cyrilzakka/clinical-trials huggingface dataset:
Knowledge, and Practice of Helicobacter Pylori Infection

Helicobacter Pylori infection is very common in Our community However, it may be misdiagnosed and treated from the start until the patient present with complications. Therefore, it is essential that primary care physicians have the appropriate knowledge for making adequate decisions and preventing incorrect practices that result in elevated costs and absolutely no health benefits for the population. So this study aims to evaluate the knowledge and practice of primary healthcare physicians at Sohag health care units concerning H. Pylori infection.

The most common cause of chronic gastritis is Helicobacter pylori, which can also cause serious gastroduodenal diseases in some patients. These include gastric cancer, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, and gastric and duodenal peptic ulcer disease (PUD). Strong correlations have been shown between H. pylori and a number of extra-gastric illnesses, including vitamin B12 deficiency, idiopathic thrombocytopenic purpura, and unexplained iron-deficiency anemia. Identifying and eliminating H. pylori in people suffering from these conditions is also advised. Furthermore, neurological disorders, cardiovascular disorders, hepatobiliary disorders and autoimmune disorders may be associated with H. pylori infection. Age, ethnicity, degree of hygiene, and social and economic circumstances are risk factors for H. pylori infection An elevated prevalence of gastrointestinal diseases or symptoms (for example, dyspeptic symptoms) in populations where H. pylori infection is high, implies that a large number of subjects receive primary health care.Therefore, it is essential that primary care physicians have the appropriate knowledge for making adequate decisions and preventing incorrect practices that result in elevated costs and absolutely no health benefits for the population.

Since day-to-day clinical practice demonstrates that many healthcare disciplines surprisingly deal with H. pylori infection in the absence of local guidelines on this matter, there has been no study conducted in Sohag Governate evaluated knowledge, practice and attitude about H. pylori among healthcare physicians as of the time I conducted this survey.

Eligibility Criteria:
Inclusion Criteria:

* physicians at primary healthcare units in Sohag governorate

Exclusion Criteria:

* Nonmedical personnel
* GIT specialists
* physicians at secondary or tertiary healthcare centers
Effectiveness of Manual Therapy in Non-specific Low Back Pain

Low back pain affects many people and involves high medical costs. For this reason, we wish to test the efficacy of dry needling VS ischaemic compression in patients with non-specific low back pain. To this end, an investigation was carried out on 40 patients diagnosed with this ailment, divided into two groups by randomisation to assess the intensity of pain, range of movement, pain threshold to pressure and quality of life, measuring these variables prior to the intervention, immediately, at 48 hours and one week after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form.
* Presence of non-specific low back pain for more than six weeks.
* Presence of a palpable tight band nodule in the gluteus medius muscle.
* Presence of a hypersensitive or hyperirritable point in the tight band.
* Patients reporting local or referred pain in the area of the latent MGP after mechanical stimulation mechanical stimulation.

Exclusion Criteria:

* Surgeries in the lumbopelvic region.
* Diagnosis of herniated discs in the lumbar region.
* Positive cognitive screening according to the Pfeiffer questionnaire.
* Heterometrics.
* Age outside the range of 18 to 75 years.
* Ingested or injected anticoagulant or antiplatelet drugs.
* Systemic or local infection in the lumbar region.
* Pregnancy.
* Presence of fear of needles (belonephobia).
Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage

The aim of this study is to compare the effect of pre-procedural ketorolac to ibuprofen on immediate post-procedural pain scores in patients undergoing first trimester suction curettage with local anesthesia only.

Our primary hypothesis is that IM ketorolac compared to oral ibuprofen will result in an approximate 30% reduction in pain scores on a 21-point numerical rating scale immediately after the procedure.

Secondary hypotheses include:

* Pain scores on the 21-point scale will also be significantly lower in the ketorolac group immediately after cervical dilation and 15 minutes post-procedure.
* Fewer patients in the ketorolac group will rate their pain as "severe" on a subjective pain rating scale.
* Patients in the ketorolac group will be more satisfied with their pain control.
* Side effects will be similar between groups.


Eligibility Criteria:
Inclusion Criteria:

* Women age 18 or older seeking suction curettage at Planned Parenthood League of Massachusetts (PPLM)
* Gestational age less than or equal to 11+6, confirmed by ultrasound
* Eligible for suction curettage according to PPLM protocols
* Choice of local anesthesia

Exclusion Criteria:

* Choice of IV sedation for pain control
* Hypersensitivity to NSAIDs or lidocaine
* Contraindications to NSAIDs:

Active renal disease Active hepatic disease Gastric ulcer disease or gastritis Long-term NSAID or aspirin use Bleeding disorder

* NSAIDs taken \< 8 hours prior to procedure
* Need for cervical ripening with either misoprostol or mechanical priming agent (laminaria/Dilapan)
* Long-term narcotic use
* Unable or unwilling to complete required study procedures
* Previous participation in the study
Feasibility of Non-pharmacological Insomnia Therapy in People Living With HIV

To establish with a prospective randomized placebo-controlled study the feasibility of allied-health personnel-administered cognitive behavioral insomnia therapy (CBTI) as a means of improving HIV/AIDS treatment adherence.


Eligibility Criteria:
Inclusion Criteria:

* provide documentation of HIV seropositivity, and have been on current HAART (Highly Active AntiRetroviral Therapy) or antiretroviral regimen without any foreseeable reason to discontinue the HAART during the course of the study;
* males or females age 18-75 years of age;
* ≥3 month history of insomnia meeting standard psychiatric criteria for insomnia based on DSISD;
* sleep onset latency (SOL) and/or wake after sleep onset (WASO) greater than 30 minutes, with a corresponding sleep time of less than 6.5 hours at least 3 nights per week (as measured by the 7-day sleep diary);
* be able to read, understand, and sign an informed consent form before entering into the study and must be willing to comply with all study procedures as well as to agree to participate for the entire study period.

Exclusion Criteria:

* use of any medication with a significant effect on sleep/wake function within 5 half-lives of baseline or during the study including hypnotics, over-the-counter sleep aides, sedating antidepressants or sedating anxiolytics;
* history or DSISD (Duke Insomnia Sleep Diagnostics) suggests sleep disorder other than insomnia (e.g., sleep apnea, narcolepsy, periodic leg movements, etc.), or have insomnia associated with circadian rhythm disturbances, such as night or rotating shift work or travel across more than four time zones in the 14 days before Initial Screening (Visit 1) or during the study;
* clinically significant unstable medical or psychiatric condition, or have any clinically significant abnormal finding in physical examination, neurological assessment, or vital signs, as determined by the Investigator;
* self reports typical consumption of more than five alcoholic beverages on a single day or greater than 14 alcoholic beverages weekly at Initial Screening (Visit 1);
* have used any investigational drug within 30 days or five half-lives (whichever is longer) prior to Initial Screening (Visit 1), or plans to use an investigational drug during the study;
* unable to give informed consent or comply with study procedures.
Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair

The study aims to establish whether one month postoperative immobilization compared early passive motion after rotator cuff arthroscopic repair in small or medium ruptures with double row technique has any healing significance.


Eligibility Criteria:
Inclusion Criteria:

* Patients skeletally mature (older 18 years old)
* Small or medium rupture of rotator cuff
* Repaired with arthroscopic double row technique

Exclusion Criteria:

* Impossibility to perform MRI (claustrophobic, pacemaker, heart or brain metallic implants)
* AC arthritis with mumford procedure
* Smokers
* Diabetes
* Postoperative complication (severe pain, thrombosis, infection)
* Psychiatric disorder
Craving to Biologics Used in Severe Asthma

Some patients treated with biologics for severe asthma experience a craving to the next biological administration. This phenomenon has never been described before. In this study, the researchers aim to further elucidate the feeling of needing the next administration of a biologic for severe asthma.

Recent research by Kroes and colleagues on omalizumab levels has shown that approximately half of patients on long-term omalizumab therapy (\>4 months) experience a subjective craving for the next dose. These patients had a need (Borg scale 3-10) for the next dose of biologic before the usual periodic dose, while other patients indicated that they had no or a low need (Borg scale 0-2) for the next dose at the usual dosing moment. This so-called 'craving' has not been described in the literature before. Patients in the high-requirement group had significantly lower median omalizumab trough levels than patients in the low-requirement group. There may be a relationship between blood levels of biologics and the need for the next dose. However, data is currently only available on the variability in serum trough levels of omalizumab, but not yet on the other biologics for asthma, some of which are administered as a fixed dose and some are dosed by body weight. No assays are currently available for blood level determinations from the other biologics.

Before investigating the relationship between blood levels and the need for biologics, it is important to fully map the 'craving'. Some patients who are responders to biologic therapy based on improvements in clinical outcomes still do not have good enough control of their asthma and indicate that the dosing interval is not optimal. In addition to patients that indicate a need for the next dose, there are also patients that would like a longer dosing interval. To date, dosing interval adjustments have been made based on the patient's subjective experience and the physician's clinical judgment. This study investigates how big the problem of need for the next dose is, how patients experience this need, what this need exactly entails, whether this occurs more often in patients treated for a longer period and what possible problems patients experience in the treatment with biologics against serious problems.

Eligibility Criteria:
Inclusion Criteria:

* Treated with a biologic for severe asthma in the Medical Centre Leeuwarden for more than 4 months

Exclusion Criteria:

* Not speaking Dutch
Clinical Study of HMPL-689 for Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma

A Multi-center, Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of HMPL-689 in Patients with Relapsed/Refractory Marginal Zone Lymphoma (MZL) and Follicular Lymphoma (FL)

This is a multi-center, single-arm, open-label clinical study to evaluate the oral therapy with HMPL-689 in patients with relapsed / refractory MZL and FL. Relapse / refractory is defined as such a situation when a patient has not achieved response (CR or PR) after the latest line of systemic treatment, or has disease progress (PD) or relapse after achieving response. Two (2) cohorts of patients will be enrolled in this study:

Cohort 1: approximately 81 patients with histologically confirmed MZL

Cohort 2: approximately 104 patients with histologically confirmed FL (pathological grade 1-3a)

All patients are to receive monotherapy of HMPL-689 30 mg once a day (QD) continuously in 28-day treatment cycles until PD / recurrence, patient death, intolerable toxicity, initiation of other antitumor therapy, the patient unable to further benefit from the study treatment as judged by the investigators, the patient or his/her legal representative's request to withdraw from the clinical study treatment, the patient lost to follow-up or end of the study, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years;
2. Patients with relapsed/refractory marginal zone lymphoma or follicular lymphoma
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-2;
4. At least one measurable lesion by computerised tomography (CT) / magnetic resonance imaging (MRI) (the longest diameter of nodal lesion \> 1.5 cm or extranodal lesion \> 1 cm);
5. Expected survival of more than 12 weeks;

Exclusion Criteria:

1. Having lymphoma with central nervous system (CNS) or cerebral pia mater invasion;
2. Known histologic transformation to aggressive lymphomas such as diffuse large B-cell lymphoma (DLBCL);
3. Prior use of any phosphatidylinositol 3-kinase (PI3K) inhibitor;
4. Inadequate organ function of liver and kidney;
5. Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV);
6. Having received systemic antitumor therapy or radiotherapy within 4 weeks prior to the first dose of the investigational product;
7. Toxicity of previous antitumor therapy not recovered to CTCAE grade ≤ 1, except alopecia, prior to the first dose of the investigational product;
8. Complicated with uncontrolled systemic infection requiring intravenous antibiotic treatment;
9. Pregnant (positive serum pregnancy test) or lactating women;
10. Any other disease, metabolic abnormality, physical examination abnormality or clinically significant laboratory test abnormality, one disease or state providing a reason to suspect that the subject is not suitable for HMPL-689 at the investigator's discretion, or one condition that will affect interpretation of the study results or bring the subject at high risk.
Testing Palbociclib (PD-0332991) as a Potential Targeted Treatment in Cancers With CCND1, 2, 3 Amplification (MATCH-Subprotocol Z1B)

This phase II MATCH treatment trial identifies the effects of palbociclib in patients whose cancer has genetic changes called CCND1, 2, or 3 amplification. Palbociclib blocks proteins called CDK4 and CDK6, which may stop cancer cell growth when CCND1, 2, or 3 amplifications are present. Researchers hope to learn if palbociclib will shrink this type of cancer or stop its growth.

PRIMARY OBJECTIVE:

I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.

SECONDARY OBJECTIVES:

I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma.

II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms.

IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens.

OUTLINE:

Patients receive palbociclib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months if less than 2 years from study entry, and then every 6 months for year 3 from study entry.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol
* Patients must have amplification of CCND1, 2, or 3, or another aberration, as determined via the MATCH Master Protocol
* Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)

Exclusion Criteria:

* Patients must not have known hypersensitivity to palbociclib or compounds of similar chemical or biologic composition
* Patients must not have breast cancer, mantle cell lymphoma or myeloma
* Patients with known or symptoms of left ventricular dysfunction will be excluded
* Patients must not have had prior treatment with palbociclib, ribociclib, abemaciclib or any other CDK4/6 inhibitors
* Patients must not be using drugs or foods that are known potent CYP3A4 inhibitors or inducers, or are CYP3A4 substrates with narrow therapeutic indices
Prevention of New Onset AF After TAVI (PAF-TAVI Trial)

New onset atrial fibrillation (NOAF) is a relatively frequent complication after transcatheter aortic valve implantation (TAVI). This complication has been related with worse short and long-term outcomes, including higher stroke, mortality, readmission and bleeding rates. The aim of this study is to evaluate the effectiveness of amiodarone in the prevention of the NOAF after TAVI.

The study is a multicenter, randomized double-blinded trial including 120 patients without prior AF that will undergo TAVI in a scheduled basis. Patients will be randomized to be treated with amiodarone orally from 6 days before to 6 days after the TAVI procedure versus placebo.

All the patients will be monitored with a 60-day holter to evaluate NOAF incidence. The main objective is NOAF incidence after TAVI at 30-day. Secondary endpoints are the incidence of NOAF, stroke, bleeding and all-cause and cardiovascular mortality in both groups at 60-day. Results of this study can contribute to optimize TAVI results in a short and long term, potentially improving the survival and quality of life in this group of frail patients with comorbidities, which makes them vulnerable to NOAF, stroke, bleeding, heart failure and readmission.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years old. Women of childbearing age must commit to the use of contraceptive methods of assured efficacy.
* Patients that will undergo TAVI due to aortic stenosis.
* Sinus rhythm showed by an ECG during 72 hours previous to the inclusion in the study.

Exclusion Criteria:

* Pregnancy or lactation. Women of childbearing age who do not have a negative pregnancy test.
* Paroxysmal persistent or persistent AF (documented record in electrocardiogram or ECG holter)
* Congestive heart failure with functional class NYHA IV despite optimal medical treatment.
* Sustained hypotension (TAS \< 80mmHg)
* Severe mitral stenosis or regurgitation
* Treatment with antiarrhythmic drugs (amiodarone included) 3 months before the procedure, treatment with beta-blockers or dihydropyrimidine calcium channel blockers are not considered an exclusion criteria.
* Sinus bradycardia (\< 50 lpm), PR interval \>240 mseg or second or third degree AV block.
* QT interval longer than 480 msec in an EKG performed in 72 hours before the inclusion, without a permanent pacemaker.
* Clinical hypo- or hyperthyroidism, clinical or subclinical autoimmune thyroid disease, or multinodular goiter.
* Allergy or adverse reaction known or suspected to the amiodarone.
* Denial of the patient or inability to give informed consent.
* Hypersensitivity to iodo
* Concomitant drugs that, in association with amiodarone, can induce torsades de pointes
Determinants of Insulin-induced Weight Gain in Type 2 Diabetes Mellitus

The purpose of this study is to find determinants of insulin-induced weight gain in type 2 diabetes mellitus

Primary objective: To find an association between weight gain after start of insulin therapy and physical activity levels.

Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2 diabetes mellitus (T2DM), but often at the expense of weight gain. Insulin-induced weight gain is obviously undesirable in an already overweight population and may negatively affect blood pressure, lipid levels, inflammatory and fibrinolytic parameters, adipocytokines and also deter further optimization of insulin therapy. It is unknown what determinants predict insulin-induced weight gain in type 2 diabetes mellitus.

The aim of this study therefore, is to assess determinants of insulin-induced weight gain in type 2 diabetes mellitus. In a retrospective and cross-sectional study (Jansen HJ et al., submitted) two extreme subgroups were identified (subjects with a weight gain above 80th percentile) and subgroup non-weight gainers (subjects with a weight gain below the 20th percentile). It was found that the gainers had less energy expenditure after initiation of insulin therapy than non-weight gainers. Therefore, the primary aim of this study is to detect an association between energy expenditure and weight gain

Eligibility Criteria:
Inclusion Criteria:

* patients with type 2 diabetes mellitus
* age 18-85 years
* Hba1c at baseline \< 12.0%
* written informed consent

Exclusion Criteria:

* Clinical evidence of psychiatric, renal, cardiovascular or liver or other diseases which may influence study results regarding glucose and weight
* Patients with hormonal disorders which may influence weight (i.e. thyroid diseases), even if properly treated with stable hormonal levels
* Excessive alcohol consumption (\>20 g/day), and drug abuse
* Use of thiazolidinedione derivatives (TZDs)
* Pregnancy or intention to become pregnant during the study