cyrilzakka/clinical-trials huggingface dataset:
Effects of Acupuncture Stimulation on Systemic Inflammation

60 ASA physical status I or II patients, aged 18-75 years old , scheduled for elective video-assisted thoracoscopic lobectomy surgery,will be randomized into 2 groups,with 30 patients in each group: 1. control group and 2. treatment group. Patients in treatment group will receive transcutaneous electrical acupoint stimulation(TEAS) during the surgery and at 6h and 24h after surgery. Patients in the control group received only TIVA general anesthesia and sham electrical stimulation. Serum from patients of both groups will be collected at before surgery, 1h and 25h after surgery, respectively. Serum levels of TNF-alpha, IL-1 beta, CXCL8, IFN gamma and IL-4 at different time points will be measured and compared between the two groups.

60 ASA physical status I or II patients, aged 18-75 years old , scheduled for elective video-assisted thoracoscopic lobectomy surgery,will be randomized into 2 groups,with 30 patients in each group: 1. control group, who will receive total intravenous anesthesia(TIVA) and sham stimulation; and 2. treatment group, who will receive (TIVA) and transcutaneous electrical acupoint stimulation(TEAS). Since 30 min before induction of anesthesia, patients in treatment group will be stimulated at the 4 acupoints , Houxi、Zhigou、Neiguan and Hegu on both sides by Han's Acupoint Nerve Stimulator(HANS) until the end of the operation. At 6h and 24h after surgery, patients in treatment group will receive TEAS again, for 30 min each time.The frequency was 2/100Hz,the stimulate intensity was the maximum current that could be tolerated when the patients were awake.The control group received only TIVA general anesthesia and sham electrical stimulation.Serum from patients of both groups will be collected at before surgery, 1h and 25h after surgery, respectively and serum levels of TNF-alpha, IL-1 beta, CXCL8, IFN gamma and IL-4 at different time points will be measured. The primary outcome measures are serum TNF-alpha and IL-1 beta levels at 25h after surgery. The secondary outcome measures include serum levels of TNF-alpha, IL-1 beta, CXCL8, Th1/Th2 ratio (by calculating IFN gamma/IL-4) at 1h post surgery and serum levels of CXCL8, Th1/Th2 ratio at 25h post surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed Non-Small Cell Lung Carcinoma (NSCLC) and will have elective video-assisted thoracoscopic lobectomy surgery
* ASA grade 1-2
* BMI between 18 to 31 kg/m2

Exclusion Criteria:

* with a history of thoracic surgery
* Unwilling to receive transcutaneous electrical acupoint stimulation
* BMI ≥ 32 kg/m2
* Infection or scars at the acupoints
* periphery nerve injury at the upper or lower limbs
* Severe liver, renal, brain or lung disease
* Drug abuse
* Patients who cannot coordinate with investigators, such as dysphasia，severe infectious disease and disturbance of consciousness
* Patients participating other trials
Effectiveness and Safety of Atypical Antipsychotic Agents in Augmenting SSRI-Refractory Obsessive-Compulsive Disorder

Objective: Although atypical antipsychotic drugs (AAPDs) have been found effective in the augmentation of serotonin reuptake inhibitors (SRIs) for treatment-resistant obsessive-compulsive disorder (OCD) in short terms trials, there are few data on the effectiveness and safety of these agents in clinical settings over the long term.

Method: Subjects (n=46) who responded to selective SRIs (SSRIs) in an initial 12-week trial were continued on SRI-monotherapy plus cognitive-behavioral therapy (CBT) for one year. Subjects (n=44) who failed to respond to SSRIs were randomly assigned to one of 3 AAPDs such as risperidone and were consecutively treated using SSRI+AAPD combined with CBT for a year.

More recently, second-generation atypical antipsychotic drugs (AAPD) that modulate both 5-HT and DA function, such as risperidone (RIS), olanzapine (OLZ) and quetiapine (QET), have been found effective in the augmentation of SSRIs for treatment-resistant OCD.

Nevertheless, the AAPDs have been associated with common and serious adverse effects, such as body weight (BW) gain and metabolic dysregulation. Metabolic dysregulation includes glucoregulatory dysfunction and dyslipidemia. Indeed, studies of some AAPD in SSRI-refractory OCD patients have similarly reported significant BW gain. AAPD-induced BW gain may influence patients' adherence to medication and places them at risk for a broad range of medical problems.

Most work on AAPDs in treatment-refractory OCD has been conducted in the form of short-term efficacy studies. There have been fewer studies of the effectiveness, safety, and tolerability of these agents in the context of a clinic where CBT is also provided, and where treatment is continued for a significant period of time. In the current effectiveness study, we sought to examine the response of SSRI-refractory patients to augmentation with AAPDs, comparing adverse events in such compared to a control group of SSRI responders.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or over
* Patients were diagnosed as having obsessive-compulsive disorder by the Structured Clinical Interview for DSM-IV Patient version (SCID-P)
* They received standardized treatment for at least 1 year at the OCD clinic in our university hospital.
* Each subject gave written informed consent to take part after receiving a complete description of this study.
* All subjects were free of medical illness based on results of physical examination and screening tests of blood and urine, and no subjects received any lipid lowering or hypoglycemic agent during the 1-year study period.

Exclusion Criteria:

* Current clinically significant medical conditions such as diabetes
Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application

The MegaCarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent high tibial osteotomy(HTO) were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients participating in the "Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® ; Cartilage Defect Treatment Assisting Cartilage Regeneration in Knee Cartilage Defects : Multicenter, Independent Evaluator and Subject Blinded, Microfracture Comparative, Superiority, Randomized, Confirmatory Clinical Study and 5 Years Follow up Study"
2. Patients who simultaneously underwent HTO during knee joint cartilage surgery

Exclusion Criteria:

N/A
Effect of a Novel Sweetener on the pH of Dental Plaque.

Bacteria that live in the mouth can digest fermentable carbohydrates such as sucrose, fructose, and glucose to make acid. This acid can cause demineralization of the tooth and lead to dental caries or decay. Noncariogenic carbohydrate sweeteners, such as sugar alcohols, can be used to replace fermentable carbohydrates in foods, thereby decreasing the risk of caries. In order for a sweetener to be labeled as a noncariogenic sweetener, the FDA requires that when present in food, the food should not lower the dental plaque pH below 5.7 either during or up to 30 minutes after consumption. The purpose of this study is to determine whether a new developmental sweetener can be fermented by the bacteria in the mouth and lead to acid production. This will be done by measuring the pH of dental plaque following consumption of the sweetener.


Eligibility Criteria:
Inclusion Criteria:

* Good general health as evidenced by the medical history.
* Male or non-pregnant, non-lactating females ages 18 to 75 inclusive.
* Caries experience in the past year.
* More than 5 decayed, missing, or filled teeth demonstrating a high caries experience.
* Acidogenic plaque as demonstrated by a drop in pH to 5.7 or lower when challenged with sucrose rinse at the screening visit.
* Willing to abstain from all oral hygiene procedures, brushing and flossing, for 48 hours prior to each test day and drink only water for the four (4) hours prior to each test.
* Willing to abstain from the use of mouthwashes during the study.

Exclusion Criteria:

* Presence of orthodontic appliances.
* Systemic conditions which could influence the pH of the oral cavity (i.e., diabetes, salivary gland disorders etc.).
* Use of medications that would influence the pH of the oral cavity. Specifically, concomitant use of neuroleptics, atropine, chemotherapeutic agents, diuretics, antibiotics, antihistamines, decongestants, and muscle relaxants. Also, anticipated need for intermittent use of any medications in these classes or history of use during the 72 hours immediately prior to the screening visit.
* Patients with aggressive periodontitis, acute necrotizing ulcerative gingivitis, or gross decay at discretion of Investigator.
* Females who by self report are pregnant, lactating, planning to be pregnant during the study period, or women of childbearing potential who are unwilling to commit to the use of a medically approved form of contraception during the study period.
* Exposure to any investigational agent within the 30 days prior to study visit 1
* Individuals requiring prophylactic antibiotics
* Allergy or intolerance to food ingredients and products including artificial sweeteners.
Corticosteroids in Severe COVID-19(ASAP-C Study)

Administration of systemic corticosteroids for patients with severe forms of severe acute respiratory syndrome(SARS-Co-2) infection are recommended by several guidelines. In the very beginning of SARS-Co-2 pandemic the early recommendation by professional organization was against routine use of corticosteroids for patients with coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS), despite previous data and clinical practice for patients with refractory or severe form of ARDS.

Administration of systemic corticosteroids for patients with severe forms of SARS-Co-2 infection are recommended by several guidelines. In the very beginning of SARS-Co-2 pandemic the early recommendation by professional organization was against routine use of corticosteroids for patients with coronavirus disease 2019 (COVID-19) ARDS, despite previous data and clinical practice for patients with refractory or severe form of ARDS. But at the latest after publication of RECOVERY trial (Randomized Evaluation of Covid-19 Therapy, July 2020) and ensued metaanalysis of World Health Organization (WHO) working group, the routine administration of systemic corticosteroids was revisited. However, there are ongoing critical debate of the evidence regarding the dose, administration, timing and type of corticosteroids and ongoing randomized controlled trial (RCT) are challenging the recommendation of 6 mg of dexamethasone for all patients with severe form of COVID-19. The dynamic of COVID-19 surges, flip-flop of official recommendations within very short period of time and ongoing critical debate could be with possible variations of daily clinical practice regarding using systemic corticosteroids. In an electronic evaluation form that will be send to European Society of Intensive Care (ESICM) Members. The electronic survey will contain 10 question. In the questionnaire the participants will have to describe their routine clinical practice regarding administration of systemic corticosteroids among patients with COVID-19 ARDS.

Eligibility Criteria:
Inclusion Criteria:

* Members of European Society of Intensive Care

Exclusion Criteria:

* not members of European Society of Intensive Care
Artoss Foot and Ankle Surgery Registry

This prospective registry was designed as an observational study to ascertain how commercially available NanoBone products are being used by surgeons performing foot and ankle surgery which involves bone grafting, as well as determining relevant patient outcomes.

This multicenter prospective patient registry was developed with the aim of documenting how surgeons are utilizing NanoBone products in foot and ankle surgery along with relevant patient outcomes. These outcomes include radiographic measures such as fusion or graft consolidation success, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.

The primary objective of this study is to document and analyze the use of NanoBone products in foot and ankle surgery (as a stand-alone bone graft, no other local bone, autograft, bone graft substitute, or biologic product used) and determine both radiographic success and clinical outcomes. All product related adverse events will be documented, tabulated, and summarized.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older.
* Patient is or was diagnosed with a pathology of the foot or ankle, having failed conservative treatment, and surgeon has determined that surgery with bone graft is medically necessary.
* The surgeon has determined that NanoBone is or was clinically indicated.
* NanoBone will be or was used as a stand-alone bone graft (no autograft, other bone graft substitute, or biologic planned or used).
* Patient capable of understanding the content of the Informed Consent Form
* Patient willing and able to participate in the registry protocol including the surgeon's standard follow-up visits and clinical evaluations.
* Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the declaration of Helsinki.

Exclusion Criteria:

* Severe vascular or neurological disease
* Uncontrolled diabetes
* Severe degenerative disease (other than degenerative disc disease)
* Severely impaired renal function
* Hypercalcemia, abnormal calcium metabolism
* Existing acute or chronic infections, especially at the site of the operation
* Inflammatory bone disease such as osteomyelitis
* Malignant tumors
* Patients who are or plan to become pregnant.
* Uncooperative patients who cannot or will not follow post-operative instruction, including individuals who abuse drugs and/or alcohol.
Intracutaneous Sterile Water Injections for Acute Low Back Pain in the Emergency Department

The purpose of this study is to evaluate the efficacy of intracutaneous sterile water injections (ISWI) for treatment of acute low back pain in patients presenting to the emergency department. The primary aim is to determine if ISWI provides pain relief for acute low back pain in the ED. The secondary aim is to evaluate whether ISWI provides improved patient satisfaction in the ED setting. The hypothesis is that ISWI will improve pain amongst patients presenting with acute low back pain to the ED.

The purpose of this study is to evaluate the efficacy of intracutaneous sterile water injections (ISWI) for treatment of acute low back pain in patients presenting to the emergency department. The primary aim is to determine if ISWI provides pain relief for acute low back pain in the ED. The secondary aim is to evaluate whether ISWI provides improved patient satisfaction in the ED setting. The hypothesis is that ISWI will improve pain amongst patients presenting with acute low back pain to the ED.

This pilot study will use a randomized controlled trial design to compare the effects of ISWI to intracutaneous dry injections in patients presenting to the ED with acute low back pain.

Eligibility Criteria:
\*\*Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\*

Inclusion Criteria:

* Active Duty and DoD Beneficiaries aged 18 to 64 years.
* Presenting to the ED with a chief complaint of acute low back pain of less than 2 weeks in duration.
* Pain severity on presentation of greater than or equal to 5/10 on Visual Analogue Scale.

Exclusion Criteria:

* Traumatic low back pain
* New weakness or neurologic deficit
* New loss bowel/bladder control
* Back pain above T12
* Active cancer
* Currently taking anticoagulant medications
* Signs of infection or trauma over the injection site
* Non-English speaking
* Pregnancy
Efficacy of Probiotics in the Gut Microbiota and H Pylori Density

We aimed to assess the efficacy of Lactobacillus acidophilus and Lactobacillus rhamnosus in the reduction of bacterial load of H. pylori and in the modification of gut microbiotia in this double blind, placebo controlled, randomized trial.

Subjects: Adult subjects aged 20 or greater with moderate to high bacterial load of H. pylori defined as a DOB value greater than 10 will be eligible to this trial. We will screen 150 subjects and it is estimated that 40 H. pylori infected subjects will be eligible. Eligible subjects will be randomized to receive probiotic (Lactobacillus acidophilus and Lactobacillus rhamnosus) or placebo, one pack twice daily, for 28 days. The primary outcome was the reduction in H. pylori load of greater than 20% than baseline. The secondary outcome was the impact of the probiotic on the gut microbiota and the adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects aged 20 or greater with moderate to high bacterial load of H. pylori defined as a DOB value greater than 10 will be eligible to this trial

Exclusion Criteria:

* history of gastrectomy and colectomy
* severe underlying illness, such as malignancy, ESRD, liver failure, etc
* allergy to probiotics
* symptomatic patients who need PPI, antibiotics, or other probiotics
* pregnancy and lactating women
* unable to cooperate with the protocol
Influence of CYP3A4-induction by St. John's Wort on the Steady State Pharmacokinetics of Bosentan

The aim of the present study is to assess the impact of the cytochrome P450 2C9 (CYP2C9) genotype (\*2 and \*3 allele versus wild type; \~3-5% poor metabolisers in Caucasian population) on the pharmacokinetics of bosentan and the impact of CYP3A4-induction by St. John's wort (SJW) on steady state bosentan which is a CYP3A4 inducer itself.

We evaluate the effect of SJW on bosentan pharmacokinetics and its relationship to polymorphisms in the CYP2C9 gene known to reduce CYP2C9 activity. This study will be conducted at bosentan steady-state because concentrations decrease in the first 10 days of treatment due to auto-induction of the metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Good state of health (physically and mentally)
* Able to communicate well with the investigator, to understand and comply with the requirements of the study
* Voluntarily signed informed consent after full explanation of the study to the participant.
* No clinically relevant findings in any of the investigations of the pre-study examination, especially aminotransferase elevations ≥ 3 × upper limit of normal(ULN). Minor deviations of other laboratory values from normal range may be acceptable, if judged by the investigator to be of no clinical relevance.
* Known genotype for CYP2C9 polymorphism.
* Agreement to abstain from alcoholic beverages during the time of the study.
* Females must agree to use a reliable contraception (Pearl Index \<1%), e.g. double barrier method.

Exclusion Criteria:

* Any regular drug treatment within the last two months, except for oral contraceptives in female volunteers and L-thyroxine.
* Any intake of a substance known to induce or inhibit drug metabolising enzymes or drug transporters within a period of less than 10 times the respective elimination half-life or 2 weeks, whatever is longer
* Any participation in a clinical trial within the last month before inclusion
* Any physical disorder which could interfere with the participant's safety during the clinical trial or with the study objectives
* Any acute or chronic illness, or clinically relevant findings in the pre-study examination, especially: a) any condition, which could modify absorption, distribution, metabolism, or excretion of the drug regimen under investigation b) Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
* Regular smoking
* Blood donation within 6 weeks before first study day
* Excessive alcohol drinking (more than approximately 20 g alcohol per day)
* Inability to communicate well with the investigator due to language problems or poor mental development
* Inability or unwillingness to give written informed consent
* Known or planned pregnancy or breast feeding
* Pre-existing moderate or severe liver impairment
Motivational Interviewing for Weight Loss With Young Adults

This study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of an MI-based program for weight loss in young adults.

This study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of an MI-based program for weight loss in young adults. Participants will be assigned to either the MI Behavioral Weigh Loss or Behavioral Weight Loss arms - both arms will receive a 12-week Behavioral Weight Loss program, including 2 individual in-person sessions, followed by weekly Behavioral Weight Loss modules, reporting of key behaviors, and feedback on progress relative to goals, all via email. Session content will be quite distinct between the two arms, with an increased emphasis on personalized feedback relative to healthy norms, enhancing autonomous motivation, and choice surrounding diet and activity goals in the MIBWL arm. Assessments will take place at 0, and 3 months, followed by exit interviews to help refine the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-25 years of age.
* Body Mass Index (BMI) between 25 and 45 kg/m2.
* Men and women will be recruited.
* All race and ethnic groups will be recruited.

Exclusion Criteria:

1. Currently receiving treatment for Type 2 Diabetes, hypertension, hyperlipidemia, or report a history of cardiovascular disease.
2. Other health problems which may influence the ability to walk for physical activity or be associated with unintentional weight change, including cancer treatment within the past 5 years or tuberculosis.
3. Report a history of, or current diagnosed DSM-IV-TR eating disorder (i.e., anorexia nervosa or bulimia nervosa) or any current compensatory behaviors (e.g., vomiting, laxative use, excessive exercise).
4. Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
5. Report a history of any psychotic disorder, bipolar disorder, or organic brain syndromes; report hospitalization for any psychiatric disorder within the last 12 months.
6. Are currently participating in a weight loss program and/or taking weight loss medication.
7. Lost \> 5% of body weight during the past 6 months or history of bariatric surgery.
8. Participation in any other research study that may interfere with this study.
9. Intend to move outside of the surrounding area within the time frame of the investigation or will be out of town / unavailable for three or more weeks during the initial intervention period.
10. Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.
11. Failure to complete screening appointments. -