cyrilzakka/clinical-trials huggingface dataset:
Sirolimus and Cyclophosphamide in Metastatic or Unresectable Myxoid Liposarcoma and Chondrosarcoma

Chondrosarcoma and liposarcoma consists of different subtypes with a wide range of patient survival. Current treatment options consist of wide surgical resection, however for patients with a local recurrence or metastatic disease the outcome is poor. New treatment options being evaluated and mouse models show in vivo that mammilian target of rapamycin (mTOR) inhibition can prevent tumour growth. mTOR is an kinase that is present in two complexes and thereby activates multiple pathways. Aberrant mTOR signalling is known to be involved in cancer cell survival. Several clinical studies for patients with bone or soft tissue sarcoma treated with mTOR inhibitors have been conducted and they show promising results. From these studies the investigators can conclude that the combination of an mTOR inhibitor with cyclophosphamide shows promising results in chondrosarcoma. With the lack of other treatment options for unresectable and metastatic chondrosarcoma or myxoid liposarcoma the Eurosarc consortium (www.eurosarc.eu) decided to treat these patients in a standardised way according to a common protocol with the combination of sirolimus and cyclophosphamide using the growth modulation index for evaluation in the current clinical study protocol.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven conventional chondrosarcoma
* Or pathologically proven myxoid liposarcoma with PIK3CA mutation or Phosphatase and tensin homolog (PTEN) loss
* Or pathologically proven mesenchymal or dedifferentiated chondrosarcoma
* Patient is 18 years and up
* Documented radiographic progression of disease according to RECIST 1.1 criteria in last 6 months
* Written signed informed consent
* Adequate bone marrow function (Hb ≥ 6.0 mmol/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 80 x 109/L)
* Availability of archival tumor material for central review or be able to perform a 3 core fresh biopsy
* Ability to adhere to the study visits and all protocol requirements

Exclusion Criteria:

* Previously treated with an mTOR inhibitor
* Known to be allergic to cyclophosphamide
* Life expectancy of less than 3 months
* No measurable lesions according to RECIST 1.1
* Eastern cooperative oncology group (ECOG) Performance status \>2
* Major surgery less than 4 weeks prior to start of treatment
* Known human immunodeficiency virus (HIV) positivity
* A decreased renal function with calculated glomerular filtration rate (GFR) \< 30ml/min
* Systemic anti-cancer therapy within 28 days prior to the first dose of study drug , or radiotherapy to a target lesion within 21 days prior to the first dose of study drug
* Pregnant or lactating women
* Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localised cured prostate and cervical cancer
Objective Brain Function Assessment of mTBI/Concussion in High School Athletes

This study (Part 2) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery. In addition, neuroimaging will be conducted at time of injury and following Return to Play (RTP).

Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. Matched controls will be tested following the same schedule as the injured athletes. In addition, the study will include an additional pool of contact and non-contact athletes who are not head injured and will be assessed prior to the season and then after the season has ended. This data will be used to populate a database for the purpose of deriving a multimodal concussion index.

Eligibility Criteria:
Inclusion Criteria:

* Concussion-Injury subjects will be defined as follows: Any player who, based on independent clinical impression, is suspected of having suffered a concussion of any severity level, and on whom a routine clinical examination for concussion or head injury would have been conducted prior to implementation of this research protocol according to current standard practice.

  1. If loss of consciousness, total duration less than \<20 minutes
  2. No evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment)
  3. No hospital admission due to either head injury or collateral injuries for \>24 hours.
  4. GCS between 13-15

Exclusion Criteria:

1. Do not speak or read English
2. Current CNS active prescription medications, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD)
3. Skull abnormalities, e.g. metal plate
4. History of brain surgery or neurological disease
5. Pregnant women.
Plasma B-Type Natriuretic Peptide Concentrations in Preterm Infants < 28 Weeks

The aim of the study was to evaluate BNP in preterm infants \< 28 weeks on the second day of life, when it is still unknown, if a patent ductus arteriosus is hemodynamic significant or not. We hypothesized that high plasma BNP concentrations on day 2 are associated with the need of PDA intervention in the further course.

From the study infants blood samples (0.1ml) were collected in K-EDTA microtubes within 24 to 48 hours of age through umbilical artery catheter aspiration or routine venous puncture. The samples were spun at 7000 rpm for 3 minutes. Platelet-free plasma was stored at -20°C until BNP analysis of all collected samples was carried out. The BNP assay was performed using a fully automated immunoassay system ADVIA method for the Centaur System (Bayer Diagnostic Division).

In preterm infants who were treated with indomethacin or surgical ligation we collected additional blood samples 2-4 hours before intervention and 24 hours after the completion of the ductus treatment.

Eligibility Criteria:
Inclusion Criteria:

* Written parental informed consent
* Preterm infant \< 28 weeks of gestation
* Admitted to our NICU within 48 hours after birth

Exclusion Criteria:

* No written parental informed consent,
* Congenital heart disease,
* Death
Comparison of Ultrasound-guided Steroid Injection and Dry Needling in Piriformis Muscle Syndrome

The aim of this study is to to compare its effectiveness ultrasound-guided steroid injection, dry needling treatments and exercises in patients diagnosed with piriformis syndrome.

Piriformis syndrome is a painful entrapment neuropathy caused by compression of the sciatic nerve under the piriformis muscle. The most common cause is myofascial pain syndrome. There is no gold standard treatment for piriformis syndrome. The main purpose of treatment methods is to reduce local pain, muscle tension and spasm. This work; it will contribute to the literature by comparing steroid, dry needling and exercise treatments in patients with piriformis syndrome.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-60,
2. Hip pain for ≥1 month
3. Local piriformis pain with prolonged sitting (\>20 minutes) and increased sensitivity
4. Patients with suspected piriformis syndrome based on clinical maneuvers
5. Signing and informed consent from showing consent to participate in the study

Exclusion Criteria:

1. Hip surgery
2. Lumbar disc disease
3. History of inflammatory hip disease
4. Medical treatment for pain is started
5. Neurological deficit
6. Breastfeeding or pregnant
7. Allergy to local anesthetic
8. Use of anticoagulants
9. Body mass index \>35
10. Active psychiatric illness
11. Uncontrolled hypertension and diabetes mellitus disease
12. Noncompensated chronic lung/heart/renal failure
13. History of vascular/tumoral disease
An Evaluation of a Web-based System for Optimization of Behavioral Childhood Obesity Treatment

This study evaluates the families' and health care professional's experience from using a web based support system including mobile applications for self-monitoring weight and physical activity. Changes in BMI standard deviation score are compared between usual care (control) and usual care with complementary web-based support system (intervention).

In this study children with obesity were randomized to either usual care according to regular routine (control group) or to usual care plus a web-based support system (intervention group). The system is based on a smartphone application connected to a scale and an activity measuring wrist-band. Data is automatically transferred from the accessories to the smartphone, where data is presented graphically. The data is transferred to the clinic for support. The system is developed for communication between the clinic and family. The randomization was done at the start of individual treatment and lasted for 6 months. Investigators studied the families and health care professional's experience of using the web-based support system as well as changes in BMI standard deviation score in the control and intervention group.

Eligibility Criteria:
Inclusion Criteria:

* Obesity according to International Obesity Task Force (IOTF)
* Swedish speaking parents
* Parents able to use a smart phone
* No pharmacological treatment that could intervene the obesity treatment

Exclusion Criteria:

* Diagnosed with or undergoing assessment of neuropsychiatric disorder
* Structured obesity treatment the past 6 months
* Hypothalamic obesity
Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) in Human Obesity

The aim of the study is to analyze the effects of Lipoic acid and/or EPA supplementation on weight loss, lipid profile, insulin resistance, oxidative and inflammation parameters, metabolomic profile as well as on adipose tissue gene profile in healthy overweight/obese subjects following an energy-restricted diet.


Eligibility Criteria:
Inclusion Criteria:

* Women
* Ages between 20 and 45 years, and with regular menstrual cycles
* Body Mass Index (BMI) between 27.5 and 39.9 kg/m2
* Weight unchanged (± 3 kg) for the last 3 months
* All subjects should have an overall physical and psychological condition that the investigator believes is in accordance with the overall aim of the study.

Exclusion Criteria:

* Use of prescription medication
* To suffer from any chronic metabolic or obesity related disease, hepatic or renal systemic disease: Hypertension, dislipidemia, type 1 or 2 diabetes, thyroid function disorders, cirrhosis, fatty liver, etc.
* Food allergies or food intolerance expected to come up during the study
* Special diets (Atkins, vegetarian, etc.) prior three months the start of the study.
* Eating disorders
* Surgically treated obesity
* Pregnant or lactating women or planning to be pregnant in the next two months
* Alcohol or drug abuse (based on clinical parameters)
Telephone Follow-up From an Intensive Care Nursery

The first few weeks after leaving the Neonatal Intensive Care Unit (NICU) can be a difficult transition time for caregivers of a previously hospitalized infant. To help ease this stressful period, doctors and nurses give caregivers a large amount of information prior to their infant leaving the NCIU. How much caregivers remember about medications, follow-up appointments, and general well-child care has not been studied. Caregivers who choose to participate will receive a phone call 2-7 days after discharge where they will be asked questions pertaining to the information that was discussed with them at the time of discharge. The purpose of the study is to determine how much information caregivers retain after leaving the NICU.


Eligibility Criteria:
Inclusion Criteria:

* Parents/caregivers of infants who have spent one week or longer in the NICU at Christiana Hospital or Thomas Jefferson University Hospital.

Exclusion Criteria:

* Parents / caregivers of infants who have spent less than one week in the NICU at Christiana Hospital or Thomas Jefferson University Hospital.
Neoadjuvant Radiation in Locally Advanced Breast Cancer

The purpose of this study is to determine whether neoadjuvant radiation therapy is effective in improving local-regional control and to explore predictors of response to treatment in inoperable breast cancer patients after 2-6 courses of neoadjuvant chemotherapy.

RATIONALE: The optimal management of patients with locally advanced breast cancer(LABC) remains unknown. It is currently accepted that the administration of radiation therapy prior to surgery might result in higher surgery rate or improvement of clinical outcomes.

OUTLINE： This is a prospective phase II study. The purpose is to evaluate the effectiveness of neoadjuvant radiotherapy in combination with chemotherapy. The primary objective in this study is to assess clinical outcomes of these patients. A secondary objective in this study is to identify biomarkers and imaging parameters that can be used as early predictors of treatment response in women with locally advanced breast cancer. Fresh tumor tissue or fresh peripheral blood should be collected as the test sample and stored before treatment. Ultrasound spectroscopy including shear wave elastography parameters should be done before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced breast carcinoma
* Inoperable with with 4-6 courses of prior chemotherapy
* No contradiction of radiation or chemo-radiotherapy
* Patients should have the ability to understand and the willingness to sign a written informed consent document
* Signed informed consent must be obtained prior to any study specific procedures

Exclusion Criteria:

* Other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or contralateral breast DCIS
* Coagulation disorders
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia
* Serious underlying medical illness with life expectancy less than 2 years.
* Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
Echinacea Junior vs Vitamin C in Children 4-12 Years Old

Aim of this study is to investigate efficacy and safety of Echinaforce Junior Tablets (250mg) in comparison with Vitamin C tablets in the prevention of acute viral respiratory tract infections.

200 children aged 4-12 years are recruited by pediatricians and general practitioners and are allocated to preventive treatment with either Echinaforce Junior tablets or Vitamin C. Children take 3 x 1 tablet per day over a period of 2 months followed by 1 week treatment break and an intermediate study visit (V2). Thereafter children continue with preventive Treatment for another 2 months, followed by exclusion visit (V3).

Parents are required to contact a study coordinator at the occurrence of acute respiratory Symptoms to initiate symptom recording via internet-based e-diary. On day 1 - 3 of episode parents will sample nasal secretion, which will be analysed for common respiratory agents.

Eligibility Criteria:
Inclusion Criteria:

* 4-12 years
* written informed consent by parents and optionally by child
* daily Access to computer/email
* german language skills

Exclusion Criteria:

* 13 years or older, younger than 4 years
* participation in a clinical study during past 30 days
* intake of antimicrobial, antiviral, immunosuppressive substances, salicylic medicaments (like Aspirin)
* surgical intervention 3 months Prior to inclusion or planned intervention during the observation period
* known Diabetes mellitus
* known and treated atopy or Asthma
* cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease (COPD)
* diseases of the immunosystem (like autoimmune disorders, degenerative illnesses (like AIDS or leucosis))
* Metabolic or Resorption disorders
* Liver or kidney diseases
* Serious health Problems (e.g. neurological Problems)
* known allergies against compositae (e.g. camomile or dandelion) or any of the substances of the investigational product
Myocardial Work for Prediction of Left Ventricular Remodeling in Patients With STEMI

The study intends to investigate the alteration of regional myocardial work in patients with acute anterior myocardial infarction underwent primary percutaneous coronary intervention (PCI), and compare the distribution of regional myocardial work in patients with/without early remodeling at acute phase and 3-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Anterior myocardial infarct (anterior myocardial infarct is defined as persistent chest pain for 30 mins at least, with ST-segment elevation of at least 0.2 mV in two or more contiguous precordial leads) within 12 hours after onsets of symptom;
* Left anterior descending (LAD) as culprit vessel, with TIMI 0-1 grade.

Exclusion Criteria:

* significant valvular disease;
* cardiomyopathy; l
* left bundle branch block;
* atrial fibrillation;
* previous myocardial infarction (MI);
* history of cardiac surgery;
* pacemaker implantation.
" Effect of Single-nucleotide Polymorphism of CD40 Gene rs1883832 C/T on the Risk of Immune Thrombocytopenic Purpura "

Immune thrombocytopenia is an acquired autoimmune disease, in which platelets are opsonized by auto-antibodies and destroyed by phagocytic cells .Genetic polymorphisms in the immune mediators have been suggested to play a pivotal role in the pathogenesis of many autoimmune disorders . Several genetic polymorphisms of the immune system genes have been described in ITP such as interleukins, tumor necrosis factors (TNF) alpha and beta, and interferon-gamma., These polymorphisms were found to be associated with an increased risk of ITP progression or exacerbation .CD40 is a co-stimulatory 4348 kDa glycoprotein molecule composed of 277 amino acid residues which belongs to the tumor necrosis family. It is encoded by a gene which is located at chromosome 20q11-13, expressed mainly on antigen presenting cells (APCs), some non-immune cells and tumors.Antinuclear antibodies (ANA) is a collective term for a large and heterogeneous group of circulating autoantibody. Reflecting their clinical importance, ANA are diagnostic, prognostic or classification criteria for many autoimmune diseases.


Eligibility Criteria:
Inclusion Criteria:

* sign an informed written consent from the patients or their parents
* patient with newly diagnosed ITP
* patient age \> 1 year and \< 65 years and both sexes are included.

Exclusion Criteria:

* Refusal to sign an informed written consent
* patient with persistent ITP, patient with secondary immune thrombocytopenia
* patient age \< 1 year or \> 65 years.
Ultrasound-Guided 5% Dextrose Injection for Carpal Tunnel Syndrome

This study was a prospective randomized double-blind clinical trial conducted at the Physical Medicine and Rehabilitation Clinic of a local research and training hospital in Turkey from October 2023 and May 2024. Patients diagnosed with CTS were classified into three groups: severe, mild, and moderate CTS, based on the results of electrophysiological tests. An ultrasound-guided 5% Dextrose in Water injection was performed. The primary outcome measurement was the Visual Analog Scale (VAS), while secondary measurements were the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the Dolour Neuropathic en 4 Questions (DN4) questionnaire. The measurements were performed before the injection and at the first week, first month and third month follow-up times. The distribution of data within groups was examined using the Shapiro-Wilk test and Q-Q plots. The study also analyzed temporal changes, group differences, and intergroup changes using repeated measures ANOVA models.


Eligibility Criteria:
Inclusion Criteria:

1. Paresthesia/dysesthesia, painful swelling with clumsy weakness of the hand exacerbated by sleep or repetitive use of the wrist, and relieved by shaking the hand with postural change.
2. Sensory loss with numbness in the median nerve-innervated regions of the hand.
3. Weakness with atrophy of the median nerve-innervated thenar muscles.
4. Positive Phalen's test and/or Tinel's sign.
5. The diagnosis should be confirmed with electrodiagnostic studies.

Exclusion Criteria:

1. History of cervical myelomalacia, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
2. History of systematic infection, and rheumatologic disorders.
3. Previous steroid injection for carpal tunnel syndrome.
Almond Consumption and Glycemia

This study will examine the effects of almonds consumed by adults with different body fat distributions on indices of carbohydrate and lipid metabolism.

There is considerable evidence supporting a causal role for truncal visceral fat depots in glucose dysregulation. Individuals with large visceral fat depots have impaired suppression of free fatty acid release in response to insulin, elevated triglycerides and low concentrations of high density lipoprotein cholesterol. The high free fatty acid concentration may induce insulin resistance in the muscle and liver. There is more recent evidence that truncal subcutaneous fat depots are also problematic, though this literature is mixed. In contrast, gluteo-femoral fat depots have not been implicated in insulin resistance and dysregulation of carbohydrate metabolism. Failure to account for differences in the contributions of these depots will add noise to measurements of dietary interventions to mitigate glucose dysregulation. Previous studies have reported evidence indicating acute and chronic consumption of almonds improves glycemia. Acute effects are important indicators of health benefit, but longer-term trials, ones permitting identification of the effects of a dietary intervention on HbA1c, are more telling and clinically relevant. To more definitively establish the association between almond consumption and improved carbohydrate metabolism, we propose a six-month trial that contrasts the effects of almond consumption at optimal times of the day versus consumption of low nutrient dense snack foods on indices of carbohydrate metabolism, food intake and appetite in adults characterized by three distinct fat depots.

Participants will consume either almonds, or no nuts every day for 6 months. At baseline, participants will be weighed and undergo a DEXA scan to determine body fat composition and will be assigned a group. Blood will also be collected fasted and at stipulated times in response to a meal tolerance test to measure insulin, glucose, C-peptide, HbA1c, lipid panel, gut peptides, and compliance to the diet. Participants will be given links to complete appetite ratings and record food intake. Participants will report to the lab every two weeks to be weighed, and get a resupply of almonds (if in the almond group). At the two-week mark on months 2 and 4, participants will be weighed, blood will be taken to assess compliance to the diet, and links will be given to complete appetite ratings and record food intake. At month 6, all measurements from baseline will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Meeting one of the following body fat distribution criteria determined by DEXA: 1. High visceral fat 2. High gluteo-femoral fat 3. High truncal subcutaneous fat
* 18-60 years
* no nut allergies

Exclusion Criteria:

* Not meeting one of the body fat distribution criteria
* allergic to nuts