cyrilzakka/clinical-trials huggingface dataset:
SHAPE for ICP Assessment

The Subharmonic Aided Pressure Estimation (SHAPE) technique is a noninvasive ultrasound-based imaging technique that can estimate ambient pressure using subharmonic emissions from ultrasound contrast agents. Ultrasound contrast agents are encapsulated microbubbles (mean diameter \< 8 µm) with a lipid, protein, or polymer shell that traverse the entire vasculature. When the contrast microbubbles are insonated with relatively high acoustic pressures (\>100-150 kPa), these microbubbles act as nonlinear oscillators yielding energy components in the received echo signals at frequencies ranging from the subharmonic (half of transmit frequency) to higher harmonics and even ultraharmonics. Based on empirical evidence, the subharmonic signal exhibits a sigmoidal relationship with incident acoustic pressure i.e., subharmonic signal can be divided into occurrence, growth and saturation stages. In the growth stage, the subharmonic signal has shown sensitivity to ambient pressure characterized by an inverse linear relationship between subharmonic signal and ambient pressure changes. This inverse linear relationship forms the basis for the SHAPE technique. Several pre-clinical and clinical studies have been conducted to utilize the SHAPE technique for in vivo pressure estimation e.g., to diagnose portal hypertension, to estimate intra-cardiac pressures and to determine interstitial fluid pressures. The core imaging mode underpinning the SHAPE technology (subharmonic imaging) is now available on some commercial scanners. In the proposed pilot study, the SHAPE technique will be leveraged for monitoring intracranial pressure (ICP). The use of SHAPE technique for the ophthalmic artery could potentially provide an accurate noninvasive method of measuring ICP in patients with idiopathic intracranial hypertension (IIH) and other conditions of raised ICP, which would revolutionize the field.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for lumbar puncture to assess ICP pressures
* Age over 18.

Exclusion Criteria:

* Pregnant or nursing
* Medically unstable
* Allergy to any components of Definity.
* Unable to provide written informed consent
Testing Tolerance in Cow Milk Protein Allergy Patients: Milk Ladder or Direct Milk Administration?

Majority of children outgrow their allergies, however there are two different methods to re-introduce milk products in the infant diet either direct milk intake in escalating doses or milk ladder, starting with baked milk products instead of pure milk.

This study aims to compare rate of tolerance after milk reintroduction among patient with cow milk protein allergy (CMPA) diagnosed by elimination re-challenge test after six months of elimination diet by milk ladder versus direct milk intake.

CMPA is an immunological response to one or more milk proteins. CMPA may be IgE mediated or Non-IgE mediated. It is one of the most frequent causes of food allergies in young children with an estimated prevalence between 1.9% and 4.9% in the first year of life.

CMPA has a good prognosis and cow milk is reintroduced in child diet. Natural history of CMPA shows heterogeneity and it is closely related to the clinical phenotype by which it was presented.

The timing and evaluation of developing tolerance is determined by clinical response to milk introduction.

When diagnosis of CMPA is confirmed, fresh pasteurized cow's milk can be used above 12 months of age in oral food challenge procedure, the starting dose should be lower than a dose that can induce a reaction and then increased step wise to 100ml, in children with mild to moderate reactions doses of 1ml, 3ml, 10ml, 30ml, and 100ml may be given at 30 minutes' intervals.

The milk ladder is an evidence-based plan to re-introduce milk products gradually and in stages for infants and children with mild to moderate cow's milk allergy, starting with food that contain only small amount of well-cooked milk and progressing towards uncooked dairy products and fresh milk. It's only started once child has been on a milk free diet for at least 6 months and they are completely well with no active eczema or gastro-intestinal symptoms.

Addition of baked- milk to the diet appears to accelerate the development of unheated-milk tolerance compared to strict avoidance, also its consumption is considered a form of immunotherapy with favorable safety, higher convenience, lower cost and less intensity when compared to oral immunotherapy. It's suggested to enhance the quality of life by removing unnecessary dietary restrictions and change the natural evaluation of milk allergy by promoting the development of tolerance to regular cow's milk.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age between 9 months old till 3 years old.
2. Patients with symptoms that suggest mild to moderate non IgE mediated Cow Milk Allergy
3. Patients on strict elimination diet for at least six months duration

Exclusion Criteria:

Patient with:

* Chronic gastrointestinal disease (malabsorption, irritable bowel syndrome).
* Multiple food allergy and/or history of anaphylaxis.
* Ongoing eczema or severe gastrointestinal symptoms.
Stereotactic Body Radiotherapy for Head and Neck Tumors

This study will evaluate the local control rates as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and neck tumors.

This single site, non-randomized, prospective, phase IV study includes 3 patient groups to be treated with SBRT:

* Benign tumors, such as paraganglioma, chordoma, chondrosarcoma, as the sole treatment or to gross residual disease after maximal safe resection
* Malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, after initial external beam radiation (Residual Disease Group)
* Unresectable malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, adenocarcinomas, and sarcomas which are recurrent after prior radiation (Primary RT Group) Data collected will include baseline patient demographics, pathology data, radiation therapy procedure, tumor recurrence data, and toxicities.

Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patient age \> 18 years
* Zubrod performance status of 0-3
* Benign head and neck tumors such as paragangliomas, chordoma, chondrosarcoma
* Malignant head and neck cancers such as invasive squamous cell carcinoma, adenocarcinoma, nasopharyngeal carcinoma, salivary gland cancers, and sarcoma
* Signed study-specific consent form

Exclusion Criteria:

* Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
* Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
Attentional Bias Modification Treatment in OCD

Obsessive-compulsive disorder is a chronic condition. Even with proper treatment, no significant improvement is reached in about 30% to 40% of patients. Thus, the development of new treatment strategies is necessary. The attentional bias - ability to aversive stimuli in capturing the attention of an individual compared to a neutral stimulus - has been extensively studied. Already training attentional bias modification has been shown effective in reducing anxiety present in other anxiety disorders.This project aims to: 1 - generate knowledge on attentional bias in individuals with OCD through the use of a standardized protocol developed for OCD; 2 - available to the scientific community the first specific paradigm for the study of attentional bias in OCD patients, 3 - test the effectiveness of a training protocol for reversing attentional bias in individuals with OCD.


Eligibility Criteria:
Inclusion Criteria: - 30 patients with obsessive-compulsive diagnosis according to DSM-V (with cleaning and or symmetry dimensions)

* 30 health controls

Exclusion Criteria: - doing any kind of behavioral therapy in the moment
Rehabilitation Status of Children With Cerebral Palsy and Anxiety of Their Caregivers During the Covid19 Pandemic

Rehabilitation status of children with cerebral palsy (CP) and anxiety of their caregivers during the covid19 pandemic were explored. 206 caregivers who voluntarily accepted to participate were administered the State-Trait Anxiety Inventory and evaluated about the rehabilitation status of their children.The anxiety levels of all caregivers were found high and the rehabilitation programmes of the children were interrupted.

Investigators aimed to explore the rehabilitation status of children with CP and anxiety of their caregivers during the covid19 pandemic. Caregivers of children with CP who were under follow up in the outpatient CP clinic were called up during pandemic period. 206 caregivers who voluntarily accepted to participate were administered the State-Trait Anxiety Inventory and evaluated about the rehabilitation status of their children. Demographic data, associated problems of children, Gross Motor Function Classification System (GMFCS) and Manual Ability Classification System (MACS) levels were recorded from their files. For the statistical analysis, IBM SPSS Statistics 22 (SPSS IBM, Turkey) programs were used. While evaluating the study data, the suitability of the parameters to the normal distribution was evaluated with the Shapiro Wilks test. Significance was evaluated at the p \<0.05 level.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers of children with CP who were under follow up in the outpatient CP clinic who voluntarily accepted to participate

Exclusion Criteria:

* Caregivers of children with CP who were under follow up in the outpatient CP clinic who didn't accept to participate
Lipidic Differences of Sperm Between Normal and Low Fertilization Patients

Although in vitro fertilization (IVF) involve the use of semen samples, there is little scientific methodology applied when selecting sperm. To select the most appropriate spermatozoa, first the operator need to define the optimal molecular markers. Sperm lipids may contribute to sperm function, thus the investigator's aim was to compare the lipidic profiles differences of sperm samples used in IVF cycles that ultimately led to normal fertilization or low fertilization.

There is increasing evidence that male fertility/infertility and sperm physiology are determined by multiple factors, necessitating the use of numerous molecular biomarkers to precisely assess male reproductive potential. The study has reported that the lipids are special interest as fertility markers and therapeutic targets not only due to their functions in sperm, but also because they are sensitive to external and environmental signals.

Sperm samples from infertile patients after IVF ( normal fertilization group, n=25; low fertilization group, n=25) were collected. Following standard density gradient separation operating procedure, the sample were incubated in 37°C, 5%CO2, for 3 hours. The sample included 10x10\^6 spermatozoa after sample preparation and aliquots in 100 μL PBS were analyzed for lipid composition using ultra-high performance liquid chromatography coupled to mass spectrometry. Lipid compositions and levels were compared between the two groups. The results will describe the composition and contents of lipids linked to capacitation of sperm, opening a new possibilities for the development of male fertility diagnostic tools and culture media formulations to improve sperm quality and enhance fertilization result.

Eligibility Criteria:
Inclusion Criteria:

* Tubal factor infertility,
* The women's BMI (Body mass index) ranged from 18.5 to 24,
* The women's AMH (Anti-Müllerian hormone) ranged from 2 to 6.8 ng/ml,
* The oocyte mature rate was greater than 75%,
* 8 ≤ Number of retrieved oocytes ≤ 16.
* Analysis of the spouse's semen conventional parameters showed normal.

Exclusion Criteria:

* The age is over 35 years old.
* The women with polycystic ovary syndrome (PCOS).
* The endocrine function of the women was disordered.
* The women has metabolic disease.
Effectiveness of Modified Constraint Induced Movement Therapy to Improve Lower Extremity Function in the Acute and Subacute Stroke Patients by Providing 1 Hour of Intense Massed Practice in the Form of Shaping or Task Practice

This is a prospective randomized control trial of patients with unilateral impairment of the lower extremity after stroke. Patients will be randomized to intervention group and control group. Intervention group will receive one hour of intense massed practice of lower extremity either in the form of shaping or task practice. Control group will receive conventional physical therapy for 1 hour as per current standard of care that follows stroke clinical practice guideline.


Eligibility Criteria:
Inclusion Criteria:

* Age 55 or older
* new ischemic stroke as revealed by CT scan or MRI of a brain or as per updated definition by American heart and American stroke association (Sacco et al., 2013)
* Manual muscle testing with grad of \> 1+ in hip and knee joint musculature
* able to walk atleast 10 feet indoors with or without assistance and assistive device.
* Motivated to participate and some initiation of flexion and extension movement in hip, knee and ankle joints.
* Ability to follow visual/verbal instructions as assessed by a minimum score of 24/30 points on the minimental state examination
* Fairly intact sensation

Exclusion Criteria:

* Serious cardiac or pulmonary condition or other medical condition that make it difficult or risky to participate in intensive training
* Severe joint pain or degenerative disease to the musculoskeletal system of the lower extremity
* other neurological disease 4) problems with following instructions.
Feasibility of Gamma Transcranial Alternating Current Stimulation to Reduce Beta-amyloid Load and Improve Memory

This project assessed the feasibility of transcranial alternating current stimulation in the gamma band to lower beta-amyloid load and improve memory performance.

Thirteen individuals with aMCI received eight 60-minute sessions of 40-Hz (gamma) transcranial alternating current stimulation (tACS) in a single-arm design. Outcome measures were assessed pre- and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Grade 12 or more education
* Normal or corrected to normal vision and hearing
* Ability to complete cognitive tasks
* Ability to cooperate and comply with all study procedures
* Ability to tolerate tACS
* Self-reported memory complaint
* Diagnosed with mild cognitive impairment
* Amyloid positive

Exclusion Criteria:

* Neurological or psychiatric disorders other than mild cognitive impairment
* Receiving investigational medications or have participated in a trial with investigational medications within last 30 days
* Family history of epilepsy
* Implanted electronic devices (e.g., pacemaker)
* Prior head trauma
* Pregnant
* IQ \< 80
* Taking cholinesterase inhibitory, memantine, or psychotropic medication
* Taking anti-depressants or anti-anxiety medication
* Color blind
* Substance abuse
* Glaucoma
* Macular degeneration
* Amblyopia (lazy eye)
* Strabismus (crossed eyes)
MRD in PAAD Adjuvant Therapy

Our preliminary research has explored the detection efficacy of minimal residual disease (MRD) in pancreatic cancer. In patients with pancreatic cancer undergoing dual-agent adjuvant chemotherapy, the median recurrence-free survival (RFS) is approximately 13.9 months. Due to the high postoperative recurrence rate, short survival time, and intense systemic chemotherapy in pancreatic cancer patients, there is an urgent clinical need to more accurately identify which patients will benefit from adjuvant therapy. This study aims to evaluate the application value and guiding significance of peripheral blood MRD in the decision-making process for adjuvant treatment in patients with resected pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

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  1. Patients clinically diagnosed with pancreatic cancer, staged I-III (AJCC V8.0), who are scheduled to undergo curative surgery.
  2. No restrictions on gender; age between 18 and 70 years.
  3. Eastern Cooperative Oncology Group (ECOG) performance status score: ≤2.
  4. Expected survival time of ≥3 months.
  5. Willingness to comply with the study protocol for testing, treatment, and follow-up; consent to provide necessary clinical, pathological, and follow-up data for the study; and agreement to use the research data for future studies and product development.
  6. Voluntary participation in this clinical study, with an understanding of the study procedures and the ability to sign an informed consent form.

Exclusion Criteria:

1. Patients who have had other malignancies within the five years prior to this study.
2. Patients who have received any antitumor treatment within six months prior to enrollment.
3. Patients with concomitant diseases that, in the investigator's judgment, pose a serious risk to patient safety or could affect the patient's ability to complete the study (such as poorly controlled hypertension, severe diabetes, thyroid disorders, psychiatric disorders, etc.), or any other conditions deemed unsuitable for participation.
Collection of Blood and/or Bone Marrow for Investigation and Characterization of Normal and Abnormal Cell Growth

The collection of Blood and/or Bone Marrow from patients with blood disorders, blood cell malignancies and associated conditions will serve as a convenient and comprehensive source of tissue to give us further information about the differences between normal blood cells and blood cells of affected individuals. This will be an invaluable asset for understanding the biology of blood disorders. The collected samples will be used by investigators for studies including immunology, molecular biology and genetics to name a few.


Eligibility Criteria:
Inclusion Criteria:

* Selected patients over the age of 18 with hematologic malignancies or other blood disorders (leukemia, myeloproliferative disorders, lymphoma, other malignancies involving the bone marrow or patients with unexplained alterations in their complete blood count).

Patients who are scheduled to undergo a bone marrow aspirate and/or phlebotomy for other clinical indications will be asked to participate. They will be asked to donate an additional small aliquot of bone marrow and/or blood during the course of their already scheduled bone marrow aspiration or phlebotomy.

Exclusion Criteria:

* Patients with pre-existing medical conditions that might be exacerbated by the procedure of obtaining bone marrow or blood
* Patients who are allergic to Lidocaine, which is used as a local anesthetic, and who cannot receive a suitable substitute anesthetic.
* Patients who have a bleeding diathesis which might pose a problem with marrow aspiration.
* Patients unable to give informed consent.
* Pregnant patients
Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins

Endovenous laser ablation is a common therapy of great saphenous vein insufficiency with a very high success rate. It works by heating and thereby obliterating the vein. Steam ablation is a new therapy that also works by heating and thereby obliterating the vein. The hypothesis of this study is that steam ablation is as effective as laser ablation, but that it results in better secondary outcomes (e.g., lower pain scores).

The study is a randomized clinical trial comparing two different therapies for endovenous ablation of great saphenous veins. The aim of the study is to test whether the anatomical success rate of Steam Ablation is not inferior to that of Endovenous laser ablation (EVLA) in treatment of great saphenous vein insufficiency and compare the treatment safety, patient reported outcomes and cost-effectiveness analyses between EVLA and Steam Ablation.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Insufficiency of the GSV measured with ultrasound imaging, reflux \> 0.5 s, and diameter of vein \> 0.5 cm
* Symptoms of chronic venous insufficiency
* No prior treatment of the insufficient GSV
* Informed consent

Exclusion Criteria:

* Acute deep or superficial vein thrombosis
* Agenesis of deep vein system
* Vascular malformation or syndrome
* Post-thrombotic syndrome, occlusive type
* Pregnancy
* Immobility
* Allergy to lidocaine
* Arterial insufficiency
Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma

The purpose of this research study is to see if people can produce ketones in their blood with the modified Atkins diet. Modified Atkins diet is a diet that produces ketones in your blood by restricting carbohydrates to \<20 grams per day. Ketones are substances that are produced in the blood when fat is being broken down. Ketones may help radiation work better and may starve your tumor because it is thought that some brain tumors can not use ketones to grow and can only use sugar or glucose to grow.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary malignant glioma, Grade III or IV
* No uncontrolled infection or other active malignancy or chronic systemic immune therapy.
* ECOG performance status \< 3.
* Life expectancy \> three months.
* Adequate labs

Exclusion Criteria:

* Diagnosis of genetic disorder of fat metabolism.
* Type 2 diabetes diagnosed with a hemoglobin A1C \> 6.4
* Allergic to dairy or lactose intolerance
Prospective Comparison of Pull-PEG and Pull-PEG With Gastropexy

The study aims to compare the conventional pull-percutaneous endoscopic gastrostomy (pull-PEG) with a pull-PEG with gastropexy suture regarding the peristomal infection rate.

Pull-percutaneous endoscopic gastrostomy (Pull-PEG) is currently the standard technique for enteral nutrition in patients with swallowing disorders. Fistula and peristomal infection rates are one of the most common early complications which are caused by bacterial transmission through the oropharyngeal passage of the tube and by bacterial translocation out of the stomach into the abdominal wall. Retrospective data have shown that if pull-PEGs are attached with a gastropexy suture, the abdominal wall and stomach are fixed tightly and peristomal infection rates can be reduced significantly.

This randomised study wants to compare the peristomal infection rate of standard pull-PEGs and pull-PEGs with gastropexy suture. Peristomal infection rate is detected by classical inflammation rates including erythema, exsudates, and induration, development of pus, or focal peritonitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and over with an indication for a PEG-insertion

Exclusion Criteria:

* ASA-classification \>4
* female patients who are pregnant or breast feeding
* existing contraindications for a PEG-implantation