cyrilzakka/clinical-trials huggingface dataset:
Radiation Oncology Mobile Application

To develop a novel a mobile phone application (available on Android and IOS) for patients receiving radiation treatment for head and neck cancer. Through this application, patients will get access to their treatment calender, through a system connected with Mosiac database, which provides a timely and precise access to their treatments schedule.

In addition, patients will be able to report their treatment related toxicity in real time fashion, these symptoms will be addressed daily instead of the weekly floor clinic checks.

Furthermore, the radiation oncologist will receive an instant notification through the application, if there is error in patient's treatment (missing field, wrong dose, etc..)


Eligibility Criteria:
Inclusion Criteria:

Adult patients receiving definitive or adjuvant RT to head and neck site Chemotherapy is allowed PS:0-1 Has a smart phone

Exclusion Criteria:

Poor performance early laryngeal cancer Patient with metastatic disease, or palliative intent.
Functional Outcome After Treatment for Oropharyngeal Squamous Cell Carcinoma

To investigate the treatment related effects of transoral robotic surgery (TORS) or oncological treatment of oropharyngeal squamous cell carcinoma with a 1-year follow up.

Patients are enrolled prospectively at the department of Otorhinolaryngology, Head and Neck Surgery \& Audiology at Copenhagen University Hospital, Rigshospitalet.

All eligible patients with histologically verified squamous cell carcinoma of the oropharynx regardless of treatment option (as long as the intent is curative) can be included.

Outcome measures are assessed at baseline and repeated 3 and 12 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

TORS group:

1. WHO performance status 0-2
2. Squamous cell carcinoma of the oropharynx
3. TNM: T1-2, N0-1 (without of evidence of extra capsular extent), M0.
4. No previous head and neck cancer
5. Absence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other.
6. Signed written consent.
7. Cancer eligible for surgery in the absence of significant trismus.

Oncological group:

1. WHO performance status 0-2
2. Squamous cell carcinoma of the oropharynx
3. Qualified for curative intended oncological treatment
4. Signed written consent

Exclusion Criteria:

TORS group:

1. Serious co-morbidity
2. Distant metastasis
3. Previous radiotherapy to the head and neck region.
4. Concurrent treatment eller investigations for another cancer, except carcinoma in situ.

Oncological group:

1. Previous radiotherapy to the head and neck region.
2. Concurrent treatment eller investigations for another cancer, except carcinoma in situ.
3. Presence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other.
4. Presence of facors that inhibit the patient from completing the treatment.
5. Previous head and neck cancer
6. Distant metastasis
Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI

Prospective, randomized, controlled, multicenter, open-label trial to study whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease.

The complete revascularization versus culprit lesion only PCI in NSTEMI (COMPLETE-NSTEMI) trial aims to investigate whether multivessel complete PCI is superior over culprit-lesion only PCI in patients with NSTEMI and multivessel coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* NSTEMI as suggested by high-sensitivity troponin algorithms
* Multivessel coronary artery disease
* Identifiable culprit lesion
* Informed consent

Exclusion Criteria:

* Age \<18 years
* Cardiogenic shock
* Sustained ventricular tachycardia (VT) or ventricular fibrillation (VF)
* Contraindication for coronary revascularization
* Prior coronary artery bypass graft
* Indication for coronary artery bypass graft surgery
* Non-culprit lesion located in the left main coronary artery
* Co-morbidity with life expectancy less than 6 months
* Type 2 myocardial infarction
* Pregnancy and breast feeding period
Effect of Repeated Removal and Re-placement of Abutments Around Dental Implants

Repeated removal and re-placement of healing and prosthetic abutments result in frequent injuries to the soft tissues. The purpose was to evaluate the effect of repeated removal and re-placement of laser microgrooved and smooth/machined healing and prosthetic abutments during restorative stages, and 1 year after functional loading, on proinflammatory cytokine levels around dental implants.

Twenty-four patients each received 2 one-stage implants in a split mouth design on the same jaw. In each patient one healing and prosthetic abutments with a laser microgrooved surface (LMS group) and one healing and prosthetic abutments with smooth/machined surface (S/MS group) were used. Four months following implant placement \[Baseline (BSL)\], the healing abutments were disconnnected and reconnected three times to carry out the impression procedures and metal framework try-in. Four weeks later (T0), definitive prosthetic abutments were installated with screw retained crowns. Samples for immunological analyses were taken from the sulcus around each implant at BSL, T0, and 1 year after functional loading (T1). Peri-implant crevicular fluid samples were analyzed for interleukin-1beta (IL-1β), interleukin-6 (IL-6) and tumor necrosis factor (TNF)-α levels using the ELISA kit.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, in good general health, and with sufficient amount of bone available to place a standard implant

Exclusion Criteria:

* natural teeth adjacent to surgical area affected by untreated periodontal or endodontic infections, peri-implant bone defects requiring bone augmentation, absence of opposing occlusion,
Endoscopic Vital Nerve Staining in Gastrointestinal Diseases

In this study, methylene blue (MB) was used as vital nerve staining agent. During gastroenteroscopy, mucosal nerve staining was achieved by endoscopic submucosal injection of MB solution. To observe the staining of nerve fibers, neurons and glial cells in mucosa and submucosa, as well as the morphological changes, density differences and function of mucosal nerve tissues in different gastrointestinal lesions, in order to explore the role of endoscopic vital nerve staining in the diagnosis of gastrointestinal lesions.

This study is a prospective experimental study. The baseline data of the patients were recorded objectively: sex, age, vital signs, body weight, some laboratory examination results (blood routine, liver function, blood coagulation function and electrolytes, etc.) and related medical history (comorbidities, treatment history and life history). Mucosal nerve staining was achieved by endoscopic submucosal injection of methylene blue (MB) solution. The following features were identified and then compared between normal, adenoma and neoplastic mucosa on magnifying endoscopy images in vivo: nerve morphology (straight or irregular), nerve diameter, branching patterns and nerve density. Immunohistochemistry was used to further confirm the presence and to study the morphology of neural structures (PGP9.5 and GFAP staining) and neural attribute (VIP, nNOS, TH, ChAT and SOM staining) on tumor, adenoma and normal mucosal sections.The aim of this study was to explore the role of MB based topical submucosal chromoendoscopy in the identification of neural architecture and special morphology in normal gastrointestinal mucosa, adenomas and malignant lesions during routine endoscopy.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis or suspected diagnosis of one of the following common gastrointestinal diseases: chronic non-atrophic gastritis, chronic atrophic gastritis, gastric polyps, gastric early cancer, advanced gastric cancer; colonic polyps, colonic Melanosis, early colon cancer, advanced colon cancer
2. Written informed consent

Exclusion Criteria:

1. Those who are allergic to nerve dye components (such as methylene blue, etc.)
2. Complicated with cardiovascular and cerebrovascular diseases, or severely impaired liver, kidney and hematopoietic system.
3. Psychopath
4. There are hemorrhagic diseases
5. Platelet count \< 50 × 10 \^ 9 / L
6. Those who are allergic to body mass are
7. Unable to tolerate or cooperate with endoscopy
8. Patients with serious complications, such as severe infection, gastrointestinal bleeding, obstruction and perforation, etc.
9. Pregnant or lactating women
Ultrasound in Detecting Lymph Node Metastasis in Older Patients Undergoing Breast Sonography

This pilot clinical trial studies ultrasound in detecting lymph node metastasis in older patients with undergoing breast sonography. Diagnostic procedures, such as ultrasound, may help find breast cancer and find out how far the disease has spread

PRIMARY OBJECTIVES:

I. To develop a reliable and consistent set of guidelines for utilizing diagnostic ultrasound to assess axillary lymph nodes for patient suspicious of breast cancer with possible nodal metastasis.

SECONDARY OBJECTIVES:

I. To explore whether the data collected can be used for pathologic validation of metastatic disease.

OUTLINE:

Patients undergo breast ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for a breast ultrasound
* Patients who have had a mammogram with a Breast Imaging Reporting and Data System (BIRADS) of \>= 4
* Patients who are undiagnosed for breast cancer

Exclusion Criteria:

* Patients who have had breast cancer surgery
Effect of Dietary Protein Restriction on Prognosis in Patients With Diabetic Nephropathy

The purpose of the investigators study was to determine the effect of dietary protein restriction on survival and progression to end stage renal disease (ESRD) in diabetic nephropathy.

The study was a prospective, randomized, unmasked, controlled trial carried out at the Steno Diabetes Center. With concealed randomization the patients were (in blocks of two according to the level of GFR) assigned to receive either a usual-protein diet or a low-protein diet.

After randomization an iso-caloric low-protein diet of 0.6 g/kg/day was prescribed to patients in the low-protein diet group. The usual-pro tein diet consisted of the patients' pre-study diet.

The planned duration of follow-up was four years, scheduled visits every three-months. All patients gave complete history of medication, underwent examination of weight, urinary albumin-, sodium- and urea excretion, serum albumin, serum urea, hemoglobin, hemoglobin A1c, blood pressure, serum total-cholesterol, high-density lipoprotein (HDL) cholesterol.

GFR, serum triglycerides,calcium and phosphorous, anthropometric measurements, nutritional status and smoking habits were evaluated every six months.

Dietary protein intake was estimated on the basis of three consecutive 24-hour urine samples completed before each visit, using urinary excretion of urea nitrogen.

GFR was measured by plasma clearance of 51Cr-EDTA over a 4 hour period and standardized for 1.73m2 body surface area using the same surface for each patient during the study.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type 1
* duration at least 10 years
* onset before age of 35,
* presence of diabetic retinopathy
* albuminuria\>=300mg/24 h in at least 2/3 sterile urine samples
* no clinical or laboratory evidence of other kidney or urinary tract disease
* GFR above 20mL/min/1.73M2
* pre-study decline in GFR\>= 2 mL/min/year

Exclusion Criteria:

* pregnancy
* history of congestive heart failure or myocardial infarction or coronary bypass surgery within the last three months
Acceptability and Feasibility of Micronutrient Powders Versus Iron Syrup for Anemia Prevention in Young Children

This study seeks to assess the acceptability, compliance, and preference for iron supplementation; micronutrient powders (MNP) versus iron syrup. Additionally, this study seeks to assess front line health worker perceptions and experiences regarding ease of implementation of each strategy and delivery strategy preference.

The specific aims of this study are to assess the acceptability of, compliance, and preference for two delivery vehicles for pediatric prophylaxis iron supplementation (micronutrient powders (MNP) that contain iron versus iron syrup) among rural households in Bihar India delivered through home visits by front line health workers. Additionally, this study seeks to assess front line health worker perceptions and experiences regarding ease of implementation of each strategy and delivery strategy preference.

Eligibility Criteria:
Inclusion Criteria:

* Singleton Children or one child per home

Exclusion Criteria:

* Currently taking iron supplements
* Mid upper arm circumference (MUAC) or less than 11.5 cm
* Suspected severe anemia
* Known case of haemoglobinopathy
* History of repeated blood transfusion
* Current pneumonia
* Current fever
* Acute diarrhea
Comparing Effects of 3 Sources of Garlic on Cholesterol Levels

The purpose of this study is to determine whether fresh garlic can positively affect cholesterol in adults with moderately high cholesterol levels. This study will also determine whether the same effects can be found for two main types of garlic supplements: a dried powdered garlic (designed to yield the same effect as fresh garlic) and an aged garlic extract preparation.

Garlic supplements are the most consumed herbal products in the United States. The most common health claim made for garlic supplements is cholesterol lowering activity. This claim has not been supported by recent clinical trials and meta-analyses. However, data suggest that it is not necessarily the garlic that has been ineffective, but rather the particular garlic preparations being used. To date, the predominant type of garlic preparation used in these clinical trials has been dried garlic powders. A few clinical trials have reported beneficial lipid effects using an aged garlic extract, and only a small number of inconclusive uncontrolled trials have used fresh garlic. A rigorous trial directly comparing different types of garlic preparations for their effects on serum lipids is needed.

Adults with moderately elevated low density lipoprotein cholesterol (LDL-C) will be randomized to one of four groups for 6 months: fresh garlic, dried powdered garlic tablets, aged garlic extract tablets, or placebo control. The fresh garlic will be provided to patients with "study sandwiches"; all other groups will receive the same study sandwiches without the garlic. All patients will take daily study tablets, but the tablet assignment will be double-blind. Patients will pick up study sandwiches twice a week and study tablets once every 2 weeks for 28 weeks. Blood samples will be taken once a month, with additional blood draws at the start and end of the study.

Eligibility Criteria:
Inclusion Criteria:

* LDL-C 130-190 mg/dL (fasting single sample)
* BMI (body mass index) 19-30 kg/m2 (42-66 lb/m2)
* Weight stable for last 2 months
* Not actively on a weight loss plan
* Ethnicity representative of local population
* No plans to move from the area over the next 9 months

Exclusion Criteria:

* Pregnant, lactating, within 6 months postpartum, or planning to become pregnant in the next year
* Diabetes (type I or II) or history of gestational diabetes
* Heart disease
* Active neoplasms
* Renal or liver disease
* Hyperthyroidism or hypothyroidism
* Lipid lowering medications (known to affect lipid metabolism, platelet function, or antioxidant status)
* Blood pressure medications
* Excessive alcohol intake (self reported, more than 3 drinks/day)
* Currently under psychiatric care or severely clinically depressed
Factors Associated With Occluding the Upper Esophagus by Paratracheal Force

We aim to identify anatomical factors that affect upper esophageal occlusion during the application of paratracheal pressure.

Measure the sternomental distance, thyromental distance, neck length, neck circumference, Mallampati score, BMI, Neck motion, inter-incisor gap, thyrosternal distance. And analysis these factors are associated with upper esophageal occlusion or not.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 19 years old
* schedule for general anesthesia

Exclusion Criteria:

* Limited neck extension
* Abnormality or anomaly, history of surgery in the neck, esophagus, face, upper airway part.
* Who has weak teeth
* Who has pulmonary aspiration risk
Safety and Efficacy of Primaquine for P. Vivax

The Melanesian states of the Western Pacific (Papua New Guinea, Solomon Islands and Vanuatu) represent a unique and especially prescient challenge to malaria control and elimination.

While the use of bed nets and other vector control and case management measures have achieved major advances in overall malaria control, the P. vivax and P. ovale species account for an ever-increasing burden of clinical disease.

The lack of effective treatment of the hypnozoite stages of infection with these species result in ongoing relapses and a continuing reservoir of infection.

The only known drug effective for treatment of the hypnozoite stage is primaquine; however the safe and effective dose of this drug in malaria treatment is still unclear.

A recent study evaluated the safety and efficacy of two primaquine dosing regimens (0.25mg/kg and 0.5mg/kg) in a population in New Ireland province, PNG. This study aims to replicate this methodology in Vanuatu and Solomon Islands, to provide a more complete picture of primaquine efficacy and safety in each of the three countries of this region.

Study Aims

Primary To define and compare the efficacy of standard (0.25mg/kg/day for 14 days) and high-dose (0.5mg/kg/day for 14 days) primaquine in preventing early relapses from P. vivax in Solomon Islands and Vanuatu.

Secondary To measure safety and toxicity of primaquine when administered as a standard or high-dose regimen in Melanesian adults and children in Solomon Islands and Vanuatu.

Eligibility Criteria:
Inclusion Criteria:

1. Age 12 months to 60 years
2. Melanesian background and living in local area
3. Microscopically (based on field microscopy) or RDT confirmed P.vivax regardless of parasite density. Mixed infections (P.falciparum-P.vivax and P.malariae-P.vivax) can be included.

Exclusion Criteria:

1. Any signs of severe malaria (see WHO definitions) including: impaired consciousness, respiratory distress, severe anaemia (Hb\<5), multiple seizures, frequent vomiting/ inability to swallow tablets, prostration, jaundice, hypotension, abnormal bleeding or hypoglycaemia.
2. Clinical evidence of non-malarial illness (such as pneumonia or otitis media)
3. Severe malnutrition (weight-for-age nutritional Z score \[WAZ\] \<60th percentile)
4. Permanent disability, which prevents or impedes study participation.
5. Treatment with primaquine in the previous 14 days
6. Residence or planned travel outside the study area during the follow-up period (precluding supervised treatment and follow-up procedures)
7. Known or suspected pregnancy
8. Currently breastfeeding
9. A positive rapid test for G6PD deficiency (Binax or Carestart RDT)

Following later PCR-based confirmation of malaria speciation, there may be some post-hoc exclusion of subjects in whom it is thought the initial field-based microscopic diagnosis may have been incorrect.
STAND UP - Sedentary Behaviour in Older Adults: Investigating a New Therapeutic Paradigm

Research has shown that reducing the time spent sitting can reduce the risk of many diseases, such as diabetes and heart disease, and improve health. It is estimated that many older adults typically spend 70% of their waking day sitting, but little is known about whether reducing sitting promotes health and well-being in this age group. The aim of this research is to investigate the health effects of reducing sitting time by replacing it with short periods of standing or walking in adults over the age of 65.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 65 to 79 years inclusive
* Able to walk (without any assistive devices and not requiring assistance from another person)
* Ability to communicate in and understand English to participate in the informed consent process.

Exclusion Criteria:

* Regular purposeful exercise (≥75 minutes of self-reported vigorous exercise per week)
* Inability to stand or undertake light ambulation
* Psychological condition which limits participation in the study (e.g. dementia)
* Inability to communicate or understand English
* Steroid use
* Use of glucose lowering medication
* Inability to give informed consent
ED90 of 0.75% Bupivacaine for Bilateral Tubal Ligation (BTL)

The purpose of this study is to determine the dose of bupivacaine that provides effective pain management in 90% (ED90) of patients undergoing bilateral tubal ligation. This will guide anesthesiologists on the most effective dose to minimize intraoperative pain during this procedure. The goal is to make women as comfortable as possible when they undergo this procedure while also minimizing the amount of time they are required to remain in the hospital afterwards for monitoring.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* American Society of Anesthesiology class II or III
* bilateral tubal ligation

Exclusion Criteria:

* patient refusal
* BMI ≥ 50 kg/m2
* American Society of Anesthesiology class IV or above
* contraindication to neuraxial anesthesia
* allergy to bupivacaine