cyrilzakka/clinical-trials huggingface dataset:
The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Individuals With Low Back Pain

The purpose of this experiment is to determine the effects of a non-thrust manipulation procedure on muscle function, spinal mobility, and pain level on those experiencing low back pain (LBP) in a sample of individuals who identify English as their primary language. The rationale for this language criterion is provided in Section 9:F of this application. Muscle function will be measured via the muscle thickness of a deep spinal stabilizing muscle (multifidus, MF) while in both a resting state and during a maximum voluntary contraction (MVC). Spinal mobility will be measured as the active range of motion of both forward and backward trunk bending. Pain level will be a self-report measure recorded during rest and active range of motion.

Hypothesis 1: A non-thrust manipulation procedure will increase the thickness of the sacral multifidus both at rest and during a maximum voluntary contraction

Hypothesis 2: A non-thrust manipulation procedure will result in greater low back active range of motion.

Hypothesis 3: A non-thrust manipulation procedure will result in a reduction in the participant's self-reported pain levels both at rest and during active range of motion movements.

The proposed study aims to determine if the impact of a newly-described manual procedure, that includes a non-thrust force applied to the low back region, has an impact on patient centered-outcomes. Rehabilitation Ultrasound Imaging (RUSI) will be used to determine MF muscle thickness (MT) at rest and during a maximum voluntary contraction (MVC) immediately following application of the manual procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Participants are individuals with current complaint of low back pain, defined as pain that is present in the region from just below the rib cage to just below the buttocks.
2. Participants will be 18 years of age or older
3. Participants must be experiencing an episode of low back pain at the present time that is at any level on a Numerical Pain Rating Scale \& Pain Diagram (NPRS) from 1-10
4. Participants must demonstrate the ability to maintain standing and prone postures for several minutes at a time and perform lumbar active range of motion in a standing position
5. Participants must report the presence of their low back pain during performance of active forward and/or backward bending in standing
6. Participants must demonstrate the ability to communicate in conversational English, that includes speaking, reading, and writing.

Exclusion Criteria:

1. Participants who are currently involved in litigation that is directly related to the participant's current episode of low back pain
2. Participants with known or suspected pregnancy
3. Participants with confirmed diagnosis of any of the following conditions:

   * Central nervous system disorder
   * Rheumatoid Arthritis
   * Spinal Fracture
   * Spondyloarthropathy (i.e., Ankylosing Spondylitis)
   * Tumor or infection of the spine
REduction of Contrast Via DyeVert Used in CTO Procedures

The is an observational, prospective study to evaluate the effect of the DyeVert System on contrast volume administration in patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)

The DyeVert System is a disposable, FDA-approved device that interfaces with standard manifold systems to reduce the amount of contrast used in catheterization procedures, while maintaining fluoroscopic image opacity.

No study has assessed use of the system in CTO PCI. It would be expected that savings in CTO procedures may be less than non-CTO procedures due to catheter sizing and number of open guide injections required. Open guide injections through larger catheters do not provide for the as much resistance, therefore decreasing the need for contrast to be diverted

Eligibility Criteria:
Inclusion Criteria:

1. Subjects undergoing CTO PCI at each of the participating centers.
2. Contrast volume recorded during CTO PCI
3. Subjects included in the "Multicenter Registry of Chronic Total Occlusion Interventions" study (Allina IRB approval # 948134-1)

Exclusion Criteria:

None
Accuracy and Primary Stability in Immediate Implant Placement: Dynamic Navigation Versus Freehand

Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning. However, dynamic navigation's application to immediate implant placement has not been studied, and its exact role is still needed to be investigated further. Besides, implant insertion angle may influence primary stability, which is a prerequisite in achieving osseointegration, while dynamic navigation can precisely control angle and position. Therefore, the investigators designed a randomized controlled clinical trial study to verify the clinical efficacy of dynamic navigation and freehand in immediate implant placement. Patients will then be followed up one year after delivery of the crown to assess additional parameters.

Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning. However, dynamic navigation's application to immediate implant placement has not been studied, and its exact role is still needed to be investigated further. Besides, implant insertion angle may influence primary stability, which is a prerequisite in achieving osseointegration, while dynamic navigation can precisely control angle and position. Therefore, the investigators designed a randomized controlled clinical trial study to verify the clinical efficacy of dynamic navigation and freehand in immediate implant placement. Patients will then be followed up one year after delivery of the crown to assess additional parameters.

