cyrilzakka/clinical-trials huggingface dataset:
Low Level Laser Therapy to Reduce Comorbidity in Spinal Surgery

Each year, more than one million individuals worldwide are submitted to laminectomies, with a failure rate higher than 40%. Postlaminectomy epidural adhesion is implicated as a main cause of ''failed back surgery syndrome'' and associated with increased risk of complications during revision surgery. The postoperative epidural scar can cause extradural compression or dural tethering, which results in recurrent radicular pain and physical impairment. Several studies in the literature are signalizing that Low-Level-Laser-Therapy (LLLT) is proven to be an effective tool to assist the inflammatory process and wound healing, as well to prevent infection. Thus, the objectives of this project are to delineate and evaluate the LLLT effects in spinal surgery. A prospective randomized, controlled trial with a total of 48 patients who underwent laminectomy, were divided into 2 groups. In the first group, 25 patients received LLLT during the surgical procedure over dura mater, over subcutaneous and on the skin, as well as 24h and 72h post surgery. In the second group, 23 patients were induced to think they will be getting the same treatment, although the laser is not operating. In those groups, C reactive protein, Lactate Dehydrogenase and Creatine kinase were evaluated in the second and fifth days after surgery, digital temperature will be measured and scores in visual analogue scale will be used, 5 minutes pre and 5 minutes post Laser application. The drainage output was collected in the first three days following surgery in both groups. Interleukins were evaluated in interstitial infiltrate drained in 24h and 48h. The data was evaluated for normality and subjected to appropriate statistical analysis, in order to seek representation, as same as the level of significance of the studied samples.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing to lumbar laminectomy

Exclusion Criteria:

* Active lumbar cancer
* Infectious disease
* Coagulation disorders
* Dural injury during the surgery
Ultra-brief Psychological Treatments for Emotional Symptoms and Disorders

The main objective of this randomized clinical trial is to study if various modalities of brief (eight sessions) and ultra-brief (four sessions) transdiagnostic cognitive-behavioral treatment work for decrease emotional symptoms and disorders, as well as to find out which variables of cognition and of the intervention process itself are involved in the therapeutic improvement.

The investigators will compare the interventions of four groups: brief group treatment (1), ultra-brief group treatment (2), ultra-brief individual treatment (3) with the ultra-brief relaxation (control) group.

The main questions the study aims to answer are:

* Will the brief and ultra-brief treatment formats works better than the relaxation-based control group?
* Will results obtained between the brief group therapy group and the ultra-brief group therapy group be similar?
* Will the individual ultra brief therapy be more effective than the two group therapies because of common factors, such as the therapeutic alliance?
* Will group therapies be more beneficial for cost and in terms of capability to reduce emocional symptoms than individual therapy? Participants will be randomly assigned to each of the groups and will receive the corresponding treatment, with different number of sessions. They will answer a series of questionnaires at the beginning and at the end of the intervention, as well as 3 months and 6 months after the end of the treatment.


Eligibility Criteria:
Inclusion Criteria:

- Patients presenting negative emotional symptomatology (anxiety, depression or somatizations), mild or moderate. Specifically, they will be included in the study if they present a score ≥ 5 on the PHQ-9, the GAD-7 or the PHQ-15.

Exclusion Criteria:

* Bipolar disorder, personality disorder, psychosis or substance abuse, indicated by SCID-5-CV
* Recent suicide attempt.
* Severe emotional symptoms (PHQ-15 or GAD-7 ≥ 15; or PHQ-9 ≥ 20).
Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis

To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in AIDS patients. Both newly diagnosed and relapsed patients are eligible.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiviral therapy such as zidovudine.
* Prophylaxis for Pneumocystis carinii pneumonia.
* Aerosolized pentamidine.

Concurrent Treatment:

Allowed:

* Radiation therapy for mucocutaneous Kaposi's sarcoma.

Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.

* No prior systemic antifungal therapy for cryptococcosis.
* Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.

