cyrilzakka/clinical-trials huggingface dataset:
RFA Plus Carrizumab vs Carrizumab Alone for HCC

The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS.

The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS. 120 patients were enrolled into two groups respectively, the experimental group and reference group.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18-75 years
2. Diagnosis as hepatocellular carcinoma from histology and cytology
3. BCLC B-C degree
4. Score of ECOG PS: 0-2
5. Child-Pugh Score: A or B
6. Not suitable for resection or liver transplantation
7. Have not received systemic therapy
8. Have at least one evaluable target mass from CT or MRI according to mRECIST
9. The estimated survival time ≥ 12 weeks
10. Patients with HBV infection having HBV-DNA \<500IU/mL and standard anti-virus treatment. Patients with HCV infection must receive standard anti-virus treatment.
11. The function of main organs normal
12. Sign informed consent

Exclusion Criteria:

1. Have cholangiocarcinoma, mixed type of hepatocarcinoma and fibrolamellar hepatocellular carcinoma. Have incurable malignant tumor in five years.
2. Have local ablation, TACE or radiotherapy in 3 months before enrolled.
3. Prepared to or have received organic or bone marrow transplantation.
4. Uncontrollable ascites, hepatic encephalopathy or esophageal and gastric varices.
5. Have hypertension and can't lower down to the normal level using blood pressure medication.
6. Have type II myocardial ischemia or myocardial infarction, uncontrollable arrhythmia.
7. Have diseases to influent the effect of oral drugs, for example, unable to swallow, chronic diarrhea and intestinal obstruction.
8. Have gastrointestinal bleeding in 6 months
9. Have abdominal fistula, gastrointestinal perforation or abdominal abscess
10. Patients with lung fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug related pneumonia or severe dysfunction of lung.
11. Routine urine test showed urinary protein ≥++ or the 24 hours amount of urinary protein ≥1.0 g
12. Patients have autoimmune disease
13. Patients need corticosteroid or other immunosuppressant therapy
14. Patients have anti-tumor vaccine and other immunostimulate anti-tumor drugs in 3 months
15. Allergy to monocloning antibody
16. Pregnant or breastfeeding female Other patients not suitable to be enrolled in the study.
Glioblastoma Platelet Activation Study

Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (M2) phenotype.

Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.

Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (M2) phenotype.

Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.

Eligibility Criteria:
Inclusion Criteria:

* MR-morphological suspicion for glioblastoma
* informed consent

Exclusion Criteria:

* no informed consent
Effect of Performance-specific Cleft Speech Intervention and Long-term Learning in Children With a Cleft Palate

Speech therapy in children with a palate deals with two scientific challenges that will be addressed in this project.

The first challenge is selecting the best speech approach for a child with a specific cleft speech characteristic (CSC). Many speech therapists use a 'one-size-fits-all' approach to treat compensatory CSCs resulting in poor short- and long-term speech outcomes. To increase the effectiveness and quality of cleft speech care, it is necessary to find the best match between a specific therapy and a given type of CSC. Therefore, this proposal will compare the effect of 3 different speech approaches on the speech and quality of life in Dutch speaking children with different types of CSCs.

The second challenge is selecting the best speech approach to enhance long-term learning and transfer of newly established speech skills to untrained consonants. To date, research mainly focused on immediate therapy effects. It is unknown if permanent speech changes occur. Hence, this project will also investigate the short-term and long-term learning effects (retention and transfer) of the different speech approaches from the first objective.

This proposal will improve evidence-based and patient-tailored cleft speech therapy.

Objective 1: To compare the (immediate) effect of three speech therapy approaches (i.e.

a motor-phonetic approach, a phonological approach, and a combined phonetic-phonological approach) on the speech and health-related quality of life (HRQoL) in Belgian Dutch-speaking children with a CP±L and different subtypes of compensatory CSCs (anterior oral CSCs, posterior oral CSCs, or non-oral CSCs) measured by perceptual and psychosocial outcome measures.

Objective 2: To measure the short-term effects (performance to learning) and the long-term learning effects (retention and transfer) of the three different speech therapy approaches (i.e. a motor-phonetic approach, a phonological approach, and a combined phonetic-phonological approach) on the speech and HRQoL in Belgian Dutch-speaking children with a CP±L and different subtypes of compensatory CSCs measured by perceptual and psychosocial outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Belgian Dutch-speaking children with a cleft palate with or without a cleft lip
* Aged between 4 and 12 years
* Presence of at least one compensatory speech error in their speech based on the perceptual assessment of one experienced speech-language pathologist

Exclusion Criteria:

* Children with syndromic clefts
* Oronasal fistula
* Velopharyngeal insufficiency
* Hearing disabilities based on pure tone audiometry (\>25 dB HL)
* Cognitive and/or related learning disabilities or neuromuscular disorders
Parents Reading Comprehension of Their Child's Post-Operative Medicine Fact Sheets

The objective of this study is to test legal guardians reading comprehension of their child's post-operative medication administration using three different versions of written medication information (standard fact sheets, easy-to-read fact sheets, and easy-to-read fact sheets accompanied by illustrations).

It is important for the child's welfare and comfort that the legal guardian can read and comprehend their child's pain medication information. Failure to understand the full implications of the medication may jeopardize the child's comfort level or welfare. Readability of printed education materials is a key to comprehension and supplements what healthcare providers verbally tell the parents/legal guardians. Several studies have demonstrated the benefits of using illustrations to convey intended messages. Simple line drawings appear to do well with those who have low-literacy skills.

The following hypothesis will be tested:

* There is no difference in level of comprehension of medication administration by the legal guardians who receive standard fact sheets about medication, those who receive easy-to-read fact sheets, and those who receive easy-to-read fact sheets accompanied by illustrations.
* There is no difference in level of comprehension of pain assessment by the legal guardians who receive standard fact sheets about assessing pain, those who receive easy-to-read fact sheets, and those who receive easy-to-read facts sheets accompanied by illustrations.
* There is no relationship between legal guardians' satisfaction with medication education and whether they receive standard fact sheets, easy-to-read fact sheets, or those who receive easy-to read fact sheets accompanied by illustrations.

Eligibility Criteria:
Inclusion Criteria:

* be 18 years of age or older or an emancipated minor
* ability to see, speak, and hear English
* have a child who will be undergoing surgery
* signed surgical consent form
* have a child staying on hospital pediatric surgical unit after surgery until discharge
* have a child admitted for at least one day but not more than 7 days.
The Less is More Study

In this project, the investigators will implement innovations to extend use of Contingency Management (CM) to facilitate alcohol use reduction among people living with HIV (PLWH). The investigators' approach to extending CM will use mobile health (mHealth) tools including a smartphone breathalyzer device with accompanying app and a wrist worn alcohol biosensor. Participants will be engaged in mobile facilitated CM for 30-60 days with follow-up out to 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Frequent alcohol use in the past 30 days based on responses on the Timeline Followback (TLFB; Sobell and Sobell, 2003)
* HIV positive
* Fluency in English
* Willingness to attempt alcohol abstinence for at least 30 days and then to attempt alcohol use on fewer days than at baseline after that
* Willingness to use smartphone applications and biosensor devices (i.e., breathalyzer device and wrist sensor) for alcohol use reduction purposes in the study. If participants do not have a compatible smartphone to use, they will be loaned one by the study

Exclusion Criteria:

* Psychiatric conditions that would interfere with participation in the study
* Current alcohol withdrawal as indicated by a score of 8 or higher on the Clinical Institute Withdrawal Scale (CIWA; Sullivan et al., 1989) or lifetime history of medically assisted detoxification
* Two positive breath alcohol concentration (BrAC) readings (i.e., \> 0.00%) at an in-person screening appointment. After participants blow their first positive BrAC, they will be allowed to reschedule and participate at another time, however if they blow a second positive BrAC, they will be excluded from this study and offered referrals for alcohol treatment.
* Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors
* Psychosis or other severe psychiatric disability
* Pregnancy, nursing or lack of reliable birth control use for women who have not yet reached menopause
Absolute Bioavailability Study With Ipragliflozin

A study to assess the absolute bioavailability of ipragliflozin in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) more than or equal to 18.5 and less than 30.0 kg/m2

Exclusion Criteria:

* Any of the liver function tests above the upper limit of normal.
* Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: Pulse \<40 or \>90 bpm; mean systolic blood pressure \>140 mmHg; mean diastolic blood pressure \>90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically)
* A QTc interval of \>430 ms (males) or \> 450 ms (females) consistently after duplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
Effectiveness of Medical Taping Concept in Cancer Patients

Nausea and vomiting are two of the side effects associated with the most common antineoplastic chemotherapy treatments. The Medical Taping Concept (MTC) is an economical technique, easy to apply. This is a technique that may help reduce nausea and vomiting after application of chemotherapy in cancer patient.

Nausea and vomiting are two of the side effects associated with the most common antineoplastic chemotherapy treatments. There are some studies that support the use of physical measures such as TENS or acupuncture to lessen these effects.

The Medical Taping Concept (MTC) is an economical technique, easy to apply and few side effects. In some manuals on this technique the possibility that it may act to reduce nausea and vomiting described. Sim But after a comprehensive literature search have not found jobs to support these assumptions. With this work, the research team will attempt to obtain evidence on the effects of its application in the areas of influence of the dermatome T7 and T8. For this, two adhesive tapes of this type of bandage is placed on the front and back on a group of patients after receiving chemotherapy session and compared with a control group that will apply this technique outside the dermatome indicated . Both groups will receive antiemetics according to the service routine. If the hypothesis were positive it could extend the application of this simple technique to cancer patients from other centers in order to help reduce nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

* Neoadjuvant and adjuvant breast cancer
* To have been diagnosed with a severe comorbid disorder
* To have received at least the first cycle of emetogenic chemotherapy

Exclusion Criteria:

* Not suffer nausea or vomiting episodes in the previous cycle of chemotherapy,
* To Shower inability to report nausea and / or vomiting.
Melanoma Vaccine in Treating Patients With Stage III Melanoma After Surgery to Remove Lymph Nodes

RATIONALE: Vaccines made from dendritic cells and tumor antigen peptides or a person's tumor cells may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best way to give melanoma vaccine in treating patients with stage III melanoma after surgery to remove the lymph nodes.

OBJECTIVES:

* Determine the feasibility of adjuvant melanoma vaccine comprising autologous dendritic cells pulsed with tumor antigen peptides in patients with stage III melanoma following lymphadenectomy.
* Determine the immune response (skin test of delayed-type hypersensitivity and flow cytometric enumeration of peripheral blood CD8+ lymphocytes producing IFN-γ) to this regimen in these patients.
* Determine clinical outcome (disease-free survival, overall survival, and adverse events) in patients treated with this regimen.

OUTLINE: Patients undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMCs) and bone marrow mononuclear cells. Autologous dendritic cells (DCs) prepared from PBMCs and bone marrow mononuclear cells are exposed to various antigens and peptides, and autologous tumor cell lysate, if available. Patients receive autologous DCs pulsed with melanoma-associated antigen peptides, and autologous DCs pulsed with tumor lysates (if available), subcutaneously in weeks 0, 2, 5, 8, 12, 16, 20, 26, 31, 50, and 102. Patients with no evidence of disease may receive another booster injection 5 years after the start of vaccination.

Blood samples are examined via flow cytometry and skin testing is performed to evaluate immune response.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of stage III melanoma

  * Has undergone therapeutic lymphadenectomy
  * More than 1 lymph node involvement or extracapsular extension of metastatic melanoma cells (stage N1b-N3 disease according to AJCC 2002)
* HLA type A1 and/or A2 or A3 (if autologous tumor lysate is available)
* No presence of distant metastases

PATIENT CHARACTERISTICS:

* No other malignancy
* No evidence of lung, heart, liver, or renal failure or severe neurologic disorder
* No autoimmune disease or atopic allergy
* No HIV infection or presence of anti-HIV antibodies
* No presence of hepatitis B surface antigen or antibodies against hepatitis C virus

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Screening for Abdominal Aortic Aneurysm in 65 Year Old Males in Oslo

Male subjects, 65 years of age, living in Oslo, Norway will be invited to be screened for abdominal aortic aneurysm.

The invited population will be offered ultrasound investigation of their abdominal aorta. Further information regarding risk factors will be noted and measurement of ankle-brachial index will be measured/calculated. A further step in the future will be to sample blood with focus on different cytokines and genmediators.

Eligibility Criteria:
Inclusion Criteria:

* Males aged 65 years

Exclusion Criteria:

* None
Standardization of Quantitative Muscle Ultrasonographic Parameters Among Egyptian Population

1-standardization of semi quantitative muscle ultrasonographic parameters ( muscle thickness (MT) and echo intensity (EI) ) in healthy adults and to obtain a set of normal values of all accessible muscle in both upper and lower limbs.

2.standardizaition of quantitative muscle ultrasonographic parameters (Gray scale level (GSL), Calibrated muscle backscatter values (cMBs), Optical Density (OD), 2D Textu1) in healthy adults and to obtain a set of normal values of all accessible muscle in both upper and lower limbs.

. Ultrasound is a widely used imaging technique in many different medical specialties. It is a non-invasive, safe and relatively cheap investigation method.

Ultrasound is a non-invasive method to quantitatively measure various muscle parameters.

Ultrasound imaging (US) has shown to be capable of visualizing normal and pathological skeletal muscles.(1) By measuring muscle thickness (MT) and echo intensity (EI) (=grey-value) of the muscle, structural changes caused by neuromuscular disorders can be detected. (2, 3, 4) Quantitative evaluation of US images is preferable over visual evaluation, because it is more sensitive and objective and offers the possibility to perform statistical analysis.(5) A prerequisite for the diagnostic use of quantitative muscle US is the availability of normal reference values.

Ultrasonography can detect structural muscle changes caused by neuromuscular disease. Quantitative analysis is the preferred method to determine if ultrasound findings are within normal limits, but normative data are incomplete.(6)

Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects were recruited amongst colleagues and family members of the researchers
2. Age group (5-70)years
3. Male and female.

Exclusion Criteria:

1. Patient refuse to participate
2. The anatomy is altered due to sever trauma,tumor,or surgery
Comparison of Straumann BoneCeramic vs. Allograft Bone in Extraction Sockets

The primary objective of this study is to evaluate the implant stability at the time of abutment placement on implants placed in healed extraction sockets treated with Straumann BoneCeramic (SBC) versus Freeze Dried Bone Allograft (FDBA).

Subjects will undergo a single tooth extraction and then will be randomized to receive SBC or FDBA. Following a healing period of 6 months, a core biopsy will be taken of the augmented site and a dental implant will be placed. The subject will be followed for one year following dental implant placement for implant success and survival.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have voluntarily signed the informed consent form
* Subjects must be between the ages of 18 and 80
* Subjects must need a single tooth extraction in ADA sites 3-6 and 11-14 without septal bone in the maxilla and in ADA sites 19-30 without septal bone in the mandible and would benefit from prosthetic reconstruction with a dental implant
* Subjects must be committed to the study and the required follow-up visits
* Subjects must be in good general health as assessed by the Investigator

Exclusion Criteria:

* Presence of conditions requiring chronic routine prophylactic use of antibiotics
* Pregnancy
* Medical conditions requiring prolonged use of steroids
* History of leukocyte dysfunction and deficiencies
* History of bleeding disorders
* History of neoplastic disease requiring the use of chemotherapy
* History of radiation therapy to the head and neck
* Subjects with a history of renal failure
* Subjects with severe or uncontrolled metabolic bone disorders
* Uncontrolled endocrine disorders
* Subjects who knowingly have HIV or hepatitis
* Physical handicaps that would interfere with the ability to perform adequate oral hygiene
* Subjects who have undergone administration of any investigational drug or device within 30 days of enrollment in the study
* Alcoholism or drug abuse
* Subjects who are heavy smokers (\>10 cigarettes per day or cigar equivalents) or chew tobacco
* Conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
* Local inflammation including untreated periodontitis
* Mucosal diseases such as erosive lichen planus
* History of local radiation therapy
* Presence of oral lesions (such as ulcerations or malignancy)
* Bone defects that exclude implant restoration
* Subjects who have a full mouth plaque level \>30% at the baseline visit
* Severe bruxing or clenching habits
* Persistent intra-oral infection
* Subjects presenting with an acute abscess in the tooth to be extracted or in the adjacent teeth to the extraction site (sites with presence of asymptomatic chronic lesions are eligible)
* Subjects with inadequate oral hygiene or unmotivated for adequate home care
* At the time of tooth extraction, if any bony wall is severely damaged or completely lost (i.e., anything other than a four wall extraction socket)
Change of Glucose Metabolism and Fibrosis Markers in Patients With Hepatitis C Under Treatment With Antiviral Agents

Chronic hepatitis C infection is associated with changes of glucose metabolism end increased frequency of impaired glucose tolerance. This might be a additional risk factor for disease and fibrosis progression. The study aims to evaluate whether a therapy with direct-acting antiviral agents leading to a sustained virologic response directly impacts parameters reflecting glucose metabolism and fibrosis.

Chronic hepatitis C infection is associated with changes of glucose metabolism end increased frequency of impaired glucose tolerance. It is well known that metabolic factors play an important role in fibrosis progression and steatohepatitis for example in non-alcoholic steatohepatitis (NASH). Accordingly changes in glucose metabolism in patients with chronic hepatitis C might directly impact disease and fibrosis progression. The study aims to evaluate whether a therapy with direct-acting antiviral agents leading to a sustained virologic response directly impacts parameters reflecting glucose metabolism and fibrosis. Follow-up examinations will determine the long-term metabolic changes of successful elimination of the virus by antiviral treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic hepatitis C infection and planned antiviral therapy with direct-acting antiviral agents
2. Age 18-99
3. Informed Consent

Exclusion Criteria:

1. Patients without legal capacity for informed consent
2. alcohol intake ≥ 20 g/d (f) und 30 g/d (m) within one year of study screening
3. Decompensated cirrhosis
4. viral co-infection
5. HIV infection
6. Non-viral chronic liver disease
7. Malignancy within 5 years before study screening except basalioma
8. liver transplant recipients
9. weight loss ≥10% within 3 months before study screening
10. Changes of diabetic drug treatment, lipid lowering therapy oder vitamin E within three months before study screening.
11. Intake of medication associated with hepatic steatosis (e.g. steroids, methotrexate, amiodarone, tamoxifen, valproat, flutamide, tetracyclins, cytostatics etc.)
12. Bariatric surgery in personal history
13. Clinically relevant congestive heart disease, cardiac arrythmia, valvular heart disease)
14. Implanted cardiac pacemaker or defibrillator
15. Patients during pregnancy or lactation