cyrilzakka/clinical-trials huggingface dataset:
Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants

We hypothesize that feeding preterm infants while they receive indomethacin or ibuprofen therapy for treatment of a patent ductus arteriosus will decrease the incidence of feeding intolerance and shorten the time period that infants need to tolerate full enteral nutrition. We also hypothesize that this intervention will minimize the alterations in intestinal permeability that occur with these drugs and will improve the infants' hemodynamic response to enteral nutrition

This study is a randomized controlled multi-center clinical trial to determine whether very low birth weight infants should receive feedings during indomethacin or ibuprofen treatment of a patent ductus arteriosus (PDA). Many neonatologists withhold feeds from premature infants receiving indomethacin or ibuprofen therapy for a PDA because of concerns that these drugs alter intestinal blood flow and permeability. However, there are no established studies which show that feeding during these medical treatments leads to bowel injury. At the same time, studies suggest that withholding feedings from premature infants may lead to intestinal atrophy and injury, leading to increased difficulty with feedings when they are initiated or re-started. Thus, this multi-center study evaluates whether feeding infants during indomethacin or ibuprofen therapy improves feeding tolerance by measuring the number of episodes of feeding intolerance and the number of days required to attain full feedings. In addition, this study will employ techniques to measure gastrointestinal permeability and mesenteric blood flow in patients who receive and don't receive feedings for their PDA treatment.

Eligibility Criteria:
Inclusion Criteria:

* Infants between 401-1,250 g birth weight who

  * Are receiving or are scheduled to begin enteral feedings and
  * Are about to receive pharmacologic treatment (either indomethacin or ibuprofen) to close their PDA.

Exclusion Criteria:

* Serious congenital malformations
* Chromosomal anomalies
* Congenital or acquired gastrointestinal anomalies
* Prior episode of necrotizing enterocolitis
* Use of inotropic support for hypotension
* Renal anomalies or disease
* Are receiving \> 80 ml/kg/d of enteral feeding
Argatroban Plus R-tPA for Acute Ischemic Stroke

Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. Therefore, all guidelines recommend intravenous thrombolysis as the first treatment of ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. How to improve the neurological prognosis of thrombolytic patients has been a hot topic in the world.

Recent studies have found that the combined application of argatroban and rt-PA in the treatment of AIS might improve the clinical prognosis and not significantly increase bleeding. Some studies have reported that the combined application of argatroban and rt-PA could improve the blood vessel opening rate, and prevent re-occlusion after opening.

Based on the discussion, the present study is designed to explore the efficacy and safety of argatroban plus rt-PA in the treatment of AIS.


Eligibility Criteria:
Inclusion Criteria:

1. 18-80 years old;
2. Time from onset to treatment ≤4.5 hours;
3. NIHSS ≥ 6
4. Diagnosis of ischemic stroke
5. Signed informed consent by patient self or legally authorized representatives.

Exclusion Criteria:

1. mRS≥2;
2. History of stroke within 3 months;
3. History of intracranial hemorrhage;
4. Suspected subarachnoid hemorrhage;
5. Intracranial tumour, vascular malformation or arterial aneurysm;
6. Major surgery within 1 month;
7. Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg;
8. Platelet count \< 105/mm3;
9. Heparin therapy or oral anticoagulation therapy within 48 hours;
10. Abnormal APTT;
11. Thrombin or Xa factor inhibitor;
12. Severe disease with a life expectancy of less than 3 months;
13. Blood glucose \< 50 mg/dL (2.7mmol/L);
14. Patients who have received any other investigational drug or device within 3 months;
15. Pregnancy;
16. Researchers consider patients inappropriate to participate in the registry.
Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury

The purpose of this study is to determine whether rosuvastatin could alter the immunological response after head injury by modulating TNF-alpha,IL6,IL-1.

The head injury is a frequent problem of health, which produces high morbid-mortality. Today is the main cause of death and disability between 18 and 40 years. In addition it originates expensive expenses in health care systems.

Head injury produces damage by primary mechanisms related to impact, then by biochemical ways which are activated and they carry to secondary damage. Many studies have been conducted for explaining secondary injury, the majority conclude there is a kind of ischemic lesion related maybe with changes in cerebral flow and metabolism. All these changes are associated to a immunological response. Up to now some drugs are directed to modulate the immunological system, although many of them have been ineffective.

Statins o inhibitors of HMG CoA reductase are drugs used in dyslipidemia, frequently for reduction in LDL. Experimental and clinical studies in stroke have shown improvement in outcome. The toxicity related to statin is myopathy and hepatopathy, both with low incidence without fatal cases. Rosuvastatin has been postulated be the most powerful with longest life and toxicity similar to another statins. Many studies have suggested an important immunomodulator effect after statins administration, The investigators have previously demonstrated the possible effect of statin on amnesia and disorientation improvement with patients who suffered a moderated head injury (Glasgow 9-13). The aim of this new study is to analyze the possible immunomodulator role of statins on head injury.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman \> 16 and \< 60 years old with HI less 24 hours in progression and Glasgow between \< 13
* Acceptance of family to participate (first grade)

Exclusion Criteria:

* Previous head injury with severe disability
* History of neurological or psychiatric disease with severe disability
* Administration 24 hrs previous of: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem,amiodarone
* Very poor possibilities for survival
* Use of Administration of THAM, mannitol, barbiturates, corticosteroids, scavengers of free radicals, inhibitors of lipidic peroxidation, indometacin, calcium antagonist, antagonists of neurotransmitters before randomization
* isolated lesions in brain stem
* Allergy to the drug
* Hepatopathy or myopathy (or) history of this, or clinical data of hepatic disease
* Management previous in other Hospital
* Pregnancy
Study of Huperzine A Sustained-Release Tablets in Patients With Alzheimer's Disease

The main purpose of this study is to evaluate the safety and efficacy of Huperzine A sustained release tablets in patients with mild to moderate Alzheimer's Disease.

The primary aim of this multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled therapeutic trial is to determine whether treatment with huperzine A sustained-release tablets can improve cognitive function in individuals with AD.

A total of 390 participants will be randomly assigned to three groups of equal size. This will allow a comparison of huperzine A sustained-release tablets 400µg once a day, huperzine A tablets 200µg twice a day, and placebo.

The study is divided into 2 periods:

1. A two-week placebo run-in period
2. A 6-month double blind treatment period, consisting of three months of titration and three months of fixed dose treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Male/female patient aged between 50 and 85
2. Clinical diagnosis of mild to moderate probable AD based on DSM-IV and the NINCDS-ADRDA criteria
3. Middle school or above: 11 ≤MMSE ≤ 24, elementary school: 8 ≤ MMSE ≤ 20, illiteracy: 5 ≤ MMSE ≤ 16;
4. CT or MRI scan excluding another structural brain disease;
5. Hachinski Ischemic Score \< 4
6. Hamilton Depression Scale ≤10
7. Informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study.

Exclusion Criteria:

1. Proven or clinically suspected other type of dementia such as vascular dementia, mechanic or chemical caused dementia, vitamin B12 deficiency, hypothyroidism etc.
2. Epileptic Patient
3. Severe liver or renal disease
4. Resting pulse less than 50
5. Mechanical intestinal obstruction patient
6. History of stroke
7. History of angina or other severe cardiac, vascular, lung, gastrointestinal and hematopoietic system disease
8. Cognitive damage caused by alcohol or substance abuse
9. Disable to participate or cooperate in the protocol
10. Use of any agent for the treatment of dementia within 2 weeks of randomization
11. Use of another investigational agent within 3 months of screening
12. Be sensitive to Huperzine A or other ACHEIs.
Using Combined EEG and Non-invasive Brain Stimulation to Examine and Improve Reward Functioning in Opioid Use Disorder

The primary aims of this study are to identify impaired cognitive control in opioid use disorder (OUD) and subsequently to examine the effects of transcranial magnetic stimulation (TMS) on reward processing, as measured by the reward positivity (an electrophysiological signal) in people with OUD. To this end, the investigators will adopt a randomized sham-controlled trial to evaluate the efficacy of Ri-TMS on cognitive control in OUD.

The investigators hypothesize that Ri-TMS will be successful in modulating the reward positivity in opioid users in the active TMS condition.

The design is primarily a randomized control-trial design, comparing the effects of placebo (sham) and active TMS stimulation on reward processing across two groups of participants - healthy controls and opioid users.

Participants will be asked to engage in a virtual T-maze task, a reward-based choice task that elicits robust reward positivities. During this task participants will receive simultaneous EEG/TMS, while they engage in the virtual T-maze decision making task, used in our previous reward positivity studies on SUDs. ERPs will be recorded throughout the T-Maze task, and the reward positivity will be measured as the difference in maximum amplitude between reward and no-reward feedback conditions.

The TMS coil will be positioned using a an Adept Viper s850 robotic arm (SmartMove, ANT Neuro, Enschede, The Netherlands), providing precise targeting of the predetermined left dorsolateral prefrontal (DLPFC) coordinate (\< 10 mm from the scalp, orientated at a 45º angle). Participants in the active TMS condition will receive rTMS pulses throughout the duration of the T-Maze task, with a maximum of 2000 pulses delivered to each participant. Identical parameters will be applied to the SHAM group with the exception that the TMS coil will be flipped 180º to mimic auditory stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Native English speakers
* Males and Females aged 18-55 years old
* Ability to provide informed written or verbal consent
* Opioid dependent individuals (according to the Alcohol, Smoking and Substance Involvement Screening Test opioid dependence score), or
* Healthy controls with no history of significant substance use

Exclusion Criteria:

* Un-correctable visual impairment
* Uninterruptable central nervous system medication
* TMS contraindications (e.g., pregnancy, braces, history of seizures, metal implants).
* History of neurological or psychiatric illness
* Diagnosed learning disability
* History of significant head injury (loss of consciousness for more than five minutes)
* Substance abuse (Participants who score above 39.5 on the Global Continuum of Substance Risk scale of the Alcohol, Smoking and Substance Involvement Screening Test - controls only)
* Use of psychoactive or vasoactive medications
A Retreatment Study With Bortezomib for Multiple Myeloma

The purpose of this study is to monitor such factors as a past history, a previous history of drug use, the degree of response to initial treatment, the frequency of previous therapies, age, Eastern Cooperative Oncology Group (ECOG) performance status, which is used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis, before the bortezomib re-treatment, the concomitant drugs that are used for re-treatment and the pattern of treatment in patients with multiple myeloma who were re-treated with injectable bortezomib.

It will be essential to obtain the Korean clinical data about the efficacy and safety of the re-treatment with bortezomib as well as to analyze its actual pattern. The current trial is a prospective, multi-center, Phase 4, observational study that will be conducted to collect such demographic data as a past history, a previous history of drug use, the degree of responses to initial treatment, the frequency of previous therapies, age, Eastern Cooperative Oncology Group (ECOG) performance status, the concomitant drugs that are used for re-treatment and the pattern of treatment for patients with multiple myeloma and who were re-treated with injectable bortezomib. Also safety data will be collected. Observational Study -No investigational drug administered

Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple myeloma
* Patients who were treated with bortezomib monotherapy or bortezomib combination therapy
* Patients who relapsed after \>= six months interval since last dose of bortezomib
* Patients who had a treatment response of higher than partial remission (PR) to the previous bortezomib therapy
* Patients who were fully aware of the objectives and essential procedures of the current trial and then submitted a written informed consent declaring that they will voluntarily participate in the current trial

Exclusion Criteria:

* The current presence of or a past history of hypersensitivity to bortezomib or its constituents
* Severe hepatic dysfunction (AST or ALT at first use\>= x 5 upper normal)
* Pregnant women
Online Fatigue Intervention Program for People With Scleroderma

This research is being done to evaluate if an online fatigue intervention program will decrease fatigue, pain and increase confidence managing fatigue and being able to do daily tasks. This study involves competing a series of questionnaires before and after the intervention , and attending and participating in the online videoconference fatigue program for 1 1/2 hour meetings each week over a 6-week period of time.

If eligible and give consent, participants will be asked to complete 2 online questionnaires. The first questionnaire asks basic information such as your age, gender, educational level, and amount of time diagnosed with systemic sclerosis. The second questionnaire asks about your disease symptoms.

You will also be asked to complete questionnaires about your fatigue, pain, mood, confidence in managing your disease and performing daily tasks, and knowledge and use of energy saving techniques.

Once you compete the questionnaires, you will be asked to compete a survey about times and days you would be available to attend the online videoconference fatigue program meeting over a 6 week period of time.

Once the time and dates for the fatigue program are scheduled, you will be expected to attend and take part (using visual and audio) in each 1 ½ hour meeting for 6 weeks online.

The fatigue program includes information on causes of fatigue, ways to protect joint and save energy, ways to manage stress, pain, good eating habits, and exercise. Outside of meetings, you will also be expected to do any "homework" assignments in between the group meetings such as setting goals and doing activities to reach your goals.

At the end of the 6 weeks, you will be asked to complete the same questionnaires you did at the beginning of the study regarding, fatigue, pain, and ability to perform daily tasks. You will also be asked to complete an evaluation of the course.

3 months later, you will be asked to take part in a 45 minute telephone interview to talk about your fatigue and how you are using the ideas from the program.

Eligibility Criteria:
Inclusion Criteria:

* Resident of the United States
* Diagnosis of systemic scleroderma
* 18 years of age or older
* Have use of a device with internet and email access, and video conferencing capabilities (both audio and visual)
* Communicate in English
* Have fatigue (combined score of \>12 on 3 questions that rate degree of fatigue, severity of fatigue, and level of stress caused by fatigue on a scale from 1 - 10)
* Be willing and available to complete the study protocol which consists of attending a 1.5 hour virtual meeting once a week for 6 weeks.

Exclusion Criteria:

* Pregnancy
* Not having use of a device with internet, email access, and video conferencing capabilities (both audio and visual)
* Not able to communicate in English
* Score \< 12 on the fatigue screening questions
* Not willing or not able to complete the study protocol or participate in the program at the designated times and days.
Effects on Health Related Quality of Life Among Patients With Chronic Pain by Interventional Pain Management

How are the health related quality of life among patients with chronic pain effected by interventional pain managment?

Hypothesis:

Health related quality of life can be improved by interventional pain management both among patients with localizable pain focuses and among patients among whom no pain focuses can be found.

Method:

Health related quality of life using EQ-5D and EQ-VAS is registered at first visit, at the time of treatment for pain focuses an during the following 12 months.


Eligibility Criteria:
Inclusion Criteria:

All patients

Exclusion Criteria:

-
Colorectal Cancer: Screening vs. Non-Screening

The purpose of this study is to determine whether colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after immunochemical based faecal occult blood test) has more favourable clinical-pathological characteristics than colorectal cancer diagnosed for symptoms. We aimed to compare these two groups of patients at the time of diagnosis and confirm the efficiency of the screening programme.

Multicentre prospective observational study. 12 centres across the Czech rep. included. Study approved by Ethical Committee.

All participants gave their informed signed consent. Each centre was assigned a unique ID number to distinguish between the locations in which patients were enrolled.

Patients informations were stored under identification number in secure internet database (RedCap) run by The International Clinical Research Center of St. Anne's University Hospital Brno.REDCap is a secure, web-based application designed to support data capture for research studies.

Statistical analysis was done with SAS, ver. 9.3. Descriptive statistics such as absolute and relative frequencies and median with 95 % confidence intervals were used. Differences between the screening and non-screening groups were compared using the Chi-square test or Fisher's exact test (categorical parameters) and Mann-Whitney test (continuous parameters). Results with a p-value \< 0.05 were considered statistically significant

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed colorectal cancer

Exclusion Criteria:

* unsigned informed consent
* mental disorder
Virtual Reality for Hemophilia

Children with hemophilia are exposed to intravenous (IV) procedures that cause pain/anxiety and distraction methods can be employed to improve the patient experience. Three-dimensional virtual reality (VR) environments can reduce distress related to procedures. To be utilized in a clinical setting, however, these devices must address infection control concerns and fit pediatric patients. Additionally, for use in hemophilia care, environments should encourage a subject to keep their hands/arms still to facilitate procedures. Nursing orchestration of the VR environment via an iPad dashboard has the potential to increase feasibility and acceptance by patients, families and providers of the VR experience without disrupting routine clinical care.

Patients with hemophilia A and B (HA/HB) are frequently treated with IV infusions of clotting factor concentrates to treat and prevent bleeding. Additionally they typically have at least yearly IV laboratory assessments. Pain and anxiety with needle related procedures particularly in children with hemophilia can lead to development of needle phobia, treatment avoidance and poor adherence to treatment regimens. Conventional virtual reality (VR) environments have been shown to reduce pain/anxiety in pediatric populations however in a clinical setting children with hemophilia have specific VR design needs that have not been addressed. Certain issues related to VR environments are related to the pediatric age range. These include the size and weight of VR headsets, the ease of donning and doffing headsets, and degree of engagement with VR environments. Hemophilia specific issues include the need for the VR experience to limit movement of the hands/arms to facilitate IV procedures, customization to prevent boredom/disengagement from repeated use and ability of clinical staff to trigger events via an orchestration dashboard that occur for the patients benefit at key times during IV procedures. Lastly, there are issues related to integration into a clinical setting. These include ability to integrate into clinical care without adversely affecting clinic flow, and infection control issues related to headset design.

Eligibility Criteria:
Inclusion Criteria:

1. Provide signed and dated informed consent form
2. Willing to comply with all study procedures and be available for the duration of the study
3. Diagnosed with Hemophilia A or B
4. Male or female, aged \>6 years to \<19 years
5. Subject and caregiver able to understand and speak English
6. Being seen for routine comprehensive hemophilia care visits during which an IV procedure is planned as standard of care.

Exclusion Criteria:

1. Inability to use the VR equipment (ie visual, cognitive or hearing impairment that would preclude engagement with the VR environment)
2. History of motion sickness as reported by patient or caregiver
3. History of poorly controlled seizures as reported by patient or caregiver