cyrilzakka/clinical-trials huggingface dataset:
A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus

This randomized, double-blind, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO6811135 or placebo daily for 2 weeks, with a follow-up examination 2 to 3 weeks after the last dose of study drug.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18 to 65 years of age, inclusive
* Type 2 diabetes mellitus according to WHO criteria diagnosed for at least 3 months prior to screening
* On stable dose of metformin for at least 2 months prior to screening
* Fasting plasma glucose during the screening period \</= 240 mg/dL
* Hemoglobin A1c (HbA1c) levels at screening \>/= 6.5% and \</= 10.5%
* Evidence of insulin secretory capacity at screening
* Body mass index (BMI) 27 to 42 kg/m2, inclusive
* Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol

Exclusion Criteria:

* Type 1 diabetes
* Acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes
* History of acute metabolic complications such as diabetic ketoacidosis or state of hyperosmolar hyperglycemia
* Evidence or history of clinically significant diabetic complications such as clinically severe diabetic peripheral neuropathy, clinically significant nephropathy as judged by the investigator, or pre-proliferative/proliferative diabetic retinopathy as judged by the investigator
* History of severe symptomatic hypoglycemia (requiring assistances of a third party) within 6 months prior to screening
* History or presence of clinically significant concomitant disease or disorder
* Hemoglobin level below the lower limit of reference range at screening
* Pregnant or lactating women
* History of anaphylaxis or severe systemic hypersensitivity or allergic reactions
Diagnostic Laparoscopy for Unexplained Abdominal Pain

To evalute the efficiency and safety of diagnostic laparoscopy for patients who have unexplained abdominal pain after completing all needed imaging and laboratories in general surgery depatment Assuit university hospital

Abdominal pain may be a simple thing or it may be a dangerous and life threatening one.It is very difficult to come to a correct diagnosis(1).Diagnostic laparoscopy gives many advantages in the management of many intra-abdominal conditions where the correct diagnosis could not establish clinically or even with the help of imaging studies(2).Diagnostic laparoscopy can be done under direct vision using simple instruments of laparoscopy. With advances in optics, laparoscopy allows visualization of entire peritoneal cavity and further makes possible histological diagnosis of target biopsy under vision(3).In case of diagnostic uncertainty, laparoscopy may help to avoid unnecessary laparotomy, provides accurate diagnosis, helps to plan surgical treatment, improves the outcome in the majority of patients with abdominal pain and allows surgeons to diagnose and treat many abdominal conditions that cannot be properly managed otherwise(4).Many factors like high diagnostic yield, its applicability and therapeutic management in both elective and emergency setups, reduced hospital stay, low morbidity, and expenditure have made this treatment modality most popular(5). On the otherhand there are Complications related to laparoscopic surgery up to one-half of complications occur at the time of abdominal access for camera or port placement , Others arise from abdominal insufflation, tissue dissection, and hemostasis .Conversion to an open procedure may be needed to manage complications (6).Recent treatises deficient in evalution of the role of lap in cases with vague abdominal pain for this the interest of our study is to evalute the efficiency and safety of diagnostic laparoscopy for patients who have unexplained abdominal pain after completing all needed imaging and laboratories.

Eligibility Criteria:
Inclusion Criteria:

* Patients with obscure abdominal pain
* Age from 18 years old up to 70 years old

Exclusion Criteria:

1. Current use of narcotics
2. patients have uncontrolled coagulopathy
3. Patients are Haemodynamically unstable
4. patients have Cardiopulmonary problems
5. Patients refusing the diagnostic laparoscopy after routine investigations
Effects of Nattokinase on Inflammation and Cardiovascular Risk Markers in Patients With Dyslipidemia

The study aims to evaluate the effect of the nattokinase enzyme on inflammation and markers of cardiovascular risk in participants with dyslipidemia. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants with dyslipidemia for two months.

Nattokinase has potent fibrinolytic/antithrombotic, antihypertensive, antiatherosclerotic, lipid-lowering, antiplatelet/anticoagulant and neuroprotective activities. Nattokinase is capable of inhibiting platelet aggregation by blocking the formation of thromboxane and inactivating the type 1 plasminogen activator inhibitory factor. Recently, it was proposed that nattokinase can attenuate oxidative stress and the inflammatory process in in vitro and animal models. However, there are no studies in dyslipidemic patients evaluating these data.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes;
* Over 18 years of age;
* Isolated increase in LDL-c (LDL-c ≥ 160 mg/dL);
* Isolated increase in triglycerides (TG ≥ 150 mg/dL or ≥ 175 mg/dL, without fasting);
* increased LDL-c (LDL-c ≥ 160 mg/dL)
* TG (TG ≥ 150 mg/dL or ≥ 175 mg/dL, without fasting);
* Reduction in HDL-c (men \< 40 mg/dL and women \< 50 mg/dL) alone or in association with an increase in LDL-c or TG. If TG ≥ 400 mg/dL.
* Individuals who are already using lipid-lowering therapy (statins or non-statins) will also be included.

Exclusion Criteria:

* Participants with autoimmune and infectious diseases, diabetes, cancer and AIDS;
* Pregnant women;
* Participants using catabolic drugs or antibiotics
* Participants on anticoagulant medication
* Participants using antioxidant vitamin supplements, prebiotic, probiotic or synbiotic and who are allergic to corn or soy starch.
Bioequivalence of the Tablet and Liquid-Filled Capsule Forms of MK0974 (0974-042)

This study will demonstrate the definitive bioequivalence of a solid dose formulation of MK0974 to the liquid filled capsule formulation of MK0974.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good health
* Subject is a nonsmoker
* Subject is willing to comply with the study restrictions

Exclusion Criteria:

* Subject has history of stroke, chronic seizures, or any major neurological disorder
* Subject has a history of cancer
* Subject is a nursing mother
* Subject has uncontrolled high blood pressure
* Subject has or has a history of any disease or condition that might made participation in the study unsafe or confound the study results
Effect of Bariatric Surgery on Cognition, Genetics and Lifestyle

Obesity bariatric surgery patients usually lose more than 50% of their former obesity within a relatively short time (\~ 2 years). There is still a lack of knowledge about underlying psychological and biological mechanisms of decline in body weight. The intention of this project is to investigate whether bariatric surgery is associated with patients' cognitive ability, lifestyle and/or gene expression and metabolomics.


Eligibility Criteria:
Inclusion Criteria:

* First bariatric surgery

Exclusion Criteria:

* More than one surgery
Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema

Immersion Pulmonary Edema (IPE) is a relatively new form of hemodynamic pulmonary edema. The number of cases has been increasing over the last ten years and it has become the second most common cause of hospitalization for military divers, after decompression sickness. The pathophysiological mechanisms of IPE are not completely known. Its occurrence is linked to a combination of factors related to the environmental constraints of diving, as well as to the diver's equipment. The main external factors are increased hydrostatic pressure, cold, intense effort and emotional stress. The impact of internal factors is not known. At this time, no severe forms of IPE have been identified in the military. However, it is important to identify this pathology at an early stage, even if the signs appear minor, because the continuation of underwater activity can significantly worsen the clinical picture. The risk of recurrence (greater than 15%) could result in a severe or even lethal accident.


Eligibility Criteria:
Inclusion Criteria:

* Military or civilian diver with at least 100 dives
* Between the ages of 18 and 60
* Good physical condition (able to run/swim for 30 minutes at a constant pace).

Exclusion Criteria:

* Divers with a current temporary medical incapacity to dive
* Persons with contraindications to physical exercise and/or scuba diving
* Pregnant or breastfeeding women
Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva

Lichen sclerosus is a chronic dermatosis of the skin and semimucous membranes, characterized by the presence of well-defined atrophic white papules or plaques, which appear mainly on the skin of the anogenital region of both sexes, and less frequently on the skin of the trunk. , mainly affecting postmenopausal women. There is no absolutely effective treatment. Only potent topical corticosteroids control symptoms and improve outcomes, although prolonged use can increase skin atrophy. In severe vulvar lesions, 0.05% clobetasol propionate is indicated, followed by a less potent topical corticosteroid. Relapses often occur if treatment is discontinued altogether, but respond well to reintroduction of treatment.

Plasma Rich in Growth Factors (PRGF®) is a mixture of autologous proteins, prepared from a certain volume of platelet-rich plasma obtained from a small volume of blood, which does not contain leukocytes. To date, there have been no studies evaluating PRGF® treatment in vulvar lichen sclerosus. However, there are several publications that assess the efficacy of PRPs as a treatment for vulvar lichen sclerosus. This clinical study has been designed with the aim of evaluating the efficacy of PRGF® in reducing the main symptoms of vaginal lichen sclerosus atrophicus.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Woman with symptoms associated with LEA confirmed by histological study
* Being 1 month without prior treatment in the affected area as a washing period
* Availability of observation during the treatment period
* Signature of the informed consent

Exclusion Criteria:

* Acute somatic disease
* Infection in the intervention area or active systemic infection
* History of cancerous or precancerous lesions in the intervention area
* In active treatment with other local treatments in the intervention area
* Under active treatment with immunosuppressants and/or anticoagulants
* History of allergies to blood derivatives
* Previous diagnosis of coagulopathies
* Regular and continuous treatment with NSAIDs
* Positive markers for HCV, AfHBs, HIV-I/II or PT
* Pregnancy or women of childbearing age not taking contraceptive measures
* Lactating women
* Treatment with monoclonal antibodies
* Liver failure
* Any inability to participate in the study
Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis (Exo-LCR)

The investigators are interested in one of the most frequent tumor types causing leptomeningeal metastasis in order to investigate whether a profile can be established by a high-throughput clinical proteomic approach. All the data acquired will allow a tailored and promising approach to improve the knowledge of metastatic tumor meningitis.

The primary objective is to describe on an exploratory basis the association between the type of proteomic profile from cerebrospinal fluid (CSF) microvesicles (from unsupervised bioinformatics analysis) and CSF cytology analysis (positive, negative, equivocal) in breast cancer patients with suspected leptomeningeal metastases, on initial CSF samples (hereafter referred to as initial proteomic profile and initial cytology).

Eligibility Criteria:
Inclusion Criteria:

* Patient with histologically proven breast cancer;
* Patient with suspected metastatic leptomeningeal involvement;
* Age ≥ 18 ans ;
* WHO performance status ≤ 2 ;
* Affiliation to the National Social Security System ;
* With informed and signed consent

Exclusion Criteria:

* History of another cancer than the one for which the patient is referred;
* Contraindication to lumbar puncture or cerebrospinal MRI
* Pregnant or breastfeeding woman
Relapse Prevention and Changing Habits in Anorexia Nervosa

This study aims to optimize a treatment package for the relapse prevention treatment of AN. In the Preparation Phase, we examined accessibility and feasibility of the treatment package.

In the current Optimization Phase, we will identify which components of treatment contribute to positive outcomes after acute hospitalization. We will carefully evaluate maintenance of remission, measured by rate of weight loss and end-of-trial status.

While many approaches to reducing relapse after hospital care have been tried, there is little information about which treatment elements confer benefit. This trial, Relapse Prevention and Changing Habits (REACH+), targets the habitual control of maladaptive behavior to support patients with AN in the 6 months after acute treatment, a time of high vulnerability to relapse. Each component of REACH+ addresses a question that is critical to answer in order to identify and optimize a relapse prevention treatment package that balances efficacy and burden. We will test the acceptability and feasibility of 5 components that together target habits: 1) Behavioral, 2) Cognitive, 3)Motivation, 4) Food Monitoring, and 5) Skill Consolidation. In the Preparation Phase, 10 participants were enrolled, and accessibility and feasibility of the treatment package was examined. The current Optimization Phase includes a finalized treatment manual (including an online platform) and will test each component's contribution to weight maintenance after acute treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Anorexia Nervosa at hospital admission
* Medically Stable
* Internet capability with videoconferencing
* Weight restored (BMI \> 19 kg/m2) at New York State Psychiatric Institute

Exclusion Criteria:

* Current substance use or other comorbid disorder requiring specialized treatment
* Pregnancy
* Imminent risk of suicide
* Serious medical illness
* Daily psychotropic medication other than antidepressants (medications that are known effect weight are exclusionary, i.e. stimulants, olanzapine, mirtazapine)
* Participation in outside psychotherapy or structured treatment program (support groups will be allowed). Individuals who are discharged on medications would need to have a non-study psychiatrist.
Building Resilience for Healthy Kids

School based, mental-health intervention focused on improving self-efficacy and coping skills in children aged 9-13 years. The overall premise of our intervention is that by teaching children these skills they will in-turn become more resilient when faced with life-stressors and/or adverse events.

Healthy Kids is a 1:1 health coaching intervention delivered in school-settings. Students meet weekly with their assigned health coach and together they identify both strengths and areas for improvement with respect to resilience, developing resilience skills, and setting resilience goals. Topics discussed include coping skills, self-efficacy, and interpersonal relationships. The program was developed using the social determination theory (SDT), goal theory, and elements from the social-ecological model. SDT was used within the intervention to promote and facilitate behavior change. Goal theory was also utilized to develop strategies to support youth short- and long-term goal setting. Finally, weekly discussions about resilience and goal setting activities accounted for elements of the social-ecological model which acknowledges that behaviors are not independent factors, but are influenced by multiple levels of one's personal and social environment.

Eligibility Criteria:
Inclusion Criteria:

* All children in participating school

Exclusion Criteria:

* None.
Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study

The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. The goals of this study are to determine if bilateral erector spinae plane blocks (ESPB) after sternotomy for congenital heart repair in high risk children and adults can decrease outcomes such as duration of postoperative mechanical ventilation (MV), perioperative opioid consumption, days in the intensive care unit (ICU) and length of stay (LOS).


Eligibility Criteria:
Inclusion Criteria:

i) Ages 0-99 ii) Give consent/parental consent to participate in study iii) Patients undergoing sternotomy for congenital heart repair surgeries

Exclusion Criteria:

i) Participants who do not consent or have parental consent ii) Patients who are clinically unstable or require urgent/emergent intervention iii) Patients under 5kg
Association of Autophagy-related Genes ,LncRNA and SNPs With Colorectal Cancer in Egyptian Population

1. Determination of expression level of HOTTIP and EIF4EBP1(Eukaryotic translation initiation factor 4E-binding protein 1) .
2. Investigation of the SNP HOTTIP rs1859168 and it's association with CRC susceptibility.
3. Correlation of the expression of these genes with various stages of CRC to determine the prognostic value of each of them.

Colorectal cancer (CRC) is a common digestive tract tumor 1.It is the third leading cause of death in the world. Overall 5-year survival rate is less than 40%, and the occurrence is rising 2. However, the prognosis and therapy have not been significantly improved. Therefore, a proper selection of patients for aggressive treatment is necessary, new therapeutic and prognostic strategies are urgently needed 3.

Autophagy is a pathway for self-digestion, in which unwanted cytoplasmic components are recycled 4.In normal conditions, autophagy is essential for cellular homeostasis 5. Autophagy has dual roles in cancer cells, stimulation or suppression , with effects on progression and oncogenesis 6.Recent research established that autophagy is important target for controlling cancer depending on stage and type of tumor 7.Diverse molecular mechanisms contribute to cancer cells resistance to treatment 8.Among these mechanisms , autophagy appears to be critical 9.

EIF4EBP1 (Eukaryotic translation initiation factor 4E-binding protein 1) is encoded by EIF4EBP1 gene.It acts as an effector in mTOR (mammilian target of rapamycin) pathway which on activation ,EIF4EBP1 is phosphorylated promoting cell proliferation 10. Studies have suggested that EIF4EBP1 promotes carcinogenesis as in hepatocellular carcinoma .However, its role in CRC have not been elucidated 10.

Long non-coding RNAs (lncRNAs) are group of RNA , 200 nucleotides in length 11,. Expression of lncRNAs has been discovered in multiple tumors, acting as oncogenes. 'HOXA(hydrogenase transcriptional regulatory protein) transcript at the distal tip' (HOTTIP) has received attention lately.It is up-regulated in CRC tissue, regulating genes via epigenetic modification. Therefore, it might be a candidate for cancerization and therapy of CRC 12.

Expression of lncRNAs could be affected by single nucleotide polymorphisms (SNPs), the most common genetic variation in human genomes13. rs1859168 was reported as a potential functional polymorphism on HOTTIP that alters its expression level 14.. Also, it was recently reported that HOTTIP enhances interleukin 6 expression, which potentiates immune escape of cancer cells 15.

Eligibility Criteria:
Inclusion Criteria:

* No sex predilection.
* Age (25-65 yr).
* Colorectal carcinoma confirmed by histopathological examination

Exclusion Criteria:

* -patients who received any treatment.
* Cases with other organ cancers.
* History of chemotherapy and radiotherapy.
* Systemic diseases such as renal failure, diabetes mellitus, and hypertension.
International Cancer of the Head and Neck, Genetics and Environment (InterCHANGE) Study

Our overall objective is to understand the role of lifestyle factors, genetics and HPV infection in the development and prognosis of head and neck cancer particularly in Asia.


Eligibility Criteria:
Inclusion Criteria:

Age 18\~80 Incident head and neck cancer patients

* Oral, oropharynx and hypopharynx (C00-C14)
* Laryngreal cancer (C32)
* \*Esophageal cancer if possible (C15)

Exclusion Criteria:

* Salivary gland (C07-C08)
* Nasopharynx (C11)
* Thyroid (C79.3)
McKenzie vs Manual Therapy for Low Back Pain

A comparative study evaluating the effectiveness of the McKenzie technique versus manual therapy in patients with nonspecific low back pain. The study aims to assess which intervention is more effective in reducing pain and improving functional mobility.

The study compares McKenzie Method, a directional preference-based approach involving repeated movements and posture correction, against Manual Therapy, which includes hands-on techniques such as mobilizations and manipulations. Patients with nonspecific low back pain will be randomly assigned to one of the two groups and treated over a defined period. Outcomes will be measured using pain and disability scores.

Eligibility Criteria:
Inclusion Criteria: Diagnosis of nonspecific low back pain lasting \>4 weeks Age 35-45 years Willing to participate and follow protocol

Exclusion Criteria:

History of lumbar spine surgery Spinal fracture, tumor, or infection Pregnant women Severe osteoporosis or deformity
Development and Validation of the Food Acceptability Questionnaire

The Food Acceptability Questionnaire (FAQ) is a self-report measure of palatability, ease of preparation, satisfaction, and perceived benefits and adverse effects related to a prescribed or self-selected diet. This study intends to develop a reliable and valid food acceptability questionnaire for use in clinical studies in which dietary interventions are administered.

Two hundred adult participants who follow a therapeutic diet will be recruited from the Washington DC area. Participants will be asked to rate their impression on the foods that they were eating in the past two weeks. Fifty participants will be chosen at random and asked to complete the questionnaire a second time, three weeks later, to assess reliability. Ratings will be used to assess the validity and reliability of the Food Acceptability Questionnaire (FAQ).

Eligibility Criteria:
Inclusion Criteria:

* Participants must be older than 18 years and follow any kind of therapeutic diet.

Exclusion Criteria:

* Those who have difficulty eating by themselves will be excluded. No vulnerable subjects will be included.