cyrilzakka/clinical-trials huggingface dataset:
Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1

Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.

Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.

However, it is unclear, if these findings are valid for all kinds of AS, as they are chemically different. Furthermore, data on human subjects are sparse and controversial.

The investigators will therefore conduct 7 consecutive single oral stimulations with glucose or AS alone or a combination. Three different AS will be tested.

Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.

Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.

However, it is unclear, if these findings are valid for all kinds of AS, as they are chemically different. Up to now, no single study has ever compared metabolic responses to different AS in the same subjects. Furthermore, data on human subjects are sparse and controversial. This is partially explained by different methodical approaches such as intragastral/intraduodenal application of AS, rather than conventional oral consumption.

The investigators will therefore conduct 7 consecutive single oral stimulations with glucose or AS alone or a combination. Three different AS will be tested: saccharin, aspartame and sucralose.

Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
Music-instruction Intervention for Treatment of Post-traumatic Stress Disorder

The purpose of this study was to examine the feasibility and potential effectiveness of an active, music-instruction intervention in improving psychological health and social functioning among Veterans suffering from moderate to severe Post-traumatic Stress Disorder (PTSD).

The study was designed as a prospective, delayed-entry randomized pilot trial. Regression-adjusted difference in means were used to examine the intervention's effectiveness with respect to PTSD symptomatology (primary outcome) as well as depression, perceptions of cognitive failures, social functioning and isolation, and health-related quality of life (secondary outcomes).

Eligibility Criteria:
Inclusion Criteria:

* Veterans who (i) had at least one visit for mental health treatment in the prior six months with a primary diagnosis of PTSD (ICD9CM 309.81-83) and (ii) exhibited moderate to severe PTSD symptoms at the time of enrollment (Posttraumatic Stress Disorder Checklist \>=50)

Exclusion Criteria:

* Veterans who were currently participating in an intense psychotherapy program (residential or outpatient)
* Veterans who were already receiving guitar lessons from a Guitars for Vets volunteer
ED Physical Therapy for Acute Low Back Pain

Emergency department (ED)-initiated physical therapy is a rapidly growing resource and represents a promising treatment approach to low back pain. This clinical trial will evaluate an innovative model of an emergency department "embedded" physical therapist to treat patients with acute low back pain, with a focus on improving patient functioning and reducing opioid use.

Low back pain represents a significant health care burden in the United States and accounts for nearly four million emergency department (ED) visits per year. In nearly two thirds of these visits, an opioid medication is administered or prescribed, making low back pain the most common reason for which opioids are prescribed. Despite this aggressive medication-based approach, patient outcomes after an ED visit for back pain remain poor: after three months, nearly half of all patients report persistent functional impairment, and one in five patients report continued opioid use.

ED-initiated physical therapy (ED-PT) is a promising new resource to improve patient care for low back pain. A growing number of EDs now have dedicated physical therapists that evaluate and treat patients through a combination of education, prognostic guidance, and early mobilization and exercise. Preliminary data indicate that patients receiving ED-PT, compared to usual care, report more rapid functional improvement and use fewer opioids. However, these observational data are limited by biases in treatment selection due to physician discretion in which patients receive ED-PT, as well as other measured and unmeasured confounders.

To more rigorously evaluate the efficacy of ED-PT for acute low back pain, the investigators will conduct a single-center physician-randomized trial of an embedded physical therapy intervention (NEED-PT) versus usual care in ED patients with acute low back pain, comparing a primary outcome of pain-related functioning and a secondary outcome of opioid use at the primary endpoint of three months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Low back pain (originating between 12th rib and buttocks)
* Symptom duration ≤ 30 days (current episode)
* Evaluated by a physician randomized to either study arm
* Evaluated when ED physical therapy is available (e.g., Mon-Fri, 8am-4pm)
* Likely to be discharged home (based on physician assessment)
* Ability to complete follow-up data collection electronically or by telephone
* English-speaking

Exclusion Criteria:

* Chronic low back pain or prior lumbar surgery
* Serious red-flag signs/symptoms (bladder/bowel incontinence, saddle anesthesia, debilitating motor weakness)
* Obvious non-musculoskeletal etiology for low back pain (e.g., shingles, kidney stone)
* Other concomitant injuries or pain (e.g., closed head injury, shoulder pain)
* Unable to ambulate at baseline
* Known pregnancy, under police custody, unable to consent
Hormonal Effect of Different Menstrual Phases on Dynamic Balance in Postpubertal Females

High rate of injuries detected during certain periods of menstrual cycle, raised the suggestion of the effecacy of the female sex hormones on soft tissue and neuromuscular control with subsequent deterioration of postural stability and high injury prevalence in post pubertal females so the aim of the present study is to investigate the effect of female sex hormones on postural stability in post pubertal females.

Thirty-six post pubertal females will participate in this study. They will be selected from students and graduates of Faculty of Physical Therapy, Deraya University and they will be assigned into one group. Postural stability assessment will be carried out throughout three menstrual cycle phases, early follicular, ovulation and mid luteal phases by Biodex balance system. The timing of menstrual cycle phases will be determined by measuring serum estradiol and progesterone level. The exact time of ovulation will be determined by urine lutenizing hormone ovulatory strip test.

Eligibility Criteria:
Inclusion Criteria:

1. All females will be virginal.
2. Their ages will range from 15-25 years.
3. Their body mass index (BMI) will range from 18-27 kg/m2.
4. All females will have regular menstrual cycle within average of 28 days.

Exclusion Criteria:

1. Females having menstrual irregularity.
2. Use of oral contraceptives or any hormonal treatment in the previous six months before participate in this study.
3. History of lower extremity injury, surgery or pain during ADL.
4. Females having any vestibular problems , otitis media, labyrinthitis or any inner ear problems that affect balance.
Internet Delivered Cognitive Behavior Therapy Based on Intolerance of Uncertainty

The goal of this clinical is to pilot test an internet delivered cognitive behavior therapy (ICBT) based on intolerance of uncertainty (one of several existing specific cognitive models for how worry works) in treating generalised anxiety disorder (GAD). The main aims is to:

* Test the preliminary effect of the intervention in lowering symptoms of GAD as measured by the self report scale GAD-7
* Test procedures for recruitment, assessment, treatment and follow up
* Test the acceptability of the intervention as measured by the Client Satisfaction questionnaire-8, dropout and adverse events

Participants will apply for treatment in an online system, be assessed via video by a licensed clinical psychologist and then receive a 10 week long ICBT intervention based on the intolerance of uncertainty model. This is a pilot study for an upcoming randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more.
* Diagnosis of GAD based on clinical assessment.
* At least 10 points on GAD-7 at screening.
* Proficient in written Swedish.
* Access to internet enabled device and Swedish BankID for authentication
* Able to make sufficient time for the 10 week long treatment
* Consents to study

Exclusion Criteria:

* In need of treatment for other psychiatric diagnosis as priority (eg depression, psychosis) or high risk of suicide based on clinical assessment
* Ongoing risk use of alcohol or drugs
* Ongoing serious somatic of social disease/problem that is deemed to be to much of a hindrance for the completion of the treatment
Biomarker in Lung Diseases

Disease related biomarkers have been established decades ago, e.g. blood glucose for diabetes diagnosis and management. Their discovery has grown dramatically during the past decade and they have the potential to lead the physician in diagnosis -especially differential diagnosis - and therapy.

However, a specific serum-biomarker in lung diseases has not been established. Aim of the current study is to to measure lung specific proteins in the serum in patients with various lung diseases and to correlate those with disease severity, lung function and other laboratory results


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18
* acute or chronic lung disease

Exclusion Criteria:

* HIV
* lactation or gestation
PROSPECTIVE EVALUATION OF BLOOD BIOMARKERS AS AN AID TO DIAGNOSTIC AND TREATMENT IN DRUG-NAIVE PATIENTS WITH DEPRESSION

This is an observational (non-interventional) prospective study, carried out in drug-naïve outpatients who start a treatment with escitalopram, fluoxetine, sertraline or quetiapine. Five blood samples are collected (i.e. before initiating the drug, and then after 1, 2, 4 and 8 weeks of treatment). It does not affect the choice or the treatment dose. The primary objective of this study is to measure the association between the EDIT-B® editing signature and response to pharmacological treatment in drug-naïve patients. Results of this research could provide an aid to early diagnosis, optimize pharmacological treatment and guide clinical practice towards individualized treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult drug-naïve outpatients suffering from depression and/or bipolar disorders who start a pharmacological treatment with escitalopram, fluoxetine, sertraline or quetiapine and who gave his written informed consent to participate in the present study.

Exclusion Criteria:

* Any patient without capacity of discernment or with harmful use of psychoactive substances
Does Inhaled Busedonide or Fluticasone Impair Adrenal Function?

Inhaled corticosteroids are largely used in patients with asthma or chronic obstructive lung diseases. The purpose of this study is to determine if the use of inhaled corticosteroids is associated with suppression of endogenous cortisol production, as seen in patients treated with pharmacologic doses of oral or parenteral steroids.

The normalcy of the hypothalmic-pituitary-adrenal (HPA) axis of enrolled subjects will be assessed by low dose (1mcg) corticotropin (ACTH)stimulation test. Serum cortisol levels will be measured before , 30 minutes and 60 minutes after 1 mcg ACTH intravenous injection.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving inhaled busedonide or fluticasone at daily dose of 200-800 mcg ' for at least 4 weeks

Exclusion Criteria:

* patients receiving any corticosteroid therapy, except inhaled busedonide or fluticasone.
A 12 Week Study of QVA149 Compared to Fluticasone/Salmeterol (Advair) for Treatment of COPD

Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in patients with moderate to severe airflow limitation


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 40 years, patients with airflow limitation indicated by post-bronchdilation FEV1 \>=30% and \<80% of predicted normal, current or ex-smokers with a 10 pack year smoking history, patients with a mMRC grade 2 or greater

Exclusion Criteria:

* prolonged QTCF \>450 ms, paroxysmal atrial fibrillation, Type I or uncontrolled Type II diabetes, history of asthma, COPD diagnosis before age 40, receiving treatments not allowed in the study, other concomitant pulmonary diseases.

Other protocol-defined inclusion/exclusion criteria may apply.
Progress Bifurcation Global Registry

Coronary bifurcation lesions are lesions (or blockages) that occur at or near the intersection of a major coronary artery and one of the arteries' side branches.

Numerous techniques and devices have been developed to treat coronary bifurcations; however, these types of lesions remain some of the most challenging, both in terms of procedural success and outcome. This study is designed as an observational, multi-center registry that will collect information on treatment strategies and outcomes of consecutive patients undergoing percutaneous coronary interventions (PCI) in coronary bifurcations among various participating centers, in order to determine the frequency of bifurcation PCI, the procedural strategies utilized, and the procedural outcomes.

Numerous techniques and devices have been developed to treat coronary bifurcations; however, these types of lesions remain some of the most challenging, both in terms of procedural success and outcome. Several techniques are currently being utilized to treat coronary bifurcation lesions, including a 1-stent provisional stenting technique. Various 2-stent techniques are also performed, including: double kiss crush (DK crush4), culotte, T and protrusion (TAP), crush, mini-crush, reverse crush and V-stenting. The optimal technique for bifurcation stenting when two stents are required remains controversial; however, the DK crush technique appears to have stronger data, especially for left main bifurcations. However, DK crush can be challenging to perform, requiring several steps and frequent troubleshooting.

The adoption of DK crush and other 2-stent bifurcation strategies, as well as the rigor of implementation, have received limited study. This study is designed as an observational, multi-center registry that will collect information on treatment strategies and outcomes of consecutive patients undergoing percutaneous coronary interventions (PCI) in coronary bifurcations among various participating centers, in order to determine the frequency of bifurcation PCI, the procedural strategies utilized,

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* undergoing bifurcation percutaneous coronary intervention
Sacrospinous Ligament Fixation vs Ischial Spine Fascia Fixation

A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.

Investigational intervention：SSLF or ISFF operations

Study title：A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.

Principal Investigator：Chang Ren, M.D., Department of Obstetrics \& Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College.

Study subjects：Adult patients with symptomatic stage II\~IV pelvic organ prolapse will be eligible if all the inclusion criteria are met and without any reason for exclusion.

Study objectives：The primary objective of this study is to assess the short and mid-term efficacy of Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation in treating stage II\~ IV pelvic organ prolapse and their recurrence rate as well as their impacts on quality of life.

Study design：Prospective, Single-Blind, Randomized, Clinical Trial

Intervention：

* ISFF group：Patients receive ISFF according to randomization.
* SSLF group：Patients receive SSLF according to randomization

Sample size：76 patients (38 in ISFF group, 38 in SSLF group)

Primary endpoint:

•objective success rates at 3 months after operations.

Secondary endpoints:

* peri-operative parameters .
* subjective satisfactory rates at 1 year after operations
* quality of life questionnaires at 1 year after operations

Safety endpoints: complications

Eligibility Criteria:
Inclusion Criteria:

* age≤65 years, for those scheduled to receive hysterectomy age≥40 years
* patients with symptomatic stage II\~IV uterine or vaginal vault prolapse
* receiving SSLF or ISFF in the gynecological department at Peking Union Medical College Hospital

Exclusion Criteria:

* plans to live abroad within follow-up span
* contradiction to these two operations: acute genital infection, narrow vagina (less than two finger-breadth), too-ill to receive operations
* patients with hip joint problem who could not pose a lithotomy position
Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma

This multicenter, open-label trial will randomize participants with multiple myeloma to a regimen of ibandronate or zoledronate in order to compare the incidence of nephrotoxicity, measured as creatinine clearance (CrCl) reduction greater than (\>) 30 percent (%) or an absolute value of 30 milliliters per minute (mL/min) or lower.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed multiple myeloma, Stage II-III as per Salmon and Durie (1975)
* Indication for biphosphonate therapy

Exclusion Criteria:

* Previous therapy with ibandronate or zoledronate within the past 12 months
* Renal insufficiency with serum creatinine \>3.0 mg/dL or \>265 micromoles per liter (µmol/L) or CrCl \<30 mL/min
* Hypersensitivity to ibandronate, zoledronate, or other biphosphonates
* Presence of secondary malignomas, apart from basaliomas and cervical carcinoma in situ
* Severe accompanying illness with organ impairment
* Osteonecrosis of the jaw at the start of the study
* Life expectancy ≤12 months
Changes of Oropharyngeal Flora

Hospitalised patients have in contrast to healthy people enteric pathogenic bacteria in their oropharynx Increased risk of pneumonia due to the pathogens in the oropharynx Probiotics can reduce such bacteria in intubated critically ill patients This study will use two strain of probiotic bacteria for half of the patients and a placebo for the rest Active arm gurgles with a suspension twice a day Cultures at inclusion and at set time intervals The results of cultures from the two groups will be compared as will the use of antibiotics

When patients are admitted to hospital some of them are already colonized in the oropharynx with pathogens that are normally found as commensal or possible pathogens in the gastrointestinal tract. This is probably a consequence of the illness that is the cause of their hospital admission.

Most patients admitted to hospital are elderly. Those patients often have their natural functions down regulated including their ability to secure their airway from aspiration. Acute illness whether you are old or young leads to changes in the intestinal microbiological flora. Bacteria normally found in the colon or distal ileum frequently appear in the stomach and more alarming in the oropharynx. Weakened by the illness, acute or chronic, there is an increased risk of aspiration and when there are pathogenic bacteria in the oropharynx, aspiration is likely to induce pneumonia - health related pneumonia.

For intubated ICU patients we have demonstrated a reduction of colonization with enteric bacteria by applying probiotics in the mouth.

After a screening period to find out what groups of patients that are most vulnerable, we will in a randomised way give probiotics to half of the included patients and to the other patients only the filling material (maltodextrin).

With this procedure our aim is to show a reduction of pathogens in the oropharynx and as a secondary outcome we hope to see a reduction of pneumonia.

Samples for microbiological analysis will be taken during the first day of admission to hospital and then at specified intervals.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to hospital
* Anticipated length of hospital stay 3 days or more

Exclusion Criteria:

* Immune insufficiency
* Prior participation in the study
* Not being able to understand study information
An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients

This clinical study was designed to demonstrate that a single, intravenous dose of palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed CINV and was also well tolerated in the Chinese cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age ranging from 18 yrs to 70 yrs, with histologically or cytologically confirmed malignant disease
* naive to chemotherapy or nonnaive with an interval of at least 14 days to the last one
* Karnofsky index more than 70% and anticipated survival time more than 90 days
* Scheduled to receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) on study Day 1 and the chemotherapy should be accomplished on study Day 1
* No emetic episodes and antiemetic medication during the 24 hours preceding chemotherapy administration
* Adequate organ functions(No impairment to renal, hepatic, cardiac or bone marrow function )
* Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit
* Provision of written informed consent

Exclusion Criteria:

* Inability to understand or cooperate with study procedures
* Receipt of investigational drugs 30 days before study entry
* Scheduled to receive any drug with antiemetic efficacy from 24 hrs before to 5 days after treatment
* Contraindications to 5-HT3 receptor antagonists
* Woman Patient with Pregnancy or lactation
* Diagnosed with hypertension or severe infectious diseases
* Obstructive symptom of gastrointestinal tract
* Symptomatic brain metastasis or mental dysfunction
* Baseline QTc \> 500 ms
Continuous Cardiorespiratory Monitoring in Cystic Fibrosis

Cystic Fibrosis (CF) is a disease without a primary cure that requires lifelong care and is characterized by pulmonary exacerbations (PEx). Wearable devices could provide a way for long-term monitoring of disease progression and early signs of PEx to intervene as early as possible, thereby improving long-term outcomes.

This in-hospital feasibility study will assess the ability of Byteflies Sensor Dots to collect relevant cardiorespiratory data in people with CF and its compatibility with clinical workflows, 2) identify candidate digital biomarkers, and 3) collect user feedback from patients and healthcare providers.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Confirmed CF diagnosis as determined by a sweat chloride ≥ 60 mmol/L or the presence of two known disease-causing mutations

Exclusion Criteria:

* Inability to provide written informed consent
* A known allergy to any of the used medical adhesives
* Presence of any type of electronic implanted medical device