cyrilzakka/clinical-trials huggingface dataset:
Prevention Of Recurrence Of Atrial Fibrillation

The purpose of this study is to determine whether the study drug is effective in preventing the recurrence of atrial fibrillation (an abnormal heart rhythm).


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic persistent atrial fibrillation requiring DC cardioversion.
* Duration of AF \>48 hrs. \<6 months

Exclusion Criteria:

* Concomitant Class I and/or III anti-arrhythmic drugs.
* Amiodarone treatment within 3 months of the study.
* Other inclusion or exclusion criteria to be determined by the physician and study sponsor.
Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound on Osteoarthritis Pain of the Knee

The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain associated with osteoarthritis of the knee. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation. Before, during and after stimulation, the investigators will measure and assess changes intracranial blood flow with transcranial ultrasound.


Eligibility Criteria:
STUDY ELIGIBILITY CRITERIA

Inclusion Criteria:

1. Providing informed consent to participate in the study
2. 18 to 64 years old
3. Having chronic osteoarthritis knee pain in either knee (existing pain for more than 6 months with an average of at least 3 on a 0-10 VAS scale)
4. Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
5. Must have the ability to feel pain as self reported

Exclusion Criteria:

1. Subject is pregnant.
2. Contraindications to tDCS:

   * metal in the head
   * implanted brain medical devices
3. Contraindications to TUS:

   * metal in the head
   * implanted brain medical devices
4. History of alcohol or drug abuse within the past 6 months as self reported
5. Use of carbamazepine within the past 6 months as self reported.
6. Suffering from severe depression (with a score of \>30 in the Beck Depression Inventory)
7. History of neurological disorders as self reported.
8. History of unexplained fainting spells as self reported,
9. History of head injury resulting in more than a momentary loss of consciousness as self reported
10. History of neurosurgery as self reported
The Effects of Use of Auditory Stimulation Methods on Cardiac Patients' Clinical Outcomes

This study will be used to compare the effects of two auditory stimulation methods on improving vital signs parameters, reducing the severity of chest pain, and improving the sleep quality of cardiac patients.

This study aims to To evaluate the relative efficacy of two auditory stimulation techniques in enhancing cardiac patients' vital sign assessments.

* This study aims to examine two auditory stimulations for their ability to alleviate chest pain in patients with heart conditions.
* The goal of this study is to evaluate two audio stimulations for their potential to help heart patients have a better night's rest.

This research made use of two different therapies including audio stimulation. Group A used familiar auditory stimulus, which was a spoken message, and group B used sounds of nature.

Patients with preexisting cardiac conditions who were admitted to a predetermined critical care unit and who subsequently intended to have percutaneous coronary artery intervention (PCI)

Eligibility Criteria:
Inclusion Criteria:

* adult (aged≥18 years).
* diagnosed with cardiac disease.
* patient with hemodynamic stability
* consciousness and ability to communicate.

Exclusion Criteria:

* patients unable to comply with study interventions
* patients with cognitive impairment
* patients with severe unstable cardiac condition
* having a history of hearing loss or the use of a hearing aid.
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section

The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % versus Ropivacaine 0.2 % versus Placebo in patients undergoing elective caesarean section.

The hypothesis is that systemic local infiltration will reduce pain and postoperative opioid consumption.


Eligibility Criteria:
Inclusion Criteria:

* eligible for elective caesarean section
* able to speak and understand Danish
* able to give informed consent

Exclusion Criteria:

* alcohol or medical abuse
* allergies to local anesthetics
* age \< 18 years
* intolerance to opioids
A Pilot Study of a Blended Intervention Targeting Emotion Dysregulation in Adults with ADHD

The current study aims to investigate the feasibility and preliminary clinical effects of a blended psychological intervention targeting emotion dysregulation in adults with ADHD.

Adults with ADHD with co-occurring deficits in emotion regulation are expected to have more severe impairment than those without such deficits in several life domains. Both pharmacological and psychological treatment interventions for adults with ADHD tend to target core symptoms of inattention and hyperactivity, and there are few available interventions targeting emotional symptoms. The current study aims to investigate the feasibility and preliminary clinical effects of a blended psychological intervention targeting emotion dysregulation in ADHD. The intervention consists of eight face-to-face group sessions and a companion app to be used by the participants between the sessions for skills training. The investigators seek to recruit between 15 to 20 adults with ADHD to participate in the pilot study. Feasibility outcomes include adherence, treatment satisfaction and treatment credibility. Self-report questionnaires assessing emotion dysregulation, ADHD symptoms, quality of life, anxiety and depression will be used to examine preliminary clinical effects. There will also be conducted qualitative process interviews to examine the participants expectations and experiences with the program. The investigators expect the intervention to be feasible and to find positive preliminary effects. The findings from the study will be of importance for to further improve the intervention for for a future randomized-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or older
2. A diagnosis of ADHD
3. Current problems with emotion regulation as indicated with a score above 80 on the Difficulties in Emotion Regulation Scale (DERS)
4. Access to a smartphone

Exclusion Criteria:

1. Current self-reported diagnosis of severe psychiatric illness such as ongoing substance abuse or psychosis.
2. High risk of suicidality, as indicated by a) has attempted suicide within the last year, b) has previously attempted suicide and reports suicidal ideation, or c) reports current ideations and has a plan or preferred method.
3. Other ongoing psychological treatment for ADHD or other psychiatric illnesses.
The Endocrine Colon in Humans

This study will examine the role of the colon as an endocrine organ with a focus on the secretion of gastrointestinal peptides.

This study will examine the role of the colon as an endocrine organ with a focus on the secretion of gastrointestinal peptides.

We aim to determine the contribution of the colon to the fasting and postprandial release of gut peptides such as glucagon-like peptide-1 (GLP-1) and peptide YY (PYY). Young healthy men will be examined on three occasions at a clinical research Facility after an overnight fast. On one occasion the colon will also be emptied using a cathartic (picoprep). On two occasions an oral solution of lactulose will be administered to stimulate fermentation by colonic bacteria.

Eligibility Criteria:
Inclusion Criteria:

* Healthy young men (self-reported)
* BMI between 18,5-24,9 kg/m\^2

Exclusion Criteria:

* Diabetes mellitus (elevated fasting plasma glucose or HbA1c)
* Family history of diabetes mellitus
* Intestinal disease (e.g. inflammatory bowel disease, malabsorption)
* Family history of intestinal diseases
* Previous gastrointestinal surgery
* BMI \>25 kg/m\^2
* Tobacco use
* Alcohol consumption \> 14 standard drinks/week
* Drug use
* Kidney, Heart- or Liver disease
* Treatment with prescription drugs that can not be held for 12h
* Constipation
* Accelerated or delayed gastric emptying
* Absence of daily bowel movements
* Vegetarian lifestyle
* \> than 3kgs weightloss or weight gain within 3 months
* Haemoglobin concentration \< 8,0mmol/L
* Bleeding diathesis
* Latex or bandaid allergies
ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.

To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.


Eligibility Criteria:
Inclusion Criteria:

1. Gender and age: Japanese patients, regardless of gender, aged 18 years or older at the time of informed consent.
2. Subject has a clinical diagnosis of Primary Generalized Tonic-Clonic (PGTC) seizures in the setting of idiopathic generalized epilepsy.
3. Subject experiences at least 5 Primary Generalized Tonic-Clonic (PGTC) seizures in 12 weeks.
4. Subject is currently receiving 1 to a maximum of 3 concomitant Antiepileptic Drugs(AEDs) with fixed dosing regimens

Exclusion Criteria:

1. Subject has a history of status epilepticus that required hospitalization within 15 months prior to enrollment.
2. Subject has seizure clusters where individual seizures cannot be counted orclassified.
3. History of non-epileptic or psychogenic seizures.
4. Subject has a concomitant diagnosis of Partial Onset Seizure(POS).
5. Subject has a history of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms(DRESS), Drug-induced hypersensitivity syndrome(DIHS)) or any drug-related rash requiring hospitalization.
A Study With CIT-013 in RA Patients

The goal of this clinical trial is to learn if CIT-013 works to treat rheumatoid arthritis in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are:

Does CIT-013 lower the disease activity of RA patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of RA.

Participants will:

Take receive CIT-013 or placebo every other week for 12 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) ≥ 3 months prior to screening
* Aged 18-85
* DAS28-CRP ≥ 3.2, with ≥ 2 Swollen Joints, and ≥ 2 Tender Joints, and CRP ≥ ULN at screening and confirmed prior to randomization
* At history of at least 3 months treatment and ≥ 4 weeks stable on a conventional synthetic disease modifying antirheumatic drug (csDMARD)

Exclusion Criteria:

* Contra-indication for CIT-013
* Current inflammatory joint disease other than RA (Sjogren with active disease is included).
* The washout period for bDMARD or JAKi prior to the first dose of investigational product should be at least:

  1. ≥ 1 week for etanercept;
  2. ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab;
  3. ≥ 6 months year for rituximab;
  4. ≥ 2 weeks for tsDMARD (either investigational or commercially available treatment).
* Treated with ≥ 3 bDMARD or tsDMARD
* Injectable corticosteroids or treatment with \> 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.
Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder with characteristic deficits in social functioning and presence of stereotypic behavior. Several research studies have examined potential deficits in cognitive skills, such as working memory, in this condition. A meta-analysis of the studies aimed at evaluating working memory (WM) in autistic population suggested deficits in visual and verbal aspects of WM. Working memory training has also been studied in other neurodevelopmental disorders such as Attention Deficit Hyperactivity Disorder (ADHD). The study includes development of mobile-based games for training WM and other cognitive skills in patients and the evaluation of such training in reducing symptoms of ASD. These games may also be useful for other neurodevelopmental disorders.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autism Spectrum Disorder or another related neurodevelopmental disorder with symptoms of ASD

Exclusion Criteria:

* Inability to use smartphones/tablets
* Serious intellectual disabilities.
* Sensory impairment
Formative Study of Tailored Survivor Health Promotion

The overall goal of this study is to explore colorectal cancer patients' concerns and interest about their health and behavior changes post treatment. Investigators will conduct formative research, which includes qualitative interviews, to assess the issues that cancer survivors are willing to work on as they transition out of active treatment.

The specific aims are as follows:

Aim 1: Use qualitative interview methods to describe the taxonomy of domains health promotion and illness prevention behavior changes for which colorectal cancer survivors need new information, skills training and support.

Aim 2: Explore colorectal cancer patients' perceptions of their post treatment functional status.

Aim 3: Explore the impact of cancer, treatment, and co-morbidities on colorectal cancer patients' health goals and functional status.

Study Procedures:

If you agree to take part in this study, you will be asked to fill out a questionnaire about the your current health status, social support and goals.

After completing the questionnaire, you will have an interview with a research assistant. The interview will be audio recorded. You will be asked about goals you have for your health, what you are doing to reach those goals, resources you would like to receive, and challenges you faced since completing your treatment.

Your name and any of your other personal identifying information will not be linked to or collected with any of your responses. All audio tapes will be destroyed at the end of the study.

Length of Study :

The total time of participation for this study is about 45 minutes.

This is an investigational study. Up to 45 patients will be enrolled in this multicenter study. Up to 15 will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with Stage IIB or III colorectal cancer.
2. Men and women within 1 year of ending primary treatment for colorectal cancer.
3. Over 18 years of age.
4. Must be able to read and write English.
5. Must be able to understand and provide written informed consent.

Exclusion Criteria:

1) Patients who have had previous treatment for cancer before treatment at M.D. Anderson, Kelsey-Seybold, and the VA Medical Center.
Iressa Follow-up Trial

The purpose of this study is to assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839 (gefitinib).


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent to participate in the trial.
* Female or male aged 18 years and over.
* Patients with previously diagnosed cancer who have been treated with ZD1839 in a parent ZD1839 clinical trial and may benefit from continuation

Exclusion Criteria:

* Known severe hypersensitivity to ZD1839
* Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
* Withdrawal from a parent ZD1839 trial because of tumor progress
Comparison Between TOF and SWAN Sequences in the Detection of Arterial Occlusion in Acute Ischemic Stroke Using MRI

Optimizing the MRI protocol in acute ischemic stroke remains a challenging issue. In this field, susceptibility-weighted sequences have proved their superiority over T2. Besides the strengthened susceptibility effect, enhanced susceptibility-weighted angiography (eSWAN) sequence provides also a time-of-flight (TOF) effect, allowing the exploration of the intracranial arterial circulation. The objective of this study is to compare eSWAN and 3D TOF, considered as the reference, in the detection of arterial occlusion in acute stroke.

Patients who undergo MRI for suspected acute stroke with an acute ischemic lesion on diffusion-weighted imaging (DWI) will be prospectively included in this study.eSWAN and TOF images will be analyzed under double-blind conditions by a junior radiologist and a senior neuroradiologist for the detection of arterial occlusion. eSWAN images will be assessed in order to estimate the inter-observer agreement. After a consensus, eSWAN and TOF data will be compared to calculate inter-modality agreement.

Eligibility Criteria:
Inclusion Criteria:

* clinical symptoms compatible with acute stroke;
* time range between symptoms and magnetic resonance imaging less than 4 h 30
* presence of at least one acute ischemic lesion on the diffusion-weighted images (DWI).

Exclusion Criteria:

* MR contraindications;
* negative DWI;
* differential diagnosis;
* incomplete acquisition of the full magnetic resonance imaging protocol or technical issues leading to uninterpretable eSWAN and/or TOF sequences (e.g.motion artifacts).
Insulin Iontophoresis Mixed With Oleic Acid Versus Topical Insulin in Patients With Chronic Diabetic Foot Ulcer

This study will be conducted to investigate the effect of Insulin iontophoresis mixed with oleic acid versus topical insulin in patients with chronic diabetic foot ulcer

Despite insulin treatment and a meticulously controlled diet, approximately 15% of all patients with diabetes will, at some time, have non-healing wounds and this is the leading cause of lower extremity amputation. Wound healing involves cell adhesion, migration, proliferation, differentiation, and apoptosis at cellular and molecular levels. Abnormalities of distinct factors of wound healing contribute to defective wound healing in diabetes ulcers, including decreased growth factor production, angiogenic response, macrophage function, collagen accumulation, epidermal barrier.

Insulin has great effect on ulcers healing and tissue regeneration but there is a catch that insulin is a large polymer that have difficulty crossing skin barrier but with using penetration enhancers like oleic acid combined with iontophoresis helps insulin to get through skin especially that affect locally on wound not systematic. Insulin help in restoring the function and structure of the vasculature and improving angiogenesis, reduces the local wound blood glucose concentration, thus reducing the damage resulting from the accumulation of high levels of glucose metabolic intermediates, insulin is the inhibitor of three major proinflammatory transcription factors: Nuclear factor-κB, activator protein-1 and early growth response-1 (EGR-1). insulin relieves the inflammatory response and prevents an excessive inflammatory reaction. Furthermore, insulin inhibits the degradation of immune cell proteins, thus enhancing immune activity. 45 patients with diabetic feet will be assigned randomly into 3 equal group; group A will receive insulin iontophoresis for 13 sessions, group B will receive topical insulin and group C will receive saline dressing for 13 weeks

Eligibility Criteria:
Inclusion Criteria:

* All patients had chronic wound at foot
* The patients ages were ranged from 40 to 70 years
* The subjects were chosen from both sexes
* All patients were diabetic patients

Exclusion Criteria:

* uncontrolled wound bleeding
* severe malnutrition
* severeinfection
* Immunodeficiency
* age\>70 years
* renal failure
* liver dysfunction
* ischaemic limbs
Flow Sensor and Colourimetric Capnometer in Verifying Tracheal Tube Positioning in Term and Preterm Infants

This is a multicentre clinical trial with medical device. As currently recommended by international neonatal resuscitation guidelines, the most reliable method to verify the correct positioning of the endotracheal tube, in association with clinical signs, is the end-tidal capnometry obtained either by infrared spectroscopy or colorimetric method. The aim of the present study is to evaluate whether the flow sensor of a standard mechanical ventilator can discriminate with similar or faster times the correct positioning of the tube after a tracheal intubation attempt compared to the colorimetric capnometer, in newborns undergoing this procedure during hospitalization in the neonatal intensive care unit.

Given the importance of defining a rapid and effective method to prevent possible adverse events of incorrect endotracheal intubation, this study aims to verify whether the ventilator flow sensor can allow a reliable assessment of the correct positioning of the endotracheal tube, with timing and success rates equivalent to or better than the colorimetric capnometer.

Specifically, the neonatologist performing the procedure will follow the standard procedure for tracheal intubation, which includes using a colourimetric capnometer to confirm the correct tube positioning. However, he/she will remain blind and not aware of the flow sensor signal, while a study investigator will monitor that.

The investigators will measure the percentage of responses of correct positioning of the endotracheal tube as well as the number of insufflations and the time elapsed before obtaining a signal of correct intubation by simultaneously comparing both methods and checking any differences based on the characteristics of the sample analyzed (e.g. premature infants versus term infants, elective versus emergency intubations).

Eligibility Criteria:
Inclusion Criteria:

Term and preterm infants requiring tracheal intubation within the neonatal intensive care unit, both in elective and emergency conditions.

Exclusion Criteria:

* intubation at birth
* intubation during cardiopulmonary resuscitation
* absence of informed consent by parents
Examination of the Large Intestine With Camera Capsule in Patients With Blood Stream Infection With Gut-associated Bacteria

The goal of this observational study is to diagnose colorectal cancer or precancerous tumors in participants over the age of 18 hospitalized with blood stream infection with anaerobic gut-associated bacteria. The main question it aims to answer is:

• How prevalent is cancer and precancerous tumors in the large intestines and rectum in patients with anaerobic bacteremia? Participants will be offered an examination using colon capsule endoscopy 4-8 weeks after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Blood culture with growth of one or more of the following bacterial genera Bacteroides, Clostridium, Filifactor, Fusobacterium, Gemella, Granulicatella, Parvimonas, Peptostreptococcus, Prevotella, Solobacterium, Peptoniphilus, Ruminococcus, Finegoldia and Streptococcus.
* Able to provide oral and written informed consent

Exclusion Criteria:

* History of stenosis of the gastrointestinal tract
* Previous treatment of inflammatory bowel disease
* Previous major surgery of the gastrointesinal tract (e.g. gastric bypass)
* Colostomy
* Pacemaker/ICD
* Pregnancy or breastfeeding
* Allergies to the bowel preparation regimen
* Severe kidney disease
* Focus of infection in skin and soft tissue or outside the truncus (e.g. decubitus, diabetic foot ulcer)