cyrilzakka/clinical-trials huggingface dataset:
Aspirin Effects on Emotional Reactions

The aim of this study is to determine whether the drug aspirin has effects on emotional reactivity, emotional memory, and risk-taking behaviors.

The goal of this study is to determine if aspirin (acetylsalicylic acid) alters emotional reactions to emotion evoking pictures as well as memory for them. Using a double-blind parallel arm study, participants will receive either placebo or a pain-relieving dose of aspirin (500mg). One hour later they will complete 30 minutes of tasks. This will include ratings of emotional pictures and memory for them. The paradigm is similar to previous experiments done in this lab using other cyclooxygenase inhibitors: ibuprofen and acetaminophen (Durso, Luttrell, \& Way, 2015; Psychological Science, https://doi.org/10.1177/0956797615570366). Risk taking on the Balloon Analogue Risk Task will also be assessed. Participants will be healthy young adult males at Ohio State University.

Eligibility Criteria:
Inclusion Criteria:

At least 18 years old and biologically male

Exclusion Criteria:

Due to the use of aspirin in this study, women will be excluded from the study due to potential negative effects it may have on pregnancy

Participants will also be excluded for the following medical reasons:

1. Having an allergy to aspirin, other salicylates, or any other pain reliever/fever reducer.
2. Having or recovering from a viral infection such as the chicken pox or flu.
3. Having taken aspirin or another NSAID drug (aspirin, ibuprofen, naproxen, or others) within the last 8 hours or plan to take aspirin or another NSAID drug in the 8 hours after the end of the study.
4. Having more than three drinks of alcohol in the 8 hours after completion of the study.
5. Having asthma, hay fever, nasal polyps, or chronic respiratory disease.
6. Impaired liver/kidney or impaired cardiovascular circulation (renal vascular disease, congestive heart failure, volume depletion, major surgery, sepsis or major hemorrhagic events)
7. Active or severe liver or kidney disease.
8. An ulcer, history of ulcers or are prone to bleeding.
9. A history of blood clotting defects.
10. Severe anemia.
11. Taking any of the following drugs: A blood thinning anticoagulant (e.g. warfarin), Digoxin, An Angiotensin Converting Enzyme (ACE) Inhibitor, Methotrexate, An oral glucocorticoid (e.g. hydrocortisone),Valproic Acid, A Selective Serotonin Reuptake Inhibitor (SSRI; e.g. Prozac; Zoloft)
12. Have had stomach ulcers or bleeding problems.
13. Have stomach problems such as heartburn, upset stomach, or stomach pain that does not go away or reoccurs.
14. Surgery in the last week or will have a surgery in the next week.
15. High blood pressure.
16. Diabetes, gout, or arthritis.
17. Low uric acid or Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Individual Patient Compassionate Use of Crenolanib

Compassionate use of crenolanib for patients with serious life-threatening illness that have exhausted all available therapies used to treat the disease, with no other viable therapy options, who is not eligible for clinical trials. This program is designed to evaluate the requests on a patient by patient basis.

Patients must have documented evidence of a point mutation in position 842 in platelet derived growth factor receptor alpha (PDGFRA-D842V) or amplification of PDGFRA or internal tandem duplication within the FMS-like tyrosine kinase 3 (FLT3-ITD) or point mutations within the tyrosine kinase domain (TKD) of FLT3 (FLT3-TKD)

This program is being offered on a patient by patient basis while phase 3 studies with crenolanib are ongoing.

Institutional Review Board-/Independent Ethics Committee approval must be granted before, The experimental intervention will be administered over 28-day cycles. Compassionate use of crenolanib will be limited such that it does not interfere with the supply need for phase 3 studies.

There must be adequate understanding of the indication for the requested use.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have a serious life threatening cancer with FLT3/PDGFRa mutation or PDGFRa amplification who has exhausted all other treatment options
* Subject and their partner (if adults) must use 2 forms of contraception during study and for 3 months following last dose of study drug

Exclusion Criteria:

* Subject is eligible for enrollment in an ongoing clinical trial
* Subject has any condition which, in the investigator's opinion makes the subject unsuitable for participation
Naltrexone and Clonidine Combination (ATNC05) in the Treatment of Chronic Back Pain

The study includes back pain of the cervical, thoracic, and the lumbar regions.


Eligibility Criteria:
Inclusion Criteria:

The subject has chronic back pain for \> 3 months in the lumbar, thoracic or cervical regions.

The average pain intensity scale during the screening week is 4/10 - 8/10 (On an 11-point Numeric Pain Intensity Scale with 0 = no pain and 10 = worst pain imaginable).

The subject has not taken Opioid medications 7 days prior to initiation of study drug.

The subject has a heart rate of 60bpm or above and/or systolic blood pressure 90 or above.

The subject is willing to refrain from using NSAIDS, Acetaminophen or muscle relaxants, unless for rescue, for the duration of the study The subject is willing to refrain from using Opioid medications and excessive alcohol for the duration of the study.

The subject is able to read, understand and follow the study instructions, including completion of questionnaires at home.

The subject must sign an informed consent document indicating willingness to participate.

If the subject is a female, she must be post-menopausal, not currently pregnant or nursing. A female of child bearing potential should be using a reliable contraception method during the course of the study.

Exclusion Criteria:

The subject has a positive urine drug screen. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.

The subject has any significant deviations from normal in physical examination, electrocardiogram (ECG), Echocardiogram or clinical laboratory tests, as evaluated by the investigator.

The subject has a history of an allergic reaction to the components of the study drug.

The subject has acute back or cervical pain. The subject has muscular back or cervical pain. The subject has back or cervical pain other than chronic Radicular pain.
Comparing the Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy

The aim of this study is to compare and evaluate the analgesic effects of ultrasound-guided Erector Spinae Plane block using low volumes and high concentrations versus high volumes and low concentrations in patients undergoing MRM.

Multiple regional techniques have been developed in recent years for postoperative analgesia of breast surgery including ESPB aiming to be effective and associated with less complications when compared to the gold standard techniques (thoracic epidural analgesia or paravertebral block)..

Ultrasound guided erector spinae plane (ESPB) block was described in 2016 as a novel regional anesthetic technique for acute and chronic thoracic pain, it has been used as a regional anesthetic technique for breast surgery based on case reports and case series. It is a paraspinal fascial plane block that involves injection of local anesthetic deep in the erector spinae muscle and superficial to the tips of the thoracic transverse processes. The site of injection is distant from the pleura, major blood vessels, and spinal cord; hence, performing the ESPB has relatively few contraindications. The injected local anesthetic drug blocks the ventral and dorsal rami of spinal nerves on the paravertebral area .

Multiple studies have reported improved efficiency of interfascial blocks by increasing the volume of injection promoting better spread of local anesthesia. According to the authors best knowledge there is no studies comparing different volumes and concentration in ESPB in patients undergoing MRM This study aims to see the effect of fixing the drug mass of anaesthetic given in both groups, while altering the concentration of the anesthetic and total volume administered. One group will receive a lower concentration and higher volume, while the other will receive a higher concentration and lower volume.

Eligibility Criteria:
Inclusion Criteria:

Age starting from 18 to 60 years.

* Genders eligible for study: female sex.
* ASA II-III.
* Patients undergoing modified radical mastectomy.
* Body mass index (BMI) from 18.5 to 30 kg/m2.

Exclusion Criteria:

Patient refusal

* Known allergy to local anesthetics
* Bleeding disorders; platelets count \<50,000, prothrombin concentration \<60% or any coagulopathy disorder.
* Use of any anti-coagulants
* Inability to provide informed consent
* ASA IV
* Neurological disorders
* Patient with psychiatric disorders
Resistance Versus Balance Training in Parkinson's Disease

Comparison of resistance training versus balance training to improve postural control in patients with Parkinson's Disease


Eligibility Criteria:
Inclusion Criteria:

* idiopathic Parkinson's Disease, postural instable

Exclusion Criteria:

* cardiopulmonary/metabolic diseases that could interfere with the safe conduct of the study protocol, unstable medication, severe cognitive impairments that do not allow the patients to follow exercise instructions, participation in a resistance or balance training program (beside usual physical therapy), Deep Brain Stimulation.
Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy

Gene therapy is a promising strategy to treat hearing loss and vestibular disorders, and Associated adenovirus (AAV) is shown as a good viral vector for inner ear therapy in animal models.

This study aims to study in vitro viral transduction of AAV in human inner ear cells, collected during non-conservative surgeries for vestibular schwannoma.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* Operative indication for a non-conservative resection of vestibular schwannoma, decided by the surgeon in accordance with the patient
* Informed consent obtained
* Patients with a french social protection (AME excluded)

Exclusion Criteria:

* Intravestibular or intra-cochlear extension of the tumor
* Pregnant woman
* Patient with administrative control
* Medical contra-indication
Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma

Open-label, multicenter, single arm phase II study, set up in collaboration with the "Réseau d'Expertise Français sur les Cancers ORL Rares" (REFCOR), evaluating the activity and safety of single agent pazopanib in recurrent or metastatic tumors in salivary gland including adenoid cystic carcinoma (ACC) and to exploring the activity and safety of pazopanib in non-adenoid cystic carcinoma (non-ACC).

In the non-ACC SGCHN population, assessment of the activity of pazopanib is exploratory without a predetermined study design, with up to 20 patients. A planned interim analysis of acute toxicities was conducted 3 months after the 14th non-ACC inclusion.

ACC As the endpoint will be evaluated at 6 months after treatment start, a one-stage phase II study design was chosen. The unacceptable 6-month rate of progression free survival is 20% and the promising 6-month rate of progression free survival is 40%.

43 patients are to be treated. If ≤12 patients alive without progression at 6 months will be observed, the drug will be declared ineffective.

If ≥13 patients alive without progression at 6 months will be observed, the drug will be declared promising.

The α error rate (accepting a poor treatment) is 0.07 and the β error rate (rejecting a promising treatment) is 0.07.

Analysis of results will be separated between non ACC and ACC.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of recurrent and/or metastatic salivary glands (including ACC and non ACC).
* Progressive disease within 6 months before inclusion as assessed by CT and/or MRI using at least two measurements (RECIST v1.0) with at least one measurable target lesion \>10 mm.
* Recurrent and/or metastatic salivary glands carcinoma failing locoregional therapy, without possibility of curative treatment.
* Patients may have had unlimited prior therapy but must have had at least 4 weeks between any chemotherapy, radiotherapy, surgery and study enrollment.
* Tumoral tissue must be provided for subsequent histological review and biomarker analysis.
* Euthyroid patient.
* Hepatic, renal, cardiac and hematology normal functions.
* Ability to take oral medication.

Exclusion Criteria:

* Non salivary gland carcinoma (lachrymal gland tumor is excluded).
* Known or symptomatic cerebral metastasis.
* Patients treated with strong inhibitor or inductor of CYP3A4 within 14 days before inclusion.
* Presence of uncontrolled infection.
* Diagnosis of any previous malignancy within the last 5 years, except for completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma.
* Stable disease.
* Corrected QT interval (QTc) \>480 msecs using Bazett's formula.
Barrett's Esophagus - 315 - 3 Way Cross-Over

This study looks the intragastric and intraesophageal pH in patients with documented Barrett's esophagus whilst taking esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.


Eligibility Criteria:
Inclusion Criteria:

* Must have a previously established, biopsy-proven diagnosis of Barrett's esophagus with segment length greater than 3cm, with no dysplasia or adenocarcinoma within the previous 12 months

Exclusion Criteria:

* A history of esophageal, gastric, or duodenal surgery, including anti-reflux surgery or endoscopic anti-reflux procedures, except for simple closure of a gastric or duodenal ulcer.
* History of various gastrointestinal diseases - please see investigator for full list.
* Evidence of any malignant disease in the last 5 years, except minor superficial skin disease.
* Unstable diabetes mellitus. Stable on a controlled diet, oral agents or insulin are acceptable.
Gut Microbiota and Metabonomics

To evaluate the correlation between gut microbiota and metabolites in Borrmann type IV gastric cancer; To find the effects of microflora and metabolites on target organs; To detect the mechanism of key flora and metabolite by in vitro and in vivo experiments; To construct models of gut microbiota and metabonomics by machine learning.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who sign informed consent.
2. Borrmann classification of gastric cancer is determined by more than 2 pathologists.
3. Patients with BMI 24-28.
4. Karnofsky (KPS) score \>80.

Exclusion Criteria:

1. Patients who take any aspirin, antibiotics, prebiotics, or probiotics within 4 weeks and steroids or immunosuppressants within 6 months prior to specimen collection.
2. Patients who complicate with other malignant tumors.
3. Patients who complicate with diabetes, hypertension, heart disease and infectious diseases.
4. Patients who complicate with inflammatory bowel disease or irritable bowel syndrome.
5. Patients with metastasis.
Thoracoscopy Versus Fibrinolysis in Children With Empyema

The null hypothesis is that patients receiving either thoracoscopy or fibrinolysis for empyema recover in the same amount of time. Therefore, we will test this by randomizing the next 40 patients who consent to the study to one treatment or the other.

This will be a single institution, prospective, randomized clinical trial involving patients who are found to have at least a single septation within a pleural effusion as diagnosed by ultrasound or computed tomography. Additionally, patients with a pleural effusion wherein a pleural tap reveals pus as defined by many (\> 10,000/mm3 ) white blood cells or positive cultures will be considered. This is intended to be a definitive study.

Power calculations based on the known 4.8 post intervention hospital days after VATS and the estimated 7 post intervention days after fibrinolysis with α = 0.05 and power of 0.8 show the need for 18 patients in each arm. We will intend to recruit 40. This sample size was constructed in consultation with Dr. Steve Simon, and the range of hospital stay in our retrospective experience was utilized. Therefore, this number should represent an adequate power in spite of the known varied level of illness.

One group will undergo thoracoscopy to clean the pleural space and leave a chest tube postoperatively to drainage. The other group will undergo chest tube placement with subsequent infusion of fibrinolytics to dissolve the thick purulent material allowing drainage.

Both groups will have the same antibiotic regimen with the same management algorithm.

Eligibility Criteria:
Inclusion Criteria:

* Patients less than 18 years of age requiring an intervention for empyema by one of the following:

  1. Septation or loculation seen on ultrasound or computed tomography
  2. Many white blood cells, bacteria present, or thick viscid purulence identified on pleural tap

Exclusion Criteria:

1. Immunodeficiency process
2. Secondary diagnosis or condition that will keep them in the hospital beyond the empyema
3. Existing contraindications to VATS or chest tube.
Letrozole and Misoprostol for Termination of Pregnancy up to 63 Days' Gestation

Study to determine if a user-friendly medical abortion regimen using letrozole and misoprostol is safe and acceptable.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy ≤ 63 days gestational age by ultrasound seeking termination of pregnancy
* Pregnancy visible on ultrasound
* Speaks English or Spanish
* Willing and able to return for follow-up appointment

Exclusion Criteria:

* People with gestations \> 63 days gestational age
* Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
* Pregnancy of unknown location
* IUD or contraceptive implant in place
* History of allergy to letrozole or misoprostol
* Unable to return for clinic-based follow-up
* Currently breastfeeding
* Twin or multiple pregnancy
* History of liver disease or abnormal liver function
Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients

The aim of present study is to evaluate if the addition of Aprepitant to multiple doses of palonosetron IV enhances the efficacy of multiple doses of palonosetron IV alone, in preventing CINV in AML or High risk MDS patient, treated with multiple days chemotherapy.

This is an open-label, randomized, comparative, multicenter phase II study in patients with AML scheduled to receive multiple days chemotherapy.

Patients will receive either PALO+APR or the PALO regimen in a 1:1 ratio according to a computer-generated, random allocation schedule. Below are described the details for both antiemetic regimens:

PALO+APR regimen: oral aprepitant will be given on days 1-3 (day 1, 125 mg, days 2-3, 80 mg 1 hour before chemotherapy ) and multiple intravenous bolus of Palonosetron without dexamethasone, prior to the administration of chemotherapy, starting the first day of treatment.

PALO regimen: multiple intravenous bolus of Palonosetron without dexamethasone, prior to the administration of chemotherapy, starting the first day of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Acute Myeloid Leukaemia or High-risk MDS according to IPSS
* Patient eligible for AML-like induction therapy
* Candidate for multiple-days chemotherapy (minimum 3 days)
* Age more, equal18 years
* ECOG 0-2
* Not pregnant or nursing
* Must be able to complete the patient's diary
* Provide written informed consent

Exclusion Criteria:

* AML or HR-MDS therapy-related
* Active infection requiring intravenous antibiotics
* Prior malignancies at other sites except surgically treated non-melanoma skin cancer, prostate cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for more/equal 5 years
* Unacceptable hepatic function (more of 2 times the upper limit of normal for liver transaminases) and renal function (creatinine more of 1.5 times the upper limit of normal) unless disease-related
* Myocardial infarction within the past 6 months
* Psychiatric or CNS disorders interfering with ability to comply with study protocol
* Known hypersensitivity to 5-HT3 antagonists and their components CSF involvement
* Pre-existing nausea or vomiting
TELSYS - TELmisartan Effectiveness in Isolated SYStolic Hypertension Versus Systolic/Diastolic Hypertension Patients Aged 55 or Older

The aim of this study is to compare the effect of treatment with telmisartan on patients in whom the systolic BP is approximately 12 weeks after starting treatment under control for the first time between patients with isolated systolic hypertension (ISH) at the beginning to patients with systolic/diastolic hypertension (SDH)


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 55, with no upper limit
* Patient who has been treated and followed up for more than 12 months by the same general practitioner (GP)
* Hypertension measured at least once during the past 12 months and not under control at the time of inclusion in the study:

  * isolated systolic hypertension, namely systolic blood pressure ≥ 140 mmHg and diastolic blood pressure \< 90 mmHg or
  * systolic/diastolic hypertension, namely systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg; or
  * systolic blood pressure ≥ 130 and diastolic blood pressure ≥ 80 mmHg, if the patient has diabetes or chronic renal insufficiency
* Treatment with one or more antihypertensives which remains unchanged during the month prior to collecting the data
* Decision by the GP to add telmisartan (either in combination with hydrochlorothiazide (HCTZ) or not) to the antihypertensive treatment; this decision is made by the treating doctor regardless of participation in the study. The prescription is issued in the normal way, in accordance with the conditions set down in the marketing authorisation
* Written informed consent of the patient to collect his/her data

Exclusion Criteria:

* The patient refuses to allow his/her data to be collected
* Change in the antihypertensive treatment during the month prior to collection of the data
* Blood pressure under control
* The recommended target values corresponding to control of diastolic and systolic blood pressure are important because of the diseases associated with hypertension consequently, and in order to prevent the collection process becoming too complicated, data from patients with severe renal insufficiency or with proteinuria of ≥ 1 g/L or more are not collected in the context of this study