cyrilzakka/clinical-trials huggingface dataset:
Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants

To assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations (episodes of oxygen désaturations, and/or apnea- bradycardia), and the oral feeding performance, in preterm infants born between 26 to 29 weeks of gestation age.

Preterm infant were randomized into an experimental or an control group. Infants in the experimental group receive an oral stimulation program consisting of stimulation of the oral structures during 10 consecutive days. Infant in the control group receive no stimulation only non nutritive sucking during feeding. Both were administered twice per day, during 20 minutes, 48 hours after discontinuation of nasal continuous positive air pressure. A long term evaluation of oral feeding difficulties and neuromotor development are organized.

Eligibility Criteria:
Inclusion Criteria:

* Children whose born term is included between 26 and 29SA past and whose postnatal age is lower or more equal in 33SA past, at the time of the inclusion.
* Term of certain child (calculated according to the date of the last rules and\\or a premature obstetric echography).
* Children devoid of neurological pathology making him(it) clinically unstable (echography transfontanellar and\\or intellectual MRI, electroencephalogram normal, either, intraventricular bleeding of rank 1 and 2 of Papile \[40\], or, intellectual abnormalities in the MRI of type(chap) 1 - 4 according to the classification of modified Paneth \[41\]. (Annex X)
* Children devoid of infectious pathology making him(it) clinically unstable (Protein C-reactive lower than 7).
* In case of ebb gastroenteritis - esophageal symptomatic ( RGO): the child will be treated(handled), by oral route, by location + thickening +/-prokinetic +/-inhibitor pumps in proton.
* According to a protocol of service, all the premature babies of less than 32.

Exclusion Criteria:

* Born Child \> 29 limited companies.
* Child not included at the postnatal age of 33 past(over) LIMITED COMPANIES.
* Child presenting a genic syndrome, an evolutionary neurological disease, a pathology malformative.
* Child presenting a bleeding intraventricular of rank 3-4 \[ 40 \], intellectual abnormalities in the MRI of type(chap) 5 and 6 according to the classification of modified Paneth \[ 41 \], an ulcer-necrotizing entérocolitis.
* Child among whom both relatives(parents) or legal representatives refused that their child participates in the study.
Intravenous Infusion of Lidocaine in ERCP

Intravenous infusion of lidocaine significantly reduces propofol dose for ERCP and improve patients' recovery after ERCP.

This study divide patients into two groups, one will be given lidocaine; another group was given placebo . to observe two groups of patients blood pressure, body movement, and propofol dosage , and the difference in operator satisfaction, and how many people need to give fentanyl again; and two groups of patients after the operation of the reaction, if there are dizziness, nausea, and other adverse reactions; finally, the differences of these two schemes in different populations were analyzed, and the rationalization and individualized medication will be put forward.

Eligibility Criteria:
Inclusion Criteria:Inpatients aged \>18 years who were scheduled for ERCP at Qilu hospital.

Exclusion Criteria:

* Patients with ASA class 4 or 5,
* Patients with pre-existing hypoxaemia (SpO2\<90%),
* Patients with hypotension (SBP\<90mmHg)
* Patients with bradycardia (HR\<50 bpm)
* patients with severe chronic renal failure (creatinine clearance\<30 ml/min)
* patients with uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg)
* patients with pregnancy or lactation
* Patients hemodynamically unstable
* Patients unable to give informed consent
* Patients with a history of drug allergies;
Alpha Lipoic Acid in Ulcerative Colitis

This study aims at evaluating the efficacy and safety of alpha-lipoic acid as adjuvant therapy to mesalamine in patients with mild to moderate ulcerative colitis due to its effect as anti-oxidant and anti-inflammatory drug which can help to improve disease.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old.
* Both male and female sex.
* Newly diagnosed patients with active mild and moderate ulcerative colitis according to American College of Gastroenterology (ACG) Clinical Guideline for diagnosing Ulcerative Colitis in Adults.26
* Patients treated with 5-aminosalisylic acid (mesalamine).

