cyrilzakka/clinical-trials huggingface dataset:
A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839

EGFR and COX-2 are involved in tumorigenesis, angiogenesis and metastases and are frequently over expressed in NPC.COX-2 and EGFR inhibitors are active in NPC.There is synergistic action between COX-2 and EGFR inhibitors.

Study hypothesis: Celecoxib and gefitinib can reduce angiogenesis and induce anti-tumorigenicity in patients with nasopharngeal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven NPC.
2. Any clinical stage NPC as defined by the AJCC/UICC System.
3. No prior radiotherapy, chemoradiotherapy, immunotherapy or investigational agents.
4. No prior NSAIDs or corticosteroids for at least 4 weeks.
5. ECOG performance status ≤ 2.
6. Adequate end organ function
7. Life expectancy \> 3 months.
8. Signed informed consent -

Exclusion Criteria:

1. Inability to take celecoxib and gefitinib for the specified period of time (14 days) prior to definitive therapy.
2. Tumor not visible on fibre nasopharyngoscopy for biopsy.
3. Known peptic ulcer disease.
4. Evidence of clinically active interstitial lung disease.
5. Previous or concomitant malignancies with the exception of adequately treated carcinoma-in-situ of the cervix and basal or squamous cell carcinoma of the skin.
6. Women who are pregnant or lactating. Females with child-bearing potential must have a negative serum pregnancy test within 7 days prior to study enrolment.
7. Women of childbearing potential who are not practising adequate contraception.
8. Concurrent medical problems that would significantly limit compliance with the study.
9. Presence of any underlying medical conditions (eg. Unstable or uncompensated respiratory, cardiac, renal or hepatic disease) that in the opinion of the investigator would make the patient unsuitable for study participation.
10. Known hypersensitivity to celecoxib and gefitinib or any of the excipients of the products, known sulphonamide sensitivity and allergic reaction following the ingestion of NSAIDs.
11. Known HIV, HBV or HCV infection. -
A Study in Healthy Subjects to Investigate Pharmacokinetics of AZD8683 When Administered in Different Ways

The purpose of this study is to look at drug levels of AZD8683 in blood when the drug is administered in different ways - orally, intravenously or inhaled (with two different devices), to healthy subjects

A Phase I, Single-centre, Open-label, Partly Randomised, Cross-over Single Dose Study in Healthy Volunteers to Evaluate the Absolute Pulmonary Bioavailability of AZD8683 when Administered Inhaled via a New Dry Powder Inhaler and via Turbuhaler™

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or women of non-childbearing potential aged 18-45 years inclusive with suitable veins for cannulation or repeated vein puncture
* Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive) and weight between 50 and 100 kg (inclusive)
* Be able to inhale from the inhaler devices used in the study.

Exclusion Criteria:

* History of any clinically significant disease or disorder
* Current smokers
* Any clinically relevant abnormal findings in physical examination or laboratory values.
Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery

The primary objectives of this trial are:

* to show differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the test or a control product
* to investigate whether there is equivalence in growth between the four different groups of infant described above.

The primary objectives of this trial are:

* to show differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the test or a control product
* to investigate whether there is equivalence in growth between the four different groups of infant described above.

Design:

This is a controlled, double blind, randomized, multi center, clinical trial of 4 groups in parallel.

Two groups of infants (born from normal or caesarean delivery) will each consume one of 2 milk formulae.

Number of patients (to be enrolled / to be analyzed): Approximately 450 / 240 Stratification will be done by gender and delivery mode.

Description of subjects and main criteria for inclusion:

Healthy full term infants born from HIV positive mothers who have elected to feed their child exclusively with a milk formula from birth. Children born after normal or caesarean delivery will be considered separately.

Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn infant from HIV positive mother
* Full term infant (more or equal to 37 weeks gestation; less or equal to 42 weeks gestation)
* Age of infant 3 days at the time of enrollment
* Birth weight between 2500 and 4500 grams
* Singleton birth
* The infant's mother has elected to feed their child exclusively with a milk formula from birth
* Informed consent from the parent or legal guardian

Exclusion Criteria:

* Congenital illness or malformation that may affect normal growth
* Significant pre-natal and / or post-natal disease
* Newborns who have received antibiotics during the first 3 days of life
* Newborns whose parents / caregivers cannot be expected to comply with the study protocol
* Newborns currently participating in another clinical trial
An Analysis of Treatment Patterns and Outcomes for Basal Cell Carcinoma (BCC) Cancer Participants

This multi-center, observational study involves reviewing the medical records of approximately 100 adult participants diagnosed with advanced BCC from 01 January 2005 until 31 December 2010. Participant records will be analyzed to identify participant characteristics, treatment patterns and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of advanced BCC, defined as (1) locally advanced BCC (inoperable as determined by the site investigator or surgery contraindicated) with receipt of radiation therapy (unless radiation was contraindicated), or (2) metastatic BCC, from 01 January 2005 through 31 December 2010

Exclusion Criteria:

* Participation in an interventional trial that dictated treatment during the study time period (01 January 2005 - 31 December 2010), or within 90 days prior to individual participant' study enrolment dates
* Participants undergoing treatment with a Hedgehog pathway inhibitor
Physiological and Clinical Changes in NHF Therapy

The study explores the changes in pressure, volume and in hypercapnia in patients with COPD and ILD. The investigators will use different application forms.


Eligibility Criteria:
Inclusion Criteria:

* COPD, ILD

Exclusion Criteria:

* Unstable disease
Prevent Diabetic Kidney Disease Among Egyptians

Study of the possibility to prevent the development of Diabetic kidney disease in type 2 diabetic patients

Study of the possible role of the SGLT2 inhibitors to prevent the development of frank type2 DM among prediabetic candidates.

Study of the possible role of the SGLT2 inhibitors to prevent the development of diabetic complications, namely diabetic kidney disease, diabetic retinopathy and neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* diabetics,prediabetics

Exclusion Criteria:

-
Effects of Eicosapentaenoic Acid on Subjects at High Risk for Colorectal Cancer

The aim of this study is to test Eicosapentaenoic acid's effects on markers relevant to colorectal carcinogenesis, RNA and DNA profiles, and the possibility that Eicosapentaenoic Acid treatment might be associated with changes of the gut microbiota and metabolomic profiles in patients with long-standing ulcerative colitis.


Eligibility Criteria:
Arm: experimental

Inclusion Criteria:

* Patients with ulcerative colitis (diagnosed based on clinical criteria, endoscopic and histological) lasting over 8 years, with no clinical activity (SCCAI = 0), and in stable treatment (without any change in treatment in the previous 3 months) with mesalamine, immunomodulators and / or biologics.
* Baseline fecal calprotectin\> 150 micrograms / g.
* Signed informed consent.

Exclusion Criteria:

* Patients receiving systemic steroids in the two months prior to study entry.
* Patients taking concomitant warfarin or other blood thinners.
* Known or suspected hypersensitivity to eicosapentaenoic acid/omega 3.
* Women who are pregnant or of childbearing age who do not accept the use of contraceptive methods specified in the study (oral contraception, IUDs) and breastfeeding women.
* Patients with severe medical conditions that, in the opinion of the investigator, contraindicate the patient's participation in the study.
* Changes of treatments and / or use of experimental drugs within 3 months before inclusion in the study.
* Use of Probiotics

Arm: no intervention

Inclusion criteria

* Subjects undergoing screening colonoscopy within the regional colorectal cancer screening programme
* Signed informed consent
* Polypectomy with biopsy forceps.

Exclusion criteria

* HBV-positive, HCV-positive, HIV-positive or otherwise affected by infectious diseases
* Subjects undergoing chemo and radiation therapy within six months prior to surgery
* Patients receiving systemic steroid in the two months prior to study entry
* Patients undergoing antibiotic therapy within three months prior to the study
* Patients treated with probiotics
A First In Human Study to Assess CiVi007 in Subjects With an Elevated LDL-Cholesterol Level

The primary objective of the study is to assess pharmacokinetics, dynamics, safety and tolerability of CiVi007 following single and multiple subcutaneous doses in subjects, including those on statin therapy


Eligibility Criteria:
Key Inclusion Criteria:

* Males or females, of any race, with fasting LDL C \>2.6 mmol/L (100 mg/dL) and fasting serum triglycerides \<4.52 mmol/L (400 mg/dL)
* haematology and clinical chemistry without clinically significant abnormal values
* Normal renal and hepatic function
* Women must not be pregnant, lactating or of child bearing potential
* Men must be willing to use appropriate contraception during the study
* Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Key Exclusion Criteria:

* Any uncontrolled or serious disease, or any medical or surgical condition
* History or presence of coronary heart disease, peripheral artery disease, or cerebrovascular disease
* Uncontrolled hypertension
* Insulin dependent diabetes mellitus
* Secondary dyslipidemia
* History of renal or hepatic diseases, acquired immune deficiency syndrome, positive human immunodeficiency virus test and/or history of viral hepatitis B or C
* History of cancer within 5 years
* History of high alcohol consumption or positive alcohol breath test or urinary test for drugs of abuse
* Participation in another clinical study within 3 months prior to screening or participation in another study
* Use of treatment (e.g. antibody) towards PCSK9
* History of multiple drug allergies or intolerance to subcutaneous injection.
Prevent/Delay Development of Type 2 Diabetes in Subjects With Impaired Glucose Homeostasis Treated With Acarbose in Primary Care

The purpose of the study is to determine if the administration of small doses of Acarbose can prevent or delay the appearance of Type 2 Diabetes Mellitus in a population of subjects with prediabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 40 and \< 75 years old
* Men and women
* Able to give voluntary informed consent
* Existence of one or more of the following risk factors:
* Body Mass Index (BMI) \> 27 mg/Kg2
* One or more family members with diabetes determined by anamnesis.
* Personal antecedents of previous blood glucose anomalies (gestational diabetes reverted after the lactation time, before-during surgical stress, fasting glycaemia \> 110 mg/dL (6,1 mM) and \< 126 mg/dL (7 mM) registered in the Clinical History during the last 3 years, etc.)
* Previous consumption of drugs with hyperglycaemic capacity for a period of 3 months continuously or more than 6 months discontinuously

Exclusion Criteria:

* Type 2 DM
* Pregnancy during the study
* Nursing women
* Major debilitating (e.g. collagen vascular diseases, failure of major organ, psychosis, severe infections, neutropenia, BMI \< 20 mg/Kg2)
* Subjects taking a prohibited drug (see protocol)
* Subjects taking drugs that can impair intestinal motility and/or carbohydrate absorption (i.e. cholestyramine, neomycin)
* Recent cardiovascular events (within last 6 months) such as myocardial infarction, cerebrovascular accident, congestive heart failure
* Serum creatinine \> 2 mg/Dl
* Fasting triglycerides \> 10 mm/L (\> 885 mg/dL)
* AST elevation \> 2.5 times above the upper limit of normal
* Subjects with hyper/hypothyroidism non compensated
* Subjects with documented gastrointestinal diseases that are likely to be associated with abnormal intestinal motility or altered absorption of nutrients (e.g. gastroparesia, malabsorption syndrome, chronic diarrhoea states, enteropathies, inflammatory bowel diseases, partial intestinal obstruction, large hernias)
* Subjects with any emotional disorder or substance abuse (e.g. severe depression, alcohol or drug abuse)
* Hypersensitivity to Acarbose
Systematic Search for Primary Immunodeficiency in Adults With Infections

Antibody deficiencies and complement deficiencies are the most frequent Primary immunodeficiencies (PIDs) in adults, and are associated with greatly increased susceptibility to recurrent and/or severe bacterial infections - especially upper and lower respiratory tract infections and meningitis. The literature data suggest that PIDs are under-diagnosed in adults. The current European and US guidelines advocate screening adults for PIDs if they present recurrent benign especially upper and lower respiratory tract infections, or if they have experienced at least two severe bacterial infections and/or have a recurrent need for intravenous antibiotics. The objective of the demonstrate the interest of PIDs screening in adult patients who present such recurrent infections and/or after the first severe bacterial infection, especially when the patients do not present with known, etiologically relevant comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 yrs old patients
* ≥ 2 bacterial upper or lower respiratory tract infections/years, for at least 2 years, or
* ≥ 1 severe bacterial upper or lower respiratory tract infection requiring hospitalization and IV antibiotics, or
* ≥ 1 invasive infection (meningitis, bacteriemia, arthritis) due to Streptococcus pneumoniae, group A Streptococcus, Haemophilus influenzae, Neisseria meningitidis or Neisseria gonorrhoeae

Exclusion Criteria:

* concomitant, systemic comorbidity that predisposes to infection (solid or hematological cancer, diabetes mellitus, severe alcohol or intravenous drug abuse, chronic liver or kidney failure, human immunodeficiency virus infection, anatomic or functional asplenia, drug-induced 1 neutropenia, or solid organ or hematopoietic stem cell transplantation).
* the presence of a local predisposing factor: cigarette smoking (\> 5 pack-year and/or 5 cigarettes/day), underlying infection (tuberculosis, influenza...), chronic obstructive pulmonary disease, cystic fibrosis or bronchiectasis for pulmonary infections; cerebrospinal leak or preceding upper respiratory tract (URT) infections for non-meningococcal meningitis; oral, dental or skin condition for GAS infections
* use of corticosteroids, non-steroidal anti-inflammatory drugs, immunosuppressants or cytotoxic chemotherapeutics
* PID diagnosed before the infectious episode in question.
* current or recent pregnancy
* hospital-acquired infection (including infections of prostheses).
EACA VS CCA in Postoperative Evaluation of Middle Ear Pressure

Is to evaluate the effect on Eustachian Tube (ET) and changes in middle ear pressure in early period after adenoidectomy by using Endoscopic Assisted Coblation Adenoidectomy (EACA) VS Conventional Curettage Adenoidectomy (CCA)

Adenoid hypertrophy is a common condition in children causing symptoms such as mouth breathing, nasal discharge, snoring, sleep apnea, and hypo nasal speech. It also plays a role in the pathogenesis of rhinosinusitis, recurrent otitis media, and otitis media with effusion. Currently, adenoidectomy is one of the most commonly performed pediatric surgical procedures worldwide. Although there is still poor evidence in the literature, recurrent upper respiratory infections, otitis media with effusion, and obstructive sleep apnea syndrome are considered to be the main indications of adenoidectomy . Conventional curettage adenoidectomy (CCA) is a widely adopted method for over a hundred years. Conventional curettage adenoidectomy is performed blindly via adenoid curette; this may be associated with residual adenoid tissue existence and increased postoperative morbidity including, Eustachian tube dysfunction, inadvertent injury to peripheral tissue and postoperative bleeding . An ideal adenoidectomy technique should be safe, quick, easy, and provide decreased postoperative complication and morbidity .Recently Adenoidectomy can be carried out with several techniques such as electrocautery, bipolar coagulation, radiofrequency ablation, and coblation techniques .

Eustachian tube dis function (ETD) can develop due to surgical trauma , edema in surrounding tissues and clots in early period following adenoidectomy surgery performed with curettage technique .

Eligibility Criteria:
Inclusion Criteria:

- Pediatric patients presented with adenoid hypertrophy who undergoing primary adenoidectomy with or without tonsillectomy , with the following criteria:

* Age: between ( 5-14 years )
* With or without chronic tonsillitis
* Clinicaly Normal tympanic membrane without secretory otitis media .

Exclusion Criteria:

* Patients with the following criteria will be excluded from the study :
* Patients with secretory otitis media .
* Previous adenoidectomy.
* Previous ear surgery, cleft palate, Down's syndrome, congenital malformation of the ear and cholesteatoma.
* Recurrent upper respiratory tract infection.
Group Psychotherapy in Long COVID

The aim of the present study was to establish a single-arm group psychotherapy and to evaluate its clinical effectiveness in long COVID patients.

This study took place at the Cantonal Hospital St.Gallen, a tertiary care hospital in Eastern Switzerland, and included data collection between November 2021 and January 2024. During this time span, the same licensed psychotherapist conducted the group psychotherapy six times in total with a maximum of nine patients each. Each of the six groups had one-hour group therapy sessions weekly within eight consecutive weeks. During the study period, the group psychotherapy was part of a more comprehensive treatment for long COVID as all patients primarily received active pacing therapy.

The investigators implemented cognitive-behavioral therapy (CBT) and acceptance and commitment therapy (ACT) elements into group psychotherapy and focused on fatigue, insomnia, depression, anxiety, somatic symptoms, psychotraumatology, and quality of life as psychosomatic outcome measures (pre- and post-interventional).

Eligibility Criteria:
Inclusion Criteria:

* Signed general consent form of the Cantonal Hospital of St.Gallen
* Adult patients (≥ 18 years of age)
* Long COVID diagnosis made as part of the long COVID consultation at the Cantonal Hospital of St.Gallen
* Screening for psychological stress and suitability for group therapy through an initial consultation with a psychotherapeutic specialist from the Department of Psychosomatic Medicine and Consultation-Liaison Psychiatry at the Cantonal Hospital of St.Gallen

Exclusion Criteria:

* Insufficient language skills for completing the questionnaires in German
* Refusal to sign the general consent form
* Severe mental disorders requiring an individualized setting, i.e. suicidal tendencies at the time of screening, acute psychosis and personality disorder
Personalized Support Using Instant Messaging Applications to Increase Smoking Cessation

This study aims to assess the effect of personalized support using instant messaging application on smoking cessation in smokers proactively recruited from smoking hotspots in Hong Kong.

Detailed Description: With the advancement of information communication technologies (ICTs), instant messaging applications (IM Apps, e.g. WhatsApp and WeChat) can be used for providing synchronous, personalized, interactive interventions for health promotion. This study proposes to apply IM Apps for enhancing our tested brief smoking cessation (SC) intervention model from AWARD to e-AWARD (AWARD: Ask, Warn, Advise, Refer, Do-it-again,) without medications to increase SC in smokers proactively recruited in smoking hotspots in Hong Kong. Such smokers are the majority and have low quit rate. IM Apps allows trained SC advisors to proactively deliver personalized SC advices, response to smokers' needs promptly, and provide psychosocial support. No similar trials are found in PubMed, Cochrane Library and trial registries (ClinicalTrials.gov \& ISRCTN) (except the pilot trial of this study). The aims of this study are as follows:

1. To assess the main effect of the personalized support using instant messaging applications (Intervention) vs. Control group on biochemical validated smoking abstinence at 6-month and 12-month.
2. To assess the effects on self-reported past 7-day abstinence, 24-week continuous abstinence, smoking reduction, self-efficacy of quitting, intention to quit, quit attempts and SC medications and services use at 6-month and 12-month.
3. To identify the mediators, which can inform mechanisms of the intervention on SC.
4. To evaluate the cost-effectiveness of the above interventions.
5. To understand the effects subjects' experience of IM support on SC using a qualitative study approach.

Eligibility Criteria:
Inclusion Criteria:

* Adult smokers aged 18+ who smoke cigarette(s) daily.
* Exhaled carbon monoxide (CO) level of 4ppm or above.
* Having smartphones with IM Apps (WhatsApp) and have experience in using.
* Hong Kong residents able to read and communicate in Chinese (Cantonese or Putonghua).

Exclusion Criteria:

* Smokers who have psychiatric/psychological diseases or are on regular psychotropic medications.
* Smokers who are using SC medication, NRT, other SC services or projects.