louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02638324: Supportive Treatment of Severe Heart Failure by Renal Denervation
Official title: Supportive Treatment of Severe Heart Failure by Renal Denervation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: Renal nervous denervation
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Satakunta Central Hospital
First posted: 2015-12-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overactivity of sympathetic nervous system is worsening the hemodynamic state of heart failure patients. The present study is planned to reduce the sympathetic tone in patients with severe heart failure by renal nervous denervation.

Detailed description: The patient population consists of heart failure patients who are not responding properly to medication and biventricular pacing therapy. The inappropriate response to these therapies is evaluated by patient history (NYHA III-IV), echocardiography (EF \< 45%), 6-minute walking test (\<440m) and measurements of P-ProBNP. The patients who fulfill the inclusion criteria will undergo renal nervous denervation. The patients will be followed up with the same methods as they were recruited to the study (by patient history (NYHA III-IV), echocardiography (EF \< 45%), 6-minute walking test (\<440m) and measurements of P-ProBNP). The overall time of follow-up will be 24 months. The patients are randomised according to the waiting list principle in a manner to 1:1. The waiting time will be 6 months.

Eligibility criteria: Inclusion Criteria:

* NYHA III-IV
* ejection fraction \<45 %
* 6-minute walking test under 440m

Exclusion Criteria:

* Unstable hemodynamic state
* uncooperation

Primary outcomes:
measure: 6-minute walking test
timeFrame: 24 months
Secondary outcomes:
measure: Patient history
timeFrame: 24 months
measure: Cardiac echocardiography
timeFrame: 24 months
measure: P-proBNP
timeFrame: 24 months
Other outcomes:
Locations:
city: Vaasa
country: Finland
facility: Vaasa Central Hospital
Study officials:
affiliation: Vaasa Central Hospitla
name: Mari-Anne Vaittinen, MD
role: STUDY_CHAIR
affiliation: Vaasa Central Hospital, Vaasa, Finland
name: Mari-Anne Vaittinen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03420924: Thermal Suit With Forced-air Warming in Breast Cancer Surgery
Official title: Thermal Suit With Forced-air Warming in Breast Cancer Surgery: A Randomized Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia, Accidental
Keywords: intraoperative hypothermia
thermal suit
forced-air warming
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this clinical investigation is to prove that the thermal suit with forced-air warming is more effective to prevent inadvertent intraoperative hypothermia than conventional warming methods. The study group will have the thermal suit from arriving to the hospital until to the ward after surgery. In the operating theatre forced-air warming device will be connected to the trouser legs of the thermal suit and the device will be turned on during surgery. The control group will have normal hospital clothes. Intraoperative warming will be managed with the warming mattress and a forced-air warming blanket. The primary endpoint is core temperature after arriving to the post-anaesthesia care unit.


Eligibility criteria: Inclusion Criteria:

* primary breast cancer surgery
* unilateral resection or mastectomy with or without axillar lymphadenectomy
* body mass index 25-40

Exclusion Criteria:

* ASA \> III
* decreased mental status
* inadequate Finnish language skills
* other than general anaesthesia

Primary outcomes:
measure: Core temperature
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: TAYS Hatanpää
Study officials:
affiliation: Tampere University Hospital
name: Maija-Liisa Kalliomäki
role: STUDY_DIRECTOR
References:
Clinical trial NCT02042924: Pilot Study of Multi-Modality Imaging in Patients With Hematologic Malignancies
Official title: Pilot Study of Multi-Modality Imaging in Patients With Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hematologic Malignancy
Keywords: Leukemia
Lymphoma
Myeloma
Myelodysplastic Syndrome
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot sub-study of patients receiving myeloablative transplant using total body irradiation (TBI) or total marrow irradiation (TMI) in their preparative regimen. The objective of this stub-study is to estimate the heterogeneity in cellular proliferation (FLT-PET uptake) as well the heterogeneity in marrow composition distribution (measured using whole body water-fat MRI) using positron emission tomography imaging. This will be used to design future trials as well as to determine the feasibility of PET and MRI imaging.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of hematologic malignancy and fitting into one of the following categories:

  * Newly diagnosed and/or day 14 post-induction chemotherapy
  * Relapsed, including relapse after hematopoietic cell transplant
  * Planned hematopoietic cell transplant (if enrolling at "close") or within 100 days post hematopoietic cell transplant (if enrolling post-transplant) with a preparative regimen that includes either total marrow irradiation (TMI) or total body irradiation (TBI)
  * Undergoing natural killer cell therapies (with or without subsequent transplant)
* Aged 18 years and older
* Not pregnant - women of childbearing potential will have a confirmatory pregnancy test prior to each imaging per routine procedures
* Adequate renal function (estimated glomerular filtration rate \> 60 ml/min) as determined by a serum creatinine level performed as a part of standard of care within 7 days of imaging
* Able and willing to provide written consent

Exclusion Criteria:

* Otherwise eligible patients meeting one or more of the contraindicates for an MRI, may enroll in the study without undergoing the MRI:

  * ferromagnetic implants
  * history of shrapnel or shot gun injury
  * too large to fit in the magnet (approximate body mass index ≥ 40)
  * cardiac pacemakers or other implanted devices that are not MR-compatible
  * claustrophobia
  * large tattoos

Primary outcomes:
measure: Difference in Percentage of Proliferating Bone Marrow Between Baseline and 100 Days
timeFrame: 100 days
measure: Difference in Water Fat
timeFrame: 100 days
measure: Percentage of Proliferating Bone Marrow in the Femur
timeFrame: 100 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Susanta K Hui, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05611996: PEERS Plus mHealth Enhanced Peer Support
Official title: PEERS Plus - mHealth Enhanced Peer Support to Reduce Depression Among Low-income and Ethnic Minority Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression in Old Age
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-11-10
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A cohort of 20 older adults will be assigned to the Peer plus program for 8 weeks, without a comparison group.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this intervention study is to design and learn whether peer support that is delivered through video chats and texting can decrease depression among older adults. Participants will be assigned to a peer support program where they will receive 8 video chats with a peer mentor who provide social support and supportive texts over 8 weeks.

Detailed description: PEERS plus is a psychosocial intervention being developed to reduce depression among older adults. In this intervention peer mentors who are also 50 years of age and older and who have experiential knowledge of depression provide depression care. Older adults with depression will be recruited and assigned to the peer support program. This will consist of 8 weekly peer mentor - older adult video chats that provide emotional support and sharing of self-care skills for depression. Supportive texts will be sent on a weekly basis to older adults by peer mentors. These texts will provide encouragement, affirmations and information about mental health resources. Peer mentors are trained and supervised by a mental health professional during the 8 week period. We will assess at baseline, post study and 3 months after the intervention.

Eligibility criteria: Inclusion Criteria:

1. 50 years and older
2. PHQ-9 score \> 5,
3. on the same antidepressant dose for at least 3 months
4. if receiving psychotherapy, frequency is a most once a month
5. able to communicate in English
6. able to give informed consent.

Exclusion Criteria:

1. meet diagnostic criteria for mania or hypomania
2. active suicidal ideation, 3) meet diagnostic criteria for psychotic syndrome
3. meet diagnostic criteria for substance abuse or dependence
4. a score on the Mini mental state exam (MMSE) \< 24.

Primary outcomes:
measure: Depression
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01234896: Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products
Official title: Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products. A Study in Healthy Smokers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Smoking Cessation, Nicotine pharmacokinetics
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-11-04
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study in healthy smokers.

Detailed description: Forty-four (44) healthy male or female subjects will be included. Single doses of an experimental Nicotine medicated chewing gum 6 mg and Nicorette® Freshfruit gum 4 mg and 2 mg and NiQuitin™ Mint lozenge 4 mg will be administered in a standardized mode, on four separate treatment visits. Periods without nicotine replacement therapy, each lasting for at least 36 hours, will separate the treatment visits. The subjects will abstain from smoking from 8 pm the evening before each treatment visit and until the end of each visit. Blood for pharmacokinetic analyses will be drawn before, and at 2, 4, 6, 8, 10, 15, 20, 30, 45, and 60 minutes as well as at 1.5, 2, 4, 6, 8, 10, and 12 hours after, product administration. Subjects will be monitored to capture any adverse events that may occur.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kilograms per square meter and a total body weight of at least 55.0 kilograms.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 12 hours post-dose
measure: Area Under the Curve (AUC)(0-t)
timeFrame: 12 hours post-dose
measure: AUC (0-∞)
timeFrame: 12 hours post-dose
Secondary outcomes:
measure: AUC(10 min)
timeFrame: 10 minutes post-dose
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: McNeil AB Clinical Pharmacology R&D
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02209896: BlueWind Reprieve System for the Treatment of PNP
Official title: Safety and Performance of the BlueWind Medical Reprieve System for the Treatment of Patients With Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathic Pain
Keywords: Peripheral Neuropathic Pain
PNP
Lead sponsor: BlueWind Medical
Sponsor class: INDUSTRY
First posted: 2014-08-06
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The BlueWind Reprieve system is a neurostimulator consisting of an Implant and external components.

The system is intended for home care use. The chronic pain treatment is achieved by an electrical stimulation of peripheral nerve fibers. The stimulation is set so that it generates paresthesia in the stimulated area (e.g. foot), reducing the pain sensation and improving the quality of life for the patient.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent.
* Male or female aged 18 - 80.
* Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out pain questionnaires.
* Diagnosis of chronic neuropathic pain due to peripheral neuropathy.
* Documented pain attributed to neuropathy for at least 6 months.
* Pain intensity with an average daily VAS score of at least 6, demonstrated by 3 ratings per day across 7 days.
* Patient refractory to conservative treatments including pain medication, for at least 6 months.
* Stable pain medication for at least 4 weeks prior to study enrollment.

Exclusion Criteria:

* Previous participation in another study with any investigational drug or device within the past 90 days.
* Any active implant (cardiac or other).
* Any metal implant in the area of BlueWind device implantation site.
* Current pregnancy or attempting to get pregnant (female patient).
* Any clinically significant neurologic disorders (except PNP).- Any clinically significant or unstable medical or psychiatric condition that would affect the patient's ability to participate in the study.
* Patients with severe or unstable cardiovascular, pulmonary, gastrointestinal, hematological, hepatic, renal or endocrine diseases.
* Severe peripheral vascular disease that may cause intermittent claudication or ischemic ulcers.

Primary outcomes:
measure: The incidence of serious adverse events
timeFrame: 6 months
measure: Pain assessment
timeFrame: 6 months post system activation
Secondary outcomes:
measure: Clinical success defined as the effect of the Reprieve System on patient's symptoms
timeFrame: 6 months post system activation
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health care campus
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
Study officials:
affiliation: Wolfson Medical Center
name: Ron Dabby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01416896: New Needle for Two-Needle Hemodialysis
Official title: New Needle for Two-Needle Hemodialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: End Stage Renal Disease
Keywords: End stage Renal Disease
Hemodialysis
Oxidative Stress
Inflammation
Lead sponsor: Biomedical Enterprises Inc
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-08-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Our preliminary studies have demonstrated that an innovative new design of the hemodialysis venous needle (the needle that returns the cleaned blood from the hemodialysis filter to the patient) with three jets is superior to the standard venous needle because it decreases the velocity and turbulence of the blood when compared with the standard venous needle, it is more efficient in the removal of toxins from the blood, and it is safe and effective. More importantly, our preliminary studies suggested that the new needle causes less damage to the dialysis vascular access and to circulating blood cells and less inflammation and oxidative stress. These will decrease medical complications, the high cost of care and death in dialysis patients. The current study will corroborate the finding of previous studies.


Eligibility criteria: Inclusion Criteria:(1) end stage renal disease receiving hemodialysis in an ambulatory outpatient dialysis facility (2) male or female, (3) ages 18-80, (4) arterio-venous graft or AV fistula as vascular access,

Exclusion Criteria:patients with fever, infection, inflammation or malignancy will be excluded

Primary outcomes:
measure: Net change in intracellular oxidative stress and intracellular proinflammatory cytokines levels
timeFrame: 4 hours of hemodialysis
Secondary outcomes:
measure: Net change in oxidative stress and proinflammatory cytokines in plasma
timeFrame: 4 hours hemodialysis
Other outcomes:
Locations:
city: Washington
country: United States
facility: DaVita K Street Dialysis Center
state: District of Columbia
Study officials:
affiliation: Biomedical Enterprises Inc
name: Alfredo R Zarate, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children National Medical Center
name: Pedro A Jose, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01817296: Klinefelter Fertility Preservation
Official title: Klinefelter Syndrome: Are we Missing the Optimal Time for Fertility Preservation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Klinefelter Syndrome
Keywords: Klinefelter
Fertility
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2013-03-25
Enrollment: 15
Sex: MALE
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Klinefelter syndrome occurs in 1 in 600 males and is a common cause of infertility in men. It appears scar tissue forms in these boys' testicles, leading to progressive destruction over their lifetimes. Advanced reproductive technology can be used to surgically retrieve sperm from these individuals, but these methods have a 50% failure rate in adult Klinefelter patients. Younger men have higher success rates, suggesting that adolescence and young adulthood may be the best time to extract sperm, but these techniques have not been studied in Klinefelter patients younger than 26 years of age. Additionally, there is currently no way to predict which Klinefelter patients will have success with these methods and which of them will not. This trial will explore sperm extraction in Klinefelter syndrome in an age range (12-25 years) that has never been studied, with the ultimate hope of improving the potential for fertility in these patients. The specific goals of this study are to determine the ideal age for sperm retrieval in Klinefelter patients and to establish factors that can be used to predict which of these patients will have a higher likelihood of success with advanced reproductive technology. The hypothesis is that younger Klinefelter patients will have higher sperm retrieval rates.


Eligibility criteria: Inclusion Criteria:

* diagnosed 47,XXY (Klinefelter syndrome)
* 12-25 years of age

Exclusion Criteria:

* testosterone therapy within past 6 months
* history of surgery, injury, or infection in the testicle
* solitary testicle

Primary outcomes:
measure: Sperm retrieval rates based on age
timeFrame: Assessed at the end of the 6 month study period
Secondary outcomes:
measure: Correlation between sperm retrieval rates and physical and biochemical markers
timeFrame: Assessed at the end of the 6 month study period
measure: Correlation between sperm retrieval rates and neurocognitive survey data
timeFrame: Assessed at the end of the 6 month study period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
citation: Nahata L, Yu RN, Paltiel HJ, Chow JS, Logvinenko T, Rosoklija I, Cohen LE. Sperm Retrieval in Adolescents and Young Adults with Klinefelter Syndrome: A Prospective, Pilot Study. J Pediatr. 2016 Mar;170:260-5.e1-2. doi: 10.1016/j.jpeds.2015.12.028. Epub 2015 Dec 31.
Clinical trial NCT00981396: The Effect of Emotional Freedom Techniques (EFT) in Smokers Failing a Smoking Cessation Program
Official title: The Effect of EFT (Emotional Freedom Techniques) in Smokers Failing a Smoking Cessation Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Smoking
Keywords: smoking
EFT (Emotional Freedom Techniques)
CBT (cognitive behavior therapy)
cravings
trauma
Lead sponsor: Soul Medicine Institute
Sponsor class: OTHER
First posted: 2009-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The National Health Service (NHS) stop smoking service at the Central Lancashire NHS Trust serves a diverse population of smokers, with a very good quit rate and high standards. However, clinical experience predicts that some clients are unlikely to succeed through the NHS smoking cessation program. This special population has difficulty quitting for a variety of reasons. Some relapse over the course of the following two years and return repeatedly to the service. Others, for instance those with health problems, may be highly motivated to quit, but unable to resist their cravings. The purpose of this study is to determine if EFT makes a difference in quit rates with the most challenging population of clients.


Eligibility criteria: Inclusion Criteria:

* High anxiety related to the quit attempt
* Cravings which sabotage the quit attempt
* Low confidence at their ability to quit and remain quit

Exclusion Criteria:

* None, all NHS clients are eligible

Primary outcomes:
measure: Quit rate
timeFrame: treatment period
Secondary outcomes:
measure: Psychological symptoms and physiological symptoms
timeFrame: Three, 6, and 12 months after intervention
Other outcomes:
Locations:
city: Ormskirk
country: United Kingdom
facility: NHS Central Lancashire Primary Care Trust
state: Lancashire
Study officials:
affiliation: Soul Medicine Institute
name: Dawson Church, PhD
role: PRINCIPAL_INVESTIGATOR
References: