cyrilzakka/clinical-trials huggingface dataset:
Hepatic Arterial Infusion in Treating Patients With Locally Advanced, Non-Metastatic Cholangiocarcinoma

This pilot clinical trial studies the safety and effectiveness of continuous hepatic arterial infusion (HAI) of floxuridine (FUDR) alone or in combination with other chemotherapeutic drugs in treating patients with locally advanced cholangiocarcinoma that cannot be removed by surgery. HAI is a method to deliver higher concentrations of FUDR more directly to liver tumors and reduces side effects. HAI alone or in combination with oxaliplatin and/or gemcitabine may significantly improve clinical outcomes of patients with locally advanced cholangiocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have suspected intrahepatic or hilar cholangiocarcinoma with minimal extrahepatic disease. Diagnosis must be histologically or cytologically confirmed for continued treatment on study after pump placement.
* Patient must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan/MRI
* Patient must have disease that is unresectable or borderline resectable with \< 70% liver involvement by cancer
* Patient must be \>= 18 years old.
* Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =\< 2 (Karnofsky \>= 60%)
* Patient must have normal organ and marrow function as defined below:

  * Absolute neutrophil count \>= 1,500/mcL
  * Platelets \>= 75,000/mcL
  * Total bilirubin =\< 2 mg/dL
  * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) =\< 5 X institutional upper limit of normal
  * Creatinine \<= institutional upper limit normal
* Patient must be able to understand and willing to sign a written informed consent document

Exclusion Criteria:

* Patients must not have had prior treatment with FUDR
* Patient must not be receiving any other investigational agents
* Patient must not have a diagnosis of Gilbert's disease
* Patient must not have a diagnosis of hepatic encephalopathy
* Patient must not have had prior external beam radiation to the liver
* Patient must not have a diagnosis of sclerosing cholangitis
* Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patient must not be pregnant or breastfeeding
Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325

The purpose of this study is to assess the effect of a high fat meal and light meal on the blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs as a fixed-dose combination in healthy subjects.

IND Number: 100,932/79,599/101,943

Primary Purpose:

Other: Phase 1 clinical pharmacology bioavailability study to assess food effect

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy male and female subjects ages 18 to 49 years, inclusive.
* Women of childbearing potential must be using an acceptable method of contraception for at least 4 weeks prior to study drug administration.

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Any gastrointestinal surgery that could impact upon the absorption of study drug, including cholecystectomy
* History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease
* Use of tobacco-containing or nicotine-containing products
* Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration, confirmed by repeat:

  * PR ≥210 msec
  * QRS ≥120 msec
  * QT ≥500 msec
  * QTcF ≥450 msec
* Any of the following laboratory results outside of the ranges specified below prior to study drug administration, confirmed by repeat:

  * Alanine aminotransferase (ALT) \>Upper limit of normal (ULN)
  * Aspartate aminotransferase (AST) \>ULN
  * Total bilirubin (TBILI) \>ULN
  * Creatinine \>ULN
A Dose Ascending, Study To Examine The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of GSK233705B.

GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for the treatment of chronic obstructive pulmonary disease. This is a randomised, double-blind, placebo-controlled, dose ascending, parallel group study to examine the safety, tolerability, pharmacokinetics and pharmacodynamics of twice daily inhaled doses of GSK233705B for 7 days, in COPD subjects.


Eligibility Criteria:
Inclusion Criteria:

* Men or women who are between 40 and 75 years of age
* Female subjects must be of non-childbearing
* Subject diagnosed with COPD
* Body Mass Index 18.0 - 32.0 kg/m2 (inclusive)
* Subject is a smoker or an ex-smoker
* Subject has post-bronchodilator (200µg salbutamol) FEV1 of = 40% to = 80% of predicted normal.
* Subject has FEV1/FVC \< 0.7 post-bronchodilator (200µg salbutamol).
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Subject is available to complete all study measurements and procedures.
* Subjects have a 24hour holter recording that is within normal limits and does not demonstrate any clinically important abnormality that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.

Exclusion Criteria:

* Subjects who have a past or present disease, which as judged by the Investigator and the Medical Monitor, may affect the outcome of this study.
* The subject has a positive pre-study alcohol screen.
* The subject has a positive pre-study drug screen.
* History of alcohol/drug abuse or dependence within 12 months of the study: Abuse
* The subject has a positive pregnancy test.
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
* Subject has tested positive for HIV
* The subject has participated in a clinical trial and has received a drug or a new chemical entity within 60 days or 5 half-lives
* Exposure to more than three new chemical entities (NCE) within 10 months prior to the first dosing day or one NCE within 3 months prior to the first dosing day.
* The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study.
* The subject has a known allergy or hypersensitivity to ipratropium bromide, atropine and any of its derivatives or milk protein/lactose.
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
* Subject has prostate hypertrophy or narrow angle glaucoma
Animal Allergy in Korean Pet Owners, Pet-related Industry Workers, and Laboratory Animal Reseachers

The investigators surveyed the prevalence of animal allergy and sensitization to animal allergen among participants in international symposium of Korean association for laboratory science (laboratory animal researchers) and companion animal exhibition (pet owner and pet-related industry workers).

The investigators enrolled participants in international symposium of Korean association for laboratory science (laboratory animal researchers) and pet animal exhibition (pet owner and pet-related industry workers) after informed consents. Subjects were asked to response to questionnaires regarding their age, gender, comorbid allergic disease, family history of allergy, pet or laboratory animal, exposure time, allergic symptoms during exposure to animals. Subjects underwent skin prick test with animal allergens and other inhalant allergens.

Eligibility Criteria:
Inclusion Criteria:

* Participants in international symposium of Korean association for laboratory science and companion animal exhibition from whom informed consents were obtained.

Exclusion Criteria:

* Subjects who reject enrollment into this study.
Study of Serum Markers for Cardiovascular Risk in Obese Youth and Impact of Lifestyle and Medication Intervention

In Protocol #2, we will select 30 obese pubertal and 30 obese prepubertal subjects with an abnormal cytokine profile (i.e. fibrinogen and/or hsCRP concentration greater than or equal to 2 Standard Deviations (SD) above the mean established in our lab for lean controls in Protocol #1). They will be randomly assigned to either lifestyle intervention (diet/exercise) or diet/exercise plus metformin for 6 months. After the 6 month evaluation the subjects will cross over the treatment arms, i.e., those that were doing diet/exercise intervention only will add metformin, those that were doing the diet/exercise plus metformin will discontinue the metformin and continue with diet/exercise changes only. Intrahepatic fat contents will be measured as well.

The investigators hypothesize that obese children in these age groups will have increased cardiovascular risk related to their obese state before reaching the currently defined criteria of metabolic syndrome.

The investigators hypothesize that these cardiovascular risks can be reduced with lifestyle and drug interventions.


Eligibility Criteria:
Inclusion Criteria:

* Ages 7-18 years.
* Greater than the 95th percentile body mass index for their age and gender.
* Children are in Tanner Stage I or IV or V.
* Normal Blood Pressure.
* Normal fasting glucose.
* Normal lipids.
* Menstruating girls must have completed their most recent period at least 2 weeks prior to blood draw.
* No recent illness, no chronic illnesses, no routine medications, no smoking or alcohol intake.
* Must pass the screening test done in Protocol #1.
* Must have higher values than normal for certain blood tests related to heart disease that were measured in Protocol #1.

Exclusion Criteria:

* Chronic active illnesses.
* Recent illnesses.
* Use of routine medications, vitamins, herbal remedies, oral contraceptive pills, or other over the counter medications within 4 weeks of blood draw.
* History of recent or chronic smoking.
* Currently pregnant.
* Impaired fasting glucose.
* Dyslipidemia.
* Actively in puberty.
* Weight greater than 300 pounds.
* Metal in the abdomen.
* History of being overweight greater than 5 years.
ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Participants With Moderate to Severe Active Rheumatoid Arthritis (RA)

This study evaluates ATI-450 plus MTX versus placebo plus MTX in participants with moderate to severe active RA who have had an inadequate response to MTX alone.

This is a Phase 2b, randomized, multicenter, double-blind, parallel group, placebo controlled, dose ranging study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of ATI-450 plus MTX versus placebo plus MTX in participants with moderate to severe active RA who have had an inadequate response to MTX alone.

Eligibility Criteria:
Inclusion Criteria:

* Able to comprehend and be willing to sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved participant ICF prior to administration of any study-related procedures.
* Diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria.
* Have active moderate to severe RA at Screening.
* A minimum of 12 weeks on MTX with a stable MTX dose.

Exclusion Criteria:

* Current acute or chronic immunoinflammatory disease other than RA which may impact the course or assessment of RA.
* Uncontrolled non-immunoinflammatory disease that may place the participant at increased risk during the study or impact the interpretation of results (eg, previous malignancy, recurrent infection, previous venous thromboembolism).
* Participant has experience with \> 2 biologics, \> 1 JAK inhibitor, or a combination of 1 biologic experience and 1 JAK inhibitor.
* Currently receiving corticosteroids at doses \> 10 mg/day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of screening.
Cognitive and Emotional Factors Relation to Treatment Adherence in Asthmatic Patients in Upper Egypt

Non-adherence to controller therapy is one of the main reasons of poor asthma control. Adherence to medication in different studies range between 30 and 70% . Several factors related to the disease, to the patient, treatment or physician- patient relationship

Non-adherence to controller therapy is one of the main reasons for poor asthma control. Adherence to medication in different studies ranges between 30 and 70%. Several factors related to the disease, to the patient, treatment, or physician-patient relationship have been identified to be related to adherence in asthma and other diseases. According to the self-regulation theory, medication beliefs and illness perception are associated with treatment adherence. Beliefs about illness, the necessity, and the concerns (addition and side effects) of the treatment have been identified as the two most important elements in the proposed theory. Other factors that impact treatment adherence are the perceived efficacy of medicines, cost of therapy, complex dosing regimens, Patient's level of education, and cultural beliefs. Evaluating the beliefs about asthma medication, and cognitive and emotional perceptions may help to identify patients with poor adherence to treatment in clinical practice. That would guide additional attention helping to increase the likelihood of taking asthma medication appropriately. However, only limited information is available on treatment adherence in Egyptian people especially in upper Egypt. Furthermore, evidence identifying medication beliefs, and cognitive or emotional factors associated with asthma medication adherence among Egyptian people in upper Egypt is currently not available

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand and provide informed consent.
2. Age ≥18y at the time of study enrollment.
3. Provider diagnosed asthma and prescribed maintenance ICS treatment and as needed bronchodilator for at least one month

Exclusion Criteria:

1. Any other medical condition that confers greater illness morbidity than asthma (e.g., active cancer)
2. Severe psychopathology (e.g., schizophrenia)
3. Apparent cognitive or language deficit
4. Patients with associated other chronic chest diseases
"A Study to Assess Knowledge and Opinion Regarding Adoption Among Adults Residing in Rural and Urban Area"

A cross - sectional comparative study to assess knowledge and opinion regarding adoption among adults residing in rural and urban area of Ambala, Haryana.

ABSTRACT INTRODUCTION: Children are regarded as the precious gift in world. It is estimated that between 8% and 12% of couples worldwide suffer from infertility with rate of 10% in India and about 20 million children are orphan even then adoption rates are falling in India.

OBJECTIVES: To assess and compare the knowledge score and opinion score regarding adoption among adults of different age groups.To determine relationship between knowledge and opinion regarding adoption among adults.To seek association of knowledge score and opinion score regarding adoption with selected variables.

METHODOLOGY: A descriptive cross sectional survey design was used. 400 adults of rural (200) and urban (200) area were selected by using quota sampling technique. The data was collected by structured knowledge questionnaire and structured likert scale.

Eligibility Criteria:
Inclusion Criteria:

* Adults who were able to understand Hindi and English.
* Who were willing to participate in the study.

Exclusion Criteria:

* Adults who were not available at the time of data collection.
* Adults having any psychological impairment.
Toripalimab Based Induction Chemotherapy Followed by De-escalation Protocols in HPV-related OPSCC

Human papillomavirus (HPV)-related oropharyngeal carcinoma are exquisitely radiosensitive. Several studies attempted to reduce the toxicities of treatments through reduced-dose radiation and showed promising results, but all data were collected from non-Chinese areas. Like nasopharyngeal carcinoma (NPC), oropharyngeal carcinoma may have different biological behavior and relationship with HPV infection. So the investigators studied whether toxicities reducing treatment with reduced radiation dose and omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with HPV-positive oropharyngeal carcinoma. Immune checkpoint inhibitors (ICIs) have proved to improve outcomes of head and neck cancers including EBV-related NPC. Oropharyngeal carcinoma was considered to be similar with NPC in terms of immune environment. So we added anti-PD-1 antibody Toripalimab to induction chemotherapy in order to achieve better response rates to receive de-escalation chemoradiotherapy followed.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of squamous cell carcinoma of oropharynx with IHC p16
* positive or PCR HPV16 positive
* T1-2/N1-3M0（except T1N1M0 and single LN\<3cm）or T3-4N0-3M0 according to UICC/AJCC 8th staging system
* Age ≥18
* No prior anti-tumor treatment
* Karnofsky Performance Score (KPS)≥70
* Adequate blood supply
* Informed consent obtained

Exclusion Criteria:

* Cannot take contrast-MRI imaging
* Pregnant
* Combined with other malignant tumor (except basal cell carcinoma of skin)
Safety and Efficacy of Carbohydrate Drink Ingested Two Hours Before Upper Endoscopy Under General Anaesthesia

In several national anaesthesia societies, clear fluids are allowed up to 2 hours before general anaesthesia (GA) and light meals up to 6h. Because of aspiration risk, strict fasting remains routine. Recently, surgical studies proved that pre-operative carbohydrate-rich drink reduces preoperative discomfort without affecting gastric fluid volume and acidity.The aim of this study was to show the effects of preanaesthetic oral fluid in patients undergoing upper endoscopy without emergency. The expected efficacy is a reduction of the preoperative discomfort. The investigators thus propose a randomised prospective open-label study to assess efficacy of preanaesthetic oral glucose drink in patients undergoing upper endoscopy without emergency. Study compare two groups : group "drink" (200 ml of fruit juice without pulp ± 200 ml of coffee or tea, 2 at 4 hours before the induction of anaesthesia) and group "overnight fasting".Discomfort was measured at 2 hours before GA (H-2), just before GA (H0) and 4h after anaesthesia (H+4). Each item (anxiety, thirst, hunger, nervousness, tiredness, nausea) was estimated by visual analogue scale (VAS from 0 to 100mm) and handgrip strength by dynamometer. Gastroenterologist assessed the quality of endoscopy (VAS), gastric residual fluid and acidity.The main aim of this study was to assess in patients referred for upper endoscopy under general anaesthesia, the effect of carbohydrate drink on preanaesthetic discomfort. Secondary purpose were to compare quality of endoscopy, residual gastric volumes, gastric acidity and incidence of side effects. 118 patients will be included in the study. A stratification will be made on the type of endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 yrs
* undergoing upper endoscopy procedure under general anesthesia without emergency
* informed written consent

Exclusion Criteria:

* emergency
* might impair gastrointestinal motility (intestinal obstruction, stenosis)
* diseases of the central and peripheral nervous system or neuromuscular diseases
* drug-induced gastric emptying disorders
* pregnancy
* ionic disorders (hyponatremia\<125mmol/l ; hypokalemia\<3,5mmol/l
* hemodynamic disorders (systolic arterial pressure \<100mmHg)
* unstable diabetes (glycemia\>2,5g/l) ± insulin- dependent diabetes ± diabetic gastroparesis
* the potential for difficult airway management
* understanding of the information
* patient with bad prognosis
Plasma Exchange Therapy for Post- COVID-19 Condition: A Pilot, Randomized Double-Blind Study

PAX is a prospective, randomized (1:1), double-blind, placebo-controlled study, that have as a objective to evaluate the safety and tolerability of plasma exchange (PE) in patients with Post Acute Covid-19 Syndrome (PCC) comparing to sham plasma exchange. The participants will be randomized in two arms: (1) 6 sessions of PE (Plasma Exchange) with human serum albumin 5% or (2) 6 sessions with placebo (infusion of of sterile saline solution 0.9%) on days 1, 3, 8, 10, 15 and 17.

Randomized participants will receive plasma exchange (PE) or sham PE (placebo) (6 sessions: V2, V3, V4, V5, V6 and V7) and will continue their follow-up visits(V8d22, V9d45, V10d90). Plasma volumes will be replaced, which will vary depending on sex, height, weight and hematocrit.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female individuals 18 years-old or older.
2. Evidence of previous SARS-CoV-2 infection at least 90 days prior to study recruitment, defined by either (a) Nasopharyngeal SARS-CoV-2 nucleic acid test (Polymerase chain reaction \[PCR\] or Transcription-Mediated Amplification \[TMA\] (b) validated Nasopharyngeal Lateral Flow Assay rapid antigen test \[RAT\], or (c) SARSCoV-2 serology before SARS-CoV-2 vaccination.
3. Symptoms of PCC after 90 days of infection and that last for at least 2 months and cannot explained by an alternative diagnosis.
4. Not able to perform all usual duties/ activities due to symptoms, pain, depression or anxiety, defined as grades 3 or 4 in the post-COVID-19 Functional Status (PCFS) scale.
5. Availability of an adequate peripheral venous cannulation.
6. If women of childbearing potential, use of a highly effective method of contraception (abstinence, hormonal contraception, intra-uterine device \[IUD\], or anatomical sterility in self).
7. Willing to comply with the requirements of the protocol and available for followup for the planned duration of the study.
8. Has understood the information provided and capable of giving informed consent. Exclusion criteria

Exclusion Criteria:

1. SARS-CoV-2 infection diagnosed during the previous 90 days.
2. Last SARS-CoV-2 vaccine dose during the previous 30 days.
3. No significant limitations in the subject's ability to perform all usual duties/activities (i.e., grades 0, 1 or 2 in PCFS scale).
4. Medical conditions for which 250 mL of intravenous fluid is considered dangerous (i.e., decompensated heart failure or renal failure with fluid overload, among others).
5. Pregnant or breastfeeding women.
6. Contraindications for therapeutic PE: Non-availability of an adequate peripheral venous catheter, hemodynamic instability, septicemia, known allergy to fresh frozen plasma or replacement colloid/albumin, known allergy to heparin.
7. Current or planned hospital admission for any cause during the study follow-up.
8. Inability to consent and/or comply with study requirements, in the opinion of the investigator.
9. Currently participating or planning to participate in any other clinical trial until day 90 of follow-up.