louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03979807: A Study Based on Medical Records That Looks at the Duration of Use of Two Types of Inhalers With Different Medicines in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: The Role of Inhaler Device in the Treatment Persistence With Dual Bronchodilators in Patients With COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-06-07
Enrollment: 11296
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients initiating Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol up to 2.5 years

Brief summary: To compare the persistence in using two different medications from the same drug class (LAMA/LABA FDC) which are delivered through different devices, a dry-powder inhalers (DPI) and Soft Mist Inhalers (SMI).


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Aged \<40 years
* Enrolment with medical and pharmacy coverage prior to the cohort entry \< 180 days
* Never had COPD diagnosis on the cohort entry date or prior to cohort entry
* A record for dispensed Olodaterol/Tiotropium Bromide delivered with Respimat inhalator or Umeclidinium/Vilanterol delivered with the Ellipta Inhaler during the 180-day baseline prior to cohort entry
* Diagnosis of asthma any time prior to cohort entry
* Diagnosis of lung cancer any time prior to cohort entry
* Diagnosis of lung transplant any time prior to cohort entry

Primary outcomes:
measure: Rate of Discontinuation of Index Treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol)
timeFrame: From first day after the cohort entry date to the earliest occurence of the outcome (discontinuation or refills), or any censoring criteria (365 days of follow-up without discontinuation, death, disenrollment end of data).
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Aetion Inc.
state: New York
Study officials:
References:
Clinical trial NCT05075707: Comparison Between Magnetic Field and Laser Therapy in Management of Trigeminal Neuralgia
Official title: Magnetic Field and Laser Therapy in Management of Diabetic Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigeminal Neuralgia
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trigeminal neuralgia (TN) was defined by The International Association for the Study of Pain (IASP) as severe, sudden, usually unilateral, stabbing, brief, recurrent attacks of pain in one or more distributional branches of the trigeminal nerve. The purpose of the current study will to investigate the effect of Low level laser therapy versus electromagnetic therapy on diabetic trigeminal neuralgia pain intensity and amplitude of the compound muscle action potential of the masseter and temporalis muscles in diabetic TN patients.


Eligibility criteria: Inclusion Criteria:

* All participants will between the ages of 25 and 45, will of both sexes (male and female), diabetic type two patients with chronic trigeminal neuralgia, (from three to six months).
* Patients will awake, cooperative, and free of psychiatric issues (as determined by a psychologist) as well as difficulties resulting from orthopaedic or special sensory deficits.

Exclusion Criteria:

* Patients will ruled out if they developed TN due to a tumour, herpes zoster, or any other reason other than diabetes, such as significant coagulation dysfunction, cardiopulmonary dysfunction or previous invasive treatment (ethanol, radiofrequency, Gama-knife microvascular decompression, glycerinum injection).
* They will not have a previous disability in the face.

Primary outcomes:
measure: Studies using electromyography and complex muscle action potentials
timeFrame: at the beginning of the study
measure: Studies using electromyography and complex muscle action potentials
timeFrame: by the end of successful two month of intervention
measure: Visual analogue scale (VAS)
timeFrame: at the beginning of the study
measure: Visual analogue scale (VAS)
timeFrame: by the end of successful two month of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AAA
Study officials:
References:
Clinical trial NCT01321307: Aphtostomatitis and Mucositis Treatment by Natural Herbal Formula (Sorend®)
Official title: Aphtostomatitis and Mucositis Treatment by Natural Herbal Formula (Sorend®)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aphtostomatitis
Mucositis
Keywords: Aphtostomatitis
Mucositis
Mouth sores
Natural
Herbal
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: R&T Health Products Ltd.
First posted: 2011-03-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community population care

Brief summary: Sorend is a water-based formula, which contains carob, melissa and sage. Elder inhabitants of Israel are known to use carob extract to ease sores in the mouth, due to the tannins which create a complex with various proteins and polysaccharides, thus creating an impenetrable layer covering the sores, allowing spontaneous healing.


Eligibility criteria: Inclusion Criteria:

* Herpetic aphtomatitis
* Bacterial aphtostomatitis
* Viral aphtostomatitis
* Fungal aphtostomatitis

Exclusion Criteria:

* Oncology patients
* Systematic diseases (Colitis, Crohn, diabetes, Behcet)
* Pregnancy
* Arthritis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe MC, Otolaryngology - Head & Neck Surgery Unit
Study officials:
affiliation: Hillel Yaffe Medical Center, Hadera, Israel
name: Galit Avior, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06321107: Long-term Follow-up Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference
Official title: A Phase II/III Extension Study Comparing the Long-term Safety of GenSci094 and Gonal-f® in Chinese ART Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Infertility
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Sixth Affiliated Hospital, Sun Yat-sen University
First posted: 2024-03-20
Enrollment: 158
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who indentified an ongoing pregnancy in Phase II or Phase III clinical trial of GenSci094

Brief summary: The purpose of this study is to evaluate the safety of a single injection of GenSci094 during Controlled Ovarian Stimulation up to 1 year old of the infants from previous studies.

Detailed description: Two previous RCTs (a phase II and phase III studies of GenSci094, one is NCT06091436) investigated if a single injection of GenSci094 was non-inferior to daily treatment with recFSH in initiating multi-follicular growth. The two studies followed 12 weeks after embryo transfer. This study is a follow-up to the above mentioned RCTs. The purpose of this study is to follow-up with participants of the original study to determine the long-term effect a single injection of GenSci094 during Controlled Ovarian Stimulation might have on newborns until they are 1 year old.

Eligibility criteria: Inclusion Criteria:

1. Willing and able to sign informed consent
2. Subjects who participated in Phase II or Phase III clinical trial of GenSci094 and received at least one treatment with GenSci094 or Gonal-F ®
3. Subjects who indentified an ongoing pregnancy in Phase II or Phase III clinical trial of GenSci094

Exclusion Criteria:

NA

Primary outcomes:
measure: Summary of Pregnancy Outcome
timeFrame: To be assessed at late abortion or birth (up to 10 months)
Secondary outcomes:
measure: neonatal birth outcomes
timeFrame: To be assessed at birth (up to 10 months)
measure: Infant development
timeFrame: up to infant age 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital
state: Guangdong
Study officials:
affiliation: The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital
name: Xiaoyan Liang, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT05445388: Feasibility of Middle Ear OCT Imaging
Official title: Feasibility of Structural and Functional Imaging of the Middle Ear and Its Constituents by Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Image, Body
Keywords: Middle Ear
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Feasibility of structural and functional imaging of the middle ear and its constituents by optical coherence tomography.

Detailed description: Rationale: Various middle ear diseases can affect anatomical structures of the middle ear in different ways. Unfortunately, current methods for assessing the structure and function of the constituents of the middle ear are limited and often fail to provide all clinically relevant data. Optical coherence tomography (OCT) is a technology that can provide valuable, additional information with a newly developed prototype OCT-device for structural and functional imaging of the middle ear.

Objective: To assess the feasibility and the clinical potential of structural and functional OCT imaging with a newly developed OCT-device in patients with various middle ear problems.

Study design: Observational study Study population: Adult patients presenting with various middle ear complaints at the Ear Nose Throat department of the Department of Otorhinolaryngology and Head and Neck Surgery, Erasmus Medical Center, Rotterdam, the Netherlands.

Main study parameters/endpoints: Percentage of patients in which structural OCT imaging was feasible (i.e., the OCT images showed a discernible tympanic membrane (TM) and at least one of the ossicles).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden is minimal: patient examination with Aurisvue is similar to the conventional examination with a standard otoscope and will take approximately 5 to 10 minutes. The risks are negligible: imaging is done with light levels well below the maximum permissible exposure level and sound levels to induce movement of the TM and the ossicular chain are well below the hazardous threshold.

Eligibility criteria: Inclusion Criteria:

* age 18 or older
* competent, willing and able to cooperate

Exclusion Criteria:

* any acute or chronic condition that would limit the ability of the patient to participate in the study, per attending physician's indication
* refusal to give informed consent
* pregnancy or breastfeeding

Primary outcomes:
measure: Middle ear structures identified with the Aurisvue OCT device
timeFrame: 1 Year
Secondary outcomes:
measure: OCT-vibrometry measurements with the Aurisvue OCT device
timeFrame: 1 Year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01090388: Bladder Cancer Patient-Reported Outcomes
Official title: A Cross-Sectional Study Of Patient-Reported Outcomes For Bladder Cancer Patients With Non-Invasive Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Neoplasms
Keywords: Cross-sectional survey
Health-related quality of life
Symptom management
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2010-03-22
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bladder cancer patients (all stages) recruited at hospitals affiliated with Baylor College of Medicine and MD Anderson Cancer Center and via the websites of bladder cancer survivor organizations

