cyrilzakka/clinical-trials huggingface dataset:
Study of Lopinavir/Ritonavir Tablets Comparing Once-Daily Versus Twice-Daily Administration When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced Human Immunodeficiency Virus Type 1 Infected Subjects

The purpose of this study was to compare the safety, tolerability, and antiviral activity of once-daily (QD) and twice-daily (BID) dosing of the lopinavir/ritonavir (LPV/r) tablet formulation in combination with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) in antiretroviral-experienced human immunodeficiency virus type 1 infected subjects with detectable viral load while receiving their current antiretroviral therapy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral-experienced adults at least 18 years of age currently receiving an antiretroviral regimen which had not changed for at least 12 weeks.
* Subjects had plasma HIV-1 ribonucleic acid (RNA) levels \> 1,000 copies/mL at screening and were not acutely ill.
* Subject was currently failing his/her antiretroviral regimen with the most recent 2 consecutive prestudy plasma HIV-1 RNA levels \> 400 copies/mL with the most recent being \> 1000 copies/mL, and in the investigator's opinion, should change therapy
* Female subjects were nonpregnant and nonlactating.

Exclusion Criteria:

* Subjects were excluded if screening laboratory analyses showed hemoglobin \<= 8.0 grams per deciliter.
* Subjects were excluded if screening laboratory analyses showed absolute neutrophil count \<= 750 cells/microliter.
* Subjects were excluded if screening laboratory analyses showed platelet count \<= 50,000 per cubic millimeter.
* Subjects were excluded if screening laboratory analyses showed alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>= 5.0 x upper limit of normal (ULN).
Stereotactic Radiosurgery in the Treatment of Essential Tremor

The goal of this interventional study is to evaluate the effectiveness of treatment using stereotactic radiosurgery in the treatment of essential tremor in adult patients

The study will include patients diagnosed with essential tremor who have insufficient tremor control despite the use of available pharmacotherapy methods. The study will include patients who have been disqualified from the Deeply Brain Stimulation procedure or who do not consent to its performance. Additional conditions for the examination are age over 50 and the duration of the disease over 5 years.

After qualifying and giving written informed consent, the patient will be randomly assigned to one of two study arms:

1. control arm: patients irradiated with the CyberKnife with a dose of 130 Gy
2. test arm: patients irradiated with the CyberKnife with a dose of 80 Gy

The primary aim of the study is to determine the effectiveness of radiosurgery in patients with essential tremor. Secondary objectives will be to determine the impact of treatment on the quality of life of, as well as to assess the safety and possible complications of radiosurgery.

Eligibility Criteria:
Inclusion Criteria:

* Essential tremor diagnosed, Parkinson's disease and other causes of tremor excluded.
* Insufficient tremor control despite the use of available pharmacotherapy methods.
* Disqualification from the Deeply Brain Stimualtion procedure/lack of consent to perform it on the side qualified for Stereotactic Radiosurgery
* Consent to participate in a clinical trial.

Exclusion Criteria:

* Age under 50
* Pregnancy
* Duration of the disease less than 5 years
* Dementia, psychosis or other condition that prevents giving informed consent to participate in the study
* Poor general condition, serious comorbidities
* Structural changes in the basal ganglia or major atrophic changes
* Previous radiotherapy to the brain covering the potential treatment area
* Medical contraindications to magnetic resonance imaging
Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment

This study is designed as a parallel, masked, randomized, placebo-controlled clinical trial to assess the clinical, microbiological, and immunological outcomes of scaling and root planning (SRP) or full-mouth ultrasonic debridement (FMUD) with AM (Amoxicillin + Metronidazole) for the treatment of Generalized Aggressive Periodontitis (GAgP).

Forty eight GAgP patients were divided into 4 groups: the SRP group (n = 12), which received SRP plus placebo, and the SRP+AM group (n = 12), which received SRP and 375mg amoxicillin plus 250 mg metronidazole for 7 days, the FMUD group (n = 12), which received FMUD plus placebo, and the FMUD+AM group (n = 12), which received FMUD and 375mg amoxicillin plus 250 mg metronidazole for 7 days. The following clinical outcomes were tested: plaque and bleeding on probing indices, pocket probing depth (PD), relative gingival margin position (GMP), and relative clinical attachment level (CAL). The total amount of Porphyromonas gingivalis (Pg), Aggregatibacter actinomycetemcomitans (Aa), Tannerella forsythia (Tf), and gingival crevicular fluid (GCF) concentration of interleukin (IL)-10 and IL-1b were also determined. All clinical, microbiological, and immunological parameters were assessed at baseline and at 3 and 6 months post-therapy. The ANOVA/Tukey test was used for statistical analysis (a = 5%).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of GAgP;
* presence of 20 teeth;
* presence of teeth presenting PD\>5 mm with bleeding on probing (BOP) and 2 teeth with PD\>7mm (including incisors and first molars, in addition to two other non-contiguous teeth between them);
* good general health;
* \<35 years of age.

