cyrilzakka/clinical-trials huggingface dataset:
Lung Microbiome and Inflammation in Early COPD

This is a cross sectional case controlled study to assess lung microbiome and inflammation in smokers with and without Chronic Obstructive Pulmonary Disease (COPD). Investigators will look at active bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches an assess relationships among microbiome, metagenome, metabolome and host immune responses in COPD and controls. Investigators believe COPD cases will have higher prevalence of pneumotype supraglottic predominant taxa (SPT) than matched controls.


Eligibility Criteria:
Inclusion Criteria:

* Case definition: Smokers (\>20 pack-year) with airflow obstruction (FEV1/FVC\<70) and FEV1\>50% predicted (early COPD GOLD 1 or 2)
* Control definition: Smokers with normal spirometry will serve as controls.

Exclusion Criteria:

* FEV1 \< 50% NOT 70
* Significant cardiovascular disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.
* Diabetes mellitus
* Significant liver or renal disease
* Severe coagulopathy (INR \> 1.4, PTT \> 40 seconds and platelet count \< 150x103 cells).
* Pregnancy
* ETOH use of more than \>6 beers or \>4 mixed drinks daily
* Lack of capacity to provide informed consent.
* Antibiotic use within the prior 2months
Intraventricular Transplantation of Mesenchymal Stem Cell in Patients With ALS

ALS is a debilitating disease with varied etiology characterized by rapidly progressive weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment that has been found to improve survival but only to a modest extent. It lengthens survival by several months, and may have a greater survival benefit for those with a bulbar onset. It also extends the time before a person needs ventilation support.Stem cell transplantation is a new hopeful way to improve the patients conditions and reduce the period of disabilities.

In this study our purpose is to evaluate the safety of intraventricular injection of bone marrow derived mesenchymal stem cell.the patients who are eligible,underwent bone marrow aspiration.after cell separation and preparation,the patients underwent mesenchymal stem cell intraventricular injection by stereotaxis.after injection he will be under observed in ICU to monitor the adverse events(allergic and neurological side effects).patients are followed 1th,3th ,6th and 12 months after injection and each time these parameters are checked:ALS-FRS,EMG-NCV,FVC,side effect check list.

Eligibility Criteria:
Inclusion Criteria:

* Age:18-65
* both gender
* duration of disease\<2 years
* FVC\>40% ALS-FRS\>26

Exclusion Criteria:

* neurological and psychiatric concomitant disease
* concomitant systemic disease
* treatment with corticosteroid,Ig,immunosuppressive during 12 months.
Post-market Evaluation of Clinical Outcomes in China for the TECNIS Model ZMT

This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Multifocal Toric 1-Piece IOL. The study will enroll up to 120 subjects from up to 8 sites in China. The subjects will be followed for 12-months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female at least 22 years of age
2. Have a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation
3. Regular corneal astigmatism that is planned for correction with an intraocular lens in the study eye(s)
4. Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with postoperative visits that are required by the study protocol
5. Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian.

Exclusion Criteria:

1. Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
2. Ocular disease (other than cataract) that may significantly affect postoperative vision, such as visually significant keratopathy, macular lesions, diabetic retinopathy, chronic or severe uveitis, etc.
3. Planned monovision correction (one eye designated for near correction)
4. Severe or unstable systemic disease that may affect the heart, liver, kidney, lung, endocrine (including thyroid insufficiency), blood, or psychoneurological dysfunction
5. Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study.

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Phase 2 Trial to Evaluate 18-Methoxycoronaridine Efficacy, Safety and Tolerability in Cutaneous Leishmaniasis Patients

It is a randomized phase II clinical study, unicentre aimed to evaluate the tolerability, safety and efficacy of 18-Methoxyoronaridine as a candidate of tegumentary leishmaniasis treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 59 years of age;
* Clinical diagnosis of leishmaniasis with at least one ulcerated lesion with evolution time from one month;
* Parasitological confirmation;
* Women of childbearing potential should not be pregnant or breastfeeding, confirmed by examination of b-HCG (Gonadotrophic-Chorionic Hormone beta) at the time of screening;
* Men and women should use barrier contraceptive methods during the course of the study;

Exclusion Criteria:

* History of any disease or comorbidities that, in the opinion of the investigator, can either put the individual at risk or influence the results and ability of the subject to participate in the study;
* History or presence of gastrointestinal, hepatic, cardiac, renal disease or any other known condition that may interfere with the absorption, distribution, metabolism or excretion of the investigational product;
* Any evidence of underlying serious disease (cardiac, renal, hepatic or pulmonary);
* Pregnancy or the patient's unwillingness to use barrier contraceptive methods during and 3 months after therapy;
* History of gastrointestinal ulcer disease, inflammatory bowel disease, symptoms of indigestion;
* Any clinically important abnormality in biochemistry, hematology, urinalysis or clinical outcomes judged by the investigator;
* Any positive screening result for hepatitis B antigens, hepatitis C antibodies, and human immunodeficiency virus (HIV);
* Any clinically significant abnormalities in the rate, or driving the resting ECG morphology that may interfere with the interpretation of the QT interval variations;
* History of cancer;
* History of drug abuse, judging by the investigator
* History of alcohol abuse or excessive alcohol consumption, judged by the investigator;
* History of smoking
* History of severe allergy / hypersensitivity, judged by the investigator;
* History of hypersensitivity to drugs with similar chemical structure.
Sufficient Treatment of Peripheral Intervention by Cilostazol

Recently, Nanto et al. reported that cilostazol effectively prevented restenosis in a retrospective analysis of 121 femoropopliteal artery lesions in percutaneous transluminal angioplasty (PTA) patients who had undergone PTA. In a prospective 3-year follow-up study in 127 patients with similar diseases, the patency rate was significantly higher in the cilostazol group than in the ticlopidine group. It was also found that cilostazol markedly inhibited restenosis during the first 1-year period following endovascular therapy when restenosis is most frequently observed. In addition, there have been sporadic reports that cilostazol was effective in preventing post-stenting restenosis in the coronary artery area.

Based on these results, this multicenter study is going to be conducted to prospectively evaluate the usefulness of cilostazol in lower limb endovascular therapy.


Eligibility Criteria:
Patient criteria:

* Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area\*
* Patients who can be monitored for at least 2 years after surgery

Lesion criteria:

* Angiographically-confirmed new significant superficial femoral artery stenosis or occlusive lesions that are 30 cm long or less if stented
* At least 1 arterial runoff below the knee; stenosis lesions not limiting flow may be included.
* Occlusive lesions may be included.

Exclusion criteria:

* Patients with or at risk of hemorrhagic complications or patients with bleeding tendency
* Patients with congestive cardiac failure
* Patients with a drug-eluting stent
* Patients with acute lower limb ischemia
* Patients with creatinine of 2 mg/dL or more(without dialysis)
* patients with a history of serious adverse reaction such as leukopenia, hepatic dysfunction, or renal dysfunction, or hypersensitivity to any component of the study drug.

Lesion criteria:

* Remnant inflow
* Severe calcification
* No arterial runoff below the knee
Clinical Decision Support to Increase Use of Medications for Opioid Use Disorder

The objective of this study is to evaluate the impact of clinical decision support (CDS) in the form of an alert to identify patients who may be at risk of opioid use disorder (OUD) and a clinical care pathway helping providers treating patients with opioid use disorder. The pathway provides health care providers with information and suggestions for screening and treatment of opioid use disorder, including treatment with medications. The 2022 Centers for Disease Control and Prevention (CDC) clinical practice guideline for prescribing opioids for pain recommends providers asses for and treat opioid use disorder using approved medications for opioid use disorder (MOUD). This project will randomize primary care providers at the clinic level to a control arm or intervention arm. The control arm will have access to the clinical care pathway, but will not be reminded to utilize the pathway when treating a patient with opioid use disorder. The intervention arm will receive a reminder nudge about the pathway. Buprenorphine (a medication used to treat opioid use disorder) prescribing behavior of providers and outcomes of patients will be examined based on medical records data collected during routine care. The study period will be approximately 18 months.


Eligibility Criteria:
Inclusion Criteria:

* Primary care encounter AND
* Current opioid prescription (not buprenorphine) and Active opioid medications over the last 90 days OR
* Documented as on local Pain Registry "Does the patient fit the criteria to be included on the Pain Registry?" OR
* Has active problem list diagnosis of long-term (current) use of opiate analgesic OR
* Is taking \>=90 morphine milligram equivalents (MME) per day OR
* Prior positive toxicology screen for illicit drugs OR
* Diagnosis of opioid use disorder

Exclusion Criteria:

* Active cancer diagnosis in the last 1 year
* Hospice care/palliative care order
* Sickle cell disease diagnosis
Prolongation of Progesterone Supplementation in Antagonist Cycles and Pregnancy Outcomes

The objective of this study is to evaluate the effect of the prolongation of luteal support on the ongoing pregnancy rate (beyond 12 weeks of gestation )in recFSH/GnRH antagonist cycles.


Eligibility Criteria:
Inclusion Criteria:

* Age equal or less than 39
* Body mass index between 18-29 kg/m2
* Presence of both ovaries
* Basal hormonal values on day 2 of the cycle
* Embryotransfer day3 or day5
* 1 to 3 cycles

Exclusion Criteria:

* Endometriosis stage 3
* Polycystic ovarian syndrome
* Frozen or testicular sperm
Monitor Response to Treatment in Neuroblastoma Using 3&Apos;-Deoxy-3&Apos;-Fluorothymidine- Positron Emission Tomography (FLT-PET)

The purpose of this study is to gain knowledge about how to best diagnose and treat tumors, how tumors affect normal tissue and how treatment of tumors with radiation therapy and chemotherapy affect tumors.

The purpose of this research study is to observe the changes within the tumor cells which may improve the understanding of how tumors grow and how they respond to various treatments. These changes will be compared with results of the physical examination and scans (CT and MRI) that are done as part of clinical care. Images will be made showing the distribution throughout the body of substances containing a small amount of radioactive material. This procedure is called a PET scan. The radioactive substances (tracer compound) in this study are \[F-18\] FLT.

Eligibility Criteria:
Inclusion Criteria:

* All patients with neuroblastoma or suspected neuroblastoma seen at Children's Hospital of Michigan (CHM). Patients need to be 2 years or older to be eligible for the initial study
* Patients must be 1 day to 21 years old, there is no gender limit.
* Diagnosis: All patients with neuroblastoma or suspected neuroblastoma, including newly diagnosed and relapsed patients, are eligible for Objective 1. To be eligible for Objective 2, patients must have a diagnosis of neuroblastoma verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites, and have measurable disease after the initial surgery
* Female adolescent patients must have a negative pregnancy test within 14 days of first imaging and should not be pregnant
* Patients must be able to lie still for the tests, or have no contraindication for sedation
* Patients or their legal guardian must sign an informed consent indicating that they are aware of the investigational nature of this study
* A total number of 40-50 patients will be included in the study

Exclusion Criteria:

* Patients who do not have a histology diagnosis of neuroblastoma are not eligible for the study
* Patients whose definite diagnosis after surgery is not consistent with the diagnosis of neuroblastoma will be included in the Objective 1 but excluded for Objective 2.
Glycogen Metabolism in Children

It is not fully understood in children how much of hepatic and muscle glycogen is used during a night and how they are replenished after a breakfast. This study aims to analyze the glycogen metabolism before and after an overnight sleep as well as after a breakfast in children between 8 and 12 years old.

The aim of the study is to investigate if liver and muscle glycogen stores are depleted in children after overnight fasting and to what extend the stores are replenished with the intake of small breakfast.

The study is a balanced incomplete crossover design. Participants (children between 8 and 12 years old) have to be two periods of two days in the study. They will be randomized in 6 arms, receiving either water, 1 serving of a small breakfast (Breakfast 1) or 2 servings of the small breakfast (Breakfast 2).

An Interim Analysis after 9 completed subjects will be performed in order to calculate the total number of subjects needed to adequately power the Primary Endpoint.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy girls and boys between 8 and 12 years of age
2. Clinically healthy body weight (5 to 85th rounded percentile from UK)
3. In good health as determined by health screening questionnaires
4. English proficiency as per investigator judgment
5. Informed consent signed by parent(s), or legal representative if applicable and signed child assent according to local legislation

Exclusion Criteria:

1. Girls having menstruations
2. Any type of self-reported food allergies
3. Lactose intolerance
4. Claustrophobic
5. Diagnosis of Diabetes Mellitus
6. Diagnosed acute or chronic medical conditions that could impact study outcomes (asthma)
7. Ongoing diseases or intake of any prescribed or over the counter drugs
8. Participants or participants' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol (including a consumption of 200 ml study drink)
9. Currently participating or having participated in another clinical trial within 12 weeks prior to trial start.
Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth

The aim of this study is to evaluate the effectiveness of Casein phosphopeptide-amorphous calcium phosphate fluoride varnish (CPP-ACP FV) in comparison to fluoride varnish (FV) as a remineralizing agent for white spot lesions in primary teeth (WSLs).

The study is a two parallel arms double blinded randomized controlled clinical trial. A total of 180 WSL in primary teeth in chikdren aged 2-5 y and satisfying the inclusion criteria were selected. Patients will be randomly allocated into 2 groups allocated to two varnishes: study group: CPP-ACP FV (MI varnish), Control group FV (Duraphat). Both fluoride varnishes applications are applied with identical intensive protocols every 2 weeks for 6 weeks. The application of each varnish will be according to manufacturer's instructions. The operator is not blinded to treatment type. Only the participants and statistician are blinded to treatment groups. The whole sample (N=180) will be followed up at 6 weeks and at 18 and 30 weeks for Visio-tactile assessment and DIAGNOdent measurements

Eligibility Criteria:
Inclusion Criteria:

* Healthy children with no systemic diseases.
* High caries risk children with the presence of at least one visible active WSL in primary teeth with ICDAS II score of 1,2 or 3
* Completion of a parental consent to participate in the study.

Exclusion Criteria:

* Selected tooth with cavitated lesion.
* Selected tooth with enamel defects.
* Participants allergic to milk products.
Assessment of Implants Placed in Consolidated Graft With Different Bone Drills.

The anterior iliac crest is a popular source of bone harvest. However, when fused to the intramembranous jaw bones, it yields low-density bones that qualitatively and quantitatively endanger the fixture's stability.

In 1994, Summers first documented using the bone-condensing approach to improve the primary stability of dental implants.

This study aims to determine whether osseodensifying the consolidated mandibular bone grafts will improve implant stability and marginal bone loss


Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes with an age range of 18-55 years.
2. Patients subjected to a successful iliac crest mandibular bone graft after segmental mandibular resection.
3. A minimal ridge height of ten millimeters and a ridge width of seven millimeters.
4. Healthy soft tissue coverage, with a reasonable interaction space.

Exclusion Criteria:

1. Clinical or radiographic signs of graft infection, rejection, or massive resorption.
2. The previous exposure to radiotherapy or chemotherapy.
3. Any systemic disease that would affect bone healing or implant osseointegration.
Bias Source of Signal in SCOUT DS

The primary objective is to identify device characteristics, components or subsystems that manifest as screening score bias in SCOUT DS.

In the process of calibrating multiple SCOUT DS units, consistent inter-device score differences were found. These differences could create a bias in the measurement of Diabetes Risk scores (DRS) in human subjects. This study is intended to examine two of the various subsystems of the SCOUT DS to determine whether either of them might be capable of introducing bias into the measurements, with the ultimate aim of eliminating inter-device measurement variation.

The testing of human subjects in this trial is necessary to determine whether variability in the performance of these device subsystems actually affect DRS scores in a real world setting.

The trial will be a prospective, single site, investigational trial. The trial will utilize four SCOUT DS devices. Subjects will report to the investigative site for multiple visits. The number of visits will vary between three to seven visits.

Eligibility Criteria:
Inclusion Criteria:

* Males and/ or females greater than or equal to 18 years of age

Exclusion Criteria:

* Have received investigational treatments in the past 14 days
* Have psychosocial issues that interfere with an ability to follow study procedures
* Are known to be pregnant
* Have scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
* Have been treated in the past month with oral steroid therapy or topical steroids applied to the left forearm. Inhaled steroid therapy is not a basis for exclusion
* Are receiving medications that fluoresce (A list of excluded medications is located in Appendix H)
* Are known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler Technique

This study was designed to examine the effectiveness of a breath-operated albuterol inhaler in asthma patients who have difficulty using their standard "press-and-breathe" inhaler.

This was a single-center, randomized, open-label, active-controlled, 2-period, 2-sequence, single dose-dose, crossover comparison of the ability of Albuterol BOI-HFA to produce bronchodilation relative to that produced by to albuterol MDI-HFA in at least 12 asthmatics with poor inhaler coordinating ability.

Eligibility Criteria:
Inclusion Criteria:

* Asthma diagnosed ≥6 months prior and stable for 4 weeks prior to screening
* Poor inhaler coordination as assessed at screening
* Reversible bronchoconstriction (≥ 12% increase in FEV1)

Exclusion Criteria:

* Albuterol allergy
* Investigational drug within 30 days
* Injected corticosteroid within 6 weeks
* Requires beta-blockers, MAO inhibitors, tricyclic antidepressants, long-acting beta-blockers, steroids other than those inhaled
* Other criterial apply
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SLE with positive ANA
* Stable disease with no change in SLE therapy within the previous 30 days
* BMI from 18 to 38 kg/m2

Exclusion Criteria:

* Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization
* Evidence of renal disease or liver disease
* Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis
* Prior administration of any other biologic that primarily targets the immune system