cyrilzakka/clinical-trials huggingface dataset:
Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer

Patients with metastatic cancer are generally treated with chemotherapy, which has improved median survival compared to best supportive care. Despite this, patients continue to have persistent disease at sites that were initially involved with cancer. Radiation therapy is an effective modality for treating localized cancer but generally has been only used for palliation of symptoms once a patient develops metastatic disease. Since patients often have persistent disease after chemotherapy, the goal of this trial is to use increasing doses of radiation therapy to all sites of involved disease in order to determine the safety and efficacy of hypofractionated radiation therapy.

The purpose of this study is to establish a maximum tolerated dose, dose-limiting toxicities, and recommended phase 2 dose of hypofractionated radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of cancer (including epithelial carcinoma, sarcoma, and melanoma)
* Age 18 years and older
* Life expectancy of \> 3 months
* Patients with AJCC (6th edition, 2002) stage IV cancer with distant metastases and without pleural or pericardial effusion at diagnosis and before start of study
* Patients with 1-5 sites of maximum tumor dimension (for each individual site) of ≤ 10 cm or \< 500 cc volume and amenable to radiation therapy as seen on standard imaging
* Unidimensionally measurable disease (based on RECIST) is desirable but not strictly required
* Brain metastases must have been treated prior to enrollment on study, preferably with stereotactic radiosurgery
* ECOG performance status ≤ 2 or Karnofsky Performance Status ≥ 60%
* No prior radiation therapy to currently involved tumor sites
* Room air saturation \> 90%
* Hemoglobin \> 9.0 g/dl
* ANC \>=1,500/microliter
* Platelets \>=100,000/microliter
* Total bilirubin within institutional limits
* Albumin \> 2.9 g/dl
* Alkaline phosphatase \< 2.5x upper limit of normal
* AST and ALT \< 2.5 x upper limit of normal
* Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

* Uncontrolled intercurrent illness
* Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. Exclusion of patients with active coronary heart disease will be at the discretion of the attending physician
* Patients with significant atelectasis such that CT definition of gross tumor volume is difficult to determine
* Pregnancy or breast feeding
* Patients must have no uncontrolled active infection other than that not curable with treatment of their cancer.
* Patients may not be receiving any other investigational drugs during RT
Opioid Free Anesthesia on the Quality of Early Recovery

To analyze and compare the effect of OFA scheme and traditional balanced anesthesia scheme on QoR15 after thyroidectomy, and further clarify the safety and rationality of OFA scheme in perioperative application of thyroid surgery.

OFA scheme (group T) was given dexamethasone 8mg for anti-inflammatory and antiemetic before operation, flurbiprofen axetil 50mg for preemptive analgesia, and dexmedetomidine was infused under ECG monitoring at an initial rate of 0.5 μ G/kg (more than 10min), then changed to 0.2ug/kg/h, and stopped infusion 20 minutes before operation closure. Before induction, lidocaine (1mg/kg), esketamine (0.5mg/kg), propofol (1-2mg/kg) and rocuronium (0.6mg/kg) were infused slowly, and endotracheal intubation was carried out when the anesthetic was fully effective and the BIS value was about 40. After successful intubation, an experienced anesthesiologist guided by ultrasound performed bilateral superficial cervical plexus block with 0.5% ropivacaine and injected 3-4ml at two points respectively; During the operation, sevoflurane (MAC1.0 - 1.4) was used to maintain the depth of anesthesia; The routine anesthesia group (Group C) was induced to give sufentanil 0.3-0.5ug/kg, propofol 1-2mg/kg, rocuronium 0.6mg/kg slowly, and then intubated when the anesthetic was fully effective and the BIS value was about 40. Remifentanil was continuously pumped 0.1-0.2ug/kg during operation min； Combined with sevoflurane (MAC 0.8-1) to maintain the depth of anesthesia.

Eligibility Criteria:
Inclusion Criteria

* Patients undergoing elective thyroidectomy under general anesthesia
* \>18 year old
* The informed consent form has been signed
* American Society of Anesthesiologists (ASA) anesthesia grade I - II

Exclusion Criteria:

* Long term use of opioids
* Long term use of NSAIDs
* Have a history of psychosis, epilepsy, preoperative anxiety, depression, and emotional management disorders
* Patients with increased gastric contents reflux and respiratory tract aspiration
* Operation time\>3h
* Severe liver and kidney insufficiency, cardiac insufficiency, bradycardia with 2 ° II or 3° atrioventricular block
* Those who are allergic to or have contraindications to drugs that may be used in the test
* Those who cannot cooperate with researchers
Efficacy of Dialectical Behavior Therapy Versus CAMS-informed Supportive Psychotherapy on Self Harming Behavior

Purpose: The purpose of this study is to investigate the efficacy of Dialectical Behavior Therapy (DBT) versus CAMS (Collaborative Assessment and Management of Suicidality) -informed supportive psychotherapy on the risk of self-harm acts and suicide attempts in patients with self behavior and personality traits within the spectrum of borderline personality disorder.

Hypothesis: The hypothesis is 16 weeks of treatment with Dialectical Behavior Therapy (DBT) after a defined manual has a higher efficacy than CAMS-informed supportive psychotherapy on self-harm acts, suicide attempts, suicidal ideation, depressive symptoms, impulsiveness and consumption of hospital services in patients with symptoms within the spectrum of borderline personality disorder (BDP).

Method: The investigators will include 160 patients in the randomized trial to investigate whether 16 weeks of DBT-treatment as a higher efficacy than CAMS-informed supportive psychotherapy on the risk of self-harm acts and suicide attempts in patients with self-harm behavior and personality traits within the spectrum of borderline personality disorder. The trial will meet strict criteria for high quality randomized trials, and will hopefully help to establish evidence for the treatment of this patient group at higher risk of later suicide. There will be performed follow up interviews after 16 weeks, 28 weeks and 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age.
* Newly suicide attempt within one month of the inclusion date.
* A minimum of two characteristics in the DSM-IV Borderline Personality Disorder (BPD)
* Informed consent.

Exclusion Criteria:

* Severe depression.
* Bipolar disorder.
* Psychosis within the schizophrenic spectrum.
* Anorexia Nervosa.
* Substance abuse.
* Mental retardation.
* Dementia.
* Lack of informed consent
Review of Anaesthetic Practice in Orthognathic Surgery

Orthognathic surgeries for maxillofacial deformities are commonly performed globally. However, they are associated with significant blood loss which can affect the surgical field and result in blood transfusion and its risks. We aim to review the different hypotensive anaesthetic practices for orthognathic surgeries, and their effects on intraoperative blood loss and transfusion requirements.


Eligibility Criteria:
Inclusion Criteria:

* All patients who were scheduled for orthognathic surgeries from January 2014 to March 2017

Exclusion Criteria:

* surgery was not done
* there were missing anaesthetic records
The Effect of Topical Brimonidine on the Ocular Hemodynamics in Patients of POAG Using OCTA

Topical Brimonidine is a well-established topical antigalucoma, ocular hypotensive therapeutic that has been in use since 1996. Brimonidine stands out among other topical ocular hypotensives in that it has a neuroprotective effect that is independent of IOP reduction. This has been demonstrated in multiple animal and human controlled studies both in vivo and in vitro. The mechanisms proposed so far to account for this neuroprotection focus mainly on molecular level antiapoptotic effects and modulation of some excitatory stimuli like glutamate. In this study we try to test the hypothesis that a positive hemodynamic profile of Brimonidine on ocular blood flow may be responsible at least in part for its unique neuroprotective effects.

* Study Design: A prospective, longitudinal, interventional, uncontrolled study
* Participants: primary open angle glaucoma patients recruited during the period of study from the fayoum university hospital ophthalmic outpatient clinic.
* Methods:

Primary open angle glaucoma patients that are Brimonidine naiive and at the same time either medication naiive or have been on a fixed antiglaucoma medication for at least a month prior will be commenced on Brimonidine 0.2% bid with prior baseline imaging by OCT angiography (Optovue) of macula 6\*6 mm and ONH 4.5\*4.5 mm. After commencing Brimonidine patients will be followed up by OCT angiography at three visits assigned for 1,2,3 months after commencing Brimonidine. Every time the patient is imaged by OCT, imaging is done twice, once in a seated position at presentation and another- also in a seated position-, but after a protocol of right recumbency for 30 minutes in order to produce a postural position change as a vascular stress test to assess autoregulatory capacity of ocular and systemic circulation.

At each visit, IOP and arterial blood pressure are measured both in the seated position and after the 30-minute recumbency protocol in order to mathematically calculate the mean ocular perfusion pressure that will be correlated with OCT angiography data including vascular density, as well as indirect parameters of blood flow.

Data will be statistically analysed using the SPSS software.

Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma patients.
* Brimonidine naiive.
* Medication naiive or on a fixed antiglaucoma medication for at least a month prior to commencing Brimonidine.

Exclusion Criteria:

* Glaucomas other than primary open angle glaucoma.
* Other comorbid diseses both ocular and systemic that might confound the density and flow measurements ( hypertension, diabetes, vasculitis, MacTel, Uveitis)
* Comorbid diseases that constitute relative or absolute contraindication to Brimonidine ( pregnancy, lactation, bronchial asthma, cardiovascular diseases)
* Prior use of Brimonidine.
* A change in the glaucoma medication regimen within Less than one month at time of presentation.
* Allergy to Brimonidine or related compounds.
Tolerability of ALK Grass Tablet in Children

The purpose of this trial is to assess whether the ALK Grass tablet treatment is safe to use in children aged 5-12 years


Eligibility Criteria:
Inclusion Criteria:

* Grass pollen induced rhinoconjunctivitis
* Boys and girls, 5-12 years of age
* Positive skin prick test to grass pollen

Exclusion Criteria:

* Severe asthma
* Previous treatment with immunotherapy
Evaluating the Impact of Omega-3 Fatty Acid Supplementation (Soloways™) on Lipid Profiles in Adults With PPARG Polymorphisms

In this study, 102 patients will be evenly randomized into two groups: one set to receive omega-3 fatty acids and the other a placebo. The process will be blinded, ensuring that neither the researchers nor the participants will know which group they are in. Each participant will take two capsules daily for a duration of 90 days, with the active group receiving capsules containing 1000 mg of fish oil each. All participants will be instructed to maintain their usual diet, lifestyle, and medication regimen.

At the beginning and end of the study, various health assessments, including lipid panels and C-reactive protein measurements, will be conducted. Additionally, DNA samples will be collected for genotyping to identify patients with specific PPARG gene polymorphisms, leading to the creation of four distinct subgroups: those receiving omega-3 with and without polymorphisms, and those receiving placebo with and without polymorphisms.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 75;
* ( LDL-C level between 70 and 190 mg/dL, confirmed in at least two sequential checks conducted within the last six months prior to signing the consent form.

Exclusion Criteria:

* Personal history of cardiovascular disease or hight risk (≥ 20%);
* Triglycerides (TG) ≥ 400 mg/dL;
* Obesity (Body Mass Index \> 32 kg/m2);
* Assumption of lipid-lowering drugs or supplements affecting lipid metabolism within the last three months;
* Diabetes mellitus;
* Known severe or uncontrolled thyroid, liver, renal, or muscle diseases.
Periodontal and Orthodontic Outcomes of Straight vs. Looped Fixed Retainers

The goal of this split-mouth, head-to-head, randomized controlled trial is to compare the effects of a fixed straight retainer with the V- loop bonded retainer on periodontal health in patients with the requirement of continuous fixed retention for 12-24 months after orthodontic treatment.

The main question it aims to answer is whether the V- loop bonded retainer is more effective than fixed straight retainer for periodontal health management.

Each patient will receive 2 lower fixed and bonded retainers: (1) a straight wire retainer (SWR) and (2) a looped wire retainer (LWR). Patients will be asked to floss once daily with a thread flosser.

Researchers will compare the effects of two types of retainers to see if there is a statistically significant difference.

Ensuring alignment stability is a major challenge for orthodontists following an orthodontic treatment. This has led to the development of various orthodontic retention methods to enhance stability. Both fixed and removable retainers have been in use for years. However, most orthodontists nowadays prefer fixed bonded retainers over removable ones due to their many advantages, including easy to wear, being patient compliance free, long-term usability and stability, and better aesthetics. Over the past decades, many variations of fixed retainers have been developed. Of these, the current gold standard is the straight type flexible spiral (multistranded) wire retainer. Nevertheless, a major concern of using fixed straight retainers is the potential for periodontal health compromise. They are known to make oral hygiene maintenance more difficult for the patient, which in turn may lead to periodontal diseases due to more plaque and calculus accumulation. The wave or V- loop bonded retainer may be a solution to this problem, as it provides stability of teeth yet allows flossing with ease.

Eligibility Criteria:
Inclusion Criteria:

* Patients in need of continuous fixed retention for 12-24 months after orthodontic treatment
* Good periodontal health (i.e., no clinical attachment loss and \< 10% bleeding on probing)

Exclusion Criteria:

* History of oral prophylaxis in the past 6 months
* History of any systemic illness such as diabetes
* Preexisting or post-orthodontic periodontal disease
* Current intake of antibiotic and/or anti-inflammatory medications
* Smoking
* Pregnancy
Accuracy Study of a Non-Invasive Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure

The purpose of this study is to establish the performance of a blood pressure cuff. The hypothesis is that the blood pressure reading from the cuff will provide similar blood pressure as a radial artery.

Blood pressure reading from the cuff will provide similar blood pressure as a radial artery.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent or have a legally authorized representative provide written informed consent
* Any volunteer subjects ≥ 18 years of age
* Subject must have the presence of normal sinus rhythm on ECG
* Subject will return for follow-up visit from 5 days to 8 days after study procedure

Exclusion Criteria:

* Any subject who is unable to provide written informed consent
* Any subject with the presence of peripheral vascular disease in either arm
* Any subject that demonstrates an initial NIBP screening for a blood pressure distribution range that has already been filled.
* Any subject who cannot tolerate 21 repeated BP measurements
* Any subjects with clotting or bleeding disorders
* Any subjects taking medications that are considered anticoagulants or blood thinners (For example, Clopidogrel, Warfarin, Dipyridamole, Aspirin, and Enoxaparin)
* Any subject who is unable to have arterial line placed in the radial artery
* Any subject that cannot tolerate 4 fast flushes for the frequency response
* Any female subjects pregnant or lactating
* Any subject that has previously participated in this study
* Any subjects that cannot return 5 to 8 days post study procedure for a follow-up visit
Effect of Early Administration of TXA in Adult Hip Fractures

This is a prospective clinical study designed to assess blood loss in intracapsular and extracapsular hip fractures undergoing operative fixation at a Level II trauma center. It is well established in the orthopedic literature that tranexamic acid (TXA) decreases blood loss and need for postoperative blood transfusion in hip fracture patients as well as total joint arthroplasty patients. A typical dosing pattern, and the dosing pattern employed at our institution, is 1 gram IV infused prior to incision followed by 1 gram IV infused at the time of wound closure.


Eligibility Criteria:
Inclusion Criteria:

* 1. All adult (18 years old or older) hip fracture patients presenting with an acute hip fracture and undergoing operative fixation

Exclusion Criteria:

1. Polytrauma patients
2. Previous operation on the ipsilateral hip
3. Patients with coagulopathies (Factor V Leiden, Sickle Cell Anemia, Etc.)
4. Patients with \< 6-month history of thromboembolic event (DVT/PE), Stroke, Cardiac Stents, or Myocardial Infarction (MI)
5. History of seizure disorder
6. Patients on birth control
7. Pregnant Women
8. Prisoners
9. Active thromboembolic disease (DVT/PE, MI, Stroke)
Parkinson's Disease G2019S LRRK2 Genetic Testing Program

Increase awareness of the G2019S LRRK2 mutation in Parkinson's and no cost genetic testing program.

This program is intended to increase awareness of genetic Parkinson's, in particular the G2019S LRRK2 mutation, and provide no cost genetic testing to determine if they carry the G2019S LRRK2 mutation.

Eligibility Criteria:
Participants include those with a clinical diagnosis of Parkinson's, in particular those who have a first- or second-degree relative with Parkinson's, or who have young onset Parkinson's (age less than 50 at diagnosis) or are of Ashkenazi Jewish or North African Berber descent, or have a relative with a known genetic mutation in the LRRK2 gene, or who have a genetic mutation in the LRRK2 gene.

Inclusion Criteria:

Participant eligible for enrollment in the program must meet all of the following criteria:

1. Participant must be a person diagnosed with Parkinson's disease who is 18 years or older.
2. Participant is under the care of a physician for their Parkinson's disease.
3. Participant is able to read, write and understand English, and reside in a country where the shipment of biological samples is allowed.
4. Participant is able to grant informed consent.
5. In the case of participants, willing to participate in a free genetic testing program to determine if they carry the G2019S LRRK2 mutation.
6. Willing to be notified of eligibility for clinical studies (if appropriate).
7. Particpants who already believe they have tested positive for the mutation will be allowed to be retested through this program and be notified of potential eligibility for studies.

Exclusion Criteria:

1. Inability to meet any of the inclusion criteria.
2. Participant has received on of the following advanced treatments to manage their Parkinson's: gene therapy, deep brain stimulation (DBS), injections into the brain, continuous infusion of medication into their stomach/intestines with a pump.
Dexamethasone for Migraine - Dose Comparison

Dexamethasone is an evidence-based treatment of acute migraine. This is a randomized comparison of two different doses of dexamethasone for acute migraine.

All patients will also be treated with metoclopramide.

Investigational medications. Medications in each study arm are as follows:

A. Metoclopramide 10mg IV drip over 15 minutes (for acute treatment)+ dexamethasone 4 mg IV B. Metoclopramide 10mg IV drip over 15 minutes (for acute treatment)+ dexamethasone 16 mg IV Assignment. Will be concealed. The research pharmacist will determine assignment based on a random number sequence. Randomization. Randomization will occur in blocks of 4 based on a random number generator. Blinding. Patients, clinicians, and research personnel will be blinded. Stratification. Subjects will be stratified by study site (Moses or Weiler) and baseline pain intensity (moderate or severe).

Follow-up phone calls will be performed 48 hours and 7 days after ED (emergency department) discharge. At the first call, the next follow-up phone call will be scheduled. Attempts to complete the follow-up calls successfully will be made every eight hours until deemed futile. At this point, questionnaires will be sent by express courier, and failing this, the investigator will perform a home visit.

At the 48-hour phone call, the focus will be assessments of pain, functional status, migraine associated features, adverse events, satisfaction with the medication received, and use of rescue medication. The focus of the seven day phone call will be on the total number of days with headache since ED discharge, the need for repeat ED visits, healthcare providers visited, days of work missed, and adverse medication effects.

Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe migraine

Exclusion Criteria:

* Medication contra-indication
* Concern for secondary cause of headache
A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria

The purpose of this study is to evaluate the efficacy and safety of TAS5315 in chronic spontaneous urticaria patients with an inadequate response to H1-antihistamines

The main purpose of this study is to assess the efficacy of TAS5315 in chronic spontaneous urticaria patients with an inadequate response to H1-antihistamines compared with placebo as measured by the change from baseline in weekly Urticaria Activity Score (UAS7) at week 12

Eligibility Criteria:
Key Inclusion Criteria:

* Aged 18 to 75 years
* Diagnosis of chronic spontaneous urticaria (CSU)
* Presence of itch and hives for at least 6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines for CSU
* UAS7 score ≥ 16 and HSS7 score ≥ 8 during 7 days prior to study entry
* In-clinic UAS ≥ 4 on study entry
* Willing and able to complete and Participate Daily for the duration of the study

Key Exclusion Criteria

* Diseases other than CSU with symptoms of urticaria or angioedema, including urticarial vasculitis, erythema multiforme, mastocytosis, or hereditary or acquired angioedema
* Atopic dermatitis, psoriasis, ichthyosis, or other skin disease associated with chronic itching
* Bleeding diathesis
* Uncontrolled hypertension disease states
* Treatment with omalizumab or other humanized anti-human IgE monoclonal antibody therapies used to treat CSU within 4 months prior to screening
* Nonresponse to omalizumab or other humanized anti-human IgE monoclonal antibody therapies
* Have been treated with other Bruton's Tyrosine Kinase inhibitors
* Pregnant or lactating women