Exclusion Criteria:

* were pregnant or lactating;
* were suffering from any other systemic diseases (e.g., cardiovascular, diabetes);
* received antimicrobials in the previous 3 months;
* were taking long-term anti-inflammatory drugs;
* received a course of periodontal treatment within the last 6 months;
* smoked
Federal Evaluation of Selected Programs for Expectant and Parenting Youth

Under contract to the U.S. Department of Health and Human Services (DHHS), Mathematica Policy Research is conducting an impact study of Healthy Families Healthy Futures in Houston, Texas for a Federal Evaluation of Programs for Expectant and Parenting Youth (PEPY). The impact study will be designed to address three main questions:

* Was the program successful in exposing participants to program content, such as information about methods of birth control?
* Was the program successful at improving short-term outcomes, such as use of a LARC and intention to space births?
* To what extent did treatment youth receive the intended program components?

A random assignment design will be used to assess the program's impact on exposure to program content and short term outcomes. Potential study participants were recruited between June 2015 and October 2016, and were considered eligible for participation if they were first time mothers between the ages of 14 and 19, English or Spanish speakers, had not enrolled in the program in the previous six mounts, and were not enrolled in the Nurse Family Partnership program. Potential participants who were eligible and who consented to participate were randomly assigned to (1) a treatment group that was eligible for Healthy Families Healthy Futures (HFHF) services or (2) a control group that was not eligible for HFHF. Random assignment was conducted within two blocks determined by whether study participants were pregnant at the time of random assignment or were parenting at the time of random assignment. The study draws on data from HFHF administrative records on service receipt, a baseline survey administered prior to random assignment, and a follow-up survey administered approximately 12 months after random assignment.

Eligibility Criteria:
Inclusion Criteria:

• Must be expectant or parenting

Exclusion Criteria:

* Participated in HFHF in six months prior to random assignment
* Enrolled in Nurse Family Partnership program at time of random assignment
* Oldest child is older than 3 months at random assignment
* Primary language is neither English nor Spanish
Acceptability Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene

The purpose of this study is to demonstrate the safety of the gynaecological formulation in normal and usual usage condition.


Eligibility Criteria:
Inclusion Criteria:

* Integral skin in the tested region

Exclusion Criteria:

* Pregnancy or breastfeeding women
* Use of antiinflammatory or immunosuppression drugs
* Topical medication use at the tested region
* Active cutaneous gynaecological disease
* Personal history of allergic disease at the area to be treated
* Allergic or atopic history
Health Economy Register

In breast oncology, the increasing number of oral and intravenous drug therapies pose great challenges for patient management. Numerous studies demonstrate that well-informed patients develop higher confidence in their treatment and a greater sense of disease control, resulting in increased adherence and persistence as well as potentially better outcome. The electronic Patient Reported Outcome (ePRO) tool CANKADO is designed to help oncologists to fill the gap between good, personalized care and a time and resource-saving treatment for cancer patients. CANKADO helps patients and their physicians regarding therapy management by a standardized documentation procedure and, if needed, direct feedback to patients by the integrated Pro-React system. GeRA includes patients undergoing systemic therapy for breast cancer with access to CANKADO. The trial is based on questionnaires that are answered by patients via the CANKADO Patient App. Primary objective is to gain knowledge on the health economic impact of CANKADO resource utilization in breast cancer care including the evaluation of physicians' time and patient experience.


Eligibility Criteria:
Inclusion Criteria:

* Men and women with breast cancer
* Ongoing medical drug treatment
* 18 years or older
* CANKADO account

Exclusion Criteria:

* Lack of consent to study participation or lack of patient's ability to stuconsent
Circulating Non-coding RNA in Acute Ischemic Stroke with Endovascular Treatment (EVTRNA)

EVTRNA is to analyze the differentiated expression pattern of circular RNA (circRNA), long non-coding RNA (lncRNA) and micro-RNA (miRNA) by next-generation sequencing in acute ischemic stroke patients before and/or after endovascular treatment. The candidate circRNA/lncRNA/miRNA will be verified as the biomarker and regulator for progression and prognosis of acute ischemic stroke with endovascular treatment. Further, the candidate non-coding RNA will be used to evaluate the effect of endovascular treatment on both peripheral and central immune after stroke.

