cyrilzakka/clinical-trials huggingface dataset:
PD-1 Inhibitor Plus Anti-EGFR Therapy And Radiotherapy in Locally Advanced NPC Resistant to Induction Chemotherapy

Because nasopharyngeal carcinoma （NPC）is very sensitive to radiation and the specificity of the anatomical structure, radiotherapy has become the core treatment for NPC. Although induction chemotherapy combined with cisplatin-based concurrent chemoradiotherapy can effectively improve the overall survival and progression-free survival of NPC, such a sequential pattern can further exacerbate the toxic side effects of treatment, such as mucosal reactions and gastrointestinal toxicity. Therefore, it is particularly important to explore another treatment mode with high efficiency and low toxicity. Secondly, patients with poor response after induction chemotherapy indicate chemotherapy resistance. Whether patients can still benefit from concurrent platinum-based chemotherapy in the followed radiotherapy is doubtful. PD-1 inhibitor and anti-EGFR monoclonal antibody have proved to improve outcomes of head and neck cancers including EBV-related NPC, which have also showed relatively low toxicity. In this study, radiotherapy combined with PD-1 inhibitor and anti-EGFR monoclonal antibody were applied to treat patients with locally advanced NPC who were resistant to induction chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

Histologically confirmed locally advanced NPC; IHC EGFR positive; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Imaging assessment of MR after induction chemotherapy revealed the responses to induction chemotherapy are less than 50% Partial Response(PR) or EBVDNA copy number decreased by less than 50%; No prior anti-tumor treatment; Normal complete blood count; Normal hepatic function; Normal renal function (creatinine ≤ 1.5 times the upper limit of normal). -

Exclusion Criteria:

Previous radiotherapy; A history of any other type of malignancy; Pregnancy or lactation; Allergy to anti-EGFR monoclonal antibody; IHC EGFR negative; Allergy to PD-1 inhibitor; Obvious disfunction of liver, renal, cardiac or lung function; Un controlled infection; Systemic metastasis or distant metastasis; Patients with severe gastrointestinal diseases; Patients with mental disorders affecting patient participation in trial judgement; Cannot take contrast-MRI imaging.

-
A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of PA-111 compared with coadministration PA-111A in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Body weight equal to or greater than 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit

Exclusion Criteria:

* Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
* Other exclusions applied
Long-Term Effect of Soy Consumption on Cardio-Renal Indices and CRP in Type 2diabetes With Nephropathy

we conducted a longitudinal 4-year clinical trial to determine the long-term effects of soy consumption on lipid profiles, renal-function indices and CRP level among type 2 diabetic patients with nephropathy.

Background: Several short-term trials on the effect of soy consumption on cardiovascular risks are available, but little evidence exists regarding the impact of long-term soy protein consumption among type 2 diabetic patients with nephropathy.

Objectives: To determine the effects of long-term soy consumption on cardiovascular risks, C-reactive protein and kidney-function indices among type 2 diabetic patients with nephropathy.

Design: This longitudinal randomized clinical trial was conducted among 41 type 2 diabetic patients with nephropathy (18 men and 23 women). Twenty patients in soy protein group consumed a diet containing 0.8 g protein/kg body weight (35% animal proteins, 35% textured soy protein, and 30% vegetable proteins) and 21 patients in control group consumed a similar diet containing 70% animal proteins and 30% vegetable proteins for 4-years.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes with Nephrophaty

Exclusion Criteria:

* Dialysis
* Transplantation
Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism

The project is aimed to determine the value of synacthen infusion on the results of adrenal venous sampling in patients examined for primary aldosteronism

We aim to compare the results of adrenal venous sampling performed without and during synacthen infusion.

Eligibility Criteria:
Inclusion Criteria: Confirmed primary aldosteronism

Exclusion Criteria: Inability to undergo unilateral adrenalectomy
The Study on the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure

The patients who accepted the quadruple eradication program of the helicobacter pylori but failed to eradicate helicobacter pylori will be assessed the most suitable re-eradication time of helicobacter pylori.

Helicobacter pylori (HP) infection is a common global infectious disease, which is an important cause of chronic gastritis, peptic ulcer and gastric cancer.

At present, due to the non-standard Helicobacter pylori eradication program in clinical work, poor patient compliance and other reasons, the phenomenon of HP eradication treatment failure is more and more common. However, there is still no conclusion on the most appropriate time for remedial treatment in patients with Hp eradication failure.

Eligibility Criteria:
Inclusion Criteria:

* Patients, aged between 18 and 70 years old, with positive H. pylori infection that was eradicated by previous therapies but failed are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria:

* Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.
Genetic Assessment of Early to Late Macular Degeneration Study

The purpose of this study is to determine if polymorphisms at rs11200638 on HTRA1 and rs1061170 on CFH are associated with an accelerated progression to advanced AMD (wet AMD or GA) in patients with early AMD (soft confluent drusen\>120 microns ) in the study eye, and with either early AMD or advanced AMD in the non-study eye.

Age-related macular degeneration (AMD) is the leading cause of blindness in the developed world. To date, two major polymorphisms on the HTRA1 and CFH genes have been associated with AMD. Progression and vision loss need to be followed and treated promptly in order to preserve vision. This study will provide more information on the genetics of disease progression and may lead to future guidelines for patient follow-up and treatment.

This study consists of a blood draw and observation of eye conditions. Consented, enrolled patients will come in every four months as per standard of care. At each visit, visual acuity measurement, slit lamp exam, indirect ophthalmoscopy, fundus photos, and spectral domain optical coherence tomography will be performed. Every 8 months, or per standard of care, fluoroscein angiography will be performed. DNA extraction and genotyping will be performed, and correlations between HTRA1 and CFH genotypes and the progression to bilateral advanced AMD will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be eligible if the following criteria are met:
* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 45 years
* Disease related considerations
* Subjects with a diagnosis of advanced AMD in one eye (either CNV or geographic atrophy) and soft confluent drusen in the study eye OR subjects with bilateral large soft drusen.

Exclusion Criteria:

* Subjects with any other progressive retinal disease that may impair the physician's ability to assess the severity of AMD
Alemtuzumab and Rituximab in Aplastic Anemia

The purpose of the study is to evaluate the efficacy of combination of alemtuzumab and rituximab as first line therapy in aplastic anemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with aplastic anemia diagnosis

Exclusion Criteria:

* Patients with prior treatment with monoclonal antibodies and/or antithymocyte globulin.
* Patients with a diagnosis or history of HIV/AIDS, Hepatitis B, Hepatitis C, Cytomegalovirus.
* Patients who do not agree to sign a Letter of Informed Consent.
The Combination of PECS II Block and Parasternal Block for Radical Mastectomy

The combination of PECS II and parasternal Block provides analgesia after radical mastectomy

The cambionation of PECS II block and parasternal block

Eligibility Criteria:
Inclusion Criteria:

* ASA status patients:1,2 and 3
* patients undergoing to radical mastectomy with axillary dissection and breast-implant reconstruction

Exclusion Criteria:

* patients with allergy to local anesthetics
* ASA status patients: 4
* breast anatomy abnormalities
* neurological diseases
* septic conditions
* coagulopathies
* drug abuse history
A Comprehensive Approach To Relief Of Digestive Symptoms In Cystic Fibrosis: CARDS-CF

Development of a new patient reported outcome measure (PROM) that will measure the daily burden of gastrointestinal symptoms over the previous 24 hour period for people with cystic fibrosis.

Development of a Patient Reported Outcome Measure (PROM) in line with FDA guidance. The PROM is intended for daily use to measure the symptom burden of gastrointestinal symptoms for people with CF over the last 24 hours.

* Development of the initial conceptual framework underpinning the PROM and confirmed through a patient focus group.
* Primary item (question) generation for the PROM which will then be refined through a series of interviews with people with CF.
* Testing of the items through an online patient questionnaire for testing of frequency, burden and impact of the items.
* Piloting testing of the draft PROM daily for 2 weeks via smartphone app. The recall period of the PROM will be gastrointestinal symptom burden over the previous 24 hours.

Potential participant's will be identified through 6 UK CF care centres at Nottingham University Hospitals NHS Trust (paediatric and adult CF centres), Leeds Teaching Hospital NHS Trust, Manchester University NHS Foundation trust, Royal Brompton and Harefield NHS Foundation Trust and Kings College Hospital NHS Foundation Trust. In addition, recruitment for the survey and trialing the PROM on a smartphone app will also take place via social media and is therefore also open to people with CF from outside these CF centres.

Eligibility Criteria:
Inclusion Criteria:

* People with cystic fibrosis age 12 years and over
* Confirmed diagnosis of cystic fibrosis based on genotype or sweat chloride testing
* Capacity to consent, or to understand the requirements of the study where parental consent is required

Exclusion Criteria:

* \< 12 years age
* Unable to give informed consent
Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis

The objective of the study is in subjects with Insulin Treated Diabetes Mellitus type 1 or 2 and gastroparesis:

* validate radiopaque markers with fluoroscopy with gastric scintigraphy method
* study the difference of metabolic control including the frequents of hypoglycaemia, gastrointestinal symptoms, quality of life and nutrition state during dietary treatment of food of small particle size compared with food of large particle size
* validate the radiopaque markers method and measurement of the blood glucose and gastrointestinal symptoms after a test meal, against the gastric scintigraphy
* determine if the function of gastric emptying can be improved after intervention


Eligibility Criteria:
Inclusion Criteria:

* diabetes type 1 or 2 and gastroparesis
* must be able to understand oral and verbal instructions

Exclusion Criteria:

* gastrointestinal surgery
* other gastrointestinal disease
* S-Creatinine \>150 umol/L
* mental disease
* cerebral disease
* collagen disease
* untreated endocrine disease
* anticholinergic drugs
* psychopharmacologic drugs
* opiates
* addiction to drugs as alcohol and narcotics
* vegetarian
Evaluation of Text Message Engagement Support of Mindfulness Smartphone Applications

The aim of this study is to assess the usability of two mindfulness smartphone applications (apps) and to evaluate whether text message support can promote engagement with those apps through a 4-week trial comparing support vs. no support.

Part one of this study is to conduct usability testing to understand more about the acceptability and usability of these existing mindfulness apps in a population with depression and anxiety. The goal of usability testing is to identify any usability problems, provide information for future app development, and determine the participant's satisfaction with the apps. Participants will then be randomized to receive either engagement support or no support which will be delivered via text messaging, and will be randomized to use one of the two mindfulness applications for the 4 week period. Specific Aim 2.1 is to evaluate any differences on outcome measures between the two mindfulness apps. Specific Aim 2.2 is to evaluate the differences of outcome measures between text message engagement support versus no support, regardless of the mindfulness app. For Aim 2.1, the investigators predict that all mindfulness apps will be capable of leading to improvements on outcome measures. For Aim 2.2, the investigators predict that the text message engagement support arm will engage more with the mindfulness app and will see greater improvements in outcome measures regardless of the mindfulness app.

Eligibility Criteria:
Inclusion Criteria:

1. meet criteria for clinically significant distress caused by anxiety defined by a Generalized Anxiety Disorder-7 (GAD-7) greater than a 10 or clinically significant distress caused my depression defined by a Patient Health Questionnaire (PHQ-9) greater than 10
2. 18 years of age or older;
3. fluent in English;
4. lives in the Chicago area and are able to attend and in person session;
5. own an internet ready smartphone with data and text plans.

Exclusion Criteria:

1. have visual, hearing, voice, or motor impairment that would prevent completion treatment procedures;
2. past or current diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, substance or alcohol abuse dependence, or other diagnosis for which participation in the trial would be dangerous;
3. suicidal, defined as a 1 or higher on item 9 of the Patient Health Questionnaire (PHQ-9);
4. adults unable to consent.
Inflammation, Intracellular Invasion and Colonization of the Nasal Mucosa by Staphylococcus Aureus

An inflammatory state of the nasal cells (very close to keratinocytes) could favour the internalization of Staphylococcus aureus and thus constitute a persistent reservoir for the carriage of this bacterium.

Staphylococcus aureus is a commensal bacterium of the skin and mucous membranes that colonizes approximately 2 billion people worldwide Staphylococcus aureus is also a leading cause of community and healthcare-associated infection. Staphylococcus aureus has demonstrated its ability to invade many non-professional phagocytic cell lines such as keratinocytes, osteoblasts, fibroblasts, epithelial cells and endothelial cells. During pro-inflammatory stimulation, internalization of Staphylococcus aureus into keratinocytes is mainly mediated by ICAM-1. These results suggest that, in humans, an inflammatory state of the nasal cells (very close to keratinocytes) could promote the internalization of Staphylococcus aureus and thus constitute a persistent reservoir for the carriage of this bacterium.

The main objective is to compare the expression level of ICAM-1 in nasal cells with and without the presence of Staphylococcus aureus.

Eligibility Criteria:
Inclusion Criteria:

* Subject affiliated to a social security scheme or entitled person
* Subject who received informed information about the study et signed consent
* Adult subject (≥18ans)
* Healthy Volunteer

Exclusion Criteria:

* Subject undergoing antibiotic treatment or having received antibiotic treatment (oral, IV or local) in the month prior to inclusion
* Subject with a major haemostasis disorder or anticoagulant treatment contraindicated for surgery
* Subject with a pathology increasing the nasal carriage of S. aureus (chronic furunculosis, diabetes, HIV infection, chronic rhinosinusitis)
* Subject under guardianship or trusteeship
* Pregnant woman
Effect of Intradialytic Physical ACTIvity in Addition to a NUTritional Support on Protein Energy Wasting and Physical Functioning in Chronic Hemodialysis Patients ("ACTINUT" Study)

Sedentary behavior and protein-energy wasting (PEW) are well known risk factors of adverse outcome and low quality of life in chronic renal failure patients treated by dialysis. Treatment strategies of PEW by different types of nutritional support (as dietary counseling, oral nutritional supplements or intradialytic parenteral nutrition) have limited efficacy. Physical activity has been shown to have numerous positive impacts in pathologic conditions associated to end stage renal disease.

Concomitant prescription of physical activity and nutritional support might mutually enhance the anabolic effects of these interventions and improve the rate of remission of PEW.

The aim of this study is to analyze the effect of a programmed, progressive endurance training performed during the dialysis session on a cycle ergometer under the supervision of a qualified trainer, on protein energy wasting and physical functioning of chronic hemodialysis patients.

Aim 1: To determine the percentage of patients in remission from the state of protein- energy wasting. Hypothesis 1: Patients in the exercise group will more frequently reverse the PEW than in the control group Aim 2: To determine the patterns of change in body composition (fat free mass). Hypothesis 2: Patients in the exercise group will maintain or increase their fat free mass and patients in the control group will decrease their fat free mass Aim 3: To determine the effects of exercise on muscle strength. Hypothesis 3: Patients in the exercise group will maintain or increase their quadriceps strength while patients in the control group will decrease their muscle strength Aim 4: To determine the effects of exercise on postural balance. Hypothesis 4: Patients in the exercise group will maintain or increase their body balance while patients in the control group will decrease their body balance Aim 5: To determine the effects of exercise on quality of life as assessed by the SF-36. Hypothesis 5: Patients in exercise group will maintain or increase their quality of life form while patients in the control group will decrease their quality of life

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18 years, treated by hemodialysis since more than 3 months
* Patients considered to be in a clinical stable state, defined as the absence of acute disease or hospitalization during the last month prior to study begin
* Patients fulfilling the diagnostic criteria of protein energy wasting according to the definition proposed by the International Society of Renal Nutrition and Metabolism (ISRNM)
* Patients having signed the informed consent for the study participation
* Patients covered by medical insurance

Exclusion Criteria:

* Medical contraindication or inability to perform physical exercise
* Inadequate dialysis (KT/V\< 1.2)
* Poor hemodynamic tolerance of dialysis
* Systemic inflammation (CRP \>20 mg/l)
* Pregnancy
* Major trust
A Study in Healthy Volunteers

This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers. The second part of the study will be a single dose drug-drug interaction study in healthy volunteers with CRV431 co-treated with TDF. The third part of the study will assess the safety, tolerability, PK, and preliminary signal for antiviral efficacy and identification of clinically-relevant biomarkers of CRV431 with TDF in stable HBV patients.


Eligibility Criteria:
Inclusion Criteria:

* Capable of giving written informed consent
* Willing and able to complete all study requirements
* Healthy male or female between 18 and 55 years of age (inclusive);
* Body mass index 16 to 32 kg/m2 (inclusive);

Exclusion Criteria:

* Positive test for HCVAb or HIVAb. For healthy subjects only: positive test for HBsAg
* Current or history of abuse of alcohol or illicit drugs
* Received an investigational drug, vaccine or medical device within 90 days prior to first dose of study drug.

Additional Exclusion Criteria for HBV Pilot Subjects Only:

* Evidence of significant liver fibrosis or cirrhosis
* History of NAFLD or NASH
* Positive test for HDV
Safety of Estrogens in Lupus: Hormone Replacement Therapy

Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether postmenopausal women with systemic lupus erythematosus (SLE, or lupus) can safely use the hormone estrogen. In this part of the study, we will look at the effects of estrogen replacement therapy on the activity and severity of disease in women with SLE.

This study tests the effect of exogenous female hormones on disease activity and severity in women with systemic lupus erythematosus (SLE). Physicians generally do not prescribe hormone replacement therapy (HRT) to women with SLE because of the widely held view that such treatment can activate SLE. This practice is based on the greater incidence of SLE in women than in men, biologic abnormalities of estrogen metabolism, murine models of lupus, several anecdotes of patients having disease flares while receiving exogenous hormones, and a single retrospective study in patients with preexisting renal disease. By contrast, recent retrospective studies suggest that the rate of flare is not significantly increased in patients taking HRT.

We will examine, in a multicenter, randomized, double-blind, placebo-controlled trial, the effect of hormonal replacement with conjugated estrogens on disease activity in postmenopausal women with SLE. We will recruit patients from clinics and private practices that include over 4,000 women with SLE, most belonging to minority groups.

We will give patients hormones for 1 year.

NOTE: This trial has been terminated as of August 2002 upon recommendation of the Data Safety Monitoring Board (DSMB), based on the findings of the WHI Trial. Study subjects have discontinued study drug but will continue followup visits to study doctors through May 2003

Eligibility Criteria:
Inclusion Criteria:

* Female
* Unequivocal diagnosis of SLE
* Inactive disease or stable on 0.5 mg/kg/day or less of prednisone
* Chemical evidence of menopause or have stopped periods for at least 6 months

Exclusion Criteria:

* Blood pressure \>145/95 on three occasions
* Deep vein, arterial thrombosis or pulmonary embolus
* GPL \>40; MPL \>40; APL \>50; dRVVT \>37 sec
* APL antibody syndrome ever
* Gynecologic or breast cancer
* Hepatic dysfunction or liver tumors
* Diabetes mellitus (NOT due to steroids) with vascular disease
* Congenital hyperlipidemia
* Complicated migraine
* Severe disease activity (SLEDAI \>12)
* Increase in SLEDAI \>2 points in 3 months
* Unexplained vaginal bleeding
* Use of estrogen (HRT or OCP) for \>1 month at any time after SLE diagnosis
* FSH \<40
* Premenopausal myocardial infarction