cyrilzakka/clinical-trials huggingface dataset:
Retro Comparison of Subsidence Following Interbody Devices in Lumbar Spine

The objective of this retrospective study is an investigational clinical follow-up, of patients treated with interbody fusion devices (IBFD), both expandable (EXP) and static (STC), according to their intended use and cleared labeling to understand IBFD design and technique characteristics that affect occurrence rates of subsidence.

Patients treated with IBFD's (both EXP and STC) according to their intended use and cleared labeling

1. EXP IBFD's that expand in width and height demonstrate reduced occurrence of subsidence post-operatively when compared to EXP IBFD's that expand in height only and STC IBFD's.
2. EXP IBFD's that are comprised of multi-material composition with Polyetheretherketone (PEEK) endplate contacting surfaces demonstrate reduced occurrence of subsidence on post-operative radiographs when compared to EXP and STC IBFD's that are primarily comprised of Ti with Ti endplate contacting surfaces.
3. achieve radiographic fusion at a rate consistent with the state-of-the-art
4. achieve significant improvements in pain and function compared to baseline
5. experience adverse events at a frequency comparable to reported rates for TLIF or PLIF surgery
6. not demonstrate any intraoperative complications during the implant process
7. operative approach does not correlate with increased rates of subsidence


Eligibility Criteria:
Inclusion Criteria:

1. The patient was treated with TLIF or PLIF surgery using the IBFD according to the cleared labeling, based on the surgeon's clinical judgment and patient-specific decision making. Based on the product labeling, the patient must:

1. Was at least 18 years of age and skeletally mature at the time of surgery
2. Had clinical and radiological evidence of DDD of the lumbar spine
3. Undergone treatment with the IBFD with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone at 1 or 2 contiguous levels from L2 to S1

Exclusion Criteria:

1. History of fusion surgery or large laminectomy at L2 to S1 prior to treatment with the IBFD(s) Spondylolisthesis unable to be reduced to grade 1 as part of the surgical procedure
2. Surgery with the IBFD(s) at more than 2 contiguous levels
3. Surgery with the IBFD(s) at levels outside the range of L2 to S1
4. Treated with any bone grafting material other than autogenous or allogenic bone graft in the device(s) or surrounding disc space
5. Any contraindications listed in the cleared product labeling
6. Osteoporosis, Other Systemic Bone D.O. T score ≤ -1.5
7. BMI \> 40
8. Systemic Infection
9. H/O IV Drug Use
10. Cancer
Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy

In the literature there is conflicting data on administration of local analgesia in addition to the general anesthesia to the trocar sites during laparoscopy, We believe that adding local analgesia to the general anesthesia during laparoscopy is beneficial . the current study will evaluate prospectivly the impact of local analgesia on postoperative pain and recovery in patients undergoing operative laparoscopy

Methods: this is a blinded prospective randomized study. After approval of IRB and informed consent 120 patients undergoing for laparoscopy will be randomized after the induction of general anesthesia into three groups: Group A will receive preemptive analgesia using 3-5 cc of 0,5 % marcaine at the beginning of the procedure. Group 2 will receive a local analgesia using 3-5 cc marcaine at the end of the procedure. Group 3 will be operated under general anesthesia only. The post operative pain and patient recovery will be assessed by the nurses during the hospitalization using a VAS (Visual Analog Scale) the total analgetic drugs will be noted and after the patients discharge the patient status and satisfaction will be evaluated by phone up to 2 wks

Eligibility Criteria:
Inclusion Criteria:

* Female older then 18 y/o

Exclusion Criteria:

* Allergy to marcaine
Determining the Etiology of Febrile Neutropenia Using the Karius Sequencing-based Infectious Disease Diagnostic Assay

Prospective, observational study at Stanford University Hospital comparing the Karius Infectious Disease Diagnostic Sequencing Assay to the Final Microbiologic Diagnosis in Patients with Fever and Neutropenia.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Are or will be admitted to Stanford University Hospital for fever and neutropenia
* Neutropenia - an absolute neutrophil count of \<500 per cubic mm
* Documented fever or report of fever ≥38.3 or ≥38.0 on two episodes separated by at least one hour, resulting in hospitalization for febrile neutropenia

