cyrilzakka/clinical-trials huggingface dataset:
Effects of Peanut Consumption on Postprandial Inflammation, Glucose and Triglycerides

This pilot study will investigate the effects of acute peanut consumption on markers of inflammation, triglycerides and glucose. The hypothesis is that a high glucose/SFA meal will increase postprandial production of the inflammatory marker, C-reactive protein (CRP), and that the addition of peanuts to the control meal will reduce the production of CRP, as well as triglycerides and glucose.

Previous research has demonstrated that a single meal high in saturated fatty acids (SFA) and glucose can induce increases in IL-6, TNF-α and CRP in abdominally obese and diabetic subjects. As over two-thirds of the U.S. population is overweight or obese, it is important to identify foods that can attenuate postprandial increases in lipids, glucose and inflammation in this population. Therefore, the purpose of the pilot study is to determine whether a high SFA / high glucose control meal will induce an acute inflammatory response in overweight individuals, and whether the addition of peanuts to this meal will ameliorate this response. To ensure that these effects are due to peanuts, and not to the increase in total fat, we will compare this response to another test meal that includes an oil blend with a similar fatty acid composition to peanuts.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>28
* LDL_C below 130 mg/dl
* TG below 350 mg/dl
* Blood pressure within normal ranges (below 140/90 mmHg)

Exclusion Criteria:

* Smoking
* Allergies to peanuts or dairy products
* Known intolerance for high fat meals
* History of CVD, kidney disease, diabetes or inflammatory disease
* Use of non-steroidal anti-inflammatories or immunosuppressants
* Conditions requiring the use of steroids
* Use of medication or supplements for elevated lipids, blood pressure or glucose
A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome

The purpose of the study is to evaluate efficacy and safety of rozanolixizumab to treat adult study participants with severe fibromyalgia syndrome (FMS).


Eligibility Criteria:
Inclusion Criteria:

* Study participant must be ≥18 years and ≤70 years of age at the time of signing the informed consent form (ICF)
* Study participant with a diagnosis of fibromyalgia as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary

Diagnostic Criteria) plus the following characteristics during the Screening Period:

1. Brief Pain Inventory-short form (BPI-SF) interference score ≥6.
2. Study participant has been diagnosed with fibromyalgia syndrome (FMS) for at least 6 months.
3. Study participant has been having FMS symptomatology for at least 2 years before enrollment - Capable of giving signed informed consent as described in the Protocol which includes compliance with the requirements and restrictions listed in the ICF and in the Study Protocol

Exclusion Criteria:

* Study participant has been diagnosed with fibromyalgia syndrome (FMS) for \>15 years
* Study participant has any systemic autoimmune inflammatory disease
* Study participant has any medical or psychiatric or separate chronic pain condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study or the ability to assess FMS-related pain
* Study participant has severe renal impairment, defined as estimated glomerular filtration rate \<30 mL/min/1.73 m\^2, (calculated using Modification of Diet in Renal Disease \[MDRD\] study equation), at Screening visit
* Study participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator
* Study participant has chronic inflammatory demyelinating polyneuropathy
* Study participant has a current or medical history of primary immunodeficiency
* Study participant is pregnant or lactating
* Study participant

  * Has suicide attempt in the past 2 years (including an active attempt, interrupted attempt, or aborted attempt),
  * OR had suicidal ideation with at least some intent to act in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening or Baseline (Visit 3);
  * OR is otherwise judged clinically to be at a serious suicidal risk based on the investigator's judgment
Efficacy of Fractional Er:YAG Laser in Lupus Erythematosus Scars

Cutaneous Lupus erythematosus (CLE) is a chronic autoimmune connective tissue disease with a prevalence of 14.6 - 73.2/100,000, predominantly in women in mid adulthood. Cutaneous lesions occur in about 75-80% of patients with systemic lupus erythematodes.These lesions unfortunately and invariably lead to significant scarring and postinflammatory hypo- and hyperpigmentation.

Several studies have reported that laser treatments in patients with CLE have a positive effect and safety. However, only few case reports exist about the effect of ablative lasers such as Carbon Dioxide (CO2) and Erbium-doped Yttrium Aluminum Garnet (Er:YAG) lasers in CLE scarring.

Although no study shows a flare-up of CLE after laser treatment of the scars, many physicians are afraid of treating these often stigmatizing scars. Considering the huge psychological impact of facial scaring on quality of life, it is essential to explore and assess the value of already well-established treatment options for the management of scars also in patients with cutaneous lupus erythematodes.