Prior Medication:

Allowed:

* Antiviral therapy such as zidovudine.
* Prophylaxis for Pneumocystis carinii pneumonia.
* Aerosolized pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
* History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
* Moderate or severe liver disease defined by specified lab values.
* Patients who are unable to take oral medication.
* Unlikely to survive more than 2 weeks.
* Renal impairment.

Concurrent Medication:

Excluded:

* Coumarin-type anticoagulants.
* Oral hypoglycemics.
* Barbiturates.
* Phenytoin.
* Immunostimulants.
* Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.
* Excluded within 4 weeks of study entry:
* Greater than 1 mg/kg/wk amphotericin B.
* Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.

Concurrent Treatment:

Excluded:

* Lymphocyte replacement.

Patients with the following are excluded:

* Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
* History of allergy to or intolerance of imidazoles or azoles.
* Moderate or severe liver disease defined by specified lab values.
* Patients who are unable to take oral medication.
* Life expectancy of \< 2 weeks.
* Any condition that may impair absorption of oral medication.

Prior Medication:

Excluded:

* Coumarin-type anticoagulants.
* Oral hypoglycemics.
* Barbiturates.
* Phenytoin.
* Immunostimulants.
* Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.
* Excluded within 4 weeks of study entry:
* Greater than 1 mg/kg/wk amphotericin B.

Prior Treatment:

Excluded:

* Lymphocyte replacement.
To Predict Efficacy by Detecting Circulating Endothelial Cell Subsets and Blood Perfusion Parameters Changes in Vivo Tumor in the Phase II/III Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer

1. To reveal changes of peripheral markers and blood perfusion parameters in vivo tumor in the phase II study of anlotinib in patients with advanced non-small cell lung cancer.
2. To clarify the meaning of peripheral markers and blood perfusion parameters in vivo tumor in predicting the effect of anti-angiogenic therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Pathology diagnosed with advanced NSCLC with measurable lesions;
2. Have failed for 2 lines of chemotherapy; 3.18-70 years,ECOG PS:0-2,life expectancy of more than 3 months;

4.Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks; 5.Main organs function is normal; 6.Women of childbearing age should take contraceptive measures during the study and within 6 months after end.

Exclusion Criteria:

1. SCLC(including mixed with NSCLC);
2. The central cavity of Squamous cell carcinoma and hemoptysis with NSCLC;
3. Patients failed to use the anti-tumor angiogenesis therapy;
4. Patients have many influence factors toward oral medications ;
5. Brain metastases patients accompanied by symptoms or symptom control for less than two months;
6. Patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG\>10mmol/L);urine protein≥++,etc.
7. Patients failed to heal wounds or fractures for Long-term;
8. 4 weeks before enrollment, patients appeared NCI CTC AE grading \>1 pulmonary hemorrhage; 4 weeks before enrollment, patients who appeared NCI CTC AE grade\> 2 had other parts of the bleeding; patients have a tendency to bleed (e.g active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy such as Warfarin, heparin or its analogues;
9. Patients occurred venous thromboembolic events within 6 months;
10. Patients who have HIV-positive or organ transplantation.
The Effect of Primary Care Interventions on Children's Media Viewing Habits and Exposure to Violence

The American Academy of Pediatrics recommends that parents receive anticipatory guidance about violence prevention as part of the routine well child visit. Educational resources are needed to help physicians routinely provide these important anticipatory guidance messages. In this study, consecutive parents will be exposed to routine anticipatory guidance messages before the well child visit with the physician. After the clinic visit, parents will be invited to participate in a research study to determine if they plan any changes at home. The key research question of this study is:

Can a brief multimedia program (i.e. Play Nicely program) and/or the AAP Connected Kids brochure, entitled, "Pulling the Plug on TV Violence", help parents develop plans to decreases their children's exposure to violence in the media (e.g. less media time, no TV in the bedroom)?


Eligibility Criteria:
Inclusion Criteria:

* Participants included English and Spanish speaking caregivers of 2-12 year old children presenting to the pediatric primary care clinic for a well-child visit.

Exclusion Criteria:

* Parents who could not speak either English or Spanish.
Leukotriene Antagonism in Recruitment of CD49d Expressing Neutrophils in Atopic Subjects

The purpose of this study is to see if the recruitment of a certain cell type (the alpha 4 integrin (CD49d) expressing neutrophil) during a nasal allergen challenge can be inhibited by pretreatment with an FDA approved leukotriene antagonist (montelukast).

Subjects will be consented, undergo skin testing, medical history questionnaires, and randomized to either placebo or montelukast (10 mg). In one week, subjects return, undergo a blood draw, medical history questionnaires, nasal lavage, and nasal allergen challenge (followed by lavage in 6 hours). Subjects will then cross-over to the other study drug. One week later subjects will undergo a blood draw, medical history questionnaires, lavage, allergen challenge, and repeat lavage (after 6 hours).

Eligibility Criteria:
Inclusion Criteria:

* 21 - 65 years of age, inclusive
* A personal history of allergic rhinitis (hayfever) (by self-report)
* At least one positive skin test to cat, dust mite mix, Timothy grass, Bermuda grass, Bluegrass, or Ragweed
* Ability to provide informed consent
* Willingness to undergo epicutaneous skin testing
* Willingness to undergo nasal lavages and nasal allergen challenges
* Willingness to undergo 2 peripheral blood draws (10 cc each)

Exclusion Criteria:

* Use of systemic antihistamine in the past 5 days
* Use of intranasal corticosteroids or intranasal antihistamines currently or in the past 2 weeks
* Use of Montelukast currently or in the past week
* Hypersensitivity or allergy to Montelukast
* Inability to perform/undergo any study procedures
* Pregnancy (by subject report) or breastfeeding
* Confirmed or suspected immunodeficiency
* Persistent asthma, atopic dermatitis, or any other co-morbid disease except for allergic rhinitis
* Any symptoms of asthma in the past 2 weeks (shortness of breath, wheezing, and/or use of albuterol)
* Fever (temperature over 99F) currently or in the past 2 weeks
* Current or previous use of a biologic or investigational agent in the past 6 months
* Current or past suicidal thoughts/attempts
Trial of Sodium Valproate in Amyotrophic Lateral Sclerosis

The purpose of this study is to determine whether the use of sodium valproate is effective in slowing the disease progression in Amyotrophic Lateral Sclerosis.

Amyotrophic lateral sclerosis (ALS) is a devastating disease characterized by progressive degeneration of motor neurons leading to muscle weakness.

The pathogenesis of ALS is unknown, but there is convincing evidence that several molecular mechanisms play a role. Previous studies investigated the role of the Survival Motor Neuron (SMN) gene in ALS. Recent data suggest that SMN genotypes producing less SMN protein increase susceptibility and severity of ALS. This leads to the hypothesis that the clinical expression of ALS is influenced by the total SMN protein level in affected patients. In a population of ALS patients in the Netherlands we found that SMN genotypes producing less SMN protein appear to increase susceptibility and severity of ALS. It was shown that the HDAC inhibitor sodium valproate (SVP) increases levels of SMN protein in vitro. From these results and from data suggesting neuroprotective properties of SVP, it is hypothesised that SVP could extend survival of patients with ALS. In addition, sodium valproate significantly prolonged the disease duration in the animal model for ALS, the SOD1 transgenic mouse. Given that SVP is a FDA-approved compound with well-known pharmacokinetic and toxicity profiles, it is an attractive candidate for a clinical trial in ALS patients.

Eligibility Criteria:
Inclusion Criteria:

* Definite, probable, or probable-laboratory supported ALS according to the revised El Escorial World Federation of Neurology criteria.
* Intake of riluzole 50 mg twice a day (bid)
* A disease duration at inclusion of more than 6 months and less than 36 months \[inclusive\] (disease onset is defined as the date of first symptoms excluding muscle cramps and fasciculations)
* Vital capacity (VC%) ≥ 70% of normal value (slow expiration, best of a minimum of three and a maximum of five measurements, with a respiratory function validly assessable and a spontaneous, non-assisted ventilation)
* Ages 18 - 85 years (inclusive)
* Capable of thoroughly understanding the trial information given; has signed the informed consent.

Exclusion Criteria:

* Tracheostomy, tracheostomal ventilation of any type, non-invasive ventilation more than 16 hours/ day, or supplemental oxygen during the last three months prior to inclusion.
* Any medical condition or intoxication known to have an association with motor neuron dysfunction, which might confound or obscure the diagnosis of ALS.
* Presence of any concomitant life-threatening disease or any disease or impairment likely to interfere with functional assessment.
* Confirmed hepatic insufficiency or abnormal liver function (ASAT, ALAT greater than twice the upper limit of normal range).
Human Intestinal Microbiome and Surgical Outcomes in Patients Undergoing Colorectal Cancer Surgery

Intro: Recent studies on colorectal cancer surgery have been focusing on the role of intestinal microbiome on surgical outcomes. Standard perioperative cares, like mechanic bowel preparation (MBP), administration of antibiotics (ABT) and surgery-related stress and injury influence the microbiome composition and possibly induce a shift toward a microbiome dysbiotic state, which predisposes to complicated postoperative course. Microbiome composition changes and enhanced virulence factors may increase the risk of postoperative complications, such as anastomotic leakage (AL), surgical site infection (SSI), and postoperative ileus (PI), which are known to impact on patient's overall survival and cancer recurrence.

Objective: The primary objective is to investigate if a significant association might exist between the microbiome composition and the occurrence of postoperative complications at 90 days.

Methods: 3 different microbiome samples will be taken from all patients. Two fresh fecal samples for detection of LM and fecal water preparation: a) a day before the surgery before MBP and/or ABT (LM1), b) postoperatively after first bowel movement (LM2). One sample will be taken intra-operatively from the stapled resection lines of circular stapler used for forming a colorectal anastomosis, to detect the MAM and to perform immunohistochemistry staining for detection of HACE1 expression.

DNA analysis will be performed for all samples. IHC will be performed for detecting HACE1 expression in the tumor and colorectal anastomosis tissues using anti-HACE1 antibodies. .

For proliferation assessment, human colon carcinoma cell lines HT29 will be plated in monolayers and scratched with a single scratch. Monolayers will be incubated for 24 hours with fecal water from patients with surgical complications and matched control patients without complications.

Descriptive statistics will be performed to describe the study population. This project aim to describe microbiome composition and its impact on postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years old
* With histologically confirmed rectal or left colon adenocarcinoma by biopsy material from colonoscopy
* Having elective colorectal surgery after standardized bowel preparation
* Affiliated to a social security system
* Signature of informed consent

Exclusion Criteria:

* Major surgery 30 days before scheduled colorectal surgery
* Administration of systemic antibiotic therapy within 30 days prior to planned colorectal surgery
* Presenting a contraindication to elective colorectal surgery
* Patient protected by law
* Pregnant or breastfeeding woman
PXVX0200 (CVD103-HgR) vs Shanchol in Mali

To compare the ability of a single dose of PXVX0200 at two different dose levels, to placebo to elicit a significant antibody response 14 days after vaccination, compared to baseline.

To compare the ability of a single dose of PXVX0200 to a comparator vaccine Shanchol, a two dose administration, to elicit antibody response by 14 days after vaccination.

Currently there are two licensed inactivated vibrio oral vaccines (Dukoral® \[Crucell; Leiden, The Netherlands\] and Shanchol™ \[Shantha Biotechnics; Hyderabad, India\]) that are pre-qualified by the World Health Organization (WHO) for procurement by United Nations (UN) agencies. Each of these vaccines requires a two-dose regimen which is difficult to implement in the face of explosive outbreaks of cholera in unsettled situations in developing countries. For this reason there is great interest in identifying a cholera vaccine that can provide rapid onset of protection following the ingestion of just a single oral dose.

This Phase 2 randomized, observer-blinded and subject-blinded clinical trial to be conducted in Bamako, Mali will assess the immunogenicity of the 10\^8 cfu versus the 10\^9 cfu formulation of PaxVax-manufactured CVD 103-HgR.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand the study and give consent (either written or through a process that involves audio tapes explaining all aspects of the study and the consent form in local languages \[Bambara and French\] followed by making a mark and signature by a literate witness)
* Healthy men or women, age 18 to 45 years (inclusive) without significant medical history
* Women of child-bearing potential must have negative urine pregnancy test at baseline, prior to vaccination. They must also be willing to use adequate birth control for the duration of the 28-day study and have additional pregnancy tests if indicated. Effective methods of birth control for this study include abstinence, intrauterine device (IUD), oral or depot contraceptive, or barrier plus spermicide
* Willingness to remain in the study area until at least 42 days after receipt of the first vaccine dose

Exclusion Criteria:

* Health care workers who have direct contact with patients who are immune deficient, HIV-positive, or have an unstable medical condition
* Clinically significant history of immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurologic illness, psychiatric disorder requiring hospitalization, current drug or alcohol abuse
* History of an abnormal stool pattern or regular use of laxatives
* Previously received a licensed or investigational cholera vaccine
* History of cholera illness
Photonic Needle and Paravertebral Space Detection

For effective anesthesia and interventional pain treatments, correct needle placement is crucial. Currently used methods to guide needle placement and confirm the actual treatment location before injection of the medication include: image-guidance, loss-of-resistance, and electrical stimulation. However, accuracy of needle placement could be improved if information would be available that would complement the current methods. We have developed the so-called "photonic needle" technology based on optical spectroscopy that has the potential to provide such complementary information.

This study is an observational study in a limited number of patients. A common ultrasound-guided regional anesthesia procedure has been selected, during which data will be acquired with the photonic needles at a number of points along the needle trajectory that allow for confirmation by imaging.

Rationale for this study is to investigate the potential of the technology to discriminate tissues that are relevant to distinguish during the procedure.

The primary objective of the trial is to investigate if the photonic needle technology can reliably identify the thoracic paravertebral space. Diffuse reflectance spectra will be acquired during needle advancement, with custom-made needle stylets that contain optical fibers.

Main study parameters are:

1. Successfully acquired diffuse reflectance spectra obtained in the thoracic paravertebral space, and spectra obtained during needle advancement.
2. Confirmation of sonographic thoracic paravertebral localization, defined as tissue imaging in all locations of the needle where the diffuse reflectance spectra have been collected .
3. Recordings of reaction to a small test dose of lidocaine 2% with epinephrine 1:200.000 at target position for regional anesthesia (to exclude vascular localization of the needle)
4. "certainty score" on a 3-point scale (1 = uncertain, 2 = certain, 3 = very certain) provided by the physician for assignment of the type of tissue present at the needle tip, based on the information available from imaging and/or aspiration and/or reaction to a small injection of epinephrineOther study parameters

The endpoint of the study is a statistical analysis of the difference between diffuse reflectance spectra obtained at non-paravertebral and paravertebral measurement locations.

Eligibility Criteria:
Inclusion Criteria:

* Elective unilateral thoracic surgery
* Age between 18 and 80 years of age
* Ability and willingness to provide informed consent

Exclusion Criteria:

* Pregnancy
* Photodynamic therapy
* Contraindications to regional anesthesia and/or allergy to amide local anesthetics.
* Subjects \< 18 years of age or \>80 years of age
* Severe coagulopathy
* Subjects with severe thoracic deformities
* Subjects with contraindications to methylene blue