louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06472804: Insomnia in Patients With Metastatic Lung Cancer
Official title: Insomnia in Patients With Metastatic Non Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic non small cell lung cancer recruited from Mayo Clinic Oncology Center

Brief summary: This study evaluates how common insomnia (difficulties with sleep) is in patients with lung cancer that has spread from where it first started (primary site) to other places in the body.

Detailed description: PRIMARY OBJECTIVE:

I. Evaluate the frequency of insomnia in patients with metastatic non-small cell lung cancer.

OUTLINE: This is an observational study.

Patients undergo medical chart review and complete a questionnaire on study.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of metastatic non small cell lung cancer

  * Undergoing 1st, 2nd or 3rd line of treatment or are in maintenance therapy
  * Older than 18 years old at the time of diagnosis

Exclusion Criteria:

* Subjects will be excluded if they are considered to have advanced terminal cancer, severe depression or other psychiatric disorder or a sleep disorder other than insomnia (sleep apnea, restless leg syndrome, sleep related disorder of breathing), regular use of psychotropic medication other than hypnotics (eg antidepressants) per chart review

Primary outcomes:
measure: Frequency of clinically significant insomnia
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Konstantinos Leventakos, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03480204: Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY
Official title: Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmia
Keywords: Telemetry, Patch Monitor, Alarm Fatigue
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Isansys Lifecare LTD
First posted: 2018-03-29
Enrollment: 25
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: Non-ICU hospitalized patients on the J8-3 nursing ward at the Cleveland Clinic Heart and Vascular Institute

Brief summary: This study evaluates the feasibility and usability of a wearable patch as a cardiac monitor for non-ICU hospitalized patients.

Detailed description: This study evaluates the feasibility and usability of a wearable patch cardiac monitor, gateway and server concomitant with standard-of-care cardiac telemetry monitoring for non-ICU hospitalized patients on a selected nursing ward at the Cleveland Clinic Heart and Vascular Institute. All patients will receive routine clinical care on the basis of the traditional telemetry monitoring using the usual processes. The patch monitor data will not be reviewed in real-time, and only analyzed post hoc for agreement with the standard-of-care.

Eligibility criteria: Inclusion Criteria:

* \>= 18 years old and able to provide informed consent
* Standard indication for cardiac telemetry monitoring (institutional standardized criteria) with valid electronic order

Exclusion Criteria:

* Cardiac implantable device (pacemaker or ICD)
* Contact precautions or isolation
* Telemetry discontinuation planned within 12 hours (i.e. anticipated discharge)

Primary outcomes:
measure: Connectivity
timeFrame: 48 hours
measure: Continuity
timeFrame: 48 hours
Secondary outcomes:
measure: Agreement for cardiac arrhythmia detection (post hoc, offline)
timeFrame: 48 hours
measure: Body temperature (post hoc, offline)
timeFrame: 48 hours
measure: Cardiac waveform (post hoc, offline)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel J Cantillon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01872104: Safety and Efficiency of Photodynamic Therapy for Rectal Cancer
Official title: Longterm Outcome of Photodynamic Therapy Compared With Chemotherapy Alone in Patients With Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
PHASE3
Conditions: Advanced Rectal Cancer
Keywords: rectal cancer
rectal adenocarcinoma
photodynamic therapy
chemothrapy
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is a prospective randomized controlled trial.It aimed to determine longterm outcomes and factors associated with increased survival after photodynamic therapy (PDT) through colonscopy compared with chemotherapy alone in patients presenting with advanced rectal cancer.


Eligibility criteria: Inclusion Criteria:

* 1.Patients with advanced rectal cancer 2.Patients are willing to join in this clinical trial.

Exclusion Criteria:

* 1.Patients with advanced rectal cancer can not suffer PDT procedure. 2.Allergy to photosensitizer

Primary outcomes:
measure: Survival rate
timeFrame: one month
Secondary outcomes:
measure: Progression-free survival
timeFrame: One month
Other outcomes:
measure: Quality of life
timeFrame: one month
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
citation: Allison RR, Sheng C, Cuenca R, Bagnato VS, Austerlitz C, Sibata CH. Photodynamic therapy for anal cancer. Photodiagnosis Photodyn Ther. 2010 Jun;7(2):115-9. doi: 10.1016/j.pdpdt.2010.04.002. Epub 2010 May 7.
Clinical trial NCT06788704: Tadalafil Daily Used Post Turp
Official title: The Effect of Tadalafil 5 mg on Erection and Persistent Storage Lower Urinary Tract Symptoms After Transurethral Resection of Prostate: a Randmized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction Following Urethral Surgery
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 270
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sexual active male patients underwent TURP

Brief summary: to assess the effect of early tadalafil 5 mg once daily on persistent storage lower urinary tract symptoms (LUTS) and erectile function after transurethral resection of the prostate (TURP).


