louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01505751: The Association of G9a Protein and the Outcome of Patients With Cervical Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Outcome of cervical cancer
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2012-01-09
Enrollment: 69
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cervical cancer, and underwent primary treatment (surgery, radiotherapy or chemotherapy) in Far Eastern Memorial Hospital

Brief summary: G9a protein was approved to be highly associated with recurrence of breast cancer, gastric cancer, hepatocellular cancer, prostate cancer and lung cancer. Therefore, the aim of this study was to clarify the association and G9a protein and cervical cancer by analyzing the immunohistochemical staining of G9a protein to the histopathologic specimen of cervical cancer and clinical data.


Eligibility criteria: Inclusion Criteria:

* cases with cervical cancer

Primary outcomes:
measure: determine whether G9a protein is a risk factor of overall survival of patients with cervical cancer
timeFrame: From the date of primary treatment until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 100 months
Secondary outcomes:
measure: determine whether G9a protein is a risk factor of progression-free survival of patients with cervical cancer
timeFrame: From the date of primary treatment until the date of first documented progression or last follow-up, whichever came first, assessed up to 100 months
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT01033851: Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects
Official title: Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Generalized Anxiety Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2009-12-17
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Current therapies for Generalized Anxiety Disorder (GAD) have limited effectiveness. This study measures the efficacy of two different approaches to reducing anxiety and stress. One approach uses education, nutrition, exercise, and time management training, and another uses mindfulness meditation and yoga, which is taught as part of the Mindfulness-based stress reduction (MBSR) course, an 8-week manualized mindfulness intervention. We hypothesize that the two approaches will reduce anxiety in individuals with GAD in different ways. We will measure changes in stress hormones associated with these changes.


Eligibility criteria: Inclusion Criteria:

* Adults with generalized anxiety disorder
* medically healthy

Exclusion Criteria:

* substance abuse
* history of other psychiatric diagnoses such as psychosis, Obsessive Compulsive Disorder, PTSD
* use of certain types of psychotherapy, meditation training, yoga
* pregnant or lactating women

Primary outcomes:
measure: Active Symptoms of Generalized Anxiety Disorder
timeFrame: 2 months
Secondary outcomes:
measure: Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms.
timeFrame: 2 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elizabeth A Hoge, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoge EA, Guidos BM, Mete M, Bui E, Pollack MH, Simon NM, Dutton MA. Effects of mindfulness meditation on occupational functioning and health care utilization in individuals with anxiety. J Psychosom Res. 2017 Apr;95:7-11. doi: 10.1016/j.jpsychores.2017.01.011. Epub 2017 Jan 23.
citation: Hoge EA, Bui E, Marques L, Metcalf CA, Morris LK, Robinaugh DJ, Worthington JJ, Pollack MH, Simon NM. Randomized controlled trial of mindfulness meditation for generalized anxiety disorder: effects on anxiety and stress reactivity. J Clin Psychiatry. 2013 Aug;74(8):786-92. doi: 10.4088/JCP.12m08083.
Clinical trial NCT00229151: Sleep Deprivation and Advancement of Sleep Period as Treatment for Bipolar Depression.
Official title: Sleep Deprivation and Three Days Sleep Phase Advancement as Treatment for Bipolar Depression.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2005-09-29
Enrollment: 5
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: The purpose of this study is to determine if sleep deprivation and sleep phase advancement is effective treatment of bipolar patients in a depressive phase.

Detailed description: Background: The onset of therapeutic action for most anti-depressive treatments is usually two weeks. During this period patients suffer from great symptomatic distress. Treatment options that are effective in this period is therefore of interest for psychiatric wards.

Aim: To explore if sleep deprivation and three days sleep phase advancement is effective treatment for inpatients with bipolar disorder in a depressive phase.

Method: A randomized controlled trial with 24 patients diagnosed with bipolar disorder. Patients will be randomized to treatment as usual in an psychiatric ward, or sleep deprivation and three days sleep phase advancement. Patients in the treatment as usual group will be offered treatment with sleep deprivation and sleep phase advancement after five weeks if they still meet inclusion criteria.

Eligibility criteria: Inclusion Criteria:

* Bipolar disorder, depressive phase

Exclusion Criteria:

* substance abuse, psychotic symptoms, suicidal intentions, active mania/hypomania.

Primary outcomes:
measure: Scores on rating scales for depression and symptom severity.
timeFrame: one month
Secondary outcomes:
measure: Scores on rating scales for anxiety, mania, cognitive processing, and sleep quality.
timeFrame: one month
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology, Institute of Neuroscience
Study officials:
affiliation: Norwegian University of Science and Technology
name: Gunnar Morken, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00961051: Evaluation of an Investigational Multi-Purpose Solution (MPS)
Official title: Evaluation of an Investigational MPS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Study Focus is Healthy Contact Lens Wearers
Keywords: adapted contact lens wearers
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2009-08-18
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of an investigational multi-purpose contact lens solution.

Detailed description: A new multi-purpose solution has been developed for optimal lens disinfection and lens wearing comfort, compatible with a wide variety of commercially available lenses. Ten investigative sites were selected to evaluate 274 soft contact lens wearers in a parallel group study of one investigational multi-purpose solution and one marketed predicate solution.

Eligibility criteria: Inclusion Criteria:

* Have successfully worn hydrogel contact lenses of the same material to be worn during the study
* Have normal eyes (with the exception of unaided visual acuity)
* Have successfully used a multi-purpose contact lens care solution
* Have acceptable visual acuity and lens wearing comfort at time of enrollment

Exclusion Criteria:

* Concurrently enrolled another clinical trial
* Have a known sensitivity to any study product ingredient(s)
* Have a condition that may put them at significant risk

Primary outcomes:
measure: Mean Lens Cleanliness as Measured by Light Reflectance
timeFrame: Day 30
Secondary outcomes:
measure: Number of Subjects With no Corneal Staining
timeFrame: Day 180
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Complete Family Vision Center
state: California
city: Waipahu
country: United States
facility: Eye Care Associates of Hawaii
state: Hawaii
city: Warrensburg
country: United States
facility: Insight Eyecare
state: Missouri
city: Athens
country: United States
facility: Drs. Quinn, Quinn & Associates
state: Ohio
city: Beachwood
country: United States
facility: Western Reserve Vision Care
state: Ohio
city: Columbus
country: United States
facility: Central Ohio Eyecare
state: Ohio
city: Scranton
country: United States
facility: Northeastern Eye Institute
state: Pennsylvania
city: Warwick
country: United States
facility: West Bay Eye Associates
state: Rhode Island
city: West Allis
country: United States
facility: Ziegler Leffingwell Eyecare
state: Wisconsin
Study officials:
affiliation: Abbott Medical Optics
name: Nicholas Tarantino, OD
role: STUDY_CHAIR
References:
Clinical trial NCT02956551: Personalized DC Vaccine for Lung Cancer
Official title: Neoantigen-primed DC Vaccine Therapy for Refractory Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: advanced non-small cell lung cancer
cell based therapy
safety
clinical efficacy
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is aimed to the test the efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for refractory non-small cell lung cancer.

Detailed description: Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial. Patients' rebiopsy tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.

Eligibility criteria: Inclusion Criteria:

* pathologically confirmed non-small cell lung cancer
* failed in previous standard chemotherapy and targeted therapy
* anticipated life time \> 3month
* Karnofsky performance status 0-1
* rehabilitate from previous therapy
* adequate organ functions

Exclusion Criteria:

* mixed histological types
* tumor emergency
* abnormal coagulation condition
* contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection
* concomitant tumors
* immunological co-morbidities

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 3 months after the last administration of cells
Secondary outcomes:
measure: objective response rate
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: China West Hospital
state: Sichuan
Study officials:
affiliation: Sichuan University
name: Zhen-Yu Ding, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05381051: Faster Peritoneal Solute Transfer Rate and Survival in a Pre-APD and Icodextrin Peritoneal Dialysis Cohort
Official title: Faster Peritoneal Solute Transfer Rate and Survival in a Pre-APD and Icodextrin Peritoneal Dialysis Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Dialysis
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 430
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both gender, end stage renal disease on PD treatment

Brief summary: A fast peritoneal solute transfer rate (PSTR) has been linked to worse survival especially in continuous ambulatory peritoneal dialysis (PD) cohort. In more recent cohorts, where automated PD and icodextrin were more widely used, this association disappears. The current study intended to clarify whether fast PSTR is related to worse outcome in this single center cohort with minimal use of APD and no icodextrin and otherwise modern management practice. Our study found that baseline PSTR predicted patient outcome in univariate survival analysis but not in multivariate analysis. The relationship between comorbidity and faster baseline PSTR may partly explain it.


Eligibility criteria: Inclusion Criteria:

1. Patients are Han Chinese;
2. Patients prepare for dialysis in our center, and start PD within 3 months after abdominal catheterization;
3. Patients successfully complete the first peritoneal equilibration test(PET);
4. Follow up regularly in our PD center.

Exclusion Criteria:

1. Patients from hemodialysis to peritoneal dialysis;
2. Patients who need peritoneal dialysis due to transplant-renal loss;

Primary outcomes:
measure: The relationship between fast PSTR and worse outcome in PD.
timeFrame: The data collection time period of the study is over 10 years.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00422851: Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 3c
Official title: Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 3c
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: otitis
gas diffusion
Eustachian tube
tympanic membrane
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2007-01-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults 18-50 years old with at least one intact and effusion-free middle ear

Brief summary: This study will determine if gas can pass between the environment and the middle ear by way of the eardrum. This route of gas exchange was observed in animals but has not been studied in humans. If gas exchange across the eardrum is documented and the rate is sufficiently high, this can help explain certain past observations such as why middle ear pressure does not change very much in some children and adults when they have a cold or flu. The investigators also expect that the rate of gas exchange across the eardrum will depend on whether or not the eardrum has scarred or abnormally thin regions.

Detailed description: Middle-ear (ME) pressure is a measure of the number of contained gas moles, and processes that addd or remove gas moles from the relatively fixed volume ME cavity change its pressure. Experimental results from animal studies document significant gas exchange across the tympanic membrane and if confirmed for humans may explain some of the paradoxical findings for children with poor Eustachian tube function such as the preservation of an aerated ME when the normal routes of gas supply are disrupted. This study measures the rates of reactive and inert gas exchange across the adult tympanic membrane with and without structural abnormalities and determines if these transfers are purely diffusive phenomena. The resulting data will be used to develop species-specific rate-constants that will be used as parameters in modeling ME pressure regulation.

Eligibility criteria: Inclusion Criteria:

* 18-50 years old
* at least one intact and effusion-free middle ear

Exclusion Criteria:

* bilateral otitis media
* unable to remain relaxed and quiet for up to 2 hours

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: ENT Research Center Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: William Doyle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: J. Douglas Swarts, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002751: Monoclonal Antibody Therapy in Treating Patients With Brain Metastases
Official title: PROTOCOL FOR A PHASE I STUDY OF INTRATHECAL MONOCLONAL ANTIBODY FRAGMENT 131I Me1-14 F(ab')2 IN PATIENTS WITH NEOPLASMS METASTATIC TO THE LEPTOMENINGES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Cancer
Keywords: leptomeningeal metastases
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2004-07-01
Enrollment: 6
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have brain metastases.

Detailed description: OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of 131-iodine-labeled monoclonal antibody fragment Me1-14 F(ab')2 administered intrathecally in patients with neoplasms metastatic to the leptomeninges. II. Identify objective therapeutic responses to this treatment.

OUTLINE: Radioimmunotherapy. Iodine-131-Labeled Monoclonal Antibody Fragment Me1-14 F(ab')2, 131I-Me1-14 F(ab')2.

PROJECTED ACCRUAL: Three to 6 patients will be treated at each dose studied.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically confirmed neoplasm that is recurrent in the subarachnoid space Biopsy of recurrent lesion required if original diagnosis made more than 2 years prior to entry and CSF cytology negative Radiographic evidence of measurable lesion in the leptomeninges (by myelography, CT, or MRI) or cytologic evidence of malignancy in the CSF Any type of neoplasm eligible provided tumor cells (tissue or CSF preparation) bind significantly to intact monoclonal antibody Me1-14 IgG2a or to Me1-14 F(ab')2 Patency of subarachnoid pathways demonstrated by isotopic intraventricular flow

PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Karnofsky 50-100% Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: AST less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase less than 1.5 times ULN Renal: Creatinine less than 1.2 mg/dL Other: No allergy to iodine Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior antineoplastic chemotherapy unless unequivocal evidence of tumor progression No concurrent systemic chemotherapy Endocrine therapy: Corticosteroids allowed if at lowest possible dose and stable for at least 10 days prior to entry Radiotherapy: At least 3 months since prior radiotherapy to site of measurable disease unless unequivocal evidence of disease progression Surgery: Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Darell D. Bigner, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00399451: Polidocanol Sclerotherapy of Pharynges for Obstructive Sleep Apnea (OSA) and Snoring Subjects(SS)
Official title: Preliminary Study on Submucous Sclerosis of Pharynges With 1% Polidocanol to Treat Obstructive Sleep Apnea (OSA) & Snoring Subjects (SS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Apnea
Snoring
Keywords: Sleep Apnea,Obstructive
apnea-hypopnea index (AHI)
polidocanol
sclerotherapy
pharynges
Lead sponsor: Liaoyang Central Hospital
Sponsor class: OTHER
First posted: 2006-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this prospective study is to evaluate the results of polidocanol sclerotherapy of pharynx for OSAS \& SS,to reduce pharyngeal compliance.

Detailed description: Polidocanol submucous sclerosis in the part of pharynges with 1% polidocanol injection.The injection should be in the retropharyngeal submucosa and lateral pharyngeal bands and lateral pharyngeal submucosa and in front submucosa of soft palate.The injection is multi-point,and each point injection is 0.3\~0.5ml;the total quantity/each time is not more than 5ml.Every patient have to be treated about 1\~2 time.

Eligibility criteria: Inclusion Criteria:

* OSAS \& SS which palatopharyngeal collapse.

Exclusion Criteria:

* obstructive sleep apnea syndrome (osas) \& snoring subjects (ss),which anatomic narrow result in.

Primary outcomes:
measure: apnea-hypopnea index (AHI)is on polysomnography(PSG),to compare AHIanterior and posterior treatment.
Secondary outcomes:
measure: Arterial oxygen saturation (SaO2) and body mass index (BMI)will be measured on polysomnography
Other outcomes:
Locations:
Study officials:
name: Youliang YIN, MB
role: STUDY_DIRECTOR
References:
Clinical trial NCT05040854: Can we Rely on HLA to Predict Resistance to Biological Therapy in IBD Patients
Official title: Can we Rely on HLA to Predict Resistance to Biological Therapy in IBD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Keywords: Inflammatory Bowel Diseases
HLA
Biological therapy
Lead sponsor: Centro Hospitalar Tondela-Viseu
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 600
Sex: ALL
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: Patients with Inflammatory Bowel Disease under biological therapy with anti-TNF, anti-integrin α₄β₇ or and anti-interleukin 12-23, followed in a gastroenterology outpatient consultation at the Centro Hospitalar Tondela-Viseu.

Brief summary: The investigators propose an observational study including patients with inflammatory bowel disease under biological therapy with anti-TNF, anti-integrin α₄β₇ or anti-interleukin 12-23 (Ustekinumab), followed by an external Gastroenterology consultation at Centro Hospitalar Tondela-Viseu.


Eligibility criteria: Inclusion Criteria:

* Patients with the diagnosis of IBD (according to ECCO diagnosis criteria);
* Adult patients (over 18 years);
* Full capability of signing informed consent.

Exclusion Criteria:

* Patients who refuse to participate in the study;
* Patients submitted to prior biological therapy (only for the IBD-naive group)

Primary outcomes:
measure: Response to biological therapy
timeFrame: 36 months
Secondary outcomes:
measure: Prevalence of HLA-DQ1*05 and DRB1
timeFrame: 36 months
Other outcomes:
Locations:
city: Viseu
country: Portugal
facility: Centro Hospitalar Tondela Viseu
Study officials:
affiliation: Centro Hospitalar Tondela-Viseu
name: Paula Ministro, MD
role: STUDY_DIRECTOR
References: