cyrilzakka/clinical-trials huggingface dataset:
Creatine Supplementation in Chronic Fatigue Syndrome

This study evaluates the effectiveness of medium-term supplementation with creatine to improve clinical outcomes in well-defined adult CFS population. Half of the participants will receive creatine while the other half will receive placebo.

Chronic fatigue syndrome (CFS) is a debilitating and complex condition characterized by profound fatigue of unknown cause, which is permanent and limits the person's functional capacity, producing various degrees of disability. It seems that inadequate or impaired energy provision through cellular metabolism may contribute to the pathogenic initiation and maintenance of CFS.

A variety of dietary interventions have been used in the management of CFS, yet no therapeutic modality demonstrated overall positive results in terms of effectiveness. Previous studies have evaluated the effects of essential fatty acids, vitamins, minerals and/or enzymes, with findings that do not support the use of a broad-spectrum nutritional supplement in treating CFS-related symptoms. Considering the fact that patients with CFS have lower levels of high-energy compounds (e.g. phosphocreatine, adenosine triphosphate), effective dietary treatment of CFS should be focused on providing compounds that facilitates cellular bioenergetics. Besides other candidate agents, creatine (Cr) could be of particular interest since it occurs naturally in the human body.

Placebo-controlled, randomized, double-blind, cross-over clinical trial examining the effectiveness of Cr for the treatment of CFS will be organized according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* fulfilled CDC criteria for CFS

Exclusion Criteria:

* psychiatric co-morbidity
* use of dietary supplement within 4-weeks prior to the study commencing
* pregnancy
Identification of Prognostic Factors and Role of Radiotherapy in Patients With Ewing Sarcoma

assess whether there is a correlation between some factors (age, sex, tumor volume, tumor site, chemotherapy-induced necrosis, radiation and biomarkers) and overall survival (OS) and relapse-free survival (RFS) in patients with Ewing sarcoma.

Identification of reliable prognostic factors could help to identify high-risk patients, which may require a different treatment and follow up.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients treated at Rizzoli Orthopaedic Institute between 01/01/1991 and 31/12/2021
* Age ≥ 2 years
* Diagnosis of Ewing Sarcoma
* Patients with available clinical and imaging data

Exclusion Criteria:

* At least one inclusion criterion not met
Thymoglobulin Induction Therapy in Kidney Transplantation (6mg/kg vs 4mg/kg)

This is a prospective randomized controlled study to evaluate feasibility and safety of early steroid withdrawal after 6mg/kg vs 4.5mg/kg Thymoglobulin induction therapy in kidney transplantation. Patients are enrolled from June, 2015 for 24 months. They are randomized to either 6mg/kg or 4.5mg/kg Thymoglobulin induction group. Steroid withdrawal is done within one week after kidney transplantation for all the patients. Maintenance immunosuppressants are Tacrolimus and Mycophenolate mofetil (or Myfortic). Primary outcome is a composite of biopsy-proven acute rejection, delayed graft function, graft loss or death within one year post transplant.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with renal failure from 18 to 70 years of age
* Candidates for cadaveric or living donor kidney transplantation
* Patients who are able and willing to consent the protocol of the study

Exclusion Criteria:

* Patients who have been receiving immunosuppressive therapy before transplantation
* Patients who have received an investigational medication within the past 30 days
* Patients who have a known contraindication to the administration of antithymocyte globulin
* Patients who are suspected or known to have an infection or were seropositive for hepatitis B surface antigen (HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
* Patients who have had cancer (except non melanoma skin cancer) within the previous 2 years
* Pregnant women, nursing mothers, and women of childbearing potential who were not using condoms or oral contraceptives
Premedication and Haemodynamics After Spinal Anesthesia

Blood pressure drop following spinal anesthesia is connected with sympathetic/parasympathetic activity which may be determinated by Heart Rate Variability (HRV) assessment. Sympathetic predomination expressed as LF/HF ratio above 2.5 is strongly connected with deeper blood pressure fall. As drugs given for premedication may have impact on HRV variables, the investigators would like to determine if pharmacological premedication may modify hemodynamic changes following spinal blockade. Two drugs will be compared - midazolam which is known to lead to increase in LF/HF ratio and morphine - opioid which provokes opposite effect.


Eligibility Criteria:
Inclusion Criteria:

* spinal blockade for elective surgery

Exclusion Criteria:

* contraindications for spinal anesthesia
* hypertension
* heart failure
* chronic respiratory failure
* hypersensitivity for midazolam or morphine
Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder

It has been suggested that N-acetylcysteine exerts neuroprotective effects by regulating neurotransmitters and cell signaling pathways. We hypothesize that oral N-acetylcysteine augmentation will help reduce symptoms in patients with posttraumatic stress disorder as well as improve cognitive functions. We also expect that the N-acetylcysteine augmentation will induce change in structural, functional, and neurochemical aspects of the brain.

In this study, we plan to conduct a randomized, double-blind, placebo-controlled augmentation study with N-acetylcysteine in addition to escitalopram. We will assess the efficacy and safety of the N-acetylcysteine augmentation.


Eligibility Criteria:
Inclusion Criteria:

* 20-65 year-old male or female
* Posttraumatic stress disorder diagnosed by SCID-IV
* Written informed consent

Exclusion Criteria:

* Medication treatment for posttraumatic stress disorder within 2 weeks
* Neurologic disease (eg., penetrating or open head injury, epilepsy, multiple sclerosis, brain tumor, cerebrovascular diseases)
* Any other axis I psychiatric disorder
* IQ below 80
* Contraindications to magnetic resosnance imaging (e.g., pacemaker implantation, claustrophobia, etc.)
* Any psychotropic medication within 2 weeks
* Unstable medical illness or severe abnormality in laboratory test at screening assessment
* Women who are pregnant, breastfeeding, or planning pregnancy
* History of myocardial infarction within 6 months
* Current diagnosis of duodenal ulcer or asthma
* Contraindications to drugs used in the study (e.g., epilepsy, uncontrolled narrow-angle glaucoma, etc.)
* Allergy or intolerance to the study drug
Response Assessment During MR-guided Radiation Therapy for Glioblastoma

The study seeks to assess the response of glioblastoma multiforme to treatment using weekly low field (0.35 T) MR-images of the brain at a MRIdian® linac system during standard radiotherapy at the same system. A total of 20 patients in a single arm will be recruited for this investigation.

The imaging data will be used to evaluate the change in tumor volume over the course of the treatment and to perform radiomics in order to investigate the possibility of response prediction using these images.

In order to assure sufficient image quality, prior to the main investigation, a group of up to 20 volunteers has MR scans taken with identical sequences to the main study phase.


Eligibility Criteria:
Inclusion criteria patients:

Subjects fulfilling all of the following criteria are eligible for the study:

* Informed Consent as documented by signature according to Swiss law and ICH/GCP regulations before any trial specific procedures (Appendix I Informed Consent Form)
* Histologically confirmed diagnosis of GBM
* Indication for fractionated radiation therapy for GBM
* Age: ≥ 18 years old
* Gender: any
* Karnofsky performance status ≥60
* Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures

Exclusion criteria

* The presence of any one of the following criteria will lead to exclusion of the subject:
* Previous cranial radiation therapy
* Contraindications to MR examinations, e.g., non-compatible implantable device or metallic foreign bodies
* Inability to complete MR examination due to claustrophobic anxiety
* Women who are pregnant or breast feeding,
* Intention to become pregnant during the course of the study
* Lack of safe contraception, defined as: Female subjects of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female subjects who are surgically sterilized / hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides

The primary purpose of this study is to test the effect and safety of three different doses of ABT-143 compared to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol ("bad cholesterol") and triglycerides.

There are 4 treatment groups in the study: ABT-143 capsules 20/135 mg, ABT-143 capsules 10/135 mg, ABT-143 5/135 mg, and simvastatin capsules 40 mg. The primary outcome measure only compares 2 of these groups: ABT-143 capsules 20/135 mg and the simvastatin capsules 40 mg groups, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure . Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 10/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 10/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 5/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 5/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. For the other pre-specified outcome measures, median percent change in triglycerides from baseline to the final visit and mean percent change in HDL-C from baseline to the final visit for the full analysis sets, all 3 ABT-143 capsules 20/135 mg, 10/135 mg, and 5/135 mg groups were compared to the simvastatin capsules 40 mg group, therefore there are results for all 4 treatment groups for these outcome measures.

Eligibility Criteria:
Inclusion Criteria

* Participants with hypercholesterolemia and hypertriglyceridemia.
* Participants had the following fasting lipid results following a greater than or equal to 12 hour fasting period (measured at the Screening Visit(s)):

  * Triglycerides level greater than or equal to 150 milligrams/deciliter (mg/dL) and less than 400 milligrams/deciliter, and
  * Low-density lipoprotein cholesterol greater than or equal to 160 milligrams/deciliter and less than or equal to 240 milligrams/deciliter.

Exclusion Criteria

* Participants with certain chronic or unstable medical conditions.
* Participants receiving coumarin anticoagulants, systemic cyclosporins, or certain other medications.
* Pregnant or lactating women, or women intending to become pregnant.
* Participants with diabetes mellitus that is poorly controlled.
* Participant was of Asian ancestry (having Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian origin).
TrueTear in Sjogren's Disease Patients

The purpose of this study is to evaluate acute tear production produced by the intranasal tear neurostimulator in participants with Sjögrens syndrome and aqueous tear deficiency. Our primary goal is to evaluate whether Sjögrens patients respond to this intervention and whether there is a baseline tear production level below which these patients do not respond.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Sjögren's syndrome based on American-European Consensus Group (AECG) American College of Rheumatology (ACR), or American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria
* Baseline Schirmer score (with topical anesthesia) of ≤10 mm/5 min and retest value (during nasal stimulation with cotton swab) of at least 4 mm/5min higher than baseline value
* Baseline Ocular Surface Disease Index® (OSDI) total score ≥13
* Age greater than or equal to 22 years old
* Able to complete questionnaires independently
* Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

Exclusion Criteria:

* Use of any topical ophthalmic medication, including artificial tears, within 4 hours of either visit
* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
* Use of systemic anticoagulants
* Nasal or sinus surgery including nasal cautery or significant trauma
* Severely deviated septum
* Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
* Have an active implanted metallic or active implanted electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
* Known hypersensitivity to any of the procedural agents or materials in the study device that contact the nasal mucosa
* Corneal transplant in either or both eyes
* Participation in any clinical trial within 30 days of the Screening Visit
* A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit
Paceport Swan-Ganz Data Collection Study

In association with Edwards LifeSciences, the study will aim to develop an algorithm based on right heart (right atrial, right ventricular and pulmonary artery) waveforms for the early detection of RV dysfunction in cardiothoracic and liver surgery patients at UMMC. This is a prospective, non-interventional, observational study.


Eligibility Criteria:
Inclusion Criteria:

1. Be ≥ 18 years of age presenting to the University of Minnesota Medical Center undergoing any cardiac surgery with cardiopulmonary bypass (CPB) or liver transplantation
2. Participate in the Informed Consent process and sign/date the approved informed consent forms
3. Projected to receive Swan-Ganz paceport catheter as part of procedure/standard of care with intermittent cardiac output and mixed venous oxygen saturation (SvO2) measures

Exclusion Criteria:

1. Patients with a history of internal jugular vein thrombosis or known reasons for not being able to thread a central venous catheter through either internal jugular vein
2. Patients with a history of known esophageal strictures, esophageal or stomach cancer, esophageal varices, or any patient in whom a TEE is contraindicated
3. Patients with permanent pacemakers whose right ventricle is being paced and not in normal sinus rhythm
4. Patients unable to consent to participating in the study
5. Patients who are pregnant will be excluded, as part of standard care, all female patients are screened for pregnancy prior to surgery
6. Patients under the age of 18 years old
7. Patients with left bundle branch block, recurrent sepsis, or hypercoagulopathy
8. Patients allergic to FORE-SIGHT Elite sensor adhesive
9. Patients with latex allergy due to presence of latex in the Swan-Ganz catheter balloon.
A Motor Learning Intervention to Target Walking Performance in Ambulant Children With Cerebral Palsy

The goal of this clinical trial is to learn if a new therapy approach to improve walking ability in children with Cerebral Palsy is acceptable to the children and the families in a community setting.

The main questions we look to answer are:

1. Do the children/teens tolerate the therapy and feel that it is helpful?
2. Do the parents/ families feel the therapy helps and is easy to commit to?
3. Do the children/teens complete all their therapy sessions and assessments as planned?

The participants will trial the therapy for 30 hours over 6 weeks and will perform assessments before and after to see if they meet their goals. They will also be interviewed to see how they felt about the therapy when they finish.

The therapy being trialed in this study uses motor learning theory to try and improve or change walking patterns to improve the child/teen's walking goal.

Therapy will target their own walking goal and they can choose the format of their therapy as long as they complete 30 hours of which 24 hours must be in the clinic within a 6 week period.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Cerebral Palsy (GMFCS Levels I-III)
* Has a specific walking related goal
* Has capacity to follow instruction
* Has a primary caregiver who can support a home program

Exclusion Criteria:

* Has had surgery within 6 months of intervention start date
* Has had botox/ baclofen within 3 months of intervention start date
* Has a dual diagnosis that impacts ability to follow instruction
* Has a significant cognitive impairment
Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors

This study is an Open-Label, Phase 1/2a, First-in-Human, Dose-Escalation, Dose-Expansion, and Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 and older.
2. Capable of giving signed informed consent.
3. Diagnosed with particular disease characteristics.
4. Expected survival ≥ 3 months.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
6. A female patient is eligible to participate if she is not pregnant or breastfeeding.
7. A male patient is eligible to participate if he agrees to remain abstinent or use a male condom when having sexual intercourse with a WOCBP, or if he has had a bilateral vasectomy.
8. Have measurable disease by revised RECIST v1.1 criteria.

Exclusion Criteria:

1. Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption.
2. Current enrollment or past participation in another clinical trial.
3. Unresolved adverse reactions (except alopecia) from previous cancer-directed therapy.
4. Use of cancer-directed therapies, including chimeric antigen receptor T cell therapy.
5. Autologous transplantation within 60 days.
6. Prior allogeneic transplantation.
7. Major surgery within 30 days, or unresolved complications after a major or minor surgery.
8. History of or currently active cardiovascular disease.
9. Clinically significant respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
10. History of other malignancy.
Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects

A single-arm study to observe NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System hemodynamic and other physiologic effects.


Eligibility Criteria:
Inclusion Criteria:

* Normal sinus rhythm by ECG
* Men and women 21-75 years old
* Patients with stable symptomatic heart failure, New York Heart Association (NYHA) class II, III, or IV.

Exclusion Criteria:

* Systolic Blood Pressure \< 90 mmHg or \> 160 mmHg
* Current amiodarone therapy or any other antiarrhythmic therapy
* Coronary artery bypass graft surgery or percutaneous coronary intervention within prior 1 month
* Enzyme-positive MI within prior 1 month
* Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment (measured from release)
* History of recent severe ventricular arrhythmias
* Pre-existing carotid artery or cerebral disease
* Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
* Patients with prior vagalotomy
* Patients with current or prior vagal nerve stimulators
* Subjects with narrow angle glaucoma
* Renal failure - on dialysis or serum creatinine \> 2.0 mg/dl
* Hepatic failure - bilirubin, SGOT, or SGPT \> 4X upper limit of normal
* Patients with a life expectance \< 12 months per physician judgment
* Women who are pregnant
* Allergy to fentanyl, midazolam, propofol, eggs, egg products, soybeans, or soy products
* Subjects unwilling or unable to provide consent for the protocol
A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain

This will be a randomized blinded clinical trial. Patients will be randomized to receive either a remifentanil or dexmedetomidine infusion for general anesthesia. The anesthesia team will know the result of randomization at induction. Data will be gathered by research personnel who will be blinded to the anesthetic method used. Patients will be blinded to the anesthetic they receive till they are discharged from the PACU when they will have the option to be unblinded. The Data Safety and -Toxicity Committee will review all serious adverse events and toxicity reports as well as annual reviews.

Anesthesia for craniotomy presents a unique challenge to the anesthesiologist. Anesthesia for neurosurgical procedures should provide optimal surgical conditions while maintaining appropriate cerebral oxygen supply and stable systemic hemodynamics. (1) It is important to prevent patient response to noxious stimuli during the procedure like pinning, drilling of the bone, opening and manipulation of the dura etc., avoid coughing and bucking during surgery and during extubation thus necessitating a deeper level of anesthesia and analgesia. At the same time it is desirable to have the patient fully awake toward the end of the surgery in order to facilitate neurologic evaluation. Management of the above presents a challenge during induction, maintenance and extubation and also during multiple critical stages of surgery Fear of the side effects of analgesic drugs frequently leads to the under-treatment of post-craniotomy pain. (2) Nevertheless, this pain continues to be commonly observed, is frequently severe, and, if unrelieved, may cause distress for the neurosurgical patient and serious complications for the operative brain. (2) There is a need for larger trials to delineate safety and efficacy of analgesic therapies with a focus on short- and long-term outcomes.

Eligibility Criteria:
Inclusion Criteria:

Patients who undergo general anesthesia for elective surgical excision of a brain tumor with following specifications:

* Age: Older than 18
* Primary and redo cases will be included
* Duration of surgery not exceeding 6 hrs.

Exclusion Criteria:

* Patient refusal
* Emergency craniotomy
* Morbid obesity
* Uncontrolled hypertension - DBP more than 110
* Cardiac conduction defects
* Patients with chronic pain.