cyrilzakka/clinical-trials huggingface dataset:
Preference for Clarinex Tablets vs. Zyrtec Tablets in Patients With Allergies (P03182)

This was a crossover study designed to see if patients with allergy symptoms preferred Clarinex® or Zyrtec®. Patients were randomized to take 7 days of Clarinex or Zyrtec treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked questions to determine which drug, Clarinex or Zyrtec, the patient prefers more.


Eligibility Criteria:
Inclusion Criteria:

* had at least a two-year history of seasonal allergic rhinitis and/or perennial allergic rhinitis;
* currently experiencing symptoms of AR, including nasal symptoms at Visits 2 and 4, prior to entering each treatment phase;
* had not taken Zyrtec® or Clarinex® within the previous year;
* were 18 years of age or older;
* had negative urine test (hCG) for females of childbearing potential;
* for women of childbearing potential, agreed to use a medically accepted method of birth control;
* were free of any clinically significant disease (other than AR) that would interfere with study evaluations.

Exclusion Criteria:

* were pregnant or nursing;
* had allergic or idiosyncratic reaction to antihistamines;
* had current or history of frequent, clinically significant sinusitis or chronic purulent nasal discharge;
* had rhinitis medicamentosa or nasal structural abnormalities (including large nasal polyps and marked septal deviation) that significantly interfered with nasal airflow;
* in the opinion of the Investigator, were dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids (ie, subjects who could or would not observe the washout period for these prohibited medications);
* had an upper respiratory tract or sinus infection that required antibiotic therapy with the last dose within 14 days prior to Screening, or had a viral upper respiratory infection within 7 days prior to Screening;
* had asthma, unless their symptoms could be controlled by a short-acting inhaled Beta2-agonist used on an "as needed" basis;
* were on immunotherapy, unless they were on a stable maintenance schedule prior to screening. The dose of immunotherapy should remain constant and subjects could not receive immunotherapy within 24 hours prior to any visit;
* had a history of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that were likely to limit the validity of consent to participate in the study;
* had a history of non-compliance with medications or treatment protocols;
* had any clinically significant deviation from normal in the physical examination that, in the Investigator's judgment, may have interfered with the study evaluations or affect subject safety;
* had any clinically significant metabolic, cardiovascular, immunologic, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the Investigator, might interfere with the study evaluations or affect subject safety;
* had liver or renal impairment.
The CX-DZ-Ⅱ Intelligent Electroacupuncture Instrument for Neck Pain

The present study is a prospective, two-center, randomized, controlled, open-label, non-inferiority trial evaluating the efficacy and safety of a new intelligent electroacupuncture instrument in treating neck pain caused by cervical spondylosis.

A total of 160 eligible patients will be included in this trial and randomly assigned to experimental group and control group in a 1:1 ratio. In experimental group, selected acupoints will be stimulated by the new intelligent electro-acupuncture instrument; while for control group, electroacupuncture treatment will be accomplished by a pre-existing electro-acupuncture instrument. The duration of treatment will be 2 weeks. The primary outcome is the change of visual analog scale score after one course of treatment. The secondary outcomes are visual analog scale score after each treatment, the responder rate, drug-usage rate of non-steroidal antipyretic analgesics, the occurrence rate of adverse events, defect rate of instrument, and excellent rate of instrument.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 75 years old.
* Subject is diagnosed with CS of neck type or nerve-root type by clinical and medical imaging examination.
* A history of recurrent episodes of neck pain (one or more neck pain per month lasting for more than 3 months).
* Pain intensity is more than 3 points on a VAS upon recruitment.
* Subject or his guardian comprehend the aims of this trial, promise not to accept other relative treatments during the trial, and sign the informed consent.

Exclusion Criteria:

* Subject has acute neck trauma.
* Previous medical history of neck trauma treated by surgery, or neurological deficit, or congenital and developmental spinal disorders, or systemic bone diseases, or systemic joint diseases (e.g. joint slippage).
* Subject is diagnosed with carotid artery dissection.
* Subject is unable to express clearly self-feelings (e.g. subject with severe cerebrovascular accident sequelae).
* Subject has infection in acupuncture region.
* A history of acupuncture treatment for neck pain in the previous 1 week.
* Use of non-steroidal antipyretic analgesics in the previous 3 days.
* Subject has to use central analgesics or narcotic analgesics (e.g. Tramadol, Morphine, Dolantin) during the period of clinic trial.
* Use of various ointments or medicinal liquors with functions of promoting blood circulation and/or easing pain.
* Use of oral and intravenous medicines with functions of opening blood vessels and providing nutrition to nerve.
* Combinations of severe systematic diseases (e.g. a history of myocardial infarction, or severe hepatic and renal dysfunction, or acute infectious diseases, or malignant tumors, or severe mental disturbance diseases in previous 12 months).
* Intolerance of acupuncture and electro-acupuncture.
* Allergy to acupuncture.
* Female in pregnancy or lactation.
* Subject participate other clinic trials in previous 3 months.
* Subject is considered to be unsuited to this trial by investigators.
Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer

Study to determine the feasibility of Sentinel Lymph Node (SLN) mapping using novel magnetic tracers (FerroTrace) and indocyanine green (ICG) for colorectal cancer; and to evaluate safety by assessing short term toxicity associated with colonoscopic peritumoral injection of novel magnetic nanoparticles (FerroTrace) and ICG for colorectal cancer.

PRIMARY:

1. To determine the feasibility of Sentinel Lymph Node (SLN) mapping using novel magnetic tracers (FerroTrace) and indocyanine green (ICG) for colorectal cancer.
2. To evaluate safety by assessing short term toxicity associated with colonoscopic peritumoral injection of novel magnetic nanoparticles (FerroTrace) and ICG for colorectal cancer.

SECONDARY:

1. To determine the additional positive diagnostic value of adding sentinel lymph node mapping to lymphadenectomy by assessing the SLNs with detailed immunochemistry versus the normal H\&E staining pathology tests.

PRIMARY END POINTS:

1. Feasibility: Number of registered patients who complete all study procedures with at least one sentinel node identified.
2. Safety: Rate of any grade III or greater toxicity attributable to FerroTrace injection, evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. Adverse events according to general peri-operative complications.

SECONDARY ENDPOINTS:

1. The identification rate and number of FerroTrace-positive lymph nodes for each patient.
2. Incidence of pathological upstaging of LN metastasis status by the addition of (non-routine) serial H\&E and immunohistochemistry in the pathological assessment of identified FerroTrace-positive lymph nodes.

Eligibility Criteria:
Inclusion criteria:

* Age 18 or older
* Willing to provide informed consent
* Biopsy proven colon or rectal cancer
* No distant metastases

Exclusion criteria:

* Serious medical comorbidities or other contraindications to surgery +/- adjuvant therapy as determined by the treatment team
* Previous pelvic radiotherapy or radiotherapy planned prior to surgery
* Allergy or intolerance to iron oxide compounds
* Iron overload disorder
* Allergy or intolerance to iodides
* Pregnant or lactating women\*
The Effect of Foot Reflexology Applied on Dialysis Patients

Reflexology is massage therapy used to maintain and improve health, as well as relieve some symptoms. Foot reflexology, which is thought to have an effect on dialysis symptoms, will be applied to hemodialysis patients in 9 sessions. In this study, it is aimed to determine the effect of foot reflexology applied to dialysis patients on sleep, anxiety and quality of life.

Reflexology is defined as a holistic treatment based on stimulating the nerves and blood circulation in the body by manually stimulating the reflex points in the hands and feet corresponding to all parts of the body, organs and systems. In the literature, there are many studies conducted in different samples to evaluate the effectiveness of reflexology massage. Hemodialysis patients are also included in these samples. Hemodialysis patients are faced with many physical and emotional symptoms such as lifestyle changes, psychosocial effects, side effects due to treatment, during their treatment process. Nurses play an important role in alleviating and eliminating these complaints. Objective: It is aimed to determine the effect of foot reflexology applied to dialysis patients on sleep, anxiety and quality of life. Design: Randomized, controlled, prospective study. Setting: University Hospital Hemodialysis Center in Izmir. Patients: Forty patients receiving hemodialysis treatment. Interventions: Nine sessions of reflexology massage will be given to reflex points including the solar plexus, brain, pituitary, thyroid, diaphragm, upper lymphs, lung, spinal cord and adrenal glands. Main Outcome Measures: sleep, anxiety, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Conscious and oriented with no communication problem
* Agreeing to participate in the study
* Receiving hemodialysis treatment 3 times a week for 6 months or more
* Patients who have no problem to apply massage; Those who do not have any skin lesions, burns, pathological diseases related to muscles and bones, phlebitis, embolism or bleeding disorder.

Exclusion Criteria:

* Patients who have received hemodialysis treatment for less than 6 months.
* Patients with diabetic neuropathy
* Those who have any skin lesions, burns, open wounds, muscle and bone-related pathological disease, phlebitis, embolism or bleeding disorder in the foot.
* Patients with infection
Bimatoprost 0.03% Solution With NB-UVB Versus Their Use With Fractional Carbon Dioxide Laser in Treatment of Generalized Vitiligo

Vitiligo is a chronic disorder of pigmentation characterized by the development of white macules on the skin due to loss of epidermal melanocytes. It affects approximately 0.5%-2% of general population world-wide, without predilection for sex or race.Vitiligo can be classified into segmental or non-segmental. Non-segmental or generalized vitiligo is the most common clinical presentation and often involves the face and acral regions.

Multiple monotherapy modalities are established to treat vitiligo but the response is variable, unsatisfactory, and requiring a prolonged course. This problem is exaggerated by the multifactorial and polygenic nature of the pathomechanism of the disease. These facts pave the way to combination therapy that showed better and safe repigmentation response than monotherapy.

Bimatoprost 0.03% ophthalmic solution is a synthetic prostaglandin F2 alpha analog that is approved for the treatment of glaucoma and eyelashes hypotrichosis (Lee et al, 2017). Cutaneous hyperpigmentation of the treated sites has been reported as a side effect with this agent. Phototherapy (narrow band ultraviolet B (NB-UVB)) of wavelength 308 nm, is considered as a successful method of treatment of vitiligo. The cytotoxic T-cells accountable for the destruction of melanocytes and disappearance of melanin are eliminated by phototherapy through apoptosis (diffuse repigmentation) and UVB does stimulate melanocytic proliferation and their migration to the epidermis from nearby follicular units (follicular repigmentation) and perilesional active melanocytes (marginal repigmentation).

In recent years, fractional carbon dioxide laser has been introduced as an add-on treatment for vitiligo. It represents a new modality for skin resurfacing based on the theory of fractional photothermolysis. The beneficial effect of fractional carbon dioxide laser on vitiligo is the release of cytokines and growth factors that act as mitogens for melanogenesis. It also alters the skin barrier, which results in increased penetration of topical drugs and ultraviolet (UV) radiation, so it can be used in combination therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 12.
2. Patients with non-segmental vitiligo.
3. Lesions stable for at least one year.
4. Patients who were unresponsive to medical treatment or photo therapy for at least 3 months.
5. No sex or site predilection.
6. Bilateral and symmetrical lesions with maximum size of 10×10 cm.

Exclusion Criteria:

1. Patients with active infection.
2. Patients with sensitivity to bimatoprost or photosensitivity.
3. Patients with history or active skin cancer.
4. Pregnant or lactating females.
Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)

The objective of the study is to evaluate the safety, effectiveness and anti-microbial effects of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when used in combination with mechanical debridement.

The hypothesis of the study is that Arestin in combination with mechanical debridement is more effective in the treatment of peri-implantitis when compared to mechanical debridement alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as measured at qualifying implant sites.


Eligibility Criteria:
Inclusion Criteria:

* A minimum of one osseointegrated implant with a diagnosis of peri-implantitis
* Absence of any significant oral soft tissue pathology
* At least one peri-implant site with an average of 2 probing depth readings between 5mm and 7mm (inclusive) when using a light force and with bleeding on probing within 30 seconds of the probing
* Confirmed evidence of pathologic bone loss
* At least 1mm of keratinized gingiva present around the implant

Exclusion Criteria:

* Pregnancy
* Allergy to tetracycline-class drug(s)
* Systemic medical condition(s) requiring antibiotic prophylaxis prior to invasive dental procedures
* Presence of active systemic infectious disease such as hepatitis, HIV, history of tuberculosis
* Diagnosis of clinically significant or unstable organic disease, or compromised healing potential
* Signs of untreated advanced periodontal disease and/or poor oral hygiene
* Subjects having a probing depth greater than 8mm at time of enrollment
* Subjects presenting with mobility of any dental implant
* Subjects having a qualifying implant under occlusal trauma or overloaded (as determined by the investigator)
A Study to Observe How Insulin Glargine 300 U/ml is Working and is Tolerated in Elderly Patients ≥75 Years of Age With Type 2 Diabetes

Primary objective:

- Glycemic control after initiation or switch to insulin glargine 300 U/ml in everyday clinical practice

Secondary objective:

- Treatment satisfaction

Study duration per participant is expected to be approximately 24 weeks

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (T2DM) with oral antidiabetic drug (OAD) ± Glucagon-like-peptide-1 receptor agonist (GLP-1-RA) ± basal insulin (other than insulin glargine 300 U/ml)
* Age ≥75 years incl. patients from outpatient and inpatient care forms
* Glycohaemoglobin (Hba1c) ≥8.0% and ≤11.0%
* Inadequate glycaemic control (HbA1c), defined by the treating physician
* Ability and willingness to perform fasting blood glucose (BG) measurements themselves or with the support of third parties
* Signed consent form

Exclusion Criteria:

* Type 1 diabetes mellitus
* Age \<75 years
* Contraindications to insulin glargine 300 U/ml
* Short-acting insulin in medication
* Current participation in clinical research
* Life expectancy \<1 year
* Known alcohol or drug abuse
* Mini Mental State Examination Score ≤19

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Deep Brain Stimulation Therapy and Intestinal Microbiota

This study aims to observe the changes of intestinal microbiota after deep brain stimulation (DBS) therapy for Parkinson's disease, and explore the role of intestinal microbiota in the neuroprotective effect of DBS.


Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years of age;
2. Primary Parkinson's disease diagnosed according to British Brain Bank criteria (Hoehn and Yahr);
3. Deep brain stimulator therapy;
4. Sign the informed consent.

Exclusion Criteria:

1. Use of probiotics or probiotics during the study;
2. Use antibiotics against intestinal bacteria at present or within the last 1 month;
3. With cognitive dysfunction or mental illness;
4. With severe diseases or is not expected to survive for more than a year;
5. A history of gastrointestinal surgery;
6. AIDS patients, hepatitis B/C positive.
Bioavailability of Chemopreventive and Nutritional Compounds in Broccoli

The aim of this study was to determine the absorption of isothiocyanates (ITC) after ingestion of kailan-hybrid broccoli through the analysis of the correspondent urinary biomarkers. Furthermore, the effect of cooking (microwave) on the mentioned metabolic fate of these ITC was studied comparing to the uncooked vegetable.

Background Glucosinolates (sulphur-containing compounds) are hydrolyzed by the plant enzyme myrosinase to ITC, which have chemopreventive properties. No information has been reported about the metabolic fate of ITC in the kailan-hybrid broccoli, which physicochemical characteristics could greatly influence that metabolic fate. Previous studies have shown that cooking process of vegetables may vary the human absorption of the correspondent nutritional and bioactive compounds.

Research Methods \& Procedures A cross-over-design study of 7 subjects after ingestion of 200-g raw or microwaved kailan-hybrid broccoli was conducted. Total ITC equivalents in the vegetable, urine and blood samples were determined by HPLC as the cyclocondensation product of 1,2-benzenedithiol.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a body mass index between 19 and 28.
* Subjects age: 22-50 years-old.
* Good health of subjects: confirmed by medical history, physical examination and clinical laboratory analysis of urine and blood (complete blood count and liver function markers including serum glutamic-pyruvic transaminase bilirubin test and glucose-6-phosphate dehydrogenase).

Exclusion Criteria:

* Tobacco smoking.
* Use of regular medications.
* Had taken antibiotics for 4 weeks immediately preceding the study.
* History of kidney stones, diabetes mellitus, bleeding disorders or family history of iron overload/hemochromatosis.
Treatment of Survivors After Botulism Outbreak

Background. Northern Thailand's biggest botulism outbreak to date occurred on 14 March 2006 and affected 209 people. Of these, 42 developed respiratory failure, and 25 of those who developed respiratory failure were referred to 9 high facility hospitals for treatment of severe respiratory failure and autonomic nervous system involvement. Among these patients, we aimed to assess the relationship between the rate of ventilator dependence and the occurrence of treatment by day 4 versus day 6 after exposure to bamboo shoots (the source of the botulism outbreak), as well as the relationship between ventilator dependence and negative inspiratory pressure.

Methods. The investigators reviewed the circumstances and timing of symptoms following exposure. Mobile teams treated patients with botulinum antitoxin on day 4 or day 6 after exposure in Nan Hospital (Nan, Thailand). Eighteen patients (in 7 high facility hospitals) with severe respiratory failure received a low- and high-rate repetitive nerve stimulation test, and negative inspiratory pressure was measured.


Eligibility Criteria:
Inclusions:

* Ate the bamboo shoots in Banluang district, on March,14 2006
* Clinical of respiratory failure and need ventilator assistant
* Needed to referred to other hospital
* The staffs of referred hospital willing to participate in the Thai Botulism study group

Exclusion Criteria:

* Patients who did not eat bamboo shoots in Banluang district on March14,2006.
* No clinical of respiratory failure.
* Not referred to other hospital.
Modulating Early-life Nutrition for Childhood Obesity Prevention

In this study, betaine intake will be increased in formula-fed infants through formula milk supplementation. To do this, a double-blind randomized study has been designed with the supplementation group (infant formula supplemented with betaine) and control group (unsupplemented infant formula). The main objectives of the study are to determine the safety of supplementation and to assess whether there are changes in infant growth.

Childhood obesity is one of the main public health concerns worldwide. Previous results have linked a nutrient called betaine (trimethylglycine) to the risk of childhood obesity. Betaine is a modified amino acid with osmotic properties that participates in the methionine cycle as a methyl group donor. Specifically, previous data demonstrate a link between breast milk betaine content, postnatal growth, and long-term metabolic health, suggesting that betaine supplementation may be an effective strategy for regulating growth trajectories and preventing childhood obesity. This study will assess the effects of increasing betaine intake in formula-fed infants through formula milk supplementation. To do this, a double-blind randomized study has been designed where participants will be randomly assigned to the control group or the supplementation group. The main objectives of the study are to determine the safety of supplementation and to assess whether there are changes in infant growth. Additionally, potential changes in the intestinal microbiome induced by the increase in betaine intake will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age between 17 and 42 years
* Maternal pre-pregnancy BMI equal or higher than 25
* Gestational age at birth \> 37 weeks
* No exclusive breastfeeding at time of recruitment

Exclusion Criteria:

* Presence of disease or malformations in the infant
* Infant birth weight \< -1 SD (standard deviations)
* Multiple pregnancy
* Elective c-section