Eligibility criteria: Inclusion Criteria:

* sexual active men

Exclusion Criteria:

* sexual inactive men
* cardiac patients

Primary outcomes:
measure: Assess erectile function
timeFrame: One month
measure: Assess erectile function
timeFrame: 3 month
Secondary outcomes:
measure: Assess storage symptoms
timeFrame: One month
measure: Assess storage symptoms
timeFrame: 3 month
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Elsayed Abdelhalim Elsayed
Study officials:
References:
Clinical trial NCT03698604: Total Laparoscopic Hysterectomy Versus Total Abdominal Hysterectomy in Women With Endometrial Neoplasia
Official title: Total Laparoscopic Hysterectomy Versus Total Abdominal Hysterectomy in Women With Endometrial Neoplasia; Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterectomy
Laparoscopy
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 52
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare operative time between total laparoscopy hysterectomy with bilateral salpingoophrectomy (TLH+BSO) versus total abdominal hysterectomy and bilateral salpingooophorectomy (TAH+BSO) in women with uterine neoplasia.

Detailed description: Research Questions:

Is total laparoscopic hysterectomy associated with similar operative operative time as total abdominal hysterectomy and bilateral salpingoophrectomy in women with uterine neoplasia?

Research Hypothesis:

In women with uterine neoplasia TLH with BSO may be similar to TAH with BSO as regard operative time.

Eligibility criteria: Inclusion Criteria:

The presence of perimenopausal bleeding

* Early stage endometrial carcinoma.
* Endometrial hyperplasia with/without atypia.

Exclusion Criteria:

* Obese patients i.e., BMI\< 29 k.g/m2.
* Patients unfit for laparoscopy as patients with cardio-pulmonary compromise.
* Presence of adnexal mass.
* End stage endometrial carcinoma stage 3 \& 4.

Primary outcomes:
measure: Operative time
timeFrame: From skin incision till closure of the vault "up to 4 hours".
Secondary outcomes:
measure: Blood loss
timeFrame: From skin incision start until skin suturing is finished "up to 4 hours".
measure: Blood transfusion
timeFrame: From admission to the hospital until the home discharge "up to 1 week".
measure: Postoperative pain
timeFrame: 8 hours after the end of operation.
measure: Hospital stay
timeFrame: From admission to the hospital until the home discharge "up to 1 week".
measure: Incidence of operative complications
timeFrame: During operation.
measure: Incidence of postoperative complications
timeFrame: Up to 1 week postoperative.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Walid E Mohammed, MD
role: STUDY_DIRECTOR
affiliation: Ain Shams Maternity Hospital
name: Mortada E Ahmed, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01643304: A Swedish Questionnaire Study to Investigate the Perception of Menstrual Bleedings
Official title: A Swedish Cross-sectional Study With Questionnaire to Investigate Perception of Menstrual Bleeding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menorrhagia
Keywords: Menorrhagia
Heavy menstrual bleeding
Uterine Hemorrhage
Menstruation Disturbancies
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-07-18
Enrollment: 1547
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects included in the SIFO (Swedish institute of market research) volontary subject pool.

Brief summary: This field based, questionnaire study will document observational data on womens perception of menstrual bleeding in a cross-section of women in Sweden. Each subject will complete the questionnaire at one occasion.


Eligibility criteria: Inclusion Criteria:

* All women 40-45 years available in the web-panel of SIFO
* Completion of the web-based questionnaire

Exclusion Criteria:

* None

Primary outcomes:
measure: Prevalence of subjectively experienced heavy menstrual bleeding assessed by questionnaire
timeFrame: Once at baseline
Secondary outcomes:
measure: Social consequences of heavy menstrual bleedings assessed by questionnaire
timeFrame: Once at baseline
measure: Costs; e.g. pads, absence from work, loss of income assessed by questionnaire
timeFrame: Once at baseline
measure: The treatments given for heavy menstrual bleedings, as surgery or medication assessed by questionnaire
timeFrame: Once at baseline
Other outcomes:
Locations:
city: Many Locations
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06080204: Real-world Study on Adjuvant Octreotide Therapy in pNETs
Official title: Real-world Effectiveness of Adjuvant Octreotide Therapy in High Recurrence Risk Patients With Pancreatic Neuroendocrine Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neuroendocrine Tumor G2
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adjuvant therapy in pancreatic neuroendocrine tumors (pNETs) after radical resection lacks evidence-based data and is controversial. Real-world data were clustered to validate whether the long-acting octreotide is a potential candidate for adjuvant therapy in high recurrence risk G2 pNET patients.

Detailed description: Adjuvant therapy for pNETs was proposed as an unmet clinical need by the European Neuroendocrine Tumor Society Group in 2016.1The Clinical Practice Guidelines for pNETs in China recommended initiation of clinical trials to investigate the role of adjuvant therapy for patients with a high-risk of recurrence. To address this unmet clinical need, the investigators initiated this real-world study. The aim of the current study was to assess the impact of octreotide LAR as an adjuvant therapy in reducing recurrence and prolonging survival in Chinese non-metastatic pNETs patients at risk for recurrence.

Eligibility criteria: Inclusion Criteria:

* pNETs lesions pathologically classified as WHO grade 2
* Complete surgical resection (R0 or R1 was achieved)
* Adjuvant treatment was performed within 12 weeks after surgery

Exclusion Criteria:

* Stage IV
* Other oncological history
* Previous antineoplastic systemic therapy
* Lack of information/details on recurrence or death.

