cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study of MGCD0103 Given Twice Weekly in Patients With Leukemia or Myelodysplastic Syndromes

In this study, MGCD0103, a new anticancer drug under investigation, is given twice weekly to patients with leukemia or myelodysplastic syndromes.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of one of the following:

  * relapsed or refractory AML or ALL that has failed to respond to standard therapy, has progressed despite standard therapy.
  * relapsed or refractory Myelodysplastic Syndromes including CMML (chronic myelomonocytic leukemia) or other myeloproliferative disorders provided there is an MDS component.
  * previously untreated AML or Myelodysplastic Syndromes in patients \>60 years of age who refused or are not candidates for induction chemotherapy
  * Patients with relapsed or refractory CML that has failed to respond to imatinib therapy or standard therapy, has progressed despite standard therapy, or for which no standard therapy exists.
* ECOG performance status of 0, 1, or 2.
* Age ≥18 years.
* Laboratory requirements.
* Patients or their legal representative must be able to read, understand, and sign a written informed consent (approved by the IRB/EC) prior to study entry.

Exclusion Criteria:

* Patients with other active malignancy except basal cell carcinoma or cervical intraepithelial neoplasia (CIN / cervical in situ).
* Patients with suspicion of CNS involvement (tests are not required to rule out CNS involvement in the absence of signs or symptoms).
* Pregnant or lactating women. Women of child-bearing potential must have a negative serum pregnancy test documented within 7 days prior to registration on study.
* Patients and their partners, if either are of childbearing potential, not using adequate birth control measures throughout the course of the study. Both men and women enrolled on study must agree to use a medically acceptable effective form of contraception during the study and for 90 days following the last dose of study medication. An effective form of contraception is an oral contraceptive or a double barrier method, such as condom with diaphragm.
* Patients with serious illnesses, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with a patient's participation in the study, or with the interpretation of the results.
* Patients who have been treated with any investigational drug within 30 days prior to study initiation (an investigational drug is one for which there is no approved indication), or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy.
* Known hypersensitivity to any of the components of MGCD0103.
* Known HIV or Hepatitis B or C (tests do not need to be performed to rule out any of these infections).
* Any psychiatric illness/social situations that would, in the judgment of the investigator, limit compliance with study requirements.
The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear

This study aims to evaluate the effect of platelet rich plasma combined with exercise therapy for patients with partial thickness rotator cuff tears.

The purpose of this study is to exam the outcome of rotator cuff tear patients who received platelet rich plasma injection followed by rehabilitative exercise. The specific aim of this study is to determine the outcomes of treatment of partial thickness rotator cuff tears with platelet rich plasma (PRP) and rehabilitative exercise. Subjects with partial thickness rotator cuff tears will be designated to receive an injection of PRP or hyaluronic acid, followed by rehabilitative exercise. Shoulder function and tendon healing will be evaluated using the patient surveys as well as ultrasound. Subjects will be followed for 3 months to determine the outcomes of the treatment.

The hypothesis is that there is no difference in healing rate or functional outcomes in patients treated with PRP injections plus rehabilitative exercise compared with hyaluronic acid injection plus rehabilitative exercise for the treatment of partial thickness rotator cuff tears.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 85 years old, without significant cognition impairment (MMSE\>20)
* Shoulder pain score(NRS)\> 5
* Partial tear of supraspinatus tendon, proved by ultrasonography or MRI
* Patients who signed informed consent
* Patients who agreed to stop using analgesics during the experimental period

Exclusion Criteria:

* Thrombocytopenia (platelets less than 15000 per microliter)
* Patient who is using anticoagulant or has history of coagulation dysfunction
* Uncontrolled infection
* End stage malignant disease
* Infection or other skin condition over injection site
* History of shoulder or humeral fracture, dislocation or operation
* Psychiatric problems that precludes informed consent or inability to read or write
* Other serious problems that preclude participation of the study
Midline Lumbar Fusion Versus Posterior Lumbar Interbody Fusion

Degenerative lumbar spondylolisthesis is the forward displacement (slip) of one vertebra on an adjacent vertebra resulting in narrowing of the spinal canal or compression of the exiting nerve roots. It is commonly associated with low back and leg pain, and is a frequent reason for spine surgery particularly in individuals over age 65 years. Recently novel minimally invasive surgical techniques have heightened public and government interest by touting benefits of reduced approached-related morbidity which in turn leads to quicker recovery, shorter hospital stay, improved short-term clinical outcomes, and reduced health care cost. However, there is no randomized controlled trial evidence to describe the actual advantages and disadvantages associated with minimally invasive spinal fusion. This pilot study is a randomized control trial comparing minimally invasive MID-line Lumbar Fusion (MIDLF) to traditional "open" posterior lumbar interbody fusion (PLIF) with respect to length of stay, approach related morbidity, patient centered outcome measures, and cost-effectiveness in the treatment of degenerative lumbar spondylolisthesis.


Eligibility Criteria:
Inclusion Criteria:

* Patients attending Victoria Hospital
* Degenerative spondylolisthesis in the lumbar spine at one level
* Medically Suitable for surgical management
* Able to consent for surgery

Exclusion Criteria:

* Lytic spondylolisthesis
* Non degenerative stenosis: tumor, trauma
* Active infection
* On long term disability or workers compensation claims
* Drug or alcohol misuse
* Lack of permanent home residence
* Previous surgery in the lumbar spine at the surgical level
* Previous fusion in the lumbar spine
* Contraindication to surgery: medical co morbidities
* Unable to complete questionnaire: eg dementia
* Unable to give voluntary consent
* Pregnant
Effects of Laugh-yoga Intervention on Mood and Quality of Life Among Oncologic Patients in a Oncologic Clinic Setting.

Previous studies report low levels of mood and of quality of life among cancer patients. Laugh has been proved to improve mood and immune system function. The investigators propose to assess in a prospective randomised case-control study the affects of laugh-yoga intervention on mood levels and quality of life among cancer patients in a cancer clinic. The main hypothesis is that patients in laugh-yoga group will report higher mood and quality o life levels after intervention in comparison with no-intervention group. The second hypothesis is that immune system is the mediator of the effects of laugh-yoga intervention on mood and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* oncologic patients treated in oncologic clinic in Wolfson MC,
* must be able to participate in Laugh Yoga session

Exclusion Criteria:

* psychiatric or cognitive impairment,
* deterioration in physical status,
* treatment discontinuation
Post Operative Sensitivity of MTA Obturation

The aim of this study was to investigate the difference in postoperative pain caused by different root canal sealers in patients with irreversible pulpitis symptoms and no apical lesions.


Eligibility Criteria:
Inclusion Criteria:

* asymptomatic tooth with delayed positive response to thermal tests and electric pulp tests
* large pulp perforation during caries removal,
* inflamed pulp in which bleeding could not be controlled within 5 min,
* periodontally healthy mature mandibular first or second molar tooth.

Exclusion Criteria:

* patients if they were diabetic, immunocompromised, pregnant,
* had a positive history of antibiotic use during the past 1 month,
* required antibiotic prophylaxis
* used analgesic within 7 days prior to the beginning of treatment,
* were allergic to the materials used during root canal treatment,
* if the bleeding could be controlled within 5 min and vital pulp treatment could be performed,
* the tooth had negative response to vitality tests and/or was symptomatic,
* had an associated periapical lesion visible on a radiograph,
* needed a post-core or was planned to serve as prosthetic support,
* had a calcified root canal and internal or external root resorption,
* had tooth with open apex
* mandibular third molars
Hypertensive Treatment Pattern Survey for Type II Diabetes Mellitus Patients With Complication and Hypertension

This study will address the treatment rate and control rate of hypertension, treatment pattern and factors to affect blood pressure control by examining (retrospective) medical records of Type II DM patients with DM related complication and hypertension, among outpatients coming to the Endocrinology Department in 20 general hospital settings nationwide.


Eligibility Criteria:
Inclusion Criteria:

* After diagnosed type II DM, patients received treatment for a least 3 years
* Type II DM patients with hypertension and its complication.
* Visited out-patients to care center after 1 Jan. 2008

Exclusion Criteria:

* Secondary hypertension patients
* Patients not receiving hypertension medication
* Patients stopping BP medication, by physician's order
* Patients currently enrolled in other clinical studies
Transcutaneous Application of Gaseous CO2

The research is designed to evaluate influence of transcutaneous application of CO2 (carbon dioxide) on peripheral diabetic neuropathy. Transcutaneous application of CO2 is known to have immediate effect on vasodilatation and elevates oxygen release from Hb via the Bohr effect. After repetition of the therapies neoangiogenesis is induced. Impairment of microcirculation is one of the causes of diabetic peripheral neuropathy and improvement in circulation could have positive effect also on peripheral neuropathy. In order to evaluate the effect of transcutaneous application of CO2 on peripheral neuropathy in diabetic patients the investigators designed a randomised double blind clinical trial.

Transcutaneous application of gaseous CO2 showed to be a successful adjuvant therapy in treatment of chronic wounds in diabetic patients (PMID: 32633896). During that research patients reported improvement in peripheral sensation after treatment. Therefore, in order to investigate the influence of transcutaneous application of gaseous CO2 in peripheral diabetic neuropathy the investigators designed a randomised double blind research. 60 diabetic patients with peripheral diabetic neuropathy will be randomised in study and control group. Study group will receive 20 treatments with CO2 (each workday for 4 weeks). Lower part of the body is inserted into therapeutic wrap that is filled with 99.9% CO2 gas for 45 minutes. The same approach will be used in control group but in their case the therapeutic wrap will be filled with air. In both groups investigator will evaluate vibration sensation, monofilament test and temperature of the big toe before first and after 4 weeks of treatment. Patients as well as investigator (doctor) will be blind for the group belonging of the patients. The medical nurse performing all the therapies will randomise the patients using random number generator into study and control group. The nurse will be the only one knowing group belonging of the patients until the obtained results from both groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* patients with diabetes and peripheral symmetrical diabetic neuropathy
* with unilateral chronic wound, without previous amputations
* with scores above 3 on the Michigan Neuropathy Scoring Instrument

Exclusion Criteria:

* diabetic patients with asymmetrical peripheral neuropathy
* patients with severe comorbidities: deep vein thrombosis, chronic kidney diseases grade III and IV, chronic heart diseases NYHA (New York Heart Association) III and IV, patients with known malignant diseases, patients with progressive infection, signs of systemic infection with elevated inflammatory markers or osteomyelitis
Exercise Interventions in Post-acute Sequelae of Covid-19

The COVID-19 pandemic severely impacted the medical system both directly but also through incomplete recovery from the virus in the form of post-acute sequelae of COVID-19 (PASC). PASC affects at least 9.6 million individuals as of May 2022 and continues to affect many more. PASC is a multisystem disorder often presenting with mental fog, dyspnea on exertion, and fatigue among other symptoms. The etiology of PASC is uncertain but theories include direct cytotoxicity, dysregulated immune responses, endotheliitis associated with microthrombi, eNOS uncoupling, and myocardial fibrosis with impaired ventricular compliance. To date, there are no established treatments. Exercise has the potential as a therapeutic option to improve VO2peak and improve each of the aforementioned underlying etiologies. The investigators plan to examine the effect of High-Intensity Interval Training (HIIT) and Moderate intensity exercise training (MOD) on the symptoms and exercise tolerance of patients with PASC.

The investigators approach will consist of a randomized, blinded, 2-arm, parallel-group design. Enrolled subjects will be randomly assigned to one of two groups in a 1:1 allocation ratio. All groups will undergo a 4-week intervention of 3 days of HIIT per week and 2 days of MOD per week or control of light stretching and controlled breathing. Subjects will be assessed before and after the 4-week intervention to examine the extent to which 4 weeks of the HIIT and MOD combination improves VO2peak and left ventricular diastolic function, global longitudinal strain (GLS), and global circumferential strain (GCS). Further, the investigators will explore changes in markers such as heart rate, heart rhythm, blood pressure, quality of life, exercise tolerance, and PASC symptoms as well as blood/serum markers.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age
* Diagnosed with Post Acute Sequelae of COVID-19
* Physician clearance to undergo exercise training (see section titled cardiorespiratory fitness testing for details; page 6)
* Complete COVID-19 vaccination status

Exclusion Criteria:

* Unstable angina or myocardial infarction in the past 4 weeks
* Uncompensated heart failure
* NYHA class IV symptoms
* Complex ventricular arrhythmias
* Musculoskeletal contraindications to stationary bicycling exercise
* Symptomatic severe aortic stenosis
* Acute pulmonary embolus
* Acute myocarditis
* Uncontrolled Hypertension as defined as systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 120 mm Hg
* Medication non-compliance
* Pregnant women-self reported
* COPD GOLD stage D
* Malignancy currently actively being treated
* Uncontrolled Asthma
* Uncompensated Cirrhosis of the Liver
* Chronic Kidney disease requiring dialysis therapy
* Symptomatic Anemia
* Hemoglobin \<7g/dL
* Poorly controlled diabetes or A1c\>9%
* BMI \>35kg/m2
* Pulmonary Hypertension stage IV
* Any condition requiring supplemental oxygen
* Multiple Sclerosis
An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary Angioedema

The purpose of this study is to evaluate the safety and efficacy of extended dosing of donidalorsen administered subcutaneously (SC), with alternative dosing and/or dose frequency with donidalorsen in participants with hereditary angioedema (HAE).

This is an open-label extension study of donidalorsen in up to 24 participants with HAE. The length of participation in the study is approximately 68 weeks, which includes an up to 4-week qualification period, a 52-week treatment period, and a 12-week post-treatment period. Following the Week 53 treatment period visit, participants will receive donidalorsen in an extended treatment period for up to an additional 156 weeks. Participants taking part in the extended treatment period will enter the 12-week post-treatment period after completion of, or early termination from, the extended treatment period.

This study was extended to allow participants to receive donidalorsen for an additional 156 weeks following the initial 53-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Satisfactory completion of ISIS 721744-CS2 (index study) through Week 17 with an acceptable safety and tolerability profile, per Sponsor and Investigator judgement
2. Able and willing to participate in a 64-week study
3. Females must be non-pregnant, non-lactating and either surgically sterile or post-menopausal
4. Males must be surgically sterile or abstinent\* or if engaged in sexual relations with a female of child-bearing potential, participant is utilizing an acceptable contraceptive method
5. Participants must have access to, and the ability to use, ≥ 1 acute medication(s) (e.g., plasma-derived or recombinant C1- inhibitor (C1-INH) concentrate or a bradykinin-2 \[BK-2\] antagonist) to treat angioedema attacks

Exclusion Criteria:

1. Have any new condition or worsening of an existing condition or change or anticipated change in medication, which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study
Role of suPAR in Periodontitis and CVD

soluble urokinase-type plasminogen activator receptor (suPAR) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and cardiovascular disease (CVD). The investigators compared the impact of gingival health, periodontitis (CP), CHD or of both diseases (CP+CHD) on saliva and serum suPAR levels.

The aim of this study was to evaluate a possible association between both saliva and serum suPAR levels in patients with CP and with CVD and if the serum suPAR levels are mediated by serum CRP.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least 15 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL) ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
A Single-center Study Designed to Evaluate the Safety and Efficacy of Tulipon

Subjects who normally use tampons will use Tulipon device during one menstrual cycle. Baseline and post usage clinical evaluation will be performed for safety testing.

Subjects use Tulipon device during one menstrual cycle. Baseline and post usage clinical evaluation will be performed for safety testing.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18-45 years
2. Regular menstrual cycles (21-35 days)
3. Uses tampons every month for the last 2 months to handle their monthly bleeding.
4. Active Bleeding lasts at least 3 days
5. Willing not to change their feminine care or hygiene practices during their participation in the study (except as directed by the protocol and instructions for participants)
6. Non-pregnant, with no intentions to get pregnant during the clinical trial
7. Willing to use pads provided thought the study only for the duration of this study
8. Subject is able to comply with all the requirements of the study and agrees to participate in all the activities of the study
9. Signed written informed consent form (ICF) to participate in the study

Exclusion Criteria:

1. Pregnant or lactating women
2. Gave birth less than a 12 month prior to the study.
3. Virgin
4. Using medications to manage pain during active bleeding
5. Using intrauterine device or intrauterine device with hormones (Mirena)
6. Had experienced Toxic shock syndrome (TSS)
7. Previous diagnosis of primary or secondary dysmenorrhea
8. Previous diagnosis of endometriosis
9. Experiences urinary incontinence
10. Suffers from uterus or urine prolapse
11. Abnormal findings following the gynecological exam
12. Subjects with a known or suspected sensitivity to any of the device materials (Polyethylene, Polyurethane, Nylon, Cotton)
13. Been through a vaginal operation in the last 6 months prior to the study.
14. Participation in current or recent clinical trial within 30 days prior to baseline visit
Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture

This is clinical feasibility study on the device performance with paediatric patients. The main objective is to validate the performance of investigational device in distinguishing and identifying the cerebrospinal fluid (CSF) inside the subarachnoid space during a lumbar puncture on paediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Children whose diagnosis or treatment plan requires lumbar puncture to acquire a CSF sample.
* Consent from the parents

Exclusion Criteria:

* Being a high risk patient (as determined by the investigator)
* Any contraindication to a common lumbar puncture apply also in the investigation
The Role of Genetic Factors in the Development of Myocardial Infarction in the Kazakh Population

This is a GWAS study that aims to identify possible candidate genes associate to heart attack by exploring single nucleotide polymorphism (SNP) in a group of heart attack, in the Kazakh population. The investigators hypothesize that the careful phenotyping of the subject sand matching with increase the power to find SNP significantly associate with heart attack

A genome-wide association study (GWAS) is an approach used in genetics research to associate specific genetic variations with particular diseases. The method involves scanning the genomes from many different people and looking for genetic markers that can be used to predict the presence of a disease. Once such genetic markers are identified, they can be used to understand how genes contribute to the disease and develop better prevention and treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* Persons of Kazakh nationality
* Age up to 59 years inclusive at the time of primary myocardial infarction
* Myocardial infarction was established in accordance with the EOC criteria: An increase and / or decrease in the level of cardiac troponin must be combined with at least one of the following: • Symptoms of myocardial ischemia • Newly occurring ischemic changes on the ECG • The appearance of a pathological Q wave • Identification according to imaging data methods of new areas of non-viable myocardium, or new areas of local contractility disorders of presumably ischemic etiology • Detection of a thrombus in the coronary arteries according to coronary angiography
* Presence of coronary angiography
* Persons able and willing to provide written informed consent;

Exclusion Criteria:

* Age at primary myocardial infarction 60 years and older
* Heart defects, congenital and acquired
* Non-ischemic cardiomyopathies
* Autoimmune diseases
* Diabetes mellitus at the time of development of primary myocardial infarction
* Terminal stages of renal and hepatic failure