These will include the assessment of soft tissue inflammation, cytokine concentrations, microbiome, stability of the buccal bone plate.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old and in good health;
2. The maxillary incisor that cannot be retained due to non-periodontitis;
3. The buccal bone plate is complete;
4. No acute infection;
5. The extraction socket have at least 3-5 mm apical bone.

Exclusion Criteria:

1. General contraindications of oral implant surgery (such as immunodeficiency, long-term use of corticosteroids);
2. Treatments or diseases that may affect bone tissue metabolism (for example, taking bisphosphonates or receiving local radiotherapy);
3. Periodontitis history or uncontrolled periodontitis. Bleeding of probing (BOP) positive site ≥ 10%, or probing depth (PD) ≥ 4mm;
4. Heavy smokers or previous heavy smoking history (quit smoking time \<5 years or\> 20 cigarettes per day);
5. Refuse to participate in this trial.
Maxillary Sinus Grafting With Deproteinized Porcine or Bovine Bone Mineral.

The present study aimed to compare the histomorphometrically evaluated new bone formation, the radiographically measured graft stability and the clinical implant outcome between maxillary sinuses grafted either with deproteinized porcine bone mineral (DPBM) or deproteinized bovine bone mineral (DBBM). Conclusions: From a clinical point of view, the present results demonstrate that DPBM provides for comparable bone formation and stable graft dimension and high implant success rates combined with healthy peri-implant condition:

Materials and Methods: Thirty maxillary sinuses in 28 participants were initially included and randomly assigned to the test group (TG;DPBM: n=15) or the control group (CG,DBBM: n=15). After a healing period (6 months) bone core biopsies were axially retrieved in the molar site for histological/ histomorphometrical analysis of new bone formations. In addition, radiographically measured graft stability as well as the clinical implant outcome (implant survival/success/peri-implant health) were assessed at the 1-year and 3-year follow-up evaluations.

Eligibility Criteria:
Inclusion Criteria:

* maxillary sinus atrophy in the need of sinus augmentation, 2 stage augmentation procedure

Exclusion Criteria:

* drug abuse, additional augmentation procedure, heavy smokers, bisphosphonate abuse
A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The anticipated time on study treatment is 3-12 months.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* locally advanced or metastatic NSCLC (Stage IIIB or IV);
* not a candidate for curative surgery or radical chemotherapy;
* no brain metastases, or clinically stable metastases for \>=2 months.

Exclusion Criteria:

* radiotherapy over the previous 2 weeks;
* weight loss \>10% in the previous 6 weeks.
Home Exercise for Individuals with Neurodegenerative Disease

The primary goal of this study is to address the need for targeted therapeutic interventions for impairments that impact walking in related neurodegenerative diseases.

This study will inform clinicians in quantitatively assessing baseline disease severity, selectively applying the appropriate exercise to the disease pathology, and measuring efficacy of the exercise intervention.

As part of this overall goal, the aims are to:

A. Determine feasibility of remotely supervised exercise programs. B. Optimize remote outcome measures for clinical monitoring and towards future clinical trials.

C. Measure changes in balance and walking post intervention.

Eligibility Criteria:
Inclusion Criteria:

* The eligibility criteria for males is X-linked adrenoleukodystrophy as determined by biochemical determination or genetic testing.
* The eligibility criteria for females is X-linked adrenoleukodystrophy as determined by biochemical determination, genetic testing, or pedigree analysis.
* The Leukoenceophalopathy with brainstem and spinal cord involvement and lactate elevation inclusion criterion is a confirmed DARS2 mutation through genetic analysis.
* For people with cerebellar ataxia, people with diagnoses of cerebellar damage from stroke, tumor or degeneration will be included. Those with a genetically confirmed cerebellar disorder will be asked to provide their genetic testing to note their particular type of ataxia.
* We will also include patients with other neurodegenerative diseases similar to these disorders as determined by chart review and clinical exam.

Healthy Volunteers

* Able to stand for 30 seconds without upper extremity support
* Ambulatory (including use of a cane or a walker)
* Able to walk for 2 minutes

Exclusion Criteria:

* Other medical or psychological conditions which in the clinical judgement of the investigator would interfere with acquiring the study information or performing the exercises safely including but not limited to:

Uncontrolled hypertension, orthopedic conditions, diabetes, seizure disorder, peripheral vestibular loss, severe aphasia, dementia, pregnancy
Feasibility Study of Platelet Activation and Inflammatory Response of Platelets in Hematopoietic Stem Cell Allograft Patients Post-transplant: Spontaneously and After Stimulation by an CMV Antigen

Traditionally known for their role in haemostasis, platelets have also an immune role.

Platelets play a key role in immune mediator secretion, and interact with innate and adaptive immune cells, contributing to the fight against pathogens, as viruses.

Cytomegalovirus (CMV) is responsible of allograft patients' serious infections, because of the induced immune depression. Platelets activation for patients is not determined during the post-graft period, and platelet induced inflammation following a CMV infection is not described.

The descriptive present study will determine if platelet activation is altered during the post-graft follow-up (day 30 to 90).

The activation will be studied spontaneously and after simulation by a CMV (Cytomegalovirus) antigen.

The study will also focus on inflammatory response variation, focusing on the cytokines release during the same post-graft follow-up (spontaneously and after CMV antigen stimulation).

This preliminary study could lead to a better understanding of the immune-modulator role of inflammation, controlled by the platelets, particularly in the initiation of the Graft-versus-host disease in this kind of population.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received an allogeneic haematopoietic stem cell transplant for less than 2 months for any indication ;
* Platelets \> 20 G / L (Giga per Litre) for at least 7 days without transfusion support ;
* Patients affiliated to a social security scheme.

Exclusion Criteria:

* Patients receiving antiplatelet therapy ;
* Major protected or unable to give consent ;
* Pregnant women ;
* Vulnerable persons defined by French legislation.
Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol

The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).

Propofol (2,6-diisopropylphenol) is one of the most common induction and sedative agents used today. Properties that make this agent popular include rapid onset and quick recovery. However, as its use became more widespread, side effects such as pain on injection have attracted more attention. The incidence of pain on propofol injection is as high as 70 - 90%. Numerous studies report that more than 50% of patients recall the unpleasant burning sensation during injection.

Many techniques to minimize pain on injection associated with propofol have been described; pre-administration of different medications including lidocaine, ketamine, thiopental, metoclopramide, dexamethasone, ondansetron, and remifentanil have been reported with mixed success. Some have even tried to use lidocaine with a tourniquet. Others have reported the use of distraction techniques including counting numbers aloud.

Recently, a solvent mixture of medium chain triglyceride and long chain triglyceride has been tested for prevention of pain on propofol injection. Lusedra (fospropofol disodium), the water-soluble prodrug of propofol, does not cause pain on injection as it is water based medication. Demonstrating the benefit of fospropofol over propofol in patient satisfaction will improve acceptance by anesthesia providers.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I, II or III.
* Age 18 - 65.
* Both male and female.
* No significant laboratory abnormalities.

Exclusion Criteria:

* Chronic pain patients or patients receiving benzodiazepines or opioids / other analgesics for control of acute pain will be excluded.
* Patients with known allergies to any of the study drugs, or to soybean oil or egg lecithin are excluded.
* Women with a positive pregnancy test reported from pre-surgical testing or their physician's office or who are breast feeding at the time of surgery.
* No emergency patients will be recruited for this study.
ClearVoice Sound-processing Strategy for AB HiRes 120 Cochlear Implant Users

The purpose of this study is to collect information about how the new sound-processing affects the ability to hear in everyday listening situations.


Eligibility Criteria:
Inclusion Criteria:

* Post-lingually deafened,
* experienced (6 months device use),
* adult users of the Harmony HiResolution Bionic Ear System and HiRes Fidelity 120 sound processing.
* English language proficiency
Microbiota Footprint and Frailty Phenotype in Virologically Suppressed People Living With HIV

Analysis of gut microbiota becomes more and more accessible in recent years. Experimental data in both animal and human studies have demonstrated that imbalance of the gut microbiota which is called symbiosis may participate in an accelerated procedure of ageing as well as the expression of frailty phenotype. People living with HIV (PLHIV) present markers of phenotypic frailty on average 10 years before uninfected people.

In this population structural and functional modifications of GALT (Gut Associated Lymphoid Tissue) are observed early after HIV infection and persist despite virological suppression on ART (AntiRetroviral Treatment). These GALT modifications are associated with microbial translocation that is also correlated with immune activation and dysbiosis.

The objective of study is to explore gut microbiota of PLWH over 5 years, as well as to study associations of its longitudinal evolution with frailty markers and burden of comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* Individuals infected with HIV in the stable phase of their disease (absence of disease outbreak and absence of therapeutic modification within 3 months before inclusion),
* Subject with ongoing HIV follow-up on an outpatient basis (outpatient or day hospital consultation) in the participating center, and having virological suppression at the threshold of 50 copies / mL for at least 5 years (tolerance of blips \< 200 copies / mL during this period)
* Aged ≥ 55 at baseline
* CD4 + T cell nadir\> 200 / mm3
* Giving free and informed written consent
* Being affiliated with or benefiting from a social security scheme.

Exclusion Criteria:

* Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within two months before stool sampling.
* Subject not followed regularly in the participating center,
* Subject only coming for full hospitalization
* Subject in the primary infection phase of less than 1 year
Evaluating Dactinomycin and Vincristine in Young Patients With Cancer

This laboratory study is evaluating how well dactinomycin and vincristine work in treating young patients with cancer. Studying samples of blood and urine in the laboratory from patients with cancer may help doctors learn how dactinomycin and vincristine affect the body and how patients will respond to treatment.

PRIMARY OBJECTIVES:

I. To characterize the pharmacokinetics (PKs) of dactinomycin in infants, children, and adolescents with cancer.

II. To identify demographic or physiological factors that are determinants of dactinomycin disposition.

III. To characterize the PKs of vincristine (VCR) in infants, children, and adolescents with cancer.

IV. To identify demographic or physiological factors that are determinants of VCR disposition.

SECONDARY OBJECTIVES:

I. To examine the correlation of dactinomycin and VCR systemic exposure metrics with toxicity outcomes.

II. To explore the PK, pharmacodynamic, and pharmacogenetic relationships of dactinomycin and VCR in children with cancer.

OUTLINE: This is a multicenter study.

Patients undergo blood and urine collection prior to, periodically during, and after treatment with dactinomycin and vincristine for pharmacokinetic, pharmacodynamic, and pharmacogenetic analysis. Samples are analyzed using a liquid chromatography-tandem mass spectrometry assay. Genomic DNA extracted from peripheral blood mononuclear cells is isolated and analyzed by polymerase chain reaction and genotyping assays for genetic variation in genes relevant to the pharmacology of dactinomycin and vincristine.

After the final pharmacokinetic sample is collected, patients are followed for up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer, including, but not limited to, any of the following:

  * Acute lymphoblastic leukemia
  * Ewing sarcoma
  * Rhabdomyosarcoma
  * Soft tissue sarcoma
  * Wilms tumor
* Due to receive or receiving dactinomycin and/or vincristine as a component of cancer treatment on another clinical trial
* Able to comply with study requirements
* Other concurrent chemotherapeutic agents allowed
Hypertensive Heart Disease in DR Congo

In this Cross-sectional study, we will analyzed data from a tertiary referral Congolese hospital to find whether or not Congolese patients with hypertensive heart disease have multiple comorbid conditions. Will report on the management and outcomes of the patients.

This will be done by collecting individual data on BMI, dyslipidemia, stroke, diabetes, serum creatinine, HDL, LDL, and urea levels for patients diagnosed with hypertensive heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients is 18 year or older
* Patient is diagnosed with hypertensive heart disease

Exclusion Criteria:

* Patient is not 18 year or older
* Patient is not diagnosed with hypertensive heart disease
Onset of Labour Epidural Analgesia With Different Concentration Bupivacaine and Different Doses of Sufentanyl

This study aimed to compare the effects of three commonly used combination doses on the onset time and adverse reactions.

Epidural block is widely used as an analgesic method during labor. During epidural anaesthesia, lipophilic opioids such as sufentanil, are often combined with local anesthetics to prolong the duration of analgesia and improve the analgesic effect. However, dose combinations of local anesthetics and opioids, especially in the initial loading dose, vary greatly from hospital to hospital and often depend upon the different routines adopted by anesthesiologists. In clinical practice, there are still some controversy about opioid dose selection in terms of analgesic onset time and adverse reactions.

In this study, three combinations of bupivacaine and sufentanil were chosen, commonly used in the clinic, and extended the observation period to 24 hours after delivery. We hypothesized that increasing the concentration of local anesthetic, rather than increasing the dose of sufentanil, would achieve a faster analgesic effect with minimal adverse effects on the mother and fetus. To test our hypothesis, our primary outcome was to compare the times of analgesia onset of the three combinations, and the secondary outcomes were to compare the effects on maternal and infant adverse reactions.

Eligibility Criteria:
Inclusion Criteria:patients ASA physical status 1 or 2; early labour (cervical dilation 5 cm or less); singleton fetus; gestational age \> 36 weeks; and normal fetal heart rate (FHR) tracing. -

Exclusion Criteria:severe preeclampsia;antepartum haemorrhage; ASA 3 or more; chronic pain; substance abuse;contraindications to epidural analgesia; allergies to local anaesthetics or fentanyl; body mass index (BMI) over 40; and previous administration of opioid analgesia within 24 h.

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