cyrilzakka/clinical-trials huggingface dataset:
Effects of Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells on Patients with Rotator Cuff Disease

The purpose of this study is to evaluate safety and efficacy of Allogenic Umbilical Cord-derived Mesenchymal Stem Cell in Patients with Rotator Cuff Disease


Eligibility Criteria:
Inclusion Criteria:

* Male or female 19 years of age and older.
* Patients with unilateral shoulder pain lasting for at least 3months
* Patients who do not respond to conservative treatment.
* Patients who have not responded to sufficient non-surgical treatments, including medication, injection therapy, physical therapy, or exercise therapy, for more than 3 months
* Patients who have a partial-thickness rotator cuff tear confirmed with magnetic resonance imaging (MRI) or ultrasonography (US).
* Patients without any restrictions on clinical trial procedures, including hospitalization.

Exclusion Criteria:

* Patients who have received subacromial injection therapy on the affected shoulder within the past 3 months.
* Patients who have undergone rotator cuff surgery on the affected shoulder within the past 6 months
* Patients with a history of receiving stem cell therapy for the shoulder.
* Patients with the following shoulder conditions: complete rotator cuff tear, adhesive capsulitis, or isolated acromioclavicular joint arthropathy.
* Patients showing or suspected of having the following radiological findings: malignancy, severe osteoarthritis of the glenohumeral joint, or skeletal abnormalities decreasing the subacromial space.
* Patients presenting with symptomatic cervical spine disorders.
* Patients with concurrent bilateral shoulder pain
* Patients with polyarthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia.
* Patients with neurological deficit
* Pregnant women or lactating mothers.
* Patients unwilling to use effective contraception during the clinical trial period.
* Patients with current HBV, HCV, or HIV infections, or those with a positive RPR test.
* Patients with severe diseases that may affect the clinical trial, including cardiovascular disease, renal disease, liver disease, endocrine disorders, or malignancies.
* Patients who are unable to understand the questionnaires used for assessing their clinical status, including the Visual Analogue Scale (VAS), or those with psychiatric disorders impairing communication.
* Patients who do not wish to participate in the clinical trial or are unable to comply with follow-up schedules.
* Patients who have participated in another clinical trial within the last 3 months.
* Patients deemed unsuitable for participation in this clinical trial at the investigator's discretion
Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy

The purpose of this study is to assess the safety and effectiveness of a new oral immunosuppressant agent compared to standard care in renal transplant patients diagnosed with BK nephropathy.

The purpose of this study is to assess the efficacy and safety of FK778 compared with standard care in renal transplant recipients with newly diagnosed and untreated BK nephropathy.

Eligibility Criteria:
Inclusion Criteria:

* Renal transplant recipient with newly diagnosed BK nephropathy.

Exclusion Criteria:

* Previous treatment for BK nephropathy
* Organ transplant other than kidney
* Uncontrolled concomitant infection other than BK nephropathy
Comparsion of King Vision® Standard Blade and King Vision® Channeled Blade in Patients Scheduled for Tracheal Intubation

Comparison of intubation time from the time to fix the Trachealtube to the first end-tidal CO2 ventilation by means of the curve on the ventilator at KV standard blade and KV channeled blade

In the proposed clinical trial the time measured until the first manual ventilation at 44 study participants with elective anesthesia by using the KV standard blade and KV channeled blade. Bedside the time for tracheal intubation, we documented the view on the monitor which is connected to the instrument, the C\& L classification and POGO Scale.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 Years No concurrent participation in another study
* capacity to consent
* Present written informed consent of the research participant
* Elective surgery under general anesthesia

Exclusion Criteria:

* Age \<18 years
* Existing pregnancy
* Lack of consent
* inability to consent
* emergency patients
* Emergency situations in the context of a Difficult Airway Management
* ASA classification\> 3
* situations where the possibility of accumulated gastric contents
* Participation in another study
The Effects of LAF237 on Gastric Function in Type 2 Diabetes

Administration of the incretin hormone, Glucagon-Like-Peptide-1 (GLP-1), has been shown to enhance insulin secretion and suppress glucagon secretion in response to meal ingestion. In addition, GLP-1 also delays gastric emptying and has been shown to enhance gastric accommodation. These characteristics make GLP-1 an ideal therapy for type 2 diabetes (T2D). However, because of its rapid breakdown by dipeptidylpeptidase IV (DPP IV), GLP-1 has to be administered by continuous intravenous infusion. This would be a drawback in clinical usage. LAF237 is a synthetic inhibitor of DPP IV which has been shown to raise GLP-1 levels and potentiate meal-induced insulin secretion and glucagon suppression. However, the effects of LAF237 on gastric emptying and satiety are at present unknown. The investigators propose to study the effects of LAF237 on gastric emptying, gastric volume and satiety in patients with T2D in addition to examining the direct and indirect (mediated via insulin and glucagon) of this compound on postprandial glucose metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes without microvascular or macrovascular complications treated with diet or up to 2 oral agents
The Effect of Antenatal Education on Fear of Birth, Physiological Ability to Give Birth and Traumatic Birth Perception

Today, pregnancy and childbirth are important life events that involve many challenges and changes for both men and women. During this process, changes occur in the pregnant woman's body, emotional state and family life. These changes often lead to anxiety about the health of the baby and her own health and to the creation of new stressful situations. During antenatal education, deep relaxation and breathing techniques taught to pregnant women during labour and delivery allow the mother to relax and cope with birth pains more easily and on her own. There are not enough studies in the literature to evaluate the effectiveness of online antenatal classes. In cases where face-to-face antenatal education is not possible during pregnancy, online education is an important option. In the literature, there is no study evaluating how antenatal education affects women's fear of childbirth, physiological ability to give birth and traumatic birth perception together. Therefore, the aim of this study is to examine the effect of antenatal education on fear of childbirth, physiological ability to give birth and perception of traumatic birth. The type of the study is a randomised controlled experimental study with pre-post and control group. The research will be conducted in the form of online training meetings on pregnant women reached through social media. The population of the study will consist of healthy pregnant women who apply to the researchers as a result of the announcements made through social media and who are at the 20th gestational week at the earliest. The sample size was determined by t-test analysis in independent groups in G\*power statistical programme, based on two variables, 0.05 significance level, 80% power and medium effect (0.50). Accordingly, a total of 42 pregnant women, 21 pregnant women in each group, are planned to be included in the study. Intention-to-treat analysis will be performed to prevent bias and losses. As an intervention programme, a total of three weeks and six hours of childbirth preparation training will be given, two hours each week. The programme has been prepared by faculty members who have conducted childbirth preparation classes, based on the literature and by making use of childbirth preparation philosophies and methods.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary acceptance to participate in the research
* Being over 18 years of age
* Being at the 20th gestational week at the earliest.
* Not carrying a high risk in pregnancy
* Nulliparity
* Expected to have a normal spontaneous labour

Exclusion Criteria:

* Refusal to participate in the research
* Failure to complete six hours of the childbirth preparation class
* Inability to use the Zoom application
* Psychiatric illness
Regional Blocks for CABG Artery Bypass Graft Surgery

Pain control after CABG is an essential step to guard against postoperative complications such as lung atelectasis. This major step can be achieved by opioids or regional blocks.

Regional blocks allow better pain control and avoid side effects of opioid based pain control

Ultrasound guided External oblique intercostal plane block and pectointercostal plane block for perioperative analgesia in coronary artery bypass graft surgery: Prospective randomized controlled study

Introduction:

Pain control is a vital component to achieve enhanced recovery after cardiac surgery. Effective postoperative pain control will reduce the incidence of numerous postoperative complications, can facilitate early mobilization and may result in earlier recovery.

Pain control is historically achieved by the administration of opioids, which is associated with well-documented side effects, such as sedation, respiratory depression, pruritus, hallucinations and postoperative nausea and vomiting (PONV). Enhanced recovery following coronary artery bypass grafting (CABG) has gained attention even though there is limited evidence on the efficacy and effectiveness of existing analgesic techniques.

The external oblique intercostal plane and pectointercostal plane blocks are a new modality that will be used to improve pain-related outcomes after CABG surgery, and has not been extensively investigated. Therefore, we will test the hypothesis that external oblique intercostal plane and pectointercostal plane blocks can reduce cumulative opioid consumption for the patients undergoing CABG surgery when added to conventional multi-model intravenous analgesic technique.

The aim of this prospective comparative investigation is to assess the impact of external oblique intercostal plane and pectointercostal plane blocks in a multimodal perioperative analgesic regimen and any related side effects in patients undergoing CABG surgery.

Patients and Methods:

A prospective study will be carried out in Alexandria Main University Hospital on 120 American society of anaesthesiologists (ASA) II, III physical status aged 40-60 years scheduled for major upper abdominal surgery, after approval of the Medical Ethics Committee and an informed written consent. Patients will be categorized into two equal groups, group I (60) will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks and group II (60) will be subjected to fentanyl infusion at a rate of 1μg/kg/h. During the patient stay in the ICU, total analgesic requirements will be measured in both groups. Also, sedation level, duration of intubation and length of ICU stay will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing CABG surgery

Exclusion Criteria:

* BMI above 40
* allergy for drugs used
* complicated cases
* patient refusal
* chronic opioid use
* cognitive dysfunction
* chronic kidney disease
Spinal Cord Stimulation for Predominant Low Back Pain

The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).

The study has a multi-center, prospective, randomized (1:1), open-label, parallel-group design of two alternative treatments:

* SCS group (SCS+OMM)
* OMM group

Eligibility Criteria:
Inclusion Criteria:

* SCS candidate with the Specify 5-6-5 surgical lead
* Has FBSS and does not require further surgery (defined as persistent or recurrent low back and leg pain of at least 6 months duration following at least one decompression and/or fusion procedure)
* Average low back pain is ≥ 5 as assessed by the baseline NPRS
* Average low back pain is greater than leg pain
* Subject has persistent moderate to severe low back and leg pain despite other treatments

Exclusion Criteria:

* Treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the location related to his/her original back pain complaint or experimental therapies
* Most recent back surgery \< 6 months ago
* Low back pain only (no leg pain)
* Investigator suspects substance abuse that might confound the study results
* Radiographic evidence of instability requiring fusion
* Pain relieved completely by lying down
* Life expectancy of \< 24 months
* Subject is pregnant or planning to become pregnant during the course of the study
* Subject is unable to undergo study assessments or complete questionnaires independently
Relationship Between Treatment With Bach´s Flower Remedy and Spiritual Well-Being of People With Common Mental Disorder

The Common Mental Disorders (CMD) refer to health states involving non-psychotic psychiatric symptoms. Part of this broad diagnostic category, symptoms such as difficulty concentrating, forgetfulness, insomnia, fatigue, irritability, feelings of worthlessness, somatic complaints, etc. The CMD has a big social impact, and its prevalence in the general population is 25% and graduate students in health care reaches 40%. The Bach´s Flower Remedies are considered a complementary therapy approved and recommended by World Health Organization and by the Brazilian Ministry of Health and in his theory it has great spiritual nature. In addition, international scientific research have suggested that the strengthening of spiritual well-being can help significantly and positively promoting mental health. This project aims to assess the relationship between treatment with Bach´s Flower Remedies and Spiritual well-being of people with Common Mental Disorders in undergraduate health students of a university located in São José dos Campos, state of São Paulo, Brazil. This research presents a quantitative and qualitative methodology, experimental clinical trial, triple blind. The treatment will take place with two groups of forty people, the group of treatment and the placebo´s. The trial will happen in six sessions at intervals of 30 days, totaling eight months of treatment. Statistical analysis will be used chi-square or Fisher exact test to study the association between the scale of spiritual well-being and the use of Bach Flowers for each time point (3 times). To compare the evolution of the results (scales) during the study will set a model for ordinal data with repeated measurements over time. For these statistical tests is assumed a significance level of 5% (p \< 0.005).


Eligibility Criteria:
Inclusion Criteria:

* People over 18 years old
* People who have read and agreed to participate by signing an informed consent
* People who obtain scores equal to or above 8 for women and equal to or above 6 for men in SRQ - 20
* People who does not ingest medication
* People who does not use any type of complementary therapy and integrative such as Herbal Medicine, Aromatherapy, Homeopathy, Flower Essences, Reiki, acupuncture, etc.

Exclusion Criteria:

* Not meet the assumptions of the inclusion criteria
Treatments of Acquired Apraxia of Speech

This study was designed to examine the effects of speech therapy on ability to produce speech sounds in persons with acquired apraxia of speech.

This study was designed to investigate the effects of Sound Production Treatment (SPT; a treatment for acquired apraxia of speech) on sound production accuracy in persons with chronic apraxia of speech (AOS). Organization of practice (blocked practice or randomized practice) will be manipulated in an effort to determine the most efficacious application of SPT. A combination of group and single-subject experimental designs wasl be completed with 20 speakers with AOS (2 groups of 10 participants).

Eligibility Criteria:
Inclusion Criteria:

* Must have acquired apraxia of speech that occurred following a stroke or other brain injury.
* Must be at least 6 months post-onset of brain injury.
* May have aphasia.

Exclusion Criteria:

* History of drug or alcohol abuse.
* History of mental illness.
* Neurological condition other than that which resulted in apraxia of speech.
Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis

Objective: To determine the preliminary outcome of external over the counter (OTC) povidone iodine (PI) application in the management of chronic and acute blepharitis vs. currently clinically accepted medical regimen, i.e. eyelid hygiene, antibiotic drops, or antibiotic/steroid ointments.

Methodology: One hundred adult patients with chronic and acute blepharitis will be enrolled and randomized into four groups.

In group one, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI twice daily for 10 days and the other eye with no intervention.

In group two, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive warm soaked eyelid wash.

In group three, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive 1 drop of azithromycin ophthalmic solution twice daily for 10 days.

In group four, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive tobradex ointment applied to the lid margin.

Subjective variables assessed included itchiness, foreign body sensation and eyelid edema (grade 0-4). Objective variables assessed included lid margin redness, meibomian gland plugging and presence/absence of collarets (grade 0-4). Cultures of lid margin at the initiation and at the cessation of treatment were obtained.

Final statiscial analysis for subjective and objective numerical values following treatment for each group of subjects (group 2,3,4) should show equal or almost equal efficacy in treatment of blepharitis.

Eligibility Criteria:
Inclusion Criteria:

* All potential subjects with symptomatic blepharitis examined to have blepharitis with healthy mental status, able to give consent, with/without co-existing medical consitions will be considered.

Exclusion Criteria:

* All subjects with history and/or probable history of allergic reaction to povidine-iodine, azithromycin, \& tobramycin/dexamethasone and all subjects who have mental disability and are unable to give direct consent will be excluded
Copley II: Long-term Outcome Follow-up Study of Osteoporotic Women Who Underwent a Local Osteo-Enhancement Procedure (LOEP) in the Proximal Femur

To evaluate longer-term (5-7 years) outcomes of the twelve (12) subjects treated with AGN1 Femoral LOEP in the clinical study "A Prospective Pilot Evaluation of Percutaneous Osteo-supplementation in the Proximal Femur of Osteoporotic Patients". Performance will be evaluated via medical history evaluation, X-ray, DXA, CT and mobility testing.

The study will look at the extent to which the benefits demonstrated in the initial, baseline study were sustained over time. In this manner, it may be possible to determine the rate of change in BMD following the treatment; thereby allowing prediction of the total benefit period. In addition, this longer period of observation allows for further evaluation of the safety profile of the material in osteoporosis patients.

This observational single arm study will be broken into two parts:

1. A retrospective component which will evaluate the original FRAX score along with any events or medications received after the end of the original study.
2. A prospective component which will evaluate longer term outcomes following the use of the AGN1 synthetic bone graft material in a local osteoenhancement procedure through evaluation of mobility and imaging.

In the original study, subjects completed a twenty-four (24) month follow-up visit after receiving a unilateral hip injection with the device. The contralateral hip acted as the control. The purpose of the study was to determine the safety of the injection as well as the initial improvement in femoral bone density in a twenty-four (24) month period.

In this follow-up study the subjects, after signing the informed consent form, will complete a short medical history (focused on their osteoporosis management) and a mobility test.

Subjects will also undergo a DXA, X-ray and CT scans of both hips.

Eligibility Criteria:
Inclusion Criteria:

* participated in the original study and signed the consent form
* received treatment with AGN1 Femoral LOEP
* completed the study.

Exclusion Criteria:

* There is no exclusion criteria for this study.
Masitinib in Non-Resectable or Metastatic Stage 3/4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of c-Kit

The objective is to assess the efficacy and safety of masitinib at 7.5 mg/kg/day in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-Kit and who have not previously been treated for melanoma.

Masitinib is a selective tyrosine kinase inhibitor with potent activity against the juxta membrane domain of c-Kit. Masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this study was to evaluate the efficacy and safety of masitinib with respect to dacarbazine in the treatment of non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-Kit. Following a protocol amendment, the dacarbarzine treatment group was closed and recruitment restricted to masitinib treatment of chemo-naïve (first-line) patients.

Eligibility Criteria:
Main inclusion criteria include:

* Patient with histologically or cytologically confirmed non-resectable or metastatic stage 3 (non-resectable IIIB or IIIC, AJCC TNM staging system 7th edition) or stage 4 melanoma
* Patient with detectable c-Kit JM mutation (mutation in exon 9, 11 or 13) confirmed by DNA or RNA sequencing, which is expected to be mainly found after screening of mucosal or acral melanoma or melanoma on skin with chronic sun-induced damages (defined by a microscopically marked elastosis involving the skin surrounding their primary melanoma).
* Patient not previously treated for melanoma (first-line)

Main exclusion criteria include:

* Pregnant, or nursing female patient
* Patient with active brain metastases.
* Prior treatment with a tyrosine kinase c-Kit inhibitor