cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Intraoperative Blood Recovery System in Cardiovascular Surgery in Brazil

Randomized trial to evaluate the effectiveness of a intra operative blood recovery system in reducing the need for allogeneic transfusion in cardiovascular surgeries using cardiopulmonary bypass

To evaluate the effectiveness of a intra operative blood recovery system in reducing the need for allogeneic transfusion in cardiovascular surgeries using cardiopulmonary bypass, a randomized clinical trial will be conducted. The study will be conducted at a teaching hospital, which is a reference for major cardiac surgeries and receives patients from the Brazilian Unified Health System (SUS). The patients will be randomly assigned to two groups: with and without the use of the system, and allocation concealment will be performed. Continuous variables will be analyzed through frequency distributions and appropriate descriptive measures (mean or median), while categorical variables will be presented through frequency distributions. For categorical variables, the confidence interval will be calculated, conventionally set at 95%. For continuous variables, the T-test will be used to measure differences, while for categorical variables, the McNemar statistical test will be used. For all analyses, a significance level of 5% will be used, and the data will be analyzed according to the intention-to-treat principle.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing CABG or Valve surgery singly.

Exclusion Criteria:

* Emergency cardiac surgery;
* Previous heart surgery;
* End-stage chronic kidney disease;
* Inability to receive a blood transfusion (refusal);
* Anemia (hemoglobin less than 10g/dl);
* Thrombocytopenia (platelet count less than 100,000/mm3);
* Coagulopathy (RNI \> 1.5);
Assessment of Drug-drug Interactions Between Feminizing Hormone Therapy and Emtricitabine/Tenofovir Alafenamide Concomitantly for Pre-exposure Prophylaxis Among Transgender Women

Recent studies have showed that there were significant drug-drug interactions (DDI) from feminizing hormone therapy (FHT) towards emtricitabine/tenofovir disoproxil fumarate (F/TDF)-based pre-exposure prophylaxis (PrEP) among transgender women (TGW). New strategies for PrEP among TGW who use FHT are urgently needed. Because tenofovir alafenamide (TAF) can achieve higher intracellular TFV-DP levels with lower tenofovir plasma concentrations, it is promising that both plasma TFV and intracellular TFV-DP levels might not be significantly affected by FHT. The current study aims to determine the pharmacokinetics DDI between FHT and F/TAF-based PrEP among TGW.

Two full pharmacokinetic (PK) measurements will be performed. Samples collected will include: plasma for estradiol (E2), emtricitabine (FTC), tenofovir (TFV), and tenofovir alafenamide (TAF) measurement; and peripheral blood mononuclear cells (PBMC) for emtricitabine-triphosphate (FTC-TP) and tenofovir-diphosphate (TFV-DP) intracellular quantification.

Eligibility Criteria:
Inclusion Criteria:

1. Thai nationality
2. Age 18-40 years old
3. Transgender women
4. HIV-negative
5. Body mass index 18.5-24.9 kg/m2
6. Calculated creatinine clearance (CrCl) ≥60 mL/min, as estimated by the Cockcroft-Gault equation
7. Alanine aminotransferase (ALT) ≤2.5 x ULN
8. Signed the informed consent form

Exclusion Criteria:

1. Known history of allergy to hormonal component to be used in the study
2. Male-to-female transgender who underwent orchiectomy
3. Use of pre-exposure prophylaxis or post-exposure prophylaxis in the past 30 days
4. Use of injectable FHT in the past 3 months
5. Evidence of current hepatitis B virus infection (HBV) - i.e. hepatitis B surface antigen (HBsAg) positive
6. Evidence of current hepatitis C virus infection (HCV) - i.e. HCV antibody positive
7. Current use of any of the following:

   * Anticonvulsants: carbamazepine, felbamate, oxcarbazepine, phenytoin, phenobarbital, primidone or topiramate
   * Herbs: gingko biloba, St John's wort or milk thistle
   * Anti-infective agents: azole antifungals, macrolides, griseofulvin, protease inhibitors, rifampicin or rifabutin
8. Participant-reported active rectal infection requiring treatment
9. History of gastrointestinal tract surgery that alter gastrointestinal tract and/or drug absorption
10. Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
Menthol, Inflammation, and Nicotine Transition Study

This study will focus on examining the potential impact of menthol flavoring in cigarettes on biomarkers of systemic inflammation as a subclinical indicator of cardiovascular disease risk.

The goal of this study is to examine how switching from menthol (MC) to non-menthol (NMC) cigarette smoking may impact biomarkers of systemic inflammation, smoking behavior, and subjective responses related to smoking. MC smokers (N=68) will be recruited for a five-week study, with one-week of baseline of MC smoking (Phase 1), followed by four weeks of switching to study-provided, brand-matched NMCs (Phase 2). Biomarkers of systemic inflammation and tobacco exposure will be analyzed from blood samples before, during, and after switching for four weeks (baseline, week 1, week 3, and week 5). Ecological momentary assessment methods will also be gathered to measure patterns of smoking and smoking-related subjective responses (affect, craving).

Eligibility Criteria:
Inclusion criteria

* Men and women between 21-85 years old
* Currently uses menthol cigarettes
* Daily smoking rate of ≥5 cigarettes/day for ≥1 year
* Currently own and regularly use an iOS/Android smartphone device able to download the LifeData application
* Able to read and communicate fluently in English

Exclusion criteria

* Currently pregnant or breastfeeding
* Actively trying to quit smoking
* Current heavy alcohol use
* Frequent use of non-menthol cigarettes, other smoking products, or illicit substances
* History of severe medical/psychiatric condition or treatment
Cognitive Behavioral Therapy for Trichotillomania

This study aims to develop a comprehensive Cognitive Behavioral Therapy protocol for adult patients with Trichotillomania that emphasizes relapse prevention and that addresses comorbid affective symptoms, as well. The study will compare the efficacy of CBT with a minimal attention control (MAC)condition. We hypothesize that outcome at post-treatment, 3-month, and 6-month follow-up will be better for the CBT vs. MAC condition including higher responder rates and greater reduction in hair pulling severity.

The purpose of this study is to assess the efficacy of cognitive behavioral therapy for patients with trichotillomania.

Following entry into the study, subjects will be randomized into a cognitive behavioral therapy (CBT) or a minimized attention control (MAC) condition. Subjects will be assessed with the Acceptance and Action Questionnaire (AAQ), the Affective Regulation Rating (ARR), the Barratt Impulsivity Scale (BIS-11), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Clinical Global Impressions Scale (CGI), the Difficulties in Emotion Regulation Scale (DERS), Hair Pulling Scale (HPS), Trichotillomania (TTM) Impact Scale, Psychiatric Institute Trichotillomania Scale (PITS), National Institute of Mental Health Trichotillomania Severity Scale(NIMH-TSS), the Generalized Expectancy for Negative Mood Regulation Scale (NMR), The Milwaukee Inventory for Subtypes of Trichotillomania- Adult Version (MIST-A), the Positive and Negative Affect Scale (PANAS), the Quality of Life Inventory (QOLI), the Readiness to Change Hairpulling Behavior (RCHPB), the Self-Esteem Scale (SES), the Skin Picking Scale (SPS) and the Scales of Psychological Well-Being (SPWB). Subject randomization to a treatment arm will be determined by a random number generator.

Subject change scores will be assessed for the above scales.

Eligibility Criteria:
Inclusion Criteria:

* primary DSM-IV diagnosis of TTM
* outpatients who are 18 or older
* a minimum MGHHPS total scale score of 10
* a minimum TTM symptom duration of 1 year with no significant remissions (as defined by complete abstinence of hair extraction for a 2-week period during the prior 6 months)

Exclusion Criteria:

* presence of a serious psychiatric condition including mental retardation, psychosis, pervasive developmental disorder, organic mental disorders, manic episode, ADHD, suicidality, lifetime alcohol or substance dependence, or alcohol or substance abuse within the past 3 months
* presence of a serious medical condition that would limit ability to routinely attend sessions and complete homework assignments
* individual or group psychotherapy (not addressing TTM) that has not been ongoing for the past 3 months and/or without intent to continue same treatment during study tenure)
* previous CBT for TTM
* involvement in other treatment for TTM
* psychotropic medication that has not been stable for 3 months prior to study enrollment and/or without intent to continue same medication regimen during study tenure)
Infants Fed an Amino Acid-based Formula

To observe the effects of an amino acid-based formula on symptoms associated with food allergies in infants.


Eligibility Criteria:
Inclusion Criteria:

* Subject is judged to be in good health as determined from subject's medical history
* Subject is from a full-term birth with a gestational age of 37-42 weeks
* Subject's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.)
* Subject has been documented to have CMPA and/or multiple food allergies, FPIES or gastrointestinal eosinophilic disorders.
* Subject is experiencing persistent feeding intolerance symptoms including any of the following: regurgitation/vomiting associated with feeding (within 1 hour), constipation, diarrhoea, hematochezia (blood in the stool), crying, gassiness (wind), and/or skin rash/eczema.
* Parent(s) confirm their intention to feed their infant study product during the study period.
* Parent(s) confirm their intention not to administer vitamin or mineral supplements to their infant from enrolment through the duration of the study, unless instructed otherwise by their healthcare professional.
* Infant using medications (OTC medications for gas \[wind\]), home remedies (such as juice for constipation), herbal preparations, prebiotics, probiotics or rehydration fluids that might affect Gl tolerance may not be enrolled unless the parent agrees to discontinue the use of these agents prior to enrolment or a healthcare professional recommends their continued use.
* Subject's parent(s) has voluntarily signed and dated an ICF, approved by an IEC/IRB and provided applicable privacy regulation authorisation prior to any participation in the study.

Exclusion Criteria:

* Subject is receiving steroids or antibiotics
* Subject is tube-fed
* Subject has received an amino acid-based formula
* Subject has been diagnosed with: Short bowel syndrome, Inflammatory bowel disease, Pancreatic disease, Protein maldigestion (malnutrition), Mast cell disorder
* Subject is participating in another study that has not been approved as a concomitant study by AN
Optical Coherence Tomography (OCT) in Elderly Patients After Elective Orthopaedic Surgery

After obtaining informed consent each patient underwent OCT examination, usually one day before elective orthopaedic surgery (knee replacement). The OCT examination was repeated after the surgery. Both eyes were examined separately. After obtaining data the investigators compared the difference.

Inclusion and exclusion criteria evaluated during the pre-anesthesia visit. After obtaining informed consent, patients were referred to OCT examination in the Ophthalmology clinic. The examination was performed in the 48 hours before the surgery. Between the fourth and the seventh postoperative day, the patients underwent control OCT examination. The results of OCT examinations, baseline clinical data and the data on the course of surgery and postoperative care were recorded for further analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Signed informed consent
* Elective operation

Exclusion Criteria:

* Age under 18
* Refusal to sign informed consent
* Non-elective operation
* Hospitalization on ICU more than 48 hours after surgery Inability to undergo OCT examination Protocol violation
When to Start Anti-HIV Drugs in Children Infected With HIV (The PREDICT Study)

The purpose of this study is to determine when HIV infected children should begin taking anti-HIV medications in order to improve both patient quality of life and survival.

The use of highly active antiretroviral therapy (HAART) has resulted in a significant reduction in AIDS-related deaths and complications among adults and adolescents. However, the medical management of HIV infected children remains challenging. Access to HIV treatment is limited and early treatment initiation can cause serious complications. Since there is currently no cure for HIV, a balance between treating the disease and maintaining quality of life must be weighed carefully. An evaluation to determine the appropriate time to initiate HAART is necessary to improve both quality of life and survival for HIV infected children.

This study will last 144 weeks. All participants will have a CD4 percentage (CD4%) between 15% and 24% and will be randomly assigned to either receive immediate or delayed HAART. The HAART regimen will consist of two nucleoside reverse transcriptase inhibitors, zidovudine and lamivudine. In addition, participants will also receive either one non-nucleoside reverse transcriptase inhibitor, nevirapine or efavirenz, or one protease inhibitor, ritonavir-boosted lopinavir or nelfinavir. Abacavir will replace zidovudine or lamivudine if participants experience toxicity to the regimen. Participants in the immediate treatment arm will receive HAART on Day 1 of the study regardless of their CD4%. Participants in the delayed treatment arm will receive HAART if their CD4% falls below 15 or if they develop a CDC Category C illness.

Study visits will occur every 4 weeks for the first 12 weeks and then every 12 weeks until the end of the study. Blood collection, physical exams, and medical and medication history reviews will occur at all visits. Adherence, quality of life, and lipodystrophy assessments will occur every 12 weeks for participants on HAART. Participants will be encouraged to enroll in a related substudy to examine the neurodevelopment of HIV infected children.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected
* Antiretroviral naive, defined as never receiving anti-HIV medications, receiving them for less than 7 days, or only receiving them to prevent mother-to-child transmission (MTCT)
* CD4% between 15 and 24 within 30 days prior to study entry
* CDC pediatric clinical classification A or B
* Parent or guardian willing to provide informed consent and willing to follow all study procedures and requirements

Exclusion Criteria:

* Use of systemic chemotherapy, immunomodulators, HIV vaccines, immune globulin, interleukins, or interferons within 30 days prior to study entry
* Active AIDS-defining illnesses (CDC Category C) within 30 days prior to study entry
* Certain abnormal laboratory values
* Known kidney disease
* Known allergy or sensitivity to study drugs
* Require certain medications
* Pregnancy
Ultrasound-guided Intermediate Cervical Plexus Block

The investigators test with the present study design, whether an ultrasound-guided blockade of the cervical plexus in combination with an additional application of local anesthetic to the superficial cervical ansa (facial nerve: cervical branch) leads to an improved quality of anesthesia.

The innervation of the neck area is complex and includes cranial nerve (innervation of the vessel wall (IX,X) and of the neck muscles (VII,XI)), as well as the cervical plexus and brachial plexus. This is a major cause of insufficient anesthesia quality during carotid endarterectomies.

The investigators test with the present prospective study design, whether an ultrasound-guided blockade of the cervical plexus in combination with an additional application of local anesthetic to the superficial cervical ansa (facial nerve: cervical branch) leads to an improved quality of anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* internal carotid stenosis: open surgical revascularization
* age over 18 years
* written informed consent

Exclusion Criteria:

* allergy (local anesthetics)
* pregnancy
* participation in other studies
* drug addiction
* non-cooperative patients
Use of a Novel Synbiotic to Change Human Gut Bacteria and Improve Health in Obese Adults

This study evaluates the effect of a dietary supplement to improve gut health. The participants will take one of six dietary treatments for three weeks, and the gut bacteria and the gut intestinal barrier will be assessed to determine if these dietary treatments beneficially change these markers of gut health.

In this study, we intend to test the ecological and therapeutic functionality of a synbiotic combination of a Bifidobacterium adolescentis strain and the prebiotic galactooligosaccharide (GOS) in a human clinical trial. The synbiotic combination was selected based on a novel in vivo selection; specifically, the strain (BD1) is an human autochthonous gut organism that was enriched in an individual by GOS. Our experiments will test the efficacy of this synbiotic compared to a conventional synbiotic. We hypothesize this rationally selected synbiotic will improve intestinal barrier function in obese adult subjects, thereby preventing endotoxemia and metabolic inflammation, physiologically relevant functions that are increased in obese individuals. Our objectives are to: (1) compare the ability of the test and control synbiotic preparations to alter the gut microbiota in obese individuals; (2) test if GOS supports colonization and metabolic activity of test and control strains in the human gut; (3) compare the ability of the two synbiotic preparations to improve intestinal permeability and endotoxemia in obese subjects; and (4) assess associations between the gut microbiota and the test strain with biomarkers for translocation and endotoxemia.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 yrs, obese (30 kg/m2 and greater)

Exclusion Criteria:

* (1) prior intestinal resection, (2) patient history of GI diseases except for hiatal hernia, GERD, hemorrhoids, (3) severe renal disease defined by creatinine more than twice normal, (4) markedly abnormal liver function defined by ALT/AST over 4 times normal levels or elevated bilirubin (5) antibiotic use within the last 12 weeks prior to enrollment, (6) lean or overweight (BMI \< 30 kg/m2), (7) intolerant to aspirin, (8) regular use of aspirin, (9) excessive alcohol intake (\>2 drinks for men, 1 drink for women daily), (10) presence of uncontrolled chronic metabolic disease (cardiovascular disease, insulin requiring diabetes or uncontrolled diabetes, cancer, etc, (11) a plan to have a major change in dietary habit during the following 6 months, (12) consumption of probiotics, prebiotics or synbiotics without an appropriate 4 week washout period, (13) lactose intolerance or malabsorption; (14) subjects younger than 18 or older than 65, (15) unwillingness to consent to the study.
The Safety and Effectiveness of Low and High Carbohydrate Diets

This study will compare the safety and the effectiveness of a low carbohydrate diet (Atkins diet) with a high carbohydrate diet (conventional USDA diet).

Despite the considerable mass appeal of popular diet books, such diet approaches lack data to support their efficacy and safety. Despite its widespread use for more than 30 years, the Atkins diet has never been evaluated in a large, randomized, controlled trial. This study will assess the short-term and long-term clinical effects of a low-carbohydrate diet and a high-carbohydrate diet in overweight and obese men and women.

Participants in this study will be randomly assigned to the Atkins diet (low-carbohydrate, unlimited fat and protein) or a conventional USDA diet (high-carbohydrate, low-fat). The study will evaluate the effects of each dietary approach on changes in: 1) weight and body composition; 2) metabolic and organ function; and 3) exercise tolerance. Each participant will be enrolled in the study for 2 years.

Eligibility Criteria:
Inclusion Criteria

* Body mass index between 30 and 40
* Live and work within 1 hour of the study site
* Stable psychological status

Exclusion criteria

* History of heart disease, heart attack, or stroke
* Blood pressure \>140/90 mmHg
* Abnormal cholesterol levels
* Significant psychiatric illness
* Any medication that affects weight or metabolic rate
* Presence or history of a chronic disease that is known to affect appetite, food intake, or metabolism (i.e., diabetes, thyroid disease, or cancer)
* Currently using antidepressants, steroids, tobacco, or illegal drugs
* Pregnant, breastfeeding, or planning pregnancy
* 10 lb change in weight within 6 months of study entry
* History of malignant arrhythmias or cerebrovascular, renal, or hepatic disease
* History of protein wasting diseases or gout
* Severe arthritis
* Osteoporosis
* Certain types of hormone replacement therapy
* Currently following a vegetarian diet
MSOT As Non-invasive Biomarker for Diagnosis and Monitoring of Neuromuscular Diseases

The goal of this study is to learn if Multispectral Optoacoustic Tomographs (MSOT) works to diagnose and follow the course of neuromuscular diseases (NMDs) in children. MSOT scans will be obtained from muscle region to measure hemo/myoglobin, collagen and lipid content/signal and oxygenation in patients with neuromuscular diseases. No additional research activities -other than MSOT - will be done during this study. Existing clinical, laboratory and imaging data from standard-of-care procedures will be correlated with the MSOT data. The expected total duration of the study is approximately 36 months. Repeated measurements will be done to evaluate disease progression and the value of MSOT in NMD.


Eligibility Criteria:
Inclusion Criteria:

Patients with neuromuscular disease

* Children (from birth (infants that are born term) to 18 years of age) participants or consent through authorized guardian
* Confirmed or suspected diagnosis of a neuromuscular disease (through molecular genetics, biopsy, clinical examination)

Exclusion Criteria:

Participants:

* Diagnosis is not consistent with a confirmed or suspected neuromuscular disease
* Patients with active skin lesions (e.g. infections, trauma) or confirmed genetic disorders (e.g. epidermolysis bullosa) that predisposes to skin lesion
* Medically unstable patients
* Tattoo on skin overlying the area to be examined
* Missing consent form
* Exclusion due to safety concerns of the investigator (subject who has any condition, including any physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study)
* Medication leading to increased light sensitivity