louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01297101: Evaluating Efficacy and Safety of Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Chemotherapy
Official title: A National, Multi Center, Randomized, Open-label, Phase II Trial of Tarceva Versus Combination of Gemcitabine Plus Cisplatin as Neoadjuvant Treatment in Stage IIIA-N1,N2 NSCLC With Activating EGFR Mutation in Exon 19 or 21
Study type: EXPANDED_ACCESS
Overall status: TEMPORARILY_NOT_AVAILABLE
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
name: Shanghai Pulmonary Hospital, Shanghai, China
First posted: 2011-02-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The aim of this study is to investigate the efficacy and safety of Tarceva versus combination of Gemcitabine plus Cisplatin as neoadjuvant treatment in patients with stage IIIA-N1,N2 NSCLC with EGFR activating mutation in exon 19 or 21.

Detailed description: Concurrent Chemoradiation therapy remain the standard treatment for stage IIIA disease, but its treatment-related life threaten toxicity limit its use for those patients.

Tarceva monotherapy have been demonstrated a significant improvement in overall survival and disease progression free survival when used for the treatment of patients with metastatic NSCLC, after failure of at least one prior chemotherapy regimen. It is well tolerated without the side effects usually associated with chemotherapy.

Based on the encouraging results reported from the SLCG phase II study reported the efficacy of Tarceva as first line treatment for metastatic NSCLC with EGFR mutation patients would prolong overall survival, delay disease progression and be well tolerated, mOS reached 27 months, ORR reached 71%. Besides, with different mechanism and more tolerable than chemo, Tarceva may provide an important treatment alternative for local advanced pts with EGFR mutation.

Eligibility criteria: Inclusion Criteria:

* Pathologically diagnosed of non-small cell lung cancer
* Diagnosed as stage IIIA-NI, N2, except for T4N1M0
* The diagnosis standard of N1 or N2 is as below:
* The short axis of N1 lymph node of Stage IIIA-N1 must be ≥ 10 mm on Computed Tomography, and the Standard Uptake Value (SUV) on PET-CT of N1 lymph node must be \> 2.5

Exclusion Criteria:

* Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab)
* Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy)
* Resection of primary malignancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chen Z, Shen S, Shi W, Jiang G, Wang X, Jian H, Zhou Z, Ding Z, Lu S. Intercalated combination of chemotherapy and erlotinib for stage IIIA non-small-cell lung cancer: a multicenter, open-label, single-arm, phase II study. Cancer Manag Res. 2019 Jul 12;11:6543-6552. doi: 10.2147/CMAR.S189287. eCollection 2019.
Clinical trial NCT01961401: Acute Effects of Moderate Versus High Intensity Exercise on Insulin Sensitivity in Gestational Diabetes Mellitus
Official title: Acute Effects of Moderate Versus High Intensity Exercise on Insulin Sensitivity in Pregnant Women With and Without Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes, Gestational
Keywords: exercise
exercise therapy
insulin resistance
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-10-11
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Exercise training is recognized as effective in preventing and treating many chronic metabolic disorders (1), and long-term exercise programmes have similar effects on glucose control as long-term drug or insulin therapy in type 2 diabetic patients (2). The precise intensity and volume of aerobic exercise needed to produce the most wanted effects on targeted risk factors for subjects at risk of/with established type 2 diabetes, is still uncertain. In this study the investigators will investigate the acute effects of a single bout of moderate versus high intensity exercise on insulin sensitivity in pregnant women with and without gestational diabetes mellitus (GDM). The investigators think that very short bouts of high intensity exercise can be a way to reduce blood glucose in these women.


Eligibility criteria: Inclusion Criteria:

* pregnant
* Gestational diabetes mellitus or normal glucose tolerance
* able to exercise

Exclusion Criteria:

-

Primary outcomes:
measure: insulin sensitivity
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of circulation and medical imaging
Study officials:
affiliation: Norwegian University of Science and Technology
name: trine Moholdt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05658601: A Study to Describe the Switching From a First- or Second-line Disease Modifying Therapy (DMT) to Ozanimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
Official title: SWITCH - ITA A Multicentre, Single Country, Prospective Non Interventional Observational Study to Describe the Switching From a First- or Second-line Disease Modifying Therapy (DMT) to Ozanimod, in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated According to Clinical Practice.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
Ozanimod
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-12-21
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is composed of 180 participants 18-55 years with Relapsing Remitting Multiple Sclerosis (RRMS) diagnosed according to 2017 revised McDonald criteria, switching from a first or second line Disease Modifying Therapy (DMT) to ozanimod, and in treatment with ozanimod between 4 and 12 weeks before the enrollment.

Brief summary: The purpose of this study is to describe the reasons, therapy, and/or disease for changing first or second line Disease Modifying Therapy (DMT) to ozanimod in participants with Relapsing Remitting Multiple Sclerosis (RRMS).


Eligibility criteria: Inclusion Criteria:

* Patients with RRMS according to 2017 revised McDonald criteria
* Patients who switched a previous first or second line DMT to ozanimod between 4 and 12 weeks before the enrollment
* Patient with a MRI performed within three months before the enrollment
* Patient eligible to ozanimod according to SmPC

Exclusion Criteria:

* Patients with clinical forms of MS other than RRMS
* Patients unable to participate for various reasons
* Patients participating in another clinical study with an investigational product if the study considers the switching behavior as an endpoint or objective
* Contraindications to ozanimod according to SmPC

Other protocol-defined Inclusion/Exclusion Criteria apply.

Primary outcomes:
measure: Reason for switching treatment
timeFrame: At baseline
measure: Mode of switching treatment
timeFrame: At baseline
Secondary outcomes:
measure: Expanded Disability Status Score (EDSS)
timeFrame: At baseline, week 12, and week 24
measure: MRI
timeFrame: At baseline, week 12, and week 24
measure: TSQM
timeFrame: At baseline and week 24
measure: Lymphocyte sub populations
timeFrame: At baseline, week 12, and week 24
measure: Incidence of Adverse Events (AEs)
timeFrame: Continuous (Up to 42 months)
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Continuous (Up to 42 months)
Other outcomes:
Locations:
city: Isernia
country: Italy
facility: Neuromed Istituto Neurologico Mediterraneo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04946201: Premolar Extractions for Obstructive Sleep Apnea in Children with Overjet
Official title: The Effect of Upper Premolars Extraction on Obstructive Sleep Apnea in Growing Children with Prominent Upper Front Teeth
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Malocclusion
Keywords: orthodontic
braces
extraction
teeth
overjet
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Registered orthodontic patients at the College of Dentistry and Turfland Dental Clinics.

Brief summary: This research aims to provide pediatric patients with polysomnography (a sleep study) before and after orthodontic treatment to determine if the extraction of upper premolars for treating excessive overjet results in an increase of the AHI (Apnea Hypopnea Index) compared to similar patients treated without upper premolar extractions.


Eligibility criteria: Inclusion Criteria:

* 10-15 years old
* registered orthodontic patients
* able to undergo routine orthodontic care and are registered to obtain an orthodontic appliance in the future.
* do not have a high care need
* no known hypercapnia or hypoventilation
* no known allergies or nose blockages
* diagnosed as Class II Division I (=6mm of overjet) and bilateral Class II half cusp or unilateral Class II full cusp.

Exclusion Criteria:

* known hypercapnia or hypoventilation
* patients with hypertrophic tonsils and adenoids
* patients with allergies or nose blockages that interfere with breathing
* patients who are not registered as orthodontic patients at research sites deemed acceptable to undergo routine orthodontic care

Primary outcomes:
measure: Risk of Obstructive Sleep Apnea
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
References:
Clinical trial NCT04244201: Vaporous Hyperoxia Therapy (VHT) in the Treatment of Foot Wounds
Official title: Evaluation of Vaporous Hyperoxia Therapy (VHT) for Chronic Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Foot Ulcer
Foot Ulcer
Keywords: diabetic foot
leg ulcer
skin ulcer
Lead sponsor: Vaporox
Sponsor class: INDUSTRY
First posted: 2020-01-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000) for the treatment of chronic foot ulcers.

Detailed description: The Vaporox VHT1 study is a single arm study evaluating the efficacy of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000), as an adjunctive therapy for the treatment of chronic foot ulcers.

Eligibility criteria: Inclusion Criteria:

* Diabetic, arterial, and venous foot ulcers as well as decubitus ulcers
* University of Texas Health Science Center classification: Grade 0, 1, and 2

Exclusion Criteria:

* Ulcers above the medial and lateral malleoli
* Etiology of cancer/neoplastic
* Etiology of collagen vascular disease
* Etiology of gangrene
* Etiology of osteomyelitis (Grade 3)
* Etiology of thermal burns
* Etiology of radiation injury
* Pregnancy
* Acute skin conditions
* Inadequate perfusion to support treatment
* Wounds where the end cannot be probed
* Wounds covered with petroleum based dressing
* Non-compliant patients

Primary outcomes:
measure: Wound healing rate at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Time to wound healing
timeFrame: up to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Wolf Podiatry
name: Clifford J Wolf, DPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04831801: OAB and the Microbiome
Official title: Trends in the Microbiome Profiles of Women With Urgency and Frequency Syndrome, With or Without Pelvic Pain?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Overactive Bladder
Urgency-frequency Syndrome
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with OAB and controls will be enrolled from University of Miami's or Holy Cross Hospital's female pelvic medicine and reconstructive surgery clinics.

Brief summary: To determine differences in the urinary microbiomes, identified by polymerase change reaction (PCR) (UTIP™), of female patients with urgency and frequency syndrome with or without pelvic pain (Group A) compared to female controls without symptoms of lower urinary tract symptoms (LUTS) (Group B).


Eligibility criteria: Inclusion Criteria:

* 18 y/o-90 y/o
* Able to consent
* Group A only: Urgency and Frequency Syndrome or OAB only. UDI-6 answer of "moderately" to "quite a bit" on questions 1 or 2.
* Group B only: Urinary Distress Inventory 6 (UDI-6) answer "not at all" or "somewhat" for questions 1 or 2.

Exclusion Criteria:

* Pregnant
* Pelvic radiation
* Urinary retention (\>200 ml)
* Renal calculi
* Recurrent urinary tract infection (UTI) (2 in 6 months), or
* Current UTI
* Immunosuppressed or radiation history
* Neurologic disorder

Primary outcomes:
measure: Proportion of patients with Lactobacillus in samples.
timeFrame: Day 1
measure: Proportion of patients negative for repeat sequencing.
timeFrame: Day 1
measure: Proportion of patients with change in UDI-6 score
timeFrame: Up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Laura Martin, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01198301: Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy
Official title: Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Neoplasm Metastasis
Keywords: Metastatic Breast Neoplasms
Gene Expression Profiling
Drug Therapy
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: female patients with metastatic breast cancer treated by Docetaxel-based chemotherapy

Brief summary: The investigators want to develop a gene expression profile the for prediction the chemotherapeutic response of patients with metastatic breast cancer.

Detailed description: 1. Metastatic breast cancer tissue is obtained from core needle biopsies pretreatment and is flash frozen and stored at -70℃ until processing.
2. After patients received docetaxel combination thiotepa for two cycles, response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups-sensitive and resistant tumours.
3. The gene expression in metastatic breast cancer tissue sample is detected by microarray to screen gene markers that are differently expressed between groups
4. Statistical analysis is performed using unsupervised hierarchical cluster.

Eligibility criteria: Inclusion Criteria:

* Patients should be histologically confirmed with metastatic breast cancer;
* Patients who had completed the planned chemotherapy regimen with no major protocol violation;
* an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* At least one measurable lesion;
* Normal cardiac, hepatic, renal and bone marrow functions;
* Life expectancy ≥3 months;
* Discontinuity of previous chemotherapy for a minimum of 4 weeks.

Exclusion Criteria:

* previous history of other malignancies;
* previous surgery history on the needle biopsy organ;
* Central nervous system metastases;
* Serious or uncontrolled concurrent medical illness.

Primary outcomes:
measure: Chemotherapy response
timeFrame: four-months
Secondary outcomes:
measure: Time to disease progression
timeFrame: six months
measure: Overall survival
timeFrame: one year
measure: clinical benefit response
timeFrame: six months to one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Zheng Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Cancer Hospital & Institute
name: Jun Ren, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02445001: Erythrocyte Ghost Mediated Retinal Diagnosis
Official title: Erythrocyte Ghost Mediated Retinal Diagnosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Retinal Disease
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Instead of the usual procedure of injecting ICG dye directly into an arm vein, now the dye can be placed inside of RBCs. When a small volume of the RBC's with the dye is injected into a person's arm, the individual RBCs can be seen as they flow through the retinal blood vessels.

Detailed description: Capillary erythrocyte movement throughout the entire human macula can be observed routinely for periods up to 20 minutes by autologous re-injection of a small volume (about 1 mL) of indocyanine green (ICG)-loaded erythrocytes, making possible for the first time quantification of blood flow in individual capillaries, including abnormal structures like choroidal neovascularization (CNV), and it makes possible characterization of vasomotion in ocular vasculatures.

Eligibility criteria: Inclusion Criteria:

1. A male or female, of any race who is at least 40 years of age and has clinical signs of CNV or exudative manifestations of AMD, has clinical signs of DR, or clinical signs of retinal occlusive disease.
2. Patients with subfoveal, extrafoveal or juxtafoveal CNV, which is classic, minimally classic or occult and has dimensions less than 25.0 mm2 as measured on the sodium fluorescein angiogram (SFA).
3. Patient with recurrent CNV, where previous treatment never involved the foveal avascular zone (FAZ).
4. Analysis of highspeed ICGA must show one or more welldefined feeder vessel.
5. Patient must have best corrected visual acuity based on the ETDRS chart between 20/40 and 20/320 in the study eye.
6. Patient must be willing, be able to comply with the protocol and provide informed consent.

Exclusion Criteria:

1. CNV secondary to any cause other than AMD or DR.
2. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
3. Patient participating in any other investigational drug study.
4. Patient with significant liver disease or uremia.
5. Patient with known adverse reaction to indocyanine green or iodine.
6. Patient is pregnant or nursing.

Primary outcomes:
measure: Capillary erythrocyte movement
timeFrame: 1 hour
Secondary outcomes:
measure: Retinal capillary movement
timeFrame: 1 hour
Other outcomes:
Locations:
city: New York
country: United States
facility: Northshore LIJ/MEETH Campus
state: New York
Study officials:
affiliation: NSLIJ/MEETH
name: Lawrence A Yannuzzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flower RW. Experimental studies of indocyanine green dye-enhanced photocoagulation of choroidal neovascularization feeder vessels. Am J Ophthalmol. 2000 Apr;129(4):501-12. doi: 10.1016/s0002-9394(99)00411-0.
Clinical trial NCT02117401: A Prospective, Multi-center, Randomized Controlled Study of Muscle Relaxation Effect and Safety of Mivacurium Chloride in Pediatric Surgery Patients
Official title: A Prospective, Multi-center, Randomized Controlled Study of Neuromuscular Blocking Effect and Safety of Mivacurium Chloride in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Efficacy and Safety of Mivacurium Chloride for Pediatric Patients
Lead sponsor: Jiangsu Nhwa Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 1152
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect and safety of mivacurium chloride in pediatric patients.


Eligibility criteria: Inclusion Criteria:

* The parent/guardian must sign a parental permission consent document
* American Society of Anesthesiologists (ASA) physical status class 1-3
* Elective surgery patients with tracheal intubation, and the operation duration is expected to be longer than 30 min but no longer than 120 min(cleft lip and palate, orthopedic, bilateral hernia, bilateral cryptorchidism, hypospadias crack, and other ear, nose and throat surgery, etc)
* Age between 2 months to 14 Years

Exclusion Criteria:

* BMI\<18kg/m2 or BMI\>31kg/m2
* Patients with serious respiratory, cardiovascular disease, and liver and kidney dysfunction\[AST（glutamic oxalacetic transaminase）,ALT(glutamic-pyruvic transaminase)\>1.5 Normal;BUN(blood urea nitrogen)\>Normal)\]
* Patients with asthma or airway hyperresponsiveness, neuromuscular patients disease or cachexia
* Preoperative hemoglobin less than 10g/L
* Hypoproteinemia TP（total protein) \<45g/L
* Diabetic patients
* Patients with difficulty airway
* Patients with Known or suspected atypical plasma cholinesterase gene homozygous
* Burn patients
* Patients with serious acid-base imbalances, or severe electrolyte imbalance
* Patients with neuromuscular relaxants in a week
* Patients prohibited with muscle relaxants, or allergy to any component of mivacurium
* Patients participated in any drug clinical trial with 30 days before the start of the study
* Other situations not suitable for inclusion
* Blood loss more than 10 ml/kg in surgery

Primary outcomes:
measure: intubation score
timeFrame: 1 minute within intubation
measure: muscle relaxation effect
timeFrame: from baseline to no more than 120 minutes after intubation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Zeng R, Liu X, Zhang J, Yin N, Fei J, Zhong S, Hu Z, Hu M, Zhang M, Li B, Li J, Lian Q, ShangGuan W. The efficacy and safety of mivacurium in pediatric patients. BMC Anesthesiol. 2017 Apr 17;17(1):58. doi: 10.1186/s12871-017-0350-2.