louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03161145: A Study to Observe the Treatment Patterns and Outcomes of Patients in Japan With Kidney Cancer That is Unable to be Removed by Surgery or That Has Spread
Official title: Treatment Patterns and Outcomes in Unresectable or Metastatic Renal Cell Carcinoma (mRCC) Patients in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2017-05-19
Enrollment: 297
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The medical records of about 500 patients diagnosed with unresectable or metastatic renal cell carcinoma, including those who have progressed from or discontinued from first-line therapy, between 01-Jan-2012 and 31-Aug-2015 will be enrolled in this study from sites in Japan.

Brief summary: A medical review chart study in Japan to describe the treatment patterns and outcomes of patients with kidney cancer that is unable to be removed by surgery or that has spread. The clinical data is to be abstracted using electronic data capture (eDC) from patient medical records in Japan.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Adults 20 years and older at the time of initial diagnosis of mRCC
* Alive or deceased as of the date of data collection
* Diagnosis of mRCC between 01-Jan-2012 and 31-Aug-2015

Exclusion Criteria:

* Previously and/or currently enrolled in RCC clinical trials
* Patients have primary cancer other than renal cell cancer

Primary outcomes:
measure: Treatment patterns
timeFrame: Approximately 5 years
measure: Overall survival
timeFrame: Approximately 2 years
measure: Reason for terminating or switching treatment
timeFrame: Approximately 5 years
measure: Adverse Events
timeFrame: Approximately 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01866605: A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients
Official title: A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anxiety
Keywords: anxiety
midazolam
forced-air warming
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients are often anxious immediately before surgery. The investigators hypothesis is that a warming blanket is as effective as the sedative midazolam in allaying anxiety before surgery.

Detailed description: The investigators are randomising patients aged 18-70 having elective surgery to 1) a cotton blanket and reassurance as required; 2) midazolam, a cotton blanket and reassurance as required; and 3) forced-air warming, a cotton blanket and reassurance as required. The primary endpoint is a visual analog scale of anxiety.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 70 years
* male and female
* presenting for elective surgery
* requiring general anaesthesia
* ASA 1-3

Exclusion Criteria:

* Cardiothoracic and intracranial surgery
* Day case surgery
* Pre-existing anxiety disorder
* Patients on psychotropic drugs preoperatively Febrile patients T \> 37.5 degrees Celsius Allergy to midazolam Obstructive Sleep Apnoea diagnosed on sleep study

Primary outcomes:
measure: Visual analog scale score for anxiety
timeFrame: During immediate pre-operative phase
Secondary outcomes:
measure: Thermal comfort
timeFrame: During immediate pre-operative phase
measure: Recovery from anaesthesia
timeFrame: During immediate post-operative phase
measure: Satisfaction with care
timeFrame: During immediate post-operative phase
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Kate Leslie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00229905: Child With Anomalous Drainage of IVC to Left Atrium
Official title: A Case Report of a Child With Anomalous Drainage of the Inferior Vena Cava to the Left Atrium
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: pediatric health
children
single case study
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-09-30
Enrollment: 1
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: child with anomalous drainage of the inferior vena cava to the left atrium

Brief summary: The purpose is to see if any conclusions can be drawn about the uncommon heart defect: anomalous drainage of the inferior vena cava to the left atrium.

Detailed description: Dr. Kogon would like to do a case-report and review of the literature regarding children with the diagnosis of anomalous drainage of the inferior vena cava to the left atrium. At Children's Healthcare of Atlanta, we have seen a single patient with this diagnosis in 2004 and Dr. Kogon would like to discuss this patient in combination with the others already in the literature to see if any conclusions can be drawn about this uncommon heart defect. Currently there are about 20 cases reported in the literature and Dr. Kogon will be reporting on this one case seen in 2004.

The case report of our patient will utilize his medical chart. We hope to provide a brief summary of his clinical presentation, his radiographic evaluation, his operative findings, and his outcome. The only PHI that will be collected will be dates (i.e. date of birth, dates of procedures).

Eligibility criteria: Inclusion Criteria:

* single case
* child with anomalous drainage of the inferior vena cava to the left atrium
* at Children's Healthcare of Atlanta

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
Study officials:
affiliation: Emory University
name: Brian Kogon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04175405: Low-level Laser Therapy With a 635nm Diode Laser on Orthodontic Mini-implants Stability.
Official title: Low-level Laser Therapy With a 635nm Diode Laser Affects Orthodontic Mini-implants Stability. A Randomized Clinical Split-Mouth Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion, Angle Class II
Keywords: ATP, biostimulation, micro-screw, Periotest, semiconductor laser
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to clinically estimate an influence of a 635nm diode laser on the primary and secondary stability of orthodontic mini-implants placed in a maxilla, to assess mini-implants failure rate (mini-implant loss) and to evaluate a pain level after the treatment. The randomized clinical split-mouth trial included 15 subjects, 30 implants (Dual Top Anchor System, Seoul, Korea) with a diameter 1.4mm and length of 10mm. Mini-implants were placed in the area of the attached gingiva between the second premolar and first molar teeth 2 mm below the mucogingival junction of both sides of the maxilla in 20 patients (13 women and 7 men; age: 32.5 ± 6.1 years).


Eligibility criteria: Inclusion Criteria:

* patients with class II malocclusion defect requiring lateral maxillary teeth distillation based on the use of orthodontic mini-implant;
* the patients were treated first time using fixed orthodontic appliance;
* no systemic diseases;
* were not using anti-inflammatory drugs;

Exclusion Criteria:

* had used antibiotics in the previous 24 months;
* smokers;
* had history of radiotherapy,
* taking bisphosphonate medication

Primary outcomes:
measure: stability of orthodontic mini-implants
timeFrame: 60 days
Secondary outcomes:
measure: Pain level
timeFrame: 24 hours
measure: mini-implants loss
timeFrame: 60 days
Other outcomes:
Locations:
city: Wschowa
country: Poland
facility: Private Dental Healtcare
Study officials:
References:
Clinical trial NCT03065205: Breathing Counts: Evaluating Adherence in the Presence of Asthma Navigation Support
Official title: Breathing Counts: Evaluating Adherence in the Presence of Asthma Navigation Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 65
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine if an asthma navigator is helpful in improving communication between care providers and improving patient adherence to asthma medications after an asthma exacerbation.

Detailed description: This study will aim to use technology to evaluate the effectiveness of a patient navigator for childhood asthma. The Investigators will place adherence monitoring devices on patient inhalers, and track use of patient asthma medicines. The Investigators will also utilize an asthma navigator who will discuss adherence with families and help to address any barriers to adherence that families identify. Additionally, the navigator will communicate patient specific adherence information to the patient's primary care physician (PCP) and school nurse. The adherence monitor will monitor communications between these providers.

Eligibility criteria: Inclusion Criteria:

* Age 6-17 years old,
* Admission to Children's Hospital Colorado with an asthma exacerbation between Jan 1 2017 and Dec 31 2017.

Exclusion Criteria:

* Language other than English or Spanish (application for monitoring adherence is only available in these languages)
* Presence of other complex medical problems including:

  * Cystic Fibrosis,
  * Tracheostomy/ventilator dependence,
  * other severe chronic lung disease, and
  * significant developmental delays.
* Home schooled or not in school
* Following up with an allergy or pulmonary provider outside the CHCO system after hospital discharge.

Primary outcomes:
measure: Change in Adherence of Use of Patient Asthma Inhalers
timeFrame: Week 1 to Week 24
Secondary outcomes:
measure: Degree of Asthma Control
timeFrame: 6 months
measure: Barriers to Adherence of Patient Asthma Inhalers
timeFrame: 6 months
measure: Effectiveness of Communication Between Providers
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Childrens Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Heather E Hoch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06876805: The Role of Ceus in the Characterization of Focal Liver Lesions Indeterminate to Second-level Methods
Official title: The Role of Contrast Enhanced Ultrasond (Ceus), in the Characterization of Focal Liver Lesions Indeterminate to Second-level Methods
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Focal Liver Lesion
Keywords: CEUS
Ultrasound
Liver
HCC
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 100
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: All patients who have previously resulted positive to CT, MRI and/or PET scans for liver lesions but with no information on the nature of the lesion and that will undero CEUS for further characterization of the lesion(s) will be consecutively enrolled.

Brief summary: The primary objective of the study is to determine the accuracy of CEUS in characterizing (as benign or malignant) focal liver lesions for which CT, MRI and/or PET have not been conclusive.

Detailed description: The study conducted will be a non-profit, observational, non-pharmacological, cross-sectional, but also partly cohort, retrospective and prospective study. The study is cross-sectional in nature, but will require 6 months of follow-up to evaluate the gold standard reference outcome in patients diagnosed with a benign pathology that does not require further investigations, and in patients with suspected malignant lesion for which histological diagnosis has not been performed on biopsy.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years.
* CEUS performed performed in the last 6 months a CT, MRI and/or PET not decisive in characterizing a liver lesion.
* Obtaining informed consent.

Exclusion Criteria:

* Technical impossibility to perform the ultrasound evaluation.
* Documented allergy to the ultrasound contrast medium.

Primary outcomes:
measure: CEUS diagnostic accuracy
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola Malpighi
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Carla Serra, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01675505: Psychological Well-being Outcomes in Disease-free Survivors of Colorectal Cancer Following Curative Surgery
Official title: Psychological Well-being Outcomes in Disease-free Survivors of Colorectal Cancer Following Curative Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adaptation, Psychological
Functional Insufficiency
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Greek population from Northern Greece who are diagnosed with colon cancer for the first time and are admitted to the 1st Propedeutic Surgical Department of AHEPA General University Hospital of Thessaloniki for surgery.

Brief summary: The purpose of the study is to investigate whether there are prognostic factors regarding the mental and functional adjustment of colon cancer patients following curative surgery. Patients will be selected using specific inclusion criteria. Prognostic factors investigated include personality characteristics, initial distress, medical, social and economic factors. The utmost purpose of the study is to assist clinicians with the timely identification of vulnerable patients in order to ensure their proper management and their optimal adjustment.

Moreover this is the first study using the Distress Thermometer in Greek patients with cancer.


Eligibility criteria: Inclusion Criteria:

* Patients with first-diagnosed colon cancer.
* Age 18-60 years

Exclusion Criteria:

* Metastatic colon cancer.
* Former psychiatric history.
* Substance use.
* Previous serious medical conditions.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Greece, 1st Propedeutic Surgical Department, AHEPA General University Hospital
Study officials:
References:
citation: Jimmie C. Holland, William S. Breitbart, Paul B.Jacobsen, Marguerite S. Lederberg, Matthew J. Loscalzo, Ruth McCorkle. Psycho-oncology, second edition, Oxford University Press, 2010 National Comprehensive Cancer Network. Distress management. Clinical practice guidelines. J Natl Compr Canc Netw. 2003;1:344-74. Ward WL, Hahn EA, Mo F, Hernandez L, Tulsky DS, Cella D. Reliability and validity of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) quality of life instrument. Qual Life Res. 1999;8:181-95. Watson M, Law M, dos Santos M, Greer S, Baruch J, Bliss J. The Mini-MAC: further development of the Mental Adjustment to Cancer Scale. J Psychosoc Oncol1994;12:33-46.
Clinical trial NCT00543205: Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic Impairment
Official title: A Pharmacokinetic Study of Genasense® (Bcl-2 Antisense Oligonucleotide) in Combination With Dacarbazine (DTIC) in Subjects With Advanced Melanoma and Normal or Impaired Hepatic Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Advanced Melanoma and Normal or Impaired
Hepatic Function
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2007-10-12
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, parallel-group study with a total of 16 evaluable subjects. Subjects will be assigned to 1 of the following cohorts: Cohorts I (subjects with normal hepatic function; n+8 and Cohort II (subjects with moderate hepatic impairment, Child-Pugh classification Grade B; n=8). If, for any reason, the Genasense infusion is interrupted or discontinued prior to completion or the rate of administration of the Genasense infusion is changed, the subject will be replaced.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of malignant melanoma
* Metastatic Stage IV disease, or Stage III disease that is not surgically resectable
* ECOG Performance status of 0,1,or 2
* Adequate venous access
* Agreement to practice effective methods of birth control
* Hepatically impaired consistent with Child-Pugh classification Grade B

