cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Interbody Cage Insertion in Treatment of Lumbar Disc Prolapse

Comparison between discectomy alone and interbody cage insertion in treatment of lumbar disc prolapse

Discectomy for lumbar disc herniation is one of the most common operation performed worldwide for lumbar-related symptoms. The basic principle of the various techniques is to relieve the nerve root compression induced by the herniation. Over the past 30 years, many technical improvements have decreased operative trauma by reducing incision size, thereby reducing postoperative pain and hospital stay and time off work, while improving clinical outcome. Magnification and illumination systems by microscope and endoscope have been introduced to enable minimally invasive techniques. Lumbar interbody fusion using cages has gained momentum in the recent years after approval of the cages by the FDA (United States Federal Drug Administration) for lumbar interbody insertion. The indications for this procedure remain controversial and include mechanical low back pain, degenerative disc disease, recurrent disc herniation, spondylolisthesis (grade I). In degenerative disc disease or following surgical discectomy, segmental stenosis occurs due to a combination of disc herniation, posterior osteophyte formation, facet overriding and hypertrophy and ligamentum flavum hypertrophy. All these factors combine to compromise the nerve root as it exits through the intervertebral foramen resulting in recurrent radiculopathy. In such cases, Lumbar inter body fusion using cages can open up the intervertebral foramen by maintaining or restoring disc height. On the other hand, there is considerable controversy surrounding the effectiveness of lumbar fusion for the treatment of low back pain. Among the different surgical approaches available, with or without instrumentation, none can be considered the "gold standard". The technique and results of inter body fusion were first reported by Cloward. It did not, however, gain widespread acceptance due to technical difficulties. Insertion of a rectangular bone graft makes it difficult to avoid nerve root trauma resulting in radicular deficit or irritation and dural tears. Non-union or bone graft extrusion were reported as well as bone graft collapse with subsequent segmental stenosis.In the past few years, rigid cages housing autogenous bone have become increasingly popular for the purpose of interbody fusion. Their ease of insertion has decreased the technical difficulties of the earlier Cloward approach and makes the procedure more reproducible. The rigidity of the cages also allows for the preservation of the disc space. Cages are available in a wide variety of shapes and designs, the most common being the cylindrical and rectangular wedge shaped cages.

Eligibility Criteria:
Inclusion Criteria:

* Patients with lumbar disc prolapse one or two levels.
* Patients (age \>18 and \< 70 years old).
* Patients fit for surgery.

Exclusion Criteria:

* Patients with instability of lumbar spine.
* Patients with degenerative diseases.
* More than two levels
* Patients \<18 or \>70 years.
* Patients unfit for surgery.
A Randomized, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.

This study is to compare two Virtual Reality (VR)-based interventions, BVR-100 and BES-100, for the treatment of Social Anxiety Disorder (SAD).


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female, aged 18 or above.
* Subject has English fluency and literacy.
* Subject meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5) criteria for Social Anxiety Disorder
* Subject has a total Liebowitz Social Anxiety Scale (LSAS) score at Screening of ≥ 70.

Exclusion Criteria:

* Subject has significant visual, auditory or balance impairment
* Subject has history of photosensitive epilepsy or seizure disorder
* Subject has history of motion sickness or medical condition predisposing to nausea or dizziness.
* Subject has injuries, inflammation or infection affecting the eyes, ears or face that would make the use of the hardware uncomfortable.
* Subject has, current or lifetime history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, major neurocognitive disorder, neurodevelopmental disorder of greater than mild severity or of a severity that impacts the subject's ability to consent, follow study directions, or otherwise safely participate in the study; posttraumatic stress disorder, major depressive disorder (MDD) with psychotic features, borderline or antisocial personality disorder
* Subject has met DSM-5-based criteria for Alcohol or Substance Use Disorder (other than nicotine or caffeine) within one (1) year prior to Screening.
* Subject has received ketamine, esketamine, arketamine, or psychedelic therapies (eg, psilocybin, methylenedioxymethamphetamine \[MDMA\]) for MDD or any psychiatric condition within one (1) year prior to Screening.
* In the opinion of the Investigator: (a) study participation may pose a significant or undue risk to the subject; (b) the subject is unlikely to successfully complete all of the requirements of the study per protocol; or (c) study participation may adversely impact the integrity of the data or the validity of the study results.
Serum Biomarkers in Parkinson's Disease at Different Stages

* Determine clinical characteristics of parkinsonian patients in various stages of disease;
* Measure peripheral neurodegeneration, synaptic, and inflammation biomarkers in a population of parkinsonian patients at various stages of disease.
* Measure vesicular neurodegeneration, synaptic and inflammation biomarkers


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with idiopathic PD according to Movement Disorders Society (MDS) criteria;
* Age: 18-80 years;
* Signature of informed consent to participate in this study

Exclusion criteria.

* Women pregnant
* Inflammatory or autoimmune diseases
Dermal and Gynecological Acceptability (Irritability and Sensitization in the Genital Mucosa) of an Investigational Product and Evaluation of Moisture Efficacy by TEWL and Perceived Efficacy.

To evaluate the safety of an investigational product through the verification of signs of irritability and sensitization of the genital mucosa, as well as the instrumental moisturizing efficacy by TEWL and barrier integrity analysis, in addition to the efficacy perceived by the volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female sex with active sex life;
* Age group: between 45 and 65 years old;
* Menopause for at least six months;
* Whole skin in the region of product analysis;
* No history of reaction to products of the same category
* Understanding, agreement and signature of the Term of Free and Informed Consent.

Exclusion Criteria:

* Gestation or risk of gestation;
* Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study);
* Active cutaneous pathologies (local and / or disseminated) in the evaluation area;
* Pathologies that cause suppression of immunity, such as diabetes, HIV, etc.;
* Endocrine pathologies such as thyroid disorders, ovarian or adrenal gland disorders;
* Any infection in the region of analysis of the product diagnosed at the time of inclusion;
* Other conditions considered by the investigating physician as reasonable for disqualification of the individual from the study participation.
A Multicenter, Randomized, Open Label Trial of a New Animal Extracted Surfactant to Treat RDS in Preterm Infants

The purpose of this study is to determine the efficacy and safety of the new pulmonary surfactant produced by Butantan Institute among premature infants with gestational age below 34 weeks with RDS, comparing to the pulmonary surfactants commercially available in Brazil.

Exogenous surfactant replacement therapy has been one of the major advances in the treatment of premature infants with respiratory distress syndrome (RDS). It has decreased the mortality among premature infants with RDS, determining changes in the children mortality rates among the developed countries. High cost, however, has been a major handicap for its wide use in developing and underdeveloped countries. Based on that, Butantan Institute (Sao Paulo, Brazil) has developed a new porcine pulmonary surfactant preparation at lower production cost. Initial animal studies showed similar improvement in lung mechanics and histopathologic findings to those observed with commercially available preparations.

Comparison(s): The new surfactant developed and produced by Butantan Institute will be compared to the commercially available pulmonary surfactants in Brazil, regarding to the efficiency to maintain a good arterial oxygenation, low airway pressures after treatment, similar mortality rates, and similar rates of complications like bronchopulmonary dysplasia and pulmonary hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age below 34 weeks
* RDS diagnosis based on clinical and RDS radiographic patterns
* Need of mechanical ventilation
* Parental consent

Exclusion Criteria:

* Age greater than 24 hours
* Major congenital malformations
* Unstable hemodynamic status
* Occurence of seizure during the stay in the Neonatal Intensive Care Unit
* Maternal and/or fetal infection (chorioamnionitis: maternal fever, foul vaginal discharge, fetal tachycardia, uterine tenderness, leukocytosis or leukopenia) or congenital infection
Functional Review of Distal Biceps Re-Insertion

This study seeks to test the hypothesis that endobutton repair of the ruptured distal biceps successfully restores elbow function.


Eligibility Criteria:
Inclusion Criteria:

* primary distal biceps repair with endobutton
* at least two years from date of surgery

Exclusion Criteria:

* any ipsilateral wrist, forearm, or elbow condition
* any contraindication to having an MRI
Patent Ductus Arteriosus (PDA) Screening Trial

The ductus arteriosus directs blood away from the pulmonary circulation and toward the systemic circulation during fetal life, then closes after birth. In preterm infants the incidence of spontaneous closure decreases with gestational age. Patent ductus arteriosus (PDA) increases the risks of bronchopulmonary dysplasia (BPD) and necrotizing enterocolitis (NEC). However, this association may not be a causal relationship.

Echocardiography is required to diagnose PDA. However, routine screening echocardiograms lead to detection of asymptomatic PDAs, for which the benefit of therapy remains unproven.

A randomized controlled trial has been designed in which 88 infants with birth weight less than or equal to 1250 grams and gestational age less than or equal to 30 weeks will be enrolled. The investigators' goal is to determine how screening echocardiography influences clinical management and outcomes in these infants.


Eligibility Criteria:
Inclusion Criteria:

* birth weight less than or equal to 1250 grams
* gestational age less than or equal to 30 weeks
* postnatal age less than or equal to 72 hours
* have a guardian or acceptable surrogate capable of giving consent on his/her behalf

Exclusion Criteria:

* not considered viable
* dysmorphic features or congenital malformations that adversely affect growth
* have known or suspected congenital heart disease (other than PDA)
Inhibition of Ovulation, Patch, Ethinylestradiol and Gestodene

Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers

Study was suspended due to inconclusive toxicology findings regarding the used patch formulation to be clarified prior to re-start of the study.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent,
* BMI: 18 - 30 kg/m²,
* Healthy female volunteers,
* Age 18-35 years (smoker not older than 30 years, inclusive),
* Ovulatory pre-treatment cycle, at least 3 month since delivery,
* Abortion or lactation before the first screening examination,
* Willingness to use non-hormonal methods of contraception during entire study

Exclusion Criteria:

* Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/arterial thromboembolic disease
* Regular intake of medication other than OCs
* Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination)
* Anovulatory pre-treatment cycle
Effect of Liking on Fruit Intake

Increased dietary variety has been shown to increase intake in animals, as well as humans, as compared to a diet or meal composed of one food. While most studies investigating dietary variety have focused on energy-dense foods (i.e., snack foods) and have emphasized the negative component that variety has on intake, very little research has been conducted with variety to determine if this food characteristic can be used to increase consumption of healthy foods (i.e., fruits). We hypothesize that increasing variety of fruits provided in an eating bout will lead to increased intake of these foods. Therefore, the aim of this investigation is to test the environmental factor of variety on fruit intake in males and females aged 18 to 45 years.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking
* Non-obese
* Unrestrained males and females

Exclusion Criteria:

* Health condition or use medications that influence food intake
* Require specialized diet therapy
* Following a weight loss diet, an athlete, or pregnant or breastfeeding
* Have allergies or aversions to foods used in study
* Report being a binge eater
Expanded Access Program With Nivolumab Therapy for Treatment of Advanced/Metastatic SqNSCLC or Non-SqNSCLC After One Prior Systemic Regimen

The purpose of this study is to provide treatment with nivolumab, a fully human monoclonal antibody, to subjects who have relapsed after treatment with a minimum of 1 prior systemic treatment for advanced or metastatic squamous (Sq) or non-squamous (non-Sq) non-small cell lung cancer (NSCLC) , Stage IIIB/IV and whose physicians believe that nivolumab treatment is appropriate.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Sq or Non-Sq NSCLC, Stage IIIb/IV (histologically or cytologically confirmed)
* Relapsed after 1 prior platinum-based systemic treatment
* Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2
* CNS metastasis must be treated and returned to baseline at least 2 weeks before first dose of nivolumab and off steroids or using stable or decreasing dose of \< 10 mg prednisone or equivalent
* Prior chemotherapy, Tyrosine Kinase Inhibitor (TKI) therapy or Immunotherapy (tumor vaccine, cytokine or growth factor to control cancer) must be completed at least 2 weeks before first nivolumab dose

Exclusion Criteria:

* CNS metastases (untreated and/or symptomatic)
* Carcinomatous meningitis
* ECOG Performance status \> 3
* Corticosteroids \> 10 mg prednisolone/day (or equivalent)
* Prior treatment with anti-PD-1, anti-PD-L-1, anti-PDL2, anti-CT137 or anti-CTLA antibody, including ipilimumab or any other drugs specifically targeting T cell costimulation or checkpoint pathways
Impact of Residual Renal Function on Complications in Chronic Hemodialysis Patients

Our aim is to study the impact of residual renal function on hemodialysis patients mortality and morbidity .

Chronic kidney disease (CKD) is a progressive loss in renal function over a period of months or years. As kidney function declines, there is progressive deterioration in mineral homeostasis manifesting as disruption of serum and tissue concentrations of phosphorus and calcium (Ca), as well as changes in circulating levels of hormones such as parathyroid hormone (PTH). These mineral and endocrine functions are critically important in the regulation of both initial bone formation during growth (bone modeling) and bone structure and function during adulthood (bone remodeling) Residual renal function (RRF) plays an important role in maintaining fluid balance, phosphorus control, nutrition, and removal of middle molecular uremic toxins. Decline of RRF also contributes significantly to anemia, inflammation, and malnutrition in patients on dialysis.

Inflammation and activation of acute-phase responses are common in chronic kidney disease patients.

The causes of inflammation in HD patients are multifactorial. Inflammatory reaction may originate from several sources, including graft or fistula infections, bioincompatible dialysis membrane, dialysate, endotoxin exposure, back filtration, chronic infections, and malnutrition. High-sensitivity C-reactive protein (hsCRP) assay is useful for sensitive detection of the inflammatory state.

Residual renal function (RRF) in patients with end-stage renal disease (ESRD) receiving renal replacement therapy is defined as the ability of native kidneys to eliminate water and uremic toxins. In clinical practice, it is considered synonymous with such parameters as daily diuresis and/or glomerular filtration rate (GFR). The optimal method to measure RRF has not been established . RRF remains important even after beginning of dialysis. RRF contributes significantly to the overall health and well-being of patients on dialysis Residual Renal (RRF) plays an important role in maintaining fluid balance, phosphorus control, nutrition, and removal of middle molecular uremic toxins and shows inverse relationships with valvular calcification and cardiac hypertrophy in patients on dialysis.

Decline in RRF also contributes significantly to anemia, inflammation, and malnutrition in patients on dialysis . RRF may allow for a reduction in the duration of hemodialysis (HD) sessions and the need for dietary and fluid restrictions in both patients on peritoneal dialysis (PD) and patients on HD. More importantly, the loss of RRF is a powerful predictor of mortality. Much of RRF is lost during the first 18 months of HD, and appears to depend on the primary cause(s) of kidney failure as well as on other patient-related and treatment-related factors

Eligibility Criteria:
Inclusion Criteria:

* Chronic renal failure patients on maintenance hemodialysis after at least six months.

Exclusion Criteria:

1. Obstructive uropathy.
2. Heart failure.
3. Chronic liver disease( decompensated liver cirrhosis and ascites).
Opioid-free Anesthesia in Thyroidectomies

The aim of this study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus fentanyl analgesia in elective thyroidectomies. Recovery parameters and nociception levels throughout the operation will be evaluated

In the usual anesthetic practice opioids are often administered in the perioperative period for intraoperative analgesia to control the nociceptive pathway of pain and post-surgical pain management. However, in recent years, opioid Free Anesthesia (OFA) has become increasingly popular, in which opioid administration is avoided intraoperatively and minimized or avoided in the postoperative period.

Opioid-free anesthesia (OFA) has been shown to decrease postoperative complications associated with opioids, include sedation, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression.

Therefore, the investigators aim to perform this study to determine a goal-directed approach, which targets adequate antinociception (e.g., by measuring nociceptive/antinociceptive balance) that could reduce the negative effects of excessive drug infusion, prevent postoperative pain and improve patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* American Society of Anesthesiologists (ASA) classification I-II
* elective thyroidectomy

Exclusion Criteria:

* body mass index (BMI) \>35 kg/m2
* contraindications to local anesthetic administration
* systematic use of analgesic agents preoperatively
* chronic pain syndromes preoperatively
* neurological or psychiatric disease on treatment
* pregnancy
* severe hepatic or renal disease
* history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
* bradycardia(\<55 beats/minute)
* drug or alcohol abuse
* language or communication barriers lack of informed consent
A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily

The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult subjects.

ING113086 is a Phase 3 randomized, double-blind, double dummy, active-controlled, multicenter, study conducted in approximately 788 HIV-1 infected ART-naïve subjects. Subjects will be randomized 1:1 one of the following treatment arms:

1. GSK1349572 50 mg once daily (approximately 394 subjects) + fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC)

   OR
2. 400 mg RAL twice daily (approximately 394 subjects) + fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC)

Analyses will be conducted at 48 weeks and 96 weeks. Subjects randomized to receive GSK1349572 and who successfully complete 96 weeks of treatment will continue to have access to GSK1349572 through the study until either it is locally available, as long as they continue to derive clinical benefit.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship

Eligibility Criteria:
Inclusion Criteria:

* Screening plasma HIV-1 RNA ≥1000 c/mL
* Antiretroviral-naïve (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection)
* Ability to understand and sign a written informed consent form
* Willingness to use approved methods of contraception to avoid pregnancy (women of child bearing potential only)
* Age equal to or greater than 18 years

Exclusion Criteria:

* Women who are pregnant or breastfeeding;
* Active Center for Disease and Prevention Control (CDC) Category C disease
* Moderate to severe hepatic impairment
* Anticipated need for HCV therapy during the study
* Allergy or intolerance to the study drugs or their components or drugs of their class
* Malignancy within the past 5 years
* Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
* Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any immunomodulator within 28 days of Screening
* Exposure to an agent with documented activity against HIV-1 in vitro or an experimental vaccine or drug within 28 days of first dose of study medication
* Primary viral resistance in the Screening result
* Verified Grade 4 laboratory abnormality
* ALT \>5 xULN
* ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with \>35% direct bilirubin);
* Estimated creatinine clearance \<50 mL/min
* Recent history (≤3 months) of upper or lower gastrointestinal bleed