louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00351325: A Study of BMS-663513 Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies
Official title: A Phase I, Multiple Ascending Dose Study of BMS-663513, an Agonistic Anti-CD137 Monoclonal Antibody, Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Malignancies
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-07-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of multiple escalating doses of BMS-663513 when given in combination with paclitaxel and carboplatin.


Eligibility criteria: Inclusion Criteria:

* Good activity level
* Life expectancy of ≥ 6 months
* Solid tumor malignancy for which paclitaxel and carboplatin are appropriate

Exclusion Criteria:

* Major surgery within 4 weeks
* Any concurrent cancer
* History of autoimmune diseases
* Symptomatic bowel obstruction
* Continued use of steroids
* Symptomatic brain metastases
* Current nerve damage in fingers/toes
* Positive for HIV, hepatitis B/C
* White blood cells \< 3,000
* Hemoglobin \< 9
* Platelets \< 100,000
* ALT/AST and/or alkaline phosphatase \>= 2.5 x ULN
* Creatine \> 1.5
* Prior BMS-663513

Primary outcomes:
measure: To assess the safety and tolerability of multiple ascending doses of BMS-663513 when given in combination with paclitaxel and carboplatin to subjects with advanced malignancies
timeFrame: throughout the study
Secondary outcomes:
measure: Explore PK and PD associations of BMS-663513 and the effect of BMS-663513 on immune system markers.
timeFrame: throughout the study
measure: Describe anti-tumor activity
timeFrame: throughout the study
measure: Obtain tissue or ascites for exploratory research
timeFrame: throughout the study
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University Of Pennsylvania Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital Of Upmc
state: Pennsylvania
city: Charlottesville
country: United States
facility: University Of Virginia
state: Virginia
city: Seattle
country: United States
facility: University Of Washington
state: Washington
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06761625: Changes in Hormonal Profile and Body Mass Index in Women With Polycystic Ovary Syndrome After Probiotic Intake
Official title: Changes in Hormonal Profile and Body Mass Index in Women With Polycystic Ovary Syndrome After Probiotic Intake: A 12-week Placebo Controlled and Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PCOS
Keywords: PCOS
probiotics
hormones
BMI
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Changes in hormonal profile and body mass index in women with polycystic ovary syndrome were analised after probiotic intake.

Detailed description: 50 women with PCOS , diagnosed based on Rotterdam ESHRE criteria,were assigned to two groups - the probiotics one and the placebo one. Women from the probiotics group were given SanProbi® Barrier capsules. They were taking probiotics for 12 weeks. The placebo group received identical-looking capsules filled mainly with maize starch and maltodextrins. The study concentrates on analysing specific hormones before and after the intervention (giving the probiotics or a placebo to the patients). The serum samples were obtained on days 3-5 (early follicular phase) of menstrual cycle. In the laboratory studies, the following hormones were measured before and after 12-week intervention: Testosterone, Androstenedione, 17-hydroxyprogesterone (17(OH)P); follicle stimulating hormone (FSH), luteinising hormone (LH); estradiol (E2), prolactin (PRL), thyroid stimulating hormone (TSH), thyroxine (T4) and sex hormone binding globulin (SHBG). The weight and height were measured before and after 12-week intervention. BMI was also calculated.

Eligibility criteria: Inclusion Criteria:

* women with PCOS, diagnosed based on Rotterdam ESHRE criteria

Exclusion Criteria:

* The patients with comorbidities such as diabetes mellitus type I and II, heart diseas-es, liver diseases, hypertension, hypothyroidism should be excluded from the study

Primary outcomes:
measure: Changes in hormonal profile after probiotics intake
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in FSH and LH levels in women with polycystic ovary syndrome after probiotic intake
timeFrame: 12 weeks
measure: Change in Estradiol levels in women with polycystic ovary syndrome after probiotic intake
timeFrame: 12 weeks
measure: Changes in TSH levels in women with polycystic ovary syndrome after probiotic intake
timeFrame: 12 weeks
measure: Changes in SHBG in women with polycystic ovary syndrome after probiotic intake
timeFrame: 12 weeks
measure: Changes in DHEA-S levels in women with polycystic ovary syndrome after probiotic intake
timeFrame: 12 weeks
measure: Changes in BMI in women with polycystic ovary syndrome after probiotic intake
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Pomeranian Medical University
Study officials:
References:
Clinical trial NCT01128725: Truncated and Extended Forms of Amyloid Beta Peptides in Alzheimer's Disease: Genesis, Toxicity and Identification as Biological Markers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2010-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Beta amyloid immunoreactivity is probably due to a significant number of Ab catabolites corresponding to N-terminally truncated and Cterminally truncated or extended forms which display distinct propensity to aggregation. Very few things are known concerning the mechanisms and proteases by which they are generated. Furthermore, the link between truncation and toxicity has not been delineated.

Finally, little is known concerning Ab fragments in biological fluids and whether they could be seen as early biomarkers and thereby, as putative targets for AD diagnostic. The present project will allow to examine the human biological samples and to identify various cohorts after complete clinical evaluation.


Eligibility criteria: Inclusion Criteria:

* 1) Coming subjects to see patients in CMRR for a complaint mnésique 2) Introducing a score in Tiny Mental the upper Test (MMSE) in 28/30 without error in under score of the recall of the 3 words 3) Introducing a score of 10/10 in the test of the 5 words of B2C 4) Introducing a score in the ladder CDR (Clinical Dementia Rating) equal to 0 5) Having given a lit consent 6) Being affiliated member or beneficiary of the regime of French national health and pensions organization

Exclusion Criteria:

* Major, all the vulnerable persons under 18 under tutelage, under legal guardianship, deprived of freedom, hospitalized in a health Establishment or social for quite other reason that searches it
* Record of neurological or psychiatric pathology and inability for sensory reasons to perform a cognitive balance sheet

Primary outcomes:
measure: Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.
timeFrame: one year
Secondary outcomes:
measure: The availability of truncated fragments designed to set up monoclonal antibodies will allow us to estimate their associated toxicity in various cellular models.
timeFrame: one year
Other outcomes:
Locations:
city: Nice
country: France
facility: Robert
state: Alpes-Maritimes
Study officials:
affiliation: CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
name: Philippe ROBERT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06223425: Virtual Reality Situation-Based Flipped Learning
Official title: Effectiveness of Virtual Reality Situation-Based Flipped Learning and Gamification on Nursing Students' Learning Attitudes, Problem-solving Abilities, and Empathetic Abilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Educational Problems
Problem;Learning
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The integration of innovative educational approaches in nursing education has become increasingly crucial for enhancing learning outcomes. Among these approaches, virtual reality (VR)

Detailed description: Situation-Based Flipped Learning, and Gamification have gained attention as promising tools to engage nursing students and promote a deeper understanding of complex concepts. This study aims to investigate the effectiveness of combining these strategies in a virtual reality Situation-Based Flipped Learning environment with elements of Gamification on nursing students' learning attitudes, problem-solving abilities, and empathetic skills. By leveraging these technologies, educators seek to create an immersive and interactive learning experience that not only aligns with the demands of modern education but also addresses the unique challenges faced by nursing students in developing critical competencies. This research explores the potential impact of this integrated approach on nursing education, contributing valuable insights to the ongoing efforts to optimize teaching methodologies for future healthcare professionals.

Eligibility criteria: Inclusion Criteria:

* willingness to participate

Exclusion Criteria:

* First-year academic students

Primary outcomes:
measure: virtual reality Situation-Based Flipped Learning
timeFrame: two months
measure: virtual reality Based Gamification
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
state: Al Iskandariyah
Study officials:
affiliation: Faculty of nursing, Alexandria university, Egypt
name: mohamed H atta
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01581125: Sleep Duration Required to Restore Performance During Chronic Sleep Restriction
Official title: Sleep Duration Required to Restore Performance During Chronic Sleep Restriction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Sleep Deprivation
Insufficient Sleep Syndrome
Keywords: Inpatients
Health Normalcy
circadian rhythm
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2012-04-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase.

Detailed description: The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase. Inpatient sleep and performance data will be collected from healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Prescription medications

Primary outcomes:
measure: Psychomotor Vigilance Task (PVT) performance
timeFrame: PVT during waking for arms 1 and 2 during the 32-day inpatient portion of the protocol
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Elizabeth B Klerman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McHill AW, Hull JT, Cohen DA, Wang W, Czeisler CA, Klerman EB. Chronic sleep restriction greatly magnifies performance decrements immediately after awakening. Sleep. 2019 May 1;42(5):zsz032. doi: 10.1093/sleep/zsz032.
citation: McHill AW, Hull JT, McMullan CJ, Klerman EB. Chronic Insufficient Sleep Has a Limited Impact on Circadian Rhythmicity of Subjective Hunger and Awakening Fasted Metabolic Hormones. Front Endocrinol (Lausanne). 2018 Jun 12;9:319. doi: 10.3389/fendo.2018.00319. eCollection 2018.
Clinical trial NCT02132325: Dignity Therapy/Life Plan in Patients With Pancreatic or Advanced Lung Cancer
Official title: Phase I/IIA: Dignity Therapy/Life Plan in Patients With Pancreatic or Advanced Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Non-Small-Cell Lung Cancer
Keywords: Pancreatic Cancer
Dignity Therapy
Palliative Care
Advanced Lung Cancer
Non-Small-Cell Lung Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-05-07
Enrollment: 19
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will evaluate feasibility and acceptability of providing the Dignity Therapy/Life Plan intervention to pancreatic or advanced lung cancer patients presenting for treatment in the outpatient medical oncology setting. Investigators hypothesize that providing dignity therapy to this population will be feasible.


Eligibility criteria: Inclusion Criteria:

* Age \>18
* Undergoing chemotherapy for pancreatic adenocarcinoma or advanced NSCLC (pancreatic arm closed)
* English-speaking
* Cognitively intact, per clinician judgment, as documented in electronic medical record (EMR)

Exclusion Criteria:

* Currently receiving hospice or palliative care services
* Concurrent diagnosis of delirium or dementia, per medical record
* Diagnosis of major depression disorder, acute anxiety disorder or schizophrenia per medical record
* Participating in other psychosocial intervention research studies.

Primary outcomes:
measure: Change in level of distress as measured by distress scores on the Distress Thermometer
timeFrame: Baseline & at the end of the dignity therapy intervention (approximately 6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ann Marie Dose, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01185925: Exercise Oscillatory Breathing and Sildenafil in Heart Failure
Official title: PDE5-Inhibition With Sildenafil Reverses Exercise Oscillatory Breathing in Chronic Heart Failure: a Long-Term Cardiopulmonary Exercise Testing Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Keywords: PDE5-inhibition
exercise ventilation
heart failure
sildenafil
pulmonary hemodynamics
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2010-08-20
Enrollment: 32
Sex: MALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Exercise oscillatory breathing (EOB) is a ventilatory abnormality that occurs in approximately 20% of heart failure (HF) patients and carries a very unfavourable prognosis.

Pathophysiology seems quite complex and putative mechanisms include increased pulmonary capillary pressure and pulmonary vasoconstriction, circulatory blood-flow fluctuations in the pulmonary arterial system and instability of ventilatory control.

Inhibition of the phosphodiesterase 5 (PDE5) isoenzyme favourably regulates pulmonary vascular tone and permeability through over signaling of the endothelial nitric oxide pathway. The investigators tested the hypothesis that sildenafil would reverse the EOB pattern in patients with HF and pulmonary hypertension.


Eligibility criteria: Inclusion Criteria:

* consent to participate in the study after detailed information about benefits and risks
* negative exercise stress test prior to study initiation
* forced expiratory volume in 1 sec/forced vital capacity ratio \>70%;
* LVEF \< 45%.

Exclusion Criteria:

* inability to complete a maximal exercise test
* resting systolic blood pressure \> 140 or \<110 mmHg
* therapy with nitrate preparations
* history of sildenafil intolerance
* significant lung or valvular diseases
* neuromuscular disorders or peripheral vascular disease

Primary outcomes:
measure: Drug Effect on Oscillatory Breathing during Exercise
timeFrame: 1 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05262725: Behavioral Activation for Opioid Use Disorder
Official title: A Pilot Study of Behavioral Activation for People With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Keywords: opioid use disorder
behavioral activation
primary care
buprenorphine
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-arm, pre/post pilot trial
Primary purpose: TREATMENT

Brief summary: The overall purpose of this pilot study is to evaluate the feasibility and acceptability of values-based behavioral activation (BA) as an adjunct intervention for patients receiving medications for opioid use disorder (OUD) in primary care. Researcher will evaluate the following aims: 1) examine the feasibility of BA for OUD in primary care, 2) examine whether the BA intervention and study requirements are acceptable to participants, and 3) determine the psychometric properties of the outcome measures in people with OUD. Participants will complete 4-6 brief counseling sessions over the course of 12 weeks. During the first session, participants will discuss values and recovery outcomes important to them. Next, they will set 2-3 personal goals to work on before the next BA session. At the follow-up sessions, participants will update the counselor on progress made or challenges experienced. Personal values will be reviewed and participant goals updated. Study measures (surveys and urine drug tests) will be completed at the start, partway through, and at the end of the intervention.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age.
* Diagnosis of opioid use disorder.
* Have an active prescription for buprenorphine-naloxone (Suboxone) for at least one month.
* Patient at Broadway Family Medicine (BFM)

Exclusion Criteria:

* Concurrent individual psychotherapy with a psychologist or counselor at least monthly
* Active suicidal ideation (intention, plan, or attempt in the past 30 days, as determined by chart review)
* Dementia, developmental disabilities, or cognitive functioning that is too low to participate in therapy, as determined by chart review

Primary outcomes:
measure: Feasibility of Recruitment
timeFrame: 3 months from baseline
measure: Recruitment Pace
timeFrame: 3 months following intervention
measure: Retention Percent
timeFrame: 3 months following intervention
measure: Treatment Satisfaction
timeFrame: 3 months following intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Robert Levy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05960825: Maxillary Canine Retraction Assisted With Micro-osteoperforations Versus Injectable Platelet Rich Fibrin
Official title: Assessment of Two Different Modalities of Maxillary Canine Retraction Assisted With Micro-osteoperforations Versus Injectable Platelet Rich Fibrin: A Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Effects of; Movement of Teeth Assiste Wit MOPS and I-prf
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 18
Sex: ALL
Minimum age (years): 15
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The present clinical comparative study will be undertaken for assessment of two different modalities of maxillary canine retraction assisted with microosteoperforations versus injectable platelet rich fibrin.

Detailed description: Group I: will include 9 patients who willreceive MOPs with maxillary canine retraction that will be performed on intervention sides according to a standardized protocol.

▪ Group II: will include 9 patients receive i-PRF that will be performed on intervention sides according to a standardized protocol.

Eligibility criteria: Inclusion Criteria:

1. An age ranges from 15-22 years.
2. Severe crowding or protrusion requiring 1st premolars extractions followed by symmetrical canine retraction.
3. All permanent teeth present, 3rd molars are excluded.
4. Good oral and general health.
5. No systemic disease/medication that could interfere with OTM.
6. No previous orthodontic treatment.

Exclusion Criteria:

1. Patient diagnosed to have an indication for non-extraction approach.
2. Poor oral hygiene or periodontally compromised patient.
3. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
4. Previous orthodontic treatment.

Primary outcomes:
measure: Direct clinical assessment of the amount of maxillary canine retraction i.e. amount of extraction space closure before and after four months observation period and on every 28 days observation period according to standardized method
timeFrame: 4months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AlAzhar university
Study officials:
References:
citation: Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
citation: Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.