louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02070016: Transcranial Magnetic Stimulation for Low Back Pain
Official title: Clinical Applicaitons of Non-Invasive Brain Stimulation for the Treatment of Chronic Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether non-invasive brain stimulation, such as Transcranial Magnetic Stimulation (TMS) may alleviate pain associated with various chronic pain conditions. We will test various methods of TMS to identify a treatment approach that may reduce the symptoms of chronic pain for the patient.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Patient with Chronic Low Back Pain
* Meets minimum pain level criteria
* Ability to perform the experimental Task and Procedures

Exclusion Criteria:

* MRI contraindication if an MRI exam is required per protocol
* TMS Contraindication
* History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
* Neurologic illness that would interfere with brain integrity
* Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
* Currently pregnant or planning to become pregnant.
* On going legal action or disability claim.

Primary outcomes:
measure: Change in Average Daily Pain
timeFrame: Baseline Compared to each treatmeant series (at 4 weeks, 8 weeks, and 12 weeks)
measure: Change in Worst Daily Pain
timeFrame: Baseline Compared to each treatment series (at 4 weeks, 8 weeks, and 12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References:
Clinical trial NCT05083416: Effect of Prolonged Nightly Fasting on Immunotherapy Outcomes in HNSCC - Role of Gut Microbiome
Official title: Effect of Prolonged Nightly Fasting (PNF) on Immunotherapy Treatment Outcomes in Patients With Advanced Head and Neck Cancer (HNSCC)-Role of Gut Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Intermittent Fasting
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2021-10-19
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate if eating within an 8-10-hour window during the day, without any caloric restriction, can lead to better response rates to immunotherapy in head and neck cancer patients.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed recurrent /metastatic head and neck squamous cell cancer that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy) and initiating standard of care immune checkpoint blocker- (Nivolumab, pembrolizumab, Atezolizumab, Avelumab or Durvalumab with or without chemotherapy), for the first time.
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as outlined in RECIST version 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Exclusion Criteria:

* BMI\< 18.5.
* Diabetes mellitus, hyperthyroidism, pregnancy, any eating disorder including anorexia nervosa or bulimia, metabolic disorders that may affect gluconeogenesis or adaptation to short fasting periods
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune disease requiring systemic steroids, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients who have known leptomeningeal metastases or untreated or symptomatic brain metastases. Treated, asymptomatic brain metastasis can be included.

Primary outcomes:
measure: Rates of Prolonged Nightly Fasting (PNF) compliance
timeFrame: at 3 months
measure: Change in gut microbiome and microbial metabolites
timeFrame: Baseline and at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Christine Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02917616: The Effect of Drinking-Water pH on the Human Gut Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Lead sponsor: The Novo Nordisk Foundation Center for Basic Metabolic Research
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the effect of alkaline (pH=9) versus neutral (pH=9) drinking-water on the gut microbiota of healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Male
* Non-smoker
* Age 18 - 35 years
* Weight stabile for at least 2 months
* BMI between 20.0 - 27.0 kg/m\^2

Exclusion Criteria:

* Habitual consumption of caloric or artificially sweetened beverages in excess of 1L/week
* Habitual average consumption of alcohol in excess of 7 drinks/week
* Antibiotic treatment within two months of inclusion
* Chronic or acute illness
* Previous abdominal surgery

Primary outcomes:
measure: Shannon's alpha diversity index
timeFrame: Intervention day 14
Secondary outcomes:
measure: Simpsons' reciprocal diversity index
timeFrame: Intervention day 14
measure: Observed richness
timeFrame: Intervention day 14
measure: Estimated richness
timeFrame: Intervention day 14
measure: Unweighted UniFrac
timeFrame: Intervention day 14
measure: Weighted UniFrac
timeFrame: Intervention day 14
measure: Bray-Curtis
timeFrame: Intervention day 14
measure: Operational taxonomic unit
timeFrame: Intervention day 14
measure: Bacterial genera
timeFrame: Intervention day 14
measure: Plasma glucose; global
timeFrame: Intervention day 14
measure: Serum insulin; global
timeFrame: Intervention day 14
measure: Serum insulin; individual timepoints
timeFrame: Intervention day 14
measure: Plasma glucose; individual timepoints
timeFrame: Intervention day 14
measure: High sensitivity C-reactive protein
timeFrame: Intervention day 14
Other outcomes:
Locations:
Study officials:
affiliation: The Novo Nordisk Foundation Center for Basic Metabolic Research
name: Oluf Pedersen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hansen TH, Thomassen MT, Madsen ML, Kern T, Bak EG, Kashani A, Allin KH, Hansen T, Pedersen O. The effect of drinking water pH on the human gut microbiota and glucose regulation: results of a randomized controlled cross-over intervention. Sci Rep. 2018 Nov 9;8(1):16626. doi: 10.1038/s41598-018-34761-5.
Clinical trial NCT01000116: Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)
Official title: Fibrin Glue Versus Tacked Fixation in Laparoscopic Groin Hernia Repair. A Randomized Double-blind Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Femoral Hernia
Keywords: Tapp
Early pain
well-being
Seroma
Haematoma
Fibrin glue
tacks
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2009-10-22
Enrollment: 112
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the researchers want to compare fibrin glue versus tacked fixation in fixation of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the first 3 days postoperative days. Moreover, the researchers investigate general well-being, fatigue, seroma, haematoma, postoperative nausea and vomiting. Thirdly, they are investigating chronic pain and clinical recurrence.


Eligibility criteria: Inclusion Criteria:

* unilateral groin hernia
* planned laparoscopic inguinal or femoral herniorrhaphy
* ASA I-III
* fluent Danish

Exclusion Criteria:

* converting to open operation
* low compliance
* daily use of morphine or similar drugs daily in the last month
* complications to the operation

Primary outcomes:
measure: Early pain after operation
timeFrame: 1 month
Secondary outcomes:
measure: haematoma in groin region
timeFrame: day 10
measure: seroma in groin region
timeFrame: day 10
measure: fatigue
timeFrame: 10 days
measure: discomfort
timeFrame: 6 month
measure: Postoperative nausea and vomiting (PONV)
timeFrame: 10 days
measure: Use of Analgesics at PACU
timeFrame: 1 day
Other outcomes:
Locations:
city: Søborg
country: Denmark
facility: Private Hospital Hamlet
Study officials:
affiliation: University Hospital Koege
name: Mette A Tolver, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Koege
name: Thue Bisgaard, M.D. DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Hospital Hamlet
name: Poul Juul, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Herlev Hospital
name: Jacob Rosenberg, M.D. DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tolver MA, Rosenberg J, Juul P, Bisgaard T. Randomized clinical trial of fibrin glue versus tacked fixation in laparoscopic groin hernia repair. Surg Endosc. 2013 Aug;27(8):2727-33. doi: 10.1007/s00464-012-2766-6. Epub 2013 Jan 26.
Clinical trial NCT02682524: Phase IV Clinical Trial to Evaluate the Efficacy and Safety of PlbCR and Aceclofenac in the Treatment of Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis of Knee
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-02-15
Enrollment: 191
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized, double-blinded, parallel, active-controlled, phase IV clinical trial to evaluate the efficacy and safety of PlbCR and aceclofenac in the treatment of patients with osteoarthritis of the knee


Eligibility criteria: Inclusion Criteria:

* both male and female who is over 35year-old and below 80year-old
* patient who diagnosed as Kellgren \& Lawrence stage I\~III by X-ray
* osteoarthritis patient who is stable within 3months form starting this clinical trial
* patient who is over 40mm in 100mm Pain VAS at Visit 2
* patient who agreed to participate this clinical trial spontaneously

Exclusion Criteria:

* second osteoarthritis
* patient who has inflammatory disease which can effect efficacy outcomes such as bursitis, tenosynovitis, rheumatoid arthritis, etc.
* patient who diagnosed as gastric ulcer or GI disease by esophagogastroduodenoscopy
* patient who had joint surgery within 12months form screening visit of this clinical trial or planned to operate in this clinical trial period
* patient who has had artificial joint surgery of knee
* malignant tumor patient
* patient who has taken Psychopharmaceutical or Narcotic Analgesics over 3months continuously
* patient who took steroid by oral, inhalation or intraarticular injection within 3months form screening visit of this clinical trial
* patient who took intraarticular hyaluronic acid injection of knee within 2months form screening visit of this clinical trial
* patient who cannot take NSAIDs because of disease or medicine
* allergy of aspirin of other NSAIDs
* patient who has to handle his/her pain by or for CABG
* galactose intolerance, Lactose Intolerance or glucose-galactose malabsorption
* inflammatory bowel disease such as ulcerative colitis or Crohn's disease
* moderate renal disease
* moderate hepatic disease
* moderate hypertension(SBP=\>160mmHg, DBP=\>100mmHg)
* female who consents to contracept
* patient who is not appropriate for this clinical trial

Primary outcomes:
measure: Change from baseline 100mm Pain VAS at 4weeks
timeFrame: 4weeks
Secondary outcomes:
measure: Change from baseline 100mm Pain VAS at 2weeks
timeFrame: 2weeks
measure: Change from baseline K-WOMAC Scale at 2weeks and 4weeks
timeFrame: 2weeks, 4weeks
measure: Patient Global Assessment
timeFrame: 4weeks
Other outcomes:
Locations:
city: Chung gu
country: Korea, Republic of
facility: Inha university hospital
state: Incheon
Study officials:
References:
Clinical trial NCT05577624: A Study to Evaluate the Drug-drug Interaction Effect of Rifampin on the Pharmacokinetics of AMG 510 in Healthy Participants
Official title: An Open-label Study to Evaluate the Drug-drug Interaction Effect of Rifampin, a CYP3A4 Inducer, on the Pharmacokinetics of AMG 510 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy participants
AMG 510
Rifampin
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-10-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of AMG 510 alone and in combination with rifampin in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.
* Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.
* Females of nonchildbearing potential

Exclusion Criteria:

* Inability to swallow oral medication or history of malabsorption syndrome.
* History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* Poor peripheral venous access.
* History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of AMG 510
timeFrame: Days 1, 3 and 8
measure: Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 510
timeFrame: Days 1, 3 and 8
measure: AUC from Time Zero to Infinity (AUCinf) of AMG 510
timeFrame: Days 1, 3 and 8
Secondary outcomes:
measure: Number of Participants with an Adverse Event (AE)
timeFrame: Day 1 to Day 20
measure: Cmax of AMG 510 Metabolite M24
timeFrame: Days 1, 3 and 8
measure: AUClast of AMG 510 Metabolite M24
timeFrame: Days 1, 3 and 8
measure: AUCinf of AMG 510 Metabolite M24
timeFrame: Days 1, 3 and 8
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit, Inc 3402 Kinsman Boulevard
state: Wisconsin
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01992224: Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis
Official title: Effect of Early Mechanical Ventilation to Severe Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pancreatitis
Complication of Ventilation Therapy
Keywords: severe acute pancreatitis
mechanical ventilation
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute lung injury (ALI) and acute respiratory distress syndrome(ARDS) represent the most common and earliest organ dysfunction in acute pancreatitis, presenting as dyspnea and intractable hypoxemia, with secondary bilateral pulmonary infiltrates on radiograph. And mechanical ventilation (MV) is the essential intervention to improve oxygenation. When to initiate MV remains uncertain. In this study, we aim to compare the effect of early MV and conventional MV, and we hypothesize that early MV may be a better treatment option.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of pancreatitis:typical pain, increase in serum lipase or amylase, onset of abdominal pain within 72h before admission
* The diagnosis criteria of Severe Acute Pancreatitis is according to Atlanta criteria revisited in 2012
* the diagnosis of ARDS meets the criteria of Berlin definition

Exclusion Criteria:

* chronic respiratory disease as chronic obstructive pulmonary disease (COPD), asthma
* organic cardiopathy
* pregnancy

Primary outcomes:
measure: Mechanical Ventilation Time
timeFrame: 28 days
Secondary outcomes:
measure: the incidence of ventilation associated pneumonia
timeFrame: 28 days
Other outcomes:
measure: mortality
timeFrame: 60 days
measure: the incidence other complications of mechanical ventilation
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 months
measure: hospital stay
timeFrame: the participants will be followed till the discharge, an expected average of 2 months
Locations:
city: Shanghai
country: China
facility: Department of EICU, Ruijin Hospital
Study officials:
References:
Clinical trial NCT02458924: Niacin Skin Flush Response in Patients With Schizophrenia
Official title: Niacin Skin Flush Response in Patients With Schizophrenia, Their First Degree Relatives, Bipolar Disorder Patients, and Healthy Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 100
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: DIAGNOSTIC

Brief summary: Patients with schizophrenia have abnormal skin flush response to niacin, but the niacin skin test accuracy is not well studied in these patients. The study evaluated the niacin skin test accuracy in adult hospitalized schizophrenia patients and their first degree relatives, bipolar disorder patients, and healthy controls.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia patients and bipolar disorder patients diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders version IV criteria
* Normal healthy subjects without a psychiatric history
* First degree relatives of schizophrenic patients

Exclusion Criteria:

* Dermatological lesions, asthma or allergic disease, diabetes, chronic hypertension, vasculitis, substance use disorders (except cigarette smoking), or pregnancy
* Taking any oral medication that could affect the metabolism of prostaglandins such as nonsteroidal anti-inflammatory drugs or corticosteroids

Primary outcomes:
measure: Skin flush response
timeFrame: Every 5 minutes for 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Maryam Tabatabaeian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01108224: Psychotherapy to Patients With Primary Breast Cancer - Psycho-social and Survival Outcome From a Randomised Trial
Official title: Psychosocial Group Intervention to Patients With Primary Breast Cancer - Psychosocial and Survival Outcome From a Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Quality of life
Coping
Social relations
Survival
Psychotherapy
Lead sponsor: Danish Cancer Society
Sponsor class: OTHER
First posted: 2010-04-21
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether an intervention to breast cancer patients including psycho-education and group psychotherapy can enhance quality of life and survival.

Detailed description: PURPOSE: This randomized study included patients diagnosed with breast cancer who participated in an intervention including education and group psychotherapy lasting 10 weeks after surgery. The purpose of the study was to enhance Quality of Life, coping and social relations and to support the women when going through treatment. PATIENTS AND METHODS: We randomly assigned 210 patients with primary breast cancer to a control or an intervention group. Patients in the intervention group were offered 2 weekly 6-hour sessions of psycho-education and eight weekly 2-hour sessions of group psychotherapy. Participants and nonparticipants were followed up for QoL, coping and social relations after one, six and twelve months post intervention and on vital status 5 years after surgical treatment.

Eligibility criteria: Inclusion Criteria:

* Eligible patients were 18-70 years of age with stage I-IIIA primary breast cancer

Exclusion Criteria:

* Distant metastasis
* Not speaking or understanding Danish
* Over 71 years
* Other life-threatening diseases
* Brain-damaged

Primary outcomes:
measure: Quality of life
timeFrame: 12 months post intervention
Secondary outcomes:
measure: Survival
timeFrame: 5 years post surgery
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Cancer Epidemiology, Danish Cancer Society, Strandboulevarden 49, DK-2100
name: Ellen H Boesen, MSc, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Cancer Epidemiology, Danish Cancer Society, Strandboulevarden 49, DK-2100
name: Christoffer Johansen, DSc (Med)
role: STUDY_CHAIR
References: