louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00365482: Bipolar Disorder in Epilepsy
Official title: Bipolar Disorder in Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Bipolar Disorder
Keywords: Epilepsy
Bipolar Disorder
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2006-08-17
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Epilepsy patients at the Long Island Jewish Comprehensive Epilepsy Center

Brief summary: The purpose of this study is to find out how often major mood swings occur in patients treated in a specialty epilepsy center.

Detailed description: Bipolar disorder (a condition of major mood swings) or milder forms of ups and downs in mood may occur with a number to neurological conditions. Recently, one study showed that these mood changes occur fairly often in individuals with epilepsy studied in the general community. We speculate that bipolar symptoms occur with even higher frequency in a tertiary epilepsy center than that encountered in the previous community-based study. The goals of this study are to assess:

* the rate of bipolar symptoms as measured by a self-reporting screening tool in a tertiary epilepsy center setting
* the meaning of a positive screening score in epilepsy patients
* the utility, sensitivity and specificity of alternative screening tools for mood instability in epilepsy patients
* the correlation of mood instability with seizure-related variables
* the relation of a positive screening score on quality of life.

Eligibility criteria: Inclusion Criteria:

* Male or female 18 years of age or older
* Being evaluated at the Long Island Jewish Comprehensive Epilepsy Center
* Capable of completing self-reporting questionnaires

Exclusion Criteria:

* Patients with mental retardation
* Patients with pseudoseizures

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Great Neck
country: United States
facility: North Shore Long Island Jewish Health System
state: New York
Study officials:
affiliation: Long Island Jewish Medical Center
name: Sean Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03354182: Surgical Treatment of Mandibular Furcations Using a Xenograft With/Without a Collagen Membrane
Official title: Treatment of Mandibular Type II Furcations Using Bovine-derived Bone Xenograft With or Without a Collagen Membrane: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Furcation Defects
Keywords: Mandibular type II furcations
Periodontal treatment
Demineralized bovine bone mineral
Collagen membrane
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical study with 1 control group and 1 test group
Primary purpose: TREATMENT

Brief summary: The aim of the study was to perform a randomized controlled clinical study in order to compare the effects of a bovine derived xenograft (with 10% collagen) + a bioabsorbable membrane (control group, CG) vs a bovine derived xenograft (with 10% collagen) alone (test group, TG) on the surgical treatment of mandibular type II furcation defects.

Detailed description: The aim of the study was to perform a randomized controlled clinical study in order to compare the effects of a bovine derived xenograft (with 10% collagen) + a bioabsorbable membrane (control group, CG) vs a bovine derived xenograft (with 10% collagen) alone (test group, TG) on the surgical treatment of mandibular type II furcation defects. The patients all underwent the same surgical intervention with the only difference between the two groups being the use or not of a collagen membrane.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with chronic periodontitis
* Initial phase (oral hygiene instructions + full mouth scaling and root planing) performed at least eight weeks before inclusion
* Full-mouth plaque score ≦ 20% (at least eight weeks after initial phase and during the whole treatment)
* Clinical evidence of vestibular or lingual mandibular Class II furcation defects (≧ 3mm of horizontal probing depth)
* Presence of at least 2 mm of keratinized gingiva on the selected tooth surface facing the furcation
* Tooth vitality confirmed by clinical tests (cold testing)

Exclusion Criteria:

* Presence of any systemic disease
* Smokers
* Devitalized tooth or tooth presenting periapical or pulpar pathology (confirmed with a retro-alveolar radiograph)
* Allergies to any of the products used in the present study
* Pregnant or breastfeeding women
* History or current RX therapy

Primary outcomes:
measure: Horizontal Probing Attachment Level
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02552082: Scorpio Non Restricted Geometry (NRG) Study in Japan
Official title: The Verification Study on the Effectiveness of Rotational Tolerance of Scorpio NRG Study in TKA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Rheumatoid Arthritis
Lead sponsor: Stryker Japan K.K.
Sponsor class: INDUSTRY
First posted: 2015-09-16
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient who has diagnosis of osteoarthritis or rheumatoid arthritis.

Brief summary: The purpose of this study is to evaluate the range of motion (ROM), mid-flexion stability (gap balance), and implant position (size and angle) for the Scorpio NRG device. Relationship between these parameters and clinical outcomes will be evaluated as well as the importance of rotational tolerance. It is expected that the Scorpio NRG will have good clinical outcomes and perform the same or better than other total knee implants.


Eligibility criteria: Inclusion Criteria:

1. Patient who is candidate for primary total knee arthroplasty (TKA).
2. Patient who has diagnosis of osteoarthritis or rheumatoid arthritis.
3. Patient who is age 20 or over.
4. Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
5. Patient who is willing and able to comply with postoperative scheduled evaluations.

Exclusion Criteria:

1. Patient who has a bacterial infectious disease or has a risk high of a bacterial infection.
2. Patient who requires revision surgery.
3. Patient who is morbidly obese, defined as having a Body Mass Index (BMI) \> 40.
4. Patient who is or may be pregnant female.
5. Patient who has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
6. Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
7. Patient who is immunologically suppressed or receiving chronic steroids.
8. Patient who is judged ineligible with specific reason by primary doctor.

Primary outcomes:
measure: Change in Range of motion(ROM)
timeFrame: Pre-operation, intraoperative, 6 months and 1 year after surgery
Secondary outcomes:
measure: Change in Japanese Orthopaedics Association (JOA) score,
timeFrame: Pre-operation, intraoperative, 6 months and 1 year after surgery
measure: Change in Knee Society Score (KSS)
timeFrame: Pre-operation, intraoperative, 6 months and 1 year after surgery
Other outcomes:
Locations:
city: Kasuga City
country: Japan
facility: Fukuoka Tokushukai Hospital.
state: Fukuoka Prefecture
Study officials:
References:
Clinical trial NCT01091220: Evaluation of the Effects of Certolizumab Pegol on Semen Quality in Healthy Male Volunteers
Official title: A Randomized, Single-center, Double-blind, Placebo-controlled Study to Explore the Effect of a Single Dose of Certolizumab Pegol 400 mg on Semen Quality in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sperm Quality
Keywords: certolizumab pegol
Cimzia®
healthy male volunteers
sperm
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-03-23
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary objective of this study is to evaluate the effect of certolizumab pegol (CZP) on the quality of sperm obtained from healthy male volunteers.

Detailed description: CZP is a PEGylated humanized Fab' fragment with specificity for human tumor necrosis factor alpha (TNFα). Evidence suggests that modulation of TNFα signaling may affect male spermatogenesis. Therefore, this study will compare semen quality parameters before and after a single 400 mg dose of CZP, or matched placebo.

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers with normal baseline semen quality parameters

Exclusion Criteria:

* Previous participation in studies involving TNF inhibitors
* Prior treatment with biologic response modifiers within 5 half-lives
* History of trauma or surgery to the pelvis/genital area
* Tests positive for tuberculosis, HIV, Hepatitis B or C

Primary outcomes:
measure: Total sperm motility (%)
timeFrame: baseline to 99 days
measure: Sperm morphology (%)
timeFrame: Baseline to 99 days
Secondary outcomes:
measure: Progressive motility (%)
timeFrame: Baseline to 99 days
measure: Non-progressive motility (%)
timeFrame: Baseline to 99 days
measure: Sperm vitality (%)
timeFrame: Baseline to 99 days
measure: Semen volume (mL)
timeFrame: Baseline to 99 days
measure: Sperm count (millions)
timeFrame: Baseline to 99 days
measure: Sperm concentration (millions/mL)
timeFrame: Baseline to 99 days
Other outcomes:
Locations:
city: Liège
country: Belgium
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02230020: Efficacy of High Flow Therapy in COPD At Home
Official title: Efficacy of High Flow Therapy in COPD At Home
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: COPD
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Obstructive Pulmonary Disease

Brief summary: Preliminary data show that in COPD patients, HFT substantially decreases ventilatory demand during sleep. The central hypothesis of this proposal is that lowering ventilatory demand using nasal high-flow therapy during sleep will elevate lung function, reduce dyspnea on exertion and improve quality of life. Thus, this proposal aims will determine the effects HFT over time on 1) lung function; 2) dyspnea on exertion; and 3) quality of life.


Eligibility criteria: Inclusion Criteria:

* 1. Consenting adults over the age of 18 with COPD

Exclusion Criteria:

* 1. Apnea Hypopnea Index\>15 events/hr 2. Use of Non-invasive positive pressure ventilation (CPAP + Bilevel) 3. Severe bilateral nasal obstruction (apparent mouth breathing at rest) 4. Documented clinical cardiovascular disease, as defined below:

  1. myocardial infarction in past 3 months
  2. revascularization procedure in past 3 months
  3. implanted cardiac pacemaker or ICD
  4. unstable arrhythmias
  5. congestive heart failure with ejection fraction \< 40%
  6. uncontrolled hypertension (BP \> 190/110) 5. History of end stage renal disease (on dialysis) 6. History of end stage liver disease, such as:

  <!-- -->

  1. Jaundice
  2. ascites
  3. history of recurrent gastrointestinal bleeding
  4. transjugular intrahepatic portosystemic shunt (TIPS) ; 7. Transportation industry worker (commercial truck or bus drivers, airline pilots) 8. Known pregnancy (by self report) 9. Known coagulopathy or anticoagulant use (e.g. coumadin) other than aspirin. 10. Do you take medications for any of the following reasons:

  <!-- -->

  1. Pain control (besides NSAIDs)
  2. Sleep medication
  3. Benzodiazepines
  4. Methadone

Primary outcomes:
measure: Lung Function
timeFrame: Baseline and 1 month
measure: Dyspnea score
timeFrame: Baseline and 1 month
measure: Sleep quality
timeFrame: Baseline and 1 month
measure: Quality of life
timeFrame: Baseline and 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jason Kirkness, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00815620: Best Therapy for Patients With Neuroendocrine Tumors
Official title: Best Therapy for Patients With Neuroendocrine Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Keywords: neuroendocrine tumors
transcatheter arterial chemoembolization
selective internal radiotherapy
surgery
radio-frequency ablation
peptide-receptor radiotherapy
progression-free survival
quality of life
overall survival
weight
time of hospitalization
Lead sponsor: Zentralklinik Bad Berka
Sponsor class: OTHER
First posted: 2008-12-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with neuroendocrine tumors in a tertiary referal center

Brief summary: A prospective observational study containing three arms comprising different therapeutic measures to treat patients with neuroendocrine tumors in advanced stages. The therapy arms include local ablative therapy such as TACE or SIRT, surgery and RFA with peptide receptor radiotherapy.

Detailed description: Study design:

Prospective observational study comparing ablative measures as TACE or SIRT with surgery/RFA and with peptide receptor radio-therapy in patients with advanced well-differentiated neuroendocrine tumors with lymph node or distant metastases (N1, M1) Prospective evaluation Primary end points: time to progression Secondary end points: survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index) Non-randomized cohort study Number of patients needed in all groups: 70 per group, 210 overall Evaluation of response to therapy every 3-6 months by imaging, clinical status, weight, quality of life, Karnofsky-index Cross-over allowed if therapy changes

Eligibility criteria: Inclusion Criteria:

* Biopsy-proven neuroendocrine tumor (WHO class I-II, TNM grading 1-2)
* Advanced disease with lymph node or distant metastases (N1, M1) undergoing cytoreduction by surgery/local ablative therapy or peptide receptor radiotherapy
* curative intent of all therapies possible

Exclusion Criteria:

* Undifferentiated neuroendocrine carcinoma (WHO class III, TNM grading 3)
* secondary tumor
* advanced carcinoid heart disease requiring surgery

Primary outcomes:
measure: progression-free survival
timeFrame: 2 years
Secondary outcomes:
measure: overall survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index
timeFrame: 2 years
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
Study officials:
affiliation: Zentralklinik Bad Berka GmbH
name: Dieter Hörsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00735020: Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines
Official title: A Phase I, Observer-Blind, Randomized, Single-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines in Healthy Adults Aged 18 to 39 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: influenza
vaccine
adjuvants
flu
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-08-14
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.


Eligibility criteria: Inclusion Criteria:

* Healthy 18 to 39 year old males and females who are in good health and have provided informed consent prior to enrollment

Exclusion Criteria:

* serious medical conditions
* allergies to vaccine components, including but not limited to egg/chicken products
* reduced immune function
* recent use of immunosuppressive therapy
* recent use of influenza vaccine

Primary outcomes:
measure: Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers.
timeFrame: 36 Days
Secondary outcomes:
measure: To evaluate immunogenicity of a single IM injection of adjuvanted Influenza vaccine
timeFrame: 36 Days
Other outcomes:
Locations:
city: Ligornetto
country: Switzerland
facility: I.P.A.S.
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Della Cioppa G, Vesikari T, Sokal E, Lindert K, Nicolay U. Trivalent and quadrivalent MF59((R))-adjuvanted influenza vaccine in young children: a dose- and schedule-finding study. Vaccine. 2011 Nov 3;29(47):8696-704. doi: 10.1016/j.vaccine.2011.08.111. Epub 2011 Sep 9.
Clinical trial NCT03381820: Effectiveness of Thai Northeastern Folk Musical Therapy for Blood Pressure Control in Hypertensive Patients
Official title: Instrumental Folk Music Listening Reduced Home Blood Pressure in Stage-2 Hypertensive Patients; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musical Therapy as a Complementary Treatment of Hypertension
Keywords: music therapy
hypertension
Asian
stage-2 hypertension
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised control trial
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial was conducted in a tertiary care hospital, Khon Kaen province, Thailand. Sixty participants were randomized to music listening group and control group. The music listening group was assigned to listen to 30-minute instrumental folk music everyday for one month. Home BP and office BP were monitored and recorded.


Eligibility criteria: Inclusion Criteria:

* 40-80 years old
* Diagnosed stage-2 hypertension (HT) (defined by office systolic blood pressure \>= 140mm Hg and/or diastolic blood pressure \>= 90 mm Hg at first hospital visit)

Exclusion Criteria:

* Pregnant women, white-coat HT, secondary HT and hearing loss or blind.

Primary outcomes:
measure: Change from baseline of home systolic and diastolic blood pressure at day 30th
timeFrame: Day 0th (baseline) to day 30th.
Secondary outcomes:
measure: Change from baseline of office systolic and diastolic blood pressure at day 120th
timeFrame: Day 0th and day 120th
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Emergency Medicine, Khon Kaen University
state: Muang
Study officials:
References:
citation: Im-Oun S, Kotruchin P, Thinsug P, Mitsungnern T, Techa-Atik P, Pongchaiyakul C. Effect of Thai instrumental folk music on blood pressure: A randomized controlled trial in stage-2 hypertensive patients. Complement Ther Med. 2018 Aug;39:43-48. doi: 10.1016/j.ctim.2018.05.014. Epub 2018 May 26.
Clinical trial NCT04027920: Postpartum Hemorrhage After Shenghua Decoction Treatment
Official title: Disastrous Delayed Postpartum Hemorrhage After Three Days of Shenghua Decoction Treatment: a Case Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Keywords: postpartum hemorrhage
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 1
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A postpartum woman with delayed pospartum hemorrhage

Brief summary: A rare case of disastrous delayed postpartum hemorrhage after three days of shenghua decoction treatment.

Detailed description: A rare case of disastrous delayed postpartum hemorrhage after three days of shenghua decoction treatment.

Eligibility criteria: Inclusion Criteria:

* Postpartum hemorrhage after shenghua decoction treatment.

Exclusion Criteria:

* Nil

Primary outcomes:
measure: Presence of postpartum hemorrhage or not
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References: