cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Lauric Acid, a Dietary Fatty Acid, in Modifying the Latent Reservoir of HIV

Dietary lauric acid supplementation could have a significant impact on the HIV reservoir in antiretroviral-treated patients by inducing HIV viral transcription in latently infected cells and preserving the HIV-specific immune response, without causing toxicity.

Design: Pilot, randomized, placebo-controlled, patient-blind study. Patients ≥18 years old with HIV-1 receiving stable ART (no change in ART for at least 6 months) and a serum HIV RNA load of \< 50 RNA copies/mL for at least 2 years and with a CD4 T cell count \>300 cells/μl will be randomized 1:1:1 to dietary supplementation with placebo (controlled group) or lauric acid 1.5 g once daily (experimental group 1) or with lauric acid 3 g once daily (experimental group 2) for 24 consecutive weeks.

Primary objective: To assess the effect of dietary lauric acid supplementation, compared with placebo, on the reactivation of HIV transcription in latently infected CD4 T cells in HIV-infected patients on suppressive antiretroviral therapy.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected men or women ≥18 years old
* Not having interrupted current antiretroviral treatment at least 6 months before the screening visit.
* Acceptable stable ART regimens prior to screening include 2 more NRTIs: INI or NNRTI or boosted PI.
* Documented prior evidence of at least 2 years prior to enrollment with a serum HIV RNA load of \<50 RNA copies/ml (viral load of \>50 copies but \<200 is allowed).
* Plasma HIV-1 RNA \<50 c/ml at screening visit.
* CD4 T cell count \> 300 cells/µL at screening visit.

A woman may be eligible to enroll and participate in the study if:

* Not pregnant, not of childbearing potential or physically unable to become pregnant
* You are of childbearing potential with a negative pregnancy test at the screening visit and agree to use contraception to prevent pregnancy.

Exclusion Criteria:

* Have suffered any significant acute illness in the last 8 weeks.
* Having been diagnosed in the past or present with an AIDS-defining illness
* Previous CD4 T cell count \<200 cells/μL.
* Having suffered an infection with Hepatitis B or C
* Having any disease or condition that in the investigator's opinion is not appropriate for the patient's participation in the study.
Physical Exercise and Dairy Probiotics in Childhood Cancer Survivors

The goal of this clinical trial is to to compare the structure of the intestinal microbiome between children shortly after treatment for acute lymphoblastic leukemia (1-3 years after cancer treatment) and healthy controls. And then to provoke a positive shift of bacterial diversity by physical activity and probiotics in cured pediatric oncology patients with persistent gut microbiome disruptions.

The main question\[s\] it aims to answer are:

* Are differences in bacterial richness between healthy controls and pediatric oncology patients ≥12 months after cancer treatment apparent?
* Has the combination of physical exercise and probiotics had a positive influence on the structure of the gut microbiome in childhood cancer survivors in remission? Two times per week of physical activity and daily dairy consumption with probiotics will be required of participants for eight weeks.


Eligibility Criteria:
Inclusion Criteria:

- children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years

Exclusion Criteria:

* acute respiratory infection during intervention
* more than 20% skipped exercise training sessions
Safety/Efficacy Study to Assess Whether FVIII/VWF Concentrate Can Induce Immune Tolerance in Haemophilia A Patients

The purpose of this study is to assess the role of a FVIII/VWF complex concentrate (Emoclot) in successfully inducing immune tolerance (I.T.I.) in patients with Haemophilia A with inhibitors, including patients at high risk of failure.

The development of factor VIII inhibitors occurs in approximately 30 to 40% of patients with severe Haemophilia A. The main negative clinical and cost consequence is the ineffectiveness of replacement therapy in patients with high-titer antibodies, who have a shorter life and greater morbidity than those who do not develop inhibitors. It is known from immunology that a regular and frequent exposure to the antigen of FVIII can induce tolerance of the immune system of the patient with inhibitors. This effect, called "immune tolerance induction" (ITI) is usually achieved after a prolonged exposure of the patient to FVIII, and is a common way of managing the condition of patients with inhibitors as well as the treatment of bleeding episodes with large amounts of hemostatic agents. In vitro and retrospective clinical studies suggest that FVIII/VWF complex concentrates may have less immunogenicity with respect to those plasma-derived concentrates purified with monoclonal antibodies (MABs), and recombinant DNA factor VIII concentrates (rFVIII), in both which the von Willebrand factor (VWF) is absent. Immune tolerance induction (ITI) showed to be effective in about 70% of Haemophiliacs with inhibitors. Poor prognosis factors have been identified by different registries: age ≥ 6 years, ITI started \>1 year from inhibitor development, inhibitor peaks \>200 BU, inhibitor titer \>10 BU at the start of ITI and previously failed ITI. The results of clinical studies suggest that complex concentrates of VWF/FVIII can be effective in ITI, even in patients at high risk of failure. To explain these findings, a role for VWF (i.e. prolonged antigen exposure) has been hypothesized.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects (his/her parent/legal representative), must have given a written informed consent.
2. Male children: age \<12 years.
3. Severe or moderate Haemophilia A (FVIII \<2%).
4. High responders (clinical history of inhibitor peak \> 5BU) or low-responders (clinical history of inhibitor peak \< 5 BU) with potential bleedings, assessed by responsible physicians as not to be treated with high FVIII doses.
5. Any level of inhibitor at study enrollment.
6. Willingness and ability to participate in the study.
7. No other experimental treatments (involving or not FVIII concentrates).

Exclusion Criteria:

1. Any clinically relevant abnormality, in hematological, biochemical and urinary routine examinations, or any condition or treatment which in the investigator's opinion, makes the patient not eligible for the study.
2. Intolerance to active substances or to any of the excipients of FVIII / VWF concentrates.
3. Concomitant systemic treatment with immunosuppressive drugs.
Lidocaine 10% Spray Reduces Pain During Intrauterine Device Insertion

Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Misoprostol and nonsteroidal drugs have found to be ineffective by clinical trials.Investigators tested whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

Age \>18 Not pregnant Smear negative

Exclusion Criteria:

Chronic pelvic pain Pregnancy Uterine anomaly Fibroid Acute cervicitis Pelvic inflammatory disease Cervical stenosis
Surveillance in Ulcerative Colitis: Narrow Band Image Versus Chromoendoscopy for High-risk Groups

The risk of colorectal cancer (CRC) is increased in patients having ulcerative colitis (UC). Patients with long-standing extensive colitis, concomitant primary sclerosing cholangitis, or previous history of dysplasia carry an exceptionally high risk of CRC and require regular and short-interval surveillance colonoscopy. Recent guidelines recommend surveillance colonoscopy based on target biopsy rather than random biopsy applying chromoendoscopy (CE) or narrow band image (NBI) technique in UC at risk for CRC. However, the diagnostic yield of NBI-based surveillance and CE-based surveillance is not extensively investigated in the high-risk UC population. The investigators aimed to compare the dysplasia detection rate of NBI with that of CE in UC patients with a high risk of CRC by performing a multicenter, randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* At least one of the followings should be satisfied;

  1. A patient having extensive ulcerative colitis with 8-year or longer disease duration
  2. A patient having both ulcerative colitis and primary sclerosing colitis
  3. A patient having a previous history of dysplasia at the colitic segment within recent 5 years

Exclusion Criteria:

* All of the following conditions should be excluded for 1st surveillance colonoscopy study

  1. A patient who underwent total or segment colectomy.
  2. A patient who taking (warfarin or direct oral anticoagulants and cannot stop them for procedures owing to the high thromboembolic risk
  3. A patient who has known thrombocytopenia (less than 80,000/µL in recent 6 months
  4. A patient who has a coagulopathy
  5. A patient who has chronic renal disease evidenced by serum creatinine \> 1.2 mg/dL within 6 months of study participation
  6. A patient who has already undergone surveillance colonoscopy within 1 year
* All of the following conditions should be excluded for 2nd surveillance colonoscopy study even if they were included in 1st surveillance study.

  1. A patient who underwent total or segment colectomy after 1st surveillance colonoscopy for this trial.
  2. A patient who taking (warfarin or direct oral anticoagulants and cannot stop them for procedures owing to the high thromboembolic risk
  3. A patient who has known thrombocytopenia (less than 80,000/µL in recent 6 months
  4. A patient who has a coagulopathy
  5. A patient who has chronic renal disease evidenced by serum creatinine \> 1.2 mg/dL within 6 months of study participation
YAG Laser Versus Punch Biopsy for the Treatment of Tattoo Skin Markers

The purpose of the study is to compare patient satisfaction, clinical efficacy and adverse effects of Q-switched YAG laser versus punch biopsies for the treatment of tattoo dots that are applied as skin markers in relation to X-ray treatment of malignant disorders.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older,
* Skin types I-IV,
* No previous laser treatment for the condition.

Exclusion Criteria:

* Younger than 18 years,
* Skin types V-VI,
* Pregnant or lactating women,
* Previous laser treatment for the condition,
* Recent exposure to sun or sun-beds,
* Treatment with oral retinoids within 3 months,
* Tendency to produce hypertrophic scars or keloids,
* Immunosuppressive treatment or disorders
A Phase 2, Multi-center Study to Evaluate the Efficacy and Safety of ONO-2952 in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

The objective of this study is to explore efficacy, safety and tolerability of ONO-2952 in female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).


Eligibility Criteria:
Inclusion Criteria:

1. Female 18-65 years of age (inclusive)
2. Diagnosed with IBS based on the following criteria (Rome III criteria):

   * Symptom onset at least 6 months prior to diagnosis, and
   * Recurrent abdominal pain or discomfort at least 3 days per month for the past 3 months, and
   * Abdominal discomfort or pain associated with two or more of the following at least 25% of the time:

     1. Improvement with defecation
     2. Onset associated with a change in frequency of stool/defecation
     3. Onset associated with a change in form (appearance) of stool
3. Diagnosed with IBS-D, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤ 25% of defecations

Exclusion Criteria:

* Any structural abnormality of the gastrointestinal (GI) tract (other than esophagitis or gastritis)
* History of Crohn's disease, ulcerative colitis, diabetes mellitus, lactose malabsorption, malabsorption syndromes, celiac sprue, or any upper GI symptoms that may impact the assessment of IBS symptoms
Telepharmacy on Patients With Arterial Hypertension

The goal of this clinical trial is to compare the effectiveness of a pharmaceutical care protocol via teleconsultation in the management of uncontrolled hypertension with pharmaceutical care carried out in elderly patients assisted in primary health care. The main questions it aims to answer are:

1. How effective is a pharmaceutical care protocol via teleconsultation on the clinical outcomes of elderly people with uncontrolled hypertension, when compared to in-person pharmaceutical care?
2. How effective is a pharmaceutical care protocol via teleconsultation in adherence to the treatment of elderly people with hypertension, when compared to in-person pharmaceutical care?

Participants will undergo four visits. Two visits will be for the application of instruments and measurement of clinical parameters to be carried out at the beginning and end of follow-up (visits 1 and 4). These will be carried out in a pharmacist's office at the pharmacy by previously trained pharmacists and pharmacy students. Visits 2 and 3 will be pharmaceutical consultations to be carried out in person and/or via telepharmacy.

Researchers will compare pharmaceutical care via telepharmacy with in-person pharmaceutical care to see how effective these services are in controlling blood pressure in elderly patients with uncontrolled blood pressure.

Specific objectives

* Characterize the clinical and socio-demographic profile of the studied population.
* Compare the acceptance and clinical importance of interventions carried out by the pharmacist between the telepharmacy and in-person (control) groups.
* Evaluate patient adherence to medication treatment in the teleconsultation group and in person
* Evaluate patient satisfaction in the teleconsultation group and in-person consultation.
* Compare satisfaction between the telepharmacy and in-person (control) groups.

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients admitted to the service with a diagnosis of systemic arterial hypertension made by a physician based on a patient report, report or medical prescription.
* Patients who present uncontrolled blood pressure at the time of assessment based on the average of three measurements using a standardized protocol at the pharmacy will be included;
* Patients must have a cell phone and know how to use it;
* Patient not have previously received pharmaceutical care.

Exclusion Criteria:

* Elderly people who are unable to use their cell phones due to cognitive impairments (Mini Mental State Examination (MMSE).
* Elderly person considered unable of using a telephone (Instrumental Activities of Daily Living)
* Elderly with controlled blood pressure according to home monitoring.
Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes

Patients who are intolerant of statins in routine practice, but who lack objective evidence of significant harm, will be randomized to receive statins by either n of 1 trials or standard practice. Our hypothesis is that n of 1 trials will improve statin adherence, thereby improving low density lipoprotein cholesterol (LDL-C) levels.

Cholesterol lowering medications called "statins" decrease heart disease in people with diabetes but research shows that many patients are not taking these medications, sometimes because of side effects. In our experience, the side effects attributed to statin therapy are often subjective, non-specific, and not associated with objective evidence for a clinically important problem. The most common example is muscle cramps despite a normal CK level, but other symptoms include fatigue, GI intolerance, and neurological symptoms.

Traditionally, the effects of treatments are determined using randomized controlled trials. N of 1 trials minimize these biases through randomization, double-blinding, and multiple crossovers, and are therefore excellent tools to evaluate adverse effects of therapies when symptoms are non-specific and objective evidence for a causal relationship is ambiguous.

Patients who are intolerant of statins in routine practice, but who lack objective evidence of significant harm, will be randomized to receive statins by either n of 1 trials or standard practice. Our hypothesis is that n of 1 trials will improve statin adherence, thereby improving low density lipoprotein cholesterol (LDL-C) levels. Patients in the n of 1 trials group will be given 1 month courses of either simvastatin or placebo. Patients in the group who are receiving statins according to standard practice will be given a prescription by the doctor in the usual way.