Exclusion Criteria:

* Patients with severe ulcerative colitis.
* Patients with colorectal cancer.
* Patients on rectal or systemic steroids.
* Patients on immunosuppressants or biological therapies.
* Patients with previously failed treatment with sulphasalazine.
* Patients with known allergy to study medications.
* History of complete or partial colectomy.
* Patients with significant liver disease (fibrosis, cirrhosis, NASH, NAFLD).
* Patients with other inflammatory diseases.
* Patients with thyroid diseases.
* Patients with arrhythmia, ischemic heart disease, and heart failure.
* Patients with diabetes.
* Patients on antioxidants supplement (vitamin A, C, E), selenium, co-enzyme Q.
* Patients on amlodipine, levothyroxine, low strength aspirin, warfarin, atorvastatin, insulin, oral hypoglycemic, chemotherapy (drug-drug interaction).
3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)

Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. This is a 3-week study that will test the safety and efficacy of this medication. Participants will receive either asenapine, olanzapine (a medication that is already approved for the treatment of bipolar mania), or placebo (no active medication). Participants will be required to stay in the hospital for at least the first seven days of treatment. Participants who complete the 3 week study may be eligible to continue in extension studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of bipolar I disorder, current episode manic or mixed.

Exclusion Criteria:

* Participants with unstable medical conditions or clinically significant laboratory abnormalities or participants who are rapid cyclers (i.e., have had 4 or more (including current) mood episodes in the past 12 months); have any other psychiatric disorder other than bipolar I disorder as a primary diagnosis.
The Added Value of Contrast Enhancement for Guiding EUS-FNA in Solid Pancreatic Masses

A prospective study designed to show the superiority of contrast guided echoendoscopy versus conventional echoendoscopy

A prospective study that compares the results using FNA contrast echoendoscopy versus standard FNA echoendoscopy in the diagnosis of solid pancreatic tumors

Eligibility Criteria:
Inclusion Criteria:

* solid pancreatic tumor lesions

Exclusion Criteria:

* severe coagulopathy of trombocytopenia \<50.000
* patients refuse for biopsy prelevation or pacient's refuse to participate in the study
Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness

Elevated systolic blood pressure is by far the largest single contributor to cardiovascular risks in middle-aged and older adults. Lifestyle modifications, including dietary modifications, are the first line approach for treating and preventing hypertension. The general aim of the proposed study is to address the efficacy of conventional dairy products as part of the normal routine diet for lowing arterial blood pressure in middle-aged and older adults with elevated blood pressure. The investigators hypothesize that the dietary intervention including dairy products will induce significant decreases in arterial blood pressure in this population. A secondary aim will be to test the hypothesis that these reductions in systolic blood pressure will be associated with increases in arterial stiffness/compliance and endothelial vasodilatory function.


Eligibility Criteria:
Inclusion Criteria:

* Prehypertension or stage-1 hypertension

Exclusion Criteria:

* Consume \> 3 servings of dairy or fruit per day
* Strenuous physical activity \> 3 time per week
* Lactose intolerance, pregnancy, lactation, and/or alcohol abuse
* Taking cardiovascular-acting drugs
* Overt cardiovascular disease, metabolic disease, GI disorders and/or renal disease
Yinhu Qingwen Granule in the Treatment of Viral Pneumonia

This is a non-randomized single arm clinical study to observe the effect of Yinhu Qingwen Granule in the relief of fever and improvement of related-symptoms of patients with viral pneumonia.

Preliminary pharmacodynamic and toxicological studies can show that Yinhu Qingwen Granule has a certain effect on pneumonia caused by various viruses, and its safety is good. This study aims to observe the effect of Yinhu Qingwen Granule in the relief of fever and improvement of related-symptoms of patients with viral pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of viral pneumonia;
* Clinical diagnosis of Shi-du-yun-jie Zheng (damp stagnation syndrome) according to Chinese medicine, including fever,cough,sore throat,stuffy chest,irritability and thirst,short yellow urine,constipation or loose stool,thick and greasy yellow coating,and slippery pulse;
* Chest CT showed signs of acute exudative pneumonia in the lungs;
* Over 18 years old, regardless of gender, voluntarily signed an informed consent form;
* Those who were hospitalized and were accompanied by fever (body temperature ≥37.3℃) and respiratory tract symptoms like cough or dyspnea, when they were enrolled.

Exclusion Criteria:

* Patients that are susceptible to sensitivity or known to be allergic to the study drug;
* Patients whose white blood cell count ≥12×10\^9 or neutrophil percentage ≥80%;
* Patients whose weight is less than 40 kg;
* Patients with respiratory failure or need mechanical ventilation;
* Patients with shock;
* Patients required to be in ICU monitoring and treatment;
* Patients participated in other clinical trials within 1 month;
* Patients with known renal impairment;
* Patients with any of the following laboratory parameter abnormalities during the screening period or within 24 hours before screening: ALT or AST level\> 5 times the upper limit of normal range (ULN) or-ALT or AST level \> 3 times ULN and total bilirubin level\> 2 times ULN;
* Patients with immune system diseases and long-term use of immunosuppressive agents;
* Pregnant or breastfeeding women, or who have a positive pregnancy test during the screening period, or plan to become pregnant within 3 months after the study treatment.
Α Prospective Observational Study for the Evaluation of Disease Control and Quality of Life in Patients With Benign PROStatic hyPERplasia Under Fixed Dose combΙnaTion Treatment With Dutasteride and Tamsulosin . PROSPERITY Group of Studies (I&II)

Investigation of the efficacy and safety of the stable combination of dutasteride and tamsulosin (Dinaplex®) in the Greek population as well as the evaluation of the quality of life of patients with benign prostatic hyperplasia (BPH) in treatment with a stable combination of dutasteride and tamsulosin (Dinaplex®)

Combination therapy with the 5-α reductase inhibitor, dutasteride, and the α-blocker, tamsulosin, in men with moderate to severe benign prostatic hyperplasia and prostate enlargement, was studied in the Combination of Avodart ™ and Tamsulosin (CombAT) which was a four-year, global, multicenter, randomized, double-blind, parallel design (3 arms) study. The aim of the study was to investigate the benefits of combination therapy (dutasteride-tamsulosin) compared to monotherapy in terms of improvement of symptoms and long-term results (AUR and surgery), in men with moderate to severe BPH. The primary endpoint in the two years since the start of the study was the change in the IPSS score, while the primary endpoint, after four years of treatment, was the time until the long-term results manifested (i.e. AUR or CF surgery) as well as the percentage of participants who were led to them. Patients were at least 50 years old with a prostate tumor ≥30 cm3 and a PSA level ≥ 1.5 ng / mL. 4838 men (39) participated in this study.

Eligibility Criteria:
Inclusion Criteria:

* Adult male patient with moderate to severe BPH symptoms receiving either monotherapy, dual medication as monoproducts or other stable combination and not responding adequately to treatment.
* Adult male patient with BPH who has fully understood the study procedures and has signed a consent form after information.

Exclusion Criteria:

* Patient who does not meet the criteria for taking the study drug (s), according to the Summary of Product Characteristics of each drug in the study.
A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies

The main goal of this study is to evaluate the efficacy of roxadustat for treatment of anemia in participants with non-myeloid malignancies receiving multi-cycle treatments of myelosuppressive chemotherapy.

Participants who are eligible for participation will be randomized to roxadustat and SEPO® (recombinant human erythropoietin-α \[rHuEPO-α\]), and undergo a 12-week treatment period followed by a 4-week follow-up period.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of non-myeloid malignancy, by histological or cytological confirmation.
* Anemia related to myelosuppressive chemotherapy, defined as Hb ≤100 g/L at screening with documented participant's Hb level decrease ≥10 g/L after the initiation of chemotherapy as judged by the investigator.
* Planned concurrent treatment of cancer (myelosuppressive chemotherapy) for at least 8 additional weeks.
* Body weight ≥40 kg.
* Eastern Cooperative Oncology Group (ECOG) performance status of 1 or 2.
* Ferritin ≥50 nanograms (ng)/milliliter (mL) and transferrin saturation (TSAT) ≥10%.

Key Exclusion Criteria:

* Participants with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
* Participants who are only receiving hormonal products, biological products, novel immunosuppressive products (such as programmed cell death protein-1 \[PD-1\] and programmed death-ligand 1 \[PD-L1\] checkpoint inhibitors) or targeted biological or radiation therapy to treat/manage their cancer, however if chemotherapy is co-administered with these products, then it is acceptable to enroll the participant.
* Participants with hematocrit (HCT) ≥36%.
* Participants who have received an RBC transfusion or ESA within 4 weeks of randomization.
* Thromboembolic event (including but not limited to deep vein thrombosis \[DVT\], pulmonary embolism, myocardial infarction, stroke, transient ischemic attack \[TIA\] within previous 6 months of screening.
* Clinically significant anemia due to other etiologies such as iron deficiency, vitamin B12 or folate deficiency, autoimmune anemia, hemolysis, hemorrhage, or hereditary anemia such as sickle cell anemia or thalassemia.
* The Investigator judges that the participant will be unable to fully participate in the study and complete it for any reason, including inability to comply with study procedures and treatment, addiction, or any other relevant medical conditions.

Note: Other inclusion and exclusion criteria may apply.
Plaque Removal Effectiveness of a Flossing Device Compared to the Conventional Flossing in Adults

* Objective: To evaluate the effectiveness in plaque removal of the new device; Dental floss holders and compare the results to the conventional way of flossing.
* Methods: Thirty adult male and female participants participated in this randomized, single-use, single-blind clinical study. Participants were randomly assigned to one of two groups; Group A: Consists of 30 participants in whom Dental Floss Holders (DFH) was constructed to either maxillary or mandibular arch randomly. Group B: Consists of 30 participants in whom conventional flossing (CF) was done to the other arch.

Participants attended the first visit for primary impression taking in order to construct the DFH. In the second visit, participants were examined by a blinded examiner to record their plaque index using O'Leary index. Then, they flossed using DFH and CF according to the group they were assigned to. Participants were monitored to ensure proper coverage of all the areas following precise instructions. They then brushed their teeth for approximately 2 minutes using modified bass technique. Next, plaque index was recorded again using the O'leary index. Time was recorded during flossing of each arch. Finally, participants were given a questionnaire to assess their satisfaction of the device.

* Results: The differences between the groups showed the DFH group with a 62.8% reduction in whole mouth plaque and 63.3% for proximal plaque compared to 52.9% and 50.4% for the CF group, respectively (p = 0.01). The DFH was more time efficient in removing plaque from the marginal regions with an average time of 00:00:37 in comparison to the CF which averaged in 00:02:07 (p \< 0.001). A total of 26 participants (86.7%) preferred using the DFH over the CF.
* Conclusion: With the combination of toothbrushing, the Dental Floss Holders is significantly more effective and time efficient than conventional flossing in removing plaque from tooth surfaces.


Eligibility Criteria:
1. Able to understand, read, and write in Arabic or English and provide written informed consent prior to participation.
2. Not engaged in any other clinical study during the day of examination.
3. Non-smoker and in good general health.
4. Does not have any systemic disease that influences the oral tissue (e.g., diabetes, autoimmune disease, medication/antibiotics).
5. Fully dentate (not including 3rd molars) with established proximal contacts.
6. Good oral health with no hard or soft tissue lesions, no gross caries, no probing depths greater than 4 mm, no obvious advanced periodontal disease, no fixed orthodontic appliances, nor removable partial dentures.
7. Does not have any dexterity limitation.
8. Not pregnant at the time of the study.
Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

The purpose of this study is to determine if giving an experimental drug called venetoclax in combination with lenalidomide and rituximab is safe and effective for treating people with Mantle Cell Lymphoma (MCL).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Diagnosis of mantle cell lymphoma (MCL) established by histologic assessment
* Laboratory, radiographic, physical exam findings and/or symptoms attributable to MCL
* ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death) less or equal to 2
* All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program
* Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
* Men and Women of childbearing potential on appropriate contraception
* Adequate organ function
* Ability to understand and the willingness to sign a written informed consent.
* Ability to swallow oral capsules/tablets

Exclusion Criteria:

* Prior treatment for MCL with chemotherapy
* Pregnant or breastfeeding women
* Grade 2 or higher peripheral neuropathy
* Known history of CNS (Central Nervous System) or leptomeningeal by MCL prior to study enrollment
* Significant cardiovascular disease
* Any condition that might significantly impair drug absorption as determined by the investigator
* Uncontrolled active systemic fungal, bacterial, viral, or other infection, or intravenous anti-infective treatment within 2 weeks before first dose of study drug
* History of stroke or intracranial hemorrhage within 6 months of 1st dose of study drug
* Concurrent participation in another clinical trial
* Subject has received a moderate or strong CYP3A inhibitor or inducer within 1 week prior to treatment initiation.
* Psychiatric illness or social situations that would limit compliance with study requirements
* Subject has known positivity to HIV
* Active infection with Hepatitis B or C virus as determined by a detectable viral load on PCR.
* Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to\< 2 years.
Neonatal Brain Waves After Electrocoagulation

Electrocoagulation effect of neonatal brain waves after cesarean section

Electrocoagulation is used for bleeding control on usual basis in cesarean sections and other surgical procedures .

We are planning to test the effect of electrocoagulation unipolar on neonatal brain waves compared with neonates that were exposed to bipolar electrocoagulation .Bipolar electrocoagulation should have les of an effect because of it coagulates in a close ,closed electrical cycle .

Eligibility Criteria:
Inclusion Criteria:

* term normal newborn after normal pregnancy after elective cesarean section

Exclusion Criteria:

* any fetal or neonatal disease or condition that may affect brain waves
Plasma Exchange and Continuous Hemodiafiltration in Treatment of Wilson's Disease-related Liver Failure

This study is to investigate the clinical efficacy of artificial liver support system using combination of plasma exchange and continuous hemodiafiltration in treatment of Wilson's Disease - related liver failure. 30 patients will receive treatment of plasma exchange and continuous hemodiafiltration and internal medicine. 30 patients will receive treatment of internal medicine.

Wilson's disease (WD) is an inherited disorder in which defective biliary excretion of copper leads to its accumulation, particularly in liver and brain. Presenting symptoms of liver disease can be highly variable, ranging from asymptomatic, with only biochemical abnormalities, to overt cirrhosis with all its complications. Acute liver failure (ALF) presentation is the most dramatic and may arise with catastrophic suddenness. It is considered rare, constituting only 3% of ALF cases in the pediatric ALF series in USA and associated with a high mortality reaching 95%. Patients with acute liver failure due to WD require liver transplantation, which is lifesaving. Kido J et al reported clinical outcomes of patients with liver failure were improved by artificial liver support system using combination of plasma exchange and continuous hemodiafiltration. So the investigators design this protocol: 30 patients will receive treatment of plasma exchange and continuous hemodiafiltration and internal medicine, 30 patients will receive treatment of internal medicine.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Wilson Disease: serum ceruloplasmin \< 0.2g/L, 24 hours urinary copper \> 40μg, Kayser-Fleischer ring present;
2. Do not receive drugs to promote the excretion of copper ever before;
3. Serum total bilirubin \> 10 times upper limit of normal, prothrombin time activity \< 40% or prothrombin time international ratio \> 1.5.

Exclusion Criteria:

1. Other active liver diseases;
2. Hepatocellular carcinoma or other malignancy;
3. Pregnancy or lactation;
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases;
6. Other important organ dysfunctions.