cyrilzakka/clinical-trials huggingface dataset:
Beetroot Enriched Bread, Blood Pressure and Vascular Function

Dietary nitrate is known to lower blood pressure. Beetroot is a rich source of nitrate and could therefore be an important dietary component in the management of hypertension and cardiovascular disease, however consumption is relatively low. We evaluated the effects of beetroot enriched bread ingestion on acute microvascular reactivity, arterial stiffness and blood pressure response in healthy men.


Eligibility Criteria:
Inclusion Criteria:

* Male
* A signed consent form
* Age 18-64 years
* Body mass index - 18.5-30 kg/m2
* Non-smoking, healthy individuals
* Normal blood pressure at screening (\< 150/90)

Exclusion Criteria:

* Subjects with anaemia
* Sufferers of chronic illnesses
* Individuals with food allergies
* People with diabetes
* People with coeliac disease
* Women
* Vegetarians
Safety Study of ALRN-6924 in Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

Phase 1/1b, open label, multi-center dose escalation and dose expansion study designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and anti-tumor effects of ALRN-6924 alone or in combination with cytarabine in patients with relapsed/refractory acute myeloid leukemia or advanced myelodysplastic syndrome with wild-type (WT) TP53

Phase I, open label, multi-center dose escalation (DEP) and dose expansion (EXP) study designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and anti-tumor effects of ALRN-6924 in patients with acute myeloid leukemia or advanced myelodysplastic syndrome with wild-type (WT) TP53. ALRN-6924 is a stabilized cell-permeating peptide designed to disrupt interaction between the p53 tumor suppression protein and its endogenous inhibitors murine double minute 2 (MDM2) and murine double minute X (MDMX)

Men and women 18 years of age and older with relapsed or refractory acute myeloid leukemia or advanced myelodysplastic syndrome and for which standard treatment(s) are not available or are no longer effective can be enrolled. Treatment of patients in the DEP and EXP phases will continue in the study until documentation of disease progression, unacceptable toxicity, or patient or physician decision to discontinue study participation is made.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory acute myeloid leukemia or IPSS-R intermediate/high/very high-risk MDS patients
* Confirmed or anticipated wild-type TP53
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2
* Adequate hepatic and renal function
* Acceptable coagulation function
* Negative serum or urine pregnancy test within 7 days prior to the first dose of ALRN-6924 for women of child-bearing potential
* Sufficient wash out from prior therapies and recovery from all significant toxicities

Exclusion Criteria:

* Patients are eligible for available approved standard therapies
* Prior treatment with MDM2 inhibitor, with protocol specified exceptions
* Patients with history of allogeneic stem cell transplantation
* Leukemic blast counts of \>25,000/µl
* Deletion of chromosome 17, or del(17p)
* Patients with evidence of current central nervous system leukemic involvement
* Known hypersensitivity to any study drug component
* History of coagulopathy
* Prior specified cardiovascular risk factors
* Clinically significant gastrointestinal bleeding within 6 months
* Clinically significant third-space fluid accumulation
* Pregnant or lactating females
* Evidence of any serious and/or unstable pre-existing medical condition that would interfere with patient safety ability to provide informed consent
* Active uncontrolled infection, including HIV/AIDS or Hepatitis B or C
* Second malignancy within one year, with protocol specified exceptions
Product Evaluation of a Newly Developed Intermittent Catheter.

The aim of the study is to investigate the navigation of a newly developed catheter.


Eligibility Criteria:
Inclusion Criteria:

1. Male and at least 18 years
2. Has used Intermittent self-catheterization at least 3 months
3. Has normal to slightly reduced hand mobility
4. Use catheter size CH12 or CH14 (must use same size during product evaluation)

Exclusion Criteria:

1. Currently receiving treatment for urinary tract infection
2. Currently receiving chemotherapy
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
* Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
* Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
* Healthy children as established by medical history and clinical examination when entering into the study.
* Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
* Clinically or virologically confirmed influenza infection within six months preceding the study start.
* Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
* Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
* Acute disease and/or fever at the time of enrolment
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
* Previous administration of any H1N1 A/California-like vaccine.
* Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
* If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
* Any known or suspected allergy to any constituent of influenza vaccines;a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
* Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
* Child in Care.
The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee

A clinical study to measure the effects of injection-site cooling on pain experienced after knee injections of capsaicin in healthy subjects and in patients with knee osteoarthritis.


Eligibility Criteria:
Cohort 1 Key Inclusion Criteria:

* Subject is aged between 18 and 45 years, inclusive.
* Subjects Body Mass Index (BMI) is between 18 and 32 kg/m\^2, inclusive and subject's weight is greater than or equal to 50 kg.
* Subjects must be in good health, in the opinion of the Investigator, as determined by a medical history, physical examination, clinical laboratory tests, vital signs and 12 lead electrocardiogram (ECG).

Cohort 1 Key Exclusion Criteria:

* Subject has had a clinically significant illness that has not completely resolved in the four weeks before screening.
* Subject has a history of neurological disorder which may impact the perception of pain or impairs the subject's ability to fully participate in the trial.

Cohorts 2-4 Key Inclusion Criteria:

* Subject is aged between 45 and 75 years, inclusive.
* Subject's BMI is between 18 and 32 kg/m\^2, inclusive and subject's weight is greater than or equal to 50 kg.
* Subject has a diagnosis of bilateral moderate to severe painful knee OA (subjects will be required to have a score on Pain with walking in the previous 24 hours, of 4 to 9, inclusive NPRS 0-10). The condition must be chronic with a history of painful arthritis for at least 3 months prior to entry in the study.

Cohorts 2-4 Key Exclusion Criteria:

* Subject has had a clinically significant illness, other than osteoarthritis, that has not completely resolved in the four weeks before screening.
* Subject has a history of neurological disorder which may impact the perception of pain or impairs the subject's ability to fully participate in the trial.
* Subject has used analgesic medications in the 2 days prior to dosing, except for paracetamol, as needed.
* Subject has used topical medications applied to the knee for OA pain (including capsaicin, lidocaine, prescription or OTC medications) from 90 days prior to screening through to dosing.
* Subject has been injected with corticosteroids in the knee 90 days prior to screening through to dosing.
* Subject currently uses opioids for any condition other than OA knee pain (maximum dose 15 mg hydrocodone, or equivalent, per day prescribed by a physician).
Effect of Physical Activity on NAFLD

It has been demonstrated the essential role of physical activity in the prevention of overweight and obesity. Nevertheless, the effect of a program of physical activity on the maintenance of body weight in subjects who have previously followed a dietary intervention is still unknown. The aim of this study was to investigate this topic by evaluating the effect of two different programs of physical activity on subjects who have followed a dietary intervention but presented again NAFLD a year after the treatment.

Subjects who were previously enrolled in the trial NUTRIEP and who still have NAFLD a year after the end of the study, were invited to participate in a program of physical activity to assess the effect of endurance and resistance training on weight and NAFLD score. Participants (100 subjects) were randomized and divided into two groups: the first followed a program of endurance activity consisting in a 30 minute walk, 5 times/week; the second followed a program combining the just described aerobic exercise with a resistance training based on 30 minute of musculation involving all the bigger muscles, 3 times/week. The trial lasted six months and subjects underwent liver ultrasonography (to assess NAFLD score), indirect calorimetry, bioimpedenziometry, the measurement of anthropometric variables (body height and weight) and biological parameters (glucose, insulin, cholesterol, HDL cholesterol, triglycerides, GOT, GPT and GGT) at the baseline and at the third and the sixth month. The aim of the study was to estimate the effect of the two different programs of physical activity on NAFLD score. Secondary end-points included: the effect on basal metabolism, the modification of fat mass (FM), lean mass (LM) and muscle mass (MM) and on several biological markers associated with NAFLD.

Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe NAFLD
* Enrolled in the previous trial called NUTRIEP

Exclusion Criteria:

* Not enrolled in the previous trial called NUTRIEP
Warm Acupuncture for Breast Cancer Related Lymphedema

The purpose of this study is to clarify whether local-distal point association is more effective than local point association by warm acupuncture in the management of breast cancer related lymphedema.


