cyrilzakka/clinical-trials huggingface dataset:
Mild, Moderate and Severe Renal Impairment Study

This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD) study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
* Subject with renal impairment, as determined at Screening, with creatinine clearance as calculated by the Cockcroft-Gault formula of 60 to \< 90 mL/min (mild impairment), 30 to \< 60 mL/min (moderate impairment), or 15 to \< 30 mL/min (severe impairment), or a matched control subject (by age and body mass index) with a creatinine clearance of ≥ 90 mL/min.
* Subject has a Screening serum urate level ≥ 4.5 mg/dL and ≤ 10 mg/dL

Exclusion Criteria:

* Subject has a history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
* Subject has a history or suspicion of kidney stones.
* Subject has a history of asthma.
* Subject has undergone major surgery within 3 months prior to Day 1.
* Subject has donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation
Brain Effect Mechanism of Lever Positioning Manipulation on LDH Analgesia Based on Multimodal MRI

In order to further investigate the key brain targets and central response mechanism characteristics of analgesia, the dominant disease of LDH was taken as the object of this study, which was divided into operation group, comfort group and healthy subjects group. Firstly, DTI probabilistic tracking method was used to detect the changes of the brain white matter in each group. Then, the low-frequency amplitude (mfalff) and local consistency (ReHo) of each group were compared by fMRI scanning imaging technology, and the features of local brain functional connectivity (FC) of pain matrix related brain regions as seed points were analyzed. Finally, MRS Technique was used to detect the brain signals of related metabolites glutamic acid (Glu) and 1-aminobutyric acid (GABA), so as to elucidate the network regulation of lever-positioning operation on the analgesic brain effect of LDH and the biochemical mechanism of central nervous system. This multimodal MRI technique provides biological basis for the clinical application of lever localization in LDH.


Eligibility Criteria:
Inclusion Criteria:

1. patients suffering from low back pain and/or radicular leg pain;
2. persistent pain for at least six months that was nonresponsive to conservative treatments;
3. at least one epidural or facet joint corticosteroid injection in the last past year without pain relief or with an improvement in pain of less than two months.
4. Lumbar protrusion level discopathy on MRI corresponding to the level of pain.
5. No interventional pain treatment was applied within the last three months and patients needed a pain score equal or greater than four on the visual analogic scale (VAS).

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   Exclusion Criteria:

1.patients with motor deficits, systemic infection, coagulation disorders, pregnancy； 2.VAS pain score lower than four； 3.Patients with any other condition that prevents an MRI scan from being performed.

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Relationship Between Plasma Metabolome and the Efficacy of Systemic Glucocorticoid in AECOPD

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) significantly increases the mortality of the patients with COPD. Guidelines have recommended systemic glucocorticoid as regular treatment. Recently, evidences have shown that systemic glucocorticoid cannot not be benefit to all of the patients with AECOPD. Thus the problem that how the clinicians can screen the patients who can benefit from systemic glucocorticoid needs to be solved urgently.

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) significantly increases the mortality of the patients with COPD. Guidelines have recommended systemic glucocorticoid as regular treatment. Recently, evidences have shown that systemic glucocorticoid cannot not be benefit to all of the patients with AECOPD. Thus the problem that how the clinicians can screen the patients who can benefit from systemic glucocorticoid needs to be solved urgently. A previous study found that plasma metabolome changed significantly after dexamethasone treatment in health participants. Furthermore, inter-person variability was high and remained uninfluenced by treatment, suggesting the potential of metabolomics for predicting the efficacy and side effects of systemic glucocorticoid. Our previous study found that serum metabolites profile in COPD patients differed from that in controls. Therefore, the investigators hypothesized that metabolome changes in patients with AECOPD may be associated with the efficacy of systemic glucocorticoid. In this study, the investigators will utilize ultraperformance liquid chromatography / mass spectrometry (LC-MS) and gas chromatography / mass spectrometry (GC-MS) methods for analysis of the metabolites in AECOPD patients and compare the metabolites profiles between patients with systemic glucocorticoid treatment success and treatment failure. The investigators aim to detect the metabolic biomarkers and metabolic pathways which are related to efficacy of systemic glucocorticoid and contribute to the precise treatment of COPD.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the diagnostic criteria for acute exacerbation of chronic obstructive pulmonary disease in GOLD 2016 and require hospitalization.

Exclusion Criteria:

* Bronchial asthma, bronchiectasis and other airflow obstructive diseases;
* Combined with community-acquired pneumonia, hospital-acquired pneumonia or aspiration pneumonia;
* Combined with severe liver and kidney insufficiency;
* Malignant tumor;
* Immune deficiency due to chemotherapy or HIV infection;
* Received systemic hormone therapy due to acute exacerbation of chronic obstructive pulmonary disease within 1 month before this admission;
* Severe trauma or stress, etc.
Gut Microbiome and Obesity

Pediatric obesity is a risk factor for the onset of obesity in adulthood and is a risk factor for various chronic non-communicable diseases. Metabolic syndrome (MS) is the name for a group of risk factors that increase cardiovascular risk and other health problems characterized by the presence of abdominal obesity, dyslipidemia, hyperglycaemia and high blood pressure. Numerous preclinical and clinical data suggest a potential role of the intestinal microbiota in these diseaes. Unfortunately, comparative studies of the gut microbiota are still scarce in pediatric subjects suffering from obesity than obesity complicated by MS. The aim is to study the metagenomics and metabolomics characteristics of the intestinal microbiota in obese children/adolescents with or without MS, that could provide useful data for innovative intervention strategies for these conditions.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 10-16 years,
* diagnosis of obesity or obesity complicated by metabolic syndrome
* healthy controls

Exclusion Criteria:

* Age at enrollment \< 10 or \>16 years,
* concomitant presence of chronic diseases,
* neoplasms,
* immunodeficiencies,
* chronic infections,
* autoimmune diseases,
* chronic inflammatory bowel diseases,
* celiac disease, -genetic-metabolic diseases, -
* cystic fibrosis
* chronic lung diseases,
* malformations of the cardiovascular/respiratory/gastrointestinal system,
* neuropsychiatric disorders
* neurological pathologies,
* assumption of antibiotics and/or pre/pro/synbiotics
* onset of diarrhea or acute gastrointestinal disease during the 12 weeks prior to enrollment.
Effect of Cervical Epidural Steroid Injection With Neural Mobilization in Patients With Cervical Radicular Pain

This study examines the effectiveness of cervical epidural steroid injections (CESI) and neural mobilization (NM), individually and in combination, in alleviating cervical radicular pain-a condition characterized by nerve root compression or irritation often due to herniated discs or bony spurs. Cervical radiculopathy leads to chronic pain, sensory and motor deficits, and disability in the upper limbs.

The study is a randomized controlled trial conducted between April and October 2024, with patients diagnosed with cervical radicular pain randomized into three groups: CESI-only, NM-only, and combined CESI and NM.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-65 years, diagnosed with chronic cervical radicular pain.
* Patients with chronic cervical radicular pain (\>6 months).
* Patients who had been confirmed through clinical examination and imaging studies (MRI or CT) showed evidence of nerve root compression.
* Participants were included if they provided written informed consent, demonstrated the ability to adhere to the study protocol, and committed to attending follow-up appointments while completing the required outcome measures.

Exclusion Criteria:

* Patient refusal.
* Patients above the age of 65 were eliminated to reduce confounding by age-related health concerns and to provide a more homogenous study population for more accurate treatment outcomes.
* Patients with a history of cervical spine surgery, Uncontrolled Diabetes Mellitus, Hypertension Ischemic Heart Disease, and Pregnancy
* Patients with chronic pain syndromes that may interfere with cervical radicular pain evaluation, such as fibromyalgia, rheumatoid arthritis, or hypersensitivity, will be excluded. These disorders will be evaluated during screening using a complete medical history review, physical examination, and precise diagnostic criteria to guarantee correct detection of cervical radicular discomfort.
ABCA2 GIRMS Analytical Validation Clinical Performance Study

The purpose of this study is to collect human breath samples for use in a validation study intended to demonstrate equivalent clinical performance measures of new ABCA2 GIRMS (Automated Breath Carbon Analyzer-2 Gas Isotope Ratio Mass Spectrometer) instruments to the currently FDA-approved ABCA GIRMS (Automated Breath Carbon Analyzer Gas Isotope Ratio Mass Spectrometer) system. ABCA GIRMS systems are used to analyze the ratio of 13CO2 to 12CO2 in patient breath samples during the GEBT (Gastric Emptying Breath Test) procedure.

In this study the participants will be administered the FDA-approved GEBT test, which involves collecting breath samples prior to and after consumption of a non-radioactive carbon stable isotope (13C) labeled test meal. Breath samples will be collected at times consistent with FDA approved labeling. Participant's breath samples will be analyzed on the currently approved ABCA GIRMS and on the new ABCA2 GIRMS instruments. The values collected from both systems will be used to determine the clinical diagnostic agreement at each individual time points and percent agreement in diagnosis between the approved ABCA GIRMS and the new ABCA2 GIRMS.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18-85 old at time of signing the informed consent form fro healthy and intended use population participants (i.e. symptomology of gastroparesis). Women of childbearing potential must not be pregnant at the time of GEBT administration.
* Ability to eat test meal and provide breath samples

Exclusion Criteria:

* History or physical exam suggestive of pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease or malabsorption syndrome
* History of abdominal surgery except appendectomy
* Use of any medications that may alter gastric motility within two days of the study
* Use of narcotics or anticholinergics within two days of the study
* Females on hormone replacement therapy other than birth control medications
* Receipt of an investigational drug within 4 weeks of the study
* Pregnancy
* Intolerance or allergy to any component of Gastric Emptying Breath Test meal
* History of neurologic or psychiatric disorders
Effectiveness of Acupuncture for Depressed Patients Taking Antidepressant Medications

In this research study, the investigators piloted a uniform acupuncture treatment protocol among adults with depression who were taking an antidepressant medication that was providing only partial or no symptom alleviation. The study's aims were evaluate the efficacy, safety, and tolerability of acupuncture augmentation treatment among this population. The investigators hypothesized that acupuncture as an augmentation treatment would be associated with a response rate of at least 50%, which the investigators defined as a decrease in depressive symptoms from the beginning to the end of the study of 50% or more, and that the response would be greater among patients who received acupuncture 2 times per week (vs. 1 time per week). The investigators also hypothesized that acupuncture would be associated with minimal side effects.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-65
* A HAM-D-17 score of \>= 14
* Partial or nonresponse to a standard antidepressant (monotherapy or combination) at an adequate dose over the past 8 or more weeks (natural agents such as omega-3 fatty acids, St John's wort, SAMe, and folic acid, were allowed as antidepressants)
* Concurrent psychotherapy was allowed, provided that it was not initiated within the 3 months prior to study entry.

Exclusion Criteria:

* A primary diagnosis other than major depressive disorder, or any history of psychosis or mania
* Conditions that could make it difficult to conclusively determine that depressive symptoms were the result of major depression and not some other condition, including any form of substance abuse or dependence within the last 6 months, other medical conditions that could be the basis of a depression (including epilepsy, history of an abnormal EEG, severe head trauma, or stroke)
* Serious uncontrolled medical conditions (e.g. poorly controlled diabetes, severe congestive heart failure), or other medical conditions that had not been stable for at least 3 months
* Having had electroconvulsive therapy (ECT) during the past year
* Current active suicidal or self-injurious potential necessitating immediate treatment.
Screening Program of Relative Energy Deficiency in Sports in College Athletes

The investigators hope that through this study will know the prevalence of Relative Energy Deficiency in Sports (RED-S) and its impact on sports injuries, performance and illness among college athletes in Taiwan. And also to find an appropriate diagnosis and intervention model to take care of athletes' health and improve sports performance Taiwan's athletes in the future.

This project is divided into 3 steps for a period of two years. The first step (0-6 months) is expected to recruit a total of 100 college athletes from Taekwondo, judo, rhythmic gymnastics, and long-distance runners for Relative Energy Deficiency in Sports (RED-S) screening. The second step (7-18 months) is targeted at athletes who have been screened for potential RED-S risk (the number is tentatively 30) in the first step.

The diagnostic tools refer to the clinical assessment of Relative Energy Deficiency in Sport Clinical Assessment Tool (RED-S CAT). The third stage (19-21 months) is intervention programs targeted at the athletes who are diagnosed with RED-S (the number is tentatively 20) at 2nd step. The intervention programs consist of nutrition monitoring and diet intervention. The investigators hope that through this study will know the prevalence of RED-S and its impact on sports injuries, performance and illness among college athletes in Taiwan. And also to find an appropriate diagnosis and intervention model to take care of athletes' health and improve sports performance Taiwan's athletes in the future.

Eligibility Criteria:
Inclusion Criteria:

* (1) agree to participant this study and sign the Informed Consent Form
* (2) college athletes in National Taiwan Sport University
* (3) over the age of 18

Exclusion Criteria:

* (1) disagree to participant or unwilling to cooperate with the screening, intervention and tracking of this study
* (2) diabetes
* (3) thyroid disease
* (4) hereditary anemia
* (5) pregnancy
The Relationship of Sevoflurane Consumption With Metabolic Age

The aim of this clinical study is to determine the consumption of sevoflurane, which is one of the inhalation anesthetics, with metabolic age and basal metabolic rate. The basal metabolic rates and metabolic ages of the patients who will be given sevoflurane- maintained general anesthesia were measured preoperatively. The relationship between the amount of sevoflurane consumption and the measured data of the patients in the postoperative period was examined.

Standard monitoring, BIS, TOF (train of four) were performed from the premedication application. Aspect A 2000 (Aspect Medical Systems, Newton) monitor and single-chip BIS electrodes will be used for BIS. The total amount of sevoflurane consumed and MAK values of these components will be recorded. Chronological age, metabolic age, BMR, height, weight, ideal body weight, BMI, body adiposity, body fluid ratio, body fluid care, fat mass, lean body weight, muscle registered, visceral adiposity, obesity degree in the preoperative period of the patients. Values, ASA scores and demographic data will be recorded for the operation process, cutting time, anesthesia time, extubation time, total sevoflurane consumption throughout the case, and the relationship with basal metabolism and metabolic age will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

Between the ages of 18-65 who are scheduled for rhinoplasty or septoplasty with ASA I-II Cases lasting 1 to 3 hours

Exclude Criteria:

Patients at high risk of malignant hyperthermia, with a history of allergy to general anesthesia or any of the drugs to be used in the study, accepted as ASA III- ASA IV
Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy

The study hypothesis is that XOMA 052 improves glycemic control in subjects with Type 2 Diabetes.

Study X052078 is designed to establish efficacious dose(s) for future studies based on improvement in HbA1c.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with T2D (disease duration ≥ 6 months)
* HbA1c ≥ 6.8% and ≤ 10.0%
* Have been on a stable regimen of metformin monotherapy for at least 12 weeks prior to Day 0
* Willingness to maintain stable diet and exercise regime throughout the study
* Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study

Exclusion Criteria:

* Uncontrolled hypertension
* History of malignancy within 5 years
* History of allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Advanced stage heart failure (New York Heart Association \[NYHA\] class 3 or 4)
* Clinically significant uncontrolled arrhythmias
* History of tuberculosis
* Active leg, foot, or decubitus ulcer
* Any significant inflammatory, rheumatologic, or systemic autoimmune disease
* History of chronic infections
* History or any symptoms of a demyelinating disease
* Major surgery within 3 months
* Female subjects who are pregnant, planning to become pregnant

Other protocol-defined inclusion/exclusion criteria may apply
Schistosomiasis in Women of Reproductive Age in Burkina Faso: Implications for Control

Cross-sectional study of prevalence and intensity of schistosome infection in pregnant women, follow-up into postpartum, and the association of schistosome infection with haemoglobin concentration, compared to a group of non-pregnant women.

The objective of this study is to investigate the epidemiology of schistosomiasis and anaemia among pregnant and non-pregnant women in Burkina Faso and explore the implications for the national schistosomiasis control programme and future studies.

Specific objectives are:

* to determine the prevalence and intensity of schistosome infection in pregnant women attending for antenatal care and in non-pregnant women of reproductive age in an area which is hyperendemic for S.haematobium infection and in which there is little or no S.mansoni infection
* to determine the prevalence and intensity of schistosome infection in pregnant women attending for antenatal care and in non-pregnant women of reproductive age in an area in which S.mansoni infection is common
* to determine Haemoglobin concentration in pregnant women attending for antenatal care and in non-pregnant women of reproductive age in the regions described above
* to investigate the association between infection and haemoglobin concentration in pregnant and non-pregnant women
* to determine the prevalence of other parasitic infections in pregnant women and non-pregnant women including hookworms, ascaris, trichuris and malaria
* to demonstrate the research team's ability to follow-up pregnant women recruited at antenatal care clinics onto the postpartum period

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women attending for ANC
* Non-pregnant women age 15-45 years accompanying relatives or children to the health centres or for immunization
Safety of Lactobacillus Reuteri in Healthy Volunteers

This is a phase one study to assess the safety of daily dosing of Lactobacillus reuteri in healthy adults in Peru. It is conducted as a preliminary study in support of a clinical trial to assess safety and efficacy of Lactobacillus reuteri versus placebo for treatment of pediatric diarrhea in Peru.

This is a phase I blinded randomized study of the safety and tolerability of Lactobacillus reuteri DSM 17938 given daily for a period of five consecutive days. Upon enrollment subjects will be randomized to one of two treatment groups in a ratio of treatment to placebo of 2:1. Subjects will be randomized to receive either:

A. Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).

B. Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-65 with no exclusion criteria
* Subject is a male or, if the subject is female and of childbearing potential then she must have a negative serum or urine pregnancy test result within 48 hours of initiating study preparations and agree to use an acceptable method of contraception. Acceptable methods of contraception include depot forms of progesterone containing therapies or an intrauterine device (IUD).

Exclusion Criteria:

* No enrollment of family members in households where any of the following are present:

  * Another study participant in the household
  * Pregnancy or current breastfeeding by any household member
  * Presence of an infant under age 6 months living in the household
  * Presence of immune suppressed individuals or use of immunosuppressive agents (corticosteroids, methotrexate) by any household member
  * Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation in any household member, including history of gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy, or abnormal bowel functionality
* Allergy to penicillin or cephalosporins
* History of antibiotic use in the last 30 days
* Use of probiotic products within the past 90 days
* History of diarrheal illness within the past 30 days
* Presence of fever or a pre-existing adverse event monitored in the study
* Positive results on serum diagnostic tests for antibodies to HIV, Hepatitis B core antigen, and Hepatitis C.