cyrilzakka/clinical-trials huggingface dataset:
Perceptions of Side Effects of Cancer Chemoradiotherapy

This study is asking patients who are undergoing radiation therapy with or without chemotherapy on how well they evaluate their side effects on the last day of treatment. This study is not to change health outcomes of the patients in this study. Asking patients to rank side effects in order of which ones bother them the most may help researchers identify the most troubling side effects of cancer treatment.

PRIMARY OBJECTIVES:

I. To examine the perceptions of side effects and their subjective severity of patients treated with radiotherapy with and without concurrent chemotherapy at Los Angeles County (LAC) + University of Southern California (USC) Medical Center.

SECONDARY OBJECTIVES:

I. To identify the most troubling side effects of patients treated with radiotherapy with and without concurrent chemotherapy at LAC+USC Medical Center.

II. To evaluate the impact of chemotherapy combined with radiation therapy, in regards to whether or not perceptions of side effects are altered by what cancer treatment is given.

OUTLINE:

Patients are shown two groups of cards on the last day of radiation treatment. Group A lists 48 physical side effects and group B lists 27 psychosocial side effects. The cards are shuffled and patients view one card at a time and select the side effects they attribute to their current treatment. Patients rank the selected cards from each group by order of severity. The top 5 cards from each group are then shuffled together and patients rank the remaining 10 cards in order of severity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer
* Has received at least 4 consecutive weeks of definitive radiation treatment, with or without concurrent chemotherapy
* Has not received greater than 4 weeks of chemotherapy prior to radiation therapy start
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Patients with either a central nervous system (CNS)-primary cancer or with brain metastases
Kinematics of Youth (Age 12-15) on Stationary All Terrain Vehicles

To assess the relationship between pre-teen/teen height, age, weight, gender, and body proportions and shape and size of youth and comfort and safety when operating adult All Terrain Vehicles (ATV).


Eligibility Criteria:
Inclusion Criteria:

1. males
2. age 12-15
3. a minimum level of physical skill to mount and dismount the vehicle
4. ability to speak and understand English.

We have used this age group because it is the most often injured group and represents an entire age group for ATV size restriction (other age groups not studied here are 6-11, and 16 or greater).

Exclusion Criteria:

1. inability to participate in physical education without restrictions
2. visual acuity \< 20/40 corrected
3. females
4. emancipated minors.

We have excluded females to gain the most consistent body dimensions in this preliminary study.
Study With GW274150 In Patients With Mild Asthma

This is a study investigating whether 14 days of dosing with GW274150 has a beneficial effect on a model of asthma type inflammation called the allergen-induced late asthmatic response. This will be compared with the response after treatment with a dummy (placebo) and a tablet treatment for asthma called Singulair (montelukast). Subjects in the study will receive all 3 treatments in a random order. The study is double-blind so subjects will not know which treatment they are taking at any given time.


Eligibility Criteria:
Inclusion criteria:

* Mild asthma: taking reliever medication (e.g. salbutamol) only.
* Screening involves measuring responses to the lung challenge agents: allergen, AMP, and methacholine. Only those with specific types of response to these will be eligible for the study.

Exclusion criteria:

* Recent steroid treatment.
* Significant illnesses or diseases other than asthma.
RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses

The proposed study will investigate the efficacy of the peripheral cutting balloon (PBC) compared to the high pressure balloon in dilating venous stenosis in hemodialysis fistulas.

2. SPECIFIC AIMS

Study endpoints will be:

Primary Endpoint

1. Primary and assisted patency at 6 months

Secondary Endpoints:

1. Procedure effectiveness/residual stenosis
2. Procedure-related complications
3. Primary patency and primary assisted patency 12 months
4. Secondary patency at 6 and 12 months
5. Number/type of secondary interventions.


Eligibility Criteria:
Inclusion Criteria:

* Dysfunctional fistulas will be recruited based on the presence of clinical and hemodialysis parameters

Exclusion Criteria:

* Arteriovenous prosthetic grafts
Postoperative Artificial Nutrition After Pancreaticoduodenectomy

Pancreaticoduodenectomy is a major surgery burdened by important morbidity and mortality partially related to the altered nutritional status of the patients. The perioperative malnutrition is a major risk factor of postoperative complications and worsens the prognosis of the patients. The perioperative artificial nutrition has for objectives to correct the preoperative malnutrition, and to maintain the nutritional status in the post-operative period. The current guidelines in surgery are in favour of a realisation of a perioperative artificial nutrition support that privilege the enteral nutrition. However, after pancreaticoduodenectomy, the total parenteral nutrition remains most usually used in the early postoperative period, although rare studies suggest a benefit of the enteral nutrition in term of reduction of the post-operative complications. Indeed, no recommendation was formulated concerning early enteral nutrition after pancreaticoduodenectomy because few studies were realized on its profits.

The data of the literature report rates of complications (essentially major) from 49 % to 59 % after major digestive surgery (not only pancreatic) on patients having received a total parenteral nutrition versus rates from 34 to 43.8 % in patients having received an early enteral nutrition.

A preliminary prospective study realized in the investigators centre showed a rate of 74 % complication versus 44 %, respectively in the total parenteral nutrition and early enteral nutrition groups (50 patients in every group, with p \< 0.01. All the complications were listed prospectively).

Hypothesis :

The early enteral nutrition will allow, after pancreaticoduodenectomy, a decrease of, at least, 19 % complications of any stage according to the classification of Dindo-Clavien (59 % versus 40 %).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients more than 18 years of age.
* Pancreatic surgery by pancreaticoduodenectomy.
* Patient affiliated to a mode of the social security or receiving of such a mode.
* Having given written informed consent prior to any procedure related to the study

Exclusion Criteria:

* ASA score ≥4
* Pregnant women
* Patient who cannot give written informed consent.
* Concomitant participation in a biomedical study being able to interfere with this research
* Patient less than 18 years of age or more than 18 years of age, protected by the Law, under guardianship
Macrolide Mediates Pulmonary Infection of Pseudomonas Aeruginosa

It is acknowledged that IL-18, as a product of the inflammasome, is involved in host defence against viral and bacterial stimuli by modulating the immune response. The aim of this study was to determine IL-18 levels in serum of patients with Bronchiectasis and to investigate whether macrolide attenuate its levels.

Non-cystic fibrosis bronchiectasis is a respiratory disease characterized by persistent airway inflammation and dilation of bronchial wall driven by various causes. Patients with bronchiectasis suffer from excessive sputum production, recurrent exacerbations, and progressive airway destruction. It was reported that 30%-40% patients were infected with Pseudomonas aeruginosa. Major therapy for bronchiectasis is focused on breaking the "vicious cycle" of mucus stasis, infection, inflammation, and airway destruction. Currently a number of clinical trials have showed that macrolide effectively used in the treatment of non-CF bronchiectasis. Evidence has indicated that 14- and 15-membered ring macrolides possess immunomodulation and anti-inflammatory functions beyond their antimicrobial properties. However, the underlying mechanisms that account for the anti-inflammatory actions of macrolides have not yet to be elucidated, and the activities do not appear to be controlled by a single mechanism.Interleukin-18 (IL-18), along with interleukin-1b (IL-1b), is produced by inflammasomes when activated by a number of pathogen, environmental or host-derived danger signals. Inflammasomes are innate immune regulatory protein complexes which seem to play a key role in the host immune response of patients with Bronchiectasis. The aim of this study was to determine IL-18 levels in serum of patients with Bronchiectasis and to investigate whether macrolide could attenuate its levels.

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide written informed consent.
2. Confirmed diagnosis of bronchiectasis by HRCT.
3. Aged 18-85 years.

Exclusion Criteria:

1. Bronchiectasis as a result of CF or active tuberculosis or non-tuberculous mycobacterial (NTM) infection.
2. Allergy to macrolide antibiotics
3. Any history of severe cardiopulmonary dysfunction, eg. left heart failure, Unstable cardiac arrhythmias
4. pregnant or nursing
5. hypogammaglobulinemia or other autoimmune disease 6. diagnosed with ABPA
Beta Blockers In Acute Ischemic Stroke

The objective of this trial is to assess the safety and efficacy of neuro- and cardioprotective effects of propranolol in acute ischemic stroke. Furthermore, exploratory analyses of cardiologic-electrophysiologic and immunologic parameters will be performed.

The main objective of this trial is to assess the efficacy and safety of propranolol in middle cerebral artery stroke patients. The primary hypothesis is as follows: Early administration of propranolol reduces the frequency of cardiovascular and/or neurological complications including vascular death in the first 30 days after acute ischemic stroke. Secondary hypotheses are as follows: Early administration of propranolol improves neurological and functional outcome of patients with acute ischemic stroke. Early administration of propranolol reduces post-stroke immunodepression and therefore lowers the rate of pneumonia after acute ischemic stroke, without increasing the frequency of auto-aggressive, CNS antigen-specific T cells. Early administration of propranolol influences alterations in cardiologic, electrophysiologic phenomenons as a reaction to autonomic dysregulation after acute ischemic stroke. Early administration of Propranolol reduces growth of infarct as determined by MRI examinations in the first 6 days.

Eligibility Criteria:
Inclusion Criteria:

* Symptom onset within 18 hours
* Acute ischemic MCA-territory stroke
* Patients with suspected stroke in MCA-territory and a) NIHSS \> 3 or b) imaging evidence of MCA-infarction

Exclusion Criteria:

* Patients already receiving beta-blockers
* Anti-arrhythmic, antiinfectious, antiinflammatory or immunosuppressive therapy
* Patients with a major heart disease, hypotension, bradycardia or any contraindication to the use of Propranolol
A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy

Background: Single-incision laparoscopic cholecystectomy (SILC) is increasingly being used as a minimally invasive surgery with potential benefits over 4-port laparoscopic cholecystectomy (LC) in terms of postoperative pain and faster recovery.

Methods: Seventy-three patients with symptomatic cholelithiasis were randomized to SILC (n=37) or LC (n=36). Data measures included operative details, adverse events, postoperative pain and analgesic requirements, success of the ambulatory process, return to normal activity and return to work, cosmetic results and quality of life score.


Eligibility Criteria:
Inclusion Criteria:

* age higher than 18 and lower than 80
* American Society of Anesthesiologists class (ASA) I-II,
* absence of any previous anesthetic complication,
* accompaniment by a responsible adult during 24 hours,
* symptomatic gallstones candidate to cholecystectomy
* and a signed informed consent.

Exclusion Criteria:

* a Body Mass Index (BMI) higher than 35,
* any laparoscopic contraindication,
* acute cholecystitis background, suspect of Mirizzi's Syndrome, common duct stones or malignancy,
* anti-inflammatory allergy
* psychiatric history that could hinder ambulatory procedure
A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)

The historical standard treatment for early-stage squamous cell carcinoma of the oropharynx is radiation therapy. Some patients require chemotherapy with the radiation, and some patients require surgery if the tumour or lymph nodes have not responded after radiation.

This study will compare radiation therapy with a new surgical treatment called transoral robotic surgery (TORS). TORS is a new surgical approach using a robot to assist the surgeon in removing the tumour, potentially with fewer side effects than older surgical techniques.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* willing to provide informed consent
* ECOG performance status 0-2
* Histologically confirmed squamous cell carcinoma primary rumour site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)
* Tumour stage:T1 or T2, with likely negative resections at surgery
* Nodal stage: N0, N1, or N2 (less than or equal to 4 cm in maximum dimension in any plane, on either side of the neck), without extranodal extension on pre-randomization imaging.
* Patient assessed at head and neck multidisciplinary clinic (with assessment by radiation oncologist and surgeon) and presented at multidisciplinary tumour board prior to randomization.

Exclusion Criteria:

* Serious medical comorbidities or other contraindications to radiotherapy, chemotherapy or surgery
* Prior history of head and neck cancer within 5 years
* Prior head and neck radiation at any time
* Metastatic disease
* Inability to attend full course of radiotherapy or follow-up visits
* Neck disease with unknown primary site
* Prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer
* unable or unwilling to complete QoL questionnaires
Effects of Various Modalities Water Immersion on Veins

Objectives In this study the investigators examined the changes in common femoral vein (CFV) and great saphenous vein (GSV) calibre during thermo neutral water immersion (TNI), cold water immersion (CWI) and contrast water therapy (CWT).

Design Ten professional handball players visited the laboratory on three occasions. At each visit, participants completed a 20-minutes procedure in an upright position: 4-minutes in air (baseline) and then 16-minutes lower limbs TNI (\~35°C), CWI (\~12°C) or CWT (2:2minutes (\~12°C to \~35°C) ratio), selected randomly.

Methods CFV and GVS calibres were evaluated by echo Doppler measures at baseline and at the end of 16 min immersion.


Eligibility Criteria:
Inclusion Criteria:

* Free healthy voluntary

Exclusion Criteria:

* hypersensitivity to cold
Attitudes and Understanding of Sodium Claims on Food Labels

Sodium-related claims on food labels should help people find lower sodium food choices; however consumer attitudes and understanding of such claims are unknown.

The objective of this study was to evaluate: 1) the attitudes and understanding to different types of permitted sodium claims and 2) the effect of hypertension on responses to such claims.


Eligibility Criteria:
Inclusion Criteria:

* Primary grocery shoppers
* Canadian adults between the ages 20 to 69 years

Exclusion Criteria:

* Did not have an email address or have access to internet
Effect of Covid-19 Pandemic on Emergency Surgery Practice

A retrospective study at a tertiary university hospital to determine the effect of the COVID-19 pandemic on the emergency surgery practice in the hospital.

The investigators conducted a retrospective review of all the patients who were admitted to the surgical wards through the emergency department at the Jordan University Hospital in the periods from March 2020 to May 2020. The records were compared to those of the patients who were admitted in the same period from the year 2019.

Data collection includes the number of admissions, the reason for admission, the average of symptoms duration until admission, the age of the patients admitted, gender, type of management, and the average length of stay before discharging the patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients who were admitted to the surgical wards via the emergency department during the study periods

Exclusion Criteria:

-
Comparison of Blood Sampling Methods for Hemoglobin Measurement

This study is designed to inform The DHS Program on whether there are variations in hemoglobin concentration using the DHS standard technique of a single drop of capillary blood and alternative blood sources (pooled capillary and venous blood) using the HemoCue 201+ analyzer compared to venous blood using a clinical hematology autoanalyzer.

Research Objectives:

1. To determine if there are differences in the hemoglobin concentration between a single drop of capillary blood (blood drop #3) and a pooled drop of capillary blood measured on the HemoCue 201+ analyzer in apparently healthy non-pregnant women age 15-49 and children age 6-59 months in a controlled setting (i.e., blood specimens are collected in a laboratory setting).
2. To determine if there are differences in the hemoglobin concentration between a single drop of capillary blood (blood drop #3) measured on the HemoCue 201+ analyzer against venous blood measured on HemoCue 201+ analyzer and a clinical autoanalyzer in apparently healthy non-pregnant women age 15-49 and children age 6-59 months in a controlled and field setting.
3. To determine if there are differences in the hemoglobin concentration between a pooled drop of capillary blood measured on the HemoCue 201+ analyzer against venous blood measured on HemoCue 201+ analyzer and a clinical autoanalyzer in apparently healthy non-pregnant women age 15-49 and children age 6-59 months in a controlled and field setting.
4. To compare results of hemoglobin distribution and estimates of anemia prevalence using two types of capillary blood (single drop and pooled) and venous blood measured on the HemoCue 201+ analyzer and a clinical autoanalyzer using venous blood in a controlled and field setting.


Eligibility Criteria:
Inclusion Criteria:

* Children 6-59 months or non-pregnant women 15-49
* Apparently healthy individuals
* Consent to participate in the study

Exclusion Criteria:

* Children less than 6 months or over 59 months
* Women less than 15 years of age or greater than 49 years of age
* Pregnant women
The Efficacy of Oral Antiseptics Against COVID-19

In a study conducted on 75 COVID-19 patients, the effect of SARS-CoV-2 on viral load was investigated as a result of the use of hypochlorous acid and povidone-iodine as an oral antiseptic.

Before and 30 minutes after rinsing with mouth antiseptics, the participants were asked to rinse the mouth and throat for 30 seconds with 0.9% isotonic saline. The sample was sputtered into a sterile plastic container. The participants were grouped according to the type of oral antiseptics used. The effectiveness of SARS-CoV-2 viral load was investigated by rinsing the mouth and throat for 30 seconds with 20 ml of hypochlorous acid, povidone-iodine, and isotonic saline. Viral load was analyzed by RT-PCR analysis. The results were evaluated by statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Positive SARS-CoV-2 RT-PCR result,
* Adult hospitalized patient,
* The participants have the physical and psychological ability to follow the instructions in the study.

Exclusion Criteria:

* Patients intubated and supported by a mechanical respirator,
* Severe acute or chronic medical or psychiatric condition,
* History of significant adverse effects following use of oral hygiene products such as toothpaste and mouth rinses,
* Active uncontrolled thyroid disease,
* Developmental/cognitive disability,
* Pregnancy,
* Undergoing radioactive iodine therapy.
Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)

This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting."

A total of 1088 subjects were enrolled in the study at 61 sites internationally, outside the United States.

The study assessed acute and late serious adverse events and reports the rate of stroke and bleeding events through 2 years. No formal hypothesis were tested for this observational post-market study.

Each patient was followed at study visits at baseline, implant, 1-3 months, 6 months, 12 months, and 24 months post implant."

Eligibility Criteria:
Inclusion Criteria:

1. Subject with history of paroxysmal, persistent or permanent NVAF
2. Subject who is 18 years or older, or of legal age to give informed consent specific to state and national law
3. Subject who is eligible for an Amulet LAA Occluder device according to current international guidelines and per physician discretion
4. Subject who is willing and capable of providing informed consent, participating in all associated study activities

Exclusion Criteria:

1. Subject with evidence of an intracardiac thrombus
2. Subject with active infection or active endocarditis or other infections producing bacteremia
3. Subject where the placement of the device would interfere with any intracardiac or intravascular structures
4. Subject with any medical disorder that would interfere with completion or evaluation of clinical study results
5. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
6. Subject with LAA anatomy that does not accommodate a device per the sizing guidelines
Probiotics in Infants With Cyanotic Congenital Heart Disease

Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. It is unknown how congenital heart disease affects the development of bacterial colonization of the intestines. It is also unknown whether probiotics will change the bacteria in the intestine of infants with heart disease to become more like those of healthy infants without heart disease. This pilot trial is designed to address these two questions.

Infants with cyanotic congenital heart disease will be randomly assigned to receive either a placebo or probiotic Bifidobacterium infantis. Comparisons will be made between the infants receiving the placebo and healthy infants without heart disease and between the infants receiving the placebo and those receiving the probiotic.

Eligibility Criteria:
Inclusion Criteria:

* Cyanotic congenital heart disease
* Term infant
* Born at or transferred to UC Davis Children's hospital

Exclusion Criteria:

* Congenital anomalies of the intestinal tract