cyrilzakka/clinical-trials huggingface dataset:
Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients

Serial transcranial Doppler (TCD) exams in healthy volunteers and in animal models showed a strong linear relationship between middle cerebral artery (MCA) flow velocity (FV) and dexmedetomidine infusion. The concomitant elevation of pulsatility index (PI) indicates vasoconstriction of the cerebral vasculature as the most profound underlying mechanism.

Available clinical evidence on the use of dexmedetomidine sedation in neurosurgical and neurocritical care is limited and no definite conclusion can be drawn. There is a need for The use of dexmedetomidine might be a useful adjunct in clinical situations when the increase in CBF could be detrimental such as vasogenic cerebral edema (i.e., TBI, large brain tumors). However, dexmedetomidine sedation is questionable in patients with subarachnoid hemorrhage and acute stroke, since the associate drop in arterial pressure could worsen the coexisting increase in circulating catecholamines and massive sympathetic outflow. Further high-quality RCTs to evaluate the use of dexmedetomidine as a sedative agent both in general ICU patients and in patients with TBI.

Transcranial Doppler (TCD) is a simple noninvasive bedside tool to assess the cerebral blood flow pattern. The new development of transcranial color Doppler with angle correction option helps to improve the sensitivity of test results. TCD can assess the evolution of CBF alterations and possibly cerebral autoregulation performance and ICP estimation in patients presenting with cerebral pathology.

Eligibility Criteria:
Inclusion Criteria:

* Adult trauma patients (18-50 years old, ASA I-II).
* With and without mild TBI.
* Mild traumatic brain injury will include; brain edema, brain contusion, fracture base, fissure fracture and depressed fracture.
* The severity of traumatic brain injury will be defined as mild based on basal Glasgow Coma Scale and basal Computerized tomography scanning.
* Requirements of endotracheal intubation, mechanical ventilation and light to moderate sedation because of associated abdominal or chest traumatic injuries.
* The sedation needed should of an estimated duration not less than 24h.
* Baseline hemodynamic parameters within the normal range.
* Baseline middle cerebral artery flow velocity within the normal range.

Exclusion Criteria:

* Severe traumatic brain injury, subarachnoid hemorrhage and Intra-cerebral hemorrhage.
* Spinal cord injury.
* Hemodynamically unstable patients and patients on inotropes.
* Patients who have a cardiac pacemaker or automatic implantable cardioverter defibrillator.
* Patients with hepatic or renal impairment.
* Pregnant females.
* Patients who are incarcerated.
Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children

Atopic dermatitis (AD) is an immune disorder, characterized by chronic skin inflammation or relapsing, whose prevalence is increasing worldwide. Its exact etiology remains unknown. The hypothesis that an appropriate early stimulation of the intestinal flora contributes to the establishment of the immune system balance has led to the use of probiotics in the prevention and treatment of AD in several clinical and experimental studies.

Therefore, the objectives of this study will evaluate the clinical efficacy of the mixture of probiotics (Lactobacillus and Bifidobacterium) in children with AD through the SCORAD (scoring atopic dermatitis) and to evaluate the effects of this medication in the following laboratory parameters: skin prick test, total serum immunoglobulin E (IgE), inflammation composite (interferon gamma \[ɣ - IFN\], interleukins \[IL1-β, IL-4, IL-6, IL-8\] and tumor necrosis factor alpha) and immune tolerance composite (IL-10, IL-17 and transforming growth factor beta \[TGF - β\]).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Atopic Dermatitis
* Children over 6 months.
* Teens lower than 19 years

No inclusion / Exclusion Criteria:

* Diagnostic presence or clinical signs suggesting acute or chronic skin diseases, as well as pertinent to the study, which may affect the outcome of the research.
* Being in use of drugs that can affect systemically in the course of the disease, such as systemic corticosteroids and immunosuppressants, for at least 30 days.
* Allergy or severe adverse reactions attributable to the administration of the probiotic.
* Non adherence to treatment (ie not present regular use, as prescribed) for at least one continuous month.
* Lack of attendance by more than 50% of ratings (clinical and/or laboratory) to be held during the search.
* Patient's request (or responsible's request)
Plant Stanols and Type 1 Diabetes

In type 1 diabetes (T1D) coronary artery disease (CAD) is an important cause of morbidity and mortality. Although serum cholesterol concentrations are not always elevated in T1D, cholesterol metabolism is different from non-diabetics, so that cholesterol absorption is enhanced. The aim of this study is to investigate the effects of plant stanol esters on serum lipid and lipoprotein lipid concentrations, plant sterol and cholestanol concentrations as well as cholesterol metabolism in T1 diabetics on statin use. The study will give new information about how addition of plant stanol esters on statin use improve hypolipidemic effects in type 1 diabetes.

In type 1 diabetes (T1D) coronary artery disease (CAD) is an important cause of morbidity and mortality. Although serum cholesterol concentrations are not always elevated in T1D, cholesterol metabolism is different from non-diabetics, so that cholesterol absorption is enhanced. Thus, theoretically, the best way to reduce serum cholesterol concentrations is to reduce cholesterol absorption. However, statins are recommended to T1 diabetics at the same LDL cholesterol levels as for type 2 diabetics to reduce risk to CAD.

The aim of this study is to investigate the effects of plant stanol esters on serum lipid and lipoprotein lipid concentrations, plant sterol and cholestanol concentrations as well as cholesterol metabolism in T1 diabetics on statin use.

Altogether, twenty-four T1 diabetics (HbA1c \<9%) on stabile statin use will be recruited to the study from an announcement in the local newspaper and from Kuopio University Hospital and Harjula Hospital. The study is carried out with a randomized, double-blind and parallel design. The intervention group (n=12) consumes spread enriched with plant stanol esters (3 g/d stanols) and the control group (n=12) the same spread containing no added stanols for 4 weeks. The fasting blood samples are taken at weeks 0, 3 and 4. From blood samples concentrations of serum lipids, squalene and non-cholesterol sterols will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes, stabile statin drug use, HbA1c \<9%

Exclusion Criteria:

* liver, kidney and thyroid dysfunction, severe diabetic proteinuria, gastroparesis, unstable CAD, unstable inflammatory gastrointestinal disease
Community Based Screening for Colorectal Cancer in an Underserved High Risk Population in Nigeria

Patient age 45 year old and above who presented with rectal bleeding at three tertiary hospitals in South West Nigeria were invited for colonoscopy. The clinical information of the patients and the colonoscopy data were analyzed

Patient age 45 year old and above who presented with rectal bleeding at Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife, Nigeria, University College Hospital, Ibadan, Nigeria, and University of Ilorin Teaching Hospital, Ilorin Nigeria were invited for colonoscopy. Categorical variables were compared using χ2-test or Fisher's exact test while the Kruskal-Wallis test was used for quantitative variables. Multivariate analysis was performed using logistic regression model. All statistical tests were two-sided and p-values below 0.05 were considered statistically significant. Statistical analysis was carried out using SAS 9.4 and R 3.3.1.

Eligibility Criteria:
Inclusion Criteria:

* must be 45-years of age or older
* has rectal bleeding lasting at least one week
* has had a complete colonoscopy performed

Exclusion Criteria:

* Individuals with a personal history of inflammatory bowel disease, colorectal polyps, colorectal adenoma or CRC
* Individuals with a family history of familial adenomatous polyposis syndromes or other hereditary polyposis syndromes, hereditary nonpolyposis colorectal cancer
* Individuals with severe comorbidities that were contraindication to colonoscopy
* Individuals who had a previous history of colectomy
Apatinib for Advanced Sarcoma: Results From Multiple Institutions' Off-label Use

Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising effects on prolonging progression-free survival (PFS) for advanced sarcoma after failure of standard multimodal Therapy. Methylsulfonic apatinib is one of those TKIs which specifically inhibits VEGFR-2. This study summarizes the experience of three Peking University affiliated hospitals in off-label use of apatinib in the treatment of extensively pre-treated sarcoma.

The investigators retrospectively analysed files of patients with advanced sarcoma not amenable to curative treatment, who were receiving an apatinib-containing regimen between June 1, 2015 and December 1, 2016. Fifty-six patients were included: 22 osteosarcoma, 10 Ewing's sarcoma, 3 chondrosarcoma and 21 soft tissue sarcoma.

Eligibility Criteria:
Inclusion Criteria:

* 1) histologically confirmed high-grade sarcoma;
* 2) initial treatment in the orthopedic oncology departments of the three affiliated hospitals of Peking University;
* 3) tumors not amenable to curative treatment or inclusion in clinical trials;
* 4) unresectable local advanced lesions or multiple metastatic lesions that could not be cured by local therapy;
* 5) measurable lesions according to Response Evaluation Criteria for Solid Tumors (RECIST1.1) \[8\];
* 6) Eastern Cooperative Oncology Group performance status 0 or 1 \[9\]; and 7) acceptable hematologic, hepatic, and renal function.

Exclusion Criteria:

* had been previously exposed to other TKIs;
* had central nervous system metastasis;
* had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia;
* had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++ and so on;
* had pleural or peritoneal effusion that needs to be handled by surgical treatment;
* combined with other infections or wounds
* were pregnant or breastfeeding.
HIV, Abuse, and Psychiatric Disorders Among Youth

One subgroup of adolescents at particular risk for HIV is those with psychiatric disorders. Furthermore, those with histories of sexual abuse have been found to have riskier attitudes, poorer sexual communication skills, and less consistent condom use than non-abused peers. This study implemented and evaluated interventions for adolescents in intensive psychiatric treatment settings, particularly those with histories of sexual abuse. It is hypothesized that those participating in the intervention that addresses affect management and cognitive monitoring strategies will show fewer HIV-risk related behaviors and attitudes at posttest than peers in an information-based intervention.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent attending therapeutic school

Exclusion Criteria:

* Adolescent is HIV positive
* Adolescent is developmentally delayed
* Adolescent is pregnant
* Adolescent has a history of sexual crime
Supplements for Controlling Resistance to Insulin

The purpose of this study is to evaluate the effects of a combination of hydroxcycitrate (HCA) and niacin-bound chromium, in conjunction with nutrition education, over a twelve week period. Participants will be evaluated with regard to BMI, percent body fat, insulin activity, and hunger.

The prevalence of obesity among youth has increased dramatically in recent years. Parallel to the increased rates of pediatric obesity, overweight children present clinically with adiposity related comorbidities such as insulin resistance and type 2 diabetes. The prevailing recommendations for overweight youth are to increase physical activity levels and limit energy intake in order to improve body composition. Currently there is little empirical evidence to support the efficacy of these recommendations. Alternatively, evidence in adults suggests that nutritional supplementation with (-) hydroxycitric acid (HCA), an organic acid found naturally in citrus fruits, and chromium may lead to favorable changes in body composition and improve glucose regulation. To date, these issues have not been tested in youth. Therefore, the purpose of the present investigation is to examine the effects of a nutritional education program combined with either HCA + chromium or placebo on measures of body composition and glucose regulation in overweight adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Age

  * All subjects will be between 13 and 17 years of age
* Overweight

  * All subjects will be overweight as defined by an age \& sex-specific body mass index ≥ 85th percentile based on CDC BMI growth charts \[US Department of Health and Human Services, 2000\], calculated by Epi Info Software, version 3.3.

Exclusion Criteria:

* Presently taking any prescribed medication(s) or diagnosed with any syndrome or disease that could influence dietary intake, body composition and fat distribution, or insulin action or secretion.
* Previously diagnosed with any major illness since birth (e.g. sever intrauterine growth retardation, chronic birth asphyxia, cancer).
* Children with type 1 and/or type 2 diabetes will be excluded are referred to a physician.
* Currently involved with any dietary, exercise, or weight loss program or have been in the 6 months prior to participation.
* Unexplained weight loss or gain in the prior six months.
* Oral contraception use in sexually active females
* Children who live further than 20 miles away from the USC Health Science Campus (HSC).
Endostar Combined With Corticosteroid for Treatment of Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma

To evaluate the effectiveness and safety of Endostar combined with corticosteroids on Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma patients.

detailed description:

This was a single-arm, open-label study. We aimed to evaluate the effectiveness and safety of Endostar combined with corticosteroids on Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma patients. Magnetic resonance imaging (MRI) was performed pre- and post-treatment to define the radiographic response.The primary outcome was a 2-month response rate as determined by MRI and clinical symptoms. All of the patients were followed up with for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Cytologically or histologically proven Nasopharyngeal Carcinoma(WHO 2003 I-III) .
* Presence of at least one measurable target lesion (RECIST rules) in a non irradiated region;
* age ≥18 years;
* radiation therapy history for histologically confirmed NPC administered≥6 months prior to study entry;
* radiographic evidence to support the diagnosis of RN with out tumor recurrence or metastases;
* patients had never received Antiangiogenic agents for RN treatment prior to the screening;
* patients had never received corticosteroids for RN treatment prior to the screening;
* no evidence of very high intracranial pressure suggestive of a brain hernia requiring surgery routine laboratory studies including urinalysis, complete blood count, liver function, renal function, and coagulation test within a normal range;
* to understand and be willing to sign a written informed consent.

Exclusion Criteria:

* Other types of Nasopharyngeal Carcinoma;
* Recurrent nasopharyngeal carcinoma, resection of encephalopathy, metastasis, hepatitis, other malignant tumors, neurovascular diseases, or other diseases of the nervous system;
* Inadequately controlled diabetes (FBG \> 10mmol/L) and hypertension(systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg);
* Other severe concurrent disorders that occurred before enrollment (severe or unstable angor, NYHA class 3 or 4 congestive heart failure, Myocardial infarction occurred within 6 months before enrollment；Aortic dissection aortic aneurysm.) active central nervous system hemorrhage;
* pregnant or lactating women, women who have not undergone a pregnancy test (within 14 days prior to initial administration), and pregnant women;
* Patients with a history of severe mental illness or communication disorders.
Effects of Sufentanil Target Controlled Infusion on Patient State Index Values and Electroencephalographic Spectrum During Total Intravenous Anesthesia With Propofol

Sufentanil Target Controlled infusion (TCI, Gepts model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol TCI (Eleveld model) has not been investigate yet.

Authors aim to investigate its effect on Patient State index (PSi), the power spectrum EEG, the Analgesia Nociception Index (ANI) nad pupillometry values during maintenance durin TIVA-TCI with Propofol and Sufentanil.

Sufentanil Target Controlled infusion (TCI, Gepts model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol TCI (Eleveld model) has not been investigate yet.

Authors aim to investigate its effect on Patient State index (PSi), the power spectrum EEG, the Analgesia Nociception Index (ANI) and pupillometry values during maintenance during TIVA-TCI with Propofol and Sufentanil.

Eligibility Criteria:
Inclusion Criteria:

* Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld model) and Sufentanil (Gepts model)

Exclusion Criteria:

* Neurological disease
* Psychiatric disease
* Obesity
* Regional anesthesia performed
Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa

To establish the safety of radiotherapy in the treatment of advanced hidradenitis suppurativa. Patients will receive radiotherapy treatment over one week and then they will be followed for the next three months.

This is a phase I clinical trial using a Simon-two stage design to establish the safety of radiotherapy in the treatment of advanced hidradenitis suppurativa (HS). In the first six months, 6 patients will be enrolled, if the patients in the study do not meet the termination criteria, then the study will extend to a second stage. A maximum of 20 patients will be enrolled. Patients will be treated with skin-directed radiotherapy, using a total prescription dose of 7.5 Gy in five fractions of 1.5 Gy over one week. Patients will then be seen in the HS specialty clinic at Montefiore Medial Center for at least three months. Quality of life changes, immunohistochemical changes, and cutaneous discharge will also be evaluated during the study period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Hidradenitis Suppurativa made at the Montefiore Hidradenitis Suppurativa Treatment Center, with Hurley Stage 2-3 (defined as recurrent abscesses or boils with diffuse or broad involvement, multiple interconnected sinus tracts in the whole area)
* Failed maximal medical therapy for Hidradenitis Suppurativa or ineligible for "standard" medical therapy or surgery
* Age \> 20 years
* Women of childbearing age: must have a negative pregnancy test within 72 hours prior to the start of study therapy and agree to an adequate method of contraception throughout treatment and for at least 4 weeks after study contraception.

Exclusion Criteria:

* Pregnant women
* Individuals \< 20 years old
Chemotherapy and Amifostine in Treating Patients With Recurrent or Refractory Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the bad side effects of chemotherapy.

PURPOSE: Randomized phase I trial to study the effectiveness of amifostine in treating patients who are receiving chemotherapy for recurrent or refractory solid tumors.

OBJECTIVES: I. Evaluate the ability of amifostine to facilitate increased dose escalation of gemcitabine and cisplatin. II. Compare the dose limiting toxicities of gemcitabine and cisplatin administered with and without amifostine in these patients. III. Determine the maximum tolerated dose of gemcitabine and cisplatin administered with amifostine in these patients. IV. Determine whether synergy is produced by administering gemcitabine and cisplatin on the same day.

OUTLINE: This is a two stage study. The first stage is a randomized study, and the second stage is a dose escalation study. In the first stage of the study, patients receive either intravenous gemcitabine/amifostine/cisplation (GAP) or gemcitabine/cisplatin (GP) in the first cycle. Patients are administered the other arm in the second cycle. In the second stage of the study (dose escalation), the initial dose of GP or GAP is given on days 1 and 8 every 28 days. Dose escalation is carried out in cohorts of 3 patients per dose level. If 1 of 3 patients experiences dose limiting toxicity (DLT), then 3 more patients are accrued at the same dose level. The maximum tolerated dose (MTD) is defined as the lowest dose at which 2 of 6 or 2 of 3 patients experience DLT. Patients experiencing grade 3 or 4 toxicity or tumor progression are removed from the study. Patients will be reassessed every 12 weeks.

PROJECTED ACCRUAL: A total of 32 patients will be accrued over 12-24 months in the first stage of this study, and 9-12 patients will be accrued for the second stage..

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory solid tumors Platinum sensitive

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-2 Life Expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Other: No psychosis No significant medical illness No sensory neuropathy greater than grade 2

PRIOR CONCURRENT THERAPY: At least 3 weeks since prior therapy
DDI Study Between Dorzagliatin and Rifampicin

The purpose of this drug-drug interaction study is to investigate the impact of rifampicin on the pharmacokinetics of Dorzagliatin.


Eligibility Criteria:
Inclusion Criteria:

* Body weight ≥ 50 kg (male) or ≥ 45 kg (female)
* BMI within 19～26 kg/m2

Exclusion Criteria:

* History or disease status that may impact the ADME of the study
* Use of any drugs, OTCs, or hebal within 4 weeks of screening
* Drug abuse
* Blood donation
Reserpine for the Treatment of Cocaine Dependence - 1

The purpose of this study is to assess the efficacy and safety of reserpine for the treatment of cocaine dependence.

To assess the efficacy and safety of reserpine in reducing cocaine use in subjects with cocaine dependence. This is a double-blind, placebo-controlled, parallel-group design with a 2 week baseline period.

Eligibility Criteria:
Inclusion Criteria:

Be at least 18 yrs of age; DSM-4 diagnosis of cocaine dependence; treatment seeking individuals; have the ability to understand and provide written informed consent; females of child bearing potential using appropriate birth control method

Exclusion Criteria:

Additional criteria available during screening at the site.