Exclusion Criteria:

* Inability to understand instructions and comply with study-related procedures
* Any condition that in the opinion of the treating physician will prevent the subject from completing the study
4 Week, Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease

The primary purpose of the study is to determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil for 4 weeks in patients with mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* history of progressive worsening of memory and other cognitive functions for at least 12 months
* treatment with stable dose of donepezil (10 mg) for at least 3 months
* the patient should have an appropriate caregiver, who is required for all study visits

Exclusion Criteria:

* history of allergy/hypersensitivity reactions
* significant neurological disease or dementia other than Alzheimer's disease
* myocardial infarction or acute coronary syndrome within the last year
BPD Saturation TARgeting

Bronchopulmonary dysplasia (BPD), or chronic lung disease of prematurity, affects nearly half of extremely preterm infants.This study evaluates the use of supplemental oxygen to manage infants with established BPD. Participants will be randomly placed in either a higher oxygen saturation group or a lower oxygen saturation target group.

Bronchopulmonary Dysplasia is diagnosed only in babies who are born prematurely, and affects about half of extremely preterm infants. The incidence of BPD has increased over time. It is most commonly defined as oxygen dependence at 36 weeks postmenstrual age (PMA).

Infants with BPD face more than doubled odds of death after 36 weeks PMA or disability at 5 years compared to preterm infants without BPD. BPD is associated with abnormal lung function throughout childhood and significantly increases health care costs. Cognitive and respiratory outcomes are closely linked throughout the life course; thus, optimal long--term management of BPD during infancy may ultimately improve cognitive outcomes of this high--risk population.

Supplemental oxygen is a lifesaving therapy for premature infants; yet, there is limited evidence about the safety or efficacy of using supplemental oxygen to target higher versus lower oxygen saturations in infants with established BPD.

Infants between the ages of 34-44 weeks post-menstrual age with moderate or severe BPD will be randomly assigned to higher or lower oxygen saturation target ranges. The study intervention will begin in the hospital and will continue at home until 6 months corrected age. When infants are discharged with supplemental oxygen, this will be titrated according to a study algorithm in order to ensure that the target saturations are maintained throughout the study period.

Eligibility Criteria:
Inclusion Criteria:

* Pre-term males or females infants born at \<30 0/7 weeks gestation at birth
* Current age 34 0/7 to 43 6/7 weeks postmenstrual age
* Diagnosis of moderate or severe Bronchopulmonary Dysplasia based on the NIH consensus definition
* Infant has never been discharged to home from the hospital

Exclusion Criteria:

* Congenital anomaly or oncologic process likely to affect growth or respiratory status
* Hemoglobinopathy or other blood disorder likely to affect oxygen saturations
* Contraindication to nasal cannula use (for example, severe nasal septal breakdown).
* Pulmonary hypertension requiring pharmacotherapy at the time of screening/enrollment.
* Tracheostomy
* Intubated during entire eligibility period
A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction

Adverse reactions of simvastatin are mostly slight and transient, however, the incidence of simvastatin-induced hepatic impairment and myopathy are obviously higher in Chinese population than other racial groups. There is still lack of research data in Chinese. In this study, we will investigate whether there are specific genotypes which may predict the incidence of simvastatin-induced hepatic impairment and myopathy in Chinese so as to provide a basis for developing guidelines on precise medication in simvastatin therapy apply to Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* Patients taking simvastatin therapy
* Signed informed consent.

Exclusion Criteria:

* Patients not taking simvastatin therapy
* Intolerance or unwillingness to blood sample collection.
Biodiversity Interventions for Assisted Living Centers

Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities, which weakens the functionality of the urban ecosystems and the well-being of citizens. This may also increase the risk of immune-mediated disorders among urban dwellers.

In Biodiversity interventions for assisted living centers (BIWE 2), microbial biodiversity interventions are performed to increase biodiversity in urban housing units for people with autism spectrum disorder, disabled people and elderly. Results from the intervention trials are combined with publicly available land cover and ecological data. These are analyzed from the viewpoint of shifts in ecosystems and human well-being and immune regulation, ecological quality, and urban planning.

The investigators set up an intervention study in which yards of the housing units are rewilded with diverse vegetation and decaying deadwood and plant residuals. The investigators aim to evaluate the effect of rewilding, and yard management practices on commensal microbiome, cortisol levels and well-being and salivary cytokine levels, and gene pathways.

Our specific aims are:

To assess if rewilding diversifies health-associated skin microbiota and is associated with salivary cytokine levels, gene pathways, cortisol levels and commensal microbiota.

Assess whether there are patterns in the microbiome associated with the salivary cytokine levels and hair cortisol levels.

Assess whether rewilding affects health and psychological measures. The investigators will recruit approximately 36 study subjects living in assisted housing units in urban areas and aged between 18-82.

Eligibility Criteria:
Inclusion Criteria:

* Person lives in assisted living center

Exclusion Criteria:

* Immunosuppressive medications
* Immune deficiencies
* a disease affecting immune response (colitis ulcerosa, rheumatoid arthritis, Crohn's disease, diabetes)
* cancer diagnosis within the last year or on-going cancer treatment
Polyglucosamine L112 in Overweight and Obese Subjects

This research proposes as its main purpose to evaluate the effectiveness of the intake of Polyglucosamine at a dose of 3 g / day on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 kg / m2). and with weight\> 75 kg


Eligibility Criteria:
Inclusion Criteria:

* weight \> 75 Kg
* absence of previous diet therapy attempts
* no fluctuation of at least 3 kg in the previous 3 months
* Beck Depression Inventory score \< 20 pt
* Binge Eating Scale score \< 27 pt

Exclusion Criteria:

* allergy to shellfish
* pregnancy or breast feeding
* presence of cardiopathies, nephropathies, liver diseases, bronchopneumopathies, haemopathies, dermopathies, chronic-degenerative diseases of the Central Nervous System
* presence of active peptic ulcer, ulcerative colitis, Crohn's disease, celiac disease, inflammatory bowel disease
* symptomatic cholelithiasis
* previous or current neoplasms
* epilepsy
* obesity secondary to endocrinopathies or genetic syndromes
* significant motor disability or mental retardation
* major depressive disorder, bulimia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar disorder (I or II), schizophrenia
* previous history or current diagnosis of drug abuse or alcoholism
* changing in smoking habits or quitting smoking in the last 6 months
* current use or in the last 3 months of psychoactive drugs or current use or in the last 12 months of drugs affecting body weight or appetite
Vancomycin Dosage Adjustment for MRSA Infections

An open-label randomized controlled trial to compare two vancomycin dosage adjustment methods

An open-label randomized controlled trial to compare two vancomycin dosage adjustment methods; a vancomycin trough concentration method and a equation-based method.

Eligibility Criteria:
Inclusion Criteria:

1. Thai hospitalized patients, age\>18 years
2. Require vancomycin therapy ≥ 3 days
3. Documented MRSA infection including pneumonia, bacteremia, intra-abdominal infection or skin and soft tissue infection
4. Have been checked for serum creatinine within 48 hours and serum albumin within 7 days prior to enrollment
5. Received an appropriate loading dose of vancomycin
6. Have been treated with an appropriate maintenance dose of vancomycin
7. Willing to sign an informed consent

Exclusion Criteria:

1. CrCl\< 10 ml/min or receiving renal replacement therapy
2. Pregnancy or lactation
3. Actual BW\> 90 kg
4. Serum albumin \<2 g/dl
5. Having an active cancer or receiving chemotherapy
6. Hx of vancomycin allergy
Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves' Ophthalmopathy (GO)

The purpose of this study was to evaluate safety, tolerability, and pharmacodynamic parameters of RVT-1401 in graves' ophthalmopathy (GO) patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years of age.
2. Clinical diagnosis of Graves' disease with hyperthyroidism associated with active, moderate to severe GO with a Clinical Activity Score (CAS) ≥ 4 for the most severely affected eye at Screening (on the 7-item scale) and Baseline (on the 10-item scale).
3. Onset of active GO within 9 months of screening.
4. Moderate-to-severe active GO (not sight-threatening but has an appreciable impact on daily life), usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, proptosis ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
5. Other, more specific inclusion criteria are defined in the protocol

Exclusion Criteria:

1. Use of any steroid (intravenous \[IV\] or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of GO within 3 weeks prior to Screening.
2. Use of rituximab, tocilizumab, or any monoclonal antibody for immunomodulation within the past 9 months prior to Baseline.
3. Total IgG level \< 6g/L at Screening.
4. Absolute neutrophil count \<1500 cells/mm3 at Screening.
5. Participants with decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months at Screening.
6. Previous orbital irradiation or surgery for GO.
7. Other, more specific exclusion criteria are defined in the protocol
Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)

The purpose of this study is to assess the safety and efficacy of the NeuroFlo™ catheter for use in patients with ischemic stroke. The NeuroFlo device is intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.

The study is a prospective, controlled, randomized, single-blind, multi-center study of NeuroFlo treatment plus standard medical management versus standard medical management alone. Randomization will be 1:1 and stratified to ensure equivalent patient distribution between treatment and control for the following key parameters:

1. National Institute of Health Stroke Scale (NIHSS) at baseline (stratify \<10, 11-18)
2. Time from symptom onset (TFSO) to time of baseline NIHSS evaluation (stratify \<5 hrs, or ≥5 hrs).

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke
* NIHSS between 5-18
* Time from symptom onset less than 14 hours

Exclusion Criteria:

* Hemorrhagic stroke
* Certain types of heart disease
* Kidney disease
* Other conditions the doctor will assess
Behavioral Intervention to Increase Physical Activity in Patients with Asthma: Identifying Responders

To identify clinical, personal and anthropometric characteristics among patients with asthma who respond and non-responders to a behavioral intervention to increase the level of physical activity.

Adult participants of both genders with moderate to severe asthma, not physically active, will be evaluated after being informed about the study, agreeing and signing the informed consent form. After two days of evaluations, with an interval of 7 days between them, the participants will be included in a behavioral intervention program to increase physical activity for 8 weeks (once a week).

Eligibility Criteria:
Inclusion Criteria:

1. Participants not physically active;
2. Partially/uncontrolled asthma;
3. Diagnosis of asthma based on the recommendations of the Global Initiative for Asthma (GINA 2020);
4. Be under outpatient follow-up at the Pulmonology or Immunology service of the University of Sao Paulo General Hospital;
5. Be under outpatient medical treatment for at least six months, with a stable clinical condition for at least , 30 days;
6. Being using optimized drug therapy for asthma.

Exclusion Criteria:

1. Participation in another research protocol;
2. Difficulty in understanding any of the questionnaires used;
3. Practitioners of regular physical activity;
4. Pregnancy and psychiatric problems that make it difficult to understand the questionnaires and the study protocol.
Evaluation of a Novel Transfemoral Prosthetic Socket System

The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a novel prosthetic transfemoral socket system. A conventional prosthesis will be compared to the novel transfemoral socket system.

Conventional transfemoral socket designs impose an array of limitations on transfemoral amputee patients. Flexion, extension, and abduction are considerably impaired and end basic functions like sitting are usually uncomfortable or even painful. An alternative socket design that lowers the socket trim-lines and still provides structural support would greatly improve the socket comfort for transfemoral amputees.

Eligibility Criteria:
Inclusion Criteria:

* Consenting Adult
* Unilateral transfemoral amputee
* Currently suing a liner with prosthesis
* Uses a prosthesis to ambulate
* Ability to read, write, and understand English
* Available during regular business hours for appointments

Exclusion Criteria:

* Impaired contra lateral leg
* Ambulates with the aid of an additional assistive device (e.g. walker, cane, etc.)
* Diagnosis of renal failure
* Smoker
Personalized Functional Profiling in Metastatic Gastrointestinal Cancer or Recurrent Glioblastoma Patients in Luxembourg.

The investigators are developing a novel standardized and centralized approach named Integrated Personalized Functional Profiling (PFP) in Luxembourg. Based on recent improvements in cancer biopsy-derived 3D-culture technologies the PFP process will screen patient derived cells (PDCs) with FDA/EMA-approved drugs to generate personalized functional response profiles. The selected drug through PFP technology will provide personalized treatment recommendation for the patient.

This pilot study will evaluate the clinical feasibility of setting-up an effective workflow as a first step. Outcomes from this study will be used subsequently to help plan the clinical validation of the implementation of PFP.


Eligibility Criteria:
Inclusion Criteria:

* Patient with recurrent Glioblastoma (rGBM) or with metastatic gastrointestinal cancer (mGIC), i.e. adenocarcinoma (any grade) of stomach, liver, pancreas, small intestine, colon, rectum
* The patient has received previous cancer treatment for mGIC or rGBM
* Male or female ≥ 18 years
* Life expectancy ≥ 12 weeks
* Histologically or cytologically confirmed diagnosis for mGIC or recurrence of a glioblastoma, WHO grade IV
* For women of childbearing potential, a negative pregnancy test documented prior to the screening visit is required
* Signed Inform Consent Form before any study related procedure

Exclusion Criteria:

* For female patient, being pregnant, planning a pregnancy or breastfeeding
* No fresh and viable tumor material available
* Known active Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection
* Uncontrolled medical conditions (i.e, diabetes mellitus, hypertension, etc), psychological, familial, sociological, or geographical conditions that do not allow compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol
* In mGIC arm, patient with non-adenocarcinoma gastrointestinal cancer
* Patient unable to understand and consent himself
Invasive Arterio-Venous Fistula Blood Pressure Monitoring & Fluid Dynamics Study

The surgical formation of an AVF offers a unique example of vascular remodelling and adaption. Yet, the specific factors which elicit remodelling events which determine successful maturation or failure have not been unambiguously determined.

Computational fluid dynamic (CFD) simulations are increasingly been employed to investigate the interaction between local haemodynamics and remodelling and can potentially be used to assist in clinical risk assessment of maturation or failure.

However, these simulations are inextricably linked to their prescribed boundary conditions and are reliant on in vivo measurements of flow and pressure to ensure their validity. This study will compare in vivo measurements of the pressure distribution across an AVF against a representative numerical model.

Most patients with End Stage Renal Disease (ESRD) will require haemodialysis. Several studies have recognized a well-functioning Arterio-Venous Fistula (AVF) as the best modality for access in patients with ESRD undergoing haemodialysis.

A mature AVF has lower incidence of thrombosis and stenosis compared to the other two available modalities of the Arterio-Venous Graft (AVG) and Central Venous Catheter (CVC). This translates into prolonged patency rates and lower risk of infection. The use of AVF's are also associated with lower mortality, and costs.

However, significant numbers of AVFs \[20% to 60 %\] are known to fail to mature into functioning fistulas. Issues such as impaired vein remodelling, intimal hyperplasia, technical problems, unrecognized stenosis within the outflow vein, inflow problems, or steal syndromes can all lead to failure of achieving a mature AVF.

The aim of the study is to examine the relationship between the pressure gradient within the surgically formed AVF and its' maturation and functioning status.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing AVF formation surgical procedure or AVF intervention surgery.
2. Willing and capable of signing an informed consent form.

Exclusion Criteria:

1. Patients unable to provide informed consent.
2. Patients under the age of 18
3. Patients who are deemed unsuitable due to any circumstances as deemed appropriate by the P.I.