louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01483443: Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients
Official title: Prophylactic Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Patients With or Without Ovarian Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stage IV Colon Cancer
Keywords: oophrectomy
survival
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 140
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective phase III trial to define the role of oophorectomy in metastatic colorectal cancer patients with ovarian metastasis.

Detailed description: A recent study demonstrated that colorectal cancer with ovarian metastases were less responsive to chemotherapy compared to extraovarian metastases. The survival impact of oophorectomy has not been defined yet in this clinical setting. The incidence of microscopic ovarian metastasis has been reported to be approximately 10%. Therefore, the investigators propose a prospective study of oophorectomy followed by standard chemotherapy versus standard chemotherapy alone to determine whether oophorectomy increases survival.

Eligibility criteria: Inclusion Criteria:

1. age ≥ 18
2. histologically confirmed adenocarcinoma of colon
3. documented ovarian metastasis in CT or MRI or PET-CT
4. advanced (stage IV), metastatic, or recurrent
5. ECOG performance status of 0\~2
6. adequate marrow, hepatic, renal and cardiac functions
7. no prior surgical treatment to ovary
8. provision of a signed written informed consent

Exclusion Criteria:

1. patient who refuses oophorectomy
2. medical condition in which surgery cannot be tolerated Any waiver of these inclusion and exclusion criteria must be approved by the investigator on a case-by case basis prior to enrolling the subject. This must be documented by the investigator. No subject will be allowed to enroll in this study more than once.

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Disease free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Won-Suk Lee
Study officials:
affiliation: Gachon Univ. GIl Hospital
name: Won-Suk Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moore RG, Chung M, Granai CO, Gajewski W, Steinhoff MM. Incidence of metastasis to the ovaries from nongenital tract primary tumors. Gynecol Oncol. 2004 Apr;93(1):87-91. doi: 10.1016/j.ygyno.2003.12.039.
Clinical trial NCT06734143: High Diagnostic Performance of the Indicator Plaster Neuropad for the Detection of Diabetic Autonomic Neuropathy
Official title: Diagnostic Performance of the Indicator Plaster Neuropad for the Detection of Diabetic Autonomic Neuropathy: a Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Autonomic Neuropathy
Diabetic Neuropathy
Keywords: diabetic neuropathy
neuropad
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
First posted: 2024-12-16
Enrollment: 174
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: people with diabetes mellitus

Brief summary: Diabetic autonomic neuropathy (DAN) is a prevalent and severe complication of Diabetes Mellitus (DM). When the autonomic regulation of the cardiovascular system is affected, it is referred to as cardiovascular autonomic neuropathy (CAN), the most critical subtype of DAN. Early diagnosis of CAN is crucial, as it can identify patients at elevated risk for cardiovascular complications. This study aimed to assess the Neuropad test's effectiveness, specificity, sensitivity, and accuracy as a diagnostic tool for detecting DAN.

Detailed description: Diabetic autonomic neuropathy (DAN) is a prevalent and severe complication of Diabetes Mellitus (DM). When the autonomic regulation of the cardiovascular system is affected, it is referred to as cardiovascular autonomic neuropathy (CAN), the most critical subtype of DAN. Early diagnosis of CAN is crucial, as it can identify patients at elevated risk for cardiovascular complications. This study aimed to assess the Neuropad test's effectiveness, specificity, sensitivity, and accuracy as a diagnostic tool for detecting DAN.

Eligibility criteria: Inclusion Criteria:

* diabetes mellitus

Exclusion Criteria:

* age\>75 years,
* estimated creatinine clearance rate (using the Cockcroft-Gault formula) \<30 ml/ min,
* history of limp amputation,
* causes of neuropathy other than diabetes,
* drugs that can affect perspiration, and
* skin disorders that could affect the result.

Primary outcomes:
measure: sensitivity, specificity and accuracy of Neuropad to detect DAN
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: University General Hospital of Thessaloniki AHEPA
Study officials:
affiliation: University Hospital Tuebingen
name: Konstantinos Kantartzis, Professor MD
role: STUDY_DIRECTOR
affiliation: Aristotle University Of Thessaloniki
name: Triantafyllos Didangelos, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02090543: BAY 59-7939 (Xarelto, SPAF), Non Interventional Studies
Official title: Rivaroxaban Versus Vitamin K-Antagonist (VKA) in Thromboprophylaxis of Patients With Atrial Fibrillation: Patient Preference Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2014-03-18
Enrollment: 647
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: Adult AF-patients, within 3 month of anticoagulation (VKA or rivaroxaban) therapy, recruited by GPs

Brief summary: According to recent guidelines, long-term anticoagulation is recommended for patients with atrial fibrillation (AF) and a risk profile with CHA2DS2-VASc score of 1 or more. Vitamin K antagonists(VAK) and novel oral anticoagulants such as rivaroxaban are current treatment options for AF patients with additional risk factors for stroke. Currently there are only limited information to what extend AF patients prefer one or the other treatment option based on patient relevant characteristics of novel oral anticoagulants vs. VKAs. It is also unknown which of the characteristics influences patient preference most and how this relates to a neutral comparator. Furthermore, an additional unknown factor is also how patient evaluate their current treatment and if this leads to differences among treatment with VKAs and rivaroxaban.


Eligibility criteria: Inclusion Criteria:

A.General Criteria (Group 1and Group2):

* diagnosed non-valvular AF
* older than 18 years
* general capability and willingness to perform a structured patient interview in German
* no participation in any other clinical or observational study over the last 3 month

Additional criteria for Group1 (VKA-experienced):

* active VKA-therapy for at least 3 month without significant interruptions
* in case of perioperative interruption VKA treatment should not have been hold for more than two weeks.

Additional criteria for Group2 (rivaroxaban-experienced patients):

* active rivaroxaban-therapy for at least 3 month without significant interruptions
* in case of perioperative interruption VKA treatment should not have been hold for more than two weeks.

Exclusion Criteria:

* participation in any other clinical or observational study over the last 3 month

Primary outcomes:
measure: A prescription of patient preferences pattern including 5 attributes for Discrete-Choice-Experiment(DCE)-design in patients with atrial fibrillation
timeFrame: Within 1-4 weeks after patient enrollement
measure: Patient relevant burden/benefit due to anticoagulation using the ACTS-questionnaire
timeFrame: At study entry
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01270243: Bacterial Microbiota In The Tonsils Of Children
Official title: Bacterial Microbiota In The Tonsils Of Children Undergoing Adenotonsillectomy And Normal Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenotonsillitis
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2011-01-05
Enrollment: 24
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children undergoing adenotonsillectomies at the Comer Children's Hospital

Brief summary: We, the investigators, propose to look at the bacteria on and in tonsils using gene microarrays. We expect to find previously reported bacteria but also the possibility of previously undetected organisms. We think that the bacterial pathogens present on the tonsillar surface are different from the tonsil core. And we also think that the bacteria of the tonsil surface will differ between patients undergoing adenotonsillectomy and normal controls with no adenotonsillar problems.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria for subjects undergoing surgery:

* Age 2-12 yrs
* Both males and females
* Undergoing adenotonsillectomy

Additional criteria for subjects in the recurrent infection group:

* Sleep questionnaire score \<5
* Designated by surgeon as having recurrent adenotonsillitis as reason for surgery

Additional criteria for subjects in the airway obstruction group:

* Sleep questionnaire score \>5
* Presence of positive polysomnogram desired but not necessary
* Designated by surgeon as having airway obstruction or sleep apnea as reason for surgery

Inclusion criteria for control subjects:

* Age 2-12 yrs
* Both males and females
* No history of adenotonsillar problems
* Sleep questionnaire score \< 5

Exclusion Criteria:

Exclusion Criteria for both groups:

* Antibiotic intake in the past 10 days
* Other major medical problems (immune deficiency, cystic fibrosis, malignancy) In the surgery group: designated by surgeon as having both recurrent adenotonsillitis and airway obstruction as reason for surgery Menstruating females

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Fuad M Baroody, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00616343: Zonisamide in the Treatment of Essential Tremor
Official title: Pilot Study of Zonisamide in the Treatment of Essential Tremor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Essential Tremor
Keywords: ET
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2008-02-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if Zonisamide is effective in reducing tremors in patients with Essential Tremor.

Detailed description: The subjects will remain on their usual medication and a baseline assessment using the Fahn Tolosa Marin tremor rating scale will be performed and will be video taped.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Essential Tremor based on the Tremor Investigational Group criteria for definite or probable Essential Tremor.
2. Age: 18 years or over.
3. Willingness and ability to comply with the study requirements and give informed consent.

Exclusion Criteria:

1. Known history of psychiatric disorder, major depression, dementia, aplastic anemia, or Stevens-Johnson syndrome.
2. Known alcohol or substance abuse in previous 12 months.
3. Positive pregnancy test.
4. Unwillingness to use adequate contraceptive methods if of childbearing potential.
5. Known allergy to sulfonamides.
6. Laboratory abnormalities prior to onset of trial.

Primary outcomes:
measure: Tremor Severity
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Loma Linda University
name: David M Swope, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03516643: Extracorporeal Shockwave Myocardial Revascularization in Refractory Angina
Official title: Improving Myocardial Perfusion in Refractory Angina. Extracorporeal Shockwave Myocardial Revascularization in a Large Prospective Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angina Refractory
Angina Pectoris
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective cohort study to examine the efficacy of ESMR application in patients with refractory angina despite optimal medical therapy, not suitable for further PCI or CABG. Characteristics such as angina class scores (CCS class score), nitroglycerin consumption and hospitalization were compared at baseline and 1, 6 and 12 months after ESMR therapy. The effect on cardiac perfusion was assessed at 6 months.


Eligibility criteria: Inclusion Criteria:

* history of coronary artery disease;
* refractory angina pectoris, defined as the persistence of a angina pectoris (Canadian Cardiovascular Society class ≥ 2) for more than 3 months, despite the use of optimal medical therapy (which included β blockers, calcium channel blockers, long-acting nitrates, ivabradine, ranolazine and trimetazidine, up-titrated to the maximal tolerated dose) and coronary disease not amenable for further revascularization (as determined by an interventional cardiologist and cardiac surgeon);
* stable maximal medical therapy for at least 6 weeks;
* stress-induced ischemia at baseline SPECT;
* left ventricular ejection fraction higher than 40%;
* age higher than 18 years.

Exclusion Criteria:

* myocardial infarction or unstable angina in the previous 3 months,
* acute myocarditis, pericarditis, left ventricular thrombus, cardiac malignancies, chronic pulmonary disease (including emphysema and pulmonary fibrosis), endocarditis
* pregnancy

Primary outcomes:
measure: Improvement of myocardial perfusion
timeFrame: 6months after ESMR
Secondary outcomes:
measure: Reduction of symptoms
timeFrame: 1, 6, 12 months
measure: Reduction of symptoms
timeFrame: 1, 6, 12 months
measure: Reduction of symptoms
timeFrame: 1, 6, 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Città della Salute e della Scienza of Torino
name: Gianluca Alunni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06740643: Evaluation of Intracanal Reinforcement with Short Composite Post in Upper Primary Incisors with Severly Carious Teeth As in Early Childhood Caries Cases Using Randomized Clinical Trial
Official title: Evaluation of Intracanal Reinforcement with Short Composite Post in Upper Primary Incisors: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Composite Post
Intracanal Reinfocement
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 62
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Severely damaged incisors may lead to difficulty in speech, decreased masticatory efficiency, abnormal tongue habits, subsequent malocclusions, and psychological and self-esteem problems. There are several methods mentioned in the literature for the restoration of severely decayed primary anterior teeth. The benefits of pulp therapy include: removing cavitations or defects to eliminate areas that are susceptible to caries; stopping the progression of tooth demineralization; restoring the integrity of tooth structure; preventing the spread of infection and preventing the shifting of teeth due to loss of tooth structure. The risks of pulp therapy include lessening the longevity of teeth by making them more susceptible to fracture as after removal of gross caries lesion and gaining access to the pulp the tooth become too weak, recurrent lesions, restoration failure, complications, and iatrogenic damage to adjacent teeth.

There are different techniques can be used for gaining intracanal retention in primary teeth. one of these techniques is resin composite posts.

Composite post restorations have been in used in primary teeth from 1986. They yield satisfactory results when there is normal masticatory function, a balanced diet, and hygiene control.

The evidence to support any method of intracanal reinforcement for restoring grossly broken down anterior teeth is presently lacking.

This study aims to Evaluate the intracanal reinforcement with short composite post in upper primary incisors versus no reinforcement.


Eligibility criteria: Inclusion Criteria:

* Children Criteria:

  * Medically free.
  * Cooperative patient.
  * Age (3 - 5 years)

Incisors criteria:

• Upper primary incisors show large carious lesions.

Radiographic criteria:

• No evidence of internal/external pathologic root resorption.

Exclusion Criteria:

* • Uncooperative children.

  * Children with systemic disease.
  * Refusal of participation in the study.

Primary outcomes:
measure: Crown success
timeFrame: 1 year
Secondary outcomes:
measure: Clinically :Gingival health.
timeFrame: 1 year
measure: Radiographic assessment.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Rana T Brtaw, Lecturer
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Ahmed H Elkadem, professor
role: STUDY_CHAIR
References:
Clinical trial NCT06039943: Relationship Between Acoustic Breath Sounds and Spirometry
Official title: A Comparative Single Centre Study Assessing the Relationship Between Acoustic Breath Sounds as Measured by a Commercially Available Sound Recording Device Against Standard of Care (Spirometry) in the Assessment of Airflow Obstruction in Patients Who Plan to Undergo Spirometry Testing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma COPD
Lead sponsor: University Hospital Birmingham
Sponsor class: OTHER
Collaborators: name: Respiri US
First posted: 2023-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to assess whether wheeze as assessed by a commercially available wheeze monitor is comparable to lung function as measured during a spirometry test. The main questions it aims to answer are whether measures of airflow obstruction (FEV1, FEV1/FVC, PEF) correlate with wheeze score (Tw/Ttot%).

Participants consenting to take part will undergo wheeze measurement prior to and during a spirometry test and will be asked to complete a series of symptom questionnaires.


Eligibility criteria: Inclusion Criteria:

* Consenting adult (aged 18-95) University Hospitals Birmingham patient's attending the Lung Function and Sleep Department (LF\&S) routinely as part of their standard clinical management pathway for Lung Function testing that includes Spirometry assessments.
* All patients irrespective of condition will be approached to participate.

Exclusion Criteria:

* Subjects who are contraindicated to perform spirometry on the day of testing
* Subjects who cannot speak or read English
* Patients accessing non-adult services
* Subjects who are unable or do not wish to consent
* Patients with known or suspected restrictive lung disease

Primary outcomes:
measure: Wheeze score (Tw/Ttot%)
timeFrame: Day 1
measure: FEV1/FVC
timeFrame: Day 1
measure: FEV1
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
state: West Midlands
Study officials:
affiliation: University Hospitals Birmingham
name: Richard Glover
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01703143: Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy
Official title: A Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate whether MR-guided laser induced thermal therapy in patients diagnosed with focal lesional epilepsy using the Visualase Thermal Therapy System is both a feasible and safe minimally invasive technique for control of seizures in such patients.

Detailed description: In this study, we propose to evaluate a novel, thermal therapy and feedback system (Visualase® Thermal Therapy System) as an alternative to surgical resection for the treatment of focal lesional epilepsy in patients that are considered high risk surgical candidates. This system includes the FDA-cleared Visualase Cooled Laser Applicator System (VCLAS), which allows delivery of laser energy while the patient is being imaged by an MRI unit. The Visualase® System works via real-time MR thermal imaging (MRTI) to provide information on the thermal dose delivered to the target, resulting in a more precise and controlled delivery which has heretofore not been possible with previous non-image guided laser technology. We hypothesize that the Visualase system can be used in patients refractory to medication therapy in a minimally invasive procedure to destroy epileptogenic focal lesions in the brain.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older at entry to protocol.
* History of MRI lesional-related epilepsy for at least one year.
* Failure to respond to more than 2 anti-epileptic drugs at adequate dose and duration.
* Candidate for resective epilepsy surgery.
* Considered healthy enough to undergo surgery with general anesthesia.
* The patient has given written informed consent after the nature of the study and alternative treatment options have been explained.
* Must have 3 months of seizure frequency recorded prior to procedure.

Exclusion Criteria:

* Presence of any non-MRI compatible implanted electronic device.
* Presence of a metallic prosthetic or implant including artificial hips, knees, joints, or rods and screws.
* Active Major depression
* History of Suicide attempts
* History of Non-Epileptic Behavioral Spells

Primary outcomes:
measure: The number of seizures recorded in seizure diary
timeFrame: Baseline to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: W Marsh, MD
role: PRINCIPAL_INVESTIGATOR
References: