cyrilzakka/clinical-trials huggingface dataset:
Neuroblastoma Biology Study

Medical scientists want to find better ways to treat neuroblastoma and to find ways to prevent the tumor from growing back. To do this, they need more information about the characteristics of neuroblastoma cells. Therefore, they want to study samples of neuroblastoma tissues and neuroblastoma and normal cells in the blood and bone marrow that may be related to the growth of neuroblastoma cells. Doctors and other medical scientists also want to find better ways to detect and measure neuroblastoma to improve the ability to follow the response of tumor cells to therapy.

The purposes of this study are:

To establish a storage place or bank of samples of blood, bone marrow, and/or tumor, and molecular components isolated from these samples from children with neuroblastoma. The stored specimens will be shared with laboratory researchers studying high risk neuroblastoma.

To collect clinical data (such as treatments received, date of diagnosis, tumor stage, etc) and radiology scans to provide this information as needed for the laboratory studies to be done on the specimens.

To obtain neuroblastoma tumor cells from tumor tissue, bone marrow, and/or blood to use to start cell lines, or tumor cells that will keep growing in the laboratory. These cell lines will be shared with laboratory researchers studying high risk neuroblastoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be greater than or 31 days of age.
* Patients must have had a diagnosis of high risk neuroblastoma either by histological verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines.
* All patients with refractory or recurrent high risk neuroblastoma at NANT institutions are eligible regardless of disease status (including no measurable or evaluable tumor) as long as they undergo a disease evaluation and appropriate samples are submitted.
* Additionally, all patients with high risk neuroblastoma without relapse treated at a NANT institution are eligible if undergoing a disease evaluation, as long as Children's Oncology Group specimens are prioritized.

Exclusion Criteria:

* There are no exclusion criteria on this study.
Does the Mesh Have to be Fixed in Laparoscopic eTEP Repair of Inguinal Hernia?

Inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. As with many open surgical methods, this repair is also performed laparoscopically. Among these closed methods, the one method is laparoscopic extended total extraperitoneal repair (eTEP). The benefits of laparoscope include less postoperative pain and complications, faster recovery, reduced chronic pain, and recurrence rate.

One of the recent debates regarding the laparoscopic technique is mesh fixation. Fixation of the mesh to the cooper ligament can prevent mesh migration and consequently reduce the recurrence rate. However, it has been reported that this fixation may increase postoperative pain. Several studies have reported that recurrence may be due to inadequate mesh fixation technique. In contrast, other prospective randomized studies have found relapse unrelated to mesh fixation.

In the eTEP technique, dissection is performed in a larger area than in TEP. For this reason, it can be thought that the possibility of mesh displacement is higher in the eTEP procedure. The purpose of this study is to confirm this idea with a prospective study. There are studies in the literature on mesh fixation related to the total extraperitoneal repair (TEP) technique. However, there is no study on mesh detection in the eTEP technique. The aim of the study is to compare patients who underwent without mesh fixation laparoscopic TEP and eTEP repair in terms of clinical data such as mesh displacement and hernia recurrence, chronic pain, length of hospital stay, and postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral inguinal hernias,
* Patients aged 18-65.

Exclusion Criteria:

* Younger than 18 years, and older than 65 years,
* Incarcerated or strangulated inguinal hernias,
* Recurrent hernias,
* Patients with bilateral inguinal hernias,
* Patients who are contraindicated to receive general anesthesia,
* Pregnancy
Compliance Feasibility Study for Remote Phase 2 Cardiac Rehabilitation

This study evaluates the compliance of patients in a Phase 2 (outpatient clinic based) cardiac rehabilitation program, who are offered the opportunity to perform the rehab remotely (e.g. at home, not at the clinic), using a remote monitor and smart-phone application.

In spite of the fact that cardiac rehabilitation has been shown to be beneficial to patients who have had a cardiac event, such as a heart attack, only 5% of eligible patients complete this program. Some of the reasons cited include limited facility access, travel time and cost.

We are testing the hypothesis that cardiac rehab compliance will be greater if patients are offered the opportunity, and associated technology, to perform cardiac rehab anywhere.

Eligibility Criteria:
Inclusion Criteria:

* referred to SLU cardiac rehab facility

Exclusion Criteria:

* does not own app compatible smart phone
* dementia
* syncope
* valvular disease
* life expectancy \< 1 year
* non-English speaking
* unstable angina
* decompensated congestive heart failure
* ventricular arrhythmia
Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes

The purpose of the study is to determine the beneficial effects of CBX129801 (PEGylated synthetic human C-peptide) following weekly subcutaneous administration for 12 months in type 1 diabetes mellitus patients (T1DM) with mild to moderate diabetic peripheral neuropathy (DPN).


Eligibility Criteria:
Key Inclusion Criteria:

* Give informed consent;
* 18-65 years old;
* Have type 1 diabetes mellitus for a minimum of 5 years, with a stable diabetic regimen (for at least 3 months);
* Have clinical signs of diabetic peripheral neuropathy at screening;
* Have abnormal sural nerve conduction observed bilaterally during screening;
* Be C-peptide deficient;
* Be in good general health (besides having type 1 diabetes mellitus);
* Practice effective contraception during and for at least 12 weeks after study participation;
* Have a body mass index (BMI) ≥18.0 and \<35.0 kg/m2.

Key Exclusion Criteria:

* Any significant cardiovascular, hematological, lymphatic, immunologic, urologic, dermatologic, psychiatric, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, gastrointestinal, or other major disease;
* Unstable or inadequate glucose control;
* Any clinically significant laboratory value at screening;
* Occurrence of a severe, unexplainable hypoglycemic event (defined as requiring the assistance of another individual) within 6 months of Day 0, or recurrent episodes of non-severe hypoglycemia (≥3 per week on average) that are deemed clinically significant by the Investigator;
* Have had an islet cell, kidney, and/or pancreas transplant;
* If female, is pregnant or lactating;
* History of alcohol or substance abuse within 2 years;
* Positive screen for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibody;
* Initiation of treatment or change of dose of medication that could affect peripheral nerve function within 60 days;
* Previous treatment with CBX129801 or unmodified C-peptide;
* Receipt of an investigational product or therapeutic device, or participation in a drug research study, within a period of 30 days;
* Chronic use of oral steroids or use of Ampyra (dalfampridine) within 60 days.
Evaluation of Patient Satisfaction and Biting Force of New Design of Extracoronal Attachment (O T Cap Unilateral Attachment) Versus Conventional Partial Denture for Treatment of Unilateral Mandibular Distal Extension Area

Comparison of new design of extra coronal castable precision attachment (OT unilateral attachment) and conventional partial denture in patient satisfaction and biting force.


Eligibility Criteria:
Inclusion Criteria:

* patients with unilateral mandibular distal extension area
* Normal crown/root ratio of last premolar
* co-operative patients

Exclusion Criteria:

* completely edentulous patient
* few remaining teeth
* patients exposed to radiotherapy and chemotherapy
* patients with maxillary or mandibular defect
A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated and Taken up by the Body With or Without Food

The main objectives of the single rising doses (SRD) trial part are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1819479 in healthy male subjects following administration of single rising doses.

The main objective of the food effect part is to investigate the influence of food on the relative bioavailability of BI 1819479.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
2. Age of 18 to 50 years (inclusive)
3. BMI of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (ALT/AST) or renal parameters (creatinine) exceeding the ULN after repeated measurements
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts -Further exclusion criteria apply
A Pilot Study to Evaluate Skin Swabbing with Chlorhexidine to Prevent Skin and Soft Tissue Infections Among People Who Inject Drugs

The study examined chlorhexidine gluconate (CHG) swabs as a skin disinfectant in combination with a single-session safer injection training to prevent skin and soft tissue infections (SSTI) in people who inject drugs.

Skin and soft tissue infections (SSTI) are a serious and preventable complication of intravenous drug use, yet few interventions have been developed to reduce SSTI in people who inject drugs (PWID). This study tested two interventions to reduce SSTI in PWID: 1) a single-session behavioral intervention to inculcate skin swabbing behaviors, and 2) chlorhexidine swabs to be used as for cleaning the skin prior to injecting.

Eligibility Criteria:
Inclusion Criteria:

* Self-report intravenous drug use within past 30 days

Exclusion Criteria:

* None
Induced Hypertension in Acute PRogrESsive Perforating Artery Stroke Using Peripheral Dilute noREpinephrine

PRESSURE is a multicenter, prospective, randomized, open, blinded end-point assessed (PROBE) trial, that aims to evaluate the efficacy and safety of drug-induced hypertension using peripheral dilute norepinephrine, in patients with acute ischemic stroke in a perforating artery territory and experiencing early neurological deterioration.

Perforating artery strokes represent 25% of all ischemic strokes and is a well-known cause of progressive symptoms : 12 to 36% of cases experience early neurological deterioration in hours or days after stroke onset. A possible mechanism is hypoperfusion due to lack of a rapid development of collateral flow because of the terminal distribution of perforating arteries. Moreover, arterioles are maximally dilated within penumbra region, resulting in a cerebral autoregulation failure and a passive dependence of cerebral blood flow on arterial pressure. Thus, induced-hypertension therapy by using vasopressive agents is an attractive therapy to increase the cerebral perfusion pressure and therefore restore blood flow in the ischemic penumbra.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke \< 72 h in a perforating artery territory on brain MRI
* Early neurological deterioration or fluctuation, attested by the neurologist in charge, defined by a ≥ 3-point increase in global NIHSS score OR a 2-point increase on motor or ataxia score, whether this deterioration is transient or permanent.
* Time between early neurological deterioration and randomization \< 6 hours
* Age ≥ 18 years
* Contraception required in women of childbearing potential (Intra-uterine device, hormonal contraception associated with inhibition of ovulation (combined or progestogen-only; oral, intravaginal or transdermal), Female Sterilization, Vasectomised partner, sexual abstinence)
* Beneficiary of a health insurance system

Exclusion Criteria:

* - Pre-Stroke Modified Rankin Score \> 3
* Contraindication to brain Magnetic Resonance Imaging (MRI)
* High risk of intracerebral hemorrhage:

  * Cerebral microbleeds ≥ 10
  * Non traumatic focal superficial siderosis
  * Hemorrhagic transformation of the present ischemic stroke
  * Previous history of intracerebral hemorrhage (symptomatic or asymptomatic identified on brain MRI)
  * Intracranial vascular malformation or tumor with suspected risk of rupture or bleeding
* Prior intravenous thrombolysis \< 24 hours
* Requirement for anticoagulation in the first 7 days after randomization
* Systolic blood pressure (SBP) \> 180mmHG and/or mean arterial pressure (MAP) ≥ 110mmHG at inclusion
* Large artery atherosclerosis (ipsilateral atherosclerotic stenosis \> 50%), intra and extracranial dissection, or cardio-embolic stroke mechanisms
* Drugs with important interactions with norepinephrine: monoamine oxidase inhibitors (including reversible, non-selective agents such as linezolid), tricyclic antidepressants, entacapone.
* Pregnancy or breastfeeding
The Effect of Citrus Extract on Oxidative Stress

This randomized, cross-over, double-blind, placebo-controlled trial aims to determine the effects of daily administration of citrus extract over a period of 4 weeks on markers of oxidative stress in elderly.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Age 70-85 years
* BMI \< 30 kg/m2

Exclusion Criteria:

* History or actual status of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
* Disease with a life expectancy shorter than 5 years
* Institutionalized (e.g. hospital or nursing home).
* Subjects with abnormalities in haematology which may interfere with the endpoints of the study (to be decided by the principle investigator)
* Use of drugs or hormones within 3 months prior to the start of the study which may interfere with the endpoints of the study (to be decided by the principle investigator)
* Self-admitted Inflammation, (viral) infection (e.g. HIV or hepatitis B)
* Subjects with an autoimmune disease (e.g. Rheumatoid arthritis)
* Subjects with intestinal disorders which may interfere with the endpoints of the study (to be decided by the principle investigator)
* Use of immunosuppressive drugs within 3 months prior to the start of the study
* Use of medication (e.g. NSAIDs), antibiotics or corticosteroids which may interfere with the endpoints of the study (to be decided by the principle investigator)
* Changes in medication that may significantly affect the study outcome (according to the investigator's judgment) within 1 month prior to the start of the study.
* Use of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days before the study
* Use of (dietary) supplements containing antioxidants, vitamins and minerals
* Smoking
* Weight gain or loss (\> 3 kg in the previous 3 months)
* Excessive intake of foods with a high polyphenol concentration
* Use of pre-, pro or synbiotics within 1 month prior to the start of the study
* Blood donation within 1 month prior to the start of the study
* Excessive alcohol consumption (\>20 alcoholic consumptions per week)
* History of any side effects towards the intake of flavonoids or citrus fruits
Virtual Reality-based Interactive Treadmill Gait Training System for Parkinson's Disease

Virtual-reality-based interactive treadmill system will be applied to the Parkinsons' disease patients who can walk (Hoehn and Yahr stage 2 to 4). Subjects will be randomly allocated to either VR-based treadmill training group or treadmill training without VR-based interaction. The training will be provided for 3 sessions (30min/session)/week for 4weeks, the total of 12 sessions. The outcomes will be measured at baseline, immediately after the completion of the intervention and 1 month after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* definite or probable idiopathic Parkinson disease patient
* age from 18 to 80 years old
* H\&Y stage 2 to 4 and who can walk 10 meter independently regardless of the use of gait aids

Exclusion Criteria:

* unstable medical conditions
* cognitive impairments which interfere with participation in virtual-reality based training
* hemispatial neglect, visual disturbance, apraxia
* other pre-existing disease involving the central nervous system (e.g. stroke, brain tumor)
* requiring the continuous manual assist with touch during the treadmill training
* can not give a consent
Assessment of Telomerase Activity in Endometrial Tissue and Serum in Endometriosis Patients

The goal of the study was the detection of telomerase activity in eutopic, ectopic endometrial tissue and in peripheral blood and finding the correlation between the telomerase activity and clinic findings. With these results, confirmation of the hypothesis regarding the endometriosis pathogenesis and endometriosis-related infertility was aimed.

Although distorted pelvic anatomy, impaired peritoneal, humoral and cellular functions, decreased implantation rate, oocyte and embryo quality, obstructed utero tubal connection are most researched aspects of endometriosis-related infertility, etiopathogenesis of endometriosis-related infertility still remains controversial.

Endometrial cell is a unique eukaryotic somatic cell with cyclic telomerase activity. Hormone-dependent cyclic variation of endometrial telomerase activity was stated in previous studies. On the other hand telomerase, activity was shown in endometriotic lesions, whereas this activity lacks in most of the somatic cells.

In this study, assessment of possible relation to increased telomerase activity in infertile patients with endometriosis was aimed.

Before published studies were assessed telomerase activity in benign and malign gynecological conditions and in endometriosis tissue, as well. But evaluation of ectopic and eutopic endometrial tissue and serum telomerase activity in infertile and fertile endometriosis and healthy control subjects was not performed.

Correlation of telomerase activity and endometriosis-related infertility was aimed in this study.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Infertility Clinical and histological diagnosis of endometriosis

Exclusion Criteria:

Malign disorders Hormone replacement treatment Oral Contraceptive using
Long-term Effects of Family WISH Program for Adolescents with Congenital Heart Disease

The goal of this clinical trial is to learn the long-term effects of "Family Walking Instruction with Support by Heart" (Family WISH) on frailty state, quality of life and family functioning among adolescents with congenital heart disease (CHD).

Researchers will compare the 12-week Family WISH program, based on self-efficacy theory, to a comparison group receiving a family walking health education sheet to evaluate the long-term effectiveness of the Family WISH program.

Participants will:

* Walk with family members for 20-30 minutes daily, at least 5 times per week, totaling 150 minutes per week.
* Keep a diary to record the frequency of their walks and any symptoms experienced.
* Complete questionnaires at baseline, and at 6, 12, and 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* being between 12 and 18 years old;
* having received a diagnosis of CHD by a physician before age 2;
* having received a diagnosis of CHD with New York Heart Association (NYHA) functional class I, II, or III;
* having parents or guardians who were able to communicate in Mandarin, and being able to communicate in Mandarin themselves;
* not having cognitive impairments, and;
* voluntarily signing informed consent forms.

Exclusion Criteria:

* undergoing heart transplant surgery within the past year;
* receiving cardiac catheterization intervention or open-heart surgery within the past 6 months;
* having CHD with NYHA functional class IV; and
* having other congenital diseases
Safety and Efficacy of Human Umbilical Cord Blood Plasma Infusion for Age-Related Cognitive Decline

This study is designed to investigate the safety of Umbilical Cord Blood Plasma infusions in elderly adults regardless of gender, with age-related cognitive decline. Human clinical data of the use of young plasma appear to show beneficial cognitive effects.


Eligibility Criteria:
Inclusion Criteria:

1. Age 65-85 years old
2. Evidence of cognitive decline on neuro-cognitive testing
3. Able to participate in research trial for 12 months
4. Women must have documented menopause or infertility determination
5. Ability to receive intravenous infusions
6. Patient or legally authorized representative able to sign informed consent

Exclusion Criteria:

1. Patients receiving any other investigational biologics or drugs
2. History of transfusion reaction
3. Dementia related to specific pathology (Alzheimer's Disease, Alcohol-related, etc.)
4. Inability to participate in cognitive or performance testing
5. History of cancer in the last 5 years
6. History of infectious disease within the previous 12 months
7. Severe kidney (eGFR\< 30) and heart failure (Class III/IV)
8. History of Human Immunodeficiency Virus Infection
9. History of Hepatitis B, or C
10. History of immunosuppressive therapy
11. History of organ transplantation
12. Difficulty of obtaining peripheral venous access
13. Allergy to histamine blockers
14. Inability to participate in the clinical trial at any data collection and end points

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Ministry of Child and Family Development (MCFD) Interpersonal Psychotherapy for Adolescents (IPT-A) Training Project

Evaluating the Effectiveness of Different Interpersonal Psychotherapy for Adolescents (IPT-A) Therapist Training Models


Eligibility Criteria:
Inclusion Criteria:

-adolescent undergoing psychotherapy

Exclusion Criteria:

-
Effect of Intraoperative Remifentanil Infusion Rate on Postoperative Tolerance and Analgesic Consumption in Pediatric Laparoscopic Ureteroneocystostomy

Effect of intraoperative remifentanil infusion rate on postoperative tolerance and analgesic consumption in pediatric laparoscopic ureteroneocystostomy.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (ASA physical status I and II) aged between 1-5 yrs and scheduled elective laparoscopic ureteroneocystostomy

Exclusion Criteria:

* cardiovascular, renal, liver disease or growth retardation