cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus

SPIL1033 resembles a gut hormone, which increases the insulin secretion, thus helps in reducing blood glucose levels. The purpose of study is to establish safety and efficacy of SPIL1033

SPIL1033 is subcutaneous injection is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus.

In this study, efficacy and safety of SPIL1033 will be evaluated. Subjects will receive SPIL1033 or placebo, 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 20 years of age and older.
* Established clinical diagnosis of type 2 diabetes mellitus treated with diet and exercise or anti-diabetic agents as monotherapy or combination therapy.
* Weight stable: their weight should not have varied more than 10% of screening visit weight, within 6 months prior to screening visit.
* Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s); with a negative urine pregnancy test.
* Willing to participate and give written informed consent.

Exclusion Criteria:

* Previous exposure to exenatide (anti-exenatide antibodies at screening) or a glucagon-like peptide (GLP-1) analogue.
* Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, rimonabant, or similar over-the-counter medications) within 3 months of screening.
* Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of trial entry.
* Severe renal impairment (creatinine clearance \<30 ml/min) or end stage renal disease.
A Randomized Trial Comparing Optimized rhTPO Treatment With Eltrombopag Treatment in Pre-treated ITP Pts

TE-ITP study: Compare the efficacy and safety of optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia patients.

A multicenter randomized open-label trial to compare the efficacy and safety of an optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia. Total treatment duration is 6 weeks, the primary endpoint is "median time to achieve platelet count ≥50x10\^9/L during 6 weeks observation".

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥18 years old.
* Disease duration is ≥3 months, diagnosed and treated as ITP prior to screening.
* Baseline platelet count \<30×10\^9/L.
* Subjects treated with maintenance corticosteroids or immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
* Informed consent has been signed.

Exclusion Criteria:

* Classified as refractory ITP.
* Subjects with any prior history of arterial or venous thrombosis, or thrombophilia in recent 1 year.
* Subjects who have previously received any platelet increasing drug such as rhTPO, thrombopoietin receptor agonist(TPO-RA), etc. within 30 days.
* Subjects who are known nonresponders to rhTPO or TPO-RA therapy.
* Subjects with positive hepatitis C virus antibody or human immunodeficiency virus(HIV) antibody, positive HBsAg and serum levels of hepatitis B virus (HBV) DNA \>1000cps/ml.
* TBil or Scr\> 1.5 x upper limit of normal (ULN), ALT or AST\> 3.0 x ULN in recently 2 weeks.
* Subjects with any prior history of tumor.
* Female subjects who are nursing or pregnant.
* Any situation that investigate consider not suitable for pts to join the study.
A Prospective Cohort Study of Compound Nanxing Zhitong Ointment

The purpose of this study is to evaluate the safety and the efficacy of compound Nanxing pain relief cream in the treatment of chronic pain in the musculoskeletal system

Chronic pain, especially in the musculoskeletal system, is prevalent worldwide. Many studies show the burdens they impose: pain, disability, reduced quality of life (QoL), marked impairment of participation in work and social activities, and heavy financial costs.The purpose of this study is to evaluate the safety and the efficacy of compound Nanxing pain relief cream in the treatment of chronic pain in the musculoskeletal system. To provide a safe and effective treatment of Chronic Musculoskeletal Pain.

Eligibility Criteria:
Inclusion Criteria:

* Attendance at orthopedic, rheumatology and pain clinics for.

Exclusion Criteria:

* Indication for surgery.
Auto Transplantation of Wisdom Teeth

Autotransplantation emerges as a viable alternative to tooth extraction and prosthetic restoration when conventional endodontic treatments are unfeasible or contraindicated. The success of autotransplantation is influenced by diverse factors, including root development stage, tooth morphology, surgical technique, extraoral duration, recipient socket shape, recipient bed vascularity, and periodontal ligament cell vitality. Preserving periodontal ligament quality and achieving tissue adaptation are pivotal for successful tooth transplantation. Successful donor tooth replacement is influenced by variables like fitting attempts, alveolus-root distance, extra-alveolar time, surgical skill, and extraction trauma intensity.


Eligibility Criteria:
Inclusion Criteria:

* male and female
* aged between 20 and 50 years
* devoid of systemic ailments
* complying with the study procedures
* holding an Anesthesiologists classification of 1 or 2
* possessing mandibular or maxillary immature wisdom teeth

Exclusion Criteria:

* systemic diseases that might impede the healing process
* Patients with pacemakers
* Individuals harboring allergies to medications or antibiotics
* active smokers
* patients afflicted with periodontal diseases
A Study of LY2541546 in Healthy Postmenopausal Women

The purpose of this study is to determine if a single dose of LY2541546 has any side effects on the body and to determine how long and how much LY2541546 stays in the bloodstream of the body.


Eligibility Criteria:
Inclusion Criteria:

* Healthy postmenopausal females, as determined by medical history and physical examination
* Body mass index (BMI) at screening between 19.0 and 32.0 kilograms per square meter (kg/m\^2), inclusive
* Acceptable Clinical laboratory test results, blood pressure and heart rate
* Have given written informed consent
* Additional Inclusion Criterion for Participants in Open Label Groups: Are currently taking or recently discontinued (not more than 3 months prior to study randomization) alendronate and have taken alendronate for at least 12 of the last 18 months

Exclusion Criteria:

* Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
* Known allergies to LY2541546, its constituents, or related compounds
* Persons who have previously participated in this study
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
* History of or high risk for adverse outcome from bleeding, for example, transient ischemic attacks, cerebrovascular attacks, and ulcer disease
* Paget's disease, parathyroid disease, or thyroid disease
* Fracture of a long bone within 12 weeks of screening
* Regular use of known drugs of abuse and/or positive findings on urinary drug screening
* Evidence of human immunodeficiency virus (HIV), hepatitis C, hepatitis B and/or positive for anti-HIV antibodies, hepatitis C antibody, or hepatitis B surface antigen
* Current use of therapies for osteoporosis or use of hormone replacement therapy (HRT) within the previous 12 months
* Blood donation within the last month
* Participants who have an average weekly alcohol intake that exceeds 14 units per week
* Cigarette consumption of more than 10 cigarettes per day, or are unable or unwilling to refrain from nicotine during Clinical Research Unit (CRU) confinement

Additional Exclusion Criterion for Participants in Double Blind Groups Only

* Have received bisphosphonates during the previous 24 months.

Additional Exclusion Criterion for Participants in Open Label Groups

* Have received intravenous bisphosphonates within the previous 18 months
A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices

The main purpose of this study is to look at the amount of the study drug, tirzepatide, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of tirzepatide and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 14 weeks, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures
* Body mass index (BMI) between 18.5 and 30.0 kilograms per meter squared (kg/m²), inclusive, at screening
* Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
* Are agreeable to receiving study treatment by injections under the skin
* Are agreeable to following study contraception requirements

Exclusion Criteria:

* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Smoke more than the equivalent of 10 cigarettes per day
* Is a known user of drugs of abuse
Ketamine Patient-Controlled Analgesia for Acute Pain

This study will compare ketamine and hydromorphone as alternative patient-controlled interventions for trauma-related pain. Patients receiving ketamine PCA are expected to require less total and breakthrough opioid and to have similar or improved objective pain scores. Patients receiving ketamine are also expected to have shorter duration of supplemental oxygen requirement, fewer episodes of oxygen desaturation, improved pulmonary toilet, lower use of antiemetics, and shorter times to first bowel movement. Ketamine is further expected to be associated with decreased intensive care unit and hospital lengths of stay, faster time to maximum allowable ambulation, decreased opioid dosage at discharge, and lower report of chronic pain syndromes.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Total Injury Severity Score greater than 9
* Functioning intravenous catheter present per standard of care
* Patient planned to receive PCA for acute pain per standard of care
* Patient ability to effectively use a PCA device as assessed by the primary attending trauma service
* Negative pregnancy test for women of childbearing age

Exclusion Criteria:

* Body mass index greater than 35
* History of active psychiatric disease
* Acute or chronic liver or renal failure
* History of heart failure or coronary artery disease
* Patients with documented chronic pain syndrome who use opioids as maintenance medication in outpatient therapy
* Patients who abuse alcohol and are at high risk for alcohol withdrawal
* Intubated patients
* Glasgow Coma Scale score less than 13, or motor subscore less than 6
* Documented allergy to ketamine, hydromorphone, or lorazepam
* Pregnancy
* Incarceration
Study to Assess the Effect of Intravenous Supplementation of Omega-3 Fatty Acids on Outcome of Recipients in Living Donor Liver Transplantation

In this study, the investigators aim to analyse the effect of Omega 3 fatty acid supplementation on recipients undergoing living donor liver transplantation. In Group A, the patients receive Omega 3 fatty acid on preoperative day 1, intraoperatively and up to day 5 post operatively; and the effect of omega 3 fatty acid supplementation on early allograft dysfunction, its correlation with occurrence of postoperative complications and liver regeneration measured by CT volumetry on Day 7. Group B, the patients are controls for the study and hence attempt to find out the effect of omega 3 fatty acid supplementation on outcome of recipients of Living donor liver transplantation. the investigators will analyse the data and elucidate the value of omega 3 fatty acid supplementation in reducing the occurrence of early allograft dysfunction , complications and effect on liver regeneration in recipients of Living donor liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* All elective liver transplant recipients
* Adult patients
* Those who consent

Exclusion Criteria:

* Liver transplantation for fulminant hepatic failure
* Re-transplantation
* Known allergy to the study emulsion
Safety and Efficacy of an Adult Acute Lymphoblastic Leukemia Chemotherapy for Adult Lymphoblastic Lymphoma

The primary objective of this study is to evaluate the safety and the efficacy of an adult "acute lymphoblastic leukaemia" type chemotherapy in patients less than 60 years with lymphoblastic lymphoma. Treatment principle is based on an intensive induction and a delayed intensification.

Lymphoblastic lymphomas (LL) are rare and represent less than 2% of the malignant non-Hodgkin lymphomas (NHL). The distinction between a LL and an acute lymphoblastic leukaemia (ALL) is difficult; it is arbitrarily based on the percentage of medullary blasts. Above 20% of blasts, it is an ALL. In both cases, the same type of cells is affected: the lymphoblast. Thus the LL were treated either as aggressive NHL or as ALL. The results of the various clinical studies, have shown a best efficacy of ALL type treatments(in terms of overall survival and disease free survival). These treatments are based on an induction phase with reinforced cyclophosphamide and L-asparaginase, and a re-use of the first drugs after consolidation (delayed intensification). The prognostic factors of ALL are now better defined, determining risk groups. According to these prognostic indicators, the allograft could be proposed in first complete remission. Indicators are biological (hyperleukocytosis, chromosomal abnormalities as t(4;11), t(9;22), t(1;19) translocations), clinical (central nervous system involvement), evolutive (salvage therapy needed to obtain complete remission), consideration of early response (cortico-sensibility and chemo-sensibility) and molecular responses (residual disease). On the other hand, the prognostic factors of LL are not well known. This study should permit to better define them. So the prognostic indicators of ALL, in this study, will be decisional for the indication of allograft. This treatment is based on a parallel currently recruiting adult patients with ALL (protocol GRAALL 2003).

Eligibility Criteria:
Inclusion Criteria:

* Patient with lymphoblastic lymphoma.
* Aged from 18 to 59 years.
* Medullary blasts rate less than 20%
* Non previously treated
* With or without central nervous system or meningeal involvement.
* No contra-indication to anthracyclines.
* No contra-indication to intensive treatments
* Negative HIV serology test
* Negative pregnancy test for all female patients of childbearing potential.
* Able to be regularly followed up.

Exclusion Criteria:

* Evolutive cancer with the exception of non melanoma skin tumours or stage 0 (in situ) cervical carcinoma.
* Prior treatment with chemotherapy.
* Lymphoblastic Transformation of chronic myeloid leukaemia
* Patient unable to be regularly followed-up.
A Trial of One to One Weight Management in Primary Care

The purpose of this study is to conduct a randomised controlled trial to assess the sustained effects on weight, selected risk factors and sense of well-being of offering individualized weight management advice in the primary care setting to patients who wish to lose weight; and to identify the key factors influencing the success of the intervention.

Primary care could make a substantial impact on the increasing prevalence of overweight and obesity and their associated adverse impact on health. The lack of a proven intervention may deter health professionals in primary care from providing support to their overweight patients as few obese people recall receiving weight control advice from a health professional.

In this study we aim to conduct a large scale randomised controlled trial to assess the effectiveness of a longer-term structured lifestyle support programme provided by a research nurse and the provision of pedometers compared to usual care in overweight/ obese adults who wish to lose weight. We will assess the degree of weight loss over a period of 12 months as well as related factors such as changes in waist circumference, quality of life and cost-effectiveness of the interventions.

The research is highly relevant to policy making at both national and local levels.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or over
* BMI ≥ 25 kg/m2
* GP confirmation

Exclusion Criteria:

* pregnant or lactating women
* patients with renal failure, pacemakers or cancer
* participating in other research affecting weight
* Ability to complete questionnaires
* Ability to give consent
Evaluation of the Efficacy and Safety of Common Sage in Controlling Hot Flashes in Prostate Cancer Patients Treated by Androgen Deprivation

The purpose of this clinical phase I study is to measure the efficacy and side effects of Common Sage in the treatment of hot flashes in 10 patients with prostate cancer who receive androgen deprivation (AD) (exclusively or as part of a multimodality treatment) for a period of minimum 6 months. Concomitant use of a non-steroidal anti-androgen during the first month of the AD is permitted to prevent the flair-up phenomenon. However, the inclusion of patients in the study will only start at least 2 weeks after the cessation of the anti-androgen. This is done to exclude a possible influence of the anti-androgen on the severity and frequency of hot flashes.

Once the informed consent is signed, the patient receives the study diary to note the daily frequency and severity of hot flashes and their effect on daily quality of life. The severity of the hot flashes is measured by the Moyad scoring scale. The effect on daily quality of life is measured using the Hot Flash Related Daily Interference Scale (HFRDIS). The patient will be instructed in detail how to use the diary.

After week 1, the patient returns the diary to the responsible physician. In return the patient receives the study medication (Common Sage, product) and a diary for the next week (=week 2). This procedure will be repeated until the end of the observation period (2 months after enrollment in the study). The common Sage will be provided in tablets. The suggested dose of Common Sage is 3 tablets a day (morning - noon - evening).

To be sure that the effect of Common Sage is NOT due to an inhibition of the effect of the LHRH analogue, the related hormones (testosterone, FSH, LH, free testosterone and SHBG) will be tested at three fixed moments: day of study enrollment, 1 month after study enrollment and at the end of the study. In order to check the level of hemoglobin and cholesterol, every 2 weeks a blood count will be performed. It has been shown that LHRH analogues can induce anemia and hypercholesterolemia. The investigators want to measure a possible effect of Common Sage on both.

There are no known side-effects of the use of Common Sage. All symptoms that could be related to the use of Common Sage will be recorded in detail. Therefore, a clinical examination including blood pressure registration will be performed by the responsible physician on a weekly base.


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer patients treated with androgen deprivation and experiencing hot flashes.
* Karnofsky performance status ≥70%
* Age ≥18 years
* Informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

* Other therapy for hot flashes
* Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study
* Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to complete the diary, inability to return for follow-up visits, and unlikely to complete the study.
Flax Muffins and Cholesterol Lowering

This Clinical Trial is being conducted to study the LDL (bad) cholesterol lowering abilities of flax. The purpose of this study is to find the lowest dose of flax that can lower LDL-cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* male and non-pregnant/non-lactating female
* Body mass index 18.5-40.0 kg/m2
* Fasting plasma LDL cholesterol 2.6-5.0 mmol/L
* Regular dietary habits (ie. breakfast, lunch and dinner meals consumed daily)
* Willing to comply with protocol requirements
* Willing to provide informed consent

Exclusion Criteria:

* Medical history of cardiovascular disease, use of cholesterol-lowering or blood pressure-lowering medications
* Fasting plasma triglycerides ≥ 4.0 mmol/L
* Medical history of diabetes mellitus, fasting plasma glucose ≥ 7.0 mmol/L or use of insulin or oral medication to control blood sugar
* Medical history of gastrointestinal disease, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use within the past 6 weeks
* Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis)
* Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥ 1.5 times the upper limit of normal (ULN))
* Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN)
* Active treatment for any type of cancer within 1 year prior to study start
* Major surgery within the last 3 months
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
* Unstable body weight (defined as \> 5% change in 3 months) or actively participating in a weight loss program
* Tobacco and/or nicotine replacement use, current or within the last 3 months
* Taking medication (prescription or non-prescription) or dietary supplements (pre/probiotics, vitamins, minerals, fats, herbals) known to affect blood lipids, with the exception of stable doses of thyroxine and oral contraceptive agents
* Any food allergy, aversion or unwillingness to eat wheat or flax
* Daily consumption of flax containing products in the past month
* Regular intake of \> 2 alcoholic drinks per day. Standard drink (13.6 g alcohol)= Beer (5% alcohol) 360 mL (12 fl.oz); Spirits (40% alcohol) 45 mL (1.5 fl.oz); wine (12% alcohol) 150 mL (5 fl.oz)
* Participation in another clinical trial, current or in the past 4 weeks