cyrilzakka/clinical-trials huggingface dataset:
Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients

Pain is a major complaint in hemodialysis (HD) patients. Concentrations of parathyroid hormone (PTH) \>250 pg/ml are associated with chronic pain. Visual Analogue Scale (VAS) score which is used to assess the pain severity is positively related to PTH levels. This study is aimed to assess the effects of multiple mega dosages vitamin D supplementations in HD patients with chronic pain. It's a single-center, parallel, double-blind randomized control trial that administrations of 576,000 IU once a week of vitamin D3 for 4 weeks or placebo are for 120 eligible subjects. VAS and laboratory tests including serum concentrations of 25(OH)D, calcium, phosphorus, PTH and C-reactive protein will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Haemodialysis subject ≥ 20 years old
2. iPTH \> 250 pg/mL
3. Chronic pain with visual analogue scale (VAS) score ≥ 4
4. Voluntary to check serum 25(OH)D levels two times by his/her own payment during the study
5. Sign the informed consent

Exclusion Criteria:

1. Used to participate in other clinical trials
2. Chronic liver disease
3. Sarcoidosis or multiple myeloma
Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran

To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075 dose(s) effective to reverse prolongation of blood coagulation time by dabigatran


Eligibility Criteria:
Inclusion criteria:

* Healthy midage male and female volunteers, age =45 and =64 years, BMI range: =18.5 and =29.9 kg/m2
* Healthy elderly male and female volunteers, age =65 and =80 years, BMI range: =18.5 and = 32 kg/m2
* Male and female volunteers with mild renal impairment (CLcrd 60-90 (mL/min)) in relatively good health, age =45 and =80 years, BMI range: =18.5 and =32 kg/m2 Moderate renal impaired (CLcrd =30 to \<60 mL/min according Cockcroft\&Gault formula in relatively good health, age =45 and =80 years, BMI range: =18.5 and =32 kg/m2

Exclusion criteria:

* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease (other than mild renal impairment in the respective group) A significant disease is defined as a disease which in the opinion of the investigator
* put the volunteer at risk because of participation in the study
* may influence the results of the study
* may influence the volunteer¿s ability to participate in the study
* is not in a stable condition Diabetic, hypercholesterolemia or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts.
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT Imaging in the Same Group of Prostate Cancer Patients

18F-labeled prostate-specific membrane antigen (PSMA) ligand-positron emission tomography (PET) offers advantages over 68Ga-labeled PSMA ligands. Al18F-PSMA-617 is a novel 18F-PSMA compound used for prostate cancer (PCa) imaging. This pilot study was prospectively designed to compare the lesion detectability of Al18F-PSMA-617 and related 68Ga-PSMA-617 PET/CT in patients with PCa

Prostate cancer (PC) is one of the most common malignancies worldwide in men, with persistently high numbers dying from this disease. Due to low levels of glycolysis in prostate cancer cell, the uses of 18F-FDG PET/CT to detect prostate cancer and its metastases are limited. Prostate specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. Various low molecular weight radiopharmaceuticals targeting PSMA such as PSMA-617, PSMA-11 for 68Ga-labeling have been developed. 68Ga-PSMA PET/CT has demonstrated desirable sensitivity and specificity in the detection of prostate cancer lesions, which can find many micro lesions that cannot be identified by CT, MRI and bone scan. Al18F-PSMA-617 is a novel radiopharmaceutical targeting PSMA. Liu T et.al had demonstrated that Al18F-PSMA-617 accumulates specifically in PSMA-positive tumors with high binding affinity and selectivity. The first in-human evaluation of Al18F-PSMA-617 in a small PCa sample size also confirmed the good detectability of tumor lesions. This pilot study was prospectively designed to evaluate the early dynamic distribution of Al18F-PSMA-617 compared with 68Ga-PSMA-617 in the same group of prostate cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* confirmed untreated prostate cancer patients;

  * 68Ga-PSMA617 and Al18F-PSMA-617 PET/CT within two consecutive days;
  * signed written consent.

Exclusion Criteria:

* known allergy against PSMA; • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis

* Evaluation of the microbiota modulation away from inflammation associated microbiota profile Bacteroides2 (Bact2)
* Evaluation of the microbiota modulation potential of statins in Bact2- enterotyped, healthy volunteers and ulcerative colitis patients.
* Evaluation of the effect of microbiota modulation on disease activity in ulcerative colitis patients.
* Evaluation of reduced inflammatory parameters of participants involved in trial


Eligibility Criteria:
Inclusion Criteria:

* General criteria

  * Bact2 enterotyped one month before start of study intervention (at least 150 of enrolled participants must meet this criteria)
  * Willingness to participate in the study and to sign the informed consent (Dutch)
  * Between 18 and 70 years old
  * Access to a -20°C freezer Criteria specific to UC patients
  * Patients in remission (mayo score below 4) or with currently mild to moderate active ulcerative colitis (defined by Mayo score of 4-10), despite stable medication (8 weeks) and a Mayo endoscopic sub-score 2- 3 at week 0 Criteria specific to healthy Bact2 participants
  * Individuals with no physician diagnosed diseases or disorders

Exclusion Criteria:

* General criteria

  * Prior and/or ongoing use of statins before study start
  * History of surgical intervention in gastrointestinal tract (appendectomies are allowed)
  * Females who are pregnant or actively trying to become pregnant
  * Individuals with active liver disease including unexplained persistent elevations of serum transaminases and any serum transaminases elevation exceeding three times the upper limit of normal (ULN)
  * Lactose intolerance
  * Pre-diabetic participants
  * Personal or family history of hereditary muscular disorders
  * Individuals with a history of or diagnosed with alcohol abuse Criteria specific to UC patients
  * Other conditions leading to profound immunosuppression such as HIV, infectious diseases leading to immunosuppression, bone marrow malignancies, liver cirrhosis
  * A diagnosis of Crohn's disease or indeterminate colitis
  * Individuals with hypothyroidism
  * Individuals with a diagnosis of diabetes mellitus
  * Individuals with severe renal impairment (creatinine clearance \<30 ml/min)
  * Individuals with myopathy
  * Participants who have taken antibiotics sometime in the past four months
  * Use of antibiotics one month prior to week 0
  * Steroid dependency and requiring \>16mg Medrol (methyl prednisone) or equivalent two week before week 0 Criteria specific to healthy Bact2 participants
  * Participants with family history of autoimmune chronic inflammatory diseases like multiple sclerosis, IBD, and rheumatoid arthritis
Registry With Information About Colitis Ulcerosa and Familial Adenomatous Polyposis Patients

The purpose of this registry is to collect information about patients in which a pouch has been created to improve in the future the quality of the surgery of the pouch.

To improve the quality of the surgery of the pouch created in CU and FAP patients, the following information will be collected: Patients Characteristics, Operative Data, Postoperative Outcome and Functional Postoperative Recovery.

Eligibility Criteria:
Inclusion Criteria:

* Colitis Ulcerosa or Familial Adenomatous Polyposis Patients With IPAA

Exclusion Criteria:

* No
A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in refractory open-angle glaucoma subjects.

Glaukos Corporation conducted a clinical research study at multiple (approximately 7) investigational sites within Europe.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma (POAG)
* Subject on maximally tolerated medical therapy or where noncompliance with medication has been document
* Subject has failed a conventional glaucoma surgical procedure. (trabeculectomy, Trabeculoplasty(ALT), viscocanalostomy, collagen implant)

Exclusion Criteria:

* Angle closure glaucoma
* Fellow eye already enrolled
Feeding Regulation in SCI

The overall purpose of this research is to understand the reasons why persons with spinal cord injuries eat more calories than they need to "burn", stay alive, and function. This research will investigate how quickly food moves through a participant's body, the hormones in the participant's body that control energy and digestion, and a participant's impressions of hunger after eating a meal. This will be compared in persons with and without a spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

Spinal Cord Injury (SCI) Participants:

1. Adults (≥ 18 years) with tetraplegia (C5-C8) or paraplegia (T1-L2) SCI
2. Chronic SCI, denoted as ≥ 12 months post-injury
3. American Spinal Injury Association Impairment Scale164 A, B, and C
4. Persons with tetraplegia self-report they are able to feed themselves
5. Self-report on a bowel care program every-other-day
6. English speaking

Control Group (Healthy) Participants:

1. Adults (≥ 18 years) without a SCI (will be sex- and age-matched to persons with SCI)
2. English speaking

Exclusion Criteria:

For All Participants:

1. Currently on a weight loss program/diet and/or actively trying to lose weight
2. Have a self-reported history of

   * Diabetes
   * Thyroid disease
   * Gastrointestinal disease
   * Previous abdominal surgery ≤ 3 months prior to the study
   * Peripheral nervous system prosthesis
   * Swallowing disorders
3. Self-reported food allergies to or dislike the test meals.
4. Self-reported use of a prokinetic agent, antipsychotic agent, or Glucagon like Peptide 1 (GLP-1) agonists
5. Individuals who are not yet adults (infants, children, teenagers)
6. Women that self-report they are pregnant or likely to become pregnant
7. Prisoners
The Effects of Spinal Mobilizations on Symptoms, Neck 3D Movement, Neck Muscle Electromyography and Sympathetic Nervous System Activity in People With Neck Pain

This study investigates the effects of spinal mobilizations on symptoms, 3D movement of the neck, neck muscle electromyography and sympathetic nervous system activity in people with neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Intermittent neck pain
* That worsens or improves with certain neck movements or positions
* Has not been caused by a blow, fall or accident

Exclusion Criteria:

* Cervicobrachialgia
* Has been treated with or is awaiting neck surgery
* Diagnosed with a particular inflammatory disease or spinal condition
* Where treatment with cervical mobilizations is contraindicated
Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients

Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach.

Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia.

This was a randomized controlled study with 60 CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy. Patients enrolled were randomly divided into the observation group (with IOE, n=30) and the control group (with NGT, n=30). At admission and after treatment, Video Fluoroscopic Swallowing Study (VFSS) and Functional Oral Intake Scale (FOIS), body mass index (BMI), serum albumin (Alb), and hemoglobin (Hb), Modified Barthel Index (MBI) and World Health Organization Quality of Life Assessment Instrument Brief Version (WHOQOL-BREF) were recruited to assess and compare dysphagia, nutritional status, activities of daily living (ADL) and quality of life (QOL). The incidence of pneumonia was recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of CSVD;
* Must be able to cooperate with treatment and questionnaire investigation, (Generally with a Mini-Mental State Examination (MMSE) score ≥ 24) ;
* Clinical diagnosis of dysphagia through the Functional Oral Intake Scale (FOIS) and Video Fluoroscopic Swallowing Study (VFSS);
* Age between 40 and 70 years;
* Enteral nutrition support was required and feasible.
* No history of prior stroke.

Exclusion Criteria:

* Dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases;
* Complicated with severe liver and kidney failure, tumors, or hematological disorders;
* Simultaneously need to undergo other therapy that might affect the outcomes of this study;
* Pregnant or nursing females.
Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia

The purpose of this study is to compare Cinitapride tablets with domperidone tablets (motilium), and to evaluate the efficacy and safety of Cinitapride tablets in the treatment of mild to moderate functional dyspepsia.


Eligibility Criteria:
Inclusion:

1. Aged between 18\~65 years, both males and females;
2. Patients with symptoms of mild to moderate functional dyspepsia;
3. Symptoms related to dyspepsia were developed 6 months ago and early satiety or/and discomfort after meal were developed in the past 3 months;
4. Gastrointestinal malignancy, peptic ulcer, liver, gallbladder and pancreas diseases were excluded through gastroscopy, B-ultrasonography and laboratory examination within 4 weeks prior to administration (endoscopy results considered to be clinically unrelated will not be excluded, such as small hiatal hernia and chronic nonatrophic pangastritis);
5. Patient has signed informed consent form.

Exclusion criteria

1. Patients with gastroesophageal reflux and/or irritable bowel syndrome;
2. Acid regurgitation more than once per week;
3. Previously received abdominal surgery (except appendectomy and herniorrhaphy);
4. A history of gastric or duodenal ulcer;
5. Patients with depression and anxiety neurosis;
6. Patients with arrhythmia;
7. QTc more than 0.5s;
8. Hepatic and renal insufficiency: AST or/and ALT equal to or above 1.5 times of the upper normal limit; Cr above the upper normal limit;
9. Pathological lactorrhea;
10. Patients with alcohol abuse (daily alcohol intake more than 40g), drug dependence or neuropsychiatric disorders that are difficult to control, as well as others who are not appropriate to participate in a drug trial;
11. Pregnant or lactating women;
12. Patients who require other therapy to change gastrointestinal mobility;
13. Patients who are participating or participated in other drug clinical trial within 3 months prior to entry;
14. Known to be allergic to cinitapride; Patients who are considered by investigators to be inappropriate to participate.
Cost Effectiveness Analysis of Critical Care in Resource Limited Setting

The purpose of this study was to examine the cost effectiveness of critical care in a middle income country with limited resources.

The main study hypothesis was that critical care is cost effective in low resources setting.

The investigators objective was to calculate the cost effectiveness of treatment of critically ill patients in a medical ICU of a middle income country with limited access to ICU resources.

Methods: Consecutive critically ill medical patients treated in a recently established medical ICU in Sarajevo, Bosnia and Herzegovina, were prospectively recorded and a subsequent cost utility analysis of intensive care in comparison to hospital ward treatment from the perspective of health care system was performed. Incremental cost effectiveness was calculated using estimates of ICU versus non-ICU treatment effectiveness based on a formal systematic review of published studies. Decision analytic modeling was used to compare treatment alternatives. Sensitivity analyses of the key model parameters were performed.

Eligibility Criteria:
Inclusion Criteria:

* patients treated between June 1 2011 and June 29 2012 in the medical ICU

Exclusion Criteria:

* Patients who stayed in the ICU less than 24 hours and
* hospital readmissions
A Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years

This trial is conducted in the United States of America. The aim of this trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of liraglutide in obese children aged 7 to 11 years


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 7-11 years (both inclusive) at the time of signing informed consent
* Tanner stage 1 (including subjects with premature adrenarche) at the time of signing informed consent
* BMI (body mass index) corresponding to above or equal to 30 kg/m\^2 for adults by international cut-off points (Cole et al 2000)1 and BMI below or equal to 45 kg/m\^2 as well as BMI above or equal to 95th percentile for age and gender

Exclusion Criteria:

* Subjects with secondary causes of childhood obesity (i.e., hypothalamic, genetic or endocrine causes)
* Subjects with confirmed bulimia nervosa disorder
* Diagnosis of type 1 diabetes mellitus or type 2 diabetes mellitus as defined by glycosylated haemoglobin (HbA1C) Above or equal to 6.5 %
* History of pancreatitis (acute or chronic)
* Presence of severe co-morbidities as judged by the investigator
* Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC)
* History of major depressive disorder within 2 years before randomisation
Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy

Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction \>50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages.

Patients will be randomized 1:1 to right ventricular apical pacing vs left septal or deep septal pacing. The primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* First implant of a single-chamber or dual chamber pacemaker due to persistent bradycardia associated with high degree atrio-ventricular (AV) block (complete AV block or second degree type II AV block), with second-degree type I AV block (symptomatic or associated with intra-hisian or infra-hisian block), or with atrial fibrillation with symptomatic slow ventricular rate (\<45lpm).
* LVEF\>50% at echocardiography performed maximum 7 days before pacemaker implant.
* Informed consent signature.

Exclusion Criteria:

* Life expectancy \<12 months
* Severe cardiac valvular abnormality requiring intervention
* Unstable Angina, Acute myocardial infarction, coronary revascularization, valvular surgery or valvular percutaneous intervention in the 90 days prior to pacemaker implant.
* Inclusion in another trial which may influence the results of this study.
Deep Venous Thrombosis Screening in the ICU by Nurses

Despite of preventive measures, the incidence of deep venous thrombosis (DVT) in ICU patients is estimated to range from 5-31%. While clinical diagnostics is unreliable, ultrasound compression test (UCT) has proven to be a highly sensitive and specific modality for the recognition of lower extremity DVT. Delegating this competence to ICU nurses can increase UCT availability and enable preventive DVT screening. Therefore, the investigators decided to conduct a clinical study to evaluate the sensitivity and specificity of UCT performed by general ICU nurse in ICU patients compared to an investigation by ICU physician certified in ultrasound. Prior to the study, each nurse-investigator participating in the study undergo one-hour training in UCT and examine 5 patients under supervision. Then, ICU patients without known DVT will be investigated by UCT in the femoral and popliteal region of both lower extremities by trained general ICU nurse-investigators. On the same day, the examination will be repeated by an ICU physician-investigator. The results of the examinations of each patient will be blinded to each other for both investigators until both tests are performed. The sensitivity and specificity of the test performed by general nurse will be calculated in comparison with the examination by a specialist.


Eligibility Criteria:
Inclusion Criteria:

* all ICU patients without known deep venous thrombosis, hospitalised more than 72 hours

Exclusion Criteria:

* contraindication of compression ultrasound testing
* end-of-life decision regimen of care
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for TBI

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of traumatic brain injury

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Traumatic brain injury (TBI). This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of TBI. Patients with TBI will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of traumatic brain injury
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
* Seizure disorders