cyrilzakka/clinical-trials huggingface dataset:
A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Prolonged Fasting

The study will investigate the safety of once weekly insulin icodec subcutaenously (s.c.) during and after exercise and prolonged fasting in patients with type 2 diabetes (T2D). Participants will first receive insulin decludec (Tresiba®, a long-acting insulin taken once daily) for atleast one week. Afterwards participants will receive insulin icodec that will be administered once weekly at the study site (for a minimum of 7 weeks and maximum of 14 weeks). Insulin icodec is a novel long-acting insulin analogue for once-weekly administration for the treatment of type 2 diabetes. The study will last for about 16-30 weeks. Participant must not participate if participant have suspected hypersensitivity reactions to the study products or cardiovascular diseases within the last 180 days. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male or female.
* Age 18-75 years (both inclusive) at the time of signing the informed consent.
* Body mass index between 18.0 and 38.0 kilogram per meter\^2 (kg/m\^2) (both inclusive).
* Glycated hemoglobin (HbA1c) less than or equal to (\<=) 9 percent (75 millimoles per mole \[mmol/mol\]) at screening.
* Treated with basal insulin with or without any of the following anti-diabetic drugs/regimens with stable doses \>= 90 days prior to the day of screening:

  * Metformin,
  * Dipeptidyl peptidase 4 (DPP-4) inhibitors,
  * Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors
* Oral combination products (for the allowed individual oral antidiabetic drugs), Injectable and oral glucagon-like peptide 1 (GLP-1) Receptor Agonists.
* Physically active \>= 300 metabolic equivalent of task (MET) minutes/week as determined by an International Physical Activity Questionnaire (IPAQ) at screening.
* Mass-specific oxygen volume (VO2) peak greater than (\>) 25 milliliters per kilogram per minute (mL/kg/min) as determined by cardiopulmonary testing (CPX) test at screening.

Exclusion Criteria:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
* Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders within 180 days prior to the day of screening.
The Clinical Effect of Normal Diet and Absolute Diet on Post-polypectomy Patients: an Open-label, Randomized Controlled Trial

There is no evidence to prove the impact of post-procedural diet on post-polypectomy bleeding (PPB) or delayed perforation. No relevant study has been conducted and it is yet to be determined if absolute diet is necessary for post-polypectomy patients, and the comparison between normal diet and absolute diet also remains unclear. Therefore, we carried out this randomized controlled study to evaluate and compare tthe clinical effect of different diets on post-polypectomy patients.


Eligibility Criteria:
Inclusion Criteria:

1. 18-75 patient with initial diagnosis of colorectal polyp by colonoscopy;
2. The maximum size of polyp is more than 20mm;
3. The patients underwent single ESD procedure for the polyp and agreed to participate this trial.

Exclusion Criteria:

1. Uncontrollable hypertension or diabetes；
2. Severe comorbidities such as cancer and organ failure etc；
3. Patients who were pregnant;
4. Patients had anticoagulants during perioperative period;
5. Patients with poor compliance. -
A Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer

The purpose of this study is to evaluate the investigators ability to obtain reliable and meaningful 11C-Choline PET-CT images of esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed or recurrent patients with locally advanced esophageal cancer with either squamous or adenocarcinoma histology.
* Ability to tolerate PET imaging
* Prior malignancy is allowed, but the expectation of survival must be that beyond that expected for patients with locally advanced esophageal cancer.

Exclusion Criteria:

* Pregnant or lactating females are not eligible for this pilot study.
* Patients having received chemotherapy in the 3 months prior to registration for any reason
* Patients with metastatic disease requiring chemoradiation for palliation are not allowed.
Chest Compression Technique in Infants

Evaluate the effect of chest manual compression technique (CCT) in the variables of oxygenation, hemodynamic and respiratory work in infants with respiratory diseases that are associated with atelectasis.


Eligibility Criteria:
Inclusion Criteria:

Group A

* Infants (29 days to 24 months of age).
* After the legal representatives of the patients have read agreed and signed an informed consent
* Infants diagnosed with atelectasis by medical staff, with chest x-ray with opacification directors
* Respiratory disease

Group B (control group)

* Infants whose inpatient diagnosis has not been respiratory ailments that did not show any pain at the time of the evaluation.

For the control group followed the same evaluation criteria of group A.

Exclusion Criteria:

* Infants with respiratory disorders that don't have with atelectasis
* Infants who showed signs of irritability or intense crying at the time of evaluation
Dose Finding Study to Assess Octenidine Mouthwash Concentrations in Comparison to Placebo

The objective of this clinical trial is to identify the most efficacious octenidine dihydrochloride concentration regarding bacterial count reduction in comparison to a placebo in the oral cavity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild gingivitis (mean GI: 0.2 - 1.0)
* Patients with complete natural "Ramfjord-teeth" or their replacement teeth
* Caucasian
* Signed Informed Consent

Exclusion Criteria:

* Patients with severe systemic diseases (diabetes, hepatitis, HIV, tuberculosis, cancer)
* Patients who require endocarditis prophylaxis for dental examination and treatment
* Caries requiring treatment (e.g. caries with cavity) or other oral diseases (incl. gingival hyperplasia, diseases of the oral mucosa, periodontal screening index PSI \> 2)
* Patients with orthodontic appliances and removable dentures
* Patients treated with antibiotics less than 3 months prior to the baseline examination at V1 and/or such a treatment planned for the duration of the trial
* Patients chronically treated with steroids
* Patients who suffer from xerostomia
* Patients who regularly smoke more than 10 cigarettes per day
* Patients who have a known hypersensitivity or allergy to the test product and its ingredients or to medications that have a similar chemical structure
* Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial
* Incapability of assessing essence and possible consequences of the trial (e.g. alcoholism)
* Pregnant or breastfeeding women
* Women with childbearing potential except those who fulfill the following criteria:

  * Post-menopausal (12 month of natural amenorrhoea or 6 months of amenorrhoea with Serum FSH \> 40 U/ml)
  * Postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy)
  * Continuous and correct application of a contraception method with a Pearl Index \< 1% (e.g. implants, depots, oral contraceptives, intrauterine device - IUD)
Effect of Doxycycline in Levodopa Treated Parkinson's Disease Patients

This study is a Randomized, Double-Blind, Placebo-Controlled Trial. The objective of the study is to assess the effect of doxycycline in levodopa treated Parkinson's disease patients regarding motor performance and cognitive functions. Parkinson's disease patients on levodopa medications will be assigned to receive doxycycline 50mg twice daily or placebo over 8 weeks. The motor and cognitive symptoms of Parkinson's disease will be assessed after 4 weeks and 8 weeks follow up.

Parkinson's disease is a progressive neurodegenerative disorder that is caused by degeneration of dopaminergic neuron in the substantia nigra. Most commonly used drug, levodopa can improve the dopamine level in brain but cannot give neuroprotection and also induces motor fluctuations and dyskinesia in many patients. Doxycycline has been shown anti-inflammatory and neuroprotective effects against Parkinson's disease on animal model. It also reduced Levodopa induced dyskinesia without compromising the motor benefits of Levodopa. Therefore, the present study is to attempt to improve the sign symptoms of Parkinson's disease by giving doxycycline along with Levodopa.

This study is a Randomized, Double-Blind, Placebo-Controlled Trial and conducting at Department of Pharmacology, BSMMU in collaboration with Department of Neurology, BSMMU. A total of 60 patients suffering from Parkinson's disease is selected according to inclusion and exclusion criteria. The diagnosis of the patients suffering from Parkinson's disease will be performed by a neurologist at movement disorder clinic of department of Neurology, BSMMU. Patients will undergo MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) to assess the severity of the disease. The patients will be randomly allocated into two arms: control and intervention. Patients in intervention arm consisted of 30 patients who will receive levodopa plus doxycycline orally for 8 weeks. On the other hand, control arm consisted of 30 patients who will receive levodopa plus placebo for 8 weeks. The severity of Parkinson's disease will be assessed after 4 weeks and 8 weeks follow up.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Parkinson's disease patient taking Levodopa
* Age: More than 18 years
* Sex: All

Exclusion Criteria:

* Secondary causes of parkinsonism
* Atypical parkinsonian syndromes
* Prior stereotaxic surgery for Parkinson's disease
* Known hypersensitivity to doxycycline
* Pregnancy and lactation
* Suffering from active malignancy
Improving Health Awareness Using Social Network Interventions

The overarching hypothesis of our study is that social network interventions using artificial intelligence and social media can be used to increase population awareness about health issues. The overarching objective is to improve population awareness on multiple relevant health issues using social network interventions (SNI) and estimate the effect by conducting randomized control trials. Increase population awareness about organ donation in California, especially among minorities

The population of California will be stratified into demographic environments which are groups of ZIP Codes of similar cultural, socioeconomic, and ethnic/racial factors. Digital markers of population awareness about organ donation will be estimated from publicly available online conversations of users in social media. A clustered randomized control trial will be conducted and ZIP Codes from each demographic environment will be randomly assigned to control and intervention arms. Digital educational materials about organ donation will be exposed to online users in social media belonging to ZIP Codes assigned to the intervention arm.

Eligibility Criteria:
Inclusion Criteria:

* Have a California zip code.
* Be a Facebook user
Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks

The objective of this study is to evaluate the effectiveness of ketamine (infusion of 0.5mg/kg) and venlafaxine compared to the use of venlafaxine alone in the treatment of major depression (MADRS score ≥ 20 ) to six weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or over,
* Introducing a single depressive episode or recurrent unipolar
* Responding to the diagnosis of severe major depressive episode according to DSM IV (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition): MADRS score ≥ 20,
* absence of treatment with ketamine for analgesia or anesthesia during the last 6 months
* Affiliate (or beneficiary) to a social security system
* Informed consent signed

Exclusion Criteria:

* Contraindication to ketamine administration or treatment with venlafaxine;
* Failure of treatment with venlafaxine in the current episode (as low as 150 mg for 15 days);
* Axis I diagnosis according to DSM IV bipolar disorder (type I, II or III), schizoaffective disorder, schizophrenia, alcohol and other toxic or weaned for at least 6 months;
* Current Episode resistant stage V according to the classification of Thase and Rush (failed a course of bilateral ECT);
* Major depressive episode with severity criteria (significant risk of suicide is a MADRS score ≥ 5-SI; decubitus complications, intravenous hydration);
* episode currently being treated with fluoxetine;
* Patients hospitalized without their consent or measure of legal protection (guardianship, curatorship);
* Affection Organic likely to affect cognitive abilities and brain structures (eg, HIV, MS, lupus, Parkinson's disease, epilepsy, dementia ...) or decompensation;
* Pregnancy or breastfeeding underway.
Nitroprusside for Prevention of no-Reflow in Primary Angioplasty

In patients admitted with acute myocardial infarction, there is a total occlusion of a coronary artery. Even after emergency catheterization and angioplasty, in some patients, the resumed blood flow is suboptimal and impacts on heart function. The study is aimed at examining whether nitroprusside, an anti-hypertension medication, given directly into the coronary artery, can improve the blood flow after the removal of the obstruction that caused the infarction.

Inadequate myocardial tissue perfusion despite successful relief of the culprit occlusion and restoration of epicardial coronary flow for ST-segment elevation acute myocardial infarction (STEMI) results in poor outcome. The investigators hypothesized that nitroprusside (NTP) injected intracoronary immediately before angioplasty might prevent no-reflow and improve vessel flow and myocardial perfusion.

Eligibility Criteria:
Inclusion Criteria:

* Acute ST elevation myocardial infarction (MI) patients planned for primary PCI
* Diagnostic angiography demonstrating a TIMI flow grade \<3 in the coronary artery before the PCI

Exclusion Criteria:

* An admission electrocardiogram (ECG) showing complete left bundle branch block or a paced rhythm
* Systolic blood pressure \< 90 mmHg
* A history of coronary bypass operation
* A known allergic reaction to nitroprusside
* Chronic hemodialysis
* Intravenous drug abuse
* Pregnancy
* Rescue intervention after failed thrombolysis
* Contraindications to aspirin or clopidogrel
* Need for emergent coronary artery bypass surgery
* Inability to provide informed consent
Data on the Impact of Different Treatment on the Quality of Life of Patients With Acute and Chronic Hemorrhoid Disease

The program is aimed at obtaining data on the impact of the method and type of treatment on the quality of life of patients with acute or chronic hemorrhoids with option of conservative treatment with Detralex

Changes in the quality of life of patients suffering from acute or chronic hemorrhoids within 1 month after presenting to a doctor, in general population and in specific demographic and clinical groups.

The program included patients who presented to a doctor for acute or chronic hemorrhoids. All the treatment was fully compliant with the conventional clinical practice, instructions for medical use of drugs and a specific clinical situation. The standard parameters usually evaluated in patients with hemorrhoids were studied during the program. In addition, at the first visit to the doctor and at the end of the study, the patient filled out an SF-36 questionnaire for assessing the QoL

The general population of patients included in the program, the following three groups of patients were considered:

* Group 1, with only conservative (medical) therapy during the study;
* Group 2, with conservative (medical) therapy and additional minimally invasive procedure during the study (no surgery);
* Group 3, with conservative (medical) therapy and additional surgery for hemorrhoids during the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years;
2. Providing written information to a patient about inclusion in the program, and his/her consent to participate in it,
3. Absence of conditions requiring urgent medical care and not related to hemorrhoids;
4. The patient was diagnosed with:

   * Acute hemorrhoids;
   * Exacerbation of chronic hemorrhoids;
   * Chronic hemorrhoids

Exclusion Criteria:

1. The patient is consulting for an urgent issue not related to hemorrhoids;
2. The presence of severe systemic diseases;
3. Pregnancy;
4. Inability to understand the meaning of the Program and follow the doctor's recommendations
5. Patients with inflammatory bowel diseases
6. Patients with concomitant diseases of the anal canal
7. Patients taking anticoagulants;
8. Patients with previous anorectal surgeries, including hemorrhoidectomy or excision of anal fistula.
TAE and Surgery in Patients With Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy

The aim of the study is to compare the outcomes of trans-catheter arterial embolization (TAE) and surgery as salvage therapy of peptic ulcer bleeding after failed endoscopic therapy.

The aim of the study is to examine the hypothesis that trans-catheter arterial embolization (TAE) is safer than and probably as effective as surgery in the control of bleeding from ulcers after failed endoscopic therapy. Patients with major arterial bleeding that cannot be stopped by endoscopic therapy will be randomly assigned to receive immediate TAE or surgery. Primary outcome will be death within 30 days of randomization. Secondary outcomes include recurrent bleeding after assigned treatment, need for additional intervention either in the form of interventional radiology or surgery, and post procedural morbidities.

Eligibility Criteria:
Inclusion Criteria:

* Patients with bleeding peptic ulcers documented during endoscopic therapy AND anyone of the following:
* Forrest I bleeding that fails to be controlled by therapy during first endoscopy
* Check endoscopy after clinical re-bleeding of Forrest I bleeding
* Forrest IIa or an initial IIb but a sizable artery unveiled upon clot elevation in a high risk ulcer defined by:
* posterior bulbar duodenal ulcer \> 2cm, or
* an angular notch / lesser curve gastric ulcer \> 5cm that fail an attempt at endoscopic therapy together with evidence of a significant bleed (hypotension with SBP \< 90mmHg, fresh hematemesis or hematochezia).

