cyrilzakka/clinical-trials huggingface dataset:
Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

RATIONALE: Octreotide may stop or slow the growth of tumor cells and may be an effective treatment for liver cancer.

PURPOSE: This phase II trial is studying how well octreotide works in treating patients with locally advanced or metastatic liver cancer.

OBJECTIVES:

Primary

* To verify that long-acting somatostatin analog octreotide (Sandostatin LAR) depot will extend median survival from 5 months to 8.75 months in patients with locally advanced or metastatic hepatocellular carcinoma with a CLIP score of 3 or more.

Secondary

* To document tolerability of this drug in this patient population.

OUTLINE: Patients are stratified according to underlying degree of liver disease as defined by CLIP score classification.

Patients receive short-acting octreotide subcutaneously three times daily on days 1-21 OR days 1-28. If the patient tolerates short-acting octreotide, the first dose of long-acting octreotide (Sandostatin LAR) depot will be given intramuscularly beginning on day 8 OR day 15. Treatment with long-acting octreotide repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After the completion of study treatment, patients are followed monthly for 6 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed or recurrent hepatocellular carcinoma (HCC) as defined by tissue biopsy OR alpha fetoprotein (AFP) \> 1,000 ng/mL with compatible mass on CT scan or MRI

  * Recurrence of previously resected HCC will not require tissue confirmation if there is clear radiographic recurrence, in the judgment of the investigator
* Locally advanced OR metastatic disease
* Unmeasurable disease allowed if initial diagnosis was made according to the above criteria and/or recurrence has been confirmed by tissue biopsy or radiological imaging
* CLIP score ≥ 3
* Not a candidate for surgical resection or liver transplant
* Not a candidate for loco-regional therapy (e.g., ablation, embolization, hepatic arterial infusion therapy), but could have received such therapy in the past
* No fibrolamellar HCC
* No clinically apparent central nervous system metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 8 weeks
* Karnofsky performance status 60-100%
* Hemoglobin ≥ 8.5 g/dL
* Platelet count ≥ 50,000/mm³
* Total bilirubin ≤ 5.0 mg/dL
* AST or ALT ≤ 5 times upper limit of normal (ULN)
* Creatinine ≤ 2 times ULN
* PT ≤ 28
* INR ≤ 2.5
* No active variceal bleeding within the past 3 months
* No encephalopathy grade 3-4
* No ongoing ethanol or intravenous drug abuse
* Not pregnant or breast feeding

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Any number of prior therapies (e.g., chemotherapy, resection, embolization, or radiofrequency/ethanol ablation therapy) allowed
* No concurrent chemotherapy, radiotherapy, or immunotherapy
Atopy Patch Test in Normal Population : Pilot Study

Atopy patch test in normal population

The initial diagnostic work up of suspected food allergy includes patient's history, skin prick test (SPT), measurement of food specific immunoglobulin E (IgE) with serological assays, and more recently the atopy patch test. A positive SPT seems to reflect early reactions to food challenges, whereas the atopy patch test has a high diagnostic efficacy for late phase clinical reactions. The purpose of this study was to evaluate atopy patch test reaction in non-atopic population.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* Age 18-40 yrs
* Volunteer sign for informed consent

Exclusion Criteria:

* who have dermographism
* who have chronic disease eg.autoimmune disease, immune deficiency, cancer or allergic disease
* pregnant women
* who have severe eczema
* who receive antihistamine, topical steroid and systemic steroid \> 20 mg/day within 7 days prior study
Facilitating Positive Adaptation to Breast Cancer

The purpose of this study is to test the effects of a 10-wk cognitive behavioral stress management (CBSM) intervention vs. a single-day psycho-educational seminar on psychosocial adaptation and physiological adaptation in women being treated for stage I-III breast cancer.

The study tests the effects of a 10-wk group-based cognitive behavioral stress management (CBSM) intervention (relaxation, stress awareness, cognitive restructuring, coping skills training, interpersonal skills training) versus a single-day psycho-educational seminar (general information about stress and coping) in women who have recently had surgery for breast cancer but have not yet started adjuvant therapy. The study evaluates the effects of CBSM on psychosocial adaptation (includes measures of negative adaptation \[distress and social disruption\] and positive adaptation \[benefit finding and positive affect\]) at 6-month and 12-month follow-up. The study also evaluates the effects of CBSM on physiological adaptation (includes levels of PM serum cortisol and T-helper-type 1 (Th1) cytokine \[interleukin-2, IL-2, and interferon-gamma, IFN-g, production after anti-CD3 stimulation of peripheral blood mononuclear cells (PBMC).

Eligibility Criteria:
Inclusion Criteria:

-women diagnosed with breast cancer at stage III or below who had recently undergone lumpectomy or mastectomy

Exclusion Criteria:

* prior cancer,
* prior psychiatric treatment for a serious disorder (e.g., psychosis, suicidality),
* lack of fluency in English and had begun adjuvant therapy at time of first assessment
A Study of EDP-938 in Healthy Subjects

This randomized, double-blind, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-938 in healthy adult subjects

The first phase assesses single ascending doses for EDP-938 (active drug or placebo) in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.

The second phase assesses multiple ascending doses (active drug or placebo) for 7-days in healthy subjects.

Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-938 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-938 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease.
* Pregnant or nursing females.
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
* A positive urine drug screen at screening or Day -1.
* Current tobacco smokers or use of tobacco within 3 months prior to screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
* History of regular alcohol consumption.
* Participation in a clinical trial within 30 days prior to the first dose of study drug.
Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC

This study is conducted to evaluate the efficacy and safety of lenvatinib plus SIRT (LEN+SIRT) compared with lenvatinib (LEN) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).

This is a prospective, non-randomized controlled trial to evaluate the efficacy and safety of LEN+SIRT versus LEN alone for patients with TACE-refractory HCC.

78 patients (39 in each arm) with TACE-refractory HCC will be enrolled in this study. The patients will receive either LEN+SIRT or LEN.

Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be administered to the patients and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the LEN+SIRT arm, lenvatinib will be started at 3-7 days after SIRT.

The primary end point of this study is objective response rate (ORR). The secondary endpoints are disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and adverse events (AEs).

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed or clinically diagnosed HCC
* Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021)
* Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
* At least one measurable intrahepatic target lesion
* Child-Pugh class A/B
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Tumor extent \<70% liver occupation
* Candidates for SIRT must be confirmed suitable for SIRT after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA)
* Adequate organ and hematologic function with platelet count ≥50×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, albumin ≥28 g/L, total bilirubin ≤3× ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds
* Life expectancy of at least 3 months

Exclusion Criteria:

* Extrahepatic metastasis
* Tumor thrombus involving main portal vein or both the first left and right branches of portal vein
* Vena cava invasion
* Patients who received prior hepatic arterial infusion chemotherapy (HAIC), radiotherapy, or systemic therapy, for HCC
* History of organ and cell transplantation
* History of esophageal or gastric variceal bleeding
* History of hepatic encephalopathy
* History of other malignancies
* Human immunodeficiency virus infection
Comparison of Two Types of Family Therapy in the Treatment of Adolescent Anorexia Nervosa

This study will compare the effectiveness of two different family treatments for the treatment of adolescent anorexia nervosa.

The long-term objective of this study is to enhance the treatment and outcome of anorexia nervosa (AN). Research on the treatment of AN has lagged that of other conditions, even other eating disorders such as bulimia nervosa. The focus of this study is on adolescent AN. Successful early treatment is likely to reduce the prevalence of chronic AN with its high rates of morbidity and mortality and high health care costs. The most promising treatment for adolescent AN is a specific form of family therapy called behavioral family therapy (BFT). This treatment is focused on the disordered eating behavior that characterizes AN and enables parents to refeed their child. Although there have been several small scale studies of BFT there has been no controlled comparison with another form of family therapy. Therefore we propose to use systems family therapy (SFT) which has been developed to represent the type of family therapy practiced in the community.

One hundred and sixty adolescents of both genders aged 12-18 years meeting DSM-IV criteria for anorexia nervosa will be entered to the study. Recruitment is projected to extend for 2 years. Participants will be randomly allocated to one of the two types of family therapy. Family therapy will be given for 36-weeks. For the purpose of the present study, patients will be followed for 12-months after the end of family treatment. Hence, each family will participate for approximately 2-years, with a total participation time of some 40-hours. In a sub-study blood will be drawn from those volunteering for genetic analysis focusing on the subset of non-responders to treatments.

Eligibility Criteria:
Inclusion Criteria:Diagnosis of anorexia nervosa with Ideal Body Weight \>75% Exclusion Criteria:Current psychotic illness or mental retardation that would prohibit the use of psychotherapy Medically unstable for outpatient treatment
The Prognostic and Predictive Value of the CA-125 Marker in Lung Cancer Monitoring

The tumor associated CA-125antigen for diagnosis and follow-up of ovarian cancer was well defined. Increased serum CA125 level may have many diagnoses other than ovarian cancer, including breast, colorectal and lung cancer. 80% lung cancer patients were diagnosed at advanced stage. Malignant pleural effusion secondary to lung cancer represented the condition of cancer cell involved pleura.

The CA-125 level may reflect the extent of tumor involved in pleura (tumor burden), it could be correlated with the prognosis. This study was performed to examine the properties of CA-125 by measuring pleural and blood CA-125 levels in lung cancer with or without malignant pleural effusion; meanwhile to examine whether the rate of decline in CA 125 during primary therapy as a surrogate indicator for survival.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proved lung cancer

Exclusion Criteria:

* History of other cancers within the past 5 years
* Pregnancy or breast milk feeding
* TB pleuritis and peritonitis
Effects of Aerobic Exercise on Arteriovenous Fistula

Arteriovenous fistula (AVF) is considered the gold standard for safe and effective vascular access during hemodialytic treatment. It is known that systemic aerobic exercise is capable of promoting peripheral vasodilation, however, its effects on AVF are unknown. For this reason, we will evaluate the effects of aerobic exercise on a stationary bicycle over the AVF caliber.

Hemodialysis is a method responsible for filtering blood and helping to control excess blood fluid and impurities in patients with end-stage chronic kidney disease. The vascular accesses commonly used in this procedure is atribute catheter, which is placed in a large caliber vein, usually jugular or femoral vein, and arteriovenous fistula (AVF). In order to use the AVF in the hemodialysis procedure, a maturation process of the AVF is necessary, characterized by the increase of its caliber, which is accelerated by force exercises located in the AVF region, whose purpose is to promote the vasodilation of the AVF. Systemically performed aerobic exercises are also capable of promoting peripheral vasodilation and their effects on AVF are still unknown. Therefore, this study proposes to evaluate the behavior of the AVF through ultrasound before, during and after performing aerobic exercise on a stationary bicycle. For this, all patient will sign the informed consent form, respond to the International Physical Activity Questionnaire (IPAQ) and questionnaire Kidney Disease Quality of Life (KDQOL-SFTM), and use a pedometer for 7 days to measure the number of steps per day to characterize the sample. Patients will remain in supine position for 5 minutes to measure their vascular caliber of the AVF by echography. After, will be instructed to perform 30 minutes on stationary bike (Model Monark). The AVF vascular caliber will be measured during aerobic exercise. Because it is a cross-over trial, participants will perform the other arm after 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients who use AVF hemodialysis for at least 1 month.
* Patients on hemodialysis 3 times a week at the HCPA Nephrology Service.
* Age equal to or greater than 18 years.
* Physical conditions to perform exercises proposed in this study.
* Stability of chronic kidney disease for at least 30 days, defined by absence of hospitalization.

Exclusion Criteria:

* Acute myocardial infarction in the last 3 months.
* Acute infectious or inflammatory process.
* Decompensated coronary artery disease.
* Symptomatic peripheral arterial disease.
* Arteriovenous fistula in lower limbs.
Precise Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder

The purpose of this study is to investigate the efficacy and safety of repetitive transcranial magnetic stimulation under precise localization for post-traumatic stress disorder

Participants who meet the entry conditions and sign the informed consent will be divided into two groups. The stimulation target of each participant will be determined according to MRI. The test group will receive active transcranial magnetic stimulation for 10 consecutive days, and the control group will receive sham stimulation. Symptom severity is assessed by scales and audio and video recordings at baseline, during treatment period and follow-up.Blood samples will also be collected from patients prior to treatment and will be analyzed histologically to explore differences in response to the intervention and biological mechanisms in different subgroups of patients.

Eligibility Criteria:
Inclusion Criteria:

* The subject, regardless of gender, aged between 18 and 65 years, is admitted to the psychosomatic outpatient department of the First Affiliated Hospital of Air Force Medical University;
* The subject meets the diagnostic criteria of post-traumatic stress disorder in Diagnostic and Statistical Manual of Mental Disorders-5;
* The score of Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 \> 33；
* The subject can understand and is willing to strictly abide by the clinical trial protocol and signs the informed consent.

Exclusion Criteria:

* The subject has serious physical diseases or diseases that may affect the central nervous system (such as tumor, syphilis, etc.);
* Patients with PTSD who keep stable on their original medication/psychotherapy for more than 3 weeks before the start of the study or who have not taken the relevant therapeutic medication for more than 2 weeks before the start of the study will be included.Otherwise they will be excluded;
* The subject had previous brain diseases, head trauma, alcoholism, EEG abnormalities, MRI evidence of abnormal brain structure, or family history of epilepsy;
* The subject has contraindications to MRI scanning or transcranial magnetic stimulation treatment, such as metal or electronic instruments (intracranial metal foreign bodies, cochlear implants, cardiac pacemakers, stents and other metal foreign bodies) and space phobia;
* The subject has a history of contact with psychoactive substances or other mental diseases;
* Those at high risk of suicide, or those who have committed suicide or serious self injury and need emergency intervention;
* Pregnant, breastfeeding or planning pregnancy during the trial;
* In the judgment of the investigator, the subject has other conditions that are not suitable for the study.
CT Analysis Comparing Cast and Three-Point Indexes in Distal Radius Fracture Care

Objectives: To compare the cast index and three-point index measurements obtained using computed tomography (CT) with those acquired using conventional methods for treating distal radius fractures Design: A retrospective cohort study Setting: Level 1 trauma center Patients: One hundred and thirteen (45 men and 68 women) patients with distal radius fractures Interventions: Patients with distal radius fractures were retrospectively analyzed and received either conservative cast treatment or surgical intervention through open reduction and internal fixation between 2016 and 2022.

Main outcome measurements: The study evaluated the cast index and three-point index in the cast-treated group and their effectiveness using the Sarmiento index. Furthermore, radial height, volar tilt, and radial inclination were compared between the surgically treated and cast-treated groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years
* Diagnosed with distal radius fracture
* Treated with either cast or volar plate osteosynthesis were included in the study.

Exclusion Criteria:

* Patients with multiple fractures in the same upper extremity
* Those treated with dorsal plates or external fixators
* Individuals with open fractures
* Patients with known systemic or rheumatologic diseases
* Those with cervical disk problems
* Individuals lacking post-cast removal CT data
* Patients with incomplete medical records were excluded.
Cognitive Modulation of Dyspeptic Symptom During Food Ingestion in Functional Dyspepsia Patients Cognitive Modulation

In this functional magnetic resonance imaging study, effects of different information of fat content of high or low fat will be examined in FD patients and healthy volunteers (n=30, respectively). These data will provide a better understanding of symptom generation following food ingestion in general as well as in patients with respective functional gastrointestinal disorders.


Eligibility Criteria:
Inclusion Criteria:

* Male and female, volunteering adults BMI: 18-25 kg/m² right-handed Age: 18-65 years Capacity to give informed consent

For FD patients, Diagnosis of functional dyspepsia over the last 12 months certified by a medical record Inconspicuous gastroscopy during the last 6 months certified by a medical record

Exclusion Criteria:

* Subjects which have a non-removable metal object in or at their body, such as, for example:
* Heart pace-maker,
* Artificial heart valve,
* Metal prosthesis,
* Metallic implants (screws, plates from operations, etc.),
* Interuterine Spiral,
* Metalsplinters / grenade fragments
* Non-removable dental braces,
* Acupuncture needles,
* Insulin pump,
* Intraport, etc., Pregnant women or pregnancy cannot be excluded Nursing women Subjects with limited temperature perception and/or increased sensitivity to warming of the body A circulatory disease cannot be excluded Subjects with hearing-disease or an increased sensitivity to loud noises Subjects with fear of closed-in places (claustrophobia) Subjects which were operated less than three month ago Acute illness or infection Neurological disorder or injury (e.g. epilepsy) Moderate or severe head injury Severe psychotic illness (e.g. schizophrenia, depression) Intake of antidepressants / antipsychotics Vegetarians/Vegans Food allergies Self-reported eating disorder
Group-based Psychoeducation for Relatives of Patients With Bipolar Disorder, a Randomized Controlled Trial

Relatives of patients with bipolar disorder (BD) often experience emotional burden with stress, and depressive symptoms that again increases the likelihood of destabilization and relapses in the patient. The effects of group-based psychoeducation have not been investigated in large-scale real-world settings. The investigators are currently conducting a large-scale real-world randomized controlled parallel group trial (RCT) to test whether group-based psychoeducation for relatives to patients with BD improves mood instability and other critical outcomes in relatives and the corresponding patients with BD.

The trial is designed as a two-arm, parallel group randomized trial with a balanced randomization 1:1 to either group-based psychoeducation or a waiting list for approximately 4 months and subsequent group-based psychoeducation. the investigators plan to include 200 relatives. The group sizes for psychoeducation is between 20-40 relatives.The primary outcome measure is mood instability calculated based on daily smartphone-based mood self-assessment. Other relevant outcomes are measured, including patients' reported outcomes, assessing self-assessed burden, self-efficacy, and knowledge about BD.


Eligibility Criteria:
Inclusion Criteria:

* Relatives of patients with Bipolar Disorder who are affiliated with the Copenhagen Affective Disorder Clinic.

Exclusion Criteria:

* Insufficient Danish language.
* Age below 18 years.