louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00097916: An Evaluation of the Safety and Efficacy of Memantine in Agitated Patients With Moderate to Severe Alzheimer's Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Non-Institutionalized Agitated Patients With Moderate to Severe Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: memantine HCl
Dementia
Agitation
Alzheimer Disease
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2004-12-02
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation. There are drawbacks associated with the currently available therapeutic interventions for agitation associated with Alzheimer's Disease. In a recent trial, in the group of patients with moderate to severe AD treated with memantine, there were fewer incidences of agitation. It is hypothesized that memantine will be effective in reducing the symptoms of agitation associated with moderate to severe Alzheimer's Disease.


Eligibility criteria: Inclusion Criteria:

* Moderate to Severe Alzheimer's Disease with a score greater than or equal to 4 on agitation/aggression domain of NPI
* Stable dose of donepezil for 3 months

Exclusion Criteria:

* Other evidence of psychiatric disorders
* Oncologic diagnosis
* Clinically significant gastrointestinal, renal, hepatic, endocrine or cardiovascular disease

Primary outcomes:
measure: Neuropsychiatric Inventory
Secondary outcomes:
measure: Cohen Mansfield Agitation Inventory
measure: Clinical Global Impression Scale
measure: ADCS-ADL
measure: Agitation/aggression domain of Neuropsychiatric Inventory (NPI)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: The Forves Norris MDA/ALS Research Center
state: California
city: Westminster
country: United States
facility: Coastal Communities Hospital
state: California
city: New Haven
country: United States
facility: Alzheimer's Disease Research Unit
state: Connecticut
city: Hialeah
country: United States
facility: Berma Research Group
state: Florida
city: Miami
country: United States
facility: Baumel-Eisner Neuromedical Institute
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Honolulu
country: United States
facility: Geriatric Medicine
state: Hawaii
city: Bennington
country: United States
facility: The Memory Clinic
state: Vermont
city: Norfolk
country: United States
facility: Hampton Roads Center for Clinical Research
state: Virginia
Study officials:
References:
Clinical trial NCT04290416: Human Single Neuron Recordings in Epilepsy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Memory
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: European Commission
name: Queen Elizabeth Hospital NHS Foundation Trust
First posted: 2020-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study uses single neuron recordings in pre-surgical epilepsy patients to uncover the neural mechanisms underlying memory formation and retrieval. A secondary aim is to improve diagnostic tools to identify epileptogenic tissue.


Eligibility criteria: Inclusion Criteria:

* Interest in participation.
* Temporal lobe epilepsy that is clinically being investigated with implantations of depth electrodes as part of the pre-surgical epilepsy monitoring.
* Cognitive/language skills sufficient to follow experimental instruction and maintain focus on the experiment.

Exclusion Criteria:

* Patient does not want to participate.
* Extra-temporal epilepsy, or electrode implantation strategy that does not allow the use of micro-macrowire electrodes.
* Cognitive/language skills insufficient to follow experimental instruction and maintain focus on the experiment.

Primary outcomes:
measure: Single unit recordings
timeFrame: 14 days (patient in hospital for this length of time)
Secondary outcomes:
measure: Intracranial electroencephalogram (iEEG)
timeFrame: 14 days (patient in hospital for this length of time)
measure: Behavioural response data
timeFrame: 14 days (patient in hospital for this length of time)
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth UHB Hospital
state: West Midlands
Study officials:
affiliation: University of Birmingham
name: Simon Hanslmayr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01414816: Betaferon® Regulatory Post-Marketing Surveillance
Official title: Betaferon® Regulatory Post-Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Clinically Isolated System
Keywords: Multiple Sclerosis
Clinical Isolated Syndrome (CIS)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-08-11
Enrollment: 355
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of Multiple Sclerosis or Clinically Isolated Syndrome who have been or will be treated with Betaferon.

Brief summary: To identify problems/questions about following items in the clinical practice using Betaferon

1. Unknown adverse event (especially serious adverse event)
2. Identification of adverse event occurred in the real practice
3. Factors that may affect the safety of drug
4. Factors that may affect the effectiveness of the drug


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of MS or CIS and decision taken by the physician to prescribe Betaferon
* Patients who have not participated in Betaferon regulatory Post Marketing Surveillance before.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with local product information

Primary outcomes:
measure: Safety variables will be summarized using descriptive statistics based on adverse events.
timeFrame: Up to 6 months
Secondary outcomes:
measure: The efficacy data regarding prevention of relapse due to MS will be estimated based on the number of relapse.
timeFrame: During 6 month
measure: Progression or aggravation to Multiple sclerosis (MS) will be identified based on the change of Expanded Disability Status Scale (EDSS) and the Magnetic Resonance Imaging (MRI) outcome.
timeFrame: 0, 6 month
Other outcomes:
Locations:
city: Many Locations
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00979316: Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects
Official title: Randomized, Double-Blinded, Placebo-Controlled, Open Label Positive- Controlled, Four-Way Crossover Study of the Electrocardiographic Effects of BMS-708163 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-09-18
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to determine the effect of BMS-708163 on the QTc interval (QT interval corrected for heart rate).


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) of 18 to 32 kg/m², inclusive.
* Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55
* Healthy subjects

Exclusion Criteria:

* History of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope
* Sexually active fertile men not using effective birth control (double barrier) if their partners are WOCBP
* Women who are pregnant or breastfeeding
* History of allergy or intolerance to moxifloxacin or any member of the quinolone class of antimicrobial agents
* History of hypokalemia, history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
* Any clinically significant ECG abnormality
* History of seizure disorders
* History of drowning survival

Primary outcomes:
measure: Effect on the electrocardiographic QT interval corrected for heart rate (QTc) in healthy subjects
timeFrame: Serial triplicate ECGs at -60, -40 and -20 minutes prior to dosing: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16 and 22.5 hours after dosing on Day 1 in each period
Secondary outcomes:
measure: To assess the effects of BMS-708163 on other ECG endpoints (heart rate [HR], QRS and PR intervals), and changes in waveform morphology
timeFrame: At -60, -40 and -20 minutes prior to dosing; at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16 and 22.5 hours after dosing on Day 1 in each period
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Mds Pharma Services (Us), Inc
state: Arizona
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03801616: Virtual Reality After Breast Reconstruction Surgery
Official title: VR 4 BR: Effects of Virtual Reality on Women Undergoing Mastectomy and Breast Reconstruction, A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain, Postoperative
Non-Opioid Pain Management
Virtual Reality
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot study of virtual reality (VR) non-opioid management for women undergoing mastectomy and implant-based reconstruction. Study participants will receive specialized VR interventions, administered via VR headsets, to manage pain.

Detailed description: The primary objective of this study is to estimate the effect of utilizing VR on reducing opioid use in study participants undergoing mastectomy with implant-based reconstruction compared to the control group. Investigators will follow patients throughout the course of their hospitalization and monitor outcomes including pain levels, medication requests, and satisfaction.

Eligible participants will receive a VR headset and instructed to use the VR every time they feel pain and before asking for a pain medication. They can take pain medications, if they choose to do so. At their post-op visit, study participants will be interviewed and asked questions regarding their experience with VR.

Pain level and medication use will be compared with similar individuals who undergo the same procedure but are not provided with a VR headset.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Women who plan to undergo mastectomy and implant-based reconstruction
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
* Able to read and comprehend English

Exclusion Criteria:

* Current diagnosis of epilepsy, dementia, or other neurologic disease that may prevent use of VR headset and software
* Sensitivity to flashing light
* Diagnosis of motion sickness
* Pregnancy or a medical condition where the study participant is prone to frequent nausea or dizziness
* Current or recent (less than 6 months) use of opioids
* Individuals with psychiatric disorders, including those with delirium or other disorders that may involve hallucinations or psychosis

Primary outcomes:
measure: Morphine Milligram Equivalents
timeFrame: During hospitalization until discharge, approximately 2 days
Secondary outcomes:
measure: Mean Difference in Pain
timeFrame: From operation to discharge, approximately 2 days
measure: Mean Difference in Length of Stay
timeFrame: During hospitalization until discharge, approximately 2 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai
name: Alice Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00668616: Adjuvant Treatment of Breast Cancer With 1-3 Aflicted Lymph Nodes
Official title: Cyclophosphamid + Farmorubicin® With Subsequent Administration of Taxol® (q3w) Versus Intensified Administration of Farmorubicin® Followed by Taxol® (q2w) in the Adjuvant Treatment of Breast Cancer in Patients With 1-3 Afflicted Lymph Nodes (1-3 LK+)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: breast cancer with 1-3 afflicted axillary lymph nodes
Lead sponsor: North Eastern German Society of Gynaecological Oncology
Sponsor class: OTHER
First posted: 2008-04-29
Enrollment: 1034
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: TREATMENT

Brief summary: The purpose of this study is to determine whether a treatment with 4 cycles anthracycline + cyclophoshamide followed by administration of 4 cycles paclitaxel is more effective than therapy with 4 cy\<cles of anthracycline adminbistration followed by 4 cycles of paclitaxel


Eligibility criteria: Inclusion Criteria:

* women with histologically proven breast cancer (pT1/pT2/pT3, pN1, N0)
* ECOG performance status 0-1
* start of adjuvant therapy not later than 4 weeks after surgery
* hematology: platelets at least 100xGpt/l, neutrophiles at least 2xGpt/l
* normal liver function as defined by: bilirubine till 1.5 x normal value, SGOT/SGPT till 1.25 x normal value
* normal kidney function as defined by: creatine till 1.5 x normal value
* negative pregnancy test for patients before menopause and effective contraception
* written informed consent

Exclusion Criteria:

* prior radiation, chemotherapy, hormontherapy and immunotherapy
* patients with more than 3 afflicted lymph nodes
* afflicted lymph nodes on the cantralateal side and/or afflicted supraclavicular or intraclavicular lymph nodes
* bilateral breast cancer or second carcinoma of the breast
* inflammatory breast cancer and/or distant metastases
* existing clinically relevant peripheral neuropathie
* heart infection during the last 6 months or therapeutically not compensated heart failure or cardiac arrhythmias of at least LOWN II
* patients with active infections and/or not controlled hypercalcemia
* pregnant or breastfeeding women or women of child-bearing age who do not use effictive contrazeptiva

Primary outcomes:
measure: progression-free time
timeFrame: every 3-6 months
Secondary outcomes:
measure: toxicity
measure: overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Oskar-Ziethen-Krankenhaus
Study officials:
References:
Clinical trial NCT01893216: Risk Factors of Psychiatric Disorders and Sexual Dysfunction in Infertile Men
Official title: Study of Possible Interactions Between Psychiatric Disorders and Sexual Dysfunction in Infertile Men
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety
Depression
Sexual Dysfunction
Infertility
Keywords: anxiety
depression
sexual dysfunction
infertility
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-07-08
Enrollment: 1500
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male outpatients visiting the Centre of Reproduction at First Affiliated Hospital of Sun Yat-sen University

Brief summary: To investigate the prevalence of psychological symptoms and sexual dysfunction, and to estimate their possible interactions in infertile men.

Detailed description: Although psychological disorders such as anxiety and depression are known to be associated with sexual dysfunction, and their interactions have been reported by many studies, particularly the prevalence of these two aspects and the relationship between them in infertile men in China have not been well investigated.

The investigators' aim is to evaluate the prevalence of psychological symptoms and sexual dysfunction and interactions between them systematically by using validated questionnaires and scales.

Eligibility criteria: Inclusion Criteria:

* men who seek treatment for infertility (infertility is defined as the inability to conceive after 1 year of unprotected intercourse)
* age ≥ 18 years
* in a heterosexual, stable relationship for at least 1 year
* able to read and speak Chinese

Exclusion Criteria:

* inability to read and understand the questionnaire because of language difficulties
* already evaluated during an earlier survey
* men on medication that could have affected their ejaculatory and erectile function and/or psychological status

Primary outcomes:
measure: Incidence and Risk Factors of sexual dysfunction and psychological disorders in infertile men
timeFrame: one year
Secondary outcomes:
measure: Interactions between Psychiatric Disorders and Sexual Dysfunction in Infertile Men
timeFrame: one year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Chunhua Deng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03243916: Targeted and Staged Cyber Knife Combined With Interventional Therapy in the Treatment of MHCC
Official title: A Prospective Single-arm Study on Targeted and Staged Cyber Knife Combined With Interventional Therapy in the Treatment of Massive Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: interventional therapy
TACE
Cyberknife
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hepatocellular carcinoma is a highly malignant tumor that is progressing rapidly. Hepatic arterial embolization chemotherapy (TACE) is a common method for the treatment of unresectable of hepatocellular carcinoma.But for patients with \> 10cm hepatocellular carcinoma, the intervention effect was not satisfied.The cyberknife is a kind of stereotactic radiotherapy which can track the movement of tumor and monitor the position deviation of tumor in real time.This stuy is aimed to observe the efficiency and safety of the combination of TACE and cyberknife in the treatment of massive hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed hepatocellular carcinoma
* No lymph node metastasis or distant metastasis
* Tumor diameter at least 10 cm
* Hepatic lesions are not suitable for surgical resection or the patient refuse to surgical treatment
* Eastern Clinical Oncology Group (ECOG)score is 0， 1or2
* No history of abdominal radiotherapy
* Inoperable and untransplantable,Child-pugh score A or B
* Normal liver volume exceeds 700 cm3

Exclusion Criteria:

* Previous history of abdominal radiotherapy;
* The maximum diameter of tumor is less than 10cm;
* The liver Child is graded C;
* Contraindication for radiotherapy;
* Active gastrointestinal bleeding occurred within 2 weeks before enrollment
* Pregnancy
* Undergoing chemotherapy throughout the past six months
* Diffuse hepatocellular carcinoma
* Main portal vein tumor embolization
* Undergoing other simultaneous treatment

Primary outcomes:
measure: response rate(RR)
timeFrame: 18 months
measure: overall survival(OS)
timeFrame: 26mounth
Secondary outcomes:
measure: adverse event(AE)
timeFrame: 36 month
measure: Quality of life (QOL)
timeFrame: 36 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA Gereral Hospital
state: Beijing
Study officials:
affiliation: China PLA hospital
name: Yu Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00646516: Gemini Symbicort pMDI
Official title: A Rand, Doubleblind, Activecontrolled, Parallel-grp,Singledummy, Multicenter,12 wk Study to Assess the Effic.&Safety of Symbicort pMDI 2x160/4.5mcg QD Compared to Symb. pMDI 2x80/4.5mcg QD, Symb. pMDI 2x80/4.5mcg Bid and to Budesonide pMDI 2x160 Mcg QD in Asthmatic Sub's12yrs and Over
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mild or Moderate Asthma
Keywords: Asthma
inhaled corticosteroids
Symbicort
budesonide/formoterol
budesonide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 615
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
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 treatment with Symbicort for 12 weeks will improve lung function and symptoms of adults and adolescents with asthma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma
* Baseline lung function tests as determined by protocol.
* Required and received treatment with inhaled corticosteroids and/or lung treatments specified in the protocol within timeframe and doses specified in protocol.

Exclusion Criteria:

* Severe asthma
* Has required treatment with any non-inhaled corticosteroid within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
* Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Primary outcomes:
measure: Change from start of treatment in evening pre-dose FEV1
timeFrame: 2, 6 and 12 weeks after starting treatment
Secondary outcomes:
measure: Change from before treatment in lung function, symptoms, use of rescue medication and patient-physician reported outcomes
timeFrame: Daily
measure: Investigate safety profile of Symbicort and budesonide
timeFrame: Before and 2, 4, 12 weeks after start of treatment and 1 week after end of treatment
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Liza O'Dowd, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Catherine Bonuccelli
role: STUDY_CHAIR
References:
citation: Kerwin EM, Oppenheimer JJ, LaForce C, Parasuraman B, Miller CJ, O'Dowd L, Goldman M. Efficacy and tolerability of once-daily budesonide/formoterol pressurized metered-dose inhaler in adults and adolescents with asthma previously stable with twice-daily budesonide/ formoterol dosing. Ann Allergy Asthma Immunol. 2009 Jul;103(1):62-72. doi: 10.1016/S1081-1206(10)60145-7.