Exclusion Criteria:

* Chronic intravascular coagulopathy confirmed by the presence of fibrinogen degradation products, metastases to the liver, or exudative ascites
* Prior organ allograft
* Requirement for concomitant anticoagulant therapy (with the exception of 1 mg/day of warfarin for central line prophylaxis) while receiving protocol therapy
* Known hypersensitive to DTIC
* Prior treatment with Genasense

Primary outcomes:
measure: Pharmacokinetics of G3139
timeFrame: 6-day period
Secondary outcomes:
measure: Safety
timeFrame: 30 days post last dose of study medication
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02805205: PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy to Prevent Neutropenia
Official title: A Multi-center, Open-label,Single Arm Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia in Patients With Breast Cancer Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: PEG-rhG-CSF neutropenia
Lead sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-06-17
Enrollment: 484
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: PREVENTION

Brief summary: The purpose of this study is to estimate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients with age between 18 and 70 years
* diagnosis of breast cancer patients who need to receive multi-cycle chemotherapy
* grade III/IV neutropenia after chemotherapy
* KPS score≥70
* life expectancy of at least 3 months
* Written informed consent are acquired

Exclusion Criteria:

* Have accepted any other drug related clinical trial within 4 weeks before anticipated
* uncontrolled infection
* pregnancy
* Other situations that investigators consider as contra-indication for this study

Primary outcomes:
measure: the occurrence rate of the adverse events that are related to treatment during four consecutive cycles chemotherapy
timeFrame: up to 30 days after the patient study completion
measure: the severity of the adverse events that are related to treatment during four consecutive cycles chemotherapy
timeFrame: up to 30 days after the patient study completion
Secondary outcomes:
measure: the occurrence rate of III/ IV neutropenia during the whole chemotherapy process
timeFrame: through the study completion,an average of 5 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04703998: Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma
Official title: Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma. Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 103
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: To assess whether the use of platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair. Hypothesis: Platelet rich plasma used as an adjuvant to arthroscopic rotator cuff repairs decrease the rate of retears.

Detailed description: Platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair.

Eligibility criteria: Inclusion Criteria:

* Adults between 50 and 75 years with a defined complete rotator cuff tear as compatible clinical and confirmation by magnetic resonance imaging (MRI).
* Minimum of 3 months of failed conservative treatment (anti-inflammatory, physical therapy and infiltration with corticosteroids)

Exclusion Criteria:

* Refusal to participate or informed consent,
* Revision surgery,
* Partial repair,
* Patients with shoulder osteoarthritis\> 2
* Advanced fat infiltration of the rotator cuff muscles (STAGE 3 or 4)
* Systemic or rheumatoid arthritis,
* Uncontrolled diabetes, (patients for whom surgery is contraindicated in the preoperative evaluation by the clinician and anesthesiologist)
* Acute or chronic infections of the shoulder to be operated on
* Ongoing cancer chemotherapy therapies
* Sepsis, septic arthritis, osteomyelitis or other ongoing infectious processes;
* Previous operations on the affected shoulder,
* Patients with autoimmune diseases;
* Pregnant

Primary outcomes:
measure: Comparison of re-tear rates between groups.
timeFrame: 6 months
Secondary outcomes:
measure: Change From baseline in shoulder functional scores at 3, 6 and 12 months
timeFrame: baseline, 3, 6, and 12 months
measure: Change From baseline in pain at 3, 6 and 12 months
timeFrame: baseline, 3, 6, and 12 months
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: 3, 6, and 12 months
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Luciano Rossi, MD
role: PRINCIPAL_INVESTIGATOR
References: