cyrilzakka/clinical-trials huggingface dataset:
Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants

The goal of this randomized controlled trial is to compare the effect of direct skin-to-skin contact in moderate and late preterm infants. The main questions it aims to answer are:

* does skin-to-skin contact in moderate and late preterm infants influence gene expression in the stress signaling pathway?
* does skin-to-skin contact in moderate and late preterm infants improve the short- and long-term outcome?

Participants will either get immediate separation after vaginal birth or receive immediate skin-to-skin contact. Researchers will compare these two groups to answer the proposed questions.

The planned study investigates prospectively the effect of early intervention (skin-to-skin contact in the delivery room) in moderate and late preterm infants on neonatal programming by determining gene expression in the stress signaling pathway. The working hypothesis of our project is that the intervention will affect gene expression in a way that subsequently leads to better long-term psycho-social and neurological development of these preterm infants. The study aims to improve the understanding of the correlation of behavioral and epigenetic parameters and prove the underlying hypothesis of a novel mechanistic link between immediate skin-to-skin contact in the delivery room and life-long stress tolerance.

Eligibility Criteria:
Inclusion Criteria:

* preterm birth between gestational age of 32 0/7 and 36 6/7 weeks
* vaginal delivery
* singleton
* informed consent before birth

Exclusion Criteria:

* malformations or syndromes of the infant
* resuscitation of the infant
* maternal psychological or severe physical illness
* lack of German language skills
Clinical Study of Geranium Wilfordii Combined With Androgen Deprivation in Neoadjuvant Therapy of Prostate Cancer

The high incidence of prostate cancer is one of the important diseases that threaten the health of old men in our country. Although androgen deprivation therapy is an important treatment option for prostate cancer, although neoadjuvant androgen deprivation therapy combined with radical prostatectomy reduced the positive rate of surgical margins, it did not show statistically significant improvement in prostate-specific antigen (PSA). At the same time, few trials reported pathological complete response (pCR) and minimal residual lesion (MRD).

The purpose of this project is to verify the efficacy of geranium combined with androgen deprivation in the treatment of locally advanced prostate cancer or oligometastatic prostate cancer before radical prostatectomy through randomized controlled clinical trials, so as to find an effective treatment for locally advanced prostate cancer or oligometastatic prostate cancer.

This study will divide patients into two sections, and eligible patients will be enrolled. Patients with locally advanced prostate cancer or oligo-metastatic prostate cancer were divided into geranium combined androgen deprivation therapy group and androgen deprivation therapy group according to a computer-generated random sequence. In the treatment group, except for continuous androgen deprivation treatment, geranium geranium decoction was taken orally every day; The control group only received continuous androgen deprivation therapy, and the usage was the same as the treatment group. After starting the intervention, all patients should be followed up in our hospital 7, 14, 28, 56, 84 days after treatment to review blood PSA and other indicators. At the end of the treatment, imaging examinations were followed up and radical prostatectomy was performed 3 weeks later (±7 days).

Eligibility Criteria:
Inclusion Criteria:

* ① Age ≥18 years and ≤85 years;

  * Histologically confirmed prostate cancer without small cell features;

    * Metastatic prostate cancer was identified by imaging examination with ≤5 oligometastases (bone or lymph node metastases) or cT3-4 stages; ④The score of ECOG (Eastern Cooperative Oncology Group) was 0-1; ⑤ All patients voluntarily sign informed consent, and can adhere to treatment and follow-up;

Exclusion Criteria:

* ①Any previous or ongoing PCa treatment, including radiotherapy, chemotherapy, ADT, etc.

  * Previous prostatectomy;

    * Any other serious basic medical, mental, psychological, and other diseases that, in the judgment of the investigator, may affect the treatment of the patient

      * Allergic to the drugs used; ⑤ Refuse to undergo radical prostatectomy; ⑥ According to the investigator's judgment, it is not suitable to participate in this clinical trial;
Observational Study To Evaluate Statins Patterns Of Use In Spain

The present project is aimed at describing the statins prescription pattern in Spanish patients. It will also look into how adequate these prescriptions are accordingly to the recommendations given in Treatment Guidelines and in the Summary Product Information.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving a new statin prescription (naïve patients)
* Patients having a change in their statin prescription (dose, switching, addition to another hypolipemic drug)

Exclusion Criteria:

* Patients without enough information in the medical records to complete the fields required in the eCRF
Safety, Tolerability Study of SG2000 in the Treatment of Advanced Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia

The purpose of this study is to determine if the experimental drug, SG2000 is safe and tolerable in the treatment of participants with advanced chronic lymphocytic leukemia and acute myeloid leukemia whose standard treatment did not work, whose cancer came back or who are not candidates for other types of standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* male or female greater than or equal to 18 years of age
* have one of the following disease states: Acute Myeloid Leukemia (AML) (age \<60 years) with relapsed/refractory disease; •Chronic Lymphocytic Leukemia (CLL) with relapsed disease following a fludarabine-based regimen or relapsed disease following an alkylator-based regimen
* are recovered from the acute adverse effects of prior therapies (excluding alopecia and Grade ≤2 neuropathy).
* have blast counts that can be controlled by the use of hydroxycarbamide (500 to 3000 mg daily).
* have adequate hepatic function and renal function
* have an estimated life expectancy of \>3 months
* female subject must have a negative serum pregnancy result within 7 days before the start of the study; Both men and women must agree to use a medically acceptable form of contraception throughout the treatment period and for 3 months after discontinuation of treatment

Exclusion Criteria:

* are eligible for any standard therapy known to be life prolonging or life saving
* have diagnosis of AML French-American-British (FAB) classification (FAB) M3 (acute promyelocytic leukemia (APL))
* are receiving concurrent chemotherapy, radiotherapy, immunotherapy, biological or hormonal treatment for cancer.
* have undergone anticancer therapy including chemotherapy (except for hydroxycarbamide at a maximum daily dose of 3000 mg), endocrine therapy, immunotherapy, or the use of other investigational agents within 4 weeks before study entry.
* prior radiation therapy with volume of bone marrow treated over 25%.
* use of immunosuppressive therapy, including systemic steroids within 7 days before the first dose of SG2000.
* hyperleukocytosis (blast counts \>30 000/mm3).
* history of allogeneic stem cell or solid organ transplantation.
* positive serology for human immunodeficiency virus (HIV), hepatitis B or hepatitis C or have HIV-AIDS, or active hepatitis B or C.
* history of other invasive malignancy within 3 years except for cervical carcinoma in situ, nonmelanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has been surgically cured.
* have any coexisting medical condition that will substantially increase the risk associated with the subject's participation in the study.
* have psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of necessary studies.
* have persistent Grade 2 or greater toxicities from any cause (except alopecia or peripheral neuropathy).
* are pregnant or breast-feeding.
Multi-Site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Tilt Table Testing

PURPOSE OF THE STUDY

This study will explore the use of multi-site NIRS monitoring during tilt table testing, combining somatic and cerebral saturations data with hemodynamic data to establish the non-invasive assessment of global cardiac output distribution trends.

HYPOTHESIS / SPECIFIC AIMS

Study Aims: To evaluate the utility of multi-site NIRS monitoring in the cardiovascular hemodynamic assessment of children and adolescents during tilt table testing by establishing a non-invasive method to predict cardiac output maldistribution with the use of two-site NIRS monitoring in children and adolescents with syncope.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 7 and 21 years
* Referred to the exercise stress lab due to syncope

Exclusion Criteria:

* Under 7 or over 21 years of age
* Referred to the exercise stress lab for anything other than syncope
BBPA PET/CT in Patients With Malignant Tumors

This study is an open-labeled phase II diagnostic clinical trial to explore the safety and clinical value of BBPA-PET/CT in suspected malignant tumor patients. The investigation regarding the clinical value of BBPA concerning the metabolic characteristics of BBPA in suspected malignant tumors. Quantitative features will be extracted to analysis the PET images. For patient who took surgery after multiple examination, histopathology, molecular pathology and LAT-1 immunohistochemistry will also be obtained.

In this study, we utilized BBPA, a novel boron amino acid, which replaces the carboxyl group of 4-boronate phenylalanine (BPA) with a boron trifluoride group (-BF3) (-COOH), as a diagnostic molecule for PET imaging of brain tumors, is also a highly efficient boron carrier for BNCT. Preclinical studies suggested \[18F\]BBPA to be a pan-cancer probe that transmembrane transported through large neutral amino acid transporter type-1 (LAT-1). However more studies and evidence are warranted to investigate the clinical value of BBPA PET imaging in human.

This study aim to observe the safety of BBPA, and investigate the diagnostic value of BBPA in the patient with suspected malignant tumors. Patients who meet the eligibility criteria are included in clinical trials after fully communicating the condition, explaining the benefits and risks of clinical trials, clarifying the patient's willingness to include the clinical trial, and signing informed consent. The cohort number, BBPA administrative dose, imaging protocols are decided based on the investigators' preliminary data. The diagnosis and post- examination treatment are based on the recommended guideline, combined with the subject's own situation for standardized diagnosis and treatment

Eligibility Criteria:
Inclusion Criteria:

* Have suspected diagnosis of brain tumors, based on clinical performance and imaging results.
* Meet the indications for PET examination, show a clear indication and no contraindications;
* Have a performance status of score ≥80 on KPS scale or score 0-1 points on ECOG scale, a relatively good general situation;
* Does not appear agonal stage, deep coma, over grade 2 major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection;
* Be ≥ 18 years of age on day of signing informed consent.
* Be willing and able to understand the research content and provide written informed consent/assent for the trial.

Exclusion Criteria:

* Have a history of imaging agent allergies;
* Does not meet the PET-CT scan sedation requirements, or there are contraindications for PET-CT examination;
* Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial;
* Unable to adhere strictly to protocol requirements.
Open-Label Comparative Study of Risperidone Versus Olanzapine Versus Quetiapine for Mania in Children and Adolescents With Bipolar I and Bipolar II Disorder

The objective of this study is to compare the safety and effectiveness of Risperidone, Olanzapine, and Quetiapine in the treatment of mania in children and adolescents with Bipolar disorder over 8 weeks and then over an extension phase. This is an exploratory, open-label study, which seeks to determine if there is evidence for efficacy. The results of this study will be used to generate hypotheses for a larger study.


Eligibility Criteria:
Inclusion Criteria:

* Males and females age 6 to 18 years of age
* Patient must have a diagnosis of bipolar I or bipolar II disorder and currently displaying an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders).
* Patients must have an initial score on the Y-MRS total score of at least 15.
* Patient must be able to participate in mandatory blood draws.
* Patient must be able to swallow pills.

Exclusion Criteria:

* Patients with chronic medical illness, DSM-IV substance dependence within the past 6 months, pregnant or nursing females, and those at serious risk of suicide will be excluded from the study
Non-interventional Study With NOVOCART® 3D for the Treatment of Cartilage Defects of the Knee in Pediatric Patients

Prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART 3D in the Treatment fo cartilage defects of the knee in pediatric patients wieh closed epiphyseal growth plates.

The present study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART® 3D in the treatment of cartilage defects of the knee in pediatric patients with closed epiphyseal growth plates.

In this non-interventional study NOVOCART® 3D, which is marketed in Germany under Paragraph 4b Medicinal Products Act, will be used in routine clinical practice according to the authorized Summary of Product Characteristics (SmPC). As stated in this SmPC, NOVOCART® 3D may only be used by physicians who are trained on the product. The treatment with NOVOCART® 3D requires two surgeries. During the first surgery cartilage biopsies will be harvested arthroscopically and sent to TETEC AG (Tissue Engineering Technologies AG) for NOVOCART® 3D manufacturing, then NOVOCART® 3D will be transplanted during a second surgery about 3 to 4 weeks later.

All patients will be followed up for 5 years post NOVOCART® 3D transplantation and data will be collected at 3, 6, 12, 18, 24, 36, 48 and 60 months as outlined at the end of this synopsis.

NOVOCART® 3D post treatment rehabilitation should follow the recommendations given in the SmPC and during product training.

The primary and secondary variables (see below) will be assessed after a follow-up of 24 month post NOVOCART® 3D transplantation (primary analysis).

Long-term data will be assessed after an additional 3 years follow-up (follow-up analysis).

The collected data will be documented using dedicated case report forms (CRFs) which are created and printed by TETEC AG.

Eligibility Criteria:
Inclusion Criteria:

* 13 - 17 years old
* Medicinal indication for NOVOCART 3D treatment

Exclusion criteria:

• none
IAL vs PS for Anterior Shoulder Dislocations

This study compares intra-articular lidocaine to procedural sedation for the reduction of anterior shoulder dislocations in the emergency department.

This will be a single center, prospective, open-label, randomized controlled trial on a convenience sample of patients presenting to the ED with anterior shoulder dislocations. This study will enroll all patients between the ages of 18 and 70 who meet all of the inclusion criteria and do not meet any of the exclusion criteria, who present to the ED with an anterior shoulder dislocation as determined by the ED physician. Written, informed consent will be obtained from each patient. After enrollment, each patient will be randomized either to IV sedation (with the provider's choice of propofol or etomidate) or intra-articular lidocaine. Randomization will be done before the initiation of data collection, and will be done with a random number generator. Patients who are randomized to the intra-articular group will receive 20 mL of 1% lidocaine injected into the glenohumeral joint using a lateral approach. Treating clinicians will be instructed to wait 10 minutes after injection before attempting reduction. The primary outcome measure will be the difference in emergency department length of stay between the procedural sedation and intra-articular lidocaine groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18-70 years old in the emergency department with an anterior shoulder dislocation.

Exclusion Criteria:

* Pregnant or breastfeeding
* Is a prisoner.
* Known allergy to one of the study drugs.
* Altered mental status.
* Shoulder fracture (other than a Hill-Sachs) associated with the dislocation.
* Attending provider excludes patient.
the Effect of Broken Ganoderma Lucidum Spore Powder on Quality of Life and Immune Function in Patients With Diffuse Large B-cell Lymphoma After Chemotherapy

The purpose of this study was to explore the effect of broken Ganoderma lucidum spore powder on improving the quality of life and immune recovery of patients after chemotherapy. Objective To observe the adjuvant treatment with broken wall Ganoderma lucidum spore powder in patients with diffuse large B-cell lymphoma after standard chemotherapy according to NCCN guidelines. To evaluate and compare the immunoglobulin (IGA, IgM, IgG), T cell subsets (CD3 +, CD4 +, CD8 +, CD4 + / CD8 +), Th1 / Th2 cytokine determination, quality of life score, leukocyte recovery rate, infection rate, infection rate To evaluate the effect of Ganoderma lucidum spore powder in improving the quality of life and immune function of patients after chemotherapy. At the same time, the liver and kidney function and adverse drug events were closely monitored during the study to explore the clinical safety of wall broken Ganoderma lucidum spore powder as adjuvant drug.


Eligibility Criteria:
Inclusion Criteria:

* Diffuse large B-cell lymphoma，NOS
* all patients were diagnosed for the first time
* between 18-75 years old, male and female
* ECoG 0-3 ，the expected survival was more than 6 months
* the pregnancy test of women of childbearing age was negative; Male and female patients should agree to take effective contraceptive measures during the treatment period and one year of follow-up;
* sign the informed consent before the test screening

Exclusion Criteria:

* those who are known to be allergic to the study drug or its related components; Or allergic patients
* uncontrolled psychosis
* participating in other trials at the same time, and using experimental drugs that may affect the efficacy and safety evaluation
* impairment of liver and kidney function
* HIV antibody positive;
* HBsAg positive hepatitis B carriers and confirmed hepatitis B and C patients;
* pregnant or lactating women and patients who do not agree to take effective contraceptive measures;
* the patient is unable to swallow the capsule or has a disease or condition that seriously affects the gastrointestinal function;
Elobixibat for Chronic Constipation Without Defecation Desire

Patients of chronic constipation without defecation desire will be orally administered elobixibat 10 mg once daily before meals for 4 weeks. The primary endpoint of the pre/post comparative study will be the percentage of improvement in bowel movements from Week 2 of the observation period at Week 4 of the treatment period.


Eligibility Criteria:
Inclusion Criteria:

At the time of provisional registration

* Patients diagnosed with chronic constipation using the Rome IV criteria for the diagnosis of chronic constipation
* Age: 20 years or older (at the time of obtaining consent)
* Gender: Any
* outpatients
* Patients for whom written consent can be obtained
* Patients who can record defecation, etc. in the patient diary

At the time of registration: Dosing start criteria Patients with the following ・'Loss of defecation desire'\* in the second week of the observation period (1 week before the start of the treatment period)

\*"Loss of defecation desire " refers to patients whose "presence or absence of defecation desire" on the patient questionnaire was "4. almost never" or "5. never".

Exclusion Criteria:

At the time of temporary registration Exclude patients with any of the following conditions

* Patients with organ-related constipation or suspected of having organ-related constipation
* Patients with or suspected of having functional ileus
* Patients with or suspected of having inguinal hernia
* Patients with a history of open abdominal surgery within 12 weeks prior to obtaining consent (excluding appendicitis resection)
* Patients with a history of surgical or endoscopic procedures related to gallbladder resection and papillotomy
* Patients with complications of malignancy However, patients who have undergone radical surgery or who have completed chemotherapy or radiotherapy may be registered.
* Pregnant women, lactating women, women who may be currently pregnant, or patients who cannot give consent to use contraception while participating in the study
* Patients with serious renal, hepatic, or cardiac disease
* Patients with drug allergy to the study drug
* Patients who are participating in other clinical studies, or who have participated in other clinical studies within 4 weeks prior to obtaining consent However, observational studies are excluded.
* Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for this study.

At the time of registration: Dosing start criteria

* Patients who increased the dose of concomitantly restricted drugs during the observation period
* Patients who used concomitantly prohibited drugs during the observation period