louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02074241: Molecular Markers of Chemosensitivity for Bladder Cancer
Official title: Molecular Markers of Chemosensitivity for Locally Advanced, Recurrent and Metastatic Bladder Cancer Based on the Adjuvant Chemotherapy of Gemcitabine and Cisplatin-a Prospective Control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Effects of Chemotherapy
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. The patients of locally advanced, recurrent, metastatic transitional cell carcinoma.
2. Gone through standardize radical cystectomy and pelvic lymphadenectomy or inoperable.
3. Experienced adjuvant chemotherapy(Gemcitabine and Cisplatin).

Brief summary: The purpose of this study is to try to figure out some bio-markers of chemosensitivity for adjuvant chemotherapy for bladder cancer.

Detailed description: Figure out some bio-markers of chemosensitivity for adjuvant chemotherapy for bladder cancer.

Eligibility criteria: Inclusion Criteria:

1. Male or female, 18 years of age or older, estimated life expectancy ≥ 6 months.
2. .Gone through standardize radical cystectomy and pelvic lymphadenectomy or inoperable.
3. Transitional cell carcinoma of bladder, stage pT3N0M0,T2N1M0-T3-4N1-2M1.Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components.
4. Electrocorticography(ECOG) performance status 0-2.
5. Blood routine:Absolute neutrophil count (ANC) ≥ 1500/μL,White blood cell count ≥ 3000/μLPlatelets ≥ 100,000/μL,Hemoglobin ≥ 10.0 g/dL,
6. Total serum bilirubin≤ 1.5 x upper limit of normal (ULN).Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase(SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x upper limit of normal (ULN).
7. Creatinine clearance rate,Ccr ≥ 60%
8. ECG：no arrhythmias, no myocardial infarction. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.

Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests,and other study procedures.

Exclusion Criteria:

1. Past history of systemic chemotherapy
2. Serious heart and lung dysfunction.
3. Associated with central or peripheral neuropathy greater than 2 grade.

Primary outcomes:
measure: cancer progressive free survival rate
timeFrame: 60 months
Secondary outcomes:
measure: overall survival
timeFrame: 60 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest hospital,Chian
state: Chongqing
Study officials:
affiliation: Southwest Hospital, China
name: Zhiwen Chen, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00878241: Compression Anastomosis Using the CAR™ 27
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Surgery
Keywords: Colon Anastomosis
Rectum Anastomosis
Intestine
Colorectal Surgery
Colorectal Anastomosis
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: novoGI
First posted: 2009-04-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose:

Evaluation of the CAR™ 27 for the creation of compression anastomoses.

Indication:

Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection.

Study Design:

Prospective, open labeled study.

Patient Population:

Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the discretion of the surgeon.

No. of Subjects:

15 patients estimated up to three months to enroll.

Duration of Treatment:

During the operation - creation of the anastomosis.

Duration of Follow-up:

Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3 months.

Endpoints:

To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse events related to the use of the CAR™ 27 device.


Eligibility criteria: Inclusion Criteria:

1. Patient is over 18 years old.
2. Patient is scheduled for a non-emergency procedure.
3. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion Criteria:

1. Patient has an allergy to nickel.
2. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease.
3. Patient is participating in another clinical trial which may affect this study's outcomes.
4. Patient has been taking regular steroid medication.
5. Patient has contraindications to general anesthesia.
6. Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.

Primary outcomes:
measure: Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc.
timeFrame: 3-months
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
References:
Clinical trial NCT00375141: Long-Pulsed Dye Laser and Intense Pulsed Light for Skin Rejuvenation.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Photodamaged Skin
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2006-09-12
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of the trial is to compare clinical efficacy and occurrence of side effects in the treatment of photodamaged skin with Pulsed Dye Laser and Intense Pulsed Light.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate bilateral facial photodamage
* Symmetry in the facial area of wrinkles, skin texture, pigmentary changes and telangiectasia
* Fitzpatrick's skin type of Type I, II, or III, without significant tan
* Age \> 40 years
* Able to read and comprehend Danish
* Informed consent agreement signed by the subject
* Willingness to follow the treatment schedule and posttreatment follow-up evaluations
* Willingness to allow photographs of the treated area to be taken for evaluation of efficacy.

Exclusion Criteria:

* Scarring or infection of the area to be treated
* Known photosensitivity
* Presence of a suntan in the area to be treated
* Subjects taken medication known to induce photosensitivity in the previous three months
* Known anticoagulation or thromboembolic conditions
* Subjects taking anticoagulation medication
* Subjects taking Accutane within the past 6 months
* Subjects treated with aspirins or anti-inflammatory drugs
* Subjects who are immunocompromised or have a medical history that is inappropriate for the study per the investigator's clinical judgment.
* Dermabrasion, chemical peel, laser or IPL treatment, or collagen injection therapy in the facial area in the past 12 months.
* Previous formation of hypertrophic scars or keloids
* Subjects who are pregnant or lactating
* Asymmetry in the facial area of wrinkles, skin texture, pigmentary changes and telangiectasia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Hædersdal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00763841: Transcranial Magnetic Stimulation (TMS) for Treatment of Auditory Hallucinations
Official title: A Pilot Study Using Transcranial Magnetic Stimulation (TMS) to Investigate the Role of the Temporal Cortex in Schizophrenic Patients With Auditory Hallucinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Auditory Hallucinations
Keywords: Auditory hallucinations
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: NSW Schizophrenia Fellowship
name: Rebecca Cooper Medical Research Foundation
First posted: 2008-10-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Transcranial magnetic stimulation (TMS) involves the use of magnetic fields to non-invasively stimulate the brain. Studies overseas have suggested this may be an effective and safe treatment for auditory hallucinations in patients with schizophrenia. This is a sham-controlled, double-blind trial of TMS stimulation for the treatment of auditory hallucinations in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Over 18, with DSM-IV diagnosis of Schizophrenia and auditory hallucinations of clear external origins, refractory to pharmacotherapy and occurring at least 5 times per day.

Exclusion Criteria:

* Subjects with contraindications to TMS (e.g. epilepsy, pacemaker) or those with an unacceptably high risk (e.g. suicide risk) will be excluded from the study.

Primary outcomes:
measure: Daily Voices Ratings (Mental Health Research Institute, Victoria)
timeFrame: Daily
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: School of Psychiatry
state: New South Wales
Study officials:
affiliation: University of NSW
name: Colleen Loo, MBBS, FRANZCP. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03047941: Determination of Optimal Cutoff Value for Screening Severe Hypoxemic OSA (Obstructive Sleep Apnea) Patients
Official title: Determination of Optimal Cutoff Value of 4 Tests (DES-OSA, STOP-Bang, OSA50, P-SAP) for Screening Severe Hypoxemic OSA (Obstructive Sleep Apnea) Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients scheduled to have a PSG in the sleep laboratory center.

Brief summary: The 4 following scores have been proposed to detect OSA (Obstructive Sleep Apnea): DES-OSA, STOP-Bang, P-SAP, and OSA50.

The aim of this study is to evaluate the optimal cutoff value of these four scores to detect specifically serve OSA patients with hypoxemia.


Eligibility criteria: Inclusion Criteria:

* All patients scheduled to have a PSG in the sleep laboratory center.

Exclusion Criteria:

* Patients \< 18 years

Primary outcomes:
measure: Adequacy of STOP-Bang to detect severe hypoxemic OSA patients
timeFrame: One week.
measure: Adequacy of P-SAP to detect severe hypoxemic OSA patients
timeFrame: One week
measure: Adequacy of OSA50 to detect severe hypoxemic OSA patients
timeFrame: One week
measure: Adequacy of DES-OSA to detect severe hypoxemic OSA patients
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Bouge
country: Belgium
facility: ASTES
state: Namur
Study officials:
References:
Clinical trial NCT01874041: Effect of Massage Therapy and Occlusal Splint Therapy on the Electromyographic Activity and Mandibular Range of Motion in Individuals With Temporomandibular Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Keywords: Physical Therapy Modalities
Facial Pain
Orthodontic Appliances
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study were to investigate the effects of massage therapy and occlusal splint therapy in the electromyographic activity and mandibular range of motion (ROM) in individuals with temporomandibular disorder (TMD) and compare the results with those obtained in a group of individuals without this disorder. Twenty-eight volunteers with TMD were randomly distributed into two groups, massage therapy and occlusal splint. Both treatments lasted 4 weeks. Fourteen individuals without TMD were consecutively allocated to the control group. The Fonseca's anamnestic index was used to characterize TMD and allocate the volunteers to either the intervention groups or control group. The electromyographic activity and Mandibular ROM was evaluated before and after treatment using a digital caliper. Two-way analysis of variance with the Bonferroni test was used for inter and intragroup comparisons (level of significance was set to 5%). Cohen's d was used to calculate the effect size.


Eligibility criteria: Inclusion Criteria:

* male and female volunteers
* aged 18 to 40 years

Exclusion Criteria:

* occurrence of missing teeth
* current use of orthodontic appliance
* history of systemic or joint disease
* current use of analgesic, anti-inflammatory agent or muscle relaxant and currently undergoing physical therapy.

Primary outcomes:
measure: Mandibular range of motion
timeFrame: 1 year
Secondary outcomes:
measure: Electromyographic activity
timeFrame: 1 year
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Cid Gomes, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gomes CA, El Hage Y, Amaral AP, Politti F, Biasotto-Gonzalez DA. Effects of massage therapy and occlusal splint therapy on electromyographic activity and the intensity of signs and symptoms in individuals with temporomandibular disorder and sleep bruxism: a randomized clinical trial. Chiropr Man Therap. 2014 Dec 15;22(1):43. doi: 10.1186/s12998-014-0043-6. eCollection 2014.
Clinical trial NCT00267241: Effects of Different Assisted Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients
Official title: Effects of Different Assisted Mechanical Ventilation in ALI/ARDS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome, Adult
Keywords: ARDS
ALI
respiratory mechanics
gas exchange
assisted ventilation
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2005-12-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
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 study is to evaluate the effects in terms of gas exchange, respiratory mechanics and comfort of breathing, of different assisted mechanical ventilation in ALI/ARDS patients.

Detailed description: ALI/ARDS patients (during assisted ventilation) will be ventilated with different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation) and gas exchange, comfort of breathing, respiratory mechanics and pattern of breathing will be measured.

Eligibility criteria: Inclusion Criteria:

* Patients with ALI/ARDS

Exclusion Criteria:

* COPD patients
* Barotrauma
* Hemodynamic instability
* Age less than 18

Primary outcomes:
measure: Gas exchange and respiratory mechanics
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Policlinico Hospital
Study officials:
affiliation: Policlinico Hospital
name: Davide Chiumello, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00986141: Effects of Selective Laser Trabeculoplasty
Official title: Effect of Selective Laser Trabeculoplasty (SLT) on Diurnal Intraocular Pressure in Open-Angle Glaucoma Patients on Medical Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glaucoma
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2009-09-29
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty patients, between the ages of 40 and 80, of either gender, from all ethnic backgrounds will be recruited in this study.

Brief summary: Primary objective is to evaluate the effect of selective laser trabeculoplasty (SLT) on the diurnal intraocular pressure variation in open-angle glaucoma patients (OAG).

Detailed description: This is a prospective observational study of OAG patients undergoing selective laser trabeculoplasty at the University of Kentucky Chandler Medical Center. The patients will be recruited over 12 months. Study will include 3 visits: pre-laser visit, visit for laser treatment and post-laser visit. All visits will occur within a 3-month period.

Eligibility criteria: Inclusion Criteria:

* Subjects who have the diagnosis of open angle glaucoma
* Subjects who are able to speak and understand English and provide meaningful written informed consent,
* Subjects who are willing and able to comply with all testing and requirements defined in the protocol and willing and able to comply with all required study visits.

Exclusion Criteria:

* Subjects with previous laser treatment or intraocular surgery,
* Subjects with history of ocular inflammation and with history of previous ocular trauma.

Primary outcomes:
measure: To evaluate the effect of selective laser trabeculoplasty on the diurnal intraocular pressure variation in OAG patients.
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: Univ of KY Reseach Foundation
name: Deborah Davis, Assoc V Chair
role: STUDY_DIRECTOR
References:
Clinical trial NCT02762396: The Norwegian Stroke in the Young Study II
Official title: The Norwegian Stroke in the Young Study II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke at a Young Age
Keywords: Young ischemic stroke
Risk factors
Causes
Consequences
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
First posted: 2016-05-05
Enrollment: 130
Sex: ALL
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with documented ischemic stroke at a young age (\< 50 years) in Norway

Brief summary: NOR-SYS II is designed for finding the cause of acute ischemic stroke lesions in Young adults, age 15 to 49 years. Risk factors, arterial wall changes by intima-media thickness and plaques and consequences of stroke are examined by standardized diagnostics.

Detailed description: NOR-SYS II is as far as possible standardized concerning patients' history, ultrasound examination of pre-cerebral and femoral arteries, and standardized examinations performed by speech therapists, occupational therapists and physiotherapists.

The ultrasound-protocol for carotid and femoral arteries is the same as previously performed in the NOR-SYS study. The Methods have been published before.

Eligibility criteria: Inclusion Criteria:

* Documented acute, arterial ischemic stroke
* Speaks Norwegian fluently

Exclusion Criteria:

* Post-traumatic and procedure related stroke
* Sinus venous thrombosis, sepsis and endocarditis
* Serious co-morbidity, such as advanced cancer with "end-of-life stroke".
* Patients mentally retarded or with severe psychiatric disease who do not accept the diagnosis and who would need sedation to perform clinical diagnostics.

Primary outcomes:
measure: Established atherosclerosis
timeFrame: Established atherosclerosis will serve as outcome measure for data collected during hospital stay and will be related to risk factors. The data will be presented one year after finishing the 5-years of inclusion of the whole study group.
Secondary outcomes:
measure: New cardiovascular events
timeFrame: One year after the stroke
measure: Death
timeFrame: One year after the stroke
measure: Alive but not back to previous education or full-time job
timeFrame: One year after the stroke
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Dep. of Neurology
Study officials:
affiliation: Haukeland University Hospital
name: Ulrike Waje-Andreassen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fromm A, Thomassen L, Naess H, Meijer R, Eide GE, Krakenes J, Vedeler CA, Gerdts E, Larsen TH, Kuiper KK, Laxdal E, Russell D, Tatlisumak T, Waje-Andreassen U. The Norwegian Stroke in the Young Study (NOR-SYS): rationale and design. BMC Neurol. 2013 Jul 17;13:89. doi: 10.1186/1471-2377-13-89.