cyrilzakka/clinical-trials huggingface dataset:
Tezacitabine With or Without 5-Fluorouracil (5-FU) for Advanced Esophageal Cancer or Gastric Cancer

The purpose of this study is to evaluate the efficacy and safety of tezacitabine when given alone or in combination with 5-fluorouracil (5-FU) to subjects who have advanced esophageal or gastric adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Males and females greater than or equal to 18 years of age.
* Histologically confirmed recurrent (inoperable) or metastatic adenocarcinoma of the esophagus, gastroesophageal junction, or stomach.
* At least one bidimensionally measurable lesion, not previously irradiated, with a diameter that meets RECIST criteria, that can be serially measured. Intraluminal tumors, evaluable only by endoscopy, are not acceptable as target lesions.
* Karnofsky Performance Score greater than or equal to 70%.
* Subjects must be in the second line therapy setting, thus they must have experienced progression following treatment with one (and only one) prior chemotherapy regimen used for the treatment of unresectable locally advanced, recurrent, or metastatic disease.
* Recovery from any serious (grade 3 or higher) toxic effects of prior radiation therapy.
* Adequate hematologic profile: absolute neutrophil count greater than or equal to 1,500/mm3; hemoglobin greater than or equal to 9 g/dL; hematocrit greater than or equal to 30% (transfusion allowed); and platelet count greater than or equal to 100,000/mm3.
* Adequate hepatic function: bilirubin less than or equal to 1.5 mg/dL; AST and ALT less that 2.5 X ULN (5 X ULN if liver involved with tumor); alkaline phosphatase less than 5 X ULN
* Adequate renal function; serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than 50 mL/min.
* Both male and female subjects of childbearing potential must be using a contraceptive method that is medically acceptable to the investigative center.
* Disease-free from a prior malignancy, other than non-melanoma skin cancer or carcinoma in-situ of the cervix, for greater than 5 years.

Exclusion Criteria:

* Unstable angina or class III or IV New York Heart Association heart disease.
* CNS metastases.
* Pregnant or breast-feeding.
* Uncontrolled seizure disorder.
* Ongoing (grade 3 or higher) stomatitis, esophagopharyngitis, or uncontrolled diarrhea.
* Impaired nutritional status as evidenced by a serum albumin of 2.7 mg/dL or less.
* Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment. Concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation.
Chronic Inflammation and Exercise Responsiveness

The purpose of this study is to determine how chronic inflammation influences skeletal muscle protein metabolism and metabolic function in humans. The investigators will evaluate acute responsiveness to a single bout of exercise in men and women who are either lean or overweight/obese. The investigators will explore the relationship between circulating inflammatory markers and anabolic, proteomic, and transcriptional responses to acute exercise. The investigators will measure skeletal muscle protein synthesis in the postabsorptive state and in response to a single bout of exercise.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-55 years
* BMI 19-45 kg/m2

Exclusion Criteria:

* Anemia (female subjects hemoglobin of \<11 g/dl and male subjects hemoglobin \<12 g/dl)
* Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment)
* Renal insufficiency/failure (serum creatinine \> 1.5mg/dl)
* Oral warfarin group medications or history of blood clotting disorders.
* Pregnancy or breastfeeding
* Alcohol consumption greater than 2 glasses/day or other substance abuse
* Untreated or uncontrolled thyroid disorders
* Debilitating chronic disease (at the discretion of the investigators)
Comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone Levels Pre-post Omentectomy

Omentum is adipose tissue lying under inner anterior wall Omentectomy is routine procedure in treatment of gynecological malignancy especially ovarian cancer and some advanced stage endometrial cancer. Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone secrete from adipose tissue. These regulate matabolic process.

We aimed comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone levels derivated from adipose tissue pre-postoperatively in patient diagnosed with gynecological malignancy performed omentectomy or not

Omentum is adipose tissue lying under inner anterior wall Omentectomy is routine procedure in treatment of gynecological malignancy especially ovarian cancer and some advanced stage endometrial cancer. Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone secrete from adipose tissue. These regulate matabolic process.

We aimed comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone levels derivated from adipose tissue pre-postoperatively in patient diagnosed with gynecological malignancy performed omentectomy or not. Blood sample will study after 4000 rpm centrifugal for 10 minutes

Eligibility Criteria:
Inclusion Criteria:

* gynecologic malignancy, staging surgery with or without omentectomy

Exclusion Criteria:

* not accept inclusion to trial
Effects of Gabapentin in the Treatment of Neuropathic Pain on Driving Performance and Cognition

The aim of this study was to explore the effects of pain on the one hand and the effects of treatment of pain with gabapentin (900, 1200, 1800 or 2400 mg) on the other hand on actual driving performance and several laboratory tests in patients with neuropathic pain. It was hypothesized that gabapentin might influence performance after acute but not after subchronic administration.

Numerous studies demonstrate neuropsychological impairment in patients with chronic pain, particularely on measures assessing attentional capacity, processing speed and psychomotor speed. About 50% of the patients suffering from neuropathic pain are treated with anticonvulsants, as a treatment against serious pain complaints, and experience good pain relief. Gabapentin is one of the most prescribed anticonvulsants for the treatment of neuropathic pain. An important disadvantage of treatment with gabapentin could be the occurrence of side effects, such as somnolence and fatigue. These side effects can constitute a crucial problem for patients treated with gabapentin who must operate a motor vehicle or other dangerous machinery. However, pain affects cognition negatively, and possibly also driving. Therefore, another possibility is that treatment with gabapentin for these pain complaints can improve driving because the pain has less influence. Since driving is an activity of daily living that is important in maintaining independency in the community, such as access to employment and social activities, it is important to establish the effects of using gabapentin on these abilities. No studies have been conducted so far to investigate driving abilities of patients with neuropathic pain, treated with gabapentin.The aim of this study was to explore the effects of pain on the one hand and the effects of acute (Day 1) and subchronic (Day 15) treatment of pain with gabapentin (900, 1200, 1800 or 2400 mg) on the other hand on actual driving performance and several laboratory tests in patients with neuropathic pain. It was hypothesized that gabapentin might influence performance after acute but not after subchronic administration. This study is a two-period double-blind, placebo-controlled, cross-over randomised study.

Eligibility Criteria:
Inclusion Criteria:

* age, responder to gabapentin,succesfully treated with gabapentin at least 4 weeks before start of study, minimal VAS pain intensity scores of 4 cm on a 10 cm scale, driving licence, driving experience, fluently speaking Dutch, normal vision, right-handed

Exclusion Criteria:

* alcohol- or drug dependence, use of other psychotropic medication, use of illicit drugs, psychological or physical disorder other than pain or pain-related, excessive smoking and drinking
TBE Seropersistence up to 10 Years After First Booster in Adults

The purpose of this study is to evaluate TBE antibody persistence from 7 to 10 years after the first booster TBE vaccination with FSME-IMMUN 0.5ml.


Eligibility Criteria:
Inclusion Criteria:

Subjects who participated in the first and second precursor studies will be eligible for participation in this study if:

* they understand the nature of the study, agree to its provisions and provide written informed consent
* they received the first booster vaccination with FSME-IMMUN 0.5ml during the first precursor study and did not receive a second booster vaccination in the second precursor study
* blood was drawn after their first booster vaccination in the first precursor study

Exclusion Criteria:

Subjects will be excluded from participation in this study if they:

* received any TBE vaccination since their first booster vaccination with FSME-IMMUN 0.5ml
* have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) since their first booster vaccination with FSME-IMMUN 0.5ml
* are known to be HIV positive since their first booster vaccination with FSME-IMMUN 0.5ml
* have a known or suspected problem with drug or alcohol abuse
Fine Needle Biopsy of Solid Pancreatic Mass Lesions

This is a randomized trial to evaluate and directly compare the tissue quality, diagnostic sucess and safety profile of four different Fine Needle Biopsy needles.

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is currently the standard method for sampling solid pancreatic masses, with reported sensitivity for malignant cytology of 85-95%, specificity of 95-98% and diagnostic accuracy of 78-95%. Diagnostic failure of EUS-FNA can be due to inadequate targeting, inexperience of the endoscopist/pathologist, or necrotic or fibrotic tumors in which viable cells are difficult to obtain. The cellularity and architectural representation of the sample can also be determined by the needle used and its specific features. Recently, new needles known as "fine needle biopsy (FNB)" needles have become available that are specially designed to promote the collection of core tissue by unique designs of their needle tips. The advantages of FNB over FNA needles are that (a) the quality of tissue procured is superior: FNA needles yield cytology whereas FNB needles yield histology (b) molecular marker analysis can be performed more reliably on histology samples than cytology aspirates and (c) as histological tissue is greater in quantity than cytological aspirates, a quicker diagnosis with fewer passes can be established by histology than cytology.

Four different types of FNB needles are currently available - reverse-bevel tip (EchoTip ProCore HD Ultrasound Biopsy Needle, Cook Medical, Bloomington, IN), Menghini-tip (EZ shot, Olympus America, Center Valley, PA), Franseen tip (Acquire, Boston Scientific Corporation, Natick, MA) and fork-tip (SharkCore, Medtronic Corporation/Covidien, Newton, MA) needles, each with unique tip designs to facilitate procurement of histological core tissue. Although we have previously compared in randomized trials the diagnostic yield of Franseen and fork-tip FNB needles and have shown the two needles to be equivalent, there are currently no randomized trials directly comparing all four FNB needle types. EUS-guided tissue acquisition can also be performed using different techniques, including the use of suction, no use of suction and the stylet retraction technique. There are currently no studies comparing these different tissue acquisition techniques using the different FNB needles and no study has demonstrated the best technique for FNB.

Eligibility Criteria:
Inclusion Criteria:

1. All patients referred for EUS-guided tissue acquisition of suspected or confirmed solid pancreatic mass lesions visualized on any radiological imaging
2. Able and willing to provide written or verbal consent
3. ≥ 18 years old
4. Able to undergo conscious sedation for EUS procedure

Exclusion Criteria:

1. \<18 years old
2. Unable to obtain informed consent from the patient
3. Medically unfit for sedation
4. Pregnant patients
5. No pancreatic mass lesions visualized on EUS
6. Irreversible coagulopathy as determined by platelet count \< 50,000/microL or International Normalized Ratio (INR) \> 1.5
7. Unable to stop anti-platelet agents prior to the procedure
Group Dialectical Behavior Therapy as add-on Treatment for Adults With Attention Deficit/Hyperactive Disorder

Attention-Deficit/Hyperactive Disorder (ADHD) in adults is associated with global impairments and deficits in quality of life. The ADHD functional impairments during adulthood usually persist even after adequate medication treatment. The Skill Training Group of the Dialectical Behavioral Therapy (DBT) is one of the group therapies that had been adapted for the specific treatment of ADHD patients. Our primary aim is to explore the feasibility of the approach in different culture and to evaluate the efficacy of the Skill Training Group as an add-on treatment for adults using ADHD medication. This is a Randomized Clinical Trial comparing the Skill Training Group added to stimulants to treatment as usual. 52 adults previously diagnosed with ADHD and treated with stimulants in our ADHD outpatient program will be enrolled. Only patients with residual symptoms will be included (ADHD-Self Report Scale - ASRS ≥ 20). The intervention comprises the standard 12 sessions therapy program. The groups will have between 8 and 12 patients each, and will be conducted by a trained DBT therapist with supervision from a senior DBT therapist. The primary outcome will be the ASRS scores. Secondary outcomes include scores in ADHD Quality of Life, Beck's Depression Inventory, Beck's Anxiety Inventory, and performance in a neuropsychological test (difference between pre and post-intervention) (Stop Signal Task). Adherence to the protocol will also be checked. The recruitment was initially scheduled for beginning in November.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ADHD
* Medicated with following drugs and minimum daily dosages:

Methylphenidate ≥ 0.5 mg/kg Lisdexamfetamine ≥ 30mg Bupropion ≥ 150 mg Modafinil ≥ 200mg Imipramine ≥ 1mg/kg

* At least one month of stabilized dosage for any psychiatric medication.
* ADHD-Self Report Scale ≥ 20.
* Knowledge of oral and written communication in Portuguese
* IQ\>85 (intelligence quotient)

Exclusion Criteria:

* diagnoses of Borderline or Anti-social personality disorders.
* diagnoses of autism spectrum disorder
* current episode of major depression or suicide toughs
* current episodes of mania or hypomania
* recent episodes of drug abuse (last 6 months)
* diagnoses of drug dependence
* patients that change their medications or their psychiatric conditions in the exclusion criteria above after the beginning of the protocol will have their data censored, but included in the intention to treat analyses. These patients will keep the right to attend all the sessions in the protocol at their discretion.
Perioperative Nutritional Status and Nutritional Support in Patients With Spinal Deformity

To investigate the nutritional status, nutritional support and postoperative complications of patients undergoing spinal orthopedic surgery during the perioperative period.

Adopting the method of continuous fixed point sampling, the inpatients in the orthopedic ward of our hospital were selected as the objects of investigation.

(1) Data collection

1. general data: The information of gender, age, ethnicity, height, weight, course of disease, family history, combined diseases, medication etc.
2. Nutritional assessment：①Nutritional risk screening tool 2002(NRS 2002), an evidence-based nutritional risk screening tool developed by the European Society for Parenteral and Endoenteral Nutrition, was recommended by the Chinese Society for Parenteral and Endoenteral Nutrition as a nutritional risk screening tool for inpatients in China. The total NRS 2002 was divided into three scores, namely disease severity score, impaired nutritional status score and age score. NRS 2002 score ≥3 (accompanied by poor general conditions, such as weight loss, appetite, mental state, etc.) are at nutritional risk and require nutritional support; Those with a score less than 3 have no nutritional risk and do not need nutritional support. ②Other indicators include height, weight and body mass index, as well as biochemical indicators such as pre-albumin and hemoglobin. Nutritional assessment was performed within 24 hours of admission, on the 1d after surgery, on the 7d after surgery, every 7d after surgery, or upon discharge. NRS 2002 was repeated to assess patients' nutritional risk at the first review three months after discharge.
3. Nutritional support: The nutritional support received during the hospital was recorded, including the form of nutritional support (enteral or parenteral nutrition), energy ratio, variety selection, duration of administration, etc. 1 g carbohydrate provided 16.74 kJ(4 kcal) calories, 1 g fat milk provided 38.93 kJ(9.3 kcal) calories and 1 g amino acid provided 16.74 kJ(4 kcal) calories to calculate the energy provided by the nutritional support program. The amount of nitrogen provided by the nutritional support program was calculated with about 1 g nitrogen provided by 6.25 g amino acids.
4. Complications: Postoperative complications, such as sepsis, pneumonia, urinary tract infection, wound infection, and delayed wound healing, were recorded during hospitalization and within 3 months after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of spine deformity, complete the operation in one time；
* Age: More than 10 years old ；
* Patients and their family members agreed to participate in the study and signed the informed consent；
* Conscious, patient or family members can communicate verbally.

Exclusion Criteria:

* Emergency surgery；
* Hospital stay less than 24 hours；
* Surgery was not performed during the hospital stay；
* Nutritional metabolic diseases.
Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis

Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis

Eligibility Criteria:
Inclusion Criteria:

- male and non-pregnant females, age 6 months or older, with a confirmed diagnosis of moderate to severe atopic dermatitis (AD)

Exclusion Criteria:

- Lacks stable diagnosis of atopic dermatitis or has been diagnosed with mild atopic dermatitis.
A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion

The purpose of this research is to evaluate and validate the performance of non-invasive imaging modalities for assessment of skin. A pressure cuff occlusion will be used to stimulate blood flow dynamic that these instruments are designed to sense. The researcher currently plan to assess only basic feasibility of the imaging instruments.

The primary reason for including pressure cuff occlusion in this protocol is to test the performance of Multi-Spectral Imaging and Laser Speckle Imaging can measure in the full range of vascular conditions ranging from ischemic (under-perfused or unsaturated) to hyperemic (over-perfused and over-saturated).

1. Modulated Imaging a non-contact optical imaging technology can detect the concentration of total hemoglobin, deoxygenated and oxygenated hemoglobin in absolute amounts in units of millimoles / unit volume of tissue measured.
2. Laser Speckle Imaging a non-contact optical imaging technology consists of a coherent light source, camera, and image acquisition system. This image device can measure and compare relative flow in vasculature at varied time points.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adult 18 years and older

Exclusion Criteria:

* Younger than 18 years of age
* Pregnant women
Clinical Study Of EYE001 For Wet-Type AMD (Age-Related Macular Degeneration)

This study will examine the efficacy and safety of pegaptanib sodium in Japanese patients with wet-type AMD, in order to establish that there is no large difference in the efficacy and the safety of the drug between Western and Japanese patients.


Eligibility Criteria:
Inclusion Criteria:

* Wet AMD, Visual Acuity from 20/320 to 20/40

Exclusion Criteria:

* Diabetic retinopathy, laser coagulation history
Application and Comparison of Fuzzy Scale for the Evaluation of Pain Skeletal Muscle With the Numerical Pain Scale

This study aimed to analyze the stratification of pain levels through a mathematical model built using the diffuse joint theory and to investigate the relationship between range of motion and pain related aspects.

The incidence of pain is due to traumatic actions, surgical interventions, new habits of life, increased longevity of the individuals and the reduction of the tolerance of the suffering by the man. Musculoskeletal pain is more evident in adult individuals, being the main cause of chronic pain throughout society, generating an impact on the quality of life, interfering in the daily activity of 30 to 50% of the patients. Pain measurement can be divided into four levels, which include the nominal, the ordinal, the interval and the ratio, with both one-dimensional and multidimensional versions. In the health area, diagnosis and treatment of diseases involve various levels of imprecision and uncertainties. A single disease or symptom may manifest totally differently in different patients and with varying degrees of severity. These effects usually generate many uncertainties and inaccuracies affecting the interpretations of the exams and the diagnosis, as well as the treatment. Fuzzy Systems Theory, also known as nebulous logic, is used to interpret the approximate mode of human reasoning, to take it to a numerical format and to obtain answers in an environment of uncertainties that serve as a subsidy to decision-making . A Fuzzy system based on Fuzzy logic. It can also be considered as a kind of expert, knowledge-based system. The development of the proposed Fuzzy Scale for Skeletal Muscle Pain Evaluation used the Mamdani method that allowed the representation of specialist knowledge (s) to construct the rule base. The construction of this system was based on the numerical scale of pain adopted and spread worldwide, and on the range of motion represented by the action of the muscles and articular components of the human body. The diffuse model proposed by the Fuzzy Scale for Muscle Skeletal Pain Evaluation uses 25 rules using binary XOR logic. For the volunteer tests, the proposed model was a non-randomized single intervention transverse study to analyze and compare the model of diffuse pain evaluation with the numerical pain scale performed with 535 volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Included in this study were male and female subjects
* Age between 18 and 90 years
* With complaint of skeletal muscle pain
* Do not present cognitive deficit that makes the study impossible

Exclusion Criteria:

* Individuals who did not agree to participate in the study
* Volunteers with decreased range of motion
* Volunteers without complaint of skeletal muscle pain