cyrilzakka/clinical-trials huggingface dataset:
Radiosurgical Hypophysectomy for Bone Metasteses Pain

This research is being done to see if a delivery of a single high dose of radiation therapy to a small area of the pituitary gland and pituitary stalk in a highly precise manner may be helpful in reducing intractable pain from bone metastases.

Although not currently standard of care, small series suggest both safety and efficacy of radiosurgical hypophysectomy in reducing cancer pain from bone metastases. In spite of the demonstrated feasibility in meeting normal tissue constraints and preliminary data suggestive of both safety and efficacy, radiosurgical hypophysectomy is rarely performed in clinical practice, and many radiation oncologists are not even aware of its potential to reduce intractable cancer pain. This is likely because, to date, well-designed prospective studies have not been performed to further explore both the safety and efficacy of the intervention. This single arm pilot study is designed to fill that void. If successful, the investigators plan to utilize the data to support the proposal of a larger scale follow-up clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. Cytologic proof of malignancy
2. Radiographic evidence of bone metastases
3. Intractable pain uncontrolled by opioids, medical management, injections/ablation or surgical intervention that would be difficult to address with conventional radiation therapy or other standard options and is limiting the patient's function and quality of life. Intractable pain will be defined as a visual analogue score of at least 4.
4. Definitive radiographic progression of osseous and/or visceral metastases on standard staging scans (CT, MRI, bone scan, PET scan or any other standard of care imaging) performed within the last 3 months in spite of standard oncologic interventions and/or inability to tolerate standard oncologic interventions
5. Life expectancy at least 4 weeks
6. Age≥ 18 years
7. Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child
8. Patient must have the ability to understand and the willingness to sign a written informed consent document
9. All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

1. Prior brain radiation
2. Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician prevent informed consent or completion of protocol treatment
3. Isolated localized pain amenable to focal radiation therapy, or pain well controlled by opioids, medical management, injections/ablation or surgical intervention
4. Malignancies being managed with curative intent
5. Life expectancy \<4 weeks
6. The tumor amenable to curative management
Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia

Tardive dyskinesia (TD) is a disabling, embarrassing and often irreversible iatrogenic movement disorder that can occur in anyone exposed to drugs that block dopamine receptors, including first and second generation antipsychotics and antiemetic agents. There is no way to prevent TD except preventing exposure to the inciting agents and there are no approved symptomatic therapies. Propranolol is an FDA-approved β-blocker with limited data supporting its use as a treatment for TD.

The goal of this study is to determine the efficacy of propranolol in the treatment of TD in a double-blind, cross-over prospective manner. If propranolol is found to be an effective therapy, it will fulfill a great need in the treatment of TD with a medication that is known to be safe and inexpensive.

Tardive dyskinesia (TD) is a disabling, embarrassing and often irreversible iatrogenic movement disorder that can occur in anyone exposed to drugs that block dopamine receptors, including first and second generation antipsychotics and antiemetic agents. There is no way to prevent TD except preventing exposure to the inciting agents and there are no approved symptomatic therapies. Propranolol is an FDA-approved β-blocker with limited data supporting its use as a treatment for TD.

The goal of this study is to determine the efficacy of propranolol in the treatment of TD in a double-blind, cross-over prospective manner. Patients with a diagnosis of TD will be randomized to propranolol or identical placebo. The patients will be treated for eight weeks, complete a one week washout and then crossed over for another eight weeks. Hence, the subjects will be their own controls. Participation in this pilot trial will provide placebo controlled blinded data that will assist in planning a larger phase II trial. If propranolol is found to be an effective therapy, it will fulfill a great need in the treatment of TD with a medication that is known to be safe and inexpensive.

Eligibility Criteria:
Inclusion Criteria:

* age 18-75 years
* diagnosis of classical TD by a movement disorder expert for at least 6 months with a baseline score of at least 2 on two of the seven items on the AIMS severity scale
* stable on medication (either on or off dopamine blocking agents) for at least six months.

Exclusion Criteria:

* breastfeeding
* pregnant
* unstable psychiatric disease
* history of asthma or COPD
* baseline heart rate less than 60
* history of orthostatic hypertension or its presence at screening
* history of congestive heart failure or unstable angina pectoris
* resting SBP \<100 and DBP \< 60
* AV-block II or III without pacemaker
* history of diabetes mellitus
* previous adverse effects from use of beta-blockers
* current use of a β-blocker and the other following drugs: quinidine, amiodarone, propafenone, digoxin, verapamil, diltiazem, clonidine, and warfarin
* tremor, dystonia, akathisia or other non-tardive movement disorder
* any medical illness that precludes treatment with propranolol.
Paullinia Cupana for Anorexia in Oncologic Patients

Denutrition, lost of weight and anorexia are present in many oncologic patients at any time of the disease. Anorexia is the spontaneous loss of appetite and many changes in the metabolism are made in this case, leading to this syndrome called anorexia-cachexia, that includes changes in the tumoral response and inflammatory pathways. The guaraná (Paullinia cupana) is originally from Brazil and Venezuela and has been used culturally for headaches, muscle pains, depression and others. As it has shown a good response and tolerability for fatigue, the investigators decide to try guaraná for anorexia. Patients will receive guaraná as capsules of 50 mg twice daily, for 4 weeks, and will be weighted and respond questionaries about quality of life.

Patients 18 years and older, diagnosed with any cancer, that is losing weight and have anorexia will be selected. They must have normal levels of creatinine, thyroid evaluation and hepatic function. If they are taking corticosteroid, they must keep losing weight and refer anorexia, as well as if they are on treatment with chemotherapy.

Patients will receive 50mg of the guaraná twice daily for 4 weeks. Every week will be an evaluation of the weight, level of appetite and answer 2 questionaries of quality of life and level of symptoms (FACT-G and MDASI).

This is a fase II study, open-label, no randomized, with two steps following ¨two stages of Simon¨ model. First step 18 patients will be included and if there are 3 good responses second step will follow, including 17 more patients. Response will be considered if there is at least 5% of gain in the weight.

Eligibility Criteria:
Inclusion Criteria:

* adults (18 years old and older)
* palliative care or oncologic treatment
* loss of weight
* anorexia

Exclusion Criteria:

* gastrointestinal obstruction
* blood pressure not controlled
* diabetes not treated
Brain STimulation for ANxiety and Depression in Youth

In this open-label trial, the overall aim is to determine if TMS treatment can improve anxiety and depression in a broad group of children and youth referred by physicians.

The literature suggests the peak age of mental disorder onset within the general global population is 14.5 years; a recent meta-analysis of 192 epidemiological studies also reported approximately 83% of individuals with neurodevelopmental disorders experienced onset by the age of 18 years. Further, approximately 52% of individuals with anxiety or fear-related disorders, 48% with feeding or eating disorders or problems, 45% with obsessive-compulsive or related disorders, 28% with stress disorders, and 12% with mood disorders experienced onset by the age of 18 years. This high prevalence of mental disorders within the child and youth population is contributing to the need to explore additional treatment opportunities.

Interventions for mental disorders commonly include psycho-social and pharmacological approaches, though these therapies are largely modelled after adult populations. However, pharmacotherapy may be accompanied by side-effects, and adverse experiences with psychotropic medications at a young age may contribute to poor long-term adherence to other psychiatric therapies. Another proposed intervention strategy for mental disorders involves non-invasive brain stimulation, including transcranial magnetic stimulation (TMS). TMS can be used to measure neurophysiology or a cortical area or be used to elicit changes in neural population activation with the use of repetitive TMS (rTMS) or theta-burst stimulation (TBS). Both TMS and TBS have been well-tolerated in children, with only mild transient side effects noted, and has been approved for use in adolescents by the FDA. This study will evaluate the feasibility and acceptability of TMS in a broad group of referred children and adolescents.

Eligibility Criteria:
Inclusion Criteria:

1. aged between 6 and 18 years old;
2. diagnosis of anxiety or depression made by a qualified medical professional.

Exclusion Criteria:

1. status epilepticus in past 12-months;
2. presence of any disease, medical condition, or physical condition that, in the opinion of the study investigator may compromise, interfere, limit, affect, or reduce the participant's ability to complete the study;
3. hospitalization for suicide attempt within the past 3 months;
4. TMS-related contraindications, including implanted medical devices (e.g., pacemaker), metallic implants excluding non-ferromagnetic metals (e.g., metal dental wires), current pregnancy;
5. if actively taking prescription medication, no changes in medication for at least 3 months prior to entry into the study, with no anticipation of change in the frequency or dose over the duration of the study, unless changes to medication are required for participant safety;
6. unable to understand instructions in English.
A Randomised, Parallel-group, Double-blind, Double-dummy Study to Compare the Effects of Lacidipine Versus Bendrofluazide on Markers of Platelet Activation and Haemorheological Factors in Hypertensive Patients

The aim of this study is to compare the effects of lacidipine on markers of platelet activation and other rheological factors in hypertensive patients with those of bendrofluazide


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* Hypertensive at screening: Diastolic blood pressure (DBP) 95 - 115 mm Hg and / or systolic blood pressure (SBP) \>= 160 mm Hg on no therapy or on monotherapy. If currently on monotherapy, DBP could have been \< 95 mm Hg and SBP \< 160 mm Hg, but the patient must have been experiencing unacceptable side effects from their current treatment. Patient must then be able to stop treatment for the placebo run in phase of four weeks without endangering their health (at investigator's discretion)
* Hypertensive at randomisation: DBP 95-115 mm Hg and or SBP \>=160
* Able to give written informed consent

Exclusion Criteria:

* Grad III or grad IV hypertensive retinopathy
* Renal impairment; serum creatinine \> 150 µmol/L
* Heart failure. (New York Heart Association (NYHA) Class III or IV)
* Liver impairment (abnormal Liver function test (LFT) with aspartate-amino transferase (AST) / alanine-amino transferase (ALT) \> 2x upper normal limit or bilirubin \> 2x upper normal limit)
* Recent (\< 2 months) history of unstable angina
* Recent (\< 2 months) history of myocardial infarction
* Recent (\< 2 months) history of stroke
* History of diabetes mellitus or impaired glucose tolerance or random blood glucose \>= 9 mMol/L
* Any acute systemic illness or infection
* Any severe disease which could interfere with survival or well-being during the study (e.g. malignancy)
* Patients of child bearing potential
* Current or previous drug and / or alcohol abuse
* Severely limited venous access
* Haemoglobin \< 10g/dL (male patients), haemoglobin \< 9g/dL (female patients)
* Requirement for anticoagulant therapy
* Severe valvular heart disease (investigator's discretion)
* Atrial fibrillation or other serious cardiac dysrhythmia
* History of thyroid disease or abnormal thyroid function test (thyroid stimulating hormone (TSH) \< 0.4 mU/L or \> 5.4 mU/L)
* History of connective tissue disorder
* Concurrent participation in any other clinical trial or participation within two months enrolment
* Requirement for restricted drugs
* Patients currently on treatment with lacidipine or bendrofluazide (BNFZ)
* Patients unable to attend clinics
* Any clinical condition which in the opinion of the investigator, would preclude the safe fulfillment of the protocol and the safe administration of trial medication
* Seated blood pressure (BP) exceeding either 210 mm Hg (systolic) or 115 mm Hg (diastolic) at screening or randomization
* Standing BP \< 140 mm Hg (systolic) and \< 95 mm Hg (diastolic) at randomization
Comparison Between Internal and External Chest Impedance Measurement

To compare two methods of chest impedance: the Medtronics Optivol Measurement via CRT pacemakers for patients with heart failure and external non-invasive measurement


Eligibility Criteria:
Inclusion Criteria:

* CRT-implanted patients with heart failure

Exclusion Criteria:

* All others
rFVIII-Fc (Produced by AryoGen Pharmed Co.) Pharmacokinetic Study

The study is designed as a randomized, two-armed, double-blind, single-dose, crossover, two-sequence, active-controlled, multi-center, bioequivalence clinical trial with a primary endpoint of dose-normalized area under the curve (dnAUC last)


Eligibility Criteria:
Inclusion Criteria:

* Male patients ≥ 12 years, with signed informed consent by the patient, or the patient's legally authorized representative for patients under the legal age
* Diagnosed with severe hemophilia A (endogenous FVIII \<1% \[1 IU/dL\])
* History of at least 150 documented prior exposure days to any FVIII product
* Having adequate bone marrow and organ function:

  * Plt ≥ 80,000 cells/µL
  * Hb ≥ 8 mg/dL
  * eGFR ≥ 30 mL/min
  * ALT or AST ≤ 5×ULN
  * Serum bilirubin ≤ 1.5×ULN

Exclusion Criteria:

* Measurable anti-drug antibody activity against FVIII (≥ 0.6 BU/mL) at screening or a history of developing anti FVIII antibody
* History of other coagulation disorders except for hemophilia A
* Acute hemorrhagic state
* Infection with HCV or HBV
* HIV-positive patients
* Infusion of any products containing FVIII within 7 days prior to first administration
* Previous treatment with commercially available extended half-life FVIII products
* Receiving drugs which increase bleeding tendency (e.g: Anti-coagulants, antiplatelets, omega 3, Vit E, etc.) within 2 weeks of screening. NSAIDs are permitted.
* Current systemic treatment with immunosuppressive drugs
* Hypersensitivity or anaphylaxis associated with any FVIII concentrate or intravenous immunoglobulin (IVIG)
* Planned elective surgery
* Current enrolment or willing to enroll in any other experimental study during the time of current trial
* Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol (e.g.: physical, psychological and mental problems)
Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma

Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery.

Enrolled subjects will undergo to 3 cycles of Folfirinox before re-evaluation of the lesion. Then, 4D planning and imaging with respiratory gating end rescanning technique will be adopted to calculate the optimal treatment plan to carbon ions radiation therapy: 38.4 Gy\[RBE\] is the prescribed dose to CTV. 4.8 Gy\[RBE\]/fraction will be delivered 4 times a week in two weeks. 4/6 weeks after hadrontherapy, after a CT scan with contrast, patient will undergo to a surgery. After 4/6 weeks, Gemcitabine will be administered for 6 cycles.

Secondary endpoints of the trial are overall survival, resectability rate (operable vs borderline operable), acute toxicity within 3 months, 3-6 months, over 6 months.

Eligibility Criteria:
Inclusion Criteria:

* histologic/cytologic diagnosis of exocrine pancreas tumour
* resectable or borderline resectable exocrine pancreatic tumour (according to operability criteria)
* no metastasis from US, CT, PET, MRI or laparotomy
* Karnofsky index \>= 70
* stomach and duodenum not infiltrated by tumour
* given informed consent to study procedures
* Hb \> 9 g/dL, N\> 1500, PLT\> 100000
* creatininemia \< 1.5 mg/dL; bilirubinemia \< 1.5 times upper normal values; albumin \> 3 g/dL
* DPD normal activity
* contraception required and breast feeding not permitted

Exclusion Criteria:

* non resectable, locally advanced tumours
* insular cells tumour
* comorbidities excluding abdominal surgery and/or chemo- radiation therapy
* known metastasis
* DPD low activity
* inability to attend study procedures and follow ups
* pregnancy
* previous diagnosis of other tumour with more disadvantageous prognosis then the study object
* metallic biliary stent
* metallic prothesis or any other condition to prevent from target volume individuation and dose calculation
* clinical condition preventing from radiation therapy (i.e. infections in the irradiation area)
* medical and/or psychical condition preventing from radiation therapy
* past radiation therapy on abdomen.
Sphenopalatine Ganglion Blockade in Migraine

Migraine is a fairly common disease that is a leading cause of disability worldwide. 15% of the general population suffer from migraine headaches. Although there are currently many options for the treatment of acute migraine, these treatment options, such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDS), triptans, combinations analgesics and antiemetics, have insufficient efficacy and significant side effects. Therefore, there is a need for new treatment modalities in migraine. Sphenopalatine ganglion (SPG) block is gaining interest as an effective treatment for migraine, other headaches and facial pain syndromes.

In our study, we aimed to block the Sphenopalatine ganglion with a local anesthetic drug and compare it with the placebo control group.

Between 1 May and 1 December 2021, 50 patients aged 18-50 years, who were diagnosed with episodic migraine according to ICD III criteria, who applied to the headache outpatient clinic of Afyonkarahisar Health Sciences University Medical Faculty Hospital, are planned to be included in the study. Patients with similar age, gender and disease duration will be randomly divided into 2 groups using the closed envelope method. Demographic information of the patients, chronic disease history, medications used, and duration of disease will be questioned. Before the treatment, the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain will be questioned. VAS (visual analog scale) is a scale that evaluates the severity of pain. This scale consists of numerical values between 0 and 10. 0 is considered no pain, and 10 is considered the most severe pain. Routine attack treatment of the patients will continue. Injection into the sphenopalatine ganglion of the patients in both groups will be made by entering the arcus zygomaticum and oriented at a 45 degree angle towards the opposite tooth. Injections will be made with a dental injector. The first group will be injected with 4ml of 1% lidocaine, and the second group will be injected with 4ml of 0.9% saline. Injections will be repeated weekly for the first 4 weeks, then monthly. At the end of the 1st and 3rd months of the treatment, the patients will be evaluated in the routine outpatient clinic control, and the two groups will be compared statistically by questioning the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of episodic migraine (according to ICD-III)
* Receiving any prophylaxis treatment in the last 3 months,

Exclusion Criteria:

* Being pregnant and lactating
* Neurological and psychiatric conditions (
* Contraindications to the use of local anesthetics
* Other chronic painful conditions,
* Having a history of malignancy
Study of People's Profile Living in France Who Could be Interested in the Use of a Nanohydroxyapatite Toothpaste

Nano-hydroxyapatite is an interesting candidate to be a substitute for fluor in toothpastes or a complement to fluorides in order to prevent caries. The objective of this transversal descriptive study is to evaluate the profiles of people living in France who could be interested in using a nano-hydroxyapatite based toothpaste.

Participants in this transversal descriptive study have been chosen by a self-administered method. Before answering 16 questions, the participants were asked to watch a short video describing the main concepts to know about fluoridated toothpastes and nano-hydoxyapatite toothpastes. Pros and cons of each one them were mentioned. In order to compare the answers, pivot tables have been produced.


Eligibility Criteria:
Inclusion criteria:

* Internet acces
* Interested in the Use of a Nanohydroxyapatite Toothpaste

Exclusion criteria:

* Age \< 18 years
* Peoples who no lives in France
Stress and Recovery in Frontline COVID-19 Workers

The novel coronavirus (COVID-19) pandemic has caused an unprecedented stress on healthcare systems in affected countries, and in particular, on the healthcare workers at the frontline working directly with COVID-19 positive patients. Numerous lines of evidence support the damaging impact of stress on our immune systems which increases susceptibility to infection. Yet, the accurate measurement of immediate stress responses in real time and in naturalistic settings has so far been a challenge, limiting our understanding of how different facets of acute or sustained stress increases susceptibility. This study utilizes wearable technologies including an Oura smart ring as well as semi-continuous passive and active biometric measurements carried out using individuals' own smartphones equipped with applications to track and transmit key data to measure frontline workers stress and recovery during a uniquely stressful and high-risk work environment.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare workers working directly with COVID-19 patients, or whose work routines have been shifted from COVID-19
* Age over 18 years
* Able to speak, write and read English, given the app will be available only in English
* Able to provide informed consent
* Have a personal IOS mobile phone (OS11 and above).
* Own a personal wearable device including a Fitbit, Garmin, or Oura ring (BYOD arm only)

Exclusion Criteria:

- Prior COVID-19 infection