Eligibility Criteria:
Inclusion Criteria:

* At least 6 months after breast cancer surgery and presents with persistent breast cancer related upper extremity lymphedema for at least 3 months. Upper extremity lymphedema is defined as more than 2cm circumference difference or 5% volume difference between the affected and unaffected arms.
* Stage II or III lymphedema according to the 2016 consensus by the international society of lymphology.
* Karnofsky Performance Score (KPS) ≥ 70
* Men or women aged 18 to 80 years
* Out-patients
* Estimated life expectancy \> 6 months

Exclusion Criteria:

* Bilateral breast cancer related lymphedema
* Taking diuretic
* History of primary lymphedema
* A diagnosis of severe heart, liver, kidney or hematologic disease
* Edema caused by upper extremity disability or other conditions such as heart failure, kidney disease or malnutrition
* Have hypoproteinemia
* Inflammation, scar, or trauma at the site of operation, or other active skin infections
* Unable to self-care, had a history of psychological disorders, or unable to communicate
* Received lymphedema treatment within the past 1 month
* Pregnancy or breastfeeding
* The presence of electronic medical device implants
* Deny to sign the informed written consent, or unwilling to conform to randomization
* Participation in other clinical trials during the study period
Internet-based Treatment of Early Childhood Fecal Incontinence

Encopresis, also known as fecal incontinence, is the voluntary or involuntary passage of stools causing soiling of clothes by a child over 4 years of age. The purpose of this study is to evaluate an Internet intervention for the treatment of encopresis.

An estimated 2.3% of children suffer from encopresis. Enhanced Toilet Training (ETT) is one of the most effective ways of treating this disorder. When delivered by skilled and knowledgeable clinicians, ETT is twice as effective as intensive medical management alone. Although ETT is effective in treating encopretic children, there are six major barriers to its implementation: 1) availability of a knowledgeable and skilled clinician; 2) parental acceptance of referral to a mental health professional; 3) expense of service; 4) burden of time and distance to access such specialty services; 5) child resistance to disclosure of embarrassing material; and 6) willingness of the child and parent to follow treatment recommendations. This project will circumvent these barriers by developing an interactive Internet-based ETT program. The study will then assess the feasibility of the program by determining the acceptance, function, and effectiveness of the intervention.

This project will have four phases. Phase 1 will identify optimal Internet and treatment elements as well as issues in need of experimental investigation. Phase 2 will investigate how to enhance Internet interventions. Phase 3 will evaluate the relative benefit of adding the Internet treatment to clinical services provided by clinicians in the fields of medicine and mental health. Phase 4 will investigate the relative long-term benefits of adding such an Internet-based intervention to professional care to determine its impact on symptom improvement, relapse prevention, quality of life, and its cost-effectiveness. Phase 4 will also assess to what extent the program is disseminated worldwide when made available on the Internet.

Eligibility Criteria:
Inclusion Criteria

* Child seen by pediatrician, family physician, or psychologist for the treatment of encopresis
* Access to the Internet, either through a family computer or a community computer

Exclusion Criteria

* Diagnosis of either mental retardation (IQ \< 85) or
* A primary illness responsible for fecal soiling (e.g., spina bifida)
Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer

The purpose of this study is to determine the antitumor activity (response rate, time to tumor progression, survival) and safety of docetaxel in combination with talabostat in patients with advanced non-small cell lung cancer (NSCLC) who have failed a prior platinum-containing regimen.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed Stage IIIb/IV NSCLC
* Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC
* Measurable disease
* ECOG Performance Status of 0 or 1
* Expected survival ≥12 weeks
* Provide written informed consent

Exclusion Criteria:

* More than 2 prior chemotherapy regimens
* Brain metastases (exception: patients who have had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month)
* Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
* The need for chronic (i.e., \>7 days) oral or intravenous corticosteroid therapy
* A history of severe hypersensitivity reactions to drugs formulated with polysorbate 80
* A history of myocardial infarction within 1 year of study entry, CABG within 6 months of study entry, severe congestive heart failure (ejection fraction \<30%), history of ventricular arrhythmia, or other uncontrolled cardiac arrhythmia
* Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
* Patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC. Patients must have recovered from all of the side effects of treatment in order to be enrolled.
* Pregnant or lactating women.
* Clinically significant laboratory abnormalities, specifically:

Total bilirubin ≥institutional upper limit of normal (ULN); Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase \>2.5 x ULN; Hepatitis B surface antigen or antibody to Hepatitis C (anti-HCV antibody); Serum creatinine ≥2.0mg/dL; or Granulocytes \<1500/μL or platelets \<100,000/μL.
Mean Arterial Pressure (MAP) and Renal Perfusion: Evaluation of Critically Ill Patients With Normal Creatinine or Reduced Renal Function

The purpose of this study is to evaluate the renal perfusion depending on the MAP.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Intensive care patient
* Treated with vasopressor
* Given informed consent
* Arterial infusion
* A bladder catheter

Exclusion Criteria:

* Anamneses of hypertension
* Neurological trauma
* Acute renal insufficiency other than prerenal or acute tubular necrosis etiology
* Hepatorenal syndrome
* Treated with diuretics
* Mechanical ventilation and unstable
Effects of the Sugar Sucrose on Bodyweight and Energy Intake Over 28 Days in Obese Women

This study partially replicates two previous studies with normal weight women, and overweight women. Both found that women could compensate for sucrose added to the diet in carbonated soft drinks (4 x250ml total1800 kJ per day) when it was given blind over a period of 4 weeks. The hypothesis is that this applies also to obese women, who will not gain weight, increase overall energy intake in the diet, or eat differently whilst consuming sucrose. 42 participants shall be randomly assigned to either be given carbonated drinks that contain sucrose, or drinks that are artificially sweetened.


Eligibility Criteria:
Inclusion Criteria:

* Female
* BMI 30-35 kg/m²
* at least one period of dietary restriction of 4 weeks or more in the last 24 months

Exclusion Criteria:

* dislike of popular sweet carbonated drinks
* dieting during the last month
* history of diabetes
* having an eating disorder
* depression,
* being a smoker
* pregnant
* lactating,
* wearing a pacemaker
* currently taking medication for mood or thyroid disorders
Effectiveness and Security Testing of a Mobile App for Self-Managing Emotion Dysregulation

To assess the effectiveness and security of a mobile App (beta version) for people with borderline traits recruited from a non-clinical population of college students in Barcelona (Spain). The main primary outcome will be the severity of the emotional dysregulation. Forty participants will use the mobile app over 6 months. This group while be compared at post-treatment and at 3-month follow-up with other 40 participants (control group) with any intervention.


Eligibility Criteria:
Inclusion Criteria:

* Borderline traits
* Aged between 18 to 65 years
* College students

Exclusion Criteria:

* None
Dexamethasone for the Prevention of Post-operative Nausea and Vomiting in Patients Undergoing Cesarean Sections

Patients who present for scheduled (non-emergent) cesarean section will be given either intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal anesthetic. The investigators will then compare the incidence of nausea and vomiting and the use of rescue anti-nausea medications in both groups. Our hypothesis is that patients receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours following surgery.

Women having cesarean sections commonly experience post-operative nausea and vomiting (PONV). This can be partly attributed to the long acting morphine (duramorph) given in the anesthetic (either through the epidural or in the spinal anesthetic). Intravenous dexamethasone is a widely used steroid medication with a well-established safety profile which is the standard of care for the prevention of PONV for general anesthesia in both adult and pediatric surgical patients. Many studies have shown that when intravenous dexamethasone is administered before duramorph in the epidural, the incidence of nausea and vomiting following cesarean section is significantly reduced. However, when patients receive intravenous dexamethasone after duramorph in a spinal anesthetic, it does not reduce the incidence of nausea and vomiting. There are not any published studies where dexamethasone was administered before a spinal anesthetic. The investigators believe that if dexamethasone is given intravenously before duramorph in a spinal anesthetic it may reduce the incidence of nausea and vomiting. Patients who present for scheduled (non-emergent) cesarean section will be given either intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal anesthetic. The investigators will then compare the incidence of nausea and vomiting and the use of rescue anti-nausea medications in both groups. Our hypothesis is that patients receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours following surgery.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-46 presenting for scheduled primary or repeat cesarean sections and have consented to study

Exclusion Criteria:

* allergy to dexamethasone or morphine
* history of gastrointestinal disease
* history of severe nausea during pregnancy (hyperemesis gravidarum)
* use of anti-emetic in the past 24 hours
* history of gestational diabetes or diabetes mellitus
* history of hypertension prior to or during pregnancy
* presence of non-viable fetus