cyrilzakka/clinical-trials huggingface dataset:
Cancers Treated With Combination of Antrodia Cinnamomea and Chemotherapy

The purpose of this study is to investigate if food supplements,Antrodia cinnamomea, could minimize the gastrointestinal symptom of cancer patients with chemotherapy.

In our unpublished report shows that patients who took Antrodia Cinnamomea compound of 15 milliliters liquid twice in a day, might help white blood cells, red blood cells and hemoglobin increase after 2 months; liver glutamic pyruvic transaminase(GPT) index mitigation, P \<0.05 difference statistically; In addition, liver glutamate oxaloacetate transaminase(GOT) and biochemical index of renal function had no abnormal data statistically. However, cancer patients with gastrointestinal disorders after chemotherapy is known to be a common side effect, we seek to investigate if Antrodia Cinnamomea improves the function of gastrointestinal system.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed Cancer.
* Age ≦ 80 years old and ≧ 18 years old.
* Eastern Cooperative Oncology Group(ECOG) performance status of 0-2.
* Adequate organ function, including followings Hepatic： Total bilirubin level ≦1.5 x UNL, GOT and GPT ≦ 2.5 x UNL if no liver metastasis; GOT and GPT ≦ 5 x UNL if liver metastasis. Renal： Creatinine level\< 1.5 milligram per deciliter or Estimated creatinine clearance(CCr) ≧ 60 milliliter per minute (CCr is estimated by Cockcroft-Gault formula, as appendix II)
* Estimated life expectancy of at least 12 weeks.
* Written(signed) Informed Consent
* Ever treated and poor tolerance with platinum-based or anthracycline- based regimen, likely nausea and vomiting.

Exclusion Criteria:

* Prior participation in any investigational drug study within 28 days
* Active uncontrolled infections or human immunodeficiency virus(HIV) infection
* Significant concurrent medical diseases, such as congestive heart failure, unstable angina, acute or recent myocardial infarction( 6 months before randomization), chronic obstructive pulmonary disease with frequent exacerbation, chronic renal diseases (estimated CCr 60 milliliter per minute), uncontrolled diabetes, uncontrolled hypertension, recent cerebrovascular disease episode( 6 months before randomization )
* With clinically significant Gastrointestinal disorder (e.g. bleeding, inflammation, obstruction or diarrhea)
* Psychiatric disorders that would compromise the patient's compliance or decision.
* Pregnancy or breast feeding.
* Known hypersensitivity to the component of investigational drugs.
* Known or suspected Gilbert's syndrome
* Poor compliance
Melatonin's Effect on Nighttime Blood Pressure and Sleep in OSA Patients (MEBP-OSA)

The goal of this clinical trial is to learn if melatonin works to treat comorbid insomnia in adults with OSA and nocturnal non-dipping blood pressure pattern.

The main question it aims to answer is:

Does melatonin maintain sleep during night and recover the dipping blood pressure pattern?

The goal of this clinical trial is to learn if melatonin works to treat comorbid insomnia in adults with OSA and nocturnal non-dipping blood pressure pattern.

The main question it aims to answer is:

Does melatonin maintain sleep during night and recover the dipping blood pressure pattern?

Participants will:

* Take melatonin or the habitual treatment every day for one month
* Visit the clinic 11 times for one month
* Keep a diary of their symptom and activities and use twice a 24 h ambulatory blood pressure monitoring (ABPM), attend two overnight polysomnography studies, and use an actigraph every day for 2 weeks.

Researchers will compare melatonin to the habitual treatment to see if melatonin works to treat insomnia and recover the dipping blood pressure pattern.

The medical problems that participants would have when taking melatonin are:

* changes in blood pressure and cholesterol
* Increased risk of contracting immune system disorders
* Possible increased risk of liver damage.

Eligibility Criteria:
Inclusion Criteria:

* Polisomnographic diagnosis of Obstructive Sleep Apnea
* Non-dipping blood pressure on Ambulatory blood pressure monitoring (ABPM):

Exclusion Criteria:

* Use of sleep or psychiatric medication
* Use of Positive Airway Pressure (CPAP or Bipap)
* Neurologic or psychiatric disorder
Ultra-fractionated Radiotherapy for Rectal Cancer

The rationale of this clinical trial is to assess the feasibility of selective non-operative management for locally advanced rectal cancer using dose-escalated ultra-fractionated short course radiation therapy interdigitated with chemotherapy. We believe delivering short course radiotherapy over a prolonged interval, at escalated doses and with concurrent chemotherapy may be feasible and allow for improved clinical response.

To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated adaptive RT, in patients with locally advanced rectal cancer treated with RT, FOLFOX (5-FU, oxaliplatin, leucovorin) or CAPOX (capecitabine, oxaliplatin) chemotherapy and selective omission of surgery.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age. Both men and women and members of all races and ethnic groups will be included.
2. Willing and able to provide written informed consent
3. Pathologic diagnosis of rectal adenocarcinoma
4. T3-4 and/or N+ disease per AJCC 8th edition
5. No prior treatment for rectal adenocarcinoma
6. Eastern Cooperative Group (ECOG) performance status of 0-2.
7. Laboratory values supporting acceptable organ and marrow function within 30 days of eligibility confirmation. Defined as follows:

   * WBC ≥ 3,000/mL;
   * ANC WBC ≥ 1,000/mL;
   * PLT ≥ 75,000/mL;
   * T Bili ≤ 1.5 x upper limit of normal (ULN);
   * AST/ALT ≤ 2.5 x ULN;
   * Creatinine not above ULN, or creatinine clearance \>50 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal.
8. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) starting with the first dose of study therapy through 90 days after the last dose of study drugs. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria:

1. Distant nodal disease (retroperitoneal nodes) including inguinal nodes, or any metastatic disease by CT.
2. Prior RT to the pelvis.
3. Uncontrolled comorbid illness or condition including congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness that would limit compliance with the study requirements.
4. Psychiatric illness/social situations that would limit consenting and compliance with study requirements.
5. Participants who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
An Randomized Control Trial Comparing Two Drug Combinations for Pain Management After Third Molars Surgery

Randomised control clinical trial to compare which combination of analgesics in effective in pain management after third molar extraction of wisdom teeth. The study will assess post operative pain after third molar extraction of two groups of study participants who will be given one of the two combinations of Diclofenac/ acetaminophen/codeine and ibuprofen/acetaminophen/codeine .

Double blind randomized control clinical trial to compare the level of pain relief that occurs after third molar extraction done under local anaesthesia at the maxillofacial center, Harare, Zimbabwe. The participants will be randomized into two arms upon fitting the inclusion criteria.The pharmacist will be in charge of randomization and will randomise the participants upon giving them the medications. One group will receive combination of diclofenac/acetaminophen/codeine and the other group will receive ibuprofen/acetaminophen/codeine as post extraction analgesia.The dosages of the medications will be Diclofenac 50mg, ibuprofen 400mg, acetaminophen 500mg and codeine 15mg respectively. Questionnaires will be given to the patient to complete after discharge from the surgery and other parts of the questionnaire will be completed on review after 7 days. A record will be done of the postoperative pain experience (using visual analogue scale), use of rescue medication and details pertaining to impacted tooth.

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years of age
* patients undergoing third molar extractions
* patients with or willing to get orthopantomogram for assessment of impacted third molars

Exclusion Criteria:

* patients younger than 18 years
* patients not willing to consent to the study
* patients with associated co-morbidities
* patients not willing to undergo radiological evaluation
* patients allergic to medications used in the study
* pregnant patients
Analysis of Postoperative Bandage Use Protocols in Otoplasty

The aim of the study is to investigate the possible influence of different durations of use of postoperative elastic bandaging (seven days vs. thirty days) in the results of otoplasty. We hypothesize that the duration of elastic bandage use has no significant influence on the incidence of relapse of prominence of the ears and need for reoperation.


Eligibility Criteria:
Inclusion Criteria:

* Congenital bilateral ear prominence
* 10 years-old or older
* No previous attempt of surgical treatment

Exclusion Criteria:

* Pregnant women
* Breastfeeding women
* Blod clotting disorders or current anticoagulant use
* Uncontrolled systemic diseases
Mirror Therapy Versus PNF on LE Function in Stroke

Many rehabilitation strategies are being implemented to treat stroke. Constraint-induced movement therapy and robotics are two potentially useful treatment options for rehabilitation. Range of motion exercises, PNF, mirror therapy is also used. Fitness training, high-intensity treatment, and repetitive-task training are all promising strategies that might help improve elements of gait. Repeated task training may also help with transfer functions

PNF and mirror therapy has its effect on chronic stroke patients. Both mirror therapy and PNF work on the concept of neuroplasticity. Neuroplasticity is the ability of the nervous system to change its activity in response to intrinsic or extrinsic stimuli by reorganizing its structure, functions, or connections after injuries. Because of brain plasticity, neurorehabilitation has evolved, as evidenced by numerous physiotherapeutic approaches such as proprioceptive neuromuscular facilitation (PNF) and mirror treatment (MT). The reorganization also includes the expansion of cortical regions, which offer the neural foundation for the recovery or adaption of motor activity following injury.

As the literature supports the individual effects of both techniques in stroke population but as per author's access, there is no literature provide the comparison among both techniques i.e. PNF and mirror therapy in lower limb for chronic stroke patients on gait and functionality. Hence the author established the research question that is there any difference among these techniques in stroke population in terms of its effects and efficiency on gait and functionality. The study will provide an insight to the clinician about which technique has the superior/ better effects for the lower extremity functions in chronic stroke patients thus telling the effects two neurorehabilitation methods i.e. proprioceptive neuromuscular facilitation (PNF) and mirror therapy (MT).

Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* ACA stroke
* Ischemic and hemorrhagic stroke
* MMSE grade \>24
* Spasticity at modified Ashworth scale between 1 and 2
* Modified Rankin scale 4

Exclusion Criteria:

* Any orthopedic impairment of lower extremity like LLD, fractures, dislocations, amputations, deformity of joint
* Any other neurological condition (multiple sclerosis, Parkinson disease, SCI)
Evaluation of Dynamic Balance After Recovery From COVID 19 Disease

effect of post covid-19 on dynamic balance in patients after recovery from covid-19 disease.

effect of post covid-19 on dynamic balance in patients after recovery from COVID disease.

patients will treated with medical protocol of COVID 19 an out-patient clinic , and followed up by the chest specialist . The balance tests of the patients were performed 2 to 14 weeks after their recovery from the disease, which was confirmed by the evaluations of the COVID staff and negative polymerase chain reaction test.the patients will evaluated using questionnaires. First, the question will whether feeling in balance in the daily life or not. The answer will classified as "yes"or "no". Second, asked to fill "Dizziness Handicap Inventory"(DHI), which is a multidimensional self- assessment scale created to evaluate the effects of dizziness and balance problems on the quality of life as well as the level of disability of the patients. Assess balance , which consists of a movable balance platform that provides up to 20 of surface tilt in a 360 range of motion. The platform is interfaced with computer software that enables the device to serve as an objective assessment of balance . The measure of postural stability includes the overall (OA), the anteroposterior (AP) and the mediolateral (ML) stability scores. A high score in the OA index indicates poor balance. The OA stability score is believed to be the best indicator of the overall ability of the patient to balance the platform

Eligibility Criteria:
Inclusion Criteria:

* 25post COVID-19 patients suffering from inbalance.
* Age will be ranged from 30 to 40 years old.
* Body mass index (BMI) will be ranged from 25 to 35 Kg/m2.
* Diagnosed as COVID-19 patients with a positive reverse transcription polymerase chain reaction (RT-PCR) result of SARS-CoV-2, or typical computerized tomography (CT) evidence of viral pneumonia.
* All enrolled patients with moderate covid-19 infection.

Exclusion Criteria:

* Severe disease or hospitalization at intensive care units will excluded from the study.
* Patients with previous hearing problems or balance disorders.
* Patients who had ear surgery, cardiovascular and circulatory problems,.
* Patients with orthopedic problems in the lower extremities due to other problems
* Patients with Any history of neurological or psychiatric disease, severe visual or auditory impairments.
* Diabetic patients.
A Phase 1 Study of ARC-001 in Participants Undergoing Third Molar Extraction

The study will test the investigational product gel against placebo (which contains no active ingredient) to determine if it is safe after wisdom tooth extraction. The main questions the study will answer are:

1. How much of the investigational product is absorbed in the blood?
2. Are there side effects?


Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* In generally good health
* BMI 18 to 38kg/m²
* Scheduled to undergo wisdom teeth extraction

Exclusion Criteria:

* Serious medical condition
* Clinically significant abnormal lab values
* Blood donation in the last 60 days, or plasma donation in the last 7 days.
Effects of LopiGLIK® on Cardiovascular Risk

The study is designed to compare the effects of two combination of nutraceuticals: Armolipid Plus® and LopiGLIK® (Akademy Pharma), a new supplement that, in addition to Berberine and Red Rice, contains Morus Alba's extract. The study will analyze the impact of 16 week treatment with one of the combinations, according to a randomized scheme, on metabolic parameters in dyslipidemic subjects that do not require or not tolerate a statin therapy. In particular, it will assess the ability of the two combinations to reduce the levels of total and LDL cholesterol, HbA1C, glicaemia and insulin and increase those of HDL cholesterol.

The experimental design involves the construction of a multi-center, controlled, randomized, single-blind, versus Armolipid Plus®.

Patients with mild hypercholesterolemia, of both sexes and aged between 18 and 75 years, will be recruited, from the beginning of the study and for the next 2 weeks, from 30 Cv specialists and/or GPs (25 patients each).

The subjects will be enrolled in the 50/50% male/female ratio ± 10% comparable for age, in order to obtain a proper comparison between groups with similar demographic characteristics or not statistically different.

The subjects, selected on the basis of inclusion and exclusion criteria, will be divided into two groups, subjected to centralized randomization at the "Diagnosis and Treatment of hypertension Center" to receive one of two different treatments, a tablet/day of the new nutraceutical LopiGLIK® (Akademy Pharma) containing Morus Alba, immediately after a meal, vs. a tablet/day of Armolipid Plus, always immediately after the meal. During the first two weeks both groups will follow the prescribed diet and assume the placebo. At the end, blood tests (traditional metabolic parameters, blood glucose, HbA1C, fasting insulin, transaminase levels, CPK) and the endothelial function will be assesed. During the next 16 weeks a group will assume LopiGLIK® (Akademy Pharma) containing Morus Alba, the other will assume Armolipid Plus and everyone will continue to follow the prescribed diet. At the end of this period blood tests will be repeated. Tablets of Armolipid Plus, LopiGLIK® and placebo will be provided by Akademy Pharma free of charge

Eligibility Criteria:
Inclusion Criteria:

* Total Cholesterol\<300 mg/dL
* Total Cholesterol\>200 mg/dL
* Cardiovascular Risk\<20%

Exclusion Criteria:

* Pregnancy
* Documented intolerance to one or more 'components LOPIGLIK / Armolipid PLUS
* Previous cardiovascular events
* Familiar severe dyslipidemia
* Familiar high cardiovascular risk Hepatic or muscular disorders Subjects receiving lipid-lowering drugs
Evaluation of Consciousness Impairment in Severe TBI and Full-cycle Neuroregulation Based on Multimodal Imaging

The goal of this observational study is to learn about in Evaluation of consciousness impairment in severe TBI and full-cycle neuroregulation based on multimodal imaging. The main question it aims to answer is:

•For the existing examination means of super early neurological consciousness level recognition and function assessment accuracy of poor technical bottleneck, different period individual target brain space positioning difficulties and single rehabilitation technology of whole cycle rehabilitation system, with severe TBI patients as the research object.

Brain trauma (traumatic brain injury, TBI) is one of the most common acute and severe diseases in neurosurgery. It has the characteristics of high disability rate and high mortality rate, and has become a major global medical and public health problem. Disorder of consciousness (Disorder of consciousness, DOC) is one of the most common clinical manifestations in the early stage of severe TBI patients with coma. Long-term DOC is the main manifestation of poor prognosis and can cause disability or death. Up to 43% of patients diagnosed with vegetative patients were reclassified as minimal consciousness. How to realize the accurate assessment of DOC population consciousness state, strengthen the early identification and functional assessment of people with severe TBI, and establish the whole-process rehabilitation system and management strategy for severe neurological diseases are the main clinical concerns. This project for the existing examination means of super early neurological consciousness level recognition and function assessment accuracy of poor technical bottleneck, different period individual target brain space positioning difficulties and single rehabilitation technology of whole cycle rehabilitation system, with severe TBI patients as the research object.

The specific research was mainly conducted from the following three aspects: (1) the relationship between EEG qualitative power spectrum typing, quantitative power spectrum index and behavioral scale, and the assessment of early awareness recovery in DOC patients; (2) the auxiliary scheme for ICU based on near-infrared light therapy; (3) the light-magnetic combined neuroregulation strategy for subacute patients based on precise positioning of fMRI in the resting state.

Eligibility Criteria:
Inclusion Criteria:

1. GCS 3-8 points
2. Loss of consciousness greater than 6 hours or consciousness and coma greater than 6 hours within 24 hours after injury

Exclusion Criteria:

1. Alcohol consumption, substance abuse during or within the previous 24 hours
2. Previous history of traumatic brain injury, MRI contraindication, penetrating brain injury, psychotropic substance use, spinal cord injury, positive neurological examination, multifunctional disorder
3. Previous history of traumatic brain injury, MRI contraindication, penetrating brain injury, psychotropic substance use, spinal cord injury, positive neurological examination, multifunctional disorder
Pharmacogenomics Validation for Imatinib in Chronic Myeloid Leukemia

This is a multicenter, retrospective, observational study to validate a pharmacogenetics model for imatinib metabolism and resistance in patients with chronic myeloid leukemia among patients in different independent cohort.

1. The activity of Imatinib(IM) is mediated by blocking the activity of BCR/ABL tyrosine kinase in CML cells. However, some of the patients failed to achieve optimal response, and a substantial proportion of patients develop resistance to IM.
2. IM is a substrate for the adenosine triphosphate binding cassette (ABC) transporters, ABCB1 and ABCG2, while the active uptake of IM into cells is mediated by the human organic cationic transporter-1 (hOCT1). Also, IM is metabolized through first pass drug metabolism by the cytochrome P450 - CYP3A4 and CYP3A5. In addition, it is delivered in a bound form with a plasma protein referred to α1-acid glycoprotein (AGP).
3. Accordingly, the intracellular or systemic level of imatinib should be influenced by these factors such as ABCB1, ABCG2, hOCT1, CYP3A4, CYP3A5 or AGP genes. Inter-individual variability of 5 candidate genes associated with drug transport/metabolism (i.e. ABCB1, ABCG2, hOCT1, CYP3A4/3A5 and AGP) could affect the expression of corresponding proteins, thus influencing the treatment outcomes of imatinib therapy.
4. In the investigators' previous study, the investigators reported the cumulative incidences of MCyR and CCyR was significantly affected by the predictive model using 2 genotypes and disease stage. These predictive models for CCyR/MMoR or LOR/treatment failure seemed to work well. However, external validation of these predictive models is warranted especially using ethnically different independent cohort.

Eligibility Criteria:
Inclusion Criteria:

* Chronic myeloid leukemia of any stage including chronic phase, accelerated or blastic phase.
* Age\>18 years
* Complete set of clinical data available for review (demographic data, stage, treatment history, cytogenetic reports, and latest BCR/ABL RQ-PCR results)
* Treated with imatinib mesylate at least 3 months

Exclusion Criteria:

* Treated with imatinib mesylate less than 3 months
* Not agree with the intention of this study