louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00331045: Clinical Evaluation Of Alvimopan (SB767905) On Constipation And Related Symptoms Associated With Opioid
Official title: Clinical Evaluation of Alvimopan (SB767905) on Constipation and Related Symptoms Associated With Opioid -A Placebo-controlled Double-blind Study in Cancer Patients-
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
Constipation
Keywords: Opioids
cancer
constipation
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2006-05-29
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is intended to investigate the recommended dose of alvimopan in doses 0.25mg/day (0.25mg, OD), 0.5mg/day (0.25mg, BID) or 1mg/day (0.5mg, BID) or placebo for 3 weeks in patients who receive opioids for the management of cancer pain and develop constipation, by giving overall consideration to the efficacy and safety data in each treatment group. Also, efficacy and safety data of alvimopan in the recommended dose group will be compared with those of placebo and to confirm alvimopan's safety and efficacy.


Eligibility criteria: Inclusion criteria:

* Have cancer.
* Taking opioid therapy for continued intractable pain.
* Experiencing less bowel movement frequency compared to that before the opioid treatment.
* Must meet the protocol-definition of opioid-induced constipation.

Exclusion criteria:

* Gastrointestinal or pelvic disorders known to affect gastrointestinal functions or induce bowel transit disorder and ileus.
* Subjects, who in the investigator's opinion, have gastrointestinal dysfunction predominantly due to causes other than the use of opioids.

Primary outcomes:
measure: Change from baseline during the 1-week Pre-Treatment Period in average weekly bowel movement with no rescue laxative use in the previous 24 hours Frequency during the 3-week Treatment Period
Secondary outcomes:
measure: Proportion of responders for OBD global improvement Changes in weekly subjective bowel movement symptoms Changes in weekly constipation symptoms questionnaire
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03737045: Psoriatic Arthritis and Psoriasis Treatment Decision Aid
Official title: Developing a Patient-centered Patient Decision Aid for Psoriasis and/or Psoriatic Arthritis Using Design Thinking.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psoriatic Arthritis
Psoriasis
Keywords: Decision Aid
Shared Decision-Making
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2018-11-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients and providers will use a web-based or paper decision aid. They will not be assigned to specific arms or undergo randomized treatment.
Primary purpose: OTHER

Brief summary: The purpose of this study is to create and test a patient decision aid that facilitates the shared decision-making process when patients with psoriasis and/or psoriatic arthritis are starting or switching to a new therapy.

Detailed description: Prior to the interventional study, we will develop a decision aid using design thinking. In this interventional study, we will implement and test a patient-centered decision aid for therapy selection among patients with psoriasis and/or psoriatic arthritis who are starting or switching to a new medication.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Diagnosis of psoriasis (as confirmed by dermatologist) or psoriatic arthritis (as confirmed by rheumatologist)
3. Treated at Penn

   In addition to the above, for the observation and implementation phases of the study:
4. Initiation of a new psoriasis or psoriatic arthritis treatment

   * Biosimilars that have been approved by the FDA and available on the US market will similarly be eligible for participation
   * Patients may be taking other traditional DMARDs.
   * A washout period is not required.

Exclusion Criteria:

1. Unable to give informed consent
2. Youth, under the age of 18 years
3. Patients without psoriasis or psoriatic arthritis
4. Not being treated at a Penn clinic

   In addition to the above, for the observation and implementation phases of the study:
5. Not starting or switching to a new medication

Primary outcomes:
measure: Patient and provider self-reported perceptions of the decision aid as measured by satisfaction survey
timeFrame: Up to 24 months
Secondary outcomes:
measure: Number of times decision aid was used in consultation for patients switching therapies or starting a new treatment.
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital at the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Alexis Ogdie-Beatty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05740345: New Approaches to INOCA
Official title: Management of Hyperglycemia in INOCA Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: New Approaches in INOCA
Keywords: INOCA
Hyperglycemia
Metformin
Endothelial Dysfunction
PCI
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: INOCA with Hyperglycemia

Brief summary: Ischemia with non-obstructive coronary arteries (INOCA) is common in patients with angina. INOCA has been associated with an increased risk of death, myocardial infarction, and stroke, particularly in symptomatic subjects. Previous investigations have evidenced the key role of poor glycemic control and diabetes in coronary microvascular dysfunction. Metformin is an old oral antidiabetic drug which is currently used to achieve glycemic control.

Detailed description: Ischemia with non-obstructive coronary arteries (INOCA) is common in patients with angina. INOCA has been associated with an increased risk of death, myocardial infarction, and stroke, particularly in symptomatic subjects. Coronary microvascular dysfunction, triggering structural remodeling and vasomotor disorders of coronary arterioles, is currently one of the leading hypotheses to explain INOCA pathophysiology. Previous investigations have evidenced the key role of poor glycemic control and diabetes in coronary microvascular dysfunction. Metformin is an old oral antidiabetic drug which is currently used to achieve glycemic control. Also, previous reports evidenced that metformin improves endothelial dysfunction. Nowadays, it is used in prediabetic patients too. In this scenario, we evaluated the role of metformin in reducing the risk of re-hospitalization in INOCA.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years;
* diagnosis of INOCA;
* availability to participate in the study

Exclusion Criteria:

* cancer;
* atrial fibrillation or left bundle branch block;
* previous acute coronary syndrome (ACS) or cardiac revascularization; -pregnancy;
* severe heart valve disease

Primary outcomes:
measure: Risk of Re-Hospitalization
timeFrame: 2016-2021
Secondary outcomes:
measure: MACE
timeFrame: 2016-2021
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04964245: Respiratory Measurement of Volume Change Using Accelerometer, Thermographic Camera Electrical Impedance Tomography and Motion Correlation Analysis Using Mattress Sensor in Healthy Individuals
Official title: Respiratory Measurement of Volume Change Using Accelerometer, Thermographic Camera Electrical Impedance Tomography and Motion Correlation Analysis Using Mattress Sensor in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Adult
Keywords: Respiration
Tidal volume
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 10
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Tidal volume can be the most important technical indicator for ventilation. Measuring the volume of breathing can be used as an indicator of how effective a patient's gas exchange is, and as a predictive indicator of the statue of respiratory disease indirectly. These Tidal volumes can be measured using spirometry and pneumotachograph, and the breathing volume and the rate of airflow can directly or indirectly evaluate the lung function of the patient.

However, spirometry has limitations that patients who are difficult to measure, and that it is difficult to measure in bed. In this work, the movement of the thorax due to breathing is measured in a non-invasive manner (accelerometer, thermographic camera) and the accuracy is compared through changes in thoracic impedance obtained through Pulmovista 500. Furthermore, we would like to correlate the motion of the measured object through a mattress sensor.


Eligibility criteria: Inclusion Criteria:

1. over 19, under 50 years old and common BMI
2. non-smoking, person without cardiopulmonary disease.

Exclusion Criteria:

1. smoking, cardiopulmonary, infectious diseases.

Primary outcomes:
measure: The accuracy of respiration measurements
timeFrame: about 20 min
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
affiliation: Severance Hospital, Yonsei University Health System
name: Jeongmin Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06201845: Assessment of Physical Activity Awareness Training in Healthy Young Adults
Official title: Assessment of Physical Activity Awareness Training in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: exercise
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: According to the World Health Organization, physical activity is defined as any bodily movement produced by skeletal muscles that requires energy expenditure. Positive effects of leading a physically active life and exercise have been shown in many areas ranging from diabetes to cardiovascular diseases, cancer to mortality, pain to autoimmunity .

Detailed description: Despite the many proven benefits of regular aerobic exercise, physical inactivity remains an important public health problem. In young adults, the perception that exercise is not fun and lack of time for exercise have led to a decrease in physical activity participation . However, studies in the literature have reported that after first creating awareness in individuals about the effects of physical activity on health, creating the necessary time for exercises provides sufficient motivation for individuals to start and continue a more active life.

Eligibility criteria: Inclusion criteria:

* 18-25 years of age.
* Being cooperative.
* Voluntarily participating in the study
* Obtaining informed consent from them (Annex-1)

Exclusion criteria:

* Serious musculoskeletal disorders (disc herniation, etc. orthopedic or neurological diagnosis)
* Having a serious systemic disease
* Having a serious injury in the last 3 months.
* Having any neurological problem.

Primary outcomes:
measure: Jump
timeFrame: 10 weeks
measure: Grip Strength Assessment
timeFrame: 10 weeks
measure: Plank Test
timeFrame: 10 weeks
measure: Modified Closed Kinetic Chain Upper Extremity Stability Test
timeFrame: 10 weeks
Secondary outcomes:
measure: Sit-Up Test
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahçehir University
Study officials:
References:
Clinical trial NCT06639945: Clinical Trail of Transcranial MR-guided Focused Ultrasound in the Treatment of Motor Symptoms in Patients with Parkinson' Disease
Official title: Clinical Trail of Transcranial MR-guided Focused Ultrasound in the Treatment of Motor Symptoms in Patients with Parkinson' Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease, Idiopathic
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Randomized, double-blind, self-cross-over control (After the first visit, patients are divided into two groups, randomly receiving real stimulation/placebo stimulation. 10 days later, during the second visit, a cross-over occurs: patients who received real stimulation in the first visit will receive placebo stimulation in the second visit, and vice versa. The grouping situation remains blinded for the patients, TMS analysts, and video analysts.)


Eligibility criteria: Inclusion Criteria:

* Meets the clinical probable Parkinson's disease diagnostic criteria proposed by MDS-UPDRS;
* Disease duration of 4 years or less;
* Unmedicated or has been off medication for more than 12 hours, with H\&Y stage ≤ 2.

Exclusion Criteria:

* History of stroke or seizures, dementia; previous surgical interventions for Parkinson's disease; contraindications for TMS (such as cardiac pacemakers, transcranial implants, and metal implants); severe mental disorders such as depression or psychosis; inability to understand the study procedures; use of antipsychotic medications; pregnancy.

Primary outcomes:
measure: UPDRS-III
timeFrame: 2 weeks and 4 weeks
Secondary outcomes:
measure: TMS parameters
timeFrame: 2 weeks and 4 weeks
measure: cortical activation detected by fNIRS
timeFrame: 2 weeks and 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06513845: Drum Circle Synchrony Study 2c.a.
Official title: Evaluating the Impact of Community-Based Mindfulness and Musical Programs on Psychiatric Measures, Drum Circle Synchrony Study 2c.a.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
COVID-19
Keywords: Mindfulness
Meditation
Music
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-07-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19.

2c.a. Drum Circle Synchrony Study: This study will investigate the role that synchrony plays in subjective feelings of connection.

Detailed description: The investigators also propose a study to investigate the effects of communal drumming in reducing anxiety and increasing connectedness within drum circle community. Investigators hypothesize that these intervention will lead to reductions in scores on stress scales and will provide preliminary data for studies evaluating these types of community programs as an adjunct to the standard of care.

Musicians and non-musicians will listen to segments (\~30 sec duration) of recordings taken from the music made during a previous arm of drum circle and answer a survey. Segments will be categorized as highly synchronized or not synchronized.

Eligibility criteria: Inclusion Criteria:

* ages 18 and older

Exclusion Criteria:

* ages 17 and younger

Primary outcomes:
measure: Mean score connectedness rating
timeFrame: measured during listening session (30minutes)
measure: Mean score subjective rating of synchrony
timeFrame: measured during listening session (30minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: BLOOM
state: Connecticut
city: New Haven
country: United States
facility: Musical Intervention Studios
state: Connecticut
Study officials:
affiliation: Yale University
name: AZA Allsop, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02087345: Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion
Official title: Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion: a Longitudinal Study With pH-impedance Monitoring
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Erosion
Gastroesophageal Reflux
Lead sponsor: Brain-Gut Research Group
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Successive male and female patients with dental erosions

Brief summary: Dental erosions, the chemical dissolution of enamel without bacterial involvement, are considered to be an established complication of gastroesophageal reflux disease (GERD) by the Montreal global consensus statement. Given the high prevalence of dental erosions and the absence of any pH-impedance data or medical management guidelines for GERD-associated dental erosions, reflux characteristics will be characterized using questionnaires, endoscopy and esophageal pH-impedance testing, in successive patients dental erosions referred by dentists for evaluation of GERD. For assessment of the role of additional factors besides H+ activity in the refluxate, a sample of gastric juice will be aspirated during endoscopy and frozen for analysis of pepsin and other proteases. Prognostic factors for progression of dental erosions will be determined by repeating the evaluation after chronic dosing with esomeprazole 20mg twice-daily, which is prescribed to all patients.


Eligibility criteria: Inclusion criteria:

* Successive male and female patients
* Over 18 years of age presenting to the University of Bern Department of Dentistry and affiliated dentists
* Dental erosions

Exclusion criteria:

* Non-reflux causes of erosion
* Reduced salivary flow and buffering capacity
* History of bruxism, eating disorders, recurrent vomiting, severe obesity (BMI\>35kg/m2) or past bariatric surgery
* Dietary or abrasive causes for dental erosion

Primary outcomes:
measure: The % of time with pH<4 and 5.5 during 24-hour pH-impedance
timeFrame: 1 year
Secondary outcomes:
measure: The number of acidic and weakly acidic reflux episodes during 24-hour pH-impedance
timeFrame: 1 year
Other outcomes:
measure: Association between dental erosion grades, gastric juice pepsin conc. and reflux episodes and % time with pH<4 and <5.5 during 24-hour pH-impedance
timeFrame: 1 year
Locations:
city: Bern
country: Switzerland
facility: Gastroenterology Group Practice
Study officials:
affiliation: Brain-Gut Reserach Group
name: Clive Wilder-Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilder-Smith CH, Materna A, Martig L, Lussi A. Longitudinal study of gastroesophageal reflux and erosive tooth wear. BMC Gastroenterol. 2017 Oct 25;17(1):113. doi: 10.1186/s12876-017-0670-1.
Clinical trial NCT01273545: PRILIGY Usage Patterns in Selected Populations
Official title: PRILIGY Usage Patterns in Selected Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Dysfunction, Physiological
Keywords: Dapoxetine hydrochloride (PRILIGY)
Premature ejaculation
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Cegedim Strategic Data
First posted: 2011-01-10
Enrollment: 3000
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients prescribed PRILIGY by physicians who contributed data to the CSD electronic health services databases for German urologists, German general practitioners, or Italian general practitioners.

Brief summary: This study will use electronic health services databases to describe the usage patterns of dapoxetine hydrochloride (PRILIGY) in Germany and Italy with a focus on describing the extent and proportion of patients with characteristics suggestive of the use of PRILIGY within, versus outside of the intended use population.

Detailed description: This study will use anonymized (nameless) patient data from electronic health services databases in Germany and Italy to describe the proportion of PRILIGY (dapoxetine hydrochloride) usage among those patients with characteristics suggestive of the use of PRILIGY within versus outside (eg, those with contraindications) of the intended use (IU) population. This is an observational study; no investigational drug will be administered.

Eligibility criteria: Inclusion Criteria:

* Received a prescription for PRILIGY
* Treated by physicians who contributed data to the IMS Disease Analyzer database for Germany and Thales database for Italy

Exclusion Criteria:

* Age not specified
* Sex not specified as "male
* " Fewer than 6 months (183 days) of history in the electronic health services databases before receiving the first prescription for PRILIGY (At least 6 months of history in the database is not required for the patients of the German urologists).

Primary outcomes:
measure: The proportion patients receiving PRILIGY prescriptions who are within (versus outside of) the IU population.
timeFrame: For up to 1 year
Secondary outcomes:
measure: The number of patients prescribed PRILIGY who have conditions or use medications that are described in the special warnings and precautions section of the PRILIGY Summary of Product Characteristics (SPC)
timeFrame: For up to 1 year
measure: The number of patients prescribed PRILIGY who are at risk for bleeding due to current use of nonsteroidal anti-inflammatory drugs (NSAID's) and warfarin.
timeFrame: For up to 1 year
measure: The number of patients prescribed PRILIGY who do not have a diagnosis suggestive of the approved indication.
timeFrame: For up to 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC C. Clinical Trial
role: STUDY_DIRECTOR
References: