cyrilzakka/clinical-trials huggingface dataset:
Predictive Factors in Chronic Rhinosinusitis With Nasal Polyps

The study will be conducted to identify factors predicting the response of chronic rhinosinusitis with nasal polyps ( CRSwNP) to oral corticosteroids.

Treatment of nasal polyposis is divided into medical or surgical treatment .

Steroids are widely used as the most effective medicine in nasal polyposis. Although oral corticosteroids are one of the frequently used treatments in the management of chronic rhinosinusitis with nasal polyps (CRSwNP), there is lack of effective means of predicting corticosteroid sensitivity in those patients. It was reported that the overall sensitivity rates of corticosteroid therapy to nasal polyps( NP) were only between 53.8% and 80%.. Many reports stated that serum and tissue interleukeine 25 (IL 25) and serum and tissue eosinophalia are good predictors to the response of CRSwNP to oral corticosteroids.

Interleukeine 25(IL-25), an important epithelial-derived proinflammatory cytokine, plays various roles in different inflammatory and allergic diseases, such as asthma and atopic dermatitis .

Hong et al demonstrated that the levels of IL-25 in NP tissues and in serum, as well as the NP endoscopic scores, were significantly elevated in the corticosteroid-sensitive patients compared with the non-sensitive ones. In general, eosinophilic NPs are pharmacologically glucocorticoid responsive, but non-eosinophilic or neutrophilic CRSwNP is frequently resistant to steroid treatment.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of chronic rhinosinusitis with nasal polyps

Exclusion Criteria:

* 1-Patients who had taken any steroid , antihistamine or other immune-modulating medications within the past 4 weeks

  2- previous nasal and sinus surgery.

  3-Allergic Fungal rhinosinusitis.

  4-Unilateral rhinosinusitis.

  5- Antrochoanal polyps or cystic fibrosis.
Kinesiophobia in Prostate Cancer

This study aimed to investigate the effects of prostate cancer on patients' physical activity, kinesiophobia, fatigue and functionality.

This research is a prospective study to be conducted on volunteer individuals between the ages of 40-75. People diagnosed with prostate cancer (study group) and healthy adults who have not been diagnosed with prostate cancer before (control group) will be included in the study. The demographic characteristics, physical activity levels and quality of life of all individuals participating in the study will be evaluated with an online form. In demographic data, physical, sociodemographic data such as age (years), height (cm), body weight (kg), body mass index (kg/m2) and disease-specific information will be recorded. Physical activity level will be measured with the International Physical Activity Survey short form (UFAA), fatigue with the Functional Evaluation of Chronic Disease Treatment-Fatigue Questionnaire, fear of movement with the Causes of Fear of Movement Questionnaire, and quality of life with the Functional Evaluation of Cancer Treatment-Prostate Version questionnaire (KHTFD-Y).


Eligibility Criteria:
Inclusion Criteria:

* (for prostate cancer-study group)

  * Being between the ages of 40-75
  * Want to participate in the study
  * Being able to read and write
  * Being diagnosed with prostate cancer by a specialist physician,
  * Being able to provide their mobility independently,
* (for healthy controls - control group)

  * Being between the ages of 40-75
  * Not having any previous cancer history and not having undergone cancer surgery
  * Volunteering to participate in the study

Exclusion Criteria:

* Those with a previously known or accompanying diagnosis of dementia
* Not wanting to participate in the study
* The individual has a disease that may prevent him or her from understanding and completing the survey.
* Illiterates
* Those who do not want to participate in the research voluntarily
* Having active metastasis
* Having undergone chemotherapy and radiotherapy in the last 6 months
USDA Healthy Incentives Pilot

The USDA Healthy Incentives Pilot (HIP) evaluated the impact of a 30% financial incentive on fruit and vegetable intake among adult participants in the USDA Supplemental Nutrition and Assistance Program (SNAP).

U.S. fruit and vegetable intake remains below recommendations, particularly for low-income populations. Evidence on effectiveness of financial incentives for addressing this shortfall is limited.

This study examined effects of USDA's Healthy Incentives Pilot (HIP), which offered financial incentives to Supplemental Nutrition Assistance Program (SNAP) participants for purchasing targeted fruits and vegetables (TFV).

A randomized controlled trial of HIP was conducted in Hampden County, Massachusetts. 7,500 randomly selected SNAP households received a 30% rebate on TFV purchased using SNAP benefits. The remaining 47,595 SNAP households in the county received benefits as usual. Adults in 5,076 households were randomly sampled to complete telephone surveys, including 24-h dietary recall interviews. Surveys were conducted at baseline-1-3 mo pre-implementation-and in two follow-up rounds, 4-6 mo and 9-11 mo post-implementation. 2,784 adults (1,388 HIP, 1,396 non-HIP) completed baseline interviews; data were analyzed for 2,009 adults (72%) also completing at least one follow-up interview.

Eligibility Criteria:
Inclusion Criteria:

* Households with residential or mailing address in Hampden County, Massachusetts
* Receiving SNAP benefits in July 2011

Exclusion Criteria:

* Child-only cases (households not including at least one member aged 16 or older eligible to serve as SNAP head of household)
* Cases with benefits signed over to residential or treatment facilities
Development of Chronic Ankle Instability After Acute Ankle Sprain

The goal of this observational prospective cohort study is to determine key clinical predictors for chronic ankle instability and return to sports in patients who suffered an acute ankle sprain.

The researchers will evaluate clinical outcome measures and patient reported outcome measures on 3 test moments and at 12 months of follow-up.

In this prospective cohort study, 4 different measurement time points will be used: 7-14 days, 6 weeks, 12 weeks and 12 months after the initial ankle sprain event. The researchers will include physically active people that engage in sports regularly, who recently suffered an acute ankle sprain. Recruitment will be done via hospital emergency departments, casualty departments and sports injury clinics, GP's, sports federations and social media.

The researchers will only use outcome measurements that are applicable in clinical practice, and patient reported outcome measures to evaluate the participants. The main outcome of this study is the development of chronic ankle instability, based on published criteria. The researchers aim to determine which clinically applicable outcome measures are key determinants for the development of chronic ankle instability. A secondary outcome is successful return to sports, with the objective to determine key clinically applicable determinants for successful recovery and return to sports.

Eligibility Criteria:
Inclusion Criteria:

* 18-55 years old
* Acute ankle sprain: \<7 days
* Athletes (recreational or professional)
* Previous ankle sprain \>12 months

Exclusion Criteria:

* Recurrent ankle sprain
* Ankle fracture
* Chronic ankle instability
* High ankle sprain (syndesmosis)
* A history of ankle or foot operations
* Other lower limb injuries and/or complaints
* Severe ocular impairments
* Any neurological, cardiac, vascular or metabolic disease
A Trial to Evaluate Faropenem Medoxomil in the Treatment of Acute Otitis Media

The study will be conducted in infants and children with acute otitis media, 6 months to less than 7 years old, in Costa Rica and Israel. The primary objective of this trial will be to describe bacteriologic efficacy in those with initial culture positive specimens with different dosages of faropenem

The study will be conducted in infants and children with acute otitis media, 6 months to \<7 years old, in Costa Rica and Israel. Faropenem is to be used as therapy for both simple and complicated AOM.

Eligibility Criteria:
Inclusion Criteria:

* Acute Otis Media

Exclusion Criteria:

* Any antibiotic for more than 24 hours (unless a treatment failure) within 7 days prior to enrollment
The Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19

The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II/III trial, and will be conducted globally. The study is comprised of two parts: dose selection (Phase II) and pivotal treatment effect (Phase III).

In this study, Phase II part will evaluate the efficacy, safety and PK of SCTA01 low dose+BSC, high dose+BSC and placebo+BSC in patients with severe COVID-19.

In Phase II part, subjects will be randomized at 1:1:1 ratio. At the end of Phase II part, a dose for the Phase III will be determined.

The Phase III part will evaluate the efficacy, safety, and immunogenicity of SCTA01 at the recommended dose recommended. Subjects in Phase III part will be randomized at 1:1 ratio to SCTA01+BSC and placebo+BSC groups.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with severe COVID-19 (5 point on NIH 8-point ordinal scale).
* Male or female adult ≥18 years of age at time of enrollment;
* Biological samples (not limited to any specific type) collected within 72 hours before randomization is laboratory-confirmed as SARS-CoV-2 infection (PCR or antigen-based diagnostic tests);
* ≤ 10 days since symptoms of COVID-19 onset.

Exclusion Criteria:

* Patients who need non-invasive ventilation or high flow oxygen (i.e., 6 point on the 8-point ordinal scale);
* Patients with critical COVID-19;
* Patients with Severe COVID-19 who received convalescent plasma or COVID-19 vaccine, or anti-SARS-CoV-2 spike (S) protein targeted therapy;
* Alanine-amino transferase (ALT) or aspartate transaminase (AST) is 5 times higher than the upper limit of the normal value;
* Estimated glomerular filtration rate (eGFR) \<30 mL/min or on dialysis {eGFR calculated by Cockcroft-Gault formula (Cockcroft DW, 1976), Male: CrCL (mL/min) = \[(140 - age) × weight (kg)\] × 1/ \[SCr (mg/dL) × 72\]; Female: CrCL (mL/min) = \[(140 - age) × weight (kg)\] × 0.85/ \[SCr (mg/dL) × 72\]}.
Real-life Experience of Tofacitinib in Patients With Treatment-Resistant Rheumatoid Arthritis

The investigators aimed to present the efficacy and safety data for patients with RA who received tofacitinib therapy in outpatient clinics.

This retrospective cohort study included 35 patients with rheumatoid arthritis who received tofacitinib therapy in rheumatology outpatient clinic between June 2015 and December 2019. Patients who received tofacitinib due to unresponsiveness to ≥2 conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and/or ≥1 biological disease-modifying anti-rheumatic drugs (bDMARDs) were retrospectively evaluated. Demographic characteristics of the patients, the disease activity score-28 for rheumatoid arthritis with erythrocyte sedimentation rate (DAS 28-4 (ESR)), change in DAS-28, health assessment questionnaire score, visual analogue scale score, and laboratory parameters such as erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) level, hemogram, lipid parameters, and uric acid were recorded. The data at six months of treatment were compared with baseline data. The effects related to the treatment as well as the undesired consequences were evaluated.

Eligibility Criteria:
Inclusion Criteria:

Patients who received tofacitinib due to unresponsiveness to ≥2 csDMARDs and/or ≥1 bDMARDs were retrospectively evaluated.

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Exclusion Criteria:

Patients who could not tolerate the treatment and whose follow-up results could not be reached were excluded from the study.

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Intrathecal Dexmedetomidine With Bupivacaine for Spinal Anesthesia in Cesarean Section

A Randomized, Controlled, Double blind study aiming to evaluate the analgesic potentials and side effect profile of different dose levels of Dexmedetomidine added to subarachnoid bupivacaine in full-term pregnant women undergoing elective cesarean section using spinal anesthesia. The investigators ultimate goal is to find out the least effective dose which will be associated with minimal or no side effects. The primary outcome will be the time to two sensory block segment regression.

Alpha 2-agonists are non-opioid adjuvants with a significant role in extending the analgesic duration of subarachnoid block. When clonidine or Dexmedetomidine was added to intrathecal local anesthetics, the regression of sensory and motor blocks increased dose-dependently. Further, a recent meta-analysis including seven randomized controlled studies reported an increase in the duration of analgesia and reduced morphine requirement after the concomitant subarachnoid administration of clonidine.

Animal studies demonstrated that Dexmedetomidine added to bupivacaine significantly enhanced the duration of sensory and motor blockade of sciatic nerve block. Histo-pathological examination proved that all of the nerves analyzed had normal axons and myelin at 24 h and 14 days after the peri-neural administration of Dexmedetomidine. Several clinical studies confirmed the analgesic potentials and safe neurological outcome of neuraxially administered Dexmedetomidine in the non-obstetric settings while intrathecal clonidine proved to be a useful analgesic adjunct for spinal anesthesia in patients undergoing cesarean section. But to the best of the investigator knowledge the effects of intrathecal Dexmedetomidine on the perioperative clinical profile of bupivacaine-induced spinal anesthesia were not studied before in the obstetric patient population.

Eligibility Criteria:
Inclusion Criteria:

* Full-term pregnant women.
* Elective cesarean section using spinal anesthesia.
* Singleton gestation.
* American Society of Anesthesiologists (ASA) physical status classes I and II.

Exclusion Criteria:

* Preterm pregnancy (\<37 wks gestation).
* Multiple gestation.
* Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of antihypertensive medication.
* Conditions that preclude spinal anesthesia.
* Failed spinal block and conversion to general anesthesia.
* A history of established chronic pain.
* Drug addiction.
* A psychiatric disorder.
* Inability to communicate effectively.
* Asthma and allergy to non-steroidal anti-inflammatory drugs.
Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Patients With Slight Hypertension and Target Organ Damage

Patients with slight increase in blood pressure levels have an increased cardiovascular risk. In particular this has been demonstrated also in subjects with high-normal blood pressure in whom an exaggerated blood pressure increase, during exercise, and structural left ventricular abnormalities have been shown. On the other hand, the last American and European guidelines for management of hypertension recommend more aggressive treatment in young-middle aged subjects to achieve a better control of cardiovascular risk due to blood pressure increase. In agreement with these recommendations the investigators share the idea that a good blood pressure control should be achieved not only at rest, but also during psycho-physical stress conditions that frequently occur during daily life. On this basis, the investigators decided to evaluate the efficacy and tolerability of the association of valsartan and hydrochlorothiazide (160 an 25 mg daily, respectively) in patients with high-normal blood pressure and first degree arterial hypertension with evidence of organ damage.

The aim of this study is to assess if an early and adequate therapy could bring to a better pressure control (even during physical activity) and a regression of organ damage without interfering with metabolism and erectile function


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65
* Gender Males
* High-normal blood pressure (130-139 mmHg or 85-89 mmHg)
* First degree hypertension (140-159 mmHg or 90-99 mmHg)
* Cardiac remodeling (left ventricular concentric hypertrophy

Exclusion Criteria:

* Coronary artery disease
* Secondary hypertension
* Diabetes mellitus
* Incapacity to perform ergometry test
* Anemia (Hb \< 12.5g/dL)
* Cardiac valve disease
* Arrhythmia
Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

This is randomized, double-blind, placebo controlled, single centre; 21 days phase II clinical trial on healthy volunteers. Following baseline visit at the day of randomization, treatment with Augmentin 875mg for 7 days will be given. Concurrently and after antibiotic treatment subjects will also receive the study treatment, either probiotic or placebo. Daily Bowel Habit Diary will be completed by the subjects. The subjects will be asked to collect fecal samples for microbiological examination. The primary objective of the study is to evaluate the maintenance of intestinal microbiota composition during antibiotic treatment with Augmentin 875mg. Secondary objectives will be to evaluate the reduction in side effects associated with antibiotic use.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 to 50 years.
* Healthy as determined by laboratory results, medical history and physical exam
* Willing to give voluntary, written, informed consent to participate in the study

Exclusion Criteria:

* Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
* Body mass index ≥ 30 kg/m2
* Average number of formed bowel movements \> 3 per day or \< 3 per week
* Smokers
* Participation in a clinical research trial within 30 days prior to randomization
* Use of antibiotics within 60 days prior to randomization.
* Habitual use of pro- and/or prebiotic products.
* Follows a vegetarian or vegan diet
* Unstable medical conditions
* Any evidence of acute or chronic gastrointestinal disorder
* Alcohol use \> 2 standard alcoholic drinks per day and/or alcohol or drug abuse within past year
* Allergy or sensitivity to test product ingredients or antibiotic
* Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
LarynGuide™ Assisted Tracheal Intubation

This study aims to asses if the application of the larynGuide™, an assistive software running on a video-laryngoscope platform guiding laryngoscopy and intubation advise correctly and reliably on the position of the tracheal tube after an intubation attempt.

Eligible patients will be prepared for intubation according to the local SOPs of the anesthesia departments with mandatory monitoring of SpO2, HR, NIBP, EtCO2.

For the anesthesia Patients will be pre-oxygenated before induction via face-mask with FiO2 = 1.0 and flow rates of 18L/min until etO2 reaches 90%. Induction of anesthesia and TI will be performed using a combination of sedative/hypnotic drugs, opioids and non-depolarizing muscle relaxant. The following medications will be mandatory as per protocol:

* Hypnotic agent (Propofol 1-4 mg/kg).
* Opioids (Fentanyl 1-3 mcg/kg, Remifentanyl 1-3 mcg/kg).
* Non-depolarizing muscle relaxant (Rocuronium 0.5-1 mg/kg). After induction of anesthesia and the administration of the muscle relaxant, bag-mask ventilation with FiO2 = 1.0 (flow rates of 18 Lmin-1) will be performed until apnea sets in. After induction all patients will be paralyzed to facilitate airway management. Neuromuscular blockade will be assessed by train-of-four monitoring. Thereafter oxygen administration, laryngoscopy and tracheal intubation are performed as usually.

Tracheal intubation performed with the aid of larynGuide™, an assistive software running on a video-laryngoscope platform guiding laryngoscopy and intubation (aiEndoscopic, Zürich, Switzerland). The larynGuide™ will be combined with the C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with a Macintosh nr 3 or 4 blade by a board-certified anesthesiologist. The board-certified anesthesiologist performing the intubation communicates to the research staff when he completed the intubation attempt. The anaesthesiologist in charge (board certified) checks to assess the correctness of the tube position by visual check and by attaching the patient to the ventilator and measuring the endtidal CO2 (Gold standard for detection of tube placement in anesthesia).

For the study the research staff will then - after the confirmation of the anaesthesiologist in charge of the tubes correct placement - look if the software displays a green light or the words "Bad intubation" on the monitor and document either outcome.

Eligibility Criteria:
Inclusion Criteria:

* male or female patients ≥18 years
* ASA class I to III
* undergoing elective surgery in general anesthesia with tracheal intubation

Exclusion Criteria:

* Contraindication for intubation with C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with a Macintosh nr 3 or 4 blade
* Patients \< 18 years
* No proper trained personnel for the device at the study site
* Expected impossible mask ventilation.
* High risk of aspiration (requiring rapid sequence induction intubation)
* Intracranial surgery
* Limited knowledge of German language or refusing informed consent
Vascular Impact of Omega-3 in Metabolic Syndrome

The overall aims of the present project are to investigate the impact of a nutritional approach based on omega-3 from vegetal origin on vascular function in hypertension associated with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients with treated essential hypertension (blood pressure values\<140/90 mmHg under antihypertensive treatment).
* Presence of at least two of the following criteria of the metabolic syndrome: abdominal girth \>102 cm in men or \>88 cm in women, HDL-C\<0.4 g/L in men or \<0.5 g/L in women, fasting triglyceride \>1.5 g/L (or specific treatment for these lipid abnormalities), fasting glucose \>1.10 g/L.

Exclusion Criteria:

* Secondary hypertension, myocardial infarction, coronary artery disease, cerebrovascular disease, stroke or transient ischemia, cardiac failure, diabetes (or fasting glucose\>1.26 g/L) or renal failure (MDRD \< 50 ml/min)
* Severe hypercholesterolemia (total cholesterol \> 2.5 g/l), alcohol or drug abuse, toxicomania, or clinically significant abnormalities in other current biological parameters.
Malnutrition in Chinese Hospitalized Patients and Optimizing the Usage of Nutritional Screening Tools

The purpose of this study is:

* to diagnose malnutrition in Chinese hospitalized patients with four nutritional screening tools: mini-nutritional assessment - short form, subjective global assessment, malnutrition universal screening tool and nutritional risk screening 2002.
* to optimize the usage of nutritional screening tools based on data-mining methods.


Eligibility Criteria:
Inclusion Criteria:

* Ages≥18; admitted to hospital≥24h and did not receive operation until 8.am next day.

Exclusion Criteria:

* Patients who were pregnant or breast-feeding, and those who could not be interviewed or provide informed consent were excluded.