Hereby the study seeks the subjective and objective improvement of the CLE-scars after treatment with fractional Er:YAG laser compared to control (untreated) areas.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Skin type I-IV
* Presence of \>1 scar due to CLE at one localisation
* Stable disease (without or with permanent therapy \>3months)

Exclusion Criteria:

* History of adverse events related to ablative fractional laser therapy
* Ablative resurfacing within the last 6 months on the scar
* Pregnant or breast feeding women
* Intake of isotretinoin in the last 6 month
* Intention to become pregnant during the course of the study
* Any scar treatment in the last 3 month before inclusion
Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients

This is prospective randomized, double blind study designed to evaluate the use of zoledronic acid in the prevention prevention of bone loss post allogenic BMT done for beta-thalassemia major patients.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent.
* Patients must be 18 years old and over.
* Diagnosed with beta-thalassemia major
* Scheduled for allogenic bone marrow transplantation
* The date of randomization must be no more than 1 week after BMT.
* Patients must be accessible for follow-up.
* Life expectancy of at least 12 months from randomization.

Exclusion Criteria:

* Patients with any clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip.
* Patients with a history of fracture with low-density or no associated trauma.
* Osteoporotic patients with T-score \<= -2.5
* Previous treatment with a bisphosphonate.
* Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 30 ml/minute or less.
* Pregnancy and lactation.
* Women of childbearing potential not on a medically recognized form of contraception.
* Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study.
* Subjects participating simultaneously in studies with unapproved drugs, indications or treatment regimens.
* Known hypersensitivity to zoledronic acid or bisphosphonates.
* Patients with prior exposure to anabolic steroids, growth hormone, Parathyroid Hormone (PTH) or other drugs known to affect the skeleton (e.g., calcitonin, mithramycin, or gallium nitrate).
* Serious intercurrent illness
* History of metabolic bone diseases
* History of corticosteroid treatment for other causes
* History of antiepileptic drug treatment
* History or surgery at the lumbosacral spine, with or without implantable devices.
* Any disease of the spine that would preclude the proper acquisition of a lumbar spine DXA.
* Mental illness that precludes the patient from giving informed consent.
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
* Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)
GIDEON Non-Nexavar Arm - HCC Patients Who Are Treated With Any Therapy Other Than Nexavar at Individual Study Start

This study is an international prospective, open-label, multi-center, non-interventional study. The protocol will allow enrollment of all patients with diagnosis of HCC in whom a decision to treat with sorafenib has not been made at time of study enrollment. All patients will be followed-up until withdrawal of consent, lost to follow-up, death, or the end of the study. Detailed information concerning the past medical/surgical history, performance status, methods of diagnosis and staging, etc. of patients with HCC will be collected, and practice patterns of the physicians involved in the care of patients with HCC under real-life conditions will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with histologically/cytologically documented or radiographically diagnosed HCC in whom a decision to treat with sorafenib has not been made at this time. Radiographic diagnosis needs typical findings of HCC by radiographic method i.e. on multi-dimensional dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP) or MRI.
* Patients must have signed an informed consent form
* Patients must have a life expectancy of at least 8 weeks

Exclusion Criteria:

* Patients in whom a decision to treat with sorafenib is made at time of study start
* Patients who have received sorafenib in the past or are currently treated with sorafenib
* Hospice patients
The Perspective of Healthy Individuals on Breast Cancer Risk Prediction Report In The Indonesian Population

In 2016, a meta-analysis showed that DNA-based risk reporting alone does not facilitate behavior change. However, there have been several studies showing that tailoring care plans related to diet may help with adherence to a tailored diet plan.

Risk prediction report displays both Polygenic Risk Score (PRS) and modifiable (non-genetic) risk factors. Overtime, the investigators aim to combine both PRS and modifiable risk factors to have a localized and stronger prediction model for the local population. The risk prediction report is designed to tailor care plans for patients by their physicians or care planner.

Focus groups allow deeper discussions in themes important to guide design of the report. This method has been used in previous similar studies, such as one by Cutting et al to understand physicians' preference in integrating genetic reports into daily practice. Studies also have shown that local adoption of personalized medicine and care is hindered by limited infrastructure of information management and awareness, despite personalized medicine being widely adopted in healthcare systems in developing countries.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Able to give informed consent
3. Aged 25-75 years old
4. Have access to a mobile phone or computer with the Zoom application or a caregiver who is able to assist them with the Zoom application

Exclusion Criteria:

1. Ever diagnosed with breast cancer
Effects of Yoga Training on Postural Stability

Postural stability can be affected by multiple factors. Such as; body mass, inactivity, age and etc. This study was planned with the aim of investigating the effects of Yoga training on postural stability of males and females. Yoga is a treatment model for body flexibility, body awareness, and strength.

