cyrilzakka/clinical-trials huggingface dataset:
Treatment of Early Childhood Depression

Depression often occurs in early childhood. Moreover, later depression is frequently preceded by early childhood Depression (ECD). However, at present, there is a lack of evidence-based tratestments (EBTs) for ECD, posing a core research desideratum highlighted by both the American and German practice parameters for ECD. The current study seeks to redress this research gap, by evaluating the feasibility and dose-dependent effectiveness of manualized short-term psychoanalytic child psychotherapy (PaCT) compared to waitlist in a randomized controlled trial (RCT) among clinically referred 3 to 8-year-olds with ECD. Comprising 20-25 sessions in alternating settings (child-only, caregiver(s)-child, caregiver(s)-only), PaCT focuses on internal conflicts and representations underlying depressive disorders. PaCT targets the child-therapist relationship, using interpretative, play and mentalization-based techniques, aiming to elicit the interpersonal meaning of the child's symptoms within the child-caregiver relationship(s).

For this trial, 62 clinically referred children meeting criteria for DSM-5 depressive disorders, will be randomized randomized to PaCT (n=31) or waitlist (n=31). The overarching aim is to engender reduction in depressive symptoms and diagnoses following PaCT vs. waitlist in order to determine effect sizes which can be used in power calculations for future large-scale clinical trials. Moreover, effects of PaCT will also be examined at mid-treatment to provide a first insight into the necesary therapeutic dose. Moreover, the trial will also be used as a first opportunity to examine feasibility of PaCT in young children, treatment integrity, as well as treatment acceptability.

Eligibility Criteria:
Inclusion Criteria:

* Age 3 to 8 years
* DSM-5 depressive disorder (Major Depression, Dysthymia, Depression NOS), adapted for young children according to the AACAP criteria
* Written informed consent of patient's parents or guardian
* informed verbal assent from children (age \>= 6 years)

Exclusion Criteria:

* IQ \< 70
* autism spectrum or schizophrenia spectrum disorder in the child
* insufficient German language skills to participate in treatment (child or caregiver)
* ongoing litigation regarding child custody
* concurrent intensive psychotherapy
* participation in other interventional trials
* suspected lack of compliance
Use of Wikis and Evidence-Based Medicine in Surgical Practice

The goal of this study is to improve surgical residents' skills in critically appraising the literature and to promote the dissemination and application of the best available evidence to surgical practice. The hypothesis is that mandatory participation, with faculty oversight, in a journal club wiki will improve the dissemination, evaluation, and application of evidence-based medicine (EBM) in a surgical residency program at University of Texas Health Science Center at Houston (UT-Houston).

The translation of evidence-based medicine (EBM) to clinical practice requires training in literature searching and critical appraisal, which is particularly lacking in surgery. The demands of surgical residency coupled with the 80-hour work week make attendance at journal clubs suboptimal. Internet technology such as wikis, which are free user-friendly collaborative websites, may be a solution to improving resident participation in journal club-related activities, but their utility is highly dependent upon resident contributions and usage. We propose a pilot randomized trial of mandatory versus voluntary participation in a general surgery journal club wiki to verify its feasibility, sustainability, and impact on resident EBM skills as measured with a validated questionnaire. Secondary outcomes will include resident self-assessment of wiki usage and comfort with EBM skills and faculty-assessed resident application of these skills in weekly morbidity and mortality conferences. If the wiki is feasible and sustainable, then the project will be expanded to include other surgical disciplines and cohorts (i.e. students, fellows, other institutions, other medical disciplines) to ensure generalizability. If beneficial, wikis could not only improve resident EBM skills, but also have a halo effect on students and faculty, and ultimately wikis could improve patient care. The assembled multi-disciplinary and multi-institutional team has significant collective expertise in evidence-based medicine, medical education, library skills, and clinical trial design and analysis which are necessary for this project.

Eligibility Criteria:
Inclusion Criteria:

* General surgery residents at UT Health Science Center at Houston

Exclusion Criteria:

* Not a general surgery resident at UT Health Science Center at Houston
Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC

The goal of this phase 2 prospective clinical trial is to learn about the efficacy and safety of stereotactic body radiation therapy (SBRT) plus immunotherapy and targeted therapy in patients with unresectable or oligometastatic hepatocellular carcinoma (HCC).

The main question to answer is: Whether combing SBRT with immunotherapy and targeted therapy could prolong PFS. Participants will receive SBRT to all visible lesions and concurrent systemic immunotherapy and targeted therapy.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* Eastern Cooperative Oncology Group performance status of 0-1
* clinical or pathological diagnosis of HCC
* with unresectable locally advanced or oligometastatic HCC (metastatic lesions ≤ 5, metastatic organs ≤ 3, may involve extrahepatic lymph nodes or distant organs apart from brain)
* at least one measurable lesion according to mRECIST criteria
* all lesions could be included in radiation target volume
* Child-Pugh A or B (7 scores) liver function
* patients are allowed to receive systemic therapy previously other than tislelizumab plus regorafenib
* adequate hematological and renal function
* life expectancy ≥ 3 months；
* willing to participate in the study and give written informed consent

Exclusion Criteria:

* a history of liver transplantation
* with severe cirrhosis complications, including a history of esophagogastric variceal bleeding, hepatic encephalopathy, and massive ascites
* with active autoimmune diseases or a history of autoimmune disease
* with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
* allergic to the ingredient of tislelizumab or regorafenib
* with recurrent lesions treated with radiotherapy previously
* prescribed radiation does could not be delivered due to dose limits to organs at risk (OAR)
* intolerable to radiation or systemic treatment because of cardiac insufficiency, uncontrolled high blood pressure
* a history of other malignancies, except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
cfDNA in Diagnosis and Differential Diagnosis of Ovarian Endometriosis

Methylation detection of circulating free DNA to identify markers for diagnosis and differential diagnosis of ovarian endometriosis.

Methylation detection of circulating free DNA and FFPF samples from patients with ovarian endometriosis, ovarian cancer and other benign ovarian cysts will be performed to select markers for ovarian endometriosis diagnosis. The markers will be validated in patients with ovarian cysts found by ultrasound. The diagnosis accuracy of the markers will be evaluated by comparing with the pathological diagnosis.

Eligibility Criteria:
1. Marker selection group:

1. patients with ovarian endometriosis:

   Inclusion Criteria:
   1. pathologically diagnosed as ovarian endometriosis;
   2. surgery was performed in PUMCH

      Exclusion Criteria:

   a. combined with other gynecological benign and malignant tumors; b. clinically suspected malignant tumors; c. combined with other systemic malignancies or malignancies history; d. pregnant patients
2. patients with ovarian cancer:

Inclusion Criteria:

1. pathologically diagnosed as epithelial ovarian cancer;
2. surgery was performed in PUMCH

Exclusion Criteria:

1. combined with gynecological benign tumors and other malignant tumors;
2. combined with other systemic malignancies or malignancies history;
3. pregnant patients (3) patients with other benign ovarian tumors:

Inclusion Criteria:

1. pathologically diagnosed as benign ovarian tumors but not ovarian endometriosis;
2. surgery was performed in PUMCH

Exclusion Criteria:

a. combined with other gynecological benign and malignant tumors; b. clinically suspected malignant tumors; c. combined with other systemic malignancies or malignancies history; d. pregnant patients

2. Marker validation group:

Inclusion Criteria:

1. ovarian cysts found through ultrasound ;
2. surgery will be performed in PUMCH

Exclusion Criteria:

1. combined with other gynecological benign and malignant tumors;
2. clinically suspected malignant tumors;
3. combined with other systemic malignancies or malignancies history;
4. pregnant patients
A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of 2 doses of dulaglutide in Japanese participants with type 2 diabetes. The study duration is approximately 58 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Participants with type 2 diabetes (T2D) ≥ 6 months according to the World Health Organization (WHO) classification.
* Treated with stable doses of a single OAM for at least 8 weeks prior to screening; the dose must be more than or equal to minimum maintenance dose.
* Have the following HbA1c result at screening.

  * Participants taking DPP-4i: ≥7.5% and ≤9.5%,
  * Participants taking another OAM: ≥8.0% and ≤10.0%
* Stable body weight for at least 8 weeks prior to screening or not changed by more than 5 % in the past 8 weeks
* Have a body mass index (BMI) ≥18.5 kilogram/square meter (kg/m²) and \<35 kg/m² at Day 1.

Exclusion Criteria:

* Have type 1 diabetes (T1D)
* Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma
* Have had any myocardial infarction (MI), heart failure or cerebrovascular accident (stroke)
* Have a known clinically significant gastric empty abnormality
* Have acute or chronic hepatitis
* Have had chronic or acute pancreatitis
* Have any self or family history of type 2A or type 2B multiple endocrine neoplasia in the absence of known C-cell hyperplasia
* Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of Multiple endocrine neoplasia (MEN) 2A or 2B syndrome)
* Have evidence of significant, active autoimmune abnormality
* Have evidence of significant, uncontrolled endocrine abnormality
* Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years
* Have any hematologic condition that may interfere with HbA1c measurement
Moderate Sedation Educational Software

We propose to develop and evaluate an interactive education software for administering moderate sedation by non-anesthesiologists.

The course will be founded upon JCAHO's and ASA's guidelines for sedation, emphasizing the concepts with animations, audio, scenarios, and quizzes. Interactive feedback will be incorporated to guide the clinician during the course. The course will be offered commercially over the World Wide Web, with successful completion providing continuing medical education (CME) credit. It will fulfill JCAHO recommended guidelines. In a controlled simulated environment, the hypothesis that the web based training protocol will provide the practitioner the knowledge base necessary to manage the four scenarios as well or better than practitioners completing the standard moderate sedation certification course will be tested.

1) Evaluate the effectiveness of the course. The University of Utah Center for Patient Simulation is an ideal environment to evaluate the efficacy of a web-based training course. The new web-based course will be compared to standard course material and lessons. We will recruit 40 nurses who administer moderate sedation at the University of Utah Health Sciences Center. Half of the nurses will receive traditional training (typical course and guidelines published from the literature), and half will receive the web-based course. Users will be tested on their knowledge of moderate sedation with four moderate sedation scenarios, in which the simulated patient experiences over-sedation, apnea, and excessive pain.

Eligibility Criteria:
Inclusion Criteria:

* general nursing staff at the University of Utah
* currently required to obtain moderate sedation training
* an equal basis all clinicians in the respective departments

Exclusion Criteria:

* nurses and other personnel who do not administer moderate sedation
Markers of Appetite Regulation During Exogenous Ketosis

The aim of this study is to investigate the relationship, if any, between markers of satiety, desire to eat, hunger, and metabolic markers of the regulation hereof during ketosis as compared with a Glucose-containing and a Placebo drink adjusted for taste.

All subjects are, in random order, tested on three separate occasions with intake of weight adjusted and taste matched drink of i) a ketone ester, and ii) an isocaloric and -volumetric glucose drink, or iii) an isovolumetric tap water drink.

Subjects are studied for five hours with baseline and blood sampling on multiple occasions. A satiety questionaire are included.

Subjects are recruited through notice on website for this purpose. Sample size calculations were performed prior to inclusion (n=10). According to protocolized statistical plan, missing data will not be replaced and no imputation will occur. Data will be analyzed by applying a repeated measurements multilevel model with intervention, time and their interactions as categorical factors. Effects size are adjusted for small sample size.

Eligibility Criteria:
Inclusion Criteria:

* Males aged 18-65 years
* BMI 20-35 kg/m2
* Expected ease of catheter insertion
* Oral and written informed consent

Exclusion Criteria:

* Inability to fully understand the consent including consent forms
* Inability to cooperate to the trial
* Any electrolyte disorders, kidney disease or otherwise compromised renal function including excess risk hereof, e.g. hypertension, albuminuria, autoimmune disease, family history of kidney disease
* Any liver or bile disease including excess risk hereof, e.g. hepatotoxic drugs, alcohol abuse disorder, gallstones, pancreatitis, autoimmune disease, family history of liver disease
* Diabetes mellitus or any metabolic and/or hormonal disease including diagnosed/undiagnosed reactive hypoglycemia or similar disorders. This includes treatment with drugs, dietary supplement with inference on key metabolic or hormonal markers, e.g. insulin, glukagon, lipids, and GLP-1
* Any use of illegal or otherwise use of medicinal products without prescription
* Anemia or other know disease of the hematopoietic system
* Previous bariatric surgery
* Previous myocardial infarction or uncontrolled myocardial ischemia
* Recent intended/unintended weight loss
* Allergies to catheters or adhesives
Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8)

The purpose of this study is to demonstrate the advantage of using a gold alloy tip electrode over a platinum/iridium alloy tip electrode in ablation of the cavotricuspid isthmus in patients with atrial flutter.

Transvenous catheter ablation has become the therapy of choice for patients with recurring, isthmus-dependent right atrial flutter. Achieving bidirectional conduction block in the cavotricuspid isthmus is decisive for both acute and long-term therapy success and essentially depends on the selected ablation method and the lesion size. By using an 8 mm tip electrode instead of a conventional 4 mm electrode, deeper lesions can be made, thus significantly reducing the required number of energy applications for achieving a bidirectional conduction block. Experimental studies have proven that using an ablation electrode made of gold alloy allows the creation of deeper lesions than with conventional platinum-iridium electrodes. Due to the greater heat conductivity of the gold alloy as opposed to platinum-iridium, the cooling of the ablation electrode is improved and more electric energy can be transmitted to the tissue at identical temperatures.

The combination of both technologies in the form of an 8 mm-long gold electrode anticipates that the lesion depth required for an isthmus block can be achieved more quickly in comparison to the platinum-iridium electrode.

Eligibility Criteria:
Inclusion Criteria:

* At least one electrocardiogram (ECG)-documented (can be older than 3 months), symptomatic, typical atrial flutter episode with either negative, sawtooth-shaped P-waves in leads II, III, and augmented voltage foot (aVF), or positive P-waves in leads II, III, and aVF
* At least one persistent, typical atrial flutter episode of over 2 hours that has been documented in the history in the patient file and/or ECG
* Signed informed consent form

Exclusion Criteria:

* Patient has recently undergone isthmus ablation
* Acute coronary syndrome or myocardial infarction within the last 3 months
* Acute reversible causes for atrial flutter (e.g. acute myocarditis)
* Severe cardiac valvular defects
* Tricuspid valve replacement
* Atrial septum defect
* Cardiovascular surgery scheduled within the next 6 months
* Unstable medication in the last 7 days before study inclusion
* New York Heart Association (NYHA) class IV
* Women who are breastfeeding
* Pregnancy
* Abuse of drugs or alcohol
* Patient is unable to participate in follow-up examinations
* The patient has only partial legal competence
* Participation in another clinical study
* The ablation procedure presents an above average risk to the patient as compared to the normal patient group (must be noted by the physician on the appropriate form).
* Right atrial thrombus

Late Exclusion Criteria:

* Patient included by accident
* Premature termination of the ablation procedure
* Atrial flutter not dependent on the posterior isthmus
* No conduction at the posterior isthmus before ablation
Intra-uterine Injection of Human Chorionic Gonadotrophin (hCG) Before Embryo Transfer

Chorionic gonadotrophins (hCG) play an important role in implantation. The aim of the study is to evaluate the effect of intrauterine injection of hCG before embryo transfer in IVF/ICSI on the implantation and pregnancy rates. The rational is that intrauterine hCG injection will attract regulatory T cells and improve implantation.

Background :

Human chorionic gonadotrophin ( hCG) was found to secreted immediately after fertilization by the embryo. It plays an important role in implantation and in attracting regulatory T cells to the endometrium.

Rational :

Intrauterine injection of hCG before embryo transfer in IVF/ICSI may increase endometrial regulatory T cells ( Treg ) and improve the implantation and pregnancy rates.

Aim of the work :

To study the effect of intrauterine injection of hCG before embryo transfer on the implantation and pregnancy rates after IVF/ICSI.

Subjects :

Infertile patients undergoing ICSI.

Inclusion criteria :

* Female age less than 40 years
* Male factor infertility
* Normal female hormonal profile and uterine cavity

Exclusion criteria :

* Previous ICSI failure
* Azoospermia
* Endometriosis

Study group: Intrauterine injection of 100 iu of hCG (group 1)or 200 iu of hCG ( group 2) will be done during the dummy embryo transfer which is done 10-15 minutes before the actual embryo transfer.

Control group: The embryo transfer will be done without prior intrauterine injection of hCG

Main outcome measures :

Implantation and pregnancy rates

Secondary outcome measures :

miscarriage and delivery rates

Eligibility Criteria:
Inclusion Criteria:

* male factor infertility
* normal female hormonal profile
* normal uterine cavity

Exclusion Criteria:

* previous ICSI failure
* endometriosis
* azoospermia
Iressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC)

The investigators will examine efficacy and toxicity of gefitinib in Korean patients with EGFR wild tumors diagnosed with direct sequence test.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven NSCLC
* Ineligibile for curative treatment (namely, stage IIIb or IV)
* History of one to three prior systemic chemotherapy tumors without active EGFR mutations (exon 19 deletion, L858R mutation in exon 21)
* At least one lesion that was unidimensionally measurable by computed tomography (by RECIST 1.1)
* 18 years old or older
* Performance status ECOG 0-2
* Adequate organ function as evidenced by the following:

  * Absolute neutrophil count \> 1.0 x 109/L
  * Platelets \> 75 x 109/L
  * Total bilirubin ≤ 1.5 UNL
  * AST and/or ALT \< 5 UNL
  * Creatinine clearance ≥ 45mL/min

Exclusion Criteria:

* Previous EGFR TKI therapy history
* Systemic anticancer therapy within the previous 3 weeks
* Other invasive malignancy within the past 2 years except non-melanoma skin cancer, in situ cervix cancer, or papillary thyroid cancer
* Other concurrent illness that would preclude study participation (severe heart disease)
* Other concurrent physical condition (e.g., infectious disease) that would preclude study participation
* Pregnant or nursing
Kinesiophobia, Pain, Balance, Quality of Life and Mental Status in Hemodialysis Patients

The aim of our study was to investigate the relationship between kinesiophobia and pain, balance, physical performance, quality of life and mental status in patients receiving hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with end stage renal disease receiving hemodialysis
* Receiving hemodialysis for more than 3 months
* Being clinically stable
* Volunteering to participate in this stud

Exclusion Criteria:

-Having musculoskeletal disorders that may affect physical performance