At the end of the study, we will determine if more patients participating in n of 1 trials group are taking statins compared to the patients in the conventional group and if this leads to lower cholesterol levels. We plan to use the results of this small feasibility study to test the methods and to plan a larger study on the same question.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of type 1 or 2 diabetes
* Age 18-80 years
* Indication for a statin by the 2003 Canadian Diabetes Association (CDA) Clinical Practice Guidelines
* Willingness to re-try a statin despite previous apparent intolerance
* Provision of signed informed consent

Exclusion Criteria:

* Contraindication to a statin: previous rhabdomyolysis, active liver disease or unexplained persistent elevations of serum transaminases (CK, AST, ALT \>three times upper limit of normal), pregnancy or lactation
* Impaired renal function: severe renal insufficiency (creatinine clearance \<30 ml/min)
* Presence of a condition such as malignancy for which the one-year prognosis is poor
* Inability of the patient to comply with the rigorous conditions of the trial
* Any other condition deemed to render the study harmful to the participant
Study of an Experimental New Drug, PPARγ Agonist Taken by Mouth by Participants With Advanced or Metastatic Cancer

An open-label, Phase I, dose escalation study of CS-7017 administered by mouth in sequential cohorts of 3 to 6 participants with advanced or metastatic malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically diagnosed advanced or metastatic malignancy that is refractory to, not curable with, or not eligible for standard treatment(s).
* 18 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
* Resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute Common Terminology Criteria for Adverse Events v3.0 grade less than or equal to 1.
* Adequate organ and bone marrow function.
* Willing to use effective contraceptive while on treatment through at least 3 months thereafter.
* Negative pregnancy test for females of childbearing potential.
* Echocardiogram with ejection fraction within normal range.

Exclusion Criteria:

* Anticipation of need for a major surgical procedure or radiation therapy during the study.
* Treatment with chemotherapy, hormonal therapy, other thiazolidinediones, radiotherapy, minor surgery, or any investigational agent within 4 weeks (6 weeks for nitrosoureas, mitomycin C, immunotherapy, biological therapy, or major surgery) of study treatment start.
* Participants with clinically significant pleural or pericardial effusion (participants with minimal pleural effusion may be eligible at the Investigator's discretion).
* Clinically significant active infection, which requires antibiotic therapy, or human immunodeficiency virus (HIV)-positive participants receiving antiretroviral therapy.
Effect of an Iridoid Enriched Beverage on Skin Autofluorescence

The objectives of this clinical trial are to evaluate the effectiveness of an iridoid enriched beverage containing noni and cornelian juices and olive leaf extract on advanced glycation end product levels.


Eligibility Criteria:
Inclusion Criteria:

* Males and females age 25 to 60 years.
* Overweight or obese, defined as BMI 23.0 to 39.9 kg/m2.
* Impaired fasting glucose, defined as fasting blood glucose 100 to 125 mg/dl.
* Prehypertension or Grade 1 hypertension, defined as systolic blood pressure 120-159 mm Hg AND diastolic BP 80-99 mm Hg.
* Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.
* Consent to the study and willing to comply with study procedures.

Exclusion Criteria:

* Prescription medication use for hypertension, high cholesterol, diabetes, heart disease, cancer, liver disease, or AIDS/HIV 2.
* Intake of foods and/or dietary supplements that may confound study outcomes including any use of a noni-based dietary supplement in the last month.
* Regular use (\> 3 times per week over the past month) of any dietary supplement that contains "super fruits" or high antioxidant concentrations.
* Regular use (\> 3 times per week over the past month) of any dietary supplement intended to alter or regulate blood glucose levels.
* Any medical conditions or diseases that may affect subject safety or confound study results (in the opinion of the investigator).
* Pregnant or lactating female.
* History of alcohol, drug, or medication abuse.
* Current heavy smokers (1 or more packs/day).
* Allergies to any ingredient in the investigational products.
* Participation in another study with any investigational product.
The Comparative Effectiveness Dementia & Alzheimer's Registry

To evaluate the effectiveness of using clinical precision medicine to develop lifecourse interventions for Alzheimer's disease (AD) prevention and treatment. Anthropometrics, blood biomarkers (including genetics), and cognition will measured longitudinally to assess the comparative effectiveness of clinical care.

The Comparative Effectiveness Dementia \& Alzheimer's Registry (CEDAR) Project is a prospective, observational registry of adult patients at-risk for, or with, a diagnosis of dementia due to Alzheimer's disease (AD) or other neurodegenerative dementias. The purpose of this study is to develop a research repository, or database, for information collected during routine medical care of people with normal memory and family history of AD, or with memory loss or other changes in thinking. The registry will help generate empirical evidence that improves knowledge and informs care decisions about risk reduction for dementia due to AD, and about the effectiveness of a clinical precision medicine intervention. Using a life course approach to comparative effectiveness research will enable investigators to analyze the effects of evidence-based multidomain interventions on cognition, biomarkers of AD risk, and calculated AD risk across the pre-dementia spectrum of AD.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* family history of Alzheimer's disease and no cognitive complaints OR subjective cognitive decline OR preclinical AD OR mild cognitive impairment due to AD or other conditions

Exclusion Criteria:

* none