Postural stability can be affected by multiple factors. Such as; body mass, inactivity, age and etc. This study was planned with the aim of investigating the effects of Yoga training on postural stability of males and females. Yoga is a treatment model for body flexibility, body awareness, and strength.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary males and females
* want to participate

Exclusion Criteria:

* have any disorders such as; neurologic, orthopedic, psychiatric or/and systemic.
Diagnostics and Quality of Life With EIA and EILO

The purpose of this study is to investigate the quality of life of subjects suffering from dyspnoea while exercising and quantify the number of diagnoses of Exercise induced Asthma (EIA) and Exercise induced laryngeal obstruction (EILO) in our outpatient clinic using an exercise-challenge in a cold-chamber and an exercise-challenge with continuous laryngoscopy.

In this study investigators want to characterize and investigate the quality of life of all patients consulting the outpatient clinic for pediatric pulmonology suffering from dyspnoea while exercising.

Besides standard diagnostics (bodyplethysmograph, spirometry, exhaled NO, skin prick test) subjects will take part in an exercise-challenge in a cold chamber at 2-4°C. Subjects showing symptoms of exercise-induced asthma will get a treatment with ICS/LABA for six weeks. All Patients should fill out a symptom diary. On suspicion of an EILO, subjects not showing symptoms in the first exercise-challenge in the cold chamber and all subjects without improvement after EIA treatment will take part in a second exercise-challenge in the cold chamber with continuous laryngoscopy.

If EILO is proved by laryngoscopy, speech therapy is recommended. To investigate the symptoms and the quality of life of these patients, all patients and there parents should answer symptom and quality of life questionnaires (Child Behavior Checklist (CBCL/4-18), Youth Self-Report (YSR 11-18), Asthma Control Test, (ACT) Dyspnea Index (DI)) at every visit.

There are yearly follow ups of these patients for five years in order to collect long-range prognosis.

Eligibility Criteria:
Inclusion Criteria:

* written agreement
* age: \>=8 and \<= 18
* exercise induced dyspnea
* at least two training session per week
* lung function before physical exercise FVC \>= 75% and FEV1 \>= 70%

Exclusion Criteria:

* age \<8 and \>18
* lung function: forced vital capacity (FVC) \< 75% and forced expiratory pressure in one second (FEV1) \< 70%
* inability to understand the range oft the study
* chronic asthma with systemic cortisone therapy
* chronic asthma with high dose cortisone inhalation \>500 micrograms fluticasone equivalent
* intake of long acting beta-agonists (LABA) 48 h before examination
* acute severe infection (pneumonia) within the last 4 weeks
* intake of leukotriene-antagonists 48h before examination
* other chronic diseases or infections (HIV, Tbc)
* pregnancy
A Study of BND-35 in Participants With Advanced Solid Tumors

This is an open-label, multicenter, dose escalation and dose optimization study designed to evaluate safety, tolerability and preliminary anti-tumor activity of BND-35 administered alone and in combination with nivolumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization (Part 2). Part 1 is comprised of three sub-parts: BND-35 administered alone (Sub-Part 1A), BND-35 administered in combination with nivolumab (Sub-Part 1B), and BND-35 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of BND-35 per indication are administered in combination with nivolumab or with cetuximab.

Estimated Study Duration:

Dose Escalation (Part 1): Approximately 34 months. Dose Optimization/Expansion (Part 2): Approximately 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy
* Histologic confirmation of malignancy
* Measurable disease per RECIST v1.1
* Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1
* Participants must have adequate organ function as defined by laboratory tests
* Part 1: Following tumor types: Breast cancer, cholangiocarcinoma, colorectal cancer, adenocarcinoma or squamous cell carcinoma of the esophagus, gastric or gastroesophageal junction adenocarcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, melanoma, ovarian cancer, renal cell carcinoma, pancreatic adenocarcinoma, soft tissue sarcomas

Exclusion Criteria:

* Active, known or suspected autoimmune disease
* Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
* Brain or leptomeningeal metastases
* Known history of positive test for HIV or known AIDS
* Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV)
* Participants after solid organ or allogeneic hematopoietic stem cell transplant
* History of life-threatening toxicity related to prior immune therapy
* History of life-threatening toxicity related to prior cetuximab or other anti-epidermal growth factor receptor antibodies (for Sub-Part 1C)
* Unstable or deteriorating cardiovascular disease within the previous 6 months
* Any major surgery within 4 weeks of study drug administration
* Prior immune therapy treatments, unless at least 4 weeks have elapsed from last dose
* Cytotoxic/Non-cytotoxic anti-cancer agents, unless at least 4 weeks have elapsed from last dose
* Use of other investigational drugs within 28 days
* Prior treatment with immunoglobulin-like transcripts (ILT3)-targeting agents
* Administration of a live attenuated vaccine within 28 days
Evaluating Risk Factors and Biomarkers for Adaptation and Resilience to Spaceflight

This study assesses differences in biological and behavioral domains that relate to individual adaptation and resiliency to an isolated, confined and controlled environment, and evaluates the effect of confinement, work, monotony, and social and physical isolation on stress resiliency and well-being.

The goal of this study is to obtain novel information that will be used to help identify individuals who are resilient to the stressors of prolonged human spaceflight, thereby encouraging the successful completion of exploration missions and the preservation of health over the life of an astronaut. This study leverages the National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC) heuristic framework to conduct experimental studies to identify biological domains (molecular, circuitry, physiology) and behavioral domains that relate to individual adaptation and resiliency (as well as behavioral vulnerability) in spaceflight-relevant confined environments. This study focuses specifically on differences among participants in their tolerance of and adaptability to simulated conditions of spaceflight such as confinement, work, monotony, and social/physical isolation that impact behavioral health and performance.

Eligibility Criteria:
Inclusion Criteria:

* Age between 30 and 55 years
* A master's degree (or its equivalency in work experience) in Science, Technology, Engineering and Math (STEM) or military service
* Free of psychological/psychiatric conditions that preclude participation
* BMI \< 35
* Ability to read/write English

Exclusion Criteria:

* History of neurological, psychiatric, or other medical condition that excludes participation
* Current mania or psychosis
* Current depression
* Current poor resiliency
* Alcohol or drug abuse in the past year based upon history and urine toxicology screen.
* Current smoker/tobacco user.
* Acute, chronic, or debilitating medical conditions, major Axis I psychiatric illness, epilepsy, or thyroid disease based
* Cardiovascular, neurological, gastrointestinal, or musculoskeletal problems that exclude participation
* For MRI testing any of the following conditions may exclude subjects from participation in the present experiment: Tinnitus; sensorineural hearing loss \> 30 decibels; pace maker or internal defibrillator; metallic implants (e.g. orthopedic plates after bone fractures, joint replacements, surgical staples or clips, artificial heart valves, stents, cava filters); metallic splinters (e.g. after an accident or due to war injury); non-removable dental brace; tattoo (some tattoo inks contain metallic particles); permanent make-up; intrauterine contraceptive device; cochlear implant (implanted hearing device); medication pump; acupuncture needle; other foreign bodies/objects which are non-removable; pregnancy (or its possibility); previous brain and/or heart surgery; and fear of tight spaces.
Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic Impairment

Primary Objective:

- To study effect of mild and moderate hepatic impairment on the pharmacokinetics of otamixaban.

Secondary Objective:

- To assess the pharmacodynamic effects of otamixaban on subjects with mild and moderate hepatic impairment and in matched subjects with normal hepatic function.

The duration of each part of the study for one subject was 28 days of screening, 1 day of treatment, with 5 days in the unit (Day -1 to Day 4) and a 8 to 11 days of follow-up after start of infusion.

Eligibility Criteria:
Inclusion criteria:

- Subjects with hepatic impairment:

* Body weight between 50.0 kg and 115.0 kg inclusive if male, between 40.0 kg and 100.0 kg inclusive if female, Body Mass Index between 18.0 and 34.9 kg/m2 inclusive
* Stable chronic liver disease assessed by medical history, physical examination, laboratory values
* Vital signs, cardiac function and laboratory parameters within the acceptable range for subjects with hepatic impairment
* If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal
* Patients with hepatic impairment will be matched to healthy subjects who are defined as healthy by physical examination, medical history and laboratory findings and are matched to patients with respect to age, gender, and body weight. Inclusion/exclusion criteria for healthy subjects may differ slightly from those listed for patients and are defined in the study protocol

Exclusion criteria:

* Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness
* Creatinine level above the upper limit of normal
* Hepatocarcinoma
* Acute hepatitis
* Hepatic encephalopathy grade 2, 3 and 4
* History or presence of drug or alcohol abuse within two years before inclusion
* Smoking more than 15 cigarettes or equivalent per day, unable to refrain from smoking during the institutionalization
* Any significant change in chronic treatment medication within 14 days before inclusion

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Prevention of Alcohol Intolerance

This study is designed to determine whether Asians who are especially sensitive to alcohol exposure can be protected by boosting their activities of an alcohol disposing enzyme. This will be accomplished by administering broccoli sprouts that are rich in an agent that increases protective enzyme activity. The test system involves applying alcohol patches to the skin and measuring skin redness.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old,
* sensitive to alcohol on the skin, Japanese

Exclusion Criteria:

* recent skin abnormalities /tanning