louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00062647: Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia
Official title: A Phase 2, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Televancin (TD-6424) for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gram-Positive Bacterial Infections
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2003-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections.


Eligibility criteria: Inclusion Criteria

- Documented S. aureus bacteremia

Exclusion Criteria

- Patients who had received or would have received more than 72 hours of potentially effective systemic antistaphylococcal therapy within 7 days prior to randomization. The following agents were considered potentially effective antistaphylococcal therapy: antistaphylococcal penicillins (including nafcillin, oxacillin, or cloxacillin), cephalosporins, fluoroquinolones, glycopeptides (including vancomycin and teicoplanin) and linezolid

Primary outcomes:
measure: Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation
timeFrame: 12 weeks after start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Wellstar Infectious Disease
state: Georgia
Study officials:
affiliation: Duke University
name: G. Ralph Corey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stryjewski ME, Lentnek A, O'Riordan W, Pullman J, Tambyah PA, Miro JM, Fowler VG Jr, Barriere SL, Kitt MM, Corey GR. A randomized Phase 2 trial of telavancin versus standard therapy in patients with uncomplicated Staphylococcus aureus bacteremia: the ASSURE study. BMC Infect Dis. 2014 May 23;14:289. doi: 10.1186/1471-2334-14-289.
Clinical trial NCT03684577: Efficacy of Hypnotherapy for Agoraphobia
Official title: Efficacy of Hypnotherapy Compared to a Wait-list Control Group in the Treatment of Agoraphobia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Agoraphobia
Keywords: Hypnosis
Wait-list
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the efficacy of Hypnotherapy for the treatment of Agoraphobia compared to a wait-list control group.

Detailed description: With the present study, the efficacy of 8-12 sessions of individual Hypnotherapy will be compared to a wait-list control groups. At study entry and at the end of treatment with Hypnotherapy, the Agoraphobia symptoms will be assessed via clinician-rating and self-report. It is expected that Hypnotherapy will be superior to a wait-list control regarding the percentage reduction of the anxiety symptoms after three months of treatment.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Patient fulfills DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria for agoraphobia
* 18 - 65 years of age
* Sufficient knowledge of the German language in order to participate in the study
* Sufficient availability to participate in weekly therapy sessions

Exclusion Criteria:

* Acute suicidality (intended action, concrete plans or intermittent pronounced suicidal ideation)
* Lifetime diagnosis of a bipolar disorder or psychotic disorder
* Alcohol or substance use disorder without abstinence in the last 12 months
* Severe cognitive impairments (in cases of suspicion evaluation via Mini Mental State Test (MMST) \< 26, will be conducted)
* Other severe primary mental disorders to be treated: severe Major Depressive Disorder, severe personality disorder of borderline type with self-injury, severe combined personality disorder, actual posttraumatic stress disorder, anorexia nervosa, obsessive compulsive disorder
* Somatic disorder impeding participation in regular psychotherapy sessions
* Outpatient psychotherapy during the last twelve months.
* Medication with anxiolytics or anti-psychotics (antidepressant medication is permitted if stable since more than eight weeks and no planned changes during the duration of therapy)

Primary outcomes:
measure: Panic and Agoraphobia Scale (PAS)
timeFrame: Between baseline (t1) and after 12 weeks (t2)
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Prof. Dr. A. Batra/ Dr. Kristina Fuhr, University Department for Psychiatry and Psychotherapie
Study officials:
affiliation: University Hospital Tuebingen
name: Anil Batra, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02014077: VATS ( Video-Assisted Thoracoscopy) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax
Official title: VATS( Video-Assisted Thoracoscopy ) Compared to Reinsertion of a Thoracostomy Tube for Persistent Haemothorax A Single Center Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemothorax
Empyema
Keywords: VATS( Video-Assisted Thoracoscopy )
Thoracostomy Tube
Empyema
Thoracotomy
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized study comparing VATS( Video-Assisted Thoracoscopy ) to reinsertion of a Thoracostomy Tube in patients with retained haemothorax. The hypothesis is that early VATS as opposed to reinsertion of a thoracostomy tube , will lead to less complications and shorter hospital stay.


Eligibility criteria: Inclusion Criteria:

* Clinical and radiological diagnosis of retained haemothorax
* Thoracostomy tube blockage or failure to drain

Exclusion Criteria:

* more than one attempt at thoracostomy tube drainage
* unable to consent to trial
* coexisting pathology requiring other interventions

Primary outcomes:
measure: duration of hospitalization
timeFrame: patients will be followed during their hospital stay, average 5-14 days
Secondary outcomes:
measure: number of patients that develop empyema
timeFrame: 2 months form initial injury
Other outcomes:
measure: number of patients requiring thoracotomy
timeFrame: 2 months from initial injury
Locations:
city: Cape Town
country: South Africa
facility: Trauma Center, Groote Schuur Hospital,University of Cape Town
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Sorin Edu, MD,FCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02162277: Therapeutic Strategy in Postmenopausal Women Using Osteoporotic Diagnostic Kits
Official title: Phase 1 Study of Osteoporotic Diagnosis Using Osteoporotic Diagnostic Kits
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: To decrease
number
osteoporotic
patients in
Kami-Ina area
Nagano prefecture
Lead sponsor: Shinshu University
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are over 20 years old

Brief summary: The frequency of osteoporosis in Japan is increasing. Also, the frequency of osteoporosis-based fractures in postmenopausal women is increasing. Therefore, it is urgently required to improve osteoporosis. Life expectancy in Nagano prefecture is the longest in Japan, however, healthy life expectancy in Nagano is not very long in Japan. There are several problems in this issue from the medical site and the patient site. The aim of this study is, from the patient site, to increase the motivation of postmenopausal women for osteoporosis using osteoporotic diagnostic kit.


Eligibility criteria: Inclusion Criteria:

* Women, mainly postmenopausal women

Exclusion Criteria:

* Men

Primary outcomes:
measure: Number of participants with osteoporosis in Kami-Ina area of Nagano prefecture
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Yukio Nakamura
state: Nagano
Study officials:
References:
Clinical trial NCT04926077: DreamKit Respiratory Effort Signal Validation
Official title: Validation of the DreamKit Plethysmography-derived Respiratory Effort Signal Against Esophageal Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Sleep Apnea, Central
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
Collaborators: name: Pulmonary Critical Care Associates of Baltimore
First posted: 2021-06-14
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study has been developed in order to demonstrate the validity of the DreamKit respiratory effort signal.

Detailed description: The rationale for undertaking this study is to demonstrate the agreement between the respiratory effort signal amplitude derived from DreamKit vs. the gold-standard esophageal manometry. Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the DreamKit device and esophageal manometry. Data collection will be completed during wakefulness, while participants undergo a series of breathing maneuvers.

Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years;
* Fluent in English;
* Able to provide informed consent.

Exclusion Criteria:

* Contraindication to esophageal pressure monitoring, including a sensitive gag reflex (determined by a positive response to the screening question "do you sometimes or often gag while brushing your teeth?"), dysphagia, nasal obstruction, and/or esophageal disorder likely to impact placement of the balloon;
* Pregnancy or planned pregnancy during the study (self-reported);
* History of allergic reactions to medical adhesives;
* Known allergy to lidocaine;
* Known seizure disorder;
* Severe medical condition (controlled or uncontrolled) impacting breathing including neuromuscular disease, chronic obstructive pulmonary disease, respiratory failure or insufficiency, or requirement for oxygen therapy;
* Chronic cardiopulmonary or renal disease, including a history of irregular heart rhythms or dyspnea;
* At risk for excessive bleeding including use of anticoagulants;
* An employee, or spouse of an employee, of a company that designs, sells, or manufactures sleep related products (including Philips);
* An employee, or spouse of an employee, of Pulmonary \& Critical Care Associates of Baltimore.

Primary outcomes:
measure: Breath Amplitude Correlation
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pulmonary and Critical Care Associates of Baltimore
state: Maryland
Study officials:
affiliation: Pulmonary Critical Care Associates of Baltimore
name: Alan Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01447277: Prospective Femoral Versus Femoral and Sciatic Nerve Block for Anterior Cruciate Ligament (ACL) Reconstruction
Official title: The Addition of a Preoperative Sciatic Nerve Block to a Femoral Nerve Block for Ambulatory Arthroscopic ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Tear
Keywords: ACL reconstruction
Femoral Block
Sciatic Block
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-10-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators propose that a preoperative femoral and sciatic blocks vs a femoral block only, prior to ambulatory anterior cruciate ligament (ACL) reconstruction will lead to a decrease in opiate consumption, pain scores, and post-anesthesia care unit (PACU) length of stay. The investigators are prospectively randomizing patients to either a femoral or a fem/sciatic block and monitor outcomes.

Detailed description: Although femoral nerve blocks improve analgesia after anterior cruciate ligament (ACL) reconstruction, patients often complain of posterior knee pain, which can be treated with a sciatic nerve block. In a prospective randomized study, we compare preoperative femoral nerve block to a combined femoral and sciatic block in patients undergoing ambulatory ACL reconstruction. We hypothesize that the combined femoral/sciatic nerve block patients would have improved analgesia, fewer opioid-related side effects, and shorter PACU length of stay and improved patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Age 18 and over
* ASA status I-II
* Scheduled for ambulatory Arthroscopic ACL Surgery

Exclusion Criteria:

* Allergy to Local anesthetics or opiates used in the study
* Contraindications for regional anesthesia
* coagulopathy, anticoagulation, Thrombocytopenia
* infection at site of injection
* Chronic pain and high preoperative opiate requirements
* High risk for PONV

Primary outcomes:
measure: Pain Scores
timeFrame: PACU and POD1, 2 and 3.
Secondary outcomes:
measure: Length of stay
timeFrame: Duration of stay in the recovery room
measure: Opiate consumption
timeFrame: During surgery, recovery room and for 3 days after discharge
measure: PONV
timeFrame: During the recovery room stay and after discharge from surgery center for up to 3 days.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Orthopedic Institute
state: California
Study officials:
References:
Clinical trial NCT00815477: Internet-Based Strategic Transdisciplinary Approach To Risk Reduction And Treatment
Official title: I-START: Internet-based Strategic Transdisciplinay Approach to Risk Reduction And Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypertension
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Stroke Network
First posted: 2008-12-30
Enrollment: 387
Sex: ALL
Minimum age (years): 46
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: I-START is a randomized controlled trial that will evaluate the efficacy of an internet-based program of behavioural counseling for adaptive lifestyle change to subjects diagnosed with hypertension. I-START will be evaluated using objective outcome indices: systolic and diastolic blood pressure, pulse pressure, and markers of vagal-heart rate (HR) modulation and baroreflex sensitivity. The Heart and Stroke Foundation of Canada "Blood Pressure Action Plan(TM)" (BPAP) will be adminisered over a 4-month period, and evaluated in a 2 (Intervention vs. Wait list Control) X 2 (Baseline vs. Post-Intervention) factorial design, blocking for 3 recruitment sites (Toronto, London, the Grey Bruce region of Ontario, Canada), and stratified for sex and age group (45-59, 60-74 years).


Eligibility criteria: Inclusion Criteria:

* Stage 1 OR Stage 2 hypertension
* 46 -74 years of age
* able to read \& write English or French
* living in private residence

Exclusion Criteria:

* Cardiovascular disease
* Major psychiatric disorder (e.g. psychosis)
* Dependence on Alcohol or Drugs with in past year
* Diabetes \>= 5 years

Primary outcomes:
measure: Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure
timeFrame: 4 months
Secondary outcomes:
measure: Lifestyle Behavior: exercise and diet assessed by questionnaire
timeFrame: 4 months
measure: laboratory assessment of estimated vagal-heart rate modulation and baroreflex sensitivity
timeFrame: 4 months
Other outcomes:
Locations:
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
city: Owen Sound
country: Canada
facility: Grey Bruce Public Health Unit
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Robert P Nolan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Durrani S, Irvine J, Nolan RP. Psychosocial determinants of health behaviour change in an e-counseling intervention for hypertension. Int J Hypertens. 2012;2012:191789. doi: 10.1155/2012/191789. Epub 2011 Dec 20.
citation: Nolan RP, Liu S, Shoemaker JK, Hachinski V, Lynn H, Mikulis DJ, Wennberg RA, Moy Lum-Kwong M, Zbib A. Therapeutic benefit of internet-based lifestyle counselling for hypertension. Can J Cardiol. 2012 May;28(3):390-6. doi: 10.1016/j.cjca.2012.02.012. Epub 2012 Apr 11.
Clinical trial NCT00886977: Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
Official title: Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS
Lead sponsor: Yoshino Neurology Clinic
Sponsor class: OTHER
First posted: 2009-04-23
Enrollment: 25
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS).


Eligibility criteria: Inclusion Criteria:

* Patients aged between 25 and 65 years
* ALS patients who can visit the clinic for six months
* Forced Vital Capacity (FVC) \> 70%
* Patients who can walk by themselves
* Change in ALSFRS-R score from -1 to -4 during 12 weeks before the initial administration
* Patients who are willing to give informed consent

Exclusion Criteria:

* Tracheotomy and invasive ventilation
* Pregnant or possibly pregnant female patients
* Female patients of childbearing potential who cannot practice contraception during and two years after the administration, and male patients who cannot practice contraception during and six months after the administration
* Patients with clinically significant conditions such as cardiovascular, respiratory, haematological, and renal diseases.
* Patients who are being treated with investigational drugs
* Patients who are treated with other ALS drugs within 2 weeks prior to the first administration

Primary outcomes:
measure: ALSFRS-R
timeFrame: 24w + follow-up period
measure: Safety
timeFrame: 24w and the follow up period
Secondary outcomes:
measure: Manual Muscle Testing
timeFrame: 24w + follow-up period
measure: Grip/pinch strength
timeFrame: 24w + followup period
measure: Pulmonary function (forced vital capacity)
timeFrame: 24w + follow-up period
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Yoshino Neurology Clinic
Study officials:
affiliation: Yoshino Neurology Clinic
name: Hiide Yoshino, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01068977: A Study of the Safety and Pharmacology of MetMAb (PRO143966), a Monovalent Antagonist Antibody to the Receptor C-Met, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors
Official title: A Phase I, Open Label, Dose Escalation Study of the Safety and Pharmacology of MetMAb (PRO143966), a Monovalent Antagonist Antibody to the Receptor C-Met, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Cancers
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase I, open label, dose-escalation study of MetMAb administered by intravenous (IV) infusion in patients with advanced solid malignancies that are refractory to or for which there is no standard of care. The study consists of a dose-escalation stage, an expansion stage testing MetMAb at the recommended Phase II dose (RP2D), and a dose-escalation stage testing the combination of MetMAb, at two different doses with bevacizumab at a recommended dose.


Eligibility criteria: Inclusion Criteria:

* Histologic documentation of incurable, locally advanced, or metastatic solid malignancy that has failed to respond to at least one prior regimen or for which there is no standard therapy
* Disease that is measurable or evaluable by Response Evaluation Criteria In Solid Tumors (RECIST)
* Life expectancy ≥12 weeks

Exclusion Criteria:

* Less than 4 weeks since the last anti-tumor therapy
* Patients receiving erythropoietin products
* Active infection requiring antibiotics
* Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs
* Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
* Clinically important history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
* Known human immunodeficiency virus infection
* Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases

Primary outcomes:
measure: Safety and tolerability of MetMAb alone or in combination with bevacizumab will be assessed (frequency and nature of dose-limiting toxicities; nature, severity, and relatedness of adverse events; changes in vital signs and clinical laboratory parameters)
timeFrame: Length of study
Secondary outcomes:
measure: Objective response, defined as a complete or partial response confirmed ≥4 weeks after initial documentation
timeFrame: Length of study
measure: Duration of objective response
timeFrame: Length of study
measure: Progression-free survival
timeFrame: Length of study
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Premal Patel, M.D.
role: STUDY_DIRECTOR
References: