cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular (CV) Risk Evaluation In Type 2 Diabetes Subjects

The primary objective of this study is to assess the total CV risk in patients with type 2 diabetes and also to assess the impact of rosiglitazone in the total CV risk and the parameters of metabolic syndrome.


Eligibility Criteria:
Inclusion criteria:

* Patients with diabetes type 2 that their physician has decided to prescribe AVANDIA for better control of their condition
* Have signed informed consent

Exclusion Criteria:

* Patients with ALT \> 2.5x the normal value
* With heart failure symptoms
* With diagnosis of angina pectoris or stable angina demanding continuous treatment with nitrates
* With recent myocardial infarction (\<6 months)
* With severe renal disfunction
* Pregnant or lactating or planned to be pregnant during the study
* Under investigational drug treatment
* Alcoholic or drug abuser
CA 125 and VAS Pain Score Changes to Diagnose Endometriosis

To assess the diagnostic accuracy for the noninvasive detection of pelvic endometriosis of the combination of two simple parameters: modifications of serum CA 125 and VAS pain score following one dose of GnRH-analog (GnRH-a).

Between January 2010 and January 2014, women scheduled for a diagnostic laparoscopy for CPP at our Department will be enrolled in the current prospective observational study. For these patients, laparoscopy represents the last diagnostic step after medical history negative for gastrointestinal, urological, musculoskeletal and psychoneurological disorders related to pelvic pain, physical examination, ultrasonographic assessment and laboratory testing. From all patients, at enrollment, blood samples for serum CA125 determination will be taken during the early follicular phase (2nd-3rd day of the menstrual cycle) and VAS score for menstrual pain will be assessed. Electrochemiluminescence immunoassay (Immunoassay Elecsys Systems, Roche Diagnostics, Italy) for serum CA125 assay will be used (kit coefficient of variation between-run 0.0% and within-run 2.0%).

During the time passed on surgery waiting list, patients will received leuprolide acetate depot (LAD) at a dose of 3.75 mg IM at the 21st day of the menstrual cycle. One month later LAD administration, serum CA125 levels and VAS score will be assessed again, and then the surgical procedure will be performed in all these patients.

After laparoscopy and definitive histological examination, the population initially enrolled will be sub-grouped according to endometriosis diagnosis in two groups, i.e. group 1 (subjects with endometriosis) and group 2 (subjects without endometriosis).

Eligibility Criteria:
Inclusion Criteria:

* chronic pelvic pain

Exclusion Criteria:

* age less than 18 and greater than 38
* oligo-amenorrhea
* use of hormone medications (including oral contraceptives pill, progestogens, and so on)
* conditions affecting serum CA125 levels (such as, pregnancy, ovarian endometrioma seen at ultrasonography, pelvic inflammatory diseases, neoplasm, tuberculosis, hepatitis, peritonitis, recent abdominal surgery and pelvic organic disease)
The Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis

Anidulafungin is a medicine being developed for treatment of patients with certain kinds of fungal infections. These infections due to yeast (a type of fungus) in the mouth/esophagus, in the blood or in other areas within the body.

Anidulafungin is an investigational drug being developed as an intravenous treatment for esophageal candidiasis, candidemia and other invasive fungal infections. Anidulafungin is an antifungal agent of the echinocandin class, which targets the fungal cell wall of yeast and other filamentous fungi.

Eligibility Criteria:
* Diagnosis of candidemia and/or other forms of invasive candidiasis.
* Should not have received greater than 48 hours of systemic antifungal therapy.
* Life expectancy should be greater than 72 hours.
* Should not have received greater than one week of prophylactic azole therapy 30 days prior to enrollment
Impact of Phenylketonuria-type Diet on Appetite, Appetite Hormones and Diet Induced Thermogenesis

Low-phenylalanine diets are commonly prescribed to people with phenylketonuria (PKU), an inborn disease which causes accumulation of amino acid phenylalanine (Phe) in the blood. High blood Phe levels can cause mental, behavioural, neurological, and physical problems. Thus, low-phenylalanine diets help patients to manage their condition but it is not clear whether they have an impact on appetite, energy intake and changes in body weight. This is important to explore as prevalence of obesity in this population is rising high. This study aims to find out the effect of PKU-type meals on appetite, appetite biomarkers, and post-meal energy expenditure. The investigators will recruit 26 healthy adults and ask them to participate in two experimental trials. On one occasion the participants will be asked to consume a PKU-supplemented drink followed by a PKU type-lunch and on another occasion the supplement and lunch will be based on normally consumed foods. Series of blood samples will be taken and appetite will be assessed during both experiments. Both experimental trials will finish with consuming an "all-you-can-eat" buffet.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult
2. Body weight stable for previous 4 months
3. Regular menstrual cycle (females)

Exclusion Criteria:

1. Pregnancy or lactation (females)
2. History of eating disorder
3. History of gastrointestinal problems or surgery
4. History of allergy
5. History of chronic illness
6. On any medication
7. Smoking
8. On nutritional supplements
9. Following specific diet
10. Currently taking part in other research
Clinical Observation on the Treatment of Motor and Sensory Dysfunction After Stroke With Ruyizhenbao Pill

Many years of clinical practice experience has found that Ruyi treasure pill can be used to treat nerve meridian injury caused by cerebrovascular disease, but in the end, the clinical efficacy is still lacking systematic clinical evidence-based medical research data. Based on this, the clinical observation of Ruyi treasure pill in the treatment of post-stroke motor and sensory dysfunction was carried out to verify its clinical location, to provide evidence for the application of clinical subdivision of later products and two development of products, and to publish academic papers on the expected research results.


Eligibility Criteria:
Inclusion Criteria:

1. Compliance with stroke diagnostic criteria;
2. The course of the disease is 15 days to 6 months;
3. People who are conscious and have no severe cognitive impairment, and those who cooperate with examination and treatment;
4. Age 20 to 80 years old;
5. Sign an informed consent and participate voluntarily in the study.

Exclusion Criteria:

1. Diseases such as brain tumours, traumatic brain injury, brain parasitic diseases and metabolic disorders have been confirmed by examination;
2. Combining patients with severe heart, liver, kidney, hematopoietic and endocrine systems, gastrointestinal diseases, etc.;
3. Those who are not aware or concoced due to more severe cognitive impairment and complete aphasia;
4. People who are allergic to the drug or are allergic to multiple medications.
Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain

The goal of this observational study is to better understand the role of the brain in chronic low back pain patients.

Chronic pain affects millions of people worldwide, and the main cardinal sign of any arthritis condition is pain. Several arthritis conditions can cause chronic low back pain (CLBP).The mechanisms that contribute to CLBP are not yet fully understood, but considering the role of the brain in the context of chronic pain, it is only logical to investigate structural and functional brain properties in CLBP, in order to improve diagnosis and treatment of this condition.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain (≥ 6 months) with or without pain radiating to the legs or radiating to the neck
* Positive medial branch blocks, suggesting that the pain originates from the lumbar facet joints
* Average pain intensity of ≥ 3/10 in the 24-hour period before the initial visit
* Pain primarily localized in the lower back

Exclusion Criteria:

* Inadequate pain relief or relief of less than three months following selective thermoablation of medial lumbar branches by radiofrequency
* Neurological, cardiovascular, or pulmonary disorders
* Comorbid pain syndrome
* History of surgical intervention in the back
* A corticosteroid infiltration within the past year
* Pregnancy (current or planned during the course of the study)
* Contra-indication to Magnetic Resonance Imaging (MRI)
FMT as a Treatment for Severe Motility Disorder

Many patients that are treated with anorectal malformations are fecally incontinent for life. A Bowel Management Program has been developed to help these patients by creating a daily enema regimen to keep them artificially clean of stool in the underwear. Due to the high success rate of the program, many patients who suffer from fecal incontinence due to other reasons such as, spina bifida, sacrococcygeal teratoma and sacral agenesis are referred to the program. A new issue is emerging with a group of patients that no longer obtain effective results from their daily enemas, even though they have worked successfully for years. These same patients are presenting with a narrow, spastic left colon and remarkably dilated right colon. Our hypothesis is that prolonged enema administration negatively impacts the microbiota of the colon causing the lack of response from enema administration. The purpose of this study is to restore the normal flora of the colon by fecal microbiota transplant (FMT) which we believe will improve responsiveness to enemas. By restoring colonic flora, patients will again become responsive to daily enemas and regain successful bowel management.


Eligibility Criteria:
Inclusion Criteria:

* The study population to be enrolled in this study will include patients 18 years of age and older, with a Malone (appendicostomy) or with a cecostomy, that have received daily enemas for the treatment of fecal incontinence with prior good results for months to years. However, now these patients report not having an acceptable enema response (up to 4 hours for evacuation) despite numerous attempts to adjust the enema additives. The patients typically display a narrow, spastic left colon and a dilated right colon on contrast enema. A minimum of 10 adult subjects will be enrolled first and followed for safety and efficacy outcomes for at least one month. After the initial 10 adult subjects, there will be a pause in enrollment to allow for a formal review of the adult safety and efficacy data by the primary investigator. At this time a request will be made to open enrollment of this study up to the pediatric population as well as adults.

Exclusion Criteria:

* Any patient who does not meet the above criteria will be excluded from this study. Also excluded: pregnant women, women of child-bearing potential who are unwilling to use an effective form of contraception for 30 days after FMT, women who are breastfeeding, subjects with end stage liver disease or cirrhosis, subjects with a life expectancy of less than 6 months, subjects with an absolute neutrophil count \<500 cells/µL and those with severe food allergies.
Efficacy and Adverse Effects of Prapchompoothaweep Remedy and Loratadine for Treatment in AR Patients

1. To compare the effectiveness of Prapchompoothaweep crude drug at 3,000 mg per day and Loratadine 10 mg per day for treatment in Allergic Rhinitis patients. (Clinical Trial Phase II)
2. To evaluate the safety and adverse effect of Prapchompoothaweep crude drug at 3,000 mg and Loratadine 10 mg for Allergic Rhinitis patients.

this study is a double blind randomized controlled trial study.

the volunteers will be divided into 2 groups. One is received Prapchompoothaweep crude drug capsule at 1,000 mg 3 times a day before meals and the other is received Loratadine 10 mg per day before meals. it takes 6 weeks to complete the project for each volunteers.

Before enrolling, volunteers will stop using any anti-histamine drug for 1 week (wash-out period). All volunteers will be followed up in the 3rd and 6th week to evaluate the efficacy and adverse effect after received drugs.

The researcher will record characteristic data such as gender, age, BMI, vital signs and symptoms . The adverse effect will be monitored by hematology test e.g. liver function test, renal function test, lipid profile and blood sugar test.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-70 years old.
* Patients with history of allergic rhinitis based on ARIA guidelines. (itching and nasal obstruction, watery nasal discharge, sneezing ,congestion)
* Patients with moderate allergic rhinitis was diagnosed by physicians.
* Have no nasal septum perforation, nasal polyp or sinus surgery.
* Have no serious medical conditions: Heart disease, Liver disease, Renal disease, Hypertension, Peptic Ulcer and Gastroesophageal reflux disease (GERD), severe Asthma, Tuberculosis.
* Have normal range of Hematology test for Liver and Renal function.
* No Pregnant or Lactation.
* Do not taking a medicine constantly.
* Volunteers are willing to participate this study.

Exclusion Criteria:

* Allergic reactions to Prapchompoothaweep remedy and Loratadine.
* Allergic reaction to dairy products.
* Have severe urticaria and anaphylaxis.
* Have a serious condition of immunodeficiency disease: HIV in the previous month before being recruited in the study.
* Participate in another study.
A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain

The study is designed to assess the efficacy and tolerability of diclofenac potassium soft gelatin capsules compared with ibuprofen tablets in patients with moderate to severe postoperative dental pain.


Eligibility Criteria:
Key Inclusion Criteria:

* Patients requiring surgical removal of 2 ipsilateral third molars, of which the mandibular must be fully or partially impacted. The ipsilateral maxillary third molar may be of any impaction level.
* Patients having a moderate to severe Baseline pain intensity as assessed by a score of 2 (moderate) or 3 (severe) on the 4-point categorical pain intensity VRS, confirmed by a VASPI score of ≥ 50 mm within 5 hours of surgical completion, after local anesthetic dissipation.

Key Exclusion Criteria:

* Patients who require the removal of a single third molar, or 2 ipsilateral third molars where mandibular molar is not fully or partially impacted.
* Patients with active peptic ulcer disease or a history of significant gastrointestinal disease or any gastrointestinal bleeding.
* Patients with coagulation or bleeding disorders.
* Patients with a positive drug or alcohol screen.
* Patients who have received an anti-inflammatory agent, analgesic, sedative, hypnotic, muscle relaxant, or tranquilizer within 5 elimination half-lives before administration of study drug (other than surgical anesthetic prior to and during dental surgery).
Dermoscopy and Histopathology in Non-melanocytic Skin Tumors

The main aim of the study is to investigate the relation between dermoscopic findings in pre-operative diagnosis of non-melanocytic skin tumors and post-operative histopathology findings .


Eligibility Criteria:
Inclusion Criteria:

* All patients with NMST clinically of both genders in all ages with positive dermoscopic findings and definite histopathologic diagnosis of NMST

Exclusion Criteria:

* No exclusion criteria
Impact of Periodontal Treatment on Growth Differentiation Factor-15 Levels

In light of the controversy that are already approved but that however still exists regarding the efficacy and influence the management of Periodontitis, the aim of this study was to evaluates, at 6-months follow-up, the post-treatment clinical and serum parameters in patients with periodontitis, treated by either Full Mouth Scaling and Root Planing (FM-SRP) treatment versus conventional oral hygiene treatment on serum CRP and Growth differentiation factor-15 levels.

This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2016. The local ethical committee approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent.

Subjects with a diagnosis of periodontitis were enrolled in this clinical trial. The inclusion criteria were: 1) good condition of general health, 2) a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm, 3) no involvement of the furcation, 4) a minimum of six teeth per quadrant, respectively. The exclusion criteria were: 1) periodontal therapy during the last 12 months, 2) assumption of antibiotics during the last 6 months, 3) pregnancy, 4) any systemic condition which might affect the effects of the study treatment, 5) previous or current radiation or immunosuppressive therapies, 5) use of mouthwash containing antimicrobials during the previous 3 months, 6) no use of hormonal contraceptives, 7) medication by anti-inflammatory and immunosuppressive drugs, 8) previous history of hard-drinking, 9) smoking, 10) class II and III tooth mobility. Patients randomly undergo to full mouth SRP or Quadrant SRP

Eligibility Criteria:
Inclusion Criteria:

* good condition of general health
* a minimum of 2 teeth for each quadrant with
* Pocket Depth (PD) ranging from 4-6 mm
* no involvement of the furcation
* a minimum of a six teeth per quadrant, respectively

Exclusion Criteria:

* periodontal therapy during the last 12 months
* assumption of antibiotics during the last 6 months
* pregnancy
* any systemic condition which might affect the effects of the study treatment
* previous or current radiation or immunosuppressive therapies
* use of mouthwash containing antimicrobials during the previous 3 months
* no use of hormonal contraceptives
* medication by anti-inflammatory and immunosuppressive drugs
* previous history of hard drinking
* smoking
* class II and III tooth mobility
A Study of LY2181308 in Patients With Advanced Hepatocellular Carcinoma

The primary objective of this study is to estimate the time to progressive disease for patients with advanced hepatocellular cancer who receive LY2181308.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with hepatocellular cancer
* Discontinued all previous therapies
* At least 18 years of age

Exclusion Criteria:

* Have other treatment options that are potentially curative or effective--such as surgical resection, liver transplant or percutaneous ablation, and/or transcatheter arterial embolization.
* Transplanted liver
* HIV positive
* More than 2 previous systemic chemotherapy treatments
Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis

Accelerometer-based neuromuscular monitoring is not the gold-standard method to evaluate residual postoperative paralysis but it represents the most simple, inexpensive and widespread tool in clinical practice. Train-of-four ratio (TOF-ratio) of 100% is considered the gold-standard to avoid PORC (post operative residual curarization).

This clinical trial is conducted to verify the reliability of accelerometer-based neuromuscular monitoring in order to exclude postoperative residual paralysis which is not highlighted by this instrument at a TOF-ratio=100%.

The study evaluates patients' neuromuscular recovery evaluated using pulmonary function tests after extubation at a TOFratio=100%. Administering placebo or sugammadex at a TOF ratio=100% allows to evaluate whether the recovery of muscle function is concrete, although the monitoring device shows a complete decurarization; patients treated with sugammadex should not be capable to perform better pulmonary function tests if a TOF ratio=100% is reliable.

From the beginning of the surgery to the time of extubation neuromuscular block is monitored with accelerographic monitor TOF-Watch SX. Patients are extubated when TOF-ratio is 100%.

Patients will perform pulmonary function tests (PFTs):

* the day ahead of surgery (for elegibility and training)
* 60 minutes before surgery
* 10 minutes after extubation
* 5 minutes after sugammadex or placebo administration
* 20 minutes after sugammadex or placebo administration.

The following parameters will be evaluated and compared between the 2 groups:

* Maximal Inspiratory Pressure (MIP)
* Maximal Expiratory Pressure (MEP)
* Forced Expiratory Volume in the first Second (FEV1)
* Forced Vital Capacity (FVC)
* Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50)
* PaO2, PaCO2, pH
* heart rate, blood pressure and respiratory rate

Changes of pulmonary tests performed before and after sugammadex or placebo will be compared between study groups.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing major abdominal surgery
* age between 18 and 70 years
* ASA class 1 or 2
* patients scheduled for blended anesthesia (epidural + general anesthesia)
* patients capable to perform pulmonary function tests (preoperative values of MIP, MEP, FEV1% and FEV1/FVC in normal ranges).

Exclusion Criteria:

* known or suspected respiratory, cardiovascular or neuromuscular disease
* renal or hepatic failure
* known or suspected allergies to drugs used in the study
* risk for malignant hyperthermia
* pregnancy
* diagnosed depressive disorder
An Investigational Immuno-therapy Safety and Effectiveness Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas

The purpose of this study is to determine whether Nivolumab, in combination with brentuximab vedotin, is safe and effective in patients with certain subtypes of non-Hodgkin's lymphomas with CD30 expression that have not responded to treatment or have come back. The subtypes we are studying are Diffuse Large B-Cell Lymphoma (DLBCL), Peripheral T-Cell Lymphoma (PTCL), Cutaneous T-Cell Lymphoma (CTCL), Primary Mediastinal Large B-Cell Lymphoma (PMBL) and Mediastinal Gray Zone Lymphoma (MGZL).


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Relapsed/refractory diffuse large B cell lymphoma (DLBCL), relapsed/refractory peripheral T cell lymphoma (PTCL) (all subtypes excluding anaplastic large cell lymphoma), relapsed/refractory Cutaneous T cell lymphoma (CTCL) mycosis fungoides/sezary syndrome (MF/SS), relapsed/refractory primary mediastinal B lymphoma (PMBL), and relapsed/refractory mediastinal gray zone lymphoma (MGZL)
* Expression of CD30
* Subjects must be 18 years or older (≥ 15 years for PMBL)

Exclusion Criteria:

* Known central nervous system (CNS) lymphomas; Active cerebral/meningeal disease related to the underlying malignancy
* Active, known, or suspected autoimmune disease