cyrilzakka/clinical-trials huggingface dataset:
A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Pancreatic Cancer Related Cachexia

The purpose of this study is to evaluate the effectiveness and safety of infliximab, the active ingredient in Remicade, for the treatment of cachexia in pancreatic cancer patients who are receiving chemotherapy with gemcitabine.

Cachexia is a condition that occurs in cancer patients and other chronically ill patients and is characterized by rapid loss of fatty tissue and skeletal muscle. The key feature of this condition is weight loss, but other symptoms, such as anorexia (loss of appetite), fatigue, vomiting and anemia (low numbers of red blood cells) may also occur.The purpose of this study is to evaluate the effectiveness and safety of infliximab, the active ingredient in Remicade, for the treatment of cachexia in pancreatic cancer patients who are receiving chemotherapy with gemcitabine. In cycle 1 (8wks), patients will receive weekly infusions of gemcitabine from wk 0 to 6 and infusions of infliximab or placebo at wks 0, 2, and 4. For additional cycles, patients will receive an infusion of gemcitabine for the first 3wks and infliximab or placebo at wk 0 of each 4 wk cycle for a maximum of 5 cycles. Patients with stable disease may receive extended dosing if qualified.Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. In cycle 1 (8wks), patients will receive weekly infusions of gemcitabine from wk 0 to 6 and infusions of infliximab or placebo at wks 0, 2, and 4. For additional cycles, patients will receive an infusion of gemcitabine for the first 3wks and infliximab or placebo at wk 0 of each 4 wk cycle for a maximum of 5 cycles.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have documented diagnosis of pancreatic cancer that is newly diagnosed
* Patients must have documented loss of \>=10% body weight compared to weight prior to diagnosis, or \>=5% weight loss within 90 days prior to randomization
* Patients must have Karnofsky performance status of 70 to 100
* eligible according to country specific tuberculosis (TB) screening rules.

Exclusion Criteria:

* Patients must not have received any previous chemotherapy, biologic therapy or radiation therapy for pancreatic cancer
* Patients must not have a history or current evidence of active TB, skin test or screening evidence of latent TB, or history of treated TB, active or latent
* Patients must not have evidence or history of congestive heart failure
* Patients must not have any opportunistic infection within 6 months prior to screening
* Patients must not be pregnant, nursing or planning pregnancy
* Patients must not have ongoing use of tube feedings or TPN
Efficacy and Tolerance of High Flow Nasal Cannula for Respiratory Distress Syndrom in Late Preterms (34-36 Weeks)

The main objective of the study is to gather preliminary data on the effectiveness of High Flow Nasal canula (HFNC), provided since the delivery room, for ventilatory support in newborns of 34-36 weeks with moderate respiratory distress syndrome (RDS).

The secondary objective is to evaluate the safety of HFNC in this indication.

Treatment with HFNC will start maximum 30 minutes after birth at an initial flow rate of 2L/Kg/min.

According to retraction signs, flow may be increased by gradual increments of 1L/min to reach a maximum flow rate of 5L/kg/minute.

Patients not improving after 2 hours of support with HFBNC will be hospitalized in the neonatal intensive care unit (NICU), and HFNC maintained as long as necessary, with regular attempts of weaning.

At any moment during the study, aggravation will lead to stop HFNC trial, and the infant management decided by the physician involved in the patient's care.

Aggravation is definined by one of the following conditions: Silverman-Anderson score \> 6, and / or FiO2 \> 0.5 and / or severe apneas and / or hemodynamic instability.

Eligibility Criteria:
Inclusion Criteria:

* Newborn premature between 34 and 36 weeks of gestational age
* Moderate RDS after 30 minutes of life while treated with + 5cm H2O positive airway pressure
* Presence of a dedicated pediatric nurse and pediatrician
* Parental consent

Exclusion Criteria:

* Need for early intubation
* Severe RDS, defined by one of the following: Silverman-Anderson score \> 6, severe hypoxia (FiO2 \> 0.5), hemodynamic disorders (HR\> 180 / min, MABP \<30mmHg, capillary refill time \> 5s, pallor), and severe apneas (\> 5s and / or with bradycardia \<80 /min)
* 1 minute Apgar score \< 3 and / or five minutes Apgar score \< 7
* Birth weight \< 1800g and / or IUGR \<-2 SD
* Congenital heart, pulmonary, facial, or digestive malformation
* Subject not affiliated to social security system
* Legal representatives unable to understand the terms of the study
Observational Study in Patients With Schizophrenia Treated With Long-Acting Risperidone Injection (RISPERDAL CONSTA)

The purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection over a two-year period of observation.

This is a 2-year, prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), multi-center (at multiple sites), longitudinal (study that involves repeated observations of the same outcomes in the same people over long periods of time), observational study (study in which the investigators/ physicians observe the patients and measure their outcomes) in adults with schizophrenia (mental disorder characterized by a breakdown of thought processes and by poor emotional responsiveness). Physicians will determine the appropriate treatment for their patients, according to their usual practice. Patients starting treatment with long-acting risperidone injection (an antipsychotic medication) and meeting all the study criteria will be enrolled in the study. They will receive a dose of 25, 37.5 or 50 mg of risperidone every 2 weeks by intramuscular injection, and continue their treatment for schizophrenia according to usual care by their physicians. Patients will be asked questions at baseline and every three months for a period of two years to assess: efficacy of the medication, how well the patient is functioning, use of healthcare resources (eg, emergency room visits and hospitalizations) patient work status, quality of life and patient satisfaction with the medicine. Safety will be monitored throughout the study duration of 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients had schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated) that met disease diagnostic criteria as defined in Diagnostic and Statistical Manual of Mental Disorders IV (\[DSM-IV\]
* Requiring new treatment with long-acting risperidone injectable
* Patients were cooperative, reliable, and able to complete all aspects of the protocol

Exclusion Criteria:

* Use of an investigational drug in the past 30 days
* At risk to self or others
Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma

i. To determine whether Confocal Laser Endomicroscopy (CLE) with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol.

ii. To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with standard biopsy, can reduce the number of biopsies needed per patient for detection of gastric IM/IN/carcinoma without the loss of corresponding diagnostic yield.

iii. To compare the sensitivity and specificity of CLE with WLE for the detection of gastric IM/IN/CA.

Gastric cancer remains the world's second leading cause of cancer-related deaths. The prognosis for patients with this cancer clearly depends on stage at diagnosis. At least for the intestinal subtype of gastric adenocarcinoma, a cascade of histopathologic lesions has been defined: chronic gastritis, atrophic chronic gastritis, intestinal metaplasia (IM), and intraepithelial neoplasia (IN). The identification of these lesions and follow-up of patients in whom they are found could lead to diagnosis of gastric cancer at an early stage, thus improving patients' survival. The diagnosis of these lesions, which often appear in flat mucosa, is currently based on histopathologic examination of endoscopic biopsy specimens. However, conventional white-light endoscopy (WLE) for this purpose has high interobserver variability and a poor correlation with histopathologic finding.

Confocal laser endomicroscopy (CLE), producing both conventional WLE and confocal microscopic images, can provide a direct histological observation of the in vivo tissue without the need for biopsy. Recently, CLE has shown its value for diagnosing gastric IM, intraepithelial neoplasia and carcinoma. However, none of those CLE criteria for gastric IM, IN or carcinoma (CA) has been validated in various endoscopic centers, hence reducing the reliability and clinical application of them.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female aged 18-80
* Patients with H. pylori infection, or histologically verified gastric intestinal metaplasia, low-grade intraepithelial neoplasia, and atrophic gastritis

Exclusion Criteria:

* Patients with gastrectomy, acute GI bleeding, and advanced gastric cancer
* Patients under conditions unsuitable for performing CLE including coagulopathy, impaired renal function, pregnancy or breastfeeding, and known allergy to fluorescein sodium
* Inability to provide informed consent and other situations that could interfere with the examination protocol
Caloric Compensation in Infants

The aim of this study is, first, to describe the evolution of the caloric compensation ability in infants from 3 to 15 months old and, secondly, to assess the links between changes in the caloric compensation ability and the individual characteristics (adiposity, age, gender, infant's eating behavior) and maternal feeding practices.

Three series of measurements of caloric compensation abitlity were conducted: at 3-4 months old, at 10.5 months old and at 14.5 months old in the laboratory.

In this study, a preload paradigm usually employed in children and adults to measure the caloric compensation ability was adapted to infants below 15 months old. The maternal eating behavior and their feeding practices were measured by questionnaires. The infants' height and weight were measured at the laboratory by trained experimenters.


Eligibility Criteria:
Inclusion Criteria:

* no chronic health problem or food allergies
* not having been fed with hydrolysate formula
* gestational age ≥ 37 weeks
* born weight ≥ 2.5kg
* without having being tube fed at any moment

Exclusion Criteria:

* infants from diabetic mothers
* infants from mothers having celiac disease
* infants from minor parents (\<18 years old) were excluded
Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty

Conventional rehabilitation after total hip arthroplasty (THA) does not seem to restore muscular strength or walking speed. Three-5 years after surgery patients are still not fully rehabilitated. This study evaluates the effects of maximal strength training on the muscular strength in leg press and abduction in patients undergoing THA. Aim of the study is to increase the patients physical function through evidence-based rehabilitation in clinical practice, with gradually less supervision.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for total hip arthroplasty (THA)
* living nearby Trondheim
* diagnosis of primary osteoarthritis as the main cause for elective THA
* ASA score of I-III (stable)

Exclusion Criteria:

* muscular or skeletal disease which might influence the training and/or physical testing performance
* communication difficulties
* postoperatively discharged to a rehabilitation institution
* THA in the bilateral hip that is not fully rehabilitated.
Time Restricted Eating (TRE) and High-Intensity Interval Training (HIIT) to Improve Health in Patients With Metabolic Syndrome (METS)

Studies in mice provide compelling evidence that feeding/fasting cycles can be altered to produce beneficial effects on weight loss and cardiometabolic health markers in the absence of caloric restriction. Limited research in subjects with metabolic syndrome (MetS) suggests that this feeding paradigm may also apply to human health when combined with an exercise training program, but more research is needed to confirm this hypothesis.

This project will determine the independent and combined effects of high-intensity interval training and time-restricted eating on cardiometabolic factors among overweight or obese patients with MetS.

The intervention period will be sixteen weeks. Before and after the intervention, MetS components (i.e., MetS Z score), body composition, and physical fitness will be measured and compared between groups who are doing either high-intensity interval training, time-restricted eating, both high-intensity interval training and time-restricted eating, or who are in a control group. Physical activity, diet, sleep quality, and intervention adherence will also be measured.


Eligibility Criteria:
Inclusion Criteria:

Metabolic syndrome patients diagnosed according to The International diabetes federation consensus of 2009 (Alberti, et al., Circulation):

* Waist circumference ≥ 92 cm (Men) or ≥ 80 cm (Women).
* Triglycerides ≥ 150 mg/dL (or on drug treatment for elevated triglycerides).
* Reduced HDL-C \< 40 mg/dL (Men), \< 50 mg/dL (Women) (or on drug treatment for reduced HDL-C).
* Elevated blood pressure, systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg (or treatment with an antihypertensive drug with a history of hypertension).
* Elevated fasting glucose ≥ 100 mg/dL (or drug treatment of elevated blood glucose).
* Age ≥18 to ≤65 years
* Previously inactive (\<150 min·wk-1 of the moderate-intensity activity assessed by 7-d IPAQ

Exclusion Criteria:

* Pregnancy, and lactation within 24 weeks of study commencement
* Untreated cardiovascular or renal disease
* Type 1 diabetes
* Any condition associated with exercise intolerance.
* Habitual eating window \< 12 hours
* Performing high-intensity training more than once a week
* Body mass variations \> 4 kg three months prior to study commencement
* Shift work that includes night shifts
Trial of a Nutritional Blend to Prevent Cognitive Decline in Older Adults

To demonstrate the beneficial effects of 1-year intervention with a nutritional blend of ingredients on blood levels of nutritional biomarkers known to be linked with cognitive decline in non-demented adults with subjective memory concerns aged 70+ years

This multicenter trial will be a placebo-controlled, double-blind, randomized, 2 parallel groups study. The subjects will be randomly allocated to one of two treatment groups (placebo or nutrition product). The duration of the intervention is 1 year.

The total sample size at baseline is 364 subjects, consisting of non-demented adults with subjective memory concerns aged 70+ years.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 70 years
2. Spontaneous memory complaints
3. Adequate fluency in the local language to understand the inform consent form and complete any other study document
4. Sufficient vision and hearing to complete study protocol procedures based on medical judgement
5. Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication)
6. Has general health status that will not interfere with the ability to complete the study
7. Willing and able to participate and to give written consent to comply with study procedures
8. Willing to be informed in case a new clinical pathology is discovered through clinical examinations

Exclusion Criteria:

1. Exhibiting a loss of independence in basic activities of daily living (ADL score \< 4)
2. MMSE score \< 24
3. Dementia as determined by DSM-V criteria
4. Suffering from diseases that are likely to be life-threatening in the short-term
5. History or presence of a severe disease (e.g., cardiovascular, hepatic, renal (e.g., End Stage Renal Disease), gastroenteral, respiratory, endocrine, neurologic, psychiatric, immunologic, or hematologic disease or other conditions) that could, in the opinion of the investigator, interfere with the subjects safety or ability to complete the trial
6. Food allergy
7. Taking omega-3 dietary supplements containing \>200 mg DHA per day during the last 6 months
8. Receiving or having received in the past 3 months a physician prescribed vitamin B12, B3 or vitamin B-complex
9. Receiving Alzheimer's Disease medication (Galantamine, Memantine Donezepil and Rivastigmine)
10. Deprived of their liberty by administrative or judicial decision, or under guardianship or admitted to a healthcare or social institution (subjects in non-assisted living facilities could be recruited).
11. Having participated in another clinical study in the previous month or is currently participating in another study.

    Subjects meeting one or more of the following criteria below will not be included in the PET scan and MRI-scan subset groups:
12. Wearing a pace-maker or having metal in the body which is exclusionary for MRI
13. Claustrophobic

Subjects who will participate in the PET-scan and MRI-scan subset groups, will be excluded for a 1-year period of any future projects involving investigations using ionizing radiation.
Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan A Real World Study

Magnesium Lithospermate B, the main constituent of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza), is the active ingredient of Salvia Miltiorrhiza. This study record clinical use of The injection of DanShenDuoFenSuanYan in the real world, and observe the adverse drug reactions/ adverse drug events during treatment.

As a traditional chinese medicine, the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza) was approved by State Food and Drug Administration of China in May,2005. This cardiovascular drug is one of the few Traditional Chinese Medicine pharmaceuticals where the active ingredients have been identified in the molecular levels. In its 8 years marketing in China, there is no serious adverse drug reactions.

In this study, clinical pharmacists in selected hospitals will record the clinical use and the adverse drug reactions/ adverse drug events of this injection.

This real world study for the Injection of DanShenDuoFenSuanYan with 30400 patients will be conducted from June.2012 to May.2014.

Eligibility Criteria:
Inclusion Criteria:

* Patients who use the Injection of DanShenDuoFenSuanYan in 30 hospitals in china(including the inpatient and the outpatient(only in some hospitals which can get the information)).

Exclusion Criteria:

* none
The Safety, Tolerability and Pharmacokinetics Study of RAY1216 in Healthy Adult Participants

This is double-blind,randomized, single and multiple dose trial to evaluate the pharmacokinetics(PK), safety, tolerability and drug-drug interaction of RAY1216, and the effect of food on RAY1216 Pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

1. Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
2. Subjects must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
3. Subjects (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
4. Males and female subjects between 18-50 years (Both inclusive). Body weight is no less than 50 kg in males and no less than 45 kg in females. Body mass index (BMI) 18≤BMI≤28 kg/m2; BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
5. Physical condition and vital signs: Normal or abnormality has no clinical significance.

Exclusion Criteria:

1. Known hypersensitivity and/or allergy to some drugs and food, especially for the composition that is similar to the investigative product;
2. The average daily smoking are more than 5 cigarettes within 3 months prior to screening.
3. Known history of drug or alcohol abuse.(defined as consumption of 14 units of alcohol per week: 1 unit = 285 ml of beer; or the equivalent of 25 ml of spirit, or 100 ml of wine )
4. Subjects who donated blood or bleeding profusely (\> 400 mL) in the 3 months preceding study screening.
5. Dysphagia or any medical history in gastrointestinal that interferes with the absorption of drugs, include a history of frequent nausea or vomit causes by any etiology.
6. History or presence of any disease or condition known to increase the risk of bleeding , eg. acute gastritis, duodenal ulcer, etc.
7. Participated in another clinical research study and received any investigational products within 3 months prior to dosing.
8. History of having any special food (including dragon fruit, mango, grapefruit, etc.), strenuous exercises, or other factors may interfere with the absorption, distribution, metabolism, or excretion of drug within 7 days prior to screening.
9. Inability to consume the food provided in the study ( a high fat diet).This requirement only applies to subjects under fed condition.
10. Presence of clinically significant abnormalities in ECG or QTcF\>450ms
11. Subjects who may not complete the study for other reasons or should not be included in the study in the opinion of the investigator.
Effects Of Different Periodontal Treatments On Quality Of Life In Patients With Periodontitis

In this study, the quality of life of patients with stage 3 grade C periodontitis who underwent surgical and non-surgical periodontal treatments was evaluated. Patients were compared based on their quality of life using OHIP-14 and OHRQoL-UK questionnaires, as well as a VAS scale, against those who did not receive periodontal treatment, those who received only phase 1 treatment one month prior, and those who underwent periodontal surgical treatment three months prior.

Currently, the most commonly used reliable scales to measure oral health-related quality of life are the OHIP-14 (Oral Health Impact Profile) and OHRQoL-UK questionnaires. Fifty patients with stage 3 and grade c whose clinical periodontal records (PI, GI, PD and BOP) were obtained were included in the study. OHRQoL-UK, OHIP-14 questionnaires and VAS were applied at the first session (T1). Initial periodontal treatment (scaling, polishing and oral hygiene education) was performed, and non-surgical periodontal treatment (root surface debridement under local anesthesia) was performed in the next session. Three to four weeks after this treatment, patients were recalled for follow-up and all clinical indices and questionnaires were repeated (T2). After re-evaluation, the patients were divided into a surgical group (23 patients) and a non-surgical group (27 patients). Open flap debridement was performed in areas requiring surgery (radiologic bone loss and SCD\>5mm). Patients were recalled 12-14 weeks after surgery and all indices and questionnaires were repeated (T3).

Eligibility Criteria:
Inclusion Criteria:

* Literate
* Over 18 years of age
* Willing to voluntarily participate in the study
* No mental retardation or any other disorder that would impede communication

Exclusion Criteria:

* Presence of any systemic disease affecting periodontal tissues or use of medication that impacts periodontal health
* Pregnancy or lactation
* Having undergone periodontal treatment in the past 6 months