Brief summary: The purpose of this study is to identify aspects of the bladder cancer (BlCa) survivorship experience that differ by clinical risk at diagnosis. The investigators will collect cross-sectional data from persons with BlCa to identify aspects of health-related quality of life (HRQOL) and symptom management. The study originally enrolled only nonmuscle-invasive bladder cancer survivors but has been expanded to include survivors with any stage disease. Information from this study will be used to develop a new patient education and counseling intervention.


Eligibility criteria: Inclusion Criteria:

* \> 18 years
* Diagnosed with BlCa within the past 4 years
* Able to read, speak, and understand English
* Able to provide informed consent.

Exclusion Criteria:

* Younger than 18
* Diagnosed BlCa longer than 4 years ago
* Unable to read, speak, and understand English
* Unable to provide informed consent.

Primary outcomes:
measure: Health-related quality of life as measured by the EORTC QLQ C30 and BLS24 (nonmuscle-invasive) or BLM30 (muscle-invasive or metastatic)
timeFrame: Duration of Study
Secondary outcomes:
measure: Illness intrusiveness
timeFrame: Duration of Study
measure: CaPSURE Fear of Recurrence
timeFrame: Duration of Study
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: David M Latini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Latini DM, Lerner SP, Wade SW, Lee DW, Quale DZ. Bladder cancer detection, treatment and outcomes: opportunities and challenges. Urology. 2010 Feb;75(2):334-9. doi: 10.1016/j.urology.2009.09.051. Epub 2009 Dec 5.
citation: Kowalkowski MA, Chandrashekar A, Amiel GE, Lerner SP, Wittmann DA, Latini DM, Goltz HH. Examining sexual dysfunction in non-muscle-invasive bladder cancer: results of cross-sectional mixed-methods research. Sex Med. 2014 Aug;2(3):141-51. doi: 10.1002/sm2.24.
citation: Kowalkowski MA, Goltz HH, Petersen NJ, Amiel GE, Lerner SP, Latini DM. Educational opportunities in bladder cancer: increasing cystoscopic adherence and the availability of smoking-cessation programs. J Cancer Educ. 2014 Dec;29(4):739-45. doi: 10.1007/s13187-014-0649-3.
Clinical trial NCT01477788: Prediction of Ovarian Malignancy in the Presence of Sonographic Pelvic Mass
Official title: Prediction of Ovarian Malignancy, in the Presence of Sonographic Pelvic Mass Using Patient History, Sonographic Parameters and Serum Markers
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ovarian Neoplasm
Keywords: pelvic mass
ovarian mass
ultrasound
serum markers
ovarian malignancy
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
Collaborators: name: Women and Infants Hospital of Rhode Island
First posted: 2011-11-23
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the department's sonographic unit with diagnosis of adnexal or pelvic or ovarian mass

Brief summary: The objective of the study is to create a test that will discriminate between malignant and benign ovarian mass that was diagnosed by ultrasound. The investigators will examine about 800 women and at the end of the study the investigators will combine data from the woman's history, the sonographic characters of the mass and serum biological markers along with the woman's outcome (which means - whether the mass was malignant, benign, or disappeared or remained constant with no intervention).

Detailed description: Patients that arrive to the sonographic unit of the gynecological department with a diagnosis of ovarian mass will have a sonographic examination that include: Trans-vaginal +- trans-abdominal ultrasound with Doppler and three dimensional sonographic exam. anamnestic data will be collected and serum test for CA 125, HE4 and CEA. The management of the specific patient will be according to the department protocol, regardless the study data. The investigators will collect data about operation outcome and histological results of women that will be operated. Women that won't be operated on will be followed up every 6 months by the study team.

At the end of the study a statistical analysis will be made to create a sensitive and specific test for the prediction of malignancy in sonographic diagnosed ovarian mass.

Eligibility criteria: Inclusion Criteria:

* Patients referred with sonographic diagnosis of pelvic mass

Exclusion Criteria:

* Pregnant women
* Known gynecologic malignancy

Primary outcomes:
measure: The risk of malignancy in the presence of pelvic mass demonstrated by sonography.
timeFrame: Up to 2 months after recruiting and examining the last participant of the study
Secondary outcomes:
measure: number and kind of operative complications
timeFrame: within one month after operation
measure: Reasons for intervention
timeFrame: within one month after operation
measure: operative finding and histologic results
timeFrame: within one month after operation
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Sonographic unit, Department of Ob/Gyn, Haemek medical center
Study officials:
affiliation: Department of Ob/Gyn, Haemek medical center, Afula Israel
name: yfat kadan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01159288: Trial of a Vaccination With Tumor Antigen-loaded Dendritic Cell-derived Exosomes
Official title: Phase II Trial of a Vaccination With Tumor Antigen-loaded Dendritic Cell-derived Exosomes on Patients With Unresectable Non Small Cell Lung Cancer Responding to Induction Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: Advanced unresectable non small cell lung cancer
Responding or stabilized after induction chemotherapy
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2010-07-09
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lung cancer is the worldwide leading cause of cancer death. In France, with 28,000 new cases per year, lung cancer is the 4th in terms of incidence but remains the leading cause of cancer death. The 5-year survival of lung cancer, all stages and all types, is very low, estimated at 12% among men and 16% among women in France. In advanced unresectable non small cell lung cancer, standard treatment relies on platinum-based induction chemotherapy. The median progression-free survival (PFS) in patients responding or stabilized after 4 chemotherapy cycles ranges from 2 to 2.8 months. Gustave Roussy and Curie institutes have developed an immunotherapy involving metronomic cyclophosphamide (mCTX) followed by vaccinations with tumor antigen-loaded dendritic cell-derived exosomes (Dex). mCTX inhibits Treg functions restoring T and NK cell effector functions and Dex are able to activate the innate and adaptive immunity. Phase I trials showed the safety and feasibility of Dex vaccines but no induction of T cells could be monitored in patients. Since 2007, we validated a new process for isolation of second generation Dex with improved immune stimulatory capacities. We propose a maintenance immunotherapy in 47 advanced unresectable NSCLC patients responding or stabilized after induction chemotherapy with Dex-based treatment to improve PFS rate at 4 months in these patients.


Eligibility criteria: Inclusion Criteria:

* advanced unresectable non small cell lung cancer
* responding or stabilizer after induction chemotherapy

Primary outcomes:
measure: Progression free survival
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References:
Clinical trial NCT01427088: rTMS-induced Cumulative Pattern of sBDNF in Chronic Schizophrenia
Official title: Short-Term Response of Serum Brain-Derived Neurotrophic Factor to Repetitive Transcranial Magnetic Stimulation in Patients With Chronic Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: rTMS-induced cumulative pattern of sBDNF
Lead sponsor: Jeonbuk Provincial Maeumsarang Hospital
Sponsor class: OTHER
First posted: 2011-09-01
Enrollment: 21
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims at investigating the neuroplastic potential and the possible factors affecting rehabilitation in chronic schizophrenia patients on stable medication, by investigating the cumulative pattern of serum BDNF representing the neuroplasticity in the brain, through quantitative stimulus such as rTMS.

Detailed description: Subjects who have been enrolled for this study will take baseline evaluation for sociodemographic data and serum level of BDNF, plasma Prolaction, and magnesium, etc. And then, weekday regular stimulation through rTMS will be applied on DLPFC of brain. After the completion of stimulation for 2 weeks, the change or response of serum BDNF will be analyzed and compared.

Eligibility criteria: Inclusion Criteria:

* duration of illness over 10 years
* on stable medication, antipsychotics
* no change on medication within at least 2 weeks
* Diagnosis of Schizophrenia according to DSM-IV-TR

Exclusion Criteria:

* left or both-handedness
* anticonvulsant use
* lorazepam equivalent over 3 mg

Primary outcomes:
measure: change from baseline of serum BDNF concentration
timeFrame: baseline-1 week-2 week-4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Wanju
country: Korea, Republic of
facility: Jeonbuk Provincial Maeumsarang Hospital
state: Jeonbuk
Study officials:
affiliation: Jeonbuk Provincial Maeumsarang Hospital
name: TAEYOUNG HWANG, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: