louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02623751: Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
Official title: Phase 1 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-12-08
Enrollment: 15
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the open-label, dose-escalation study is to investigate the safety of single-dose monotherapy and repeated-dose of KHK2375 combined with exemestane in female subjects with advanced or recurrent breast cancer. The secondary objective is to investigate the pharmacokinetics and efficacy.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women aged ≥ 20 and \< 75 years at the time of consent;
* Estrogen receptor positive and/or progesterone receptors positive;
* HER2-negative
* Nonresectable advanced or recurrent breast cancer previously treated with nonsteroidal aromatase inhibitor (AI), and planning to be treated with exemestane

Exclusion Criteria:

* Radiation therapy or immuno therapy within 14 days before the first dose of investigational product;
* Chemotherapy, biological medicines, other pharmacotherapy or major surgery within 21 days before the first dose of the investigational product;
* Prior chemotherapies of ≥ 3 regimens for advanced or recurrent breast cancer;
* Ongoing treatment with other investigational product

Primary outcomes:
measure: Number and percentage of subjects with treatment-emergent adverse events including dose-limiting toxicities and serious adverse events
timeFrame: Assessed up to 28 days after study discontinuation
Secondary outcomes:
measure: Pharmacokinetics of KHK2375 [maximum concentration (Cmax)]
timeFrame: Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1
measure: Pharmacokinetics of KHK2375 [Area under the curve (AUC)]
timeFrame: Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1
measure: Pharmacokinetics of KHK2375 [Half-life (t1/2)]
timeFrame: Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1
Other outcomes:
Locations:
city: Chikusa-ku
country: Japan
state: Aichi
city: Chuo-ku
country: Japan
state: Osaka
city: Chuo-ku
country: Japan
state: Tokyo
Study officials:
References:
citation: Masuda N, Tamura K, Yasojima H, Shimomura A, Sawaki M, Lee MJ, Yuno A, Trepel J, Kimura R, Nishimura Y, Saji S, Iwata H. Phase 1 trial of entinostat as monotherapy and combined with exemestane in Japanese patients with hormone receptor-positive advanced breast cancer. BMC Cancer. 2021 Nov 24;21(1):1269. doi: 10.1186/s12885-021-08973-4.
Clinical trial NCT04989751: A Multicenter Phenotype-Genotype Analysis of LGMD Patients in China
Official title: A Multicenter Phenotype-Genotype Analysis of Limb Girdle Muscular Dystrophy Patients in China
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: LGMD
LGMDR2
LGMDR1
Keywords: Observational
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 450
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients are mainly from neuromuscular diagnostic centers that participat this study in China.

Brief summary: Limb-girdle muscular dystrophies (LGMD) are a series of rare progressive genetic disorders that are characterized by wasting and weakness of the voluntary proximal muscles. The onset of the disease is usually at young age, and most patients will be wheelchair-bound due to the progressive deterioration. Since currently genetic therapies for this disease are still immature, better natural history and genotype-phenotype studies are needed for preparing future therapies.

Detailed description: This is multicentered-based, prospective, and observational study, which mainly focuses on the diagnosis and progression of limb-girdle muscular dystrophies (LGMD) in China. the investigators collect patient data including basic information, strength evaluations, genetic data, electromyography results, pathology imaging from muscle biopsies, and MRIs. Previously collected patient data may also be enrolled in this study.

Eligibility criteria: Inclusion Criteria:

* Identified with variants regarding LGMD related genes revealed by genetic sequencing
* Progressive weakness involving shoulder girdle and/or pelvic girdle
* Myopathic changes in electromyography or in pathological studies

Exclusion Criteria:

* Identified with variants in other genes (non-LGMD related) that may cause muscular dystrophies

Primary outcomes:
measure: Changes in NSAA score
timeFrame: Baseline, Year 1, Year 3, Year 5
Secondary outcomes:
measure: Changes in muscle fat infiltration
timeFrame: Baseline, Year 3, Year 5
measure: Changes in 6 Minute Walk Test
timeFrame: Baseline, Year 3, Year 5
measure: Changes in 10 Metre Walk Test (10MWT)
timeFrame: Baseline, Year 3, Year 5
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
affiliation: Huashan Hospital
name: Chongbo Zhao, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01845051: Is There a Comorbidity Between Migraine and Allergic Rhinitis?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Allergic Rhinitis
Keywords: Migraine
allergic rhinitis
Specific Immunoglobulin E (IgE)
nasal symptoms
signs of allergy.
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Migraine patients attending neurology clinic and healthy subjects

Brief summary: The researchers investigated the relationship between migraine and allergy. For this purpose, the researchers designed a controlled study to evaluate nasal symptoms and signs; and to perform Specific Immunoglobulin E (IgE) measurements in migraine patients and healthy subjects. According to these results the prevalence of allergic rhinitis in migraine group was planned to be compared to that of the healthy controls, statistically.


Eligibility criteria: Inclusion Criteria:

* patients with migraine

Exclusion Criteria:

* other neurologic disorders that may contribute to headaches, such as stroke, cerebral palsy, trigeminal neuralgia, and seizure disorder
* also acute and chronic sinusitis.

Primary outcomes:
measure: Specific Immunoglobulin E (IgE)
timeFrame: 1 day
measure: Nasal Symptom Scores
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
measure: İnferior turbinate color and edema
timeFrame: 1 day
Locations:
Study officials:
References:
Clinical trial NCT03602651: MAGZEN® Effect on Recent Anxiety Reaction
Official title: MAGZEN® Effect on Recent Anxiety Reaction (STRESS2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety Disorders
Lead sponsor: Laboratoire Dielen
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients suffuring from a recent anxiety reaction not already treated.

Brief summary: Multicentres, observational study, prospective, to evaluate the effect of MAGZEN® in the treatment of recent anxiety reaction.

Detailed description: 107 patients suffering from recent anxiety reaction will be included in the study. They will be treated by MAGZEN® during 4 weeks and we will study the effect of this treatment on the evolution of their anxiety after the cure.

Eligibility criteria: Inclusion Criteria:

* patient suffering from recent anxiety reaction
* Hamilton-anxiety score ≥ 20 at inclusion
* recent anxiety disorders (less than 3 months) not treated by pharmacological or psychological treatment

Exclusion Criteria:

* major depressive syndrome
* anxiety disorders more than 3 months
* anxiety due to death

Primary outcomes:
measure: number of "responders patients"
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Private practice
Study officials:
affiliation: Hôpital St Anne
name: Frédéric MD ROUILLON
role: STUDY_CHAIR
References:
Clinical trial NCT05076851: Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer
Official title: A Randomized, Controlled, Double-blind, Single Center，Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neoadjuvant Therapy \High Risk Prostate Cancer
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Proxalutamide: androgen deprivation therapy（ADT）=2:1
Primary purpose: TREATMENT

Brief summary: This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Proxalutamide combined with androgen deprivation therapy（ADT）for High risk prostate cancer ，This trial is A randomized, controlled, double-blind, single center.Treatment cycle is 6 months,


Eligibility criteria: Inclusion Criteria:

1. Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study
2. Patients must be ≥ 18，male
3. Histopathological by Prostate biopsy confirmed prostatic cancer（No Neuroendocrine prostate cancer or small cell carcinoma）
4. High-risk prostate cancer (T2c≤ clinical stage ≤T4 or Gleason score ≥8 or PSA≥20ng/ml)
5. Patients willing to undergo laparoscopic radical resection of prostate cancer and extensive lymph node dissection
6. ECOG PS：0-1

Exclusion Criteria:

1. Imaging or biopsy confirmed distant Metastatic lesion
2. The number of regional lymph nodes metastasis \>3
3. Patients had undergone The treatment of Systemic chemotherapy and endocrine therapy for prostate cancer
4. Patients had undergone prostate surgery、radical radiotherapy or Bilateral orchidectomy

Primary outcomes:
measure: Pathologic Complete Response Rate
timeFrame: up to 6months
measure: Proportion of Subjects With Minimal Residual Disease
timeFrame: up to 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: Study Chair Department of Urology, Drum Tower Hospital, Medical School of Nanjing University
name: Hongqian Guo, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT03644251: FLO for Discogenic Pain
Official title: FLO Injection for Discogenic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Discogenic Back Pain
Lead sponsor: BioTissue Holdings, Inc
Sponsor class: INDUSTRY
First posted: 2018-08-23
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Discogenic pain is pain originating from a damaged vertebral disc and be caused by inflammation, dehydration of the nucleus pulposus, decreased disc height, annular tears and impaired mechanical function of the disc.Non-operative treatment may include traction, steroid therapy, methylene blue injection and ablative therapy. However, there are few high quality studies evaluating these treatments for reducing discogenic low back pain and most clinical trials failed to detect significant differences between treatments and placebo therapies. Hence, there remains an unmet clinical need.


Eligibility criteria: Inclusion Criteria:

* subject (male or female) is at least 18 to 70 years of age
* diagnosed with single level discogenic back pain confirmed by MRI and positive discography per Spine Interventional Society Guidelines
* Diagnosis of disc degeneration with Pfirrmann score of 1-3
* Subject has failed at least six months of conservative care
* Subject is symptomatic with axial lower back pain greater than lower limb pain at the intensity of \>6/10 concordant or partially concordant
* The subject is able to comply with all post-operative standard of care and follow instructions.

Exclusion Criteria:

* Subjects has significant disc protrusion, severe lumbar spinal stenosis, spine tumor, severe disc degeneration, or Sacroiliac (SI) joint syndrome
* Subject had previous surgery at the disc level
* Patient has previously received injection of FLO within 3 months of screening
* The subject is unable to comply with follow-up or not appropriate for inclusion based on investigator decision

Primary outcomes:
measure: Change in patient back pain determined by visual analog scale
timeFrame: 3 months
Secondary outcomes:
measure: Change in quality of life determined by SF-36
timeFrame: 3 and 6 months
measure: Change in patient back pain determined by visual analog scale
timeFrame: 6 months
measure: Change in Oswestry Disability Index
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Laser Spine Institute
state: Florida
Study officials:
References:
Clinical trial NCT04032951: 22 Gauge Needle for EUS Guided Tissue Acquisition of Samples for Histologic Examination
Official title: Evaluation of a Newly Designed 22 Gauge Needle for EUS Guided Tissue Acquisition of Samples for Histologic Examination in Patients With Solid Lesions: A Prospective Two Centers Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Neoplasms
Keywords: EUS-guided biopsy
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
First posted: 2019-07-25
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To determine the yield of tissue biopsy specimen and the diagnostic accuracy of tissue acquisition using a newly developed 22 gauge needle in patients with solid lesions throughout the GI tract.

Detailed description: The use of 22 gauge needle to gather tissue samples under EUS guidance has not been associated with an increased risk, and no major complications have been described so far both for the 22 gauge Procore needle and for standard 22 gauge.20, 21 Potential benefits of this new needle are the possibility of increasing the chance of retrieving tissue specimens for histological examination, with the possibility of increasing the diagnostic accuracy of the procedure saving the need and the cost deriving from on-site cytopathology examination. This may reduce the need to repeat EUS procedures or other more invasive sampling procedures, including surgery.

Eligibility criteria: Inclusion Criteria:

* Age greater than 18 and less than 80.
* Presence of a solid lesion within or adjacent of the gastrointestinal tract. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
* Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
* Informed consent is obtained

Exclusion Criteria:

* Previous biopsy of the lesion with diagnosis of malignancy
* Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
* They are unable to understand and/or read the consent form.

Primary outcomes:
measure: - Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNTA.
timeFrame: intraoperative
Secondary outcomes:
measure: rate of complications
timeFrame: perioperative
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: ISMETT
city: Rome
country: Italy
facility: Universita cattolica del sacro cuore
Study officials:
affiliation: Catholic University of the Sacred Heart
name: GUIDO COSTAMAGNA, PROF
role: STUDY_DIRECTOR
References:
Clinical trial NCT01670851: Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement
Official title: Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: eLAPE,
perineum,
pelvic floor reconstruction
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Slagelse Hospital
First posted: 2012-08-22
Enrollment: 20
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 with low rectal carcinoma

Brief summary: This is a prospective, multicenter, single arm, observational pilot study to assess the clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction following eLAPE and simultaneous stoma reinforcement.

Detailed description: About 40 subjects will be enrolled from 4 centers over approx 24 months. Subjects will all be undergoing extralevator abdominoperineal excision with concomitant ostomy creation.

Eligibility criteria: Inclusion Criteria:

* Primary cancers undergoing curative surgery (R0)
* Life expectancy \> 2 yrs
* Neoadjuvant radiotherapy with or without chemotherapy

Exclusion Criteria:

* Pelvic extenteration or extended resections
* Previously irradiated patients (i.e. radiation therapy for a previous cancer)
* Co-morbidities of: systemic infection, chronic liver failure, chronic renal failure, HIV, Hepatitis C, other advanced/metastatic cancer, collagen disorder
* sensitivity to porcine derived products or polysorbate

Primary outcomes:
measure: Perineal wound healing
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of perineal herniation
timeFrame: 24 months
measure: Incidence of parastomal hernia
timeFrame: 24 months
Other outcomes:
Locations:
city: Slagelse
country: Denmark
facility: Slagelse Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals Leicester
Study officials:
affiliation: University Hospital Leicester, UK
name: Baljit Singh, FRCS, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Leicester, UK
name: Sanjay Chaudhri, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Per J Nilsson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Slagelse Hospital, Denmark
name: Pierre J Maina, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academic Medical Center, Amsterdam, Netherlands
name: W Bemelman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02060851: Effects of Early Short-term Intravenous Iron Supplements Combined EPO in Preterm Infants
Official title: Effects of Early Parenteral Iron Combined Erythropoietin in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malnutrition
Keywords: EPO
Intravenous iron
iron storage
preterm anemia
Lead sponsor: Kunshan First People's Hospital Affiliated to Jiangsu University
Sponsor class: INDUSTRY
First posted: 2014-02-12
Enrollment: 96
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are wide variations in iron supplementation practices in NICU.Guidelines on pediatric Parenteral nutrition suggested the dose of 200μg/kg.d iron by parenteral nutrition.

Detailed description: The study was approved by the ethics committee of Xinhua Hospital, and all parents gave written informed consent.

Study Design This was a randomized, controlled, double-blind, interventional trial of iron (iron sucrose) supplementation given from age of 1 day until full 2 weeks to preterm infants in NICU, who divided into three groups, control(PN without iron and EPO), Vifor and vifor and EPOE group, according to the recommended dosage of ESPEN .

Outcome Measures General information and indicators including anemia iron storage were measured. And the same time oxidative stress indicators were monitored at age of 1day and 2 weeks.

General growth parameters including the blood sugar, liver and renal function index before and after the intervention were tested.

Hematological evaluation including RBC, Hb, MCV, MCH, MCHC, RET, CRP were mesured before and after the intervention. The three groups were all peripheral blood.

Iron storage evaluation including ferritin, serum iron, TIBC on the days were measured before and after the intervention. We used the radio-immunoassay method to test the ferritin (DADE BEHRING, Germany), the chemical method to the serum iron and the automatic biochemical analyzer (automatic biochemical analyzer, 7600, HITACH).

Eligibility criteria: Inclusion Criteria:

* Preterm infants with birth weight less than 2.5kg Have parenteral nutrition indication With written informed consent of parents or guardian

Exclusion Criteria:

* Kidney and liver function abnormal have hemolytic disease have hemorrhagic disease have Serious congenital malformation have septicemia have plethora newborn use TPN less than ten days

Primary outcomes:
measure: Number of participants with Hematological evaluation
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Iron storage
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Kunshan, ,
country: China
facility: Kunshan First Hospital
state: Jiangsu
Study officials:
References: