louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00010712: Effects of Black Cohosh on Menopausal Hot Flashes
Official title: Effects of Black Cohosh on Menopausal Hot Flashes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postmenopause
Hot Flashes
Osteoporosis, Postmenopausal
Keywords: Menopause
Hot Flashes
Osteoporosis
Postmenopausal
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2001-02-05
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study will assess whether treatment with black cohosh is effective in reducing the frequency and intensity of menopausal hot flashes. In addition, this study will determine whether or not black cohosh reduces the frequency of other menopausal symptoms and improves quality of life.

Detailed description: Most American women will spend the last third of their lives post-menopause. During this time, chronically low levels of steroidal estrogens may lead to a number of short and long-term medical sequelae such as hot flashes, vaginal dryness, heart disease, and osteoporosis. While some physicians believe that demonstrated beneficial effects of estrogen, particularly on the cardiovascular and skeletal systems, warrant the taking of hormone therapy from menopause on, many women choose not to take estrogen replacement therapy (ERT) and are increasingly exploring alternative approaches to ERT.

For centuries, black cohosh (Cimicifuga racemosa) has been used worldwide for women's health. Despite its long-standing use, studies of black cohosh have yielded conflicting data, in part because of lack in study design rigor and the short duration of studies to date. The primary aim of this study is to correct past shortcomings in study design to determine whether treatment with black cohosh is effective in treating menopausal symptoms.

Participants in this study will be given black cohosh for a 12-month period. Potential mechanisms of action of black cohosh will be examined by quantifying the levels of sex hormones, including estradiol, estrone, FSH, and LH. Because black cohosh may act as an estrogenic agent, the effect on endometrium will be evaluated by sonogram and by monitoring the incidence of adverse events and compliance with the study.

Eligibility criteria: Inclusion Criteria:

* Resident of the New York Metro Area
* Postmenopausal
* Weight within 90% to 120% of ideal body weight

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Rosenthal Center for CAM
state: New York
Study officials:
affiliation: Columbia University
name: Dr. Fredi Kronenberg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01950312: The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease
Official title: An Open-label Study of the Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autoimmune Inner Ear Disease
Keywords: Autoimmune Inner Ear Disease
Inner Ear Disease
Meniere's Disease
Sudden Sensorineural Hearing Loss
Lead sponsor: XOMA (US) LLC
Sponsor class: INDUSTRY
Collaborators: name: Feinstein Institute for Medical Research
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2013-09-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if gevokizumab therapy may be an alternate therapy in patients with steroid resistant Autoimmune Inner Ear Disease.


Eligibility criteria: Inclusion Criteria:

* Autoimmune Inner Ear Disease with active deterioration in at least one ear
* Failure to respond to a trial of high-dose corticosteroid therapy
* Contraceptive measures adequate to prevent pregnancy during the study

Exclusion Criteria:

* Evidence of retrocochlear pathology (vestibular schwannoma) or inner ear malformation (Mondini Malformation or Enlarged Vestibular Aqueduct)
* History of active or chronic infections
* Currently receiving, or having received treatment for a malignancy in the past three years
* Hearing loss that coincides with significant, disabling episodes of vertigo
* History of allergic or anaphylactic reactions to monoclonal antibodies
* Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Improved hearing threshold, as defined by an improvement in either the PTA (Pure Tone Average) of >=5 dB (Decibel), or 12% in the WRS (Word Recognition Score)
timeFrame: Day 28 to Day 84
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center, Hearing & Speech Center
state: New York
Study officials:
References:
Clinical trial NCT03828812: Temporal Patterns of Diet and the Changes in Body Composition and Blood Pressure
Official title: Temporal Patterns of Diet and the Changes in Body Composition and Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Composition
Blood Pressure
Mealtimes
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study includes two parts: 1) an observational study examines the association of meal frequency, meal timing, and meal regularity with short-term changes in blood pressure and body composition; 2) a randomized controlled intervention examines the influence of recommendation of increase breakfast frequency and decrease nighttime snacking on 1-year changes in blood pressure and body composition.


Eligibility criteria: Inclusion criteria:

* Adult
* Willing to participate

Exclusion criteria:

* Being pregnant
* hemodialysis patients
* clinical diagnosis of cardiovascular diseases
* clinical diagnosis of cancer
* clinical diagnosis of dementia
* clinical diagnosis of eating disorders
* having metal orthopedic implants
* having pacemaker implanted

Primary outcomes:
measure: Body weight
timeFrame: 1 year
measure: Standing height
timeFrame: 1 year
measure: Body fat%
timeFrame: 1 year
measure: Body mass index
timeFrame: 1 year
measure: Systolic blood pressure
timeFrame: 1 year
measure: Diastolic blood pressure
timeFrame: 1 year
Secondary outcomes:
measure: Frequency of breakfast per week
timeFrame: 1 year
measure: Frequency of nighttime snacking per week
timeFrame: 1 year
Other outcomes:
measure: Sleep quality score
timeFrame: 1 year
measure: Mood status
timeFrame: 1 year
Locations:
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Hsin-Jen Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03866512: Forearm Immobilization, Metabolic Health, and Muscle Loss
Official title: The Impact of Acipimox and Salbutamol Supplementation on the Development of Insulin Resistance and Anabolic Resistance During Forearm Immobilization in Healthy, Young Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
First posted: 2019-03-07
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The present study will investigate the impact of altered substrate availability on muscle atrophy, insulin sensitivity and muscle protein synthesis following short-term forearm immobilization

Detailed description: Thirty-six healthy young volunteers will undergo 2 days of forearm immobilization combined with ingestion of one of two drug or placebo. Before and after immobilization, they will receive a stable isotope tracer infusion (5.5 h) combined with repeated blood and muscle sampling under insulin clamp conditions, in order to measure insulin sensitivity and muscle protein synthesis in the fasted and fed state.

Eligibility criteria: Inclusion Criteria:

* Males and females 18-40 years of age
* Body mass index between 18 and 27

Exclusion Criteria:

* Any diagnosed metabolic impairment (e.g. type 1 or 2 diabetes)
* Any diagnosed cardiovascular disease
* Hypertension (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
* Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
* Regular use of nutritional supplements
* Metallic implants
* A personal or family history of thrombosis, epilepsy, seizures or schizophrenia
* Any previous motor disorders
* Any known disorders in lipid metabolism
* Any known disorders in muscle metabolism
* Known allergy for Acipimox, beta agonist, or other substances in the tablets
* Known sensitivity for sympathomimetic drugs
* Known hypokalaemia
* Presence of an ulcer in the stomach or gut and/or strong history of indigestion
* Known severe kidney problems
* Pregnancy
* Unable to give consent

Primary outcomes:
measure: Percent Change in Forearm Glucose Uptake
timeFrame: During the steady-state phase of the insulin clamp (i.e. last 30 min)
Secondary outcomes:
measure: Percent Change in Muscle Protein Synthesis
timeFrame: In the fasted state (30 min before starting insulin clamp), and during the steady-state phase of the insulin clamp (i.e. last 30 min)
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Royal Exeter & Devon NHS Foundation Trust
state: Devon
Study officials:
affiliation: University of Exeter
name: Marlou Dirks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01907412: Trial of Transition to Parenthood Program for Couples
Official title: Trial of Transition to Parenthood Program for Couples
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parent-Child Relations
Keywords: First time parents
Coparenting
Family Foundations
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a research study to evaluate the effectiveness of the Family Foundations program and to better understand how families cope with having a new baby. The research questions include: What is the effectiveness of the Family Foundations program? How do families cope with having a new baby?


Eligibility criteria: Inclusion Criteria:

* Expecting first child
* Couple living together and planning to raise child together
* 18 years or older

Exclusion Criteria:

* not first child

Primary outcomes:
measure: Coparenting Quality
timeFrame: Up to 2.5 years from baseline
Secondary outcomes:
measure: Aggressive Parenting
timeFrame: Up to 2.5 years after baseline
Other outcomes:
measure: Cardiovascular disease risk
timeFrame: 8 years from baseline
Locations:
city: University Park
country: United States
facility: Penn State University, Prevention Research Center
state: Pennsylvania
Study officials:
References:
citation: Feinberg ME, Jones DE, Roettger ME, Hostetler ML, Sakuma KL, Paul IM, Ehrenthal DB. Preventive Effects on Birth Outcomes: Buffering Impact of Maternal Stress, Depression, and Anxiety. Matern Child Health J. 2016 Jan;20(1):56-65. doi: 10.1007/s10995-015-1801-3.
Clinical trial NCT02701712: Receiving Radiation Therapy in the MRgRT Research Facility
Official title: Receiving Radiation Therapy in the MRgRT Research Facility
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Tumors and Metastatic Lesions
Keywords: magnetic resonance
external beam radiotherapy
brachytherapy
radiotherapy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the technical performance of magnetic-resonance guided radiotherapy (MRgRT) facility at the Princess Margaret Cancer Centre and the impact on the workflow of the clinical team in this facility.


Eligibility criteria: Inclusion Criteria:

* Ability to provide informed consent
* Planned to receive clinical intervention (imaging or treatment) in the MRgRT facility
* At least 18 years of age

Exclusion Criteria:

-

Primary outcomes:
measure: Proportion of planned patients receiving treatment in the MRgRT facility
timeFrame: 2 years
Secondary outcomes:
measure: Measure tumor size before, during and after radiotherapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Michael Milosevic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05128812: Study of the Effects of Plx on Bioparametric Measurements.
Official title: Study of the Anxiolytic Effects, Improvement of Sleep Quality and Bioparametric Measures in Individuals Taking an Extract of Lippia Citriodora.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Antidepressive Agents
Depression, Anxiety
Sleep Initiation and Maintenance Disorders
Body Composition
Stress, Psychological
Lead sponsor: University of Alicante
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective is to study the effects of the intake of a nutraceutical on health indicators, focused on sleep and stress, as well as cardiovascular (blood pressure...), circulating (cortisol) and body composition parameters in a Spanish adult population.

Detailed description: Anxiety is a normal part of life, and generally is a temporary condition. However, anxiety can occasionally prolong in time, having an impact on everyday activities, and give rise to other conditions, such as depression, drug abuse, cardiovascular disease, and insomnia. There are a number of synthetic drugs that are commonly used to treat anxiety. These are mainly antidepressants and benzodiazepines. However, their high cost, important side effects and a rising interest in natural solutions have driven researchers to search for botanical-based formulas. To this end, there are a number of plants that have been described to possess potential sedative and anxiolytic effects. Of note is lemon verbena (Lippia citriodora), which is native of Western South America but is also cultivated in the Mediterranean region and Middle East.

Eligibility criteria: Inclusion Criteria:

1. Over 21 years of age;
2. Without any chronic pathology;
3. Score on the Spielberg Trait-State Anxiety Inventory (STAI-S) comprising 20 items, greater than 40 (probable clinical levels of anxiety);
4. Pittsburgh Sleep Quality Index (PSQI) score greater than 5 (poor sleep quality).

Exclusion Criteria:

* Failure to meet the inclusion criteria.

Primary outcomes:
measure: WEIGHT
timeFrame: 3 months
measure: HEIGHT
timeFrame: 3 months
measure: BLOOD PREASURE
timeFrame: 3 months
measure: FAT MASS
timeFrame: 3 months
measure: VISCERAL FAT
timeFrame: 3 months
measure: BLOOD CORTISOL
timeFrame: 3 months
measure: SLEEP QUALITY
timeFrame: 3 months
measure: STRESS
timeFrame: 3 months
measure: ANXIETY
timeFrame: 3 months
measure: PERCEIVED QUALITY OF LIFE
timeFrame: 3 months
measure: HEART RATE
timeFrame: 3 months
measure: SLEEP HOURS
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: University of Alicante
Study officials:
affiliation: Alicante University
name: Alejandro Martinez Rodriguez, Assistant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03178812: Role of the Cystic Fluid Interleukins and Tumor Necrosis Factor (TNF) Levels in Characterizing Pancreatic Cysts Detected by Endoscopic Ultrasound (EUS)
Official title: The Role of the Cystic Fluid Interleukins 1,8, & 10 and Tumor Necrosis Factor (TNF) Levels in Characterizing Pancreatic Cysts Detected by Endoscopic Ultrasound (EUS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One arm containing patients with pancreatic lesion and one control group arm of healthy volunteers
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to find a correlation between cytokines levels and malignancy potential of different cystic types.


Eligibility criteria: Inclusion Criteria:

* Patients with pancreatic cyst

Exclusion Criteria:

* None

Primary outcomes:
measure: Prediction of malignant potential of pancreatic cyst by measuring Interleukin levels
timeFrame: Two years
measure: Prediction of malignant potential of pancreatic cyst by measuring TNF levels
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: H̱adera
country: Israel
facility: Hillel Yaffe Medical
Study officials:
References:
Clinical trial NCT02693912: Changes in Alveolar Macrophage Function During Acute Lung Injury
Official title: Changes in Alveolar Macrophage Function During Acute Lung Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lung Injury
Keywords: efferocytosis
macrophage
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ALI and acute respiratory distress syndrome (ARDS) are characterized by an increased permeability of the alveolar-capillary barrier resulting in lung edema with protein-rich fluid, thus resulting in impairment of arterial oxygenation. ALI/ARDS is defined as a lung disease with acute onset, noncardiac, diffuse bilateral pulmonary infiltrates and a paO2/FiO2 ≤ 300 for ALI or a paO2/FiO2 ≤ 200 for ARDS. The ageadjusted incidence of ALI/ARDS is estimated with 86.2 per 100,000 person-years. Despite all innovations in intensive care medicine, the mortality of ARDS remains up to 40%.

Brief summary: In this study, the investigators aim to observe the change in alveolar macrophage function during acute lung injury.

Detailed description: Alveolar macrophages are tissue-resident or recruited cells with key functions in recognition of pathogens, initiation of host defensive ang protective inflammation,and in clearance of pathogens from the airways. However, macrophages are also responsible for efficient clearance of apoptotic neutrophils, termed efferocytosis, which is a prerequisite for the timely resolution of inflammation. In this study, the investigators aim to observe the change in alveolar macrophage function during acute lung injury.

Eligibility criteria: Inclusion Criteria:

* Patients in ICU with diagnosed ALI under mechanical ventilation

Exclusion Criteria:

* Patients with cardiac dysfunction, using steroid drugs or other drugs can that affect efferocytosis

Primary outcomes:
measure: alveolar macrophages (AMs) phagocytic index
timeFrame: 7 days after admission
Secondary outcomes:
measure: 30 days mortality
timeFrame: 30 days after admission
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: Jin Liu
role: STUDY_CHAIR
References:
Clinical trial NCT00990912: A Study to Document Long-Term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects With Refractory Solid Tumors (Rollover Study -001, -002)
Official title: A Study to Document Long-term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects 1 - 21 Years of Age With Refractory Solid Tumors Who Have Experienced Clinical Benefit Following a Minimum of 6 Cycles of Therapy on BMS Protocol CA124-001 or BMS Protocol CA124-002
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pediatric Solid Tumors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the long term safety of patients with refractory solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in BMS Protocol CA124-001 or CA124-002.


Eligibility criteria: Inclusion Criteria:

* Completion of at least 6 cycles of therapy on BMS clinical protocol CA124-001 or CA124-002 and who continue to derive clinical benefit and are not experiencing intolerable toxicity from the therapy
* Karnofsky score of at least 50 for subjects \> 10 years of age; Lansky play scale of at least 50 for children 10 years of age and younger
* Recovery to baseline or Grade 1 from toxicities (except alopecia or asthenia) resulting from previous therapies
* Males and females, ages 1 - 21 years of age at the time of consent into CA124-001 or CA124-002

Exclusion Criteria:

* A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy
* Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy, or any other investigational drug while on study
* Inadequate bone marrow and renal function
* Concurrent receipt of Dilantin®(phenytoin), phenobarbital, primidone, Tegretol®(carbamazepine), Depacon®, Depakene®, Depakote®, and Deproic®(valproic acid)

Primary outcomes:
measure: Assessment of safety and tolerability
timeFrame: 22 months
Secondary outcomes:
measure: Assessment of duration of clinical benefit per CT or MRI, steroid use and neuropathy assessment
timeFrame: Every other cycle for 22 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: