixture and Microneedling in Treatment of Alopecia Areata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alopecia Areata
Keywords: alopecia areata
Microneedling
Cryotherapy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be divided into two groups (randomly assigned and comparably cross matched for age and sex) Cryotherapy group (No.= 50): Superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C Microneedling group (No. = 50): Microneedling
Primary purpose: TREATMENT

Brief summary: This study is randomized comparative analytical prospective study that included patients with mild and moderate alopecia areata. Patients was divided into two groups Patients in the first group underwent Superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C (Cryotherapy group). Patients in the second group underwent Microneedling (Microneedling group). A total of six sessions were done at 2 weeks interval. Patients were followed-up for next 3 months to evaluate the persistence of hair regrowth after therapy. Patients were assessed at baseline and during follow up using photography, Dermoscopy, SALT score and regrowth scale.


Eligibility criteria: Inclusion Criteria:

* ِAlopecia areata patients

Exclusion Criteria:

* Alopecia totalis and universalis
* ِAge less than four years.
* ِPregnancy or breast-feeding.
* ِActive infection at the site alopecia patch(s).
* ِInflammation ate site of the alopecia patches
* ِIntolerance to cold.
* ِAssociated systemic illness such as thyroid, pernicious anaemia, diabetes mellitus, autoimmune connective tissue diseases.
* ِPrevious treatment for alopecia areata over the last three months.

Primary outcomes:
measure: Regrowth Scale
timeFrame: Change in regrowth scale from baseline to 3 months follow after end of sessions
Secondary outcomes:
measure: SALT score
timeFrame: Change in salt score from baseline to 3 months follow after end of sessions
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Faculty of Medicine
Study officials:
affiliation: Sohag Faculty of Medicine
name: Zeinab A Gouda, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT06500234: Nutrition Impact on Immunotherapy of Cancer
Official title: Phase III Study on the Relation of Nutrition and Immunotherapy of Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Nutrition Disorders
Immunotherapy
Cancer
Survival, Prosthesis
Lead sponsor: Qingdao Central Hospital
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Malnourished patients with megestrol acetate 160mg oral, olanzapine 2.5mg oral, everyday during the immunotherapy course or intolerable.
Primary purpose: TREATMENT

Brief summary: This study investigates nutritional status and outcomes of immuntherapy in cancer patients.

Detailed description: Studies have shown that more than half of the patients with cancer are also malnourished at diagnosis. This increases patients' risk of complications associated with the treatment as well as the abandonment of care, as well as decrease the level of survival rates.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cancer, malnutrition Age \>18 years Performance status ECOG of 0 or 2. Life expectancy ≥ 6 months. At least one lesion measurable as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1) Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment Postmenopausal or evidence of non-childbearing status for women of childbearing potential Patient is willing and able to comply with the protocol for the duration of the study.

For all oral medications patients must be able to comfortably swallow capsules;

Exclusion Criteria:

* Patients unable to swallow orally administered medication and patients with Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs History of allogenic organ, bone marrow or double umbilical cord blood transplantation.

Active or prior documented autoimmune or inflammatory disorders Uncontrolled intercurrent illness or patient considered a poor medical risk due to a serious, uncontrolled medical disorder, including but not limited to, ongoing or active infection, symptomatic congestive heart failure Currently taking medications with known risk of prolonging the QT interval or inducing Torsades de Pointes.

Primary outcomes:
measure: ORR
timeFrame: 12 months
Secondary outcomes:
measure: PFS
timeFrame: 12 months
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shandong
Study officials:
affiliation: Qingdao Central Hospital
name: chunling zhang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01085734: Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion
Official title: A 6-Month, Single Site, Masked, Randomized,Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retinal Vein Occlusions
Lead sponsor: Maturi, Raj K., M.D., P.C.
Sponsor class: INDIV
First posted: 2010-03-12
Enrollment: 30
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: Comparative study to see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes


Eligibility criteria: Inclusion Criteria:

* male or female age 18 years or older
* Branch retinal vein occlusion or central retinal vein occlusion of less than one year duration
* Best correct visual acuity of greater than 24 and less than 80
* Presence of macular edema defined as OCT central subfield thickness of \>250

Exclusion Criteria:

* intravitreal anti-VEGF treatment in study eye within six weeks of baseline
* intravitreal steroid treatment in the study eye within eight weeks of baseline visit
* PRP in the study eye within 4 month of baseline visit
* Active iris neovascularization in study eye
* Uncontrolled systemic disease
* Known history of IOP elevation in response to corticosteroid treatment that is not controlled on 2 glaucoma medications

Primary outcomes:
measure: Change From Baseline Visual Acuity at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Number of Injections Needed
timeFrame: baseline to 6 months
measure: Change in Macular Thickness and Macular Volume
timeFrame: 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Raj K. Maturi, MD
state: Indiana
Study officials:
affiliation: Raj K. Maturi, MD, PC
name: Raj K Maturi, MD
role: PRINCIPAL_INVESTIGATOR
References: