cyrilzakka/clinical-trials huggingface dataset:
Intracoronary Human Wharton's Jelly- Derived Mesenchymal Stem Cells (WJ-MSCs) Transfer in Patients With Acute Myocardial Infarction (AMI)

The purpose of this study is to investigate the safety and efficacy of intracoronary human umbilical Wharton's jelly-derived mesenchymal stem cell (WJ-MSC) transfer in patients with ST-segment elevation acute myocardial infarction.

It has been demonstrated that MSCs have the potential to differentiate into cardiomyocytes both in vitro and in vivo. Several clinical trials have been performed using autologous bone marrow-derived MSCs, but the results of these trials have been unsatisfactory because of a low number of MSCs in older patients and in those with coronary heart disease. WJ-MSCs from the human umbilical cord matrix which are of epiblastic origin and contain both human embryonic stem cell (hESC) and human mesenchymal stem cell markers appear to have a number of important advantages: they do not raise ethical issues, are widely multipotent, are not tumorigenic, and are not immunogenetic. Because of a short population doubling time they can be rapidly scaled up in large numbers. We performed a double-blind, placebo-controlled, multicenter trial, randomly assigning 160 patients with acute ST-segment elevation myocardial infarction to receive an intracoronary infusion of WJ-MSCs or placebo medium into the infarct artery 4-7 days after successful reperfusion therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients at least 18 years of age；
2. Patients with 1st acute ST-elevation myocardial infarction (AMI) who undergo successful primary percutaneous coronary intervention (PCI) thrombolysis in myocardial infarction (TIMI) flow grade 3, but have a substantial residual left ventricular regional wall-motion abnormality measured by 2-D echocardiography.
3. No contraindications to undergoing cell-therapy procedure within 1 weeks after AMI and PCI.
4. Hemodynamic stability-defined as no requirement for intra-aortic balloon pump or for inotropic or blood-pressure supporting medications.
5. Consent to protocol and agree to comply with all follow-up visits and studies.

Exclusion Criteria:

1. Presence of cardiogenic shock ( defined as systolic blood pressure \< 80 mmHg requiring intravenous pressors or intra-aortic balloon counterpulsation);
2. Major bleeding requiring blood transfusion after acute reperfusion treatment;
3. A history of leucopenia;
4. Thrombocytopenia;
5. Hepatic or renal dysfunction;
6. Evidence for malignant diseases;
7. Unwillingness to participate;
Blood Pressure Monitor Clinical Test (Cuff Range: 13.5cm-22cm)

The purpose of this study is to verify the accurancy of the blood pressure monitor device.

Cuff size of arm circumference: 13.5cm- 22cm.


Eligibility Criteria:
Inclusion Criteria:

* Normal blood pressure and hypertensive patients over 12 years old

Exclusion Criteria:

* Patients with serious arrhythmias or a high frequency of arrhythmias
* pregnant woman
* Other investigators believe that it is not suitable to participate in this clinical trial
Acute Regulation of Parathyroid Hormone by Dietary Phosphate

Patients with end stage renal disease often have secondary hyperparathyroidism due to high phosphorus and low calcium levels in the blood. Preliminary animal studies and our initial human study indicate that the parathyroid hormone levels may change quickly based on the ingestion of phosphorus, prior to any change in the blood levels of calcium or phosphorus. This follow-up study will attempt to determine if the effect is independent of an increase in the blood glucose level. If so, this would suggest an as yet unidentified gastrointestinal receptor that mediates parathyroid hormone levels. This may affect the timing of administration and the type of phosphate binder used in treating patients with secondary hyperparathyroidism. The knowledge that parathyroid hormone levels can change acutely may also affect the recommended timing of blood samples

This study is observational and no drugs or other interventions will be used. The population targeted in this study will be adult patients already on chronic hemodialysis with a diagnosis of secondary hyperparathyroidism. Experimental design will involve the use of a glucose clamp to maintain a constant, mild increase in blood glucose levels. Frequent, scheduled lab tests will be obtained during the period of hyperglycemia to evaluate phosphorous, calcium, and glucose levels and the relationship of any change in their values to changes in the parathyroid hormone level. The primary outcome will be to evaluate for any change in the parathyroid hormone level in the presence of hyperglycemia and to compare these results to that of our initial study

Eligibility Criteria:
1. Patients 21 years of age or older
2. Receiving treatment with hemodialysis for at least 90 days.
3. Serum parathyroid hormone level greater than 200 pg/ml
4. Serum phosphorus level greater than 4 mg/dl
Assessment of Response to NCRT for GEJ Cancer Using a Fully Integrated PET/MRI

Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT).

This is a prospective, observational single center study which plans to enroll patients with biopsy proven potentially resectable esophageal or junctional cancer scheduled to receive nCRT (CROSS regimen) prior to surgery.

The study aims to evaluate Routine pre-treatment work-up includes PET to stage the tumour extension.

* PET/MRI (Magnetic resonance imaging) will replace the PET component of CT(computed tomography)
* An additional intermediate 18-FDG (Fluorodeoxyglucose) PET/MRI will be performed during nCRT
* Post nCRT imaging, as required prior to surgery, will be PET/MRI six weeks after treatment completion.
* 8-12 weeks post nCRT completion surgery will be performed, based on each patient's performance status and response to nCRT
* Histopathological samples of the excised tumor and lymph nodes will be used for diagnosis, staging and description of qualitative and quantitative parameters Routine clinical and radiological follow-up for 24 months (for the scope of this study) will follow the standard clinical workflow assigned to this group of patients.

Eligibility Criteria:
Inclusion Criteria:

* biopsy-proven esophageal or junctional carcinomas (either adenocarcinoma (AC) or squamous cell carcinoma (SCC) for which an Ivor-Lewis transthoracic esophagectomy with supramesocolic and mediastinal lymphadenectomy is indicated;
* visible tumor on pre-treatment imaging;
* ≥ 18 years of age;
* signed informed consent.

Exclusion Criteria:

* - incomplete preoperative imaging assessment;
* contraindications to neoadjuvant treatment;
* contraindications to preoperative imaging (such as pacemaker, allergy to contrast agents);
* inability to complete imaging examinations (i.e. severe claustrophobia);
* contraindication to surgery (comorbidities, distant metastatic disease (imaging confirmed));
* pregnant or lactating women
* severe hypersensitivity to gadobutrol or fludeoxyglucose F18.
Study To Evaluate The Pharmacokinetic, Safety And Tolerability Of Single Or Multiple Subcutaneous Doses of Recifercept

This will be a single center, randomized, parallel group, repeated dose study of recifercept (Cohort 1 and Cohort 2) or placebo (only in Cohort 1) in approximately 18 healthy participants, using 2 cohorts (N = 9) at two dose levels of recifercept.


Eligibility Criteria:
Inclusion Criteria:

* Male participants and female participants of nonchildbearing potential
* Participants who are overtly healthy
* Capable of giving signed informed consent

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing
Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy of apatinib mesylate combined with pemetrexed alone in advanced non-small cell lung cancer patients in the second or second line of treatment of progression-free survival

It is a one-arm study. The progression-free survival will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Aged from 18 years to 70years.
2. Histologically or cytologically confirmed non-squamous non-small cell lung cancer(stage IIIB/IV).
3. Measurable lesions as defined by RECIST criteria.
4. Locally advanced lung cancer cannot treat with surgery, recurrent or metastatic lung cancer
5. ECOG performance status (PS) of 0 to 1.
6. Life expectancy ≥3 months.
7. Informed consent.

Exclusion Criteria:

1. Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer.
2. Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
3. Tumor invade big vessels or close to big vessels (less than 5mm)
4. Obvious cavity or necrosis formed in the tumor
5. Uncontrolled hypertension
6. Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
7. Abnormal coagulation (INR\>1.5 or PT\>ULN+4, or APTT\>1.5 ULN), bleeding tendency or receiving coagulation therapy
8. The active HBV or HCV infection
9. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.
10. Hemoptysis, more than 2.5ml daily
11. Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
12. Unhealed bone fracture or wound for long time
13. Received big surgery, had bone fracture or ulcer in 4 weeks.
14. Urine protein≥++, or urine protein in 24 hours≥1.0g
15. Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment
16. Have received prior treatment with VEGFR TKI (Bevacizumab is permitted).
17. Pregnant or lactating woman, or woman unwilling to practice contraception during the study.
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination, as judged by the investigator
* Body Mass Index (BMI) between 19.0-30.0 kg/m\^2
* Glycohemoglobin (HbA1c) within laboratory normal range
* Non-smokers

Exclusion Criteria:

* Clinically significant abnormal haematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
* Liver enzyme values (ALAT and ASAT) exceeding 2 times the upper reference limit according to the local laboratory
* A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the trial or pose additional risk in administering the investigational product to the subject
* History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive urine drug screen and breath alcohol screen)
* HIV (human immunodeficiency virus), Hepatitis B or C positive
* Subjects with a first-degree relative with diabetes mellitus
* A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions
* Known or suspected allergy to trial product or related products
* Smoking during the past three months
Explore the Short- and Mid-term Effects of Fespixon in Scar Cosmesis Following Cervical or Abdominal Surgery

The aim of this study is to evaluate the efficacy of the Fespixon cream for prevention and/or appearance reduction of different types of linear scars during the 12-week treatment phase, which is assessed by the blinded independent evaluator.

Methods: This study was designed as a prospective, double-blind, placebo-controlled trial involving 50 patients with linear scars. Bounded by the midpoint of the scar, each patient received a topical scar formulation consisting of fespixon cream on one side of scar, and placebo cream on the other side of scar. Treatment was given twice a day for 84 days. Assessments of the scars were performed at visit 1, 2, 3 following the onset of topical application using three methods: a clinical assessment using the Vancouver Scar Scale/ modified Vancouver Scar Scale, a photographic assessment to establish before and after treatment improvements, and at the end of the study period, patients completed a final satisfaction questionnaire.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged over 20 years old (inclusive).
2. Subjects with linear scar in neck or abdomen following elective surgery, including thyroid and parathyroid surgery, excision of neck mass, caesarean section, trans-abdominal hysterectomy, trans-abdominal myomectomy or any neck or abdominal surgeries which can be managed by primary closure of clean surgical wounds.

Exclusion Criteria:

1. Subjects who have previous neck or abdominal trauma that will affect the surgical incision site.
2. After radiation therapy for cervical/abdominal cancer, or previous medical history with chemo-therapy or targeted therapy for any reason.
3. Laboratory values at Screening of:

   Note: The investigator will decide which of the following laboratory tests should be performed considering the condition of the subject.
   1. Albumin \< 2.5 g/dL (for subjects with severe malnutrition)
   2. HbA1c \>12.0% (for subjects with severe diabetes)
   3. Liver function test \[ aspartate aminotransferase (AST) and alanine transaminase (ALT)\] \> 3x the upper limit of normal
   4. Renal function test \[Serum Creatinine\] \> 2x the upper limit of normal
4. Subject is currently receiving immunosuppressant or systemic corticosteroids.
5. Has any other factor which may, in the opinion of the investigator, compromise participation in the study.(Including subjects with medical history of keloid or hypertrophic scar).
To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.

The purpose of this study is to determine whether Forlax® is more effective than placebo in relieving chronic constipation in children who may also suffer from soiling or faecal incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Chronic constipation (defined as at least 3 months of less than 2 bowel movements (BMs) per week and/or one of the following symptoms : hard stool, painful defecation, encopresis)
* Constipation previously treated by dietary advice (high fiber diet) for at least two weeks without efficacy

Exclusion Criteria:

* Organic bowel diseases
* Suspected GI obstruction
* History of GI surgery
Psychometric Evaluation in Patients With Brain Damage During Neuroinflammation

The presence of a damage to the central and / or peripheral nervous system resulting from diseases of a different nature (such as, Multiple Sclerosis, Parkinson's disease, dementia, head trauma, stroke, epilepsy or other neurological syndromes) is commonly cause of both physical than mental disability. The evaluation of certain domains may be more difficult so, specific assessment tools are necessary to analyze them.

The presence of a damage to the central and / or peripheral nervous system resulting from diseases of a different nature (such as, Multiple Sclerosis, Parkinson's disease, dementia, head trauma, stroke, epilepsy or other neurological syndromes) is commonly cause of both physical than mental disability. The presence of cognitive deficits in the sphere of memory or language is often evident at a first clinical examination. However, the evaluation of certain domains such as mood disorders, behavior, sleep-wake cycle or eating habits, may be less evident, even if they have a very strong impact on the quality of life of patients. Specific assessment tools are therefore needed such as psychometric tests, to collect information and analyze the results.

The main evaluation scales we will use are the Beck Depression Inventory-II (BDI II), the State-Trait Anxiety Inventory (STAI), The twenty-item Toronto Alexithymia scale- I (TAS-20), The fatigue severity scale (FSS), Modified Fatigue Impact Scale (MFIS), The Multiple Sclerosis Impact Scale (MSIS-29), The Epworth Sleepiness Scale (ESS), The Pittsburgh Sleep Quality Index (PSQ1), The Multiple Sclerosis quality of life Inventory (MSQOLI), The work productivity and activity impairment instrument (WPAI), Frailty Index.

These rating scales will be administered in person, by telephone and / or by sending them electronically.

Eligibility Criteria:
Inclusion Criteria:

* Presence of brain damage resulting from: Multiple Sclerosis, Parkinson's Disease, Dementia, head trauma, neurosurgery, Stroke, Epilepsy or other neurological syndromes (for the experimental group only);
* Be able to perform the tests to be administered for the duration of the study;
* Patients must be able to follow protocol directions throughout the study;
* Patients must be able to understand the purpose of the study;
* Signature of informed consent, approved by our Ethics Committee.

Exclusion Criteria:

* Inability, even partial, to understand and want;
* Patients with other pathologies that in the opinion of the scientific responsible prevent their recruitment
Comparative Performance of PureVision Lens Designs

The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous wear basis


Eligibility Criteria:
Inclusion Criteria:

* subject is myopic
* VA correctable to 0.3 logMAR or better (driving vision)
* Clear central cornea

Exclusion Criteria:

* Systemic disease affecting ocular health
* using systemic or topical medications
* wear monovision, multifocal or toric contact lenses
* Any grade 2 or greater slit lamp findings
Effect of Dietary Components on Gastrointestinal Side Effects Induced by Orlistat, a Lipase Inhibitor

The objective of the Orlifat trial is to investigate if dietary fibres from linseeds and dairy calcium (Capolac ®) may reduce gastrointestinal side effects related to increased fecal fat content, induced by treatment with Alli® (orlistat). Secondly, effect on food intake, anthropometry, Quality of Life and cardiovascular risk markers will be evaluated. The trial is designed as a randomised 2 x 2 factorial 13-weeks parallel intervention, in which 72 obese participants will be randomised to supplementation with flaxseed fibres and/or dairy calcium concentrate (Capolac) in addition to treatment with Alli ®:

1. Alli® (60 mg t.i.d) plus placebo (rice flour)
2. Alli® plus 5 g flaxseed fibers
3. Alli® plus 1200 mg Ca from Capolac
4. Alli® plus 5 g flaxseed fibers and 1200 mg Ca from Capolac


Eligibility Criteria:
Inclusion Criteria:

* 20-60 years of age
* men and women
* BMI 30-40 kg/m2

Exclusion Criteria:

* Dairy allergy and/or intolerance, allergy to Orlistat
* Infectious and metabolic diseases
* Gastrointestinal diseases (previous and current)
* Troubles swallowing tablets and capsules
* Dietary supplement use during the trial and 1 month prior to the trial
* Postmenopausal (selfreported)
* Pregnancy and lactation
* Treatment with oral anticoagulation medications, ciclosporin, levothyroxin, antiepileptika, acarbose and amiodaron
* Prescription medication will be considered on an individual basis at the screening visit according to SOP
* Dieting or other changes of diet within 3 months
* Participation in other trials
Single Tooth Restoration in the Maxilla Using the Straumann® PURE® Ceramic Implant Monotype: One Year Follow up

The main objective is to evaluate peri-implant hard and soft tissues's stability with the use of a ceramic implant (Implant Straumann®Pure Ceramic) during one year follow up.

Nowadays, the material of choice for the manufacture of dental implants is titanium. However, if we consider the aesthetics, the use of metallic implants can lead to complications, namely metal translucency through the peri-implant mucosa or the presence of soft tissue recessions causing metal exposure. As an alternative to the use of titanium, we have zirconium, that is highly biocompatible and whose use in implantology has demonstrated a predictable osseointegration. In addition, some studies suggest a different histology that could help maintaining the stability of the peri-implant mucosa and, therefore, an improvement in long-term aesthetic results.

The reason for designing this study is that there is not too much data about this type of implants, that can be, really, an alternative to those we know.

To achieve those objectives a single-arm clinical trial is designed, using marginal bone loss as a primary response variable. It is estimated with the calculation of the sample size, we would need 30 patients to get relevant data.

An experienced surgeon (M.V) will perform implant surgery. Later, experienced and calibrated examiners (R.E and E.RG) will collect the following clinical parameters at baseline, and at 4, 8 and 12 months: gingival recession, papillary Jemt index, width and height of the keratinized gingiva, probing depth, plaque index and bleeding on probing.

Finally, a blind statistic (X.M) will analyze the data using the SPSS software, having as unit of analysis the implant.

Eligibility Criteria:
Inclusion Criteria:

* Patients of the Master of Periodontology of the UPV/EHU
* Age \> 18 years
* Patient with one single tooth gap in the anterior maxilla
* Plaque and bleeding index (FMPS \< 20%).
* Treated periodontal conditions
* The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent

Exclusion Criteria:

* General contraindications for dental and/or surgical treatment are present.
* The patient is taking medications or having treatments which have an effect on healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
* Untreated periodontal conditions
* Patients not willing to participate
Effect of Exercise Before Gastric Bypass

Exercise training is proved to protect against premature cardiovascular mortality. Additionally there is evidence that relatively high exercise intensity may be an important factor for improving aerobic capacity and endothelial function in patients with post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in overweight and obese individuals.

The aims of this study is to investigate if High-intensity exercise before a gastric bypass operation will decrease hospitalization days and complications after the gastric bypass.


Eligibility Criteria:
Inclusion Criteria:

* Age: \> 20 years
* BMI: \> 40 or \> 35 with comorbidity
* Resident: Sør Trøndelag

Exclusion Criteria:

* Unstable Angina
* Resent cardiac infarction (within last year)
* heart failure
* Uncontrolled hypertension
* cardiomyopathy