Noncoding RNAs have been highlighted to be involved in the pathological process of ischemic stroke (IS). The purpose of this protocol will investigate the differentiated expression pattern of circular RNA (circRNA), long non-coding RNA (lncRNA) and micro-RNA (miRNA) by next-generation sequencing in acute ischemic stroke patients before and/or after endovascular treatment. The candidate circRNA/lncRNA/miRNA will be verified as the biomarker and regulator for progression and prognosis of acute ischemic stroke with endovascular treatment. Further, the candidate non-coding RNA will be used to evaluate the effect of endovascular treatment on both peripheral and central immune after stroke. Distinctive expression patterns of circRNA/miRNA/lncRNA will be identified by the next-generation sequencing and individual quantitative real time polymerase chain reaction (qRT-PCR). A predictive model will be established using logistic regression. The panel of these altered ncRNAs may be associated with the immune status after acute IS and could serve as a regulator for progression and prognosis of acute ischemic stroke with endovascular treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Confirmed acute ischemic stroke by a diffusion-weighted imaging-position lesion on magnetic resonance imaging (MRI) and a new lesion on a brain computed tomography (CT) scan
* Within 24 hours of symptom onset and treat with endovascular therapy
* Good performance status
* Signed an approved informed consents

Exclusion Criteria:

* a history of hemorrhagic infarction, chronic kidney/liver diseases, peripheral arterial occlusive disease, active malignant disease, and inflammatory or infectious diseases
Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation in Congenital Cataract

This study was conducted to evaluate changes of reduction of corneal astigmatism with toric intraocular lens(IOL) in congenital cataract.

This retrospective study included 6 eyes from 4 patients (mean age 7.2 years) with congenital cataract who had an astigmatism of 2.5 to 4.0 D prior to cataract surgery. Review of preoperative and postoperative visual acuity (UCVA), refraction, toric axis was performed.

Eligibility Criteria:
Inclusion Criteria:

* Children less than 14 years
* Congenital cataract at initial visit
* Symmetrical keratometric astigmatism more than 2.0 D

Exclusion Criteria:

* Microcornea (horizontal corneal diameter less than 9.5mm-asper that particular age)
* Corneal pathology
* Keratoconus
* Irregular astigmatism
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)

This study will assess the initial safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-8655, after single and multiple daily oral administrations to participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of non-child bearing potential
* Body Mass Index ≤40 kg/m\^2
* Diagnosis of Type 2 Diabetes (T2DM) and is either drug naive or is being treated with metformin only
* In good health except for T2DM
* Willing to follow a standard diet
* Nonsmoker and/or no use of nicotine or nicotine-containing products for 6 months

Exclusion Criteria:

* Mentally or legally incapacitated
* History of stroke, chronic seizures, or major neurological disorder
* History of clinically significant endocrine (except T2DM), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* History of neoplastic or myeloproliferative diseases
* Has clinical unstable or rapidly progressing diabetic retinopathy, neuropathy, and/or frequent nausea, bloating or vomiting, severe gastroesophageal reflux or early satiety
* Has a history of Type 1 Diabetes and/or history of ketoacidosis
* Use of any lipid-lowering therapies in the past 3 months
* Non-permitted medication for a co-morbid condition
* Excessive alcohol or caffeine use
* Participation in another investigational study within 4 weeks prior to this study
* A history of significant multiple and/or severe allergies or anaphylactic reactions
* Regular user of any illicit drugs or history of alcohol abuse within 6 months
Comparison Between Intrathecal and Intravenous Dexmedetomidine

A prospective, randomized, comparative controlled clinical trial, aiming to compare the use of intrathecal dexmedetomidine by intravenous dexmedetomidine in concern of the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.

Seventy patients undergoing lower limb surgeries were included in this study. Using a random number sequence, patients were enrolled in one of two groups: Group T receiving 5 µg of dexmedetomidine (Precedex® 100 µg/mL, Hospira, Inc., IL, U.S.A.) combined with 12.5 mg of 0.5% hyperbaric bupivacaine (Marcaine® Spinal Heavy; Astra, Sodertalje, Sweden) and Group V receiving the same bupivacaine DOSE AND 0.75 microgram/kilogram of body weight dexmedetomidine intravenously. Dexmedetomidine 100 µg/mL was mixed with preservative-free normal saline to 10 µg/mL. The 0.5 mL of dilute dexmedetomidine was added to the bupivacaine in group T. An independent investigator prepared the drug solutions and provided the coded drug to the anaesthetic administrator before the start of the anaesthesia. The anaesthetic administrator, patients, outcome assessors, and data analysts were blinded to the allocation. Spinal Anesthesia Patients were hydrated with 500 mL of 0.9% sodium chloride solution before anaesthesia. The spinal puncture was performed at L3-4 or L4-5 with a midline approach using a 25 G Quincke needle in the lateral decubitus position. After confirmation of free flow and clear cerebrospinal fluid, the drug was administered and the patients were then placed in the supine neutral position.

Assessment: The primary end-point of this study was the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients
* age 18-65 years
* scheduled for lower limb surgery
* spinal anaesthesia

Exclusion Criteria:

* patients with coagulopathy
* infection at the site of lumbar puncture
* beta-blockers or calcium channel blockers usage
* hypersensitivity to Bupivacaine or Dexmedetomidine
* any other contra-indications for spinal anaesthesia.
A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease

This study will evaluate Advanced Laboratory Services Borrelia diagnostic test by culturing Borrelia spirochetes from human serum in subjects with early or late Lyme disease.

This is an 8 month study. Subjects entering the study will have two blood samples collected one month apart if they have early Lyme disease and one blood sample collected if they have late Lyme disease. Subjects who sign an IRB-approved consent form and meet the inclusion and exclusion criteria will be entered into the study. Subjects will be assigned a subject number upon entry and this number will be retained throughout the study.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must provide written informed consent prior to the conduct of any study-related procedures.
2. Male or female subjects who are at least 18 years of age.
3. Subjects are suspected to have early Lyme disease based on the following criteria: Signs, symptoms and clinical history consistent with early-stage Lyme disease. Subjects must have a medical practitioner-diagnosed erythema migrans (EM) rash and should have systemic symptoms indicative of disseminated infection. Symptoms may include fever, headache, fatigue, myalgias, arthralgias, and stiff neck. Paired acute and convalescent titers will be drawn (first draw at time of initial visit and second draw 4 weeks later) or,
4. Subjects are suspected to have late Lyme disease based on the following criteria: Signs, symptoms and clinical history consistent with late stage Lyme disease, including but not limited to disseminated rash, arthritis, meningitis, facial palsy, or carditis.
5. Subjects must be willing and have the ability to safely have the required quantity of blood drawn for the study at the discretion of the investigator.
6. Subjects must have blood samples freshly collected (no supplemental frozen samples) and the samples must reach ALSI's laboratory on a weekday and within 24 hours of being drawn.

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Exclusion Criteria:

1. Early Lyme disease: Subjects without an EM rash or do not have symptoms recognized as being associated with Lyme disease.
2. Exposure to antibiotics of any type during the 6 weeks prior to the initial blood sample collection.
3. Immune deficiency significant enough to render serological tests less reliable.
4. The subject is unwilling or unable to safely have the required quantity of blood drawn for this study.
5. Subjects who are not able to understand all of the requirements of the study or unable to give informed consent and/or comply with all aspects of the evaluation.
6. Subjects that have any other condition or situation which, in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study.
7. Subjects that have undergone testing for Lyme disease within the past year.
8. Subjects that have a prior diagnosis of Lyme disease.
Non-Invasive Biomarkers For Early Detection Of Lung Cancers

Recent studies have shown that low-dose chest CT scans can detect lung cancers in high-risk populations (age \>50yo, \>30 pack-years of tobacco use), and can lower cancer mortality. Unfortunately, the vast majority of "positive" findings on these CT scans are benign (\>95%). Currently, an inordinate amount of expensive follow-up testing is required for these patients to try to prove who among them truly has a cancer.

Several new emerging non-invasive and potentially cheaper tests are now being investigated to help differentiate patients with cancers versus just benign lung nodules. These new tests include a new type of sputum analysis, a breath analysis, a blood test measuring certain tumor markers, a blood test looking for auto-antibodies, and a standard PET/CT scan. Each of these tests have different sensitivity and specificity rates when looking for lung cancer, and it is unclear which test is best.

This study will employ a panel of all 5 of these non-invasive tests on an initial cohort of 50 patients with recently diagnosed lung cancer to try to measure the sensitivity of the tests. A follow-on study will then perform the same panel of tests on 300 lung nodule patients to see which test, or combination of tests, gives the best overall accuracy in terms of predicting who really has lung cancer. It is hoped that the use of such a panel could lead to dramatically decreased need for expensive and morbid invasive testing for this population.

The study revolves around specifying the exact signatures and accuracy associated with discriminating between benign and malignant SPNs for each of the biomarkers in the specific high risk cohort under the NLST screening protocol. To help identify and quantify these signatures, we will evaluate specifically the volatile signature in the exhaled breath, the accuracy of LuCED sputum detection, the profile of tumor markers and the specifications of auto-antibodies through immunoassays and Orbitrap technology, and the PET/CT in patients already diagnosed with lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed cancer, prior to treatment

Exclusion Criteria:

* prior treatment for this cancer
* a history of any other cancer