cyrilzakka/clinical-trials huggingface dataset:
Study to Determine the Antiviral Activity and Safety of Alovudine in Nucleoside-experienced HIV-infected Subjects Experiencing Virologic Failure

The primary objective was to determine the mean change in HIV viral load from baseline to Week 4 compared with placebo after 4 weeks of treatment in highly experienced HIV-infected patients.

Secondary objectives were to determine (1) the tolerability, hematologic and hepatic safety of different doses of alovudine and (2) the effect of baseline nucleoside genotypic susceptibility on virologic response after 4 weeks of alovudine administration


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent before any trial procedure
* HIV-1 infected males or females ≥18 years of age
* Screening genotypic resistance report indicating two or more of the following nucleoside reverse transcriptase inhibitors (NRTI) resistance mutations: 41, 67, 70, 210 and 215
* Stable NRTI regimen without stavudine and zidovudine for at least 6 weeks before screening and stable antiretroviral (ARV) background treatment for 3 months before screening
* HIV-1 viral load ≥1000 copies/mL and \<75,000 copies/mL at screening
* Change in viral load between previous test within 3 months before screening, using local laboratory for routine tests, and screening test was \<1.0 log10 copies/mL
* Acceptable medical history, as assessed by the investigator
* Current stable ARV medication regimen between screening (Visit 1) and Visit 2

Exclusion Criteria:

* ARV medication naïve
* Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the previous 3 months
* Female patients of child-bearing potential who :

  * have a positive serum pregnancy test
  * are breast feeding,
  * are planning to become pregnant, or
  * are not willing to use a barrier method of contraception
* Prior alovudine use
* Use of investigational medications within 30 days before study entry or during the trial
* Use of immunomodulatory drugs within 3 months before study entry or during the trial (e.g. interferon, cyclosporine, hydroxyurea, interleukin-2)
* Current use of rifampin, rifabutine, isoniazid, pyrazinamide, stavudine, zidovudine, ganciclovir, chronic use of hepatotoxic drugs, anti-tumour therapy or probenecid
* Laboratory values:

  * Neutrophils of Grade 2 or greater abnormality
  * Hemoglobin of Grade 2 or greater abnormality
  * Platelets: Grade 2 or greater abnormality
  * Creatinine of ≥1.25 Upper limit of the normal (ULN)
  * Lipase of Grade 1 or greater abnormality
  * Alanine aminotransaminase (ALT) or Aspartate aminotransaminase (AST) of Grade 2 or greater abnormality
  * Direct bilirubin of Grade 1 or greater abnormality
* CD4 ≤50 cells/mm3
* Hepatitis B (+HBsAg or +HBcAB) or C +Hepatitis C virus (+HCV AB ) co-infection, chronic hepatitis, on-going hepatitis or pancreatitis
* Any new or active AIDS-defining event within 30 days before study entry
* Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator
* In the opinion of the investigator, likely survival of less than 6 months because of underlying disease
Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months

This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as a nasal spray. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 6 and 24 months who are seronegative to RSV.


Eligibility Criteria:
Key Inclusion Criteria:

1. Children aged 6-36 months
2. Good health based on history, physical examination, and medical record review, without evidence or suspicion of chronic disease
3. Seronegative to RSV, as defined by serum nAb titer below the threshold described in the study protocol and operations manual
4. Written informed consent provided by parent(s)/guardian(s)

Key Exclusion Criteria:

1. Known or suspected chronic illness, particularly cardiopulmonary (including asthma or reactive airways disease), genetic or metabolic, hepatic, renal, infectious (including recurrent or chronic sinusitis), or immunodeficiency
2. Prior lab-confirmed RSV infection
3. Household or close contact (including but not limited to daycare) during the 21 days post-inoculation with anyone \< 6 months old or immunocompromised (applies to first study inoculation)
4. Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
5. Receipt of immunoglobulins, monoclonal antibodies and/or any blood products, or ribavirin within 6 months prior to study inoculation, or planned use during study period
6. Receipt of an investigational RSV vaccine at any time
7. Any other condition that, in the judgment of the investigator, would be a risk to subject's safety and/or may interfere with study procedures or interpretation of results
Investigation Of The Relationship Between Imagery Ability, Balance And Functionality After Stroke

It was aimed to determine the relationship between post-stroke imagination ability, balance, and functionality, and to compare the motor imagery skills of those who had stroke with compatible healthy individuals.

İn the study, 20 individuals with hemiplegic or chronic hemiparesis who agreed to participate by signing the voluntary consent form, who meet the inclusion criteria, and 20 healthy individuals who are similar in terms of age, gender and education level will be included.

The individuals included in the study will be divided into two groups:

Group 1: Stroke Patients Group 2: Control Group

Eligibility Criteria:
Inclusion Criteria:

* Post-stroke hemiplegia or chronic hemiparesis
* Not having any neurological disorder other than stroke
* Not having vision problems that will affect the materials to be used during the treatment.
* To be able to communicate enough to understand the orders given
* Standardized Mini Mental Test (SMMT) score of 24 and above
* Not having seen a visualization application before

Inclusion Criteria for Healthy Participants:

* Being between the ages of 40-80
* To be similar in terms of age, gender, education level of individuals with stroke

Exclusion Criteria:

* Having an advanced degree of aphasia
* Unilateral neglect
* Standardized Mini Mental Test (SMMT) score below 24 points
* Multiple stroke history
* Having pain and limitation of joint motion that will interfere with functional activity
* Walking restriction
* Serious communication or understanding problems
* Presence of serious cardiovascular, respiratory, metabolic or orthopedic problems
* Presence of a secondary neurological disease
Comparative Clinical Effects of Salvadora Persica Oral Rinse And A Phenolic Commercial Mouth Wash On Human Oral Health

ABSTRACT:

OBJECTIVE: To compare the clinical effects of Salvadora persica (miswak) oral rinse and commercial Listerein mouth wash on oral health of socially deprived madrasa girls.

METHODS: Girls aged 18-22 years living permanently in a madrasa of Multan city will be recruited. Sample size and trial duration will be determined using the American Dental Association guidelines. Participants will be randomized into two interventional groups; A and B and will be either provided with Salvadora persica oral rinse and commercial Listerein mouth wash respectively. Pre, mid and post-intervention examinations will be executed by a blind and calibrated examiner using Turesky Quigley Hein Plaque and Loe and Silness Gingival indices. Statistical analysis will include descriptive statistics and two sample independent t-tests. The p-value of \<0.05 will be considered significant at 95 % confidence level.

KEY WORDS: Dental plaque, Gingivitis, Miswak, Mouthwash

Comparative clinical effects of Salvadora persica (miswak) oral rinse and commercial Listerein mouth wash will be studied on the oral health of socially deprived madrasa girls. Girls aged 18-22 years living permanently in a madrasa of Multan city will be recruited. Sample size and trial duration will be determined using the American Dental Association guidelines. Participants will be randomized into two interventional groups; A and B and were either provided with Salvadora persica oral rinse and commercial Listerein mouth wash respectively. Pre, mid and post-intervention examinations will be executed by a blind and calibrated examiner using Turesky Quigley Hein Plaque and Loe and Silness Gingival indices. Statistical analysis will include descriptive statistics and two sample independent t-tests. The p-value of \<0.05 will be considered significant at 95 % confidence level.

Eligibility Criteria:
Exclusion Criteria:

* Participants/girls with any medical or dental disease,
* Participants/girls with any dental prosthesis,
* Those taken antibiotics in last 6 months,
* Those received any periodontal therapy in last 3 months

Inclusion Criteria:

\*Participants with at least 10 sites of chronic mild gingivitis with bleeding on probing but not having periodontal pockets of greater than 3mm
Characterization of a Clinical Subpopulation With Autism Spectrum Disorder

The main objective for this research study is to gather additional information to help confirm identification of new subgroups within the autism spectrum.


Eligibility Criteria:
Inclusion Criteria:

* Participants previously diagnosed with ASD (DSM-5) supported by either autism diagnostic interview revised (ADI-R) or Autism Diagnostic Observation Scale (ADOS-2) scores
* Available health records within the first 2 years of life
* Participants must have a parent or reliable caregiver who agrees to provide information about the participant

Exclusion Criteria:

* Genetically identified ASD (syndromic form of autism, e.g. fragile X)
* Episode of fever (i.e. ≥100.5 °F) or clinically significant illness without fever (as judged by the Investigator), within 10 days before the study visit
Multiple Ascending Dose Study of Miravirsen in Treatment-Naïve Chronic Hepatitis C Subjects

The main purpose of this study is to determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with chronic hepatitis C.

Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of miravirsen's effect on HCV viral titer.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18-38 kg/m2
* Treatment-naïve to interferon-alpha based therapies
* HCV genotype 1
* Clinical and laboratory findings consistent with a clinical diagnosis of CHC, including:

Previous documentation of positive HCV serology (HCV antibody or HCV RNA) at least 24 weeks prior to enrollment, OR Positive HCV serology (HCV antibody or HCV RNA) with a prior remote risk factor (more than 24 weeks prior to Screening) for the acquisition of hepatitis C

* Serum HCV RNA \> 75,000 IU/mL at Screening
* (North American sites only). Liver biopsy within 36 months of Day 1, indicating the absence of cirrhosis
* Screening hematology, clinical chemistries, coagulation and urinalysis are not clinically significant and the following criteria are met:
* Platelets \>100,000/mm3
* Total WBC \> 3000/mm3 and ANC \>1500/mm3
* Hemoglobin \> 11 g/dL for females and \> 12 g/dL for males
* Total and direct bilirubin, WNL (except for clearly documented Gilbert's Syndrome)
* ALT \< 5 x ULN
* Serum creatinine WNL and creatinine clearance as calculated by the Cockcroft-Gault formula \> 80 ml/min
* Negative results on the following Screening laboratory tests: urine or serum pregnancy test (for women of childbearing potential), hepatitis B surface antigen and human immunodeficiency virus (HIV) antibody.
* For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner become pregnant) during the full course of the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to Screening). IUD, Depo-Provera, Norplant System implants, bilateral tubal ligation, vasectomy, condom or diaphragm plus either contraceptive sponge, foam or jelly and abstinence.

Exclusion Criteria:

* Other known cause of liver disease except for CHC
* History or symptoms of decompensated liver disease: Child-Pugh Class B or C, including ascites, hepatic encephalopathy, esophageal variceal bleeding, fibrosis or other signs of hepatic insufficiency or portal hypertension
* History of hepatocellular carcinoma (HCC) on imaging studies or serum alpha-fetoprotein (AFP) \> 50 ng/mL at Screening
* Concurrent clinically significant medical diagnosis (other than hepatitis C-related conditions) that would potentially interfere with the subjects study compliance or confound study results
* Concurrent social conditions (e.g. drugs, alcohol, transportation) which would potentially interfere with the subject's study compliance
* Clinically significant illness within 30 days preceding entry into the study
* Participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication.
Effect of Maternal and Neonatal Oxygenation

Intraoperative supplemental oxygen has been given for most parturients undergoing cesarean section under spinal anesthesia. However, evidences supporting the practice is not clear nowadays, especially for healthy parturients who are monitored continuously with pulse oximeter. Furthermore, hyperoxia may produce free radicles which could harm fetus and newborns.

Changing practice is not that easy. This study has been conducted to prove that supplemental oxygen is not necessary for healthy parturients during cesarean section.

Supplemental oxygen has been routinely given to parturients because doctors were concerned about desaturation. However, the evidences for giving oxygen was not strong, and the condition nowadays can be detected immediately with pulse oximeter which is a standard monitoring.

After this study finished, we will set a safety guideline for supplemental oxygen for healthy parturients undergoing elective cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* Aged \> 18 years old.
* Term pregnancy (gestational age 37 -42 weeks).
* Singleton
* Elective cesarean section.

Exclusion Criteria:

* History of infertility
* Diabetes
* Hypertension or preeclampsia
* Heart disease
* Morbid obesity
* Premature rupture of membrane
* Placenta previa
* Preoperative oxygen saturation \< 95%
Cerebrovascular Dysregulation in Chronic Kidney Disease

The purpose of this study is to test whether or not regular exercise training may improve brain blood flow regulation in patients with chronic kidney disease (CKD).

Prior research has shown that CKD patients have an increased risk of stroke and that impairments in brain blood flow regulation predict stroke in other chronic disease states. This study will test whether exercise training can improve brain blood flow regulation via improved dynamic cerebral autoregulation and cerebrovascular carbon dioxide reactivity in CKD. Participants will undergo exercise training on a stationary bicycle, or stretching exercises, 3 times per week for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

• Individuals with chronic kidney disease stages III-IV.

Exclusion Criteria:

* Heart failure
* Chronic obstructive pulmonary disease
* Uncontrolled hypertension or hypotension
* Pregnancy or plans to become pregnant
* Inability to exercise on a stationary bicycle
* Current participation in exercise more than 20 minutes twice per week
Dataglove to Measure Joint Stiffness in Patients With Arthritis

This study will investigate if an electronic dataglove can be used to measure joint stiffness in patients with Rheumatoid Arthritis.

We will use a dataglove to record joint movements in a small number of patients with rheumatoid arthritis. The aim of the study is to find out if changes in dynamic movements measured by the glove will correlate with symptoms of joint stiffness in the hands of patients with rheumatoid arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 to 80
* Diagnosis of Rheumatoid arthritis
* Patients who have significant pain and stiffness in their hands
* Correct hand size to achieve a good fit to the dataglove
* Able to follow instructions for use of dataglove/computer

Exclusion Criteria:

* Severe pain in the right hand
* Severe swelling in the right hand (rated as such by the investigator)
* Severe permanent deformity or loss of function in the fingers of the right hand
* Broken or infected skin in the right hand
* Known to have been MRSA positive currently or in the past
* Unable to don and doff the disposable lining glove and the dataglove without significant discomfort
* Poor fit for the disposable lining glove or the dataglove
* History of latex allergy
Survival and PN Dependence in SBS Patients

Short bowel syndrome (SBS) is a rare condition resulting from the loss of portions of the small intestine, and can cause a spectrum of metabolic and physiologic disturbances.The objective of this study was to determine the longterm survival and parenteral nutrition dependence of adult patients with SBS.

Short bowel syndrome (SBS), the most common form of intestinal failure, is a rare condition resulting from the loss of portions of the intestine, typically because of extensive surgical resection or loss of intestinal function. Patients with SBS often stuffer from intestinal insufficiency or intestinal failure because they are unable to maintain fluid and nutrient balances on a normal diet. SBS can cause various metabolic and physiologic disturbances. Although parenteral nutrition is a life-saving measure for many patients with SBS, patients with SBS is associated with decreased survival and parenteral nutrition (PN) dependence. Few studies have reported the survival and PN dependence in adult SBS patients in China.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients diagnosed with SBS.

Exclusion Criteria:

* age \<18 years; patients with active malignant tumors.
Bioequivalence Study of Doxazosin 4 Mg Orally-Disintegrating Tablet With Or Without Water To Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition

To test bioequivalence of Doxazosin 4 Mg Orally-disintegrating Tablet with Or Without Water to Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition


Eligibility Criteria:
Inclusion Criteria:

* Japanese healthy male subjects

Exclusion Criteria:

* Baseline orthostatic hypotension defined as a ≥20 mm Hg reduction in SBP, a ≥10 mm Hg reduction in DBP and/or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.
Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus

Epicardial fat thickness, carotid intima-media thickness, and augmentation index from arterial stiffness indicators are increased in children with T1DM compared to the healthy control group. These results support the idea that children with T1DM present significant changes in important subclinical indicators for the development of cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

1. type T1DM patients
2. body mass index (BMI) between the 5th and 85th percentile according to age and gender
3. having T1DM for at least 2 years
4. ages 8-18 years

Exclusion Criteria:

1. having any chronic diseases other than T1DM
2. presence of a congenital and/or acquired heart disease, hypertension etc.
Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain

Lumbar spinal fusion was introduced approximately 70 years ago and has evolved as a treatment option for symptomatic spinal instability, spinal stenosis, spondylolisthesis, and degenerative scoliosis.

Many techniques evolved since then, from wiring, rods, pedicle screws, and recently inter-spinous fixation devices like the Aspen. Along its evolutionary trail, various methods for achieving circumferential fusion have arisen. Distinct from staged anterior/posterior fusion techniques, two methods of achieving an interbody fusion from a posterior approach have emerged: posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF). Recently, the lateral approach for interbody fusion (XLIF) has became a more common technique, requiring in some cases, complemental posterior fixation with pedicle screws, facet screws or interspinous fixation devices like the Aspen device.

In this study, we address the clinical and radiological outcome of a novel technique using standard PLIF interbody fusion and insertion of the Aspen device via posterior lumbar approach.


Eligibility Criteria:
Inclusion Criteria:

* Oswestry Disability Index score \>30%
* Diagnosis of low back pain and/or radicular pain associated to spinal instability
* Diagnosis of low back pain and/or radicular pain associated to degenerative disc disease
* Elective single level surgery
* Signed informed consent form

Exclusion Criteria:

* Previous surgery with complete laminectomy, pars defect, etc
* Patients that during the surgery requires complete laminectomy at level of the surgery
* Structural lesion to facet joints
* Osteoporosis
* Systemic or local infection
* Pregnant or planning to become pregnant
Video Gaming Improves Robotic Surgery Simulator Success

Investigators aimed to investigate the effects of video game habits, duration of experience, and training in different surgical clinics on the success of robotic surgery simulators.

In this prospective, observational, comparative, and multi-clinic study, all participants played the Temple Run and Piano Tiles 2™ mobile games for one month after responding to a questionnaire including their sociodemographic characteristics, surgical experience, and past and current video game experience. At the end of the study period, participants experienced four different robotic surgery simulator tasks (Camera Targeting 1, Energy Switching 1, Ring \& Rail 2, Vertical Defect Suturing) in the da Vinci® Skills Simulator™. Additionally, sociodemographic data were statistically analyzed with mobile game scores, and 13 different performance scores were obtained from the simulator.


Eligibility Criteria:
Inclusion Criteria:

* To be a physician trained in Surgery in the Department of General Surgery. Pediatric Surgery and Urology.
* To be an assistant and specialist of the departments with robotic surgery experience.
* To be acquainted with laparoscopic surgery.
* Having played video games.

Exclusion Criteria:

* Participation in our study is on a voluntary basis and we have no criteria other than physicians who want to leave the study voluntarily.