louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04612907: Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer
Official title: A Randomized Phase III, Multicenter Study to Evaluate Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Radiotherapy Side Effect
Metastatic Cancer
Keywords: Metastatic prostate cancer radiotherapy primary tumor
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 420
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to one of two treatment fractionations of radiotherapy
Primary purpose: TREATMENT

Brief summary: de Novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate. Two different fractionation schedules will be tested.

Detailed description: Patients with de Novo metastatic prostate cancer with limited disease spread has been shown to gain benefit from local radiotherapy to the prostate. The internationally accepted fractionation schedule is 3 Gy (Gray) x 19-20 over a course of 4 weeks.

There is continous evidence for even more hypo-fractionated radiotherapy with higher fractionation doses. We will test if the schedule of 6.1Gy x 6 compares to standard of 3 Gy x 19 with regard to patient reported side-effects.

Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent
2. Histological confirmed prostate cancer
3. Indication for early palliative radiation therapy of low burden metastatic prostate cancer. Low burden as defined by modified CHAARTED trial criteria to maximum 4 skeletal mets at any site and/or any number of lymph nodes
4. baseline E-PROM

Exclusion Criteria:

1. High burden metastatic prostate cancer including all with visceral mets.
2. Unable to comply with study procedures.
3. Other diseases or medication that will put the patient at risk for more toxicity from radiotherapy
4. Radiation treatment start later than nine months after the prostate cancer diagnosis.
5. Severe micturition problems, IPSS \> 20 ( International Prostate Symptom Score)

Primary outcomes:
measure: Toxicity as scored by PROM (Patient Reported Outcome Measures) at 8 weeks
timeFrame: 8 weeks
measure: Toxicity as scored by PROM at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Failure free survival
timeFrame: 12 months, 36 months
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Cancercenter University hospital of Umeå
Study officials:
affiliation: Cancercentrum Umeå University
name: Camilla of T Karlsson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04382807: Internet-delivered Group Counseling for Chronic Tinnitus
Official title: Internet-delivered Group Counseling for Chronic Tinnitus
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Tinnitus, Subjective
Keywords: tinnitus treatment
delivery method
psycho-educational counseling
internet-based
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjective, chronic tinnitus patients

Brief summary: In the treatment of chronic tinnitus, psycho-education plays an import role to provide more insights into the symptoms of tinnitus. However, the need for e-health is increasing. As such, it is important to investigate if these psycho-education sessions can be delivered online, with the same efficacy compared to the traditional face-to-face delivery.


Eligibility criteria: Inclusion Criteria:

* Patients with subjective, chronic tinnitus

Exclusion Criteria:

* Enrollment in other tinnitus treatments simultaneously at the time of the intervention

Primary outcomes:
measure: Change in Tinnitus Functional Index (TFI)
timeFrame: before intervention, 3 months follow-up
Secondary outcomes:
measure: Change in Visual Analogue scale (VAS) for tinnitus loudness
timeFrame: before intervention, 3 months follow-up
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: before intervention, 3 months follow-up
measure: Change in Hyperacusis Questionnaire (HQ)
timeFrame: before intervention, 3 months follow-up
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
Study officials:
References:
Clinical trial NCT01940107: Domiciliary Physiotherapy in Women Undergoing Treatment for Breast Cancer Radiation
Official title: Domiciliary Physiotherapy in Women Undergoing Treatment for Breast Cancer Radiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frozen Shoulder,
Shoulder Pain
Keywords: breast cancer,
radiotherapy,
physical therapy,
upper limb
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To observe the effect of domiciliary physiotherapy on the upper limb applied during the period of radiotherapy in women submitted to surgical and radiotherapy for breast cancer. The parameters evaluated were: shoulder range of movement (ROM) and arm circumference. There was significant difference between the ipsilateral and contralateral limbs for flexion, abduction and external rotation. There was no difference in perimetry in either group


Eligibility criteria: Inclusion Criteria:

* be diagnosed with unilateral breast cancer;
* be submitted to surgical and radiation treatment as part of the treatment for breast cancer.

Exclusion Criteria:

* patients with neurological or orthopedic diseases that could impair the upper limb movements
* bilateral breast cancer;
* prior thoracic radiotherapy;
* presence of distant metastasis.

Primary outcomes:
measure: Recovery of shoulder range of movements (ROM) and prevention of arm lymphedema
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas de Ribeirão Preto da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
state: Saõ Paulo
Study officials:
References:
Clinical trial NCT02709707: Lay-user Trial of the iGlucose Blood Glucose Monitoring System
Official title: A Lay User Study of the iGlucose, a Device for Self-Monitoring of Blood Glucose (SMBG), Marketed by the Smart Meter Corporation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes, Blood Sugar
Lead sponsor: Smart Meter Corporation
Sponsor class: INDUSTRY
First posted: 2016-03-16
Enrollment: 153
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a diagnosis of diabetes, either type 1 or type 2, of various duration with blood glucose levels covering the entire measurement range. .

Brief summary: Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users

Detailed description: A non-randomized, prospective study of recruited subjects with diabetes. Subjects will include those with type I or type II diabetes of various duration and those who are naive to self-testing of blood glucose. Subjects will use provided instructions-for-use to undergo self-training on the use of the device and will then self-test their blood glucose level. Results will be compared to those obtained by a lab glucose analyzer.

Eligibility criteria: Inclusion Criteria:

* Be 12 years of age and older
* Have pre-existing diagnosis of diabetes
* Be able to read and understand English
* Agree to participate in the study
* Be able and willing to provide informed consent

Exclusion Criteria:

* Do not meet Inclusion Criteria
* With Hemophilia or any other bleeding disorder
* With any condition which in the opinion of the Investigator may place the subject or site staff at excessive risk
* With physical condition/limitation preventing the use of SMBG on their own

Primary outcomes:
measure: Accuracy of blood glucose measurements as performed by lay users
timeFrame: 10 minutes to produce self blood result and to perform lab comparative method
Secondary outcomes:
measure: Assessment by lay users of the ease of use of the iGlucose Blood Glucose Monitoring System
timeFrame: 2 -3 hours of going through a self-training session and producing an assessment
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
Study officials:
References:
Clinical trial NCT03240107: Levator Resection with3 Point Fixation Versus 2 Point Fixation Tucking for Congenital Ptosis
Official title: Standard Levator Aponeurosis / Muscle Resection With Three Point Fixation Versus Two Point Fixation Tucking for Congenital Ptosis With Fair to Good Levator Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Ptosis
Keywords: levator resection
levator tucking
Fair levator function
Eyelid contour
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-08-04
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to evaluate the surgical effect of levator aponeurosis resection Versus two point fixation levator aponeurosis Tucking for Congenital Ptosis

Detailed description: Target population for the study is children under twelve years old presenting to ophthalmology clinic at Cairo university specialized pediatric hospital with congenital ptosis.

Patients will be randomly divided into two groups First group (A) will contain 20 patients who will undergo standard levator aponeurosis resection Second group (B) will contain 20 patient who will undergo two point fixation levator tucking

Eligibility criteria: Inclusion Criteria:

1. Unilateral or bilateral simple isolated congenital ptosis.
2. Levator function more than 4mm

Exclusion Criteria:

1. Congenital ptosis associated with other ocular syndromes.
2. Recurrent ptosis following any attempt for repair.
3. Traumatic ptosis or acquired ptosis
4. -ve bell's phenomenon.

Primary outcomes:
measure: Comparison of surgical efficacy of standard levator aponeurosis resection and two point fixation tucking regarding MRD1
timeFrame: 6 to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo City
country: Egypt
facility: HEBA
state: Zahraa AL Maadi
Study officials:
affiliation: Cairo University
name: RANIA AS EL ASSAWY, PhD
role: STUDY_CHAIR
affiliation: Cairo University
name: Sameh HA ABDEL BAKY, MD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: DINA HO HASSANIEN, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02019407: Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus Block in Patients With Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
atrial flutter
catheter ablation
cavo-tricuspid isthmus block
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus (CTI) Block in Patients with Paroxysmal Atrial Fibrillation (PAF) will be performed. Study will be composed with two arms including 4 pulmonary vein isolation and pulmonary vein isolation with CTI block. After that all patients will be followed up by HRS(Heart Rhythm Society) 2010 expert consensus guideline.


Eligibility criteria: Inclusion Criteria:

* patients with documented AF
* Drug refractory AF
* Non-valvular AF
* No structural cardiac disease
* No intracardiac thrombi in cardiac CT and TEE

Exclusion Criteria:

* permanent AF refractory to electrical cardioversion
* LA size \>55 mm as measured by echocardiography
* AF with valvular disease
* associated structural heart disease other than left ventricular hypertrophy
* prior AF ablation.

Primary outcomes:
measure: Recurrence of Atrial fibrillation (AF free survival)
timeFrame: 3 month after catheter ablation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ivision of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
Study officials:
References:
citation: Mohanty S, Mohanty P, Di Biase L, Bai R, Santangeli P, Casella M, Dello Russo A, Tondo C, Themistoclakis S, Raviele A, Rossillo A, Corrado A, Pelargonio G, Forleo G, Natale A. Results from a single-blind, randomized study comparing the impact of different ablation approaches on long-term procedure outcome in coexistent atrial fibrillation and flutter (APPROVAL). Circulation. 2013 May 7;127(18):1853-60. doi: 10.1161/CIRCULATIONAHA.113.001855. Epub 2013 Apr 9.
Clinical trial NCT00725907: Treatment of ATFL Tears With PRP
Official title: Treatment of ATFL Tears After Ankle Sprains With PRP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Healing
Keywords: PRP
ATFL
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2008-07-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: PRP will enhance ATFL tears healing by time and quality.


Eligibility criteria: Inclusion Criteria:

* athletes 18-30 years old 1st sprain within 3 days from injury

Exclusion Criteria:

Primary outcomes:
measure: time to return to active sport
timeFrame: 2
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: omer mei-dan, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02700607: Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity
Official title: Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Coiling Embolization Procedure for Cerebral Artery Aneurysm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Aneurysm
Keywords: cerebral aneurysm, coiling embolization, blood viscosity
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing interventional cerebral aneurysm coiling procedure are enrolled in this prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES (n=15).

All recruited patients will be given patient identification number (PIN) for the present study of 01-30 according to their order of interview and recruitment. Investigators will prepare 15 yellow and 15 green cards, which will be inserted in 20 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30 (Envelop number). After printing the envelope number outside envelope, all sealed envelopes with cards will be conveyed to and kept in pharmacy department.

According to the color of the card, attending anesthesiologists will give crystalloid for yellow card or HES for green cards, respectively, to maintain stroke volume variation lesser than 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.

Patient data and statistical analyses:

Patients demographic data, whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be obtained


Eligibility criteria: Inclusion Criteria:

* Patients undergoing coiling embolization procedure due to cerebral aneurysm
* Patients provided a written informed consent.
* Patients with preoperative serum hemoglobin concentration \>13 g/dL (male) and \>12 g/dL (female)
* Patients with PaO2/FiO2 ratio \>150

Exclusion Criteria:

* Patients with history of anemia, dyspnea, active infection.
* Patients with endocrine disease
* Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-platelet drug, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.

Primary outcomes:
measure: whole blood viscosity
timeFrame: with 1 hour after the completion of procedure
Secondary outcomes:
measure: PaO2/FiO2 ratio
timeFrame: 1 hour after the completion of procedure
measure: hematocrit
timeFrame: 1 hour after the completion of procedure
measure: glucose
timeFrame: 1 hour after the completion of procedure
measure: osmolarity
timeFrame: 1 hour after the completion of procedure
measure: urine output
timeFrame: 1 hour after the completion of procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02822807: Q Fever and Auto-immunity
Official title: Q Fever and Auto-immunity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Q Fever
Auto-Immunity
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The IHU Mediterranean infection is national reference centre for Q fever. Coxiella burnetii is the bacteria responsible of this infection. The bacterium Coxiella burnetii infection is associated with secretion by the body both many antibodies against the bacteria but also against certain cells of the body (autoantibodies). These autoantibodies may have no effect or be associated with specific symptoms. Anti-Phospholipid antibodies are especially prevalent in the Q fever. Apart from this infection, they are associated with thrombocytopenia, obstetric complications, thrombosis and heart valve damage. These conditions have also been described as complications during Q fever. In a retrospective preliminary work on Q fever, we have shown that the presence of high levels of IgG anti-cardiolipin was associated with the presence of valvular and the evolution to endocarditis. Such associations have a therapeutic involvement and must therefore be confirmed. Indeed, if these associations were confirmed, a trans-esophageal ultrasound could be systematically proposed to patients with valvular disease of trans-thoracique ultrasound but IgG anticardiolipin high levels. Other special attention could be given to patients with high autoantibodies.


Eligibility criteria: Inclusion Criteria:

* Patients with a current or former Q fever diagnosis
* Patient \> or = 18 years old.
* Patient who does not declined to have his medical records reviewed for research.
* Patient with health insurance.

Exclusion Criteria:

* Minor patient (\<18 years )
* Adult patient under guardianship .
* Patient deprived of liberty or judgment.
* Patient refusing to sign the informed consent form .

Primary outcomes:
measure: Occurrence of a complication, linked to the rate of autoantibodies.
timeFrame: 2 years
Secondary outcomes:
measure: Rate of anti- cardiolipin antibodies
timeFrame: 1 day
measure: Rate of anti- phagosome autoantibodies
timeFrame: 1 day
Other outcomes:
Locations:
city: Marseille Cedex 05
country: France
facility: Assistance Publique - Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique - Hôpitaux de Marseille
name: Didier RAOULT, PR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00039507: Radiofrequency Ablation During Surgery in Treating Patients With Non-Small Cell Lung Cancer
Official title: Pilot Study: Radiofrequency Ablation Of Resectable Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer
stage II non-small cell lung cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining radiofrequency ablation with surgery in treating patients who have stage I or stage II non-small cell lung cancer.

Detailed description: OBJECTIVES:

* Determine the acute effects of intraoperative radiofrequency tumor ablation (RFA) in patients with resectable non-small cell lung cancer.
* Determine the treatment-related toxicity in patients treated with this therapy.
* Determine the dimensions of the RFA lesion produced by the ablation procedure in these patients.

OUTLINE: Patients undergo intraoperative radiofrequency tumor ablation over 10-15 minutes for each tumor immediately followed by tumor resection.

PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of malignant non-small cell lung cancer (NSCLC)

  * Intraoperative needle biopsy confirmation allowed
* Resectable disease (stage I or II)
* All tissue to be treated by radiofrequency tumor ablation must be completely contained within boundaries of planned lung resection
* Medically fit to undergo lung resection

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior or concurrent biologic therapy

Chemotherapy:

* No prior or concurrent chemotherapy

Endocrine therapy:

* No prior or concurrent endocrine therapy

Radiotherapy:

* No prior or concurrent radiotherapy

Surgery:

* See Disease Characteristics

Other:

* No other prior therapy for NSCLC

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Walter J. Scott, MD, FACS
role: STUDY_CHAIR
References: