louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00587106: Studies of Neurological Paraneoplastic Syndromes
Official title: Studies of Neurological Paraneoplastic Syndromes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paraneoplastic Neurologic Degenerations (PNDs)
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-01-07
Enrollment: 51
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: Patients are selected from severals clinics within Memorial Sloan-Kettering Cancer Cetner

Brief summary: This study is for patients with cancer, a known paraneoplastic syndrome, or neurological problems that suggest a paraneoplastic syndrome.

Detailed description: Patients usually go to their doctors with neurological complaints and later find they have cancer, a known paraneoplastic syndrome, or neurological problems that suggest a paraneoplastic syndrome. Paraneoplastic syndromes are rare conditions in which the immune system is involved in causing brain damage and fighting cancer.

Such patients with paraneoplastic neurologic degenerations(PNDs) may have autoantibodies, an antibody or protein the immune system creates that is directed against his or her own proteins. This study aims to better understand PNDS by:

* analyzing for autoantibodies in serum and cerebral spinal fluid
* analyzing for antigen specificity and for antigens in cancer tissue
* comparing PND autoantibodies with those in cancer patients but no PND
* comparing PND autoantibodies with those in PND patients but no cancer
* studying the immune performance of patients with PNDs

As this study is not a treatment study, tissues for this study will only come from procedures necessary for the patient's treatment.

Eligibility criteria: Inclusion Criteria:

* All adults are potentially eligible.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Increase understanding of PNDS
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jerome Posner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04332406: Normal Ventilatory and Perfusion Pulmonary Function in TEMP
Official title: Normal Ventilatory and Perfusion Pulmonary Function in TEMP: Generation of 3D Statistical Maps From Normal Examinations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patents With Normal VQ/SPECT
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the department of nuclear medicine of Brest University Hospital, France, for suspected acute pulmonary embolism

Brief summary: Ventilation - perfusion SPECT is attractive for lung function assessement. Unfortunately, it is very difficult to delineate normal to abnormal areas because of physiological uptake heterogeneity.

In that context, it would be of interest to build statistical maps from registrered normal studies and propose a new methodology for normal SPECT delineation

Detailed description: Patients with normal VQ SPECT-CT will be analysed. After a image proccesing workflow including rigid registration, non rigid registration and normalization, a voxelized mean and standard deviation map will be created. Those maps will be analyzed in regards of physiology and litterature.

Eligibility criteria: Inclusion Criteria:

* normal perfusion and ventilation scans, and no parenchyma or pleural abnormality on low dose CT
* confirmation by a second senior physician

Exclusion Criteria:

Patients with history of pulmonary disease:

* chronic obstruction pulmonary disease,
* previous pulmonary embolism,
* surgery of the lungs
* radiotherapy of the lungs

Primary outcomes:
measure: Posterior to Anterior and Inferior to Superior uptake relative difference on parametric mean registered SPECT map versus non registered SPECT
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Médecine nucléaire - Hôpital Morvan (CHRU de Brest)
Study officials:
affiliation: CHRU Brest
name: Pierre Yves Le Roux, MD, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT03488706: Assessing Circulating Tumor Cell as a Biomarker for Prostate Cancer Detection in Patients With Gray Zone PSA Level
Official title: Assessing Circulating Tumor Cell as a Biomarker for Prostate Cancer Detection in Patients With Gray Zone PSA Level
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: CellMaxLife
Sponsor class: INDUSTRY
First posted: 2018-04-05
Enrollment: 500
Sex: MALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PSA 4.00- 10.99 ng/ml patients

Brief summary: Prostate cancer screening with PSA is plagued by high rate of unnecessary prostate biopsies, especially in the "gray zone" (4.00ng/ml e 10.99ng/ml). We introduce a new circulating-tumor-cell (CTC) biomarker for detection of prostate cancer in patients in the PSA "gray zone" level, with the clinically verified potential to substantially decrease the number of unnecessary prostate biopsies.


Eligibility criteria: Inclusion Criteria:

* Subjects are willing to sign the informed consent and agree to comply with the study procedures.
* Age from 20 to 99 years old
* Subjects with a PSA 4.00- 10.99 ng/ml and will receive biopsy within 3 months

Exclusion Criteria:

* Age \< 20 years
* Refuse to sign the informed consent form
* Received regional anesthesia and general anesthesia within one month
* Previous cancer history
* Autoimmune diseases
* Chronic inflammatory diseases
* Diagnosed with colorectal polyps or adenomas
* Acute inflammatory or infectious diseases in three months
* Other diseases decided by PI

Primary outcomes:
measure: Circulating tumor cells detection
timeFrame: Prior to prostate biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ying-Hsu Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00619606: To Determine the Efficacy of the TwinGuard in Oxygen Delivery During and Post Endoscopic Procedure
Official title: A Randomised, Parallel, Open Label Study to Determine the Efficacy of a New Oral-Nasal Oxygenating Device (TwinGuard) Compared to Standard Bite Block Plus Nasal Cannulae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypoxia
Hypercapnia
Keywords: prevention of hypoxia
prevention of hypercapnia
Lead sponsor: Trawax Pty Limited
Sponsor class: OTHER
First posted: 2008-02-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A comparative study which compares the end-tidal carbon dioxide and oxygen saturation levels of patients during endoscopy which have used either the new oral-nasal oxygenating device (TwinGuard), or a standard bite block plus nasal cannulae using an equivalent flow rate of oxygen.

Detailed description: Hypoxia is common during endoscopy. Following sedation induction, oxygen saturation falls moderately in most patients, whilst some drop to unacceptable levels. To monitor such changes endoscopic practices routinely use oximeters and capnography.

TwinGuard is an all-in-one device which incorporates a bite block with the functionality of nasal cannula as well as monitoring expired air (carbon dioxide)

Eligibility criteria: Inclusion Criteria:

* Provided written fully informed consent as per protocol
* No clinical evidence of significant respiratory conditions
* Fasted for 6 hours prior to enrolment as per standard clinical practice for panendoscopy

Exclusion Criteria:

* Patients suffering from cardio respiratory disease, moderate to severe asthma, lung and heart disease
* Patients who have a history of drug or alcohol abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre for Digestive Diseases, Sydney
name: Thomas J Borody
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01473706: Validation of a Nutrition Screening Tool
Official title: Mini Nutritional Assessment: Consumer Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Keywords: Malnutrition
Nutrition status
Elderly
Nutrition screening
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 463
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consumers aged 65 or older with or without their caregiver

Brief summary: The purpose of this study is to compare the accuracy of a new consumer nutrition screening tool to an established and validated nutrition screening tool currently completed by healthcare practitioners.

Detailed description: The main objective of the study is to determine the accuracy of the self-administered consumer Mini Nutritional Assessment by comparing the level of agreement in the categorization of nutritional status between the self-administered Mini Nutritional Assessment and a validated nutrition screening tool in a population aged 65 and older.

Eligibility criteria: Inclusion Criteria:

- Consumer

* Age ≥ 65 years
* Employed part-time, unemployed, retired, full-time homemaker
* English speaking

  - Caregiver of Consumer
* Family, relative, friend, professional caregiver of an individual age ≥ 65 years
* Lives with individual aged ≥ 65 years OR Visits individual aged ≥ 65 years five or more days a week

  * Makes decisions or has strong influence on the individual aged ≥ 65 years' diet and medical needs.
* English speaking

Exclusion Criteria:

- Consumer

-- Full time employment

Primary outcomes:
measure: Sensitivity and the specificity (in percent) of the consumer version of the Mini Nutritional Assessment versus a validated nutrition screening tool
timeFrame: Within a one hour visit
Secondary outcomes:
measure: Ability of the consumer version of the Mini Nutritional Assessment to predict the accuracy of the nutrition status classifications (normal nutritional status, at risk of malnutrition & malnourished)
timeFrame: Within a one hour visit
Other outcomes:
Locations:
city: New York
country: United States
facility: Kantar Health
state: New York
Study officials:
affiliation: Kantar Health
name: Kerri Lehrhaupt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04603599: Relationship of Endometrial Cancer and Serum Soluble L1CAM Level
Official title: Relationship of Endometrial Cancer and Serum Soluble L1CAM Level
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrium Cancer
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: benign endometrial changes, endometrial hyperplasia or endometrial cancer

Brief summary: The aim of this study is to evaluate the effect of serum soluble L1CAM (sL1CAM) on the diagnosis and prognosis of endometrial cancer. This prospective randomized controlled trial will be conducted in patients who have undergone endometrial biopsy and whose pathology results are reported as benign endometrial changes, endometrial hyperplasia, or endometrial cancer. The sL1CAM level between groups will be compared. The relationship between prognostic factors and serum sL1CAM will be evaluated in patients with endometrial cancer.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent endometrial biopsy due to abnormal uterine bleeding and whose pathology results were reported as benign endometrial changes, endometrial hyperplasia or endometrial cancer were included in the study. All patients participating in the study signed informed consent.

Exclusion Criteria:

* Patients who did not have consent, received neoadjuvant therapy and who would not have surgery despite endometrial cancer were excluded from the study.

Primary outcomes:
measure: serum sL1CAM level
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Merve Demir
Study officials:
References:
Clinical trial NCT00663299: COMPLEX Post Market Surveillance Electronic Registry
Official title: COMPLEX Post Market Surveillance Electronic Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysm
Keywords: Intracranial aneurysm
Lead sponsor: Codman & Shurtleff
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 299
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To demonstrate performance of TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils in the treatment of aneurysms.

Detailed description: This Post Market Surveillance Registry collect baseline characteristics, aneurysmal features, procedural and follow-up information, and complications/adverse events on the performance intracranial aneurysms treated with the Trufill DCS Orbit detachable platinum coils.

Eligibility criteria: Inclusion Criteria:

1. Patients with angiographically documented aneurysms,
2. Either ruptured or unruptured,
3. Aneurysm deemed by the attending neurointerventionalist to be acceptable candidates for endovascular embolization

Exclusion Criteria:

1) Patient / Treatment outside of the approved labeling, indications for use.

Primary outcomes:
measure: To demonstrate performance of TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable Coils in the treatment of aneurysms
timeFrame: Between 3-6 months
Secondary outcomes:
measure: Adverse events and product complaints
timeFrame: Ongoing throughout study
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe City General Hospital
Study officials:
affiliation: Northwestern University
name: Bernard Bendok, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hirsch JA, Bendok BR, Paulsen RD, Cognard C, Campos J, Cronqvist M. Midterm clinical experience with a complex-shaped detachable platinum coil system for the treatment of cerebral aneurysms: Trufill DCS Orbit detachable coil system registry interim results. J Vasc Interv Radiol. 2007 Dec;18(12):1487-94. doi: 10.1016/j.jvir.2007.07.020.
Clinical trial NCT00637299: Osteopathy in Chronic Obstructive Pulmonary Disease (COPD) Rehabilitation Trial
Official title: Osteopathic Treatment May Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
First posted: 2008-03-17
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this trial is to verify if an osteopathic treatment added to usual pulmonary rehabilitation trial is able to improve the walking ability of COPD patients and if there is any influence on lung functionality.

Detailed description: The investigators decided to perform an osteopathic manipulative treatment (OMT) in a population of COPD patients. OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner to improve physiologic function and/or support homeostasis that has been altered by somatic dysfunction. Concerning the respiratory system, osteopathy considers a model that describes the interdependent functions among five body components as follows: 1: the inherent motility of the brain and spinal cord; 2: fluctuation of the cerebrospinal fluid; 3: mobility of the intracranial and intraspinal membranes; 4: articular mobility of the cranial bones; 5: the involuntary mobility of the sacrum between the ilia. This model is the so called primary respiratory mechanism.

Eligibility criteria: Inclusion Criteria:

* patients affected by COPD

Exclusion Criteria:

* other diseases other than COPD

Primary outcomes:
measure: Walking Ability
timeFrame: 4 weeks
Secondary outcomes:
measure: Lung Function Test
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Montescano
country: Italy
facility: Fondazione Salvatore Maugeri
state: Pavia
Study officials:
affiliation: Fondazione Salvatore Maugeri
name: Ercole Zanotti, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00231699: A Comparison of Prevention of Hypothermia in Pediatric Patient Between Wrapping With Cotton and Plastic.
Official title: A Comparison of Prevention of Hypothermia in Pediatric Patient Between Wrapping With Cotton (Webril) and Plastic (Mwrap).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Hypotension
Prevention
Child
Keywords: Prevention of Hypothermia
Pediatric Patient
Cotton
Plastic wrap
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2005-10-04
Enrollment: 42
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypothermia leads to increased morbidity and mortality. Heat loss mainly occurs during anesthesia and surgery. Therefore prevention of hypothermia in pediatric patients undergoing general anesthesia is very important. However, there is very little information about effectiveness of various insulating materials used in the operating room.

Objective: To compare the effectiveness of cotton and plastic for prevent intraoperative hypothermia in pediatric patients.

Detailed description: A randomized controlled trial was conducted in 42 pediatric patients (age 1 month-3 years, ASA physical status 1-2) who were scheduled for elective maxillofacial or genitourinary surgery. The patients were randomly allocated into 2 groups. The patient's arms, legs and bodies were wrapped with either plastic (study group) or cotton (control group). All patients received standard general anesthesia with endotracheal tube and control ventilation with a fresh gas flow at 1 l/min. The core temperature (rectal temperature) was recorded every 10 minutes for 60 minutes.

Eligibility criteria: Inclusion Criteria:

* 42 pediatric patients (age 1 month-3 years
* ASA physical status 1-2) who were scheduled for elective maxillofacial or genitourinary surgery.

Exclusion Criteria:

Primary outcomes:
measure: Core temperature
Secondary outcomes:
Other outcomes:
Locations:
city: KhonKaen
country: Thailand
facility: Warporn Chau-in
Study officials:
affiliation: Faculty of Medicine,KhonKaen University
name: waraporn chau-in, Asso Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00251199: VX-950 and Peginterferon for Hepatitis C
Official title: A Phase 1b Viral Kinetic Study of VX-950 and Peginterferon in Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2005-11-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: VX-950 is an investigational drug , which is being tested in combination with a known treatment for hepatitis C, peginterferon.


Eligibility criteria: Inclusion Criteria:

* infected with Hepatitis C virus

Exclusion Criteria:

* contraindications to peginterferon therapy

Primary outcomes:
measure: Viral kinetics
Secondary outcomes:
measure: Assess the safety of VX-950 in combination with peginterferon
Other outcomes:
Locations:
city: Homburg/Saar
country: Germany
facility: Call for information
city: Amsterdam
country: Netherlands
facility: Call for information
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04849299: Effect of Cyclosporine on the Pharmacokinetics (PK) of AT-527 (R07496998)
Official title: A Phase 1, Randomized, Open-Label Study to Evaluate the Effect of Cyclosporine on the Plasma Pharmacokinetics of AT-527 in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2021-04-19
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the effect of cyclosporine on the PK of AT-527 (R07496998) in healthy male subjects


Eligibility criteria: Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Concomitant use of prescription medications, or systemic over-the-counter medications
* Other clinically significant medical conditions or laboratory abnormalities

Primary outcomes:
measure: Pharmacokinetics (PK) of AT-527 (R07496998): Cmax
timeFrame: Day 1 vs Day 7
measure: Pharmacokinetics (PK) of AT-527 (R07496998): AUC
timeFrame: Day 1 vs Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Atea Study Site
state: Quebec
Study officials:
References: