cyrilzakka/clinical-trials huggingface dataset:
The Roles of Hilotherapy in the Management of Epistaxis and Nasal Fractures

The Investigators aimed to assess primarily whether or not Hilotherapy masks are a tolerable treatment for the conservative management of epistaxis and nasal fractures.

Participants who had ongoing epistaxis and met the inclusion criteria where enrolled in the pilot study . Bleeding severity was not recorded. All participants enrolled were clinically stable with active epistaxis. Participants who were unstable or were ineligible were not referred to the recruiting doctors by A\&E triage. Following informed consent the Hilotherm mask was fitted for an initial period of 20 minutes. If the bleeding had improved or stopped following 20 minutes of treatment the Hilotherm mask remained fitted for a 20 further minutes . A subjective decision was made by the supervising doctor and the participant to whether the flow of epistaxis had improved after the initial 20 minutes of hilotherapy.

The mask was removed if there was no improvement after the initial 20 minutes of hilotherapy, 40 minutes of total hilotherapy treatment, participant preference, worsening observations or profuse bleeding. Participants received conventional epistaxis management simultaneously, this involved continued nasal pressure application during hilotherapy. Following hilotherapy if epistaxis continued then either nasal cauterisation or packing was performed. Participants who were packed cessation of epistaxis was determined at the time of packing if bleeding had ceased. Bleeding time was accurately assessed by the recruiting doctor from the time of hilotherm mask application to the time of complete epistaxis cessation. All of the participants were treated in the sitting position.

Participants were free to withdraw from the trial at any time and no further data was analysed from the individual. Clinicians recorded anticoagulant and antiplatelet use, duration of bleeding and patient demographics. All participants completed a questionnaire following their hilotherapy treatment independantly.

A similar protocol was devised for nasal fractures.

Eligibility Criteria:
Inclusion Criteria:

* presenting to ED with epistaxis or nasal fractures ( over 18 years)

Exclusion Criteria:

* laceration around site of mask, reduced GCS, concurrent head injury, systemic shock
Drug Interactions Between Echinacea Purpurea and Etravirine

The purpose of this clinical trial is to characterize drug interactions between one medicinal herb: Echinacea purpurea and the protease inhibitor etravirine.

Because of its CYP3A4 inducer activity in the liver but its inhibitor effect at the intestinal site, concomitant administration of Equinacea purpurea (a medicinal herb frequently used by HIV-infected patients) and etravirine (an HIV reverse transcriptase inhibitor) might result in clinically relevant pharmacokinetic drug interactions.

15 HIV-infected patients on stable antiretroviral therapy including etravirine at the dosage of 200 mg twice daily during at least 4 weeks will be enrolled. After their inclusion in the study, patients will receive Echinacea purpurea root (500 mg every 8 hours) in addition to their antiretroviral treatment, from day 1 until two weeks later (day 14). On days 0 and 14, blood samples will be drawn immediately before and 1, 2, 4, 6, 8, 10 and 12 hours after the administration of an etravirine dose, and etravirine concentrations in plasma will be determined by high performance liquid chromatography using a validated method.

Eligibility Criteria:
Inclusion criteria:

1. Patients infected with HIV-1 (at least one documented positive Western-Blot).
2. Age 18 years or more.
3. Patients receiving antiretroviral therapy including etravirine at the approved dose of 200 mg twice daily for at least 4 weeks
4. HIV viral load in plasma \<50 copies / mL
5. Absence of acute infections and / or tumors in the three months prior to inclusion.
6. Subject able to follow the treatment period, without suspicion of poor adherence in previous antiretroviral treatments.
7. Voluntary written informed consent.

Exclusion criteria:

1. Any clinical or historical observation that could interfere with the pharmacokinetics of medications, such as gastrointestinal illness or surgery (except for herniotomy and appendectomy), changes in the composition of plasma proteins, some indication of hepatic or renal dysfunction.
2. Antiretroviral regimen including drugs ritonavir or atazanavir (CYP3A4 inhibitors)
3. Concomitant treatment with drugs inductors of CYP3A4 (rifampicin, fenitoin, carbamazepin, ...)
4. Active alcohol consumption (\> 50 g / day) or illicit drugs (except cannabis).
5. Pregnancy or lactation
A Double Blind Crossover Study on the Effect of MPH on Decision-making Ability of Adults With BPD Compared to Adults With ADHD and Healthy Adults

The study assesses the effect of Ritalin on working memory,attention,and decision-making measures in adults with BPD and compares it to its effect on healthy adults and adults with BPD (using data form study SHA 01-10), in a double-blind crossover design. The investigators hypothesize that Ritalin will result in better performance in all measures.

Participants will be required to arrive at the cognitive laboratory in "Shalvata" for two visits: the first visit will include obtaining informed consent, screening (as detailed below), and performing a battery of computerized tasks. The second visit will include performing of the same battery of tasks, and payment.

In one of the visits, participants will receive a capsule containing Methylphenidate or placebo (MPH; Ritalin) (dosage: 10 mg in case weight\<40 kg; 30 mg in case weight\>90 kg; otherwise 20 mg -( The pills will be 10mg each, and the number of pills will be administered according to the dosage stated; 1-3 pills, according to weight). Prior to performing the tasks, and in the other visit they will receive a capsule containing placebo.

Eligibility Criteria:
Inclusion Criteria:

* Adults in the age of 21-50 with diagnosed with Borderline Personality Disorder (BPD)

Exclusion Criteria:

* People diagnosed with a clinical disorder other than BPD or ADD/ADHD that may impair their performance in the tasks used in the study.
* People for whom there is a contra-indication for consuming Ritalin.
* Pregnant women and nursing women; Women participants will be required to report whether they are pregnant, and in case they are, they will not participate.
A Trial of Traffic Light Labeling With Behavioral Nudges and a Healthy Recipe Database to Increase Selection of Healthier Foods in Client-choice Food Pantries

This study is a pilot evaluation of the Healthy Pantry Program, a new behavioral economics-based training that allows pantry staff to learn how to implement nudges integrating traffic-light nutrition labeling and a healthy recipe database in the pantry environment. The hypothesis is that participation the Healthy Pantry Program will lead to increases in pantry purchases of healthy foods.

Food insecurity affects more than one in 10 Americans and is associated with poor nutrition and adverse health outcomes, including diabetes, hypertension, and mental health issues. Many food-insecure individuals use food pantries, which provide charitable food, to supplement household food needs. The emergence of client-choice food pantries, where individuals can select the foods they take home, provides a novel opportunity to intervene on the diets of food pantry clients.

This study evaluates the Healthy Pantry Program (HPP) in a sample of 10 food pantries in the greater Boston area. Pantries will be matched on baseline characteristics and randomized 1:1 into participation in HPP (intervention) or wait list (control). Outcomes data will be collected at the pantry and client level. The aims of the study are as follows:

Aim 1: To evaluate whether HPP is associated with increased healthy food purchases from the food bank by intervention food pantries compared to control food pantries.

Aim 2: To evaluate whether HPP is associated with increases in the availability of healthy food in intervention food pantries compared to control food pantries.

Aim 3: To evaluate whether HPP is associated with an increase in healthy food selection and dietary intake by clients of intervention food pantries compared to clients of control food pantries, using a cross-sectional sample of 400 food pantry clients at baseline and 400 food pantry clients at 6-month follow up.

Eligibility Criteria:
Pantry Inclusion Criteria:

* maximum client-choice (clients can choose all items that they take from pantry)
* operate at least once weekly
* affiliated with the Greater Boston Food Bank

Pantry Exclusion Criteria:

* not affiliated with the Greater Boston Food Bank
* operating less than once weekly
* not a maximum client-choice food pantry
* \>1 hr drive from Boston
* \<50 clients on average per open day

Client Inclusion Criteria (for cross-sectional surveys at baseline and 6-month follow up):

* ≥18 years old
* pantry client
* speaks English or Spanish

Client Exclusion Criteria:

* \<18 years old
* does not speak English or Spanish
Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's Disease

The dopamine agonists, pramipexole (Mirapex) and ropinirole (Requip), are drugs that are used to treat symptoms of Parkinson's disease. However, these drugs can induce bothersome leg swelling or edema in about 20 percent of patients. The cause of this edema is unknown but may be secondary to stimulation of peripheral dopamine receptors in the kidney or blood vessels. We hypothesise that a peripherally acting dopamine receptor antagonist, will reduce edema in PD patients. This study will assess the effect of the peripheral acting dopamine D2 receptor antagonist, domperidone as a potential treatment for dopamine agonist-induced leg swelling.

The study is a phase II, randomised double-blind, placebo-controlled, cross-over trial. There are four periods: recruitment and randomisation; treatment period one (4 weeks); washout (1 week); and finally treatment period two (4 weeks). Patients will be randomly assigned domperidone 20 mg tid in treatment period one followed by placebo tid in treatment period two, or placebo tid in treatment period one followed by domperidone 20 mg tid in treatment period two.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic PD
* On a stable medication regimen for at least one month with leg edema occurring after the start of pramipexole or ropinirole and the absence of other possible reasons for discontinuation of pramipexole or ropinirole treatment (e.g. other adverse effects).

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Women of child bearing age not using a reliable method of contraception
* Coronary disease, abnormal QT interval on electrocardiogram (EKG)
* Diabetes mellitus
* Hepatic disease
* Alcohol abuse
* Renal disease
* Edema of one leg only
* Presence of other conditions possibly causing leg edema
Multicenter Validation of the PREDICT Score

Even after adequate TME with grade III mesorectal grading, local recurrence remains a possible event. Several studies investigated different parameters and assessed their predictive power in regards to local recurrence after TME. These parameters included a variety of patient-related, tumor-related, and treatment-related factors. A recent meta-analysis reviewed the current literature for the predictors of local recurrence after TME for rectal cancer and developed a prognostic scoring system, the PREDICT score.

The present study aimed to validate the PREDICT scoring system by applying it to a prospective cohort of patients with rectal cancer who underwent curative TME in three


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of either sex with non-metastatic low or middle rectal cancer who underwent elective TME with curative intent

Exclusion Criteria:

* Patients with recurrent or metastatic rectal cancer at the time of presentation
* Patients with synchronous colon cancer
* Patients with missing data on the outcome of TME.
A Phase I, Randomized, Open-label, Cross-over, Pharmacokinetic Study of Genasense With and Without Dacarbazine

This clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics of dacarbazine(DTIC) when administered in combination with Genasense


Eligibility Criteria:
Inclusion Criteria:

* Metastatic Stage IV disease, or Stage III disease that is not surgically resectable
* ECOG Performance Status of 0, 1, or 2
* Life expectancy of at least 12 weeks
* Adequate venous access
* Agreement to practice effective method of birth control

Exclusion Criteria:

* Less than 3 weeks of recovery from prior major surgery or other therapy, including radiation therapy, chemotherapy, or immunotherapy, or cytokine, biologic, or vaccine therapy
* Significant medical disease
* Known hypersensitivity to phosphorothioate-containing oligonucleotides
* Known hypersensitivity to DTIC
* Pregnancy/Lactation
Blue Blockers at Night and Insomnia Symptoms

Under entrained conditions, humans maintain a consolidated nocturnal sleep episode that coincides with environmental darkness and endogenous melatonin secretion. Various factors, such as artificial light, can compromise this temporal harmony, resulting in sleep disruption. Light is the strongest synchronizer of the circadian clock, with direct inputs via the retinohypothalamic tract to brain centers regulating sleep and circadian rhythms. Evening light exposure can suppress melatonin secretion and worsen sleep. This is critical, since most individuals routinely expose themselves to light before bedtime. The high sensitivity of the circadian system to blue wavelength light indicates that modern light sources such as light-emitting diodes (LED) may have particularly deleterious effects on sleep. It is possible to selectively filter out blue light while maintaining other visible spectra with blue-blocking (BB) lenses. Wearing BB lenses before bedtime may present a simple, affordable, and safe method to improve sleep. None have yet investigated the effects of BB lenses on subjective and objective sleep in insomnia patients, while simultaneously exploring the effects on melatonin secretion.

This study seeks to investigate the impact of BB lenses on melatonin and sleep in insomnia patients using a randomized, placebo-controlled crossover study, with the aim of developing a novel non-pharmacological approach for the treatment of insomnia. 15 individuals with insomnia will wear either BB or placebo (clear) lenses for 2 hours preceding bedtime while at home, for 1 week in a cross-over design. Sleep quality will be documented while at home, at also melatonin secretion while in the laboratory. It is predicted that compared to placebo, wearing BB lenses for 2 hours preceding bedtime will attenuate bright light associated melatonin suppression and improve sleep.

Eligibility Criteria:
Inclusion Criteria:

* Insomnia for at least 1 month based on Insomnia Symptoms Questionnaire

Exclusion Criteria:

* obstructive sleep apnea; narcolepsy; periodic leg movement disorder
* currently shift worker
* psychiatric or neurologic disorders
* deep vein thrombosis
* current cigarette smoker
* currently taking beta-blockers
* pregnant/breastfeeding
* children less than 1 year old at home
* excessive daily caffeine intake
(TAP) Block vs. Systemic Lidocaine: Effects on Recovery

It has been demonstrated that female patients have poor quality of surgical recovery compared to male patients. Increased sensitivity to pain and increased susceptibility to postoperative nausea and vomiting have been attributed as causal factors. Currently, few strategies have been shown to improve quality of recovery in female patients undergoing laparoscopic hysterectomy. A better recovery in female patients undergoing outpatient laparoscopy is particularly desirable since those patients do not have access to potent intravenous medications and nursing support after hospital discharge.

Our group has previously demonstrated that both TAP block and systemic lidocaine improve quality of recovery after outpatient laparoscopic gynecological surgery. The TAP block, however, requires expertise, equipment (ultrasound), and additional time to perform as compared with a simple lidocaine infusion. It is currently unknown if a systemic lidocaine infusion provides non-inferior quality of recovery when compared to TAP block for outpatient laparoscopic gynecological surgery.

The main objective of the current investigation is to examine the effect of TAP block on quality of recovery compared to a systemic lidocaine infusion. We hypothesize that systemic lidocaine infusion would provide non-inferior quality of recovery when compared to TAP block for outpatient laparoscopic gynecological surgery.

Significance: This is the first study to compare systemic lidocaine to TAP block with regard to quality of recovery.

The research question; does systemic lidocaine provide similar quality of recovery as TAP block for outpatient laparoscopy? The hypothesis; systemic lidocaine provides non-inferior quality of recovery as TAP block for outpatient laparoscopy.

Research significance: It has been shown that females have poor surgical recovery compared to males; this project intends to demonstrate that systemic lidocaine provides similar recovery as TAP blocks but it does not require the expertise, equipment, and time needed to perform TAP blocks.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years of age
* Surgery type: Outpatient Gynecological Laparoscopy
* ASA status: I and II
* Fluent in English

Exclusion Criteria:

* History of allergy to local anesthetics
* History of chronic opioid use
* Pregnant patients
* Drop Out: Conversion to open surgery, patient or surgeon request.
Study of Rituximab Plus High-Dose Chemotherapy Non-Hodgkin's Lymphoma

This study is being conducted to determine the safety, side effects, and response to a combination of an established high-dose chemotherapy regimen, plus the addition of Rituximab (which is a form of immunotherapy).

Combination chemotherapy is the standard treatment as initial therapy for advanced stage aggressive Non-Hodgkin's lymphoma (NHL). Standard chemotherapy cures less than 40% of patients. When patients relapse, they may be eligible to receive high-dose chemotherapy with autologous stem cell support. Multiple studies have shown the value of high-dose chemotherapy, with increased disease-free survival and overall survival, when compared with second-line conventional chemotherapy. Unfortunately high-dose chemotherapy is curative in less than half the patients who receive it, and other treatment strategies are needed to improve the cure rate.

Another treatment option called immunotherapy is being tested in lymphoma patients. Immunotherapy involves attempts to use the immune system or products of the immune system to fight lymphoma. For example, NHL cells have a protein called CD20 on their surface. Rituximab is an antibody directed against the CD20 protein, which may result in the death of the lymphoma cell. Patients in this study will receive Rituximab to see if it is a safe treatment option for NHL patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented, aggressive and/ or intermediate grade and high-grade B cell NHL, CD20 positive.
* In relapse after primary conventional chemotherapy
* Tumor sensitive (at least a partial response) to induction chemotherapy and/ or radiation therapy after treatment for relapse
* Treatment of CNS or meningeal disease (cytology-negative CSF) if present
* Treatment of CNS or meningeal disease (cytology-negative CSF) if present.
* Cumulative total doxorubicin dosage \<500 mg/m2
* Performance score: 0-2
* Prior malignancies eligible if treated for cure and without active disease
* Patients must not be pregnant or nursing.
* Prior Immunotherapy is allowed
* Signed Informed Consent
* Absolute neutrophil count \> 1500/ µl, platelet count \>100,000/ µl
* Bilirubin \<1.5 x normal, SGOT \<2.5 x normal
* Serum creatinine \<1.5 mg/dl
* Ejection fraction \> 45% or \> 40% with normal wall motion
* HIV negative
* FEV1, DLCO \> 50% predicted

Exclusion Criteria:

* Pregnant or nursing
Computation Prediction of Drug Response Based on Omics Data

The goal of this observational study is to assess the performance of computational medicine technology in predicting patients response to anticancer drugs based on omics data.The main question it aims to answer is test consistency between the computing drug response and the response of real-world clinical trials. Participants will take part in silico.

A companion trial in silico was planned to compare head-to-head with a real clinical study of anti-tumor registered new drugs to verify the consistency between the efficacy prediction results of virtual clinical studies and the efficacy results of traditional clinical trials.

Subjects simultaneously entered real world clinical trials and virtual clinical trials built by computer modeling and artificial intelligence technology. The results of traditional clinical trials were compared with those of virtual clinical trials to calculate the consistency of virtual clinical trials.

By predicting the population with consistent efficacy, locking the response population to new drugs, using the innovative technology of computational medicine, grasping the omics characteristics of the response population, and using this as a starting point to determine the target population of clinical trials, so as to determine new screening conditions, design new clinical trials, accurately match the effective population, and revolutionary change the efficiency of clinical trials, thereby shortening the process and cost of clinical trial development.

Eligibility Criteria:
Inclusion Criteria:

1. clinical diagnosis of triple-negative breast cancer
2. The subjects agreed to participate in the traditional clinical trial and signed informed consent.
3. The subjects agreed to participate in the virtual study and signed informed consent.

Exclusion Criteria:

1. Subjects do not meet the inclusion criteria of traditional clinical trial.
2. Subjects suffered from other cancer disease