Exclusion Criteria:

* Refusal to participate in trial
* No consent
* Age \< 18
* Pregnancy
* Moribund patients
* Patients with terminal malignancy
Identifying Cancer Genes in in Blood and Bone Marrow Samples From Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify genes related to cancer. It may also help doctors diagnose cancer and predict how patients will respond to treatment.

PURPOSE: This research study is identifying cancer-related genes in blood and/or bone marrow samples from patients with acute myeloid leukemia.

OBJECTIVES:

* To identify and validate individual genes for diagnosis of three major translocations in acute myeloid leukemia.
* To correlate transcript expression data in the various translocations with age, sex, race, response to treatment, and survival and with other known mutations.

OUTLINE: Blood and/or bone marrow samples previously procured from patients on CALGB-9665 are obtained from the CALGB Leukemia Tissue Bank from patients enrolled on CALGB AML treatment studies. Mononuclear cells are isolated from samples and mRNA is extracted. Gene expression profiles are analyzed via custom mRNA microarray and confirmed by quantitative real-time PCR.

Eligibility Criteria:
* Enrolled on CALGB acute myeloid leukemia (AML) treatment studies AND concurrently enrolled on Leukemia Tissue Bank Protocol CALGB-9665
* Short-term or long-term survivor
* Bone marrow and/or peripheral blood obtained at diagnosis
* Leukemia is one of the following cytogenetic subtypes:

  * t(8;21)
  * t(15;17)
  * inv(16)
Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)

Multicenter randomized clinical trial with two arms in patients hospitalized for an AMI nested in the Frenchie registry. Periodontal therapy is performed by periodontists in the intervention group versus treatment by dental surgeons as part of their usual practice in the control group.

For the intervention group, periodontal management will be carried out for a maximum of 6 months after randomisation, prolonged by a follow-up of 6 months including a maintenance visit at M9.

All patients will have an FDG-PET at M0 and M12 for evaluation of inflammation on carotid atherosclerotic plaques.

Eligible adults 30 to 70 years old hospitalized for an MI, (cf inclusion and non-inclusion criteria), will be asked to participate in the study. (screening)

At M0 :

* patients will be examined by a periodontist for assessing the severity of periodontitis (standard oral examination including a periodontal screening test).
* Patients with severe periodontitis will then receive: Complete periodontal examination of all teeth (6 sites per tooth) including pocket depth measurement, measurement of gingival recession, plaque index, gingival bleeding index, and a gingival fluid sample. Patients will then be informed of their periodontal status and therapeutic options. At this point, the patient may decide not to follow the treatment and will not be randomized.
* Patients who agree to continue the study will have a venous blood sample and a PET-FDG examination. Patients in whom the acquisition of FDG-PET is impossible will not be randomized.

At the end of these examinations, if all the conditions are met, the randomization will be carried out :

* Intervention group: Periodontal treatment, for a maximum of 6 months. At the end of the periodontal treatment, a follow-up of at least 6 months, including a maintenance visit to M9, will be performed.
* Control group: patients will be referred to their treating dentist for usual care.

At M12 (+12 months) : All patients (intervention group and control group) will have the same tests as M0

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized for an acute myocardial infarction and included in the Frenchie registry
* Score ≥ 5 on the screening questionnaire for periodontitis
* Six teeth at least (excluding wisdom teeth)
* Consent signature
* Affiliation to a French medical insurance (Sécurité Sociale)

Exclusion Criteria:

* Patients with diseases,other than cardiovascular and diabetes, known to change the periodontal state such as AIDS, rheumatoid arthritis, Chediak-Higashi syndrome, Papillon-Lefèvre
* Systemic antibiotic therapy\> 48 hours in the 3 months prior to inclusion
* Acute heart failure
* Uncontrolled ventricular rhythm disorders
* Impossibility for the patient to attend follow-up visits
* Impossibility to maintain the extended position for 20 minutes
* Immunosuppressive therapy\> 1 month in the 6 months prior to inclusion
* Pregnancy, breastfeeding
* Known hypersensitivity to chlorhexidine, povidone, 18-fluoro-deoxyglucose