Primary outcomes:
measure: Disease-free survival time
timeFrame: From the date of surgery to the date of distant metastasis or recurrence or death due to any cause, whichever came first, assessed up to 120 months
Secondary outcomes:
measure: Overall survival time
timeFrame: From the date of surgery to the date of death due to any cause, whichever came first, assessed up to 120 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00598104: Safety and Efficacy of QAX576 in Adults With Moderate Persistent Allergic Asthma
Official title: A Randomized, Double-blinded, Placebo Controlled, Parallel Group, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Doses of QAX576 in Moderate Persistent Allergic Asthmatics Following Inhaled Corticosteroid Withdrawal
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Asthma
Keywords: Asthma, interleukin-13
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-01-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of QAX576 against asthma attacks in adults with moderate persistent allergic asthma


Eligibility criteria: Inclusion Criteria:

* History of asthma attacks
* Taking inhaled corticosteroids
* Non-smoking

Exclusion Criteria:

* Women of child-bearing potential
* History of respiratory disease other than asthma
* History of severe allergy to food or drugs
* Previous use of monoclonal antibodies
* Very low or high body weight

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: - Forced expiratory volume in 1 second (FEV1)at baseline and until study completion - Levels of eosinophils in sputum
timeFrame: Throughout the study
Secondary outcomes:
measure: - Three doses of QAX576 on time to treatment failure, plasma IL-13 levels and immunogenicity in asthmatics - Sputum biomarkers
timeFrame: Throughout the study
Other outcomes:
Locations:
Study officials:
affiliation: Novartis investigative site
name: NOVARTIS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02349204: The Effect of Music on Surgical Skill in the Setting of Simulated Intraocular Surgery
Official title: The Effect of Music on Surgical Skill in the Setting of Simulated Intraocular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Performance
Keywords: Simulator
Music
Mozart Effect
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Music is commonly heard in operating room. The goal of this study is to measure the effect of music on surgical performance using a intraocular surgery simulator. The music chosen is Sonata for 2 pianos D-440 from Mozart. The participants will complete 2 tasks on the simulator, both with and without music, in a randomized sequence. The results will be subtracted from the simulator and analyzed.


Eligibility criteria: Inclusion Criteria:

* Ophthalmology residents at Laval University
* Ophthalmologist at Centre Hospitalier Universitaire de Québec

Exclusion Criteria:

* None

Primary outcomes:
measure: Task score
timeFrame: Assessed up to 12 weeks after randomization
Secondary outcomes:
measure: Time to complete the task
timeFrame: Assessed up to 12 weeks after randomization
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre Universitaire d'Ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
Study officials:
affiliation: Centre de recherche du CHU de Québec : Université Laval
name: Mathieu Caissie, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00678704: BAY38-9456 - Pivotal Trial for Diabetes Patient
Official title: A Randomized, Placebo-controlled, Double-blind, Multi-centre, Parallel Group Study to Investigate the Efficacy and Safety of BAY 38-9456 in Males With Diabetes Suffering From Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Diabetes Mellitus
Keywords: Vardenafil
PDE5 inhibitor
Erectile Dysfunction
Diabetes Mellitus
Sexual Dysfunction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-05-15
Enrollment: 790
Sex: MALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.


Eligibility criteria: Inclusion Criteria:

* Male with erectile dysfunction for more than 3 years according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
* Diabetes for more than 3 years

Exclusion Criteria:

* Following to the labeling of Japanese package insert for vardenafil 5/10 mg, except for the highest dose
* Spinal cord injury
* History of surgical prostatectomy (excluding TURP)
* Patients with an HbA1c \> 12% at Visit 1
* Use of nitrates
* Use of potent CYP3a4 inhibitors
* Severe liver disease
* Presence of Peyronie's Disease

Primary outcomes:
measure: The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15
timeFrame: At 12 weeks after start of study drug administration using data at LOCF to account for dropouts
Secondary outcomes:
measure: The Global Assessment Question
timeFrame: At 4, 8, 12 weeks after start of study drug administration and LOCF
measure: The IIEF EF domain score
timeFrame: At 4, 8, 12 weeks after start of study drug administration
measure: IIEF domain scores other than the EF domain score[intercourse satisfaction (Q6 to Q8), overall satisfaction (Q13, Q14), orgasmic function (Q9, Q10), sexual desire (Q11, Q12)]
timeFrame: At 4, 8, 12 weeks after start of study drug administration and LOCF
measure: Scores of Questions 1 to 15 on the IIEF Questionnaire
timeFrame: At 4, 8, 12 weeks after start of study drug administration and LOCF
measure: Patient's diary response concerning hardness of erection, maintenance of erection, satisfaction with overall hardness of erection, ability of insertion, overall satisfaction with sexual experience and ejaculation
timeFrame: At 4, 8, 12 weeks after start of study drug administration and LOCF
measure: Safety data
timeFrame: Throughout the study
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: