cyrilzakka/clinical-trials huggingface dataset:
Eight-Weeks Of Treatment With Talnetant In Subjects With Irritable Bowel Syndrome (IBS)

This study will evaluate the effectiveness and safety of the investigational drug talnetant in treating subjects with irritable bowel syndrome (IBS).


Eligibility Criteria:
Inclusion criteria:

* Subjects will be required to conduct self-assessments of their IBS symptoms using a touch-tone telephone system for the duration of the study (15 weeks).
* Must be diagnosed with IBS consistent with the Rome II criteria.
* Must have normal results from a colonic procedure within 2 years of randomization.
* Must have conducted self-assessments on at least 12 days and have a documented average IBS pain or discomfort score of greater than or equal to 1.5 during the two-week screening phase.

Exclusion criteria:

* Self-assessment of no stool for 7 days during the two-week screening phase.
* Clinically significant abnormal laboratory tests.
* Current evidence or history of various conditions, comorbidities, or surgeries such as Irritable Bowel Disease (IBD), gastrointestinal surgeries, and diverticulitis.
* Inability to use the touch-tone telephone system.
* Hypersensitivity to quinolone antibiotics or quinolone derivatives.
* Diagnosis of a psychiatric disorder within the past 2 years and not on a stable dose of medication for at least 6 months.
* Women who are pregnant, breast feeding, or planning to become pregnant during the study.

Permitted medications: The subject is allowed to take any of the following medications, provided they maintain a stable dose for at least 30 days prior to the Screening visit and throughout the remainder of the study:

* Antidepressants, except REMERON
* Antihypercholesterolemics
* Iron supplements
* Bulking agents
* Fiber supplement
* Thyroid replacement therapy (levothyroxine)
* Antipsychotics
* Cox-2 inhibitors (CELEBREX)

Prohibited medications: Subjects must stop taking any medications they are taking to treat their IBS symptoms and must not have taken any of the prohibited medications at least 7 days prior to the Screening visit and must remain off these medications for the duration of the study.

* Anticholinergics (dicyclomine, hyoscyamine, propantheline)
* Cholinomimetic (bethanechol, pyridostigmine, tacrine, physostigmine)
* All narcotics (morphine, codeine, TYLENOL #3, propoxyphene, either alone or in combination)
* Tramadol hydrochloride (ULTRAM)
* Colchicine
* Orlistat (XENICAL)
* Misoprostol, alone or in combination (ARTHROTEC, CYTOTEC)
* 5-HT3 receptor antagonists (ondansetron, tropisetron, dolasetron, granisetron, mirtazapine, cilansetron, alosetron)
* Tegaserod (ZELNORM)
* Gabapentin
* Lupron
* Antacids containing magnesium or aluminium
* Antidiarrheal agents
* Bismuth compounds
* Prokinetic agents (cisapride, metoclopramide)
* Sulfasalazine
* Laxatives
* Cholestyramine
A Trial to Investigate Different Needle Features Assessed by Comparing Insulin Aspart Pharmacokinetic Profiles

This trial is conducted in Europe. The aim of the trial is to investigate different needle features assessed by comparing insulin aspart Pharmacokinetics profiles (the exposure of the trial drug in the body)


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male, age at least 18 years at time of signing informed consent
* Considered generally healthy upon completion of medical history, physical examination, analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
* Body mass index (BMI) 28-39.9 kg/m\^2 (overweight to obese)
* Caucasian

Exclusion Criteria:

* Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
* Non-fasting blood glucose test with blood glucose values above 11.1 millimol per liter (mmol/L)
* HbA1c (Glycosylated Haemoglobin) equal to or above 6.5%
* Known active or in-active skin disease in the injection area or that could affect pain perception
* History of deep leg vein thrombosis or repeated episodes of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children) as judged by the investigator
* Use of any prescription or non-prescription medication, including herbal products and nonroutine vitamins, within the last 2 weeks before screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the inpatient period
* Known or suspected abuse of alcohol (defined as regular intake of more than 14 units weekly for men where 1 unit equals 300 milliliter (mL) of beer, 100 mL of wine, or 25 mL of distilled spirits)
* Positive result of an alcohol breath test
* Known or suspected drug/chemical substance abuse within 1 year from screening
Evaluating the Mobile Clinic Model as a Means of Increasing Access to Reproductive and Sexual Health

The mobile health clinic evaluation study examines the impact of mobile health clinics on access reproductive and sexual healthcare services in underserved communities. Multiple mobile clinics operating throughout the U.S. are participating by implementing the same evaluation plan for their programs and contributing de-identified data into a shared database. This allows the investigators to both determine the impact of individual programs and to compare and contrast their impact across different programs, states, population densities (rural, urban, suburban), and populations.

The purpose of this prospective/retrospective cohort study is to evaluate the effectiveness of each individual participating mobile health clinic in improving their community's health and access to care, and to compare each clinic's performance and reach within their respective communities. This Institutional Review Board (IRB)-exempt study is a descriptive review of de-identified evaluation, clinical, and operations data, including staff and patient surveys, patient metrics, and clinic operations metrics. The investigators anticipate that additional mobile clinic programs will submit de-identified data from evaluations done under local IRB exemption. The study will utilize data already collected or to be collected by each mobile health clinic as a part of its clinical and operational activities. Each mobile health clinic will decide which indicators from the evaluation instrument it will use for its own evaluation, and which will be reported to the shared database, depending on the specific services provided and population served. Data will be tracked on a per-patient-visit level or per-operational day, whichever is more relevant to the variable at hand. Data will be sourced from each mobile health clinic's current evaluation sources, including patient intake records (for demographic information, clinic visit dates, clinic procedures done), time and budget tracking software (for hours/patient and cost/patient spent), patient questionnaires (for patient satisfaction and attitudes about their mobile health clinic visit), patient post-visit follow-up questionnaires (for simple referral or prescription follow-up), and clinic operational records (for distance traveled).

Eligibility Criteria:
Inclusion Criteria:

* Patient at a participating mobile clinic

Exclusion Criteria:

* None
Validating 4Ts for Heparin Induced Thrombocytopenia (HIT)

The purpose of this study is to evaluate a scoring tool to help determine the presence of Heparin Induced Thrombocytopenia (HIT), which is an adverse reaction to heparin. We hypothesize that this scoring tool will be very useful in excluding patients who are suspected of having HIT.

HIT is an immune response to heparin that can result in thrombogenic thrombocytopenia. It is often a difficult diagnosis to make, and its diagnosis is dependent upon both clinical and serologic criteria. Due to this ambiguity, increased testing and treatment may occur until serologic test results return. Recently, scoring tools have been developed to assist with the diagnosis of this disease. However, these scoring tools have yet to be validated. Thus, we plan to conduct a prospective, observational study to validate two scoring tools, the 4Ts and the Chong scale, in the diagnosis of HIT.

In order to validate these scoring tools, two physicians will independently score the 4Ts and the Chong scale for all patients suspected of having HIT. These patients will be identified if a physician has ordered HIT antibody testing using the enzyme immunoassay (EIA) method. Confirmatory testing with a serotonin release assay (SRA) will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected HIT.

Exclusion Criteria:

* None.
Prevalence and Characteristics of Nonpolypoid Colorectal Neoplasms - A Chinese Cohort Study

The nonpolypoid colorectal neoplasms (NP-CRNs) are relatively common in patients with gastrointestinal alarm systoms. The depressed lesions have a greater risk of having cancer than flat and polypoid lesions.


Eligibility Criteria:
Inclusion Criteria:

* consecutive adult patients undergo colonoscopy by one endoscopist
Transplantation for Patients With Chronic Lymphocytic Leukemia

To evaluate the role of high dose therapy and autologous or allogeneic hematopoietic cell transplantation for the treatment of chronic lymphocytic leukemia.

To determine effectiveness of allogeneic transplantation in eradicating chronic lymphocytic leukemia.

Eligibility Criteria:
Inclusion Criteria:- adequate organ function

* normal bone marrow cytogenetics Exclusion Criteria:- active CNS disease
* For autologous patients more than 30% bone marrow involvement
A Phase Ⅱ Study of F520 in Patients With Urothelial Carcinoma

This is a multicenter, Phase 2 study to evaluate the efficacy and safety of the anti- programmed cell death-1(PD-1) monoclonal antibody F520 in participants with locally advanced or metastatic Urothelial Cancer (UC).


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed,locally advanced（T4b,any N or any T,N2-3 or metastatic carcinoma（including renal pelvic, ureter bladder and urethra）;
2. Cohort 1：Patients with First-line platinum ineligible must meet criteria for either option a or option b (below):

   1. Has a tumor(s) with PD-L1 combined positive and is considered ineligible to receive cisplatin-based combination therapy, based on 1 of the following:

      * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 2 within 7 days prior to randomization
      * National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Grade ≥2 audiometric hearing loss
      * NCI CTCAE Version 5.0 Grade ≥2 peripheral neuropathy OR
   2. In the opinion of the investigator, is considered ineligible to receive any platinum-based chemotherapy (i.e., ineligible for cisplatin and carboplatin) based on:

      * ECOG PS of 2 within 7 days prior to randomization. and ≥1 of the following:
      * Documented visceral metastatic disease
      * NCI CTCAE Version 5.0 Grade ≥2 audiometric hearing loss
      * NCI CTCAE Version 5.0 Grade ≥2 peripheral neuropathy

Cohort 2: Inoperable Patients in sencond line（or beyond）with locally advanced or metastatic urothelial carcinoma who have disease recurrence or progression during or after a platinum-based chemotherapy regimen;

* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1
* Calculated creatinine clearance ≥ 30 milliliter (mL)/min (Cockcroft-Gault formula)

Exclusion Criteria:

1. Has received prior therapy with an anti-PD-1, anti-PD-L1 agent or with CTLA-4 receptor;
2. Has a known hypersensitivity to anti-PD-1 / PD-L1 agent;
3. Known pia meningeal metastasis or active central nervous system (CNS) metastasis revealed by CT or MRI. Participants with asymptomatic brain metastases may participate without evidence of progression for at least 1 month.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Neurophysiological Correlates of Exposition Therapy in Spider Phobia

This study aims to investigate the neurophysiological correlates of spider phobia and its treatment with CBT based Exposure Therapy. This is the first study to investigate the neurophysiological correlates of Exposure Therapy in situ by means of functional Near-Infrared Spectroscopy (fNIRS).

30 spider phobic patients will be assessed and randomly allocated to 5 sessions of exposure therapy or waiting-list. Further, 30 non-phobic control subjects will be assessed (primary assessment only).

During Exposure Therapy, changes in blood oxygenation will be measured with fNIRS in areas of the Cognitive Control Network. Regions of interest are the bilateral dorsolateral prefrontal cortex (DLPFC), bilateral inferior frontal gyrus (IFG) and somatosensory association cortex (SAC). Before the treatment, subjects will have one session of psychoeducation in which the rationale for the treatment is explained. In each therapy session subjects are exposed to 20 trials (each lasting 40s) of guided exposure by a psychotherapist. Further, 20 control trials of equal length are assessed in which subjects work with an earthworm. During the therapy additional anxiety coping strategies (e.g., controlled breathing, attention refocusing, cognitive reappraisal) are trained. After the treatment or waiting-list phase, treatment conditions are switched: The waiting list will be treated and the treated subject will wait for approximately 6 weeks.

Before treatment (primary assessment), after treatment (secondary assessment) and after study completion (final assessment), additional combined NIRS EEG measurements are done. On a peripheral physiological level heart rate and EMG of the facial corrugator supercilii are measured. During these measurements subjects are asked to watch 10s lasting video clips showing spiders (experimental condition) or pets (dogs and cats). On a psychometric level, spider phobia will be assessed by questionnaires (SPQ, FSQ, SBQ) and behavioral assessments.


Eligibility Criteria:
Inclusion Criteria:

* Spider Phobia or no fear of spiders
* Age between 18 and 50
* normal vision (or corrected with glasses)
* German mother tongue or comparable knowledge

Exclusion Criteria:

* pregnancy
* medication with exception of contraceptive medication
* acute or chronic disease that affects brain functioning (other mental diagnosis than spider phobia, cardial diseases, diabetes, kidney diseases, concussion)
Impact of Obicetrapib and Obicetrapib Plus Repatha on Lp(a) Levels

The goal of this open label 16 week trial is to evaluate Lp(a) levels for patients with elevated Lp(a) being treated with obicetrapib and obiceptrapib/evolocumab

Patients will:

Have baseline Lp(a) tested at randomization Take 10mg/dL obiceptrapib daily for 8 weeks and have Lp(a) tested at Week 8 Take 10 mg/dL obicetrapib daily/evolocumab 140 every other week for 8 weeks and have Lp(a) retested at Week 16


Eligibility Criteria:
Inclusion Criteria:

* Lp(a) \>50 mg/dL
* LDL-C \>70 mg/dL
* TG \< 400mg/dL

Exclusion Criteria:

* HbA1c\>=10 or FPG \>=270 mg/dL
* CV events within 3 months of screen
Localization of Intercostal Perforating Vessels Reduces Wound Complications From Nipple Sparing Mastectomy

Approximately 100 women scheduled for NSM will be consented pre-operatively to participate in the study. US will be performed after induction of general anesthesia, prior to surgery using Sonosite™ portable US, 5-12mHz transducer using doppler mode.

Nipple Sparing Mastectomy (NSM) has been increasingly utilized over the last ten years for risk-reducing surgery and surgical treatment for breast cancer. The oncologic safety has been well established in multiple studies in appropriately selected individuals. Additionally, rates of wound complications and risk factors for wound problems are well documented. The intercostal perforating vessels (IPV) have been demonstrated to provide a significant proportion of the blood supply to the nipple-areolar complex1-3. Thus, preservation of these vessels is essential to reducing ischemic necrosis of the nipple-areolar complex. We propose that localization of these vessels utilizing intra-operative ultrasound (US) will reduce ischemic necrosis complications of NSM.

Objectives

* Demonstrate that US is an effective means of localizing the IPV intraoperatively.
* Evaluate the frequency of IPV preservation with the use of US.
* Measure rate and severity of ischemic necrosis when US is utilized to preserve IPV.
* Compare observed rate with historical controls.

Eligibility Criteria:
Inclusion Criteria:

* Females 18 years of age or older
* Planned nipple sparing mastectomy

Exclusion Criteria:

* Contraindication to nipple sparing mastectomy
Effect of Microbiome Modulation by Diet in Functional Constipation

Current medications and behavioral modifications have limited success in the treatment of functional constipation (FC). An individualized diet based on microbiome analysis may improve symptoms in FC. In the present study, we aimed to investigate the impacts of microbiome modulation on chronic constipation. patients fulfilling Rome IV criteria for functional constipation were randomized into two groups. The Control group received sodium picosulfate plus conventional treatments (i.e., laxatives, enemas, increased fiber, and fluid intake). The study group underwent microbiome analysis and received an individualized diet with the assistance of a soft computing system (Enbiosis Biotechnology®, Sariyer, Istanbul). Differences in Patient Assessment Constipation-Quality of Life (PAC-QoL) score and complete bowel movements per week (CBMpW) were compared between groups after 6 week-intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling Rome IV criteria for functional constipation (FC)
* Patients who had a colonoscopy performed within the last 5 years
* Patients who had a colonic transit time assessment within the last 3 months
* Patients who had a magnetic resonance defecography within the last 3 months

Exclusion Criteria:

* Use of antibiotics, probiotics, and/or prebiotics within the last 4 weeks
* Gastrointestinal endoscopy within the last 4 weeks
* Major gastrointestinal surgery (total/segmental gastrectomy, small bowel and/or colonic resection)
* Cholecystectomy
* Inflammatory bowel diseases
* Celiac disease
* Any etiology of chronic constipation other than FC (irritable bowel syndrome, rectocele, dyssynergic defecation, opioid use)
* Endocrine, metabolic or neurologic disorders causing constipation (hypothyroidism, Parkinson's disease, paraplegia)
Cancer Prevention & Online Technologies

The overall goal of this research is to develop interventions that leverage online technology (e.g. ads, social media) to reduce individuals' skin-cancer-related risk behaviors and ultimately to reduce skin cancer incidence.

This research includes three phases:

1. To better understand the motivators and inhibitors of skin cancer risk behaviors in various populations including use of indoor tanning and outdoor sun exposure;
2. To develop content messages and images related to skin cancer risk that are resonant with various populations;
3. To test the relative effectiveness of these messages in reducing likelihood of or actual skin cancer risk behaviors in various populations.

Eligibility Criteria:
Inclusion Criteria:

* Facebook user between the age of 18 and 65
* Self-identifies as male
* Profile indicates interest in at least one of the following: LGBT community, LGBT culture, LGBT social movements, Rainbow flag, Gay pride, GAY-friendly, homosexuality

Exclusion Criteria:

* Failure to meet inclusion criteria
Opioid Free Anesthesia in ENT Surgery

Opioid Free Anesthesia (OFA) - which has been applied mainly in bariatric surgery - has begun to receive more and more attention and to obtain fanatical supporters versus conventional anesthesia. The advantages of this type of anesthesia are mainly achieved by the action and effect of the various drugs that compose it.

Functional Endoscopic Sinus Surgery is performed in cases where sinusitis or its complications are difficult to treat with medication. With special cameras and endoscopes, the narrow anatomical regions of the sinus can be depicted and precisely surgically approached. Usually surgery is conducted under general anesthesia. According to the literature, total intravenous anesthesia should be used for sinus surgery to achieve blood pressure control as well as controlled hypotension to prevent intraoperative bleeding. Most of the studies agree that the best type of anesthesia for this type of surgery is total intravenous anesthesia. When it comes to Opioid Free Anesthesia in FESS, there are not many studies, except of some studies that don't use solely Opioid Free Anesthesia but some of the drugs that consist it.

Patients scheduled for elective Functional Endoscopic Sinus Surgery will be randomised in two groups. One receiving OFA and one receiving TIVA.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 - 75 years old
* Elective FESS

Exclusion Criteria:

1. Patients \< 18 or \>75 years of age
2. Patients who can't read of speak the Greek language
3. Patients with psychiatric disorders
4. Patients with atrioventricular block in ECG
5. Patients with musculoskeletal disorders
6. Patients with coronary artery disease
7. Patients uncapable of giving informed consent
A Clinical Trial of Fluvoxamine for Melancholia

This study aims at investigating the special effectiveness of antidepressant effect of Fluvoxamine for endogenous depression. The investigators also aim to assess the effect of Fluvoxamine on the multimodal magnetic resonance imaging(MRI), blood cytokines, feces bacteria flora and neuropsychological performance in depression patients with melancholic features. The investigators further aim to identify the predictors of Fluvoxamine's antidepressant effeect using the above techniques.

This study aims at investigating the special effectiveness of antidepressant effect of Fluvoxamine for melancholia. The investigators also aim to assess the effect of Fluvoxamine on the multimodal magnetic resonance imaging(MRI), blood cytokines, feces bacteria flora and neuropsychological performance in depression patients with melancholic features. The investigators further aim to identify the predictors of Fluvoxamine's antidepressant effeect using the above techniques.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18-55 years, both sexes), with DSM-4 criteria for MDD without psychosis, as determined by a structured clinical interview Mini International Neuropsychiatric Interview
* Moderate to severe depression, as defined by a pretreatment score ≥17 on the HDRS-17 scale
* Informed consent to participate in this study
* ethinic Han, right-handed, Junior high school education or above

Exclusion Criteria:

* A history of bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, or documented Axis II diagnoses; active suicidal intention, as determined by clinical interview
* Active or recent (\<12 months) substance abuse or dependence; excluding nicotine
* Presence of ECT treatment in recent 6 months
* period of pregnancy or lactation
* hearing disorder or colour blindness
* Immediate relatives have bipolar disorder or mania disorder